User Guide

ManualsBrandsKonica Minolta ManualsBlood Pressure MonitorPULSOX 300

OXYGEN SATURATION MONITOR

PULSOX

-300

Instruction Manual

This instrument must be used

according to the instructions of

the doctor.

Summary of content (32 pages)

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OXYGEN SATURATION MONITOR PULSOX -300 ® Instruction Manual This instrument must be used according to the instructions of the doctor.
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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. This indicates an action which is prohibited. The prohibited action should never be carried out, under any circumstances. This indicates instructions concerning an action.
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Foreword 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 oxygen saturation (SpO2) of arterial blood and the pulse rate.
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Foreword 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 KONICA MINOLTA SENSING, INC. When installing batteries in the instrument, make sure that they are mark. correctly oriented according to the 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.
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Safety Symbols Safety Precautions..............................................................1 Foreword.............................................................................4 Foreword Contents Safety Notes............................................................................4 Package Contents...................................................................5 About Probe.............................................................................5 System Diagrams and Accessories............
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Foreword 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 (SpO 2 ) of arterial blood and the pulse rate. Do not use it for any other purposes, such as warning of sleep apnea and breathing abnormalities.
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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. Foreword Package Contents About Probe The following probe types can be used with this instrument.
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Foreword System Diagrams and Accessories The instrument consists of the following items.
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Foreword 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.
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Foreword 8 Notes on Use • This instrument should be used under the following operating 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.

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• • • Foreword • 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

HbCO Methemoglobin SaO2 SaO2 1% 5% 10% 1% 5% 10% -0.1 -0.7 -1.5 +0.2 +1.3 +3.2 50 50 70 70 -0.1 -0.7 -1.5 -0.6 -2.

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Foreword 10 Notes on Storage • This instrument should be stored under the following storage conditions. • Temperature of –10 to 60°C (14 to 140°F), relative humidity 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 exposed to water.

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• When disposing of the used battery, insulate the polarity terminals with insulating tape etc. If the terminals of the battery come into contact with metal objects, heat generation, explosion or fire may result. • Make sure that the battery is either disposed of or recycled correctly in accordance with local laws and regulations.

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Preparations 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 1 2 Place the instrument with its rear side up.

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4 Pass the other end of the band outward through band fixture B. Band fixture B ◆ Take care not to twist the band. Preparations 5 Fold back and secure the band with the hookand-loop tape section. ◆ When attaching the instrument to an arm, adjust the band length and fitting at this hookand-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.

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3) Installing the battery Procedure Preparations 1 2 Turn the battery cover clockwise approximately 90 degrees to open the cover. ◆ When turning the 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. 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. ◆ This instrument requires one AAA-size battery.

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Measurement 1) Starting the Measurement 1 2 Attach the probe to a finger of an adult patient. Press the Power button. PULSOX-300 Measurement ● 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. ◆ Until the measurement value has been calculated and displayed, "---" will be displayed as the values of the oxygen saturation (SpO2) and the pulse rate.

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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 SpO 2 value are displayed during measurement. Battery indicate Measurement Flashing when battery is nearly empty. Pulse Level Meter Indicate the pulse level. ✻ 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. 16 Pulse rate (P.R.

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3) Ending the Measurement Press the Power button, the measurement is finished and the Power is off. PULSOX-300 Measurement 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.

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Trouble Shootings Error Messages The instrument display error messages when the error occurs. Check and correspond to them correctly.

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%RROR -ESSAGES s -EASUREMENT VALUE AND h,v FLASH ALTERNATELY #AUSE s #HECK THAT THE PROBE IS PROPERLY ATTACHED TO THE PATIENT s "E SURE THAT THE LIGHT SOURCE AND SENSOR SECTIONS ARE PROPERLY LINED UP s )F THE PART BEING MEASURED IS THICK INSUFFICIENT LIGHT WILL BE TRANSMITTED !TTACH PROBE TO A THINNER PART s #LEAN THE LIGHT SOURCE AND SENSOR SECTIONS s 4AKE MEASURES TO PREVENT DIRECT ENTRY OF STRONG LIGHT TO THE PROBE s )F THIS MESSAGE REAPPEARS EVEN THOUGH THE ABOVE POINTS HAVE BEEN CHECKED THE P

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%RROR -ESSAGES #AUSE 3OLUTION s 4HE PULSE IS TOO STRONG FOR CORRECT MEASUREMENT s !TTACH THE PROBE TO THE BODY CORRECTLY )F THIS MESSAGE IS DISPLAYED WHEN THE UNIT IS ATTACHED TO THE PATIENT CORRECTLY THE MEASUREMENT CONDITIONS ARE REGARDED AS BLOOD CIRCULATION OR OTHER CIRCULATORY PROBLEMS )F THIS OCCURS SEARCH FOR A LOCATION WHERE MORE STABLE PULSE SIGNALS CAN BE OBTAINED s )F THIS MESSAGE REAPPEARS EVEN THOUGH THE ABOVE POINTS HAVE BEEN CHECKED THE PROBE MAY BE MALFUNCTIONING 5SE ANOTHER PROBE

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%RROR -ESSAGES s -EASUREMENT VALUE BLINKS #AUSE 3OLUTION s 4HE 3P/ VALUE IS BELOW THE LOWER LIMIT 3P/ OF THE MEASUREMENT RANGE 4HE MEASURED VALUE WILL STILL BE DISPLAYED BUT ITS ACCURACY CANNOT BE GUARANTEED 4HIS MESSAGE INDICATES THAT THE MEASURED VALUE IS OUTSIDE THE ACCURACY GUARANTEED RANGE s "ATTERY /UT s 2EPLACE THE BATTERY WITH NEW ONE s )N THIS CASE THE MEASUREMENT DATA IS NOT LEFT IF THE BATTERY IS REMOVED s "ATTERY POWER IS NEARLY EMPTY s "ATTERY WILL BE EMPTY IN ABOUT S

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Check Points before repairing Before taking any actions, check the following points first. ◆ If the abnormality continues to reappear, the instrument might be faulty, so contact the nearest distributor or authorized service facility. 0ROBLEM q .O DISPLAY APPEARS WHEN THE 0OWER IS TURNED /.

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Specification ■ Dual-wavelength pulse type (665nm/880nm) arterial blood oxygen saturation measuring instrument • Name: Oxygen Saturation Monitor • Model name: PULSOX-300 ■ Functions: • Measuring range: SpO2: 0 to 100% SpO2 Pulse rate: 30 to 230 bpm • Accuracy: SpO2: ±2% SpO2 (70 to 100% range, 1S.D.) 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.

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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: Polycarbonate Wrist band: Polyethylene terephthalate, nylon 6 Rating nameplate: Polyethylene terephthalate Cover Wristband Rating nameplate Appendix 24 Equipment classification (based on “UL 60601-1/EN 60601-1”) • Protection against electric shock: Internally

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Appendix Calculation Method for Displayed Values 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%).

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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 Group 1 The Model PULSOX-300 uses RF energy only for its internal function.

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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 Conducted RF IEC61000-4-6 Radiated RF IEC61000-4-3 IEC 60601 Test level Compliance level 3 Vrms 3 Vrms 3 V/m 3 V/m 150kHz to 80MHz 80MHz to 2.

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Measurement Principle This instrument measures the oxygen saturation (SpO2) in arterial 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): C (HbO2): Concentration of reduced hemoglobin Concentration of oxyhemoglobin The light-absorption characteristics of reduced hemoglobin (Hb) are very different from those of oxyhemoglobin.

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Relation between Oxygen Saturation and Partial Pressure The relation between oxygen saturation (SpO 2) 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 SpO2 30 pH=7.