OXYGEN SATURATION MONITOR
PULSOX®-300i
Instruction Manual
This instrument must be used
according to the instructions of
the doctor.
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Safety Precautions
To ensure correct use of this instrument, read the following points
carefully and adhere to them. After you have read this manual,
keep it in a safe place where it can be referred to anytime a
question arises.
WARNING
(Failure to adhere to the following points may result in death or serious injury.)
The instrument is designed for measurement of the ox-
ygen saturation (SpO2) of arterial blood and the pulse
rate. Do not use it for any other purposes, such as
warning of sleep apnea and breathing abnormalities.
Do not use the instrument in places where flamma-
ble or combustible gases (anesthetic gas etc.) are
present. Doing so may cause a fire.
Do not disassemble or modify the instrument and
accessories. Doing so may cause a fire or electric
shock.
The instrument should not be operated if it is dam-
aged, or smoke or odd smells occur. Doing so may
result in a fire. In such situations, turn OFF the pow-
er immediately, remove the battery, and contact the
nearest authorized service facility.
Do not put the batteries on a fire, short-circuit them,
heat them or disassemble them. Doing so may
cause explosion or heat generation, resulting in fire
or injury.
1
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CAUTION
(Failure to adhere to the following points may result in injury or damage to the in-
strument or other property.)
Do not use batteries other than those specified by
KONICA MINOLTA SENSING, INC. When installing
batteries in the instrument, make sure that they are
correctly oriented according to the
mark.
If alkali fluid from the battery comes in contact with
eyes, skin, or clothing, immediately wash the affect-
ed area and see a physician for treatment.
Do not use probes other than those specified by
KONICA MINOLTA SENSING, INC. Use of alterna-
tive probes may cause the probe to overheat, result-
ing in burns.
Do not operate the instrument for long periods
of time with a probe attached to a patient. Low-
temperature burn, redness or rash may result. If you
feel pain or itchiness, stop use of the instrument im-
mediately and consult a doctor. A doctor should also
be consulted before using the instrument on patients
with high fever, those with peripheral blood circula-
tion problems or those with sensitive skins.
When attaching the probe to a patient for use during
sleep, care must be taken to avoid the cable from
becoming twisted around the neck of the patient, for
instance when he/she turns over.
2
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Contents
Safety Symbols
Safety Precautions .............................................................1
Foreword ............................................................................4
Safety Notes ...........................................................................4
Package Contents...................................................................5
About Probe............................................................................5
System Diagrams and Accessories ........................................6
Names of Parts.......................................................................7
Notes on Use..........................................................................8
Notes on Storage..................................................................10
Disposal Method...................................................................11
Preparations.....................................................................12
1) Attaching the Wrist Band ..................................................12
2) Connecting the probe .......................................................14
3) Installing the battery..........................................................15
4) Attaching the PULSOX to the wrist...................................16
Measurement....................................................................17
1) Starting the Measurement (Power ON) ............................17
2) Reading the display..........................................................19
3) Ending the Measurement (Power OFF)............................20
About Auto Power-Off function..............................................20
Regarding the memory function............................................20
External Connection.........................................................21
Trouble Shootings ............................................................23
Error Messages.....................................................................23
Check Points before repairing...............................................28
Maintenance and Inspection.................................................28
Cleaning................................................................................28
Specification.....................................................................29
Appendix...........................................................................31
Calculation Method for Displayed Values .............................31
EMC Guidance......................................................................32
Measurement Principle.........................................................34
Relation between Oxygen Saturation and partial Pressure.............. 35
3
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Foreword
Safety Notes
CAUTION: U.S.Federal law restricts this device to sale
by or on the order of a physician.
The instrument is designed for measurement of the
oxygen saturation (SpO2) of arterial blood and the
pulse rate. Do not use it for any other purposes, such
as warning of sleep apnea and breathing abnormalities.
The Oxygen Saturation Monitor PULSOX-300i is designed
to measure oxygen saturation (SpO2 value) in arterial blood
and pulse rate by attaching a probe to a peripheral part of
the body, such as a finger, in a non-invasive method.
PULSOX-300i is intended for continuous data-collection
use such as during a sleep study and not for traditional
continuous use.
• The compact, lightweight and portable body has a large
LCD for easy operation.
• The LCD has a backlight function, providing high
visibility even in dark areas.
• Built-in memory enables storage of up to 300 hours of
measured data.
• Use of the optional software allows you to set the date/
time and to set the auto-power-off time on the PULSOX-
300i. In addition, the measured data stored in the
memory can be processed, stored collectively or output
via a printer using a personal computer.
4
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Package Contents
Before using the instrument, make sure that the following items
are present.
1) PULSOX-300i main body × 1
2) Wristband WB-300 × 1
3) AAA-size alkaline battery × 1
4) Instruction manuals
• PULSOX-300i instruction manual × 1
• Separate manual (Using manual for Probes) × 1
The probe is optional.
✻
About Probe
The following probe types can be used with this instrument.
•
Finger Clip Probe SR-5C
Spot Check Probe SP-5C
•
•
Monitor Probe LM-5C
Personal Probe SD-5C
•
As shown in the table below, the measuring point varies with
the probe used, so select the one that is suitable for your
purpose.
◆
Probe type
SR-5C
Patient
Allowed measuring point
SP-5C
Adult
Finger (hand)
LM-5C
SD-5C
For the usage method, please refer to “Connecting the probe”
(page 14) on this manual and the probe’s instruction manual.
◆
5
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System Diagrams and Accessories
The instrument consists of the following items.
Standard accessories
Optional accessories
Optional accessories
Finger Clip Probe SR-5C
05,3/8ꢀꢁꢂꢂI
Spot Check Probe SP-5C
Extension cable EC-300
Monitor Probe LM-5C
USB adapter UA-300
Personal Probe SD-5C
Standard accessories
Wristband WB-300
AAA-size alkaline battery
6
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Names of Parts
Power button
Used to start measurement
( P o w e r - O N ) o r e n d
measurement (Power-OFF).
PULSOX-300i
LCD Display
(with the backlight function)
Measurement results and
messages are displayed.
Probe connector
Connect the probe or
extension cable EC-300 to
this connector.
Backlight button
Press it to turn ON the
backlight of the LCD.
External output
terminal
Connect the optional
USB adapter “UA-300”
to connect the
instrument to a personal
computer.
Battery cover
The cover can be opened by
turning it approximately 90
degrees.
Wristband
Used to set the instrument
on your wrist.
7
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Notes on Use
•
This instrument should be used under the following operat-
ing conditions.
•
Temperature of 0 to 40°C (32 to 104°F), relative humidity
of 30 to 85%, with no condensation.
Atmospheric pressure of 700 to 1060 hPa (altitude of
•
–400 to 3000m).
•
This is a precision instrument. To avoid the possibility of it
being damaged, the instrument should not be dropped nor
should heavy objects be placed on top of it.
Do not expose this instrument to rain and water.
•
•
This instrument has no alarm function. Do not use this in-
strument if an alarm function is necessary.
•
•
This instrument is designed for use on adults. When using
the instrument on infants or babies, please note that the de-
signed measurement accuracy cannot be guaranteed.
Do not use the instrument on a point where there is exces-
sive vibration. In addition, to avoid excessive impact on the
instrument, it should be handled gently. Failure to observe
this may cause breakdown.
•
•
A maximum of 300 hours of measurement data can be stored,
or the maximum storable number of data files is 399 files. If
measurements are continued after the maximum number of
storable data has been reached, the new data will overwrite
the oldest data. To keep data, be sure to download it before
the memory becomes full.
Accurate measurement data may not be obtained in the fol-
lowing cases.
•
When body movement is excessive
When the probe is not attached properly
•
•
When blood circulation at the measuring point is poor (due to
pressure on arm/finger, peripheral circulatory insufficiency)
When ambient light (e.g. panel light, fluorescent light, in-
•
frared heat lamp, direct sunlight) is too strong
8
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•
When influenced electromagnetically by other electronic de-
vices (e.g. near electrical appliances like TV, medial device)
When a mobile telephone is used during measurement
When influenced by abnormal hemoglobin like carbon
monoxide hemoglobin (HbCO) and methemoglobin
When pigments such as cardiogreen, intravascular dyes
and indocyanine greenare present in the blood
•
•
•
•
When finger nails are polished
•
Tables 1 and 2 below show the errors which may occur due to
these hemoglobins.
Difference from the SaO2 value to displayed value
<Table 1>
<Table 2>
HbCO
5% 10%
Methemoglobin
1% 5% 10%
SaO2
SaO2
1%
50
70
90
-0.1 -0.7 -1.5
-0.1 -0.7 -1.5
-0.2 -0.8 -1.6
50
70
90
+0.2 +1.3
-0.6 -2.3
-1.5 -6.0
-1.8 -7.5
+3.2
-3.2
-9.6
100 -0.2 -0.8 -1.7
100
-12.2
Measured value is always
lower than the actual value.
Displayed value is sometimes
higher than the actual value if
SaO2 is around 50%.
•
•
•
Do not immerse the probe, the extension cable or the con-
necter of PULSOX-300i in disinfectant. Doing so may cause
a malfunction.
When using the Extension Cable EC-300, fit and secure ca-
bles so they are not too loose or too tight.
Before connecting to a personal computer, remove the Pulsox
from the patient.
9
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Notes on Storage
•
This instrument should be stored under the following storage
conditions.
•
Temperature of –10 to 60°C (14 to 140°F), relative humid-
ity of 10 to 95%, with no condensation.
•
Atmospheric pressure of 700 to 1060 hPa (altitude of –400
to 3000m).
•
When storing the instrument:
•
Do not store the instrument in an area where it will be ex-
posed to water.
Do not store the instrument in an area where direct sun-
•
light, pressure, temperature, humidity, ventilation, sunlight,
dust, strong magnetic fields, and/or saline or sulphurous
atmospheres may affect the instrument.
•
Do not store the instrument on an inclined surface or on
a surface which may be subject to vibrations or physical
shock. (Also avoid vibrations or physical shock during
transportation.)
•
Do not store the instrument in areas where chemicals are
stored or where gas may be emitted.
•
•
To avoid any problems occurring the next time the instrument
is used, make sure the instrument, cords, probes and other
accessories are cleaned and stored safely.
If the instrument will not be used for more than 2 weeks, re-
move the batteries from the battery to avoid the possibility of
damage due to leakage of electrolyte.
•
The time/date set to the instrument using the optional soft-
ware will be reset to the factory setting (Jan. 1, 2000/0:00)
if the instrument is left for more than one day without the
battery.
•
The measurement data and the auto power-off time set
to the instrument using the optional software will be kept
even if the instrument is left without the battery.
10
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Disposal Method
• When disposing of the used battery, insulate the polarity ter-
minals with insulating tape etc. If the terminals of the battery
come into contact with metal objects, heat generation, explo-
sion or fire may result.
• Make sure that the battery is either disposed of or recycled
correctly in accordance with local laws and regulations.
11
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Preparations
Before starting measurements using this instrument, follow the
procedure given below to ensure that measurements are stable.
1) Attaching the Wrist Band
Attach the Wrist Band WB-300 (supplied as a standard
accessory) to the instrument. Since the WB-300 is made of
elastic material, it allows for flexibility and comfort of fitting on
the wrist.
Place the instrument
with its rear side up.
Band fixture A
1
2
hook-and-loop
section
Pass the angled tip of
the hook-and-loop tape
of the wrist band outward
through band fixture A.
When doing so, make
sure that the Velcro
tape section faces
upward.
◆
12
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Fold up the inserted
hook-and-loop section,
and stick it firmly to the
band.
3
Pass the other end of the
band outward through
band fixture B.
Band fixture B
4
5
Take care not to twist
the band.
◆
Fold back and secure
the band with the hook-
and-loop tape section.
When attaching the
instrument to an arm,
adjust the band length
and fitting at this hook-
and-loop tape section.
◆
13
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2) Connecting the probe
Connect the probe’s connector
plug into the Probe Connector
on the instrument.
Make sure that probe’s
connector plug is oriented
correctly.
Do not connect it in with
excessive force. Doing so may
damage the connector.
Do not touch the connector
terminals by hand. Contact
failure may occur.
◆
◆
◆
<When using the Extension Cable EC-300>
Connecting the extension cable EC-300 between the PULSOX-300i
and the probe extends the probe cable to a total length of 1m.
Extension Cable EC-300 (1m)
14
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3) Installing the battery
Turn the battery cover
1
clockwise approximately
90 degrees to open the
cover.
W h e n t u r n i n g t h e
cover, keep the flat
part of your finger on
the cover’s catch. This
facilitates opening the
cover with minimum
force.
◆
Insert the battery into
the battery compartment
according to the polarity
mark ( )shown on the
rear of the instrument.
2
3
This instrument requires
one AAA-size battery.
◆
Turn the battery cover
c o u n t e r - c l o c k w i s e
a p p r o x i m a t e l y 9 0
degrees to close it.
Introduction of a new
mechanism locks the
cover automatically
when it is closed.
◆
15
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4) Attaching the PULSOX to the Wrist
Remove the hook-and-
1
loop section of the band
from the side with no
probe connector.
Attach PULSOX-300i to
the arm by inserting your
hand through the Wrist
Band.
2
Adjust the fastening
position of the hook-and-
loop tape to adjust the
tension of the Band.
3
16
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Measurement
1) Starting the Measurement
Connect the probe to the
PULSOX-300i correctly.
1
2
P r e s s t h e P o w e r
button for a long time,
the Power is ON, the
backlight is ON, and
all the elements on the
display is displayed.
After 30 seconds since the
Power is ON, the Backlight
is OFF automatically.
◆
➀Display the Year as A.D.
As shown the right, the
setting date for today is
displayed.
3
By default, the date/time
has been set to Jan. 1,
2000/0:00, and it is displayed
in the order of “’00”, “1 1”
and “0-00”. The correct
date/time can be set to the
instrument using the optional
software.
◆
➁Display the Month and the Day
month
day
➂Display the Time as 24 hours
format
hour
minute
17
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Next, it will cause the
file number of the next
4
measurement to appear.
The measurement data
obtained from power-ON
(start of measurement)
up to power-OFF (end of
measurement) will be stored
in one file.
◆
A file number is given to each set
of measurement data (power-ON to
power-OFF). (Maximum: 399 files)
And, if the time for Auto-
Power-Off was set in the
instrument, the setting
time is displayed.
5
The time for Auto-Power-Off is set by using the optional software.
If the time for Auto-Power-Off has not been set, this step will be
skipped and the measurement display will appear.
◆
◆
About 10 seconds after
the Power is switched
ON, measurements
will be started and the
6
measurement data at
Pulse level meter is started to
1-second intervals will
be stored in the memory
of the PULSOX-300i.
indicate but the measuring data is
not displayed yet.
“---” is displayed until
the measuring data is
calculated.
◆
The measuring data is calculated
and displayed, and the measurement
is started.
<Regarding the measurement data>
The measurement data includes the measurement values (SpO2 value,
pulse rate, and error message information) and the file information
(file number, date and time of start of measurements, and duration of
measurement).
18
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2) Reading the display
When the instrument is turned ON, all the elements of the LCD
will light up.
The pulse level, pulse rate and SpO2 value are displayed
during measurement.
Pulse rate (P.R.)
If an error occurs, an
error message mainly
about P.R. will be
Battery mark
Indicates the
remaining battery
displayed.
capacity in three
steps.
Pulse Level Meter
Indicate the pulse level.
Oxygen saturation
(SpO2) value
✻
For stable measurement, make
sure that the pulse level meter
lights up two or more segments
by adjusting the measuring point
or rubbing or warming it up to
improve blood circulation.
If an error occurs, an
error message mainly
about SpO2 will be
displayed.
19
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3) Ending the Measurement
Press the Power button for a
long time, the measurement is
finished and the Power is off.
About Auto-Power-Off function
By connecting the instrument to a personal computer and using
the optional software, the time to be elapsed from power-on
(start of measurement) to power-off (end of measurement) can
be set as the auto-power-off timer.
If an auto-power-off timer is set, the measurement is finished
automatically in the time after power-on.
Regarding the memory function
● The memory built into the PULSOX-300i will continue to hold
data even if the battery is removed.
● A maximum of 300 hours of measurement data can be stored; e.g.,
10 hours of measurement data can be stored for 30 persons.
Storage for measurement data is set up in 30-minute blocks,
so even if the duration of measurement data is less than 30
minutes, it will be treated as a 30-minute block. For this reason, if
measurement data with durations of shorter than 30 minutes are
stored, the actual measurement duration will be different from the
stored duration, and the maximum storable time will be shorter
than 300 hours.
● The maximum storable number of data files is 399 files. After that,
the No. 400 data file will be stored as data file No. 1, overwriting
the previous No. 1 data file.
20
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External Connection
The PULSOX-300i has an external output terminal for
outputting measurement data stored in the instrument's
memory to a computer. In addition, when the Data Analyzing
Software is installed on the computer and the PULSOX-300i is
connected to the computer using UA-300, the date and/or Auto-
power-off timer (which cannot be set using only the instrument
itself) can be set. It is also possible to download the measured
data from the instrument's built-in memory to the computer
to analyze the data, display data graphically, save data in
spreadsheet format, or print data out.
● For details regarding the Data Analyzing Software, refer to
the instruction manual and/or online help of the software.
<Connecting the PULSOX-300i and a computer>
PULSOX-300i
UA-300 main unit
UA cable USB cable
Computer
● For details regarding the connection between the PILSOX-300i
and the computer, refer to the Installation Guide manual of the
software.
● For details regarding the USB Adapter UA-300, refer to the
instruction manual of the UA-300.
21
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<Regarding the display in communication mode>
● When the PULSOX-300i is connected to a computer, the
PULSOX-300i will enter UA communication mode automatically.
In UA communication mode, the display will appear as shown
below:
This shows the PULSOX-300i is in UA
communication mode. The instrument is
connected to the computer with the UA-300.
This shows measured data is being
downloaded to the computer. Do not remove
the UA cable and/or USB cable from the
PULSOX-300i and/or the computer.
<Notes on communication mode>
● It is impossible to take measurements while the instrument is in
communication mode.
● When removing the PULSOX-300i from the UA-300, the power of
the instrument will be set to OFF automatically.
22
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Trouble Shootings
Error Messages
The instrument display error messages when the error occurs.
Check and correspond to them correctly.
%RROR -ESSAGES
#AUSE
3OLUTION
s
s
4 H E R E I S N O P R O B E
C O N N E C T E D T O T H E
05, 3/8ꢀꢁꢂꢂI OR THE
P R O B E I S I M P R O P E R L Y
C O N N E C T E D T O T H E
05,3/8ꢀꢁꢂꢂIꢃ
)F USING THE OPTIONAL
%XTENSION #ABLE %#ꢀꢁꢂꢂꢄ
THE CABLE MAY NOT BE
C O N N E C T E D T O T H E
INSTRUMENT OR THE PROBE
CORRECTLYꢃ
s
s
# O N N E C T T H E P R O B E T O T H E
05,3/8ꢀꢁꢂꢂI PROPERLYꢃ7HEN USING
THE OPTIONAL %XTENSION #ABLE
%#ꢀꢁꢂꢂꢄ CONNECT THE CABLE TO THE
INSTRUMENT AND THE PROBE CORRECTLYꢃ
)F THIS MESSAGE REAPPEARS EVEN
THOUGH THE PROBE IS PROPERLY
CONNECTED TO THE 05,3/8ꢀꢁꢂꢂIꢄ THE
PROBE IS MALFUNCTIONING ꢅEꢃGꢃꢄ WIRE
BREAKAGE INSIDE THE PROBE ꢃ 5SE
ANOTHER PROBEꢃ
s
h#v BLINKSꢃ
s
4HE CONNECTED PROBE IS
NOT FOR A 05,3/8ꢀ ꢁꢂꢂIꢃ
s
5SE A PROBE THAT IS SPECIFICALLY
DESIGNED FOR THE 05,3/8ꢀꢁꢂꢂIꢃ
s
s
)NSUFFICIENT LIGHT FOR
MEASUREMENTꢃ
4HE LIGHT EMITTED FROM THE
,%$ ENTERS THE SENSOR
DIRECTLYꢃ
s
s
#HECK THAT THE PROBE IS PROPERLY
ATTACHED TO THE PATIENTꢃ
"E SURE THAT THE LIGHTꢀSOURCE AND
SENSOR SECTIONS ARE PROPERLY LINED
UPꢃ
s
3TRONG LIGHT ENTERS THE
PROBEꢆ S SENSOR DIRECTORYꢃ
s
)F THE PART BEING MEASURED IS THICKꢄ
INSUFFICIENT LIGHT WILL BE TRANSMITTEDꢃ
!TTACH PROBE TO A THINNER PARTꢃ
#LEAN THE LIGHTꢀSOURCE AND SENSOR
SECTIONSꢃ
4AKE MEASURES TO PREVENT DIRECT
ENTRY OF STRONG LIGHT TO THE PROBEꢃ
)F THIS MESSAGE REAPPEARS EVEN
THOUGH THE ABOVE POINTS HAVE BEEN
CHECKEDꢄ THE PROBE MAY BE
MALFUNCTIONINGꢃ 5SE ANOTHER
PROBEꢃ
s
h,v BLINKSꢃ
s
s
s
23
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%RROR -ESSAGES
#AUSE
3OLUTION
s
4HE LIGHT POWER REQUIRED
FOR THE MEASUREMENT ARE
N O T O B T A I N E D ꢀ 4 H E
MEASUREMENT VALUE IS
DISPLAYEDꢁ HOWEVERꢁ THE
A C C U R A C Y O F T H E
MEASUREMENT VALUES
CANNOT BE GUARANTEEDꢀ
s
#HECK THAT THE PROBE IS PROPERLY
ATTACHED TO THE PATIENTꢀ
"E SURE THAT THE LIGHTꢂSOURCE AND
SENSOR SECTIONS ARE PROPERLY LINED
UPꢀ
)F THE PART BEING MEASURED IS THICKꢁ
INSUFFICIENT LIGHT WILL BE TRANSMITTEDꢀ
!TTACH PROBE TO A THINNER PARTꢀ
#LEAN THE LIGHTꢂSOURCE AND SENSOR
SECTIONSꢀ
4AKE MEASURES TO PREVENT DIRECT
ENTRY OF STRONG LIGHT TO THE PROBEꢀ
)F THIS MESSAGE REAPPEARS EVEN
THOUGH THE ABOVE POINTS HAVE BEEN
CHECKEDꢁ THE PROBE MAY BE
MALFUNCTIONINGꢀ 5SE ANOTHER PROBEꢀ
s
s
s
-EASUREMENT VALUE AND
h,v FLASH ALTERNATELYꢀ
s
s
s
s
0ULSE SIGNAL REQUIRED FOR
MEASUREMENT IS NOT
BEING RECEIVEDꢀ
s
#HECK THAT THE PROBE IS PROPERLY
ATTACHED TO THE PATIENTꢀ )F THE PROBE
IS PROPERLY ATTACHED BUT THIS
MESSAGE STILL APPEARSꢁ THE CIRCULATION
IN THE AREA BEING MEASURED MAY NOT
BE GOODꢀ -OVE THE PROBE TO AN AREA
FROM WHICH A SUFFICIENTLY STRONG PULSE
SIGNAL CAN BE RECEIVEDꢀ
s
h0v BLINKSꢀ
s
)F A SUFFICIENTLY STRONG PULSE SIGNAL
CANNOT BE OBTAINED REGARDLESS OF THE
AREA TO WHICH THE PROBE IS ATTACHEDꢁ
THE PROBE MAY BE MALFUNCTIONINGꢀ
5SE ANOTHER PROBEꢀ
s
4HE PULSE IS WEAK AND THE
PULSE SIGNALS REQUIRED FOR
THE MEASUREMENT ARE NOT
s
!TTACH THE PROBE TO THE BODY
CORRECTLYꢀ )F THIS MESSAGE IS DISPLAYED
WHEN THE UNIT IS ATTACHED TO THE
PATIENT CORRECTLYꢁ THE MEASUREMENT
CONDITIONS ARE REGARDED AS BLOOD
CIRCULATION OR OTHER CIRCULATORY
PROBLEMSꢀ )F THIS OCCURSꢁ SEARCH FOR A
LOCATION WHERE ADEQUATE PULSE
SIGNALS CAN BE OBTAINEDꢀ !TTACH THE
PROBE AGAIN OR WARM UP THE
MEASUREMENT LOCATIONꢀ
O B T A I N E D ꢀ
4 H E
MEASUREMENT VALUE IS
DISPLAYEDꢁ HOWEVERꢁ THE
A C C U R A C Y O F T H E
MEASUREMENT VALUES
CANNOT BE GUARANTEEDꢀ
s
-EASUREMENT VALUE AND
h0v FLASH ALTERNATELYꢀ
s
)N PARTICULARꢁ WHEN THE PULSE IS WEAKꢁ
THIS ERROR TENDS TO OCCURꢀ &OR
IMPROVED MEASUREMENT ACCURACYꢁ IF
THE PROBE IS EXPOSED TO STRONG LIGHTꢁ
WRAP IT WITH A PIECE OF BLACK CLOTHꢁ ETCꢀ
!LSO MAKE SURE THAT THE PATIENT RESTS
CALMLY TO AVOID INFLUENCE OF BODY
MOVEMENTꢀ
24
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%RROR -ESSAGES
#AUSE
3OLUTION
s
4HE PULSE IS TOO STRONG FOR
CORRECT MEASUREMENTꢀ
s
!TTACH THE PROBE TO THE BODY
CORRECTLYꢀ )F THIS MESSAGE IS
DISPLAYED WHEN THE UNIT IS ATTACHED
TO THE PATIENT CORRECTLYꢁ THE
MEASUREMENT CONDITIONS ARE
REGARDED AS BLOOD CIRCULATION OR
OTHER CIRCULATORY PROBLEMSꢀ )F THIS
OCCURSꢁ SEARCH FOR A LOCATION WHERE
MORE STABLE PULSE SIGNALS CAN BE
OBTAINEDꢀ
s
h(v BLINKSꢀ
s
s
)F THIS MESSAGE REAPPEARS EVEN
THOUGH THE ABOVE POINTS HAVE BEEN
C H E C K E D ꢁ T H E P R O B E M A Y B E
MALFUNCTIONINGꢀ 5SE ANOTHER PROBEꢀ
s
-OTION ARTIFACT
!TTACH THE PROBE TO THE PATIENT
PROPERLYꢀ )F THIS MESSAGE STILL
REAPPEARS EVEN THOUGH THE PROBE IS
ATTACHED PROPERLYꢁ KEEP THE
MEASURING POINT AS STATIONARY AS
POSSIBLE OR ATTACH THE PROBE TO
ANOTHER PART OF THE BODY WHERE BODY
MOVEMENT IS RELATIVELY LOWꢀ
4HE MEASUREMENT VALUE
IS DISPLAYEDꢁ HOWEVERꢁ THE
A C C U R A C Y O F T H E
MEASUREMENT VALUES
CANNOT BE GUARANTEEDꢀ
s
-EASUREMENT VALUE AND
h!v FLASH ALTERNATELYꢀ
s
4HE PULSE RATE EXCEEDS THE
UPPER LIMIT ꢂꢃꢄꢅ BPM OF
THE MEASUREMENT RANGEꢀ
s
-EASUREMENT CANNOT BE PERFORMED
WHEN THE UPPER LIMIT OF THE
MEASUREMENT RANGE IS EXCEEDEDꢀ
s
hꢆ/ꢆv BLINKSꢀ
25
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%RROR -ESSAGES
#AUSE
3OLUTION
s
4HE PULSE RATE BELOWS THE
LOWER LIMIT ꢀꢉꢅ BPM OF THE
MEASUREMENT RANGEꢁ
s
-EASUREMENT CANNOT BE PERFORMED
W H E N T H E L O W E R L I M I T O F T H E
MEASUREMENT RANGE IS BELOWEDꢁ
s
hꢊ5ꢊv BLINKSꢁ
ꢀ4HIS INDICATES THAT THE MEASUREMENT
VALUE IS OUT OF THE GUARANTEED
ACCURACY RANGEꢁ
・ 4HE OXYGEN SATURATION ꢀꢂ
ꢃ
3P/ IS ALUE BELOW THE
LOWER LIMIT ꢀꢄꢅꢂ OF THE
MEASUREMENT RANGEꢁ 4HE
MEASURED VALUE WILL STILL
BE DISPLAYEDꢆ BUT ITS
A C C U R A C Y C A N N O T B E
GUARANTEEDꢁ
s
-EASUREMENT VALUE
BLINKSꢁ
s
"ATTERY /UT
s
s
2EPLACE THE BATTERY WITH NEW ONEꢁ
)N THIS CASEꢆ THE MEASUREMENT DATA
IS NOT LEFT IF THE BATTERY IS REMOVEDꢁ
・ "ATTERY POWER IS LOWꢁ
s
&OR ABOUT ꢇ HOURꢈ S MEASUREMENT
IS AVAILABLEꢁ
s
" A T T E R Y M A R K I S
DISPLAYED AS LEVEL ꢃꢁ
s
s
) F I T I S N E C E S S A R Y T O T A K E
MEASUREMENT OVER ꢇ HOURSꢆ REMOVE
BATTERY AND REPLACE WITH NEW ONEꢁ
)F THE BATTERY IS OUT IN THE MIDDLE OF
MEASUREMENTꢆ THE MEASUREMENT
VALUE IS NOT LEFTꢁ
s
s
2EPLACE THE BATTERY WITH NEW ONE
AS SOON AS POSSIBLEꢁ
)F THE BATTERY IS OUT IN THE MIDDLE OF
MEASUREMENTꢆ THE MEASUREMENT
VALUE IS NOT LEFTꢁ
・ "ATTERY POWER IS EMPTYꢁ
s
" A T T E R Y M A R K I S
DISPLAYED AS LEVEL ꢉ
ONLYꢁ
26
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%RROR -ESSAGES
#AUSE
3OLUTION
s
s
4URN THE 0OWER /FFꢀ AND TURN /.
AGAINꢁ
s
!NY TROUBLE MAY OCCUR IN
THE MEASUREMENT CIRCUIT
OF THE INSTRUMENTꢁ
)F THESE MESSAGE REAPPEAR EVEN
THOUGH THE ABOVE POINTS HAVE BEEN
CHECKEDꢀ THE INSTRUMENT MAY BE
MALFUNCTIONINGꢁ #ONTACT TO THE
NEAREST DISTRIBUTER OR AUTHORIZED
SERVICE FACILITIESꢁ
27
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Check Points before repairing
Before taking any actions, check the following points first.
If the abnormality continues to reappear, the instrument might
be faulty, so contact the nearest distributor or authorized service
facility.
◆
Problem
Checkpoint
Solution
Ref.Page
P.15
.O DISPLAY
·
)S BATTERY POWER
EXHAUSTEDꢁ
4URN THE 0OWER /&& AND
REPLACE THE BATTERY ꢂ!!!ꢃSIZE
WITH NEW ONEꢀ
·
·
APPEARS WHEN
THE 0OWER IS
TURNED /.ꢀ
)S BATTERY ORIENTED
CORRECTLYꢁ
-AKE SURE THAT THE BATTERY
ARE ORIENTED CORRECTLY
·
·
·
P.15
P.20
.
q
$ISPLAY
)SNꢄ T SET THE AUTO
POWERꢃOFF TIMER BY
USING THE OPTIONAL
SOFTWAREꢁ
q
)F THE AUTO POWERꢃOFF TIMER
SETꢅ THE 0OWER IS TURNED OFF IN
THE SET TIME AFTER THE POWER
HAD BEEN TURNED /.ꢀ
DISAPPEARED IN
THE MIDDLE OF
MEASUREMENTSꢀ
Maintenance and Inspection
•
Before using the instrument, make sure that there is no dam-
age to the instrument, no damage or wire-breakage in the
probe cable and the instrument operates correctly and safely.
Cleaning
•
Dampen a soft cloth with neutral detergent or water, wipe
the instrument with it, then wipe off carefully with a dry cloth.
In this way, make sure the instrument is cleaned and never
use solvent. When cleaning, take care not to touch the con-
nector terminals. Touching them may break terminal pins,
resulting in breakdown or damage.
28
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Specification
Dual-wavelength pulse type (665nm/880nm) arterial blood oxygen satura-
tion measuring instrument
¢
¢
•
Functions:
Name:
Oxygen Saturation Monitor PULSOX-300i
•
•
Measuring range:
Accuracy:
SpO : 0 to 100% SpO
2
2
Pulse rate: 30 to 230 bpm
SpO : ±2% SpO (70 to 100% range, 1S.D.)
2
2
Pulse rate: ±2 bpm (30 to 100 range)
or ±2% of value (100 to 230 range)
✻ PULSOX-300i has been clinically validated for use on adults.
¢
Display
Display type: Liquid crystal display (with back-light function)
Oxygen saturation (SpO )
2
Pulse rate number
Pulse level meter (8 steps)
Battery indication (3 steps)
Error messages indication
Warning functions
¢
¢
SpO : Low SpO warning (flashing display)
2
2
Battery indication
Error message indication
Memory function
Up to 300 hours at one-second intervals
SpO value, pulse rate, and error message information, and the file infor-
mation (file number, date and time of starting measurements, and duration
of measurement)
2
✻ Data can be downloaded or displayed using the optional software.
Operating conditions
Temperature/humidity range
¢
¢
0 to 40°C (32 to 104°F); 30 to 85% relative humidity with no condensation
Atmospheric pressure/altitude range
700 to 1060hPa (altitude: –400 to 3000m)
Storage conditions
Temperature/humidity range
–10 to 60°C (14 to 140°F); 10 to 95% relative humidity with no condensation
Atmospheric pressure/altitude range
700 to 1060hPa (altitude: –400 to 3000m)
¢
¢
Power
1 AAA-size battery: 1.5V
approx. 30 hours with alkaline battery)
100mW (Service life under continual usage:
Dimensions (W × H × D)
68 × 58 × 15 mm
29
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¢
¢
Weight
56g (including battery/excluding wrist band and probes)
Usable life
6 years [Verified by KONICA MINOLTA SENSING, INC. (based on own data)]
Probes (SR-5C, SP-5C, LM-5C, SD-5C)
¢
LED-SPD probe
Type
¢
•
•
•
•
Finger Clip Probe SR-5C
Spot Check Probe SP-5C
Monitor Probe LM-5C
Personal Probe SD-5C
✻ It can be used with one of Extension Cable EC-300
¢
Components that touch the body
Cover:
Wrist band:
Polycarbonate
Polyethylene terephthalate, nylon 6
Rating nameplate: Polyethylene terephthalate
Cover
Wristband
Rating nameplate
Equipment classification (based on “UL 60601-1/EN 60601-1”)
•
•
•
Protection against electric shock: Internally powered
Type of applied part: BF
Not suitability for use in the presence of flammable anaesthetic mixture
with air or oxygen or nitrous oxide.
•
•
The instrument is not protected against entry of water.
Only the cleaning method has been stipulated (no disinfection/sterilization
methods have been stipulated).
•
Mode of operation of Equipment: Continuous while in Use (IEC 60601-1)
30
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Appendix
Calculation Method for Displayed Values
<Pulse level meter>
The pulse level meter displays the transmitted light amount ratio calculated by the
following equation. The pulse level is indicated in eight levels (0 to 15%, full scale
if over 10%).
Transmitted light amount that varies due to the pulse
Pulse level (%) = ------------------------------------------------------------------------------------------------------------------ x 100
Transmitted light amount that does not vary due to the pulse
<Oxygen saturation (SpO2)>
Updates the moving average of the oxygen saturation over the last 12 seconds at
one-second intervals.
<Pulse rate (P.R.)>
Updates the moving average of the last 8 pulse rates at one-second intervals.
31
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EMC Guidance
Guidance and manufacture’s declaration - electromagnetic emissions
The Oxygen Saturation Monitor Model PULSOX-300i is intended for use in the electromagnetic
environment specified below. The customer or the user of the Model PULSOX-300i should assure
that it is used in such anenvironment.
Emissions test
Compliance
Electriomagnetic environment - guidance
RF emissions
CISPR 11
The Model PULSOX-300i 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 electromagnetic equipment.
Group 1
RF emissions
CISPR 11
Harmonic emissions
IEC61000-3-2
Voltage fluctuations/
flicker emissions
IEC61000-3-3
The Model PULSOX-300i 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.
Class B
Not applicable
Not applicable
Guidance and manufacture’s declaration - electromagnetic immunity
The Oxygen Saturation Monitor Model PULSOX-300i is intended for use in the electromagnetic
environment specified below. The customer or the user of the Model PULSOX-300i should assure
that it is used in such anenvironment.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic environment -
guidance
Electromagnetic
Discharge (ESD)
IEC61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile, if fllors are covered with
synthetic materisl, the relative humidity
should be at least 30%.
Electrical fast
Transient/burst
IEC61000-4-4
Not applicable
Surge
Not applicable
Not applicable
IEC61000-4-5
Voltage dips, short
Interruptions and
Voltage variations
on power supply
Input lines
IEC61000-4-11
Power frequency
(50/60Hz) magnetic
field
3 A/m
3 A/m
Power frequency magnetic fields
should be at level characteristic of a
typical location in a typical commercial
or hospital environment.
IEC61000-4-8
32
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Guidance and manufacture’s declaration - electromagnetic immunity
The Oxygen Saturation Monitor Model PULSOX-300i is intended for use in the electromagnetic
environment specified below. The customer or the user of the Model PULSOX-300i should assure
that it is used in such anenvironment.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC61000-4-6
3 Vrms
3 Vrms
Portable and mobile RF communications
equipment should be used no closer to
any part of the PULSOX-300i, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
150kHz to 80MHz
Radiated RF
IEC61000-4-3
3 V/m
80MHz to 2.5GHz
3 V/m
Recommended separation distance
Eꢀꢀꢀꢀꢀꢀꢀꢁꢂꢃꢀ√1
ꢀꢀꢀ80MHz to 800MHz
Eꢀꢀꢀꢀꢀꢀꢀꢃꢂꢄꢀ√1 800MHz to 2.5GHz
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
inmeters (m).
Field strength from fixed RF
transmitters, as determined by an
a
electromagnetic site survey , should be
less than the compliance level in each
b
frequency range
.
Interference may occur in the vicinity
of equipment marked with the following
symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 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) telephone 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 PULSOX-300i is used exceeds
the applicable RF compliance level above, the PULSOX-300i should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
PULSOX-300i series.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
33
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Measurement Principle
This instrument measures the oxygen saturation (SpO2) in arte-
rial blood and pulse rate continuously in a non-invasive method
by applying optical principles.
With this instrument, SpO2 is defined by the following equation.
C（HbO2）
C（HbO2）＋C（Hb）
×
SpO2＝
100 (% SpO2)
where
C (Hb):
C (HbO2): Concentration of oxyhemoglobin
Concentration of reduced hemoglobin
The light-absorption characteristics of reduced hemoglobin (Hb)
are very different from those of oxyhemoglobin. This instrument
measures the changes in the absorption of red and infrared
lights passing through the tissue to determine the SpO2 of the
blood. Thus, this method is free from the effects of skin color,
muscles, bones, and veins.
¢
Spectral Absorption of Hb and HbO2
Red light
Infrared light
Wavelength
34
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Relation between Oxygen Saturation and Partial Pressure
2
The relation between oxygen saturation (SpO ) and oxygen
partial pressure (PaO2) is shown in the graph below. SpO2 is the
oxygen saturation as measured by pulse oximeters.
¢
Oxygen Saturation vs. Oxygen Partial Pressure
%
100
90
85
80
70
60
50
40
30
20
10
SpO2
pH=7.4
37°C
0
10
20
30
40
50
60
70
PaO2
80
90 100 110
Torr
(mmHg)
The curve of the above graph may shift to the right or left according to
the pH of the blood or the body temperature.
•
Shift to right: acidosis, high body temperature
Shift to left: alkalosis, low body temperature
•
35
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MEMO
36
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Manufacturer
3-91, Daisen-nishimachi, Sakai-ku, Sakai-shi, Osaka 590-8551, Japan
© 2007-2009 KONICA MINOLTA SENSING, INC.
9222-1732-36
AJFAKK Printed in Japan
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