User Manual ZAN200 ProvAir II
Contents
1. 1 mg isotonic NaCl solution will be nebulized on every actuation The straw and baffle of each nebulizer are securely fixed during the calibration If used correctly this device works virtually without any loss However the position of the baffle over the straw may change during use mechanical stress etc Also the nebulization capacity could be reduced if the nebulization nozzle is obstructed For those reasons nSpire Health recommends calibrating the DeVilbiss nebulizer regularly Calibration Calibration is recommended after approximately 100 measurements or one year assuming proper usage Calibration makes sure that the required nebulizer output of 14 mg isotonic NaCl solution will be created on every nebulization process which is equivalent to a volume of 14pl of a liquid with the same density and viscosity with open vent A standard method must be used to carry out the reproducible calibration 10 nebulization cycles with 0 9 sodium chloride solution will be performed according to the method used by nSpire Health The nebulizer will be weighed on a precision scale before and after the nebulization This infers the nebulized quantity of every nebulization This quantity must be 14 mg 1 mg Since there is no way to adjust the output of the nebulizer once the straw and baffle have been fixed the device must be exchanged if the nebulized quantity is more or less than specified Important Calibration is strongly recommende2. 2 0 STARTUP MEUM MM MEME 9 2 1 CONTBOES UM MAI eM MIDI UE 9 3 NEBULIZATIION c 10 3 1 GENERAL INFORMATION ABOUT PROVOCATION TESTS eeeeeeeeee en n e nn n nnn nnn nnn 10 3 2 LOADING AND HANDLING THE DEVILBIS 646 NEBULIZER DOSIMETER eee ee nnne nnn 10 3 3 5 esee Pe edu qur de 10 4 SECURITY AND MAINTENANCE eene 11 AT SECURITY ADVICE c m 11 4 2 TYPE PLATE OF ZAN 200 PROVAIR II COMPRESSOR UNIT cemere 12 4 3 TYPE TEMPLATE OF THE ZAN200 PROVAR II NEBULIZER TYPE DEVILBIS 646 13 4 4 ELECTROMAGNETIC COMPATIBILITY 13 4 5 CALIBRATION MAINTENANCE 0c 00sseeeesesesesseesseesseeseseseseseeesssesesecesesesecseeseseceseceeeseeeeeseceeeseseeeseeeseeess 13 5 CONSUMER PARTS SPARE 5 2 15 6 TECHNICAL DATA 0 cccccecccssssssesesececcnessserseesecececonsterssececccnsonsdeneaereceneezavenexenecensnnrsserecccesens 15 7 DISINFEG TION L 16 7 1 NEBULIZER MOUTHPIECES T VALVE cccccccssesssscececeecessnseeececeessessaeeeeceecesseuseeeeeeseessaseeeceeeessenaaeees 16 7 2 EXPIRATION FIL
3. 3 2 AZ from conc 2 4 4 6 AZ from conc 2 4 AZ from conc 2 5 2 AZ from conc 6 6AZ from conc 3 4 AZ from conc 3 7 2 AZ from conc 4 8 6 AZ from conc 4 4 AZ from conc 4 9 6AZ from conc 5 2 AZ from conc 1 conc x concentration in accordance to mixing instructions When the FEV1 falls to 9096 of the baseline value in short protocol carry out the further provocation from the next stage of the long protocol When the FEV1 falls to 80 of the basic value or application of the 9 dose the provocation should be stopped 7 When the FEV1 falls to 80 or less give 2 puffs salbutamol and 20 mins repeat the measurement The FEV1 should return to baseline 1 FEV1 1 2 FEV 1 1 8 Calculate the 20 FEV1 ZAN200 ProvAir 22 27 Part No 5001002US A ZAN200 Pt INSPIRING RESPIRATORY HEALTH 8 6 Mixing Instructions Mix 800 mg metacholine with 30 ml isotonic NaCL solution This volume is enough for ca 10 provocations This main solution corresponds the concentration number 5 Mix now 0 7 ml in 2 1 ml solution and you will get the concentration number 4 Proceed in the same way until you get all five concentrations Concentration Isotonic NaCL solution number 5 2 ml main solution 4 2 1 ml 0 7 ml of main solution 3 2 1 ml 0 7 ml of the concentration 4 2 2 1 ml 0 7 ml of the con
4. A AX ZAN200 INSPIRING RESPIRATORY HEALTH 7 3 Compressor Unit The electrical parts are safely enclosed in the case The devices and their components remote control inspiration recognition must not be immersed in any solution nor exposed to spray water The modules can be cleaned with a piece of cloth that has been moistened in soapy water Make sure that no moisture gets inside or on the contacts of the device This could lead to short circuits or shock hazards and the contacts may oxidize Dirt on the stand can be cleaned the same way followed by use of a disinfecting spray Dirt on the stand can be cleaned the same way followed by use of a disinfecting spray Warning The ZAN electronic modules are not protected against harmful ingress of moisture Before cleaning the surface please unplug the device Important Make sure that no moisture can enter the device This could lead to short circuits or shock hazards and the contacts may oxidize There is a outlet faucet on the back of the compressor unit to release water Please open the faucet every 4 weeks and drain the water Close the faucet carefully ZAN200 ProvAir 17 27 Part No 5001002US A we 5 INSPIRING RESPIRATORY HEALTH 8 Provocation Course 8 1 Standard Procedure according to Chai and Al Metacholin concentration from 0 1 to 8mg ml Doubling of the concentration between the stages 5 inhalations per sta
5. be available during every provocation test We strongly recommend that medication and equipment to treat even severe bronchospasm are to hand Provocation solutions are drugs which have the potential to trigger hyperreaction and allergic reactions A successfully performed provocation test in the past allows no prediction about the course of the current test In no event will nSpire Health LLC be liable for any damages harm or other consequences by the use of medications or the correctness of the delivered protocols ZAN200 ProvAir 3 27 Part No 5001002US A 2 5 INSPIRING RESPIRATORY HEALTH 1 3 Operating environment Following requirements for operating and storage should be observed Room temperature between 10 and 35 C Relative humidity between 20 and 80 without condensation Stable environmental conditions no sudden temperature or humidity changes Do not expose the parts to direct sunlight chemical products or vibration Never operate the devices outdoors or in an environment which is endangered by explosions 2 Start up 2 1 Selecting the Location The ZAN200 device needs a solid base to be mounted on It has to be placed in a way that vibrations created by the compressor should be damped and can not cause damage or irritations to other equipment The device should not be placed close to other devices which are sensitive to vibrations 2 2 Overview Clampholder Insp
6. 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 authorized 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 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 ZAN200 ProvAir is a trademark of nSpire Health GmbH All other brand and product names mentioned in this document are trademarks and or registered trademarks of their respective holders we 5 INSPIRING RESPIRATORY HEALTH Prefa
7. 2 So C1 is 0 125 mg ml and C2 is 0 17mg ml The baseline FEV1 is 80 of which is 41 The FEV1 is 4 21 after 6 inhalation breaths i e at C1 the value after 2 inspirations of concentration 2 the FEV1 is 3 6 i e at C2 1 The quotient of the concentration is 0 17mg ml 1 36 0 125 mg ml The logarithm is equal to 0 134 2 difference between 80 of the FEV1 value and the at C1 5 41 4 21 0 21 3 Thedifference between the FEV1 values is 3 61 4 2 0 61 4 quotient of differences is 0 21 0 33 multiplied by the quotient of the concentration is 0 33 x 0 134 0 045 5 The inverse logarithm of this value is 1 11 being multiplied by C2 0 125 mg ml gives the value 0 14 mg ml for the PC20 FEV1 ZAN200 ProvAir 24 27 Part No 5001002US A A ZAN200 INSPIRING RESPIRATORY HEALTH 9 Reduction Recycling 9 1 Electronic Components waste management of these components is based on particular regulations depending on local laws These regulations may vary widely from place to place W Some products contain electronic components To avoid environmental risks or hazard 9 2 Mechanical Components Wherever possible only recyclable materials are used inside the mechanical units and accessories of ZAN devices The most common materials used are coated aluminum and POM Polyoxymethylen Ultraform H2320 from BASF Refer to the waste management regulations of your r
8. Air 20 27 Part No 5001002US A 2 ZAN200 mms RESPIRATORY HEALTH 8 5 Analysis for Metacholine Provocation ID Date of birth Name 1 Carry out the basic measurement FEV1 through N FEV1 I 1 3 2 5 2 Measure the FEV1 after the inhalation of 3 inspirations NaCL solution Ne FEV1 1 1 3 2 5 3 Calculate the theoretical value of the FEV1 Theoretical value of the FEV1 1 4 Calculate the FEV1 as per cent of the theoretical value Best FEV1 1 Theoretical value of the FEV 1 FEV1 is FEV1 theo 5 Transfer the questionnaire Every question answered with yes has a certain value in column 4 Question No Yes Valuation FEV1 90 theo 1 FEV1 75 96 theo 1 1 1 2 1 3 1 4 2 Sum When the total value is 2 points or more carry out the provocation according to the long part protocol ZAN200 ProvAir 21 27 Part No 5001002US A AX ZAN200 INSPIRING RESPIRATORY HEALTH 6 Calculate the 80 FEV1 value and with a short part protocol provocation the 90 96 FEV1 value 80 of FEV1 90 of FEV1 Short part protocol Long part protocol 1 FEV1 2 FEV1 1 2 AZ from conc 1 2 6AZ from conc 1 4 AZ from conc 1 3
9. I IEC 417P Graphical symbols for use on equipment first edition 1973 we 5 INSPIRING RESPIRATORY HEALTH Glossary of Common ISO Symbols C 0535 This symbol indicates that this Class Q Power off equipment complies with the guidelines concerning medical devices 93 42 EEC of the council from 14 Jun 1993 Fuse e gt This symbol indicates that the t associated jack is for a USB Universal Serial Bus connection we 5 CONTENTS 1 3 1 1 GENERAL INFORMATION ABOUT THE ZAN200 PROVAIR 3 1 2 SAFETY PRECAUTIONS ce cete eua ten 3 1 3 OPERATING FNVRO NM N T 4 MEC POI 4 2 1 SELECTING THE LOCATION 2 nnn enhn nn enhn 4 2 2 OVERVIBW 4 2 3 ASSEMBLING THE DEVICE eeeeeeeeeene e nen nnn nnn nnn nnn nnn nnn nnn ananas nnn aa a nsa a as sa a asas nsa asas assa asas ns 5 2 4 ASSEMBLING THE DEVILBIS 646 NEBULIZER eene e en nn nnn nnn nnn nnn nnn 5 2 5 ASSEMBLING THE PROVOCATION SYSTEM ON THE 5 4 44 nn nnn nnn nnn nnn anna 8
10. MECHANICAL COMPONENTS 2 2 0 V0 uoi sda ssuevadesaaessdesecevadesieessdesesevades lt oeeses 25 10 CUSTOMER elU duel 25 10 1 SUPPORT FROM YOUR DEALER eene enn nnn n nana anna na a anas ana aa n a ns 25 ZAN200 ProvAir 1 27 Part No 5001002US A 2 5 INSPIRING RESPIRATORY HEALTH 10 2 DIRECT SUPPORT FROM NSPIRE HEALTH cccesscceccecessssssceececceesesseeeeecceceessssseeeceecesssssseeececeeeesstseeees 25 11 WARRANT Y vssiieccccscssccicsdcnccccessascsscdse ccanescuvsnczesscetuecsassedzennccnuanvaseseceendeausevacetecesesanssesexcducessdeaueceaveed 26 TI TONE YEAR LIMITED WARRANTY 35 7 cel cavavvestesadunouavavescoetieabsuavavesdectcts 26 11 2 cts 26 cease Head P Ra vs POE 26 11 4 MAINTENANCE DURING WARRANTY TIME cccssscceccceesssssccececcessessseeeeecceceesssaseeeseeceesnsseeeceeeeeessnseeees 26 12 PNEUMATIC SCHEME 27 ZAN200 ProvAir 2 27 Part No 5001002US A we 5 INSPIRING RESPIRATORY HEALTH 1 Preparation 1 1 General Information about the ZAN200 ProvAir II The medical product ZAN 200 ProvAir 11 is a current based compressor a compact desktop ca
11. Spire NSPIRING RESPIRATORY HEALTH ZAN200 ProvAir User Manual Part Number 5001002US Version Revision A we 5 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 nSpire Health be
12. TER 252 ses testor ve elei uva totos 16 7 3 COMPRESSOR UNIT ee eto tort ps eer teo i epa te tte ture ebe viva ep eos toes io se erai eee aerei 17 8 PROVOCATION COURSE iiir 18 8 1 STANDARD PROCEDURE ACCORDING TO CHAI AND 18 8 2 SHORT PROCEDURE OF METACHOLINE PROVOCATION ecce n ee e nnn nnn nnn nnn nnn nnn nn n nn nana nasa nan 18 8 3 FLOW CHART FOR PROVOCATION COURSE eene n nee nnn nnne n nnn nnn nhanh nn nane asa a anas ana anna sna 19 8 4 METACHOLINE PROVOCATION CHECK LIST eene sess esses 20 8 5 ANALYSIS FOR METACHOLINE 21 8 6 MIXING INSTRUCTIONS DR E ERO E Eae CES E e Ue Poe SE Ey ee 23 8 7 OVERALL VIEW OF THE CONCENTRATIONS FOR THE CALCULATION OF THE PC20 FEV1 23 8 8 CALCULATION OF THE PC20 FEV D desee ctc ht ete hoe eo Eye eo Se Roe Doe ue eo ge EE oL e o 24 9 REDUCTION RECYCLING 2 24 40 224440000 44 0808000800811 1111101 25 T 25 0 2
13. ates using such a sign on our products can be produced on request ZAN200 ProvAir 12 27 Part No 5001002US A vispire ZAN200 INSPIRING RESPIRATORY HEALTH 2 X 0 8AT Fuse parameters 0 8 Ampere slow in both fuse cartridges of the line filter ZAN nSpire health GmbH 97723 Oberthulba Ser Nr 204 9001 4 3 Type Template of the ZAN200 ProvAir Il Nebulizer Type DeVilbis 646 The DeVilbiss 646 nebulizers adjusted by nSpire Health have this label 204 is ZAN article number for the DeVilbiss 646 nebulizer 9 is the year of production Here 1999 0 is for 2000 etc 001 is the serial number 4 4 Electromagnetic c The EMC test is based on a noise immunity level of 3V m The device must not be operated in an environment with a higher level The device must not be operated near high power installation Powerful transmitting equipment must not be present in the proximity of the device 4 5 Calibration Maintenance 4 5 1 Compressor Unit ZAN 200 with Flow Sensor and Remote Control ZAN 200 ProvAir Il directly connected to main current metal case SK1 device Lifetime The compressor unit is designed for appr 3000 hours operating time Since remote control and breath sensors do not contain mechanical parts their lifetime is limited by the endurance of their electronic parts as well as the lifetime of the compressor pump only Assuming appropriate use and maintenance a lifetime of 10 years and
14. ce Thank you for purchasing the ZAN200 ProvAir Il system The product complies to the 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 ZAN200 ProvAir Il 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 5 Safety Maintenance Service nSpire Health GmbH lt 17 5 re 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 for example purposes only and the hardware illustrated may differ from your hardware Safet
15. centration 3 1 2 1 ml 0 7 ml of the concentration 2 Table 1 Instructions to producing Metacholine solution Only 2ml of each concentration is needed for the nebulizer 8 7 Overall view of the concentrations for the calculation of the PC20 FEV1 Step Concentration Breathing Concentration Doses Cumulated Doses mg ml mg ml calculated for 5 breaths ug Part protocol Part protocol short long short long short long 1 0 104 2 0 04 2 9 2 0 104 6 4 0 125 0 08 8 7 8 7 3 0 42 2 0 17 20 5 4 0 42 6 4 0 5 0 34 44 0 44 0 5 1 67 2 0 67 90 8 6 1 67 6 4 2 1 34 184 3 184 3 7 6 67 2 2 67 371 1 8 6 67 4 8 5 34 744 6 744 6 9 26 67 2 10 67 10 67 1491 3 1491 3 ZAN200 ProvAir 23 27 Part No 5001002US A we 5 INSPIRING RESPIRATORY HEALTH 8 8 Calculation of the PC20 FEV1 To calculate the PC20 FEV1 you need the values of FEV1 before and after reaching a 20 fall of the FEV1 as well as the concentration of Methacholine of the corresponding stages which you can take out of the Table 2 log 2 logC1X 20 R1 PC20 antilog iogC1 5 RZ R1 where C1 second to last methacholine concentration C2 final concentration of methacholine R1 percent fall in FEV1 after C1 R2 percent fall in FEV1 after C2 Example A patient reacts between 6 breaths of concentration 1 and 2 breaths of concentration
16. d If the nebulizer output has changed for example because of damage precise doses will N not be delivered and the accuracy of the measurement will be compromised Calibration is the only way to ensure the nebulizer is functioning correctly ZAN200 ProvAir 14 27 Part No 5001002US A ma O D 5 Consumer Parts Spare Parts Part Name Stand ZAN200 ZAN200 ProvAir compressor unit Power cable Remote control Respiration recognition Tube coupling Pressure tube T Valve IN EX with reducer Calibrated nebulizer top DeVilbis 646 with mouthpiece Breath filter User Manual ZAN200 ProvAir ll Technical Description ZAN200 Prov Air II INSPIRING RESPIRATORY HEALTH 1300205 1300220 9300497 1300222 1300221 1100004 1300563 9300411 1300204 9300410 1300000 6 Technical Data Model Type Electrical Specifications Protection class Classification Typ IEC 601 1 Power supply Current reception Protection type Environmental Conditions Operating conditions Storage conditions Physical Specifications Operating pressure ZAN 200 ProvAir Il SK1 lla BF 230V AC 50Hz 0 6A max recommended 0 5A IPXO Temperature 10 C to 35 C Humidity 20 to 80 no condensation Temperature 0 C to 35 C Humidity 20 to 80 no condensation 2 0bar 5 ZAN200 ProvAir 15 27 Part No 5001002US A AX ZAN200 INSPIRING RESPIRATORY HEALTH Flow by operating
17. der Filter Inspiration detector ONO Picture 2 10 Inspiration detector 11 Remote control Picture 3 ZAN200 ProvAir 8 27 Part No 5001002US A we 5 INSPIRING RESPIRATORY HEALTH Assemble the separate parts according to the Picture 1 Note The arrow on the T valve must show towards the respiratory filter Fix the assembled nebulizer to the stand Picture 2 Plug the remote control into the RC socket of the device Plug the respiration recognition into the BC socket of the device Connect the other end of the pressure tube to the Air socket of the device 2 6 Start up The device is turned on with the switch on the front plate When the switch is illuminated the device is running The remote control display shows a 0 zero The compressor will first build up the appropriate pressure for nebulization which usually takes 6 seconds after which the compressor is ready for use Note If the compressor is turned off and turned on again in a very short time it may not start up again If so disconnect nebulizer and press reset on the remote control This releases air to reduce the pressure and the compressor will restart Once it has started press the reset button again to stop the pressure falling any further Reconnect the nebulizer Wait for 6 seconds for the operating pressure to again be reached before continuing with nebulizations 2 7 Controls On the remote cont
18. e device Improper or inadequate maintenance by customers Connection to unauthorized hardware Unauthorized changes or misuse Usage outside advised environmental conditions Improper installation and on site servicing Incorrect voltage or current supply Mechanical damage of the flow sensor Use of disinfectants not recommended The warranty starts either on the delivery date or on the date of installation 11 3 Limitations The warranty above is exclusive No further written or verbal warranty will be granted Every legitimate warranty regarding to the usual quality or suitability to a given purpose is limited in this warranty for one year Some local authorities 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 11 4Maintenance during Warranty Time The devices must be sent in original packaging in order to avoid transport damage The customer is responsible for any damage during transportation caused by using improper packaging ZAN200 ProvAir 26 27 Part No 5001002US A U we 5 INSPIRING RESPIRATORY HEALTH 12 Pneumatic Scheme The valve will be opened for 0 6 sec when the inspiration starts recognised through the flow sensor Here the inhalation medicine will be filled and nebulised by the volume flow ofthe compressor in connection with the inner construction The nebulizers will be t
19. ebulizer The DeVilbiss 646 nebulizer consists of two parts upper and lower It can be screwed apart The upper part provides connections for the mouthpiece the T valve and the VENT opening If left open the nebulizer draws additional air through this opening The nebulization capacity will be reduced to about 5 ul when the vent is closed ZAN200 ProvAir 5 27 Part No 5001002US A Connection for Mouthpiece Nebulization nozzle Pressure adapter Disassembled nebulizer Bottom part INSPIRING RESPIRATORY HEALTH Connection for T Valve Vent lock Vent Mouthpiece ZAN200 ProvAir Part No 5001002US A INSPIRING RESPIRATORY HEALTH Complete assembled nebulizer with locked Vent In the bottom part there is a reservoir for liquid a nebulization nozzle and a pressure adapter connection Note Please use only a calibrated nebulizer You can identify a DeVilbiss 646 nebulizer calibrated for the ZAN200 ProvAir by the yellow label on the nebulizer top The nebulizer is calibrated to provide an output of 14mg ml Be sure to maintain and carefully clean the nebulizer so that correct delivery of doses is continued ZAN200 ProvAir 7 27 Part No 5001002US A INSPIRING RESPIRATORY HEALTH 2 5 Assembling the Provocation System on the Stand T valve DeVilbiss 646 Nebulizer Mouthpiece Coupling adapter for pressure tube Pressure tube arWNM Picture 1 Stand Clamp hol
20. egion when disposing of these products There is no need to send these products back to ZAN the customer may dispose of them in a suitable manner nSpire Health 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 as ordinary waste or recycled 10 Customer support nSpire Health works closely with local dealers We aim to always provide the best customer support and service 10 1 Support from your Dealer Your local dealer will be your first contact for assistance They will know precisely how to fulfil your particular needs nSpire Health will closely support your dealer 10 2Direct Support from nSpire Health Of course you may directly contact nSpire Health in the UK Germany or USA for advice and support ZAN200 ProvAir 25 27 Part No 5001002US A A ZAN200 INSPIRING RESPIRATORY HEALTH 11 Warranty 11 1 Year limited Warranty nSpire Health grants a one year warranty on manufacturing and material During this period the nSpire Health declares itself ready to replace or repair the products that have proved defective The warranty gives you defined rights which may differ from country to country 11 2Exclusions The warranty does not cover damages caused by the following Negligent handling of th
21. ge Wait 2 min between each stage Lit ChaiH Farr RS Froelich LA Mathison DA Mc Lean JA Rosenthal RR Scheffer AL Spector SL Townley RG Standardization of bronchial inhalation challenge procedures J Allergy Clin Immunol 1975 56 323 327 8 2 Short Procedure of Metacholine Provocation Metacholine concentrations 0 04 to 10 67 mg ml Double or quadruple of the concentration between the stages 5 inhalations per stage Wait 2 min between each stage Lit L Gr nke D Nowak R J rres H Magnussen Entwicklung und Validierung eines Kurzprotokolls zur inhalativen Metacholinprovokation bei epidemiologischen Studien Atemwegs und Lungenkrankheiten 21 320 321 1995 ZAN200 ProvAir 18 27 Part No 5001002US A INSPIRING RESPIRATORY HEALTH 8 3 Flow Chart for Provocation Course a ZAN200 ProvAir 19 27 Part No 5001002US A Us 5 ZAN200 Pi INSPIRING RESPIRATORY HEALTH 8 4 Metacholine Provocation Check List 1 Have you in the last 12 months been out of breath when at the time you still had Y IN a cold a whistle or a drone in your chest 2 Have you in the last 12 months been short of breath during the day while resting Y N 3 Have you in the last 12 months been woken up by coughing IN 4 Have you for 3 or more months during the last year had a productive cough i e Y IN a cough that produces phlegm ZAN200 Prov
22. ips is strongly recommended The patient should form a tight seal around the mouthpiece with his or her lips and breathe tidally When ready for the nebulization press the Start button On the next breath the nebulizer will deliver for 0 6s and the counter will be increased by 1 Repeat until the desired number of nebulizations has been reached then wait until the required time has elapsed before performing measurements If necessary repeat this process ZAN200 ProvAir 10 27 Part No 5001002US A we 5 INSPIRING RESPIRATORY HEALTH 4 Security and Maintenance 4 1 Security Advice Note This manual conforms to EN 60601 1 According to these regulations the operator of the ZAN200 ProvAir 11 is fully responsible for the maintenance and condition of the device Note Warranty by nSpire Health is restricted and depends on only authorized personnel making changes extensions repair and other installations on the device the device being used according to its functional purpose regular maintenance being carried out the electrical installation in the room in which the device is operated complying to requirements of VDEO107 User manual and technical manual being observed Attention Please read the following carefully It provides important information about security use and maintenance of this device Do not wash or submerge the device in water or cleaning fluids Do not touch elec
23. iration detector Breath Control Power switch T Valve Nebulizer RC Remote Coupling control connector adapter for pressure tube BC Breath control connector Pressure tube Air connector for pressure tube Remote control ZAN200 ProvAir 4 27 Part No 5001002US A 5 INSPIRING RESPIRATORY HEALTH 2 3 Assembling the Device 1 Mount the stand on the desktop plate with a clamp 2 Put the inspiration recognition unit into the compatible hole on the side of the moveable clamp adapter Push the t valve IN EX into the other side of the adapter so that the arrows point away from the clamp Connect the filter to the t valve make sure that the arrow shows towards the filter Connect the respiration recognition unit to the BC socket of the compressor unit Plug the remote control unit into the RC socket of the compressor Connect the pressure tube to the front panel of the compressor unit Connect the coupling adapter for the pressure tube to the bottom of the nebulizer N PF Connect power supply to the back of the compressor unit and plug it into a socket that complies with the electrical specifications Warning The current voltage must comply with the voltage indicated on the device plate A Attention All plugs and socket connectors are color coded for ease of assembly Please pay attention to the particular color markings 2 4 Assembling the DeVilbis 646 N
24. more can be expected Recommended Calibration after 1 year assumed appropriate use The compressor provides a defined pressure according to its technical data as well as a defined output and nebulization time During calibration all the parameters are tested and adjusted if necessary Additionally the overall condition of the device is tested and adjusted if necessary ZAN200 ProvAir 13 27 Part No 5001002US A 2 200 INSPIRING RESPIRATORY HEALTH Maintenance once every year All medical products should be checked for function and safety within appropriate intervals nSpire Health recommends a check of the compressor unit the breath sensor and the remote control at least once a year During the maintenance all the technical as well as the functional safety and measuring properties of the ZAN200 Prov will be checked and adjusted if necessary Important parameters are for example operating pressure output insulation resistance protective conductor resistance and discharge current Only nSpire Health is able to perform the maintenance for measurement The proper nebulization capacity requires a calibrated nebulizer as well as correct compressor pressure and nebulization period Incorrect parameters will lead to wrong measurement results 4 5 2 7 200 Nebulizer Type DeVilbis 646 Lifetime nSpire Health calibrates every DeVilbiss 646 nebulizer before delivery in a way that 14 mg
25. pressure 7 Vmin 5 Inspiration recognition automatic Nebulizing time 0 6sek Nebulizer type standard DeVilbiss 646 Average particle size of the standard 5 um nebulizer Nebulizing capacity 14 1mg shot calibrated for 10 nebulizations with phys NaCl Weight 5 5 kg Dimensions in mm h d 280 b 150 h 270 d Compressor unit 7 Disinfection 7 1 Nebulizer Mouthpieces T valve Caution To avoid cross contamination with medical devices directly contaminable parts must be disinfected after each patient Nebulizer pots mouthpieces and T valves will be contaminated by patients breath and test drugs They must be cleaned after every use The recommended method of cleaning is cold sterilization Deposits on the nebulizer particularly on the nozzles can affect the nebulizer output Therefore it is prudent to use only cleaning agents and disinfectants that do not leave deposits It is possible to clear such depositions in an ultrasound bath Do not use substances that may cause damage to the plastic parts Always rinse all parts in demineralized water after disinfection Caution Always consider the recommendations from the disinfectant manufacturers concerning concentration purpose and reaction time Note Visible dirt must be removed before immersion in disinfectant 7 2 Expiration Filter The expiration filter is in a one way circuit and will be disposed after usage ZAN200 ProvAir 16 27 Part No 5001002US
26. rol is a green Start button a yellow Reset button and the numeric display Start Button This button triggers the nebulization Once pressed the nebulizer is activated during the next inspiration for O 6sec After the nebulization the counter increments by one Reset Button Use this button to reset the counter Numeric Display The display shows the count of the nebulizations It is a single digit display with numbers from 0 to 9 The next count after 9 is zero If another nebulization is triggered the display will turn off It is possible to carry out further nebulizations but when using the DeVilbisss 646 nebulizer but they will no longer be precise for reasons outlined in chapter 4 2 ZAN200 ProvAir 9 27 Part No 5001002US A Pis User Yiopire ZAN200 Pt INSPIRING RESPIRATORY HEALTH 3 Nebulization 3 1 General Information about Provocation Tests The ZAN200 allows a simple course of provocation tests like that described by H Chai 1975 Numerous national and international authors describe this method as standard and as a reliable method of provocation testing Another commonly used protocol is the 5 breath dosimeter protocol In this protocol the patient takes 5 breaths from FRC to TLC of known concentrations of a provocation agent At certain time points 30s and 90s after the end of the fifth breath the FEV is recorded If the FEV has not dropped from baseline by 20 an increased concentration of pro
27. se with respiration recognition and remote control A nebulizer nozzle is connected to the compressor for provocation testing The DeVilbiss 646 nebulizer is used as a standard nebulizer nSpire Health GmbH will adjust it to a defined nebulization capacity in order to guarantee the comparability of the provocation results as it has been proved in international studies The recommended standard provocation method according to Chai 1975 is easy to perform using this device The automatic respiration recognition and a assured nebulization period of 0 6 sec help to get best results The preferred usage of ZAN200 ProvAir ll is clinical lung function diagnostics in pulmological offices and clinics It can be used both for in patients and out patients Particular advantages of the ZAN200 ProvAir II are It can be used both for in patients and out patients The device is ready for operation with 6 seconds after power on The automated inspiration recognition allows defined nebulization during the inspiration The remote control with a counter makes provocation easier The calibrated nebulizers control exactly the doses of nebulized provocation medication The compressor is integrated in a compact desktop case The nebulizer dosimeter system is designed as plug in components which provides easy disinfection and quick exchange of replacement parts 1 2 Safety Precautions Warning A doctor or qualified and experienced physiologist must
28. trical contacts or stand alone parts Do not insert objects into openings which are not declared as plugs or connectors N Do not hang wires over edges The device may only be connected and operated according to this User Manual Do not operate or power devices with obvious damage ZAN200 ProvAir 11 27 Part No 5001002US A AX ZAN200 INSPIRING RESPIRATORY HEALTH 4 2 Type Plate of ZAN 200 ProvAir Il Compressor Unit ZAN 200 Prov Air Il Kompressoreinheit zu A Gos SN 8201001 m nSpire Health GmbH Schlimpfhofer Stra amp e 14 D 97723 Oberthulba A 4 2 1 Assembly of the Serial Number e 1 Digit denotes the year e g 9 for 1999 e 2 4 Digits designate a product specific tag e g 201 e 5 7 Digits built a sequence number e g 100 4 2 2 Explanation of All Symbols and Warning Advices This symbol indicates the patient applied part is type BF It is isolated from the mains supply according to the standard EN 60601 1 N Caution Read and understand associated documentation IPXO No protection against condensed water This symbol indicates that the product complies with the European Union Medical 0535 Device Directive This number is the identification number of the institute that checked this device In this case it is the Institute Eurocat Company Arheiliger Weg 17 D 64380 RoBdorf by Darmstadt The corresponding Certificate that legitim
29. uned separately so that in every course of nebulisation 0 6 sec 14 mg inhalation medicine will be nebulised Movable respiratory diaphragm with Hall sensor Here the recognition of the inspiration takes place so the nebulization is synchronised with the inspiration sensor Pemanent magnet One way valves Thev let air through the flow sensor only in the shown direction Filter The expired provocation medicine will be filtered here ZAN200 ProvAir 27 27 Part No 5001002US A
30. vocation agent is used for the next 5 breaths For consistency there should be 5 minutes between delivery of the provocation agent See appropriate literature for protocols 3 2 Loading and Handling the DeVilbis 646 Nebulizer Dosimeter The DeVilbiss nebulizer is calibrated by nSpire Health so that it consistently delivers 14mg of isotonic NaCl solution on every nebulization which is equivalent to a volume of 14ul of a liquid with the same density and viscosity This is based on a particular quantity of solution 2ml being used each time A deviation from 2ml leads to either a decreased or increased nebulization capacity 2ml is enough for 10 nebulizations after 10 the nebulizer must be refilled The solution is held in the lower half of the nebulizer First unscrew the nebulizer fill with 2ml of solution and then screw the top and bottom pieces together The nebulizer with the mouthpiece in place should be pressed into the T valve The pressure tube with the coupling adapter can then be fixed to the connector on the bottom of the nebulizer Remark Although only 14 ul of liquid is administered to the patient on each nebulization 1ml of liquid is lost after 10 nebulizations The rest of the liquid is spread over the inside of the nebulizer housing This condensation is not longer available for neblisation but can reach the mouth of the test person if the amount gets to much It is therefore 3 3 Respiratory Maneuver Note The use of nosecl
31. y Precautions 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 i Do 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 l Oil and grease must be kept away from oxygen equipment m Ox
32. ygen approved regulators must be used for Oz tanks wef 5 INSPIRING RESPIRATORY HEALTH n The equipment is a Type IIA device that requires the use of a 3 wire Type cord set According to good hygiene practices filters and or mouthpieces that came into direct contact with the subject s mouth or aerosolized droplets from the subject s effort should not be touched Dispose of filters and mouthpieces as ordinary waste or as specified by your institution Labeling Glossary Glossary of Common ISO Symbols High Voltage 09 Item for single use do not use more than once This symbol indicates that the user must read and understand all instructions and warnings prior to use lt lt ad AS Acceptable Ambient Temperature Range Indicates the upper and lower temperatures allowed for 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 A k 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 Heavy weight Alternating current Fragile Direct current Keep Dry Power on OY Transport and storage humidity conditions International Standard CE
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