" Annexe P max - P max " SPIROMETER
Contents
1. 1 ESC escapes this screen and moves back to the previous one F2 Setup of references F3 Selection of graphics and time lag 11 63 2666 18 16 1 ESC escapes this screen and moves back to the previous one F2 Selects references for adults Selects references for children F5 amp F6 Moves the cursor back or forwards F7 Validates the input data and goes to the next screen Not all the references have values for adults and for children the program will not allow to select non existent references SELECTION OF GRAPHICS 11 63 2004 18 18 1 ESC escapes this screen and moves back to the previous F5yF6 Moves the cursor back or forward F7 Activates or deactivates the option F8 Validates the input data and go to the next screen The time lag for the measurement has a default value of 1 0 s although the user can configurate it between 0 15 4 9 5 This time lag has an effect on the calculation of the measurement Therefore no value in this first second or time setup by the user is taken in account The options for graphics allow to activate or deactivate the options for saving the graphics in the data base and print the curves of P max or max 1 4 PROCEDURE FOR MAXIMAL PRESSURE TEST To have access to the Maximal Pressure test press key F7 from the main menu 1 4 1 INPUT OF THE TEST DATA When entering the Maximal Pressures Program first of all enter the test data MAXIMAL RESPIRATORY2. B SH WILSON Predicted normal values for maximal respiratory pressures in caucasian adults and children SH Wilson NT Cooke Edwards SG Spiro THORAX 1984 39 535 538 C BLACK amp HYATT Maximal Respiratory Pressures Normal values and relationship to age and sex Black LF Hyatt RE AM REV RESPIR DIS 99 696 702 1969 D MR CHARFI Les pressions ventilatoires maximales la bouche chez l adulte valeurs normales et variables explicatives MR Charfi R Matran J Regnard MO Richard J Champeau J Dall ava A Lockhart REV MAL RESP 1991 8 367 374 5 MAINTENANCE PREVENTIVE AND CORRECTIVE MAINTENANCE 5 1 MAINTENANCE The maintenance is the action directed to keep the device in correct functioning The person in charge does not require any technical qualification except the knowledge of the functions and handling of the device Usually the user of the device must do it The operations to be performed are the following 5 1 1 MODULE The manometer is cleaned softly with a dry or slightly wet with water cloth drying the rests of humidity Take care that no liquid goes into the inner space or in the connectors oconnections Do notuse abrasive or solvent substances 5 1 2CLEANING OF THE SHUTTER PROBE The shutter probe and specially the reusable mouthpiece must be washed with soap or some disinfectant liquid which does not chemically attack the methacrylate or Teflon of the composition After the rinse and drying of
3. DATOSPIR 126 SIBELMED Code 1234567890 Date 27 04 2000 FRANCISCO SOPENA IBANEZ Sax Male 43 Hght icm 6 WghttKg 92 Motive Frocedence Techn References P MORALES REPORT Fimax PEmax ML 144 145 164 M3 145 153 G 165 6 157 Mean 143 167 Desv Std B Reference 143 2 CrManoeuure 101 83 Mean 190 81 IH Pimax MANOEUVRE 2 250 79 238 MINCEUURE 1 B Saving in the internal data base The test is saved in the device internal data base in order to display it afterwards print it and or transfer it to a computer 1 4 5 TRANSFER OF TESTS Like the spirometric tests the maximal pressure tests saved in the data base can be transferred to a computer See section 1 16 1 of the general manual 1212 2 TECHNICAL SPECIFICATIONS 2 1 PARAMETERS In both espiratory and inspiratory test the next values are measured Maximal pressure of the 5 manoeuvres Average of the best 3 Standard deviation of the best 3 2 2 RANGES AND MEASUREMENTS Range ofMeasurement cmH O 0 300 Resolution cmH O 1 Accuracy 3 Sample Rate Hz 100 2 3 CONTROL Number of manoeuvres Up to 5 manoeuvres for each type can be performed P max and P max Duration of the manoeuvres The maximum duration is 8 seconds Start of Manoeuvre When the threshold of 3 cmH O is surpassed End of Manoeuvre Variatio
4. Annexe SPIROMETER DATOSPIR 120 511 8D0 MU2 USER S MANUAL 2012 05 Rev 2 01 SPIROMETER DATOSPIR 120 E 2 1 2 3 3 1 3 2 USE MANUAL Annexe Pmax INSTRUCTIONS FOR USEAND INSTALLATION INTRODUCTION PROGRAM OF MAXIMAL PRESSURES SETUP OF MAXIMAL PRESSURES PROCEDURE FOR MAXIMAL PRESSURES TEST 1 4 1 INPUT OF TEST DATA 1 4 2 PERFORMANCE OF MAXIMAL PRESSURE TESTS 1 4 3 DISPLAY OF THE RESULTS 1 4 4 PRINTINGAND OR SAVING IN THE DATABASE 1 4 5 TRANSFER OF TESTS TECHNICAL SPECIFICATIONS PARAMETERS RANGES AND MEASUREMENTS CONTROL INTRODUCTION TO FUNCTIONING SIGNALS ACQUISITION CONTROL PROGRAM TECHNIQUE OF MEASUREMENTAND REFERENCE VALUES PREVENTIVE AND CORRECTIVE MAINTENANCE MODIFICATIONS Revised Approved Date 2012 05 Date 2012 05 1 4 4 7 a fae Jos Maria Plana Carlos Recio Technical Manager Sales Manager IN ACCORDANCE WITH 93 42 EEC Medical Devices Directive Il a Class SIBEL S A Rossell 500 08026 Barcelona Spain Tel 34 93 436 0008 Fax 34 93 436 16 11 e mail sibel sibelmed com WEB www sibelmed com AFTERSALES SERVICE Tel 34 93 433 54 50 FAX 34 93 436 16 11 e mail sat sibelmed com 1 INSTRUCTIONS FOR USEAND INSTALLATION 1 1 INTRODUCTION This manual is an annexe to the Spirometer DATOSPIR 120 User s Manual exclusively dedicated to the functioning of the
5. PRESSURES 1234367998 Sexi Ht Key 92 FRANCISCO SOPEMA 11 04 2068 12 58 See section 1 8 1 of the general manual for the input of data a performed test is still in memory the program will go directly to the next screen section 1 4 2 1 4 2 PERFORMANCE OF MAXIMAL PRESSURE TESTS After validating the data with F7 enter the tests performance screen In this screen the axis appear and then the DATOSPIR 120 is ready to perform maximal pressures tests i F1 ESC escapes this screen and goes back to the previous one F4 Enables to modify the Patient data F5 Starts the manoeuvre F6 Changes the test from to max or vice versa F7 Has access to the Data screen If there are performed manoeuvres F8 Performs the Report If there are performed manoeuvres It is convenient for the technician to know the usual procedure required for the patient to perform the test correctly If not it is advisable to see some bibliography on this See also chapter 4 In the performance of the test bear in mind the following steps 1 Connect the module in the connector no 9 The device detects automatically that the module is connected If the module is not connected the device will show it on screen and it will not allow to enter the screen of tests performance Make sure that the shutter Valve is connected to the module 2 Train the patient ab
6. the probe lubricate the friction space between the probe and the cursor with Vaseline Finally check that the components are not obstructed and that it works correctly 5 2 PREVENTIVE MAINTENANCE The preventive maintenance consists of all the actions directed to keep the deviceinagood status of use There are two types of preventive maintenance 1 The first type that can be performed by the user consists of a periodical supervision ofthe aspectofthe differentinterconnections andthe other external elements of the device It willbe verified that all the interconnections are perfectly connected thatthe cables and orconnectors and the rest of elements do not have breakage or external damage Incase of detecting any anomaly which the user cannot solve inform the aftersales service of SIBELS A or your Distributor to proceed with the checking or repair 2 Thesecond type consist of a general technical verification of the safety systems adjustments functions etc which configurate the device THESE CHECK UPS WILL BE PERFORMED WITH ANNUAL PERIODICITa cording to the Verification andAdjustment Procedure of the MAXIMALPRESSURES MODULE available by the manufacturer This type of operation must be performed by the qualified technical staff of the maintenance department or the technical service in the distributor or manufacturer In any case SIBEL S A as manufacturer must give a written authorization to the corresponding technical servi
7. ce atleast during the warranty period so that they are able to perform such maintenance Sibel is notresponsible for any damage misfunction etc which can come as a consequence of a faulty maintenance made by persons not belonging to SIBEL S A 5 3 CORRECTIVE MAINTENANCE The corrective maintenance consists of leaving the device in a good state of use which has failed in its correct functioning by bad functioning or misuse and has to be repaired In the case of detecting a failure in the device which prevents its normal utilization disconnect the device from the mains and contact with the Aftersales Service of SIBEL S A specifying with detail the type of anomaly produced 6 MODIFICATIONS
8. lculations we must point out Start and end of the manoeuvre The start ofa manoeuvre is considered when the level of 3cmH O is surpassed The end of the manoeuvre is considered when there is a pressure variation lower than 1 cmH O for 2s Delay for the calculation For the calculation of the maximal pressure to avoid artefacts a initial period of time is discarded This period is set to 1 s as a default but it can be set up between 0 1 anf 4 9 5 Order of the manoeuvres manoeuvres are saved in the memory inthe same order as they have been performed Automatic deleting of a remaining manoeuvre When the 5 memories are full and a new manoeuvre is performed the first manoeuvre is always deleted if this is notthe best If the firstis the best then the second oneis deleted 4 TECHNIQUE OF MEASUREMENTAND REFERENCE VALUES The maximal inspiratory pressure P max depends directly on the strength developed by the inspiratory muscles Its measurementis very useful in the diagnosis and follow up of patients with neuro muscular illnesses specific alterations of the respiratory muscles different processes of the thoracic area air trapping or modifications produced by breath depressive medicines among other clinic situations The maximal espiratory pressure also informs about the cough efficacy and the drainage of the bronchial secretions In both cases they are measures easy to performe and comfortable forthe patien
9. maximal pressures For consults and observations referred to the device as a whole see chapter 1 of the general manual The maximal pressures module has been designed in collaboration with the Pulmonary Function Laboratory of the Hospital de la Santa Creu i Sant Pau of Barcelona It is based on the criteria expressed by J L Clausen in the Thoracic Society of California It allows a measurement range of 300 cmH 0O in both inspiratory and espiratory tests and has several reference available values to be setup by the user 1 2 PROGRAM OF MAXIMAL PRESSURES Next the different options of the maximal pressures program are shown Data of the test Patient Code Age height weight and sex Name and surname Change of patient Start of the manoeuvre Change from to Pmax or vice versa Display of the test data Display of all the manoeuvres Selection of the curve to be printed or memorized Save in the Data Base Performance of the Report Performance of the Report Display and selection of the manoeuvres Display of the manoeuvre in progress Display of the 3 best manoeuvres Display of one manoeuvre 1 3 SETUP OF THE MAXIMAL PRESSURES The Maximal Pressures module is an option included in the DATOSPIR 120 It is advisable for the user to set it up according to his her needs To enter the Maximal Pressures setup menu press key F2 inthe main menu and next press F8 SETUP OF MAXIMAL PRESSURES O 11 63 2600 18 15
10. n lower than 1 cmH O inthe last 2 seconds Delay in the calculation of the maximum pressure value Selectable in the setup between 0 1 and 4 9 seconds 1 second as a default Internal Data Base The Spirometer shares the internal data base for all test types If only Maximal Pressure tests are saved counting a duration of 4seconds for the curves itis possible to save With Graphics Without Graphics 1 curve 2 curves Data Base L 150 150 150 Data Base H 400 200 1100 Inthis case Data Base H for spirometry is reduced taking into account the next table compare with table of 1 14 With Graphics Without Graphics Fleisch Des Turbina Data Base H 300 540 900 3 INTRODUCTION TO FUNCTIONING The DATOSPIR 120 optionally has an external Module of Maximal Respiratory Pressures This module is connected to the DATOSPIR through a phone connector 3 1 SIGNAL ACQUISITION The module of maximal pressures includes basically a pressure sensor a differential amplifier and a filter The pressure sensor covers the range from 0 to 300 cmH 0 The output of this sensor is amplified and filtered so thatthe analogical signal has the intended range and bandwidth Then this signal is transformed into digital with aA D converter The converter usedis the same as the one used in the spirometry See section 3 7 of the general manual 3 2 CONTROL PROGRAM The control program performs the processing of the acquired signal Among the important ca
11. out the test performance as his her collaboration is essential for the correct execution Put him her the nose clip 3 Press key F5 and wait until an intermittent arrow appears on the screen Once the patient has reached the position of Total Pulmonary Capacity move the cursor to the closed position and perform the manoeuvre 4 Once the manoeuvre is finished repeat step 3 in order to perform more manoeuvres Itis advisable a minimum of 3 manoeuvres The best 3 manoeuvres should not differ more than 5 between them and the last manoeuvre should not be the best 5 The above screen presents or can present the following information Date patient code and type of test Warnings gt 5 indicates that the variation between the best 3 manoeuvres is over 5 Pressure time Graphic for the best 3 manoeuvres Pressure time Graphic for the selected manoeuvre pressing one of the keys M1 to 5 Horizontal line of dots showing the reference value Vertical line of dots showing the maximal value for each manoeuvre Values of maximal pressure of the performed manoeuvres average and standard deviation of the best 3 ones The manoeuvres of maximal pressure are ordered chronologically according to their performance This is made because it is important to follow the evolution of the patient manoeuvres Anyway although the manoeuvres are saved in the memory in temporal order the best 3 manoeuvres are displayed on
12. rage of the best manoeuvres The selected inspiratory and espiratory manoeuvres are displayed The selected references in the setup are displayed The Icons give access to F2 Deletes the selected manoeuvre of the selected test Changes from to max and vice versa F7 Prints the report of Maximal Pressures F8 Saves the test in the Data Base WARNING The system displays saves or prints the values for all the manoeuvres but only one curve for each manoeuvre is saved or printed in the data base Default the system selects the curve of the best manoeuvre unlike the spirometry it may not be number 1 If the specialist prefers he she can select another curve as it is explained next To select a manoeuvre different to the one selected default by the system press the corresponding memory key 1 to M5 The upper right part of the screen indicates which test is selected the espiratory TEST or the inspiratory TEST Plmax To change from PEmax to Plmax and vice versa press key F3 1 4 4 PRINTING AND OR SAVING IN THE DATA BASE After performing the wanted manoeuvres of both espiratory and inspiratory pressure the following operations can be peformed A Printing the results A report displaying the same information of the data screen will be made along with the patients data and the curves of the selected manoeuvres 1 10 DATOSPIR 128 SIBEL S A DOS DE MIG 290 BARCELONA
13. screen ordered from the best to the worst the manoeuvre of highest pressure value is considered as the best Itis also important to point out that more than 5 manoeuvres may be performed despite the fact that the device has space only for 5 manoeuvres When performing the sixth manoeuvre the first performed will be deleted M1 if this is not the best Should it be the best manoeuvre the second one would be deleted M2 Once the corresponding manoeuvre has been deleted the system will reorder them 1 8 being the performed manoeuvre the 5 the M5 will be the M4 the M4 will be and so on NOTA Remember that with the backspace key F1 ESC is possible to move back in the menu without losing the information available up to that moment Only if the patient is changed by entering a new code or performing other operation the data might be lost Anyway the device will always warn with a message on screen before deleting the information 1 4 3 DISPLAY OF THE RESULTS Press key F7 Hea E Std Reference 143 4 Manoeuwre 1 y Mean 16a Ama Manoeuie 2 References F MORALES When entering this option the maximal pressure values are displayed for the espiratory and inspiratory tests as well as for the average and standard deviation of the best three manoeuvres The reference value is also displayed as well as the percentage with regard to the reference of the selected manoeuvre the ave
14. t They can be obtained near the patient and allow to follow his her evolution The procedure to obtain the P max andthe must complete the following aspects Correct collaboration ofthe patientto getamaximum effortinthe manoeuvres The patient must keep his her hands against the cheeks and leave them flaccid to attenuate the pressure generated by the facial muscles To measure the P max the patient must perform a deep inspiration from the position of Residual Volume and maintain the effort for atleast 3 seconds measure the P max the patient has to inspire previously up to the position of Total Pulmonary Capacity and from there blow with the maximum effort Itis advisable a minimum of three satisfactory manoeuvres for each pressure If measuring errors are suspected we must make sure thatthere are no leaks in the system and the correct collaboration of the patient in the maximum effort manoeuvres The Module of Maximal Pressures is useful for Pheumology Anaesthesiology ICU and Neurology units for isolated determinationsor for the follow up of interned patients The device includes 4 different references to be selected by the user Next the bibliographic reference is detailed A P MORALES Presiones respiratorias est ticas m ximas en adultos Valores de referencia de una poblaci n caucasiana mediterranea P Morales J Sanchis P J Cordero y J L Diez ARCHIVOS DE BRONCONEUMOLOGIA Vol33 num 5 1997
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