Konica Minolta PULSOX-300i manuale d’uso

OXYGEN SA TURA TION MONITOR PULSOX -300i ® Instruction Manual This instrument must be used according to the instructions of the doctor .[...]

Safety Symbols W arnings 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 indic[...]

1 Foreword Safety Precautions T o ens ure correct use of th is instrument, read th e 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. W ARNING (Failure to adhere to the following points may result in death or serious injury .) The instrumen[...]

2 Foreword 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 MINOL T A SENSING, INC. When installing batteries in the instrument, make sure that they are correctly oriented according to the mark. If alkali uid from [...]

3 Foreword Contents Safety Symbols Safety Precautions .............................................................1 Foreword ............................................................................4 Safety Notes ........................................................................... 4 Package Contents.......................................[...]

4 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. The Oxygen Sat[...]

5 Foreword 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[...]

6 Foreword System Diagrams and Accessories The instrument consists of the following items. 05,3/ 8I Optional accessories Standard accessories Wristband WB-300 AAA-size alkaline battery Finger Clip Probe SR-5C Spot Check Probe SP-5C Monitor Probe LM-5C Personal Probe SD-5C Extension cable EC-300 USB adapter UA-300 Standard accessories Op[...]

7 Foreword Names of Parts PULSOX-300i Power button LCD Display Backlight button Probe connector Wristband Battery cover External output terminal Used to start measurement (Power-ON) or end measurement (Power-OFF). Measurement results and messages are displayed. Connect the probe or extension cable EC-300 to this connector . Press it to turn ON the [...]

8 Foreword Notes on Use • This instrument should be used under the following operat - ing conditions. • T emperature 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. T o avoid the possibility of it b[...]

9 Foreword Differenc e f ro m t he SaO 2 value to displayed value <T able 1> <T able 2> SaO 2 HbCO SaO 2 Methemoglobin 1% 5% 10% 1% 5% 10% 50 50 70 70 90 90 100 100 Measured value is always lower than th e a ctual value. Displayed value is sometimes higher than th e a ctual value if SaO 2 is around 50%. -0.1 -0.7 -1.5 +0.2 +1.3 +3.2 -0.[...]

10 Foreword Notes on Storage • This instrument should be stored under the following storage conditions. • T emperature 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 instrume[...]

11 Foreword 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 re may result. • Make sure that the battery is either disposed of or recycled correctly in accordance with local [...]

12 Preparations Preparations Before starting measurements using this instrument, follow the procedure given below to ensure that measurements are stable. 1) Attaching the W rist 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 exibility and comfort[...]

13 Preparations 4 Pass the other end of the band outward through band xture B. ◆  T ake care not to twist the band. 5 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. 3 Fold up the inserted hook-and-loo[...]

14 Preparations 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 o[...]

15 Preparations 3) Installing the battery 1 T urn the battery cover clockwise approximately 90 degrees to open the cover . ◆  When turning the cover , keep the flat part of your finger on the cover ’ s catch. This facilitates opening the cover with minimum force. 2 Insert the battery into the battery compartment according to the polarity mar[...]

16 Preparations 4) Attaching the PULSOX to the Wrist 1 Remove the hook-and- loop section of the band from the side with no probe connector . 2 Attach PULSOX-300i to the arm by inserting your hand through the Wrist Band. 3 Adjust the fastening position of the hook-and- loop tape to adjust the tension of the Band.[...]

17 Measurement Measurement 1) Starting the Measurement 1 Connect the probe to the PULSOX-300i correctly . 2 Press the Power 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 . 3 As shown the right, the set[...]

18 Measurement 4 Next, it will cause the file number of the next 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 le. 5 And, if the time for Auto- Power-Off was set in the instrument, the setting time is displayed. ◆  The time for Au[...]

19 Measurement 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 2 value are displayed during measurement. Pulse rate (P .R.) If an error occurs, an error message mainly about P .R. will be displayed. Battery mark Indicates the remain ing batter y capacity in thre[...]

20 Measurement 3) Ending the Measurement 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-of f (end of measurement) can be set as the auto-power-off timer . If an auto-power-off timer is set, the measurement is n[...]

21 Ext.Connect 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 (whi[...]

22 Ext.Connect <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: <Notes on communication mode> ● It is impossible to take measurements while the inst[...]

23 Check Points T rouble Shootings Error Messages The instrument display error messages when the error occurs. Check and correspond to them correctly . %RROR-ESSAGES #AUSE 3OLUTION s  #ONNECTTHEPROBETOTHE 05,3/8IPROPERLY7HENUSING THEOPTIONAL%XTENSION#ABLE %#CONNECTTHEC[...]

24 Check Points s  #HECKTHATTHEPROBEISPROPERLY ATTACHED TOTHEPATIENT )FTHEPROBE ISPROPERLYATTACHEDBUTTHIS ME SSAG ES TIL LA PPEA RS TH EC IRCU LAT ION  INT HEARE ABEI NGMEA SURED MAYNO T BE GOOD -O VET HEPR OBE TOA NARE A[...]

25 Check Points %RROR-ESSAGES #AUSE 3OLUTION 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?[...]

26 Check Points %RROR-ESSAGES #AUSE 3OLUTION 4HISINDICATESTHATTHEMEASUREMENT VALUEISOUTOFTHEGUARANTEED ACCURACYRANGE ・  4HEOXYGENSATURATION 3 P/  ISALUEBELOWTHE LOWERLIMITOFTHE MEASUREMENTRANGE4HE MEASUREDVALUE[...]

27 Check Points %RROR-ESSAGES #AUSE 3OLUTION s  4U R N T H E  0 OW E R  / FF   A N D T U R N  /.  AGAIN s  )FTHESEMESSAGEREAPPEAREVEN THOUGHTHEABOVEPOINTSHAVEBEEN CHECKEDTHEINSTRUMENTMAYBE MALFUNCTIONING#ONTACTTOTHE NEARESTDISTRIBUTEROR[...]

28 Check Points 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 w[...]

29 Specications Specication ¢ Dual-wavelength pulse type (665nm/880nm) arterial blood oxygen satura- tion measuring instrument • Name: Oxygen Saturation Monitor PULSOX-300i ¢ Functions: • Measuring range: SpO 2 : 0 to 100% SpO 2 Pulse rate: 30 to 230 bpm • Accuracy: SpO 2 : ±2% SpO 2 (70 to 100% range, 1S.D.) Pulse rate: ±2 bp[...]

30 Specications ¢ Weight 56g (including battery/excluding wrist band and probes) ¢ Usable life 6 years [Veried by KONICA MINOL T A SENSING, INC. (based on own data)] Probes (SR-5C, SP-5C, LM-5C, SD-5C) ¢ LED-SPD probe ¢ T ype • Finger Clip Probe SR-5C • Spot Check Probe SP-5C • Monitor Probe LM-5C • Personal Probe SD-5[...]

31 Appendix Appendix Calculation Method for Displayed V alues <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%). <Oxygen saturation (SpO 2 )> Updates the moving average of the oxygen s[...]

32 Appendix EMC Guidance Guidance and manufactures declaration - electromagnetic emissions Guidance and manufactures declaration - electromagnetic immunity The Oxygen Saturation Monitor Model PULSO X-300i is intended for use in the electromagnetic environment specified below. The customer or the user of the Model PULSO X-300i should assure t[...]

33 Appendix Guidance and manufactures declaration - electromagnetic immunity The Oxygen Saturation Monitor Model PULSO X-300i is intended for use in the electromagnetic environment specified below. The customer or the user of the Model PULSO X-300i should assure that it is used in such anenvironment. Immunity test IEC 60601 T est level Complian[...]

34 Appendix ¢ Spectral Absorption of Hb and HbO 2 SpO 2 ＝  100 (% SpO 2 ) C（HbO 2 ） C（HbO 2 ） ＋C（Hb） Absorption coefficient Wa velength Red light Infrared light Measurement Principle This instrument measures the oxygen saturation (SpO 2 ) in arte - rial blood and pulse rate continuously in a non-invasive method by applying op[...]

35 Appendix Relation between Oxygen Saturation and Partial Pressure The relation between oxygen saturation (SpO 2 ) and oxygen partial pressure (PaO 2 ) is shown in the graph below. SpO 2 is the oxygen saturation as measured by pulse oximeters. ¢ Oxygen Saturation vs. Oxygen Partial Pressure The curve of the above graph may shift to the right o[...]

36 Appendix MEMO[...]

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AJF AKK Printed in Japan 9222-1732-36 © 2007-2009 KONICA MINOL T A SENSING, INC. Manufacturer 3-91, Daisen-nishimachi, Sakai-ku, Sakai-shi, Osaka 590-8551, Japan[...]