Minolta Heart Rate Monitor Pulsox 2 User Manual

Oxygen Saturation Monitor  
PULSOX-2  
INSTRUCTION MANUAL  
 
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.)  
Do not use the instrument in places where flammable or combustible  
gases (anesthetic gas etc.) are present. Doing so may cause a fire.  
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.  
This device is designed to measure the oxygen saturation level (SpO2)  
and the pulse rate. It should not be used as a warning device to detect  
cessation of breathing or irregular breathing during sleep.  
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CAUTION  
(Failure to adhere to the following points may result in injury or  
damage to the instrument or other property.)  
Do not use batteries other than those specified by MINOLTA. When  
installing batteries in the instrument, make sure that they are correctly  
oriented according to the (+) and (–) marks. For a model which use  
more than one battery, do not mix new and old batteries, or mix batteries  
of different types. Failure to adhere to these instructions may cause  
explosion of the batteries or leakage of electrolyte, resulting in fire,  
injury or corrosion.  
Do not place the instrument on an unstable or sloping surface. Doing  
so may result in its dropping or overturning, causing injury. Take care  
not to drop the instrument when carrying it.  
Do not operate the instrument for long periods of time with a finger  
holder attached to a patient. Low-temperature burn, redness or rash  
may result. If you feel pain or itchiness, stop use of the instrument  
immediately and consult a doctor. A doctor should also be consulted  
before using the instrument on infants, those with peripheral blood  
circulation problems or those with sensitive skins.  
If alkali fluid from the battery comes in contact with eyes, skin, or  
clothing, immediately wash the affected area and see a physician for  
treatment.  
Do not use wet batteries. do not use instrument if the battery  
compartment contains  
water. Doing so may cause explosion or heat  
generation, resulting in fire or injury.  
Do not disassemble or modify the instrument. Doing so may cause a  
fire or electric shock  
2
 
1. BEFORE OPERATION  
Safety Notes  
CAUTION: Federal law restricts this device to sale by or on the  
order of a physician.  
The PULSOX-2 is a medical instrument, so instructions given by a  
doctor must be adhered to.  
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.  
Package Contents  
Make sure that all the following items are supplied with the instrument.  
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2
3
PULSOX-2 main unit (×1)  
Neck strap NS-M (×1)  
AAA-size alkaline battery (×2)  
Main Features  
This pulse type oximeter emits light to the user’s finger to measure the  
oxygen saturation (SpO2 %) of arterial blood and the pulse rate.  
Compact, lightweight and portable  
The light weight, compactness, and portability of the PULSOX-2 allows it  
to be used for inspection of both outpatients and inpatients. In addition, it  
is easily transported by both doctors and nurses for house calls or home-  
care patients.  
Battery-operated  
The PULSOX-2 is operated by two AAA-size alkaline batteries.  
4
 
2. NAMES OF PARTS  
Main unit  
Finger holder  
Battery cover lock  
Battery cover  
Display  
Strap eyelet  
Thumb rest  
Battery cover: Open or close this cover when replacing the  
batteries with new ones.  
Battery cover: It is used to lock the battery cover.  
lock  
Strap eyelet: Attach the neck strap to this hook.  
Finger holder: Holds finger when inserted for measurement.  
A light source is located in the upper side, and a  
sensor in the lower side.  
Thumb rest:  
Display:  
Put the thumb here when you hold this instrument.  
Displays measured value, pulse level meter and error  
messages  
.
5
 
3. NOTES ON USE  
This instrument should be used in areas with an ambient temperature of 0 to  
40°C (32 to 104°F) and a relative humidity of 30 to 95%, with no condensation.  
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.  
This instrument conforms to water-seal rating of IPX4 (IEC 60529), which  
ensures that the instrument will show no adverse damage even if exposed  
to water splashing from any direction. However, the instrument is not water-  
proof, so it should never be washed with water or left immersed in water.  
When the water remains in finger holder, the measurement value is not  
accurate.Turn the part of strap eyelet to the bottom, and remove the water.  
This instrument should not be used in areas subject to strong vibrations, nor  
should it be subjected to physical shock. Doing so may cause breakdown.  
The finger holder is a delicate device and should not be handled roughly nor  
should objects be placed on top of it.  
The accuracy of this instrument, like that of all other dual-wavelength  
oximeters, can be influenced by the presence of abnormal hemoglobins such  
as carboxyhemoglobin (HbCO) and methemoglobin. Tables 1 and 2 below  
show the errors which may occur due to these hemoglobins. The instrument  
may also be affected by cardiogreen or intravascular dyes.  
Do not use a mobile telephone when using this instrument. Doing so may  
result in measurement error.  
This instrument may interfere with magnetic resonance imaging (MRI)  
procedure.  
The disposal method of AAA batteries varies according to local government  
regulation.  
Dispose of the battery according to the instructions given by local government  
regulations or ask a specialized waste service company to dispose of it.  
6
 
This equipment has been tested and found to comply with the limits for  
medical devices to the IEC 60601-1-2:2001, Medical Device Directive  
93/42/EEC . These limits are designed to provide reasonable protection  
against harmful interference in a typical medicitl installation. This  
equipment generates, uses and can radiate radio frequency energy and,  
if not installed and used in accordance with the instructions, may cause  
harmful interference to other devices in the vicinity. However, there is no  
guarantee that interference will not occur in a particular installation. If  
this equipment does cause harmful interference to other devices, which  
can be determined by turning the equipment off and on, the user is  
encouraged to try to correct the interference by one or more of the  
following measures:  
• Reorient or relocate the receiving device.  
• Increase the separation between the equipment.  
• Connect the equipment into an outlet on a circuit different from that  
to which the other device's are connected.  
• Consult the manufacture or field service technician for help.  
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4. OPERATING METHOD  
Preparations  
(1) Installing Batteries  
(Two AAA-size batteries are required.)  
1. Push the battery cover, and unlock  
the battery cover lock.  
1
2. Open the battery cover.  
3. Insert two AAA-size batteries into the  
battery chamber.  
3
2
4. Close the battery cover and hold it  
with a finger.  
4
8
 
5. Close the battery cover lock until it  
clicks.  
The batteries will last approxi-  
mately 80 hours.  
The battery mark will begin to  
blink when the battery power is  
low.  
5
Notes on Use  
Battery replacement is the Only User Serviceable item.  
When replacing the batteries with new ones, do not mix battery types or  
ages.  
If the instrument will not be used for a long period of time, remove the  
batteries from the battery chamber. Also remove the batteries as soon as  
possible if they are dead.  
(2) Installing the Neck Strap  
By attaching the neck strap to the instrument, the instrument can be  
hung from the neck.  
1. Pass the neck strap through the  
strap eyelet as shown in the figure.  
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Measurements  
Measurements must be taken with the index finger placed in the  
finger holder. This instrument must be held tightly. Put the thumb  
only on the thumb rest. You must not put the thumb on other positions.  
Don't take the pressure which is unnecessary for the forefinger. Those  
are important for the accurate measurement.  
1. Open the finger holder.  
2. Insert the index finger and release  
the finger holder.  
Opening the finger holder will start  
measurement automatically.  
The finger should be put on the  
position shown in the figure below.  
Measurement  
display  
10  
 
Safety Notes  
This finger holder is designed only for use on the fingers of adults,  
so it should not be used on any other body parts.  
Never secure the finger holder with tape or such like. Doing so  
may cause hemostasia or dropsy.  
Notes on Use  
Remove nail polish before taking measurements.  
If no measurement values are displayed, attach the finger holder to a  
thinner finger to take measurements.  
It may not be possible to take measurements in case of blood circulation  
or blood stream problems. In this case, remove the finger holder, rub or  
warm the finger to improve blood circulation, then re-attach the finger  
holder.  
Do not use the instrument in areas where it is exposed to strong light  
such as direct sunlight.  
Notes on Measurements  
Check that the pulse level meter changes in synchronization with the pulse  
rate during measurements. In the following cases, the level meter may  
not operate properly, hindering display of correct values.  
Rapid body movement  
Finger Holder is not attached to the patient properly.  
Arm or finger is pressed, causing bad blood circulation.  
When using the instrument, take care not to expose the finger holder to  
strong light.  
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Ending Measurements  
1. Open the finger holder and remove the finger.  
Measurement will stop automatically, and the display will go  
off after 10 seconds.  
Notes on Use  
If the instrument will not be used for a long period of time, remove the  
batteries from the battery chamber.  
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How to Read the Measurement Values  
Pulse level meter: Indicates the pulse level in 8 levels (0 to 10%, full  
scale if 10% or higher). The pulse level is defined as follows. (For  
stable measurements, adjust the measuring point of the finger holder  
or rub or warm the measuring point to improve blood circulation, so  
that the pulse level meter constantly indicates level 2 or higher.)  
Variable transmittance  
Constant transmittance  
Pulse level (%) =  
× 100  
Battery indication: The battery mark will be-  
gin to blink when the bat-  
tery power level is low.  
(For details regarding  
batteries, refer to page 8.)  
Pulse rate (P.R.)  
Oxygen saturation value  
(SpO2)  
Pulse level meter  
Calculation method for displayed values  
Oxygen saturation value (SpO2):  
Value obtained by performing moving averaging for the  
last 5 seconds is updated and displayed every second.  
Pulse rate (P.R.):  
Value obtained by performing moving averaging for the  
last 8 pulse rates is updated and displayed every second.  
13  
 
Back Light  
The backlight will light up automatically when the surroundings  
become dark.  
When backlight isn’t turned by the bright surroundings, cover the  
backlight sensor window with finger.  
Backlight sensor window  
• Once the backlight is lit, it will remain lit until measurement stops.  
• When battery mark is blinking, backlight isn’t turned on. Please  
replace the battery.  
14  
 
Error Messages  
Messages relating to connection of the finger holder and attachment to  
the patient  
15  
 
Messages relating to the condition of the main unit  
16  
 
5. TROUBLESHOOTING  
Main Unit  
17  
 
6. In Case of Malfunction  
If a malfunction occurs, contact the nearest authorized service facility.  
Never disassemble the unit or attempt to repair it yourself.  
7. Maintenance and Storage  
This instrument should be stored at temperatures of between –10 and  
60°C (14 and 140°F) at 30 to 95% relative humidity. Do not store this  
instrument in areas subject to high temperatures or high humidity, and do  
not subject this instrument to sudden temperature changes which may  
result in condensation. For protection, this instrument should be stored  
with a drying agent such as silica gel.  
When storing the instrument:  
Do not store the instrument in an area where it will be exposed  
to water.  
Do not store the instrument in an area where direct sunlight,  
pressure, temperature, humidity, ventilation, sunlight, dust,  
strong magnetic fields, and/or saline or sulphurous atmos-  
pheres 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 and finger holders are cleaned and stored safely.  
If the PULSOX-2 will not be used for more than two weeks, remove  
batteries to avoid the possibility of damage due to leakage of electrolyte.  
8. Maintenance and inspections  
Before using the instrument, carefully check that the instrument is operating  
safely and correctly.  
9. Cleaning  
When cleaning the main unit, clean it with a cloth moistened with neutral  
detergent or water. Never clean it by any other methods or with any kind  
of solvent.  
When cleaning a finger holder, clean it using a soft cloth moistened with ethyl  
alcohol or cationic soap, and wipe it off using a dry soft cloth or dry it naturally.  
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10.SPECIFICATIONS  
PULSOX-2  
Dual-wavelength pulse-type oximeter  
Functions:  
Measuring range: SpO2: 0 to 100%  
Pulse rate: 20 to 250 bpm  
Accuracy:  
SpO2 ±2% (SpO2:70 to 100%, 1 s.d.)  
Pulse rate: ±2 bpm  
Display  
Display type: Liquid crystal display  
Oxygen saturation (SpO2)  
Pulse rate number  
Pulse level meter  
Error messages  
Operating temperature/humidity range  
0 to 40°C (32 to 104°F); 30 to 95% relative humidity with no  
condensation  
Storage temperature/humidity range  
–10 to 60°C (14 to 140°F); 30 to 95% relative humidity with no  
condensation  
Power  
2 AAA-size batteries 3V  
(This instrument can use about 80 hours continuously, when the use of theAAA alkaline battery.)  
80mW  
Dimensions (W × H × D)  
69 × 60 × 28 mm  
Weight  
57 g  
Accessory  
Standard Accessory: Neck strap  
Equipment Classification  
Protection against electric shock : Internally powered  
Type of applied part : BF  
Degree of protection against harmful ingress of water : Splash-  
ploof equipment(IPX4)  
Not suitability for use in the presence of flammable anaesthetic  
mixture with air or oxygen or nitrous oxide.  
Mode of operation of Equipment : Continuous while in Use (IEC60601-1)  
19  
 
11. REFERENCE  
Measurement Principle  
Oxygen Saturation Monitor PULSOX-2 is a photometric instrument  
that non-invasively and continuously measures the oxyhemoglobin  
saturation of arterial blood (SpO2) and the pulse rate. SpO2 is  
described by the equation:  
C (HbO2)  
C (HbO2) + C (Hb)  
SpO2 =  
× 100 (% SpO2)  
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. The PULSOX-2  
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  
cm2  
mole  
×10 -6  
Red light  
Infrared light  
1.0  
0.5  
Hb  
HbO2  
600  
665 700  
800  
880 900nm  
Wavelength  
20  
 
Relation between Oxygen Saturation and Partial Pressure  
The relation between oxygen saturation (SpO2, %) and oxygen partial  
pressure (PaO2, torr or mmHg) 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  
Adult hemoglobin  
pH=7.4  
30  
37°C  
20  
10  
0
10  
20  
30  
40  
50  
60  
70  
80  
90 100 110  
Torr  
PaO2  
(mmHg)  
Oxygen Partial Pressure  
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)  
21  
 
EMC Declaration  
22  
 
23  
 
Minolta Co.,Ltd.  
3-13, 2-Chome, Azuchi-Machi,Chuo-Ku, Osaka 541-8556, Japan  
2003 Minolta Co., Ltd.  
( )  
9222-1731-13  
 
1
ADDAPX  
Printed in Japan  

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