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RHINOSPIR PRO

1. Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absortion and reflection from structures objects and people 516 500 MU2 e REV 2 03 T xouuy AqypiqizedusoD gt 21 2UBEWO0 1J23J3
2. RHINOSPIR PRO User Manual e Test with the CONCENTRATION e Once the step with solvent is made press the key corresponding to Concentration e Verify that the allergen and the doses to be applied correspond to the ones shown on screen e When the chronometer reaches the time programmed for the first reading an acoustic signal sounds indicating that it is time to perform the test as previously described e When the sampling the values of the first reading the graphic of Resistances shows the value of the resistance with solvent plus the one of the first reading e It is possible to change the doses of the test directly by pressing the key DOSE 516 500 MU2 e REV 2 03 359 uome2oA04dg ESEN pue A132WOUEUWIOUIYY E 1493 deYI Chapter 3 Rhinomanometry and Nasal Provocation Test L W 30 NASAL PROVOCATION TEST CONCENTRATION Ref 2 Grau Soler HowProssure Conc 1 Paso 1 DIE Espiration 1200 rcm3 s Inspiration R i75 100 150 M 300 Fins Mes 300 p Res P Yemas e The process is repeated for each substance concentration A maximum of 5 concentrations is possible Each step of concentration is composed of different readings at different times a maximum of 4 according to the time programming on screen Every time that we press Conc we go to the next step of concentration as long as some reading has been performed The chronometer reinitiates at the maximum value of start The key START causes that
3. Chapt Sibelmed RHINOSPIR PRO User Manual 120 e Communications controller with the PC PROGRAM Both the control and the management program are developed in language C It is divided in two parts the bios in EPROM and the application in FLASH MEMORY The storage capacity of temporal data and the device configuration is 128KB in RAM CPU This device manages and executes the process codified in the instructions which form the program The microcontroller H8 532 of HITACHITM is used as CPU CONTROLLERS They perform the information transference between the CPU and the rest of devices as the keyboard the screen and the printer They are included in the microcontroller printed circuit except the interface of the serial communications channel RS 232C QUALITATIVE DESCRIPTION The control program performs the signal acquisition and its temporal storage It is also the responsible for the communication with the PC In this sense it interprets and executes the commands received from the PC The rhinomanometry program on the PC enables the rhinomanometric measurement 516 500 MU2 e REV 2 03 Sibelmed 7 RHINOSPIR PRO User Manual 121 6 PRESERVATION PREVENTIVE AND CORRECTIVE MAINTENANCE 516 500 MU2 e REV 2 03 o2ueuo1ule 4 34112340 pue aAIueAaJd UONEAI35234Jd 9 J431dey Sibel med RHINOSPIR PRO User Manual 122 The Rhinomanometer RHINOSPIR PRO requires as any device and especially for medical applica
4. EN CASO DE DEVOLUCION DE MATERIAL O EQUIPO EN DEPOSITO ROGAMOS NOS LO ENVIEN EN PERFECTO ESTADO COMPLETO DE ACCESORIOS Y DEBIDAMENTE EMBALADO CUALQUIER DESPERFECTO OCASIONADO PROVOCARIA UN CARGO CORRESPONDIENTE A LA REPARACION O REPOSICION NOTE IN CASE TWO MODULES ARE INCLUDED IF THERE ARE TWO PIECES WITH SAME CODE FOR EXAMPLE THE 140 550 010 CLIP IN TURBINE AND FLEISCH MODULES ONLY ONE WILL BE INCLUDED THE ITEMS AND QUANTITIES RELATED BEFORE HAVE BEEN CAREFULLY CHECKED IN CASE OF ANY PART IS MISSING OR IS DAMAGED NOTIFY US AS QUICKLY AS YOU CAN IF YOU DETECT ANY DAMAGE IN THE PACKAGING CONTACT WITH YOUR DISTRIBUTOR BEFORE PROCEEDING TO INSTALL IT DO NOT THROW AWAY THE PACKAGING BAGS ETC UNTIL THE CORRECT FUNCTIONING OF THE DEVICE IS VERIFIED IN THE CASE OF RETURNING THE GOODS IT WILL BE APPRECIATED THAT YOU SEND THE DEVICE IN PERFECT ORDER WITH ALL THE ACCESSORIES AND PROPERLY PACKAGED ANY DAMAGE SUFFERED WILL MAKE A CHARGE CORRESPONDING TO REPAIR OR NEW PARTS PREPARADO PREPARED BY FECHAIDATE 516 500 MU2 e REV 2 03 T 193dey9 JEJ EISUT pue esr 405 SUOIJDNIJSUT UOI Sibelmed RHINOSPIR PRO User Manual 16 WARNING According to the different standards it is advisable to verify and or calibrate the medical productsperiodically in order to guarantee the reliability of its fundions and the safety of the patient user and environment It is advisable to perform a general revision of its
5. The graphics pressure time and flow time on screen correspond to the selected nostril NOTE All the rhinomanometric curves showed since this page and following are simulated These curves have different slopes which allow representing a variety of actual patient responses 516 500 MU2 e REV 2 03 W 30 ANTERIOR ACTIVE RHINOMANOMETRY BASAL Ref 3 Lol ESS BONE Cis 75 100 W150 7 300 Fims Fest 300 PRes P mas NOTE The curves of this screen are simulated in order to show different resistances If we press the key of Dilation Vasoconstriction Printing Itis not explored the left nasal cavity Do you want to explore it ES ey 516 500 MU2 e REV 2 03 359 uome2o0A04dg SEN pue 1J3WO0ULWOUIYY 1e3deu EIE Se ts RHINOSPIR PRO User Manual or Data Base without having performed the test to both nostrils the system shows the following warning IMPORTANT NOTE The rhinomanometer RHINOSPIR PRO stores in the computer hard disk the tests performed during the last three hours although we exit the program or the computer is stopped Each test is stored in its last state being retrieved when the corresponding patient reference is entered From that moment you can continue acting over the test according to the options exposed in step 5 This implies that we should assign a different code for each patient This option enables to perform intercalated tests to different patients as in a vasoconstriction
6. USER PROFILE The device is designed to be used by medical staff only being supervised by a physician The user can configure the device but it s not recommended that the advanced configuration is not modified without being sure with the effect to the signal adquisition The user must be familiarized with the use of the device before using with patients All necessary information can be found in the user s manual To obtain additional information regarding the product or the rhinomanometry technique consult SIBEL S A or your dealer Sibelmed Manual del usuario RHINOSPIR PRO 8 LIMITATIONS IN THE USE COUNTER INDICATIONS An analysis of the results in a rhinomanometry test is not enough by itself to have a diagnosis of the clinical condition of the patient It should be completed by the case history and the tests that the doctor considers necessary The interpretation of the tests and the derived treatments should be performed by a doctor The symptoms presented by the patient before performing any record should be considered by the medical staff The acceptability of a test is responsibility of the medical staff The rhinomanometer should not be used when the validity of the results could be altered due to external factors Take care NOT to place the equipment where it could be splashed by water or other liquids or cover it with objects that prevent air from circulating around it while it is running The device shoul
7. Technical Specifications Sibelmed RHINOSPIR PRO User Manual 116 PARAMETERS e Inspiratory and espiratory e Right nostril flow cm s e Left nostril flow cm s e Addition flow cm s e Right nostril resistance Pa s cm e Left nostril resistance Pa s cm e Total resistance Pa s cm e Best flow Worst flow e Br min MEASUREMENT SYSTEM TRANSDUCER TYPES Pneumotachometer Number 1 Fleisch type It measures air flow It is linear in the range of measurement It uses a differential semiconductor manometer with internal temperature compensation Sensor of differential pressure It measures the differential pressure It is a semiconductor type manometer with internal temperature compensation RANGES AND MEASUREMENTS e Range of measurement Flow ml s Oa 1200 Pressure Pa 0 a 1200 e Dynamic resistance to flow Pa ml s lt 0 01 e Accuracy in the measurements Flow ml s the highest 5 Pressure Pa the highest 5 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 117 D FUNCTIONING PRINCIPLES 516 500 MU2 e REV 2 03 sejdi2urid Buruod2un4 e J131dey Sibelmed RHINOSPIR PRO User Manual 118 The Rhinomanometer RHINOSPIR PRO is a device of physical signal acquisition and information processor provided by the signal related to the nasal respiratory function To perform the processing we need to change the physical into electrical magnitude The units to make this chang
8. safety systems adjustments functions etc every year Do not surpass 18 months without doing it inany case A check up should be performed at any moment when a wrong functioning of the device is suspected These revisions should be performed according to the Verifying and Adjustment Procedures of the manufacturer s SIBEL S A by the manufacturer or the technical qualified staff authorised by SIBEL S A RESPONSIBILITY OF THE MANUFACTURER SIBEL S A is responsible for the safety reliability and functioning of the device only if e The location where the device is installed meets the requirements relative to the electrical installation IEC UNE as well as the other applicable standards e The repairs revisions or modifications in or out the guarantee period are made by the technical staff of SIBEL S A e The use of the device and the use recommendations to the patients are made by qualified staff according to the User s Manual Sibelmed RHINOSPIR PRO User Manual 17 DISTRIBUTION OF CONTROLS INDICATORS AND CONNECTORS No 1 ON OFF Pilot light No 2 Connector to the transducers unit No 3 Characteristics board No 4 RS 232C Serial communications connector RS 232C No 5 Connector to the power supply No 6 Base for the connection of additional earth protection P e rinoman metro RHINOSPIR PRO rhinomenomstor m Y CJ 516 500 MU2 e REV 2 03 uomej e3sug pue esf 40J S
9. 149 182 402 491 0 40 0 49 0 67 0 83 0 25 0 31 1 70 1 70 100 150 372 455 208 255 580 709 0 27 0 33 0 48 0 59 0 17 0 21 1 79 1 79 100 150 313 382 313 382 625 764 0 32 0 39 0 32 0 39 0 16 0 20 1 00 1 00 Page 1 of 3 300 438 258 696 0 68 1 16 0 43 1 70 300 645 361 1006 0 47 0 83 0 30 1279 300 542 542 1083 0 55 0 28 1 00 SIBELMED RHINOSPIR PRO Test Date Reference Technician Motive Origin 75 218 128 346 0 59 0 22 0 59 75 321 179 500 0 23 0 42 0 15 0 56 75 269 269 538 0 28 0 28 1 00 26 11 2003 1 Espiration 100 150 300 253 309 438 149 182 258 402 491 696 0 40 0 49 0 68 0 67 0 83 1 16 0 25 0 31 0 43 0 59 0 59 0 59 100 150 300 372 455 645 208 255 361 581 709 1006 0 27 0 33 0 47 0 48 0 59 0 83 0 17 0 21 0 30 0 56 0 56 0 56 100 150 300 313 382 542 313 382 542 625 763 1083 0 32 0 39 0 55 0 32 0 39 0 55 0 16 0 20 0 28 1 00 1 00 1 00 Been Fess RHINOSPIR PRO User Manual lee Reference 1 TEST BASAL Nostril Nasal Right Nostril Nasal Left Total inspiratoy flow Nostril Right Left Possible obstruction in Possible obstruction in Final diagnosis Basal TEST DILATION Name Jordi Puig Sala DIAGNOSIS Light Obstruction Serious Obstruction Serious Obstruction espiration in the left nasal cavity inspiration in the left nasal cavity Very Serious Obstruction Test Date Ins
10. 2 If the PC s CD ROM unit has the auto run option active it will proceed to the automatic installation otherwise the program Setup exe should be executed after acceding to the corresponding CD ROM unit 3 The next options can be chosen when the following window appears Repair It reinstalls the program If there is a damaged or lost file it will repair it Remove It uninstalls the software but the database of the program is not deleted It can be found at the path where the installation was done 516 500 MU2 e REV 2 03 RHINOMANOMETRY SOFTWARE SIBELMED W30 nove the program Sibelmed A Reinstall all program Features installed by the previous setup ap as gt p ove all installed features gef ek we MM oes INSTALLATION AND COMPUTER REQUISITES The PC installation will be performed according to its User s Manual The computer used should meet the following minimum requisites Minimum Recommended Processor Pentium 133 Pentium III 500 Memory RAM W95 32 MBytes 64 MBytes W98 32 MBytes 64 MBytes W2000 64 MBytes 128 MBytes WXP 64 MBytes 128 MBytes Hard Disk 100 MBytes 100 MBytes 516 500 MU2 e REV 2 03 uoNne EISUI pue ASP 104 SUOIJ9NAJSUT T 4o3deu Sibelmed RHINOSPIR PRO User Manual 24 5 or more Graphic card 800 600 800 600 E or more E Monitor 14 7 V Other Characteristics Operative System Windows 95 Windows 98 Windows 2000 or Windows XP Back
11. 800 MHZ EN IEC 61000 4 6 150KHz to 80 MHz Radiated RF 3 Vrms 3 V m d EE AP de 80 MHZ a 800 MHZ EN IEC 61000 4 3 80 MHz to 2 5 GHz 7 ge H A P de 800 MHz a 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recom mended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip ment marked with the following symbol 2 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp tion and reflection from structures objects and people 4 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 theo retically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electro magnetic site survey should be considered If the measured field strength in the location in which RHINOSPIR PRO is used exceeds the applicable RF compliance level above RHINOSPIR PRO should be observed to verify normal operation If abnormal performance is observed additional mea
12. D Passive anterior rhinomanometry In this method breathe into through a probe situated in a nostril an constant and pre established air flow generally of 250 cm seg The pressure induced the nasal resistances over the air flow is measured at a given level respect the nasal probe Each of these four rhinomanometric methods has specific indications as well as advantages and disadvantages The Committee for Standardization of Rhinomanometry recommends for the most usual clinical evaluation the use of the active anterior rhinomanometry using the mask The active posterior rhinomanometry is reserved for studies of respiratory research and for those cases with a septal perforation is interesting to know the total resistance offered by the nostrils The passive anterior rhinomanometry is reserved for the study of the nasal provocation test or for screening studies performed to school children or large groups COMPUTERIZED RHINOMANOMETRY At present the most useful rhinomanometry system for a habitual rhinologic practice is the active anterior rhinomanometry using a mask and a computerized record We have a rhinomanometer connected to a computer and this one to a recorder which enables the study of the existent flows in cm sec in the right and left nostrils at 75 100 150 and 300 Pa of pressure for both inspiration and espiration with record of x y coordinate axes and sinusoidal oscillogramme of the most significant thirty seconds of
13. DE USO SOFTWARE W20 Doc 511 8F0 MU1 W20 SOFTWARE 02484 M DULO PRESIONES M XIMAS PARA RHINOSPIR PRO MAXIMAL PRESSURE MODULE FOR RHINOSPIR PRO 02484 MODULO PRESIONES MAXIMAS Compuesto por MAXIMAL PRESSURE MODULE Composed by x M dulo sensores PIM PEM Sensor MIP MEP Module 07266 Sonda obturadora Obturer probe 127 900 010 Boquilla multiuso adultos Multiuse adult mouthpiece 03030 MODULO SOFTWARE PIM PEM MIP MEP SOFTWARE MODULE MANUAL USO DATOSPIR 600 Doc 511 900 MU1 DATOSPIR 600 USER S 02305 SOFTWARE ESPIROMETRIA W20 SPIROMETRY W20 SOFTWARE MANUAL DE USO SOFTWARE W20 Doc 511 8F0 MU1 W20 SOFTWARE al STANDARD OPCIONAL OPTIONAL NOTA EN CASO DE INCLUIRSE DE SERIE DOS MODULOS QUE IMPLIQUEN LA INCLUSION DEL MISMO ELEMENTO POR EJEMPLO EL ELEMENTO 140 550 010 EN LOS MODULOS DE FLEISCH Y TURBINA SOLAMENTE SE INCLUIRA UNO LOS ARTICULOS Y CANTIDADES RELACIONADAS ANTERIORMENTE HAN SIDO CUIDADOSAMENTE COMPROBADAS EN CASO DE FALTAS O DESPERFECTOS PROCEDAN A COMUNICARNOSLO LO MAS PRONTO POSIBLE SI DETECTA ALGUN DETERIORO EN EL EMBALAJE CONTACTE INMEDIATAMENTE CON LA AGENCIA DE TRANSPORTE Y CON SU DISTRIBUIDOR ANTES DE PROCEDER A INSTALARLO NO SE DEBE DESPRENDER DE LOS EMBALAJES BOLSAS ETC HASTA QUE VERIFIQUE TOTALMENTE EL CORRECTO FUNCIONAMIENTO DEL EQUIPO SIRVANSE DEVOLVERNOS UNA COPIA DEL ALBARAN SELLADA Y FIRMADA
14. ESEN pue 1J3WO0ULUWOUIYY E 1e3deu Chapter 3 Rhinomanometry and Nasal Provocation Test TE uA p ANE PY Pano RHINOSPIR PRO User Manual 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 111 4 TECHNICAL SPECIFICATIONS 516 500 MU2 e REV 2 03 suoleoyigads e91Uu99 1 p 1o3deu Chapter 4 Technical Specifications Sibelmed RHINOSPIR PRO User Manual 112 GENERAL DATA Applicable standards 1 Related to the product MEDICAL DEVICE 93 42 CEE Directive RD 1591 2009 ELECTRICAL SAFETY e EN 60601 1 6 2006 AC 2010 Seg medical equipment Class I EMC e EN 60601 1 2 2007 AC 2010 EMC in medical equipment Not vital support See APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY RHINOMANOMETERS Recommendations USABILITY AND APTITUDE FOR USE e EN 60601 1 6 2010 General requirements for safety Part 1 6 Collateral standard Usability e EN 62366 2008 Application of engineering skills to use medi cal devices VIBRATION AND TEMPERATURE S Series EN 60721 1995 Classification of environmental condi ea EN 60068 1999 Environmental testing BIOCOMPATIBILITY e ISO 10993 1 2009 AC 2010 Biological evaluation of medical devices Part 1 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 113 SOFTWARE e EN 62304 2006 AC 2008 Software for Medical Devices DOCUMENTATION AND INFORMATION e EN 1041 2008 Information supplied by the manufacturer of medical devices e EN ISO 15223 1 2012 Symbols
15. PRO User Manual 58 START By pressing this key the graphics Flow Time and or Pressure Time start to be recorded according to the selection made in Graphics and Others in the Setup Menu This situation can last indefinitely It is intended for the patient relaxation and the user can check if the graphic is progressing adequately TEST It appears when we press START By pressing TEST the sampling starts restarting the graphics Flow Pressure and or Pressure Time in the coordinates origin and deleting the previous points In this situation besides the previous graphics the butterfly graphic Flow Pressure is shown END When pressing END the test sampling finishes CANCEL It appears after having pressed START or TEST When pressing CANCEL once the graphics recording stops Pressing twice the sampling process stops STOP START This key appears in the Vasoconstriction and NPT Tests It is used to stop or start the chronometer DOSE It appears in the NPT 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 59 It gives access to the dialogue test which enables us to choose between the substance and the doses to be administered to the patient in each concentration 516 500 MU2 e REV 2 03 aIEMYOS OEM GAWTAGIS iT 1o1deu5 Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 60 READING It appears in the NPT Test It enables to start the reading cancelling the alarm of the current s
16. The mask nostril and nasal probes are the most delicate parts of the rhinomanometer as they are directly in contact with the patient Therefore it is necessary to maintain them in perfect physical and hygienic conditions For this purpose clean them with detergent and disinfect them by submerging them during 10 minutes in a glutaraldehide solution at 2 INSTRUNET with glutaraldehide Follow the disinfectant product indications It can be reused around 500 times 516 500 MU2 e REV 2 03 DIUCUDUICP 9A1399 1 10 pue 2A1JUDAD IG UONEAISSIId 9 493dey9 Sibelmed RHINOSPIR PRO User Manual 124 PREVENTIVE MAINTENANCE The preventive maintenance consists of all those actions directed to keep the device in a good use condition Four types of preventive maintenance are established 1 The device as it is started performs a check of some of its parts e 2 A second type which can be carried out by the user consists of a periodical supervision of the different S interconnections and other external elements of the device In 0 this supervision the user will verify that all the interconnections D are perfectly plugged that all the cables and or connectors D as well as any other element do not present breakages or Q external damages If any anomaly is detected which the user cannot resolve by him herself inform the After Sales of SIBEL S A or your Distributor so that they proceed to its revision or repair a
17. Very Serious Obstruction F is the flow in cm s aS Lae Shetty RHINOSPIR PRO User Manual Step 2 A diagnosis is established according to the total inspiratory flow The total flow at150 Pa or 100 Pa is evaluated in the same way as in the previous step If 150 Pa Men Women Diagnosis F gt 700 F gt 630 Normal 600 lt F lt 700 530 lt F lt 630 Slight Obstruction 500 lt F lt 600 430 lt F lt 530 Moderate Obstruction 300 lt F lt 500 230 lt F lt 430 Serious Obstruction F lt 300 F lt 230 Very Serious Obstruction If 100 Pa Men Women Diagnosis F gt 550 F gt 530 Normal 475 lt F lt 550 460 lt F lt 530 Slight Obstruction 400 lt F lt 475 380 lt F lt 460 Moderate Obstruction 250 lt F lt 400 220 lt F lt 380 Serious Obstruction F lt 250 F lt 220 Very Serious Obstruction F is the flow in cm s The Final Diagnosis comes from this Total Flow Depending on what happens in Steps 3 and 4 the diagnosis grade may increase Step 3 The relationship between the best nostril flow and the worst nostril flow is evaluated At the pressure of 150 Pa or 100 Pa depending on the previous Se Soyer RHINOSPIR PRO User Manual step If the quotient lt 1 9 e unbalance does not exist e Final Diagnosis will not be modified If the quotient gt 1 9 e unbalance between nostrils e it will affect the Final Diagnosis The statistical mode of the quotient is 1
18. based in the application of a vasoconstrictor substance in the nostril to evaluate the response of the turbinate The diagnosis of a complete rhinomanometric study should take into account different aspects gt Seer Soyer RHINOSPIR PRO User Manual In the Basal test the flow of each nostril is evaluated the total flow the quotient between best and worst nostril and the linearity of the flow pressure curve In the Dilation and Vasoconstriction tests the flow for each nostril and the total flow will be evaluated These tests are mainly used to confirm a problem detected in the Basal rhinomanometry PROCEDURE FOR THE RHINOMANOMETRY To perform a rhinomanometry test we should know both the test mechanic and the rhinomanometer operation with the help of this manual and specially sections 3 1 and 2 As previously commented the rhinomanometer RHINOSPIR PRO enables to perform the rhinomanometric tests in BASAL DILATION and or VASOCONSTRICTION mode Next the mechanic to follow in each case is described INSTRUCTIONS TO THE PATIENT According to the standards of International Standardization Committee on Objective Assessment of Nasal Airway proceed as follows Inform the patient that before the exploration he she should avoid the use in the next twenty four or forty eight hours of local or general substances like irritants of the nasal mucosa membrane this is alcohol and tobacco which are capable of modifying the
19. both nostrils b Instil the allergen solvent Sample the values after 5 minutes c Instil the maximum allergen dilution in the nostril with less resistance Sample the values after 5 10 and 15 minutes d Repeat the instillations at increasing concentrations in the nostril until the test is positive or until we reach concentrations which can be irritating For the instillation it is advisable to use an air dispenser for the release of 0 1 ml per nebulization 516 500 MU2 e REV 2 03 a ee Sheva RHINOSPIR PRO User Manual PROCEDURE FOR THE NASAL PROVOCATION TEST As previously commented the user will determine how to perform the Nasal Provocation Test In this test inserting Patients is not possible The steps the user needs to follow with the SIBELMED Rhinomanometry Software are described in the next paragraphs INSTRUCTIONS TO THE PATIENT The instructions to the patient will be similar to the ones described in section 3 3 1 plus those ones that the technician who will perform the test considers necessary in each case MASK PLACING The mask placing will be the same as the one described in section PROCEDURE FOR THE RHINOMANOMETRY NPT PROGRAMMING See Chapter 2 MAIN MENU SETUP MENU NPT PROGRAMMING TEST PERFORMANCE When we select the key NPT in the Main Menu the following screen appears 516 500 MU2 e REV 2 03 359 UOI E20A0 id ESEN pue A132WUOUEWIOUIYY E 1e3deu Chapter 3 Rhinomanomet
20. linearity of the flow pressure curve Step 4 would confirm a possible hypertrophy in the turbinate tail detected in one of the nostrils in the Basal test If a wing collapse has happened in the Standard test it could become worse due to the increase of the air flow secondary to the decrease of the turbinate volume caused by the vasoconstrictor NOTE This Diagnosis is of informative character The doctor will be responsible for its verification and validation 4 DIAGNOSIS EXAMPLE A typical example of Diagnosis performed by the rhinomanometer RHINOSPIR PRO of SIBEL S A could be the following Standard Test Right nostril Serious Obstruction Inspiratory flow at 150 Pa 205 cm s Left nostril Slight Obstruction Inspiratory flow at 150 Pa 310 cm s 516 500 MU2 e REV 2 03 gt Seer Fenit RHINOSPIR PRO User Manual Total inspiratory flow Moderate Obstruction Total inspiratory flow at 150 Pa 515 cm s Left nostril Right nostril lt 1 9 No unbalance between nostrils exist Possible Obstruction in inspiration in Right Nostril Possible Obstruction in inspiration in Left Nostril Final diagnosis of the Standard Test Very Serious Obstruction Dilation Test Right Nostril Serious Obstruction Inspiratory flow at 150 Pa 210 cm s Left Nostril Normal Inspiratory flow at 150 Pa 495 cm s Total inspiratory flow Normal Inspiratory flow at 150 Pa 705 cm s Vasoconst
21. rhinomanometry which is divided into e Active anterior rhinomanometry AAR e Passive anterior rhinomanometry PAR Clement et Col has made a wide comparative analysis of both as well as a description of the physiopathologic bases Oliv has analyzed the benefits of the NPT in comparison with the cutaneous test and the RAST in comparison to different allergens He has shown the diagnostic interest of the technique PHYSICAL BASES According to Clement et Col we know the nasal flow is inversely proportional to the radius of the nasal airway At the same time the nasal resistances R follow the expression R DP V Consequently the diminution of the nasal calibre leads to an increment of the nasal resistances The increment can be caused by an increment of the numerator or to a decreasing of the denominator In the first case as the rhinomanometer performs measurements at fixed pressures we observe that the flow at 150 Pa is zero and the resistances are no longer detected In the second case the resistances Chapter 3 Rhinomanometry and Nasal Provocation Test ER Se A RHINOSPIR PRO User Manual are increased at 75 and also at 100 and 150 Pa The test is considered positive if the increment of the resistances is 100 respect the basal values TECHNIQUE OF NASAL PROVOCATION TEST The specialist should define the technique to be used For information a recommended technique follows a Sampling of the basal values in
22. screen In rhinomanometry In the NPT ORGANIZE WINDOWS Tests Selection 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 55 It locates the windows which setup the screen according to its size HELP MENU ABOUT THE SCREEN This window help is accessible Some of these options are also accessible directly through icons From left to right we have the options of New Patient Basal Dilation Vasoconstriction NPT Save the Test Report Select Tests Help and Exit This window is composed of e Three sub windows which contain the graphics of Flow Pressure Flow Time Pressure Time and Resistance Nostrils Each graphic has the following colour correlation F P F T P T Res Nostril Right Nost Red Red Black Red Left Nost Blue Blue Black Blue Total o Post Yellow Yellow Black Yellow The labels Right and Left of Nostril Selection will be RED and BLUE e Chronometer in the Vasoconstriction and NPT Tests e Option of choosing the nostril right or left 516 500 MU2 e REV 2 03 9JEMIJOS O M GIWTIYIS c 191deyo Sibelmed RHINOSPIR PRO User Manual KEYS OF CONTROL AND CONSULT OF TEST DIAGNOSIS Pressing this key the diagnosis obtained up to the moment is displayed DIAGNOSIS OF THE TEST ACCORDING TO DR FABRA ES TEST BASAL Light Obstruction Ins flow at 150 Pa 309 cm3 s Moderate Obstruction Ins flow at 150 Pa 255 cm3 s Moderate Obstruction Ins flow at 150 Pa 564
23. the chronometer starts to discount At first the value is the maximum according to the number of readings programmed for each Concentration on screen The warning for the reading x of the current step of concentration is cancelled if we have started the manoeuvre before it is time or if we press READING The timer keeps 516 500 MU2 e REV 2 03 aS Lae Shetty RHINOSPIR PRO User Manual discounting invariably For the performing of the next reading press the key READING At any momenta text appears in the upper part of the screen which informs about the step where we are in and about the Reading in the step of concentration Concentration x Step When pressing the DATA key all the results obtained up to the moment are displayed As indicated a maximum of four readings can be taken for each of the five steps of the applied concentrations e To take the values in the next reading press the key READING e To go to the next CONCENTRATION press the key corresponding to Concentration e The process is repeated the times considered convenient by the technician according to the recorded values up to a maximum of five concentrations and four readings per concentration e Every time we go to a new concentration the chronometer reinitiates e As we keep advancing the graphic dose response 516 500 MU2 e REV 2 03 1531 UOIJEIOAO d ESEN pue AsJQOWIOUeWOUIYY E J31dey Chapter 3 Rhinomanometry and Nasal Provoc
24. the hermeticism close the free nostril block the tube coming out the adhesive and indicate the patient to try to breathe with the mouth closed If it is correctly closed the nostril wall will expand If there are air leaks or are suspected place again the adhesive until its correct application Next take the finger out from the tube and check that the air circulates Then apply the mask as indicated next EA 516 500 MU2 e REV 2 03 1581 uome2oA04dg ESEN pue A132WUOUEWIOUIYY E 1e3deu Chapter 3 Rhinomanometry and Nasal Provocation Test Soni RHINOSPIR PRO User Manual RHINOMANOMETRY USING CONICAL NASAL PROBES The European committee for standardization of rhinomanometry recommends that during the performance of an active rhinomanometry test any deformation of nostrils that can alter the test results should be avoided specially the deformation due to the application of transducers to the patient This committee recommends using a face mask with transparent screen that allows seeing these nostrils deformations Nevertheless those users who are not familiarized with the use of the face mask and prefer to use other system like conical nasal probes should follow these steps e Select the nasal probe that matches to the nostrils properly e Connect the transducers unit to the nasal probes e Start the test similarly to the test performed with the face mask In the figure below the application of th
25. the test which enables ER Se Soya RHINOSPIR PRO User Manual us to obtain all the qualitative and quantitative parameters to be provided by the rhinomanometric study and have them properly filed in the computer RHINOMANOMETRY INDICATIONS This experimental test provides us indispensable information which enables us to explain the following points 1 The relation existent between the anatomic deformities and its functional repercussion enabling us to avoid the error of overvaluing very obvious septal deviations from the anatomical point of view but compensations of the turbinate wall enable the existence of a correct flow with the normal nasal cycles the overvalue of discrete septal deviations affecting the valve area and when the section of the narrow vestibulo_fosal they have a great functional repercussion 2 Study the effect of no nasal causes of nasal repercussion The rhinomanometry is conclusive in the differential diagnosis of the typography of the respiratory insufficiency 3 Make evident the patient subjectivity 4 Verify the functional efficiency of a surgical treatment 5 It enables to quantify the nasal hyper reactivity in the different tests The complete rhinomanometric study consists of three tests The first test is the Basal which evaluates the patient in a normal condition The second one called Dilation consists of the mechanical dilation of the nostril The third one or Vasoconstriction is
26. user of RHINOSPIR PRO should assure that it is used in such an environment Immunity test EN IEC 60601 test level Compliance level Electromagnetic environment Guidance Electrostatic discharge ESD EN IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or cera mic tile If floors are covered with synthe tic material the relative humidity should be at least 30 Electrical fast transient burst EN IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environ ment The input output line cables are shorter than 3 meters long 1 kV differential 1 kV differential Mains power quality should be that of a Surge typical commercial or hospital environ EN IEC 61000 4 5 2 kV common 2 kV common ment mode mode Voltage dips short in terruptions and volta Mains power quality should be that of ge variations on power lt 5 Ut SE 5 Ut ata a typical commercial or hospital envi supply input lines gt 95 dip in Ut 295 dip in Ut ronment If the user of the RHINOSPIR for 0 5 cycle for 0 5 cycle PRO requires continued operation during EN IEC 61000 4 11 power mains interruptions it is recom 40 Ut 40 Ut mended that the RHINOSPIR PRO be 60 dip in Ut
27. 2 Step 4 In a normal rhinomanometric curve there is flow linearity between 0 and 100 150 Pa As the pressure increases the curve transforms slightly into exponential In case of non normal patients wing collapse turbinate tail collapse nasal septum deviation turbinate hypertrophy the flatness is much more pronunced When this flatness occurs in the inspiration in the nostril under study a wing collapse or an obstruction of another type is detected If this happens in the expiration this indicates a possible turbinate tail hypertrophy After the analysis of 101 healthy patients 45 men and 56 women and patients with different types of obstructions 12 women and 9 men it has been observed that the parameter expressing best the normality criteria is the slope between 0 and 75 Pa Flow at 75 Pa cm s 75 Pa It has been observed that the value of slopes which best differentiates between both groups of patients is 2 70 The patients under this value are susceptible of having an obstruction and the ones who are over the value are very likely to be normal With the value of slope mentioned before 100 of the normal patients are considered normal On the contrary only 2 of the non normal patients are considered normal When we analyse the rhinomanometric curve for these patients we observe that they are patients with slight obstructions gt Seer A RHINOSPIR PRO User Manual In these cases the text w
28. 2000 o Windows XP su usuario debe disponer de privilegios de Administrador para que el programa se instale correctamente En caso de duda consulte con el Administrador de su sistema o con la ayuda del sistema operativo For the Software installation in the PC hard disk proceed as follows Sibelmed RHINOSPIR PRO User Manual 21 1 Introduce the CD_ROM in the CD ROM reading unit 2 If the PC s CD_ROM unit has the auto run option active it will proceed to the automatic installation otherwise the program Setup exe should be executed after acceding to the corresponding CD_ROM unit 3 Once installed it will appear the next window which permits to choose the installation process language Elegir idioma de instalacion i x Seleccione uno de los idiomas siguientes parala instalaci n Cancelar 4 Please choose the directory where to install the program and the group of programs name The program s default installation directory is C SIBEL RINOPRO 5 Once the installation is done it will create the SIBEL group of programs or the one chosen by the user and a shortcut will be created on the desktop 516 500 MU2 e REV 2 03 UO JE JEISUT pue esr 104 SUOIJDNAISUT T AB deYI Chapter 1 Instructions for Use and Installation Sibelmed RHINOSPIR PRO User Manual RHINOMANOMETRY SOFTWARE SIBELMED W30 Installstred UNINSTALLATION OF SOFTWARE W30 1 Introduce the CD ROM in the CD ROM reading unit
29. 3 The user can perform a Hardware Test to check that the communication of the device with the PC is correct Otherwise verify the interconnections U E The fourth type consists of a general technical verification of the safety systems adjustments functions etc which configure the device THIS TECHNICAL VERIFICATION WILL BE PERFORMED WITH ANNUAL PERIODICITY and according to the Verification and Adjustment Procedure RHINOSPIR PRO provided by the manufacturer This type of operations has to be performed by the qualified technical personnel of the maintenance department of the centre technical service of your distributor or by the manufacturer Sibelmed RHINOSPIR PRO User Manual 125 In any case SIBEL S A as manufacturer should authorize in C writing at least during the guarantee period the corresponding technical service allowing them to perform such maintenance g In any case no responsibility for damage malfunction etc will be admitted which might arise as a result of a defective maintenance by persons not belonging to SIBEL S A The Rhinomanometry SIBELMED W 30 Software does not require any specific maintenance except the one for any computer program managing information e Make a copy of the program in case the original is damaged e Make periodical backup copies in the Data Bases used so as to restore them if any piece of information is lost in the computer The computer and printer maintenance w
30. 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 129 ANNEX 1 ELECTROMAGNETIC COMPATIBILITY 516 500 MU2 e REV 2 03 Auqneduio gt 19ubeulo 399 13 T xouuy ic Compatibility Electromagnet Annex 1 Sibelmed 7 RHINOSPIR PRO User Manual Guidance and manufacturer s declaration electromagnetic emissions RHINOSPIR PRO is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment Guidance RF Radiated emissions Group 1 RHINOSPIR PRO uses RF energy only for its internal function Therefore its RF emissions are very low and CISPR 11 EN 55011 Class B are not likely to cause any interference in nearby elec tronic equipment ce RHINOSPIR PRO uses RF energy only for its internal RF Conducted emissions Group 1 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby elec CISPR 11 EN 55011 Class B tronic equipment Harmonic emissions Class A EN IEC 61000 3 2 Voltage fluctuations Flicker emissions Yes EN IEC 61000 3 2 516 500 MU2 e REV 2 03 Sibelmed 7 RHINOSPIR PRO User Manual Guidance and manufacturer s declaration electromagnetic immunity RHINOSPIR PRO is intended for use in the electromagnetic environment specified below The costumer or the
31. 516 500 MU2 e REV 2 03 1581 uome2oA04dg ESEN pue A132WUOUEWIOUIYY E 1e3deu Chapter 3 Rhinomanometry and Nasal Provocation Test EEE Ames RHINOSPIR PRO User Manual 1200 D 1200 Setup Options Hep Jump E GONE Dee H Pressure Time Flow Time EI NY 30 NJ NEZ NY NY GI 210 240 27 0 R enters to the Solvent test steps is possible Solvent Concentration 1 Concentration 2 Concentration 5 and up to four readings per concentration d Test with SOLVENT e Apply the solvent to the patient e Next press the key corresponding to Solvent e At this moment a chronometer appears in the upper part which indicates the time left for the record of the test after the application of the solvent e When the counter reaches the programmed time an acoustic signal sounds indicating that it is time to perform the test as previously described The key STOP in the chronometer stops the counter and the key START continues it e In this step the values sampling is performed after having applied the solvent e The graphic Resistance marks a point with the taken value e Once the solvent and basal steps are performed only steps of concentrations without return are possible W 30 NASAL PROVOCATION TEST SOLVENT Ref 2 C IESSE SC D e r5 De Ein a Ems est 300 rRes PYms eto 12001 122059 L 516 500 MU2 e REV 2 03 we rm B MALMEN TELT as
32. 60 dip in Ut powered from an uninterruptible power for 5 cycles for 5 cycles supply or a battery 70 Ut 70 Ut 30 dip in Ut for 25 cycles 95 Ut gt 5 dip in Ut for 5 seconds 30 dip in Ut for 25 cycles lt 95 Ut gt 5 dip in Ut for 5 seconds Power frequency 50 60 Hz magnetic field EN IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical lo cation in a typical commercial of hospital environment NOTE Ut is the a c mains voltage prior to application of the test level 516 500 MU2 e REV 2 03 T xouuy AqypiqizeduroD gt 1 2UBEWO0 1J23J3 Electromagnetic Compatibility Annex 1 Sibelmed 7 RHINOSPIR PRO User Manual Guidance and manufacturer s declaration electromagnetic immunity RHINOSPIR PRO is intended for use in the electromagnetic environment specified below The costumer or the user of RHINOSPIR PRO should assure that it is used in such an environment EN IEC 60601 Compliance Immunity test test level level Electromagnetic environment guidance Portable and mobile RF communications equi pment should be used no closer to any part of RHINOSPIR PRO including cables than the re commended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance conducted RF 3 Vrms 3 Vrms d EE AP de 80 MHZ a
33. 62 In this screen each of the last calibration records performed are displayed up to a maximum of 10 It also shows the date time device espiratory factor inspiratory factor and technician for each calibration This report can be printed as a quality guarantee of the test If a record has been wrong by any cause it can be deleted When pressing the key Cal Calibrate and starting the calibration a screen similar to this one is displayed Flow Calibration During the calibration the flows at 150 Pa are displayed espiratory and inspiratory corrected in successive approximations in base to the calibration factors up to the reference flow When two consecutive espiratory and inspiratory flows are achieved which are into the specified tolerance the label CALIBRATED appears and the sampling finishes WARNING The periodicity of flow calibration is one per day With the key Cal the calibration process can be repeated 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 63 B Pressure channel calibration For the calibration of pressure channel a manometer that generates a pressure of 500 Pa 5mbar is needed It is advisable that this operation will be performed by a technician The stability in amplification of pressure channel of RHINOSPIR PRO is stable enough in order not to modify it during long periods of time MAXIMUM 1 YEAR Nevertheless the user can calibrate or verify this channel when wished o
34. AS CSV c rinopro L ses Boa PRUEBAS COM RINOPRO testhard csv 3 APLIC E3 AppExtra Bdsibel E CURVAS vi Cancelar i Red zl Mostrar archivos de tipo Unidades Export Files CSV y c W2K Exit export It enables to go back to the main screen EXPORT Export It exports the selected tests to a format delimited by inverted comas while a bar shows the evolution of the process SELECTION Mark It marks the check box of the selection in the active window Unmark It removes the mark in the check box of the 516 500 MU2 e REV 2 03 9JEMIJOS OEM AIWTIYIS 7 194dey9 Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 48 selection in the active window Mark all It marks all the check boxes in the active window Unmark all It removes the mark of all the check boxes in the active window WINDOW Cascade It organizes the windows in cascade Horizontal Mosaic It organizes the windows in horizontal mosaic Vertical Mosaic It organizes the windows in vertical mosaic HELP Export Help Access to the help referred to the export It can execute the options Export Destination Export Export Help and Exit export directly pressing the corresponding icon in the tool bar IMPORT TESTS IN CSV FORMAT The export module to CSV format in combination with this import window enables to browse the tests performed with the rhinomanometry software in a remote consu
35. After the three hours of the test this cannot be retrieved d DILATION Test In order to perform a Dilation test the Basal test should have been previously performed Press the icon D or Options Dilation to go to the test The procedure to perform the Dilation test is the same as the one described for the Basal test with the difference that we can to perform a dilation test to the patient on screen or to other to whom we have performed a basal test in the last three hours This enables to intercalate tests of different patients In the second case if the dilation is being done previously press New Patient and enter the corresponding Reference W 30 ANTERIOR ACTIVE RHINOMANOMETRY DILATION Ref 3 Puig Sala Jordi cof x Setup Opes me X E ERA m Sees Hagen EES Ber BERT Resistance R i5 1w 7 150 7300 I Espiration eren Inspiration i 3 00 Res P mays TA ma o Ze e SR CR Y N 120 V 150 180 no 240 210 a Teerters tothe Vosoconsticton test The icon SEL enables to select the graphics present in the axes flow pressure e VASOCONSTRICTION Test The device enables to perform a Vasoconstriction test after a Basal test or after a Basal plus Dilation i DOSE VASOCONSTRICTION Kilometazolina 516 500 MU2 e REV 2 03 1531 uome2oA04g ESEN pue Jj3euroueuliouliqM E 1e3deu Chapter 3 Rhinomanometry and Nasal Provocation Test ER Ames RHINOSPIR PRO Use
36. ELECTION asieran innne n a 32 DATA BASE incide id ei AAA 33 DATA BASE SELECTO Nicosia nO 33 NEW DATA BASE ivi ea 35 DELETE DATA BASE ua ra 35 MODIFY PASSWORD dee Ree 36 IN dee ea 36 REPORT HEADER isses sese n ea repr hrs iii 37 GRAPHICS AND OTHERS rare enhn ena mah n ERR EE aa eras 38 516 500 MU2 e REV 2 03 xapuI Index Sibelmed RHINOSPIR PRO User Manual 4 NPT PROGRAMMING iii 40 HARDWARE TEST iii iaia 42 UPDATE RHINOSPIR PRO 42 SE IER 42 OPTIONS MENU eegene EE EEN 43 DATA BASE deng Eng gea Eege enin cl oc Ducale i Rc a GRO a aan 43 PATIENTS csisersecendanere pin a Fa eK a EST RA 43 EXPORT TEST IN CSV FORMAT ss coria dates en n cn i H 46 IMPORT TESTS IN CSV FORMAT Lei 48 DATA BASE MAINTENANCE Innen ne ener enne 50 RHINOMANOMETRY essssessese Imm e mmm e e nenne senes nnn 51 SETUP MENU mito tnnt ra eri ee o PT dE 52 OPTIONS MENU atraca ceo e aac ESA 52 HELP MENU c iode ai esas ndun a etse oa ni eon e coe c RD en 55 KEYS OF CONTROL AND CONSULT OF TEST 2 56 CALIBRATION iii dn en e CU ENN ete RR ADHI aaa 60 als BAILE dada 65 DESCRIPTION OF THE RHINOMANOMETRY TEST eee 68 INTRODUCTION socia a a 68 CURRENT RHINOMANOMETRIC METHODEN 68 COMPUTERIZED RHINOMANOMETRY Lee 69 RHINOMANOMETRY INDICATIONS Li 70 PROCEDURE FOR THE RHINOMANOMETRY 2 veri 71 RHINOMANOMETRY USING CONICAL NASAL PROBES 74 TE
37. ELMED W 30 have been developed by the R D department of SIBEL S A in collaboration with Dr Fabra of the Hospital de la Sta Creu i Sant Pau de Barcelona LE 0318 PRODUCT CONFORMS WITH 93 42 CEE Medical Devices Directive Class II a Revised Date 2013 10 F y ZA a Antoni Pic Technical Manager de Revised Date 2013 10 Carlos Recio Sales Manager 516 500 MU2 e REV 2 03 Sibelmed Manual del usuario RHINOSPIR PRO 7 SAFETY The Rhinomanometer RHINOSPIR PRO has been designed to have the maximum safety All the operation instructions should be read before starting the device Otherwise lesions to the user or patient and damage to the device and or accessories may happen INTENDED USE The rhinomanometer measures the nasal flow and pressure and calculates a series of parameters relative to the nasal respiratory function The rhinomanometer is designed to be used by medical staff in a hospital environment It should be supervised and instructed by a doctor In these conditions the user can setup the device It is not recommended to modify the advanced setup without understanding the signal digitalization principles The rhinomanometer is not designed to be used in the open air or with other conditions or power supplies not intended in this manual The device must be located in a safety position This avoids it falls down and consequently any failure to the device or damage to patient and or user
38. IJ22010 d ESEN pue Jj3euroueuiouliua Chapter 3 Rhinomanometry and Nasal Provocation Test RHINOSPIR PRO User Manual Reference 2 Name Anna Grau Soler Test Date 21 11 2003 This report should be validated by the specialist doctor Printing Date 26 11 2003 Page 2 of 2 516 500 MU2 e REV 2 03 CURE TENE EL ce RHINOSPIR PRO User Manual represents Resistance depending on the doses for each one of the steps to the pressures of 75 100 150 and 300 according to the selection DIAGNOSIS IN THE RHINOSPIR PRO WARNING The diagnosis shown by the rhinomanometer RHINOSPIR PRO is performed according to the criteria established by Dr Fabra from the Hospital de la Sta Creu I Sant Pau in Barcelona which is explained in the following pages The doctor who performs the test is responsible for validating or modifying the diagnosis shown by the rhinomanometer DIAGNOSIS IN THE ACTIVE RHINOMANOMETRY ACCORDING TO DR FABRA The complete rhinomanometric study consists of 3 tests The first one is the Standard test which evaluates the patient in normal conditions The second one the Dilation test consists of a mechanical dilation of the nasal window ot the patient The third one or Vasoconstriction test is based on the application of a vasoconstrictor substance in the nostril to evaluate the turbinate response The diagnosis of a complete rhinomanometric study should take into account different aspects In the Sta
39. N VASOCONSTRICTION 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 53 PATIENT DATA It enables to display and change the patient data CHANGE NOSTRIL It enables to change the data taken from the contrary nostril in those cases where the selection has been wrong If only one nostril has been performed the data pass to the other if both nostrils have been performed they interchange STORE THE TEST It stores all the tests performed to the patient up to that moment in the Data Base They can be saved during the different steps in the Data Base This does not implicate that some records of the same patient appear REPORT The printing of the report is done which has the header setup the patient data the test Selection Tests Report BASAL parameters and the selected I DILATION graphics I VASOCONSTRIC In the rhinomanometric test IV TOTAL when pressing the key report a dialogue box appears which enables the impression of each test in separated reports BASAL DILATATION VASOCONSTRICTION or all the tests in only one report TOTAL according to the user s selection Vv Xi DELETE It enables to delete a test 516 500 MU2 e REV 2 03 BIEMYOS DEM Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 54 RETRIEVE It enables to retrieve a test SELECT TESTS A dialogue box appears which enables us to choose the tests which we want to display on
40. RHINOSPIR PRO RHINOMANOMETER USER MANUAL 516 500 MU2 e REV 2 03 e 2013 10 Sibelmed SIBEL S A Rossell 500 08026 Barcelona Ventas Nacionales Tel 93 436 00 08 email comercial sibelmed com Ventas Internacionales International Sales Tel 34 93 436 00 07 email export sibelmed com Servicio T cnico Technical service Tel 34 93 433 54 50 email sat sibelmed com Fax 34 93 436 16 11 Web www sibelmed com Sibelmed 7 RHINOSPIR PRO User Manual 3 INDEX DECLARATION OF CONFORMITY 6 EE 7 1 INSTRUCTIONS FOR USE AND INSTALLATION 11 INTRODUCTION cc ri ii ii i tens 12 PREVIEW una A da 13 PACKING US Ti mei 14 RESPONSIBILITY OF THE MANUFACTURER eee 16 DISTRIBUTION OF CONTROLS INDICATORS AND CONNECTORS MENANDER 17 STANDARD ACCESSORIES voip ci 18 INSTALLATION AND SETUP aora 19 DEVICE INSTALLATION coena sanar cacas io ira 19 INSTALLATION OF SOFTWARE W30 Li 20 UNINSTALLATION OF SOFTWARE W30 iii 22 INSTALLATION AND COMPUTER REQUISITES eeeeees 23 INSTALLATION AND PRINTER REQUISITES ee eee e 24 SETUP e ee 25 2 SIBELMED W30 SOFTWARE sccescesssseesseseesseeseeseeseteaes 27 INTRODUCTION Lunder ar int 28 ABOUT HELPS ON SCREEN 2 icon ii 29 MAIN MEN USS ice a 30 SETUP MENU eege iaia dd da 20 OPTIONS MENU roll an ea 30 HELP MEN flare 30 SOFTWARE SETUP iaa a co doo ER TIU ERES 32 PRINTER S
41. S ETC UNTIL YOU VERIFY COMPLETELY THE CONTENTS AND THE CORRECT FUNCTIONING OF THE DEVICE Sibelmed RHINOSPIR PRO User Manual 13 PREVIEW This product is manufactured under strict quality controls Nevertheless accidents may happen in the transport or storage of the devices It is convenient to perform an initial check up of the status before installing it and also of the complementary accessories 516 500 MU2 e REV 2 03 UONEJJEISUT pue esf 104 SUOIJJNAISUT T 1493 deYI Instructions for Use and Installation Chapter 1 Sibelmed RHINOSPIR PRO User Manual PACKING LIST RELACI N DE CONTENIDO PACKING LIST P gina 1 de 2 RHINOSPIR PRO 516 508 030 REV 6 7 11 C DIGO DESCRIPCI N CODE DESCRIPTION RHINOSPIR PRO NUMERO SERIE SERIAL NUMBER SN 165 01307 UNIDAD DE TRANSDUCTORES TRANSDUCER UNIT MANUAL DE USO RHINOSPIR PRO Doc 516 500 MU1 USER S MANUAL RHINOSPIR PRO Doc 516 500 MU2 01210 ALIMENTADOR POWER SUPPLY bi 02224 CONEXION PC SERIE Compuesto por PC SERIAL LINK 03035 CDROM SOFTWARE RINOMANOMETRIA W 30 CDROM W30 RHINOMANOMETRY SOFTWARE 02408 MASCARA ADULTO ADULT MASK 01174 ADHESIVOS NASALES DESECHABLES 50u DISPOSABLE NOSTRIL ADHESIVES 50u 07427 SONDA NASAL 20u NOSTRIL PROBE 20u 01703 CALIBRADOR DE FLUJO FLOW CALIBRATOR 01555 BOQUILLAS DESECHABLES PARA EL CALIBRADOR 10 u DISPOSABLE MOUTHPIECES FOR
42. SIBELMED W30 SOFTWARE 516 500 MU2 e REV 2 03 948 3JOS OEM AINTIAIS c 403deyD Sibelmed RHINOSPIR PRO User Manual INTRODUCTION As previously commented the RHINOSPIR PRO includes software in the PC for its functioning called RHINOMANOMETRY SIBELMED W30 Software Next a description follows taking into account that the software includes help menus to make its use easier Version 51653A 1 02 Date 21 02 2006 SIBEL S A C7 Rossell 500 National International After sales Fax 34 93 4361611 08026 BARCELONA Spain 34 93 4360008 comercial sibelmed com 34 93 4360007 export sibelmed com 34 93 4335450 sat sibelmed com WEB www sibelmed com RHINOS Am Sibe lmed d v IL Dr f FX P RUO eet Sibelmed RHINOSPIR PRO User Manual 29 ABOUT HELPS ON SCREEN The helps included in SIBELMED W 30 Software are structured in MICROSOFT Windows system and they show the user how to handle the different options in the program The User s Manual offers in some cases a more detailed explanation about technical specifications or other aspects In general each screen includes a Help menu where there is an explanation of the different options available This help is indicated in each screen with an icon text or both Inside some texts words or underlined phrases in green are included which head to other helps for more details For this purpose the cursor is put over the word w
43. ST PERFORMANCE a 75 RHINOMANOMETRY REPORT 2 ei 83 DESCRIPTION OF NASAL PROVOCATION TEST eee 87 PROCEDURE FOR THE NASAL PROVOCATION TEST 89 DIAGNOSIS IN THE RHINOSPIR PRO cece cece nnn 99 DIAGNOSIS IN THE ACTIVE RHINOMANOMETRY ACCORDING TO DR FABRA EEN 99 GRAPHIC EXAMPLES OF WING COLLAPSE AND HYPERTROPHY IN TUR BINATES R ss de daria Ae Diet eda Seed dk be stand 106 PROCEDURE FOR RHINOSPIR PRO CALIBRATION 10 TECHNICAL SPECIFICATIONS eren nnn 111 GENERAL DATA 112 PARAMETERS amp siicesesx xe criari iii rin 115 MEASUREMENT SYSTEM ei 115 PROGRAM CONFIGURATION bi 116 516 500 MU2 e REV 2 03 Sibelmed 7 RHINOSPIR PRO User Manual 5 DATA BASE assiali diia 116 SOFTWARE COMPATIBILITY iii 116 5 FUNCTIONING PRINCIPLES rennen nnns 117 PNEUMOTACHOMETER PLETSCH emen 118 FILTERS AND AMPLIFIERS ve ee gau nit anh t eet nhe n nC notes 118 ANALOGUE DIGITAL CONVERTER esee 119 MICROPROCESSOR o gedet de piani hn NEE EN AANEREN AEN npn a X OU E ger 119 6 PRESERVATION PREVENTIVE AND CORRECTIVE MAIN Ire 121 PRESERVATION iii 122 PREVENTIVE MAINTENANCE iii 124 CORRECTIVE MAINTENANCE Hmmm 126 7 MODIFICATIONS sico 127 ANNEX 1 ELECTROMAGNETIC COMPATIBILITY 129 516 500 MU2 e REV 2 03 xopuI Declaracion de conformidad Sibelmed RHINOSPIR PRO User Manual 6 The RHINOSPIR PRO and its Rhinomanometry Software SIB
44. THE CALIBRATOR 10u 01299 TUBO PL STICO PLASTIC TUBE 2x3 5 0 5m 02263 JUEGO DE OLIVAS FLUJO Y PRESI N ADULTOS NOSTRIL CONE SET FLOW amp PRESSURE FOR ADULTS 02264 JUEGO DE OLIVAS FLUJO Y PRESI N PEDI TRICO PAEDIATRIC NOSTRIL CONE SET FLOW amp PRESSURE 02410 M SCARA PEDI TRICA PAEDIATRIC MASK 02483 ESTACI N METEOROL GICA ELECTR NICA METEOROLOGICAL ELECTRONIC 02494 M DULO ESPIROMETR A FLEISCH PARA RHINOSPIR PRO FLEISCH SPIROMETRY MODULE FOR RHINOSPIR PRO 03171 NEUMOTAC METRO FLEISCH Compuesto por FLEISCH NEUMOTACOMETER Composed by Neumotac metro Fleisch Fleisch Neumotacometer 03065 Soporte Neumotac metro Neumotacometer holder 01555 100 BOQUILLAS CARTON 100 DISPOSABLE MOUTHPIECES 02692 PINZA NASAL NOSE CLIP MANUAL USO DATOSPIR 600 Doc 511 900 MU1 DATOSPIR 600 USER S 02305 SOFTWARE ESPIROMETRIA W20 SPIROMETRY W20 SOFTWARE MANUAL DE USO SOFTWARE W20 Doc 511 8F0 MU1 W20 SOFTWARE USER S MANUAL Doc 511 8F0 MU2 07031 MODULO ESPIROMETRIA TURBINA PARA RHINOSPIR PRO TURBINE SPIROMETRY MODULE FOR RHINOSPIR PRO 03165 TRANSDUCTOR TURBINA TURBINE TRANSDUCER 01555 100 BOQUILLAS CARTON 100 DISPOSABLE MOUTHPIECES 02692 PINZA NASAL NOSE CLIP MANUAL USO DATOSPIR 600 Doc 511 900 MU1 DATOSPIR 600 USER S MANUAL Doc 511 900 MU2 02305 SOFTWARE ESPIROMETRIA W20 SPIROMETRY W20 SOFTWARE MANUAL DE
45. The graphics to appear on screen and in the report of each test The programming of times the allergen and the dose should be established by the clinical specialist A usual programming of the times can be the following Time for reading 1 5 min Time for reading 2 10 min Time for reading 3 15 min Time for reading 4 20 min Time before Solvent It is the time elapsed from the solvent application to the patient until the measurement is performed Time for reading n It is the time elapsed from the allergen application until the measurement is performed The time for the reading n should be always higher than the Time for reading n 1 Otherwise it will not be possible to continue The zero value is possible in order to cancel this concentration step 516 500 MU2 e REV 2 03 Chapter 2 SIBELMED W30 Software I 1 D d d do RY 1 gt d gt l gt h A o Epitelio Gato 516 500 MU2 e REV 2 03 Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 42 HARDWARE TEST This option enables to perform a device Test It enables to check the communications to perform an internal device Test CPU Test and a dynamic reading of the Flow and Pressure channels ADC s Test Verify that the information is transferred and that no error window appears In that case verify the interconnection and the option Links in the device setup UPDATE RHINOSPIR PRO This screen shows t
46. UOIJDNAISUT T 4o3deu 5 Chapter 1 Instructions for Use and Installation Sibelmed RHINOSPIR PRO User Manual 18 STANDARD ACCESSORIES No No No No No No No No 7 8 9 Transducers Unit Adults mask including connection tubes to the transducers unit Calibrator Disposable Mouthpiece User s Manual Power Supply Rhinomanometry Software SIBELMED W30 for PC Cable for data interconnection between RHINOSPIR PRO and PC 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 19 INSTALLATION AND SETUP E DEVICE INSTALLATION The rhinomanometer RHINOSPIR PRO is CLASS Ila according U to the EU Medical Device Directive 93 42 CEE and depending on the type of protection against electrical discharge established 2 in the standard EN60601 1 the classification of the device is 5 CLASS I type B The rhinomanometer RHINOSPIR PRO works through an external power supply connected to an external power supply connected to the mains supply from 200 to 240 V 50 60 Hz with earth connection under demand of 100 to 130 V 50 60 Hz The data link between the device and the computer is optically isolated The computer connected to the device has to meet the electrical safety standards for this type of device IEC950 EN60601 etc The maximum power required including the pneumotachometer heater is less than 25 VA The environmental working conditions are e Room temperature betwe
47. USO SOFTWARE W20 Doc 511 8F0 MU1 W20 SOFTWARE USER S MANUAL Doc 511 8F0 MU2 516 500 MU2 e REV 2 03 Sibel med RHINOSPIR PRO User Manual RELACION DE CONTENIDO PACKING LIST Pagina 2 de 2 RHINOSPIR PRO 516 508 030 REV 6 7 11 02493 MODULO ESPIROMETRIA DESHECHABLE PARA RHINOSPIR PRO DISPOSABLE SPIROMETRY TRANSDUCER MODULE FOR RHINOSPIR PRO 02269 TRANSDUCTOR DESHECHABLE Compuesto por DISPOSABLE TRANSDUCER Composed by Transductor Deshechable Disposable Transducer 01150 Adaptador para calibraci n Calibration adapter 03169 50 piezas deshechables 50 disposable pieces 02692 PINZA NASAL NOSE CLIP MANUAL USO DATOSPIR 600 Doc 511 900 MU1 DATOSPIR 600 USER S 02305 SOFTWARE ESPIROMETRIA W20 SPIROMETRY W20 SOFTWARE MANUAL DE USO SOFTWARE W20 Doc 511 8F0 MU1 W20 SOFTWARE USER S MANUAL Doc 511 8F0 MU2 02487 MODULO DE PULSIOXIMETRIA PARA RHINOSPIR PRO PULSEOXIMETRY MODULE FOR RHINOSPIR PRO 02487 MODULO DE PULSIOXIMETRIA Compuesto por PULSEOXIMETRY MODULE Composed by Placa pulsioximetr a interna Pulseoximetry internal board 01846 Sensor pulsioximetria Pulseoximetry sensor 03031 MODULO SOFTWARE PULSIOXIMETR A PULSEOXIMETRY SOFTWARE MODULE s MANUAL USO DATOSPIR 600 Doc 511 900 MU1 DATOSPIR 600 USER S 02305 SOFTWARE ESPIROMETRIA W20 SPIROMETRY W20 SOFTWARE MANUAL
48. ation Test 516 500 MU2 e REV 2 03 We mm BEE SAETTA RHINOSPIR PRO User Manual First line to configure for user Second line to configure for user Third line to configure for user RHINOMANOMETRY REPORT SIBELMED RHINOSPIR PRO Nano Grau Soler Anna Test Date 21 11 2003 Age y 48 Raference 2 Sex Woman Technician Height cm Motive Wgt Kg BMI Origin Smoker No ation CONC DILU SOLVENT 75 100 150 300 75 100 150 300 Right Flow ca3 s Left Flow cm3 s Addition Flow cm3 s Right Res Pa s cm3 Left Res Pa s cm3 Total Res Pa s cm3 CONCENTRATION 1 t3 Epitelio Gato Accum 5 mg 15 min Right Res Pa s cm3 0 34 0 40 0 49 0 68 147 147 147 147 Left Res Pa s cm3 0 23 0 27 0 33 0 47 100 100 100 100 Total Res Pa s cm3 0 14 0 16 0 20 0 28 119 119 119 119 ION 2 t3 Epitelio Gato Accum 15 mg 15 min Right Res Pa s cm3 0 59 0 67 0 83 1 16 250 250 250 Left Res Pa s cm3 0 34 0 40 0 49 0 68 147 147 147 147 Total Res Pa s om3 0 22 0 25 0 31 0 43 185 185 185 185 CONCENTRATION 3 t3 Epitelio Gato Accum 15 min Right Res Pa s cm3 0 81 0 95 1 18 1 67 354 357 359 Left Res Pa s cm3 0 34 0 40 0 49 0 66 m 147 147 147 Total Res Pa s cm3 0 24 0 28 0 34 0 49 207 208 208 209 Printing Date 26 11 2003 Page 1 of 2 321 372 455 645 321 372 455 645 641 744 909 1289 0 23 0 27 0 33 0 47 0 23 0 27 0 33 0 47 0 12 0 13 0 17 0 23 516 500 MU2 e REV 2 03 1axdeyo 359 UO
49. ccuracy in the dynamic measurements of pressure and flow CURRENT RHINOMANOMETRIC METHODS The nasal respiratory function can be measured by dynamic methods making the patient breathe actively or by static methods retaining his her breath and passing a flow through the nostrils at a certain pressure The anterior rhinomanometry consists of exploring each nostril separately and then the data are given for each nostril and for the total The posterior rhinomanometry consists of exploring simultaneously both nostrils In this case the data for each nostril are not reported but the total data for both nostrils At present we have the following rhinomanometric methods for application in the different clinical uses A Active anterior rhinomanometry using two probes one for each nostril The first one measures the pressure and the other the flow B Active anterior rhinomanometry using a facial mask One of the nostrils is sealed hermetically with an rer Suet RHINOSPIR PRO User Manual adhesive transparent tape crossed by a plastic tube which is used for recording the pressure variations whereas the flow is measured free field through a connection with the mask C Active posterior rhinomanometry Here the patient breathes through both nostrils into a mask connected to a pneumotachometer to measure the flow while the tube placed in the mouth and connected to a pressure transducer will measure the nasopharynx pressure
50. cm3 s Hostril Right Left 1 2 1 9 There is not unbalance between nasal cavities Possible obstruction in espiration in the left nasal cavity Possible obstruction in inspiration in the left nasal cavity Final diagnosis Basal Very Serious Obstruction TEST DILATION Hormal Ins flow at 150 Pa 455 cm3 s Moderate Obstruction Ins flow at 150 Pa 255 cm3 s Normal Ins flow at 150 Pa 709 cm3 s Light Obstruction Ins flow at 150 Pa 309 cm3 s Normal Ins flow at 150 Pa 382 cm3 s Y vi x Sibelmed RHINOSPIR PRO User Manual DATA Pressing this key all the results obtained up to the moment are displayed for each pressure value 75 100 150 and 300 This display shows the inspiration and the espiration values of the performed tests These results are Right nostril Flow cm s Left nostril Flow cm s Flow addition cm s Right nostril Resistance Pa s cm Left nostril Resistance Pa s cm Total Resistance Pa s cm Best Flow Worst Flow Br min DATA OF THE RHINOMANOMETRY E INSPIRATION ESPIRATION Right Flow cm3 s Left Flow cm3 s Addition Flow cm3 s Right Res Pa s cm3 Left Res Pa s cm3 Total Res Pa s cm3 Right Flow cm3 s Left Flow cm3 s Addition Flow cm3 s Right Res Pa s cm3 Left Res Pa s cm3 Total Res Pa s cm3 Best F Worst F Brimin VASOCONSTRIC vi X amp Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR
51. d NOT be used stacked or adjacent to other equipment The equipment must be stored and used within the temperature pressure and humidity ranges specified in this manual ELECTRICAL RISKS DO NOT remove the device or accessories cover Servicing and repair of the apparatus must only be carried out by trained personnel Contact with the voltage inside the system can cause serious injury DO NOT use damaged accessories or cables DO NOT submerge the device parts in any liquid IT CAN RESULT IN ELECTRICAL DISCHARGE Consult the equipment cleaning method in Chapter 8 Section 8 1 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE Sibelmed Manual del usuario RHINOSPIR PRO 9 To ensure vital safety features under the EN 60601 1 standard only equipment compliant with the electrical safety standards in force may be connected to this device To connect RHINOSPIR PRO to a non medical device with ground conductor you must install an additional ground conductor to the non medical device DO NOT use multiple mains sockets unless they comply with EN 60601 1 They can degrade electrical safety EXPLOSION RISKS DO NOT uses the device in presence of anaesthetics or flammable gases IT CAN RESULT IN EXPLOSION CONTAMINATON RISKS To avoid the contamination or infection risk the accessories should be cleaned according to the indications of this manual INTERFERENCE RISKS This is an electronic product so high frequency emissions can i
52. e are the transducers The RHINOSPIR PRO has two transducers of differential pressure for the Flow and Pressure measurement thet H The transduction function in the case of the measurement of Flow is performed by a Fleisch pneumotachometer type 1 The air flow through the pneumotachometer creates a difference of pressure that converts the electrical signal through a pressure transducer Fun hapter CI The Pressure signal is directly measured with a Pressure Sensor PNEUMOTACHOMETER FLEISCH The physical principle of the pneumotachometer Fleisch is based on the measurement of the pressure drop obtained between the ends of an obstruction which allows the air pass in a quasi capillar mode By applying the Poiseuille law the relation between flow and pressure is linear PRESSURE ct x FLOW In the pneumotachometer Fleisch the obstruction is formed by multiple capillar tubes Each tube presents a resistance to the air pass which produces a pressure drop in its ends The reason for the existence of so many tubes and their small diameter is that the air crosses the obstruction in laminar regime The relation flow pressure is linear for the range of the flow measurement FILTERS AND AMPLIFIERS The analogue signal emitted by the pressure transducer incorporated in the pressure transducers used in the device should be conditioned before it is digitalized and processed Sibelmed RHINOSPIR PRO User Manual 119 This cond
53. e nasal probes is shown 516 500 MU2 e REV 2 03 RHINOSPIR PRO User Manual TEST PERFORMANCE In the start screen press the option RHINO so that the RHINOMANOMETRY screen appears W 30 ANTERIOR ACTIVE RHINOMANOMETRY Ref 3 o x ROMA E av EN Os Dio FP 150 7300 300 p Res Pemas 1200 1000 800 600 400 200 200 400 600 800 1000 1200 800 E A R 4 L MEI ow Time 1200 H H 30 D D 120 750 180 210 gg ET 4200 120 Returns to previous menu Once we are in the tests window follow these steps to perform an active rhinomanometry a Press the icon NEW PATIENT or Options New Patient Patient Selection 516 500 MU2 e REV 2 03 1531 uorme2o0A04d IESSEN pue 1 3UWOULLUOUIYY 193deu REPE See Fem RHINOSPIR PRO User Manual b Enter the reference or the patient surname and press OK If the patient is not new in the data base a card with the test data appears to enter the convenient fields If the patient is new in the data base the patient card will appear so that we enter all his her data and next the test data card c BASAL test The Basal test will be performed according to the following steps 1 Press the icon B Basal or Options Basal 2 Select the nostril to be studied right or left in case of anterior rhinomanometry 3 Press the key TEST At this moment the graphics Flow Pressure Flow Time and or Pressure Time be
54. en 10 and 40 C e Relative humidity lower to 75 without condensation e Pressure from 430 to 800 mmHg from 4500 to 400 metres approx The net cable of the power supply has incorporated the protection conductor as the spirometer has to be connected to earth as any other electro medical device of CLASS I according to EN60601 1 You should take the precaution not to put the device near water splitting or other liquids Do not cover it with objects which prevent the air circulation around while it is functioning The operation sequence to setup the RHINOSPIR PRO for 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 20 the communication with the PC is 1 Connect the power supply output to the device power 0 connection No 5 2 Put the general switcher of the power supply in the position STOP with OFF light switcher 3 Connect the transducer unit No 7 in the connector No 2 4 Connect the transducers unit No 7 to the mask No 8 or small mask optional or nasal probe optional according to the attached drawing and the tubes colour codes 5 Connect a PC RS 232C serial port COM1 COM2 S COM3 or COM4 to the RS 232C connector of the unit No 4 through the cable No 14 6 Connect the power supply to the mains according to the voltage and mains frequency specified in the power supply INSTALLATION OF SOFTWARE W30 AVISO Si va a proceder a instalar bajo sistemas Windows NT4 Windows
55. fers an explanation on the helps incorporated in the Rhinomanometry SIBELMED W 30 Software ABOUT SOFTWARE This screen enables to enter through an index to the explanation of the different options available in the program ABOUT MAIN MENU This screen enables to enter the explanation of the different options in the main menu 516 500 MU2 e REV 2 03 9JEMIJOS OEM AINTIAIS 7 194dey9 Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 66 516 500 MU2 e REV 2 03 A Er LENET RHINOSPIR PRO User Manual 3 RHINOMANOMETRY AND NASAL PROVOCATION TEST DESCRIPTION OF THE RHINOMANOMETRY TEST 516 500 MU2 e REV 2 03 1531 uome2oA04Jd IESSEN pue 1 3WO0UPWOUIYY E 131dey Se Axes RHINOSPIR PRO User Manual INTRODUCTION The rhinomanometry is an objective exploratory technique irreplaceable for the study of the resistances offered by the nasal structure to the air flow The idea that the simple nose exploration is not enough to evaluate correctly the influence of the anatomic deformities in the nasal aerodynamics has been through the development of the speciality deeply researched by different direct and indirect methods of scarce reliability The advances of the current technique have enabled to substitute the obsolete rotor flowmetres and manometers by hypersensitive pressure transducers and pneumotachometer controlled by a microprocessor with minimum standard errors of high a
56. flow at 150 Pa 309 Ins flow at 150 Pa 182 Ins flow at 150 Pa 491 1 7 lt 1 9 There is not unbalance between nasal cavities Nostril Nasal Right Normal Ins flow at 150 Pa 455 Nostril Nasal Left Moderate Obstruction Ins flow at 150 Pa 255 Total inspiratoy flow Normal Ins flow at 150 Pa 709 TEST VASOCONSTRIC Nostril Nasal Right Normal Ins flow at 150 Pa 382 Nostril Nasal Left Normal Ins flow at 150 Pa 382 Total inspiratoy flow Normal Ins flow at 150 Pa 763 L Espiration 20097 cm3 nspiration R Pa Basal 1200 900 600 300 300 600 900 1200 Dilation Vasoconstric gt 1200 Printing Date 26 11 2003 Page 2 of 3 516 500 MU2 e REV 2 0 26 11 2003 cm3 s cm3 s cm3 s cm3 s cm3 s cm3 s cm3 s cm3 s cm3 s ci 2 193deu 5 359 uome2oA04d SEN pue ArJaWOUeWOUIYY Jibelmed a Soyer RHINOSPIR PRO User Manual DESCRIPTION OF NASAL PROVOCATION TEST INTRODUCTION The nasal provocation test NPT is a diagnostic technique essential in the allergic rhinitis The test consists of reproducing total or partially the nasal symptoms after the contact with the irritating allergen Basically the test can be performed a Through the clinical observation of the symptoms b Through the study of the nasal changes observed through rhinoscopy c Through rhinomanometry specially through anterior
57. g TT Patient Tests Param Valor Ref 001 21 11 2003 11 05 ANT R R VEL gab H jo Chapter 2 SIBELMED W30 Software Sibel med RHINOSPIR PRO User Manual 44 The fields corresponding to the card are Field Type No Characters Index A N 10 Reference A N 4 Birth Date N 8 dd mm yyyy Name A N 20 Surname A N 35 Occupation A N 25 Sex Address A N 46 City A N 28 Postal Code A N 5 Country A N 10 Telephone 1 A N 10 Telephone 2 A N 10 Commentsi A N 74 Comments2 A N 74 A N Alpha numeric field N Numeric field By pressing Options a pull down menu appears with the following options NEW It creates a new patient Then a dialogue box appears and the new reference is required If we write a used reference for other patient the program warns us DELETE It deletes a patient and all his her corresponding tests RETRIEVE It retrieves the deleted records For this purpose it is necessary to enter the Options menu in the main screen and select Data Base Maintenance Next activate Present deleted records CONSULT It searches the wished patient card According to the selected index the search is performed by reference 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 45 surname or record number EXPORT Access to the export window END Go back to the previous window The option Consult is also accessible with the icons placed in the bottom It also has slow advance keys
58. gin to be recorded according to the selection made in Graphics and Others in the Setup Menu This situation can last indefinitely This is intended for the patient relaxation and the user sees if the graphics are progressing adequately The text in the key TEST changes to START after two or three seconds of the first press The rest of keys also disappear and a new text appears Cancel which enables to change and discard the manoeuvre at any moment 4 When the user considers convenient and according to the graphics shown presses the key START to initiate the process of real sampling of the test reinitiating the new samples and deleting the previous ones In this situation besides the previous graphics the butterfly graphic Flow Pressure is shown Once the real sampling has started the key START changes to STOP The system is sampling during 30 seconds and afterwards finishes and emits a tone except if the user has previously gt Seer A RHINOSPIR PRO User Manual pressed STOP It is convenient that there are at least three or four respiratory cycles in each test for an adequate sampling At the end the system displays the curve Flow Pressure averaged as well as the interval corresponding to Flow Time and or Pressure Time curves In the lower part of Flow Pressure curve the determination coefficient is displayed squared coefficient of correlation r2 according to the following curve adjustme
59. he used port and the transference speed It enables to update the device internal software firmware to a new version This will enable to have always the software updated without the need of SIBEL s technical service For this purpose select the used program and the device serial number Next press the key to send Send In this moment the updating will start and it will take about 1 minute Warning No cancel the loading process until this has ended From that moment the device is updated with the new firmware To update the SIBELMED W30 software follow the same process as the one described in section 1 4 1 INSTALLATION END To exit the program and go back to Windows execute the option End 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 43 OPTIONS MENU DATA BASE The Rhinomanometry W 30 Software can work with different data bases according to the user s needs This option enables to enter the data base defined in the system setup and consequently store and manage the information generated in the tests For this purpose it has the following sub options PATIENTS This screen enables to enter any patient card saved in the data base and display the different tests with the most important parameters Patient Card DataBase sibel Options Index Reference 24 d Status Day Monti Year Age y Reference i Birth Date 13 2o suenan Cin vom e AAA coste TT Je m
60. ill be carried out according to their manufacturers instructions If any problem doubt suggestion etc appear before during or after the use of the device it is recommended to follow these steps 1 Use the helps available in the program 2 Consult the Rhinomanometry W 30 Software User s Manual 3 Contact with the After Sales Service of SIBEL S A After Sales Service of SIBEL S A C Rosell 500 08026 BARCELONA SPAIN Tel 34 93433 54 50 FAX 34 93436 16 11 E mail sat sibelmed com Chapter 6 Preservation Preveventive and Corrective Maintenance Sibel med RHINOSPIR PRO User Manual 126 CORRECTIVE MAINTENANCE The corrective maintenance consists of keeping the device ina good condition of use which due to bad operation or bad use has been put out of service and which is necessary to repair In case of detecting a break down in the system which impedes the normal use unplug the device from the power supply and contact the After Sales Service of SIBEL S A specifying as detailed as possible the type of anomaly detected After Sales Service of SIBEL S A C Rosell 500 8 08026 BARCELONA ESPANA Tel 34 93 433 54 50 FAX 34 93 436 16 11 E mail sat sibelmed com 516 500 MU2 e REV 2 03 Sibelmed 7 RHINOSPIR PRO User Manual 127 7 n MODIFICATIONS 516 500 MU2 e REV 2 03 SUOI2E2UyIpOW Z 133deyy Chapter 7 Modifications Sibe med RHINOSPIR PRO User Manual 128 516
61. ill be taken out Possible obstruction in expiration in right left nostril Possible obstruction in inspiration in right left nostril The doctor will be responsible for confirming or not the possible obstruction If an obstruction exists the Final Diagnosis will be modified Final Diagnosis The final diagnosis is established based on the diagnosis for the total inspiratory flow of Step 2 This is 1 Normal Test 2 Slight Obstruction 3 Moderate Obstruction 4 Serious Obstruction 5 Very Serious Obstruction If there has been unbalance between nostrils Step 3 the diagnosis will increase a grade from 1 to 2 from 2 to 3 etc If there is an expiratory or inspiratory obstruction Step 4 the diagnosis will increase in a grade Although two possible obstructions exist the diagnosis will increase only a maximum of one grade 2 DILATION TEST In the Dilation test the flows Steps 1 and 2 are evaluated but the quotient between best and worst nostril is not calculated Evaluating the linearity of the flow pressure curve Step 4 would only confirm a wing collapse detected in one of the nostrils in the Standard test Chapter 3 Rhinomanometry and Nasal Provocation Test ER Se Fem RHINOSPIR PRO User Manual 3 VASOCONSTRICTION TEST In the Vasoconstriction test as in the Dilation test the flows Steps 1 and 2 are evaluated but the quotient between best and worst nostril is not calculated Evaluating the
62. ith a hand Pressing the mouse left key the corresponding help will appear 516 500 MU2 e REV 2 03 9JEMIJOS OEM AINTIAIS 7 403deyD Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 30 MAIN MENU This screen shows the main options available in the SIBELMED W 30 Software with the corresponding sub options SETUP MENU e Printer Selection e Data Base e Links e Report Header e Graphics and Others e NPT Programming e Hardware Test e Update RHINOSPIR e End OPTIONS MENU e Data Base e Rhinomanometry e Calibration HELP MENU e About Helps e About Software 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 31 RHINOMANOME TRY SOFTWARE SIBELMED W 30 e About main Menu Entering each option the corresponding information will be available It is also possible to have five links for some of the menus corresponding to Data Base Rhinomanometry Calibration Help and End Next a description of each function available in the SIBELMED W 30 software follows 516 500 MU2 e REV 2 03 9JEMIJOS OEM AINTIAIS 7 403deyD Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 32 SOFTWARE SETUP The SIBELMED W30 Software is a versatile program with many working possibilities Some of them could not be useful for certain users Therefore once the process of Installation and Setup is finished it is necessary to adapt it to each need In this way the
63. itioning consists of an amplifying stage which adapts the dynamic range of the pressure transducer to the digitalizer range and a filter stage which removes the parasite signals This filter limits the system measurement band from 0 to 20Hz ANALOGUE DIGITAL CONVERTER The analogue digital converter samples the analogue signal when the processor indicates it It also quantifies the analogue signal of its input in the case of the pressure transducer It gives a digital word at the output which expresses a numeric value The converter used in the RHINOSPIR PRO has 12 bits and then 4096 levels available to assign to the pressure and flow signal The 2048 superior levels are used for the espiratory flows and the 2048 inferior levels for the inspiratory flows Both the resolution and the dynamic range converter used meet widely the specifications and recommendations of the international organisms MICROPROCESSOR PHYSICAL DESCRIPTION The microprocessor system consists of a series of electronic devices which store manage receive and send pieces of information They are mainly divided into e Program of hardware basic control BIOS resident in EPROM of 32KBytes e Rhinomanometry program and device management Data base for tests resident in memory FLASH of 1 MBytes FIRMWARE e RAM Memory of 128KBytes for storing the device setup and status variables e Central Process Unit CPU er 5 Functioning Principles L
64. lect Data Base 516 500 MU2 e REV 2 03 B4IEMYOS OEM AINTIAIS 7 403deyD Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 34 Warning Consult with the Administrator of your system in case of doubt The path or directory can be selected through the pull down menu or simply by entering it with the keyboard The name for the directories cannot surpass the length of 9 characters each If this happens an error message appears Incorrect Data Base name When choosing a path the Data Bases are listed in the inferior pull down menu BASE NAME When choosing a Data Base the application can give an error message It is not a Data Base If this happens and the selection really corresponds to a Data Base the base should be created in the same path and base name This is achieved by choosing in the Setup menu Data Base and the option Create Data Base The existent data WILL NOT BE LOST When the base is confirmed a PASSWORD is required which should be the same entered when created New Data Base vi si amp 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 35 NEW DATA BASE It enables to create a data base For this purpose enter the path or directory and the base name When it is confirmed a PASSWORD is required and a later reconfirmation of the password Delete Data Base mum 3 sibel T DELETE DATA BASE When deleting a data base the
65. lt The steps to follow are EXPORT In the origin PC through the export module the tests have been stored in the files PRUEBAS CSV GRAFOO1 CSV 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 49 GRAF002 CSV in the selected directory DATA TRANSFER These files can be sent by internet to other destination PC or can be transferred by means of an interchangeable disk or a floppy disk IMPORT In the destination PC the files should be stored in the default directory C RINOPRO TMP in order to import the tests correctly The key Browse enables to display the directory of the tests contained in the file TMP PRUEBAS CSV Then the interesting tests can be selected by clicking over the corresponding test or select all the tests through the key S AII Finally you can store the selected remote tests in the data base by clicking over the key Import 516 500 MU2 e REV 2 03 3J1EM1JOS OFM AINTIGIS 7 193deu5 Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 50 DATA BASE MAINTENANCE DELETE BASE It deletes the selected data base Before that a warning message appears RE INDEX It enables to reorder the data bases of patients and tests and retrieve errors if they exist PRESENT DELETED RECORDS It enables to retrieve the deletes records PACK This option is used to reorder the records in the data base after having deleted some patients This option can be
66. ndard test we evaluate the inspiratory flow of each fossae the total inspiratory flow the quotient between the best and the worst nasal fossae and the linearity of the flow B AN LR Fe RHINOSPIR PRO User Manual pressure curve In the Dilation and Vasoconstriction tests the flow for each nostril and the total flow are evaluated These tests are used mainly to confirm a problem detected in the Standard rhinomanometry test 1 STANDARD TEST The following steps are considered Step 1 A diagnosis is established for each nostril individually as follows The inspiratory flow at a pressure of 150 Pa is evaluated as this is the most significant in the medium phase of the respiratory cycle If the inspiratory pressure of 150 Pa is not reached the flow value at 100 Pa will be studied If the Flow at 100 Pa does not exist either then no diagnosis will be performed If 150 Pa Men Women Diagnosis F gt 350 F gt 315 Normal 300 lt F lt 350 265 lt F lt 315 Slight Obstruction 250 lt F lt 300 215 lt F lt 265 Moderate Obstruction 150 lt F lt 250 115 lt F lt 215 Serious Obstruction F lt 150 F lt 115 Very Serious Obstruction If 100 Pa Men Women Diagnosis F gt 275 F gt 265 Normal 237 lt F lt 275 230 lt F lt 265 Slight Obstruction 200 lt F lt 237 190 lt F lt 230 Moderate Obstruction 125 lt F lt 200 110 lt F lt 190 Serious Obstruction F lt 125 F lt 110
67. nose resistances Maintain the patient in repose during a minimum of thirty minutes before the test Keep the place where the study is performed into constant limits of temperature and relative humidity Besides the previous standards apply those instructions which the specialist or technician who performs the test considers Chapter 3 Rhinomanometry and Nasal Provocation Test RHINOSPIR PRO User Manual aero necessary Specially explain to the patient what the test consist of that this does not involve any risk and it is not painful and that he she should breathe calmly etc PLACING THE MASK With the patient sat down the nostrils are cleaned with a detergent to remove the cutaneous grease There are several techniques for the placing of the pressure tube in the nostril as a probe a sponge an adhesive membrane etc The rhinomanometry regulations recommend using a method which does not deform the nose to avoid false measurements The RHINOSPIR PRO can use any of the indicated methods but we recommend using the one with the adhesive membrane as it is the method with fewer deformities in the nostril It is easy to put and gets a perfect hermeticism AH RAT ON 516 500 MU2 e REV 2 03 Ca nexten RHINOSPIR PRO User Manual 73 The placing technique is shown in the next drawing The pressure tube is put in the contrary nostril to the one which is being explored To check
68. nt values gt 0 8 Very reliable gt 0 5 y 0 8 Reliable gt 0 25 y lt 0 5 Moderate lt 0 25 Low It also displays the bar graphic for Resistance corresponding to the studied nostril and the Total Resistance at 150 Pa The user can select the resistance at other pressures 75 100 150 or 300 Pa NOTE If when finishing the test the technician realizes that the wrong nostril was selected whereas the patient had the other one you can enter Options Change Nostril and activate this option change the graphics and position associated values If only one nostril has been performed the data pass from one to the other If both nostrils have been performed they interchange for each other 5 When one nostril has been explored the user can choose any of these options e Repeat the test in the same nostril e Study the other nostril e Display the data through the key DATA Chapter 3 Rhinomanometry and Nasal Provocation Test ER Se Zoe RHINOSPIR PRO User Manual e Display the espiratory or inspiratory Resistances at different pressures 75 100 150 or 300 e See the diagnosis through the key Diagnosis e Save the test in the Data Base e Print the test e Perform a Dilation or Vasoconstriction test e Exit the test 6 For the test performance in the other nostril follow the previous steps changing the nostril probes to the patient and selecting on the screen the nostril Right or Left to be explored
69. nterfere with the correct use For this reason the products which can generate interferences radios cellular phones etc should be kept apart The portable or mobile radiofrequency devices can affect the normal functioning of the electronic medical devices This is a medical electronic device and as such it needs special precautions regarding the electromagnetic compatibility EMC and it should be installed and setup according to the EMC information attached See Appendix 1 ELECTROMAGNETIC COMPATIBILITY The use of transducers accessories and cables different to the ones specified here except the transducers and cables sold by the manufacturer as spare parts could adversely affect patient safety cause a malfunction of the equipment and Safety Sibelmed Manual del usuario RHINOSPIR PRO 10 or produce an increase of the emissions or a decrease in the device immunity REMOVAL OF WASTE FROM ELECTRICAL AND ELECTRONIC APPLIANCES BY DOMESTIC USERS IN THE EUROPEAN UNION A mmm This symbol on the product indicates that you cannot dispose of the product with domestic waste However any removal of this type of waste is the responsibi lity of the user and must be taken to a designated collection point for the recycling of electrical and electronic appliances The separate recycling and collection of this waste at the time of removal will help preserve natural resources and ensure that recycling protects your health and the en
70. phy of right inferior turbinate tail Case 1 Sensitive to vasoconstrictors Basal Test Dilation Test Vasoconstriction Test Expiration Inspiration Expiration Inspiration A Expiration Inspiration e L E R IL 516 500 MU2 e REV 2 03 1581 UOIJ22010 d ESEN pue 1J3WO0ULUWOUIYY E 1e3deu Chapter 3 Rhinomanometry and Nasal Provocation Test Es Sse Auer RHINOSPIR PRO User Manual Case 2 Not sensitive to vasoconstrictors Basal Test Vasoconstriction Test Expiration Inspiration R Expiration Inspiration Expiration Inspiration L L Josep Maria Fabra Clinical Manager of Servicio de Otorrinolaringolog a del Hospital de la Santa Creu i Sant Pau Chairman of Comisi n de Rinolog a y Alergia de la SEORL y PCF With the collaboration of R D Department SIBEL S A 516 500 MU2 e REV 2 03 EIS pa A RHINOSPIR PRO User Manual PROCEDURE FOR RHINOSPIR PRO CALIBRATION The rhinomanometry standards recommend the user to calibrate the device Due to the time alterations the characteristics of the electronic circuits and or mechanical elements may be modified which cause a change in the calibration factor For this reason a calibration system has been included from a calibrator resistance and or an external manometer The actuation procedure is described in the Chapter 2 CALIBRATION of this manual 516 500 MU2 e REV 2 03 359 uome2oA04dg
71. r any deviation is suspected When pressing the key Pres in the initial screen the following one appears Pressure Calibration by Column x 1 003 i 10 11 2003 Technician name of the technician who performs the calibration Pressure Pa pressure in Pascal which is applied to each channel Gain Factor calibration factor which acts over the pressure channel both in the espiratory and the inspiratory cycle Cal Date date of the last calibration of the pressure channel Data Base of the last 10 calibration Original factors or manufacturer s default factors factors 1 00 516 500 MU2 e REV 2 03 9JEMIJOS OEM AIWTIYIS 7 403deyD Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 64 Pa key to verify or calibrate the pressure channel In this screen each of the last performed calibration records are displayed up to a maximum of 10 4 10 11 2003 09 01 500 1 003 0 5 SIBEL S A e gt It also shows the date time device gain factor and technician for each calibration This report can be printed as a quality guarantee of the test If a record has been wrong by any cause it can be deleted 516 520 000 Transducers unit 526 530 003 Calibrator 516 531 040 Transducer Adaptor 510 121 060 Disposable Mouthpiece for the calibrator Artificial nose assembly 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 65 HELP MENU ABOUT HELPS This screen of
72. r Manual 1 C75 Fico Riso 7300 Setup Options mb sol ERASE edel Renters to the Vasoconstricton test Press the icon V or Options Vasoconstriction to enter the test In this screen enter the allergen and the dose to be applied This information will be printed in the report The procedure for the Vasoconstriction test is the same to the one described for the Basal with the difference that a CHRONOMETER appears in the upper part if we have enabled it from the Setup menu which can be used to control the time between the first and the second nebulization of vasoconstrictor substance and between the second nebulization and the start of the test These times can be programmed in the option SETUP GRAPHICS AND OTHERS in the Main Menu The icon SEL enables to select the graphics which appear in the axes flow pressure A vasoconstriction test can be performed to the patient on screen or to other one to whom a basal test has been performed in the last three hours When the tests have been finished we will obtain the following graphics LE ANTERIOR ACTIVE RHINOMANOMETRY CONSTRICTION Ref 3 Puig Sala Jordi AE Espiration 1200 ycm amp s Inspiration R oot 2 00 p Res P ma s 00 600 1200 1000 800 600 400 200 20 516 500 MU2 e REV 2 03 ING Fen RHINOSPIR PRO User Manual RHINOMANOMETRY REPORT Pressing the key print a window appears which enables to select the repo
73. record by record or fast advance keys each 10 records to navigate through the data base until the wished card is found The card shows the number of records in the base and the number of record selected 516 500 MU2 e REV 2 03 9JEMIJOS OEM AIWTIYIS 7 403deyD Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 46 EXPORT TEST IN CSV FORMAT This option enables the export of tests to a format delimited by inverted commas files with extension CSV so that they can be read by other systems When entering this option the following window appears This window consists of two sub windows RHINOMANOMETRY SOFTWARE SIBELMED W 30 e One window for patients where all the patients stored in the data base are enumerated e One window for the patient tests complementary to the previous one where all the tests for the patient selected in the first window are enumerated At the beginning of each text line a box that enables to select the wished tests appears Only the selected tests will be exported The menu options accessible from this window are 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 47 SETUP Export Destination It enables to select the path directory By default this directory is C RINOPRO TMP The tests data are stored in the file PRUEBAS CSV and the points of the pressure graphics associated in GRAFOO1 CSV Define Export File HE Nombre de archivo Carpetas PRUEB
74. riction Test Right Nostril Slight Obstruction Inspiratory flow at 150 Pa 305 cm s Left Nostril Normal Inspiratory flow at 150 Pa 450 cm s Total Inspiratory flow Normal Inspiratory flow at 150 Pa 755 cm s 516 500 MU2 e REV 2 03 359 uome2oA04dg ESEN pue 1J3WO0ULUWOUIYY E 1e3deu Chapter 3 Rhinomanometry and Nasal Provocation Test dy qeu Sse Auer RHINOSPIR PRO User Manual GRAPHIC EXAMPLES OF WING COLLAPSE AND HYPERTROPHY IN TURBINATES TAIL Wing collapse of the right nostril The following rhinomanometric test shows a wing collapse The wing collapse disappears in the dilation test but is not affected by the vasoconstrictor substance n Inspiration Inspiration R L Vasoconstriction Test piration Ins lon L R Hypertrophy of turbinate in the right nostril Case 1 This would be a typical case of turbinate hypertrophy to be treated pharmacologically n Inspiration Vasoconstriction Test Expiration Inspiration L 516 500 MU2 e REV 2 03 PEINE Soyer RHINOSPIR PRO User Manual lr Case 2 This second case presents a hypertrophy of the inferior right turbinate that does not respond to the vasoconstrictors This is a typical case to be treated surgically Basal Test Dilation Test Vasoconstriction Test Expiration Inspiration R Expiration Inspiration R Expiration Inspiration L L Isolated Hypertro
75. rt in different setups If the option TOTAL is selected the united report for all the performed tests is printed If you mark each test separately a report by each performed test will be printed Next a complete report of the three tests Basal Dilation and Vasoconstriction is presented The date and values included in these reports are ficticious 516 500 MU2 e REV 2 03 1581 uome2oA04dg ESEN pue A132WUOUEWIOUIYY E 1e3deu B MENTE Fe RHINOSPIR PRO User Manual First line to configure for user Second line to configure for user Third line to configure for user RHINOMANOMETRY REPORT Name Puig Sala Jordi Age y 30 Sex Man Height cm Wgt Kg BMI Smoker No BASAL Right Flow cm3 s Left Flow cm3 s Addition Flow cm3 s Right Res Pa s cm3 Left Res Pa s cm3 Total Res Pa s cm3 Best F Worst F Br min DILATION Right Flow cm3 s Left Flow cm3 s Addition Flow cm3 s Right Res Pa s cm3 Left Res Pa s cm3 Total Res Pa s cm3 Best F Worst F Br min VASOCONSTRIC Xilometazolina 15 mg Right Flow cm3 s Left Flow cm3 s Addition Flow cm3 s Right Res Pa s cm3 Left Res Pa s cm3 Total Res Pa s cm3 Best F Worst F Br min COMMENTS 75 218 128 0 34 0 58 0 22 1 70 18 0 75 321 180 500 0 23 0 42 1 79 18 0 269 269 539 0 28 0 28 0 14 1 00 18 0 Printing Date 26 11 2003 Inspiration 100 150 253 309
76. ry and Nasal Provocation Test 75 C100 F150 7300 300 p Res P emss The steps to perform the NPT are the following a Select Setup NPT Programming and verify that the data i NPT PROGRAMMING SE SE SESESESI SE SE XE SEI I 516 500 MU2 e REV 2 03 B MALMEN TELT e RHINOSPIR PRO User Manual comply with the test requirements b Press the icon NEW PATIENT or Options New Patient Patient Selection x Enter the reference or the patient surname and press OK If the patient is not new in the data base a card with the test data appears to enter the convenient fields If the patient is new in the data base the patient card will appear to create it and next the test data card c BASAL Test It is advisable to perform a basal rhinomanometry to the patient before applying any substance in order to have a reference of his her condition Next a saline solution should be applied in the chosen nostril in general the nostril that presents less resistance at 150 Pa e Press the key corresponding to the Basal and proceed as described in section 3 2 3 e In this step the sampling of basal or initial values is performed e In the test of NPT inserting Patients is not possible and one nostril or both can be analyzed e The graphics Flow Pressure Flow Time and Pressure Time are the same as those of the active rhinomanometry Nevertheless a graphic of Resistances for each of the test
77. screen shows the base or bases available in the system The user selects the one to be deleted When confirming the deletion a PASSWORD is required the same entered when created When a data base is deleted the patients records and the graphics parameters and other information available is deleted therefore make sure before executing this options It is very important to enter a password easy to remember If you forget the password contact with the After Sales Service of SIBEL S A who will indicate you the process to follow 516 500 MU2 e REV 2 03 9JEMIJOS OEM AIWTIYIS 7 403deyD Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual MODIFY PASSWORD It enables to modify the password for a data base For this purpose the system requires the new password and the reconfirmation of it LINKS From this screen you can select e The device RHINOSPIR PRO e The transducer type Rhinomanometry The option disk includes stored signals which enable to verify the software without using the transducers e The serial channel which communicates the device and the computer e The speed of this communication baud rate 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 37 Device RHINOSPIR PRO sl Transducer RHINOMANOMETER DISK Serial Ze COMI con2 f COM3 C COMA Speed 19200 REPORT HEADER This screen enables to insert a three line header in the report wi
78. sures may be necessary such reorien ting or relocating RHINOSPIR PRO D Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 516 500 MU2 e REV 2 0 3 Sibelmed RHINOSPIR PRO User Manual Recommended separation distances between portable and mobile RF communications equipment and RHINOSPIR PRO RHINOSPIR PRO is intended for use in an electronic environment in which radiated RF disturbances are controlled The costumer or the user of RHINOSPIR PRO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and RHINOSPIR PRO as recommended below according to the maximum output power of the communica tions equipment bn apice uir Netus Separation distance according to frequency of transmitter mitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz v Bar Boe vie 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated 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 Note 1 At 800 MHz the separation distance for the higher frequency applies
79. system will be personalized in each case and its handling and functioning will be easier Next the different options that can be personalized in the setup menu are detailed PRINTER SELECTION The screen shows the printer selected by the operative system as well as the available printers up to that moment If the printer available is not in the list it is necessary to install it using the process defined by the operative system Consult the Printer Manual Configurar impresion HE m Impresora Fropiedades Nombre MAREAS AR ee d Estado Listo Tipo HP LaserJet 4 4M PS Ubicaci n D Comentario Papel rientaci n 4 Tamafio a4 y Vertical Origen Selecci n autom tica y f Horizontal Red Cancelar 516 500 MU2 e REV 2 03 Sibel med RHINOSPIR PRO User Manual 33 DATA BASE The option Maintenance included here refers only to the data base and not to the device hardware whose information should be consulted in the corresponding section in the User s Manual The options included are DATA BASE SELECTION It enables to select a data base For this purpose enter the path or directory where the base is located and select the name The path can be relative e g BDSIBEL BASE or absolute e g C BDSIBEL BASE It is also possible to use Network units as long as they are shared and reading and writing permits are granted Se
80. tep of concentration The counter keeps discounting invariably CALIBRATION In this section a description of the different screens and functions which setup the calibration program is made The procedure to perform a device calibration is described in section 3 of this manual i Calibration with Artificial Nose 258 oma s SIBEL S A 18 11 2003 This software enables to calibrate the flow channel through the artificial nose and the pressure channel through the application of a known external pressure A Calibration through artificial nose When pressing CALIBRATION we enter the following screen Flow at 150 Pa flow that circulates in the calibrator when it 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 61 presents a pressure difference of 150 Pa Technician name of the technician who performs the calibration Esp Factor calibration factor which acts over the espiratory cycle Insp Factor calibration factor which acts over the inspiratory cycle CALIBRATION x Cal date date of last calibration CAL key to start the calibration process Data Base of the last 10 calibrations Original Factors or manufacturer s default factors factors 1 00 Pa key to verify or calibrate the pressure channel With the key Base the following screen is presented 516 500 MU2 e REV 2 03 342M1JOS OEM AINTIAIS 7 403deyD Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual
81. th the name of the centre doctor address etc Report Header E Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 38 GRAPHICS AND OTHERS This screen enables to select e The graphics Flow Time Pressure Time and Flow Pressure to appear on screen and the report for each test Basal Dilation and Vasoconstriction e The times between the first and second nebulization and between the second one and the test in the Vasoconstriction e The diagnosis type e The rhinomanometry type anterior or posterior e The software s language e It also enables to establish the time of the chronometer in minutes in the vasoconstriction test between e First and second nebulization of the substance e Second nebulization and the test It also has a selection for the manufacturer s default setup of the parameters previously commented For this purpose press the key in the right lower part of the window 516 500 MU2 e REV 2 03 Chapter 2 SIBELMED W30 Software 516 500 MU2 e REV 2 03 Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 40 NPT PROGRAMMING With this option we can setup the parameters relative to this test e The time to be elapsed before applying the solvent and from the application of each substance until the performance of the tests e The type of allergen to administer to the patient e The doses of this in each con concentration e
82. tions a preservation and maintenance directed first of all to safety of the patient operator and environment and secondly to ensure the reliability and accuracy of the functions for which it has been developed All of this means a series of routines which must be carried out PRESERVATION Preservation is the action directed to maintain the device in a correct operation condition and the person in charge of it does not require any special technical quality except for the proper knowledge of the functions and manipulation of the device It is normally performed by the user The operations to be carried out are CLEANING OF THE DEVICE POWER SUPPLY AND TRANSDUCER UNIT The power supply and the transducers unit are cleaned with a soft cloth slightly wet with water and detergent To perform the disinfection of these units apply alcohol at 70 with a soft cloth It is recommended to perform this cleaning weekly CLEANING OF THE PNEUMOTACHOMETER In general all the devices for respiratory therapy require a high disinfection or sterilization To perform this high disinfection we should dismantle the thermostatized pneumotachometer separate all the detachable elements and then submerge it during 10 minutes in a glutaraldehide solution at 2 INSTRUNET with glutaraldehide This disinfection has to be performed with every new patient Sibelmed RHINOSPIR PRO User Manual 123 CLEANING OF THE MASK NOSTRIL AND NASAL PROBE
83. to be used with medical de vice labels labelling andi nformation to be suplplied 2 Related to the manufacturer QUALITY e EN ISO 13485 2012 AC 2012 Quality management sys tems Requirements for regulatory purposes e EN ISO 9001 2008 quality management Requirements e EN ISO 14971 2012 Risk management in medical equip ment WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of RAEE 2002 96 CE Directive 3 To be satisfied by the user DATA PROTECTION e Compliance with LOPD and 95 46 CE Directive WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of RAEE 2002 96 CE Directive 516 500 MU2 REV 2 03 suomeoyi2eds e21u29 y 1o93deu Chapter 4 Technical Specifications SE I gt ED A gt Ka Sibelmed 7 RHINOSPIR PRO User Manual 114 SIMBOLOGY SERIAL NUMBER MANUFACTURER The date of manufacture name and address of manufacturer TEMPERATURE LIMITATION HUMIDITY LIMITATION PREASURE LIMITATION DIRECTIONS FOR USE APPLICABLE PART B LOT CAUTION LAND DISPOSAL OF ELECTRICAL OR ELECTRONIC DEVICES BY DO MESTIC USERS IN THE EUROPEAN UNION 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 115 USEFUL LIFE Rhinospir Pro 7 years Neumotacometer 1 year or 900 disinfections Mask nostril cone and nostril probe 900 disinfections 516 500 MU2 e REV 2 03 SUONEIYINSdS e2iu29 y 193deu Chapter 4
84. up Unit Recommended RS 232C Port Necessary he a H 1 INSTALLATION AND PRINTER REQUISITES Ar e Chapt The printer installation in the operative system Microsoft Windows will be done according to its User s Manual It is recommended that the printer meets the following requisites e Resolution higher or equal to 300 dpi dots per inch e Printing speed higher than 5 pages per minute e Possibility of printing in colour Also the printer should meet all the current standards applicable to this type of printers WARNING If you have any problem doubt suggestion etc before during or after the use of the device it is recommended to follow these steps 1 Use the helps offered by the program 2 Consult this User s Manual 3 Contact with the After Sales Service of SIBEL S A or your distributor Sibelmed RHINOSPIR PRO User Manual 25 SETUP If all indications have been followed the device is ready to be commissioned Press the interruptor number 12 to ON position Turn on the PC computer and run W30 software Click on the W30 icon in Programs SIBEL in the Windows menu Start Press OK in the Window About to reach the main menu 516 500 MU2 e REV 2 03 uomej e3sug pue esf 104 SUOIJDNAISUT T 4o3deu 5 Chapter 1 Instructions for Use and Installation Sibelmed RHINOSPIR PRO User Manual 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 27 2
85. used when needed but it may take some time depending on the quantity of information stored 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 51 RHINOMANOMETRY In this section we have a description of the different screens which configure the specific part of rhinomanometry The procedure to perform the rhinomanometry test and the nasal provocation test NPT are described in section 3 of this manual This window enables to perform the rhinomanometry tests Basal Test Dilation Test Vasoconstriction Test Nasal Provocation Test NPT Vasoconstriction Test Nasal Provocation Test NPT W 30 RINOMANOMETRIA ACTIVA ANTERIOR BASAL Ref 22 75 Fico 150 71300 Pi ins F es 3 00 p Res PYmas R 1200 Presi n Tiempo Flujo Tiempo o x 1200 Pa em3 s 41200 eee 30 60 90 120 150 180 no 240 270 l 1201 516 500 MU2 e REV 2 03 JemYOS OEM AINTIAIS 7 194dey9 Chapter 2 SIBELMED W30 Software Sibelmed RHINOSPIR PRO User Manual 52 The following Menus and options are also available SETUP MENU PRINTER SELECTION View MAIN MENU SETUP MENU PRINTER SELECTION DATA BASE View MAIN MENU SETUP MENU DATA BASE GRAPHICS AND OTHERS View MAIN MENU SETUP MENU GRAPHICS AN OTHERS NPT PROGRAMMING View MAIN MENU SETUP MENU NPT PROGRAMMING CHRONOMETER It enables or disables the chronometer for the vasoconstriction test and NPT EXIT OPTIONS MENU NEW PATIENT BASAL DILATIO
86. vironment Should you require further information on the places where you can leave this waste for recycling contact the local authorities in your town or city the domestic waste management service or the distributor who sold you the product 516 500 MU2 e REV 2 03 Sibelmed RHINOSPIR PRO User Manual 11 1 INSTRUCTIONS FOR USE AND INSTALLATION 516 500 MU2 e REV 2 03 UOI2EJ JE3SU pue ASP 104 SUOIZINAYSUT T 4o3deu Sibelmed RHINOSPIR PRO User Manual 12 INTRODUCTION The rhinomanometer RHINOSPIR PRO is a compact device held in a platform type PC Basically it is composed of a mask for nasal application a transducers unit a unit for signal treatment and software for analysis presentation data storage etc The RHINOSPIR PRO works in Microsoft Windows and offers as main characteristics Possibility of performing Active Anterior o Posterior Rhinomanometry tests Possibility of performing the Nasal Provocation Test NPT Display of Flow Pressure Flow Time Pressure Time and Resistance Nostrils graphics Consult of diagnosis according to the recorded values Management of different data bases for patients and tests Printing of a report with Patient data Data of the performed tests Graphics to be setup by the user WARNING IF ANY DAMAGE IN THE PACKAGE IS DETECTED CONTACT IMMEDIATELY WITH THE TRANSPORT AGENT AND WITH YOUR DISTRIBUTOR BEFORE YOU PROCEED TO INSTALL IT DO NOT REMOVE THE PACKAGING BAG

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