- Piston Medical
Contents
1. ES 40 Maintenance Ergospirometer maintenance Oxygen sensor The expected lifetime of the electrochemical cell is 2 years As the oxygen sensor is getting older its sensitivity is decreasing When it reaches the critical limit the next warning appears Calibration Error 3 Oxygen sensor used up Please contact your local dealer for changing the oxygen sensor Carbon dioxide sensor It is advisable to check the linearity of the sensor annually If it is needed a new linearization has to be done Please contact your local dealer for the linearization issue Load equipment maintenance Technical maintenance According to the Users manual the regular maintenance has to be done like cleaning and lubrication Please contact your local dealer for the more complex maintenance Disinfection Those parts of the bike ergometer and of the treadmills which are in di rect contact with the patients seat handlebar and handrail have to be disinfected regularly Please follow the regulations of the manufacturers of the given load equipment Single use parts The basic lung function tests can be done with the single use parts as well as described in the Spirometry volume of this manual Reusable accessories Facial mask AM 41280 series and HR 669170 The silicone facial masks can be disinfected in a cold disinfecting solvent Glutaraldehyde Sekusept Cidex etc Rinse it carefully and dry fully before use2. Speed Speed of the treadmill If the loading device is a treadmill the speed of the treadmill If the loading device is an ergometer bike this parameter is calculated from the oxygen consumption Grade Elevation angle of the treadmill If the loading device is a treadmill this parameter is the elevation angle of the treadmill REE Resting Energy Expenditure Resting energy expenditure in kCal day This parameter is calculated from the O2 consumption and CO2 produc tion Zero setting For exact volume measurement the zero setting of flow meter channel must be performed immediately before the measurement In case of Ergospirometer pneumatic valves detach the flow meter from the pressure transducer so zero setting occurs automatically in the back ground Patient may continue breathing thru the flow meter Zero setting process The program automatically starts the zero setting process immediately before each measurement The system evaluates the data measured during the zero setting process and displays an error message and repeats the zero setting process if a zero error is encountered Manual zero setting You can reset the currently selected device anytime with the Zero but ton next to the Device selection list in the program header Notice Zero setting is automatically performed before calibration ES 20 Measurements Preparations Device Patient circuit To prevent cross contamination a new disp
3. Click on the HR VCO2 VO2 graph Push the Aerob or the Anaerob Show median AT at 2199 ml min Match the marker with the selected part of the curve with the help of the mouse VE VCO2 equivalent This algorithm determines the anaerobe threshold at the significant breaking point visible on the VE VCO2 graph Click on the VE VCO2 ekvivalens graph Push the Aerob or the Anaerob button Match the marker with the selected part of the curve with the help of the mouse VE VO2 equivalent This algorithm searches for a point where iti 123 La breath e the VE VO2 started already to in tennan i 2 cycle crease Position 2 2a R pbr the VE VCO2 is not increasing yet the pCO2 is not decreasing yet Manual correction EOCO2 Click on the Eguivalents graph AT at 2264 mlimin Modify the counter up down to reach the desired position Or push on the EQO2 or EQO2 button and move the marker on the graph with the help of the mouse ES 36 Measurement modes Result overview As the AT anaerobe threshold is determined already push the Result tab the overview of the results will be shown in a table divided by the dif ferent phases e Resting phase e Anaerobe threshold e Peak values Result Date met 2010 07 01 7 51 47 Param Dim Ref Max ikg Ref AT n l Ikg Max Nyug I kg Max AT voz mimin vco2 ml min Load BS w Load BW w VE VR I VEIVO2 HR Amin HRR T
4. Spirogram The breathing is monitored in this window the tidal volume frequency and the median of breathing can be observed Parameter table The values of the main vital parameters are shown during the test Load equipment Press the Protocol tab and in the Ergometer type section select the load equipment to use e Bicycle ergometer e Treadmill e Tidal test Ergospirometry Demo Patient 28 years 78 kg 177cm CET P Protocol F S v tt Protocol Default 10 W 60 sec CU Setup rotocol B Result Ae Measure FVC 4 Log Wasserman Ergometer type Bicycle ergometer O Treadmill Tidal test Ergoline Ergoselect 100 200 ER 800 The panel of protocol settings is automatically changes according to the selected load equipment The detailed description of the Resting Metabolic Test can be found in the Tidal test az REE Resting metabolic test chapter 38 page ES 26 Measurement modes Handling templates Configurations and settings of the exercise tests can be stored in tem plates in the following groups Bicycle protocols Treadmill protocols Measurements of blood pressure Limits Creating a new template Press the New template button e Give a name to the new template e Enter values in to the fields Editing existing template Press the Edit template button Delete a template Press the Delete template button Store After definition of a new template or modification of an ex
5. Ergospirometry Supported devices PRE 201 Ergospirometer Piston Ltd 1033 Budapest Sz l kert u 4 b Rev ES EN 04 10 1 9 9 Date modified 31 04 2014 TABLE OF CONTENT Intr d ti ik oosssscsiscccscssscsssecascccecssecsssecssccsecesessssecesccsecssessscecocvsessocossscsoscsscdcesesssssease DE V CES E E d s s OPIS PIES BESO OTD PIPES OTE OITS TIES s TES IPOS s t s PTET OOODTIOR 4 M CCW ICA VOL VICW fasted ceaciatecedisadcacdecedcaliaddicediateacdicediualiacdisadiatdiacdiscdiuadiacdiide 4 Installation eee nr Br a SO er OE PnP PRE 20 Ergospirometer installation 2 sssss ge ezee z z t t s es 6 PRE 201 Ergospirometer patient circuit assemble ssss 7 Ergospirometer placement cacd ssciigcccghecutenedstedidebadeosdesodysesedgtedadoletenadesatosebensiedis 9 Gas cylinder connection to the Ergospirometer 0 0 0 0 ceceeceeseeeceeteeeeeeeeeeeees 10 MS CR Mtera C asec cscs ci6s sackets cacsessicdcscssscisccssdessuvuctetescdstsscscdessscscssseciesesssevosvessevee LAL User interface Ergospirometty ceeceecceseeseceseeeeceseceeeeseceeeeseceeeeaeeeeeeaeeeees 14 CaliDrati i a sesseneescesesvecgesevedeibavecsossvesestvoeospetonsosavaesecapososesssssopenssesoi vessstssoesseeeiee LO Flow meter Calibration 0 0 0 ceeseessssceseeescceceecceaeecceaeeceeseceeeeseceeeeaeeeeeeaeeeeees 16 Ergospirometer calibration y s5 55cscecs sdascandcdasscads
6. The calibration of the gas analyzers is done automatically in the back ground during the zeroing of the flow channel Possible error messages Calibration Error 1 Gas plug not connected In this case the connections of gas sampling line has to be checked Calibration Error 2 Calibration constant out of range Calibration Error 3 Oxygen sensor used up If the calibration is not accepted by the system repeat the whole proce dure If the error message appears again contact your local dealer Calibration Error 4 Room s air used up Ventilate it as well as possible Thoroughly ventilate the laboratory and repeat the whole calibration pro cedure ES 17 MEASUREMENTS Available examinations The ergospirometer system provides the following basic lung function tests e Forced exhalation and inhalation e Static vital capacity e Hyperventilation For detailed description please refer to the Spirometry volume of this manual Ergospirometry A Cardiopulmonary exercise testing provides a global assessment of the in tegrative exercise responses involving the pulmonary and cardiovascular system Detailed information may be found in the Measurement modes chapter Safety precautions e The Ergospirometer can be used only by a trained and authorized personnel e A cardiologist has to supervise the whole exercise test procedure e Prior to the exercise test always get know the detailed anamnesis of th
7. 230 s ST elevation is 21 mm at the lead where is no pathologic Q wave The continuous monitoring of ECG and of the blood pressure for any reasons is interrupted The patient claims for finishing Indications of relative stopping The systolic blood pressure decreases by more than 210 Hgmm during increasing load rate Appearance of considerable ST depression gt 2 mm horizontal or down sloping or a quick change of the QRS axle Exhaust choking asthmatic breathing pain in the legs Increasing chest pain Pathologic response of tension systolic RR gt 250 Hgmm diastolic RR 115 Hgmm Attention The list of possible reason for abortion is only for information pur poses the whole responsibility of the exercise test belongs to supervis ing physician Preparation It is necessary to inform the patient about the process of the measure ment Application of different sensors is described in the chapter Interaction of the patient and medical devices Make sure that the patient obeyed all the regulations which pre scribed during the preliminary information concerning eating smoking physical activity Go through the anamnesis again According to the existing legal regulations ask the patient to sign the declaration of content for the exercise test ES 32 Measurement modes Predicted The patient has to change the dress In the meanwhile the calibration procedure has to be done Make the basic pulmonar
8. Button the white adapter ring up the facial mask Button the headgear buckle up the facial mask Connect facial mask to the headgear Push the smaller diameter side of the PinkFlow flow meter into the white adapter ring ES 8 Installation Ergospirometer placement There are numerous criteria of the ergospirometer placement Environmental requirements The equipment can be used only in a well ventilated laboratory If the laboratory has no natural ventilation for example there is no any open able window the equipment can be used only where an air exchanger installed and it guarantees open air quality of the internal air 02 concentration 20 93 CO maximal concentration 400 ppm STPD Avoid one meter proximity of any heat or cold radiating objects like heating cooling window etc Provide stable temperature in the laboratory avoid any fast change of the temperature Safety requirements All conditions of the resuscitation have to be provided both human and material ones Cardiologist and professional assistant Defibrillator Treatment bed in one meter proximity Conformity feeling of the patient The patient has to be far from the outlet of the air conditioning avoiding any air drafts since the patient s body overheats because of the exercise and could catch a cold easily Locker and shower Relax room ES 9 Installation Gas cylinder connection to the Ergospirometer Place the gas cylinder to
9. The average lifetime of the facial masks guaranteed by the manufacturer 6 months or 25 disinfecting cycles ES 41 Maintenance Siez HR 699170 series 2 Size L M S XS Pediatric A cm 15 0 14 0 13 2 12 2 11 7 B cm 8 6 7 9 7 1 6 9 6 4 C cm 10 7 10 7 10 2 9 9 9 9 Dead space ml 290 246 185 157 135 Weight g 323 297 274 257 241 Part number HR 669170 HR 669171 HR 669172 HR 669173 HR 669174 Headgear HR 201418 The headgear guarantees the proper sealing of the facial mask The lifetime of the headgear guaranteed by the manufacturer is 6 months at an average usage The headgear can be disinfected in a cold disinfecting solvent Glutaral dehyde Sekusept Cidex etc Refill of the gas cylinders General regulations Gas cylinders and their refill should be provided by the local authorised distributor or dealer e Use always medical grade gas mixtures Improper quality or concentration of the gas mixture may harm the sensitive parts of the devices e There is a high pressure in the gas cylinder handle it carefully Only authorized person is allowed to change gas cylinders e Always set the exact secondary pressure of the pressure regula tor as prescribed in the manual Over pressure may harm the device and on contrary low pres sure will not provide adequate quantity of the gas mixture ES 42 Maintenance e After each gas cylinder change always enter the actual gas con centratio
10. Basal Metabolic Rate is estimated by the system and this value is taken as a Reference value The values of the REE and of the BMR are very close to each other the difference between them is less than 10 The main difference between them is the method how to measure them The REE is determined after a 20 30 minute resting during a 5 minute long period when the oxygen consumption and the carbon dioxide pro duction are nearly constant The BMR is measured right away after waking up at severe conditions a on the same way as the REE measurement Elapsed time 08 22 Steady State 00 00 Imlmin vf veo2 Dn e Aa talk BPsys BPdiaf HR HRR VO2 C ol of ol 488 346 VCO2 RER MET HR REE 337 09 1 0 0 2517 v VE RPM Spo2 Eol ew aa 0 po2 PETO2 PETCO2 VE VO2 1431 5 51 107 44 294 AN io pe VENCO2 YO2max VcO2max VO2 HR BPsyxHR eee ae ie 679 00 0 io Ja prh BR VcOo2kg Work METc 34 0 1 0 HR BP SpO2 Main window Spirogram Timer Parameter panel table ES 38 Measurement modes HR BP SpO2 panel The basic cardiologic parameters are monitored during the whole test Main window The most important metabolic and breathing parameters are monitored VO2 VCO2 VE Spirogram The spirogram shows the breathing tidal volume breath rate and the shifting of the breathing median Timer The upp
11. Length Duration of the second cooling down phase Ramp protocol continuous increase of load The load rate is increased continuously during the test The load rate re adjusted in every second accordingly to the load rate resolution of the loading eguipment In this case the load rate is increased by the Increase value in the every Step length Example If the Step length 60 sec and the Increase 15 Watt further more the load rate resolution of the bicycle ergometer is 1 Watt it means that the load rate will be increased by 1 Watt in every 4 seconds Treadmill protocols Protocol name Bruce v Id X Manual increase of speed 0 5 i km h Manual increase of grade ho Load configuration Recovery Time Speed Grade A Time Speed Grade sec kmh sec kmh Step 1 180 27 10 0 Step 1 Step 2 180 4 0 12 0 Step 2 60 2 7 0 0 Step 3 180 5 4 14 0 Step 3 60 2 7 0 0 Step 4 180 6 7 16 0 Step 5 180 8 0 18 0 Step 6 180 8 8 20 0 A Usually treadmill protocols are defined in tables and the load rate is specified step by step The number of protocols is unlimited and there are numerous factory pre set protocols to select ES 28 Measurement modes Factory preset protocols e Bruce Bruce Mod Blake Blake Mod Naughton Cornell ACIP Ellestad I and II Manual control Manual increase of speed The speed can be increased or decreased by the specified step Manual increase of grade
12. The slope can be increased by the specified step The system may override the actual settings according to the resolution of the actual treadmill For example an 0 1 increase can be rounded to the smallest accepted value as 0 5 or 1 Manual modification does not influence the automatic protocol the next load step will be set according to the preset values Setting of particular steps Time Duration of one step in seconds Speed Speed in kilometre per hour Grade Slope of the treadmill in percent For example 5 slope means 5 meters difference of level in 100 meters Blood pressure measurement BP measurement profile Default v a fr X Blood pressure Manual BP measurement F Measuring period Ignore failed measurements Independent interval v 120 fej s Individual blood pressure measuring profile can be defined for each load ing eguipment and for each loading protocol For example if the system is equipped with a bicycle ergometer and with a treadmill as well further more a ramp protocol is used for the bicycle ergometer and the Bruce protocol is used for the treadmill While using the bicycle ergometer the blood pressure will be measured by the built in blood pressure meter of the bicycle automatically in every 2 minutes While using the treadmill a warning signal for manual blood pressure measurement will be generated in the 3 minute of the each step of the protocol ES 29 Measurement modes Manual
13. W02 H PEREP zakazan amin 20 f q an r ma eben aaah Perr rrersse er min VO2mA 3271 90 chad Gok kh baithi i v 3916 30 1000 000 2000 3000 4000 57 10 15 2 25 30 VOZZHR 0 00 BpsyxHR 0 00 VT YE RER Sana i l min ae APA 1 12 VES tn H hit 33 91 i ii 38 08 apii Fan i 0 00 p A id Dia ai tien ne peg cree jalg di t ri fo it Ve I Wmin Close iii i pit 40 60 80 100 120 140 Marker Wasserman Monitor All Close panel panels window parameters As the exercise test is completed the system determines anaerobe thresh old automatically by four different algorithms RER 1 V Slope VCO2 VO2 VE VCO2 Equivalent VE VO2 Equivalent Anaerobe thresholds calculated by the system are only for informa tional purposes they can be adjusted manually The final anaerobe thresholds have to be determined in an empiric way by physician ES 35 Measurement modes RER 1 This algorithm determines the anaerobe threshold at that point where the VCO2 exceeds the VO2 or with other words the ratio of them exceeds the 1 00 value for the first time Click on the Gas Exchange graph Modify the counter up down to reach Position 1 590 d the desired position cycle Or push the Manual correction button and move the cursor on the graph AT at 1817 ml min manually V Slope This algorithm determines the anaerobe threshold at the significant breaking point visible on the VCO2 VO2 graph Manual correction
14. higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PRE 201 Ergospirometer is used exceeds the applicable RF compliance level above the PRE 201 Ergospirometer should be observed to verify normal operation If abnormal performance is observed additional meas ures may be necessary such as re orienting or relocating the PRE 201 Ergospirometer D Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ES 51 EMC Guidance and manufacturer s declaration Recommended separation distances between portable and mobile RF communications eguipment and the PRE 201 Ergospirometer The PRE 201 Ergospirometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PRE 201 Ergospirometer can help prevent electromagnetic interference by maintaining a minimum distan
15. of the minute ventilation and the momentary oxygen consumption VE VCO2 Minute ventilation CO2 production Ratio of the minute ventilation and the momentary carbon dioxide pro duction VO2max Maximal O2 consumption Maximal oxygen consumption during the whole test VCO2max Maximal CO production Maximal carbon dioxide production during the whole test VO2 HR Oxygen pulse Oxygen delivery by one heart beat BPsysxHR Product of systolic blood pressure and heart rate Product of systolic blood pressure and heart rate BR Breath rate Breath rate breath minute RER Respiratory Exchange Ratio Ration of the CO production and O2 consumption during exercise RQ Respiratory Quotient Ration of the CO2 production and O2 consumption during resting VO2 kg Ratio of momentary O2 consumption and body weight Momentary O2 consumption body weight ml m kg VCO2 kg Ratio of momentary CO production and body weight Momentary CO production body weight ml m kg ES 19 Measurements Work Carried out work Total carried out work during the whole exercise kCal MET Metabolic Equivalent Energy request of the physical activity Base unit is the resting energy re quest of the person being tested It is a calculated value based on the VO2 METc Calculated Metabolic Equivalent Energy request of the physical activity Base unit is the resting energy re quest of the person being tested It is a calculated value based on the body weight and load
16. or diffusion capac ity test PBF 100 G M Bacterial and viral filer with elliptic patient side for the basic pulmonary function tests Facial masks Applying facial masks makes possible the oral and nasal breathing simul taneously It provides more comfort and requests less co operation Facial masks are used mostly for ergospirometry and for rhinomanometry e Select the best fitting size for the patient the full and proper sealing has to be reached e Assemble the adapter ring and the headgear ES 22 Measurements Place the facial mask to the patient s face as show non the picture Adjust the length of the belts of the headgear Fasten the headgear with the Velcro tapes Never push the facial mask too strong against the patient s face To check the proper sealing the patient has to block the orifice of the mask with hand and has to make ex and inspiration efforts No leakage is allowed at all e If necessary select an other size of the facial masks If the patient is not fully shaved some leakage may occur In this case the facial hair has to be shaved Blood pressure meter ECG A lot of different blood pressure meter can be integrated into the ergospi rometer system Always follow the regulations of the user s manual of the given blood pressure meter Take care that the built in microphone of the handcuff has to be in the position over the Arteria Brachialis A lot of different ECG can be integ
17. 0 C 40 C Relative humidity viccceisevesssscscesscsesesseesteaassasaateaacesatesevns 30 75 Atmospheric pressure ecesceeseeseeeteeeeeeneeeeeees 700 1060 mbar Informing values Expected lifetime DAT A E EEEE EE 8 years Measurement head lifetime eee eseeeeteeeeeeeeeeeeaeeeeeees 2 years Forced inhalation and exhalation Measurement duration cccessccesscesseeseeeeseeeeesseeseseeseesseeeees 60 s Volume measurement HM it cee ccscccesecceseeeeseecesseeeeseeeees 151 Vital capacity measurement M eas rementd rati sernponnonann nnna nana a 60s Volume measurement HM it ee ccccceeseccesseceeseeceseeeesseeees 151 Maximal voluntary ventilation Measurement duration ccccccsccccsscccesssceeseccesseceessecesseeeesseeees 60 s Volume measurement limit 0c cece eeeeeseseeeeereeeeeees 250 l min Ergospirometry Duration of a eSt srein n a T several hours Volume measurement limit sssss 500 l min Oz consumption CO production s ssssssesseessseeseeseseeseseee 10 min Sampling frequency PRE 20 1 device family iisi ristist ns 250 Hz Other data Analogue digital converter resolution se ssssseesesseseesessesee 12 bit Electrical data The connected computer s and printer s electrical data is found in the re spective manufacturer provided specifications The following values apply only to the Piston Ltd manufactured devices ES
18. 46 Technical data PRE 201 Ergospirometer PO COMMECHON tearena kek ennekin huni USB 2 0 compatible Mains V N SS E nenene araara ia iiaa aak 90 260 VAC Mams fregtenty ienen E ERER 50 60 Hz Power consumption without loading equipment max 20 VA Mechanical data PRE 201 Ergospirometer INAT O EEE PPF 18 PinkFlow Gas MIXtUTeE eee eee O2 16 CO2 5 szintetikus leveg Gas cylinder sssseeseesnseesseeseeseseesessrseesesseseesessesee 2 litre aluminium Secondary pressure of the pressure regulator 1 bar Size without patient circuit W 320 D 295 H 120mm Weight without patient Circuit 0 eee eeeeseeeeeeteeeeeeneeeeees 3 17 kg 02 analyzer Principle of Operation Electrochemical cell RSS sss ss g E O S aE 0 100 ACCULACY a ao aa oaa iaa naiaiae 0 05 Response time T90 zs kae R 130 ms COQ analyzer Principle of operation NDIR Non Dispersive Infrared EEEn a e 0 10 ACCUAN n E n 0 05 RESPONSE time TIO re eooo eriei oria 130 ms ECG The system can be equipped with different types of ECG device Please refer to the user s manual of the actually applied ECG Guaranteed values PPF 18 PinkFlow flow meter Typ toteen errr oye E IOI he PPF 18 Principle of Operation Symmetric Pitot tube BIOW TANG T 18 I s BIC AGS ACC sal sass says sevssessoens sas cenasans seen says ceva sausnee
19. 50 Load BPsys BPdia HR HRR ol o MET HR VO2 vco2 Ri 3106 3740 120 114 O Speed 0 0 V VT 0151283 po2 VE RPM Spo2 102 4 0 0 PETO2 PETCO2 VE VO2 161 38 330 VCO2max VO2 HR BPsyxHR 3916 00 0 VCO2 kg Work METc 479 og 00 anual con Spi ogram Parameter panel trol table ES 25 Measurement modes The ergospirometer test is a rather complex measurement consequently it requests two monitors According to the conventions the left monitor is for the ECG and right monitor is for the control and for the monitoring all vital parameters Since different models of ECG devices can be integrated into our er gospirometer system this chapter describes the right monitor in majority HR BP SpO2 panel The main cardiologic parameters are displayed in this panel during the test Main window The main pulmonary and metabolic parameters are displayed during the test VO2 VCO2 VE Manual control The load rate of the bicycle ergometer or the speed and angle of the treadmill can be modified at any time during the whole test In the case of bicycle ergometer the automatic protocol is not aborted by the manual modification only the actual load rate is increased by the Increase value In the case of treadmill the automatic protocol is not modified by the manual modification the next load steps equals to value preset in the pro tocol
20. BP measurement The blood pressure is measured manually the system does not control any automatic blood pressure meter A warning signal is generated when the blood pressure measurement is necessary Blood Pressure measurement is actual Measuring period e Independent interval The blood pressure measurements are done in predefined intervals calculated from the beginning of the test It is independent of the actually running protocol e Relative to the current step The blood pressure measurement starts in a predefined time interval calculated from the beginning of the actual load rate step Limitations The time interval defined blood pressure measurement can be used at the following conditions e This feature is not available for the ramp protocols because there are no definitive start points of the different load rates In this case the Independent interval option has to be selected e The duration of the load step has to be longer then specified delay time e The cycle time of a automatic blood pressure measurement has to be taken into consideration 30 60 sec when editing a load proto col and a blood pressure measurement profile Ignore failed measurements If a blood pressure measurement is unsuccessful only a warning message appears Limits Exercise limits profile Default v ap i X Limits Maximal Heart Rate 0 ej bpm Minimal SpO2 185 R Maximal systole 200 mmHg Maximal diastole 100 mmHg Maximal load 999 lw Iz Ent
21. ce between portable and mobile RF communications equipment transmitters and the PRE 201 Ergospirometer as recommended below according to the maximum output power of the communications equipm ent Separation distance according to frequency of transmitter m Rated maximum output power of transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz w d 117 P d 117 P d 2 33VP 0 24 0 74 2 33 7 38 100 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 80 MHzand 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ES 52
22. e gas refilling company CO2 concentration Carbon dioxide concentration specified in the certificate of the gas refill ing company Use filter for VO2 and VCO2Use filter for VO2 and VCO2 Enabling the averaging filters for VO2 and VCO2 calculations It is advisable to enable these filter during Steady state and Mixing chamber measurements FVC loop on main screen The median value of breathing can be monitored on the FVC panel This graph can be moved into the main window to substitute the spirogram ES 11 User interface Parameter columns The number of columns of the displayed parameters during the meas urement can be specified Log time interval Time interval of the registration into the log file Mixing Chamber Select this option if a Mixing chamber is in use Bicycle Port setup Treadmill Port setup BP monitor Port setup Settings of the communication ports of different connected devices Settings Pott Es Baud rate LEK Data bits a Stop bits ld Parity N Sadas Flow control None Select the appropriate PC port where the loading equipment is connected F EF F Fi al All the other settings should be set according to the specification of the loading equipment Some settings will be automatically overridden according to the selected loading equipment Bicycle Ergometer and treadmill protocols Editing and modifying protocols are possible in the Ergospirometry measuring window The d
23. e patient e The personal and the material conditions of the resuscitations has to be provided In this operating mode the device measures the following parameters Vv Volume Actual inspiration volume VT Tidal Volume Tidal volume during quiet breathing VE Minute ventilation Total volume of the breathing during one minute Load Load Actual load setting of the bike ergometer Calculated load of the treadmill based on the oxygen consumption RPM Pedal revolutions Actual pedal revolution of the bike ergometer BPsys BPdia Blood pressure Last values of the blood pressure HR Heart rate Actual heart rate ES 18 Measurements HRR Residual pulse Difference of the maximal predicted heart rate based on the age and the actual heart rate HR Percentage of the heart rate Percentage of the actual heart rate to the maximal predicted heart rate based on the age SpO2 Saturation Oxygen saturation of the blood pO2 Momentary Oz concentration Momentary oxygen concentration pCO2 Momentary CO concentration Momentary carbon dioxide concentration VO2 Momentary 02 consumption Momentary oxygen consumption ml m VCO2 Momentary CO production Momentary carbon dioxide production ml m PETO2 02 concentration at the end of expiration Oxygen concentration at the end of expiration PETCO2 CO concentration at the end of expiration Carbon dioxide concentration at the end of expiration VE VO2 Minute ventilation O2 consumption Ratio
24. environment ES 50 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PRE 201 Ergospirometer is intended for use in the electromagnetic environment specified below The customer or the user of the PRE 201 Ergospirometer should assure thatit is used in such an environment IMMUNITY IEC 60601 Compliance Electromagnetic environment test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the PRE 201 Ergospirometer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vims 3 Vims oe IEC 61000 4 6 0 15 80 MHz 0 15 80 MHz d 1174P Radiated RF 3 V m 3 V m IEC 61000 4 3 80 MHz 80MHz 2 5GHz 2 5GHz d 117VP 80 MHz to 800 MHz d 2 33VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ko NOTE 1 At 80 MHz and 800 MHz the
25. er 0 null values to disable monitoring During the exercise test some vital parameters may reach critical limits which could be risky for the patient These limits are partly published by the international recommendations and partly they are determined indi vidually for each patient Obviously these limits are sharply different for a healthy person or for an ill patient transplanted or with a pacemaker or for a professional athlete If monitoring of a certain parameter is not necessary enter 0 value and monitoring of that parameter will be suspended ES 30 Measurement modes It is impossible to suspend the monitoring of maximal heart rate If the filed value is empty the maximal heart rate is calculated from the well known equation Maximal heart rate 220 Age Contraindications According to the ATS ACCP Statement on Cardiopulmonary Exercise Testing March 1 2002 making an exercise test is severely contraindi cated upon the following circumstances Absolute contraindications Acute myocardial infarction 3 5 days Unstable angina Uncontrolled arrhythmias causing symptoms or hemodynamic compromise Syncope Active endocarditis Acute myocarditis or pericarditis Symptomatic severe aortic stenosis Uncontrolled heart failure Acute pulmonary embolus or pulmonary infarction Thrombosis of lower extremities Suspected dissecting aneurysm Uncontrolled asthma Pulmonary edema Room air desaturation at rest l
26. er counter shows the total duration of the test and the lower counter shows the duration of the steady state Parameter table Values of the vital parameters are shown during the whole test Preparation It is inevitable to inform the patient as described in the in the chapter Preparations The following steps should be done e Lay the patient down to the examination bed e The patient has to find a position whish is comfortable enough to lay without any movement for an hour e While the patient is laying down make the calibration of the system e Put the facial mask on the patient Measurement process e Select under the Protocol tab in the Ergometer type section the Tidal test option e To start the test push the Monitor button e The patient has to refrain from any movement and from speaking as well Usually 20 30 minutes are requested to reach the stable metabolic level e Push the Start button as the VO2 VCO2 VE RER parameters are getting stable e The system indicates the stable intervals by frames The REE value is updated continuously If all the conditions are met in a 5 minute interval the system indicates it Steady state criteria met e Push the Done button e Results are shown at the Result tab ES 39 MAINTENANCE Device maintenance Our lung diagnostics devices do not require special maintenance For continuous reliable operation take care of the following To prevent device contaminati
27. etailed description can be found in the Ergospi rometry chapter ES 12 User interface lcons Ergospirometry amp Settings Protocol editor Predicted values and results Actual test Breath median Diary Test interpretation Wasserman graphs Templates Enter new item Templates Edit items Templates Store edited item Templates Delete selected item Templates Abandon modifications x EL HEG ES 13 User interface User interface Ergospirometry The following image shows the general design of the measurement screen The individual measurement windows may different from each other but the main controls are identical 24 a Device selector 2012 1202 HS Zero setting Protokoll Spartolo 38 W 60 sec Menu Navigator r S Elapsedtime 00 01 Patient data Load Bigys BPdia HR HRR 070 o oO o BTPS data voz vcO2 RER MET HR 06 3740 120 114 0 z A Fee Complex curves 0 0 v VT VE RPM Spo2 Spirogram 015 283 1024 0 O poz pcO2 PETO3 PETCO VE VOZ2 Timer 2137 770 81 58 330 VENGO2 VO2maxAVC02max VO2HR BPsyxHR Parameters SEL o A BR VOZikg VCO2kg Work METe 354 398 479 00 00 Control a e e Device selector Select the device to be used from the drop down list This is necessary if for example you own a Plethysmograph and a Spi rometer and would like to perform IVC measurement Zero set
28. ing and evaluation is about one and half an hour Resting metabolic test preparations The relaxed metabolic test is for analyzing long duration processes there fore the patient has to be aware of the special aspects of the test well be fore ES 21 Measurements e The patient has to avoid any heavy physical activity before the ex ercise test by a 48 hours e The patient has to avoid eating and drinking before the exercise test by a4 hours of course water drinking is allowed e The patient has to have a loose and comfortable dress which pro vide comfortable temperature feeling e The patient lays down and relaxes for 20 30minutes e The total duration of the test is about one hour N If any of the above listed criteria is not fulfilled there is no sense to make the exercise test Interaction of the patient and medical devices The proper usage of the consumable parts is necessary to reach the most correct measurements Nose clip Apply nose clip during all pulmonary function tests expect for the tests done in facial mask in order to avoid false breathing thru the nostrils Mouthpieces The mouthpiece provides the proper connection between the patient and the device MPA 30 Simple mouthpiece Elliptic mouthpiece is for the basic pulmonary function tests PMP 30 Mouthpiece with bite on grip For the more demanding pulmonary function tests where the proper seal ing is even more important like body plethysmograph
29. ing port Patient circuit yellow connector 2 Blue Flow meter Patient circuit blue connector 3 White Flow meter Patient circuit white connector 4 Green LED indicating the data transfer 5 Black Outlet of the calibration gas Quick coupler of gas sampling line 6 White Intake port of the ambient air Never block 7 Mains socket Mains cable 8 Quick coupler of calibration gas High pressure hose of gas cylinder 9 White Exhaust output of calibration gas Never block 10 White Exhaust output of gas sample Never block 11 USB port of the Ergospirometer USB cable to the PC 12 Red Intake port of the CO2 absorber Red connector of the CO2 absorber container 13 Oxygen sensor holder 14 CO2 absorber container ES 6 Installation Connect the power and data cables and the pneumatic connectors of the patient circuit to the device according to the different connector types and colour codes PRE 201 Ergospirometer patient circuit assemble PPF 18 PEA 28 g PPF 18C 2811BY BFF230 001 N W 3435 ME 110 03 12 Push the device into the mounting frame Front panel pneumatic connectors must be located at the bottom The device should overhang on both sides equally Fasten the device using a 3 mm hex key ES 7 Installation Connect the flow meter docker to a clean Pink Flow flow meter Push the metal release button to remove the PinkFlow flow meter from the docker
30. isting tem plate e Push the Store modifications button to store modifications e Push the Abandon modifications button to cancel modifications Bicycle ergometer protocols Protocol name Derat 7 DI dx Load configuration Initial value 40 Ww Increase 10 Ie W Manual increase 5 Io Ww Step length 60 gs Recovery First phase load 50 SIRA First phase length 160 Sie Load 25 w Length 120 fs Ramp protocol continuous increase of load The loading protocols are increasing the load rate from the basic value by a given step in certain time intervals Practically the protocol is a Load Time function Afterwards the loading is followed by the cooling down phases Load configuration Initial value The starting load rate of the test Increase Increase of the load between two steps Manual increase Step of the manual modification During the manual control of the load this value will be added to the actual load rate The ES 27 Measurement modes manual modification does not abort the automatic protocols the Increase value is always added to the actual load rate Step length The load rate is increased by the specified time interval in dependently of the manual control Recovery First phase load The first cooling down phase starts with the specified load rate First phase length Duration of the first cooling down phase Load The second cooling down phase starts with the specified load rate
31. min O2pulse mlb BPsyst mmHg BPdia mmHg Aerobic capacity Fair Values of each parameter are shown in a following sequence e Reference predicted value Maximal value Ratio to the body weight Ratio to the reference value e Value at the AT Ratio of the value at the AT to the body weight Ratio of the value at the AT to the maximal value e Resting value Ratio of the resting value to the body weight Ratio of resting value to the maximal value Ratio of the resting value to the value at AT Interpretation The system evaluates the fitness level of the patient taking into consid eration the gender and age of the patient and the maximal VO2 This way of automatic interpretation is most useful in the case healthy and active persons Store If all parameters seem to be correct push the Store button to store re sults The following data will be stored ECG signals for the total duration of the test e The measured vital parameters HR BP VO2 VCO2 etc in time sequence continuously Flow and gas concentrations for the total duration of the tests The selected AT values and the relevant marker positions ES 37 Measurement modes REE Resting metabolic test Measurement goal The goal of the test is the determination of the Resting Energy Expendi ture REE The Basal Metabolic Rate BMR is the energy expenditure which is needed to supply the basic vegetative functions of a resting but awaken person The
32. n values to the system software You may find the actual concentration values of the gas mixture on the certificate supplied by the gas filling company Diffusion capacity test Gas mixture Methane CH4 2 s ssssss sastuand cacdaueecncanaade 0 3 1 relative Carbon monoxide CO cccccsscceesecceseeeeeeees 0 3 1 relative Ballist amansar ae ee Re ne AeA eA ee ee a ee ee artificial air Gas cylinder and pressure regulator VOLUME eiiie ie a e AE yagdeds EREE 10 litre Nominal pressures sz st b e elle 150 bar Secondary pressure of the pressure regulator 6 bar Ergospirometer Gas mixture OXY CEN OP e o O as 16 0 1 relative Carbon dioxide CO2 cccccccesecessecesseseesseeees 5 0 1 relative Ballasts durent vte a aa AAT a artificial air Gas cylinder and pressure regulator Vol menirienne eranen e ee 2 litre Nominal PTS SSULS vecinii ie EE 150 bar Secondary pressure of the pressure regulator 1 bar ES 43 Possible problems TROUBLESHOOTING Ergospirometer Problem Diagnosis Fixing Breathing cycles are visible but values of VO2 VCO2 are nearly zero The gas sampling line is not connected Connect the gas sampling line The median line of the breathing is drifting to the unexpected extent Wrong flow meter calibration The PinkFlow flow meter was not dried completely after disin fection The facial mask leak
33. ntact 8kV air 2kV for power supply lines 1kV for input output lines 1 kV line s to line s 2 kV line s to earth floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 U 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for5s 3 A m lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Uy 30 dip in Ur for 25 cycles Not applicable 3 A m NOTE Uris the a c mains voltage prior to application of the test level Mains power quality should be that of a typical commercial or hospital environment If the user of the PRE 201 Ergospirometer requires continued operation during power mains interruptions it is recommended that the PRE 201 Ergospirometer be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital
34. nvironment Emissions test Compliance Electromagnetic environment guidance The PRE 201 Ergospirometer uses RF RF emissions energy only for its internal function Group 1 Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment RF emissions Class A CISPR 11 am nis mis bk The PRE 201 Ergospirometer is suitable for ae RIISSIONS Class A usage in all establishments other than IEC 61000 3 2 domestic and that are not directly connected to a low voltage power supply network which Voltage fluctuations supplies domestc environment flicker emissions Complies IEC 61000 3 3 ES 49 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PRE 201 Ergospirometer is intended for use in the electromagnetic environment specified below The customer or the user of the PRE 201 Ergospirometer should assure thatit is used in such an environment IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment guidance Floors should be wood Electrostatic concrete or ceramic tile If discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 6 kV contact 8 kV air 2kV for power supply lines 1kV for input output lines 1 kV line s to line s 2 kV line s to earth 6 kV co
35. on and patient cross contamination after each test disinfect the flow meter the facial mask and the headgear or change the bacterial and viral filter after the basic lung function tests The flow sensor must be contamination free The filter elements must be replaced according to instructions The PermaPure moisture exchange capillary must be replaced ac cording to instructions The tubes must always be dry and cannot be broken Flow meter maintenance The flow meter condition and cleanliness affects measurement accuracy Cleaning measurement head main parts The individual patient circuit type installations are described in section Installation The plastic parts may be disinfected with cold water and appropriate chemicals for example Sekusept and may be used after rinsing and drying A WARNING e PermaPure moisture exchange capillary must be kept always dry Do not clean it with water or any alcohol containing cleaning agent When the system is turned on never use any alcohol containing cleaning agent because it may penetrate into the gas analyzer line and could endanger the sensitive gas analyzers The system can be turned on again only after the total drying and ventilaton of the laboratory Cleaning the pneumatic twin tubes Disconnect the twin tube from the device and the flow meter Rinse the tube Do not clean the gas sampling capillary with any kind of liquid After it is completely dried reconnect the tube
36. on usefulness of the product Safety instructions To avoid possible damages and accidents please pay attention to the fol lowing safety instructions e Make sure the mains voltage is the same as that on the product label e Make sure the connection cable is not damaged e Take care of your device according to the maintenance section e Only use the device according to the manual e Do not use any accessories not recommended for the device e Store the device in a dry place e Keep the cable away from heat source sharp objects rough sur faces and check the cable s good condition e Do not expose the device to direct sunlight or strong light more than 1500 lux e Do not use the device in a highly dusty environment e Do not use the device in a highly vibrating environment e Take care to ensure the current environmental conditions The equipment complies with the applicable requirements of laws and standards ES 45 Technical data Shipping conditions Air VER P OPAL e rests ccteted te tetede cote t dete ennas 30 C 60 C Relative midity sss sss ect arnari 10 100 Atmospheric pressure oe ccecclenceccleec eee 500 1060 mbar Storage conditions Air C3001 0 2211 eee iaaii 0 C 50 C Relative b midity ccc t4ececetacetecetece ecctecehece esac nena 10 85 Atmospheric pressure s i2201d 1 eddie adda Mella dees 500 1060 mbar Operating conditions AIC ASM Pel Alle sac nsena prairie acrenrnins 1
37. osable bacterial and viral filter must be connected before each patient measurement Patient Recommended body position e Sitting on a chair e Straight back Level head Tight clothing or jewels must not prevent free breathing Directions Prior to the tests inform the patient about the goal and way of the meas urements For detailed description please refer to the Spirometry volume of this manual Ergospirometry preparations The cardio pulmonary exercise test fully differs from the usual pulmo nary function tests It requests not only co operation but mental and physical abilities from the patient as well In order to reach the best results the patient has to be aware of the special aspects of the exercise test in advance The exercise test physically strenuous The exercise test has certain level of risk Sport dress and shoes are advisable The patient has to avoid eating before the exercise test by a few hours e The patient has to avoid eating heavy and fatty meal before the ex ercise test by a few days e The patient has to avoid any heavy physical activity before the ex ercise test by a few days e The patient has to avoid smoking before the exercise test by at least 8 hours e Prior the exercise test a full anamnesis has to be recorded including regular medical treatment medicines applied especially the cardio pulmonary aspects e The total duration of a complex exercise test including the prepara tion dress
38. rated into the ergospirometer system Always follow the regulations of the user s manual of the given ECG device Bicycle ergometer The body position may influence the maximal working capacity of the patient Further more the height of the saddle determines which the mus cles groups will be used In the case of healthy patient The ideal height of the saddle is when the patient with a stretched leg may reach the pedals with the heel The patient has to push the pedals with the middle of the sole pads Elderly and patient moving with difficultness Adjust the height of the saddle to reach the most comfortable and the most sense of security for the patient Athlete Athletes are mostly coming for the exercise tests to reach their limits so the usual position is important for them Athletes may adjust the bicycle ergometer themselves the height and po sition of the saddle and the hand bar Right position of the foot The ideal position of the feet is when the middle of the sole pads are on the pedals ES 23 Measurements However in the case of elderly and patient pushing the pedals with the full sole is allowed Treadmill Treadmill can be applied for all ambulatory patients but there are a num ber of safety precautions Read carefully the user s manual of the tread mill integrated into the system Never allow to use treadmill in a dress which may have loose part like robe belt or too long trousers because the
39. reased to the minimal or the treadmill stops The load rate the speed and the slope still can be modified manu ally If the patient got relaxed and all vital parameters returned close to the normal resting level push the Done button to finish monitor mg Evaluation of the exercise test can be done while the patient is re laxing Function buttons during the test F3 F4 F5 F6 F8 F9 ESC Start monitoring Start protocol ECG monitor ST amplitude on off Manual entry of blood pressure values Swap to the main screen Swap to the Wasserman panels Cooling down phase ES 34 Measurement modes Evaluation of the exercise test Interpretation and evaluation of the exercise test is done according to the recommendations of Karlman Wasserman e Click on the Wasserman tab 4 wW Protocol Bruce D Setup Protocol ei Result W Measure S FVC 4 Log asserman p h Ventillation HR and 02 pulse Gas exchange VEIVCO2 B Wing En vco2 2970 10 120 H ATi ii vozinR 20f 7 IEJDTOTI VE 69 70 160 Hg 17 36 120 E 40 50 moir 30 VT 2 86 i 20 VE 69 70 10 Load 0 00 444 e dekttet4 bbt4 tr2 p 4 min H bier rere er tin RPM 0 00 5 10 15 2 2 30 5 10 15 2 2 30 BPsys 0 00 0 00 0 00 0 00 220 0 00 2001 19 53 180 ETET 1601 7 i 2645 30 i 2970 10 of 692 801 ia ae a ty 40 1043 TIT IMP Eee teeter 201 vco2
40. s Repeat the flow meter calibration Install a dry flow meter and repeat the calibration Check the facial mask and readjust it It is impossible to modify the load rate of the bicycle er gometer and the pedal revolu tion RPM is zero Communication problem Abort the test Check the connections Turn off and turn on the bicycle ergometer Resume the test ES 44 TECHNICAL DATA Warranty The device complies with the effective Technical Specifications The manufacturer guarantees the product according to the terms of the Installation Delivery protocol The warranty does not cover post delivery careless shipping unprofes sional storage violent damaging abnormal operation unprofessional op eration inefficient protection against external effects natural disasters or not following the contents of the User Manual f Check package condition after delivery If packaging is damaged notify the carrier and Piston Ltd or its representative Use of any broken or otherwise damaged products devices accesso ries etc is dangerous and forbidden Limited liability Piston Ltd and its carriers according to the valid laws do not accept any responsibility for any individual unforeseeable direct or indirect dam ages including loss of business profit interruption of business activity loss of business data or any other damages due to financial loss result ing from the use or n
41. s 41 RefilL tthe Bas Cy MASS 53a cccsu cscs sesasesdcucasuseceandsuscsudass asedderddaddesevdpacautedseeeee 42 Troubleshooting sessescsscscsscsscscescsoesossceocsosscsocsosscsocsosscsossosscsoesossesossossesossessess 44 Possible problems rennin n rnr ioner rner erer ein eens 44 Technical data eesssesesorossesesososoesesososoesesososoesesososossesososoesesosososoesososoesesososossesee 45 Mechanical data Guaranteed values List of accessories EMC Guidance and manufacturer s declaration cccccccccssssssssssssceees INTRODUCTION Devices PRE 201 Ergospirometer Measurement operating modes e Forced inspiration and expiration e Static vital capacity e Maximum voluntary ventilation e Resting ECG e Ergometry e Ergospirometry EKG e Resting Energy Expenditure REE Design e Flow meter PPF 18 PinkFlow symmetric Pitot tube e Fast O2 and CO gas analyzer e USB computer connection e PC cart 2 twin monitor design Isolation transformer optional Calibration gas mixture 16 O2 and 5 CO2 Loading devices optional bicycle ergometer or treadmill Technical overview Lung diagnostic device family main parts description Flow meter PPF 18 PinkFlow symmetric Pitot tube flow meter which provides pressure difference in proportion with the flow speed A differentiate pressure sensor converts the pressure difference to electric signal Patient circuit The patient circuit provides the connec
42. s days coeseeecsaantecneses 36 ml Resistance s annnnnnuannganannnnuannadad 60 Pa I s 15 I s WIDE szesszel ee ELES S annem 34 gramm PRE 201 Ergospirometer Flow Sensor nssieicisetinnis ential PPF 18 PinkFlow Flow Tange niitit S a EES 18 I s Flow accuracy ssssessssesseessssesesseseesesseseesesseseesesseses 2 or 50 ml s Volume range a incncainnannnadanacaancnarachan 500 minute Volume ACCURACY nions n r r errereere 2 or 50 ml Range of O2 consumption ssssseseseesserseserrsersesrrrereseses 10 minute ES 47 Technical data Range Of CO2 production sssssgze esesee ree ees 10 minute 02 consumption accuracy ssssss 5 or 100 ml minute CO production accuracy sses 5 or 100 ml minute List of accessories Included accessories The current Shipping contract contains the list of accessories included in the purchase price Optionally purchased accessories The following information must be provided when ordering accessories and disposables e Description e Type e Part number e Device type and serial number for which the accessories are used ES 48 EMC GUIDANCE AND MANUFACTURER S DECLARATION Guidance and manufacturer s declaration electromagnetic emissions The PRE 201 Ergospirometer is intended for use in the electromagnetic environment specified below The customer or the user of the PRE 201 Ergospirometer should assure that it is used in such an e
43. se loose part can be cached by the rollers Never touch the moving parts of the treadmill like rollers or the height adjusting mechanism Never stand on the belt barefoot Use always training shoes Use always the safety belt which stops the treadmill immediately as the patient is not able to keep the speed Never try to block or override the safety system of the treadmill Evaluation of the cardiopulmonary test During ergospirometry only one test can be performed in contrary with the basic pulmonary function tests when 8 tests can be performed simul taneously Evaluation of the cardiopulmonary test is described in the next chapter ES 24 MEASUREMENT MODES Ergospirometry WARNING The whole ergometer test has to be supervised by a cardiologist The detailed anamnesis has to be reordered prior to ergospirometer test The ergospirometer test can be performed if all the conditions of the resuscitation are provided Goal of the test Cardiopulmonary exercise testing provides a global assessment of the in tegrative exercise responses involving the pulmonary and cardiovascular system Ergospirometry is increasingly being used in a wide spectrum of clinical applications for the evaluation of undiagnosed exercise intolerance and exercise related symptoms Doctor Dr Piston cust Ty 26c to07npa 31 BIPS ON 22 55 22 40 Elapsed time 00 01 22 35 22 45 22
44. sesdsessassdeacsausdonseduacssssssossusseedeasd 16 Measurements iasscaseatiscccecsinctiactaccaceenescacteacsecsacesecacesecacedecaseeceacseceasnessacsoseacuecsacceee LO AVailab lee x amin AMOS nsii r rtre rer rer Eer E Te E er E 18 Zero SCUING ocre iee oreen nae a nn Taaa oS Nor SEE o aS E A EEIE VEE Tra naeia 20 Prepa t ti ll s zzz taste ese eee a o n Seca o tecate tected tied 21 Interaction of the patient and medical devices 0 eee ee eeeeeeseeeeeeeeneeeeeeseens 22 Evaluation of the cardiopulmonary test s ssessesseeseseesesseseeseeseseesesseseesessesee 24 Measurement modes s sesosossesesososoesesososoesesososoesesosososoesosososoesososoesesososoesesosososse 25 ETS SD TOT GS LY AAEE E oaseaangnnstaasanasssguwaasdaagseasseansiantasedadsbapusassteguseasdaeacsdasys 25 REE Resting metabolic test eecesssceeseeseceeceeceseceeeeseceeeeaecseeeeeeeeeaeeeeees 38 M mten NnEEsssisssssrsssseresesersivsvesssssvevessvssosssssvsvosesevososvessvsssseseroi sasso vs svseso tsosa 40 Device maintenanCe ssssg ggg zezee z e z t re t t t t t e 40 Flow metet MAIN LEH ANCE 5555635 52s505ceuacassionsiagnaseagsndnevsaeasossdeonsesasssgaasesosesaaeseaws 40 Ergospirometer maintenance eeeeeseeeceeseeseceseeeeeeseceeeeseceeeeseceeeeaeeeeeeeeeeees 41 SIN SIEAISS PAIS arnnar enen se r RE RE R SE 41 Reusable accessories wcnsaieisivaieiianiainivnvaaaaianiinnninnnananannenia
45. t 85 Respiratory failure Acute noncardiopulmonary disorder that may affect exercise per formance or be aggravated by exercise i e infection renal failure thyrotoxicosis Mental impairment leading to inability to cooperate Relative contraindications Left main coronary stenosis or its equivalent Moderate stenotic valvular heart disease Severe untreated arterial hypertension at rest gt 200 mm Hg sys tolic gt 120 mm Hg diastolic Tachyarrhythmias or bradyarrhythmias High degree atrioventricular block Hypertrophic cardiomyopathy Significant pulmonary hypertension Advanced or complicated pregnancy Electrolyte abnormalities Orthopedic impairment that compromises exercise performance ES 31 Measurement modes ATTENTION The list of contraindications is only for information purposes the whole responsibility of the exercise test belongs to the supervising physician Indications of stopping of an exercise test It is advisable to stop an exercise test when any of the following symp toms or phenomenon occurs Absolute reasons of stopping The systolic blood pressure decreases by more than 210 Hgmm during increasing load rate and there are other symptoms of the myocardium ischemia Middle or even more serious level of angina pectoris Symptoms of central nerves system ataxia dizziness threaten syncope Symptoms of the Hypo perfusion considerable paleness cyanosis Sustained tachycardia of chambers
46. t after flow sensor disinfections or replacement IMPORTANT If work environment conditions temperature air pressure humid ity change significantly re calibration is recommended Flow meter calibration Please make the calibration of the flow meter according to the Spi rometry volume of this manual Ergospirometer calibration Ergospirometer calibration is performed in the Spirometry Calibration menu IMPORTANT 5 Before calibration the room has to be ventilated to reduce carbon dioxide concentration 5 Never breathe directly onto the device during calibration Ex haled carbon dioxide will corrupt calibration results In case of several connected devices select Ergospirometer from the Device selection list Prior to the calibration of the gas analyzers make the following steps Open the main valve of the gas cylinder Check the secondary pressure the nominal value is bar e Disconnect the gas sampling line from the PinkFlow docker and connect it to the Calibration gas output on the device The gas sampling line has a quick action connector For release the grey button has to be pushed and for connection it is enough to push till clicks Determining ambient carbon dioxide concentration To measure ambient carbon dioxide concentration select the Setup tab and click the button Measure CO2 ppm The measurement is performed automatically ES 16 Calibration Calibration of gas analyzers
47. t process There is a possibility for monitoring all vital signs of the patient before the exercise test In the similar way there is a possibility for monitoring all vital signs of the patient after cooling down phases for any duration All vital parameters are stored and both ECG signals and pulmonary sig nals can be retrieved and analysed later To start the ECG monitoring push the ECG button To start the pulmonary monitoring push the Monitor button The patient needs about 1 2 minutes to get accustomed to the sen sors and to the facial mask Similarly the systems needs the same period of time to calculate the resting medians of the parameters Usually protocols prescribes 3 minutes of resting monitoring but it can be overridden according to the status of the patient or any other actual needs If the manual blood pressure measurement was selected pushing the F6 button will activate the entry fields of blood pressure As the systolic and diastolic value was entered push the Enter button To start the protocol push the Start button Supervise all the vital parameters of the patient continuously If there is any sign of disturbance act according the to the Indications of stopping of an exercise test chapter If the patient reached the maximal load rate push the Recovery button to start the cooling down phase monitoring is still sustained End of the cooling down phase is indicated further more the load of the bicycle ergometer is dec
48. the PC cart and fasten it with the belt Regularly change the sealing ring of the gas cyl inder Connect the pressure regulator to the gas cylinder Plug the high pressure hose to the pneumatic con nector of the gas cylinder Fasten the high pressure hose using the fitting nut Open the main valve of the gas cylinder and set the secondary pressure to 1 bar Caution As the gas calibration is completed always close the main valve of the gas cylinder ES 10 USER INTERFACE Settings Ergospirometer Select the Ergospirometer group in the Setup Options Devices menu Bicycle ergometer Selection of the bicycle ergometer type if any connected Treadmill Selection of the treadmill type if any connected Blood Pressure monitor Available options e Manual BP measurement e Ergometer type if the loading device has a built in blood pressure meter e Selection of any other standalone blood pressure meter if any con nected Fitness interpretation Fitness interpretation evaluation is based on the maximal oxygen con sumption There are two algorithms to select e American Heart Association 1972 e Cooper Institute for Aerobics Research 1997 BMR prediction Basal Metabolic Rate There are two algorithms for calculation of reference value of the reset ing metabolic rate e Mifflin St Jeor Equation 1990 e Harris Benedict Equation 1919 O2 concentration Oxygen concentration specified in the certificate of th
49. ting Runs manual Zero setting of the selected device Without manual Zero setting the system automatically sets zero before all measurements Menu The program s general main menu which contains the grouped basic functions Navigator Control buttons which organise the basic phases of daily routine Patient data Contains the most important measurement data for the patient selected from the database ES 14 User interface BTPS data Usually our ergospirometer is equipped with the ambient module which measures the ambient temperature humidity and pressure These ambient data are shown in BTPS fields If there is no ambient module connected you may enter the ambient data manually Overview histrogram Graphical interpretation of the most iprotant parameters like VO2 VCO2 VE Load Heart rate Blodd pressure Saturation Spirogram Volume time graph which monitors the breathing of the patient Timer May show the duration of the total test or the duration of the individual load steps or countdowns the time Control These control buttons organise basic phases of daily routine as follws e Start monitoring F3 Start measurement beginning of the protocol F4 Cooling down phase End of measurement F5 Store and print ES 15 CALIBRATION After turning the device on and entering the BIPS data calibration is recommended for maximum measurement accuracy Calibration is recommended when starting a new shif
50. tion between the patient and the equipment it consists of the following units e PinkFlow flow meter e Facial mask and headgear Gas analyzer The patient s exhaled has mixture must be sampled and analyzed to de termine oxygen consumption and CO production Elements of the gas calibration line e High pressure gas cylinder with the calibration gas mixture ES 4 Introduction e Pressure regulator e Main valve e Safety vale with pressure limitation Elements of the gas analysis e Gas sampling capillary e PermaPure moisture exchange capillary to provide normalized hu midity for the gas analyzers e Gas sampling pump e QO and CO sensors Oxygen sensor e Chemical cell ultra fast oxygen sensor e Paramagnetic non depleting oxygen sensor optional Carbon dioxide sensor e NDIR Non Dispersive Infra Red fast gas analyzer Environment status measurement module PRE 201 BTPS correction requires the measurement of the following environ mental data e Environment temperature e Environment relative humidity e Atmospheric pressure Power supply PRE 201 Medical design switching power supply which enables operating the de vice from any mains voltage e Mains voltage 90 264 VAC e Mains frequency 50 60 Hz ES 5 PRE 201 Ergospirometer installation INSTALLATION Ne Colour Description Connection 1 Yellow Gas sampl
51. y function tests FVC MVV Attach the self adhesive ECG electrodes to the body of the patient Check out the user s manual of the currently applied ECG equip ment as well In the case of an ergometer bicycle ask the patient to seat on the saddle In the case of the treadmill ask the patient to stand on the equipment as all the sensors are attached Connect the cables to the electrodes Pay attention to the free movement of the patient Cables should not touch any limbs of the patient during the exercise Attach the hand cuff of the blood pressure meter Call attention of the patient that speaking is prohibited during the exercise test because it could influence the measurement Teach a simple sign language to the patient use the Borg scale Pa tient may reply with a nodding to the simple questions as Are you all right or Are you able to proceed etc Attach the facial mask to the patient with the supplied head gear values The system calculates the following predicted values according to the recommendations of the Karlman Wasserman Maximal hear rate HR max 220 Age Expected load calculated on the base of the body surface and weight Maximal oxygen consumption VO2max VO2 HR max VO2 max HR max Predicted values Maximal Heart Rate 192 bpm Needed work load by Max VO2 3515 ml min body surface 220 W VO2I HR 18 31 ml b body weight 234 W BMR 1838 kCal 24h ES 33 Measurement modes Measuremen
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