Konica Minolta Oxygen Equipment PULSOX 300 User Manual

OXYGEN SATURATION MONITOR  
®
-300  
PULSOX  
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 af-  
fected 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.  
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 .......................................................13  
)
3 Installing the battery..........................................................14  
Measurement....................................................................15  
)
1 Starting the Measurement (Power ON) ............................15  
)
2 Reading the display..........................................................16  
)
3 Ending the Measurement (Power OFF)............................17  
About Auto Power-Off function..............................................17  
Trouble Shootings ............................................................18  
Error Messages.....................................................................18  
Check Points before repairing...............................................22  
Maintenance and Inspection.................................................22  
Cleaning................................................................................22  
Specification.....................................................................23  
Appendix...........................................................................25  
Calculation Method for Displayed Values .............................25  
EMC Guidance......................................................................26  
Measurement Principle.........................................................28  
Relation between Oxygen Saturation and partial Pressure.............. 29  
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-300 is designed  
to measure oxygen saturation (SpO2 value) in arterial  
blood and pulse rate by attaching a probe to an adult  
finger, in a non-invasive method.  
PULSOX-300 is intended for spot check use.  
• The compact, lightweight and portable body has a large  
LED display for easy operation.  
4
 
Package Contents  
Before using the instrument, make sure that the following items  
are present.  
1) PULSOX-300 main body × 1  
2) Wristband WB-300 × 1  
3) AAA-size alkaline battery × 1  
4) Instruction manuals  
PULSOX-300 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  
Patient  
Allowed measuring point  
SR-5C  
SP-5C  
LM-5C  
SD-5C  
Adult  
Finger (hand)  
For the usage method, please refer to “Connecting the probe”  
(page 13) 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  
Spot Check Probe SP-5C  
Extension cable EC-300  
05,3/8ꢀꢁꢂꢂ  
Monitor Probe LM-5C  
Personal Probe SD-5C  
Standard accessories  
Wristband WB-300  
AAA-size alkaline battery  
6
 
Names of Parts  
Power button  
Used to start/end  
measurement.  
PULSOX-300  
Display (LED)  
Measurement results and  
messages are displayed.  
Probe connector  
Connect the probe to this  
connector.  
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.  
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 insuffi-  
ciency)  
When ambient light (e.g. panel light, fluorescent light, in-  
frared heat lamp, direct sunlight) is too strong  
When influenced electromagnetically by other electronic  
devices (e.g. near electrical appliances like TV, medial  
device)  
When a mobile telephone is used during measurement  
8
 
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%.  
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.  
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.  
Procedure  
Place the instrument with its rear side up.  
1
Pass the angled tip of  
Band fixture A  
2
the hook-and-loop tape  
of the wristband outward  
through band fixture A.  
When doing so, make  
sure that the Velcro  
tape section faces  
upward.  
Fold up the inserted  
hook-and-loop section,  
and stick it firmly to the  
band.  
3
12  
 
Pass the other end of the  
band outward through  
band fixture B.  
4
5
Band fixture B  
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.  
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.  
*Connecting the extension cable  
EC-300 between the PULSOX-300  
and the probe extends the probe cable  
to a total length of 1m.  
Extension Cable EC-300 (1m)  
13  
 
3) Installing the battery  
Procedure  
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.  
14  
 
Measurement  
1) Starting the Measurement  
Attach the probe to a  
finger of an adult patient.  
1
2
Press the Power button.  
The Power is ON, all the  
elements on the display  
are displayed for about  
2 seconds, and then the  
display changes to the  
measurement display.  
PULSOX-300  
Until the measurement  
v a l u e h a s b e e n  
calculated and displayed,  
"---" will be displayed as  
the values of the oxygen  
2
saturation (SpO ) and the  
pulse rate.  
all the elements on the display are  
displayed for about 2 seconds  
the measurement value is displayed  
and then the measurement is  
started  
15  
 
2) Reading the display  
When the instrument is turned ON, all the elements of the LED  
will light up.  
The pulse level, pulse rate and SpO2 value are displayed  
during measurement.  
Pulse rate (P.R.)  
Battery indicate  
Flashing when  
battery is nearly  
empty.  
If an error occurs, an  
error message mainly  
about P.R. will be  
displayed.  
Pulse Level Meter  
Indicate the pulse level.  
Oxygen saturation  
(SpO2) value  
If an error occurs, an  
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.  
error message mainly  
about SpO2 will be  
displayed.  
16  
 
3) Ending the Measurement  
Press the Power button, the  
measurement is finished and  
the Power is off.  
PULSOX-300  
About Auto Power-Off function  
The instrument has an auto power-off function that operates  
independently. If no probe is connected to the PULSOX  
("C" blinks) or no probe is attached to the patient ("L"  
blinks) continuously for more than 2 minutes, the Power is  
automatically switched off.  
17  
 
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  
0 5 , 3 / 8 ꢀ ꢁ ꢂ ꢂ O R T H E  
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  
05,3/8ꢀꢁꢂꢂꢃ  
)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  
05,3/8ꢀꢁꢂꢂ PROPERLYꢃ 7HEN 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 05,3/8ꢀꢁꢂꢂꢄ THE  
PROBE IS MALFUNCTIONING ꢅEꢃGꢃꢄ WIRE  
BREAKAGE INSIDE THE PROBE ꢃ 5SE  
ANOTHER PROBEꢃ  
s
s
h#v BLINKSꢃ  
0OWER IS AUTOMATICALLY  
SWITCHED OFF IF NO PROBE  
I S C O N N E C T E D T O  
05,3/8 FOR MORE THAN  
ꢆ SECONDS CONTINUOUSLYꢃ  
s
4HE CONNECTED PROBE IS  
NOT FOR A 05,3/8ꢀ ꢁꢂꢂꢃ  
s
5SE A PROBE THAT IS SPECIFICALLY  
DESIGNED FOR THE 05,3/8ꢀꢁꢂꢂꢃ  
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  
PROBES SENSOR DIRECTLYꢃ  
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
s
h,v BLINKSꢃ  
0OWER IS AUTOMATICALLY  
SWITCHED OFF IF NO PROBE  
I S A T T A C H E D T O T H E  
PATIENT FOR MORE THAN ꢆ  
SECONDS CONTINUOUSLYꢃ  
s
s
s
18  
 
%RROR -ESSAGES  
#AUSE  
3OLUTION  
s
4HE LIGHT POWER REQUIRED  
FOR THE MEASUREMENT IS  
N O T O B T A I N E D ꢀ 4 H E  
MEASUREMENT VALUE IS  
DISPLAYEDꢃ 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  
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  
DISPLAYEDꢃ 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  
19  
 
%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 DISPLAYEDꢂ 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 ꢃꢄꢅꢆ BPM OF  
THE MEASUREMENT RANGEꢀ  
s
-EASUREMENT CANNOT BE PERFORMED  
WHEN THE UPPER LIMIT OF THE  
MEASUREMENT RANGE IS EXCEEDEDꢀ  
s
hꢇ/ꢇv BLINKSꢀ  
s
4HE PULSE RATE BELOWS THE  
LOWER LIMIT ꢃꢅꢆ BPM OF THE  
MEASUREMENT RANGEꢀ  
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 NOT REACHEDꢀ  
s
hꢇ5ꢇv BLINKSꢀ  
20  
 
%RROR -ESSAGES  
#AUSE  
3OLUTION  
ꢀ4HIS MESSAGE INDICATES THAT THE  
MEASURED VALUE IS OUTSIDE THE  
ACCURACY GUARANTEED RANGEꢁ  
s
4HE 3P/ VALUE IS BELOW  
THE LOWER LIMIT ꢀꢃꢄꢅ 3P/  
OF THE MEASUREMENT  
RANGEꢁ 4HE MEASURED  
V A L U E W I L L S T I L L B E  
DISPLAYEDꢆ BUT ITS ACCURACY  
CANNOT BE 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  
s
s
hBT OUTv WILL NOT BE SHOWN  
WHEN THE BATTERY IS  
COMPLETELY EXHAUSTEDꢁ  
s
"ATTERY WILL BE EMPTY IN ABOUT ꢇꢄ  
SECONDSꢁ 2EMOVE BATTERY AND  
REPLACE WITH NEW ONEꢁ  
s
"ATTERY POWER IS NEARLY  
EMPTYꢁ  
"ATTERY INDICATOR IS  
FLASHINGꢁ  
s
4URN THE 0OWER /FFꢆ AND TURN /.  
AGAINꢁ  
s
/THER TROUBLE OCCURRED IN  
THE MEASUREMENT CIRCUIT  
OF THE INSTRUMENTꢁ  
s
)F THESE MESSAGE REAPPEAR EVEN  
THOUGH THE ABOVE POINTS HAVE BEEN  
CHECKEDꢆ THE INSTRUMENT MAY BE  
MALFUNCTIONINGꢁ #ONTACT TO THE  
NEAREST DISTRIBUTOR OR AUTHORIZED  
SERVICE FACILITIESꢁ  
s
$ISPLAY FOR ABOUT  
SECONDS AND THE 0OWER  
IS SWITCHED OFFꢁ  
21  
 
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.  
0ROBLEM  
#HECKPOINT  
3OLUTION  
2EFꢀ0AGE  
0ꢀꢄꢅ  
q
q
.O DISPLAY  
q
)S BATTERY POWER  
EXHAUSTEDꢁ  
q
4URN THE 0OWER /&& AND  
REPLACE THE BATTERY ꢂ!!!ꢃSIZE  
WITH NEW ONEꢀ  
APPEARS WHEN  
THE 0OWER IS  
TURNED /.ꢀ  
q
q
)S BATTERY ORIENTED  
CORRECTLYꢁ  
q
q
-AKE SURE THAT THE BATTERY  
ARE ORIENTED CORRECTLY  
0ꢀꢄꢅ  
0ꢀꢄꢈ  
$ISPLAY  
)S NO PROBE CONNECTED  
TO THE 05,3/8 OR IS  
NO PROBE ATTACHED  
TO THE PATIENT FOR  
MORE THAN ꢆ MINUTES  
CONTINUOUSLYꢁ  
&OR AUTO POWER OFF FUNCTIONꢇ IF  
NO PROBE IS CONNECTED TO THE  
05,3/8 OR NO PROBE IS  
ATTACHED TO THE PATIENT FOR  
DISAPPEARED IN  
THE MIDDLE OF  
MEASUREMENTSꢀ  
M O R E T H A N  
M I N U T E S  
CONTINUOUSLYꢇ THE 0OWER IS  
AUTOMATICALLY SWITCHED OFFꢀ  
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.  
22  
 
Specification  
Dual-wavelength pulse type (665nm/880nm) arterial blood oxygen satura-  
tion measuring instrument  
Name: Oxygen Saturation Monitor  
Model name: PULSOX-300  
Functions:  
Measuring range:  
SpO :  
2
0 to 100% SpO  
2
Pulse rate: 30 to 230 bpm  
SpO : ±2% SpO (70 to 100% range, 1S.D.)  
Accuracy:  
2
2
Pulse rate: ±2 bpm (30 to 100 range)  
or ±2% of value (100 to 230 range)  
PULSOX-300 has been clinically validated for use on adults.  
Display  
Display type: Liquid crystal display  
Oxygen saturation (SpO )  
2
Pulse rate number  
Pulse level meter (5 steps)  
Battery indication  
Error messages indication  
Warning functions  
SpO : Low SpO warning (flashing display)  
2
2
Battery indication (flashing when the battery is nealy empty)  
Error message indication  
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  
100mW (Service life under continual usage:  
approx. 16 hours with alkaline battery)  
Dimensions (W × H × D)  
68 × 58 × 15 mm  
Weight  
56g (including battery/excluding wrist band and probes)  
Usable life  
6 years [Verified by KONICA MINOLTA SENSING, INC. (based on own data)]  
23  
 
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)  
24  
 
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.  
25  
 
EMC Guidance  
Guidance and manufacture’s declaration - electromagnetic emissions  
The Oxygen Saturation Monitor Model PULSOX-300 is intended for use in the electromagnetic  
environment specified below. The customer or the user of the Model PULSOX-300 should assure  
that it is used in such anenvironment.  
Emissions test  
Compliance  
Electriomagnetic environment - guidance  
RF emissions  
CISPR 11  
The Model PULSOX-300 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-300 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-300 is intended for use in the elec-tromagnetic  
environment specified below. The customer or the user of the Model PULSOX-300 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  
26  
 
Guidance and manufacture’s declaration - electromagnetic immunity  
The Oxygen Saturation Monitor Model PULSOX-300 is intended for use in the electromagnetic  
environment specified below. The customer or the user of the Model PULSOX-300 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-300, 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-300 is used exceeds  
the applicable RF compliance level above, the PULSOX-300 should be observed to verify normal operation. If  
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the  
PULSOX-300.  
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.  
27  
 
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.  
where  
C (Hb):  
Concentration of reduced hemoglobin  
C (HbO2): Concentration of oxyhemoglobin  
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  
28  
 
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  
29  
 
Manufacturer  
3-91, Daisen-nishimachi, Sakai-ku, Sakai-shi, Osaka 590-8551, Japan  
© 2007-2009 KONICA MINOLTA SENSING, INC.  
9222-1732-34  
AJFAKK Printed in Japan  
 

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