Accuniq BP800 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.
29, Gongdan 4-ro, Jillyang-eup, Gyeongsan-si, Gyeongsangbuk-do, 38470
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. OVER VIEW ······························································································· 4
2. WORD DEFINITION ··························································································
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3. CLASSIFICATION AND COMPLIANCE ·································································
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4. SAFETY PRECAUTIONS ··················································································· 6
5. SAFETY SYMBOLS AND INFORMATION ······························································
8
6. GUIDANCE FOR ELECTROMAGNETIC COMPATIBILITY (EMC) ······························ 9
• TERMS OF EACH PART AND FUNCTION ·····························································
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1. DISPLAY ·········································································································
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2. FRONT AND REAR PART ···················································································
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3. SIDE PART ······································································································
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4. ACCESSORIES ································································································
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5. OPTIONS ········································································································
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• INSTALLATION ····································································································
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1. HOW TO PUT BATTERY·····················································································
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2. HOW TO CONNECT COMMUNICATION PORT······················································ 18
3. SETTING ·········································································································
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• MEASUREMENT ··································································································
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1. WRAPPING THE CUFF ······················································································
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2. MEASUREMENT PREPARATION ········································································
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3. MEASUREMENT ······························································································
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4. MEASUREMENT RESULT ··················································································
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• STORAGE AND MAINTENANCE ··········································································
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• SAFETY PRECAUTION ························································································
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• TROUBLE SHOOTING ·························································································
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1. MEASUREMENT ERROR AND SOLUTION ···························································· 29
2. TROUBLE SHOOTING ························································································
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3. AFTER SERVICE ································································································
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4. PACKING AND TRANSPORT ················································································
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• SPECIFICATION ··································································································
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• WARRANTY and REPAIR····················································································· 33
CONTENTS

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1. OVER VIEW
The ACCUNIQ BP800 is a compact, non-invasive Ambulatory Blood Pressure Monitoring
(ABPM) system. The appropriate use is 24-hour blood pressure monitoring and pulse wave
analysis (PWA). The ACCUNIQ BP800 should be used only under medical supervision.
INDICATION FOR USE
The ACCUNIQ BP800 Ambulatory Blood Pressure Monitor is designed to measure systolic and
diastolic blood pressure and pulse rate of adults who are eighteen (18) years and older using the
oscillometric method on a cuffed arm.
INCORRECT USE
-----------------------------------------------------------------------------------------------------------------------------
Because of the risk of strangulation from the tube and cuff, the ACCUNIQ BP800 may not be
used for patients who are legally incompetent.
The ACCUNIQ BP800 must not be used for blood pressure monitoring during surgeries. It
has not been designed for alarm-giving monitoring in intensive care units.
It is not recommended for people with serious arrhythmia to use this Wireless Blood Pressure
Monitor.
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PROPER USE OF THE ACCUNIQ BP800
1. The ACCUNIQ BP800 ABPM is intended for use by a trained medical practitioner. Interpretation of
blood pressure measurements should always be performed by a physician.
2. The reliability of the monitor and the software depend upon conformance with the operation and
maintenance instructions in this manual.
3. The ACCUNIQ BP800 ABPM is designed for use with patients with normal sinus rhythms.
4. Measurement accuracy for the ACCUNIQ BP800 ABPM may be affected by position of the subject,
physical conditions, movement, and use outside of the operating instructions contained in this
manual.
USER RESPONSIBILITY
This product is designed to perform in conformity with the description thereof contained in this manual
and accompanying labels and inserts, when assembled, operated, maintained and repaired in
accordance with the instructions provided. A defective product should not be used. Parts that are
broken, plainly worn, missing or incomplete, distorted or contaminated should be replaced immediately.
Should any repair or replacement become necessary, we recommend that service be performed at the
nearest approved service center. The user of the product shall have the sole responsibility for any
malfunction, which results from improper use, faulty maintenance, improper repair, damage or
alteration by anyone other than SELVAS Healthcare, Inc. or their authorized service personnel.
The ACCUNIQ BP800 System
The ACCUNIQ BP800 ABPM system is lightweight, quiet, comfortable, and does not interfere with
daily activities. It is easily configured and individually-fitted for each patient by a physician or nurse.
The 24-hour measurements for systolic and diastolic blood pressure, the mean arterial pressure, and
the pulse rate are automatically obtained without medical supervision, and later downloaded to a
INTRODUCTION

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computer for analysis and interpretation.
Blood pressure measurements determined with this device are equivalent to those obtained by a
trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the
ISO 81060-2.
SAFETY and EFFECTIVENESS WARNINGS
Make sure that you are familiar with all Safety and Effectiveness considerations before using the
ABPM (model - ACCUNIQ BP800).
ACCESSORIES
The SELVAS Healthcare, Inc. warranty can only be honored if you use SELVAS Healthcare, Inc.
approved accessories and replacement parts.
Caution
Use of accessories other than those recommended by SELVAS Healthcare, Inc. may
compromise product performance.
2. WORD DEFINITIONS
SYS Systolic Blood Pressure
DIA Diastolic Blood Pressure
Exhaust This means "releasing the cuff air as soon as possible".
3. CLASSIFICATION AND COMPLIANCE
1) This device is classified as;
- Battery powered and the 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(Safety of Medical Electrical Equipment)
2) This device is in compliance 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 complies with:
- IEC 60601-1:2005 Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
- IEC 60601-2-30 Medical electrical equipment -- Part 2-30: Particular requirements for basic
safety and essential performance of automated non-invasive sphygmomanometers
- ISO 81060-1: 2007 Non-invasive sphygmomanometers — Part 1: Requirements and test
methods for non-automated measurement type
- ISO 81060-2:2009 Non-invasive sphygmomanometers -- Part 2: Clinical validation of
automated measurement type
- ISO 10993-1: Biological evaluation of medical devices
4. SAFETY PRECAUTIONS
This device is designed and manufactured with consideration of safety of the operator and
patient 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.
2) The operator and patient must not touch or handle inner side of the equipment at any time.
3) Do not modify the unit. If any modification is needed, ask our company or its authorized dealer for

6
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) Continuous cuff pressure due to connection tubing kinking can cause the blood flow interference
and resulting harmful injury to the patient.
7) Too frequent measurements can cause injury to the PATIENT due to blood flow interference.
8) The application of the CUFF over a wound can cause further injury.
9) The application of the CUFF and its pressurization on any limb where intravascular access or
therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood
flow and could result in injury to the patient;
10) CUFF and its pressurization on the arm on the side of a mastectomy should not be applied.
11) The pressurization of the CUFF can temporarily cause loss of function of simultaneously used
monitoring ME EQUIPMENT on the same limb;
12) It is necessary to check that operation of the automated sphygmomanometer does not result in
prolonged impairment of PATIENT blood circulation
13) 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 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.
14) 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 AC power line voltage heavily fluctuates.
- Where the AC power line voltage changes heavily when this unit is in operation.
- Where the unit is exposed to direct sunlight.
15) 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

7
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.
16) Do not to touch signal input, signal output or other connectors, and the patient simultaneously.
17) 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;
18) a statement that portable and mobile RF communication equipment can affect MEDICAL
ELECTRICAL EQUIPMENT.
19) Please consult a physician or a trained health professional for interpretation of measurement
results.
20) No phthalates are used for this product and its container.
21) The cuff is not made with natural rubber latex
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.
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
General Warning Sign. Failure to turn off the power before you begin this
procedure can lead to product damage and result in serious injury or death.
Caution. Failure to follow instructions could result in damage to product or minor
injury
General mandatory action sign. Important to follow instructions. Not a 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.

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identifies the battery
Turning on the recorder
Turning off the recorder
Date of manufacture
Manufacturer
Non-ionizing radiation
CE mark
Serial No
Refer to instruction manual/ booklet.
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 BP800 are given below.
Before using the ACCUNIQ BP800, be sure to read and understand the following information.
1) Guidance and manufacturer’s declaration – electromagnetic emissions
The ACCUNIQ BP800 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BP800 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The ACCUNIQ BP800 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
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
The ACCUNIQ BP800 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.
2) Guidance and manufacturer’s declaration – electromagnetic immunity
The ACCUNIQ BP800 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BP800 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 lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2kV common
mode
±1 kV differential
mode
±2kVcommon
mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage drops,
dips, and
fluctuations of
input power
supply line IEC
61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
ACCUNIQ BP800 requires continued
operation during power mains
interruptions, it is recommended that
the ACCUNIQ BP800 be powered

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(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
from an uninterruptible power supply
or a battery.
Magnetic field
of commercial
frequency
(50/60Hz)
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
Note
UT is the a.c. mains voltage prior to application of the test level.
3) Guidance and manufacturer’s declaration – electromagnetic immunity 2
The ACCUNIQ BP800 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BP800 should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the ACCUNIQ BP800, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d =1.2
d =1.2 80 MHz to 900 MHz
d =2.3 900 MHz to 2,5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined 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

11
equipment marked with the following symbol:
Note
1. At 80 MHz and 900 MHz, 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.
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 ACCUNIQ BP800 is used
exceeds the applicable RF compliance level above, the ACCUNIQ BP800
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or
relocating the ACCUNIQ BP800.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
4) Recommended separation distances between portable and mobile RF communications
equipment and the ACCUNIQ BP800
The ACCUNIQ BP800 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ACCUNIQ BP800 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ACCUNIQ BP800 as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter m Rated maximum
output power
of transmitter W
150 kHz to 80 MHz
d =1.2
80 MHz to 900 MHz
d =1.2
900 MHz to 2,5 GHz
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.
Note
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.

12
1. DISPLAY
①LCD (Display)
It displays time, battery status and measurement process.
Also, systolic blood pressure, diastolic blood pressure and pulse result will be indicated after
measurement.
②Connecting part of cuff
It connects main unit and connecting hose which connected on cuff.
③START / STOP button
If measurement is set with MANUAL mode, measurement can be started with START / STOP
button.
: Systolic blood pressure : This icon will be indicated when wake-up
time is set.
: Diastolic blood pressure : This icon will be indicated when wake-up
time automatic measurement is set.
: Pulse : This icon will be indicated when bed-time is
set.
: Battery remains : This icon will be indicated when bed-time
automatic measurement is set.
: Data transmitting : Time
Pressure value will be indicated when
measuring and systolic/diastolic will be
indicated after measuring.
TERMS OF EACH PART AND FUNCTION
①
LCD
② Cuff connecting
part
③ START/STOP
button

13
2. FRONT AND REAR PART
①MENU button
This button is for setting the device such as time, measurement interval and etc.
②UP button
Number is going up when setting the device.
DOWN ③button
Number is going down when setting the device.
④Battery cover
It is a cover for protecting battery inlet.
When replace the battery, replace 4 batteries each 2 batteries on front and rear part.
① MENU button
② UP button ③ DOWN button
④ Battery cover ④ Battery cover

14
3. SIDE PART
USB ①Port
This port is for transmitting data to data managing program on PC.
①
USB Port

15
4. Accessories
①User guide ② Cuff and connecting hose(Standard)
③Battery (AAA X 4) USB ④cable
⑤Carrying bag and strap ⑥Data managing program
5. Options
①Cuff (For small adult) ② Cuff (For large adult)
② Cuff and connecting hose
④ USB cable
⑤ Carrying bag and strap
③ Battery (AAA X 4)
①Cuff (For small adult) ② Cuff (For large adult)
① User guide
⑥ Data managing program

16
1. How to put battery
Put batteries on front and rear part on the device for turning on the device.
Open the battery cover and put each 2 batteries (AAA type battery) on front and rear part.
[Front Part] [Rear Part]
After putting batteries on rear part, turn on the ON/OFF switch as shown in the picture.
Note
Replace all batteries (4 batteries) when replacing battery.
When renting the device, please be sure to put new batteries.
INSTALLATION

17
2. How to connect communication port
Connect the USB port which located on side part of main unit and computer USB port by USB
cable.

18
3. Setting
Time will be blinked when turning off the power and you can set up in this state.
If you want to change the setting, press MENU button for 5 seconds then system will enter to setting
mode.
①Date / Time setting
Setting sequence is hour/minute → month/day → year.
Note
If you want to discontinue the date and time setting, press STOP switch. Then,
device will be turning to measurable state. Hour, minute, month, day, year needs to
be set together. If you discontinue the process in the middle of setting, time display
will be returned to the state before you started setting.
Month/d
ay setting
After setting minute, press MENU button once again for entering
month setting mode. Press UP and DOWN button for setting month.
Press MENU button once again for entering date setting mode. Press
UP and DOWN button for setting day.
Year setting.
After setting day, press MENU button once again for entering year
setting mode. Press UP and DOWN button for setting year. After
setting day, press MENU button for few seconds for entering ‘Alarm
setting’ mode.
Hour/minute setting
When you turn ON the power or press the MENU button for few
seconds while using, time will be blinked. Set the hour by UP and
DOWN button.
When you press the MENU button once again, system moves to
minute setting. Press UP and DOWN button for setting minute.

19
②Alarm setting
Ring the alarm when measured systolic blood pressure is higher or lower than setting value.
Setting maximal blood pressure alarm
After setting the year, press and hold the MENU button, and the
device will show ‘SYS’ and ‘H’ on the LCD screen. You may set the
maximal blood pressure alarm. Set the desired value using the UP
and DOWN buttons. When the measured blood pressure is higher
than the preset value, the alarm will go off for 90 seconds and the
SYS icon will blink.
Setting minimal blood pressure alarm
After setting the maximal value, press the MENU button once again,
and the device will show ‘SYS’ and ‘L’ on the LCD screen. You may
also set the minimal blood pressure alarm. Set the desired value
using the UP and DOWN buttons. When the measured blood
pressure is lower than the preset value, the alarm will go off for 90
seconds and the SYS icon will blink.
Alarm ON/OFF
setting
After setting the minimal blood pressure alarm, press the MENU
button once again, and the device will show a bell icon on the top
right corner, and the screen will shift to the alarm ON/OFF setting.
Adjust alarm on or off using the UP and DOWN buttons. When the
alarm is set off, the device does not ring any alarms regardless of the
measured value.

20
③Pressure value setting
It is required to set the initial pressure for blood pressure measurement. Once the initial pressure
is set, repeated pressurization is prevented for hypertension patients.
④Wake-up time setting
Set the measuring intervals at wake-up and after wake-up times.
Setting initial pressure
After setting the alarm function, press the MENU button and the LCD
screen will display ‘PULSE’ and enters the initial pressure setting
menu. Set the desired value using the UP and DOWN buttons.
Setting measuring intervals after wake
-
up time
After setting desired wake-up time, press the MENU button again,
and the LCD screen will display ‘M’ and ‘A’, and enters measuring
intervals menu. Set desired interval using UP and DOWN button. The
device automatically measures blood pressure at every preset
interval, and the device operates manually when the value is set as
‘0’.
Setting wake
-
up time
After setting the desired initial pressure, press and hold the MENU
button, and the LCD screen will display ‘M’ and enter the wake-up
time setting menu. Set desired wake-up time using UP and DOWN
buttons.
Once the wake-up time is set, press the MENU button again and the
minute will blink, and enter the minute setting menu. Set the desired
wake-up time (minute) using the UP and DOWN buttons.