Safety Symbols Warnings and precautions noted in this manual and the instrument are indicated by the following markings, designed to prevent accidents caused by erroneous handling of the equipment. This indicates text consisting of a warning or precaution relating to safety. Please read the text carefully and use the equipment safely.
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-...
Page 4
Do not use probes other than those specified by KONICA MINOLTA, INC. Use of alternative probes may cause the probe to overheat, resulting in burns. Do not operate the instrument for long periods of time with the probe attached to a patient.
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...
) 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 (SpO 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.
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 (LR03) × 1 4) Instruction manuals • PULSOX-300i instruction manual × 1 •...
System Diagrams and Accessories The instrument consists of the following items. Standard accessories Optional accessories Optional accessories Finger Clip Probe SR-5C PULSOX-300i Spot Check Probe SP-5C Extension cable EC-300 Monitor Probe LM-5C USB adapter UA-300 Personal Probe SD-5C Standard accessories...
Names of Parts Power button Used to start measurement ( P o w e r - O N ) o r e n d measurement (Power-OFF). LCD Display (with the backlight function) Measurement results and messages are displayed. Probe connector Backlight button C o n n e c t t h e p r o b e o r extension cable EC-300 to...
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 •...
Page 11
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.
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 •...
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.
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.
Page 15
Fold up the inserted hook-and-loop section, and stick it firmly to the band. Pass the other end of the Band fixture B band outward through band fixture B. ◆ Take care not to twist the band. Fold back and secure the band with the hook- and-loop tape section.
◆ 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)
3) Installing the battery Turn the battery cover clockwise approximately 90 degrees to open the cover. ◆ W h e n t u r n i n g t h e c o v e r, k e e p t h e f l a t part of your finger on the cover’s catch.
Remove the hook-and- 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. A d j u s t t h e f a s t e n i n g...
Measurement 1) Starting the Measurement Connect the probe to the PULSOX-300i correctly. 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.
Page 20
PULSOX-300i. ◆ “ - - - ” i s d i s p l a y e d u n t i l t h e m e a s u r i n g d a t a i s calculated.
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 SpO value are displayed during measurement. Pulse rate (P.R.) If an error occurs, an Battery mark error message mainly I n d i c a t e s t h e a b o u t P.
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.
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.
Page 24
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.
• “C” blinks. Extension Cable EC-300, connected to the PULSOX-300i, the t h e c a b l e m a y n o t b e probe is malfunctioning (e.g., wire breakage inside the probe).
Page 26
Error Messages Cause Solution • The light power required • Check that the probe is properly for the measurement are attached to the patient. n o t o b t a i n e d . T h e • Be sure that the light-source and measurement value is sensor sections are properly lined displayed, however, the...
Page 27
Error Messages Cause Solution • A t t a c h t h e p r o b e t o t h e b o d y • The pulse is too strong for c o r r e c t l y . I f t h i s m e s s a g e i s correct measurement.
Page 28
Error Messages Cause Solution • The pulse rate is below • Measurement cannot be performed the lower limit (30 bpm) of w h e n t h e l o w e r l i m i t o f t h e the measurement range.
Page 29
Error Messages Cause Solution • Turn the Power Off, and turn ON • Any trouble may occur in again. the measurement circuit • If these message reappear even of the instrument. though the above points have been checked, the instrument may be malfunctioning.
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 · No display · ...
(70 to 100% range, 1S.D.) 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)
Page 32
Weight 56g (including battery/excluding wrist band and probes) Usable life 6 years [Verified by KONICA MINOLTA, 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 •...
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...
EMC Guidance Guidance and manufactureʼs 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 The Model PULSOX-300i uses RF energy only for its internal function. Therefore its RF emissions are CISPR 11 Group 1 very low and are not likely to cause any interference in nearby electromagnetic equipment. RF emissions The Model PULSOX-300i is suitable for use in all Class B establishments, including domestic establishments CISPR 11 and those directly connected to the public Harmonic emissions low-voltage power supply network that supplies Not applicable IEC61000-3-2 buildings used for domestic purposes. Voltage fluctuations/ flicker emissions Not applicable IEC61000-3-3 Guidance and manufactureʼs 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 Compliance Electromagnetic environment - Test level ...
Page 35
Guidance and manufactureʼs 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 Compliance Electromagnetic environment - Test level level guidance Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC61000-4-6 equipment should be used no closer to 150kHz to 80MHz any part of the PULSOX-300i, than the Radiated RF 3 V/m 3 V/m recommended separation distance IEC61000-4-3 80MHz to 2.5GHz calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80MHz to 800MHz 1.2 P 800MHz to 2.5GHz 2.3 P 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).
Measurement Principle This instrument measures the oxygen saturation (SpO ) in arte- rial blood and pulse rate continuously in a non-invasive method by applying optical principles. With this instrument, SpO is defined by the following equation. C(HbO ) = 100 (% SpO C(HbO )...
Relation between Oxygen Saturation and Partial Pressure The relation between oxygen saturation (SpO ) and oxygen partial pressure (PaO ) is shown in the graph below. SpO is the oxygen saturation as measured by pulse oximeters. Oxygen Saturation vs. Oxygen Partial Pressure ...