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Cosmed Pony FX - User manual

1. ee eee aaa na anawa 111 References E wawa ciowa dowsacaa H 8 Pony FX User Manual Getting started Important notices Intended use Warnings Pony FX is an electrical medical device designed to perform pulmonary function tests It is to be used by physicians or by trained personnel on a physician responsibility Caution Federal law restricts this device to sale by or on the order of a physician This equipment has been conceived with the aim of providing an auxiliary instrument allowing e the formulation of lung pathology diagnosis e important studies concerning human physiology e the collection of important information in sport medicine No responsibility attaches COSMED Srl for any accident happened after a 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 the hereunder reported precautions and instructions The device the program algorithms and the presentation of measured data have been developed according to the specifications of ATS American Thoracic Society and ERS European Respiratory Society Other international references have been followed when these were not available All bibliography references are reported in Appendix The present handbook has been developed with respect of the European Medical Device Directive requirements which sort Pony FX within Class II a It is recommended to read carefully the followi
2. 60 Pony FX User Manual You can set e The flowmeter type turbine or pneumotachograph e The airway resistance option enabled or not e The oximetry option enabled or not e The mode of the spirometer ATS ERS Standard or Office Spirometer a simplified and less detailed version Environmental data Select the menu item 2 Options 6 Environment You can set e Pressure e Relative humidity Restore of initial settings Select the menu item 2 Options 7 Defaults With this option you can reset the option and restore the original factory settings Chapter 5 Using Pony FX 61 Other functions of Pony FX There are other general functions in order to operate at the best You can access to these functions by means of the 3 Utilities menu Calibration The calibration procedure allows exact measurements of flows volumes and so on correcting errors due to climatic changes use of the device wear etc Select the menu item 3 Utilities 1 Calibration For further details see the chapter Calibration Control panel The control panel allows to monitor the device status Select the menu item 3 Utilities 2 Control panel The display is divided into 3 zones Sensors Temperature inside the unit and the flowmeter and the battery charge in mV Controls Pushing the key 1 the Charger relais activates It simulates disconnection or connection between unit and battery charger cable Pushing the key 2 the
3. Standardization of Spirometry 1987 Update American Review of Respiratory Disease Vol 136 1285 1289 1987 Lung function J E Cotes Blackwell scientific publications Guidelines for Clinical Exercises Testing Laboratories I L Pina G J Balady P Hanson A J Labovitz D W Madonna J Myers American Heart Association 1995 91 912 Office spirometry R E Hyatt P L Enright Lea amp Febiger 112 Pony FX User Manual
4. To delete a set of predicteds click on the Delete button If a set is deleted also the associated formulae are deleted 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 To import a set of predicteds click on the Import button and select a file of Predicteds files type To export a set of predicteds click on the Export button 78 Pony FX User Manual In the list Set current predicteds choose the current predicteds for printing and viewing Set the current predicted Pony FX allows to calculate the predicted values according to the following configurable sets Adults Paediatrics ERS 93 Zapletal Knudson83 Knudson83 ITS white ITS white ITS black ITS black LAM LAM MC Barcelona MC Barcelona Nhanes III Nhanes III Select the desired choice in the group Predicteds Formula definition Predicteds set Formula definition Q Predicteds set Ee A Description Use the predicteds formulae W f or the customized formulae Male Female pe Formula Standard Deviation _ Young Z Adult m Paste eel IEF DR Cancel Apply Help This form allows the user to manage the formulae associated to a set of predicteds Select the set of predicteds from the list Predicteds set To insert a new parameter click on the New button The parameter
5. Unit of meas cmikg lt 4b Turn off LCD after min 1 You can set e Date and time The date must be entered as month day year The year must be expressed in 4 digit format e Language e Measurement unit cm kg or in lb e Amount of time after which the display turns off automatically if the unit was not used Spirometry options Select the menu item 2 Options 2 Spirometry You can set e The equation set used for the predicteds values calculation e Ifthe test quality control visualisation is enabled e Ifthe BTPS correction is applied e The flowmeter temperature 58 Pony FX User Manual FVC Post options Select the menu item 2 Options 3 FVC Post Salbutamol meg o jeo J60 jJi40 300 _ 600_ 1200 2400 You can set Name measurement unit and quantity of the bronchodilator Reversibility threshold for the airways obstruction as increment of the FEV1 Name and measurement unit of the bronchoconstrictor Protocol for the use of the bronchoconstrictor quantity to be delivered to the patient in the steps of the FVC Post test Chapter 5 Using Pony FX 59 Printout options Select the menu item 2 Options 4 Printouts NO NO NO NO You can set e Ifthe unit prints the SVC and MVV tests the test quality controls and the automatic diagnosis e A page header for the printout Advanced options Select the menu item 2 Options 5 Advanced Turbine ATS ERS Standard
6. by the following high ambient light fingernail polish or artificial fingernail excessive motion Performing the test 1 Connect the sensor to the Pony FX unit through the RS232 SpO port 2 Connect the probe to patient s index finger and affix with adhesive tape if necessary 3 Select the menu item 1 Test 7 SpO2 In the first part of the test the HR and SpO values together with a plethysmographic graph are displayed The graph monitors the quality of the signal 5 Wait for an acceptable quality of the real time trace and verify that the Perfusion indicator is green Press 1 Rest to store the rest value 2 Exercise to store the exercise value 3 02 Suppl to store the value with inspired oxygen supplement 54 Pony FX User Manual It is not necessary to store all the three values during a single test Chapter 5 Using Pony FX 55 Viewing results View a test in archive After having selected a patient highlight the desired test by means of the arrow keys The graph of the selected test will appear on the right side of the display 1 Test 2 Print 3 Edit O Exit FYC 05 15 2003 vC 05 15 2003 6 8 wN 6 Param Meas Pred g FYC 5 16 7 99 65 FEY1 3 98 663 60 FEVIJFVC 77 84 92 PEF 9 69 6 99 139 JA 56 Pony FX User Manual Printing results Replace the printer paper You need thermic paper P N A 196 056 001 10 pcs 1 Ope
7. 01 20 A 362 315 001 A 182 300 004 C02388 01 05 A 196 056 001 C00067 02 94 C01999 02 DC C02361 04 91 Description Pony FX Unit Turbine Reader Turbine cable Nose clips PC Software Paediatric paper mouthpieces Adult paper mouthpieces Conic mouthpiece Paediatric mouthpiece adapter USB cable Bacterial filter Pony FX battery charger Thermic paper Registration card Conformity declaration User Manual Chapter 1 Getting started 19 Warranty registration Before using the system please take a moment to fill in the registration form and the warranty and return them to COSMED by doing this you are eligible to the customers assistance service For further information please refer to the enclosed registration and warranty form If the form is not enclosed in the packaging please contact directly COSMED Register the product via software Together with the PC software a registration software is supplied With this software it is possible to fill in an electronic form with the customer information 1 To run the software double click on the icon Registration or select Registration from menu 2 Type the requested information and click Send to send the form via e mail to COSMED How to contact COSMED For any information you may need please contact the manufacturer directly at the following address COSMED S r l Via dei Piani di Monte Savello 37 P O Box n 3 00040 Pavona di Albano Rome
8. 601 1 1990 e Temperature range 10 C 50 F and 40 C 104 F e Relative humidity range 20 to 80 e Atmospheric Pressure range 700 to 1060 mBar e Avoid to use it in presence of noxious fumes or dusty environment and near heat sources e Do not place near heat sources e Cardiopulmonary resuscitation emergency equipment accessible e Adequate floor space to assure access to the patient during exercise testing e Adequate ventilation in the room Chapter 1 Getting started 15 Safety and conformity Safety IEC 601 1 1988 EN 60 601 1 1990 Find reported below the complete classification of the device Internally powered equipment type BF device used stand alone class II type BF device used connected to mains Protection against water penetration IP00 ordinary equipment unprotected against water penetration Non sterile device Device not suitable in the presence of flammable anaesthetics Continuous functioning equipment EMC The system meets the EMC Directive 89 336 EN 60601 1 2 EN 55011 Class B emission IEC 1000 4 2 IEC 1000 4 3 IEC 1000 4 4 Quality Assurance UNI EN ISO 9001 2000 Registration n 387 A Cermet Medical Device Directive CE mark MDD 93 42 EEC Notified Body 0476 Class Ia 16 Pony FX User Manual Here are the keynotes used to make the manual easier to read Typographic keynotes These are the typographic keynotes used in the manual Style Description
9. A R R D 144 1991 1202 1218 The automatic diagnosis is calculated at the end of the FVC if the automatic diagnosis option is enabled the patient s anthropometric data allow the calculation of the LLN Lower Limit of Normal range at least one FVC test has been performed To enable disable the automatic diagnosis 1 2 Click on Enable Automatic Interpretation Select the LLN Lower Limit of Normal Range criteria among the ATS LLN Pred 0 674 SD ERS LLN Pred 1 647 SD or 80 Pred LLN Pred 0 8 specifications 76 Pony FX User Manual Quality control Pony FX allows a quality test control The calculation has been carried out referring to Spirometry in the Lung Health Study Methods and Quality Control A R R D 1991 143 1215 1223 The messages concerning the quality control are shown at the end of the test To enable disable the quality control click on Enable Quality Control checkbox Parameters manager View Print Sort Customize Not selected parameters Selected parameters Best FEY Ls go D2575Zpre DFEY1 poss DFEV1Zpre DFEY1 pred F C Post I Show Pre 7 Show Pred I Show description f All tests T Show SD Cancel Apply Help 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 sort the desired parameters only Select the menu item Options Param
10. FX 220022000000000000000000000000000000000000000000000000000 ZO Pony FX unit The display esa eaten dos O ORA hee teens 28 The keyboard ennenen inina ans 28 The Printer esse ane O arated hae na ORA RO 29 The connectors eonna n ne EE E E ethene 29 Battery Chargeka ws cece oh nave tl E oi ao BAZ 30 Connect the flowmeter to the Pony FX ceeceeceeceeseeeteeteeeteeeseeseees 31 The turbine flowmeter oueao aaa 31 The pneumotachograph c cc ecceceeeeceeceeeeeeseeeeaeesesseeseeececeeeaeens 32 Connect the Pony FX to the PC wo eee eeesseeseeseeseeeeeeceeeneeteraeeneeeees 32 Connect the Pony FX to an external printer eee eteeeeereeeees 32 Software installation 2220000220000000000000000000000000000000000000000 GO Installing the software seuee eee e aaa iiaaa 33 Run the software 0 ccecccescescessceecseceseeeeeeseeaeceseeseceeeeaeenseceeeaeeeeeeseeaeen 33 PC port configuration e eeoeeeee een 33 Software main featuresS 2222222220000000000000000000000000000000000000000 OF Display GR ALARA PAR OBAN oA PO RY 34 TOON BAW eta ot EA a dd dwa ROA 34 Show hide the toolbar eee a aaa caaaca 34 Dialog windows zew ai edi GRY E A AE een 34 Use of the keyboard a hence AR O O A O RWS O 34 Us of the MOUSE Gao A W A R WGA 34 Scroll bars On line hel Pinner eea enc Mien E SIE 35 Software VETSIOMs u wnika O OU wsie Moses dr osi 35 Calib
11. ITALY Voice 39 06 931 5492 Fax 39 06 931 4580 email customersupport cosmed it Internet http www cosmed it Complain feedback and suggestions If you have any complain feedback information or suggestion please inform us at complain cosmed it 20 Pony FX User Manual PC configuration required e Pentium II 350 MHz e Windows 98 XP e 64MbRAM e CD drive e VGA SVGA monitor e USB or RS232 port e Any Mouse and Printer compatible with the MS Windows operative system e PC conform to European Directive 89 336 EMC If you use an external printer it must support the PCL language and have an USB port for data transmission The USB connection works properly only with Windows XP Otherwise use the serial RS232 connection Chapter 1 Getting started 21 Technical features Flowmeter Flow Range Volume Range Accuracy Resistance 12 1 s Mouthpieces Internal temperature sensor Dimensions Weight Supply Power supply AC DC Interface LCD In built printer Printer paper 22 Pony FX User Manual Bidirectional digital turbine standard disposable pneumotachograph option 0 03 20 I s 121 3 or 50 ml lt 0 7 cmH2O l sec O 31 and 022 mm 0 50 C 32 122 F 198 x 238 x 76 mm 1 2 kg 4 Ni Mh rechargeable batteries 1 3V 2300 mAh no memory effect 220 110 VAC in 12 VDC IA out class II according to EN 60 601 1 standard RS232 USB A USB B f
12. Printer relais activates It activates or deactivates the internal printer Embedded Printer The Heads icon shows if the green lever is lifted or not The Paper icon shows if there is paper charged or not The Termistor value is the temperature of the printer LCD contrast In order to modify the contrast of the Pony FX display 1 Select the menu item 3 Utilities 3 LCD Contrast 2 Adjust the contrast by means of the right and left arrow keys 3 Press the confirm key 62 Pony FX User Manual Paper feed This function is useful mainly during the paper replacement Select the menu item 3 Utilities 4 Paper Feed Memory deletion It erases all the memory contents 1 Select the menu item 3 Utilities 5 Erase Memory 2 Confirm by pressing the key by side Firmware version information In order to get information about the installed firmware version select the menu item 3 Utilities 6 Information Chapter 5 Using Pony FX 63 Reset of the unit If the Pony FX does not run its firmware the program of the unit not the PC software it can be rebooted by pressing with a sharpened tool a button inside a little hole on the rear side of the unit With this operation the data will not be lost Formatting the unit If for serious reasons it is needed to erase all the archive and the memory of the Pony FX also the firmware program it is possible to format the unit Turn on the Pony FX keeping pressed the Cancel k
13. battery because of the unit has been not used for a long time The led switches to green after some time of charging Please fully charge the unit e Failed battery Please contact the technical support Note The first time you use the device charge the battery for at least 12 hours even if the led indicates the completion of the charge before the time elapsed Connect the flowmeter to the Pony FX The Pony FX can operate with two types of flowmeters e Turbine flowmeter e Pneumotachograph disposable The turbine flowmeter It is made of a handle the reader with a hole in which it is placed the turbine The air passing through the helical conveyors takes a spiral motion which causes the rotation of the turbine rotor The rolling blade interrupts the infrared light beamed by the two diodes of the reader Bacterial filter Every interruption represents 1 4 ormouthplece turn of the rotor this allows to measure the number of turn in the time It is connected to the unit through Reader the Turbine connector For hygienic reasons we strongly recommend the use of a bacterial filter to be connected as in the picture by side Note While inserting the turbine be sure to push the turbine up to touch the end of the reader Chapter 3 Installation 31 The pneumotachograph It is disposable and measures the flow detecting the difference of pressure at the two sides of a membrane It is connecte
14. is possible to define the created filename format selecting File Page Set up see Page set up 94 Pony FX User Manual Export data With this function you can export the test data in 4 different formats e txt ASCII e xls Microsoft Excel e wkl Lotus 123 e xpo Cosmed Export a test 1 Select Export tests from the File menu 2 Select the test to export from the list box and press OK 3 Type the name and the format of the file in the dialog Save as 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 With the xpo Cosmed file format it is possible to import data from another Quark archive Press OK to confirm 4 Select the folder for the export and type the file name Press OK to confirm A status bar will show the file creation Chapter 7 Spirometry 95 96 Pony FX User Manual System maintenance System maintenance All service operations which are not specified in this user manual should be performed by qualified personnel in accordance with the service handbook to be required to the manufacturer All materials used in the construction of the Pony FX are non toxic and pose no safety risk to the patient or operator Prior to the device cleaning disinfection and inspection it is necessary to switch off the device and to disconnect adapters from the supply mains In order to guarantee the highest
15. new value Turbine calibration results Ea a Default AA de 1000 i X Type mm The 3 litres calibration syringe can be purchased directly from COSMED P N C00600 01 11 Note If a bacterial filter is used for the tests do use it also during the turbine calibration 40 Pony FX User Manual Checking the system signals The control panel The Control Panel which can be activated from the Calibration Control panel menu item is a useful tool to check the main hardware functions of Pony FX By using the controls on Control Panel you are able to read the signals acquired by the system both as voltages and processed data Control panel x Y Refresh Rate ms Poo zi use Using the control panel edit parameters name unit mV real values Select all display rr 36 C Deselect all i 2 Xi channels v F temp C 25 4 IV Power Supply m 4840 Vv Turbine flow ml s o Vv Turbine volume ml o Signal refresh Refresh Rate ms Chapter 4 Calibration 41 42 Pony FX User Manual Using Pony FX Main functions of the Pony FX All the Pony s functions are controlled by means of the keyboard see the following picture o MENU F 900 Turning on off the Pony FX In order to turn on or off the device hold the MENU key pressed MAW for few seconds Pony FX has two automatic turning off functions e of the di
16. on line press the F1 key Software version To know the software version and the serial number of the software select About from Help menu Chapter 3 Installation 35 36 Pony FX User Manual Calibration The calibration program Running the Calibration program i 4 Start the program and choose Calibration from the Test Menu EARP The software runs the Calibration software and the main menu changes accordingly Log file The program creates and updates as default the calibration log file containing the conditions and the results of all the calibrations performed by the user To access the file select File Report File from the calibration program 38 Pony FX User Manual Turbine calibration Pony FX is calibrated by COSMED ATS recommends a daily calibration of the turbine However if it is correctly maintained turbine retains its precision for longer periods We advice to calibrate the turbine daily to detect malfunctioning Note if you are using a slow PC we recommend to set an higher refresh time Calibrating the turbine without a PC In order to calibrate the turbine by means of the Pony FX unit 1 Connect the turbine flowmeter to the calibration syringe 2 Select the menu item 3 Utilities 1 Calibration 3 Move the piston in and out for 10 strokes IN and EX The 3 litres calibration syringe can be purchased directly from COSMED P N C00600 01 11 Note If a bacterial filter is u
17. or for the oxymeter option e Connector for the turbine flowmeter or for the airway resistance measurement module option e USB connector for the PC e USB connector for an external printer e Battery charger connector Battery charger Pony FX is powered by a battery pack rechargeable by means of a battery charger There exist two types of battery chargers Code Description C02388 01 05 Pony FX battery charger C02383 01 05 Pony FX battery charger medical grade Other battery charger with different plugs Australia UK USA available on request The standard packaging of the Pony FX contains the first charger This one can be used only to charge the device battery It is not allowed performing tests with Pony FX connected to the mains In order to perform tests also when the device is connected to the mains use the medical grade battery charger C02383 01 05 compliant with the medical devices Standard Connect the battery charger to the Pony FX unit through the connector with the symbol by side Near the keyboard a led indicates the battery status Green led In charge Orange led Full charged Red led Error The red led can be due to e Battery temperature lt 5 C The red led should switch off when the temperature falls again in the range 5 45 C e Battery temperature gt 45 C The red led should switch off when the temperature falls again in the range 5 45 C 30 Pony FX User Manual e Very low
18. otherwise there can be damages to the plastic material cases the clinical need for such testing should justify the risks During the disinfection do not use alcohol or other liquids containing gluteraldehyde on the exterior surfaces of the equipment Actually they can damage polycarbonates plastics and may produce unhealthy substances do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas components of the equipment do not steam autoclave any parts of the equipment unless it is clearly specified do not immerse the optoelectronic reader Cleaning the turbine flowmeter It is necessary to disinfect periodically the turbine for sanitary measures or and for the correct device function As disinfecting solution it is suggested Sodium hypochlorite 5 bleach The disinfecting procedure is easy and may be effected every time the user needs keeping attention to some precautions 6 Take out the turbine Dip it in a disinfectant solution non alcoholic based for about 1 hour Rinse the turbine in a vessel filled of clean water shaking gently to remove the disinfectant do not clean the turbine by putting it under running water Let it dry to air After cleaning the turbine check if the turbine propeller rotates freely even with a low speed air flow Connect the turbine to the reader Precautions during the cleaning of the turbine 1 Do not expose the turbi
19. possible value Methacholine and Histamine Bronchial provocation Tests The most common indication for performing methacholine and histamine bronchial challenges is to diagnose hyperresponsive airways Some patients demonstrate normal baseline pulmonary function despite complaints of tightness wheezing cough and a little or not response to bronchodilator Other patients demonstrate spirometric improvement after use of bronchodilator have diurnal variation in peak flows In this groups aerosolised bronchial challenges are used to confirm a diagnosis of Asthma We can summarise the use of the test as follows 1 Diagnose asthma 2 Confirm a diagnosis of asthma 88 Pony FX User Manual 3 Document the severity of hyperresponsivness 4 Follow changes in hyperresponsivness When patients with hyperresponsive airways inhale certain pharmacologic agents i e Methacholine or histamine the airways respond by constricting Test consists of executing repeated FVC following the pharmacologic agents inhalation according to an established protocol The fall of the FEV1 parameter is used to calculate the bronchial hyperresponsivness The most important parameter is the PD20 that is amount of drug mg ml that causes a reduction of 20 of the FEV1 respect the basal value without drug Main parameters are P10 Dose that causes a 10 fall of FEV1 P15 Dose that causes a 15 fall of FEV1 P20 Dose that causes a 20 fall of FEV1 The rep
20. Bold indicates a control or a key to be pressed Ttalic indicates a messages shown by the firmware Graphic keynotes These are the graphic keynotes used in the manual Illustration Description al shows the button to click in the software to activate the related feature Chapter 1 Getting started 17 Systems Overview Pony FX is a device designed for lung function screening the core of the system is the intelligent flowmeter connected to the main unit with graphical colour display It can be considered a complete portable spirometric laboratory Pony FX can be connected to a PC in order to transfer and store the performed tests to view the tests and if it is used the medical grade battery charger to perform the tests and display them on the PC monitor The system is composed by the turbine flowmeter the measurement and data elaboration device the communication cable the battery charger and by the Software pack 18 Pony FX User Manual Before starting Before operating the Pony FX system we strongly recommend to check the equipment and register you as a customer Checking the packing contents Make sure that the package contains the items listed below In case of missing or damaged parts please contact Cosmed technical assistance Pony FX standard packaging Code C00962 01 04 C02235 01 05 C02364 01 05 A 362 100 001 A 662 100 001 C01788 02 36 C00137 01 20 C00136 01 20 C00063 01 20 C00214
21. 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 No parts of this manual may be reproduced or transmitted in any form without the express permission of COSMED Srl COSMED Software can be installed only in one device Excel is a registered trademark of Microsoft Corporation DBIII is a registered trademark of Bordland International Inc Lotus 123 is a registered trademark of Lotus Development Corporation Pony FX User manual II Edition March 2004 Copyright 2003 COSMED Copyright 2004 COSMED COSMED Srl Italy http www cosmed it Part N C02361 02 91 Table of contents Getting started 9 Important noficeS 2200222000000000000000000000000000000000000000000000000000 1 O Intended USE zycia zka tiny a wikt awa 10 WATNI OS ooo a oO EG Contraindications 2002200000000000000000000 Contraindications for the Spirometer tests ccceccesseeseeeeeeteeteeeeeeees Absolute contraindicationS e sesseas aaa ooo e wania anawa 13 Relative contraindicationS e eseea aaa aaa aaa aaa aaa aaa aaa ania 13 Contraindications for Bronchial provocation tests 141111111 1 13 Absolute contraindications e seseea seanse enia wia 14 Relative contraindications c cesceescesseeseeseceeeeeeneeeseeeeceseene
22. D prior to the repair or alteration of COSMED products s Failure of Buyer to obtain such written authorisation shall void this warranty COSMED hereby specifically disclaims any and all other warranties of any kind whether express or implied in fact or by law including but without limitation any and all warranties of merchantability and or fitness for a particular purpose COSMED shall not be liable for special indirect and or consequential damages nor for damages of any kind arising from the use of any COSMED s products whether said products are used alone or in combination with other products or substances Determination of the suitability of any of COSMED s product s furnished hereunder for the use contemplated by Buyer is the sole risk and responsibility of Buyer and COSMED has no responsibility in connection therewith Buyer assumes all risks 102 Pony FX User Manual and liabilities for loss damage or injury to persons or property of Buyer or others arising out of the use or possession of COSMED s products The limited warranty as herein above set forth shall not be enlarged diminished modified or affected by and no obligation or liability shall arise or grow out of the renderings of technical advice or service by COSMED its agents or employees in connection with Buyer s order or use of the product s furnished hereunder Return goods policy for warranty or non warranty repair Goods shipped to COSMED for r
23. SD FEV1 FVC e FEV1 VC da ERS93 Chapter 9 Appendix 109 LAM Reference Adult Paediatric 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 SDQFEV1 FVC e FEV1 VC da ERS93 Multic ntrico de Barcelona NHANES III Reference Adult Paediatric 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 Reference Adult Paediatric Spirometric reference values from a sample of the general US population John L Hankinson John R Odencrantz and Kathleen B Fedan Am J Respir Critr Care Med 1999 159 1798 187 Automatic diagnosis algorithm Reference Lung Function Testing selection of reference values and interpretative strategies A R R D 144 1991 1202 1218 LLN Pred 0 674 SD ATS 50 percentile LLN Pred 1 647 SD ERS 95 percentile LLN Pred 0 8 80 Pred Message interpretation Criterion Normal Spirometry FVC and FEV1 FVC gt LLN Obstructive abnormality it may be physiological Pred FEV1 gt 100 Obstructive abn mild Pred FEV1 lt 100 and gt 70 Obstructive abn moderate Pred FEV1 lt 70 and gt 60 Obstructive abn mod severe Pred FEV1 lt 60 and gt 50 110 Pony FX User Manual Obstructive abn sev
24. X User Manual Appendix Warranty and limitation of liability COSMED provides a one 1 year limited warranty from the date of the original sale of COSMED products All COSMED products are guaranteed to be free from defect upon shipment COSMED s liability for products covered by this warranty is limited exclusively to replacement repair or issuance of a credit for the cost of a defective product at the sole discretion of COSMED COSMED shall not be liable under the foregoing warranty unless i COSMED is promptly notified in writing by Buyer upon discovery of defect ii the defective product is returned to COSMED transportation charges prepaid by Buyer iii the defective product is received by COSMED no later than four weeks after the last day of the one 1 year limited warranty period and iv COSMED s examination of the defective product establishes to COSMED s exclusive satisfaction that such defect was not caused by misuse neglect improper installation unauthorised repair or alteration or accident If the product is manufactured by a third party COSMED shall make available for the Buyer s benefit only those warranties which COSMED has received from the third party manufacturer s COSMED hereby specifically disclaims any and all warranties and or liabilities arising from defect s and or damage s to and or caused by products manufactured by third party manufacturers Buyer must obtain written authorisation from COSME
25. accuracy of measurements we recommend you to disinfect the turbine periodically Cleaning and disinfection Cleaning and disinfecting instructions are of fundamental importance to control infections and assure patient safety In fact aspiration of residue particles and contaminated agents are life threatening In this handbook we strongly recommend you 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 summarised and adapted for COSMED products as follows e Accessible internal as well as external surfaces of equipment exposed to expired gas should be washed and disinfected prior to testing of subsequent patients e Disinfecting should ideally be performed by heat sterilisation but gas or liquid sterilisation can be used if the equipment is well cleaned first no droplets of saliva sputum remain e Disposable gloves should be worn when handling mouthpieces 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 recognised high risk communicable diseases e g tuberculosis multidrug resistant staphylococcus In these 98 Pony FX User Manual AAA Warning Do not use alcoholic solutions for the turbine
26. acquisition discarding the results 7 Repeat the test until it is correctly performed ATS recommends 3 times Chapter 7 Spirometry 83 8 Press Exit to visualise the test list carried out during current session together with the results of the main parameters 9 Select the test that you want to save the Best Test according to the ATS criteria is highlighted as default and press OK Test encouragement During FVC manoeuvre you might experience some lack of collaboration with kids or with other patients In this case you may find a good help in using the encouragement software tool Perform the FVC test with the encouragement 1 Select Encouragement from View menu 2 Perform the test as explained in the previous paragraph Kit for Windows DINE IS Real Time s By Test View Window Help la x Heelies E Forced Vital ppacity Fos 8 145 3 4 24 i 4 104 64 34 34 34 Gevi T T T T T 1 1 2 3 sj s 6 7 svo For Help press F1 12770772001 DINE IS INOW GI 84 Pony FX User Manual Slow Vital Capacity Important test for assessing COPD chronic obstructive pulmonary disease patients affected by this disease might present a the Slow Vital Capacity could be higher than the Forced one FVC The main parameters measured during SVC tests are EVC Expiratory Slow Vital Capacity IVC Inspiratory Slow Vital Capacity ERV Expiratory Reserve Volume IRV Inspi
27. anoeuvre of the FVC test 82 Pony FX User Manual Forced Vital Capacity pre FVC is a reference test to verify obstructive airflow limitations and restrictive disorders lung volume limitations To achieve good test results it is fundamental a good manoeuvre quality control messages real time plots The main parameters measured during FVC tests are FVC Forced Vital Capacity FEVI Forced Expiratory Volume in second FEVI FVC FEVI asa percentage of FVC PEF Peak Expiratory Flow FEF25 75 Forced mid Expiratory Flow The two representative plots are the Flow Volume and Volume Time loops By comparing FVC FEV1 and FEV1 FVC values the software allows an automatic interpretation concerning the levels of obstructive and or restrictive disorders Perform a FVC pre test ABORT 1 Select Forced Vital Capacity pre from the Test menu and wait for the green led is prompted on the right side of the screen 2 Explain the manoeuvre to the patient and press the F2 key 3 Wait some seconds and perform the test After having performed the test press F3 or wait for the automatic end 5 seconds without flow so that the software displays the F V and V t graphs the main parameters and the predicteds values 5 In order to visualise the F V and V t graph and the main parameters press the following buttons view Flow Volume graph view Volume Time graph aiw view data of the test 6 Press Alt F3 to stop the
28. are 1 OR 3 Select Run from Windows Start menu Insert the disk in the proper drive In the Command line type lt name of the drive gt install Click on OK or press ENTER key The program will load up a dialog box and ask for a directory where to be installed When the installation is over the program will advise you with a message indicating that the installation has been successfully completed click on End Notice The software is copy protected Install the software from the original disk Run the software l 2 In the Windows Start menu open the Program Group in which the software was installed Click the Quark PFT icon PC port configuration The first time the software is used it is necessary to configure the communication port with the PC USB COM1 COM2 For further details see the chapter Database management Chapter 3 Installation 33 Software main features Display Tool bar The program may contain several windows The active window is highlighted with a different colour of the caption Some functions of the program are active window sensitive Print right key of the mouse Many of the functions that may be selected from the menu can be activated more rapidly by clicking with the mouse on the corresponding icon in the tool bar Positioning the mouse cursor on one of the buttons of the toolbar if the option Hints is enabled the description of the correspon
29. bort in order to abort the test and discard the results Press 1 Redo in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Redo The three best tests will be displayed superimposed each to the other identified by different colours On the right side of the display the three best tests their colours and the measured parameters are reported ordered from the best to the worst The best and the last test performed are highlighted Press 2 Save amp Exit in order to exit saving a test You will be ask to select the test to store press the digit corresponding to the test to be stored Otherwise press 0 Exit without saving in order to exit the test mode without saving the tests Bronchial Provocation Test The program refers to the FVC pre which is selected highlighted at the test start The name of the drug the quantity and unit of measurement and only for bronchoconstrictor tests the delivery protocol can be customised from the Utility menu see later in this document Bronchodilators test The manoeuvre is identical to the FVC test 1 Select the menu item 1 Test 1 FVC Post BD Chapter 5 Using Pony FX 51 Wait until the program is ready for the test After having performed the test press 2 Stop or wait for the automatic end 5 seconds without flow so that the device displays the V T graph the main parameters and the predicteds values Pres
30. ccording to the desired format Using extra fields The Patient s database is organised in 3 different cards Patient card Visit Card and Test card where it is possible to store the information about patients and visits Besides the standard information it is possible to customise some fields user free fields entering and labelling measurements coming from other devices The customisable free fields are e 3 fields in the Patient Card Patient s information e 3 fields in the Visit Card information about the visits e 3 fields 2 numeric in the Test card information about Test Customise the fields In the group User free fields type the desired text in the 9 fields available Chapter 6 Database Management 67 Patient s database di AAA Note after having deleted a record patient visit or test it is recommended to reorganize the archive in order to free disk space The Patients database consists of a Patient Card a Visit Card and a Test Card in which are listed all tests performed by the patient Select Patients from the File menu or press the button by side Patient Card Sera Tests to Display ho Leh bls rg 0971071995 FVC FYC Name 1001 Last 1001 611 1D 1001 Male Birth 0170171975 SEA 4 41 Visit Card r PEF 6 85 Height cm 180 weight Ka 70 Age 20 Drug DRUG No Yes Ex Y 0 Cig Day 0 Sok paz Diag Borderline Obstruction De
31. ce for the ERV calculation is displayed on the V T graph 86 Pony FX User Manual Maximum Voluntary Ventilation Test for assessing the maximum ventilatory capacity In the past it was commonly performed during routine PF tests however its clinical use declined over the years Today MVV test is most commonly performed as part of the exercise tolerance tests where it is used as an index of maximum ventilatory capacity Test consists in breathing in and out deeply and rapidly for 12 15 seconds The expired volume during this short period is then extrapolated The most important measured parameter is the following MVV Maximum Voluntary Ventilation Perform a MVV test 1 Select Maximum Voluntary Ventilation from the test menu and wait for the green led is prompted on the right side of the screen gt 2 Press F2 and make the Patient breath as much deeply and START rapidly as possible for at least 12 seconds 3 Press F3 or wait for automatic interruption 5 seconds a without flow in order to visualise the V t graph together with the main parameters compared to the predicted values 4 To visualise the V t graph and the main parameters press the follow buttons EM view Volume Time graph view data of the test 5 Press AIt F3 to stop the acquisition discarding the results ABORT Repeat the test until it is correctly performed ATS recommends 3 times D 7 Press Exit to visualise the test list carried out durin
32. ced exhalation and finally a deep inspiration Select the menu item 1 Test 1 SVC Wait until the program is ready for the test After having performed the test press 2 Stop or wait for the automatic end 5 seconds without flow so that the device displays the V T graph the main parameters and the predicteds values Press 0 Abort in order to abort the test and discard the results Press 1 Redo in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Redo The three best tests will be displayed superimposed each to the other identified by different colours On the right side of the display the three best tests their colours and the measured parameters are reported ordered from the best to the worst The best and the last test performed are highlighted 50 Pony FX User Manual Press 2 Save amp Exit in order to exit saving a test You will be ask to select the test to store press the digit corresponding to the test to be stored Otherwise press 0 Exit without saving in order to exit the test mode without saving the tests Maximum Voluntary Ventilation 1 Explain the manoeuvre to the patient breathe as deep and fast as possible for about 12 seconds Select the menu item 1 Test 1 MVV Wait the program is ready for the test After having performed the test the device displays the V T graph the main parameters and the predicteds values Press 0 A
33. d 13 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 14 Pony FX User Manual Environmental condition of use COSMED units have been conceived for operating in medically utilised 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 measurements 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 flammable anaesthetic mixtures with air oxygen or nitrogen protoxide If not otherwise stated in the shipping documents Cosmed equipment have been conceived for operating under normal environmental temperatures and conditions IEC 601 1 1988 EN 60
34. d to the unit connecting the two tubes to the P e P connectors Connect the Pony FX to the PC E The Pony FX can be connected to the PC in order to transfer and store the performed tests to back up the data on a different unit HD floppy CD ROM to analyse the tests or to perform the tests sending the controls directly from the PC If the PC connected to the Pony FX is placed within the patient area according to the IEC 60601 1 1 norm the PC has to be made compliant with the IEC 60601 1 1 norm by means of an isolation transformer The PC is connected to the Pony FX unit through an USB connection to the USB port with the symbol by side If the PC does not have an USB port it is possible to use a RS232 serial connection The first time you connect the Pony FX to the PC through an USB connection you will be requested for the drivers Install them from the installation CD Connect the Pony FX to an external printer The Pony FX can be directly connected to an external printer in order to print the performed tests on a different paper If the printer connected to the Pony FX is placed within the patient area according to the IEC 60601 1 1 norm it has to be made compliant with the IEC 60601 1 1 norm by means of an isolation transformer The printer is connected to the Pony FX unit through an USB connection to the USB port with the symbol by side 32 Pony FX User Manual Software installation Installing the softw
35. ding function is shown in a label Show hide the toolbar Select Toolbar from Options menu in order to show or hide the toolbar Dialog windows The typical operating environment of Microsoft Windows is the Dialog box This window is provided with a series of fields in which input the information Use of the keyboard e To move the cursor among fields press the Tab key until you reach the desired field e Press the Enter key to confirm the information input on the dialog box or press the Esc key to cancel changes Use of the mouse e To move the cursor among fields move the mouse on the desired field and left click e Click on the OK button with the Left button of the mouse to confirm the information input on the dialog box or click on Cancel button to cancel changes 34 Pony FX User Manual Scroll bars Some windows are provided with scroll bars that help to see data exceeding the window space available e To move the scroll bar row by row click the scroll arrows at the end of the scroll bars e To move the scroll bar page by page click on the grey area at both sides of the scroll fields On line help COSMED Help is a complete on line reference tool that you can use at any time Help is especially useful when you need information quickly or when the user manual is not available Help contains a description of each command and dialog box and explains many procedures for accomplishing common tasks To get the Help
36. during current session together with the results of the main parameters 9 Select the test that you want to save the Best Test according to the ATS criteria is highlighted as default and press OK Bronchial Provocation protocols Database The response to a bronchoprovocator is usually assessed in terms of change in the FEV1 vital capacity or airways resistance on the basis of serial measurements FVC manoeuvres in which the results of the initial test constitute the reference values The international literature proposes several standardised protocols in order to address the methodological issues of the various available techniques The possibility to store a bronchoprovocation protocol in a database is useful to simplify and automate the sequence of operations that the Physician need to execute during the bronchoprovocation tests The typical sequence of activities to carry out a bronchoprovocation test are 1 Typing and storing a bronchoprovocation protocol in the database usually only once 2 Selection of protocol among the list of the ones already present in the database before carrying out the FVC post tests the selection of manual protocol allows to execute the test fully manually 3 Performing the Post tests 90 Pony FX User Manual Enter a new Bronchial provocation protocol in the archive 1 Select Bronchoprov protocols database from the File menu Type the Protocol name the Bronchoprovocat
37. e list e Pressing the Right key the cursor moves towards right adding blank spaces For some fields you have to select an option from a predefined list In these cases this key allows scrolling forwards the list 46 Pony FX User Manual Patient database management Create a new patient In order to create a new patient select the menu item 1 Patients 1 New and enter the required data x Cancel Confirm D Last Name 00001 First Name 00001 Company E Birth mm dd yyyy Smoke YES 4 Gender IM 4p Race Caucasian 4 Height m cm Weight Kg Notes Memory free 100 16 05 03 15 15 28 In the following you will find some useful notes for proper data entry e ID is an alphanumeric sequence which identifies the patient It is assigned automatically by the unit but can be modified as you want The maximum length is 16 chars e The birth date must be entered as month day year The year must be four digit format e The height has to be entered in the two fields the first one for metres the second one for centimetres Chapter 5 Using Pony FX 47 Search a patient in archive In order to search a patient stored in the archive select the menu item 1 Patients 2 View Search It will open a window with the patient list X Cancel Confirm GIORDANO 00001 PROVA Memory free 100 16 05 03 15 22 13 Scroll the list by means of the arrows and confi
38. eeesesseeseeseeecesenecsesseeseeseeeceeseeeesaeeatens 79 Page Setup az ad O R A W AE A O EA 80 Spirometry test 220212000000000000000000000000000000000000000000000000000000 OO Recommendations for spirometry tests 82 Forced Vital Capacity pre ess ooooooooooooooooooo0o0o00000000000000 Od Perform a FVE pre test csikos SAW 83 Test encouragement 5 aa dada EE E EEE N 84 Perform the FVC test with the encouragement Slow Vital Capacity Performa SVE tes iere nesena O IT O Maximum Voluntary Ventilation ccccccccccssscccccrscccceseee 37 Performa MVV Esta ti iio eae tern aed 87 Bronchial Provocation Test ccrcccccccscccscscssscscscssssssssseersOO Bronchodilator t st rresiaren tene nie E Ea 88 Methacholine and Histamine Bronchial provocation Tests 88 Perform the tests Ars ZARA Meanie NANDA A RODEO WA 89 Bronchial Provocation protocols Database 2 21 11 1111 90 Enter a new Bronchial provocation protocol in the fa wed n iAV ENEAN SE Oz ia A 91 Viewing results 0000000000000000000000000000000000000000000000000000000000 TA Tests of the current patient eeeee aaa 92 Delete a est sy ei O R po A AE Printing results PHINtinS REPOLts e set dz a dO aaa Printing the active window eeeeeeee oaza eacaaa niwie 94 Printing a series of reports eu eeeeee aaa 94 Electronic reports pd
39. eeseesees 14 Quality Assurance Medical Device Directive CE mark 0 00 cceceesesesseeeeeeeneeeeeeeees 16 KeynoteS 2 2220000000000000000000000000000000000000000000000000000000000000000000000 ID Typographic keynotes cecceccesceseeeseeseceeceseceeeseeeeeseceenaeeeseeeeeseeaees 17 Graphic keynotes ccceccesessessececceeceecesecseceseceeeeaeceseesecesesaeeeseeeeeaeeaees Systems Overview Before starting Checking the packing contents Pony FX standard packaging see eeee aaa aaa aoi aaa ana 19 Warranty registration 2200002000000000000000000000000000000000000000000 20 Register the product via software sz How to contact COSMED eeeeeeeae aaa aaa awa anawa raaawaacaae Complain feedback and suggestions e euaoeaa aaa aaa aewa 20 PC configuration required cccccccccsssssssssccccccsscssssssccscsseeed I Technical featureS sisi iicccciossccessdscusesdnscoscocdcccecasessesvescscoeesceeseseo Z2 Measurements 23 Measured parametersS 2 2220000200000000000000000000000000000000000000000 24 2 Pony FX User Manual FVC Forced Vital Capacity VC IVC Slow Vital Capacity and Ventilatory pattern 25 MVV Maximum Voluntary Ventilation 00 0 0 cee eeeeeeeeeeeeeeeeneeeees 25 Bronchoprovocation Response cscecesseeseeeeeeeeeeseeseeseeseeeeeeeeeeneesees 25 Installation 27 Preparing Pony
40. epair are subject to the following conditions 1 Goods may only be returned after your receipt of a Service Return Number SRN from COSMED S r l 2 Place your SRN report and Packing List outside the package 3 Goods returned must be shipped with freight and insurance charges prepaid Collect shipments will not be accepted 4 The following list of goods are not eligible for return unless proven defective Special order items Expendable products Goods held over 30 days from COSMED s invoice date Used goods not in original shipping containers Goods which have been altered or abused in any way 5 The following parts are not covered by warranty consumables fragile glass or plastic parts rechargeable batteries damages due to use of the device not conforming to the indication reported in this manual Repair Service Policy Goods returned to seller for Non Warranty repair will be subject to conditions 1 2 3 4 The returned goods need to re enter COSMED together with the customs documents Pro forma Invoice and Customs Paper as requested by the Italian law e The shipment has to be qualified as a Temporary Export Chapter 9 Appendix 103 e All the goods returned to COSMED without the customs papers will not be accepted For European Community members Pro Forma invoice complete with e Number e Description of the goods e Quantity e Serial Number e _ Valuein e Number of parcel e Gros
41. ere Obstructive abn very severe Pred FEV1 lt 50 and gt 34 Pred FEV1 lt 34 Restrictive abn mild FVC lt LLN and Pred FVC gt 70 Restrictive abn moderate Pred FVC lt 70 and gt 60 Restrictive abn mod severe Pred FVC lt 60 and gt 50 Restrictive abn severe Pred FVC lt 50 and gt 34 Restrictive abn very severe Pred FVC lt 34 Quality Control Messages Reference Spirometry in the Lung Health Study Methods and Quality Control ARRD 1991 143 1215 1223 Message Start faster Blast out harder 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 FEVI reproducible PEF reproducible MVV time too short Criterion VEXT gt 5 of the FVC and gt 150ml 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 FEV1 No errors diff 2 max FVC within 0 2 1 diff 2 max FEV1 within 0 2 I diff 2 max PEF within 10 MVV time less than 12 sec Chapter 9 Appendix 111 References ATS 94 Standardization of Spirometry 1994 Update American J Respiratory Critical Care Medicine Vol 152 1107 1136 1995 ERS 93 Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March
42. est Zl last name ij Xf first name s sex Cancel Help In the example it has been set to create a filename composed by lt date of the test gt followed by lt last name gt and lt first name gt Chapter 7 Spirometry 81 Spirometry tests Once completed the phases of the introduction of the patient s data and the visit data it is possible to carry out the spirometric AAA tests Note Read Pony FX allows to perform the following tests carefully the contraindications in Chapter 1 Key Test FVC pre Forced Vital Capacity FVC post Forced Vital Capacity after bronchial stimulation SVC Slow Vital Capacity MVV Maximum Voluntary Ventilation Before performing any test make sure that 1 Pony FX is properly connected to your PC and the selected serial port COM1 COM2 corresponds to the one effectively use The name shown on the status bar corresponds to the patient who is to carrying out the tests The today s visit card exists Recommendations for spirometry tests For The patient should wear the nose clips The turbine has been recently calibrated ATS recommends a daily calibration The paper mouthpiece or the antibacterial filter is properly connected to the flowmeter through the corresponding adapter hygienic reasons we strongly recommend the use of a bacterial filter Ifa kid must perform the test it is recommended to enable the encouragement function which shows exactly the m
43. eters View Move the parameters to view into the Selected parameters list Print Move the parameters to print into the Selected parameters list Sort Drag the parameter up or down with the mouse Customise Add modify and delete custom parameters If it is necessary to restore the default parameters press the button in the left corner of the window to initialise the parameters database Chapter 7 Spirometry 77 Predicted values manager Predicteds x Predicteds set Formula definition Q o NORMS Description Set current predicteds Name of the predicteds New Save Knudson 83 p ge ITS 5 LAM Male Copy Mc Barcelona Female Delete I Modify predicteds z Import Export Cancel Apply Help The program contains a preset of predicted equations but the user is allowed to customise its own predicted sets Select Predicteds from Options menu The window is divided into two forms Predicteds set and Formula definition Predicteds set This form allows the user to manage the set of predicteds The following information define a set Name identifies the set and cannot be duplicated Description free field Age the adult predicteds start since this age To enter 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 To save the set click on the Save button
44. euscecssessacscsestescescedecussscscesssessesstebes secsecsedsss OF Re s t 6f IhE UNE zai a A AR OWO OSOBIE 64 Formatting the unit a cd iia tay AO OB cane cn A 64 Database Management 65 Settings ccccsssscccrscscccccsscccccesccccccssccccsessccssesssccsescccsseescees OO Usitigv xtra TeldSiss jet Z RA eatin eed area een 67 Customise the fieldscnn 2k sad ANO WA ONA NEA AT 67 Patient s database cccccccccccssccssssscsccccccccecccsscccsssssssssees O Patient Card wiece dn A AO A neat Yi 68 MISIECATd da dg a e RE oi akad doki RABA JE 69 Test Card a acide niente BE OKAZANIA ted Bla dats 69 Import export a Tests card eeeeee eee aaa 69 Diagnosis Database neries erei ee o aae A aN 69 Receiving data from the Uniit ccccccssssssssccccccssssssssscscoees TI Archive maintenance 222000000000000000000000000000000000000000000000000 TZ Reorganise the archive Delete the archive aaa A W ARA AA Index 5 Spirometry 75 Setting spirometry options 22221200000000000000000000000000000000000000 FO Spirometry 16 Automatic Interpretation e e eeee eee 76 Quality CORG L 53 seo A LEA AAAA 77 Parameters Manager s aoi oai wadia kinia 77 Predicted values Manager ccesesceescesseeeeseceseeeceseeeseeseceeeeeeneeeaeeaees 78 Predicteds set Set the current predicted cccecceceeseeseceseeneeeeeeseeeseeseceeeeeenseeseees 79 Formula definition ee
45. ey Release the Menu key then the Cancel key It will be necessary retransmit the firmware from the PC software selecting from the Calibration program the menu item Calibration Transmit program Warning All the memory will be erased and you ll are not able to retrieve any data or program 64 Pony FX User Manual The software allows to configure some options selecting Configure from the Option menu Test options xl Preferences Spirometry Bo a Interface Curve n 1 Curve n 2 Curve n 3 Curve n 4 Cinve nis Unit of meas Cm Kg IV Grids V Show InfoTest C Inch Lbs r User Free Fields Patient Card Visit Card Test Card Cancel Hep Graphs All the graphs visualised and or printed can be customised in colours and appearance 1 Select the desired colours of the curves 5 curves max can be overlapped on the same graph Enable or disable the Grid option 3 Enable or disable the Show Info Test option Interface The port used for data transfer between Pony FX and the PC If the Pony FX is connected through USB select USB from the list otherwise select the serial port of the PC to which the unit is connected COM1 COM2 66 Pony FX User Manual Units of measurements It is possible to configure the units of measurements weight and height for printing and viewing To select the units of measurement click on em Kg or in Ib a
46. f 2 3 saszetce ais 94 Export data 303 Yo A R wd 95 ExXp ra ESC ww wez 95 6 Pony FX User Manual System maintenance 97 System maintenance 22022120000000000000000000000000000000000000000000000 IO Cleaning and disinfection eeee eee Cleaning the turbine flowmeter 141111111111 1 Precautions during the cleaning of the turbine Suggested disinfection Solutions ceeeceeseeseesesteeseeeeeeeereneens INSpections i nie ae een Rete See a Appendix 101 Service Warranty 2200000000000000000000000000000000000000000000000000 102 Warranty and limitation of liability eee eeeeseereeeeeeeeeeeeneeeees 102 Return goods policy for warranty or non warranty repair 103 Repair Service Policy zza wan tea kia ces 103 Privacy Information ccccccccccccscscscscssscscccccscscccscccscccscssseees 105 Personal data treatment and purposes ecesceeseeseceeeesseeseeeeeeeeseenes 105 How your personal data are treated sees sseeseeeeeeseeeceeeeeeeenees 105 The consent is optional but e seee seann aaa 105 Holder of the treatment eueeeoeeo eocen 105 Customer Tights wizaz viene geet aida eaten ees 106 Converting factors configuration 22222200000000000000000000000000 107 Index 7 Reference Adult Paediatric e eoee oazach 110 Automatic diagnosis algorithm eee aaa aaa 110 Quality Control Messages
47. formulae can be e calculated according to the predicteds in the list Use the predicteds formulae Chapter 7 Spirometry 79 e customised by the user with the option or the customised formulae The Delete button deletes the selected parameter The Copy button stores the selected parameter in memory The Paste button inserts a new parameter from the one copied If the name is not unique the user is asked whether to specify a new name or to replace the existing parameter Page set up Page setup Select Page Setup from the File menu Header All the printouts carried out by the program are preceded by 3 rows of customisable header usually they contain the name and the address of the Hospital using the spirometer Data Patient and visit information are printed below the header These data are reported on 3 columns and 5 rows the user may configure the disposition change and eventually cancel the fields as he prefers Margins Configures the print margins from the borders of the paper The unit of measure is decided in Units of measurements Footer Configures information at the bottom of the page 80 Pony FX User Manual Printed file name Defines the automatic name to be asssigned to the pdf file if the report will be printed in this format Page setup x Header Da a Margins Footer Printed file name Format d I Available fields Zb date of birth Zi ID Zd date of t
48. from the list of the tests referred to the Current Patient and press Delete 92 Pony FX User Manual Printing results You can print out in three different ways e printing the Report e printing the Active Window e printing a series of reports Printing Reports To print a report of the current visit select Print report from File menu The software will choose automatically the best performed test The standard Report is composed by 1 2 or 3 pages depending if you wish to printout the FVC data and the graphs together on the first page or if you wish to printout the bronchoprovocation response gy a 7 Multi breath N2 Wash out x 7 Single breath 02 c i I Response J Single breath CO diffusing capacity __ Cancel I Single breath CO _ no breath hold M CU diffusing capacity Steady State IV Respiratory drive Help FYC POST tests Test Drug Dose FEv1 Methacholine 8 Methacholine 0 23 5 13 3 Methacholine 0 54 5 05 10 Methacholine 1 16 4 56 11 Methacholine 2 41 4 28 12 Methacholine 4 91 3 80 ATS One page no ATS M Preview e Selecting the option One page no ATS the report will contain on one page the F V and V t graphs of the best test overlapped on the FVC Post the patient data the notes the diagnosis and the test results e Otherwise the report will contain two pages the first with the patient data the graphs and the diagnosis and the second one with the measured parame
49. g current session together with the results of the main parameters 8 Select the test that you want to save the Best Test according to the ATS criteria is highlighted as default and press OK Chapter 7 Spirometry 87 Bronchial Provocation Test Bronchodilator test AAA Bronchodilators are administered routinely in the PFT laboratory Note Read to determine whether airflow obstruction is reversible carefully the Bronchodilators increase airway calibre by relaxing airway contraindications in Chapter 1 smooth muscle The test consists of comparing results between the reference FVC FVC PRE and the FVC POST performed after the administration of the drug Increasing value of 13 15 of FEV1 respect to the basal value FVC Pre is considered as a reversible condition Main parameters are the following DFEV1 pre Change of FEV1 as a percentage of test PRE DFVC pre Change of FVC as a percentage of test PRE DPEF pre Change of PEF as a percentage of test PRE Some authors states that the above mentioned parameters are too dependent from the FVC Pre hence latest reference ERS93 A comparison of six different ways of expressing the bronchodilating response in asthma and COPD reproducibility and dependence of pre bronchodilator FEV1 E Dompeling C P van Schayck et Al ERJ 1992 5 975 981 recommend the following parameters DFEV1 pred Change of FVC as percentage of predicted value DFEV1 poss Change of FEV1 as percentage of
50. g the back extrapolation method to detect the start of the test extrapolated volume must not be higher then 5 FVC or 150ml The graphic resolution of the printed report must be as in the following Volume 10 mm l 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 4 108 Pony FX User Manual Predicted values ERS93 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 KNUDSON 83 Reference Adult 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 e FEV1 VC da ERS93 ITS White race Reference Adult Paediatric Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 Note SD FEV1 FVC e FEV1 VC da ERS93 ITS Black race Reference Adult Paediatric Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 Note
51. holder of the treatment 106 Pony FX User Manual Converting factors configuration You can edit the parameters shown in Control Panel by selecting Control Panel from the Calibration menu in the calibration program then pressing the button by side You might configure the following options Name identify the parameter Unit of meas unit of measurement Base line and Gain factors used to convert the acquired raw data mV into the final format according to Y mV BL Gain The value entered for gain must be multiplied by 1000 for Gain 1 enter 1000 Precision the number of decimals shown as 0 Chapter 9 Appendix 107 ATS 94 recommendations Reference Standardization of Spirometry 1994 Update American J Respiratory Critical Care Medicine Vol 152 1107 1136 1995 ATS recommendations Volume range 81 BTPS Flow range 14 l sec Volume accuracy 3 or lt 50ml Flow accuracy 5 or lt 200ml sec Flowmeter resistance lt 1 5 cmH20 da 0 a 14 l sec Reproducibility the 2 largest of 3 acceptable FEVI and FVC values 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 accumulation 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 maneuvres FEVI should be calculated by usin
52. is correctly performed ATS recommends 3 times by pressing 1 Redo The three best tests will be displayed superimposed each to the other identified by different colours On the right side of 52 Pony FX User Manual 10 11 the display the three best tests their colours and the measured parameters are reported ordered from the best to the worst The best and the last test performed are highlighted Press 2 Save amp Exit in order to exit saving a test You will be asked to select the test to store press the digit corresponding to the test to be stored Otherwise press 0 Exit without saving in order to exit the test mode without saving the tests Repeat all the FVC Post until the FEV1 falls down by more than 20 of the FVC Pre value Chapter 5 Using Pony FX 53 Performing the oximetry test option The oximetry test measures the haemoglobin saturation i e the percentage of the blood haemoglobin bearing oxygen The test can be performed at rest or during after a light exercise phase cycling jogging The test is completely automatic The measured parameters are SpO Haemoglobin saturation HR Heart rate Recommendations for oximetry tests e Ifyou are using the Pony FX connected to the mains use the medical grade battery charger see nstallation e Be sure that the sensor has been properly disinfected e Use only the original COSMED sensor e Operation and accuracy of the measurement may be affected
53. lators test ccccccssccessceseccssscessecesecessecssecesseceseeesseeeseees 51 Bronchoconstrictor test Performing the oximetry test option Recommendations for oximetry tests Performing the test ccceccssceseeseceseeseceseeseceseeaeeeseeseceeeeseeeeeeeenseeaees Viewing results cccccccccccccccccccccccccccccscccccccccescsecessssseeeee D View a test in archive Printing results cccccccccccccssccccccccccccccscccccccsccecccscccccssesese DJ Replace the printer paper ee eueee eee Printing tests by means of the internal printer Printing tests by means of an external printer 4 4 44 40 1 11111 ODTIONS eccsscicccsccccessccerccsccacccssscascesecevsesssccesssscceessscaserseccecesssee DO General settini Sarion ana iE a ees eae ceed 58 4 Pony FX User Manual Spirometry options FV EG Post Options z z Za A RB di ltd Printout Options zz RAE R W ANAWA Advanced options ei a ivi edge coe W A AA 60 Environmental dataran een 61 Restore of initial settings ee eee aaa aaa aaa aa 61 Other functions of Pony FX sssssooosooooocoooco0o0000000000000000000 OZ Calibratiot za a oz codec seh O sda Control panel ECD COMPAS Tacos BAZZAR ON OKAZ Paperfeedyza zas R0 ADO z BOR ZOO Memory deletions wiz OO RANO A NOAA ANZIO SR 63 Firmware version information e sees eee a wach 63 RESON cvs scessdsacsdicesccv
54. low Equipment type B EN60601 1 Danger high temperature OFF ON Protective earth ground O gt gt Alternating current 12 Pony FX User Manual Contraindications The physical strain to execute the respiratory manoeuvre is contraindicated in case of some symptoms or pathology The following list is not complete and must be considered as a piece of mere information Contraindications 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 bronchial emphysema e Bronchial non specific marked hypersensitivity e Serious problems for the gas exchange total or partial respiratory insufficiency Relative contraindications For FVC tests e spontaneous post pneumothorax state e arterial venous aneurysm e strong arterial hypertension e pregnancy with complications at the 3 month For MVV test e hyperventilation syndrome Contraindications for Bronchial provocation tests The bronchial provocation tests must be executed according to the doctor s discretion There are not data that reveal specific contraindication for the bronchial provocation test through inhalation The modern standard processes have been revealing secure in several clinical studies However it is recommendable to respect the following contraindications Chapter 1 Getting starte
55. mport on Patient card Imported Existing New Visits 0 Tests 0 3 In the left side of the window you have the patient list of the Pony FX archive in the right side there is a list of the patients in the PC archive 4 You can link the selected patient tests to a patient already present in the PC archive Existing or to a new patient New In this case it will be created a new patient with the data stored in the Pony FX unit 5 Press Existing or New to start the transmission Chapter 6 Database Management 71 Archive maintenance The software allows to manage files selecting Archive from the File menu It is advisable to perform the archive reorganisation every month in order to free space on the hard disk and or to correct possible errors present within the database It is possible also that your have no more hard disk space So you have to delete all the data In this case it is useful to perform the initialising Reorganise the archive 1 Select Reorganize archive from the File menu 2 Wait for the end of the operation before performing any other function Delete the archive 1 Select Initialize Archive from the File menu 2 Wait for the end of the operation before performing any other function Backup and restore It is strongly recommended to backup files a warning message will be displayed monthly This function allows the user to restore the data if the PC or the HD will not work anymo
56. n the azure paper cover 2 Lift up the green lever 3 Insert the paper into the slot with the two light grey stripes under the green lever Lift down the green lever 5 Select the menu item 3 Utility 4 Paper Feed and wait the paper exit above the green lever If the paper does not exit and the printer generates strange noises check that the paper is properly inserted 6 Close the paper cover Printing tests by means of the internal printer 1 View the desired test 2 Select the menu item 2 Print 1 Selected Test in order to print this test Select the menu item 2 Print 2 Report in order to print a report for the selected patient Printing tests by means of an external printer When an external printer is connected through an USB connection to the Pony FX unit the test will be printed on the external printer Note If the printer connected to the Pony FX is placed within the patient area according to the IEC 60601 1 1 norm it has to be made compliant with the IEC 60601 1 1 norm by means of an isolation transformer Note The printer must support the PCL language and have an USB port for data transmission Chapter 5 Using Pony FX 57 The Pony FX unit allows the configuration of some options by means of the 2 Options menu General settings Select the menu item 2 Options 1 Settings x Cancel Confirm Option Settings Date mm dd yyyy 116 M2003 Time hh mm 15 J35 Language English KD
57. ne to high heat and do not put it under running water Do not ever dip the optoelectronic reader in any kind of solution the liquid infiltration would damage the internal circuit Do not use alcoholic solutions to clean the turbine Chapter 8 System maintenance 99 Inspections Suggested disinfection solutions Helipur H Plus Braun Melsungen AG Gigasept FF Schulke amp Mayr GmbH Dismozon pur Bode Chemie GmbH TETA S Fresenius AG CIDEX Johnson amp Johnson The equipment requires 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 environmental conditions Referring to the electrical safety it is important to check the conditions of insulation materials of cables plugs and any other visible part by means of simple inspection when the equipment is switched off and adapters or electrical feeders are disconnected from the supply mains Extract the turbine from the unit and verify by inspection that the turbine axis fits correctly 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 Check if there are any torn or broken components in the breathing circuits remember that they can create safety risk to patients during tests 100 Pony F
58. ng 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 user 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 10 Pony FX User Manual e using the accessories described in the manual or given with the device Actually non recommended accessories can affect safety unfavourable Before using non recommended accessories it is necessary to get in touch with the manufacturer e ordinary equipment maintenance inspections disinfection and cleaning are performed in the way and with the frequency described e any modification or fixing is carried out by qualified personnel e 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 electrical plants In particular grounding reliability and leakage current suppression can only be assured when the device three wire receptacle is connected to a yellow green return connected to earth ground Attempting to defeat the proper connection of the ground wire is dangerous for users and equipment Before powering the system check the power cables and the plugs Damaged electrical parts must be replaced immediately by authorised personnel The bat
59. or name and the unit of measurement in the proper input fields If the bronchoprovocator has a cumulative effect select the cumulative check button Enter the quantities for each step and press the button E Chapter 7 Spirometry 91 Viewing results th i AII the visualisation functions refer to the test carried out by the Current Patient whose name is indicated on the left side of the status bar To view tests results 1 Select the Patients 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 view Flow Volume graph F5 JT view Volume Time graph F6 iii iii view data of the test F7 view bronchial provocation response If you need more than one visualisation meantime use the New Window function from the Window menu If you need to display a list of visits e Select Visits list from the File menu e Type the name of the Company and or the time interval desired or simply confirm for the complete list Tests of the current patient If a current patient has been selected you can quickly view his tests selecting Test current patient from the View menu Delete a test 1 Select Patients from the File menu or press the button by side 2 Select the test that you want to eliminate
60. or the external printer 320x240 STN colour backlighted Thermo sensitive 832 pixel per line 112 cm standard sensibility good stability image duration 15 years Measured parameters FVC Forced Vital Capacity FEV1 VC FEF50 75 FEF75 85 l sec FEF0 2 1 2 l sec l sec FiVC L FiF25 75 l sec FiVI I sec PIF l sec VEXT ml PEFT msec 24 Pony FX User Manual AAA Symbol UM Parameter AOC FVC I Forced Expiratory Vital Capacity computed only by FEVI l Forced Expiratory Volume in 1 sec the PC software FEV1 FVC FEV1 as a percentage of FVC PEF l sec Peak Expiratory Flow FEV0 5 1 Forced Expiratory Volume in 0 5 sec FEV6 I Forced Expiratory Volume in 6 sec FEVI FEV6 FEVI as a percentage of FEV6 FEV6 FVC FEV6 as a percentage of FVC Best FVC 1l Best Forced Expiratory Vital Capacity Best FEV 1 Best Forced Expiratory Volume in 1 sec Best PEF l sec Best Peak Expiratory Flow Vmax25 l sec Expiratory Flow 25 of the FVC Vmax50 l sec Expiratory Flow 50 of the FVC Vmax75 l sec Expiratory Flow 75 of the FVC FEF25 75 l sec Mid exp flow between 25 75 FVC FET100 sec Forced expiratory time FEV2 l Forced Expiratory Volume in 2 sec FEV3 I Forced Expiratory Volume in 3 sec FEV2 FVC FEV2 as a percentage of FVC FEV3 FVC FEV3 as a percentage of FVC Tiffenau index Mid exp flow between 50 75 FVC Mid exp flow between 75 85 FVC Mid exp flow between 0 2 I 1 2 1 Inspiratory Forced Vital Capacity Forced mid inspira
61. ration 37 The calibration program oooooo00000000000000000000000000000000000 OO Index 3 Turbine calibration 0002202222220000000 Calibrating the turbine without a PC Calibrating the turbine by means of a PC ee eececeeeeteeeeeeeeteeeeeeeees Checking the system signals cccccsssccsssssscccsssscccssssscnee T The control panel sy zania dn leis edt 41 Using the control panel ccceeceeceeseeseceeceeeeseeseceeeeseceseeseceeeeaeenes 41 Using Pony FX 43 Main functions of the Pony FX sssccccccsssssssssssssccccsseesssss 44 Turning on off the Pony FX eueeeeeee eee aaa anawa 44 Using the menu Accessing the MENU gin i Badz dy 44 Usine thekeyb ard see wz z dogi e atl Logic of the keyboard e eee e aaa ooo aaa aaa Patient database management Createa new patients icc wez A z O dad Search a patient in archive e eee eee aaa aaa aaa aaa aaa Performing the spirometric tests 0 00000000000000000000000 49 Recommendations for spirometry tests e e eeeeeaaa aaa aaa aaaanwa 49 Forced Vital Capacity pre cccccceeccescesseeseeseceseeeceseeeceseeeeeseeeeeseeaees 49 Testi e outagemeNt ssa a Oo ees ie di Slow Vital Capacity ae zez i R ia o l Ad Ezd Maximum Voluntary Ventilation Bronchial Provocation Test suase aaa aaa aaa aaa aaa aaa a aaa awaiacaa Bronchodi
62. ratory Reserve Volume If the inspiratory expiratory maximal manoeuvre is preceded by a some breaths at tidal volume the software allows to measure the Respiratory Pattern represented by the following parameters VE Ventilation per minute Vt Tidal volume Rf Respiratory frequency Ttot Breath time Ti Ttot Inspiratory time Ttot Vt Ti Vt Ti Perform a SVC test 1 Select Slow Vital Capacity from the Test menu and wait for the green led is prompted on the right side of the screen 2 Press F2 and instruct the Patient to breath normally until the message carry out is prompted then ask to perform a Slow Vital Capacity deep inhalation maximal slow expiration and deep inhalation again 3 Press F3 or wait for automatic interruption 5 seconds without flow in order to visualise the V t graph together with the main parameters compared to the predicted values 4 To visualise the V t graph and the main parameters press the follow buttons view Volume Time graph view data of the test 5 Press Alt F3 to stop the acquisition discarding the results Chapter 7 Spirometry 85 6 Repeat the test until it is correctly performed ATS recommends 3 times 7 Press Exit to visualise the test list carried out during current session together with the results of the main parameters 8 Select the test that you want to save the Best Test according to the ATS criteria is highlighted by default and press OK The referen
63. re Backup 1 Select Backup archive from the File menu Backup v 5 4 x r Statistics Backup to 60 files 2 Mb Description pn ooo OK Cancel 2 Selecting the destination path with the Browse key or press New to create a new directory Press OK to confirm 72 Pony FX User Manual 3 In the dialog box it will appear an estimate of the number of floppy you need in order to back up the archives Press OK Restore 1 Select Restore archive from the File menu Browse Cancel 2 On the Restore dialog box specify the drive source and press OK a dialog box will appear indicating all data of the backup processed Chapter 6 Database Management 73 74 Pony FX User Manual Spirometry Setting spirometry options The software allows to configure some options selecting Configure from the Option menu Spirometry Test options x Preferences Spirometry Automatic Interpretation A LLN Calculation SRAMA UA zl IV Enable Automatic Interpretation I Enable Quality Control Iv Response graph in logarithmic scale I Print active window FYC in ATS format 2 pages I Reduce scale on small curves Cancel Automatic Interpretation Pony FX has the function of interpreting each test performed by a patient visualising an automatic diagnosis The algorithm has been calculated basing on Lung Function Testing selection of reference values and interpretative strategies
64. resentative plot is the Dose response curve showing the percentage variation of FEV1 versus the Drug dose in logarithmic scale The program assumes as the baseline test the best FVC pre carried out during the today s visit You can change the reference pre test editing the Post test The name of the drug its quantity and its unit of measurement can be typed immediately before any FVC post manoeuvre manual protocol or can be stored in a database of bronchoprovocation File Bronchial Provocation protocols Database Perform the test During 1st step only select Protocol from the Test menu and choose the name of the bronchoprovocation protocol that you are going to use manual protocol if you want to type the information about the agent before any manoeuvre 1 Select FVC post from the Test menu 2 Select an existing protocol or click on manual protocol and wait the green leds turned on 3 Press F2 or the button by side to start the test 4 Press F3 or the button by side to achieve the test Chapter 7 Spirometry 89 5 In order to visualise the V t graph and the main parameters press the follow buttons view Flow Volume graph aiw view data of the test zl ZFEU view bronchial provocation response 3 6 Press AIt F3 to stop the acquisition discarding the results Repeat the test until it is correctly performed ATS recommends 3 times 8 Press Exit to visualise the test list carried out
65. rm the selected patient with the key by side 8 If necessary cancel the operation with the key by side 48 Pony FX User Manual Performing the spirometric tests ARA Once completed the phase of the introduction of the patient s carefully the data or selection of an already archived patient it is possible to contraindications carry out the spirometric tests in Chapter 1 For a complete description of the tests and of the measured parameters see the chapter Spirometry Recommendations for spirometry tests If you are using the Pony FX connected to the mains use the medical grade battery charger see Installation The patient should wear the nose clip The turbine has been recently calibrated ATS recommends a daily calibration If you are using the pneumotachograph do not breathe into the flowmeter until the proper message appears The paper mouthpiece or the antibacterial filter is properly connected to the flowmeter through the corresponding adapter For hygienic reasons we strongly recommend the use of a bacterial filter If a kid must perform the test it is recommended to enable the encouragement function which shows exactly the manoeuvre of the FVC test Forced Vital Capacity pre 1 Explain the manoeuvre to the patient breathe at rest for some time perform a maximal inspiration and then a maximal forced exhalation Select the menu item 1 Test 1 FVC Pre Wait until the program is read
66. ry to supply the Competent Authorities with the required information in order to define your commercial profile in order to use your commercial profile for own marketing and advertising purposes for accounting purposes including e mailing of commercial invoices for providing your information to selected business partners also abroad in order to supply the service How your personal data are treated Your personal data will be stored in electronic format and protected at the best from destruction loss even accidental not authorized accesses not allowed treatment or use not in conformity with the purposes above listed The consent is optional but If you deny the consent we regret we cannot supply the service Holder of the treatment The holder of the treatment is Cosmed Srl Via dei Piani di Monte Savello 37 Pavona di Albano Laziale RM The responsible of the personal data treatment is indicated in the documentation stored by Cosmed Srl itself Chapter 9 Appendix 105 Customer rights In accordance with art 7 of the Law you can a obtain confirmation of the existence of your personal data and their communication in intelligible form b obtain e updating correction or integration of your data e deletion or transformation in anonymous form of your personal data c deny your consent to the treatment of your personal data These rights can be exercised directly requesting in writing to the
67. s 0 Abort in order to abort the test and discard the results Press 1 Redo in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Redo The three best tests will be displayed superimposed each to the other identified by different colours On the right side of the display the three best tests their colours and the measured parameters are reported ordered from the best to the worst The best and the last test performed are highlighted Press 2 Save amp Exit in order to exit saving a test You will be ask to select the test to store press the digit corresponding to the test to be stored Otherwise press 0 Exit without saving in order to exit the test mode without saving the tests Bronchoconstrictor test The manoeuvre is identical to the FVC test l 2 Select the menu item 1 Test 1 FVC Post BD A window with bronchoconstrictor name quantity and measurement unit as set in 2 Options 3 FVC Post will be displayed If you accept the protocol confirm otherwise modify the values and confirm Wait until the program is ready for the test After having performed the test press 2 Stop or wait for the automatic end 5 seconds without flow so that the device displays the V T graph the main parameters and the predicteds values Press 0 Abort in order to abort the test and discard the results Press 1 Redo in order to restart the test Repeat the test until it
68. s weight e Net weight e Reason for resent i e Resent for repair In case you should send the system for repair please contact the nearest service centre or contact COSMED 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 9315492 fax 39 06 9314580 E mail customersupport cosmed it For USA customers only please contact COSMED USA Ine 1808 North Halsted Street Chicago IL 60614 USA Phone 1 312 642 7222 Fax 1 312 642 7212 email usa sales cosmed it To ensure that you receive efficient technical assistance please specify as precisely as possible the nature of the problem as it is specified on the assistance information form We advise you to save the original packaging You may need it in case to ship the unit to a technical assistance centre 104 Pony FX User Manual Privacy Information Dear Customer we inform you that your personal data are gathered and will be used by Cosmed Srl in conformity with the requirements of the Italian privacy law Decreto Legislativo 196 2003 We believe it is important for you to know how we treat your personal data Personal data treatment and purposes We request and process your personal data a to place an order register a product request a service answer a survey enter a contest correspond with us all of the above in the following service and if necessa
69. scription e gt Quality Control Diagnosis Blow out longer FET100 lt 6 sec chec Smoke Patient Card It collects all the information of a patient first name last name date of birth which remain the same for each visit For each patient there is only one Patient Card which is created the first time the Patient performs a test To move within the database use the following buttons 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 Enter a new patient in the archive Delete current patient from the archive W WPPEJJE Edit the current patient card 68 Pony FX User Manual Visit Card It collects all information relative to the visit diagnosis visit description and to the patient information subject to change between one visit and another height weight smoke Each patient can be related to several Visit Cards provided they have been created in different days Before carrying out any spirometric test it is necessary to create a new Visit Card or to open the today s Visit Card To move within the database use the following buttons 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 Enter a new visi
70. sed for the tests do use it also during the turbine calibration Calibrating the turbine by means of a PC In order to calibrate the turbine by means of the PC software 1 Connect the turbine flowmeter to the calibration syringe 2 Select Calibration from Test menu 3 Select Reference values from the Calibration menu and enter the syringe volume if different to the displayed one Select Turbine from the Calibration menu 5 When the Calibration Turbine dialog box appears with the syringe piston initially pushed all the way in move the piston in and out for 5 inspiratory strokes and 5 expiratory strokes in order to get the first values appearing on the screen Then move the syringe piston for other 10 strokes IN and EX 6 At each of the 10 steps the software displays the results of the manoeuvre and the percentage error in the reading Chapter 4 Calibration 39 Turbine Calibration Eg Syringe volume 3000 ml Results Exp Gain Ins Gain 3002 0 07 1046 2993 0 23 1027 2985 0 50 1048 2995 0 17 1028 2972 0 93 1052 3010 0 33 1026 2993 0 23 1052 2993 0 23 1027 3019 0 63 1051 2984 0 53 1027 2992 0 27 1051 2990 0 33 1028 2994 0 20 1051 3004 0 13 1027 3009 0 30 1050 3008 0 27 1027 2988 0 40 1051 2996 0 13 1027 2974 0 87 1051 3006 0 20 1027 Move the calibration syringe Help 7 At the end of this operation the software displays the new calibration factors Press OK to store the
71. splay If you don t use the unit for at least the time set in configuration see later Options the display turns off automatically In order to avoid this press any key e ofthe device If you don t use the unit for at least 5 minutes the unit turns off automatically In order to turn on the device press the MENU key Using the menu The menu bar is displayed in the upper part of the screen and it appears different depending on the context In the lower part of the display a status bar indicates useful information and short Help messages Accessing the menu You can access the menu in two ways e e Press shortly the MENU key and then change menu by means of the direction keys Confirm the selected item by means of the key 44 Pony FX User Manual e Press the key on the alphanumeric keyboard corresponding to the selected menu item until the desired function is highlighted The two methods direction keys and alphanumeric keyboard are fully interchangeable eS To exit the menu press the MENU key Using the keyboard Please find in the following a brief description of the functions of the keys and then a description of the keyboard logic Key mame Description Turns on off the Pony FX accesses the menus Goes to the upper menu item or in input data mode to the previous field Goes to the lower menu item or in input data mode to the next field Goes to the menu item on
72. t card in the archive Delete current visit card from the archive E x a a a BA ESE Edit the current visit card Test Card It contains all the information about the test To move within the database use the following buttons Delete current test from the archive Edit the current test Import export a Tests card This function allows to import export a test card with the respective visit and patient card 1 Select the patient e E 2 Choose the tests to be exported and press the key by side All data will be elon s the XPO file format Cosmed proprietary Diagnosis Database The program allows to manage a diagnosis database whose records are composed by a diagnosis ID code and a string of text Chapter 6 Database Management 69 The report of the visits can be done either by typing the desired text in the field Diagnosis of the Visit Card or more quickly retrieving from the diagnosis database the desired one If you want to insert modify or delete a diagnosis from the database select Diagnosis Database from the File menu 70 Pony FX User Manual Receiving data from the unit In order to download the tests performed and stored on the Pony FX unit please do the following 1 Connect the unit to the PC through serial or USB connection depending on the settings 2 Select Receive test from the Test menu Test Download x Pony FX Database PFT Suite Database BOND JAMES 1 I
73. ters according to the ATS recommendations e The 3 page will contain the bronchoprovocation response Chapter 7 Spirometry 93 Select the desired options FVC graph Prints the F V and V t curves for the best FVC test One page no ATS Prints data and graphs on the first page Response Prints the bronchoprovocator response FVC post Prints data and graphs for the Post FVC test the test can be selected among the test performed in the current visit Preview Views a report preview on the screen prinio 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 select Print Active window from File menu Printing a series of reports Sometimes it is useful to printout automatically a series of reports all tests carried out with the employees all tests carried out in the today s session To print out proceed as follows 1 Select Visit List from the File menu 2 Set the criteria of the visits to be added in the list from to 3 Select Print Report from the File menu Electronic reports pdf If an Adobe PDF writer Printer Driver is installed and set as the default printer it is possible to store the printout report automatically in any location of the HD or eventually LAN paths according to a customizable filename format It
74. tery charger sold with Pony FX must be used only to re charge the battery If you would like to perform test with Pony FX connected to the mains use the medical version battery charger see nstallation chapter Cleaning residue particulates and other contaminates including pieces of torn or broken components in the breathing circuit pose a safety risk to the patient during testing procedures Aspiration of contaminates can potentially be life threatening You must follow all the cleaning procedures in System Maintenance and you must thoroughly inspect the components after cleaning and before each patient test This device is not suitable for use in presence of flammable anaesthetics It is not an AP nor an APG device according to the EN 60 601 1 definitions Keep the device away from heat and flame source flammable or inflammable liquids or gases and explosive atmospheres Chapter 1 Getting started 11 In accordance with their intended use Pony FX is not to be handled together with other medical devices unless it is clearly declared by the manufacturer itself o It is recommended to use a computer with electromagnetic compatibility CE marking and with low radiation emission displays 0 It is necessary to make the PC connected to the Pony FX compliant with EN 60601 1 by means of an isolation transformer Graphical symbols used in accordance to present specifications are described here be
75. the right In input data mode adds a blank space to the right or in multi options fields scrolls forwards the available options Goes to the menu item on the left In input data mode deletes the last character entered or in multi options fields scrolls backwards the available options Enters the digit 1 or a character 2 amp Enters the digit 2 or a character A B C 0606060606 Enters the digit 0 Cancels the operation Confirms the operation or the selected menu item Chapter 5 Using Pony FX 45 Logic of the keyboard The logic of the keyboard follows these rules e If the current input field the one with the cursor allows an alphanumeric input for example name company you have to follow these instructions in order to enter the characters A repeated pressure of a key scrolls the available characters for that key until another key is pressed or it elapses 1 second If you wait more than second or if you press another key you confirm the input and the cursor moves 1 place towards right For example in order to enter the string BB4 you have to press the following keys G6 6666660 The keys will enter the character first letter or signs and then the digit e Pressing the Left key the cursor moves towards left deleting the characters For some fields you have to select an option from a predefined list In these cases this key allows scrolling backwards th
76. tory flow Forced Inspiratory Volume in 1 sec Peak Inspiratory Flow Extrapolated Volume back extrapolation Time to PEF 10 90 VC IVC Slow Vital Capacity and Ventilatory pattern Symbol UM EVC l IVC 1 ERV l IRV l IC 1 VE l min Vt l Rf l min Ti sec Te sec Ttot sec Ti Ttot Vt ti l sec Parameter Expiratory Vital Capacity Inspiratory Vital Capacity Expiratory Reserve Volume Inspiratory Reserve Volume Inspiratory Capacity Expiratory Minute Ventilation Tidal Volume Respiratory Frequency Duration of Inspiration Duration of Expiration Duration of Total breathing cycle Ti Ttot ratio Vt ti ratio MVV Maximum Voluntary Ventilation Symbol UM Parameter MVV l min Maximum Voluntary Ventilation MVt l Tidal Volume during MVV MRf l min Maximum Respiratory frequency MVVt sec MVV duration time Bronchoprovocation Response Symbol FallFEV1 FallVmax50 P10 P15 P20 Parameter Fall in FEV1 from baseline or post diluent Fall in Vmax50 from ref Provocative dose causing FEV1 to fall 10 Provocative dose causing FEV1 to fall 15 Provocative dose causing FEV1 to fall 20 Chapter 2 Measurements 25 26 Pony FX User Manual Preparing Pony FX Pony FX is mainly made of Pony FX unit Battery charger Flowmeter pneumotachograph or turbine depending on the version Let us see an overview of the parts and their assembly Pony FX unit The main elements a user can detect in the Pony FX
77. unit are the following A colour display A keyboard An internal printer Some connectors on the bottom side of the device The display The colour display interfaces the device with the user allowing the user to access to the functions of the device and to display the performed tests The keyboard Pony FX has a keyboard see the next picture which allows the user to interact with the device 28 Pony FX User Manual PY O p a a The keyboard is divided into two groups In the left one there are the on off menu key at the centre and four direction keys In the right group there are 10 alphanumeric keys the confirm and the delete keys A more detailed description of the keys functions of the keyboard logics and of the menus see the chapter Using Pony FX The printer It is a thermal printer which allows the printing of the test performed For more information about the use of the internal or an external printer see the chapter Using Pony FX The connectors On the bottom side of the device there are 7 connectors as shown in the following picture A label details the connection type P P RS 232 SpO2 Turb Raw E Chapter 3 Installation 29 From the left to the right in order e 2 pneumatic connectors for pneumotachograph if you do not use the turbine flowmeter e Connector for the RS232 cable if the PC doesn t have an USB port
78. y for the test After having performed the test press 2 Stop or wait for the automatic end 5 seconds without flow so that the device displays the F V graph the main parameters and the predicteds values Press 0 Abort in order to abort the test and discard the results Press 1 Redo in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Redo Chapter 5 Using Pony FX 49 The three best tests will be displayed superimposed each to the other identified by different colours On the right side of the display the three best tests their colours and the measured parameters are reported ordered from the best to the worst The best and the last test performed are highlighted Press 2 Save amp Exit in order to exit saving a test You will be ask to select the test to store press the digit corresponding to the test to be stored Otherwise press 0 Exit without saving in order to exit the test mode without saving the tests Test encouragement During FVC manoeuvre you might experience some lack of collaboration with kids or with other patients In this case you may find a good help in using the encouragement tool 1 2 Select the menu item 1 Test 6 Encouragement Perform the test as described in the previous paragraph Slow Vital Capacity 1 Explain the manoeuvre to the patient breathe at rest for some time perform a maximal inspiration then a slow for

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