SPIROMETER DATOSPIR - 120 511-890
Contents
1. Annex Spo SPIROMETER DATOSPIR 120 511 890 MU2 USER S MANUAL 2012 11 Rev 2 02 SPIROMETER DATOSPIR 120 USER MANUAL Annex 5002 E 2 02 1 INSTRUCTIONS FOR USE AND INSTALLATION 1 1 INTRODUCTION 1 2 PULSE OXYMETRY PROGRAM 1 3 PULSE OXYMETRY SETUP 1 4 PULSE OXYMETRY TEST PROCEDURE 1 4 1 INPUT OF TEST DATA 1 4 2 PERFORMANCE OF PULSE OXYMETRY TESTS 1 4 3 SETUP 1 4 4 TRENDS DISPLAY 1 4 5 PRINTING AND OR SAVING IN THE DATA BASE 1 4 6 TEST TRANSFERENCE 1 5 PULSE OXYMETRY MEASURES DURING SPIROMETRIC TESTS 2 TECHNICAL SPECIFICATIONS 3 FUNCTIONING BASIS 4 CLEANING 2 MODIFICATIONS Revised Approved Date 2012 11 Date 2012 11 n Jos Mar a Plana Director T cnico Director Comercial PRODUCTO CONFORME 93 42 CEE Directiva de Productos Sanitarios Clase ll a SIBEL S A Rossell 500 08026 Barcelona Espa a Tel 934360008 Fax 93436 16 11 Correo electr nico sibel sibelmed com WEB www sibelmed com SERVICIO POSTVENTA Tel 934335450 FAX 93 436 16 11 Correo electr nico sat sibelmed com SAFETY INDICATIONS FOR USE This oximetry sensor should be used by a physician or under the supervision of medical staff The pulse oximeter does NOT require calibration The pulse oximeter has NO physiological WARNINGS Pulse oximeter probes do NOT allow temporary immersion The pulse oximeter waveform is NOT normalizzed Patient movements or excessive lighting can a2. start of the study is displayed hh mm ss Each channel shows a discontinuous line of reference to be selected by the user in the setup This line is useful when verifying if the samples surpasse a certain value The key F2 enters the trends setup screen N Sup N Inf Ref spoz PR gt Pus Screen lime By pressing the key F6 we enter the SEARCH mode Pressing the keys F8 or F4 being in this mode the program will automatically go to the next or previous point where the signal of will cross the reference value SpO 1 4 5 PRINTING AND OR SAVING IN THE DATA BASE When entering this screen the parameters calculation is performed This operation can take some seconds depending on the study duration F1 ESC exit from this screen and goes back to the previous one F4 Prints the report of the study F8 Saves the Parameters in the Data Base Once a test is saved in the Data Base it can be restored in the same way as any spirometric test entering the base through F1 from the main menu screen DATOSPIR 128 SIBEL f DOS DE MAIG 290 08025 BARCELONA DATOSPIR 120 SIBELMED PULSEOXIMETRY TEST Code 1234567890 Date 27 04 0 FRANCISCO A SOPENA IBANEZ Sex Male Age y Hyht cm 176 Waht Kg Motive Procedence Techn gt 5 7 rj o 8 CT98 A 23 6 CT8 7 13 4 CT7 7 8 8 1DH 4 18 3 IDH 3 18 3 IDH 2 24 3 5202 Max 2 97 8 p02 Med 7 93 3 5002 Min 7 81 8 Sp0
3. 2 Std 7 3 2 PR Max BPM 125 6 PR Med BPM 73 6 PR Min BPM 65 6 PR Std BPM 12 8 Test Time 42 81 12 The parameters calculated to display print or save in the Data Base are the following CT90 of the time when the SpO is under 90 CT80 of the time when the SpQzis under 80 CT70 of the time when the SpO is under 70 IDH 4 rate of desaturations lt 496 per hour IDH 3 rate of desaturations lt 396 per hour IDH 2 rate of desaturations lt 296 per hour SpO Max maximum value of Saturation SpO Med average value of Saturation SpO Min minimum value of Saturation SpO Std standard deviation of Saturation PRMax maximum value of the pulse rate PR Med average value of the pulse rate PR Min minimum value of the pulse rate PR Std standard deviation of the pulse rate Test Time useful time of the test the disconnection NOTE Inthe calculation of parameters and Test Time the disconnections ofthe probel are nottaken into account 1 4 6 TEST TRANSFERENCE As in the spirometric tests the pulse oxymetry tests saved in the data base can be transferred to the computer See point 1 16 1 of the general manual 1 5 PULSEOXIMETRY MEASURES DURING SPIROMETRIC TESTS It is possible to perform pulse oxymetry measures during spirometry tests only in the FVC VC and MVV tests For that when starting the spirometry with F5 the pulse oxymetry probe must be connected While the spiromet
4. Las wavelengths used are 660 nm the red and 910 nm the infrared 4 CLEANING The clip sensor can be cleaned by wiping it off with a soap or ortho phthalaldehyde solution SpO sensor equipment must be disconnected before cleaning or disinfection WARNING The SpO sensor should not be sterilized by autoclave ETO or immerse in water or other solutions 5 MODIFICATIONS
5. R are showed together the peripherical pulse wave The duration of the wave showed on the screen is 5 seconds The maximum and minimum WARNING values for SpO and PR are also displayed respectively on screen If the value for an WARNING is surpassed an intermittent warning is displayed in the bottom part of the screen If the Acoustic WARNING is activated a sound will be heard In the upper part of the screen the time of signal trends saved in the memory up to that moment Is indicated TTE 15678909 PULS SIGNAL IN MEMORY 82 01 12 O6 O pt J M N Ud Mu F1 ESC exit form this screen and go back to the previous one F2 Setup the WARNINGS and the Averaging See Paragraph 1 4 3 F3 Enables or Disables the acoustic warning in case of WARNING FA Enables to modify the test data F5 Starts or stops the record of a study F6 Enters the Trends Menu See Paragraph 1 4 4 F8 Deletes the study in memory WARNING When the quality of the signal is low or the finger is not present the SpO2 values are set to zero to avoid showing incorrect values The device does not lost patient data if it is turned off The SpO2 data are updated every second the value of SpO2 and pulse rate is directly provided by the module A INSTANT TESTS In the instant pulse oxymetry measures the screen indicates the values for SpO and PR according to the setup average If you need to print the results you must record previously t
6. en into account for calculating the parameters and test duration 1 4 3 SETUP During the acquisition of oxymetry and pulse wave signals it is possible to enter the setup menu to modify some of the data displayed on the screen 100 Acus tic Warnings Warning Beep 4 It is possible to modify the maximum and minimum SpO and PR WARNING thresholds The acoustic signal of the WARNING and of the beep signal coinciding with each pulse can be enabled o disabled The averaged value of SpO can be changed between 4 and 16 samples The lower the selected averaged value is the quicker the response will be but also more sensitive to artefacts On the contrary if the selected averaged value is higher the measure is more stable and the response will be slower For a instant measure it is advisable a high averaged value On the contrary for a desaturation study a low value is better 1 4 4 TRENDS DISPLAY Only if a study has been recorded it will be possible to enter the trends menu 1 ESC exit from this screen and goes 0361 to the previous one F2 Setups the Trends screen F4 y FS Goes backwards or goes forwards a page 5 Enables to go to a specific page signal fragment F6 It moves to Search Mode F7 Calculates and displays the parameters values The screen displays the signal fragment of and PR according to the selected 2 time of screen In the upper left part the time related to the
7. eviation of Saturation PRMax maximum value of the pulse rate PR Med average value of the pulse rate PR Min minimum value of the pulse rate PRStd standard deviation of the pulse rate Test Time useful time of the test the disconnection of the probe is not taken into account NOTE In the calculation of parameters and Test Time the disconnections of the probel are nottaken into account 2 3 CONTROL Ifonly Oximetry tests are saved there are space for 150 tests in Data Base L and more than 1100 in Data Base H Inthis case Data Base H for spirometry is reduced taking into account the next table compare with table in 1 14 Fleisch Des Turbina With l Data Base H 300 540 900 Graphics 2 4 APPLICABLE STANDARDS PULSE OXIMETRY e EN ISO 9919 2009 General requirements for basic safety and essential performance for medical pulse oximetry DEGREE OF PORTECTION AGAINST WATER e IEC 60529 1989 M1 1999 Ed 2 1 degrees of protection provided by enclosures 3 FUNCTIONING BASIS The DATOSPIR 120 incorporates an electronic board dedicated to take samples of Oxygen Saturation and Heart Pulse Rate exclusively This board is powered from the spirometer s main board and the data are exchanged using a specific serial port The pulse oxymetry measure is based in the different absortion of some wavelengths of light red and infrared by the arterias depending on the quantity of hemoglobine which are carried by red globules
8. evious one FS Deletes the selected value FS y F6 Takes the cursor back to the previous field or advances it to the next F7 Validates the entered data and goes to the next screen This screen enables to configurate the different parameters of the pulse oxymetry Maximum and minimum values of SpO 30 100 and PR 20 250 BPM WARNINGS Average of SpO between 4 and 16 samples The Average of PR is fixed 10 samples Superior and inferior level for display of trends of SpO and PR Value of the reference line for both channels Time of record on screen between 5s and 29m 59s It is also possible to setup quickly and directly these values from inside the pulse oxymetry or trends screen 1 4 PULSE OXYMETRY TEST PROCEDURE WARNING Use only the oximetry sensor supplied by the DATOSPIR 110 120 spirometer manufacturer If you use non validated sensors with this equipment that may cause significant measurement errors Plug the pulse oximetry sensor supplied into the no 8 jack on the device WARNINGS Do not twist unnecessary or use excessive force when using connecting disconnecting or storing the finger sensor Misuse or improper handling of the sensors may cause damage to the sensor or to the cable This would cause incorrect measurements and readings Select a suitable site for the sensor The first finger index is the preferred location Alternative sites recommended are the thumb little finger or the large t
9. ffect the accuracy of the device The pulse oximetry module has CE marking and can not reach temperatures gt 42 The oxygen saturation and heart rate measures must be performed using the sensors manufactured by MEDIAID POX 050 1055 clip and POX050 820s Flexible which have been validated clinically Otherwise there may be significant measurement errors These pulse oximetry probes have been validated for the M15 module from MEDIAID The wavelengths used are 660 nm red and 910 nm infrared and the optical power is about 9 6mW Consult the instructions for use of the probes before use Follow strictly manufacturer s safety instructions as well as those specified in this manual See instructions for use of the sensor to evaluate the toxicity of SoO2 sensor The maximum recommended application s time of an oximeter in the same place is 8 hours The point of placement must be reviewed frequently to determine the position the movement and the skin sensitivity of the patient The reaction to the sensors by the patients may be different depending on their health and skin conditions No adhesive material should be used if the patient has an allergic reaction to it For log term monitoring is recommended to use flexible or disposable sensors The adult sensor is intended for use on people over 12 years old The peadiatric probe is for children between 3 and 12 years Although the adults probes can be used on any pediatric patie
10. he signal by pressing the key F5 of start during the desired time and then follow the instructions detailed in Paragraphs1 4 4 and 1 4 5 B LONG DURATION TESTS In long duration tests press F5 to start the recording An intermittent message RECORDING in the central part of the screen indicates that the study is being recorded When more than 5 minutes recording the signal without pressing any key the Display light is switched off automatically to avoid dirturbing the patient in a long duration study When pressing any key the light is switched on again It is important to point out that the signal in memory is related to the patient code entered If you start and stops the study without changing the patient code or without deleting the study fragments of signal one after one will be saved up to 8 hours The device understands that all the fragments correspond to the same patient and the calculation of parameters is made for the total memory El equipo interpretar que todos los fragmentos corresponden a un mismo paciente y el c lculo de los par metros lo realizar sobre el total de la memoria To perform the test to other patient delete the test pressing F8 and change the patient data pressing F4 To display the saved signal and calculate the parameters enter the trends screen through the key F6 the dedal disconnects the signals SpO and PR will be presented with value 0 These periods of time will not be tak
11. nt whose fingertip reaches the finger stop of the sensor and on whom the sensor fits securely The system can measure pulse and functional oxygen saturation A functional meter can not be used to evaluate the accuracy of pulse oximeter probe or a pulse oximeter monitor DEGREE OF PROTECTION AGAINST LIQUIDS Degree of protection against harmful ingress of water Drip proof IPX 1 RISKS OF CONTAMINATION Although unlikely the organisms can be transmitted by pulse oximetry Therefore the pulse oximeter finger clip should be cleaned after each patient use by either soapy water or the disinfectant solution specified by the manufacturer RISK OF INTERFERENCE Avoid interference such as electromagnetic disturbances stroke abnormal hemoglobin intravascular contrast states of low perfusion and skin pigmentation can affect the operation pulse oximeter RISKS FOF EXPLOSION DO NOT use the equipment in the presence of flammable anesthetics or gases THAT MAY CAUSE EXPLOSION REMOVAL OF WASTE FROM ELECTRICAL AND ELECTRONIC APPLIANCES BY DOMESTIC USERS IN THE EUROPEAN UNION The product must be recycled as the WEEE directive For more information consult the user s manual of DATOSPIR 110 120 1 INSTRUCTIONS FOR USE AND INSTALLATION 1 1 INTRODUCTION This manual is an annex to the user s manual of the Spirometer DATOSPIR 120 for the pulse oxymetry functioning For consults and observations referred to the device go to chapter 1 of
12. oe Insert the finger right to the end of the sensor to get accurate measurements The fingernail must be kept pointing toward the upper part of the sensor and the cable must be positioned along the top of the hand or food WARNING Ensure that long fingernails do not interfere with the proper positioning of the finger or with sensor function Remove nail polish or artificial acrylic nails before placying the SpO2 sensor as this can cause incorrect readings To obtain the best results especially during long term studies 8 hours approx fasten the cable separately from the sensor using surgical tape preferably around the base of the finger see the figure above Make sure that the tape fastening the cable does not restrict blood circulation WARNING For log term monitoring is recommended to use flexible or disposable sensors 1 4 1 INPUT OF TEST DATA When entering the Pulse oxymetry Program the first thing to do is enter the test data PULSEOXIME RY Code 1234567890 Ay Sex HCGcm WiKg gt FRANCISCO A Surn SOPENA IBA EZ 11 03 2000 18 19 oee paragraph 1 8 1 of the general manual for the data input If the memory has a saved test the program will go directly to the next screen paragraph 1 4 2 1 4 2 PERFORMING PULSE OXYIMETER TESTS When entering this screen the pulse oxymeter starts automatically to take samples the values of Oxigen Saturation SpO and Pulse Rate P
13. ric test is being performed the curve and the Saturation values SpO and Pulse PR wil be displayed on screen and they will be saved in the memory When the test ends the average of both values will be displayed you want to restore from memory all the values measured enter the menu Pulse oxymetry F6 from the main menu It will be handled like a Pulse oxymetry test saved in memory 2 TECHNICAL SPECIFICATIONS 2 1 MEASURES AND RANGES SpO Pulse Measurement range 20 100 25 250 bpm Resolution 1 9o 1 bpm Accuracy 70 to 100 2 25 200 bpm 2 bpm or 2 whichever is 60 to 69 3 greater 60 Unspecified 200 250 bpm 3 Response 8 seconds for 80 of 8 seconds for 80 of patient patient Perfusion rate 0 20 Digital Pleth Waveform Centered at 512 norm is 512 counts peak to peak 2 2 TEST AND PARAMETERS The Datospir 120 allows to perform instant or long duration measures with a long duration near of 8 hours In both types of measures it can be calculated the following parameters CT90 of the time when the SpO is under 90 CT80 of the time when the SpQzis under 80 CT70 of the time when the SpO is under 70 IDH 4 rate of desaturations lt 496 per hour IDH 3 rate of desaturations lt 396 per hour IDH 2 rate of desaturations lt 296 per hour SpO Max maximum value of Saturation SpO Med average value of Saturation SpO Min minimum value of Saturation SpO Std standard d
14. the general manual With the Pulse oxymetry option the DATOSPIR 120 can perform individual measures of the Oxigen Saturation SpO and of the Pulse Rate PR or long duration studies for the control of patients during sleep or any other situation desaturations measure etc In case of long duration studies we will be able to display the Trends afterwards By trends we mean the evolution of signals SPO and PR versus time will also be possible to calculate the parameters associated to the trends print them and save them in the data base 1 2 PULSE OXYMETRY PROGRAM Next the options of the pulse oxymetry program are shown Test Data Patient Code Name and surname Age height weight and sex Setup WARNING Thresholds Acoustic WARNINGS SpO Averaging Enable Disable Acoustic WARNING Trends Recording Trends Display Setup Forwarding and Backwarding the signal Test Parameters Parameters Printing Saving parameters in the Data Base 1 3 PULSEOXIMETRY SETUP The SpO module is an option included in the DATOSPIR 120 It is advisable for any user to set It up according to his needs To enter the Pulse oxymetry setup menu press the key F2 in the main menu and then F7 CONF I GURAT I ON 5262 SETUP WARNING CONF I GURAT I ON FJ Max Min r2 r2 Mean in Spo2 4 TRENDS CONFIGURATION N Sup N Inf Ref spoz PR Screen lime 10 1 ESC exit from this screen and goes back to the pr
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