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ZAN500 Body plus CO-Diffusio nn

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1. Online comparison Configure Instructions Engish iV FV In Ex seperate The General Set up mode allows you to set up an automatic sequence for example if you always want to perform 3 FVC tests in a row you can simply set up the sequence as shown below Cancel ZAN500 Body 64 203 Part No 5001005ENG A Flow Volume Meas INSPIRING RESPIRATORY HEALTH The Set up online comparison dialogue allows you to configure result comparisons Please see the dialogue box below for comparison options x C Reference Best Reference Best dominant fC Reference Best Reference dominant tae The hardware configuration allows you to reset the zeroing point of the flow sensor and configure the set up of the device from a filter mouthpiece perspective 3 Your system components Curent measuring system LI x ai 7102231 7 lze4t _ Teste ae This allows you to set the Fiasutc Ex parameters you want to see Oe after the test is performed from Results both the expired and inspired results and the order of the Automatic results displayed on the screen F PY In En seperate You can set the Automatic option which allows you to automatically save the results of each test In this way you can concentrate on the patient instead of having to push the enter key to save the trace at the end of the test ZAN500 Body 65 203 Part No 5001005ENG A
2. CAZAN Browse lt Back Cancel If you have selected a directory that contains an older ZAN version the set up will suggest you make a backup Clicking on Yes will store the older ZAN installation at C ZANOLD ZAN lt Date gt lt Time gt ZAN500 Body 161 203 Part No 5001005ENG A Y1Spi re Clicking on No will permanently delete the older ZAN installation as well as the archive and the new version will be installed System Software Ins INSPIRING RESPIRATORY HEALTH InstallShield Wizard Choose Destination Location Select folder where Setup will install files Setup will install ZAN in the following folder To install to this folder click Next To install to a different folder click Browse and select another folder E Backup A Do you want to save the old ZAN programme NO WILL DESTROY IRREVOCABLY Browse coca If you have an Internet Explorer Version that is older than the version 6 0 you are prompted to update lt is recommended to install Internet Explorer 6 0 or a newer version Only in DEMO MODE If you are installing the DEMO software select the ZAN Option measuring device you want to install Caution If you selected a main device all options will also be chosen Therefore also click on the H symbol on the left next to the relevant option ZAN500 Body 2s ee Pee nstalist eld 162 203 InstallShield Wizard Select Componen
3. W Automatic Procedure Start after breath IY OR Ines separa Finally the tick box allows you to remove the ability to split the inspired and expired portion of the loop Under the Hyper Responsive set up you can configure the timer for the bronchial challenge program The timer is helpful for the user to do the provocations and after a defined time period keep the cumulative effect of the medication According to ATS ERS provocations should be performed every 5 minutes The test timers allow the defining of up to three time points after the provocation that the efforts should be performed The ATS ERS recommends that these efforts be performed at 30 and 90 seconds respectively ZAN500 Body 66 203 Part No 5001005ENG A YiSpire Flow Volume Meas INSPIRING RESPIRATORY HEALTH 4 2 12 Animation Programme Ro Select this icon F 4 or F8 to display the animation programme With each click the animation selection changes The animation programmes are meant to motivate patients especially children to help perform a maximum effort for example to make all the balloons burst Go Note With each click on the F4 icon the animation selection changes Please breathe normally a ateau ee There are various motives Select the motive which your patient likes best To finish the measurement and display the results press the Enter icon ZAN500 Body 67 203 Part No 500100
4. In both views the edit screen is divided into two areas graphs on the left and data on the right Each test has a unique color code An effort is selected activated by a mouse click to the corresponding color dot 4 9 2 5 3 1 The TGV View A computer generated best fit line is placed over the effort In this view the user can adjust the tangent to correct the value of the TGV Selection dot Graphs Data Handles EE m 1 6 Fa The line can be turned or shifted using one of the three handles ZAN500 Body 122 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 9 2 5 3 2 The IC View Additional to the IC line a FRC line is generated to evaluate FRC during the bodyplethysmography Reason In some cases the result of the computer algorithm to position the line does not match the observations of the physician Mouse cursor attached to the FRC line The user can adjust the position of the line by placing the mouse cursor over the line ane drag it to the desired new position The mouse cursor is over the line when it changes its shape to FRC Press the left mouse button drag the line to the new position and release the button The FRCpleth parameter is also part of the results table Parameter TGV l 3 81 4 89 129 e TLC l 8 50 9 07 107 RV l 2 14 1 98 93 RVITLC fo 28 22 77 FRCpleth ZAN500 Body 123 203 Part No 5001005ENG A INSPI
5. Selection of the method of calculation ZAN500 Body 115 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH xi Four different methods are available jin e R effective C Averaged loop Calculation every e R 0 5 RAEE Max test duration o Ulmer e Matthys Press OK to apply the selected method on the current test Press the Apply button to apply the method on all tests in the system From the multi measure window the overview load the measurement into the display window by RA pushing the button The display becomes the edit window now Selection marker Curves Data Next Page The edit window is split into two areas Resistance curves on the left and data tables on the right Each test is marked with a colour code The curve to be edited is selected by a click on the corresponding colour dot According to the selected method of calculation the system creates a line of best fit in the active curve which represents the measured resistance Note In case the line of best fit should be displayed in all resistance curves a switch has to be toggled in the WINGPI CFG configuration file WBODYCOMBI ResShowAllRegLines NO ZAN500 Body 116 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH If the ResShowAllRegLines switch is set to YES after the start of the programme all lines will be displayed Please ask our service technicians for help The line of
6. ZAN500 Body 75 203 Part No 5001005ENG A Yispire P0 1 PEmax I INSPIRING RESPIRATORY HEALTH 4 5 4 Measuring Plmax Vvvyv gt The patient breathes normally By request the patient exhales maximally During exhalation click on the corresponding symbol to start the measurement The patient is asked to inhale as deeply as possible When the next inhalation starts the respiratory flow is interrupted for 1 2 seconds The maximum pressure after interrupting the respiratory flow is registered PO1max and Plmax require an identical breathing manoeuvre and will be measured simultaneously 4 5 5 Measuring PEmax gt YY vV Yy The patient breathes normally By request the patient inhales maximally During inhalation click on the corresponding symbol to start the measurement The patient is asked to exhale as deeply as possible When the next inhalation starts the respiratory flow is interrupted for 1 2 seconds The maximum pressure after interrupting the respiratory flow is registered ZAN500 Body 76 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 4 5 6 Performing the P0 1 Measurement Start measurement by selecting the P0 1 Symbols Eui in the MEASURE menu Screen Before Measurement normal Juergen oo o o o Symbol Definitions EA Stop the measurement and exit the S Define the user programme E Demonstrate the shutter OM Enter comments j Ler
7. lt D j Please breathe normally jaiii i l imn m ZAN500 Body 120 203 Part No 5001005ENG A Bodyplethysmog INSPIRING RESPIRATORY HEALTH Note TGV and maximum inhalation after occlusion must be performed without interruption to get the corresponding IC This is needed to calculate the correct TLC To save the TGV in the right window and start the recording the next effort press SPACE or select the button To save the TGV in the right window and exit to the main screen press ENTER or select the button Important The TGV manoeuvre should be measured at least three times to validate the measured values Results will be computed and displayed in the results window yvebery Adrian v 0 alr ixe4 lelei Fo zs Pre test Parameter Unit Ref Resistance and TGV calculations use the gradient of the computed straight lines in the graphics 4 9 2 5 3 Editing TGV Results The way of editing the TGV results is similar to the one used to edit the resistance see above To view RA the results and to edit the trace click the Expand icon Two different views are available 1 The TGV view 2 ThelC view To switch between the two views press the leftmost button in the corner menu marked with either IC to go to the IC view or TGV to display the TGV view ZAN500 Body 121 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH
8. lt o opus ZAN500 INSPIRING RESPIRATORY HEALTH i Do not connect items that are not specified as part of the ZAN hardware ZAN 100 j Do not operate the ZAN hardware ZAN100 USB or other system components on any voltage other than that specified k All flammable materials must be kept away from the equipment and No Smoking signs must be prominently displayed in the testing area Oil and grease must be kept away from oxygen equipment m Oxygen approved regulators must be used for O tanks n The equipment is a Type IIA device that requires the use of a 3 wire Type cord set Warning For Denmark it is extremely important not to use the Schuko CEE 7 7 plug it will mate with the Danish socket but it will not be grounded This may result in serious safety hazards o According to good hygiene practices filters and or mouthpieces that came into direct contact with the subject s mouth or aerosolised droplets from the subjects effort should not be touched Dispose of filters and mouthpieces as ordinary waste or as specified by your institution INSPIRING RESPIRATORY HEALTH Labelling Glossary Glossary of Common ISO Symbols High Voltage ltem for single use do not use more than once This symbol indicates that the user Acceptable Ambient Temperature must read and understand all xo Range Indicates the upper and instructions and warnings prior to use y lower temperatures allowed for
9. 1 f ay J beewror H orm ts Deactivation Symbol Spirometry Flow Vohmne pirameter usa d value oped vo 693 117 Ic 1 46 117 FV Cex 631 120 FEV1 534 125 FEV IM 1 amp 103 FEViF 1 s 10 PEF l 1 1131 114 MEP25 U om 11 MEF50 y 539 12 MEP75 U 311 114 NEF25 y 61 124 Volumes Bar deactivated ZAN500 Body 179 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH 8 3 4 Selecting a Measurements Graphic Type Clicking on the mid part of the graphics area opens the corresponding list of available graphic types Bitte Wahlen x c ps i ai 2 O 2 e Available graphic types In some cases not all possible graphic types are valid for the selected report Those graphic types can not be selected and the corresponding radio button fields are disabled greyed Only one graphic type can be selected Press OK to activate the selection or Cancel to abandon the selection 8 3 5 Select a Results Graphic Type Clicking on the right graphic element opens the results graphic types selection The behaviour is the same as in the measurement graphics Bitte W hlen x Available graphic types ZAN500 Body 180 203 Part No 5001005ENG A Yispire Setup Customizing T INSPIRING RESPIRATORY HEALTH 8 3 6 Editing a Table Below the graphics area the tables area begins A table is divided into a caption and the table itself The caption is displayed on the left of the table body To edit a
10. 4 2 2 Important Measurement Parameters Forced vital capacity Maximum expiratory volume with maximum flow speed FEV1 Forced expiratory volume Volume that can be forcefully exhaled within the first within the 1st second of second exhalation Peak expiratory flow Maximum flow speed during exhalation MEF 75 Flow at 75 of expiratory Flow speed after 25 of exhalation volume MEF 50 Flow at 50 of expiratory Flow speed after 50 of exhalation volume MEF 25 Flow at 25 of expiratory Flow speed after 75 of exhalation flow FEV1 FVC Ratio between FEV1 and Obstruction parameter FVC AEX Area underneath the Equivalent to FEV1 expiratory curve Peak inspiratory flow Peak flow during inhalation MI F5 O Flow at 50 of inspiratory Flow speed after 50 of inhalation volume 4 2 3 Flow Volume Screen before Measurement This window is displayed in the MEASURE mode after clicking on the Flow Volume symbol ZAN500 Body 59 203 Part No 5001005ENG A Flow Volume Measure INSPIRING RESPIRATORY HEALTH icl xi Pre test Parameter Unit Ref Symbol Definitions Select this icon or press the ESC key to stop the measurement and exit the programme Select this icon or press the L key to select a reference value from another test for comparison Select this icon or press the F9 key to enter the test set up Select this icon or press the F7 key to print a single test resu
11. INSPIRING RESPIRATORY HEALTH The customer can also check mechanical conditions as well as calibrate the system with the 1L Calibration Syringe which is available from nSpire Health GmbH 9 7 5 ZAN500 Body Box Lifetime Calibration Caution The lifetime of the ZAN500 Body Box depends on how the device is used and how much mechanical strain the device has had to endure When used carefully lifetime is only limited by the lifetime of the sensors and the electronic parts inside Under normal conditions a lifetime of 8 years or more is usual Calibration of the bodyplethysmograph includes volume calibration The latest detected calibration factors are saved and used by the software We recommend calibrating the bodyplethysmograph once per day Please refer to the corresponding manual chapter Calibration for details nSpire Health GmbH recommends a service of the system by nSpire Service Dept once a year The customer will receive a written test report with all results of the service and the calibration values from nSpire Health GmbH 9 7 6 CQO Diffusion Option ZAN300 Lifetime Calibration Warning ZAN500 Body The lifetime of the CO Diffusion option is limited by the CO CH4 analyser Depending on how often it is switched on and off it lasts between 3 to 6 years Another wearing part is the suction pump The manufacturer guarantees a minimum of 3000 working hours Since the pump is only working while
12. The 1 number is the year The 4 means 2004 for example Numbers 2 4 define the product code 800 in this example lf a part or product is marked with this symbol it is compliant to DIN EN 60601 1 Type BF If a part or product is marked with this symbol it is compliant to DIN EN 60601 1 Type B mains and has a built in protection against over voltage lf a part or product is marked with this symbol it is compliant to DIN EN 60601 1 Type 4 BF with additional defibrillator protection This means the device is isolated from the Caution Read the accompanied manuals m device of protection class Il IPXO Not protected against liquid D protective conductor connector This product is compliant to regulations for medical products 93 42 EWG and German C law MPG 0535 The number describes the institute which performed the CE certification In this example it is the Eurocat GmbH institute in Darmstadt If necessary nSpire Health GmbH is able to present the corresponding documents which allow application of this symbol on the device ZAN500 Body 194 203 Part No 5001005ENG A YiSpire Safety Maintenance S INSPIRING RESPIRATORY HEALTH 9 7 Maintenance Information 9 7 1 Gas Container Valves Caution Do not open the valve to the absolute ending and leave it in this position The valve might be blocked irreversibly by the internal pressure of the container Always take AN one ha
13. 0 ZAN500 Body 62 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH The four efforts are colour coded and the computer selects the best result In this example effort 3 is highlighted You can mix and match the flow a volume inspired and expired according to the ERS ATS 2005 guidelines Simply click on the coloured circle you wish to see for the final report for both the top and bottom of the graphic This example shows effort 3 for the AA expired loop combined with effort 4 for the inspired loop According to ATS there are criteria for the acceptance of the test The J computer will automatically determine whether the criteria for acceptance are met If an effort is not acceptable this is shown by a red cross over the Sg corresponding coloured dot In order to remove a loop from the selection i j gt process you simply right click on the related coloured dot The fulfilment of ATS criteria is also visualised by the result table Green and red dots show for each parameter that is defined by ATS and whether aeae the criteria were met or not This includes the criteria for acceptance as well 000G as those for reproducibility only shown when more than one effort performed The result window has a column called Best This column shows the results that are reported for this stage The results of the single efforts that are taken into account for the creation of the Best ar
14. be held responsible for possible problems System Software Inst INSPIRING RESPIRATORY HEALTH InstallShield Wizard License Agreement Please read the following license agreement carefully Press the PAGE DOWN key to see the rest of the agreement Licensed Copies 1 IMPORTANT READ CAREFULLY This End User License Agreement EULA is a legal agreement between you either an individual or a single entity and ZAN Messger te GmbH for the Z4N Messgerate GmbH software product identified above which includes computer software and may include associated media printed materials and online or electronic documentation Product An amendment or addendum to this EULA may accompany the Product YOU AGREE TO BE BOUND BY THE TERMS OF THIS EULA BY INSTALLING COPYING OR OTHERWISE USING THE PRODUCT IF YOU DO Do you accept all the terms of the preceding License Agreement If you choose No the setup will close To install ZAN you must accept this agreement No InstallShield Wizard Please enter the license number of the software License number 1 1 1 is Demo Mode License number lt Back Cancel InstallShield Wizard Choose Destination Location Select folder where Setup will install files Setup will install ZAN in the following folder To install to this folder click Next To install to a different folder click Browse and select another folder Destination Folder
15. ri 5 edit FEW iTV Ei ta 103 FEW EW 1 104 l l l PEF Us l 1131 114 I WEF25 L td 112 I l MEFS Us 7 y 121 l I MEFS Lia a ae ag I MEF 2 75 Vis ag 1 124 Table values Gee ee 1 Tables calactad 5 f ai us RAW tot kPa 130 13E eS Te Preview button Some areas can be switched off or on toggled while others are automatically filled with corresponding data etc To activate the editing functionality of an area move the mouse cursor over the desired region until the cursor shape changes to the hand symbol and press the left mouse button The editor recognises the area the cursor is in and opens the corresponding dialogue editor or menu After modification the result can be viewed using the Preview button This opens the MS Internet Explorer window showing the new content of this template ZAN500 Body 174 203 Part No 5001005ENG A Setup Customizing INSPIRING RESPIRATORY HEALTH Note The changes are not visible in the designer window The designer window acts like a big graphical menu and is designed just to select items to be edited or modified To see how the editing impacts the layout you need to use the preview button Note Please select the appropriate font size in you MS Internet Explorer To close the designer window use the Close icon in the upper right corner A verification dialogue will pop up to ask you if the changes should be stored permanently or not T
16. to the Used list and vice versa Use the arrow keys on the right most side to move an item to the desired vertical order Pressing the a button inserts a separator at the cursor position to improve readability of the table Like the paranicicis the separator can be selected and moved vertically To remove a separator simply select it with the cursor and use the left arrow button After all changes have been applied use the OK button to activate the changes Pressing the Cancel button will discard all changes The dialogue will be closed and the user returns to the overview window 8 3 7 Saving the Changes Whenever changes have been made to a template a verification dialogue pops up when the user attempts to close the overview window x G Save changes If you want to save the changes press the Yes button else the changes will be abandoned and the old design of the report is restored again ZAN500 Body 182 203 Part No 5001005ENG A YiSpire Setup Customizing 1 INSPIRING RESPIRATORY HEALTH 8 3 8 Disabled Options If you use the edit file option a html file is opened in the Notepad editor Modify report File description File ErgoSpiro Value Table Ergot ztm OK Cancel Edit file dialogue fei Ergo1 ztm Editor Datei Bearbeiten Format lt ZANTYPE Report Preset gt lt DOCTYPE HTML PUBLIC w3C DTD HTML 3 2 EN gt lt H ZAN ID INCLUDE REF MScri
17. 1 7 KoKo Moe Filter Filters have to be disposed of after use They are single patient use For replacement use only ZAN certified filters 5 4 1 8 Olive Holder Olive holders can be sterilised in 121 C hot steam autoclave and ethylenoxid 5 4 1 9 Adapter Adapters can be sterilised in 121 C hot steam autoclave and ethylenoxid ZAN500 Body 147 203 Part No 5001005ENG A Yispire Disinfection Mainten INSPIRING RESPIRATORY HEALTH 5 4 1 10 Cleaning and Disinfecting the Breathing Mask Caution Breathing mask must be disinfected after every patient We strongly advice you to follow the instructions of the manufacturer of the mask which can be found in the original packing 5 4 2 Disinfecting The Flow Sensor Caution The flow sensors can be exposed to a maximum temperature of 140 F or 60 C during disinfection Higher temperatures could destroy the variable diaphragm on the inside of N the tube To disinfect the flow sensor the sensor must be removed from the Flowhandy ZAN100 USB body and put into a disinfecting bath It is advisable to remove visible dirt before the actual disinfection An ultrasound cleaning of the flow sensors should only be carried out when it is necessary because the mechanical quality of the membrane could be influenced Caution To avoid infections in connection with the flow sensor it must be disinfected after each patient Always consider the recommendations from the
18. 3 5 ml air to unfold the balloon Then switch the valve so that the balloon is connected to the sensor On screen the oesophageal pressure signal can be observed in the right most sub window to fine tune the position of the catheter The catheter is in the right position when after inhaling the curve goes down When the curve goes up on inhalation the catheter is obviously placed in the stomach and needs to be drawn back To avoid sliding of the catheter use adhesive tape and fix the catheter tubing at the nose ZAN500 Body 97 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH 4 8 3 Three Types Of Measurement 4 8 3 1 Static Compliance From tidal breathing the patient inhales deeply three times and than exhales as deeply as possible Then he she returns to normal tidal breathing lt is important that the patient performs the inhalation and exhalation as slowly as possible to emulate quasi static behaviour The compliance value is computed from the gradient in the middle linear part of the curve 4 8 3 2 Dynamic Compliance The patient breathes with normal or slightly accelerated speed and with normal depth appr 0 5l breath The compliance is computed from the gradient at the inversion point between inspiration and expiration 4 8 3 3 Frequency Dependant Compliance The patient breathes with normal breath depth but with accelerated speed The compliance is computed from the gradient at the inversion
19. 49 0 9736 81 81 20 ZAN500 Body 201 203 Part No 5001005ENG A pire Safety Maintenance INSPIRING RESPIRATORY HEALTH 9 10 Warranty The warranty covers defective materials and manufacturing for one year Within this time nSpire will replace or repair defective parts or products at no charge except shipping costs Exclusions The warranty does not cover damages caused by the following reasons Negligent handling Improper maintenance Third party software or hardware connections Unauthorised changes or abuse Neglecting storage regulations Operation outside of the allowed environmental conditions Incorrect voltage Mechanical damage of the Flow Sensor Use of unpermitted disinfection agents Hardware damage caused by software The warranty starts on the day of delivery to the customer Terms Of Warranty The given Warranty exclusive There will be no other warranty or extensions to this warranty neither written nor verbally given Every other warranty concerning common quality or aptitude is also limited to a one year period Some states do not allow the limitation or exclusion or liability for incidental or consequential damages so the above limitation or exclusion may not apply to you Maintenance within the warranty period The devices must be shipped in original packaging to avoid damage during transportation The customer is responsible for damages caused during shipping due to improper pac
20. Body Box Controls 1 2 4 6 1 Outside On the outside right door panel can be found the chamber controls door release button door closed LED microphone Stand height adjust up Stand height adjust down 1 2 4 6 2 Inside Inside the chamber on the same right door panel are the door release button speaker and temperature sensor microphone and speaker door release button ZAN500 Body 12 203 Part No 5001005ENG A Zan500 System De INSPIRING RESPIRATORY HEALTH 1 2 4 6 3 External connectors of the chamber Underneath the body box are the external connections From the left to the right 1 compressed air from ZAN200 ProvAir CO Diffusion sample tube to analysers CO Diffusion test gas input USB connector to the PC ProvAir remote control cable Power supply input 12V o gt m e 2 mw Power supply input 24V ZAN500 Body 13 203 Part No 5001005ENG A spire Chapter 1 Yiopire Zan500 System Descrip INSPIRING RESPIRATORY HEALTH 1 3 Software The ZAN GPI 3 00 software provides a patient data management system measurement programs and a database fro measurement results Archived data and measurement results can be retrieved viewed and printed at any time Refer to Chapter 2 for additional information A detailed description of the installation can be found in Chapter A2 A guide to customisation of the system according to your personal needs is in Chapter Abd 1 3 1 PC Syste
21. FVC manoeuvre Using the delete key F3 the recording can be re started and the screen can be cleared Symbol Definitions Select this icon or press the ESC key to stop the recording without saving any data Select this icon or press the Enter key to stop recording the measurement if aa CANG t p Select this icon or press the F3 key to Select this icon or press the delete previous recordings space key to save and perform another effort Ge Select this icon or press the F8 key to switch on incentive graphics Every click on this icon will change the screen to a new incentive graph 4 2 6 FV Measurement Guidelines A flow volume measurement with meaningful results demands the optimum co operation of the patient lt is important that the patient inhales and exhales the complete volume of his or her lungs with maximum flow speed You have to distinguish between an inspiratory and an expiratory F V curve To measure the inspiratory curve the patient has to slowly exhale the complete volume of his or her lungs in order to inhale as fast and as deeply as possible afterwards In order to measure the expiratory flow the patient has to exhale as fast and as deeply as possible after maximum inhalation To guarantee a complete exhalation it is recommended to exhale for at least 6 seconds During the measurement a time bar will be displayed in the upper right of the screen It starts to increase with each
22. Part No 5001005ENG A 3 1 1 Performing Volume Calibration Make sure the flow sensor including the adapter is attached tightly to the calibration syringe Verify that the piston of the syringe is completely inserted e The syringe volume 1 000L in this case can be changed by selecting the F4 icon KE To start recording press Enter and begin to pump steadily at a medium flow rate A well defined and constant volume of air is pumped through the flow sensor To ensure an identical volume is provided in every stroke the syringe s piston has to be pushed in and pulled out as far as possible HRA The recording of the volume time curve is displayed he After about 5 to 10 pump strokes select Enter to end the calibration and begin the analysis Results of the analysis are displayed in the following window The calibration factors for each flow direction are stated RESULTS Parameter Karr Ex Kor tr Important The condition for a valid calibration is an absolutely precise calibration syringe nSpire Health GmbH is able to provide appropriate devices ZAN500 Body 34 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH If the flow sensor works properly a green field will be displayed in the calibration window Select Enter to complete the calibration and save the calibration paramet
23. Reset the zero point Patient must not Enter Start the measurement breathe through the sensor a Select a medication ZAN500 Body 77 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH After reset the patient applies the nose clip and forms a tight seal wit Note During resetting the zero point the patient must NOT breathe through the sensor h his her lips around the mouthpiece he gt Start the volume recording by selecting the Enter icon or pressing the enter key gt The patient breathes normally gt During tidal breath the measurement is started by randomly selecting the PO 1 0 1 fh Symbol 2 gt The device will automatically interrupt the flow 120ms after the beginning of the next inhalation and records the mouth pressure und Atem Antrieb i xi nalyse yon Atempumpe em 0 1 q f eo E max ae 04 Normal Juergen o After every 2 4 tidal breaths this manoeuvre is repeated at least 5 times ZAN500 Body 78 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH 4 5 7 Performing PEmax and Pimax Measurement 4 5 7 1 P0O 1max and Pimax To measure PO 1max and Pimax the patient is asked to exhale as deeply as possible i max gt During deep exhalation select the Plmax icon 3 gt The device will automatically interrupt the flow after the beginning of the next inhalation for 2 sec and records the pressure at the mouth gt The patient is asked to inhale
24. a valid CE certification If not the patient could possibly get an electric shock when touching the device because of unequalised ground potential differences between the PC frame and the ZAN device The distance between the patient and the PC during operation must be more than 1 5 m Within a distance of less than 1 5 m no nonmedical device may be associated with a medical device 5 Within 1 5 m distance to the patient no network connections may be installed without a 4kV proof disconnection indirect coupling Caution Mains operated devices which comply to DIN EN 60950 cannot be compared to devices complying to DIN EN 60601 1 for medical devices For this reason medical devices are equipped with galavanic disconnectors indirect coupling which disconnect the medical device from the PC System according to well defined rules But a minimum distance of 1 5 m from the device to the patient is necessary to keep the effectiveness of the disconnectors If this is not possible nSpire Health GmbH strongly recommends the use of the nSpire system cart which is able to completely disconnect the PC from the mains ZAN500 Body 192 203 Part No 5001005ENG A YiSspire Safety Maintenance S INSPIRING RESPIRATORY HEALTH 9 4 Connecting Devices Power cables and data connections should be fastened in a way that they cannot disconnect accidentally Always check if the device is built in accordance with the regulations in the correspon
25. an intercom is situated in the right sidebar of the door The stand height can be adjusted using the external controls allowing the operator to adjust the height without opening the chamber door or disturbing testing The door is locked by electronically controlled magnetic locks which can be unlocked from the outside as well as from the inside Important Every patient should be aware of the red door release button Showing your patient how to unlock the door may help to avoid unnecessary anxiety ZAN500 Body b 203 Part No 5001005ENG A n F Une Y Spire Zan500 System Desci INSPIRING RESPIRATORY HEALTH 1 2 3 Control Unit All necessary external devices to operate the body plethysmograph are integrated in the control unit All devices receive their operating current from the integrated power supply This specialised power supply ensures that all connected devices are electrically isolated high resolution monitor printer mouse keyboard 1 litre calibration syringe PC power supply system desk nSpire Health provide special wide screen monitors with the system to support optimal viewing of the whole user interface These high resolution monitors are connected to the system desk with an adjustable arm As an incentive or to allow the patient to read the onscreen instructions the monitor may easily be repositioned so that the patient may view the monitor from inside the body box The main power switch for all comp
26. and Residual Vi Symbol Definitions Select this icon or press the ESC key to stop the measurement and exit the program 0 Select this icon or press the F9 key Hb to input the actual Hb and HbCO F concentration t Select this icon or press the F11 t key to trigger the shutter pe Lh Select this icon or press the F12 key to reset the zero offset Patient must not breathe on the mouthpiece Select this icon or press the key to increase scale Select this icon or press the F1 key to enter comments Select this icon or press the F5 key to start CO edit mode Fast Space ae pi YL 3 Select this icon or press the F8 to start residual volume edit mode Select this icon or press the F8 key to start report printing tE 4 10 2 2 2 CO Diffusion Set up F5 The dialogue is organised in four sections ZAN500 Body Volumes INSPIRING RESPIRATORY HEALTH Select this icon or press the F2 key to change the user Select this icon or press the Enter key to start the measurement Select this icon or press the F3 key to select the medication Select this icon or press the F4 key to define type of mouthpiece and filter Deadspace Select this icon or press the key to decrease scale Select this icon or press the F5 key to enter Setup Select this icon or press the F4 key to start the inert gas edit mode Fast Space Selec
27. and cables are the same as for ZAN electronic modules ZAN500 Body 154 203 Part No 5001005ENG A 6 Troubleshooting 6 1 General Problems Problem After starting the measurement no volume line appears After starting the volume line does not run horizontally even though the patient is not breathing After starting the horizontal line runs but breathing is not shown The volume line is recorded downward with inhalation and recorded upward with exhalation The volume time curve drifts upward or downward during respiration Possible Causes Measurement device is not connected to your PC A wrong port was selected A wrong measurement device was selected e The zero point was not set correctly Condensation or Vaseline is blocking the holes of the flow sensors The flow sensor has not correctly been put into the case The interface of your PC is in the Power Down Mode The O rings are defective The holes of the flow sensors are blocked with water or Vaseline Flow sensor has been put into the handy from the wrong side The entered ambient temperature is not right The patient is not wearing a nose clip The patient does not seal the mouthpiece tightly enough The flow sensor is defective or must be calibrated 6 2 Body Plethysmograph problems ZAN500 Body 155 203 INSPIRING RESPIRATORY HEALTH Solution e Plug ZAN device into the serial interfa
28. cane as pacceacue E a aE 203 10 2 MECHANICAL COMPONENTS cresias Ea TE E 203 10 3 CO2 ABSORBING SUBSTANCES ccccccceccecceccecceececeaecaecaeeaecaeeaeeceeaueceeceecueseecuesueeuesuesuesaeens 203 ZAN500 Body 2 203 Part No 5001005ENG A pire Chapter 1 Zan500 System Descrip INSPIRING RESPIRATORY HEALTH 1 System Description 1 1 Overview 1 1 1 General Information The medical product ZAN 500 Body is a PC based constant volume body plethysmograph It consists of the hardware components chamber and control unit and specifically designed software All common lung function tests can be performed with this equipment The software delivered with the device is designed to run on standard PCs It operates on MS Windows operating systems like Win98SE Win2000 WinXP and VISTA It does not operate on WinNT due to missing USB support ZAN 500 Body is built mainly for functional diagnostics of the lung in a clinical environment as well as in practices of specialised physicians 1 1 2 Special Features e USB Interface The connection to the PC is through a USB interface This type of connection is less complicated and faster than traditional serial interfaces e NDC Numeric Drift Compensation e CO Diffusion e PC Software A particularly special feature of the ZAN 500 Body is the numeric drift compensation This newly patented feature guarantees stable resistance curves right from the start of the measurement In ad
29. disinfectant manufacturers concerning concentration purpose and reaction time gt The inside of the flow sensor must neither be rinsed with a direct jet of water out of the pipe nor must it be cleaned or touched by mechanical tools This could damage the sensitive plastic orifice and disturb the correct measuring function gt The flow sensor must be carefully dried after disinfection Before use you have to make sure that there is no more water in the holes gt If necessary blow out the holes with compressed air Hint Compressed air in sprayers for medical purposes is available from your dealer ZAN500 Body 148 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 5 4 3 Disinfection Of The Flowhandy The Flowhandy ZAN100 USB contains electronic components and may never be plunged into liquids It is possible to use surface disinfection using pieces of cloth etc If carefully applied a spray disinfection is possible The white pressure sensor on the rear side of the device must NOT be sprayed directly 5 4 4 Assembly Of Handy And Flowsensor Before the Flow sensor is inserted into the Handy again the O rings should be covered with a thin layer of Vaseline accessories to make them slide easily Caution Do not block the holes on the top side of the flowsensor Insert the flow sensor in a way that the holes and the yellow mark on the front rim are in top position This will prevent liquid ge
30. filter q SpiroBac filter without Mouthpiece Paper mouthpiece Bite mouthpiece Bite mouthpiece with adaptor Cancel Default flow sensor options Default shutter options Select a component Select a component ZAN FlowSensor Type llb ZAN FlowSensor Type lla without Shutter ZAN Shutter ErgoSensor ZAN Shutter with demand Pneumo valve valve 4 Cancel Cancel Save multiple configurations for easy selection by pressing the New button ZAN500 Body 49 203 Part No 5001005ENG A Your system components Current measuring system Remove Ok Cancel 4 1 3 Performing SVC Testing ames Select this icon located at the right hand side of the screen to start the 6 measurement 4 1 4 Symbol Definition Select this icon or press the Enter key to save the measurement and exit Select this icon or press the ESC key to end the test without saving Select this icon or press the space key to save the measurement and start a new measurement The volume trace is displayed on the graph as a blue line and scrolls from left to right The patient should use a nose clip and form a tight seal around the mouthpiece with his or her lips The patient should breathe normally through the mouthpiece The following example is an Ex In manoeuvre These have the same structure but with inhalation instead of exhalation t ap If the trace is unsatisfactory the measurement can be re star
31. for example purposes only and the hardware illustrated may differ from your hardware Safety Precautions The ZAN hardware has been tested and certified to be compliant to UL 2601 1 and CAN CSA C22 2 NO 601 1 Type equipment electric shock protection is provided by 3 wire power cord earth ground and additional external earth ground as described However the following precautions must be observed for auxiliary equipment a Connect the power cord for each individual component to a wall source b Do not connect extension cords to the system c Do not use multiple power strips and only use the power strip that is supplied by nSpire Health d Operate the hardware device only when the power cords are plugged into U grounded outlets 3 hole outlets e Unplug the power cords prior to servicing the equipment f Computer monitor printer and testing unit are components fit for use within the patient environment provided external grounding has been implemented as per instructions g The User Operator must not touch any non medical device that is any device other than the testing unit and the test subject at the same time h The ZAN hardware ZAN100 USB has been tested and meets the latest EMC requirements for immunity and emissions of IEC 60601 1 2 However electromagnetic interference may still be encountered If the device is behaving erratically due to electromagnetic interference contact nSpire Health customer support
32. from the selected loop Other parameters may be averaged like TGV while some may sro ik a Ba be calculated using the best or averaged values i I 1I mE In VT Lae ma aB ee pi f 4 9 2 2 5 3 The Slot View Parameter The slot view display an overview over all performed tests The frontpage of each slot is taken from the BEST view of the Effort Best view Double clicking on the result window toggles between the two display modes 4 9 2 3 Measurement of SVC and Flow Volume Selecting the e Button in the corresponding subwindow starts the examination The corresponding measurement window will be displayed as it is explained in Chapters 4 1 and 4 2 ZAN500 Body 111 203 Part No 5001005ENG A YiSpire me 4 9 2 4 Airways Resistance Measurement _ if The patient enters the chamber and the door is closed The door has to be pressed tightly against the door frame and the magnets have to lock in with a click sound Caution It is important to lock both magnets of the door The light on the door panel will illuminate when both A N magnets are locked 4 9 2 4 1 The Measurement Screen Selecting the e Button in the resistance subwindow starts the resistance measurement The system switches from the overview to the measurement screen 4 9 2 4 1 1 Components of the Measurement Screen Icon menu BTPS indicator Breathing frequency indicator rl i om 1 e e om Ae Breathin
33. has been opened in the meantime for any reason ever make sure the door is properly closed again and the pressure equalisation is completed 4 9 2 5 1 The Measurement Screen After the programme has been started the measurement screen is displayed 4 9 2 5 1 1 Structure of the Window Icon Menu Patient s action Frequency bar Prepare for occlusion PO 1 hPa PN 0 40 BIPS 3 Volume time graph TGV graph ZAN500 Body 118 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 9 2 5 1 2 Symbols of the Ilcon Menu The TGV measurement window has its own icon menu to call particular functions during the test REE A simple click on the icon invokes the function EN over the icon displays a hint Symbol definitions Select this icon or press the ESC a Select this icon or press the ENTER key to stop the measurement and exit pos key to finish the test the program Em Select this icon or press the F4 key ae Select this icon or press the SPACE to open the door bar to end he current test and continue space with the next one Select this icon or press the F5 key to toggle the speaker on or off Select this icon or press the key to 4 Select this icon or press the key to decrease volume of the speaker increase volume of the speaker 4 9 2 5 2 Performing the Measurement Upon selecting the fourth slot button the system will recognise the door needs to clos
34. name This is al saved with the patient record The user entered is applied to all tests that are _F2 carried out on the active patient The user has to be defined for every new patient ZAN500 Body 43 203 Part No 5001005ENG A User name field Pre entered user name selection box Display dialogue automatically at the end of the test Show always after test Clear User name field and insert new user name 4 1 2 2 2 Select Medication Selecting this icon or pressing the F3 key selects the medication for the next stage The medication and dose given to the patient can be selected from the current medications entered into the system The user has the choice to correct the medication for the current stage or to define the medication of the next stage On the left hand side of the window the user is able to select the test stage This can either be a Pre stage without medication a NaCl stage a dose of a provocation protocol or a bronchodilator Post Stage For a dose the user needs io first select a protocol from the list It is also possible to create a new protocol see below As soon as a protocol is chosen the possible doses of this protocol are shown in the list box on the right hand side If the dialogue box is opened during a provocation protocol the protocol in use and the next dose are selected automatically Again the user has a choice to create edit see below or delete doses On the bottom right hand side
35. of the window the user is shown how to do the provocation to get to the selected dose This includes concentration nebuliser and count of nebulisations For the count of nebulisations the computer calculates the difference between the target dose and the dose currently in the lung 0 if not cumulative For bronchodilators it is possible to either select none of the medications in the list box or one of those listed Bronchodilators can be created or deleted ZAN500 Body 44 203 Part No 5001005ENG A Choose medication Histamine 44 0 ug Histamine 194 3 pg Histamine 744 6 pg Histamine 1 49 mg Metachaline short Weljete With the dialogue box shown below new provocation protocols can be created The protocol needs to be given a unique name The medication that is used in the protocol needs to be chosen from the list Medications can be deleted as long as they are not being used by other protocols New medications can also be created Create new protocol Metacholine When creating a new medication the dialogue box below appears It allows the user to enter the name of the medication as well as if the medication is cumulative ZAN500 Body 45 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH New medication ue Mame M Cumulative Cancel The dialogue box shown allows the user to create or edit a dose It has an entry field for the dose read only when editing an existing dose as well
36. pire Combin F V Measurement INSPIRING RESPIRATORY HEALTH First the SVC Test is performed Please refer to the SVC Chapter for detailed information Directly after the slow inspiration the forced expiration is performed Please look for detailed information in the F V chapter 4 3 2 Airway Resistance Measurement ROCC Spirometrie Flu Yolumen HERE If your ZAN device is equipped with a valve shutter the respiratory flow can be interrupted during tidal breathing by pressing the space bar during a spirometry measurement lf the pressure that was caused during the interruption is measured and divided by the flow that was caused after opening the valve the flow resistance can be measured The last five measured interruptions will be analysed and displayed in the list of results If the valve does not close with the next exhalation after pressing the space bar the patient was probably breathing too slowly Either the breathing depth or the breathing rate must then be slightly increased ZAN500 Body 69 203 Part No 5001005ENG A X e TM 7 YAspire Combin P F V Measurement INSPIRING RESPIRATORY HEALTH 4 3 3 Spirometry Flow Volume Screen after Measurement Z Norma I Juergen 4 ALANI way yh t toggles the results table on and off or Enter saves the measurement Parameter Selection By double clicking on the results table a dialogue window is displayed with a selection
37. than those mentioned in this manual The opened door of the cabin must not be pushed downwards as this may cause the unit to tilt Patients should be shown the internal door release switch prior to closing the door 1 2 Hardware 1 2 1 System Overview The system consists of two main components the chamber and the control unit which itself consists of the system desk the PC unit and the power supply control unit with power supply and PC system chamber Test gas cylinder is not displayed on this picture ZAN500 Body 4 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 1 2 2 Body Box The test chamber also called the body box is the main component of the body plethysmograpnh It is completely transparent minimising feelings of claustrophobia Patients usually feel more relaxed and cooperate better swing door with space saving suspension upper door magnet stand height adjustment controls microphone for voice transmission and door status light measurement unit with ZAN 100 USB for flow volume and mouth pressure shutter for airway closure CO Diffusion gas demand valve only with option CO Niffiraian calibration socket for automatic calibration of plethysmograph stand which can be electrically adjusted from outside three way adjustable cabin chair lower door magnet connection cables and compensation vessel In order to enable easy communication between the patient and the operator
38. the CO diffusion measurement is running which last about 1 minute the pump will last approx 120 000 measurements A calibration of the CO diffusion option is not necessary if the device is sent in to nSpire maintenance for a service at regular intervals nSpire Health GmbH strongly recommends a service of the CO diffusion option by nSpire once a year The customer will receive a written test report with all results of the service and the calibration values from nSpire Health GmbH 197 203 Part No 5001005ENG A YiSpire Safety Maintenance INSPIRING RESPIRATORY HEALTH 9 7 7 FRC Helium Option ZAN310 Lifetime The lifetime of the FRC Helium option is limited by the lifetime of the He analyser Depending on how often the analyser is switched on and off a lifetime between 3 6 years is usual Another wearing part is the suction pump The manufacturer guarantees a minimum 3000 working hours Since the pump is only working when the measurement is running which lasts about 1 minute the pump will last about 120 000 measurements Calibration Calibration is not necessary Regular maintenance ensures proper functioning of the option Leak Tests Leak free equipment is fundamental to obtain valid results The procedure of the leak test is described in the corresponding manual The test should be performed at least once per week and it must be performed when the absorber granules have been changed Absorber The absor
39. the best in the nostril Nasal adapter connected to the tubing ZAN500 Body 84 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH The mask is connected to the flow sensor and the tubing is connected to the pressure sensor on the back of the Flowhandy The Nasal adapter is placed in one nostril Then the mask is placed over the patient s nose The patient breathes with a closed mouth Again the flow and pressure are recorded Placing the nasal adapter in the other nostril allows measurement of the second side of the nose This method is especially suited to children Important Because the mask integrates nose AND mouth it is important that the patient keeps the mouth shut and only breathes through the nose ZAN500 Body 85 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 6 1 2 Posterior Measurement Performing the posterior measurement the patient will also breathe through a mask but the nose is not blocked The pressure is measured in the mouth while the patient breathes through the nose To differentiate between the two nostrils one can be blocked after the other to get results for each The patient takes the internal tubing between his lips Use a new adapter tip for each patient Make sure that the patient holds the tip firmly between his her lips and the breath will only flow through his her nose Important After the measurement all contaminated parts like olives olive hol
40. transport and storage Protective earth ground Indicates the date by which the product must be used in the format Year Month Date e g 2005 02 19 Type B Equipment Equipment providing a particular degree of protection against electric shock particularly regarding allowable leakage current and reliability of the protective earth connection if present Alternating current Direct current Power on Transport and storage humidity conditions This symbol indicates that this Class m Power off IIA equipment complies with the guidelines concerning medical devices 93 42 EEC of the council from 14 Jun 1993 Fuse This symbol indicates that the associated jack is for a USB Universal Serial Bus connection International Standard CEI IEC 417P Graphical symbols for use on equipment first edition 1973 Table of contents 1 SYSTEM DESCRIPTION 2ccccceceenenenenenenenenenenenenenenenenenenenenenenenenenenenenenes 3 LI CV eae ese E ees es eee eee eee sete nce ae ects aes ene cise ed ste oes saree EE 3 12 MARDWARE macerie Ea AEREA ASEE A a EAE ar tet EARE AAE AEREAS vate 4 1 3 SOFTWARE es cisco hecats eo psec eats Eaa E a ria poets aa PiE ea Aa i ee ea E aaaeaii 14 1 4 OPERATIONAL PRINCIPLE cccceccecceeceeceeceeeceeceeceeceeceecuecuececaecaeeaecaesaeeauesueceeceeeueeueeueenteaes 15 1 5 TEST PROCEDURES iceiccsswinssanecaxdenteveanecsecerovesbecancnvdequc lt sdaceanesseaaeden
41. up Select this icon or press the F7 key to prit a single test result Select this icon or press the F12 key to amp Check the results meet ERS ATS 2005 Standards Enter Comments Select this icon or press the F1 key to display a dialogue box in which you can enter comments Select this icon or press the F2 key to define the user Select this icon or press the F3 key to select the medication Select this icon or press the F8 key to print out one or multiple templates Select this icon or press the Enter key to save the measurement and exit module Selecting this icon or the F1 key opens the comments dialogue box Comments can be typed into the dialogue window and saved by pressing OK By pressing the Predefined button predefined comments can be inserted by using the second shown dialogue box This dialogue box allows the user to create modify and delete predefined comments Each predefined comment consists of a full text and a short description which is shown in the list box Multiple predefined comments can be selected by pressing CTRL during selection 42 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH Comments Cancel Predefined OF Predefined Comments Use the CTAL key to select multiple lines New Modify Delete Cancel 4 1 2 2 1 Define User Selecting this icon or the F2 key enters the test operators
42. up of the measurement devices Gas suction tube is not connected to the flow sensor or Is interrupted Wrong gas calibration or calibration gas cylinder is empty Trouble INSPIRING RESPIRATORY HEALTH a la f Check power cable and switch ZAN 600 on with the switch on the backside Check connection tubes Wait until the analysers are ready Check all tubing s calibrate correctly with a refilled calibration gas cylinder Note To ensure valid measurements take always care for the following facts Always keep volume and gas sensors calibrated to the optimum Take care of cleanliness and correct assembly of the sensors e Watch for tight fit of mask and mouthpiece ZAN500 Body 159 203 Part No 5001005ENG A YiSpire System Software Inste INSPIRING RESPIRATORY HEALTH 7 Software Installation 7 1 Installation When the system is set up for the first time install the software and drivers prior to connecting the hardware to the system When the software is ready installed connect the USB plug of your device to a free USB port of your PC system The device will be recognised by your PC automatically and the appropriate driver will be installed Note If the PC fails to recognise the device remove the USB plug from the USB port of the PC and wait 30 seconds then connect again If necessary reboot your PC and connect the cable after the reboot After that install the ZAN software GP3 xx as e
43. 001005ENG A Yispir e Zan500 System INSPIRING RESPIRATORY HEALTH 1 2 4 3 4 Assembly and Attachment of the Shutter 1 Shutter engine 2 Magnet valve 3 Shutter head 1 Push the shutter 5 into the rear of the Flow Handy ZAN100 USB 6 2 Make sure that the flow sensor 7 is completely inserted in the Flow Handy ZAN100 USB 6 1 2 4 4 CO Diffusion Demand Valve The CO diffusion demand valve is an additional component required for the CO diffusion test magnet valve electronic control cable test gas tube plug in connector to the shutter head with o ring The valve is plugged directly into the shutter head Please properly maintain the o rings They should be covered by a thin layer of Vaseline accessories to make them slide easily into the shutter head Caution Replace damaged o rings before testing ZAN500 Body 10 203 Part No 5001005ENG A 1 2 4 5 Cable Connections INSPIRING RESPIRATORY HEALTH Cable and tube connectors can be found on the underside of the stand arm moveable stand arm connection for the shutter plug in connection for the power supply of the demand valve electromaanet contol connection for the ZAN200 Provair dosimeter connection for the CO diffusion sample tube Compressed air outlet for the nebuliser ZAN200 USB connection for ZAN100 Flow Handy ZAN500 Body 11 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH 1 2 4 6
44. 2 key to define the user Select this icon or press the F3 key to select the medication Select this icon or press the L key to select a reference value from another test for comparison Select this icon or press the F12 key to check that results meet ERS ATS 2005 standards Select this icon or press the F9 key to enter the test setup Select this icon or press the F7 key to print the current screen Select this icon or press the F8 key to print out one or more templates Select this icon or press the Enter key to save the measurement and exit Many symbols have already been explained in the SVC chapter Please look for additional information in Chapter 4 ZAN500 Body 106 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 9 2 2 3 The Setup The body software provides a special integrated setup window where all measurement procedures can be configured Selecting the Z Icon or pressing the F9 key opens the set up window Demo mode Lee Spirometry configuration and Result Conti i w E parameter selection P Automatic Configure for onscreen display enera configuration Es _ Configure ee Online comparison Configure Results Ex Configure F V co nfigu ration and parameter Instructions Geman Conti Be _Configue_ selection for Font size 12 i t Automatic Configure onscreen display iM Print AT S criteria if PY In Ex seperate Appl i Test device is
45. 2 2 1 Input Formats Family All letters The first 3 letters are used for an automatic Name ID number First name All letters The first 3 letters are used for an automatic ID number Date of birth MM DD YYYY Month Day Year Leading 0 does not have to be entered but the slashes between the dates are required The input of century or millennium can be left out if the patient s age is below 100 Height Input is limited between 20 and 100 Weight lbs Input is limited between 2 2 and 551 Sex Selection with arrow keys lt gt or with the mouse Comment All letters Free form text Caution If the cursor does not leave the input field it is likely the input format is wrong This happens frequently in the date of birth field but check all data fields for format errors anyway ZAN500 Body 20 203 Part No 5001005ENG A Once all fields are completed the record can be saved using the save button Caution If the cursor jumps into the ID No field this indicates that the automatically determined ID No has already been assigned to another patient As patient data must be differentiated the ID No must be modified manually Press the save button again amp Eer The patients name will appear at the top of the index card The system is now ready to begin testing sia et ZAN500 Body 21 203 Part No 5001005ENG A ma Spi re 2 3 Modifying Patient Data From the measurements screen c
46. 5ENG A INSPIRING RESPIRATORY HEALTH 4 3 Combined SVC and F V Measurement 4 3 1 Combined SVC and F V Measurement Window before Measurement Selecting the icon in the MEASURE mode enables the measurement of SVC as well as F V measurement with one single procedure 15 x 2 2 il pe 201 215 a Pre test Parameter Unit Ref fi MEFS Symbol Definitions ANGE key to stop the measurement and key to display a dialogue box to Select this icon or press the ESC oh Select this icon or press the F1 enter comments exit the programme M Select this icon or press the L key A Select this icon or press the F2 EEE REF to select a reference value from key to define the user another test for comparison Select this icon or press the F3 Select this icon or press the F9 I key to select the medication key to enter the test set up Select this icon or press the F8 key to print one or more templates Select this icon or press the F7 key to print a single test result Select this icon or press the Enter key to save the measurement and exit the module Select this icon or press the F12 key to check that results meet ERS ATS 2005 Standards The 3D icon switches to view graphic in 3D the magnifying glass icons zoom in and out Click the go icon to start the test ZAN500 Body 68 203 Part No 5001005ENG A o oO N amp TM MT
47. 5ENG A INSPIRING RESPIRATORY HEALTH 4 6 2 2 Using A Mask Flowhandy ZAN 100 USB Put the Mask 2 on the Flowhandy ZAN 100 USB 1 Connect the Nasal adapter 3 with the tubing to the Flowhandy ZAN 100 USB 1 Connect the tubing to pressure sensor of the Flowhandy ZAN 100 USB 2 NS ZAN500 Body 88 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 6 3 The Rhinomanometry Window before Measurement i Start the measurement by either selecting equipment You will then see this window amp Rhinomanometrie JPEE lelg Symbol Definitions 0 ND i Cancel measurement reset zero patient must not breathe through the sensors Zoom in Zoom out Start measuring the left part of the nose ZAN500 Body F according to your Select medication Define user Enter remarks Start measuring the right part of the nose 89 203 Part No 5001005ENG A lt e apt pire INSPIRING RESPIRATORY HEALTH 4 6 4 Performing Rhinomanometry Note Before starting the test the patient should clean his nose properly in order to obtain reproducible results Usually rhinomanometry does not require special co operation from the patient Sometimes the depth of the breath has to be adapted A gt gt Clickon or will start measurement of the right or left nose You will see this hint Please insert pressure olive into the right nostril When measuring the left par
48. 8 Set up Customising The Set up 8 1 System Set up a ZAN Settings E E ol x System Messger t Beenden Lizenz The Set up Option can be accessed by se a coir Kopfzeile selecting the icon on the lower AN portion of the screen SVR Bildschirm HL Demo mode The Set up Option enables you to set and change some of the programme settings including the following ZAN Settings T JAN Settings Language System MSi Exit Database i Patient Headline Reports Pred Formulas Printer Screen HL Demo mode Some parameters are protected with a password if you try to access or edit such parameters you will be asked to enter your password with the following dialogue box Password required x Enter password I Change password New password m Re enter new password m Cancel Enter the correct password and click on the OK button The factory setting for the password is Lufu entered without the The entry is case sensitive Click on the Change Password check box to change the password To avoid typing errors the password must be entered twice The new password is active after you leave the dialogue box by ZAN500 Body 171 203 Part No 5001005ENG A Yispire setup Customizing TI INSPIRING RESPIRATORY HEALTH clicking the OK button If you want to discard the changes and stay with the old password leave the dialogue box by pressing the C
49. ER Re ae eae here eS Se asp Meee Bae See ESSE eee pepe yd Hpi is FS ge papal pene atta E gel aah E EES aha a Pele Sets NLS geet oy e g od Binoy SEs by Saeed aaea al Ba ates See ion AN he seated fl Mi Be copay ee gc a gl yates aye ar aed Rae ed Pree pry Sy ged Bo eG es ANT L OLE a Sg a ge RT Opty et EEEE EE gd oe oe e Tl ho ee AE ENE ee ae dee ete se eee sce we eee Pe an EE E T ean pry TO WN i ge ey cays we ras Pye EO IP hear e apd Foe faye a ete boy A lege yet Pee Peyote AET IE EEE payin anes ley peas Mie R Papeete We T Wiss cs scl ce xan is aa a ko wk yas ae Sn A SS ng OD wa Sak sana eS pS pl capt S DSRS T E E e PATTO nse ss hs eT cS eG a T i i i 1 i i i i F Il Gy Systemsteuerung Compliance Test Z Nor EESE EE 408 ls Change the curves scale using Sls buttons or plus or minus keys To activate a particular compliance curve click on the corresponding raster field This will copy the curve into the left part of the screen The raster field shows a different background colour when selected ZAN500 Body 99 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH Because the compliance is computed from the gradient of the curve the result is displayed as a green Straight line overlay in the curve display The gradient of this straight line displays the result of the computations To manually modify this value pick one end of this line with the mouse cursor You know that you hav
50. F z Pulseoxymeter Port none x OFF z Use ZAN Analog Box Configure Cancel xi r Baudrate m Databits C 2400 C5 4800 CE C 9600 Ca After selecting the port you can set up the corresponding port oo Fu configuration by clicking on the port configuration button This dialogue allows you to define necessary parameters like baud rate Pait Stopbits data format parity and stop bits for a serial port for example none g C even e Please refer to the manual of the external device to find the correct es settings Cancel ZAN500 Body 187 203 Part No 5001005ENG A Setu p C ustomizing INSPIRING RESPIRATORY HEALTH 8 8 4 On line support nSpire Health uses the remote control software PC Visit for on line support PC Visit is not active during normal work and needs to be started on demand To invoke PC Visit select the corresponding item from the Settings Menu like shown below ZAN Settings o 2 lo x System Device Exit For more information refer to the product documentaion of PC Visit ZAN500 Body 188 203 Part No 5001005ENG A ire Cha 4 P ire Safety Maintenance S INSPIRING RESPIRATORY HEALTH 9 Safety Maintenance Service 9 1 General Security Informations We explicitly declare that the regulations in this manual are according to the MPG and the DIN EN 60601 1 The particular regula
51. FP Measurement51 P01 Rhinomanomet Spiro Spiro FY Modify New report OK Cancel This option has been disabled and will be removed in the next version Please do not use this option 8 4 Reference Value Editor You can define the use of the reference value tables of different authors according to your demands BjReference value authors xi Authors not taken into account Selected authors Measurements G Forche 1986 ir Aex y Uldry und Fitting Thoray 1995 a Spanien Bass Feb 1973 Vol 63 Restore defaults New author New formula Cancel Add an author with New Author and a new equation with New Formula You can also change the order in which the associated table is used To activate and deactivate a particular table use the arrow buttons on the left ZAN500 Body 184 203 Part No 5001005ENG A 2 MSP aS Setup Customizing The 5 INSPIRING RESPIRATORY HEALTH 8 5 Printer Configuration 2 Printer E xl This dialogue box is used to define the printer type Las Colar Fontes Use Black White Printer Note ZAN always uses the Windows default printer 8 6 Screen resolution xj Cancel Raster Korr f 19 f Screen Screen Resolution This dialogue defines the resolution of the computer monitor Please select the appropriate setting This setting will not change the basic Windows setting but is used to calculate the graphics and print outs inte
52. G 2c cccececececececececececececececececacecececececes 41 ALT SVC MEASUREMENT rererere anera ae EA a EREA RA a aAa a A Erei ETUNA EEEREN 41 4 2 FLOW VOLUME MEASUREMENT 2 0 cececceceececeececeececeenececaececaecececeececeeaecueaecuseseeeeaeeneaeeass 59 4 3 COMBINED SVC AND F V MEASUREMENT 02 0ccecceceeceececceceeceeceececeecuecueaececueaeeeseeseeaes 68 4 4 MEASUREMENT OF THE MAXIMUM VOLUNTARY VENTILATION MVV cccccssseeeeeeeseeeeeeees 71 45 POT POTMAX PIMAX AND PEMAX sci ciceaces ce cacscsuceneaieeratalacauscancsssiaaadstuattqceevianednueseestounes 75 4G RANOMANOMETRY sariren nonea a E A E E EAEri 83 A EE a E E E neuen 92 AS COMPLIANCE MEASUREMENT eccceiccxceccecceccacemiascecceceracnavateacsueteeacterberndmuesecnasianncapeneceeres 96 4 9 BODYPLETHYSMOGRAPHY ccccccececcececeececeececeececececeeaeceeaecueaececaesecneaeseeaeseseseseeaesneaesaes 101 4 10 MEASUREMENT OF CO DIFFUSION AND RESIDUAL VOLUME 0 cecceeececeeeeeecceeeeeeeeeneeens 128 DISINFECTION AND MAINTENANCE 0ccccccececeeeeeecececeeeeeeeeeeeeceeees 144 5 1 GENERAL DISINFECTION AND MAINTENANCE RECOMMENDATIONS ceccecceccecceeceeceeeeeeuees 144 5 2 GENERAL RECOMMENDATIONS FOR SURFACE DISINFECTION 0 0sceccecceceececceceeceeceeeeeaes 145 53 MV a ae ce sere scene wis nes dada redara oe ee cis nee e Raned einai di edad darai 145 5 4 DISINFECTION OF PARTICULAR COMPONENTS sscseececceececcecceccecceecusceeeaeee
53. Kor Pos 1 00 The results are displayed Kor Neg 1 01 H Select Enter to save the calculated correction factors ZAN500 Body 36 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH 3 3 Body Plethysmograph Calibration Lal Important The Body Plethysmograph Calibration should be executed at least once per day to ensure reliable function of the device Bodyplethysmograph calibration uses the latest results of the volume calibration see above 3 3 1 Performing the Bodyplethysmograph Calibration To perform the Body plethysmograph calibration the following steps must be taken After selecting the body plethysmograph calibration icon a xj the systems asks for the flow handy to be connected to the syst en nia eon calibration socket and the door to be closed PS Sa NL NN aes 2 aie NESE aie CIRE E MARTI Please make sure that the Flow Handy is properly connected to the socket Close the door tightly The metal plates of the door must snap in to the magnets of the frame with an audible click Important If the magnet locks are not active check if the emergency unlock button inside of the chamber is activated Deactivate the emergency unlock by pressing the button again The computer recognises if the doors are closed properly using the USB signals of the chamber and starts equalizing the pressure This message shows up After 15 seconds the process is complete and the message box closes automaticall
54. NSPIRING RESPIRATORY HEALTH 4 4 6 Post Processing A mouse click in one of the three sub windows opens a small post processing window The post processing windows of all three sub windows are almost the same A function is performed by clicking on the appropriate symbol Messen P0 1 Funktions Analyse yon Atempumpe und Atem Antrieb gt Click on or to change the scale gt Up arrow and Down arrow icons manually change Plmax value of the measurement set gt left arrow and right arrow icons selects a PO 1max value manually v selecting the K icon deactivates the selected P0 1 curve gt Using the F1 and F2 keys allows manual determination of a PEmax value of the measurement 4 4 7 Co operation lt is hard to determine if the patient co operates fully It is up to the technician to carefully observe the patient and motivate him her to obtain accurate results Important The patient must try to inhale to maximum after his her maximum exhalation ZAN500 Body 74 203 Part No 5001005ENG A Chapte P0 1 PEmax I INSPIRING RESPIRATORY HEALTH we pire 4 5 P0 1 P0 1max Pimax and PEmax Caution To perform this test the shutter unit must be connected properly to the Flowhandy ZAN100 USB Refer to chapter 1 for more information Note These tests depend on good co operation of the patient It is important to explain every aspect of the test to the patient BEFORE the test starts and make sure the patient
55. RING RESPIRATORY HEALTH 4 9 2 6 Finalise Measurement 4 9 2 6 1 1 Validate ATS Criteria ah In the main window press the button or the F12 key to invoke the automated check of the results against ERS ATS 2005 standards The result is displayed in a small report on the screen ATS ERS have provided criteria for the acceptance of the test The computer will automatically determine whether the criteria for acceptance are met If an effort is not acceptable this is shown by a red cross over the corresponding coloured dot To remove an effort from the selection process right clicking on a coloured dot also places a red cross The red crosses can be removed by again right clicking over the coloured dot The fulfilment of ATS criteria is also visualised on the result table Green and red dots show for each parameter that is defined by ATS whether the criteria were met or not This includes the criteria for acceptance as well as those for reproducibility only shown when more than one effort has been performed 4 9 2 6 1 2 Ending the Programme After the patient has left the chamber the programme is terminated by pressing the ENTER key or selecting the J button This will save data and changes in the database ANC LE To abandon test data and changes select the button or press the ESC key ZAN500 Body 124 203 Part No 5001005ENG A Bodyplethysmogre INSPIRING RESPIRATORY HEALTH 4 9 3 Values of the Body
56. RS Caution Ensure the date is adjusted correctly This could affect a patient s age and the appropriate reference values 2 7 2 Entry of Ambient Conditions Pressing the B key or clicking on the BTPS box with the mouse enables the user to change the values for ambient Tempest Cancel condition Ambient press 1018 mbar Only in the Bodyplethysmograph or when using the Humidity Bo environmental unit these data are automatically detected and transferred Use BTPS from Environment Module Caution Correct temperature adjustment is very important A mistake of 2 degrees will cause a drift in breathing of about 1 percent The absolute barometric pressure must also be entered into the system Meteorological barometers indicate a pressure which can be converted according to the sea level Note For each 100 meters of altitude the pressure will lower by 12 mbar For Example The meteorological barometer indicates 1000 mbar at 680 meters above sea level 1000mbar 6 x 12mbar 1000 72 928 mbar ZAN500 Body 30 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 7 3 Check Device Check device D Pressing the D key or clicking the Check Device button opens the check device options box This displays a list of the current hardware systems that are running on the current PC see the following example It is generally used for troubleshooting purposes if there is a communication problem with
57. Resistance A TURE ene Resistance i and hardware Ooo o Ateo O calculation and i Results Configure configuration Test shutter parameter selection Calculation Configure Device configuration Foor W Watch door Count Result Windows 5 Provocation Hyperesponsiveness TGV TGV co nfiguration test Timer Configure Results Configure and param eter configuration Hee eee aee selection for onscreen display C NaCl Bidirectional Cancel Bidirectional with this box checked the shutter will close for a preset period usually 3 or 5 sec The subject lightly pants until the shutter opens before inspiring to TLC If the box is left unchecked only one effort against the shutter is required See Chapter 5 1 2 5 2 for measurement technique 4 9 2 2 4 Subwindows The upper half of the screen is occupied by the four test subwindows Every subwindow has its own small icon menu from where particular functions can be executed The following icons can be found in each of them S Click the go icon to start the test To make the To return from RA rn Si measurement full if bel screen to multi screen measurement screen p3 To increase the pa To decrease the scaling of a graphic scaling of a graphic ZAN500 Body 107 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH Additional buttons can be found depending on the particular test window 4 9 2 2 4 1 SVC To switch SVC from bar graph to
58. Standard Patient data screen A Additional Patient Data Microsoft Internet Explorer File Edit view Favorites Tools Help lt E x a A PO search 5 Favorites E R ee 33 Address C ZAN GPIZ00 SITE EXTPAT HTM Additional Patient Data Vali H Station Treating Doctor Referng Doctor Smoking Habits igDay Annotations 4 My Computer When the required fields have been completed select the Enter key to save this data 2 5 Measurement Mode Once the input of Patient data is complete measurements can be performed on the active patient Select the Measure button from the menu or press M to display the measurement mode screen gt Fluss b a Volumen CO Ditt i F as a k Select the required test k Note The options available on this menu will vary according to the installed components and hardware ZAN500 Body 23 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 5 1 Symbol Definitions before a Measurement during a Measurement Cancel the measurement delete previous recordings and go on with the measurement Shuiter test delete FV loop on screen Zero the flow sensor Patient must Shutter test not breath into the flow sensor zoom In Zero the flow sensor Patient must not breathe into the flow sensor zoom out Activate Shutter for Rocc test choose medication save and terminate identify current
59. TH 4 1 7 Viewing Measurements In the View mode all measurements or only selected ones can be viewed Pre test Parameter Unit Ref Effort 1 Effort 5 E Ref VC e hg 479 39 IC 32 3 03 93 3 29 39 ERV 147 IRV TY 0 80 The software has two different views in which it can show the test results The first is the Effort View This view shows all efforts of one stage and allows the user to correct efforts by the use of tangents to determine the effort that represents the stage The second view is the Slot View This view shows the Best effort of each stage This viewing mode allows Pre Post comparisons as well as trending for provocation tests If in the Effort View screen the name Effort View will be shown in the grey header of the result window To move to the Slot View left click within the result window To change from Slot View see picture below to Effort View left click within the result window on the column of the stage you want to see the efforts from While in Effort View the coloured dots are used to select the best curve set the acceptance of an effort or highlight multiple curves for better visual comparison ZAN500 Body 96 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH DEMO B S r 4 Aa m eo Parameter Unit Ref VC IC ERV IRV TV aak D 4 1 7 1 Compari
60. TLE f I 6 50 WA Fs I FRC Fs I 3 26 RW Fs I 1 92 FACATLE Fs 2 Id RAY TLE Fs 2 30 Mitel Sal ire 107 1 55 100 12 98 0 710 109 6 93 0 365 112 24g 129 4 62 0 52 g8 35 116 7 32 113 715 0 387 119 270 141 53 101 a 122 Max H 12 20 1 68 4 31 44 fer 3 92 edt 447 g3 40 fide Bo 4 3 3 35 55 43 Mr 2 17 95 1 67 15 80 ral T 15 3 22 2 39 4 92 44 J3 TAF fal af 2 54 45 a4 aM ax 2 r 2 2 18 20 10 17 15 4 5 22 24 18 21 Nr 3 8 20 1 28 13 84 6 55 6 38 3 01 2 09 4 46 ata a2 E67 6 51 3 93 al g a x hd ax 33 23 49 12 12 3 30 10 20 15 15 3 34 r 23 The average value of all selected efforts is displayed Right clicking on a dot corresponding to an effort places a red cross over the dot and removes that effort from the average calculation Right clicking also removes the red cross A left mouse click on the dot will display the graph of that effort ZAN500 Body 140 203 Part No 5001005ENG A X e n Chaptel 4 pire CO Diffusion and Residual V INSPIRING RESPIRATORY HEALTH 4 10 2 4 3 Editing the Results The regression lines for evaluation of the diffusion capacity and the residual volume are computed with numeric methods Depending on the structure of the curves the resulting line may differ from the optimum result and the user may want to reposition them E
61. Waiting Room I Enable WARTEN Browse Search Results Number of persons displayed in the Select Patient list 20 Cancel After finishing the database dialogue several device settings dialogues pop up depending on your license All settings made here can be changed during normal operation using the Set Up option in the main menu ZAN500 Body 164 203 Part No 5001005ENG A Chapter7 System Software Installation INSPIRING RESPIRATORY HEALTH ZAN300 ZAN310 ZAN 310 FRC Device MicroGA C Type Type ll Flowsensor C Type ll Type lla llb Port p Stand alone I Integrated into Body Cancel C COM1 O COM 2 C COM 3 cod CO Diffusion Breath Holding Time fiz s coms C COME I Stand alone IV Integrated into Body C OFF eeeeneeeen Cancel ZAN500 ZAN600 Flow Flow 2 Volume C Typel Type ll Port Horizontal C Vertical Pree C Type ll Flowsensor Events C Type ll Type lla llb Ergometer Type Ill l HR analog H a a a a a a O l Polar USB Cabin Volume Resistance Cancel C Child Ulmer C Body Matthys Body Il C O5l s Handicapped Reff 1980 Liter Cancel External Devices Set the default device amr Default Device Ergometer Type Ergoline P10 Default Device C None 2AN 100 Cancel ZAN 300 C ZAN 400 C ZAN 500 Port Port Configuration Tre
62. Yispire NSPIRING RESPIRATORY HEALTH ZAN500 Body plus CO Diffusion Operations Manual Part Number 5001005ENG Version Revision A we pire INSPIRING RESPIRATORY HEALTH Disclaimer Information in this manual is subject to change without notice and does not represent a commitment on the part of nSpire Health The software described in this document is furnished under a license agreement The software may be used or copied only in accordance with the terms of the agreement It is against the law to copy the software on any medium except as specifically allowed in the license or nondisclosure agreement No part of this manual may be reproduced or transmitted in any form or by any means electronic or mechanical including photocopying and recording for any purpose without the express written permission of nSpire Health The software is provided as is without warranty of any kind either expressed or implied including but not limited to the implied warranties of merchantability or fitness for a particular purpose Some states do not allow the exclusion of implied warranties so the above exclusion may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from state to State nSpire Health does not warrant that the functions contained in the system will meet your requirements or that the operation of the system will be uninterrupted or error free In no event will nSp
63. admill Type Port Port Configuration JV Confirm start of belt BP Monitor Ergometer Jin Ergometer v Port Part Configuration BP Monitor Treadmill ZAN 800 Port Port Configuration Pulseoxymeter Port M Use ZAN Analog Box Configure coea ZAN500 Body 165 203 Part No 5001005ENG A 4 Sp ire System Software Inst INSPIRING RESPIRATORY HEALTH Report Header Editor After the Installation the Protocol Header Enter text for report headlines Font Bold Editor pops up nSpire Health GmbH 5 m Toa g Schlim fhofer Str 14 4 E Enter your practice or clinic data as desired z D 97723 Oberthulba foo Tel 09736 8181 0 Fax 09736 8181 20 4 E To store these data click on lt Save gt Cancel Note These data can be changed at any time using the Set up option Flow sensor calibration AN100 BetterFlow only Please enter the calibration code of Your Flow Sensor Next you will be prompted to enter the CAL A A Code of the mounted flow sensor You find the cal code on a sticker on top of the frontal rim of the sensor You find a two character code Enter the two characters and press OK Cancel Note The Cal code must be checked on every change of the flow sensor Change the settings using the option Calibration and the ch apter Volume calibration LI x Ci Please connect the device to your computer If not already done you are prompted to con
64. aemodynamics This will affect the results 4 10 2 4 Results The results will be displayed graphically and numerically From this view the editing of the gas concentration result lines can be done Fast Space The description on how this is done follows below ZAN500 Body 138 203 Part No 5001005ENG A 6 Chapte 4 P re CO Diffusion and Residual V INSPIRING RESPIRATORY HEALTH 4 10 2 4 1 Graphical Display of the Results The standard view of the results is the graphical display The left half of the window shows the volume methane and carbon monoxide traces in different colours Ge botte dorad In the right part of the window is the volume concentration graph showing the computed lung subdivisions and a graphical representation of TLCO and KCO ZAN500 Body 139 203 Part No 5001005ENG A 4 10 2 4 2 Numeric Display E CO Diffusion and Residual V INSPIRING RESPIRATORY HEALTH Selecting the f amp buttons or pressing the F6 key invokes the numeric display of the results or hides it if it is already visible Single Breath vom 11 07 2007 11 52 Mustermann Melanie 9 B S ES Tel d d Be FRC TLC fs RY TLC fs Messung J1 Tie zom ERGEBNISSE Sall TLeo Hb romol kPa mir 10 09 E co Hb mmol k Famin 1 55 t diff 3 TLE I 6 50 WA I FAL I d r Rw I 1 92 IVC CH4 I FRCTLE ae RAY TLE 3 30
65. alibration Trend O41 21 4 EGF 9 g 101113131415 1817181030112 28 2a 98 8 17 ee 16 01 19 00 Date Limits 16 07 2008 13 08 2008 2009 napire Health GmbH Germany Teki MS 49 9736 8181 0 di On closing this display the programme returns to the main menu ZAN500 Body 40 203 Part No 5001005ENG A WZ Chapte ry i 7 ilies ti SVC Measurer INSPIRING RESPIRATORY HEALTH 4 Measurement Procedures 4 1 SVC Measurement SVC Slow Vital Capacity is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time The manoeuvres to measure the individual parameters are unforced except at the point of reaching end expiration or end inspiration where extra effort is required The volumes that can be measured in spirometry consist of the following TV Tidal Volume The volume of air inhaled or exhaled during the respiratory cycle ERV Expiratory Reserve Volume The volume of air that can be maximally exhaled from a position of passive end tidal expiration IRV Inspiratory Reserve The volume of air inhaled from a position of passive Volume end tidal inspiration IC Inspiratory Capacity The volume of air inhaled from a position of passive end tidal expiration VC Inspiratory Vital Capacity The maximal volume of air inhaled from the point of maximal exhalation VCex Vital Capacity expiratory The maximal volume of air exhaled from the point of m
66. ancel button 8 1 1 Language xi Select System Language To activate German English French or Spanish language Pt Cancel settings C Deutsch Fran ais Units C Height cm Weight kg Date Day Month ear Height inch Weight Ibs Date Month Day Year Speed C kmh mph Temperature C Deg Celsius Deg Fahrenheit 8 1 2 Database In paragraph Id No the format of the patients ID is determined x xi In the paragraph Database the user can define the folder were EA ERF the patient archive has to be stored Create Patient Id Nr incrementally 001 002 003 Paragraph Search Results defines the number of patients displayed in the main window as a result of the Search Patient A Waiting Room Enable AWAR TEN Browse Search Results Number of persons displayed in the Select Patient list 30 Cancel ZAN500 Body 172 203 Part No 5001005ENG A Yispire setup Customizing INSPIRING RESPIRATORY HEALTH 8 1 3 Patient j Patient This turns on multiple tabs in the main window and activates entry ce f M Use 5 patient tabs of additional patient data and ethnic group W Additional patient data Cancel MV Ethnic group select 8 1 4 Headlines This dialogue box will change the headlines on the printout of the reports se xl Enter text for report headlines Font Bold S chlimpfhofer Str 14 D 97723 Oberthul
67. and exit the i Select medication ESC B programme i Find Zero Define User P2 OF CS B gt Zoomin Add Remarks h we Zoom out Start Measurement EF Enter ZAN500 Body 71 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH 4 4 2 Performing a MVV Measurement we Select this icon Enter or press the Enter key to start the measurement On the screen the recording is displayed as a yellow line The patient should place their lips around the mouthpiece forming a tight seal and breathe normally The patient should be instructed to begin breathing as rapidly and as deeply as possible The recommended frequency is 30 minute he Start measurement by selecting the Enter icon again Note It is important that the patient continues to breathe maximally throughout the recording phase The measurement should use this kind of running start to ensure optimum results The patient has to breathe maximally for 12 seconds If the patient is unable to continue for the whole 12 seconds it is possible to stop the measurement by he selecting this icon Enter at any time and calculate their results from the data that has been recorded up to that point The maximum minute volume will be defined by extrapolation of the volume during the real measured time After 12 seconds the measurement will finish automatically Select this icon Enter or press the Enter key to save the measurement and exit Maxi
68. ange the ee S et U DS a Current Settings The following options are installed MV Cardiac Output ZAN600 InstallShield lt Back Cancel InstallShield Wizard Setup Status ZAN Setup is performing the requested operations The ZAN programme will be installed automatically OE T InstallShield ZAN500 Body 163 203 Part No 5001005ENG A System Software Ins INSPIRING RESPIRATORY HEALTH Only with Option RHINOMANOMETRY During the install you will be asked if the Rhinomanometry will be performed with olives or with a mask Check the appropriate box and press NEXT The Installation continues ARhinomanometry InstallShield Wizard E Select the components you want to install clear the components you do not want to install Click Nest to continue W Type Olives Inetallahreld Back Cancel Only with ZAN600 and Option ECG In case the ECG option has been purchased at this time the installation process branches to the Spacelabs Cardio direct installation Please refer to the original manual for detailed information about the installation procedure x ZAN Settings System Device Exit Next dialog in the standard x installation procedure is the ldNr d at ab ase d i al 0 g ue Create Patient Id Nr automatically C Create Patient Id Nr incrementally 001 002 003 Enter Patient Id Nr manually Database Folder ARCHIV Browse
69. as a list box for the concentration and the factor to be used Again elements can be added to or deleted from the list boxes as long as they are not being used by another protocol Configure dose Medication Concentration mg ml Calculation of medication by Dose pee 520 7 fe 26 67 mg ml i Alo of breath Ho of breath Delete Delete Cancel Since the ATS 5 breath protocol requires 5 nebulizations an additional way to define the protocol exists calculating the dose by the number of breath s Simply check the No Of breath radio button and enter the desired count of breath to calculate the doses To enter a new concentration use the dialogue box shown below The description is the text that is shown in the list box and allows the physician to determine the correct dose concentration The concentration is entered in mg ml Enter concentration x Description f Concentration mg ml Cancel ZAN500 Body 46 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH To enter the factor of the nebuliser use the dialogue box below The dialogue box allows the entry of a description for instance the name of the nebuliser as well as the volume in ul that is nebulised per nebulisation x Description Factor ul Nebulisation Conce 4 1 2 3 System Set up Selecting this icon or the F9 key enables the configuration of the spirometry programme and the selection of sys
70. aximal inhalation 4 1 1 Measuring Separate Partial Volumes The most important reference point of respiration is the Tidal Volume Vt At the end of tidal expiration the retraction power of the thorax and the contraction power of the lungs are balanced ERV is measured by having the patient exhale steadily and as deeply as possible Some patients may take a small breath in before they exhale This does not affect the results Once the patient has exhaled as deeply as possible they should be encouraged to inhale maximally or as deeply as possible This manoeuvre enables the calculation of the other spirometric parameters lt is also possible to perform this measurement by getting the patient to inhale maximally from tidal breathing before exhaling as deeply as possible ZAN500 Body 41 203 Part No 5001005ENG A YiSpire 4 1 2 SVC Window This window is displayed in the MEASURE mode after clicking on the spirometry symbol After selecting the measurement the following window is displayed ZAN500 Body Chap SVC Measurerm INSPIRING RESPIRATORY HEALTH Attention Zero Adjust Please don t breath into flow sensor Symbol Definitions Select this icon or press the ESC key to stop the measurement and exit the programme Select this icon or press the L key to select a reference value from another test for comparison Select this icon or press the F9 key to enter the test set
71. ba Tel 09736 8181 0 Fax 09736 8181 20 TET ZAN500 Body 173 203 Part No 5001005ENG A 2 4 Sp re Setup Customizing The INSPIRING RESPIRATORY HEALTH 8 2 Report Designer The ZAN GPI software provides many preconfigured printout forms which match the most common formats But in some situations there might be a need to adapt the existing templates to particular demands In order to give the customer some control over the printed output of the program nSpire Health provides a simple but sophisticated tool to revise the layout of the print templates 8 2 1 Overview Every report is derived from the same basic template This template can be looked at as one side of a printer page The page is divided into areas Every area represents a particular element and provides specific editing features For example there are text areas which can be edited other areas contain graphics in which styles can be selected from a menu Header _ gt ZAN MebBgeriite GmbH i edit DATTE Oherthulba Schimpthofest 14 Tel 09796 8181 0 Fax O9TIGEIS120 Patient ID automatic Pe O eae ace V E e e e e e e e R e EE OE ee ErgoSpurna K rl 2 TV ols 342 170 cm 74 ka sale 25 011 Y Lu fee ee ee ee a i i Xi iiMli i ii i i i i Volumes toggle l I l graphics area Graphics selected I Graphics l selected l l l 1 l La a d e l o 3 l l I oi P l Table caption 7
72. because the A N patient must not change his or her breathing pattern If possible the interruption should be started unobserved by the patient Note lt is recommended to carry out the P0 1 measurement before the Plmax measurement because after maximum effort tidal respiration will not be regular 4 5 8 Completing the P0 1 Measurement and Analysis kE By re selecting the Enter symbol the measurement will be completed and the results will be calculated and inserted Z Normal Juergen With this Button you can toggle the results table on and off Parameter Selection With a double click on the results window you can open the parameter selection window Select the relevant parameters from the parameter list They will be shown in the results window from now on Refer to the parameter selection paragraph in the SVC Measurement chapter for more details ZAN500 Body 80 203 Part No 5001005ENG A Y Spire P0 1 PEm INSPIRING RESPIRATORY HEALTH 4 5 9 Editing a P0 1 Measurement By clicking on one of the three measurement screens a small window for editing a measurement is displayed These windows will differ a little from each other Click on the appropriate symbol to perform the desired function v y ZAN500 Body FPFE FTE i Increases the scale of the graphic Decreases the scale of the graphic T If more than one manoeuvre has been performed use this icon to scroll up to the prev
73. ber After confirming the rest of the process works automatically It is similar to an installation and does not need major changes Note You should use the reinstall option only to repair update or reinstall lgili lt Back Cancel InstallShield Wizard xj Setup Type Choose the setup type that best suits your needs Please choose a function If you select Delete you are prompted to Add an option to the program confirm that you are really sure that you want to Reinstall the program delete all programmes and data from your Delete the program computer InstallShield lt Back Cancel ZAN500 Body 169 203 Part No 5001005ENG A System Software Ins INSPIRING RESPIRATORY HEALTH Confirm Uninstall Do you want to completely remove the selected application and all of its components If you want to do so click on OK if you are not sure click on Cancel If you clicked on OK you are prompted to create a backup before deleting We strongly recommend creating the backup P Do vou want to save the old ZAN program My Ao WILL DESTROY IRREVOCABLY If you choose No all data related to the ZAN programme including your settings and the existing patient archive will be deleted This action is irreversible The Deinstall is finished now ZAN500 Body 170 203 Part No 5001005ENG A Y Spire Setup Customizing T INSPIRING RESPIRATORY HEALTH
74. ber granules remove the carbon dioxide from the exhaled air The capacity is limited and it needs regular replacement nSpire recommends replacing the granules every 90 minutes of breathing Please refer to the option manual for more details Maintenance nSpire Health GmbH strongly recommends a Service of the ZAN310 FRC Helium option by nSpire once per year The customer will receive a written test report with all results of the service from nSpire Health GmbH ZAN500 Body 198 203 Part No 5001005ENG A YiSpire Safety Maintenance INSPIRING RESPIRATORY HEALTH 9 7 8 Ergo Flow Sensor Lifetime The Flow Sensor is directly exposed to the patients breath disinfective agents and a permanent change of humidity and temperature That makes it impossible to guarantee a minimum lifetime The typical lifetime of a flowsensor is about 5 years according to customer reports Calibration Calibration is recommended after every disinfection or after exchange of the Flow Sensor Calibration can be performed by the customer using the 1L calibration syringe The syringe is available from nSpire Health GmbH The necessary software is already included in the standard software package If the customer does not want to calibrate Flow Sensors they can send them to nSpire for calibration If the calibration results in unacceptable deviations from the reference values the Flow Sensor should either be replaced or re encoded by nSpire Che
75. best fit has three handles to allow the user to reposition the line eo 0 25 3 Selection marked with a 14 black circle Resistance curve handles computed straight line In order to move the line place the mouse pointer on one of the handles To indicate that the mouse cn pointer is connected to a handle it changes its shape Press the left mouse button and move the handle to the desired new position This technique allows the user to place the line into the best position ZAN500 Body 117 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH In the values column of the corresponding table on the right side of the screen Same colour code the new values become visible followed by a question mark in brackets signifying that this value has been modified manually unmodified values show a character in brackets indicating the preferred method of calculation has been applied wet Closing the window by selecting the gt lt button returns to the overview Alternatively the user can use options from the main icon menu on top 4 9 2 5 Thoracic Gas Volume Measurements The resistance test should be followed by the TGV measurement The measurement is initiated when the user pushes the e button in the TGV sub window The standard procedure is that this measurement follows directly after the resistance test The chamber door therefore should be still closed If the door
76. caption of a table click on the requested caption and the edit dialogue pops up Dialog1 Please enter new Text Spirometry Flow olurme Schriftart Use the Schriftart button to select a font Use OK to activate the changes or Cancel to leave the content unchanged ZAN Mebger te GmbH DATTA Oberbulba Schlimpthoferstr 14 Tel 097J6 8181 0 Fax 08736 8191 20 Z ErgoSpire Karl T E TWoit0342 170 cm 74 eg male 25 01 12 SY I Tit 3 L22000 11 1 h Spiomety Flor wo hore parameter leat peed value tered Wit l 192 f 117 io i 431 dm iif FY Cer 1 355 835 120 FEW i dT 58 125 FE eee si Soar 103 FES Schriftgrabe 108 FEF z 114 WE ii HIE 1 1 ME Werte iid i 134 yee Eo EA Wiot kFai s z sa Wi kB ats vo 4201 Wohmmes TW 3 6 111 TLZ j 5 23 iva yo 2 35 EW i 2 146 TIWILE i aT LH BTL a 55 139 Comment When you click into the table the system offers two options in a pop up menu 1 Schriftgr e means font size to select a different font size for the table contents ZAN500 Body 181 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 Werte means parameters to select a subset of parameters from a menu of available parameters to be displayed Report Configuration x Report Configuration Files Available Parameters Used Parameters Selection of values to be displayed in the table Use the arrow keys to move a particular item from the Available
77. ce Select port or measurement device in the set up programme Disconnect the device from the USB port wait at least 30 sec reconnect the device restart the programme o With F12 key or selecting Fz set the zero point again The patient must not breathe on the device while the zero point is set e Change flow sensor and carry out new calibration Put the flow sensor correctly onto the case there must be no gap Deactivate the Power Down Mode of your PC Replace the O rings e Clean the holes of the flow sensor or the holes of the flowhandy Take off the flow sensor and put it into the handy from the right side Activate the BTPS entry module with lt B gt and correct the temperature Use a nose Clip The patient must tightly enclose the mouthpiece or use a different mouthpiece Calibrate flow sensor or exchange it Part No 5001005ENG A been activated yet The door has been deactivated by pressing the security switch The resistance curves are wide open The door is not completely closed The temperature sensor is defective The patient s mouth or nose is not completely closed The resistance curves run vertically The cabin pressure is not registered The resistance curves run horizontally The respiratory flow is not registered The TGV curves run vertically The cabin pressure is not registered INSPIRING RESPIRATORY HEALTH selecting the door s
78. cecceeceecceeceeceeceecuececcececeecaecaeeaeeaeeaeeaeeceeceeseesuesuesuesuesaeeaes 158 6 5 SPIRO ERGOMETRY PROBLEMG 2ccececceceececeecececeececeececeececueaeceeaeceseseseeaueneaeseeaeeneaeans 159 SOFT VW ARE INS PALLA TION sisscssscssscccuvcnncconiwenvccuvesusccuveouceauveeuceancweseauvuans 160 ZAN500 Body 1 203 Part No 5001005ENG A 10 Yispire 7 INSTALLATION eseri cece ee saree aasce snc aeeeat AEE AE EE 2aacenen EEEE Eee Orre AE NNE AAE ei 160 7 2 INSTALLATION OF THE ZAN GPI 3 XX SOFTWARE ccccecceeceeceeeeeeceeceececceececcueceecuseuseaseass 160 7 3 MODIFYING REINSTALLING OR DELETING THE SOFTWARE 0eceeeceeceeceececceseeseeeeeeeaeenes 168 SET UP CUSTOMISING THE SET UP cccceeeseeeeseeneenseeesenseneeenees 171 VS I FI UP seen cele he eaters Mees cence a pes ee oa EE NASA EEEE 171 82 REPORT DESIGNER sccsceadeccccacdceacnaailsenistacatw ANE E OEA A ENE AEAEE EN EErEE a aeons 174 8 3 REPORT SELECTION DIALOGUE ccccccceeececceeececeeeecceaeccuccueeceeaeeceeeaeeceeseeneeeaeeneeseeeneeens 176 8 4 REFERENCE VALUE DIG OR ssicccc rete ceccoecdacanseicuaeus tied auniresies dws tandabuviondadeee tied eastateadoustedinuuors 184 8 5 PRINTER CONFIGURATION eigctcececcceic cetera dacs aceieceasertiecddevisdacens piccasedndeiariaeedoxeerteudeetaaen 185 8 6 SOREN RE SONU ION seececrecec see seciaereisee steers cess oes ewes ects tsdec aai 185 o AANGE OPTIONAL a EE E E E E E E EE 185 86 DEVCE ETING carce
79. ck There are two criteria to determine if a Flow Sensor produces correct results 1 Raw inspection of the membranes If membranes are mechanically damaged the Sensor is unusable 2 Precise Calibration Deviation in ex gt 6 or deviation 1 00 lt gt 10 The Calibration Software provides automatic detection of deviation and gives a warning message Additionally correction coefficients cannot be saved ZAN500 Body 199 203 Part No 5001005ENG A pire Safety Maintenance INSPIRING RESPIRATORY HEALTH 9 7 9 ZAN600 USB Lifetime The lifetime of the ZAN600 USB system depends strongly on usage strain and maintenance One of the main factors is the lifetime of the analysers A lifetime of at least 5 years can be expected under normal conditions and if properly used Caution The ZAN600 USB is a medical measurement device built according to strict legal regulations of the German MPG Chapter 5 of the regulations demands regular supervision of the measurement precision nSpire Health GmbH recommends supervision by either nSpire Health GmbH or another authorised institution once a year In addition the user is also advised to follow the regulations concerning correct usage and proper handling Maintenance A service at nSpire Health GmbH includes tests of the following parameters e Leaks e Mechanical condition e Measurement precision e Data communication e Linearity The customer will receive a written test rep
80. creen change to the Measure mode The screen will now show all installed measurement procedures according to the licence code Body On the Measure screen select the button with two consecutive clicks to display Bodyplethysmography main test screen E ZAN GP1 3 00 Patient F V ROCg Ree _Olives pe Diffusion Qty Compl Sr Volume _ BP E Rhino Bue R 3 Mask PO SVC _ Rhino Es J a Hl Note After the first click on the button the button colour turns to red to show that it is pre selected The next click on this button will start the measurement programme This is not a double click but two consecutive clicks 4 9 2 2 The Multi Measurement Screen The main screen is the centre of the Bodyplethysmography measurement programme Firstly it displays the results of all performed examinations as a synopsis and secondly it works like a big graphical menu from where the user can branch into the several sections In a way one may look at the main screen as a container combining all the different and basically independent methods to one complex process ZAN500 Body 104 203 Part No 5001005ENG A YAspire Bodyplethysmog INSPIRING RESPIRATORY HEALTH Before the main screen open a warning message is displayed in the middle of the screen signalling that the sensors are being adjusted to zero Attention Zero Adjust Please d t breath Caution At this time the fl
81. cueeuseaneuseaees 145 5 5 DISINFECTION OF THE ONE WAY VALVE CO DIFFUSION OPTION ONLY ccccceseeeeeeeeeees 150 5 6 DISINFECTION OF THE ERGO FLOW SENSOR ZAN 600 680 ONLY cccceeeeeeeeeeeeeees 151 5 7 DISINFECTION AND CLEANING THE BODYCHAMBER ZAN 500 2 cccecceceeceeceeeeeeeceeeeenes 152 5 8 CLEANING THE ZAN ELECTRONIC MODULES cccccecceceeeeceeeececeececeececeeeeceseeaecusaeeeeans 153 5 9 CLEANING OF THE PERMANENT ELECTRODES OF SUCTION DEVICES c cscceccecceccecceseeeeeees 153 5 10 DISINFECTING AND CLEANING MEDICAL PRODUCTS OF OTHER MANUFACTURERS 153 5 11 CLEANING AND DISINFECTION OF THE TOUCHABLE PARTS IN THE ENVIRONMENT OF THE BT Tee cecacte cece aaasacesmcrse cece cai needa canes be ess ecmasee dee aetn eancstssee dacs secant sp aanone ass cae uastacacumte ne tataeeseannes 153 5 12 CLEANING THE COMPUTER EQUIPMENT sceseccccede icccevscedecexexnactceexedancctybocsevexedencxdseaceseeeedenecs 154 TROUBLESHOOTING 2 cccccccccececececececececececececececececececececeaececeeeceeeaeaeeess 155 6 1 GENERAL PROBLEMS c0cceccecceceeceeceececeececeececuecueceeaecaeceeaeeaecuecueseeaesuecueaeeaeeuesesaeeaeens 155 6 2 BODY PLETHYSMOGRAPH PROBLEMS 0 2sceeceeccecceeceeceececcuececceecuecuecueceeceesuecueeussaeeeeeaees 155 6 3 DIFFUSION PROBLEMG cccccceccecceccecceceeceecaeeaeeneecueceeaeeaesaeeaeeaeeaeeseeceeseecuecuesuesueeaeeneeaees 157 6 4 ERGOMETER PROBLEMS cec
82. der and flow sensor must be cleaned and disinfected according to the disinfection instructions Do not reuse disposable parts like foamed plastic etc 4 6 1 3 Important Parameters of Rhinomanometry Flow 50 Flow at50 Pa Flow speed at 50 Pa Tidal breathe through pressure difference one nostril Flow 150 Flow at 150 Pa Flow speed at 150 Pa S pressure difference S Res 150 resistance at Nasal breath resistance s a 150 Pa at150 Pa pressure difference a Res 50 resistance at 50 Nasal breath resistance at a Pa 50 Pa pressure difference Res 300 resistance at Nasal breathresistance at s a 300 Pa 300 Pa pressure difference because the flow inside of the nose is always turbulent the pressure difference shows a square function of the flow like P f F The result shows a curve similar to this example ZAN500 Body 86 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH Flow l s Druck Pa Because of the non linear relation between pressure and flow the flow resistance is not constant and also depends on the pressure 3 pressure values define this curve 50 Pa 150 Pa and 300 Pa s a 4 6 2 Assembly And Connection Of The Parts 4 6 2 1 Using Olives 1 Flowhandy ZAN 100 USB 2 Tubing connect to Olive holder 3 and Flowhandy ZAN 100 USB 1 3 Put Olive holder on the adapter 5 and the Flowhandy ZAN 100 USB 1 4 Put the 2 Olives 4 on the Olive holder 3 ZAN500 Body 87 203 Part No 500100
83. determine what particular examinations are combined to one measurement e 3 9 measurements built one test pre or post medication for example e All tests are sampled in one slot see below The cover sheet of a slot is the BEST curve One bosplethysmogray test may consist of several slots 4 9 2 2 5 1 The Effort Best View Pre teat i Parameter Unit Raf ic Lg Le l Sr Tt I FEW i int FAE I 1 FEF Fr zi 1 HEE z 7 1 WEF in 44 MEETA Wu 1 laz EM i REFA KP ca o A S GAEE S iat Kat EE I TITS LH T Toy I M37 24 E IE TIN TL l sE mi I A E TAS ev i Iti m 2m A po E i 1 ee The Effort Best View displays a particular test Every test is displayed in a coloured column with two columns of numbers Value and of the expected value In the leftmost columns the descriptions of the lines are printed like parameter name unit expected and normal value of the parameter Coloured dots at beginning of a line in a particular column depict if the value is valid according to the ATS EU citeria ZAN500 Body 110 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH 4 9 2 2 5 2 The BEST Column The best column displays a compilation of the results from all included efforts according to ERS ATS guidelines ie the highest FEV and FVC are displayed in the best column while the remaining forced spirometry parameters are
84. ding law E g In Germany a maximum overall discharge defined in DIN EN 60601 1 must not be exceeded when additional devices are connected 9 5 Special Precautions With Treadmills Treadmills use very powerful engines Only treadmills designed according to the regulations for medical products should be used Always position the treadmill so that if the patient falls accidentally he she does not encounter injuries If the patient falls he she will be moved backwards The place behind the treadmill should therefore be free from any objects equipment We recommend placing padding on the walls behind the treadmill Depending on the patients condition a special safety belt might be necessary to prevent the patient from falling On any malfunction such as a power failure the patient must leave the treadmill immediately because some treadmills accelerate on recovery skipping the normal start programme and this may cause the patient to fall off Also a sudden stop of the band must be avoided because it could make the patient fall onto or over the front of the treadmill Read the safety information by the treadmill manufacturer carefully ZAN500 Body 193 203 Part No 5001005ENG A 9 6 Product Label ZAN 800 ECG J 12V oc max 12VV Ser Nr 4800472 4 0535 Z A N leama iat IPO D 97723 Oberthulba Symbol Definitions Safety Maintenance S INSPIRING RESPIRATORY HEALTH The serial number is defined as
85. dition to the features of the ZAN 500 Body the ZAN 530 Body includes the CO Diffusion test hardware and software components A simple user interface grants optimised learning with safe and easy use e Integrated Medication Presets Database Medication presets can be added and edited at any time There are tables of standard values predefined in the software which can be edited or added to Additionally it is possible to add predicted normal equations which can also be edited any time e Integrated Patient Archive Archived data and measurement results can be retrieved and printed at any time using the printing facilities of Internet Explorer All data and results can also be computed and examined manually either directly after the measurement or if the data has been archived at a later stage e Data Import Export Interface ZAN500 Body External data exchange using HL7 is available 3 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH e Manual Re measurement Almost every curve can be re measured manually using tangential adaptation This can be done right after the data acquisition or later after the data has been archived and retrieved 1 1 3 Safety Advice Warning The Flow Handy ZAN 100 USB device must only be used in connection with PCs and peripheral devices which are compliant to DIN EN 60950 and also have a valid CE clearance A N Plugs and connectors must not be connected to any device other
86. during this time to inhale as powerfully as possible gt Repeat this manoeuvre at least 3 times to obtain acceptable results Important Between each Plmax interruption wait for a minimum 5 tidal breaths to give the patient a rest 4 5 7 2 PEmax The PEmax manoeuvre is inverse to the Plmax manoeuvre The patient starts with maximum inhalation VW gt During deep inhalation select the PEmax icon _ gt The device will automatically interrupt the flow after the beginning of the next exhalation for ca 2 sec and records the pressure at the mouth gt The patient is asked to exhale as powerfully as possible gt Repeat this manoeuvre 3 times or more Important This test should be repeated after a short pause of minimum 5 tidal breaths to give the patient a rest A N n PO t Analyse von At Messen P0 1 Funktions empumpe und Atem Antrieb max gt ilo Ke Yo xe F3 DEMU IFI tar Sa i Enter 04 Normal Juergen 0 ZAN500 Body 79 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 4 5 7 3 Additional recommendations In most cases the patient is a little nervous before the measurement and breathes too deeply or too fast If so the patient s tidal respiration has to be corrected by demonstrating the appropriate breathing pattern Important P0 1 measurement is carried out during absolute tidal respiration The time of interruption during P0 1 measurement is limited to 120 ms
87. e found the right point when the mouse cursor changes to this layout Press the left mouse button and move the line into the desired position T Select x or press the F3 key to remove the selected curve from the set It means the curve is still in the file but ignored for printing All displayed data and curves are stored when the enter key is pressed or the B icon is selected ZAN500 Body 100 203 Part No 5001005ENG A N C oo Vi YMiopire Bodyplethysmog INSPIRING RESPIRATORY HEALTH 4 9 Bodyplethysmography 4 9 1 Basic Information 4 9 1 1 Intention of the Bodyplethysmography Whole bodyplethysmography is known as the gold standard in lung function diagnostics It is able to measure the resistance of the airways as well as static lung volumes Airways resistance is an effort independent measure requiring only quiet breathing The measurement of the TGV is combined with simple spirometry to provide the total lung capacity and all its subdivisions 4 9 1 2 Resistance Airways resistance is a very sensitive parameter It is often used to assess central airways obstruction in patients unable to perform a forced manoeuvre A decrease in airways resistance after a bronchodilator is a strong indicator for a reversible and drug sensitive obstruction 4 9 1 3 Thoracic Gas Volume TGV The second important parameter measured with the bodyplethysmograph is the thoracic gas volume The TGV is the volume of ventilated and
88. e plotted in bold The value that is reported is either from the selected effort the maximum of all accepted efforts the mean of all accepted efforts or recalculated The Best efforts are determined using ATS ERS standards 4 2 9 Different views of graphics You can view the flow volume loops in the conventional 2 dimensional view or the newly available 3 dimensional view The 3D view gives the added value of depth when looking at a number of loops ajo Ple together To change the view click on the 3D icon You will get the following display for flow volume loops 00e To return to the conventional view click the 2D iconk 4 in the top right hand side of the screen ZAN500 Body 63 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 2 10 Quality guidelines Select this icon or press the F12 key Nat enough EAV efferts mast the ATS crteria to see if efforts conform to quality Effort 1 FVC not within the range for reproducability standards 4 2 11 Set up By clicking on the A icon you enter the test Set up Menu There are five sections of the Set up menu Demo Set up General Set up Hardware Set up Test Set up and Hyper Responsiveness Set up The Demo Set up mode is for sales purpose only and should not be connected to the computer Setup r Demo Denna mode OW y OUE Record mode Results Ex Configure s Results In Configure General Auto mode Automatic Configure
89. e and a message will appear in the middle of the screen instructing the door to be closed This will only disappear when both the magnets have been activated by closing the door Once the door has been closed and after a short period of pressure equalisation the ventilation valve will close and the measurement will start If the door was already closed no pressure equalisation is needed The patient should be instructed to breathe tidally The frequency bar is again shown in the top right hand side of the screen as guidance After a few breaths a message warns that the shutter is about to interrupt airflow to avoid the patient being shocked by the shutter and coming off the mouthpiece Prepare for occlusion Breathing frequency 20 ZAN500 Body 119 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH After a predefined number of breaths the shutter will activate and the user must instruct the patient to breathe lightly against the shutter EECC Gaf breathe aqainst the shutter hanane r m After the occlusion the patient MUST do a maximal inhalation to get the corresponding IC This is needed to calculate the correct TLC a l lE D blese6 IWebile WSXIWS Brahim Racer 16 ME F The system asks the patient to perform this maximum inhalation and then return to normal tidal breathing The programme automatically recognises that the manoeuvre is complete and ends the test 5 E i
90. e calculation of the diffusion capacity or transfer factor 4 10 1 2 Intention of the RV Measurement The residual volume is the volume in the lung which can not be expired Up to a particular level this is physiological This volume will increase in some diseases Measuring the residual volume is a good way to estimate the severity and progress of the disease 4 10 1 3 Measurement Principle A test gas consisting of known concentrations of carbon monoxide CO and methane CHy is inhaled by the patient Methane is an inert gas and is only diluted by the residual volume Both methane and carbon monoxide are equally diluted by the residual volume A further decrease in the expired concentration of carbon monoxide is due to its diffusion across the lung membrane From the concentration of inspired and expired gases the transfer factor and residual volume can be calculated The transfer factor and residual volume are also calculated using the Fast Space balancing method This method takes the total expiratory gas flux into account and is based on the principle that inhaled inert gas volume must equal exhaled inert gas volume plus residual inert gas volume The fast response of the multi gas analyser is utilised and the exhaled methane concentration is plotted against lung volume Distribution disease is clearly indicated by the shape of this graph Literature H J Brandt J Bender R Lodenkampfer and E Wies Balancing of a fast space by mea
91. e is a special holder for the gas cylinder If a system cart is not available the gas cylinder must be fastened to a wall ZAN500 Body 17 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH The diffusion gas is comprised of a mixture of 0 3 Carbon monoxide CO 0 3 Methane CH4 21 Oxygen O2 with balance Nitrogen N2 1 6 2 Daily Tasks Before Testing Check that all cables and tubing is well connected Check the o rings essential to a leak tight system are in place and are in good condition The o rings on a ZAN system are made of silicone and must only be replaced by ZAN o rings Calibration should be verified 1 6 3 Before the Measurement Starts For hygiene reasons only properly disinfected filters and mouthpieces must be used Before the measurement starts make sure that the flow sensor is properly inserted inside the flow handy body It has to be inserted completely and the flat portion of the front rim should point upwards Careful instruction and explanation to the patient is essential During zero adjustment the patient must NOT breathe through the device The mouthpiece must be connected firmly to the flow sensor The patient should use a nose clip and form a tight seal around the mouthpiece with his or her lips 1 6 4 Hygiene Users should always adopt appropriate hygiene practice when dealing with contaminable parts All contaminable parts should be dismantled and disinfected Refer to Chap
92. e result table Green and red dots show for each parameter that is defined by ATS whether the criteria were met or not This includes the criteria for acceptance as well as those for reproducibility only shown when more than one effort performed The result window also has a column called Best This column shows the results that are reported for this stage The results of the single efforts that are taken into account for the creation of the Best are plotted in bold The value that is reported is either from the selected effort the maximum of all accepted efforts the mean of all accepted efforts or recalculated The standard methods are according to ATS ZAN500 Body 93 203 Part No 5001005ENG A X lt na C ha t 4 pire SVC Measure INSPIRING RESPIRATORY HEALTH 4 1 5 SVC Guidelines In many cases the patient is nervous before the measurement resulting in erratic tidal breathing The patient s respiration should be corrected by verbal encouragement to give a more stable baseline for the rest of the measurement To ensure accurate results the patient should be encouraged to exhale and inhale completely This is demonstrated by a plateau at the end of each part of the manoeuvre lf there is an air leak from the patient at the mouthpiece or the patient comes off the mouthpiece the measurement should be repeated to achieve correct calculations of the partial volumes 4 1 5 1 Co operation To ensure accurate and rep
93. e user is responsible for the correct use of disinfection and proper set up of the equipment Electromagnetic Interference Medical devices require special care concerning electromagnetic interference All devices have to be installed and operated in accordance with the instructions and regulations provided with the equipment e Strong transmitters must not operate near the equipment e Portable HF devices such as Mobiles for example can possibly influence the functionality of devices Avoid using such devices near nSpire equipment ZAN500 Body 189 203 Part No 5001005ENG A lt iro Che WY pir e Safety Maintenance S INSPIRING RESPIRATORY HEALTH e The devices are tested up to a level of 3mV m and should not be exposed to electromagnetic fields of a higher level e Do not operate the device near heavy current powerlines or devices 9 2 Device specific Security Information 9 2 1 Flowhandy ZAN100 USB The Flowhandy ZAN100 USB is part of all following devices Caution The Flowhandy ZAN100 USB may only be operated in connection with peripherals which fulfil the DIN EN 60950 or DIN EN 60601 1 for medical equipment and have a valid CE certification PC devices must comply with the minimum configuration standards explained in the technical description Office equipment according to DIN EN 60950 is not the same as medical equipment according to DIN EN 60601 therefore a minimum distance of 1 5 m between the patient and the dev
94. ension of any tube will cause inaccurate results during measurement and is therefore strictly forbidden Tubes for CO diffusion and FRC measurement must not be bent Avoid sudden major changes of environmental parameters such as temperature for example This will create faulty measurement and could damage the analysers 9 2 4 ZAN600 USB Caution ZAN500 Body The ZAN600 USB may only be used in connection with devices which comply at least with the DIN EN 60950 Norm and have a valid CE certification The devices must not be operated in an environment which is endangered by explosions The ZAN600 USB must be operated with the original power supply or with the built in power supply of the ZAN system desk which complies with DIN EN 60601 1 191 203 Part No 5001005ENG A AS a A pire Safety Maintenance S INSPIRING RESPIRATORY HEALTH 9 3 Using customer supplied equipment The devices built by nSpire Health GmbH and the nSpire system cart together form a unit which is fully compliant to German MPG These sets are manufactured in a way that allows connection to a PC which is not protected by the security system built into the nSpire system cart If the nSpire devices are to be connected with the PC of a different provider consider the following instructions 1 The PC has to meet the minimum requirements defined in the technical description of the software manual 2 The PC has to meet the DIN EN 60950 norm and have
95. ent of CO Diffusion and Residual Volume 4 10 1 Basic Principles The primary function of the respiratory system is gas exchange Oxygen in transported from the environment through the lung into the blood while simultaneously carbon dioxide is released The inhaled air should distribute evenly throughout the lungs and oxygen once in the alveoli must diffuse through the alveolar capillary membrane into the blood The effectiveness of gas exchange is mainly influenced by three factors 1 distribution of air in the lung 2 perfusion of the lung 3 state of the alveolar membranes There is a volume of air that remains in the lung even after a maximal expiration Several diseases increase this residual volume and create an imbalance of actively exchanged air and the total volume of the lung This will reduce the effectiveness of breathing Measurement of the diffusion capacity and the residual volume therefore give an estimation of the effectiveness of respiration 4 10 1 1 Intention of CO Diffusion Measurement Carbon monoxide diffuses across the lung membrane in a similar way to oxygen It resembles oxygen in solubility and molecular weight and it binds to the same site on the haemoglobin molecule as oxygen but with a much greater binding affinity Baseline levels of carbon monoxide in normal non smokers are very low This allows us to easily measure the amount of inspired and after a breath hold expired carbon monoxide making possible th
96. enu in the bottom left corner When the desired tests have been selected the print a key will print these results to the local printer 12 06 1966 Selection 05 01 2006 15 33 06 01 2006 14 44 08 01 2006 12 34 Type of Test Spirometry sa The print preview option opens the report in Microsoft Internet Explorer for viewing on screen and this will also enable changes to the printer set up ZAN500 Body 37 203 Part No 5001005ENG A 2 5 6 Trend Graphs From the Archive menu it is possible to create a Trend graph for either restrictive analysis or obstructive analysis using one of the Trend buttons After clicking on the Trend button a window is displayed that enables the selection of multiple tests for trending analysis Once the desired tests have been selected it is possible to view the trend graph by clicking the Trend button or pressing Enter See Trend graph screen on next page Trend restrict creates a trend of Static Lung Volume values VC TLC RV and RV TLC Trend obstruct creates a trend of spirometry values FEV PEF FEV FVC and ROCC INSPIRING RESPIRATORY HEALTH EER ZAN500 Body 28 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 6 Archive or Delete Files From this menu the user is able to perform the following functions on the entire patient file Archive Automatically archives the entire patient file to the database Pa
97. ers If the difference between Corr In and Corr Ex exceeds 10 or if either calibration factor deviates from 1 00 by more than 6 the flow sensor should not be used A note to replace the flow sensor will be displayed in a window After replacement of the flow sensor the calibration process must be repeated Note The flow sensor that failed calibration should carefully be cleaned and the holes of the flow sensor should be checked to a A TT verify they are not blocked After drying the flow sensor perform a new calibration If the calibration fails a second time the flow ae a N sensor should not be used Humidity Bo o as After saving the calibration results some devices will still prompt a T eee cea you to enter the ambient conditions Please adjust them and save them by clicking on the Save button If the Cancel button is selected the existing values will be used The actual ambient pressure is required here not the pressure at sea level If installed check the Use BTPS from Environment Module box The temperature pressure and humidity will be constantly updated 3 2 Mouth Pressure Calibration L Mouth pressure calibration is performed using the shutter A pressure transducer is employed to Mouth Pressure Calibration measure pressures inside the flow sensor The stop ae ul mouth pressure measurement is achieved directly teo mO and is therefore generally stable for a long time The acc
98. eter and press the button To remove a particular curve from the display select the curve from the drop down list right from the Remove selected parameter and press the button The sections Start DLCO manoeuvre and Occlusion time have the option to be effective for the next measurement only This measurement only or permanently Always ZAN500 Body 132 203 Part No 5001005ENG A pes CO Diffusion and Residual V INSPIRING RESPIRATORY HEALTH 4 10 2 2 3 The Measurement Screen The Measurement screen look very similar to the master screen There s a different menu a timer is displayed and instructions are given in the centre of the screen as guidance 4 10 2 2 3 1 Structure menu timer Gas concentration window pily Please perform normal tidal breathing volume time graph instructions 4 10 2 2 3 2 The Menu The menu of the measurement screen contains the necessary controls to perform the measurement fea oles A ZAN500 Body 133 203 Part No 5001005ENG A YiSpire Symbol Definitions Select this icon or press ESC to erase the beginning of the test iii ia Select this icon or press the F12 key to reset the zero offset Patient must not breathe on the mouthpiece Select this icon or press the Enter key to start the measurement o K Enter 4 10 2 2 4 The Result Window INSPIRING RESPIRATORY HEALTH Select this icon
99. exhalation and changes colour from red to green after 6 seconds When this occurs the patient ZAN500 Body 61 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH should inhale again Also in the right hand side of the screen is the plateau graphic which is an indication of flow nearing zero This gives information to the technician on the quality of the manoeuvre performed by the patient Exhalation time S Plateau ee 4 2 7 Co operation To judge the patient s co operation the maximum exhalation should be repeated 3 times It is important that the patient exhales as fast and as deeply as possible With optimum co operation all curves will be positioned closely on top of each other and have a nearly identical form The curve s form will be pointed if the patient s co operation was at an optimum See picture below To exhale the whole volume the patient must exhale for at least 6 seconds The measurement curve must slowly merge into the base line To finish the measurement and display the results press the icon 4 2 8 Flow Volume Screen after Measurement and result edit 30 ALX Pre test Parameter Unit Ref Effort Effot2 Effot3 Effot4 Ref Ref E nana pd 4 2 22 w3 0 wen e479 9 90 MEF 25 238352 17 77 99 119 ST 9 37 Des 4 00 479 9 90 175 5 06 9 37 422 0 029 0 029 575 vs 462 2 dV EOT I l EV 016 je
100. g frequency is excellent Brat ing rosuaney PNO O Patients action Currently measured loops Average loop ZAN500 Body 112 203 Part No 5001005ENG A 4 9 2 4 1 2 Symbols of the lcon Menu The resistance measurement window has its own icon menu to call particular functions during the test INSPIRING RESPIRATORY HEALTH A single click on the icon triggers the function If the mouse pointer hovers over the icon for a while a description of the icon s function is displayed Symbol Definition ESC t RS ag oOo Select this icon or press the ESC key to end the test without saving If the trace is unsatisfactory the measurement can be re started by pressing the F3 key This deletes the results and continues the measurement Select this icon or press the F4 key to open the door Select this icon or press the F5 key to toggle the speaker on or off Select this icon or press the key to TE decrease the volume of the speaker inside the chamber 4 9 2 4 2 Performing the Measurement Select this icon or press the Enter key to save the measurement and exit Select this icon or press the space key to save the measurement and start a new measurement Select this icon or press the B key to adjust the BTPS auto correction Select this icon or press the key to increase the volume of the speaker inside the chamber e After selecting the e Button the system checks if the do
101. halation the black and red gas signal curves do not increase Volume CH4 and CO gas lines do not start at the same height The gas concentration lines heavily decrease while the patient holds his her breath ZAN500 Body The pressure regulator of the test gas cylinder is not open and or the pressure connection is not engaged properly to the test gas cylinder Check gas tube check if the pump runs check gas analysers The patient has consumed alcohol before the measurement or there is some gas left in his lungs from a previous measurement Check gas tube check if the pump runs check gas analysers When the zero point was set there was some gas left in the tube system The valve system is not tight The patient breathes heavily against the valve The connector on the shutter is loose 157 203 Troubleshoc INSPIRING RESPIRATORY HEALTH Open the valve of the pressure regulator The pressure connection of the breathing valve has to be put in order to make it engage for a second time This requires much physical effort Connect the tube start the programme again check the voltage supply of the analysers Re schedule measurement Connect the tube start the programme again check the voltage supply of the analysers Set zero point meanwhile the patient must not breathe on the system Check valve system or exchange it Ask the patient to hold his her breath and not
102. he newest state of technical development In order to improve the lifetime of this product only materials of extremely high quality are used All materials are environmentally safe and can be recycled The manual provides instructions for operating the ZAN 530 Body system The instructions in this manual assume the user is familiar with the intended use and application of pulmonary laboratory systems To avoid damage to the devices or incorrect measurement it is strongly recommended to follow the introductions in the manual and the technical description This manual is seen as part of the product according to DIN EN 60601 1 1996 It should be kept near to the device Additional safety hints according to German Medical Products Law can be found in chapter A8 Safety Maintenance Service Your nSpire Health Team na r TM Schlimpfhofer Str 14 r 97723 Oberthulba Germany iW S JI re Tel 49 9736 8181 0 4 Fax 49 9736 8181 20 info nspirehealth com www nspirehealth com nSpire Health GmbH tee i aw O SL INSPIRING RESPIRATORY HEALTH Documentation Conventions The following format conventions are used in this document to identify special information Warning statements identify conditions or practices that could result in personal injury Caution statements identify conditions or practices that could result in damage to equipment or loss of data Note The graphical illustrations in this document are
103. hen using olives make sure that they are pressed from below into the nostrils and form a tight seal They should not deform the nostrils Different sizes of olives are available so find matching pairs Two vertical lines mark the 150 Pa pressure on the screen The patient should breathe in a relaxed manner but the dotted lines need to be reached or passed If the S curves do not reach these marks the patient has to be asked to breathe deeper ZAN500 Body 91 203 Part No 5001005ENG A ispire INSPIRING RESPIRATORY HEALTH 4 7 Sniff 4 7 1 Basics The Sniff measurement is a good measure of global respiratory muscle strength It is the peak pressure obtained during a short sharp voluntary inspiratory manoeuvre performed through one or both un occluded nostrils The mouth must be closed during the manoeuvre During a maximal sniff manoeuvre the unobstructed nosiril will collapse The pressure in this nostril reflects the pressure in the nasopharanx which is a good indication of alveolar pressure which in turn approximates oesophageal pressure and therefore inspiratory muscle strength The manoeuvre should be repeated many times there is a learning process associated with the technique 4 7 2 Assembly and connection of the Sniff device The nasal olives are connected to the flow sensor via the olive adaptor A pressure tube links the adaptor to the pressure sensor inside the flow handy as shown CON Olive adaptor attached t
104. his dialogue will only appear if changes have been made to the template 8 2 1 1 Invoking the Report Designer From the main menu select Setup by either pressing ALT S or clicking the button with the mouse Patient Select the Set up with ALT S or a mouse click This opens the Setup window From the menu select the drop down list System In this list you find the item Reports Move the mouse cursor over the Reports entry and the Protocols subitem pops up Click on Protocols to invoke the Report Selection dialogue ZAN500 Body 175 203 Part No 5001005ENG A YiSpire Setup Customizing T INSPIRING RESPIRATORY HEALTH 7AN Settings E o System Device Exit F Licence Language Database Patent Headline Reports Pratocels Pred Formulas t Printer service screen HL Demo mode Setup window with open drop down menu 8 3 Report Selection Dialogue This dialogue has two different functions 1 Select a report for editing 2 Organise the print options reports list Three listboxes are in the dialogue window 1 Measurement 2 Selected reports 3 Ignored reports In the leftmost listbox all installed measurement methods are displayed If you select one of the measurements the corresponding list of installed reports for this method is displayed The list can be divided in an active part selected reports and a passive part ignored reports Only active reports are dis
105. ically after 10 seconds or with the next expiration Important If the patent starts to exhale the measurement will be stopped immediately The measurement may be repeated as often as required by starting it again with the Enter key Enter All the measurements will be saved the best one then can be selected during the analysis Once sufficient manoeuvres have been carried out the F9 save key Enter can be clicked to save and end the measurement The maximum Sniff pressure will be measured for each curve The program shows the last pressure curve on the screen automatically ZAN500 Body 94 203 Part No 5001005ENG A 4 7 5 4 7 6 pire INSPIRING RESPIRATORY HEALTH Analysis of the measurements To select the best manoeuvre click twice on the icon pu with the mouse Activate the right window by clicking on it A By pressing the Space key or the space icon the pressure curve can be selected manually Select Yes to save your changes and No to exit without saving To print measurements select the icon For acceptable results When finished press Esc or click on the icon e The olives must be pressed upwards against the nostrils from below forming a tight seal Do not deform or contort the nostril The measurement is extremely difficult if there is airway distortion or if the nose is completely blocked e The patient must keep their mouth closed during the measurement e The sniff must be maximal Repeati
106. ice which does not follow DIN EN 60601 1 is required E g The medical device Flowhandy ZAN100 USB is in accordance with DIN EN 60601 1 but the PC is only DIN EN 60950 The Minimum distance between the patient and the PC must be at least 1 5 m while there is no need to keep distance between the Flowhandy ZAN100 USB and the patient If this is not possible because of reasons such as small rooms etc we strongly recommend the use of a ZAN system desk which provides indirect coupling for the complete equipment and fulfils the necessary requirements according to the medical product law 9 2 2 ZAN500 Body Box Caution The ZAN500 Body Box requires the ZAN system desk for safe and legal operation Do not pull the door downwards while it is open This could cause the whole chamber to fall over The patient must know how to open the door of the chamber from inside by his herself Never leave the patient alone inside the chamber without supervision All connections and cables between the chamber and the system desk are purposefully short so as to avoid stumbling over them Make sure all staff are aware of the cables to avoid any accidents ZAN500 Body 190 203 Part No 5001005ENG A YiSpire Safety Maintenance INSPIRING RESPIRATORY HEALTH 9 2 3 CO Diffusion ZAN300 and FRC ZAN310 FRC Helium Options Caution The ZAN300 as well as the ZAN 310 FRC Helium must use the specially designed ZAN system desk for safe operation Ext
107. ious manoeuvre J If more than one manoeuvre has been performed use this icon to scroll down to the next manoeuvre lt Use this icon to move left to position where the measurement should be analysed manually overriding the computer selection Use this icon to move right to reposition where the measurement should be analysed manually overriding the computer selection K Deletes the selected PO 1curve 81 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH 4 5 10 Co operation The P0 1 measurement does not require the patient to perform any controlled manoeuvres however for PO 1max PEmax and Plmax measurements the patient needs to perform breathing manoeuvres for the test to be measured correctly Important After deep exhalation the patient must try to inhale with maximum effort To obtain valid results the interruption should be started unobserved by the patient so the patient does not recognise or react awaiting the interruption ZAN500 Body 82 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 4 6 Rhinomanometry 4 6 1 Principles Rhinomanometry measures the flow resistance of the nose The flow in one half of the nose is recorded and compared to the pressure which is measured in the second half of the nose We differentiate between the anterior and the posterior measurement 4 6 1 1 Anterior Measurement The anterior measurement records the pressure of both nasal
108. ire Health be liable to you for any damages including any lost profits lost savings or other incidental or consequential damages arising out of the use or inability to use such system even if nSpire Health or an authorised nSpire Health dealer or distributor has been advised of the possibility of such damages or for any claim by any other party In the event you should have any claim whether based on the license agreement express or implied warranty or otherwise you agree to accept refund of your money in full satisfaction of your claim Some states do not allow the limitation or exclusion or liability for incidental or consequential damages so the above limitation or exclusion may not apply to you www nspirehealth com Manufactured for nSpire Health Inc Tel 1 800 574 7374 1830 lefthand Circle Email sales nspirehealth com Longmont Colorado 80501 USA Authorized Representative nSpire Health Ltd Tel 44 0 1992 526 300 Unit 10 Hartforde Court Email info nspirehealth com John Tate Road Hertford SG13 7NW U K nSpire Health GmbH Tel 49 097 36 8181 17 Schlimpfhofer Strasse 14 49 097 36 8181 27 D 97723 Oberthulba Email Zan nspirehealth com Germany All brand and product names mentioned in this document are trademarks and or registered trademarks of their respective holders SL Y Spire INSPIRING RESPIRATORY HEALTH Thank you for purchasing the Flow Handy ZAN500 Body System The product complies to t
109. is willing to co operate 4 5 1 Definitions PO 1 is the pressure measured at the mouth 100ms after inhalation starts during a tidal breath manoeuvre This pressure represents the effort that the patient has to make in order to breathe normally PO 1max isthe pressure measured at the mouth 100ms after inhalation starts after a maximum exhalation manoeuvre Plmax is the maximum pressure of inhalation which the patient can cause PEmax is the maximum pressure of exhalation which the patient can cause PO1max and Plmax require an identical breathing manoeuvre and will be measured simultaneously 4 5 2 Measuring PO 1 gt The patient breathes normally gt During exhalation click on the corresponding symbol to start the measurement gt When the next inhalation starts the respiratory flow will be interrupted for 120ms The pressure is registered 100 ms after inhalation starts The pressure represents the effort a patient can make during normal breathing 4 5 3 Measuring P0 1max gt The patient breathes normally gt By request the patient exhales maximally gt During exhalation click on the corresponding symbol to start the measurement gt The patient is requested to inhale as powerfully as possible gt When the next inhalation starts the respiratory flow is interrupted for 1 2 seconds The pressure is registered 100 ms after inhalation starts This pressure represents the maximum effort which the patient can make
110. kaging ZAN500 Body 202 203 Part No 5001005ENG A 4 Sp Ire Waste Management Recy INSPIRING RESPIRATORY HEALTH 10 Waste Management Recycling 10 1 Electronic Components Some products contain electronic components To avoid environmental risks or hazard waste management of these components underlies particular regulations depending on local laws These regulations may vary widely from state to state 10 2 Mechanical Components Inside the mechanical units and accessories of nSpire devices are as far as possible only materials used which can be recycled Most used materials are coated aluminium and POM Polyoxymethylen Ultraform H2320 from BASF Refer to the waste management regulations of your state or county concerning these products There is no need to send these products back to nSpire they can be disposed of by the customer nSpire Health GmbH avoids single use components where ever possible Only parts which can be separated and disinfected easily when contaminated are used In principal only unbleached paper and cardboard is used for packing Packing material can be disposed of like ordinary waste 10 3 CO Absorbing substances The absorber granules absorbence must be handled according to the local regulations If in doubt ask the waste management department of your county administration for correct information ZAN500 Body 203 203 Part No 5001005ENG A
111. l breathing load The sensor works quietly and is insensitive to moisture from exhaled air As a result even patients with severe breathing difficulties can be examined without significant CO2 backbreath without significant resistance 1 2 4 2 Diagram of the Flowhandy ZAN100 USB variable plastic aperture computer removable flow sensor data connection and power supply ZAN500 Body 8 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 1 2 4 3 Shutter 1 2 4 3 1 Operational principle An electromagnet moves a closing piston inside a sealed tube sealing the upper and the lower rims at the same time Using this approach the shutter is virtually free from backflow The shutter unit attached to the end of the ZAN 100 USB is connected to the PC via the body box or an AccuSwitch USB device 1 2 4 3 2 Special properties Due to the low flow resistance of the shutter a flow volume loop can be carried out with the valve attached The shutter also has a very small dead space and does not influence the quality of the flow measurement The device can be disassembled without tools The interruption is carried out perpendicular to the respiratory flow Consequently the interruption is perceived as very comfortable by the patient 1 2 4 3 3 Diagram flow sensor A tube E O a magnet valve shutter engine i he 2 ee we Connector ZAN500 Body 9 203 Part No 5
112. lf turn back when the opening end has been reached 9 7 2 Pressure Reducer Pressure reducers need periodical maintenance Please refer to the manufacturers manual for the correct maintantance intervals 9 7 3 Flow Sensor Lifetime The Flow Sensor is directly exposed to the patients breath disinfective agents and a permanent change of humidity and temperature That makes it impossible to guarantee a minimum lifetime The typical lifetime of a Flow Sensor is about 5 years according to customer reports Calibration Calibration is recommended after every disinfection or after exchange of the Flow Sensor Calibration can be performed by the customer using the 1L calibration syringe The syringe is available from nSpire Health GmbH The necessary software is already included in the standard software package If the customer does not want to calibrate the Flow Sensors they can send them to nSpire for calibration If the calibration results show significant deviations from the reference values the Flow Sensor should either be replaced or re encoded by nSpire ZAN500 Body 195 203 Part No 5001005ENG A Check Safety Maintenance S INSPIRING RESPIRATORY HEALTH There are two criteria to determine if a Flow Sensor produces correct results Raw Inspection of the membranes If the membranes are mechanically damaged the Flow Sensor should not be used 2 Precise Calibration Deviation in ex gt 6 or deviation 1 00 l
113. lick the Patient button to open the patient data field for the current patient Once the patient file is open the Change button will become available Click this gt to enable changes to the patient data file After the desired changes have been made to the data select the Save button Note Archived data can also be modified in this way 2 4 Entering Additional Patient Data Optional This option can be selected to add additional patient data for each patient Setup ALT S Access the Set up menu using this icon located at the bottom of the screen From this menu select Patient Note This is password protected and should be set up by your representative during installation Please contact your representative for further information Patient On the Patient dialogue box click the Additional Patient l Data checkbox v Ethnic Group Select Cancel i Additional Patient Data Attention Once the required selections have been made the ZAN software must be restarted for the desired changes to take effect j Please restart the ZAN program Jj for the changes to take effect Once the additional patient data has been activated it will be available within the patient data screen By clicking on the Extended button the Extended Patient data screen Extended is then opened ZAN500 Body 22 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH and can be completed in the same way as the
114. lt Select this icon or press the F12 key to check that results meet ERS ATS 2005 Standards Click the go icon to start the test The button V t switches graphics to the Volume Time graph button only available if not F V and V t on the screen at the same time ts 2 E ri Ei i Ryl ap 4 2 5 Performing a Flow Volume Measurement Select this icon or press the F1 key to display a dialogue box to enter comments Select this icon or press the F2 key to define the user Select this icon or press the F3 key to select the medication Select this icon or press the F8 key to print out one or more templates Select this icon or press the Enter key to save the measurement and exit module The 3D icon switches to view graphic in 3D the magnifying glass icons zoom in and out The 2D icon switches graphics into a 2D view The button F V switches graphics to the Flow Volume graph button only available if not F V and V t on the screen at the same time On the screen the recording of the volume time curve displays in the left part of the window The flow volume loop on the right displays when respiration starts Caution ZAN500 Body lt is important that the patient uses a nose clip and forms a tight seal around the mouthpiece 60 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH The patient should perform several tidal breath s before executing a the
115. m Requirements Minimum Requirements Operatingsystem WIN 2000 WIN XP CPU Pentium IV 1 89 GHz or better RAM Size 500MB Hard disc 40GB Installationdrive CD ROM Device interface USB 2 0 Monitor 20 Colour monitor Screen resolution 1280x1024 Pixel or better Printer colour 1 3 2 Content Standard procedures are SVC Flow Volume Combined SVC FV Body plethysmography CO diffusion is part of the ZAN 530 Bodyplethysmograph Optional available procedures are Provocation Test Rocc MVV P 0 1 Rhinomanometry Compliance Sniff 1 3 3 NDC Numeric Drift Compensation Patients body heat will cause the temperature inside the box to continuously rise until it eventually reaches equilibrium Opening the door of the box will momentarily reduce the temperature These temperature drifts can cause erroneous results so on older body plethysmographs it was essential to wait for temperature to equilibrate nSpire Health has developed an advanced digital signal processing which instantly compensates for drift It is no longer necessary to wait until the temperature within the chamber has reached equilibrium the measurement can be performed almost immediately after the door is closed This means the measurement even under extreme environmental conditions is virtually free from artefacts ZAN500 Body 14 203 Part No 5001005ENG A Yispire Zan500 System Desc INSPIRING RESPIRATORY HEALTH NDC drift compe
116. male entilation 2 Normal Juergen 1985 min 1073 min FEV1 35 137 2 0 0 l min ZNormalJuergen D p ZAN500 Body 72 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 4 4 3 MVV Measurement Guidelines gt The measurement should use running start to ensure best results gt In order to inhale the absolute maximum volume the breathing frequency should not be too fast gt According to known clinical practice the optimum is about 30 cycles per minute gt It is important that the patient uses a nose clip forms a tight seal around the mouthpiece with his or her lips and breathes maximally throughout the recording phase 4 4 4 End Of Measurement And Evaluation Selection of the enter Icon or pressing the Enter key ends the measurement and displays the computed results 4 4 5 MVV Window After Measurement essen P0 1 Funktions Analyse yon Atempumpe und Atem Antrieb 04 i J i PO1 PO1max 5 9 172 z Normal Juergen P01 Plmax 3 2 74 free had ie Selecting the r Icon or pressing the F6 key toggles the results window on and off The content of the results window can be configured by double clicking on the results window This leads into the parameter selection window where parameters can be selected to be displayed in the results window for future tests The selection can be changed at any time ZAN500 Body 73 203 Part No 5001005ENG A Y Spire I
117. mo mode A detailed description of these settings can be found in the chapter Set up A5 of this manual ZAN500 Body 32 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH 3 Calibration Calibration Pressing the K key or selecting the button in the menu displays the calibration window Depending on your licence and the included options the window may have more or less symbols Only active options are displayed Select the desired device to calibrate with the mouse or the arrow keys and start it by pressing the lt ENTER gt key 3 1 Volume Calibration in Disinfection and use of the flow sensors can change the mechanical quality of the plastic membrane on the inside of the flow sensor The elasticity of the membrane fades and the difference in pressure in front of and behind the membrane will increase This will affect the accuracy of the results To ensure optimum quality of measurements at any time a calibration of the system can be performed with a calibration syringe Calibration of the flow sensor should be done at least after 50 Disinfections or it should be sent to ZAN for a service If this is not possible replace the flow sensor with a new one Using filters can reduce the number of necessary disinfections because the filter protects the flow sensor from contamination also the filter protects the patient from contamination through the device ZAN500 Body 33 203
118. ne comparison settings and auto mode settings PS Compare to C Best The online comparison settings allow you to compare to best test to RY clelenice reference or to nothing This corresponds to the test that is shown A Best Reference Best dominant in red when performing a test Reference Best Reference dominant Cancel Instructions The current language options include English German French and Spanish This language setting only affects the instruction texts during measurement This feature allows test instructions to be seen in alternative languages for patients who need instructions in a different language The Hardware Set up allows you to reset the shutter zero the flow sensor and set up the component for the test as seen below A Your system components Curent measuring system ZAN500 Body 48 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH Symbol Definitions By double clicking with the left mouse button it is possible to enter one of the option menus and select the appropriate component Select from mouthpiece options L Select from Flow sensor options To view the current configuration hold the cursor over the appropriate option field Select from filter options Select from shutter options Default mouthpiece options without Shutter Default filter options Select a component x Select a component Without Bact viral filter KoKoMoe
119. nect the devices to the PC and press OK ZAN500 Body 166 203 Part No 5001005ENG A System Software Ir INSPIRING RESPIRATORY HEALTH r zan settings n a loxi System Messger t Beenden A ZAN 100 C Type Akku unit C Typel Type ll Flowsensor When the ZAN Settings window pops up een you can configure settings of the several device interfaces and other important settings like printer type report headlines database settings etc You can change all settings at any time using the S option from the main window The active device is displayed in the upper left corner All settings relate to this device only and may vary from device to device InstallShield Wizard InstallShield Wizard Complete The InstallShield Wizard has successfully installed ZAN Click Finish to exit the wizard The installation is complete Click on Finish in order to close the Install Shield Wizard E Suea The installation is complete and the software is ready for operation Select a Neasuremen Ji ZAN500 Body 167 203 Part No 5001005ENG A System Software Ir INSPIRING RESPIRATORY HEALTH Start the ZAN programme by double clicking on the ZAN icon Before the first measurement and after the replacement of a flow sensor it is recommended to perform a calibration 7 3 Modifying Reinstalling or Deleting the Software InstallShield Wizard Setup Type Choose the setup t
120. ng help 1 6 1 1 Voltage Supply Always use the delivered ZAN power supply for energising the system If you use a ZAN system cart the power supply is connected to its socket strip If ZAN 530 is not part of a system cart it must be connected directly to a wall socket The green LED on the side of the ZAN 260 trolley indicates whether the device is switched on or off Use the power switch on the side of the ZAN 260 to power the unit on and off 1 6 1 2 PC Connection The ZAN 530 is directly connected to the PC s USB interface over a USB extension Please do not use a hub between ZAN 530 and the PC Immediately after connecting the USB plug with the PC the PC will recognise the USB device and automatically select the appropriate driver 1 6 1 3 Connecting the CO Diffusion Gas Cylinder To calibrate the multi gas analyser a cylinder of calibration test gas must be connected to the ZAN 530 with an approved and tightly fitted pressure regulator set to 50psi Please adhere to the usual precautions when dealing with gas at high pressure The large bore tubing is used to connect the regulator to the blue push fit gas input 3 connector on the underside of the body box external connections The smaller bore tubing connects the grey push fit connection 2 to the Cal Gas port on the rear of the multi gas analyser For safety reasons the calibration gas cylinder must be secured to prevent it from falling On the ZAN system cart ther
121. ng the measurement is strongly recommended ZAN500 Body 95 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH 4 8 Compliance Measurement The compliance measurement examines the elasticity of the lung tissue A balloon catheter is positioned inside the patients oesophagus to measure the oesophageal pressure Simultaneously an additional sensor measures the volume The compliance curves are diagrams of volume in relation to the oesophageal pressure 4 8 1 Application Of The Catheter Placing the catheter in the right position is the most difficult part of the procedure gt Turn the switch of the 3 way T valve so that the syringe Is directly connected to the catheter as shown in the picture below Moisten the balloon catheter and cover with lubricant Empty the tip of the balloon catheter Carefully move the catheter through the nose into the gullet lt is recommended that the patient swallows steadily or drinks some water or tea YY vY Y Y The balloon is approximately in position when the small dotmark on the catheter tubing has reached the nostril Caution Select the programme module Compliance measurement BEFORE the catheter is connected to the sensor AN Zero points on all sensors are reset during the start of the programme and the patient must not breathe at this time through any of the sensors ZAN500 Body 96 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 4 8 2 Programme sta
122. non ventilated gas in the thorax at the time a shutter interrupts airflow at the mouth On the ZAN500 530 the TGV is measured at the end of a tidal breath ie at FRC FRC is the point at which the elastic recoil of the lung and the recoil of the chest wall are equal and opposite and it is important for the correct calculation of TLC and airway resistance Measuring the lung volume at the same time as airway resistance allows the calculation of the specific conductance of the airways sGaw 4 9 1 4 Measurement Principles Neither resistance nor TGV can be measured directly so indirect methods are employed to determine these parameters 4 9 1 4 1 Resistance Resistance to airflow is defined as the quotient of pressure and flow Pr essureChange flow Re sis tan ce To determine the resistance to airflow of a pipe the pressure at either end of the pipe P and Ps and the actual flow must be recorded lt lt _____ P2 PI OW Re sis tan ce ZAN500 Body 101 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH The airways of the lung are a widely branched system of pipes running between the alveoli and the mouth P alveoli P mouth To measure airways resistance it s necessary to measure the alveolar pressure changes Pav and the mouth pressure changes Pmoutn during breathing Palv Pmouth Raw _ flow Firstly with the shutter open flow and pressure at the mouth are reco
123. ns of an alveolar mixing index Diseases of the Respiratory Tract and Lung Volume 4 No 3 1978 p160 168 4 10 2 Performing the Measurement ZAN500 Body 128 203 Part No 5001005ENG A C7 p Cha CO Diffusion and Residual INSPIRING RESPIRATORY HEALTH 4 10 2 1 Assembly of the Device ZAN 100 USB stand lever shutter head with diffusion sample tube and stand connector shutter engine USB cable diffusion sample tube CO diffusion test gas supply demand valve control cable of the valve 4 10 2 2 Structure of the Measurement Programme 4 10 2 2 1 The Master Screen After invoking the programme the master screen is displayed A timer and additional menu options appear in the measurement screen ZAN500 Body 129 203 Part No 5001005ENG A lt ira Cha ot ri po CO Diffusion and Residu INSPIRING RESPIRATORY HEALTH 4 10 2 2 1 1 Structure main menu volume time window gas concentration window CO Dithusion Single Breath Mustermann Melanie C0 D iffusion Spirceetr Mii 4 10 2 2 1 2 Menus The main menu provides access to common functions of the CO diffusion measurement The contents of the menu are different before and after the measurement Only valid functions are displayed aie Menu before Measurement A E E kE E Menu after Measurement Sall Se eelt te ZAN500 Body 130 203 Part No 5001005ENG A Chapt ae i 4 5p ire CO Diffusion
124. nsation is designed to remove warm up time and compensates for about 95 of drift and environmental interference 1 4 Operational Principle 1 4 1 General Information The cabin is designed to be airtight when the door is closed The pressure inside the cabin is then measured against a compensation chamber which is located underneath the cabin using a differential pressure transducer This approach minimizes the effect of ambient pressure fluctuations on the actual cabin pressure signal The patient breathes through the ZAN 100USB mouthpiece allowing his her flow and volume to be measured A pressure transducer located inside the 100USB measures the pressure at the mouth The digitised data from all pressure transducers are then transmitted to the PC and corrected for BTPS when appropriate 1 4 2 Measured Parameters From the measured data the following parameters can be computed pmavmic avme TF ZAN500 Body 15 203 Part No 5001005ENG A Y Spire Chamber Handy with shutter Zan500 System De p A mfa gG 197 INSPIRING RESPIRATORY HEALTH 1 4 3 Operational Diagram of the Bodyplethysmograph Temperature Measurement Reference Vessel Flow Measurement BTPS Compensation y Pressure Measurement of the chamber Pressure Measurement of gt Drift Compensation S
125. o flow sensor 2 nasal olives attached to olive adapter ZAN 100 ZAN500 Body 92 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH The two nasal tips should be pressed upwards against each nostril from below Be sure there s a good seal between the olives and the nostrils Flow measurement Pressure measurement Pressure measurement tube One of the two olives is connected to the flow sensor the other one to the pressure transducer The pressure in the unobstructed nostril is measured 4 7 3 The window prior to the measurement After starting the program the following window opens Menu Measured curve Results ZAN500 Body 93 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH End test Set the zero xo ESC FA a Delete previous curve Start next measurement F3 Enter Enter examiner s name H Save results Z S r Fa 4 7 4 Performing the Sniff measurement Meaning of the icons Ask you patient to blow their nose prior to beginning the effort The nostril should be unobstructed The measurement is started by pressing the Enter key or by clicking on this icon Enter Caution The patient should press the nasal olives firmly to his her nostrils and then sniff as forcefully as possible Important The mouth must remain closed so no pressure is lost through the mouth The pressure curve appears in red on the screen The measurement ends automat
126. oard Use the yellow coloured characters to activate the desired option 2 1 Activating the Programme After successful installation clicking on the ZAN icon on your desktop activates the programme You see the index card gt SPUL ONAL DATA E Pe Aa ZAN500 Body 19 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 2 Patient Data Entry Select a blank tab form either with the mouse or the keyboard and enter the surname just the surname without any add ons Press the enter key j Ga _0000FR200606 Fandy Mane Smith The system will now check the database to see if this name has been stored before If so you will see a list of all patients with this name Additionally this list contains an entry NEW PATIENT Using the mouse or the arrow keys you can select a patient or the NEW PATIENT Option to enter a new one Press the Enter key to confirm the selection If you select NEW PATIENT an input form appears Each field should be completed with the relevant data and confirmed with Enter The cursor will automatically jump to the next field Accurate patient biographical data is crucial for the calculation of reference values lt is important to ensure the correct format is used for each field If the wrong format is used in the date of birth field correct format MM DD YYYY it must be corrected to continue Note lf all Tab forms are in use use the Archive option to free one
127. of parameters From the list of parameters you can select the parameters you want to view in the results table These parameters will then always be shown in the results table Look in the paragraph Parameter Selection in chapter SVC for detailed instructions The results and the measurement will be saved after pressing the qi key ZAN500 Body 70 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 4 4 Measurement of the Maximum Voluntary Ventilation MVV Maximum Voluntary Ventilation MVV is the maximum volume of air a subject can breathe over a specified period of time 12 seconds for normal subjects This value is normally corrected to 1 minute and is expressed in l min MVV may be useful in those conditions where ventilatory capacity may be impaired by mechanisms that are different to those affecting FEV It can also be used to estimate maximum ventilation in cardio pulmonary exercise testing MVV is measured by getting the patient to breathe in and out as rapidly and as deeply as possible for a specified time It is similar to heavy panting To obtain accurate results only begin recording the measurement once the desired breathing pattern has been achieved 4 4 1 How to perform the MVV Measurement Selecting the icon M in the MEASURE mode enables the measurement of MVV and will lead you to the measurement window Z Mormal Juergen Symbol Definitions Stop Stop measurement
128. oncentration purpose and reaction time ZAN500 Body 150 203 Part No 5001005ENG A Disinfection Mainte INSPIRING RESPIRATORY HEALTH 5 6 Disinfection of the Ergo Flow Sensor ZAN 600 680 only Assembled Ergo Flow Sensor with adapter and mouthpiece To disinfect the flow sensor the pressure ring must be removed It can be pulled off to the back seen from the patients point of view When you put the pressure ring on the flow sensor again please consider that the blue connection points towards the flow sensor Remove gt b j Mask Adaptor lt Pressure Ring blue yellow aU Ergo Flow sensor Caution The blue connecting piece on the pressure ring must point towards the patient It is recommendable to remove visible dirt before the actual disinfection An ultrasound cleaning of the flow sensors should only be carried out when it is necessary because the mechanical quality of the membrane could be influenced ZAN500 Body 151 203 Part No 5001005ENG A Warning Disinfection Mainte INSPIRING RESPIRATORY HEALTH To avoid infections in connection with the flow sensor it must be disinfected after each patient Always consider the recommendations from the disinfectant manufacturers concerning concentration purpose and reaction time The inside of the flow sensor must neither be rinsed with a direct jet of water out of the pipe nor must it be cleaned or
129. onents including the chamber is on the system desk main switch Caution Do not switch off the main switch while the PC is still running This could cause loss of data and damage the operating system Always shut down the PC before turning off AN the main power ZAN500 Body 6 203 Part No 5001005ENG A of a Yispir Zan500 System Desci INSPIRING RESPIRATORY HEALTH 1 2 4 Measurement Unit The measurement unit is connected to the externally controlled stand CO diffusion demand valve mouthpiece with filter shutter stand extender stand From a different angle the other components can be seen Please note the mouthpiece and the filter have been removed for this picture e ZAN100 USB stand connector shutter head with CO diffusion gas sample tube and stand connector shutter engine CO diffusion gas sample tube CO diffusion demand valve All parts have plug in joints and the measurement unit can be disassembled without tools ZAN500 Body 7 203 Part No 5001005ENG A 4 P ire Zan500 System INSPIRING RESPIRATORY HEALTH Flow Handy ZAN 100 USB ZAN 100 USB Flow Handy flow sensor 1 2 4 1 Flow Sensor Like traditional pneumotachs the flow sensor works by measuring the pressure drop across a flow resistance With the ZAN flow sensor the resistance to flow is created by a variable plastic aperture Due to its low resistance the aperture will not create additiona
130. or is closed and all magnets are locked If not a window with a warning is issued and the programme does not proceed ZAN500 Body The door is open X AN Please close the door correctly 113 203 Part No 5001005ENG A Bodyplethysmog INSPIRING RESPIRATORY HEALTH e A sensor detects the door closing and automatically the pressure equalisation of the chamber starts A corresponding message is displayed in the upper left corner of the window When complete the ventilation valve will close and the measurement will begin ochy Z Nonmmal Juergen E H gt e The patient applies the noseclip and forms a tight seal around the mouthpiece with his or her lips and starts breathing with a frequency about 25 breaths per minute Body Fineberg Adrian m gt C t SD AB TE Breathing frequency is excellent Bresto to 25M Bta e The breathing frequency bar gives an indication of the patient s current breathing rate A corresponding message is displayed in the upper left corner when needed instructing the patient increase or decrease their rate The currently measured loops are displayed in the left window If the patient breathes irregularly or at the wrong frequency the curves are ignored After a certain minimum count of valid curves are measured configured in Setup the programme computes an average curve which is displayed in the right window e Every click of the gt but
131. or press the F11 key to trigger the shutter Select this icon or press Space to open the demand vavle and deliver the test gas After the measurement the results in the form of a volume concentration graph are displayed in the right half of the master window sample volume traditional calculation IVC residual volume traditional calculation additional residual volume using Fast Space CO concentration curve expiratory inert gas CH4 concentration curve expiratory ZAN500 Body 134 203 TLCO predicted G TLCO actual jp ar TLco Hb KCO predicted KCO actual Part No 5001005ENG A 4 spire CO Diffusion and Res INSPIRING RESPIRATORY HEALTH 4 10 2 3 Performing the Measurement Caution Patients who have consumed alcohol may produce erroneous results since the gas analyser also responds to alcohol 4 10 2 3 1 Start After selecting a patient in the Main Screen select the measure mode The CO diffusion measurement programme is invoked by two clicks on the CO Diff button TESIESEN Before the programme starts the analysers must be flushed and calibrated During this time the user sees the messages below in the center of the screen Ii Initialisation of Gas Analyser j ZAN500 Body 135 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH After initialisation the flow sensor must be adjusted to zero A warning message is dis
132. ort with all results of the service from nSpire Health GmbH The customer is also able to check mechanical conditions and connectivities as well as calibrate the system with the Calibration Syringe using special testgas which is available from nSpire Health GmbH ZAN500 Body 200 203 Part No 5001005ENG A pire Safety Maintenance INSPIRING RESPIRATORY HEALTH 9 8 Service Contracts nSpire Health GmbH offers Service Contracts individually customised to meet the particular needs of our customers This assists our customers correct maintenance of their nSpire products which in turn provides optimum use and reliable results Please contact our Sales Representatives or nSpire Health GmbH directly for more information 9 9 Customer Service nSpire Health GmbH co operates very closely with our associated dealers Together we endeavour to provide an optimum service for our customers Usually your dealer has good knowledge of your particular needs concerning hard and software of your nSpire products This makes them the best point of contact to ask for assistance They will be able to give competent answers and quick support Our Service Department can also be contacted directly at nSpire Health GmbH Schlimpfhofer Str 14 D 97723 Oberthulba Phones Central 49 0 9736 81 81 0 Customer Service 49 0 9736 81 81 17 or 27 Sales Germany 49 0 9736 81 81 30 Sales International 49 0 9736 81 81 14 Fax
133. ously week month or year on the same patient je access the archive folder with the Archive button or by pressing the key Archived measurements are displayed in fields 1 10 labelled with the date on which they were performed 2000 2000 z000 zo00 The question mark indicates that on this day the patient folder has been opened but the measurement has not been performed Select a date with the mouse and close the archive by pressing the key A list of all measurements on this day labelled with their time shows up Me LI ss ee iL Archiv E A F Se e e be d e ee 1430002 dS OSSD 1520 18 EIGEN DER UNTERSUCHUN VOM 2401 2001 ial B a m7 K O Select the measurement you would like to see Then click on to select the desired report type and press ENTER to print the report ZAN500 Body 26 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 5 5 Comparing Measurements of Several Days From the Archive menu it is also possible to compare measurements that were made on different days This is achieved by double clicking on the Days to Compare Button E This opens an options box This options box enables the user to select tests from a specific day and time to be included in the comparison Tests can be moved into the Selection Window using gt or removed with lt The type of test for comparison may be modified by using the drop down m
134. ow sensor will be zeroed so it is important that there is no flow through the sensor This process takes approximately 5 seconds 4 9 2 2 1 Overview The main screen is divided in a iconified menu and 5 sections FlowVolume P Be ee F E t a z A a a Results a 1 Functions called from this icon menu are related to all subsections Right below the subwindows for SVC F V Resistance and TGV measurements are located Although these four sections may look very similar they have their own special structure as one can see by the structure of the axis and submenus in the particular section Results are displayed in the lower half of the screen ZAN500 Body 105 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 9 2 2 2 Symbols of the Main Menu Global functionalities can be invoked from this line of buttons the main menu gaj A simple click on the icon activates the corresponding function If one lets the mouse pointer hover over the icon for a couple of seconds a hint is displayed giving a brief description of the icon s function Symbol definitions Select this icon or press the ESC key to stop the measurement and exit the program Select this icon or press the F4 key to open the door Select this icon or press the F5 key to switch the speaker on or off Select this icon or press the F1 key to display a dialog box to enter comments Select this icon or press the F
135. pability iro BR and HRR ErgoSpiro Report amp Diagnosis Sport Test Training Recommendation Sport Test Net Graph Metabolic calibration ZAN500 Body 177 203 ErgoSpiro Value Table 30s ErgoSpiro Value Table 10s Stress ECG 12 Strips 6s Step Stress ECG 12 Strips 3s Step 12 Complexes V6 Step 6 Complexes Strips HIl V2 5 V6 gt 6 Complexes Hll 2 5 V6 Stress ECG ST Trend 12 Leads Stress ECG Short Report i Stress ECG Graph Table i Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH 8 3 1 Editing the Report The first option is to change the description of the report displayed in the listbox and the print selections Modify report File description File fboay1 zim Press OK to save the changes made in the File Description text box or Cancel to abort the process The Edit file button can be used to enter a basic file editor to review the internal template file The Report Designer Window appears on the screen ZAN Mefgerate GmbH DOT Oberthulba Schhimptheferstr 14 Tel O9736 8181 Fax 09736 8181 20 Z ErgoSpire Karl D H LTES 170 cm M bg sale 25 01 142 58Y Test 27020007 11 11h BEF Spirometty Flor vobnne purameter usa pred value Stored Wit 1 192 695 117 W i 471 a4 117 Pua 1 356 amp 3l zt FEW i 467 5 125 FEW ITY a 5 3 103 FEY iF My Bj Be 105 FEF lg 1032 11 81 114 WEF 25 Lis BET 334 112 HEF Si I s I gf T
136. per basket Completely deletes the current patient file Caution If confirmed this action is not reversible Export Exports the complete ZAN patient files to a specified location for import 2 6 1 Archive Use the Archive option to write your Patient Data to disc 2 6 2 Waiting Room optional Pressure tube _aiting room option data is stored in an intermediate storage place As long as there is ne ae 1ediate storage a waiting room symbol will remind you that it is being stored there adapter an age ermediate storage select an empty index card select the waiting room icon and recall une Ul mie nsteu patients Once all patients are removed from the waiting room the waiting room icon disappears 2 6 3 Paper Basket Delete Data If a Patient folder has to be purged select the paper basket The paper basket option completely deletes the current patient file A N Caution If confirmed this action is not reversible ZAN500 Body 29 203 Part No 5001005ENG A pire INSPIRING RESPIRATORY HEALTH 2 Additional Functions This menu is located below the index card and can be used to alter some of the system settings and other fsa Ti ee Bee ES G important functions E 2 7 1 Change Date and Time Pressing the T key or clicking on the Date Time box with the mouse enables the user to change the date and time if necessary TIME Ensure that seconds are entered when changing time values LO
137. played during this time Caution The patient must not breathe at the mouthpiece while the flow sensor is adjusted The system is ready when the Zero Adjust message disappears 4 10 2 3 2 Preparation During the test the patient is guided by the system with a sequence of instructions This makes the test very easy and it can almost be performed without the user The directions are displayed in a coloured window in the middle of the screen ll Select the fte button to start the test Direction Please perform normal tidal breathing ZAN500 Body 136 203 Part No 5001005ENG A ri pes CO Diffusion and Residual Vc INSPIRING RESPIRATORY HEALTH The measurement begins with regular tidal breathing If the breathing trace is too erratic clicking on the button or pressing the F3 key restarts the sampling After 5 8 tidal breaths the system begins with the test gas application 4 10 2 3 3 Test Gas Application First the patient is asked to breathe steadily all the way out Important Inhalation and exhalation off the test gas must be performed steadily and without interruption The system displays the following messages After expiration the patient is asked to maximally inhale the diffusion test gas Inhale to the maximum Inhale to the maximum If an SVC has been saved a g
138. played in the print options and can be selected during the measurement Use the arrow keys to move a report from the selected to the ignored list and vice versa as well as to move a particular report to another vertical position in the selected list In the print selection the reports appear in exactly this order so it is possible to move more reports used most often into top positions for easier handling No report template will be deleted They only remain disabled in the ignored list until they are needed ZAN500 Body 176 203 Part No 5001005ENG A Setu p Cust Or ni INSPIRING RESPIRATORY HEALTH CO Diffusion Exercise FRC Fi Measurement51 P01 Rhinomanometry Sniff Spiro Spiro FY BGA single Report organiser and selection dialogue Selecting a report requires three steps 1 Select the desired measurement method in the leftmost listbox The list of available reports is displayed Select the desired report from the Selected reports listbox Press the Modify button to enter the Report Designer fed ZAN Report Editor BGA Body CO Diffusion FRC Ff Measurement51 Rhinomanometry Sniff Spiro Spiro FY ErgoSpiro Value Table ErgoSpiro Anaerobe Threshold Report ErgoSpiro 9 Wasserman Graphs i Index Report Dyspnea Report Cardiac Output Training Recommendation Training Description Indirect Calorimetry Nutritional Assessment Recovery Ca
139. plethysmography RAW tot Total Airway Total resistance of in Patient breathes quietly against Resistance and exhalation an open shutter RAWex Expiratory Airway Resistance to As above Resistance exhalation RAWin Inspiratory Resistance to As above Airway inhalation Resistance Specific Airway Resistance corrected As above Resistance by the volume at which it was measured Specific 1 sSRAW Computed Conductance Thoracic Gas Volume of gas inthe At the start of inhalation the Volume thorax at the time of breath is occluded by the occlusion shutter Residual Volume Volume of gas TGV ERV remaining in the lung after maximal exhalation Total Lung Volume of gas in the The patient inhales maximally Capacity lung after maximal after TGV measurement inspiration ZAN500 Body 120 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH 4 9 4 Specific Problems Problem Not all measurements performed with the Body are displayed for review in the Body VIEW mode Full bronchial challenge test for instance Possible Cause No TGV and or Restistance test performed Solution Only examinations including the TGV and or Rsistance procedure are displayed in the Body View menu FV and descendants like bronchial challenge are to be looked up in the Flow Volume and the Spirometry View menu Flow Problem The resistance loop is a vertical line Possible Cause Chamber pressure is no
140. point between inspiration and expiration ZAN500 Body 98 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH 4 8 4 Performing the Compliance Measurement Click on one of the three sub windows to start recording The current data input is displayed in the upper right sub window A Dyn After a complete tidal respiration selecting the 57 icon or pressing the F5 key saves the dynamic compliance curve in the intermediate buffer iste F or pressing the F4 key Selecting the The static compliance curve is saved by selecting the 6 F6 key saves the frequency dependant compliance in the intermediate storage You can see the curves ina raster field in the middle row of the right half of the window and they are kept until the final results are computed In the upper right corner of this raster field you can find the breathing frequency at which the data has been recorded Up to 10 different curves of each kind can be placed in this intermediate storage k SZ Use F3 or select the icon to delete unacceptable measurements or tests with too many artefacts In order to Stop recording select the a icon or press enter Compliance Test Z Normal Juerger S to frre Ss A C Ga Fa Ppi E Static Compliance vol essure Pr Inhale and exhale very slowly Inhale and exhale several times and very deep befor starting heed eee Ee ested See ieee TEE ae ese ar I ae a ee Se eee eR
141. pt itm gt lt ZAN ID INCLUDE REF header itm 96 gt lt H ZAN ID INCLUDE REF Zergo itm gt lt TITLE gt Test Gee lt HZAN ID DATA_DATE gt lt ZAN ID DATA_TIME gt lt TITLE lt HEAD gt lt BODY LEFTMARGIN 20 TOPMARGIN 0 gt lt ZAN ID INCLUDE REF ZANDat itm lt ZAN ID INCLUDE REF styles itm lt BASEFONT SIZE 2 gt lt ZAN ID INCLUDE REF person itm ere LANGUAGE VBScript gt porebaest Bane lt FONT SIZE 5 gt lt CENTER gt ErgoSpirometry Value Table lt CENTER gt lt FONT gt lt script LANGUAGE VBScript gt lt Dim ValueTable ValueTab le Array 340 1 310 309 338 302 305 373 315 306 307 314 313 DoT imeTab leHeader ValueTab le document write Pet document write Res DoTimeTable Valuetable 60 0 2 document write lt HR gt document write Load DoTimeTable ValueTab le 60 3 4 document write lt HR gt document write Recovery DoTimeTable ValueTable 60 4 0 Notepad with a raw template file open This edit option is not intended to be used by unauthorised personnel Please do not use this option It will be disabled and removed in the next version When you try to use the New report option you will always get a template file not defined error message ZAN500 Body 183 203 Part No 5001005ENG A YiSpire INSPIRING RESPIRATORY HEALTH JEX Measurement Selected reports Ignored reports Body Sniff rest CO Diffusion Sniff max Exercise FRC
142. ra ee ee ee ee eee eee 186 SAFETY MAINTENANCE SERVICE cccsscecsscecesceeeeceeeecueeecueeesueees 189 9 1 GENERAL SECURITY INFORMATIONS 2ccecceeeececceececeececceccecaecuecesaecaecuecesaecueceeaesaesueeneaes 189 9 2 DEVICE SPECIFIC SECURITY INFORMATION 0 cccceeececcecceccecececcecececcacececceeneecaeeneeeueeaeeens 190 9 3 USING CUSTOMER SUPPLIED EQUIPMENT csccecceeececceccecceeecuccacececcaeececcaeeneecaeeneesaeeaeeees 192 9 4 CONNECTING DEVICES cccceccecceccecceccuccccaeceecnecaeeaeeaecaecaecaecaeeaeeaeeneeseeseesuecuesueseesueeaees 193 9 5 SPECIAL PRECAUTIONS WITH TREADMILLS c ceeccecceecceeceeececceeeceeceeeceeeeeeneeeaeeneeseeeaeeens 193 9 6 PRODUCT LABEL cccceccsccceccsccceccscccecsscccecsseccucceccseccucsseecessseccussseccucsseecesseeesseneeessesess 194 9 7 MAINTENANCE INFORMATION c0cccecceeccecceeececcecececcucecucceeecuccuecaeeauecaeeaeecueeneeeateaeeseeeaeeens 195 9 8 SERVICE CONTRACTS ncvsancancsckcscneeccoscaduabsasnsdndvasedasksaanteiatendxadencndetsanoiiadeaadanisaantaebeaunted 201 9 9 CUSTOMER SERVICE vcccccccscccectinsataacescadeshenandunasasndadd sasandsadaesadecdteastncdetwadenineondscdaatadasiseantes 201 9 10 WARRANTY 0cccecceecceccecececcecececcueecuccaesceccaeesuecueeseecueeaeecaeeaeecaesauesaeeaeecaeeseeeesaeeaeeseesaeeens 202 WASTE MANAGEMENT RECYCLING 0 ccc ccccessecescecnsceeseceseeceeeseeeeesaes 203 10 1 ELECTRONIG COMPONENTS ccc acces esas
143. rded To measure the alveolar pressure during breathing a body plethysmograph must be used While the subject is seated within an airtight chamber a shutter is used to stop airflow at the mouth With no airflow the alveolar pressure is proportional to chamber pressure and so the alveolar pressure can be calculated Airway resistance can be calculated by combining the measurements from the open shutter and closed shutter recordings Resistance Loops Because the resistance is not constant but changes with the flow rate the resistance can curve show a sigmoid shaped loop 4 9 1 4 2 TGV TGV is based on Boyle s law ZAN500 Body 102 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH To measure TGV a shutter is closed at the end of a normal breath and the subject breathes lightly against the shutter Simultaneously the pressure differences in the patients mouth and inside of the chamber are measured The lung volume at the time of occlusion can be calculated using these pressure differences the known volume of the box and calibration factors TGV K x APmoutH APcHaAmBER TGV Graph There should be a linear relationship between mouth pressure and chamber pressure ZAN500 Body 103 203 Part No 5001005ENG A vpi re Bodyplethysm INSPIRING RESPIRATORY HEALTH 4 9 2 Performing the Measurement 4 9 2 1 Starting the Measurement Programme After a patient has been recalled or created in the main s
144. re of ventilated lung Lung volume at end tidal respiration Dilution of inert test gas 1 3 of inspiration up to 50 collected volume Jones Meaq Lung volume which can not be exhaled Maximum Volume of the Lung Volume participating in gas exchange TLC anatomical dead space 143 203 Part No 5001005ENG A Disinfection Mainte INSPIRING RESPIRATORY HEALTH 5 Disinfection and Maintenance 5 1 General Disinfection and Maintenance Recommendations All parts of the ZAN equipment which can get contaminated by the patients breath are designed for simple and complete disinfection Caution Important To avoid infections in connection with medical devices directly contaminable parts have to be disinfected after each patient Disinfection must be carried out at low temperature 140 F or 60 C maximum e g with cold disinfectants cold gas or plasma disinfection If you choose an antiseptic solution you have to make sure that it does not contain high concentrations of chlorid ions and that the material characteristics of the parts to be disinfected will not be influenced ZAN has tested the following disinfection fluids for their compatibility with the used materials Korsolex extra Bode Chemie Korsolex plus Aldehydfree Bode Chemie InstruPlus Dr Deppe EndoStar Aldehydfree Dr Deppe for surface disinfection Caution Note gt gt gt gt ZAN500 Body An
145. reen bar appears to indicate this patients expected inspiratory flow rate and volume This may also encourage the patient to achieve an adequate inspired volume After inhalation the patient must hold their breath for a preset time F5 to allow the CO to diffuse ZAN500 Body 137 203 Part No 5001005ENG A 4 pire CO Diffusion and Residual V INSPIRING RESPIRATORY HEALTH A countdown timer is displayed on the top bar of the window CO Diffusion Single Breath Mustermann Melanie ach 0 H xr T0RENA2ARENA 6s DE MEKA a Space Enter cO Diffusion Spirometrie Note If the patient is unable to maintain breath hold click on Ei or press the space bar to immediately reduce the breath hold time to zero and to open the shutter At the end of the breath hold time the patient is again asked to steadily exhale until empty Exhale To complete the manoeuvre for the Fast Space calculation the patient should return to normal tidal breathing Please perform normal tidal breathing The screen returns from the measurement screen to the master screen and shows the graphical results of the measurement Numerical results may be displayed by pressing F6 Click on the a button or pressing the F9 key save the results Caution During breath hold the patient should be encouraged not to breathe in or out against the shutter but to relax against it so as not to alter the intrathoracic pressure and pulmonary h
146. rnally f 1900 1200 f 1600 x 1200 f 1280 1024 1024 x 768 C 800 600 Raster size for ECG display for instance is also defined in this dialog The system detects correct values for this parameter automatically and should not be changed 8 7 ZanGate Optional When using the ZAN software in connection with a ZANGATE E CPRS you can define basic communication Undefined parameters in this dialogue box BDT and GDT are BDT data formats used in Germany to perform C GDT standardised data exchange with remote systems Import Files Patient Data Path Agate in Browse File Mask bdt Export Files Test Reults File Name Jexport bat Options Exit Zangate after every export ZAN500 Body 185 203 Part No 5001005ENG A Yispire INSPIRING RESPIRATORY HEALTH 8 7 1 HL 7 Optional This dialogue box is used to activate and configure HL7 communication with external hospital information systems Enable HL in ZAN applications T Enable Path WARTEN Browse Options M Show HIS Patient and visit Humber D Guern for patients through HIS Cancel 8 8 Device Settings System Messger t Beenden The Device setting shows the following options n ZN 300 ZAN 400 Zan 500 ZAM 600 ZAM 700 Z 600 External 8 8 1 Default Device Select your default device using this dialogue box The default device must always be the main device of the s
147. roducible results the patient should be encouraged throughout the measurement It is recommended that the test be repeated until three acceptable manoeuvres have been obtained Optimum co operation will result in reproducible results 4 1 5 2 Adjusting Lung Volume Sub Divisions Manually The position of the lung volume sub divisions can be changed and the values re calculated by selecting one of the lines with the mouse and holding down the left mouse button To illustrate the line was selected with the mouse it is shown as a thicker green line eo aiAlx Pre test Parameter Unit Ref ZAN500 Body 54 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH a button 4 1 6 Parameter Selection To alter the parameters displayed in the results table open the set up function using the ES I 102241 Cancel From the All Measurements list you can select the parameters you want to view in the results table These parameters will be inserted into the Selected Measurements list 4 1 6 1 Symbol Definition T Moves the selected parameter into the ou Removes the selected parameter from Selected Measurements list right the Selected Measurements list right window window al Moves the parameter up or down in the Selected Measurements list right window ZAN500 Body 55 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEAL
148. rt Select the Symbol from the MEASURE mode menu The following screen will show up 3 Compliance Test 2 Normal Juergen m 5 x sete S Ral Za Ze Bl A Static Compliance voi _ i Inhale and exhale very slowly Inhale and exhale several times and very deep befor starting sonedonwadascadtuwandaonadanwadaccodwananal dhenandanwaedanoadancadnnoandunnadansedanwna acon daonadonsadnacedacwndacnadannadmenen Caoasedecond a snadoccadaccodaonadoonadcoaon Coscoedoncndccwadcuuadancotenesdeccwadonwac bon ccdaccwdaesadaccadanacdacuedaconduccas Lucan tscwednacaticoadtscantaonadosuatacana Lonandoneatoucatnacndeunadeneatancutaadana Cancadtoacatdaucadncoadeoucadaanatansataawau a Sect nD pnp at T wc Pd as on SN omc ay TA g Sk sleet SD Ss T 0p er lnk Skt 1D So pH SG ct FAS rl A el oO el ess fc oa es Ee a es i ne eee ee Se i te ee re ee ee ee ee re ee ee ee eer ee ee re eal oe sre ree a eae er or rae Pri a te re OLAS EY EL Te EE Eee Ak 10mbar ee ee eee Nene ee er eee SRI ee See naam me eee ia MOIS Ula ue ea Cee era unre SEE F 3 Systemsteuerung Compliance Test Z Nor ESE ADE E E Now connect the catheter to the sensor Note the balloon catheter has been in place at this time but not yet connected to the sensor y a W ey 4 LOE ees fi MOO f AN ji f Connect the balloon to the syringe using the three way valve and inflate
149. s on cleaning the medical equipment and or accessories described in this manual Other sources of information on cleaning are the American Association of Respiratory Care AARC and ATS clinical practice guidelines 5 2 General Recommendations For Surface Disinfection All personal should wear protective clothing when handling contaminated or polluted parts Inhalation or direct contamination of the skin with the disinfectants can be dangerous to the health of the personal Always consider the recommendations from the disinfectant manufacturers concerning concentration purpose and reaction time Cleaning tissues should only be slightly moistened with the Disinfectant Warning The ZAN Electronic modules are not protected from liquids that could get inside the unit Before cleaning the surface please unplug the device Important Make sure that no moisture will get inside the device because this could lead to short circuits or shock hazards and the contacts might oxidise 5 3 Using Filters Bacterial filters do not only retain saliva but also micro organisms like viruses bacteria dust and other contaminating substances The use of a filter disposable single use between mouthpiece and flow sensor guaranties optimum security for the patient concerning infection protection Note Although the filters are very effective better then 99 they can not replace disinfection of the parts of the devices Flow sensor and the parts of the
150. sdeevesevibanddedadensadvenaxneniive 17 1 6 SPECIAL INFORMATION 0 ccccececeececeececeececeececeececeeaeceeeaeceeaeceeaececueaecueaeceeaesesnesesaeaeeneaeeees 17 USER INTERFACE onaran EAA RENNARAR 19 2 1 ACTIVATING THE PROGRAMME cccceccecceccecceeceeeeeeeeceeeceeceecuececaecaeeaeeauecueceeseesuesueeuesueeeeaes 19 22 PATIENT DATA ENTRY ceecee eiee arenae rE eR AEE AERAN Erani rn neieiet 20 2 3 MODIFYING PATIENT DATA aoanannanonnnnnnnnnnnnnnsenrnnnrnnnnrnrnnoararnannrnnnrnnannrnnnnnarntnarannnnnnannrnnnn nane 22 2 4 ENTERING ADDITIONAL PATIENT DATA OPTIONAL ccccesssecceeeeessececeeeeeseceeeseeeseeeesaeaeeeeees 22 2 5 MEASUREMENT MODE 0cccccececcececceceeeececeececeececececnececueaecueaecueeseeneaecueaeseeaesueaeeeeneaeees 23 26 ARCHIVE OR DELETE HILE cae ee ee ee ee 29 27 ADDITIONAL FUNCTIONS eee ne ee en ee eee ee 30 CALIBRATION 2 0ccceceececececececeeeneeeeneeeeneneneneneneneneneneneneneneneneneneneeenenenenes 33 3 1 VOLUME GALIBRATION cesicscccacsecteeusctadeaceceAieemcseareceanenieceeauaebenveaSeaesatadeaueteareetionadtensagateuneaae 33 3 2 MOUTH PRESSURE CALIBRATION cccccceceececeececeececeececeececeeaecueaeaeceeaeceeaececeeaeseeaesueaeensaeaes 35 3 3 BODY PLETHYSMOGRAPH CALIBRATION ccccecceccecceeceeceeceecaeeaeeceeceecueceecuecuecuecuteueseseueeeeaes 37 3 4 THE CALIBRATION TREND REPORTS cccceccecceccecceeceeceeceecaeeaeeaeeaueceecuecueceeseesueeuesueeueseeeaes 39 MEASUREMENT PROCEDURE
151. seful To create a calibration trend report press the Select a particular report type from the list Selecting the preview button or the printing button leads to the date range dialogue In the date range dialogue select the period of time to be examined Click on the desired date to select it Select multiple dates by holding the control key down during selection of dates There is a list of shorthand buttons on the left side of the dialog for quickly select frequently used ranges year month and week select the current year month or week None clears all selections OK starts the print out E Calibration Trend Report Please selectthe date range 07 08 2007 03 08 2007 02 08 2007 01 08 2007 31 07 2007 EE o 20 07 2007 e 97 07 ans button in the calibration menu H Select report j x Select reporto print Use the CTRL key to select multiple lines Quantity py Printing Cancel 31 03 2008 13 12 2007 o 23 08 2007 o 17 08 2007 16 08 2007 14 08 2007 13 08 2007 Cancel After a few seconds the print starts on your printer or when preview was selected the report is displayed on the screen ZAN500 Body 39 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH Page 1 of 1 nSpire Health GmbH ochilmpthoter Str 14 o7723 Oberthulba ZAIN preser Tal Ma 499936 8181 0 Fax 49 9796 8181 20 C
152. shutter described below should be disinfected at least once per day even if filters are used with every patient There is no difference in the way parts have to be cleaned and disinfected when filters are in use 5 4 Disinfection Of Particular Components 5 4 1 Small Parts And Materials All parts that may be sterilised may also be cleaned using a chemotechnical disinfection in an RDG device AARC Clinical Practice Guideline Spirometry 1996 Update reprinted from Respiratory Care Vol 41 No 7 pp 629 636 1996 gt American Journal of Respiratory and Critical Care Medicine Vol 152 No 6 pp 2188 2189 December 1995 ZAN500 Body 145 203 Part No 5001005ENG A Y Spire 5 4 1 1 Paper Mouthpiece Cardboard mouthpieces are disposed of after use They are single patient use 5 4 1 2 Nose clips Nose clips can be sterilised in 121 C hot steam autoclave and ethylenoxid 5 4 1 3 Plastic Mouthpiece Plastic Mouthpieces can be sterilised in 121 C hot steam autoclave and ethylenoxid 5 4 1 4 Bite Mouthpiece Bite Mouthpieces can be sterilised in 121 C hot steam autoclave and ethylenoxid 5 4 1 5 Nasal Tips Nasal tips can be sterilised in 121 C hot steam autoclave and ethylenoxid ZAN500 Body 146 203 Part No 5001005ENG A Yispire Disinfection INSPIRING RESPIRATORY HEALTH 5 4 1 6 Nasal Adapter Nasal adapters can be sterilised in 121 C hot steam autoclave and ethylenoxid 5 4
153. side the device lf moisture gets inside the device it can cause severe demage to the sensors and electronics Do not use aggressive cleansing agents ZAN500 Body 152 203 Part No 5001005ENG A Disinfection Maintenance INSPIRING RESPIRATORY HEALTH 5 7 2 Maintaining the Rubber Gasket Of The Door Never clean the rubber gaskets with aggressive cleansers To avoid early ageing of the rubber it is strongly recommended to at least once per month apply talcum powder to the gasket or use the special rubber maintenance stick which is available from your dealer Visible and cutting cracks of the rubber will influence the seal of the chamber Recalibrate the chamber for control and call the ZAN service to replace the rubber gasket if necessary 5 7 3 Disinfection Of Parts of the Chamber Which Are In Contact With The Patient Use disinfection tissues or spray for disinfection after each patient Ventilate properly to avoid irritation to the next patient 5 8 Cleaning The ZAN Electronic Modules Warning The ZAN Electronic modules are not protected from liquids that could get inside the unit Before cleaning the surface please unplug the device The ZAN modules can be cleaned with a piece of cloth that has been moistened in soapy water Make sure that no moisture will get inside or on the contacts of the device because this could lead to short circuits or shock hazards and the contacts might o
154. son to references You can select a previous test to compare the SVC measurement to even if it Test Pre test was performed on a previous visit Click the icon and the reference list will come up Select the date and type of test and click ok ZAN500 Body 57 203 Part No 5001005ENG A Yispire E INSPIRING RESPIRATORY HEALTH You will then see the comparison of current data to the reference selected Parameter Unit ZAN500 Body 58 203 Part No 5001005ENG A A en Chaptel YiSspire Flow Volume Measuren INSPIRING RESPIRATORY HEALTH 4 2 Flow Volume Measurement 4 2 1 Definition Of A Flow Volume Measurement The Flow Volume loop is the recording of the flow rate plotted against the volume The flow volume loop shows the lung s reaction during maximum flow speed According to the constitution of the lung tissue the expiratory flow is more or less strongly limited Typical loops will occur according to specific lung constitutions Flow Flow Rate Rate s l s l s Vol 1 l s The Normal Flow Volume Loop Early Small Airways Obstruction Restrictive Disease Fixed Upper Airway Obstruction PEF Pesk expiratory flow rate l s FEV Forced expired volume at Isaec 1 tant eat eee PEF reduced aed ee edad FVC Forced vital capacity 1 ike FEV FVC normal VC raria MIF Mid inspiratory flow rate 1 5 a VC reduced ron ee ee ee ne MEF hile expiratory flow rate 1 2 ateau in expirate ana sometimes inspirate
155. t gt 10 The Calibration Software provides automatic detection of deviation and will give a warning message Additionally the correction coefficients cannot be saved 9 7 4 Flowhandy ZAN 100 USB Lifetime Calibration Maintenance The lifetime of a Flowhandy ZAN100 USB depends strongly on usage and mechanical strain When used carefully lifetime is only limited by the lifetime of the sensors and the electronic parts inside The manufacturer of the Pressure Sensor guaranteed a maximum error of less then 0 2 over 1 million maximum pressure changes Under normal conditions the maximum range will never be reached A typical flow measurement produces about 20 changes in pressure If a physician uses this device frequently and about 50 patients per day are tested this would approximately define a minimum lifetime of 5 years for the Pressure Sensor Calibrating the Flow Sensor simultaneously performs a calibration of the Flowhandy nSpire recommends a technical check up after ca 1000 measurements or after 12 months of use which ever happens first The service is done at nSpire Health GmbH and includes tests of the following parameters e Tightness e Mechanical condition e Measurement precision e Data communication e Linearity The customer will receive a written test report with all results of the service from nSpire Health GmbH 196 203 Part No 5001005ENG A ZAN500 Body pire Safety Maintenance S
156. t measured correctly or pressure sensor is faulty Solution Close chamber door properly Pressure Problem Flow Chamber pressure shows random fluctuations Possible Cause Unstable environmental pressure Patient moving inside chamber Solution Be cure Keep windows and doors of the room closed Connect pressure equilibration vessel Patient should sit more quietly ZAN500 Body 126 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH Problem The TGV loop is a vertical line Possible Cause Mouthpressure Chamber pressure is not measured correctly or pressure sensor is faulty Solution Close chamber door properly pon E Pressure Problem The TGV curve is a horizontal line Possible Cause o k 7 ef ak L A prann oO Mouth pressure sensor is defective Solution gt Exchange ZAN 100 Handy _ ___ gt Pressure Problem The TGV line after evaluation is not a line but a curve Possible Cause Mouthpressure The patient did not form a tight seal with his lips around the mouthpiece The noseclip was not applied properly So A The mouthpiece was not inserted properly into the ZAN100 Pressure Handy Solution Control mouthpiece and noseclip Motivate the patient for better compliance ZAN500 Body 127 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 10 Measurem
157. t of the nose the pressure olive or the foamed plastic of the nasal adapter has to be positioned in the right nostril The pressure olive is the one which is connected to the part of the olive holder where the tubing is connected To measure the right side of the nose place the pressure olive into the left nostril gt The patient starts breathing through his her nose k 2 It is advisable to delete the first breaths from the display selecting the F3 icon or by pressing the F3 key when the curves show wide variation er gt Selecting the Enter icon or pressing the Enter key after 5 breaths stops the measurement and displays the results a Ss gt Re selecting one of the icons repeats the test or initiates measurement of the other part of the nose H gt Selecting this icon Enter or pressing the Enter key when the result window is up saves the results and ends the test ZAN500 Body 90 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 6 5 The Rhinomanometry Window After Measurement Rhinomanome trie ERGEBNISSE Symbol Definitions Save data Parameter Selection With a double click on the result window you can open the parameter selection window Select the relevant parameters from the parameter list They will be shown in the result window from now on 4 6 6 Special Recommendations When using the mask make sure that the mask is tightly connected to the patients face W
158. t this icon or press the F6 key to toggle result window Select this icon or press the F9 key to save the entry Pressing the F5 key or pushing the button opens the CO diffusion test set up dialogue This dialogue allows to change the display and a few test parameters to be modified either for the next following test or permanently modify the volume to be discarded before sampling and the volume to be sampled for measurement Curves over exhaled volume Add remove or modify the display style of the displayed curves Start DLCO manoeuvre select the starting mode for the measurement Occlusion time determine the time the shutter keeps closed to let the testgas diffuse Tot 203 Part No 5001005ENG A Y Spire Volumes Discarded volume ml sample volume ml pii 750 Curves over exhaled volume Number of sampling points Style ofthe step curves Add another parameter FRC Remove selected parameter Kco Hb Position as 2 of maximum 65 Colour of the curve dark green M Reference curve flight green start DLCO maneuver C Manually C This measurement only The program recognizes the exhalation f Always Occlusion time s C This measurement only l f Always cancel The Curves over exhaled volume allows to select the style and colour to be modified To add a new curve to the display pick a curve from the drop down list right from the Add another param
159. ted by pressing the _ F3 key This deletes the results and continues the measurement ZAN500 Body 90 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH Please breathe normally TT Gl To determine the tidal volume the patient should breathe normally through the mouthpiece If the automatic mode is selected in the set up after the predetermined number of breaths the computer instructs you to expire maximally The patient should be encouraged to exhale slowly for as long as possible ay gt 9 Ae Please go on expiring a n When the lungs are completely empty the computer will instruct you to perform a deep steady inhalation During this procedure the plateau slide bar gives an excellent indication of whether or not the patient is close to the end of their breath Plateau ZAN500 Body 51 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH za t Please inspire maximal tT al At the end of the inhalation the patient can return to normal tidal breathing m gt A Please breathe normally a 4 If a test is available for online comparison two lines will show the corresponding vital capacity The first manoeuvre that touches or crosses a line moves both lines so that the curve will not cross this line By having this visual help during the test the user can easily determine whether the effort is reproducible with respect
160. tem components The Set up screen has three active sections Test Set up General Settings and Hardware Set up Dems Tests M Demo mode SVC F Record mode General Auto mode Configure Online comparison Configure Instructions English v Font size 18 5 M print ATS criteria Results Configure Automatic Configure Hardware Device configuration Cancel Test Set up allows you to select the results shown after the test and to set up automatic saving of the results When you click on the Automatic Results x configure keys you get M Automatic the following screen Procedure graphics Start after breath iV Auto save This screen allows you 10 0 to set up the number of baseline breaths before Manoeuvre performing the test M 3 alfer manoeuvre It allows the choice of In Es an inspired or expired breath as the first breath of the test and offers you the opportunity to enter the elapse time after which the test is automatically stored L l gt Cancel ZAN500 Body 47 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH The General mode allows you to set up an automatic sequence for example the sequence shown below allows you to set up 3 consecutive FVC tests i i i i ings lan i The general setting gives online comparison settings language Setup onli
161. ter 9 Disinfection for appropriate procedures and cleaning agents Only disinfected flow sensors mouthpieces or face masks may be used Caution Always consider the recommendations from the disinfectant manufacturers concerning concentration purpose and reaction time The responsible physician has to control the proper use and appropriate intervals ZAN500 Body 18 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH 2 User interface The ZAN GPI 3 xx software interface is designed for ease of use The list of patients and the measurement results are shown in the form of an index card tabular form on the screen There are 4 programme modes Patient Mode Measure Mode View Mode Archive Mode The visible index card lets you handle the data sets of up to 5 different patients simultaneously You can switch to single patient mode using the set up alt S The number of patients in the archive is only limited by the capacity of your hard drive Software navigation is simplified by using the buttons on the right hand side of the screen allowing quick access to entering patient biographical data for performing tests with the measure button to view results of tests performed today or in the past and to archive the results to the database Note To click on or select means to move the cursor over the desired button and then press shortly the left mouse button You can also select an option with the keyb
162. the existing system ZAN Device Control z x Installed Devices H System Running H ZANETPS Flinn The most important entry in this list is the line 1 24N100 24N1310407022 Running ZAN 100 ZAN1310407022 Running ee seer This line makes sure that the Flowhandy is connected to the USB port and active The numbers may vary and depend on the particular device However the word Running has to be found at the end of this line Log File Enabled Clear Close 2 4 Calibration Pressing the K key in the menu displays the calibration window See also chapter 3 Kalibration K Select the desired programme with the mouse or the arrow keys and start it by pressing the ENTER Key ECE Oz CO 2 oe ajm ZAN500 Body 31 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 7 5 Modify set up Setup ALT Pressing alt S or selecting the Set up button on the base level menu activates the Set up window i ZAN Settings a ici xi System Messger t Beenden Lizenz Sprache Datenbank Patient Kopfzeile Reports b Sollwerte Drucker Service Bildschirm HL Demo mode This Set up window looks like this The Set up Option enables you to set and change some of the programme settings including the following ZAN Settings Licence Language Database Patent Headline Reports Pred Formulas Printer Screen HL De
163. tifect FD10 Schulke amp Meier ST Tissues Bode Chemie Sprayln Aldehydfreie Dr Deppe Caution inflammable at ow temperature 25 C Always consider the recommendations from the disinfectant manufacturers concerning concentration purpose and reaction time Visible dirt must be removed before actual disinfection Daily use and disinfection of the parts and the flow sensors will influence their mechanical quality We strongly advise you to calibrate and maintain the device according to the given recommendations Some components of the device are connected with tubes The tubes must not be put into disinfectants Water droplets have to be removed from the tube connections before putting the device into operation The complete ZAN system has gaskets O rings for connection The O rings should be covered with a thin layer of Vaseline accessories to make them slide easily The tightness of the connected parts is very important so the O rings have to be checked regularly The O rings consist of silicone and must only be replaced by ZAN replacement O rings 144 203 Part No 5001005ENG A Disinfection Mainte INSPIRING RESPIRATORY HEALTH gt PolyOxyMethylen POM Ultraform H2320 by BASF is exclusively used as the basic material for all white plastic parts In addition to the information provided in this section you should refer to your local hygiene or infection control board for their guideline
164. tions are not part of this manual Use of devices and software is exclusively reserved for medical diagnostic and therapeutical purposes Only trained and experienced personal should be allowed to use the devices on patients If there is damage to a part or system due to misuse VDE protection is broken In this case disconnect the device from any external power and contact your ZAN service before any further use nSpire Health GmbH takes responsibility for security and reliability of the device only if e All changes extensions repair or other work is done exclusively by authorised personnel of the nSpire Health GmbH e Electrical installations of the room in which the device is operated conforms to VDE 0107 e Operation of the device is done according to the instructions in the manuals e The instructions in the technical description have been observed carefully Caution Never operate medical devices of nSpire Health GmbH in an environment which is endangered by explosions Never extend cables or tubes without the explicit permission of nSpire Health GmbH In case of damage of current carrying parts or parts which have to carry weight set the equipment out of order disconnect all power cables and report to nSpire Health GmbH service or your local medical device technical department Make sure that all networking connections are equipped with indirect coupling Observe carefully the instructions in the Disinfection chapter Th
165. to breathe against the valve Tighten the connector on the shutter but not too tight Part No 5001005ENG A Yispire 6 4 Ergometer Problems Ergometer or treadmill does not work Devices are not activated or activated after the programme has been started Wrong mode protocol selected Note Bicycle and treadmill are controlled separately Maybe another user changed the particular ergometer setting on the ZAN PC INSPIRING RESPIRATORY HEALTH Activate device and restart programme Select the correct mode protocol and restart the ergometry programme Set the settings back to the correct values Note there are example settings for Ergoline and Elmed in the addendum For other types refer to the appropriate manuals in the PC control section Caution The patient must leave the treadmill immediately to avoid accidents Reset emergency Stop function Restart the treadmill Treadmill does not react If necessary disconnect the device from the PC restart the system and Emergency Stop Function is reconnect the Ergometer activated ZAN500 Body 158 203 Part No 5001005ENG A Yispire 6 5 Spiro Ergometry Problems No volume signal appears while the patient is already breathing No O2 CO2 gas signal ZAN600 control light is off Flow sensor is not connected Analysers are not yet ready Note The analysers need at least 20 minutes to heat up Heating time starts with the start
166. to the online comparison Additional VC manoeuvres can be performed when the patient is rested and ready Once sufficient manoeuvres have been made press o end the test and display the results The following screen will be displayed at the end of the test ZAN500 Body 52 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH eo Alax Pre test Parameter Unit Ref Best Effort 1 Effort 2 Ref Ref Ref 4 82 2 gt 479 99 e je 479 39 3 32 319 96 303 99 329 99 ERY 147 i2 160 18 The efforts are colour coded and the tabular data is shown at the bottom of the screen You can choose to view the graphics as a volume time trace or as a bar graph by clicking the bar graph symbol on the right hand side of the screen To zoom in and out use the magnifying glass icons The computer automatically selects the best effort to be reported for this stage This is shown by the highlighted coloured dot You can change the computer decision by left clicking on a different coloured dot ATS ERS have provided criteria for the acceptance of the test The computer will automatically determine whether the criteria for acceptance are met If an effort is not acceptable this is shown by a red cross over the corresponding coloured dot To remove the effort from the selection process right click on the coloured dot The fulfilment of ATS criteria is also visualised by th
167. ton or press of the Space bar starts a new test Already measured average curves will be displayed in the right window to theleft of the current curve in different colours ZAN500 Body 114 203 Part No 5001005ENG A Honing Ch 4 pir e Bodyplethysmc INSPIRING RESPIRATORY HEALTH Note Body heat of the patient increases the temperature inside the chamber This will cause a rise of the pressure The ZAN530 Body provides a unique method to compensate this drift This is automatically applied so that no other precautions need to be taken Caution To ensure reproducibility of the measurement at least 3 independent resistance curves should be acquired e Selecting the button or pressing the Enter key terminates the measurement and computes the results e The system returns to the overview at the multi measure screen Pre test Parameter Unit Ref Ic l 3 54 2 VE 5 07 2 TV FEV l 407 2 FyvCex 48 2 PEF Ks 945 2 MEF25 is 237 t2 MEF50 Ks 5 25 2 MEF75 Ks 3 10 2 ax 5 E RAWiot kPajs 0 30 2 O45 151 0 45 0E 151 R kPats 0 93 2 1 11 E 113 TGN 327 246 75 2468 75 TLC 6 62 2 5 09 75 509 75 V 5 m 88 50 ow 3 4 9 2 4 3 Editing Resistance Values Currently there are four different methods implemented to calculate the resistance from the measured curves The preferred method can be selected in Setup FV ineEx seperate J
168. touched by mechanical tools This could damage the sensitive plastic orifice and disturb the correct measuring function The flow sensor must be carefully dried after disinfection Before use you have to make sure that there is no more water in the holes If necessary blow out the holes with compressed air Hint Compressed air in sprayers for medical purposes is available from your dealer Caution A Hint The flow sensors can be exposed to a maximum temperature of 140 F or 60 C during disinfection Higher temperatures could destroy the variable diaphragm on the inside of the tube The pressure ring does not need to be disinfected Only pressure is detected at the orifices of the Flow Sensor and no breath flows into or out of the openings back or forth Transport of germs and viruses or infection of a patient is impossible through this path We recommend cleaning the pressure ring regularly with wipe disinfection Care must be taken to not block the holes The O rings should be covered with a thin layer of Vaseline accessories to make them slide easily 5 7 Disinfection And Cleaning The Bodychamber ZAN 500 Caution There is no protection of the electronics against incoming water or liquids 5 7 1 Cleaning The Camber And the The Glass Panes The cabin can be cleaned with ordinary cleansers Use soft tissues or leather and wipe with hot soapy water Make sure the fabric is not wet but moist and moisture will not get in
169. ts Choose the components Setup will install Select the components you want to install and clear the components you do not want to install ZAN100 1 ZAN300 1 ZAN400 Description Ergo Spirometry ZAN800 C REKG FEGA FRC S L Space Required on C 18588 K Space Available on C 49894980 K lt Back Cancel Part No 5001005ENG A 2 TM 4 3p re System Software In INSPIRING RESPIRATORY HEALTH InstallShield Wizard Select Components Choose the components Setup will install Select the components you want to install and clear the components you do not want to Only in DEMO MODE install a ZANI ao r Description wi p0 1 Measurement 0 Rhino i Compliance If you are installing the DEMO software select the Louw symbol in front of the option The check mark ZAN300 indicates your choice If you have selected all P Eon measuring devices and options you have peee z purchased click on Next Space Required on C 18588K Space Available on C 49894980 K InstallShiela lt Back Cancel InstallShield Wizard Start Copying Files Review settings before copying files C h eck th set u Ps befo re in stal latio na nd cl ick on Setup has enough information to start copying the program files If you want to review or change any settings click Back If you are satisfied with the settings click Next to begin Next If necessary click on Back and ch
170. tting inside the device ZAN500 Body 149 203 Part No 5001005ENG A Disinfection INSPIRING RESPIRATORY HEALTH 5 4 5 Disinfection Of The Shutter The Shutter can be dismantled in three parts 1 Shutter engine 2 Shuttervalve 3 Shutterhead The Shutter Valve and Shutter Head can be plunged into disinfectant liquid Spray can also be used Important Do NOT put the shutter engine in any liquid Caution The shutter head AND the shutter valve must be disinfected after each patient Always consider the recommendations from the disinfectant manufacturers concerning concentration purpose and reaction time 5 5 Disinfection Of The One Way Valve CO Diffusion Option Only Caution Do not plunge the One Way Valve into any liquid Do not dismantle the One Way Valve The One Way Valve can be disinfected using tissues Spray may also be used For disinfection separate the valve from the unit and spray it carefully Spray the orifice from the patients side Dry carefully and completely in a well ventilated area During reassembly the O rings gaskets should be covered with a thin layer of Vaseline accessories to make them slide easily Caution In order to exclude any danger in relation with the shutter the shutterhead AND the shutter valve must be disinfected after each patient Use of filters is strongly recommended Always consider the recommendations from the disinfectant manufacturers concerning c
171. tubes The pressure measurement is done while one side is blocked with a nasal tip or a foamed plastic The nasal tip or adapter is connected to the sensor by a flexible tube The patient breathes through the open half of the nose while the flow is measured with the sensor The blocking nasal tip or adapter is connected through a tube to the sensor on the rear side of the Flowhandy ZAN 100 USB Now the patient breathes with a closed mouth through the open part of the nose while the flow is measured This measurement can also be performed using a mask s b 4 6 1 1 1 Using Nasal Tips Connect the olive holder with the flow sensor on rear side of the Flowhandy Place two clean disinfected nasal tips on the olive holder Put the olives in the nostril Now one of the olives is connected with a flow meter and one with a pressure meter The patient starts breathing through his nose The data of the nasal tip connected with the flow meter will be recorded After the first measurement the equipment is turned around to measure the other side of the nose ZAN500 Body 83 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH Druckmessunq Set up for the use with nasal tips 4 6 1 1 2 Using A Mask Even with a mask the flow in one tube of the nose is compared to the pressure of the second tube Connect a new disposable nasal adapter to the internal tubing There are different sizes available Please choose the one which fits
172. ubtraction AN environment d f Z Der Kammerdruck wird in der X Richtuny aufgetragen U AP Die Atemstromung wird in Y Richtung aufgetragen Computer y P Mothpressure Measurement ZAN500 Body i if fr Lo P J gr A Munddruck nderung wird in TY Richtung aufgetragen i Der Kammerdruck wird in i der X Richtuny aufgetragen Ce AP 16 203 Compensated Chamber pressure Alveolar Pressure Part No 5001005ENG A A6 e T Che t i pire Zan500 System Descrip INSPIRING RESPIRATORY HEALTH 1 5 Test Procedures The ZAN 500 530 body plethysmograph can perform various tests Each test is explained in detail in Chapter 4 1 6 Special Information Important In order to receive precise results the user must be familiar with the handling of the device and the software It is strongly recommended the user reads the user manual prior to examining any patients The user should also be familiar with security and measurement technical issues Please read the security information in the corresponding chapter 1 6 1 First Startup Before the device is turned on for the first time the software must be installed on the PC You will find the description of the installation procedure in the addendum as well as a system checkup description Refer to the FAQ section for additional troubleshooti
173. uracy of the mouth pressure transducer can be checked by using an appropriate pressure manometer maximum 50mbar and through an access panel on the front of the device Please connect the U Tube to the pressure sensor Note Mouth pressure calibration should be performed during the annual system inspection To calibrate the mouth pressure transducer click on the mouth pressure symbol resembling a U tube manometer in the calibration window ZAN500 Body 35 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH Calibrations are performed by introducing an accurate 10 mbar pressure change to the transducer see the following dialog box By selecting F6 different calibration values can be entered or used x Calibration Setup Calibration Pressure 1 0 00 mbar Cancel 1 4 Set pressure 0 0 mbar Stant ENTER Follow the instructions on the screen First attach the pressure manometer tube to the mouth pressure connection located next to the connection cable on the backside of the flow sensor Next select Enter and the following dialogue will be displayed 2 4 Set pressure 10 0 mbar Start ENTER J Munddruck Kalibration Jive Use a 5ml syringe and the manometer to produce the mbar reference pressure 3 4 Set pressure 0 0 mbar Start ENTER 2 4 Setzen Sie Druck 10 0 mbar Start ENTER 4 4 Set pressure 10 0 mbar Start ENTER Parameter
174. user Notes display the incentive graphs With each click the incentive graph changes to a new selection Start measurement Select the measurement programme using the mouse or the arrow keys gt The programme is selected when the corresponding field is displayed in red The measurement programme starts either when you click on the selected field again or by pressing the Enter key Refer to the corresponding chapters for explanation of the particular measurement programme ZAN500 Body 24 203 Part No 5001005ENG A Y Spire INSPIRING RESPIR Once the measurement is completed all tests can be reviewed compared and printed under the View mode by clicking the View button or pressing the V key 2 5 2 Symbol Definitions automatically select best curve print report on screen fe change pre post assignment B show tests from the first on print report change position provocation test optional enter remarks delete measurement show more tests gt 10 2 5 3 Review measurements of the day ae Fluss After selecting the measurement type all measurements of this type taken ea Volumen on this day are displayed t Click on the appropriate field to select one or more from the list and display them on the screen AO ZAN500 Body 25 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 2 5 4 Displaying Archived Measurements To view measurements performed previ
175. user should ensure that the patient keeps their lips tightly sealed around the mouthpiece and uses a noseclip throughout the test Caution The patient must not try to breathe in or out against the shutter This may cause the results to be under or overestimated Important Patients who have consumed alcohol shouldn t be tested The methane analyser is also sensitive to alcohol A methane concentration trace changing with the same frequency as the tidal volume is characteristic of a patient in whom alcohol is a constituent gas of their expiration Caution Remember to allow sufficient time between tests for inhaled gases to be washed out Testing too soon after the previous test will affect the results The concentrations of carbon monoxide and methane used in the CO diffusion measurement are very small 0 3 and the equipment extremely sensitive so the measurement should be performed with due care Correct technique is important ZAN500 Body 142 203 Part No 5001005ENG A 4 10 3 Addendum 4 10 3 1 Parameter Definitions Transfer Coefficient Functional Reserve Volume Residual Volume Total Lung Capacity Alveolar Volume ZAN500 Body Chapte CO Diffusion and Residual V INSPIRING RESPIRATORY HEALTH In a single breath the test gas is inhaled and after a defined period of time exhaled test gas between the alveoli and erythrocytes in the alveolar capillaries TLCO VA As above Uptake of gas per lit
176. very line can be moved manually Selecting a button or pressing the F9 key save the edited values 4 10 2 4 3 1 Editing the inert gas line to evaluate RV CHA Selecting the button or pressing the F4 loads the inert gas line CH4 Methane in edit mode The line is visible as a thicker green line The green regression line can be adjusted by clicking on the end of the line with the left mouse button If you press and hold the mouse button you can move the line along the exhalation curve If the inclination or the position of the tangent has been changed the gradient must be faded out 4 CH4 again By clicking 4 icon again the results will be re calculated 4 10 2 4 3 2 Editing The CO Diffusion Line 4 co The CO line is edited by selecting the s buttons or pressing the F4 key Now the corresponding line can be moved with the mouse like the CH4 line above 4 10 2 4 3 3 Considering blood data Hb Selecting the te icon or pressing the F9 key opens the blood data entry dialogue HB concentration H Enter HB 14 6 gidi D HbCO 6 a In addition to the hemoglobin value now the HbCO value carbonmonoxide blocked fraction of Hb can be entered for more detailed evaluation HbCO is respected in the calculation of the predicted values ZAN500 Body 141 203 Part No 5001005ENG A pes CO Diffusion and Residual V INSPIRING RESPIRATORY HEALTH 4 10 2 5 Important Information The
177. volume time graph To switch SVC from volume time graph to bar graph 4 9 2 2 4 2 Flow Volume Switch to 3D view Switch to 2D view To show F V loops To show volume time graph ZAN500 Body 108 203 Part No 5001005ENG A INSPIRING RESPIRATORY HEALTH 4 9 2 2 4 3 Resistance To show resistance loops overlapping To show resistance separately 4 9 2 2 4 4 TGV To show TGV manoeuvres overlapping To show TGV manoeuvres separately To show the IC manoeuvres of the TGV efforts To show TGV manoeuvres 4 9 2 2 5 The Results Window ZAN500 Body 109 203 Part No 5001005ENG A Bodyplethysmc INSPIRING RESPIRATORY HEALTH Pre test Parameter Unit Ref Ic l 3 54 t2 VC i 507 5977 18 s597 118 TV z 078 FEV1 407 159 3 e159 39 FyCex 485 199 4T gt 19 4t PEF w 9 46 343 38 343 30 MEF25 Ws 2 37 064 N 064 2 MEF50 5 25 167 32 167 32 MEFTS v 10 313 39 313 39 tax 78 78 EV 007 007 RAMO kPa 0 30 O45 151 0 45 E 151 SRAMA kPats 0 98 111 113 4 99 E 113 TGV 37 246 75 246 75 TLC 6 62 2 5 09 75 5 09 75 RV 75 2 E 0 00 Bodyplethysmography is a diagnostic procedure which is combined from a series of components e Ameasurement consists of 4 examinations spirometry Flow Volume resistance and TGV Each examination has a unique color code to
178. xidise 5 9 Cleaning of the permanent electrodes of suction devices Permanent electrodes must be cleaned in regular intervals This is important to ensure good signal quality Please refer to the manuals of the manufacturer for detailed information about cleaning and maintenance of the suction device 5 10 Disinfecting and Cleaning Medical Products of Other Manufacturers To disinfect medical products which have not been manufactured by ZAN Messgerate GmbH e g bicycle ergometer treadmills and pulse oxymeter read the documents accompanying these products 5 11 Cleaning And Disinfection Of The Touchable Parts in The Environment Of The Patient For all surfaces in the environment of the patients a regular cleaning and disinfection with wipe disinfection is recommended This should be performed according to the common rules of hygiene after visible dirt has been removed To avoid any risk protective clothing during cleaning recommended especially when the patient is thought to be infectious ZAN500 Body 153 203 Part No 5001005ENG A Y Spire Disinfection Ma INSPIRING RESPIRATORY HEALTH 5 12Cleaning The Computer Equipment Computer and peripherals are usually not built for the use in an aseptic environment We recommend covering the keyboard with an appropriate coverage and cleaning it regularly with wipe disinfection There are similar covers available for the computer mouse The advice for cleaning the cases tubes
179. xplained below 7 2 Installation of the ZAN GPI 3 xx Software Insert the ZAN CD into your CD ROM drive and the programme starts automatically Follow the prompts to install the software If the installation does not start use Windows Explorer to locate the set up file setup exe on your CD ROM and start it manually Choose Setup Language Select the language for this installation from A window pops up Select the language of the installation the choices below and the ZAN Software and confirm by pressing OK Available languages are English German and French InstallShield Wizard The Install Shield Wizard will be prepared Welcome to the InstallShield Wizard for ZAN The InstallShield Wizard will install ZAN on your computer To continue click Next and opened Click Continue Cancel ZAN500 Body 160 203 Part No 5001005ENG A Y1Spi re If you agree with the license agreement click OK Enter the license number that came with your system and click on Continue lf you have the measuring device for demonstration only you can use the programme in the DEMO mode for 30 days To use the DEMO mode enter the license number 1 1 1 The standard installation directory is C ZAN Caution Do not change the destination folder This may cause problems with the software Contact nSpire Health or your local dealer if you have any questions If you change the destination folder nSpire Health cannot
180. y Pressute equaled The calibration process starts within the next 5 seconds after the START symbol has been selected The process is automated and user interaction is not required ZAN500 Body 37 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH The calibration device underneath the chamber starts to pump with a characteristic sound A pump creates a sinusoidally shaped volume stream to the inside of the chamber Measurement of the pressure inside the chamber and the volume stream creates a circular curve from which the chamber specific calibration factors are computed The user can see these curves on screen to control the process Galib valuma Volume 027 Last calibron at Lastealibr oni at 06 00 0000 00 00 00 66 000 po 00 al Korr Ex Kor In Cat 7 100 1 00 075 0 lf the chamber is tight the curve on the right should show an almost closed circular or oval shape The volume curve on the left should not show too much drift The calibration terminates automatically and the results are displayed in a small window To save the ae Of H results select the Enter icon or press the ENTER key To abandon the results select the press the ESC key Don t forget to reposition the Flow Handy to its normal position before testing ZAN500 Body 38 203 Part No 5001005ENG A In order to control the quality of the calibrations trend reports turned out to be very u
181. ymbol Press the security switch again Check door lock both magnets have to close audibly Call service Patient must use nose clip and tightly enclose the mouthpiece Check cabin door Pressure transducer is defective Repeat cabin calibration The flow sensor or the holes of the handy are blocked The flow sensor has not been put far enough into the handy The handy is defective Check cabin door Pressure transducer is defective The TGV curves run horizontally The mouth pressure is not registered The pressure transducer for the determination of the mouth pressure is defective The TGV curves have an oval form Only very small TGV curves appear but the resistance curves are normal ZAN500 Body The cabin is not completely air tight The interruption valve is not sufficiently tight The mouth does not sufficiently enclose the mouthpiece Poor co operation 156 203 Check tightness of the cabin door Check tightness of the interruption valve The patient must use a nose clip and tightly enclose the mouthpiece The patient must breathe more heavily against the shutter Part No 5001005ENG A 6 3 Diffusion Problems During test gas inhalation the air supply is blocked the patient cannot inhale During test gas inhalation the air supply is blocked the patient cannot inhale The black inert gas line reacts during the tidal breathing During test gas in
182. ype that best suits your needs To modify update or delete the programme insert the installation CD The screen to add Options to the programme or tO completely i wenn delete the program is displayed ae Please choose a function Delete the program InstallShield lt Back Cancel Note Select Modify the Programme to add new components Reinstall is only able to repair existing install updates or perform a new installation Select Delete to delete the ZAN programme and all related data ZAN500 Body 168 203 Part No 5001005ENG A Y Spire System Software Ins INSPIRING RESPIRATORY HEALTH InstallShield Wizard Demo Mode Only Select Components Choose the components Setup will install Select the components you want to install and clear the components you do not want to install Description If you chose Modify the Programme you will see EZANI this window Now you can install additional options ii p0 1 Measurement This programme behaves just like the normal E e installation programme Just follow the prompts MW A JZAN300 G ZAN400 JZAN500 JZANBOO f ZaN700 3 Space Required on C 18588 K Space Available on C 49894980 K lt Back Cancel InstallShield Wizard x Please enter the license number of the software a License number If you choose Reinstall you have to enter your new or existing license num
183. ystem E g select ZAN100 when using a ZAN100USB device Default Device Default Device None i ZAN 100 C ZAN 300 C ZAN 400 i ZAN 500 ZAN 600 C ZAN 700 C ZAN 800 Cancel ZAN500 Body 186 203 Part No 5001005ENG A Y Spire INSPIRING RESPIRATORY HEALTH CZ x Device 8 8 2 Device specific settings Topel Akku unit C Type i Type ll Select the port where your ZAN100 device is connected to With the ZAN 100 USB it is always the USB port Please do not change settings in the Device segment These settings should be changed by qualified personal only Please refer to you dealer or the ZAN service if you need to make changes here Spiro F V toggles the display of the Flow Volume chart between portrait and landscape 8 8 3 External Devices Select the type of external device The device is activated when you change the type in the drop down box from none to a different value This will also activate the associated port dialogue box Select the port where your external device is connected to Floweensor C Type II Type lla llb Cancel External Devices x Ergometer Type Port none OFF 7 i Treadmill Type Part JV Confirm start of belt none Pi OFF E fort Co BP Monitor Ergometer Port lin Ergometer x OFF Y Or Configuration BP Monitor Treadmill Part none 7 OF
184. z MEF 5 Lis 273 311 114 MEF235 73 lfs 497 l 124 Resistance BAWiot kPatts om Os 35 SEA bart kPa 165 20 40 Volumes Tay 276 3 06 111 TLE j 5 10 543 itz Wit 2 2 EY i56 2m ij TAWILE Mi J J7 1H BTL er A 55 154 Preview Report Layout Template ZAN500 Body 178 203 Part No 5001005ENG A Yispire Setup Customizing Th INSPIRING RESPIRATORY HEALTH 8 3 2 Modifying the Header To edit the Header use the mouse pointer to click into the header area A dialogue pops up which allows you to change the particular lines in the header Report Header Editor Enter Text for ReportHeadlines Font Strong ZAN Messger te GmbH bBo Bchlimpfhofer 56 14 i D 97723 Oberthulba Qo coe Note Since there is only one global header definition file in the system this will change ALL headers on ALL printouts 8 3 3 Switching the Volumes Bar The Volumes Bar is the leftmost graphic element in the graphics area By clicking on it it can become activated or deactivated which means that it will or will not be printed on this report If the Volumes Bar is deactivated the red symbol is displayed over the graphic like shown below Otherwise the element is active pilog es ZAN Mebgerite GmbH D 97723 Oberthulba Schlimptheferstr 14 Tel 09736 8181 Fax 09736 8181 20 Z ErgoSpire Karl 2 TVol 5 01162 58Y a male 25 0 23 11 2000 1111h 150342 170 cen 74 ka Volumes ee B ar AA S

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