MasterScreen series Instructions for Use Ver 04.00 Ver Sept 2019

Instructions for Use MasterScreen Body, Body/Diff, Diff, PFT, IOS

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Contact: Vyaire Medical GmbH Leibnizstrasse 7 97204 Hoechberg, Germany +49 931 4972-0 tel +49 931 4972-423 fax E-Mail: [email protected]

Copyright All rights, also those of translations, are reserved. Written permission of Vyaire 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. Note 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 obtaining written approval from Vyaire. Vyaire reserves the right 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 © 2019 by Vyaire Medical GmbH, Hoechberg

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Table of Contents Indications for Use and Usability... 5 Practical Hints... 8 Symbols for Notes on Safety in Instruction Manuals... 9 Declaration of Conformity... 9 Switching on/off MasterScreen with Trolley and System Box... 10 Handle with Pneumotach... 11 System Start... 12 Measurements with the MicroGard Filter... 12 The Start Screen/ Home Page... 13 SeSQM-Quality Management... 17 Calibration Frequency... 17 Ambient Data... 18 Volume Calibration... 20 FRC Filling Sensor Calibration... 24 Box Calibration... 27 Gas Calibration... 29 Enter Patient Data... 35 Load Patient Data ... 37 Show Patient Data... 39 Measurement Programs... 42 Basic Conditions prior to starting a Measurement... 43 Slow Spirometry... 44 Forced Spirometry... 48 Maximum Voluntary Ventilation (MVV)... 51 Bodyplethysmography... 53 R Occlusion (Option)... 60 Impulse Oscillometry (IOS)... 63 Diffusion Programs: Training Mode... 67 Diffusion SB Realtime (MS-PFT, MS-Diff (RT), MS-Body/Diff (RT))... 67 Diffusion SB Intrabreath (MS-PFT, MS-Diff (RT), MS-Body/Diff (RT))... 74 Diffusion SB CO/He (MS-Body/Diff, MS-Diff, MS-PFT*)... 80 Diffusion SB NO (MS-PFT)... 86 Preparing for a Measurement with MS-PFT... 86 FRC Rebreathing... 95 Respiratory Drive P 0.1 (Option)... 102 MIP / MEP (Option)... 105 SNIP (Option)... 111 Compliance... 114 Rhinomanometry (Option)... 125 Set Visit Levels... 131

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Quality Assessment/Interpretation/Comments... 132 Bronchoprovocation Test... 135 Provocation protocol with more than one measurement application... 155 Compressed Air Check... 157 Report... 158 Possible Sources of Error and Remedies... 159 Data Exchange with JAEGER JLAB/SensorMedics Vmax... 159 Online Manual... 160 Hygiene ... 160 General Safety Precautions... 161 Graphical Symbols... 168 Literature... 170 Body Box... 171 Esophagus Catheters... 175 Safe Gas Handling... 176 Notes on EMC... 182 Return of Goods in Medical Institutions... 185 Technical Data... 186 Item Numbers of Disposables, Spare Parts and Accessories... 190

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Indications for Use and Usability SentrySuite Indications for Use: The SentrySuite Product Line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. Use of the option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient’s sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician’s office or similar settings (professional healthcare facilities).

MasterScreen Body Indications for Use: The fundamental function of whole-body plethysmography is the measurement of absolute gas volumes and airway resistance. The methodological principle behind whole-body plethysmography is the finding, that the closed plethysmographic box “mirrors” alveolar pressure changes because of compression and decompression of thoracic gas while the subject is normally breathing entirely within the box. Therefore lung volumes and airway resistance can be determined non-invasively. The method can be utilized in patients older than 4 years, as soon as they accept sitting in the closed box, fit into the closed box and support airtight breathing via a bacterial filter or mouthpiece trough the measuring head. Measurements are performed by trained medical-technical staff under supervision of a physician in a hospital environment, physician’s offices, medical practices (professional healthcare facilities). The measuring procedure can be controlled on-line via computer screen. Test results are presented on screen, are stored in common network and data base environments or can be printed.

MasterScreen Body/Diff Indications for Use: The MasterScreen Body/Diff 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. Measurements will be performed under the direction of a physician in the clinic, doctor’s office or hospital (professional healthcare facilities). It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.

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MasterScreen PFT Indications for Use: The device 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 and lung diffusion measurements. The device provides data/ information and supports help for a diagnosis. Measurements will be performed under the direction of a physician in the clinic, doctor’s office or hospital (professional healthcare facilities). It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.

Aerosol Provocation System APS Indications for Use: The Aerosol Provocation System (APS) 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 Vyaire together with a Vyaire 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 Vyaire are allowed to be used with the APS. Currently only the SIDESTREAM nebulizer manufactured by Philips Respironics is approved (K924123). The system to be used for testing patients from 4 years upwards. Tests with the APS are to be performed by the order of a physician only. During the tests trained personal must be available.

Impulse Oscillometry (IOS) Indications for Use: The option IOS 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 and IOS (multiple-frequency oscillometric) measurements. The measurements based on impulse oscillometry are easy and quick. The device has proven successful in the field of early diagnosis at routine examinations, clinical analysis of progression, and epidemiological studies. As the required patient cooperation is reduced to a minimum, impulse oscillometry is also suitable for pediatric and geriatric studies. The system can be utilized for patients from 4 years on and older. Measurements will be performed under the direction of a physician in the clinic, doctor’s office or hospital (professional healthcare facilities).

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The application of this system is restricted to authorized and trained personnel only who can guarantee for the correct usage of the device. Information on Usability: Ambient requirements: - Use of the medical product in a medical environment (e.g. doctor‘s office, clinic, hospital) - Communication with the patient must be ensured (e.g. eye contact, duty of care) - Ambient conditions see section “Technical Data“ Operator requirements: - Operation only by specially trained physicians or medical technicians - Reading and comprehension of accompanying documents - Adequate computer skills incl. operating elements - Communication with the patient and the medical product must be ensured (use of e.g. visual and acoustic aids) Patient requirements: - Adequate patient cooperation is ensured - Use with patients > 4 years of age is possible - No restrictions with regard to height, weight and gender General requirements: - The patient must not be left unattended during the measurement. Caution: The use of C2H2 gas is not approved by FDA for sale in USA.

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Practical Hints Instructing the patient: Many of the patients will not have performed a pulmonary function test before. These patients (but also experienced ones) may be 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. Prior to a patient‘s first examination of the day, it is important to give the patient a waiting period of 10 to 15 minutes to relax and to normalize his/her ventilation which might be increased due to walking etc. A qualified physician has to reassess all measurements. An interpretation by SentrySuite is only significant by confirmation of other clinical findings.

FEDERAL U.S. LAW RESTIRCTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. (Rx only)

For more detailed information on the programs refer to the Online Manual which can be called up from every application program.

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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 Use in case of: to Property

X

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)

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 documents delivered with the equipment. Important and useful information. Information does not warn of dangerous or harmful situations.

Hints for use.

Declaration of Conformity The original document of the Declaration of Conformity can be found in the Accompanying Documents.

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Switching on/off MasterScreen with Trolley and System Box/ Isolating Transformer Switching on: For switching on the MasterScreen, switch on the main switch first and then the PC if it does not start automatically. Windows® will then start automatically. The power switch of single devices (monitor, printer, etc.) can remain switched on all the time.

Main switch

Switching off: After shutting down Windows® switch off the main switch.

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Handle with Pneumotach Prior to performing measurements with the MasterScreen, a new or disinfected pneumotach has to be connected to the handle.

1 Unlock the handle by shifting down the black locking ring. Put the pneumotach on the unlocked handle until it is locked in place. While doing so, face the “Patient“ symbol.

2 Shift the black

locking ring upwards until it is locked in place.

3 Connect the MicroGard

filter to the pneumotach via the elbow piece (see picture). Please use a new MicroGard filter and a clean mouthpiece for every patient.

Prior to connecting the MicroGard filter, hygienic hand disinfection must be performed (the general hygiene regulations of the doctor‘s office or the clinic are applicable).

Locking screw Locking screw

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If a heated digital handle is used, the pneumotach has to be protected from unintentional disconnection by the patient. For this, the black locking ring, which is shifted upwards until it snaps in place, has to be locked by tightening the two locking screws with a special Allen key.

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System Start To start the SentrySuite Software just double-click the <Launch SentrySuite> symbol on the Windows® desktop.

Measurements with the MicroGard Filter To ensure optimal patient safety, use the MicroGard filter. Before measurements are performed with the MicroGard filter the bacterial filter has to be activated in SentrySuite.

Procedure: 1. On the Home Page click “Configuration and Tools”, select “Configuration” and click on <Global Settings>. 2. Change to the “General Measurement” tab 3. Tick “Bacterial filter in use“. Ticked means: The software corrects the influence of the bacterial filter for the determination of the volume (BTPS correction). Additional filter settings can be found in the settings of the measurement programs. Refer to the Online Manual of the respective measurement program.

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The Start Screen/ Home Page The Home Page is an important part of your daily work with the system. After starting the system, the Home Page is displayed automatically and runs as long as you are working with the system. It is possible to access all applications from the Home Page. The programs are arranged in graphical items. Short explanation of the major functions of the start screen: In the top left-hand corner of the screen you will find information about the current activated patient, i.e. the ID number and visit details. For the MasterScreen IOS the warmup takes 5 minutes, for the MasterScreen Body/Body-Diffusion it takes 15 minutes and for the MasterScreen PFT, MasterScreen Diffusion (RT), MasterScreen Body/Diffusion (RT) 45 minutes. After switching on the unit, a self-test is automatically performed verifying that all hardware modules connected to the system are functioning correctly. Skipping the device warmup can cause imprecise measurement results.

Main items containing calibration tools, patient data, measurements, report and review. For further information please see Online Manual “Home and Help” Version 04.00 • 2019-09-25

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Clicking the status icon shows the user some information about the status of the measurement (measurement, result or edit mode) and information about the database connection.

Short explanation of the main items: Calibration With clicking the Calibration icon it is possible to select the desired calibration program. For further descriptions please see the corresponding chapter and the Online Manual “Calibration”. The calibration check required for the measurement to be performed at regular intervals is started from the Home Page or directly from the measurement application. Patient For entering and searching patients. For further description please see the chapter about patient data or the Online Manual “Patient Data”. Measurement With clicking the Measurement icon, the desired measurement program can be selected. For further descriptions please see the corresponding chapters or the desired Online Manual. Report With clicking the Report icon you can view, print or save a report. For further descriptions please see the corresponding chapter and the Online Manual “Report Output”. Review With clicking the Review icon, you will enter the SentrySuite Review program. For further description please see the Online Manual “Review”.

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With click on “Configuration and Tools” you will find other groups containing programs that are not routinely used: Utilities: Opens the generation programs: - Questionnaire Designer - Bronchial Challenge generation - Report Designer - Predicted Values - User Parameter - CPET Profile Editor - CPET Layout Editor - Interconnectivity Manager

What is it used for? Program for generating your own questionnaires (optional) Program for generating your own test sequence for the provocation (optional) Program for generating your own reports Program for generating your own predicted values Program for generating your own parameters (optional) Program for generating your own load profiles Program for generating user-specific screen layouts Program to import JLAB/Vmax/SPCS data into the SentrySuite database

The operator is responsible for the change of predicted modules, authors or the entry of new predicted value formulas.

Configuration: Connectivity...

System Configuration Global Settings...

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Program for configuring GDT/HIS settings and for checking the connectivity to other databases (such as JLAB, Vmax etc.). Please contact Vyaire tech support for further advice. Program for hardware/software configuration Program for performing settings which usually are only performed once

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Database Handling: Opens the programs: - Backup/Restore

- Data Export/Import...

- Patient Data Management

Program for performing a backup and restore of the complete SQL database including the stored patient and measurement data Program for exporting or importing data which has been created in SentrySuite (see Online Manual “Home and Help”) Program for changing the patient ID, deleting selected patient and measurement data, and moving measurement data (visits, levels, measurements) (optional) Caution: Program only for experienced operators.

User Administration: Opens the programs: - User Administration

Program for the administration of users and groups including distribution of rights (optional)

The programs listed above are not described in this Instructions for Use. For a detailed description refer to the Online Manual which can be started directly from the individual programs.

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SeSQM-Quality Management It is possible to check the measurement accuracy of the measurement system in the following ways: 1. Biological quality control measurements 2. Mechanical quality control measurements under real conditions for the measurements: - Spirometry: check volume VCIN, FVC - Diffusion: check volume VCIN, VA - Bodyplethysmography: check volume FRCpleth - FRC He Rebreathing: check volume FRC - Impulse Oscillometry: check resistance R5, R20 For detailed information on how to perform such SeSQM measurements, please refer to the Online Manual.

Calibration Frequency A calibration of the sensor system has to be performed as follows: Volume calibration: - daily - after the exchange of the pneumotach Gas analyzer calibration: - daily - after the exchange of a gas cylinder - after the exchange of the drying tube Box calibration: - daily FRC filling sensor calibration: - every month - after the exchange of the FRC gas cylinder

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Ambient Data The ATP-BTPS correction factor for inspiratory flows and volumes will be determined from the ambient data. Therefore, ambient data have to be updated at regular intervals. Incorrect or imprecise ambient data will result in incorrect measuring results.

Ambient Unit

If an Ambient Unit is included in the delivery package, the current values for room temperature, relative humidity and barometric pressure are recorded with the help of this module and automatically saved in the system. In order to assure correct data, the Ambient Unit must neither be exposed to direct sunlight nor positioned near heating elements.

USB Ambient Unit

If the lung function measuring station is not equipped with an Ambient Unit, the current ambient data are to be entered manually. In this case, room temperature, relative humidity and absolute barometric pressure need to be determined by a small home weather station and entered manually in the entry mask of the Ambient Data screen menu. If the ambient data change by more than 2 °C / 2 °F for temperature or 10 % for relative humidity, the current ambient conditions should be entered again in order to ensure that the parameters, especially inspiratory values, are determined correctly. The calibration procedure does not need to be repeated.

To enter the current ambient data manually or to check the data transferred into the system via the Ambient Unit, click on the “Ambient Data“ symbol. The ambient data program can be selected from each application (e.g. spirometry, Body...) and each calibration program. Following window appears:

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If no ambient unit is available, the ambient data is to be entered manually by clicking <Manual entry>.

Click on the corresponding blue field of the respective ambient unit and enter the current ambient data. Enter ambient pressure always as absolute pressure (not compensated to sea level)! Click <Save> to save the ambient data just entered. For further information regarding the ambient data, please see the Online Manual “Ambient Data”.

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Volume Calibration The measurement recording system (P-tube, P-tube screen, IOS head (option), pressure transducer, amplifier) must be calibrated in order to determine the exact lung volume.

The volume calibration/verification can either be started by calling up “Calibration” on the Home Page and selecting <Volume Calibration> or from any measurement program. Start of the program from one of the measurement programs: Call up “Calibration“ and select <Volume calibration> or, respectively, <Volume verification>.

Please note: If the volume calibration is started from the Home Page via “Calibration” icon and <Volume Calibration> on a combined measurement system, the type of system to be calibrated must be selected first. Depending on the existing MasterScreen system select the corresponding measuring system for performing a volume calibration.

For performing a calibration all parts where patients breathe through (such as measuring sensor, elbow piece, etc.) must be new or disinfected for preventing cross contamination with the calibration pump. When using bacterial filters, these filters also should be used for the calibration routine.

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