Nissei Pulsefit BO-750 User manual

PULSE-OXIMETER
Pulsefit®
BO-750/BO-750BT
Instructions
Table of contents
General information ................................................................2
Warning and precaution...........................................................3
Are the following items included?.............................................5
Inserting battery......................................................................6
Making measurement...............................................................8
Performing data communication (BO-750BT) ......................... 12
Error displays and troubleshooting......................................... 14
Care and maintenance............................................................ 16
Specifications ........................................................................ 17
Technical description ............................................................. 18
Warranty and service ............................................................. 20

Before use
- 2 - - 3 -
General information
BO-750 is designed to measure %SpO2and pulse rate accurately, quickly
and simply at a fingertip using high precision optical components and
sophisticated analogue-digital circuits.
Haemoglobin in blood turns to oxyhaemoglobin in the lungs to carry oxygen
to body cells and turn itself to deoxyhaemoglobin after transferring oxygen
to the body cells and returning to the lungs. These oxyhaemoglobin and
deoxyhaemoglobin are well known to absorb specific wavelength of lights,
infrared and visible red, respectively. BO-750 is calibrated to display
functional oxygen saturation analyzed from pulse wave length detected with
two high-precision light emitting diodes (LED) emitting infrared and visible
red lights individually from one side and a photo diode receiving these lights
passing through fingertip at the other side.
This device is for medical staff use.

Before use
- 3 -
Warning and precaution
Do not use BO-750 along with, near, in, or for,
• MRI (MR), electrosurgical unit, defibrillator, mobile phone, RF
communication equipment, or hyperbaric oxygen treatment devices
• an explosive environment such as where flammable anaesthetics
exist or inside oxygen chamber
• infant or neonate (BO-750 is designed for adults.)
Measurement can be affected by or unreliable readings may result from
• lotions, nail polish and unclean fingertip
• stain or scratch of surfaces of LED or photo sensor
• strong lights, e.g., sun light or surgical light
• improper positioning of the device: fingertip not correctly placed on
LED and under photo sensor
• movement of fingertip during measurement
• radiocontrast agent, methylene blue, indocyanine green, indigo
carmine or intravascular dye
• CPR treatment
• high level of methemoglobin or carboxyhemoglobin
• weak pulse signal
• restricted circulation of blood or congestion of blood
BO-750 is not designed to be used at a single spot for an extended
time period. Switch fingers periodically if measurement is conducted
for over 30 minutes. Change of application spot is also required under
such conditions as high fever or peripheral circulatory insufficiency for
application of the device could result in sectional rise in temperature.
Do not fix BO-750 to finger with cables or tapes.

Before use
- 4 - - 5 -
Before starting measurement, make sure that
• both LED and photo sensor surfaces are clean and clear.
• finger is clean. Do not use BO-750 on injured or wounded fingers.
• batteries have enough power for long term measurement. Exhausted
batteries may cause unexpected interruption of measurement during
operation.
Judgment such as change of dosage of a drug based on measurement
results should not be made without professional consultation.
Do not disassemble or modify the device.

Before use
- 5 -
Are the following items included?
Check if the following items are included. If anything is missing, contact
your distributor.
Light source
Photo sensor
Disp lay
Display switching button
Battery cover
Light shield
Clip
Be careful not to make a mistake
with the strap attachment.
Hole for strap attachment
Finger insertion section
Pulse oximeter
Strap
Single AAA alkaline battery
(for testing)
Instruction manual
The strap is designed to be safely detachable e.g.
when a strong force is applied.
If it is detached, align the protruding side to the side
with the opening to fix it back.
*Enclosed battery is for testing purposes.
Its life may be shorter than those sold commercially.

Before use
- 6 - - 7 -
Inserting battery
Slide the battery cover at the back of the device in the direction of the arrow
to open.
Put in the single AAA alkaline
battery (LR03) as shown on the
device and close the battery cover.
When inserting or removing the
battery, push the negative side of
the battery against the spring.
Regarding the use of rechargeable batteries
Although this device can also be used with a rechargeable battery, the
battery mark may not appear correctly.
All indicators will appear and the initial
test will be carried out if the battery is
inserted correctly.
Do not start the measurement during
the initial test.
* The display value may vary.
When the battery cover is detached
Open the finger insertion section and insert the protrusions on the cover
into the side of the device to install the cover.
Insert the protrusion on one side first
and open the cover a little to insert the
other side. Be careful not to forcefully
widen the cover too much or insert the
protrusion forcibly.
Protrusion
All indicators
(approximately 2 sec)
Initial test*
Insertion section

Before use
- 7 -
About the battery
Replace the battery when the battery mark ( )
appears. Measurement cannot be taken when the indicator
changes from flashing to lit.
The battery mark which appears when all indicators are lit does
not mean that the battery is due for replacement.
• Dispose used batteries in a proper manner in accordance with the
regulations of each municipality.
• Check the expiry date of the battery. Using expired batteries will
result in a malfunction or failure.
• Take out and store the battery when not using the product for an
extended period of time. The battery liquid may leak and damage
the product.

Measurement
- 8 - - 9 -
Measurements cannot be taken correctly in the following
situations
Hand and device are cold
When cold, blood vessels constrict and blood flow deteriorates,
making measurement impossible.
• If your fingertip is cold, warm your finger by massaging it to improve
blood flow first before measuring.
• Ifthedeviceiscold,thengertiptobemeasuredmaybecomechilled.
Warmupthedevicealittlerstbeforemeasuringinawarmplace.
Moving
Measurement is not possible if the pulse wave cannot be detected
normally.
• Do not move your fingertips or body during measurement.
• Your pulse will be disturbed by your physical and mental condition
when you are surprised or when you walk. Rest for a while first
before measuring.
Light does not reach the finger
Measurement is not possible if your finger does not touch the light
source and photo sensor inside the device.
• Insert your finger fully all the way in so that it contacts the light
source and photo sensor. In addition, take note that your finger
may not reach the light source and photo sensor e.g. when your
fingernail is long.
Making measurement

Measurement
- 9 -
Hold the clip on the device, open the finger insertion section, and fit it on
your finger so that the display is on the fingernail side.
Insert your finger fully all the way in so that it contacts the light source
and photo sensor on the inside of the device.
When measurement starts, the pulse wave is detected and the amplitude
intensity is displayed.
Measurement results are displayed about 8 sec after measurement starts.
Read the measurement value after the value stabilizes. (after approximately
8 beats)
See page 10 for the display of the measurement results.
Measurement starts automatically
when you put on the device
Amplitude intensity
Fingernail side
Display section side
Grip and open

Measurement
- 10 - - 11 -
/min
Unit of pulse rate (bpm)
Bluetooth mark
*BO-750BT only
Connection ID
(example：0123)
Pulse rate
Display for about 30 sec
BO-750BT only
Press and hold
for 3 sec
PI value
(PI：Perfusion Index Unit：%)
Amplitude intensity
The intensity of the amplitude
of the detected pulse is
indicated in 4 levels.
Battery mark
Indicates that the battery is
depleted
Stability mark
Indicates that the measurement
condition is favorable
Blood oxygen saturation
level
Backlight turns orange when
the level is less than 90%.
%SpO2
Unit of blood oxygen
saturation level
(See page 12)
(See page 7)
Press the display switching button
to switch the pulse rate display
and PI value display.
PI value display returns to the
pulse rate display automatically
after about 30 sec.
Press and hold the display switching button for 3
sec or longer to switch to the communication mode,
upon which the Bluetooth mark will flash.
If there is no connection, the display will return to the
measurement results automatically after about 60 sec.
* Communication mode is available for the BO-750BT only.
There is no communication function in the BO-750.

Measurement
- 11 -
Measurement is not possible if the backlight turns orange and
appears.
For information about the error display, see page 14.
When the device is removed, the measurement ends automatically
and the power supply is switched off after about 8 sec.
Auto display switching
Invert the device to automatically switch
the display.
If the top and bottom of the display
cannot be determined, read in the
direction that SpO2can be read
correctly.
Memory function
Press the display switching button with the power supply turned off to
display the value which appeared when the last measurement ended.
1.5 sec display 1.5 sec display
The memory is erased when the battery is removed.
is not recorded.
Up
Down

Data communication
- 12 - - 13 -
Installing the app
1. Get ready a smart phone etc.
Compatible OS
• iOS8 or higher
(Compatible with only iPhone 4s or higher and 5th generation iPod
touch)
• Android 4.3 or higher (equipped with Bluetooth 4.0 or higher)
2. Download NISSEI HealStyle from the Apple App
Store or Google Play Store.
3. Start NISSEI HealStyle and perform user
registration.
Performing communication
1. Tap the pulse oximeter on the app screen.
2. Wear the pulse oximeter on your finger and start
the measurement.
3. Once the measurement results appear, press and
hold the display switching button on the main unit
for 3 sec or longer.
The Bluetooth mark will flash and the mode will
switch to the communication mode.
If there is no connection, the display
will return to the measurement results
automatically after about 60 sec.
NISSEI
HealStyle
Performing data communication (BO-750BT)
Connection ID
(4 digits)
Example：0123
Bluetooth mark

Data communication
- 13 -
4. Tap Receive at the top right of the app screen.
5. Register the connection ID in the app (if unregistered)
Register the connection ID (4-digit number) displayed in the main unit of
the pulse oximeter in the app.
6. Start the data communication.
Using the app, the BO-750BT can manage the measurement results with
a smart phone.
See the NISSEI website for more information on how to run the app.
http://www.nissei-kk.co.jp/english/
• If the connection is not smooth, remove your finger from the main unit
to end the measurement once before re-connecting.
• Do not remove the battery from the main unit during data
transmission.
iPod, iPhone, iPad are trademarks of Apple Inc., registered in the U.S.
and other countries.
Android is a registered trademark of Google Inc.
Pulsfit®is a registered trademark of Japan Precision Instruments, Inc.
The Bluetooth®Word mark and logo are registered trademarks owned by
Bluetooth SIG. Inc., and these marks are used under license by Japan
Precision Instruments, Inc.
戻る
リスト グラフ 設定
受信
リスト
日付 時刻 脈拍
SPO2 PI値
受信

Troubleshooting
- 14 -
Indication Cause Countermeasure
Signal is not detected Re-install the device so that your
finger is in contact with the light
source and photo sensor.
An object is stuck in the
ngerinsertionsection
Remove the stuck object.
Pulse rate can be
measured but the blood
oxygen saturation level
cannot be measured
More information from the pulse
wave detected is required in the
measurement of the blood oxygen
saturation level.
Conduct the checks to ensure
correct measurement one more time
before measuring. Measure with
anotherngerifthepulseamplitude
intensity is small and the signal is
weak.
Nothing
appears
Battery is not inserted Insert the battery.
Battery is inserted with
wrong polarity
Re-insert the battery correctly.
Battery is depleted Replace with a new battery.
Battery terminal
(connection section) is
stained
Clean with a dry cloth.
Initial test:
Initial test is carried
out when the battery is
inserted
This is not a malfunction.
* The display value may vary.
Error displays and troubleshooting

Troubleshooting
- 14 - - 15 -
Indication Cause Countermeasure
Initial test error: A finger
was inserted or an object
was stuck in the finger
insertion section during
the initial test.
Check that there is nothing in the
insertion section, and start the
measurement after the initial test
error display disappears.
* Contact your distributor if the initial
testerrorappearsevenifnonger
or object has been inserted.

- 16 -
Care and maintenance
Calibration
No calibration or adjustment is required for the life of the product.
Cleaning
Wipe stain or dirt with soft cloth damped with neutral detergent or isopropyl
alcohol. Remove batteries before cleaning.
Handling and Storage
Because the unit includes precision parts, care should be taken to avoid
extreme temperature variations, humidity, shock, dust, and direct sunlight.
Do not drop or expose the device to strong shocks. Use strap to
prevent accidental fall. Avoid storing BO-750 in a gaseous atmosphere or
places where chemicals are used or they are in the air. Take out batteries
to prevent battery solution leakage when BO-750 is not to be used for an
extended period of time. Keep the batteries out of reach of children.
Disinfection
Autoclaving is not possible.
Water resistance
BO-750 has limited water resistance. Do not immerse the device in liquid,
nor expose to excessive moisture.

- 16 - - 17 -
Specications
Operating principle Double wavelength lights absorption method
Measurement Range %SpO20 - 100%
Pulse rate 30 - 240 bpm
Accuracy* %SpO2±2%(70%≤SpO2≤100%)
Pulse rate ±3%/±1 digit (30 - 240 bpm)
Power source One single AAA alkaline (LR03) battery
Rated voltage DC 1.5 V
Rated power consumption 0.09 W
Bluetooth compatibility standard Bluetooth Low Energy 4.1
Operating condition +10°C to +40°C, 30% to 85% RH (no condensation)
Transportation/storage condition -20°C to +60°C, 10% to 95% RH (no condensation)
Size Approximately 60 (H) × 35 (W) × 32 (D) mm
Weight Approximately 37 g (without batteries)
Electric-shock Protection Internally powered equipment, Type BF applied part
Protection class IP IP22: Protected against solid foreign particles with a diameter
of more than 12.5 mm, no protection against water.
Mode of operation Continuous operation
Key to symbols Type BF applied part
Refer to instruction manual/booklet.
No SpO2alarms
The used electrical and electronic products are not
household waste. Follow your national/local recycling
rules to dispose of them properly. In the EU countries,
please refer to waste management symbol(s) marked
on the package or the instrument.
Specicationsaresubjecttochangewithoutpriornoticeduetoimprovementsinperformanceand
quality. *Accuracy for %SpO2is a statistical standard deviation and up to 68.3% of reading may fall
into this limit and other may fall out of this limit. Information on the range of the peak wavelengths
and maximum optical output power of the light emitted by the pulse oximeter can be useful to
a clinicians performing photodynamic therapy. Contact Nissei Healthcare (UK) Ltd., our EC
representative for any further information.

- 18 -
Technical description
BO-750 complies with the EMC, electromagnetic compatibility, standard, IEC60601-1-2. Refer to the tables below for
specicinformationregardingcompliancetothestandard.BO-750,asamedicalelectricalequipment,needsspecial
precautions regarding EMC and needs to be installed and put into service according to the EMC information provided
below. Portable and mobile RF communications equipments can affect the device. The use of accessories other than
thosespeciedinthismanualmayresultinincreasedemissionsordecreasedimmunityofthedevice.BO-750shouldnot
be used adjacent to or stacked with other equipment.
Table 1 - Guidance and manufacturer’s declaration - electromagnetic emissions -
BO-750isintendedforuseintheelectromagneticenvironmentspeciedbelow.ThecustomerortheuserofBO-750
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 BO-750 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 BO-750 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 N/A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
N/A
Table 2 - Guidance and manufacturer’s declaration - electromagnetic immunity -
BO-750isintendedforuseintheelectromagneticenvironmentspeciedbelow.ThecustomerortheuserofBO-750
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
±6 kV contact
±8 kV air
N/A 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 transient/
burst IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/ output lines
N/A N/A
Surge IEC 61000-4-5 ±1 kV differential mode
±2 kV common mode
N/A N/A
Voltage dips, short
interruptions and voltage
variations on power
supply input lines 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(30% dip in UT) for 25 cycles
<5% UT(>95% dip in UT) for 5 sec
N/A N/A
Power frequency (50/60
Hz) magnetic field IEC
61000-4-8
3 A/m 3 A/m Powerfrequencymagneticelds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.

- 18 - - 19 -
Table 4 - Guidance and manufacturer’s declaration - electromagnetic immunity -
BO-750isintendedforuseintheelectromagneticenvironmentspeciedbelow.ThecustomerortheuserofBO-750
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
N/A
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of BO-750, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
N/A
d=1.2√P, 80 MHz to 800 MHz
d=2.3√P, 800 MHz to 2.5 GHz
Where Pis the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and dis the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,ashould be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of equipment marked with
the following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reectionfromstructures,objectsandpeople.
aField strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radios broadcast and TV broadcast cannot be predicted theoretically with
accuracy.ToassesstheelectromagneticenvironmentduetoxedRFtransmitters,anelectromagneticsitesurvey
shouldbeconsidered.IfthemeasuredeldstrengthinthelocationinwhichBO-750isusedexceedstheapplicable
RF compliance level above, BO-750 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating BO-750.
b Overthefrequencyrange150kHzto80MHz,eldstrengthsshouldbelessthan3V/m.
Table 6 - Recommended separation distances between portable and mobile RF communications equipment and BO-750 -
BO-750 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of BO-750 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and BO-750 as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter, W
Separation distance according to frequency of transmitter, m
150 kHz to 80 MHz, N/A 80 MHz to 800 MHz, d=1.2√P800 MHz to 2.5 GHz, d=2.3√P
0.01 N/A 0.12 0.23
0.1 N/A 0.38 0.73
1 N/A 1.2 2.3
10 N/A 3.8 7.3
100 N/A 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance din metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reectionfromstructures,objectsandpeople.

Warranty and service
NISSEI warrants the product for two years from the date of purchase for
functionality and accuracy without charge for inspection, adjustment, repair
and labour. Evidence of date of purchase is required for warranty. However,
this warranty does not cover defects resulting from, damage caused by wear
or misuse, damage caused by unauthorised repair or modification or damage
caused by natural disaster, violent action or war. Purchaser shall bear transport
or shipping related costs. NISSEI is not liable for any consequential damages
caused by BO-750, direct or indirect, economically or biologically.
Manufacturer: NIHON SEIMITSU SOKKI CO., LTD.
2508-13 Nakago Shibukawa Gunma 377-0293 Japan
EC-Representative: Nissei Healthcare (UK) Ltd. Henfield, BN5 9SJ UK
web site: http://www.nisseihealthcare.com
Issued on March 1, 2016 A129149-1_1