Konica Minolta Oxygen Equipment PULSOX 300i User Manual

OXYGEN SATURATION MONITOR  
PULSOX®-300i  
Instruction Manual  
This instrument must be used  
according to the instructions of  
the doctor.  
 
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
 
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
 
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
 
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
 
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
 
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
 
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
 
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
 
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
 
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  
 
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  
 
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  
 
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  
 
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  
 
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  
 
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  
 
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.  
Display 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.  
Display the Month and the Day  
month  
day  
Display the Time as 24 hours  
format  
hour  
minute  
17  
 
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  
 
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  
 
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  
 
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  
 
<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  
 
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  
 
%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  
 
%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  
 
%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  
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  
 
%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  
 
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  
 
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  
 
¢
¢
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  
 
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  
 
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  
 
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  
Eꢀꢀꢀꢀꢀꢀꢀꢁꢂꢃ1  
ꢀꢀꢀ80MHz to 800MHz  
Eꢀꢀꢀꢀꢀꢀꢀꢃꢂꢄ1 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  
 
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(HbO2C(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  
 
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  
 
MEMO  
36  
 
 
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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