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Cosmed Pony Graphic

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1. lt 0 It is strongly recommended to backup files periodically On the Backup dialog box set the different options selecting the destination path with the Browse key or pressing New to create a new directory Press OK to confirm 82 Pony graphic graphic User s Manual Restore On the Restore dialog box specify source path and press OK a dialog box will appear indicating all data of the backup pro cessed Chapter 4 Data management 83 84 Pony graphic graphic User s Manual Appendix Chapter 5 Appendix 85 Calibration The system is precisely calibrated by Cosmed and will remain so as long as it is used properly If a proper maintenance is executed it is possible to check the calibration of the Flow meter turbine even after long periods You may check the calibration by measuring a known volume syringe using the FVC and VC tests and comparing the results measured with the predicted one the syringe one If the discrep ancy is more than 3 the system should be re calibrated This standard calibrated syringe 3 Litres is supplied by COSMED Calibration syringe P N 00600 01 11 Pony graphic 86 Calibrating flows and volume 1 2 Turn the Pony graphic on and confirm or change the date Disable the expiratory correction following the instruction written in the Calculating the BTPS factor paragraph At the request Select a function execute a FVC or a VC test using t
2. H 100 2 0 17 SD H 100 2 0 19 H 100 2 0 19 H 100 2 0 17 4 55 4 55 0 52 H 100 2 0 19 Multicentrico di Barcelona Adult Pediatric Spirometric reference values from a Mediterranean population J Roca J Sanchis A Agusti Vidal F Segarra D Navajas R Rodriguez Roisin P Casan S Sans Bull Eur Physiopathol Respir 1986 22 217 224 Males gt 20 years Symbol FVC FEV1 FEV1 FVC FEF25 75 PEF Vmax75 Vmax50 Formula SD 0 0678 Ht 0 0147 A 6 05 0 530 0 0499 Ht 0 0211 A 3 84 0 444 85 58 0 1902 A 5 36 0 0392 Ht 0 0430 A 1 16 1 000 0 0945 Ht 0 0209 A 5 77 1 470 0 0190 Ht 0 0356 A 0 14 0 620 0 0517 Ht 0 0397 A 2 40 Females gt 20 years S ol FVC FEV1 FEV1 FVC FEF25 75 PEF Vmax75 Vmax50 Formula SD 0 0454 Ht 0 0211 A 2 83 0 403 0 0317 Ht 0 0250 A 1 23 0 307 0 224 A 0 1126 W 94 88 5 31 0 0230 Ht 0 0456 A 1 11 0 680 0 0448 Ht 0 0304 A 0 35 1 040 0 02 Ht 0 031 A 0 0062 W 0 21 0 405 0 0242 Ht 0 0418 A 1 62 0 925 Males 20 years Symbol FVC FEV1 FEF25 75 PEF Vmax75 Vmax50 Formula sD 0 02800 Ht 0 0345 1 W 0 05728 A 3 21 0 443 0 02483 Ht 0 02266 W 0 07148 A 2 91 0 378 0 038 Ht 0 140 A 4 33 0 796 0 075 Ht 0 275 A 9 08 1 073 0 024 Ht 0 066 A 2 61 0 562 0 017 Ht 0 157 A 0 029 W 2 17 0 811 Chapter 5 Appendix 107 Females lt 20 years Symbol Formula SD FVC 0 03049 Ht 0 02220 W 0 03550 A 3 04 0 313 FEV1 0 02866 Ht 0 0171
3. Find a patient in the archive by the Archive Navigator E Find a patient in the archive with the same ID Code of the current test to link Visualize the spirometer print report le UNK Link the current test to the current patient Chapter 4 Data management 3 Link automatically all the tests creating if necessary a new patient card with the same ID Code of the test 74 Pony graphic graphic User s Manual Managing the Paten s database The Patients database is mainly composed by the Patient Card the Visit Card and the Test card Pama Coed ak ai o fr occ Pe ie GIES a om e fee jn ten eer oo sae haa paj ise tear pel T se biki a p eu ome Cte Pe f sa i CLO k o t CET mmm 0D OU ra J a a pi al aj Do _ Sas See 0 Patient Card Contains all the information relative to the Patient that remain the same during the different visits first name last name date of birth it is created the first time that the Patient come to be tested and it is recalled during the following visits Each Patient is related to only one Patient Card Buttons description Move to the first Patient in the archive Move to the previous Patient in the archive Move to the next Patient in the archive Move to the last patient in the archive Find a patient in the archive Delete current patient from the archive E ae e dd E Edit current patient card Chapter 4 Data
4. Turbine connection Chapter 2 Setting up the Pony graphic 29 Internal Printer Pony graphic 30 To replace the printer ribbon 1 Remove the printer cover 2 Press the ribbon cartridge down where it says Push 3 4 Replace the printer cover introducing the paper roll in the Insert the new ribbon cartridge opening on the printer front To replace the printer paper l 2 3 Remove the printer cover Remove the empty roll Turn on the system until the message select a function appears on the screen Insert the roll of paper through the opening towards the rear of the printer Press the paper key to advance the roll of paper Replace the printer cover Press and push printer cover the cover forward Chapter 2 Setting up the Pony graphic 31 Power Supply The Pony graphic can be supplied by the following ways e NI Cd recharging batteries e Connection to 110 220v plug by the proper batteries charger power supply e Connection to the car lighter plug If the Pony graphic is used when it is connected to the main the recharging time will be longer 220V Power supply Connection to the net Adaptor for car Connection to the car lighter plug Once the batteries are fully charged they allow the execution of about 200 tests When the batteries reaches a lower level the Pony graphic shows it with the Battery sign on the screen In this case you can still use th
5. 26 Pony graphic Key Post test Test list Test search Transmit Data Erase Archive Configure Qonfigure Menu Function selects a reference Pre test for the execution of the post tests printouts or displays the patients contents of the archive searches for an archived test to dis play or print out of the test data or loops allows the data transferring to a PC or modem allows to erase all data of the ar chive displays the utility menu Pressing the configuration key the key board is structured as follows Key Calibrate F V Predicted values Diagnosis Units BTPS Function allows the turbine calibration allows the predicted value selection allows to disable or enable the auto matic diagnosis allows the selection of the unity of measurement allows to calculate the BTPS factor Setting up the Pony graphic Chapter 2 Setting up the Pony graphic 27 Before using the Pony graphic it s necessary e set up the turbine Flow Meter e check the paper in the printer e check the ribbon in the printer e make sure the batteries are charged Turbine To install the turbine 1 Connect the turbine flow meter to the Main Unit by inserting the 4 pin turbine Flow Meter plug in the slotted jack 2 Insert the disposable mouthpiece on the turbine flow Use the proper mouthpiece adapter for children optoelectronic reader Pony graphic 28 adults mouthpiece turbine flowmeter
6. In case of the FVC test other two tests can be executed by the patient the Pre and Post bronchial stimulation W hen the test is over it is possible to print at the Best test Best key and the last executed test Last key The Pony graphic assigns a maximum time for the execution of the test after which the test is interrupted even if has not fin ished yet If you want to interrupt the test in advance press the Stop key Forced Vital Capaaty al This test provides important information about the resistance of the airways FVC test manoeuvre 1 Breathe normally several times optional 2 Execute a maximum inspiration 3 Execute a maximum forced expiration 4 Execute a maximum forced inspiration 8 optional 5 Breath normally Chapter 3 Using the Pony graphic 45 Pony graphic 46 Parameters calculated During the FVC test the following parameters are calculated Parameter um FVC 1 FEV1 1 PEF 1 s PIF 1 s Vmax 25 1 s Vmax 50 1 s Vmax 70 1 s FEF 25 75 1 s FEVI FVC FEV VC FET100 s Parameter name Forced vital capacity Volume exhaled after 1 m Peak Expiratory flow Peak Inspiratory flow Expiratory flow at 25 of FVC Expiratory flow at 50 of FVC Expiratory flow at 75 of FVC Average Expiratory Flow between 25 and 75 of FVC 100x FEV1 FVC 100x FEV1 VC Forced Expiration Time To carry out the FVC test 1 Connect the patient to the turbine flow meter 2 App
7. the doctor s discretion There are not data that reveal specific contraindication for the bronchial provocation test through inha lation Chapter 1 Foreword 11 12 Pony graphic The modern standard processes have been revealing secure in several clinical studies However it is recommendable to respect the following contraindications Absolute contraindications Serious bronchial obstruction FEV1 in adults Recent myocardium infarct Recent vascular cerebral accident Known arterial aneurysm incapacity for understanding the provocation test procedures and its implications Relative contraindications Bronchial obstruction caused by the respiratory manoeuvre Moderate or serious bronchial obstruction For ex Predicted value FEV1 less than 1 51 in men and predicted value FEV1 in women less than 1 21 Recent infection in the superior air tracts During the asthmatic re acuting Hypertension Pregnancy A pharmacology treatment epilepsy Checking the packing contents The Pony graphic is composed by a Main unit and by some other accessories Make sure that the packing box contains the instruments listed below In case of missing or damaged parts please contact your nearest COSMED technical assistance Pony Graphic standard equipment The Pony graphic contains the following instruments Description Turbine L89 Optoelectronic reader Mouthpiece adapter for children Carrying case Paper mouthpiece for adul
8. whether on the display or on printout without downloading data on a PC Chapter 3 Using the Pony graphic 57 To search a test in the archive 1 Turn the Pony graphic on confirm the date and press the Utility key Select Search test 3 Insert the ID code or the test number you want to examine and confirm pressing Enter 4 Press 1 to display the test or 2 to print it out N l v TONY gramhic H pony graphic x y 1 QET Tham 1 POST TEST LIST THATS z z LIST TEAT He RGH TFA He HBR H T ST 1 REN HIT DAT 4 RUE T DA TA 2 HRASH AALHIVE z ERxHth aRCHLYE i DIGBY IEF EHE 1 DEMP MTA Hoo w Tesi in arciive Teagert ID gods l Display on tert Wi 2 Fri tout A Eik Data transmission The pony graphic allows to transmit the data archived on the PC hard disk by means of a serial cable RS 232 For this operation follows instructions described in the chapter concerning software Link to the PC e Connect the RS232 supplied cable as it is described in the following figure Pony graphic 58 To prepare the Pony graphic to transmit data to PC 1 Turn the Pony on 2 Onthe Utility menu select Download by pressing key 4 3 Press twice Enter to transmit all the test in the archive other wise select tests by typing the appropriate test numbers Notice The selection is relative to the numbers of the tests Before executing the selection it is advisable to print o
9. EN 60 601 1 1990 Temperature range 10 C 50 F and 40 C 104 F Relative humidity range 20 to 80 Atmospheric Pressure range 700 to 1060 mBar Avoid to use it in presence of noxious fumes or dusty envi ronment and near heat sources Do not place near heat sources Notice if accidentally droppings exposure to heat source and excessive humidity may compromise the validity of the system we recommend you a calibration check or ask for a technical assist ance Chapter 1 Foreword 17 nventions Here are the conventions used for its draft Typographic conventions The following typographic conventions are used in this manual Type Represents Bold It indicates an item to be selected or a key to be pressed in this last opportunity the beginner letter is always a capital letter italic It indicates if it is in inverted commas the message showed on the Pony display Graphic conventions The following Graphic conventions are used in this manual Symbol Description Key It represents the key to be pressed to execute the pre dicted function Display It represents prompts and messages on the Pony dis play during the execution of corresponding functions 18 Pony graphic Pony graphic which is represented in the figure below is a spiro metric system to evaluate static and dynamic lung functionality Pony graphic allows to download data to a PC through a serial RS232 connection Graphic
10. H 0 025 A 0 13 Vmax50 0 0321 H 0 024 A 0 44 Vmax75 0 0174 H 0 025 A 0 18 MVV 0 807 H 0 57 A 5 5 VC PredFVC 0 35 PIF 1 15 BSA 0 014 A 2 73 Males lt 18 years Symbol Formula IVC PredFVC 1 048 FVC 0 000358 H 3 18 1000 FEV1 0 000774 H 3 1000 FEV 1 FVC PredFEV 1 PredFVC 100 4 55 FEV1 VC PredFEV 1 PredVC 100 FEF25 75 0 000798 H 2 46 60 4 23 28 97 sD 4 7 0 69 10 71 SD 1 048 0 932 4 55 0 13 ITS Black Vmax25 0 07 H 0 147 A 7 05 Vmax50 0 0543 H 0 115 A 6 39 Vmax75 0 0397 H 0 0057 A 4 24 PEF 0 078 H 0 166 A 8 06 MVV PredFEV1 40 VC PredFVC 1 048 PIF 2 57 BSA 0 17 A 2 27 Females lt 18 years S ol Formula SD TVC PredFVC 0 716 FVC 0 00257 H 2 76 1000 0 716 FEV1 0 00379 H 2 68 1000 0 622 FEV1 FVC PredFEV 1 PredFVC 100 4 55 FEVI VC PredFEV 1 PredVC 100 4 55 FEF25 75 0 00379 H 2 18 60 0 14 Vmax25 0 044 H 0 144 A 3 37 Vmax50 0 0288 H 0 1111 A 2 3 Vmax75 0 0243 H 0 2923 A 0 0075 A 2 4 4 PEF 0 049 H 0 157 A 3 92 MVV PredFEV1 40 VC PredFVC 0 716 PIF 0 06 H 5 26 Reference Adult Pediatric Intermountain Thoracic Society Note SD FEV1 FVC and FEV1 VC from ERS93 Males gt 19 years Symbol Formula sD IVC PredFVC 0 57 FVC 4 65 0 06 H 0 0214 A 0 57 FEVI 2 19 0 0414 H 0 0244 A 0 43 Chapter 5 Appendix 103 Pony graphic 104 FEVI FVC 110 49 0 13 H 0 152 A 4 23 FEV1 VC PredFEV1 FVC FEF25 75 2 133 0 038 H 0 0204 A 0 85 Vmax25 0 088 H 0 035 A 5 62 Vmax
11. LCD Keyboard New features Graphic display The wide display allows to show in real time the flow volume loop during the Forced Vital Capacity manoeuvre and the vol ume time loop during Slow Vital Capacity and Maximum Volun tary Ventilation manoeuvre The back lighting gives a better visibility even in conditions of poor lighting Chapter 1 Foreword 19 20 Pony graphic Turbine Due to new helicoidal conveyers it offers very low resistance to the flow lt 0 7 cmH20 1 s at 12 I s of flow Printer The new High speed Epson printer 2 5 lin s Pony graphic pro vides a complete print out report in few seconds Pony graphic enables to print a wide print out meeting the ATS 1987 require ments through an external printer This feature is compatible with printers having HP PCL3 printer language and with a serial port Test management It is possible to display and print out tests stored in the archive even afterwards Bronchial provocation response With the Pony graphic it is possible to display and print out the fall of FEV1 at the end of each Post test choosing Fall Fev1 command at the end of every FVC post Predicted values By means of the Predicted command of the Configuration menu it is possible to select the following predicted values Adults Paediatric ERS 93 Zapletal ITS ITS Knudson 83 Knudson83 MC Barcelona MC Barcelona LAM LAM Calibration The calibration process is completely managed by the key
12. as soon as the execution test is completed Notice all the stored data are saved even when the Pony graphic is turned off power switch off so long as the Ni Cd batteries are sufficiently charged Archive structure Patient s ID Code Potents ID code e d Cre re iee r List of commands Pony graphic is provided with a multifuction keyboard whose keys have different meanings in relation to the kind of executing function Function Keys The main function keys list is the following Patient Utility Print FVC VC MVV Last Best Paper Function inserts anthropometric data and ID Code of a new patient modification of the sex value in the anthropometric data displays and modifies the last inserted patient s data accesses the utility menu prints out patient s data or test carries out the Forced Vital Capacity test carries out the Slow Vital Capacity test carries out the Maximum Voluntary Ventilation test displays the last test displays the best test advancing roll of printer paper Qonfirm and cancel commands The following commands are active during every Pony graphic functions Key Cancel Enter Utility menu Function cancels the last operation confirms the operation in progress Some commands like the utility and configuration commands allow to access other functions Pressing the utility key the keyboard is structured as follows Chapter 1 Foreword 25
13. in one device This manual has been compiled by means of Adobe Page Maker 6 0 Microsoft word and Cad programs Word Excel are registered trade marks of Microsoft Corporation DBIII is a registered trade mark of Bordland International Inc Lotus 123 is a registered trade mark of Lotus Development Corporation Page Maker is a registered trade mark of Adobe Corporation Pony graphic user manual IV Revision May 2000 COSMED srl Italy Part n C00296 02 91 Index iii Table of Contents Foreword 7 Intend d US s s s cstcascseschccs catestesaiatessssssannies sac Aa Ri i WaIMINGS sesiroirorsoresssisciseit si sean E AE EEEE EREK EE i RRE Contraindication 11 Contraindications for the Spirometer tests ceseseseseeeeeeeeeees 11 Contraindications for Bronchial provocation tests ssssessseeeeee 11 Checking the packing contents 00 0 0 ccc eseeeeseeseeeeeteteeeeeeeeneeaes 13 Warranty registrations scacsecissedssniessesieiei gia eiia 15 Safety and conformity cccssscccccseereoresscsccvscsecsatsccuececschccasdssasscsvesnes 15 Environmental condition of utilization 17 Conventions 18 Typographic Conventions esite erie E rE 18 Graphic Conventions cceeessesseeseesceseeeceeceseeseeseeaeeseeaeeseeaeeaeeaeees 18 Features 19 New features oo cccecceescesscsecsseeseeeceeeeeeeceeseesessecsecaecaecaecaeceeeeeneaees 19 Accessories ses Technical Features scscssvcsesscsscesiseacsassevssveevsessivecvscaschssasctasbciousdave
14. keys 369 4 Check ifthe message archive erased is shown and the message Request new ID code appears on the display 5 Confirm the ID code code 1000 or insert a new start code pressing Enter BONE graphic X Y ae 2 Tr tay Poon T s ee UE E a THF ERASE ARCHIVE wit EASE CHILE A o DONE GUR 6 CONFICUBS RTJENTION Proqressiv IL apdo Bef wo gur the Sure cL you wish te CANCEL Hew F 1200 aE fbe atelie presa Genfiec Enter z 3 79 to confi Ings tne ID ode Chapter 3 Using the Pony graphic 61 Pony graphic 62 Data management Chapter 4 Data management 63 Setting up the Pony graphic Preparing Pony graphic Before using the Pony graphic it is ne ssary Set up the turbine flowmeter e Insert the batteries placing them as indicated on the back of the instrument e Link the instrument to your PC throw the serial port available COMI or COM2 Installation of the PC software From the Windows Program Manager menu bar 1 Use the mouse or keyboard to select File 2 Select Run from the File menu 3 Inthe Command line box type a install assuming the disk is in drive A 4 Click on OK or press ENTER key The program will load up a dialog box and ask for a directory to be installed in We recommend Ponywin for the exported files and the program After the program has finished installing it will present a message indicating that the installation was successful click on e
15. operations for the number of the Post tests executed Notice The dose administered during the POST FVC execution must be a cumulative dose The last dose The addition of the previous doses since the Pony doesn t add up the value typed in the previous phases Response to the drug To analyse the response of the airways to the administered drug and to calculate the fall of the FEV1 during the administration of the different doses 1 At the end of the Post test before executing the follow ing one select Response pressing the 2 key On the display the test and the Post tests list appear The dis played fields are FEV1 FEV1 in absolute value FVC FVC in absolute value FF1 Percentage of the fall of the FEV1 in relation to the Pre value Dose Cumulative dose of the drug Chapter 3 Using the Pony graphic 53 Pony graphic 54 teda m R O twake 4 00 68 40 5 wl 2 741 da 15 13 1 42 A O F 4 45 FAO 335 an In this way it is possible to check the decrease of the FEV1 during the Post phases and to stop the test when the FEV1 reaches a significant value To interrupt the test The test is interrupted 1 Pressing the Stop key 2 In case of flow absence after 5 seconds Results After having confirmed the test with Enter the Pre and Post loops are displayed Option Operation Displaying the parameters press the Enter key several times to read the obtained results Printing out press
16. 0 01217 H 0 000189 H 2 0 263 TLC 1 7592 0 03394 H 0 0003 H 2 RV 0 805 0 0109 H FRC 0 02556 H 2 1778 0 26 RV TLC 34 7 0 0647 H 3 91 FRC TLC 38 73 0 0615 H 4 FEV1 0 0364 H 3 0378 0 42 FEVI FVC 84 47 4 55 FEV1 VC 84 47 4 55 Vmax25 0 06367 H 5 1934 Vmax50 0 04477 H 3 3655 Vmax75 0 02483 H 1 8576 PEF 0 06594 H 5 3794 VC PredFVC 0 263 Chapter 5 Appendix 99 KNUDSON 83 Pony graphic 100 Reference A dult Paediatric Changes in the Normal Maximal Expiratory Flow Volume Curve with Growth and Anging J Knudson D Lebowitz J Holdberg B Burrows ARRD 1983 127 725 734 Note SD FEV1 FVC and FEV1 VC from ERS93 Males gt 25 years S ol Formula SD IVC PredFVC 1 183 FVC 8 7818 0 0844 H 0 0298 A 1 183 FEV1 6 5147 0 0665 H 0 0292 A 1 017 FEVI FVC PredFEV 1 PredFVC 100 6 51 FEV1 VC PredFEV 1 PredVC 100 6 51 FEF25 75 4 5175 0 0579 H 0 0363 A 1 422 Vmax50 5 5409 0 0684 H 0 0366 A 1 624 Vmax75 2 4827 0 03 1 H 0 023 A 0 884 MVV PredFEV1 40 VC PredFVC 1 183 Females gt 20 years Symbol Formula sD IVC PredFVC 0 721 FVC 2 9001 0 0427 H 0 0174 A 0 721 FEV1 1 405 0 0309 H 0 0201 A 0 65 FEVI FVC PredFEV 1 PredFVC 100 6 51 FEV1 VC PredFEV 1 PredVC 100 6 51 FEF25 75 1 1277 0 0209 H 0 0344 A 1 131 Vmax50 0 6088 0 0268 H 0 0289 A 1 178 Vmax75 1 1177 0 0096 H 0 0259 A 0 848 MVV PredFEV1 40 VC PredFVC 0 721 ITS White Males lt 25 years Symbol Formula SD IVC PredFVC 1 048
17. 0 043 H 0 029 A 2 49 FEVI FVC 0 18 A 87 21 FEV1 VC 0 18 A 87 21 FEF25 75 0 0194 H 0 043 A 2 7 Vmax25 0 0546 H 0 029 A 0 47 Vmax50 0 0379 H 0 031 A 0 35 Vmax75 0 0261 H 0 026 A 1 34 PEF 0 0614 H 0 043 A 0 15 MVV 1 19 H 0 816 A 37 95 ERV Pred FRC PredRV VC Pred IVC Females gt 18 years S ol Formula TVC 0 0466 H 0 026 A 3 28 FVC 0 0443 H 0 026 A 2 89 TLC 0 066 H 5 79 RV 0 0181 H 0 016 A 2 FRC 0 0224 H 0 001 A 1 RV TLC 0 34 A 18 96 FRC TLC 0 16 A 45 1 FEV1 0 0395 H 0 025 A 2 6 FEVI FVC 0 19 A 89 1 FEV1 VC 0 19 A 89 1 FEF25 75 0 0125 H 0 034 A 2 92 Vmax25 0 0322 H 0 025 A 1 6 Vmax50 0 0245 H 0 025 A 1 16 Vmax75 0 0105 H 0 025 A 1 11 PEF 0 055 H 0 03 A 1 11 MVV 0 842 H 0 685 A 4 87 ERV PredFRC PredRV VC Pred IVC 0 41 0 6 5 46 6 74 0 51 7 17 TAT 1 04 1 71 1 32 0 78 1 21 0 56 sD 0 42 0 43 0 6 0 35 0 5 5 83 5 93 0 38 6 51 6 51 0 85 1 35 1 1 0 69 0 9 0 42 Males lt 18 years Symbol Formula SD TVC 7 9942 0 12509 H 0 000605 H 2 0 393 FVC PredIVC0 393 TLC 15 1397 0 22713 H 0 001002 H 2 RV 1 052 0 012 H FRC 9 372 0 1415 H 0 000602 H 2 0 35 RV TLC 34 7 0 0647 H 3 91 FRC TLC 38 73 0 0615 H 4 FEV1 6 63 14 0 10261 H 0 000499 H 2 0 523 FEV1 FVC 84 47 4 55 FEV1 VC 84 47 4 55 Vmax25 6 822 0 07811 H Vmax50 4 5848 0 0543 H Vmax75 2 3069 0 02817 H PEF 6 9865 0 0806 H VC PredFVC Females lt 18 years Symbol Formula sD IVC PredFVC 0 263 FVC 0 169
18. 3 W 0 02955 A 2 87 0 263 FEF25 75 0 046 Ht 0 051 A 4 30 0 651 PEF 0 073 Ht 0 134 A 7 57 0 831 Vmax75 0 027 Ht 0 032 A 2 68 0 507 Vmax50 0 046 Ht 0 067 A 4 17 0 669 Automatic diagnosis Pony graphic 108 Reference Lung Function Testing selection of refence values and interpretative strategies A R R D 144 1991 1202 1218 LLN Pred 0 8 80 of the Pred The AD is carried out at the end of the FVC manoeuvre if 1 The automatic diagnosis is enable 2 The patient s data allows the calculation of the LLN 3 It has been carried out a FVC PRE test Interpretation message Criterion Normal spirometry FVC and FEV1 FVC gt LLN Obstructive abnormality Mild Pred FEV1 lt 100 and 70 Moderate Pred FEV1 lt 70 and 60 Moderately severe Pred FEV1 lt 60 and 50 Severe Pred FEV1 lt 50 and 34 Very severe Pred FEV1 lt 34 Restrictive abnormality Mild FVC lt LLN e Pred FVC70 Moderate Pred FVC lt 70 and 60 Moderately severe Pred FVC lt 60 and 50 Severe Pred FVC lt 50 and 34 Very severe Pred FVC lt 34 Q uality Control Messages Reference Spirometry in the Lung Health Study Methods and Quality Control ARRD 1991 143 1215 1223 QC Message Star faster Avoid coughing Blow out longer Blow out more air Blow out harder Take a deeper breath Blow out faster That was a good test FVC reproducible FEV1 reproducible PEF reproducible MVV time too short Criterion VEXT gt 5 della FVC e
19. 50 0 0684 H 0 0366 A 5 54 Vmax75 0 031 H 0 023 A 2 48 PEF 0 094 H 0 035 A 5 99 MVV 1 34 H 1 26 A 21 4 VC PredFVC 0 57 PIF 1 19 BSA 0 023 A 3 09 Females gt 19 years Symbol Formula IVC PredFVC 0 35 FVC 3 59 0 0491 H 0 0216 A 0 35 FEV1 1 578 0 0342 H 0 0255 A 0 29 FEV1 FVC 126 58 0 202 H 0 252 A 4 7 FEV1 VC PredFEV1 FVC FEF25 75 2 683 0 0154 H 0 046 A Vmax25 0 043 H 0 025 A 0 13 Vmax50 0 0321 H 0 024 A 0 44 Vmax75 0 0174 H 0 025 A 0 18 MVV 0 807 H 0 57 A 5 5 VC PredFVC 0 35 PIF 1 15 BSA 0 014 A 2 73 Males lt 18 years S ol Formula IVC PredFVC 1 048 FVC 0 00107 H 2 93 1000 FEV1 0 00103 H 2 92 1000 FEVI FVC PredFEV 1 PredFVC 100 4 55 FEV1 VC PredFEV 1 PredVC 100 FEF25 75 0 000361 H 2 6 60 Vmax25 0 07 H 0 147 A 7 05 4 23 28 97 SD 4 7 0 69 10 71 sD 1 048 0 932 4 55 0 18 Lam Vmax50 0 0543 H 0 115 A 6 39 Vmax75 0 0397 H 0 0057 A 4 24 PEF 0 078 H 0 166 A 8 06 MVV PredFEV1 40 VC PredFVC 1 048 PIF 2 57 BSA 0 17 A 2 27 Females lt 18 years Symbol Formula sD IVC PredFVC 0 076 FVC 0 000834 H 2 98 1000 0 076 FEV1 0 001 14 H 2 89 1000 0 622 FEV 1 FVC PredFEV 1 PredFVC 100 4 55 FEV1 VC PredFEV 1 PredVC 100 4 55 FEF25 75 0 00145 H 2 34 60 Vmax25 0 044 H 0 144 A 3 37 Vmax50 0 0288 H 0 1111 A 2 3 Vmax75 0 0243 H 0 2923 A 0 0075 A 2 4 4 PEF 0 049 H 0 157 A 3 92 MVV PredFEV1 40 VC PredFVC 0 076 PIF 0 06 H 5 26 Reference Adult Pediatric
20. A survey of ventilatory capacity in Chinese subjects in Hong Kong Lam Kwok Kwong Pang Shing et Al Annals of Human Biology 1982 vol 9 No 5 459 472 Note SD FEVI FVC and FEV1 VC from ERS93 Males gt 20 years Symbol Formula sD IVC PredFVC H 100 2 0 22 FVC H 100 2 0 013 A 1 912 H 100 2 0 22 FEV1 FVC PredFEV 1 PredFVC 100 4 23 Chapter 5 Appendix 105 Pony graphic 106 FEV1 VC PEF PredFEV1 PredVC 100 0 86 A 0 00047 A 3 3 13 4 60 MVV PredFEV1 40 VC PredFVC FEV1 H 100 2 0 016 A 1 823 Females gt 20 years Symbol Formula IVC PredFVC FVC H 100 2 0 01 A 1 518 FEV1 H 100 2 0 012 A 1 442 FEV1 FVC PredFEV 1 PredFVC 100 FEV1 VC PredFEV1 PredVC 100 PEF 0 45 A 0 00032 A 3 259 7 60 MVV PredFEV1 40 VC PredFVC Males lt 20 years Symbol Formula IVC PredFVC FVC H 100 2 0 064 A 0 335 FEV1 H 100 2 0 059 A 0 322 FEV1 FVC PredFEV1 PredFVC 100 FEV1 VC PredFEV1 PredVC 100 PEF 15 08 A 0 0075 A 3 75 5 60 MVV PredFEV1 40 VC PredFVC Females lt 20 years Symbol Formula IVC PredF VC FVC H 100 2 0 041 A 0 507 FEV1 H 100 2 0 04 A 0 454 FEV1 FVC PredFEV1 PredFVC 100 FEV1 VC PredFEV1 PredVC 100 PEF 19 96 A 0 0209 A 3 33 8 60 MVV PredFEV1 40 VC PredFVC 4 23 0 84 H 100 2 0 19 H 100 2 0 19 SD H 100 2 0 19 H 100 2 0 19 H 100 2 0 17 47 47 0 62 H 100 2 0 19 SD H 100 2 0 17 H 100 2 0 17 H 100 2 0 15 4 55 4 55 0 54
21. FVC 6 8865 0 059 H 0 0739 A 1 048 FEVI 6 1181 0 0519 H 0 0636 A 0 932 FEVI FVC PredFEV 1 PredFVC 100 4 55 FEVI VC PredFEV 1 PredVC 100 4 55 FEF25 75 6 199 0 0539 H 0 0749 A 1 315 Vmax50 6 3851 0 0543 H 0 115 A 1 504 Vmax75 4 2421 0 0397 H 0 89 MVV PredFEV1 40 VC PredFVC 1 048 Females lt 20 years S ol Formula SD IVC PredFVC 0 716 FVC 4 447 0 0416 H 0 0699 A 0 716 FEV1 3 7622 0 0351 H 0 0694 A 0 622 FEV1 FVC PredFEV1 PredFVC 100 4 55 FEV1 VC PredFEV1 PredVC 100 4 55 FEF25 75 2 8007 0 0279 H 0 1275 A 1 01 Vmax50 2 304 0 0288 H 0 1111 A 1 074 Vmax75 0 024 H 4 4 0 2925 A 0 0075 A 2 0 763 MVV PredFEV1 40 VC PredFVC 0 716 Reference Adult Paediatric Intermountain Thoracic Society Note SD FEV1 FVC and FEV1 VC from ERS93 Males gt 19years Symbol Formula sD IVC PredFVC 0 57 FVC 4 65 0 06 H 0 0214 A 0 57 Chapter 5 Appendix 101 Pony graphic 102 FEV1 2 19 0 0414 H 0 0244 A 0 43 FEVI FVC 110 49 0 13 H 0 152 A 4 23 FEV1 VC PredFEV1 FVC FEF25 75 2 133 0 038 H 0 0204 A 0 85 Vmax25 0 088 H 0 035 A 5 62 Vmax50 0 0684 H 0 0366 A 5 54 Vmax75 0 031 H 0 023 A 2 48 PEF 0 094 H 0 035 A 5 99 MVV 1 34 H 1 26 A 21 4 VC PredFVC 0 57 PIF 1 19 BSA 0 023 A 3 09 Females gt 19 years S ol Formula IVC PredFVC 0 35 FVC 3 59 0 0491 H 0 0216 A 0 35 FEV1 1 578 0 0342 H 0 0255 A 0 29 FEV1 FVC 126 58 0 202 H 0 252 A 4 7 FEV1 VC PredFEV1 FVC FEF25 75 2 683 0 0154 H 0 046 A Vmax25 0 043
22. Foreword Chapter 1 Foreword 7 Important notices Intended use V rnings 8 Pony graphic Pony graphic is an electrical medical device designed to perform pulmonary function tests It is to be used by physicians or by trained personnel on a physi cian responsibility This equipment has been conceived to be used as an auxiliary instrument in order to e formulate lung pathology diagnosis e perform studies concerning human physiology e get information in sport medicine No responsibility attaches COSMED srl for any accident hap pened after wrong use of the device such as e use by non qualified people e non respect of the device intended use e non respect of all the following precautions and instructions The device the programme algorithms and the presentation of measured data have been developed according to the specifica tions of ATS American Thoracic Society and ERS European Respiratory Society Other international references have been followed when these were not available All bibliography refer ences are reported in manual Appendix The present handbook has been developed following the 93 42 CEE requirements according to which Pony graphic is to be considered Class Ia device It is recommended to read carefully the following precautions before putting the device into operation The precautions reported below are of fundamental importance to assure the safety of all COSMED equipment users 1 This u
23. and press OK 3 Type the name and the format of the file in the dialog Save as Nota if the ASCII format is selected the Text button in the dialog box Save as allows you to configure the separators for character based files 80 Pony graphic graphic User s Manual Page setup ae ents cen op ini i San E ra bee brisa Br rake D Fmi Wian o m o s iie Select Page Setup from the File menu Header All the printouts carried out by the program are preceded by 3 rows of customizable header usually contain the name and the address of the Hospital using the spirometer Data Patient and visit informations are printed below the header These data are reported on 3 columns and 5 rows and is possible to configure the disposition of the voices or avoid to print those that don t interest Margin Configures the print margins from the borders of the paper The unit of measure is decided in Units of measurements Footer Insert the physician name Chapter 4 Data management 81 Other features of the program Archive The software allows to manage files selecting Archive from the File menu Initialising the database It deletes all file stored by the software Select Initialize Reorganizing the archive In order to free space on the hard disk and or to correct possible errors present within the database Select Reorganize Backup ST begie SS Bee EE th ken
24. any part of the system to high heat and do not put it under running water After having cleaned the Turbine check if the Turbine propeller rotates freely even with a low speed air flow At the end reassemble the Turbine as it is described in the figure below Chapter 5 Appendix 989 Pony graphic 90 Inspections The equipment needs easy inspections to be carried out in order to assure a proper electrical and mechanical safety level in the years These inspections are highly recommended after a rough use of the equipment or after a period of storage in unfavourable envi ronmental conditions Referring to the electrical safety is important to control the con ditions of insulation materials of cables plugs and of any other visible part by means of simple inspection when the equipment is switched off and adapters or electrical feeders are discon nected from the supply mains Mechanical parts to be checked are essentially the turbine flowm eter and the breathing circuits Follow these instructions extract the turbine flowmeter form the optoelectronic reader verify by inspection that the turbine axis fits correctly in its seats and the blade is strongly fastened on the axis itself it can be useful to shake slightly the turbine in order to note any anomalous movement Control if there are torn or broken components in the breathing circuits remember that they can create safety risk to patients during tests Tr
25. ary to switch off the device itself and to disconnect adapters from the supply mains Cleaning and disinfection instructions are of fundamental impor tance to control infections and assure patient safety In fact aspi ration of residue particulates and contaminates are life threat ening In this handbook is recommended to follow the rules worked out by ATS and ERS see Lung Volume Equipment and Infection Control ERS ATS WORKSHOP REPORT SERIES European Respiratory Journal 1997 10 1928 1932 which are summa rised and adapted for COSMED products in the following part e Accessible internal as well as external surfaces of equipment exposed to expirates should be washed and disinfected prior to testing of subsequent patients e Disinfection should ideally be performed by heat sterilization but gas or liquid sterilization can be used if the equipment is well cleaned first no droplets of saliva sputum remain e Disposable gloves should be worn when handling mouth pieces when cleaning equipment exposed to saliva or sputum and especially when drawing blood e Laboratory staff should wash hands prior to testing of each patient e Adopt particular precautions when testing patients with rec ognised high risk communicable diseases e g tubercolosis multidrug resistant staphylococcus In these cases the clinical need for such testing should justify the risks During disinfection e do not use alcohol or o
26. atient ios 4 Confirm with Enter and check that the message Kind of test Post and the ID code appear on the display 5 Press the FVC key 6 At the request Insert the quantity of bronchial drug type the amount of the drug administration and confirm with En ter 7 Execute the FVC test StF ELST LIST 2 LLET laste 3 SEARCH TEST J JRAnS OAS f n 5 BRAS APCHIWE l a SOME en SEH Provocation teat ee ee eae tone eee a At the end the test will be confirmed pressing the Enter key or erased pressing the 1 key To execute several Post FVC tests and to store the best one after each administration press FVC and confirm without typing the amount of the bronchial drug Every time the quantity of bron chial drug is administered the Pony starts the next step and the best test is stored The Pre and Post flow volume loops are shown superimposed on one another for a better comparison Notice The quantity of drug must be a whole 5 digit number between 0 and 65535 To carry out a bronchial provocation test and analyse how the airways react to the drug in several steps 1 Once the first administration test has been confirmed at the request Select a function press the FVC key 2 At the request Insert the quantity of bronchial drug type the value of the addition of the data of the first administration and the second one 3 Execute the FVC test 4 Repeat the above
27. aving confirmed the date at the request Select a Junction press the Utility key The system allows to display or print out information about the tests stored in the memory To choose which test retrieve from the memory it is suggested first to get a complete list of the con tents of the archive To display the list in the archive ne ram l After having turned the Pony graphic on and confirmed the date press the Utility key 2 Press key 2 3 Press the Enter key to obtain the complete list in the archive otherwise type the code to get the list of tests that belong to it PUNY graphic x Y n cd FAT DATE 1 wer TEHAT 44 LIST TESTE 1 1000 w32 01 04 54 3 SEARCH TES 3 OCL Fle oly 4 o 1 TRANSLOT DATA Leal EC ASE AOHTWE 6 CONFIGURE fanaa na d Meet In coje gu roaa ENTERAR om full liat Traan am kerr The parameters in the list are e Progressive number of the test e Number of the patient s ID code e Patient s sex e Patient s age e Date of test execution The list is displayed on 10 lines pages to display the following lists press the Enter key If in the archive no test is present on the display the following message will appear Empty Archive Printing the list e To obtain the complete list or a partial one press the Print key Search Test The Pony graphic provides a new function to search a test stored in the archive In this way it is possible to consult an examination
28. board Automatic diagnosis The automatic diagnosis can now be enabled or disabled by user Supply The new Ni Cd batteries without memory effect and rapid bat teries charger allow to use the Pony graphic even during the bat teries charging Accessories Here following the list of the main accessories consumables for Pony graphic Accessories consumables Description Calibration syringe 3 litres Paper mouthpiece for children 500pcs Paper mouthpiece for adults 500pcs Roll of paper 10pcs Printer ribbon 5 pcs Nose clips 5 pcs Technical Features Features Flow meter Flow range Volume range Accuracy F V Dynamic res at 12 I s Mouthpieces Graphic display Printer Keyboard Serial cable Power supply Battery autonomy Battery charge Dimensions Weight Part Number C00600 01 11 C01814 01 98 C01805 01 98 C00643 01 98 A666 905 001 C00441 01 98 Value Digital bidirectional turbine 0 03 20 I s 101 3 or 50 ml lt 0 7 cm H20 I s 31 and 22 mm Back lighting LCD 70x80 mm Graphic 24 char lin 2 5 lines s 12 multifunction keys RS 232 bidirectional 4800 baud Batteries Ni Cd 5V 1 2 Ah 200 tests including prints out 12V dc 1 2 A 237x127x46 mm 1 2 kg PC configuration required e Pentium 133 MMz e Windows 95 98 NT e 16MbRAM Chapter 1 Foreword 21 e 3 5 drive e VGA SVGA monitor e Serial Port RS 232 available two serial ports available in case o
29. c graphic User s Manual Printing results You can print out in two different ways e printing the Report e printing the Active Window Printing the report The standard Report is composed by 2 or 3 pages depending if you wish to printout the bronchoprovocation response The Ist page contains the F V and V t curves of the best Forced Vital Capacity the patient data the notes and the diagnosis The 2nd page contains the numerical results of the all test FVC VC IVC and MVV carried out in the current visit The third page is the bronchoprovocation response 1 Select Print Report from the File menu 2 Select the desired option among FVC graph print the F V and V T curves of the best FVC test Response print the bronchoprovocation response FVC post Tests print curves and data of the FVC post test Printing the active window This printout function is only enabled when the active window title bar highlighted is one of the following objects e Any kind of Graph e Numeric data e List of visit To print the active window 1 Ensure that the active window is one of the preceding objects 2 Select Print Active window from File menu Data exporting With this function you can export the test in 3 formats e Lotus 1 2 3 Chapter 4 Data management 79 Excel e ASCII Text File e XPO Cosmed file format To export data 1 Select Export tests from the File menu 2 Select the test to export from the list box
30. carried out by the active patient whose name is indicated on the left side of the status bar To view the results of a test proceed as follows 1 Selectthe Archive Navigator from the File menu 2 Select the patient corresponding to the test you want to view 3 Select in the list box of the tests up to 5 tests of the kind FVC VC ivc or MVV and press OK To switch between graph and or data use the following buttons on the toolbar E view Flow Volume graph E view Volume Time graph E view data of the test m view bronchial provocation response If you need more than one visualization meantime use the New Window function from the Window menu Deleting a test from the archive 1 Select Archive navigator from the File menu or press the but ton by side 2 Select the test that you want to eliminate from the list of the tests referred to the active patient and press the button by side Chapter 4 Data management T7 Managing the optional databases Diagnosis Database The program allows to manage a diagnosis database whose records are composed by a diagnosis ID code and a string of text The report of the visits can be done either typing the desired text in the field Diagnosis of the Visit Card or more quickly re trieving from the diagnosis database the desired one If you want to insert modify or delete a diagnosis from the data base select Database Diagnosis from the File menu 78 Pony graphi
31. ces 21 List of parameters calculated 20 0 cececceseeseeseeseeeeteeteeteeteeeeeeeaeees 22 Pony sraphic archive c scstevesssenessusestiasssrieateasossctnerseseisesscrusssivesebaee 23 List of commands 25 Function Keys sisi ees hiaan nerne a i E E EAA 25 Utility Menu oo eecececceseeeeeeceeeeseeseeseeseeseeseeseeaeeaeeaecaeeaeeeeaesereaeees 25 Setting up the Pony graphic 27 Preparing the unit 28 aont alee E EAE AEE P cut cidecbccdacderacss 28 Titernal Printer ascaiscievscscsessissisatsterearesicstevstster tins anrgusseacdsceeaaderaauseres 30 Power SUPPLY saessecsessessssvecsdsssssznsseasaarvansenssabearovscrnerseseipussezessedsadioane 32 Using the Pony graphic 35 Turning the Pony graphic on 36 Configuring the Pony graphic 37 Predicted Vales s cs cc ccacazccacesccaccaiayacsas jassecetuscassvssnsansdhcot saacadcsdececunces 37 Pony graphic iv Important notices PRIS tis sec sence ances een E E E EEES 39 Calculating the BTPS factor 0 cc eeeseceesseeeesesecnesseneeseeeeaes 40 Entering data 42 New Patietittccscescassrconsadnintisiaeiisictaiaikiciiacasarataiainas 42 Test SCOPING sac5sssdssiastcesescascdsseasssneada beans tecansdecansassdecdsoissnseassantnies isa 44 Performing spirometric Tests 45 Forced Vital Capacity iesene pie 45 Slow Vital Capacity oseni 47 Maximum Voluntary Ventilation 0 0 0 ccceeeeeeeceeeeeceeeeeeceeeeeeeeees 50 Bronchial Provocation Test ATS reproducibility eissien Other Functions Utility Menu
32. cessing to other shared archives indicating your User Name Uploading data from the spirometer E erbia dala E n Temeer j mil Before starting any analysis you must upload the data from the spirometer via the serial port 1 Link up the spirometer to the PC with the RS232 cable sup plied Select Receive from the Test menu or press the button by side Prepare the spirometer to transmit the data Click the Receive button on PC Start data transmission from the spirometer nA Bw N Linking tests to a Patient in the archive The data received from the spirometer are held in temporary memory These tests must then be stored within the patient data base by linking each test to the corresponding patient 72 Pony graphic graphic User s Manual he D le F rob umi Tr me gi Liei ts i j o BG mj m fod me lo oom tam ise be i B To link a test to a patient 7 1 Selct Link from the Test menu or press the button by side mp ey 2 Select the test you want to link in the top area of the window 3 Select the correspondent Patient in the bottom area of the win dow Buttons description relative to the test link area Move to the first test to link Move to the previous test to link Move to the next test to link Move to the last test to link Delete current test e a A E E Compare the paper report of the spirometer wW uttons description relative to the patient card area
33. cs ceueas Vat NUMO soana A EE nin A E a eae System Mod l sicisaievedteineien dh aaXasdhoisiaisias IN eae ae ted aetna edc S Purchase dat nn oien enclose the bill of lading or invoice Maintenance contract M erada if there is one Before sending the system make sure you have executed the procedures of the para graph Problem solving properly Do not send superfluous accessories for assist ance manuals consumables etc List of the sent parts Is the failure intermittent yes O not O When the system is delivered enclose any evident printout Delivering instructions Chapter 5 Appendix 95 ATS 94 recommendations Pony graphic 96 Reference Standardization of Spirometry 1994 Update Ameri can J Respiratory Critical Care Medicine Vol 152 1107 1136 1995 ATS recommendations Range Volume 81 BTPS Range Flow 14 l sec Accuracy Volume 3 or lt 50 ml Accuracy Flow 5 or lt 200 ml s Flow resistance lt 1 5 cmH 0 at 14 I s Reproducibility the 2 largest of 3 acceptable FEV1 and FVC val ues should be within 5 or 150 ml The end of test no change in volume for 1 second with at least 6 seconds of collected volume Accumulation time the maximum time allowed for volume accu mulation during the VC manoeuvre should be at least 30 seconds and at least 15 seconds during the FVC The spirometer should be store at least 8 FVC manoeuvres FEV1 should be calculated by using the back ext
34. e or post diluent P10 Provocative dose or concentrat causing FEV1 to fall 10 baseline PIS Provocative dose or concentrat causing FEV1 to fall 15 baseline P20 Provocative dose or concentrat causing FEV1 to fall 20 baseline Pony graphicarchive The pony graphic archive can store data from tests conducted on over 200 patients Its actual capacity depends on the width vol ume axis of the flow volume loops stored the flatter the loops the greater the number of tests that can be stored Pony graphic assigns a progressive number to each new chart i e paper archive in which all the data and test results relative to the new patient are stored The Pony graphic also assigns an ID Code number for each patient For each patient s ID code the best FVC VC IVC MVV and Post FVC tests can be stored The criteria to choose the best tests are FVC the greatest summation value FVC FEV1 VC the greatest VC value IVC the greatest IVC value MVV the greatest MVV value The parameters calculated during the entire test session are grouped in two categories LAST data and loop of the last test executed BEST data and loop of the best test executed Chapter 1 Foreword 23 24 Pony graphic These data are stored until you enter data on a new patient with New command For each patient only the group of parameters calculated based on the best tests is transferred to the archive memory by means of the key Enter
35. e unit but it s suggested to recharge the batteries Pony graphic 32 Notice Incase of complete battery discharge the Pony graphic will lose all data To charge the batteries 1 Connect the batteries charger or the lighter adapter to a power supply connector 2 Connect the batteries charger to a socket as it is specified on the batteries charge itself and check that the charge indica tor is on Maximum recharging time is 1 hour and 30 minutes and if the batteries are not fully discharged the time is shorter Leaving the batteries charger connected longer than the maximum charging time not damage will occur Notice It s suggested not to use the pony graphic during the first minutes of charging When the green led indicator of the charger batteries is flashing the batteries are charged Pony splrlomeier battery charge led indicator Chapter 2 Setting up the Pony graphic 33 Pony graphic 34 Using the Pony graphic Chapter 3 Using the Pony graphic 35 Turning the Pony graphicon After having connected the turbine Flow Meter checked if there is any paper and ribbon in the printer turn the Pony graphic on 1 Set the power switch on TI and the display should show information about the tests in archive the free memory and the message insert date 2 Confirm or modify the date on the display pressing the keys corresponding to the number to type For example if you want to insert the da
36. ed list Order Drag the parameter up or down through the mouse Customize Insert modify and delete the custom parameters Predicteds manager The program contains a preset of predicteds but the user is al lowed to customize its own predicted sets 1 Select Options Predicteds manager The Predicteds manager window is divided into two forms Predicteds set and Formula definition Chapter 4 Data management 69 erik Ld Peistedi ot Pem mi Predicteds set This form allows the user to manage the set of predicteds The following information define a set Name Identify the set and cannot be duplicated Description free field Age the adult predicteds start since this age e To insert a new set of predicteds click on the New button The field Name must be filled and must be unique To stop without saving click on the Cancel button e To delete a set of predicteds click on the Delete button If a set is deleted also the associated formulae are deleted e It is possible to generate a new set of predicteds with the same attributes and the same formulae of the selected one To do this click on the Copy button and specify a new Name e To import a set of predicteds click on the Import button and select a file of Predicteds files type e To export a set of predicteds click on the Export button e In the list Set current predicteds choose the current predicteds for printing and viewing Set the curr
37. eeseenaes 94 ATS 94 recommendations 96 Predicted values 97 ERS 93 oiaren cobacecenesscdeasadeans cesaeuncvecshteathoane AE ERE ATA EREE 97 KNUDSON 83 wsscsss ci caauchc dices ceteedd aaseasavsacucaevessexcaegesed cea catecd eies 100 TIS Witte ic5 ds cecdecstctsctsses case E E E EAAS 101 MS BACKS yaar hen aa ATS OE ORR 103 Pony graphic vi Multic ntrico di Barcelona Automatic diagnosis cceccesceseeseeseeseeseeseeeeececeeeceseeeeeeeeesereees 108 Quality Control Messages ccescesesceseeseeseeeeeeeeeeeeeseeceeeeeeeetes 109 Bibliography 110
38. ent predicted Pony graphic allows to calculate the predicted values according to 4 configurable sets 70 Pony graphic graphic User s Manual ERS 93 Zapletal Knudson83 Knudson83 ITS white ITS white ITS black ITS black LAM LAM MC Barcellona MC Barcellona e Select the desired choice in the group Predicted Formula definition This form allows the user to manage the formulae associated to a set of predicteds 1 Select the set of predicteds to manager from the list Predicteds set 2 To insert a new parameter click on the New button 3 The parameter formulae can be e calculated according to the predicteds in the list Use the predicteds formulae or customized by the user with the option or the custom ized formulae The button Copy stores the selected parameter in memory 5 The button Paste inserts a new parameter from the one cop ied If the name is not unique the user is asked whether to specify a new name or to replace the existing parameter Chapter 4 Data management 1 Archive path This program allows to work with different archive path you can for instance use a path as C PONYGRAPHICW20 1995 to manage tests performed during 1995 and C PONYGRAPHICW20 1996 during 1996 To select a different directory 1 Select Archive Path from the Option menu 2 Select the desired directory 3 Enable the LAN Local Area Network support if you want to share the archive with other user or you are ac
39. f Ergometer control e Any Mouse and Printer compatible with the MS Windows operative system e PC conform to European Directive 89 336 EMC List of parameters calculated FVC Forced Vital Capacty Symbols um Parameter FVC 1 Forced Vital Capacity Best FVC 1 Best Forced Vital Capacity FEV1 1 Volume exhaled after 1s of the FVC PEF I s Peak Expiratory Flow PIF I s Peak Inspiratory Flow Vmax 25 I s Expiratory flow at 25 of FVC Vmax 50 I s Expiratory flow at 50 of FVC Vmax 75 I s Expiratory flow at 75 of FVC FEF25 75 I s Average expiratory flow between 25 and 75 of FVC FEVI FVC FEV1 FVC x 100 FET 100 s Forced expiration time 100 FV VEXT ml Extrapolated Volume back extrapolation VC IVC Sow Vital Capacty and Ventilatory pattern Symbols um Parameter EVC 1 Expiratory Vital Capacity TVC 1 Inspiratory Vital Capacity ERV 1 Expiratory Reserve Volume IRV 1 Inspiratory Reserve Volume IC 1 Inspiratory Capacity VE Vm Expiratory Minute ventilation Vt 1 Tidal Volume Rf resp min Respiratory frequency Te s Duration of expiratory Ti s Duration of inspiratory 22 Pony graphic Ttot sec Duration of Total breathing cycle Vt ti I s Vt ti ratio Ti Ttot 1 Ti Ttot M V Maximum Voluntary Ventilation Symbols um Parameter MVV 1 m Maximum Voluntary Ventilation Bronchoprovocation Response Symbol UM Parameter FallFEV1 Fall in FEV1 from baseline or post diluent Fall Vmax50 Fall in Vmax from baselin
40. gt 150ml Blast out harder PEFT gt 120 msec 50 drop in the flow in first second FET100 lt 6 sec flow gt 0 21 s within 20 ml of FVC dPEF lt 10 dFVC lt 200ml and 5 best FVC dFEV1 lt 200ml and 5 best FEV1 No errors At least 3 acceptable maneouvres The 2 largest FVC within 0 21 of each other FVC At least 3 acceptable maeouvres The 2 largest FEV1 within 0 21 of each other The 2 largest PEF within 10 MVV time less than 12 sec Chapter 5 Appendix 109 Bibliograph Pony graphic 110 Standardization of Spirometry 1987 Update American Review of Respiratory Disease Vol 136 1285 1289 1987 Standardization of Spirometry 1994 Update American J Respi ratory Critical Care Medicine Vol 152 1107 1136 1995 Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Jour nal Volume 6 Supplement 16 March 1993 Lung function J E Cotes Blackwell scientific publications Office spirometry R E Hyatt P L Enright Lea amp Febiger Chapter 5 Appendix 111 Pony graphic 112 No parts of this manual may be reproduced or trasmitted in any form without the express permission of COSMED srl Cosmed does not assume the liability for interpretation mistakes of this documentation or for casual or consequential damages in connection with the provision representation or use of this documentation COSMED Software can be installed only
41. h electromagnetic compatibility CE mark ing and with low radiation emission displays 8 It is necessary to make the PC connected to the Pony graphic compliants with EEN 60601 1 by mean of an isolation trasformer Chapter 1 Foreword 9 9 Graphical symbols used in accordance to present specifica tions are described here below Equipment type B EN60601 1 Danger high temperature OFF ON Protective Earth Ground O Alternating Current 10 Pony graphic ntraindication The physical strain to execute the respiratory manoeuvre is con traindicated in case of some symptoms or pathology The follow ing list is not complete and must be considered as a piece of mere information Qontraindications for the Spirometer tests Absolute contraindications For FVC VC and MVV tests e Post operating state from thoracic surgery For FVC tests e Severe instability of the airways such as a destructive bron chial emphysema e Bronchial no specific marked hypersensitivity e Serious problems for the gas exchange total or partial respi ratory insufficiency Relative contraindications For FVC tests spontaneous post pneumothorax state e arterial venous aneurysm e strong arterial hypertension pregnancy with complications at the 3 mouth For MVV test e hyperventilation syndrome Qontraindications for Bronchial provocation tests The bronchial provocation tests must be executed according to
42. he calibrated syringe in order to obtain a comparison between the volume of the Turbine Flow meter and the sy ringe one If the volume is the same you should not calibrate the system vice versa execute as it is described below Access to the Utility menu pressing the Utility menu Press the 6 key to open the Configure menu Press the 1 key and insert The value measured in cl e The predicted value in cl 300 if you are checking the sys tem with a 3 litres syringe Press the Enter key obtaining the Flow Volume correction To store the new correction type 369 and press Enter to con firm Enable the expiratory correction following the instruction written in the Calculating the BTPS factor paragraph The calibration is indicated by a message and the print out of new correction Flow Volume result Notice We advice you to maintain the print out of the new correction F V result since in case the Pony could lose the data for a batteries discharge such value will be requested If such value had been lost execute the system calibration again The calibration F V 100 value correspond to no correction Chapter 5 Appendix 87 The sistem maintenance Pony graphic 88 All service operations which are not specified in this handbook should be performed by qualified personnel in accordance with the service handbook to be required to the manufacturer Prior to the device cleaning disinfection and ispection it is neces s
43. he ones on the PC BOUT yraphiu F F CALLUBMLE 1 fy AH TORNTCTRD WALES TTAGAOS TS URITE PRIHTER UPS 1 Eccs FAftapletal ECCS voftaplelal J fuwlson Neornis Jo nc Uarcelons d TAH TTS a E s Units of measurement It is possible to select two units of measurement Unit decimal metric English Weight kg Pound Height cm inches Selecting the unit of measurement B E 1 On the Configure menu press the 4 key om gt 2 Press the key corresponding to the selected unit of measure ment Notice Modifying the unit of measurement the data in the ar chive will be erased Pony graphic 38 Printer CALIBRATE F PREDICTED VALUES DINGHOZIE UES PEER TEE Pony graphic besides to print on its own printer allows to print a wide printout report with loops and data to an external printer The external printout is compatible only with printers with HP PCL3 printer language equipped with a serial input RS232 Print out report characteristics The report is printed on a single sheet of 297x210 mm A4 stand ard size The flow volume and volume time loops are printed according to ATS 1987 Hand Measurement standards To connect Pony graphic to the external printer 1 Turn the Pony graphic on 2 Connect the serial adapter 9 25 pin to the serial cable 3 Connect the 9 pin connector in the Pony graphic plug and the 25 pin connector in the printer serial plug To select the printing mode 1 On
44. ing to the patient characteristics Typing for example the value 105 it indicates an increase of 5 The value 95 indicates a decrease of 5 of the predicted values In case of loss of patient s data it won t be possible to carry out tests and the Pony graphic will display the message Insert pa tient s data New Patient Before executing tests except for the Post FVC test it is neces F sary to insert the patient s data To insert patient s data 1 Turn the pony graphic on and confirm or modify the date Pony graphic 42 2 The message Select a function appears on the display press the New key twice the second time to confirm the selection 3 Type the new ID code or confirm the automatic ID code and input the patient s data I SS h TONY graphio H Y z pomy graphic W Y The toe OL o1 ta4 Test I oe SRE a Laue I z ae eer a EU Lucia Dams l cing xH Tert N Li y Ag z a2 eae ee Height ami 183 i Ente ass patienti i Walgrn Kq R P Hi 4E N G r 1d ke ee a in EE Eoter patient data a ut e In case the code has been already used the message already in use will appear on the display press any key and start inputting the patient s data again Press the Enter key to confirm each value To switch between Male and Female press Sex At any time it is possible to cancel the value inserted if it has not been confirmed To do this press Cancel a
45. inst water penetration IP00 ordinary equip ment unprotected against water penetration e Non sterile device e Device not suitable in the presence of flammable anesthetics e Continuos functioning equipment EMC The system meets the EMC Directive 89 336 EN 60601 1 2 Chapter 1 Foreword 15 16 Pony graphic EN 55011 Class B emission TEC 1000 4 2 1991 immunity ESD 4K V CD 8 KV AD IEC 1000 4 3 1984 immunity fields EM 3 V m IEC 1000 4 4 1988 immunity Burst 1 KV Quality Assurance UNI ISO EN 9001 Registration n 387 Cermet Medical Device Directive mark MDD 93 42 EEC Notified Body 0476 Class Ia Environmental condition of utilization COSMED units have been conceived for operating in medically utilized rooms without potential explosion hazards The units should not be installed in vicinity of x ray equipment motors or transformers with high installed power rating since electric or magnetic interferences may falsify the result of meas urements or make them impossible Due to this the vicinity of power lines is to be avoided as well Cosmed equipment are not AP not APG devices according to EN 60601 1 they are not suitable for use in presence of flam mable anaesthetic mixtures with air oxygen or nitrogen protox ide If not otherwise stated in the shipping documents Cosmed equip ment have been conceived for operating under normal environ mental temperatures and conditions IEC 601 1 1988
46. ke sure it is correctly connected Chapter 5 Appendix 91 Check the printer uses the HP PCL3 or following printing lan guage Check on the manual printer that its communication protocol is the following Bit number 8 Parity None Speed 9600 Baud Bit Stop 2 Error messages The Pony graphic points out if the system is not working prop erly by means of the following displayed message Pony graphic 92 Two can be the likely problems Problem _ _ Solujon _ Printer failure Remove the printer cover and make sure the paper is inserted properly Batteries discharged Charge the Pony graphic batteries Printer error Check if the external printer has been set up properly Pon grtaghic Y l LIB STE oY l BREDICTED VALUES Teat typ a FRE dha Ha oe 1 1 H 4 Ll td PRINTER FAILURE BATTERITS GIScHar TED P 28a ny l Press any kewy Assistance Warran If you can not solve the problems independently contact Cosmed or your nearest technical assistance centre Returning the system for service Warranty In case you should send the system for repair send it directly to the following address COSMED S r l Via dei Piani di Monte Savello 37 P O Box 3 00040 Pavona di Albano Rome Italy tel 39 06 93 25 492 fax 39 06 93 14 580 email customersupport cosmed it To ensure that you receive efficient technical assistance please specify as precisely as possible the na
47. ly the nose clamp to the patient and check if the mouth piece is properly set 3 When the message e 3 select a function appears press FVC key and start the test Notice The respiration must start only after having pressed the FVC test and do not wait longer than 5 seconds otherwise the program will return to the Main Menu To Interrupt the test The examination is interrupted when 1 Pressing the Stop key 2 In case of the flow absence after 5 seconds confirming and erasing the test Confirming or cancelling the test At the end the test will be confirmed pressing the Enter key or erased pressing the 1 key Results The Pony graphic stores the best executed test However it is pos sible to display data and loops of the last executed test Last key and of the best test Best key by means of the corresponding keys The Lastand Best functions are active until the new patient s data are inserted It is possible to display and print out the results of the tests in the following ways Option Operation Displaying the parameters press several times the Enter key to read the obtained results Printing out press the Print key Slow Vital Capaaty al The Slow Vital Capacity VC is the maximum amount of air that can be expirated after a maximum inspiration condition The Slow Inspiratory Vital Capacity is the maximum amount of air that can be inspired after a maximum expiration condition The P
48. management 75 Visit Card Contains all the information relative to the visit diagnosis visit description and those one related to the patient that can change between different visits height weight smoke Each Patient can be related to several Visit Cards but it is not possible to cre ate two different Visit Cards during the same day Before carry ing out any spirometric test it is necessary to create a new Visit Card or to open the today s Visit Card Buttons description Move to the first visit in the archive Move to the previous visit in the archive Move to the next visit in the archive Move to the last visit in the archive Find a visit in the archive Delete current visit from the archive Edit current visit card E Le a Ge Led E NOTE several features of the program are enabled only if there is an Active Patient the name of the active patient is shown on the status bar Test card Contains all the information about the test Delete current test from the archive Edit current test To import export a Tets card This function allows to import export a test card with the re spective visit and patient card k 1 Select the patient and press the key by side 2 Choose the test and press OK All data will be imported exported in the XPO file format 76 Pony graphic graphic User s Manual Viewing results ww xg All the visualization functions refer to the test
49. mouth piece is prop erly set 3 At the request Select a function press the MVV key and start the test Notice The Respiration must start after having pressed the MVV key and do not wait longer than 5 seconds otherwise the program return to the Main menu To interrupt the test To end the test before 12 seconds press the Stop key or interrupt the test and wait 5 seconds Confirming or erasing the test At the end of the test the test will be confirmed pressing the key Enter or erased pressing the Cancel key Results The Pony graphic always stores the best test executed during the tests Chapter 3 Using the Pony graphic 51 However it is possible to display or to print out the data and the loops of the last test Last key and of the best Best key by means of the corresponding keys The Last and Best function are active until the new patient s data are inserted At the end of the test on the display results are shown To print out the test press the Print key Bronchial Provocation Test aca Pony graphic 52 The Pony graphic allows the execution of the FVC Test before and after PRE and POST bronchial stimulation The values of the POST FVC tests are compared with the corre sponding PRE values To carry out the Post FVC test 1 At the request select a function press the Utility key Y Select Post test pressing the 1 key At the request Insert a code type the ID Code of the p
50. nd To actually use the program you need only to open the Program Group Ponywin and double click on the Ponywin icon 64 Pony graphic graphic User s Manual Configuring the program Test option Before using the software it is suggested to set the options in the Configure dialog window from the Option menu a Sas T im Dii Mi i in Pm i aai Mial a j Iriiri fsi fsla fe Serial port You must select the serial port that will be used to connect the Pony graphic with the PC To select the serial port 1 Select RS 232 2 Click on COM 1 or COM 2 button the selected port must be different from the mouse one Units of measurements It is possible to configure the units of measurements for weight and height both for printing and viewing To select the units of measurements e Click on em Kg or in lb according to the desired format Chapter 4 Data management 65 User free fields The Patient s database is mainly made of 3 cards Patient card Visit Card and Test card where it is possible to store the infor mation about the patient and the visits Even though the information that can be typed as a standard is a lot it is however possible to customize some fields user free fields labelling them with the desired name insurance social security The customizable fields are e 3 fields in the Patient Card Patient s information e 3 fields in the Visit Card information ab
51. nd type the new value To modify patient s data The unit allows to edit the patient s data only before having con firmed any test executed by the patient 1 Press Patient the patient s data window will appear 2 Press the Enter key until you reach the value to be edited 3 Type the new value and confirm by pressing Enter 4 Confirm or modify all the other values to save the changes Notice When you choose the Post FVC test it is not possible to modify the patient s data pressing the Patient key you will ob tain the display of the data themselves Chapter 3 Using the Pony graphic 4 Late WLSUL Sse 10mg nex H Heig t jom Tg Weight Bg an Etn Corr 100 Confirm or updatea Test storing The pony graphic stores the best test of every test If a patient executes more FVC MVC VC or IVC tests during the same examination the Pony graphic will always store the best test for any kind of test When the bronchial provocation test is executed the stored data will be e The best pre FVC Loop and parameter e Every post FVC test loop and parameter Pony graphic 44 Performing spirometric Tests Once inserted patient s data the selection of tests to be executed starts The pony graphic allows the execution of the following exams Key Exam FVC Forced Vital capacity VC Slow capacity Expiratory or inspiratory and respira tory pattern MVV Maximum voluntary ventilation
52. nu To calculate the parameters of the Respiratory Pattern make the patient breathe for 3 sufficiently regular consecutive respiration acts To interrupt the test The examination is interrupted when 1 Pressing the Stop key 2 In case of flow absence after 5 seconds 3 In any case after 45 seconds after the beginning of the test Confirming and erasing the test At the end of the test the test will be confirmed pressing the Enter key or erased pressing the Cancel key Results The Pony graphic always stores the best test executed during the tests However it is possible to display or print out the data and the loops of the last test Last key and of the best test Best key by means of the corresponding keys The Last and Best functions are active until the new patient s data are inserted After having confirmed the test with Enter on the display the results are shown To print out the test press the Print key Maximum Voluntary Ventilation Pony graphic 50 The maximum voluntary respiration is the maximum volume that can be breathed in 1 minute The measure is executed in 12 sec onds ATS and extrapolated at once MVV Test manoeuvre Have the patient breathe deeply at a rate of 30 breaths m Parameters calculated Parameter um parameter name MVV 1 m Maximum Voluntary Ventilation To carry out the MVV test 1 Connect the patient to the turbine flow meter 2 Apply the nose clamps and check if the
53. ony graphic recognises automatically during the execution of the test whether it is a VC or a IVC VC test manoeuvre 1 Breath normally for several times optional 2 Execute a maximum inspiration 3 Execute a slow maximum expiration 4 Breathe normally optional Chapter 3 Using the Pony graphic 47 Pony graphic 48 IVC test manoeuvre oY NaS Breathe normally several times optional Execute a maximum expiration Execute a slow maximum inspiration Breath normally optional Parameters calculated Parameter um VC 1 IVC 1 ERV 1 VE 1 m Rf resp m t E s t I s VT 1 VT t 1 1 s t I tot 1 parameter names Slow Expiratory Vital Capacity Slow Inspiratory Vital Capacity Expiratory Reserve Volume Minute Ventilation Respiratory Frequency Average expiratory time during rest respiration Average inspiratory time during rest respiration Tidal Volume Tidal volume average inspiratory time Average inspiratory time average inspiratory time average expiratory time To carry out the VC test 1 Connect the patient to the turbine flow meter 2 Apply the nose clamps and check if the mouth piece is prop erly set 3 At the request Select a function start the test 6 and press the VC key and Chapter 3 Using the Pony graphic 49 Notice The respiration must start after having pressed the VC key and do not wait longer than 5 seconds otherwise the pro gram will return to the Main Me
54. oo ee Tests list Search Test Data tramSmiission snena desaee dances oues caseec cas EAE EET Erasing data cocori nn ee e E aie atest Data management 63 Setting up the Pony graphic Preparing Pony graphic ccccceceseeseeseeneceeeeeeeeeeeeeeeeeeeeeeseaeeeees Installation of the PC software seeseeeeeeeeseeeeererrerererererererrrereees Configuring the program Testopti f oseca nnie e E T uate The Automatic Diagnosis Ambient conditions Parameters manager Predict eds Manager worsies ieira Arhive Path sasvacscezstessseessehsniee ses eivucvoas sducds oA EEA i Uploading data from the spirometer Linking tests to a Patient in the archive Managing the Patient s database Viewing results ierosin A E a Managing the optional databases Didenosis Database s iacsissiesieu thiestananssseas iia Printing results Printing the Teport sisterona iaei Printing the active window 0 ces scsseseseeseeeeseeseeesseeesseeeeeeaeeeens Data exporting noron n e EEA Pape SOUP 5 25 ar a E AAA E EE Index v Other features of the program 82 RECN VE sanni a 82 Appendix 85 Calibration 86 The sistem maintenance 88 Troubleshooting 91 Error MESSAGES eioen a AAE E aa E AE 92 Assistance Warranty 93 Returning the system for service sessseseeeeeisesesrsrserresrerrrersreesee 93 Wanane ereed A E E A A 93 Information form for assistance cccceseescesseessceseesseesseess
55. oubleshooting It is possible to solve some problems of the system directly with out contacting your nearest technical assistance If you need a further help consult the information of the following paragraph The printer is locked e Check the paper is not jammed e Check the batteries charge The Pony points out a memory lost If the batteries are discharged the Pony graphic loses some or all the stored data Therefore insert the predicted data to re configure the system ID code F V factor predicted values automatic diagnosis unit of measurement During the execution the loop doesn t appear e Check the Turbine connector is connected properly e Check the Turbine is deeply inserted in the optoelectronic reader e Blowing in the Turbine check it rotates freely otherwise clean it as it is described in the previous paragraph Batteries are not being charged e Check if the green led down on the left is on e Check if there is current in the power plug e Check that the batteries charger connector is inserted properly e Before connecting the battery charger make sure you are using the proper voltage and frequency The Pony does not transmit the data to the PC e Make sure the serial port RS 232 selected for the transmission is configured properly with the Software e Check the serial cable connectors are inserted properly The external printer doesn t print e Check the cable is the RS232 provided by Cosmed and ma
56. out the visits e 3 fields 2 numeric in the Test card information about Test To customize the fields e Inthe group User free fields type the desired text in the 9 fields available Graphs All the graphs visualized and or printed can customized in colors and appearance To customize the graphs 1 Select the group Graphs 2 Select the desired colors of the curves 5 curves max can be overlapped on the same graph 3 Enable or disable the Grid option 66 Pony graphic graphic User s Manual The Automatic Diagnosis EE Teeme p damm ia ae UIN Cis ET T liie iais rer F akir Daip d aee M Bg pe bei a D Epai eens mpm Sean PAT so AY Remake oe oe arii CE mj m Pony graphic has a function to calculate the automatic diagnosis The algorithm has been carried out referring to international scientific literature mentioned in the bibliography paragraph of the appendix chapter The automatic diagnosis is calculated at the end of the FVC Test if e The automatic diagnosis option is enabled e The patient s anthropometric data allow the calculation of the LNN Lower Limit of Normal range e At least one FVC test has been carried out To enable disable the Automatic Diagnosis e Click on the Enable button of the group Spirometry to en able the calculation and the visualization of the automatic interpretation Chapter 4 Data management 67 Quality control Pony graphic allows a quality
57. pe on the data pattern the PB TA RH values and press Enter key twice a y 1 CALIBRATE Ffw z PREDICTED YALUES 3 LIMONO JIE 4 UNIT E AB aamshgh fei TH dope i 25 BH ijan a Ad A Eypiraccry UeriectiMi j il r tej BTPS expiratory correction 1 Turn the system on and press the Utility Key 2 Select Configure by pressing the key 6 3 Press 6 corresponding to the BTPS choice 4 Press Enter key three times and choose 1 for enable and 2 for disable the expiratory correction ee a m e e e m e e A a 1 2 CALIBRATE gt y Z PREDICTED FALUES 3 DIMMS AB mmHg fei B dotari 28 BH j pai a BI Eypiraccry Cersectiot r il r f ij Chapter 3 Using the Pony graphic 41 Entering data Before executing tests the Pony graphic must have certain infor mation on the patient to be tested which will be inserted in the relative chart The table below shows admissible values for the above param eters Parameter min max um keyboard operation Id Code 1000 9999 type the keys corre sponding to the number sex F M press the key sex to modify the sex Age 3 100 years type the keys corre sponding to the age Height 50 230 cm type the keys corre sponding to the height Weight 5 200 kg type the keys corre sponding to the weight Eth corr 50 150 type the key corre sponding to the The Ethnic correction value allows to increase or decrease pre dicted values accord
58. rapolation method to detect the start of the test extrapolated volume must not be higher then 5 FVC or 150ml Volume 10 mm 1 Flow 5 mm l sec Time 20 mm sec F V Ratio 2 1 The total number of error FVC e FEV1 gt 3 5 FEF25 75 gt 5 5 during the measurement of the 24 standard waveforms must be lower than 4 Features F V e V t Predicted values ERS 93 Here are the formula to calculate the predicted values G enerality In the following formula are respected these conventions Ht Height in cm wt Weight in kg BSA Body Surface Area cm Age Age in year SD Standard Deviation The formula of the Body Surface Area BSA m 71 84 x Wt x Ht 75 1000 The software allows the calculation of the Predicted values ac cording to the following forms Reference Adult Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March 1993 Reference Paediatric Compilation of reference values for lung function measurements in children Ph H Quanjer J Stocks G Polgar M Wise J Karlberg G Borsboom ERJ 1989 2 Supp 4 184s 261s Males gt 18 years S ol Formula sD IVC 0 061 H 0 028 A 4 65 0 56 FVC 0 0576 H 0 026 A 4 34 0 61 TLC 0 0799 H 7 08 0 7 Chapter 5 Appendix 97 Pony graphic 98 RV 0 0131 H 0 022 A 1 23 FRC 0 0234 H 0 009 A 1 09 RV TLC 0 39 A 13 96 FRC TLC 0 21 A 43 8 FEV1
59. ser manual is to be considered as a part of the medical device and should always be kept on hand 2 Safety measure accuracy and precision can be assured only if are used the accessories described in the manual or given with the device Actually non recommended accessories can affect safety unfavourable Before using non recommended accessories is necessary to get in touch with the manufac turer ordinary equipment maintenance inspections disinfection and cleaning are performed in the way and with the frequency described any modification or fixing is carried out by qualified person nel the environmental conditions and the electrical plants where the device operates are in compliance with the specifications of the manual and the present regulations concerning electri cal plants 3 This device is not suitable for use in presence of flammable anesthetics It is not an AP nor an APG device according to the EN 60 601 1 definitions 4 Keep the device away from heat and flame source flamma ble or inflammable liquids or gases and explosive atmos pheres 5 We recommend to use only the provided battery charger P N C00766 0X 30 Any other charger could damage the device 6 According to the intended use of this device Pony graphic is not to be used together with other medical devices unless it is clearly declared by the manufacturer itself 7 In case the device is to be used with a PC is recommended to use a computer wit
60. te 12 07 1994 it is necessary to type sequential the keys 1 2 0 7 9 4 and press Enter to confirm 3 Once the date is confirmed with Enter the main pattern ap pears on the display Tania ih avcilys 1 archive free Tie Debe Olfulssd Laser date Pony graphic 36 Configuring the Pony graphic Geo The Pony graphic allows the user to configure the following fea tures e Predicted values e Automatic diagnosis e Unit of measurement Accessing to the Configuration Menu 1 Turn the system on confirm or modify the date and press Enter 2 Press the Utility key 3 Select Configure by pressing the key 6 FENI graphio a BORY yoaphiu S P ST T_sT CALIBRATE F 2 LIST TESTA a BREED ICIEE VALUES S ARCH TZST D LAG Hes bs 4 TRANELIT DATA UES C EPSE IRIHIVE 1 PPR v CAPD Chonse a function Chuve a Lugolbiuo m Mate Predicted values p a It is possible to select 6 predicted values they are 1 ERS 93 2 ITS White 3 ITS Black 4 Knudson 83 5 Multic ntrico Barcelona 6 LAM To select the predicted values 1 On the Configure menu press the key 2 Chapter 3 Using the Pony graphic 37 2 Press the key corresponding to the selected predicted value Notice Before modifying the configuration of the predicted val ues check if the software is able to read the predicted values Otherwise the patient s predicted values in the Pony graphic s archive won t correspond with t
61. test control The calculation has been carried out referring to international scientific literature mentioned in the bibliography paragraph of the appendix chap ter The messages concerning the quality control are shown at the end of the test execution e Enable disable the quality control Ambient conditions dadir i fare Ambient conditions value are used to calculate the BTPS factor to which all the measured volumes and flows are corrected BTPS Body Temperature Saturated Ambient Pressure ATPS Ambient Temperature Saturated Ambient Pressure PB Barometric Pressure mmHg PH20 Partial Pressure of water vapor mmHg T Temperature at the flowmeter C TA Ambient Temperature C V BTPS V ATPS 273 37 273 T PB PH20 PB 47 LOG PH20 8 10765 1750 286 235 TA PH20 KPa 1 63 0 07 T 0 0053 T 2 ERS 1993 To insert the ambient conditions values 1 Select Ambient conditions from the Option menu and type the values in the corresponding fields 68 Pony graphic graphic User s Manual Parameters ma nager wes her tor tome The program allows to calculate a huge number of parameters it is advisable in order to simplify the analysis of the results to view to print and to order the only desired parameters 1 Select the menu Options Parameters manager View Move the parameters to view in the Parameters se lected list Print Move the parameters to print in the Parameters se lect
62. the Configure menu press key 5 2 Press the key corresponding to the printer chose Chapter 3 Using the Pony graphic 39 BORY ygoapliu X Y 1 CALIBEATE F Yo PEEDICTED VALVES 1 DLA HIE Ls a UHT HA PEER PER L LLE HAL BILLCEHAL Notice The program maintains the configuration even after turning the unit off To print with the external printer 1 Set the unit for external printing and press Print key 2 Press Enter to confirm or DEL to cancel the task Notice The external printer setting enables the printing of a complete report all the other printouts tests list cannot be transferred and will continue to be printed with the internal printer Calculating the BTPS factor Pony graphic 40 Ambient conditions values are used to calculate the BTPS factor to which all the measured volumes and flows are corrected BTPS Body Temperature Saturated Ambient Pressure ATPS Ambient Temperature Saturated Ambient Pressure PB Barometric Pressure mmHg PH20 Partial Pressure of water vapour mmHg T Temperature at the flowmeter C TA Ambient Temperature C The BTPS factor is calculated as follows V BTPS V ATPS 273 37 273 T PB PH20 PB 47 LOG PH20 8 10765 1750 286 235 TA PH20 KPa 1 63 0 07 T 0 0053 T 2 ERS 1993 BTPS inspiratory correction 1 Turn the system on and press the Utility Key 2 Select Configure by pressing the key 6 3 Press 6 corresponding to the BTPS choice 4 Ty
63. the Print key ATS reproduability The ATS recommendations see the Appendix chapter show that the test is in agreement with the ATS reproducibility criteria 1987 if 2 tests out of at least 3 executed by the same patient differ in the FVC and FEV values of a quantity smaller than the 5 or 100 ml if the 5 was larger than 100 ml If this criteria is met the system displays ATS reproducibility message followed by the relative parameters FVC FEV1 or both E E m a 4 I Li FLEZE 54 5 39 Guy Recesatable WoO ort 1 5 iro etr Chapter 3 Using the Pony graphic 55 Other Functions The Pony graphic provides other functions to make the manage ment of the archive easier whether for the search of the data or for their transmission to a PC Utility Menu Fa Tests list Pony graphic 56 The Utility Command pools many functions to increase the Pony graphic potential These functions are Key Function _ ________ __ Post Test allows the execution of a bronchial provocation test List allows to display and print out the list of the tests in archive Search test allows the search of a test in archive to display and print out the loops and data Transmit allows the transmission of the ar chived data on the Pony to a PC Erase Archive allows to erase the data in archive Configure accesses to the Configuration Menu of the System Accessing to the Utility Menu e After h
64. ther liquids containing gluteraldehyde on the exterior surfaces of the equipment Actually they can damage polycarbonates plastics and may produce unealthy substances e do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas components of the equipment e do not steam autoclave any parts of the equipment unless it is clearly specified e do not immerse the optoelectronic reader The mouthpieces are single use not sterilized accessories It is highly recommended to follow the suggestions given in the hand book concerning the general rules for infection control in lung tests In order to ensure maximum precision in measurements we ad vise you to disinfect the system periodically As disinfecting solution it is suggested Sodium hypoclhorite 5 bleach To disinfect the turbine pour one litres of water and add the disinfecting solution The disinfection procedure is easy and can be effected every time it will be necessary keeping attention to some precautions To dean the turbine The following is the disinfection procedure you should follow 1 Disassemble the Turbine Flow meter as described in the fig ure below 2 Dip it in a disinfecting solution for about 2 hours 3 Rinse it in a container filled with clean water and shaking gently until it is clean do not clean the Turbine by putting it under running water 4 Let it dry to the air Notice Do not expose the Turbine or
65. ts Paper mouthpiece for children Nose clips Roll of paper Printer ribbon Power supply 220V 12V 1A Batteries charger adapter in car Serial cable RS232 SW_PC Win Pony Graphic User manual Registration card Turbine attention paper Part number C00292 01 05 C00095 01 05 C00214 01 20 C00109 01 30 C00136 01 20 C00137 01 20 A662100001 C00643 01 98 A 666 905 001 C00766 01 30 C00297 01 12 C00150 01 12 C01335 02 35 C00296 02 91 C00067 02 94 C00169 01 92 Quantity Chapter 1 Foreword 1 1 1 1 50 Nn SFB SFP FP SFP BP a PO WN Lb 13 14 Pony graphic Warranty registration Before operating the system please fill in the registration form and send it to COSMED To be registered means being entitled to customer s assistance For further information concerning the benefits please refer to the registration form Qontacting OCOSIVED For further information you may contact the manufacturer di rectly at the following address COSMED S r l Via dei Piani di Monte Savello 37 P O Box 3 00040 Pavona di Albano Rome Italy tel 39 06 93 15 492 fax 39 06 93 14 580 E mail info cosmed it Internet www cosmed it support Safety and conformity Safety TEC 601 1 1988 EN 60 601 1 1990 Below is reported the complete classification of the device e Class II B device if used with specified power supply or in ternally powered equipment class B device if used stand alone e Protection aga
66. ture of the problem as it is specified on the assistance information form We advise you to save the original packing box You may need it if it is necessary to ship it to a technical assistance centre The system is provided with a 12 months warranty starting from the purchasing date It covers failures happened during normal use of the system due to provable faults of the components or to manufacture Exdusions The following components are excluded from warranty e Parts subject to consume e Fragile parts of glass or plastic e The batteries the rechargeable batteries e Damages of the paintings e Damages due to a not proper use of the system or failure to observe the manual instructions Chapter 5 Appendix 93 In case the warranty is expired send besides the system the copy of a document such a bill of lading or invoice which prove the purchase date The transport must be executed in free port and it will be re shipped charges collect In case of transport damages this costs will be charged to the buyer Information form for assistance Pony graphic 94 Fill a photocopy of the form and send it with the system If not the repair can not be effected Information form for assistance CULE DAE sav covsuses cats ctsessxessasdesteetsscoetasenassass ER Dat Sv cncseteressenechshessxsrsegeescedssizessseenes POOLS Soreness taniera OEE A AE EAR AORE E raaa aS CY E E E E E A ZAP nae ra a COME E iE o EA EEE stesttett c
67. ut the list of the tests in the archive To prepare the PC for reception 1 Choose Receive from the Test menu 2 Into the Receiving Test dialogue window press the Receive button to prepare the software Chapter 3 Using the Pony graphic 59 Font graphic X Y BONY graphic Z Y 09T THA ST TEA T EAR H T ST T EAR H T ST F THAHEHIT DATA aH THAHEHIT DATA E FRRSF APR HIVE m WEES BP HIY uo CNE C uo CHIP C Stab teat h d 7 Frepare PC End teat I i For So0epeLler Prena T ter Patina t Tr smirsior R 237 To start the transmission 1 To start the transmission press 7 2 The software shows a bar indicating the transmission in progress Notice For further operation on PC consult the chapter 4 Pony graphic 60 Erasing data The Pony graphic memory has a capacity of 100 tests circa When the message Memory Full appears it is suggested to download all data to PC and than erase all tests stored to leave the memory for new tests r Notice By choosing Erase archive all data stored in the Pony graphic archive will be erased If you want to save the tests into a permanent memory before erasing them you can transfer them to a PC as it has just de scribed in the previous paragraph To erase file 1 Turn the Pony graphic on and press the Utility key N l B y Select the function Erase archive pressing the 5 key 2 3 Confirm the command typing sequentially the

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