Instructions for Use
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Instructions for Use MasterScreen™
781040-052 Version 06.00 for JLAB Software 5.x
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Version 06.00 • 2010-02-23
This manual has been composed with the assistance of PageMaker 7.0. The complete pages have been produced with the PageMaker version 7.0 for the PC and are also available as PDF files. AcrobatReader 5.0 is required in order to open these PDF files. Trademarks PageMaker and AcrobatReader are registered trademarks of Adobe Corporation. Copyright All rights, also those of translations, are reserved. Written permission of CareFusion shall be obtained for the reproduction of the manual or an excerpt thereof by any means which includes printing, photostatic duplication, microfilms or any other process.
Contact: CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany Tel. +49 931 4972-0 Fax +49 931 4972-423 E-Mail: [email protected]
Note CareFusion does not guarantee for this documentation. It is also not guaranteed but not restricted to the implied warranties that the documentation is of marketable quality and suitable for a certain purpose. CareFusion does not assume the liability for mistakes in this documentation or for casual or consequential damages in connection with the provision, representation or use of this documentation. This document contains copyright information. All rights are reserved. It is not allowed to copy, duplicate or translate this manual in any other language without having the written approval of CareFusion before. CareFusion reserves the right for itself to alter the information included in this document without notice. Names of persons mentioned in the context of this manual are fictitious - any resemblance to living or deceased persons is purely incidental and not intended. Subject to technical modifications. Copyright © 2009 by CareFusion Germany 234 GmbH, Hoechberg
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We congratulate you on buying one of the new pulmonary diagnostic systems from CareFusion, called MasterScreen, and thank you for the confidence you have placed in us and our product. We would like to thank all our customers and users of our products who helped us to improve this equipment by suggestions for improvement and critical remarks. This new program version is, however, only one step towards the improvement of the program. Therefore, we should be obliged if you would continue to inform us about your opinion on our MasterScreen and the experience you gained while working with this equipment. We should be glad for any kind of feedback be it positive or negative such as criticism, ideas, suggestions for improvement etc. regarding MasterScreen or its manuals.
CAUTION: FEDERAL U.S. LAW RESTIRCTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. (Rx only)
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On this Manual When compiling the Instruction Manual importance was placed on a description of the individual programs, making them as simple and comprehensible as possible. The user, especially the medical technician, should be able to use the MasterScreen, with all its programs, with the help of the manual. Each program has been explained in such a way that it can be used without the user having to know another program. It should, however, not be expected that this is a textbook, which, if studied, will enable the user to perform perfect lung function measurements in every detail. Instruction in this is the task of training seminars which take place at CareFusion. The following is included in the delivery of your MasterScreen: 1. Instruction Manual 2. LAB User Manuals on CD-ROM or hard disk. The LAB User Manuals describe all programs and options in detail. Printed versions of the User Manuals are optionally available. Before dispatching your system, we have already installed the LAB User Manuals on the hard disk of the delivered computer. These manuals can be loaded from the LAB application programs (see "Detailed User Manuals on Hard Disk").
The applicationof this system is restricted to experts and trained personnel only who can guarantee for the correct usage of the device.
Caution: The option NO Diffusion and the use of C2H2 gas is not approved by FDA for sale in USA.
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Table of Contents On this Manual ... 5 Practical Hints ... 8 Symbols for Notes on Safety in Instruction Manuals ... 9 Declaration of Conformity ... 9 The MasterScreen Family ... 10 Technical Data ... 21 Switching on/off MasterScreen ... 28 Automatic Self-Test ... 29 LabManager ... 30 Description of Calibration and Measurement Programs ... 33 Ambient Conditions ... 33 Volume Calibration ... 34 Box Calibration ... 38 Gas Analyzer Calibration ... 39 Patient Data ... 41 Measurement Program Spirometry/Flow-Volume ... 44 Measurement Program R OCC ... 50 Measurement Program Rhinomanometry ... 51 Measurement Program Resp. Drive, Resp. Muscle Strength ... 55 Measurement Program IOS ... 58 Measurement Program Bodyplethysmography ... 62 Measurement Program Compliance ... 64 Measurement Program Diffusion Single Breath ... 69 Measurement Program Diffusion Single Breath (RT) - Option ... 71 Measurement Program Diffusion Intrabreath - Option ... 74 Measurement Program Diffusion NO-Membrane - Option ... 78 Measurement Program Diffusion Rebreathing (Option) ... 82 Measurement Program FRC-He Rebreathing ... 86 Resting and Stress ECG ... 89 Resting ECG ... 93 Stress ECG ... 96 Bronchial Test ... 100 Output ... 108 Hygiene for MasterScreen ... 112 Detailed User Manual on Hard Disk ... 120
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General Safety Precautions ... 124 Symbols for Notes on Safety in Instruction Manuals ... 124 Electrical Safety ... 125 Ambient Conditions ... 129 Putting the Unit into Operation ... 129 Cleaning and Hygiene ... 129 Maintenance ... 130 Moving Equipment ... 131 Notes on the New Trolley ... 132 Asthma Provocation System (APS) ... 132 Literature ... 133 Graphical Symbols Equipment of Type B ... 134 Body Box ... 136 Emergency Exit from the Body Box ... 137 Esophagus Catheters ... 137 Safe Gas Handling ... 138 Return of Goods in Medical Institutions ... 144 Item Numbers of Disposables, Spare Parts and Accessories ... 148
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Practical Hints After the installation and connection of the unit, the operator and some colleagues should volunteer as test subjects for the various measurements in order to gain confidence in the handling of the unit and become familiar with the measuring values obtained (verification of multiple measurements, reproducibility). Control measurements: The measurements taken should be repeated at regular intervals (every few weeks) on the operator himself and two or three staff members. Results obtained should be recorded. An effective check is thus maintained on the functional accuracy of the unit. The information thus recorded will be extremely useful if the impression is gained that measuring values obtained from the patients are incorrect. Measurements can then be obtained once more from the staff and compared with those stored. Instructing the patient: Many of the patients will have been submitted to a pulmonary function test never before. Such patients (but also experienced ones) will generally be very agitated and nervous. It will be in the interest of the operator and patient if the procedure is thoroughly explained with regard to the time taken and purpose of the test.
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Version 06.00 • 2010-02-23
Symbols for Notes on Safety in Instruction Manuals Following the ANSI recommendations (American National Standards Institute) for safety notes, specific passages of the instruction manual are clearly marked as safety notes. Degree of Danger
Injury to Persons
Damage to Property
DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. This signal word is to be limited to the most extreme situations.
X
WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
X
X
Use in case of:
(X)
CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices.
Additional icons shown in the instruction manual: X
X
See instruction manual and observe documents delivered with the equipment. Important information on use and useful information. No information which warns of a dangerous or harmful situation. Hints on use.
Declaration of Conformity The original document of the Declaration of Conformity is deposited at Accompanying Documents.
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System Description
The MasterScreen Family Jaeger delivered the first industrially produced devices for pulmonary function testing in 1962. The sophisticated versions with computerized on-line processing were introduced to the market in the late 1960s. MasterScreen is a combination of the rich experience and the WINDOWS XP user interface from Microsoft. With its modular concept the innovative MasterScreen family is suitable for routine measurements in private and specialists' offices as well as in hospitals.
The modular MasterScreen Family This powerful unit conception meets all requirements in the field of modern lung function diagnostics. All units of the MasterScreen series are based on a powerful computer system with high storage capacitiy as well as color monitor and printer. The following is included in the delivery: mouse, LAB database and generation package as well as the graphics user interface Microsoft WINDOWS XP, which offers absolutely unique operational comfort and speed. In a well-approved network conception, all MasterScreen units can be connected to any other CareFusion equipment and to most office systems so that data can easily be exchanged on the basis of a common database. Of course, MasterScreen units comply in any respect with the relevant standards, especially ERS (European Respiratory Society) and the very strict ATS (American Thoracic Society) criteria. Excellent patient security is emphasized by meeting the Swiss safety standards (SEV).
Many diagnostically important values of the static (ERV, VCIN, VCEX, ...) and the dynamic (FVC, FEV1, MEF50, ...) lung volumes can be determined with the powerful starter device MasterScreen Pneumo. MS PNEUMO
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Indications for Use: The MasterScreen Pneumo is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent FlowVolume measurements. Mostly it will be used for COPD and Asthma patients. Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance. The MasterScreen Pneumo is powered from 100 - 240 V/50 - 60 Hz wall outlets. No energy is transferred to the patient.
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System Description
For complex measurements, CareFusion offers an easy and user-friendly solution: MasterScreen ECG, a handy and up-to-date ECG system. In combination with customized software and a modern computer system it offers a wide range of possibilities for cardiology testing. ECG during exercise as well as bike and treadmill control are avail-able as an option. MS ECG/ERGO
Indications for Use: The MasterScreen ECG/Ergo is a software-driven medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The MasterScreen ECG/Ergo interfaces to a test subject via mouthpiece or a face mask and ECG electrodes. The MasterScreen ECG/Ergo interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older. The MasterScreen ECG/Ergo is capable of performing computerized ECG interpretation during resting condition. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. It is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use. MasterScreen IOS offers completely new possibilities. It allows oscillometric diagnostics which is almost independent of patient co-operation and is therefore well established in pediatrics. With the new CareFusion Impulse Oscillometry (IOS) it is not only possible to determine quickly and reliably pulmonary obstructions, but also to differentiate between their central and peripheral components.
MS IOS
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Indications for Use: The MasterScreen IOS is intended to be used for measurement and data collection of lung function parameters in humans. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements and the IOS (multifrequent oscillometry determination) measurement. Tests can be easily and quickly conducted on the basis of Impulse Oscillometry. The device is useful in the field of early diagnosis in every-day-routine, for clinical trend observations as well as for epidemiologic studies. As only a minimum of patient cooperation is required, Impulse Oscillometry is also suitable for pediatric and geriatric studies. Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. The MasterScreen IOS is powered from 100 - 240 V/50 - 60 Hz wall outlets. No energy is transferred to the patient.
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System Description
Due to its modular concept, MasterScreen PFT is a practice-oriented pulmonary function testing station for determining static and dynamic lung volumes via the classic He-Rebreathing method and the diffusing capacity via the Single-Breath method.
MS PFT BODY
New features: MasterScreen PFT is equipped with very fast responding gas analyzers. For the first time, the diffusing capacity can be determinated according to the following methods: - Diffusion Single Breath (Real Time RT) - Diffusion Intrabreath - Diffusion NO-Membran (Option) With an analysis of the entire pulmonary breathing mechanics MasterScreen Body offers comprehensive differential diagnostics. In connection with the options "Diffusion", "Respiratory Drive", and "Bronchial Provocation", MasterScreen Body meets all of the demands on differential diagnosis which are made in private practices and hospitals, today. Indications for Use: MasterScreen PFT Body The MasterScreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data/information and supports help for a diagnosis. MasterScreen PFT CT (Clinical Trial version) includes Spirometry/Flow-Volume/ Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. investigator, doctor, study nurse, trainer and service personnel). MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements. Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance. The MS-PFT Body is powered from 100 - 240 V/50 - 60 Hz wall outlets. No energy is transferred to the patient. Page 12/150
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System Description
Specific and unspecific reproducible provocation tests can easily be performed with the Aerosol Provocation System APS pro. Up-to-date and sophisticated electronics and mechanics allow for optimal use of its nebulization technology with precise dosing.
APS pro
Indications for Use: The Aerosol Provocation System (APS pro) is intended for specific and non-specific bronchial hyperreactivity tests (provocation tests), as well as for reversibility tests using bronchodilatators. The system is to be used together with a PC-based lung-function equipment of CareFusion together with a CareFusion compressor to measure and to display simultaneously the results during a patient reaction. For the U.S. market only legally marketed nebulizers which are also approved by CareFusion are allowed to be used with the APS pro. Currently only the SIDESTREAM nebulizer manufactured by Medic-Aid Ltd. is approved (K924123). Place of use: The system is only to be used indoors. The required ambient conditions are: • Temperature: +10 to +40 °C • Relative humidity: 30 % to 75 % • Barometric pressure: 700 to 1060 mBar Patient groups: The system to be used for testing patients from 4 years upwards. Tests with the APS pro are to be performed by the order of a physician only. During the tests trained personal must be available.
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System Description
MasterScreen Pneumo MasterScreen Pneumo allows the measurement of diagnostically important parameters for the determination of static and dynamic lung volumes. These are the parameters of slow (ERV, VCIN, VCEX) and forced (FVC, FEV1, MEF50) breathing maneuvers as well as the maximum voluntary ventilation (MVV). In connection with the "Bronchial Response Test" option MasterScreen Pneumo is a vital tool for control, documentation and assessment of bronchospasmolysis and bronchoprovocation tests. Standard measurement program: - Spirometry/Flow-Volume (ERV, VCIN, FEV1, MEF50, MVV...) Unit configuration: o Current Pentium computer o Color printer o 17" TFT monitor o Mouse o Windows XP Professional o Standard measurement program: Spirometry, Flow-Volume including Maximum Voluntary Ventilation and Animation programs o LAB database o Generation package
MasterScreen ECG Resting ECG as well as ECG during exercise (included in standard delivery of MS Ergo) can be registered with the MasterScreen ECG. Data are clearly displayed during the examination and the continuous measurement of ST can be selected for one or twelve ECG channels. At the end of the measurement all important data are displayed in clear graphics. Standard measurement programs: - Spirometry/Flow-Volume (ERV, VCIN, FEV1, MEF50, MVV...) - Resting ECG - Resting ECG Interpretation Unit configuration: - Stress ECG (MS Ergo) o Current Pentium computer - Automatic ST evaluation o Color printer o 17" TFT monitor o Mouse o Windows XP Professional o ECG connection box o Standard measurement programs: Resting ECG Stress ECG o LAB database o Generation package Page 14/150
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System Description
MasterScreen IOS There are various reasons which make the Impulse Oscillometry System (IOS) an attrac-tive diagnostic system for determining the airway resistance of the lung. Impulse oscillometry only requires minimal patient co-operation so that patient groups can be included who could normally only be measured with time-consuming conventional procedures. Such patient groups are children below the age of 5, geriatric patients and patients with higher degrees of disease. Oscillometry allows detailed tidal breathing analysis which provides clinically relevant and spirometry complementary results without having to use cost- and time-intensive technology. The results are output in form of a lung model including central and peripheral respiratory parameters which are easy to understand. Referring to specific oscillometric parameters during the interpretation of spirometry provides considerably more information from the available spirometric results. The determination of a possible hyperresponsiveness due to pre and post measurement is not accompanied by the known dilatation effects which can be caused by spirometry because of the initially required deep inspiration. To get a comprehensive evaluation of pulmonary function, it is recommended to conclude the oscillometric examination with a forced spirometry. The information given by an oscillometric tidal breathing analysis is often sufficient for further trend examina-tions. In practice, it is helpful to refer the measured functional value to a predicted value which is assigned to the patient. Appropriate predicted values for all age ranges are available for both methods. This allows to follow the recommendations as far as the classification of the disease's degree of severity is concerned and the notes on differentiation of pulmonary function. In connection with the "Bronchial Test" option, MasterScreen IOS is a vital tool for control, documentation and assessment of bronchospasmolysis and bronchoprovocation tests. Standard measurement programs: - Impulse Oscillometry (R5, R20, X5, Fres, ...) - Spirometry/Flow-Volume (FEV1, FVC, FEV1/IVC%, PEF, MEFxx, MVV)
Unit configuration: o Current Pentium computer o Color printer o 17" TFT monitor o Mouse o Windows XP Professional o Standard measurement program: Impulse Oscillometry Spirometry, Flow-Volume Maximum Voluntary Ventilation Animation programs o LAB database o Generation package
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System Description
MasterScreen Body The MasterScreen Body is a universal lung function testing station with special emphasis on the bodyplethysmographic determination of airway resistance (sRtot, sReff, sR0.5) and intrathoracic gas volume (ITGV). Combined with the options "Diffusion Single Breath", "Respiratory Drive" and "Bronchial Provocation" your system can be expanded to a complete lung function laboratory. Standard measurement programs: - Spirometry/Flow-Volume (FEV1, FVC, FEV1/IVC%, PEF, MEFxx, MVV) - Bodyplethysmography (ITGV, RV, TLC, RV%TLC, Raw, sRaw, ...) Unit configuration: o Current Pentium computer o Color printer o 17" TFT monitor o Mouse o Windows XP Professional o Standard measurement programs: Bodyplethysmography Spirometry, Flow-Volume Maximum Voluntary Ventilation Animation programs o LAB database o Generation package
Aerosol Provocation System APS pro Specific and unspecific reproducible provocation tests can easily be performed with the Aerosol Provocation System APS pro. Up-to-date and sophisticated electronics and mechanics allow for optimal use of its nebulization technology and precise dosing. To use just a single concentration of the provocative substance, makes provocation tests easy and comfortable to perform. Measurement programs and provocation program work hand in hand. The response measurement can be performed in the following measurement programs: Spirometry/Flow-Volume Bodyplethysmography Unit configuration: IOS ROCC o APS pro Power Unit with compressor o Nebulizer head o Nebulizer set o Aerosol filter o Mouthpieces
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System Description
Overview of Pulmonary Function Testing Systems Measurement Programs Spirometry/Flow-Volume/MVV Flow-Volume Animation Bodyplethysmography incl. Closing Volume Diffusion Single Breath Diffusion Single Breath (RT) Diffusion Intrabreath Diffusion NO-Membrane DCO-Rebreathing FRC-He Rebreathing Airway Resistance Rocc Resp. Drive, Resp. Muscle Strength (P0.1, Pmax) Tidal Breathing Analysis Compliance Impulse Oscillometry (IOS) Bronchial Test incl. APS pro Rhinomanometry 12-channel-PC ECG
MS-Pneumo MS-ECG
MS-IOS
MS-Body
Calibration Programs Ambient Data Volume Calibration Box Calibration Gas Analyzer Calibration
Organization Programs Database Database Tools SQL Database Screen and Printer Report TIFF Report PDF Report Interpretation Off-line Input On-line Data Transfer (e.g. blood gases, ...) LabManager Generation ReportDesigner Predicted Value Utility „PredEditor“ LanguageMaker User Parameters Parameter Text Editor Bronchial Test Generation PatientManager AMOS, Software for AM1 Network Database Office connection for installation by the user HL7 Interface
Standard Option
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System Description
MasterScreen Diffusion The MasterScreen Diffusion is a universal lung function testing station with special emphasis on the determination of the diffusion capacity of the lungs according to the CO Single Breath method. Standard measurement programs: - Spirometry/Flow-Volume (ERV, VCIN, FEV1, MEF50, MVV...) - Diffusion Single Breath (VA, RV-He, TLC-He, TLCOSB...)
Unit configuration: o Current Pentium computer o Color printer o 17" TFT monitor o Mouse o Windows XP Professional o Standard measurement programs: Spirometry, Flow-Volume Maximum Voluntary Ventilation Animation programs Diffusion Single Breath o LAB database o Generation package
MasterScreen Diffusion is not for sales in the USA.
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System Description
MasterScreen PFT Due to its modular concept, MasterScreen PFT is a practice-oriented pulmonary function testing station for determining static and dynamic lung volumes via the classic He-Rebreathing method and the diffusing capacity via the Single-Breath method. Standard measurement programs: - Spirometry/Flow-Volume (ERV, VCIN, FEV1, FEF50, MVV...) - Diffusion Single Breath (VA, RV-He, TLC-He, TLCOSB...) - FRC-He Rebreathing (FRC-He, RV-He,...) MasterScreen PFT is equipped with very fast responding gas analyzers. For the first time, the diffusing capapcity can be determined according to the Diffusion Single Breath (RT) and Diffusion Intrabreath method: Optional measurement programs: - Diffusion Single Breath RT (DCOSB, KVO, VA, RV, TLC, RV%TLC, ERV, FRC, FRC%TLC, Hb) - Diffusion Intrabreath (DLCOIc, KCO IBc, VAmax, VIN IB, Hb, Optional: QT, HR ) - Diffusion NO Membrane (DLNOc, DLCOc, Dm, Vc, KNOc, DLNOc, KCOc, Hb) When a nitric oxide mixture is used with this instrument for the measurement of Lung Diffusion for Nitric Oxide (DLNO), the gas must be a 400ppm mixture of nitric oxide (NO) in nitrogen (N2). The instrument is programmed for this concentration and gas mixture. Because the gas will be inhaled, we recommend the use of a gas mixture that has been approved as a medicinal product.
Unit configuration: o Current Pentium computer o Color printer o 17" TFT monitor o Mouse o Windows XP Professional o Standard measurement programs: Spirometry, Flow-Volume Maximum Voluntary Ventilation Animation programs Diffusion Single Breath FRC-He Rebreathing o LAB database o Generation package
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System Description
Overview of Diffusing Systems Measurement Programs Spirometry/Flow-Volume/MVV Flow-Volume Animation Bodyplethysmography incl. Closing Volume Diffusion Single Breath Diffusion Single Breath (RT) Diffusion Intrabreath Diffusion NO-Membrane DCO-Rebreathing FRC-He Rebreathing Airway Resistance Rocc Resp. Drive, Resp. Muscle Strength (P0.1, Pmax) Tidal Breathing Analysis Compliance Impulse Oscillometry (IOS) Bronchial Test incl. APS pro Rhinomanometry 12-channel-PC ECG
MS-Diff
MS-PFT
Calibration Programs Ambient Data Volume Calibration Box Calibration Gas Analyzer Calibration Organization Programs Database Database Tools SQL Database Screen and Printer Report TIFF Report PDF Report Interpretation Off-line Input On-line Data Transfer (e.g. blood gases, ...) LabManager Generation ReportDesigner Predicted Value Utility „PredEditor“ LanguageMaker User Parameters Parameter Text Editor Bronchial Test Generation PatientManager AMOS, Software for AM1 Network Database Office Connection for installation by the user HL7 Interface
Standard Option
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