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Pony FX

1. 69 IO NONE OT in 69 Quality Assurance seine 69 Medical Device Directive CE Mark ii 69 Technical features iii da a iii 70 Predicted VALU GS iii iaa ia 71 B Automatic diagnosis algo th ERERREREFERFERPENEN EEE PERFERTEFER FEREFERTENFENEHNERENEEFERTELERTEFFLEBFEERELBRSSERELBRUEEEEREERSENEFERPEERELEESEERETE 72 m Quality Control Messages iiss ssssccctcasisnsisssiceetenesisehsactcasbanteisesccnsvansiasseecdeascansssesevessssnedsavasaddavsesei Poss rus desse veces 72 References 74 sers apo iii tdo 74 Resistance nia Ed 74 OA CRE ROOT NOTI 74 General NN 74 Getting started Important notices B Intended use 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 be sold by the order of a physician This equipment is intended to be used for the following applications e Formulating of a lung pathology diagnosis e Assisting with human physiology studies e Contributing to sports medicine applications COSMED Srl is not responsible for incidents which occur due to improper use of this device Examples include e Operation of the device by unqualifiedindividuals e Use of the device not indicated by this manual e Not complying with the pr
2. ii 59 AAPP o o o 60 Cleaning the turbine vienna 60 bisi iecti g the Urbieta A Z AA i ini aria iii 60 Precautions to take when cleaning disinfecting and drying the turbine i 60 LEM pc 60 E MIP MEP pressure lie cnn chain anna ARA AS NDA A RES EE ERE TES 60 Cleaning the MIP MEP pressure line i 60 Disinfecting the MIP MEP pressure line i 60 InSpectioris ioo AO O R DONNA OLO OLO OOOO DONE 61 Declaration of conformity ses 4er kennen en eisen 64 IIIa 65 m Warranty and limitation of liability 5 5 2 3 G0 0 tero to aerea R ER EXER BERE PARA ek 65 E Return goods policy for warranty or non warranty repair eeee ee eere eene ee nnne enne nese seni nie nani cesena zinene 65 M Repair Service POC asas asa aaa aiar 65 Privacy InfolfiatiOol c croire tonto aio ia aaa aaa ana a ani 67 M Personal data treatment and purposes iisciivirivionicioiinziosicainiciinianioni sa vais bens eia sine nennen nennen 67 B How your personal data is treated 1 netter ta sirio iaia ica cried criar ibrida 67 M Consent M 67 M Holderofthepersonaldat a alan li quere de SI RR A a 67 M Customer Tight ia iii 67 Disposing of electrical equipImerit 1c aaa iaia 68 Safety and conformity tiene IRA E 69 Safety
3. Pony FX Desktop Spirometer Manuale Utente User Manual Manuel d utilisation Benutzerhandbuch Manual del Usuario 39 COSMED The Metabolic Company COSMED does not assume any liability for end user interpretation of this user manual 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 expressed written permission of COSMED Srl Each copy of the COSMED Software can only be installed on one computer 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 XVI Edition 10 2012 Copyright 2012 COSMED COSMED Srl Italy http www cosmed com Part N C02361 02 91 Table of contents Table of contents Getting started El Importantinotices 2 nri OG WG Ben ARRONE RIA RR RNA ONORARIA RR RI ea a 8 ASAS O ai 8 B Warhings c T TT TT TT TI TT TT TT TT 8 Elf Comtraindications siate iii ia ia iii ni ni dan a ic sii 10 B Contraindications for the spirometry testing sssesssesscecscesssecesccoeomrecetenatocenevirosatanato tania iii Nabo iaia tin 10 Absolute c ntrai diCAtIO S aaa sica rica dada ir 10 Relative contraindication nassen 10 E Contrai
4. Phunsup Wongsurakiat Suchai Charoenratanakul Wilawan Juengprasert Chana Naruman Reference Spirometric Values for Healthy Lifetime Nonsmokers in Thailand J Med Assoc May 2000 83 457 466 DLCO Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March 1993 Appendix Predicted values 71 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 Reference Values for Residual Volume Functional Residual Capacity and Total Lung Capacity ATS workshop on Lung Volume measurements official statement of the European Respiratory Society J Stocks Ph H Quanjer ERJ 1995 8 492 506 Single Breath Oxygen Test Buist SA Ross BB Quantitative Analysis of the Alveolar Plateau in the Diagnosis of Early Airway Obstruction ARRD 108 1081 1973 Mansell A Bryan C Levison H Airway Closure in Children JAP 33 711 714 1972 Buist SA Ross BB Predicted Values for Closing Volumes Using a Modified Single Breath Test ARRD 107 744 751 1973 Rint Lombardi E Sly PD Concutelli G et al Reference values of interrupter respiratory resistance in healthy preschool white children Thorax 2001 56 691 695 MIP MEP Leo F Black Robert E Hyatt Maximal Respiratory Pressures Normal Values and Relationship to Age and Sex Americ
5. Select the menu item 4 Utilities 7 Restore Factory Settings With this option you can reset the option and restore the original factory settings B Firmware version information In order to get information about the installed firmware version select the menu item 4 Utilities 8 Information Pony FX Operation Other functions of Pony FX 53 Reset B 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 B 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 on off X key then the key Turn on the Pony FX keeping pressed the Cancel key Release the 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 54 Pony FX Operation Reset 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
6. do not wet the sampling line Use the brush point 1 step 5 only for the external parts of the turbine in order to avoid damages to the turbine blade Disinfecting the turbine 1 Take out the turbine 2 Dip it in a disinfectant solution non alcoholic based for about 20 minutes 3 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 5 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 to take when cleaning disinfecting and drying the turbine e Do not expose the turbine to high heat or to a direct flow of water e Do not expose the sampling tube or the connector on the end of the cable to any liquids e Do not use alcoholic solutions to clean the turbine E PNT X9 For cleaning and disinfecting the PNT X9 follow the same instructions as for the turbine being careful to observe the following e Use distilled water for preparing the disinfectant solution otherwise the calcium deposit could damage the flowmeter net e Do not dry the PNT X9 with hot air which may damage the flowmeter net E MIP MEP pressure line Cleaning the MIP MEP pressure line Follow the standard cleaning procedure reported above Disinfecting the MIP MEP pressure line Follow the standard disinfection procedure reported abo
7. transformers or power lines These devices could create electrical interferences when performing testing procedures COSMED devices are not AP or APG units according to EN 60601 1 and should never be operated in the presence of flammable anaesthetic mixtures COSMED equipment should be operated under normal environmental temperatures and conditions which are defined as follows IEC 60601 1 EN 60601 1 e Temperatures range 10 C 50 F and 40 C 104 F e Relative humidity range 30 to 90 not condensing e Atmospheric Pressure range 600 mBar to 1060 mBar e Avoid operating equipment in the presence of noxious fumes or in dusty environments e Do not place units near heat sources e Cardiopulmonary resuscitation equipment should be accessible in the case of an emergency e Adequate floor space and easy access to the patient during exercise testing is necessary e Adequate ventilation should be maintained in the room the testing is performed Getting started Environmental condition of use 11 EMC Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions The device uses RF energy only for its internal function Therefore its RF CISPR 11 emissions are
8. 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Nota Ur is the a c mains voltage prior to application of the test level Getting started EMC 13 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity test Test level Compliance level Electromagnetic environment guidance IEC 60601 1 Portable and mobile RF communications equ
9. az ar ASKA tu us AAA AAA AA AAA 22 Installation E Beforestarting aLaaa aa rire 24 B Checking the packing COnterts opor tror arr ARIANNA REZZA RA A RI UFNANY NE SNN 24 A nort coo ro otra sno ets iens ep arua SER AER E EEOAE CEE AE EE KEEN SEE SESS UP SES ESEESRUS SE VESPERE EE 24 Pony FX standard packaging ee ee nenne nern ten ee rennen M 24 Pony FX Flowsafe standard packaging ii 24 O O O O O O O O Pony FX MIP MEP standard packaging ii 24 A A O roues UE eats 26 Preparing PONY Fun era 27 M PonvFXconnectors ZA EBEN AO A r I ate 27 m Replacementof the power PIE iii 27 M Battery charger iii aaa iaa 27 B Connect the R ce module option to the Pony FX 28 E Connect the oxymeter option to the Pony FX scssssscscssessossesesssconsoscseonsosessosscaneeoacoscsooacosnesoacosescosscasssonscastesos 28 m Connect the Pony FX tothe PC union anidan is 28 E Connect the Pony FX to an external printer sssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssees 28 Howto contact COSMED iii AA iods onbedssneeectedenousieageccoasaes 29 Complaints feedback and suggestions ii 29 Main functions ofthe carl a 32 E T rningon offthe Pony osa asian aaa vira ra 32 M Men s M 32 How to enter the MENUS iere res tee E dod eo bran ali 32 AA A A on aai aai ai eias eais 32 Funct
10. detergents with a neutral pH 7 are recommended for cleaning Use warm water 22 43 c with the mild detergent To be effective cleaning agents must assist in the removal of residual organic soil without damaging the device cleaning agents should be used in the correct dilution concentration and at the correct temperature in accordance with the cleaning agents manufacturer s directions Cleaning supplies are very basic usually consisting of a surgical scrub brush chenille pipe cleaners cotton or foam tipped applicators soft brushes and soft cloths Cleaning supplies should be cleaned and disinfected or sterilized daily Water Quality tap water is acceptable for use in cleaning COSMED components COSMED components should be soaked and rinsed in tap water at 22 43 C to prevent the coagulation of solid substances onto the device and thus facilitate the removal of debris 58 System maintenance Cleaning and disinfecting Enzymatic detergents with a neutral pH 7 are recommended when processing difficult to clean items with dried on matter Soaking mask and valve components in an enzymatic detergent solution can effectively remove visible debris except for lubricants thus providing an acceptable alternative to manual cleaning Rinsing is necessary to remove all traces of detergent and extraneous debris Standard cleaning procedure These steps are common to all the cleaning procedures Step 1 Preparation at Point of Use The cleaning of
11. disinfection is the recommended decontamination procedure for semi critical devices Devices are classified semi critical when they touches mucous membranes or broken skin Examples of semi critical devices are flexible endoscopes laryngoscopes endotracheal tubes respiratory therapy and anesthesia equipment diaphragm fitting rings and other similar devices Preparing the disinfecting solution The recommended disinfection solutions are as follows e Sodium hypochlorite 0 5 5000 ppm prepared fresh for use within 24 hours e Sodium hypochlorite 1 10000 ppm prepared fresh for use within 30 days The first solution can be prepared by adding 1 part household bleach sodium hypochlorite 5 25 to 9 parts water The second solution can be prepared by adding 1 part household bleach to 4 parts water System maintenance Cleaning and disinfecting 59 B The turbine flowmeter Guidelines recommend that the turbine should be cleaned and disinfected prior to every test to ensure accurate measurements and to comply with recommended sanitation measures as follow Cleaning the turbine Follow the standard cleaning procedure reported above paying attention to the following 1 For rinsing do not use flowing water which may damage the turbine Rinse the turbine in a vessel filled of clean water shaking gently to remove the disinfectant Do not place the turbine under running water or move the turbine while submerged For cleaning and rinsing
12. enabled e Ifthe BTPS correction is applied e The flowmeter temperature 48 Pony FX Operation Options e Ifthe FVC encouragement is enabled EH Bronchoprovocation options Select the menu item 3 Options 3 FVC Post Cancel Confirm Salbutamol Metacholine o fo leo 140 300 600 1200 2400 You can set e Name measurement unit and quantity of the bronchodilator e Reversibility threshold for the airways obstruction as increment of the FEV1 e Name and measurement unit of the bronchoconstrictor e Protocol for the use of the bronchoconstrictor quantity to be delivered to the patient in the steps of the FVC Post test E Printout options Select the menu item 3 Options 4 Printout Cancel Confirm COSMED 37 Via dei Piani di Monte Savello 1 00040 Rome ITALY www cosmed it You can set e Ifthe unit prints the SVC and MVV tests the test quality controls the automatic interpretation and all the FVC trials e A page header for the printout E Advanced options Select the menu item 3 Options 5 Advanced Pony FX Operation Options 49 Cancel Confirm Turbine You can set e The flowmeter type turbine or pneumotachograph e The printer quality economy normal or high Note Printer quality affects battery autonomy e The operator s name e The mode of the spirometer ATS ERS Standard or Office Spirometer a simplified and less detailed version e Ifthe 3D style is e
13. 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 28 Installation Preparing Pony FX C How to contact COSMED You may contact the manufacturer directly at the following address for information COSMED S r l Via dei Piani di Monte Savello 37 00041 Pavona di Albano Rome ITALY Voice 39 06 931 5492 Fax 39 06 931 4580 email customersupport cosmed it Internet http www cosmed com Complaints feedback and suggestions If you have any complaints feedback or suggestions you may inform us at complain cosmed it Installation How to contact COSMED 29 Pony FX Operation Main functions of the Pony FX All the Pony FX s functions are controlled by means of the keyboard see the following picture abc def p 1 u SO E Y GL OK Da pars uv WXYZ E A onott X 0 6 E Turning on off the Pony FX on off In order to turn on or off the device hold the 9 key pressed for few seconds Pony FX has two automatic turning off functions e ofthe display 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 t
14. 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 accuracy of measurements we recommend you to disinfect the turbine periodically Use disposable anti bacterial filters or disinfect each part in contact with the patient before each test only Pony FX The pneumotacograph Pony FX Flowsafe is a disposable device In this case it is not necessary to use antibacterial filters 56 System maintenance System maintenance L Cleaning and disinfecting The goal of infection control is to prevent the transmission of infection to patients subjects and staff during pulmonary function testing Cleaning and disinfecting instructions should be strictly followed to control infections and assure the safety of the patient Aspiration of residue particles and or contaminated agents could be life threatening The recommendations in the following section are retrieved from Miller MR Crapo R Hankinson J et al General considerations for lung function testing Eur Respir J 2005 26 153 162 E Prevention of infection transmission Transmission to technicians Prevention of infection transmission to technicians exposed to contaminated spirometer surfaces can be accomplished through proper hand washing an
15. resistance in human J Appl Physiol 67 3 933 937 1989 Oximeter National Lung Health Education Program NLHEP Guide to prescribing Home Oxygen By Thomas L Petty ERJ 2004 23 932 646 ATS ERS Task force B R Celli W MacNee committee members Standard for the diagnosis and treatment of patients with COPD A summary of the ATS ERS position paper General ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi General considerations for lung function testing Eur Respir J 2005 26 153 161 ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Interpretative strategies for lung function test Eur Respir J 2005 26 720 735 74 Appendix References www cosmed com COSMED srl Via dei Piani di Monte Savello 37 Albano Laziale Rome 00041 ITALY 0 39 06 931 5492 F 39 06 931 4580 COSM ED info cosmed com The MetabolicCompany cosmed com
16. symbols 5S amp Cs To confirm the selected entry Functioning principles of the keyboard Hereunder are the rules that regulate the data entry e If pressing repeatedly the same button a sequence of letters figures and symbols will display in the screen The sequence will stop if leaving the button for more than one second or if pressing a different button The valid digit will be the last of the sequence and the cursor will right shift of one digit Small letters are put after the sequence of capital letters and before the number for example the key has in order the characters A B Ca bc 2 e g To enter Ba4 it will be necessary to press the following buttons abc abc abc abc abc abc ghi ghi ghi ghi ghi ghi ghi pause The order of the sequence of each single button is always letters and figures figure and symbols for the button e Pressing the Left key one or more times the cursor will move to left deleting one or more digits For the fields that must be mandatory filled in the left key allows to scroll the entry options from the list e Pressing the Right key one or more times the cursor will move to right adding blank spaces For the fields that must be mandatory filled in the right key allows to scroll the entry options from the list Pony FX Operation Main functions of the Pony FX 33 LI Calibration Please refer to the software manual for the set up and a calibration overview B Calib
17. the encouragement software tool may be useful when performing spirometry testing on children Note Cellular phones should be turned off prior to testing to eliminate potential interferences M Patient preparation Using the turbine Calibrate the turbine as indicated in the chapter Calibration ATS recommends a daily calibration Using the PNT Calibrate if needed the PNT as indicated in the chapter Calibration Connect the PNT to the unit through its pneumatic line Other operations Instruct the patient to apply the nose clips The use of antibacterial filters is strongly recommended 4 E 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 Pony FX Operation Performing the spirometric tests 37 2 Select the menu item 1 Test 1 FVC 3 Wait until the program is ready for the test 4 After having performed the test press 2 End 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 O Exit in order to abort the test and discard the results Press 1 Start in order to restart the test 6 Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Start 7 The three best tests will be displayed superimposed each to the other identified by different colours On t
18. the essential requirements of the Annex of the Medical Device Directive 93 42 EEC e are classified in Class Ila e their design manufacturing and final checks are performed according the Cosmed s Quality System conform to ISO 9001 2008 and IS013485 2003 Norms certified by CERMET certificates nr 387 A and 387 M e are CE marked according to the Medical Device Directive 93 42 EEC and certified by CERMET certificate nr MED 9811 The equipment conform with the following specifications Safety IEC 60601 1 EMC IEC 60601 1 2 Ce 0476 64 Appendix Declaration of conformity LI Service Warranty E Warranty and limitation of liability COSMED provides a one year limited warranty from the date of the original sale of the product COSMED products are guaranteed to be free from defect upon shipment Liability for products covered by this warranty is limited to the replacement repair or issuance of a credit for the cost of a defective product at the discretion of COSMED The following conditions must exist for the warranty to apply 1 COSMED is promptly notified in writing by the buyer upon the discovery of defect 2 The defective product is returned to COSMED with transportation charges prepaid by the buyer 3 The defective product is received by COSMED no later than four weeks after the last day of the one year warranty period 4 COSMED s examination of the defective product verifies that the defect was not caus
19. very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The device is suitable for use in all establishments including domestic CISPR 11 establishments and those directly connected to the public low voltage EEN Class A power supply network that supplies buildings used for domestic purposes Voltage Fluctuations Complies Flicker Emission IEC 61000 3 3 12 Getting started EMC Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Compliance level Electromagnetic environment guidance Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical transient burst IEC 61000 4 4 fast Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Test level IEC 60601 1 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines
20. 02383 01 05 1 Pony FX battery charger A 196 056 001 1 Thermal paper C00269 01 20 2 1D25mm Soft Mouthpiece C03750 01 10 1 MIP MEP pressure line C02672 01 94 Start up guide Pony FX Installation Before starting 25 _ Options Accessories The following options are available with the Pony FX system Code Quantity Description C02660 01 11 1 Oxymeter module Pony FX C02650 01 11 1 Rocc module Pony FX C00600 01 11 1 3 litres calibration syringe 26 Installation Options Accessories Preparing Pony FX EH Pony FX connectors 1 Pneumatic connector for pneumotachograph color coded This connector is available on Pony FX Flowsafe only 2 Pneumatic connector for pneumotachograph color coded or for MIP MEP pressure line Pony FX Flowsafe or Pony FX MIP MEP only Connector for the RS232 cable if the PC doesn t have an USB port or for the oxymeter option Connector for the airway resistance measurement module option USB connector for the PC USB connector for an external printer NONE e Battery charger connector E Replacement of the power plug If the power plug does not fit into the mains socket replace it with the one in the packaging In order to replace the plug 1 Extract the plug from the battery charger 2 Insert the proper plug in the battery charger E Battery charger Pony FX is powered by a battery pack rechargeable by means of a battery charger Connect
21. 1 2 Quality Assurance UNI EN ISO 9001 2008 Registration n 387 A Cermet UNI EN ISO 13485 2003 Registration n 387 M Cermet Medical Device Directive CE mark MDD 93 42 EEC Notified Body 0476 Class Ila Appendix Safety and conformity 69 Technical features Flowmeter Flow Range Volume Range Accuracy Resistance Mouthpieces Internal temperature sensor Dimensions Weight Supply Power supply AC DC Interface LCD In built printer Printer paper 70 Appendix Technical features Bidirectional digital turbine Pony FX Pony FX MIP MEP Bidirectional pneumotachograph Pony FX Flowsafe 0 16 I s Pony FX Pony FX MIP MEP 0 14 l s Pony FX Flowsafe 12 2 or 20 ml s lt 0 6 cmH20 I s 014 l s Pony FX Pony FX MIP MEP lt 1cmH20 I s O 14 I s Pony FX Flowsafe 31 and 922 mm Pony FX Pony FX MIP MEP 0 50 C 32 122 F 198 x 238 x 76 mm 1 2 kg 4 Ni Mh rechargeable batteries 1 3V 4500 mAh no memory effect old models till S N XXXXXX6999 Li lon rechargeable battery 7 4 Volts 2150 mAh no memory effect new models from S N XXXXXX7000 100 240 VAC in 12 Vdc 1A out class Il according to EN 60 601 1 standard RS232 USB A for the external printer USB B 320x240 STN colour backlighted Thermo sensitive 832 pixel per line 112 mm standard sensibility good stability image duration 12 years C Predicted values ERS93 Standardized Lung Function Te
22. 43 1215 1223 Message Criterion Start faster VEXT gt 5 of the FVC and gt 150ml Blast out harder PEFT gt 120 msec Avoid coughing 50 drop in the flow in first second Blow out longer FET100 lt 6 sec Blow out more air Flow gt 0 21 s within 20 ml of FVC 72 Appendix Predicted values Blow out harder Take a deeper breath Blow out faster That was a good test FVC reproducible FEV1 reproducible PEF reproducible MVV time too short 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 Diff 2 max FEV1 within 0 2 Diff 2 max PEF within 10 MVV time less than 12 sec Appendix Predicted values 73 References Spirometry ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Standardisation of spirometry Eur Respir J 2005 26 319 338 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 Resistance P J Chowienczyk C P Lawson S lane R Johnson N Wilson M Silverman G M Cochrane A flow interruption device for measurement of airway resistance European Respiratory Journal 1991 4 623 626 G Liistro D Stanescu D Rodenstein C Veriter Reassesment of interrupter technique for measuring flow
23. E tase cous oe EO LTD A ine 41 Mi Pertormihe the test assa a E GRE Lara 41 Performing the airway resistance measurement test option ccccssssssscccccccessssssscceececeesssssncceeeecessesssssseeeeeess 43 EH Warnings for airway resistance measurement tests uuuuu0n0n000n0nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 43 B Patient preparation o rauen innen 43 I Performing th Test eicere terere eee EEEE enna aaa NA Aa RA ei Pa sue lana 44 El Viewing and editing results iio 45 M View atestIh alchiVe scc tdci 45 L Edita diagnosis ii 45 M Delete a testis ps as A A A tdos 45 El Printing results ui 46 B R place the printer pa3pD6Ol a ironia ar Sissi a iso alari 46 Wi Printing tests by means of the internal printer 000000000000 00000 n nn nn nnnnn nam nn nn nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannn 47 E Printing tests by means of an external printer ssseeeeoe ooo anna nun nun nnnn nn nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannn 47 Doi ET iii a 48 E General Settings Zwana na ID UI 48 B Spirometry Opt 48 m Bro ch provocation oplUon s s CETTE CEDE 49 B PRINTOUT OPTIONS sisissssccsscdsssssiveccwssscosssesvscseasons EPEE 49 E Advanced options RA eee ew ee RAR 49 M Environmental data Rana 50 B Oxymetry options es en R XY 12 RATE GG cava YR RATE 0a 3E TR CE Vasa e 50 B Rog Options isbn 51 E Otherfunctions ofPonyFX assa
24. a is held by Cosmed Srl Via dei Piani di Monte Savello 37 Pavona di Albano Laziale RM E Customer rights In accordance with Art 7 you may a Obtain confirmation of the existence and sharing of your personal data b Obtain information on the e updating correction or integration of your data e deletion or transformation of your personal data c Deny your consent to treatment of your personal data These rights can be exercised by a request in writing to the holder responsible for your personal data Appendix Privacy Information 67 LI Disposing of electrical equipment The device cannot be disposed as unsorted municipal waste Electronic equipment must be collected separately according to the European Directive 2002 96 EEC Otherwise it can cause dangerous consequences for the environment and human health The crossed out wheeled bin means that the product must be taken to a separate collection when you wish to dispose of it 68 Appendix Disposing of electrical equipment Safety and conformity Safety IEC 60601 1 EN 60601 1 The complete classification of the device is as follows e Internally powered equipment type BF device used stand alone class Il type BF device used connected to mains e Protection against water penetration IP41 e Non sterile device e Device not suitable in the presence of flammable anaesthetics e Continuous functioning equipment EMC The system meets the Standard IEC 60601
25. an Review of Respiratory Disease Volume 99 1969 Vincken W Ghezzo H amp Cosio MG 1987 Maximal static respiratory pressures in adults normal values and their relationship to determinants of respiratory function Bull Eur Physiopathol Resp 23 435 439 E 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 may be physiological Pred FEV1 gt 100 Obstructive abnormality mild Pred FEV1 lt 100 and gt 70 Obstructive abnormality moderate Pred FEV1 lt 70 and gt 60 Obstructive abnormality moderately severe Pred FEV1 lt 60 and gt 50 Obstructive abnormality severe Pred FEV1 lt 50 and gt 34 Obstructive abnormality very severe 96 Pred FEV1 lt 34 Restrictive abnormality mild FVC lt LLN and Pred FVC gt 70 Restrictive abnormality moderate Pred FVC lt 70 and gt 60 Restrictive abnormality moderately severe 96 Pred FVC lt 60 and gt 50 Restrictive abnormality severe Pred FVC lt 50 and gt 34 Restrictive abnormality very severe 96 Pred FVC lt 34 B Quality Control Messages Reference Spirometry in the Lung Health Study Methods and Quality Control ARRD 1991 1
26. ance information form You should save the original packaging in case the need to ship the unit to a technical assistance centre should arise 66 Appendix Service Warranty Privacy Information Dear Customer We would like to inform you that your personal data is 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 acknowledge how your personal data is handled E Personal data treatment and purposes We request and process your personal data for the following purposes a To place an order register a product request a service answer a survey enter a contest allow communication with us and to supply necessary authorities with the required information b To define your commercial profile c To use your commercial profile for marketing or advertising purposes d For necessary accounting procedures such as emailing commercial invoices e To provide information to the selected business partners needed to supply your service E How your personal data is treated Your personal data will be stored in an electronic format and protected against destruction loss unauthorized access or use not conforming to the purposes listed above E Consent The consent to treat your personal data is optional but if denied COSMED cannot supply the appropriate services E Holder of the personal data Personal dat
27. d to the device must be compliant with EN 60601 1 by means of an isolation transformer 11 Precautions regarding EMC should be taken prior to installation and can be noted in the section EMC 12 Portable and mobile RF communication equipment may interfere with the performance of the device 13 Only the cable and accessories supplied with the equipment should be used with the device The use of accessories and or cables other than those supplied may result in increased emissions or decreased immunity of the equipment 14 The device should not be used adjacent to or stacked with other equipment If this is necessary you must verify that the device continues to operate normally in the configuration in which it will be used 15 Disconnect the battery charger from the wall socket in order to disconnect the device from the mains 16 The graphical symbols used with the device are described below Applied part type B EN60601 1 Applied part type BF EN60601 1 OFF ON Protective earth ground 0 O gt Alternating current Getting started Important notices 9 C Contraindications Performing forced expiratory manoeuvres involved in spirometry testing may be contraindicated in certain conditions B Contraindications for the spirometry testing Absolute contraindications For FVC VC and MVV tests e Post operative thoracic surgery patients For FVC tests e Severe instability of the airways patients with severe Emphyse
28. d use of barrier devices such as suitable gloves To avoid technician exposure and cross contamination hands should be washed immediately after direct handling of mouthpieces tubing breathing valves or interior spirometer surfaces Gloves should be worn when handling potentially contaminated equipment if the technician has any open cuts or sores on his her hands Hands should always be washed between patients Cross contamination To avoid cross contamination reusable mouthpieces breathing tubes valves and manifolds should be disinfected regularly Mouthpieces nose clips and any other equipment that comes into direct contact with mucosal surfaces should be disinfected or if disposable discarded after each use Only the portion of the circuit through which rebreathing occurs must be decontaminated between patients or if disposable discarded after each use Disposable sensors when appropriately used avoid the need for decontamination of sensors and mouthpieces Tuberculosis In settings where tubercolosis or other diseases that are spread by droplet nuclei are likely to be encountered proper attention to environmental engineering controls such as ventilation air filtration or ultraviolet decontamination of air should be used to prevent disease transmission Haemoptysis and oral lesions Special precautions should be taken when testing patients with haemoptysis open sores on the oral mucosa or bleeding gums Tubing and breathing
29. distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Getting started EMC 15 Overview of the manual This manual is organized in the following chapters Getting started Describes the intended use of the device how to properly use it and features of the unit and accessories Installation Lists the steps required to properly install the device Pony FX Operation illustrates the functions of the device including managing data and test performance System maintenance Describes system maintenance procedures Appendix Contains information regarding the warranty treatment of personal data reference standards technical features predicted values and bibliographic references Software and test execution are described in the Software Manual We recommend to read both manuals before using this device 16 Getting started Overview of the manual L Introduction 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 tes
30. e 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 38 Pony FX Operation Performing the spirometric tests B 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 Options menu see later in this document Bronchodilators test The manoeuvre is identical to the FVC test 1 2 3 Select the menu item 1 Test 2 FVC Post BD Wait until the program is ready for the test After having performed the test press 2 End 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 4 Press O Exit in order to abort the test and discard the results Press 1 Start in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Start 6 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 i
31. ecautions and instructions described in this manual B Warnings The device program algorithms and presentation of the measured data has been developed in accordance with the specifications outlined by the ATS American Thoracic Society and ERS European Respiratory Society Additional international references have also been applied where applicable All bibliography references are reported in the Appendix This User Manual has been developed in accordance with the Class Ila European Medical Device Directive requirements The precautions listed below should be noted before operating the device to ensure the safety of the user 1 This User Manual should always be available as a reference when testing 2 The following standards should be applied to ensure the accuracy of individual test results e Accessories should only be used as described in this manual The manufacturer does not warranty any non authorized accessories used by the end user The manufacturer may offer suggestions while using such accessories and the complications they could cause e Repairs or modifications of the device should ONLY be carried out by qualified and trained personnel e Environmental and electrical conditions in which the device operates should be in compliance with the specifications of this manual 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 c
32. ed by misuse neglect improper installation or an unauthorized repair or alteration If the product is manufactured by a third party the warranties provided by the third party manufacturer will be the only ones available for the buyer COSMED hereby disclaims any warranties or liabilities arising from defects or damages to and or caused by products manufactured by a third party The buyer must obtain written authorization from COSMED prior to the repair or alteration of any COSMED products Failure to obtain a written authorization will result in a void of the warranty The limited warranty shall not be enlarged diminished or modified by the renderings of technical service from COSMED s agents or employees when the product is ordered or following the use of the product s E Return goods policy for warranty or non warranty repair Products shipped to COSMED for repair are subject to the following conditions 1 Products may only be returned upon receiving a receipt which includes the Service Return Number SRN from COSMED S r l 2 The SRN report and packing list should be placed on the outside of the package 3 Returned goods must be shipped with freight and insurance charges prepaid Collect shipments will not be accepted 4 The following list of products is not eligible for return unless proven defective Special order items Expendable products Products held over 30 days after the COSMED invoice date Used products not in t
33. ence 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 requested The year must be four digit format X Cancel with confirm with E Search a patient in archive In order to search a patient stored in the archive select the menu item 2 View Search It will open a window with the patient list Erase Cancel Confirm Bond James Test Test Scroll the list by means of the arrows and confirm the selected patient with the key X If necessary cancel the operation with the key Pony FX Operation Patient database management 35 EM Erase a patient in archive OK Select the patient to be deleted and erase it by pressing 1 Erase Press to confirm 36 Pony FX Operation Patient database management L Performing the spirometric tests Note Read carefully the contraindications in Chapter 1 For a complete description of the tests and of the measured parameters see the chapter Spirometry E Warnings for spirometry tests 1 2 3 The name shown on the display must correspond to the patient carrying out the test If you are using the pneumotachograph do not breathe into the flowmeter until the proper message appears If you are using the turbine either a paper mouthpiece or an antibacterial filter should be connected to the flowmeter prior to executing the tests Implementing
34. g airway resistance testing include Symbol UM Parameter Ro kPa l s _ Expiratory resistance Goc ex I s kPa Expiratory conductance are in kPa l s Inspiratory resistance Goce in I s kPa Inspiratory conductance EM Warnings for airway resistance measurement tests 1 This test must be performed with the Rocc module connected to the Turb RAW port of the unit 2 The Rocc should be assembled as shown in the following picture 3 1 Occlusion valve 2 Reader 3 PNT 3 The name shown on the display must correspond to the patient carrying out the test Note Cellular phones should be turned off to eliminate potential electrical interferences B Patient preparation Prior to testing the Rocc should be calibrated as described in the chapter Calibration Ask the patient to apply the nose clips The use of antibacterial filters is strongly recommended Pony FX Operation Performing the airway resistance measurement test option 43 4 E Performing the test Select 1 Test 7 Rocc Pre or 1 Test 8 Rocc Post for tests after assumption of a bronchoprovocator Wait the end of the calibration Let the patient to breathe inside the module gt 207 en If manual occlusion was selected through the Option menu press 1 Manual each time you desire to activate an occlusion 5 After each occlusion you are asked if accept or discard the result 6 End the test pressing the key X 7 Pressthe ke
35. he 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 inappropriate use of the device M Repair Service Policy Goods returned to seller for non warranty repair will be subject to conditions 1 2 3 4 Returned goods requiring customs documents Pro forma Invoice and Customs Paper should comply with the Italian law e The shipment must qualify as a temporary export e Any goods returned to COSMED without customs papers will not be accepted For European Community members The Pro Forma invoice should include the following e Number Appendix Service Warranty 65 e Description of the product e Quantity e Serial Number e Value in e Number of parcel e Gross weight e Net weight e Reason for repair If repairs are needed you may contact COSMED at the one of the following addresses COSMED S r l Via dei Piani di Monte Savello 37 P O Box 3 00041 Pavona di Albano Rome Italy tel 39 06 9315492 fax 39 06 9314580 E mail customersupport cosmed it USA contact COSMED USA Inc 2211 North Elston Suite 305 Chicago IL 60614 USA Phone 1 773 645 8113 Fax 1 773 645 8116 email usa sales cosmed it To ensure that you receive efficient technical service please specify the nature of the problem as indicated on the assist
36. he picture by side 2 Connect the module to the Pony FX unit through the Turb Raw connector E Connect the oxymeter option to the Pony FX It is connected to the unit through the RS232 SpO connector E Connect the Pony FX to the PC 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 a If the PC does not have an USB port it is possible to use a RS232 serial connection Select the communication port both on the PC selecting the menu item Options Configure and on the unit selecting the menu item 3 Options 1 Settings 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 B 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
37. he 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 To enable the encouragement function select 3 Options 2 Spirometry and perform the FVC test as explained above B Slow Vital Capacity 1 Explain the manoeuvre to the patient breathe at rest for some time perform a maximal inspiration then a slow forced exhalation and finally a deep inspiration 2 Select the menu item 1 Test 4 SVC 3 Wait until the program is ready for the test 4 After having performed the test press 2 End 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 5 Press 0 Exit in order to abort the test and discard the results Press 1 Start in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Start 7 The three be
38. in the corresponding section Step 5 Cleaning Protective attire is required for personnel handling contaminated items Manual cleaning must be done in a manner that protects personnel handling the devices from aerosolization and splashing of infectious material 1 Manual cleaning of the items should be done under 22 43 C water Use a neutral pH 7 mild detergent Water hardness temperature and the type of soil affect the effectiveness of the detergents the detergent manufacturer s instructions should be consulted Use a small soft brush to scrub all parts Abrasive cleaning compounds and implements can damage the items and should not be used Additional cleaning supplies may be required to clean stubborn stains or hard to reach areas 2 Items must be thoroughly rinsed with clean water to remove the detergent residuals and debris from the components Use a flowing triple rinse cycle at a minimum with tap water Please note that rinse with flowing water is not possible on the turbine 3 Dry all components thoroughly using soft clean clothes or disposable paper towels B Disinfection The recommendations in this sections have been retrieved from William A Rutala Ph D M P H David J Weber M D M P H and the Healthcare Infection Control Practices Advisory Committee HICPAC Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 http www cdc gov hicpac pdf guidelines Disinfection Nov 2008 pdf High level
39. ioning principles of the keyboard nen 33 A A P 34 Ma ill Risa arr 34 E Roce calibrati assess da nai a dones catenters 34 Patient databasemanagementi ias 35 m Create a new patients assise 35 Ml Searchia patient in archives nee EARS tere MT Eth Ri 35 M Eraseapatient in archive acier nni lana RR ERN RAS 36 Performing th spirometrie t sSts issii IRA III WEEK Denia 37 E Wamlings for spIFOmeblViteste iia 37 M Patient preparatio TEILT 37 Using the t rblhe asini illa soe oui i eui nc alitalia 37 Using the PNT entri 37 Other ioperationS s c POP 37 M Forced Vital Capacity DI cadi aan ve dap raced even dasa ede needs E MINIM MINIME 37 TESE ENCOULAEEMENT aaa RE RUAS AREA ii ER 38 B Slow Vital Capacity eio teer ad pls VE YE team naaa is 38 M Maximum Voluntary VentilatioN sisi 38 B Bronchial Provocation Test ua 39 Bronchodilators test uicit cese os mornas R NO TRZA I 39 BrOnchocanstrictorteSt dt 39 Performing the oximetry test option sssscccssssseessssseesssssecesssssesessssceeessseecessccceeeseseecsseseeecaseceaeeeseceeeeassceeeeans 40 Mi Warnings for oxymet rV tests caio acilia ren 40 M Patient preparatio o iii OI EE VENS FEX V FEE FOSY AES CALA LIDA SEA KEVFAS iia 40 B Performingthetestsaar a O 40 Performing the MIP MEP test option easy cyc A rice kic eic eri i 41 M Patient preparation od
40. ipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 P d 1 17 P 80 MHz to 800 MHz Conducted RF 3 Veff 3V d 2 334 P 800 MHz to 2 5 GHz IEC 61000 4 6 150 kHz to where P is the maximum output power rating of the 80 MHz transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Radiated RF 3 V m 3 V m Field strengths from fixed RF transmitters as IEC 61000 4 3 80 MHz to determined by an electromagnetic site survey 2 5 GHz should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol te Notes 1 At 80 MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field st
41. le alain 52 BM Calibration iiie 0 iii 52 Mi Control Daemon A cir rat 52 MECO contrastadas 52 M Papertedo cortas A eee 53 MISSIS iaa AAA LEA AA AAA cia 53 Mal cla AAPP A vias svvssniendesined OEN KENEEN AWAY ABIT WA 53 B Firmware version Information 4 2 lt ic0icssisesavescceesinssveesnanscssisssaincdvensiesdsvssesecaceiicassssabuntascsdesieesdbeateasdbesveassbeaveccd useass 53 3 Systemimaintenance i uaar ire 56 El Cleaning ad dit arance 57 M Prevention of infection transmisslOh ainsi Aaa A DGA KEG FE Va 9n S89 E AGA iena b eon E a Vosa dice 57 Transmission to technicians 5 5 ccr iin euet AWA Fio ERR RARE SEEN FERANT RE ERE dA WAWA PAGE AAAA andei aca 57 CROSS CONTAMINATION ee ERR 57 WUBOERCUlOSIS c M 57 Haemoptysis and oral lesions elena ii 57 Other known transmissible infectious diseases eene eene enemies nennen 57 Disposabie in line filters aiar 57 M Other precautions and Warnings o tro En ero eas es eo ra ER Ere rp eve I AIR rane tane 57 B Introduction ssa a to LE WWS eR EE GE EE ER WRAK CF Lud ER SE ER GENE EE EE IERI KENNEN S RAR 58 GIG ANNE Me M PN Pe 58 Cleaning Agents SUpplle8 4essi cotes RE erae eor andre nero rtg ba FEE RE estas eae Persea ener eH 58 Standard Fel T To T Me de orzo P eA 59 iecit NO 59 O O Preparing the disinfecting SOIUtIon
42. ma e Bronchial non specific marked hypersensitivity e Severe gas exchange impairment total or partial respiratory insufficiency Relative contraindications For FVC tests e Spontaneous post pneumothorax e Arterial venous aneurysm e Severe arterial hypertension e Pregnant with complications in the 3 month For MVV tests e Hyperventilation syndrome E Contraindications for Bronchial Provocation testing Bronchial Provocation testing must be executed under the direction of a physician Testing is considered safe when executed properly in a clinical setting but the following contraindications should be acknowledged prior to testing Absolute contraindications e Severe bronchial obstruction decreased FEV in adults e Recent myocardium infarct e Recent cerebral vascular accident e Known arterial aneurysm e Incapacity for understanding the provocation test procedures and its implications Relative contraindications e Bronchial obstruction caused by performing respiratory manoeuvres e Moderate or serious bronchial obstruction FEV lt 1 51 in men and FEV lt 1 21 in women e Recent respiratory infection e Recent Asthma exacerbation e Hypertension e Pregnancy e Epilepsy 10 Getting started Contraindications _ Environmental condition of use COSMED units should not be operated near explosive substances Equipment should not be installed near electrical or magnetic devices such as x ray equipment
43. n 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 O Exit without saving in order to exit the test mode without saving the tests Bronchoconstrictor test The manoeuvre is identical to the FVC test 1 2 Select the menu item 1 Test 3 FVC Post BC A window with bronchoconstrictor name quantity and measurement unit as set in 3 Options 3 FVC Post will be displayed If you accept the protocol confirm otherwise modify the values and confirm 4 Wait until the program is ready for the test After having performed the test press 2 End 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 6 Press O Exit in order to abort the test and discard the results Press 1 Start in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Start 8 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 asked to select the test to store press the digit corresponding to the test to be
44. nabled e The date format mm dd yyyy or dd mm yyyy e Ifthe last calibration date is printed E Environmental data Select the menu item 3 Options 6 Environment Cancel Confirm You can set e Pressure e Relative humidity E Oxymetry options Select the menu item 3 Options 7 SPO2 50 Pony FX Operation Options Cancel Confirm You can set e Lower limits for SpO at rest and during exercise with or without oxygen supplement e The O supplement type E Rocc options Select the menu item 3 Options 8 Rocc Cancel Confirm Random Expiratory 500 15 30 hh E YES e Random or manual occlusions You can set e Occlusion activated on the inspiration or expiration e Value of the flow at which the occlusion is activated e Parameters for the back extrapolation algorithm tO t1 and t2 e Use of COSMED antibacterial filter Pony FX Operation Options 51 _ 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 4 Utilities menu B 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 4 Utilities 1 Turbine Calibration or 4 Utilities 2 Rocc Calibration For further details see the chapter Calibration E Control panel The control panel allows to monitor the de
45. ndications for Bronchial Provocation testing sssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssees 10 Absolute contraindicada lada 10 Relative contraindications REED ER 10 E Environmental condition Of use nen ee 11 El JEMC m 12 El Overview of the marnial 2 2 run ea Pre teo len tere Ple tiva ins Ei vE EY et e 16 EJ Introduction ici EUER ala RARA CIS UA TESI es DI DES grab conie IRANIANA Tia na Tata DET nao 17 El PonyEXOoVervieW t O Tia NES das Ded 18 B Pony FXUNit ass sos nt asar aran 18 The displasia 18 The keyboard ecc iia 18 The print iii 19 THE CONNECTORS ii n 19 M Batterv chaig et aclei rent 19 M Theflowmeter ceo ooo uou ue eonun tacui oou tania 19 Turbine flowmeter Pony FX Pony FX MIP MEP 0NlY nennen nennen nnns nnns 19 Pneumotach PNT Pony FX Flowsafe ONIY iii 20 EH MIP MEP pressure line Pony FX MIP MEP only eee ee eene eene nnne enn nuns ee zine assesses ean 20 B Papermouthpleces oper nero iaa e d en FR teas veh an ine lai 20 B Antibacterialfilteis dawca dia eae Pe dba Sen Re sae Pra da d Se Ley Co ada p SERERE ERR REED R GAGA Wd ROA aAa RAS 21 M Nose Clips RAT WO nd O O rale 21 M 1 11 3 711 11 12 1 ZBPPEBERRERPREERFEFSEREFFERFRPEFERERFEEEREEFPEREREESEEREREEFEENREEERLENEREEREEREREESEEREREEFREBEREFEEEREREUEEEREREREEERERETEREEERLEERPEEFEREEPEEEERERER 21 M The RgcePN zawsz
46. ng exercise Getting started Pony FX overview 21 B The Rocc PNT The Roc PNT allows the measurement of airway resistance by implementing the interruption technique 22 Getting started Pony FX overview Installation Before starting Before operating the Pony FX you should inspect the equipment and complete the product registration B Checking the packing contents When opening your product you should assure that the package contains all items listed below If there are any missing or damaged parts you should contact Cosmed s technical assistance B Device packaging Pony FX standard packaging Code Quantity Description C01788 01 36 1 PC Software C00214 01 20 1 Paediatric mouthpiece adapter Pony FX Flowsafe standard packaging Code Quantity Description C01788 01 36 1 PC Software A 362 315 001 1 USB cable C02383 01 05 1 Pony FX battery charger A 196 056 001 1 Thermal paper C02672 01 94 1 Start up guide Pony FX Pony FX MIP MEP standard packaging Code Quantity Description C00962 03 04 1 Pony FX MIP MEP Unit 24 Installation Before starting C02235 01 05 1 Turbine C02364 01 05 1 Reader A 201 500 021 1 Carrying case A 662 100 001 2 Nose clips C01788 02 36 PC Software C00137 01 20 20 Paediatric paper mouthpieces C00136 01 20 20 Adult paper mouthpieces C00063 01 20 Conic mouthpiece C00214 01 20 Paediatric mouthpiece adapter A 362 315 001 USB cable A 182 300 004 Bacterial filter C
47. ny FX overview 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 Pony FX Operation The connectors On the bottom side of the device there are some connectors described in the chapter nstallation E EPI Bo Y Some connectors can be closed depending on the Pony FX configuration M Battery charger Pony FX is powered by a battery pack rechargeable by means of a battery charger Connect the battery charger to the Pony FX unit through the connector with the symbol A more detailed description of the battery charger see the chapter Pony FX Operation E The flowmeter Turbine flowmeter Pony FX Pony FX MIP MEP only The turbine flowmeter is made of a handle the reader with a hole in which it is placed the turbine N CIA 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 Every interruption represents 1 4 turn of the rotor this allows to measure the number of turn in the time For hygienic reasons we strongly recommend the use of a bacterial filter to be connected as in the picture by side reader Note While inserting the turbine be sure to push the turbine up to touch the end of the Getting started Po
48. ny FX overview 19 Pneumotach PNT Pony FX Flowsafe only The PNT flow measurements are obtained by measuring the pressure differential between the two sides of a polyester net The device may be used to measure a wide flow range and is not affected by ambient conditions pressure humidity room temperature exhaled gas composition Daily calibration of the PNT is not necessary but calibrations should be performed regularly to assure accurate measurements The PNT should be used for spirometry testing only B MIP MEP pressure line Pony FX MIP MEP only The MIP MEP pressure line allows the user to perform MIP MEP tests E Paper mouthpieces Paper mouthpieces are available for basic spirometry tests FVC VC and MVV The mouthpieces should not be used for any other testing 20 Getting started Pony FX overview B Antibacterial filters di The use of antibacterial filters is recommended for infection control However regular cleaning and decontamination of lung function equipment should always be performed Note The use of antibacterial filters is recommended even when using disposable mouthpieces to prevent cross contamination E Nose clips o Nose clips should be used during spirometry testing to prevent respiration through the nasal passage while performing testing manoeuvres B The oximeter The oximeter probe should be placed on the patient s finger to measure oxygen saturation at rest or duri
49. o turn on on off the device press the 9 key Note Attention If the battery is very very low for example if the unit has been not used for a long time let the unit charge for some minutes without turning on it Otherwise acoustic signals and display flashes can occur To stop this sequence press the key 3 and wait some minutes before turning on the unit again E Menus Menus are displayed in the screen or in some cases in the top part of it How to enter the menus There are two ways to access the menus e Press the button number that corresponds to the menu entry to activate e Select with the up and down keys the menu option that you want to activate and press OK The methods are interchangeable E Keyboard Hereunder is a brief description of the functionality of each single button of the keyboard Button Description Di Turn on off button Px Navigator tool to scroll up a menu and or get back to the previous field when entering data Navigator tool to scroll down a menu and or pass to the next field when entering data 32 Pony FX Operation Main functions of the Pony FX Navigator tool to move right through the menu To space right when entering data and or to select an entry in case of multi options fields Navigator tool to move left through the menu To cancel the last digit when entering the data and or to select an entry in case of multi options fields 1 To enter the number 1 or one of the
50. onnected to earth ground Attempting to defeat the proper connection of the ground wire is dangerous for users and equipment e Equipment maintenance inspections disinfection and cleaning should be as described in this manual 3 Before powering on the system the power cords and plugs should be inspected Damaged electrical parts must be replaced immediately by authorized personnel 4 Residue and other contaminants in the breathing circuit pose a safety risk to the patient during testing procedures Aspiration of contaminants can be potentially life threatening If the recommended disposable anti bacterial filters are not used you must disinfect each part coming into contact with the patient and patient s breath prior to each test 5 The cleaning procedures and inspections in the System Maintenance section should be performed prior to each test 6 This device should not be used in the presence of flammable anaesthetics This is not an AP or APG device according to the EN 60 601 1 definitions 7 The device should not come near any heat or flame sources flammable or inflammable liquids or gases and explosive properties 8 The device should not be used in conjunction with any other medical device unless that device is recommended by the manufacturer 9 The device should be used with a computer with electromagnetic compatibility CE marking and low radiation emission displays 8 Getting started Important notices 10 The PC connecte
51. part of the test the HR and SpO values together with a plethysmographic graph are displayed The graph monitors the quality of the signal 3 Wait for an acceptable quality of the real time trace and verify that the Perfusion indicator is green Press e 1 Restto store the rest value e 2 RestO2 to store the rest value with inspired oxygen supplement e S Exer to store the exercise value e 4 ExerO2 to store the exercise value with inspired oxygen supplement It is not necessary to store all the values during a single test 40 Pony FX Operation Performing the oximetry test option Performing the MIP MEP test option The MIP MEP test measures the patient s maximal inspiratory expiratory pressure You should instruct the patient to begin by breathing normally perform a maximal expiration inspiration and then inhale exhale maximally against a closed valve The test can be performed on the Pony FX unit only it isn t possible to perform the test through the PC software and or download it on the PC The parameters measured during MIP MEP testing include Symbol UM Parameter MIP cmH 0 Maximum inspiratory pressure MEP cm H O Maximum expiratory pressure B Patient preparation Connect the soft mouthpiece the antibacterial filter and the MIP MEP pressure line as shown in the following picture Connect the MIP MEP pressure line to the proper connector on the rear side of the Pony FX unit Ask the patient to appl
52. ps in the reprocessing of any reusable medical device Without thorough cleaning and rinsing it might not be possible to achieve high level disinfection or sterilization of the device The purpose of cleaning and rinsing is to remove all adherent visible soil to reduce the number of particulates and microorganisms and to reduce the amount of pyrogenic and antigenic material Any organic material lubricants or residual cleaning agents remaining on a device can inactivate liquid chemical disinfectants sterilants as well as protect microorganisms from destruction The second step in decontamination is the microbicidal process which is defined as a process to provide a particular level of microbial lethality kill COSMED components are classified as semi critical items which are devices that come into contact with intact mucous membranes Semi critical devices at a minimum require a high level disinfection procedure Sterilization is not absolutely essential COSMED components require complete or partial disassembly for cleaning and disinfection It is the responsibility of the user health care personnel for ensuring that the cleaning methods recommended can be duplicated in their environment that appropriate tools and replacement parts are available and that instructions are followed correctly B Cleaning Note Please refer to additional specific cleaning instructions for the turbine assembly below Cleaning Agents supplies Mild
53. rating the flowmeter In order to calibrate the flowmeter by means of the Pony FX unit 1 Connect the flowmeter turbine or pneumotachograph to the calibration syringe 2 Select the menu item 4 Utilities 1 Turbine Calibration Date and results of the last calibration will be displayed Press 1 Default to enter the default values 2 Calibration to start a new calibration 3 Modify to edit the displayed values O Exit to exit 3 Move the piston in and out for 10 strokes IN and EX B Rocc calibration In order to calibrate the Rocc pnt by means of the Pony FX unit 1 Connect the pnt to the calibration syringe 2 Select the menu item 4 Utilities 2 Rocc Calibration Date and results of the last calibration will be displayed Press 1 Default to enter the default values 2 Calibration to start a new calibration 3 Modify to edit the displayed values O Exit to exit 3 Move the piston in and out for 10 strokes IN and EX Since ventilation is very low during Rocc manoeuvres normally lt 10 litres min the turbine calibration should be performed with very slow manoeuvres each manoeuvre lasting between 10 15 seconds 34 Pony FX Operation Calibration Patient database management M Create a new patient In order to create a new patient select the menu item 1 New and enter the required data Cancel Confirm 00001 In the following you will find some useful notes for proper data entry e ID isan alphanumeric sequ
54. rength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 14 Getting started EMC Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17 NP d 1 17 NP d 2 33 VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Notes 1 At 80 MHz and 800 MHz the separation
55. reusable items begins soon after use At the point of use personnel wearing gloves and other protective attire separate disposable items or components from reusable items and discard them in appropriate receptacles Soil is wiped from device surfaces with a moist sponge or towel The soiled contaminated items are then contained in a manner that will reduce the risk of personal exposure to pathogens Items are usually placed in a basket tray or rigid container for transportation to the processing area usually transported in or on a cart as hand carrying of soiled items is discouraged Step 2 Inspection Inspect the items for damage at all stages of handling If damage is detected on any of the components it should be identified and documented Complete the disinfection sterilization process and contact technical service for replacement Step 3 Presoak Protective attire is required of personnel handling contaminated items At the processing area soak or rinse the items in tap water 22 43 C Please note that rinse with flowing water is not possible on the turbine If an enzyme product is required soak for one to two minutes Remove and examine extend the soak time for components with dried on matter prolonged soaking of components may be detrimental causing damage to the component surfaces Refer to the detergent instructions for its usage and soak time Step 4 Disassembly Disassemble the item if necessary according to the instructions reported
56. ry Flow Volume curve Knudson et al ARRD Vol 123 p 659 664 1981 Spirometric Standard for healthy non smoking adults ARRD Vol 10 3 p 57 67 1971 Pereira Brazil Pereira CAC Barreto SP Sim es JG Pereira FWL Gerstler JG Nakatani J Valores de Refer ncia para Espirometria em uma amostra da popula o brasileira adulta Jornal de Pneumologia 1992 18 10 22 Mallozi MC Valores de refer ncia para espirometria em crian as e adolescentes calculados a partir de uma amostra da cidade de S o Paulo Valores finais publicados em Pereira CAC Lemle A Algranti E Jansen JM Valen a LM Nery LE Mallozi M Gerbasi M Dias RM Zim W Consenso Brasileiro sobre Espirometria Jornal de Pneumologia 1996 22 105 164 Scalambrini Costa F Scueiri CEB Silva Jr WC Pereira CAC Nakatani J Valores de refer ncia para espirometria em uma amostra da popula o brasileira adulta da ra a negra J Pneumologia 1996 22 165 170 Neder JA Andreoni S Castelo Filho A Nery LE Reference values for lung function tests Static Volumes Brazilian Journal Medical and Biological Research 1999 32 703 17 Neder JA Andreoni S Lerario MC Nery LE Reference values for lung function tests Il Maximal respiratory pressures and voluntary ventilation Braz J Med Biol Res 1999 32 719 27 Thai Wanchai Dejsomritrutai Khun Nanta Maranetra Kittipong Maneechotesuwan Nitipatana Chierakul Jamsk Tscheikuna Tasneeya Suthamsmai Arth Nana Benjamas Chuaychoo
57. st 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 E Maximum Voluntary Ventilation ro AUTE RO MZ a Explain the manoeuvre to the patient breathe as deep and fast as possible for about 12 seconds Select the menu item 1 Test 5 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 O Exit in order to abort the test and discard the results Press 1 Start in order to restart the test Repeat the test until it is correctly performed ATS recommends 3 times by pressing 1 Start 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 b
58. sting Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March 1993 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 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 ITS Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 LAM 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 Multic ntrico de Barcelona 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 Nhanes III 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 Pneumobil Brazil Valores extraidos do Programa Pneumobil Brasil para a Tese de Doutoramento do Dr Carlos Alberto de Castro Pereira Boehringer Gutierrez Chile Gutierrez et Al Reference values for Chile population Knudson Morris and Bass The maximal Expirato
59. stored 10 Otherwise press O Exit without saving in order to exit the test mode without saving the tests 11 Repeat all the FVC Post until the FEV1 falls down by more than 20 of the FVC Pre value Pony FX Operation Performing the spirometric tests 39 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 Parameter Haemoglobin saturation bpm Heart rate E Warnings for oxymetry tests The oximeter probe should be connected to RS232 SpO port of the unit The name shown on the display must correspond to the patient carrying out the test Be sure that the sensor has been properly disinfected Use only the original COSMED sensor U 09 IE Operation and accuracy of the measurement may be affected by the following e high ambient light e fingernail polish or artificial fingernail e excessive motion Note Cellular phones should be turned off to eliminate potential electrical interferences B Patient preparation Connect the sensor to the Pony FX unit through the RS232 SpO port Connect the probe to patient s index finger and affix with adhesive tape if necessary E Performing the test 1 Select the menu item 1 Test 6 SpO2 2 In the first
60. ted test 2 Report in order to print a report for the selected patient or 3 Post BC in order to print the test after bronchoconstrictor E 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 Pony FX Operation Printing results 47 _ Options The Pony FX unit allows the configuration of some options by means of the 3 Options menu EM General settings Select the menu item 3 Options 1 Settings Cancel Confirm OM o 2008 16 19 5 USB You can set e Date and time The date must be entered as requested 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 e LCD backlight high or low e PC communication port USB or RS232 M Spirometry options Select the menu item 3 Options 2 Spirometry Cancel Confirm You can set e The equation set used for the predicteds values calculation e Ifthe test quality control visualisation is
61. the battery charger to the Pony FX unit through the connector with the symbol Near the keyboard a led indicates the battery status Green led In charge Orange led Full charged Red led Error only old models until S N XXXXXX6999 The red led can be due to Battery temperature lt 5 C The red led should switch off when the temperature falls again in the range 5 45 C Battery temperature gt 45 C The red led should switch off when the temperature falls again in the range 5 45 C Very low 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 Failed battery Please contact the technical support Installation Preparing Pony FX 27 Note The first time you use the device charge the battery for at least 3 hours Note The batteries must be replaced when they do not maintain their charge for enough time Please contact the technical support Note Attention If the battery is very very low for example if the unit has been not used for a long time let the unit charge for some minutes without turning on it Otherwise acoustic signals and display flashes can occur To stop this sequence press the key 3 and wait some minutes before turning on the unit again E Connect the Rocc module option to the Pony FX 1 Occlusion valve 2 Reader 3 PNT 1 Connect the three parts of the Rocc module as in t
62. transport to the decontamination area so as to minimize risk of personal contact with contaminants 4 A disinfectant solution is only effective if it can contact all surfaces of the items to be disinfected or sterilized 5 Adequate ventilation is required in the disinfection area to evacuate the chemical vapors from glutaraldehyde if used Use lidded containers for the disinfectant solution when appropriate The inhalation of fumes from disinfectant solutions or skin contact with liquid disinfectants can be hazardous to personnel Warning Particular precautions should be taken when testing patients with high risk communicable diseases i e Tuberculosis Multidrug Resistant Staphylococcus infections etc When such conditions are present the clinical need for performing the test should justify the risks When performing the disinfection e Do not use alcohol or other liquids containing Gluteraldehyde on the exterior surface of the equipment e Do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas component mixing chamber or canopy of the equipment e Do not steam autoclave any component other then rubber reusable masks plastic adapter and clips should be removed B Introduction Decontamination is a multi step process that includes preparation at point of use thorough cleaning and rinsing and a microbicidal process Thorough cleaning and rinsing are the first and most important ste
63. ts and display them on the PC monitor The system is composed by the flowmeter a turbine for the Pony FX a pneumotachograph for the Pony FX Flowsafe the measurement and data elaboration device the communication cable the battery charger and by the Software pack Getting started Introduction 17 LI Pony FX overview Pony FX is mainly made of e Pony FX unit e Battery charger e Flowmeter pneumotachograph or turbine depending on the version e Other accessories Let us see an overview of the parts and their assembly B Pony FX unit The main elements a user can detect in the Pony FX unit are the following e A colour display e A keyboard e An internal printer e 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 7 abc def 1 2 3 N NN ghi y E mis pars tuv wxyz S on off x 0 The keyboard is divided into two groups In the left one there are the OK key at the centre and four direction keys In the right group there are 10 alphanumeric keys the cancel and ON OFF keys A more detailed description of the keys functions of the keyboard logics and of the menus see the chapter Pony FX Operation 18 Getting started Po
64. ues Test 2Print 3Diagn 4 Dis Mip Mep 03 20 2012 TEST TEST 42 Pony FX Operation Performing the MIP MEP test option Performing the airway resistance measurement test option Traditional methods of measuring airway resistance are based on body plethysmography which requires a great degree of patient cooperation along with extensive testing equipment and skilled clinical technicians Many patients are unable to perform plethysmography testing due to the testing conditions involved Patient populations which may benefit from measuring airway resistance using alternative methods include critically ill patients acute Asthmatics geriatrics unconscious patients neonates and pre school children Instruments based on the interrupter technique provide reliable resistance measurements and are very well tolerated by all patient populations The interrupter technique implements a transient airflow interruption and measures the pressure at the mouth immediately after the interruption occurs Since the pressure at the mouth is proportional to the patient s alveolar pressure airway resistance can be identified as the ratio between the mouth pressure and the value of flow before the interruption The Appendix reports bibliographic references which demonstrate a high reproducibility and correlation between values measured via the interruption technique and those measured by body plethysmography The parameters measured durin
65. valves should be decontaminated before reuse and internal spirometer surfaces should be decontaminated with accepted disinfectants for blood transmissible agents Other known transmissible infectious diseases Extra precautions should be taken for patients with known transmissible infectious diseases Possible precautions include the following 1 reserving equipment for the sole purpose of testing infected patients 2 testing such patients at the end of the day to allow time for spirometer disassembly and disinfection and 3 testing patients in their own rooms with adequate ventilation and appropriate protection for the technician Disposable in line filters These may be an effective and less expensive method of preventing equipment contamination The use of in line filters does not eliminate the need for regular cleaning and decontamination of lung function equipment B Other precautions and warnings Please take the following precautions during the cleaning and disinfection activities 1 The responsibility for handling cleaning and decontaminating reusable medical devices should be assigned to trained qualified individuals System maintenance Cleaning and disinfecting 57 2 Appropriate protective clothing gloves masks eye protection gowns will minimize the potential for personal exposure to blood borne and other disease producing organisms 3 Immediately separate and contain soiled reusable devices at the point of use and
66. ve 60 System maintenance Cleaning and disinfecting Inspections 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 System maintenance Inspections 61 Appendix Declaration of conformity Manufacturer COSMED S r l Address Via dei Piani di Monte Savello 37 00041 Pavona di Albano Laziale RM ITALY phone 39 06 9315492 fax 39 06 9314580 manufacturer of the following equipment Pony FX Pony FX Flowsafe Pony FX MIP MEP declares under his sole responsibility that e the above listed equipment comply with
67. vice status Select the menu item 4 Utilities 3 Control panel End m Control 1 On off fast charge OO on off Printer 385 Internal 27 7 Flowmeter 5644 mV Embedded Printer Heads Paper Thermistor mv E The display is divided into 4 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 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 t28mm The fields show actual values for flow and volume measured by the unit E LCD contrast In order to modify the contrast of the Pony FX display 1 Select the menu item 4 Utilities 4 LCD Contrast 2 Adjust the contrast by means of the right and left arrow keys 52 Pony FX Operation Other functions of Pony FX 3 Press the 2 key to confirm B Paper feed This function is useful mainly during the paper replacement Select the menu item 4 Utilities 5 Paper Feed E Memory deletion It erases all the memory contents 1 Select the menu item 4 Utilities 6 Erase Memory 2 Confirm by pressing the gt key E Restore of initial settings
68. y the nose clips B Performing the test 1 Select the menu item 1 Test 8 MIP MEP 2 Connect the patient to the mouthpiece 3 Askthe patient to complete a maximal expiration for a MIP or a maximal inspiration for a MEP Cancel Confirm co vo W mer ER RE ee pos es parao er EU 0 50 100 150 200 cmH20 2507 cmH20 i 200 150 OS Bes Res RC HART ACT TEST TEST Pony FX Operation Performing the MIP MEP test option 41 4 Instruct him her to continue to attempt the inspiration expiration with maximal force against the mouthpiece until a double acoustic signal is heard 5 Repeat the same procedure for the opposite manoeuvre expiratory or inspiratory It is not necessary to repeat the test since both MEP and MIP measurements can be obtained during the same procedure 6 On the right side of the screen it is shown both for MIP and for MEP the last measured value the best measured value the highest and if the test is reproducible green bar reproducible red bar not reproducible Cancel Confirm E Ps kt e nn LI O s 100 150 200 mH20 MEP MIP BEST 3 iH RE BST i B E i Reproducibility 50 peccese ri I je00000000000000 i MEP e MIP KUJ S 7 Repeat the manoeuvres as you wish at least until the test is evaluated as reproducible 8 Press OK to confirm and to end the test The Pony FX will show the test results together with the predicted val
69. y to end the test without saving results 44 Pony FX Operation Performing the airway resistance measurement test option LI Viewing and editing results B 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 Print 3 Diagnosis 4 Disp BC SErase O Exit Rocc PRE 05 09 2008 W Edit a diagnosis To edit the diagnosis select 3 Diagnosis B Delete a test oK To delete a test select 5 Erase Press to confirm Pony FX Operation Viewing and editing results 45 Printing results E Replace the printer paper Pony FX prints on a thermal paper code A 196 056 001 confection of 10 rolls 1 Remove the gray cover of the paper compartment 2 Lift up the green lever 3 Putthe paper roll in the paper compartment Insert one end of the roll in the slit indicated by the 2 grey guides under the green lever 4 Lift down the green lever 5 Select 4 Utility 5 Paper feed from the menu The equipment will feed up the paper If not double check whether the paper has been inserted correctly 6 Close the grey cover paying attention that the paper leans off 46 Pony FX Operation Printing results B Printing tests by means of the internal printer 1 View the desired test 2 Select the menu item 2 Print 3 Select 1 Selected Test in order to print only the selec

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