MasterScope - Instructions for Use 8.4 Subject Details Shows all available subject details. Update the values as described in Chapter “System Overview” - “New Subject“. Click on to store the data as entered. Version 03.
MasterScope - Instructions for Use 9. Spirometry Measurement Spirometry consists of the Slow Spirometry and /or Forced Spirometry measurement. 9.1 Basic Conditions prior to starting a Measurement In order to perform high-quality measurements, the following conditions should be fulfilled: • A waiting time of 10 to 15 minutes prior to the first examination ensures normal ventilation as a prerequisite for a high reproducibility of the examination results.
MasterScope - Instructions for Use 9.2 Slow Spirometry (VC and IC) Definition of VC and IVC The VC is the volume change at the mouth between the position of full inspiration and complete expiration, expressed in litres at BTPS. The slow VC can be derived in two ways. The expiratory vital capacity (EVC) is the maximal volume of air from the point of maximal inhalation.
MasterScope - Instructions for Use Definition of IC Inspiratory capacity (IC) is volume change recorded at the mouth when taking a full inspiration with no hesitation, from a position of passive end-tidal expiration, i.e. FRC, to a position of maximum inspiration, expressed in liters at BTPS. IC is an indirect estimate of the degree of lung hyperinflation at rest, and is useful to assess changes in FRC with pharmacological interventions and physical exercise.
MasterScope - Instructions for Use 9.3 Perform a Slow Spirometry Measurement Please observe the instructions for hygiene of your system. To ensure optimal subject safety, we recommend only the use of accessories which are distributed with the MasterScope. Make the proper preparations. (see “Basic Conditions prior to starting a Measurement“) Start Spirometry by pressing the icon. Version 03.
MasterScope - Instructions for Use Please follow the notes on the screen. Please check and, if necessary, correct the ambient conditions shown on the screen by clicking . Put your finger on the fingerprint sensor to continue. As an alternative, click the
MasterScope - Instructions for Use Any measurement starts with a zero adjustment of the pneumotach. Continue with . Do not breathe through the pneumotach and do not move the pneumotach during zero adjustment. If the zeroing fails, a corresponding message will be displayed. When the zero adjustment is complete, instruct the subject to close his/her nose with the nose-clip and to approach the mouthpiece. Make sure his/her lips seal around the mouthpiece.
MasterScope - Instructions for Use The results of the Spirometry measurement depend on the subject’s cooperation. Explain the breathing exercise to your subject thoroughly. Start with . The subject should breathe normally until stable tidal breathing is shown. Page 100/233 Version 03.
MasterScope - Instructions for Use After some breaths, the icon will re-appear. Wait until the baseline is stable (indicated by the dFRC and dVT bars). Stability is achieved when both bars are green. Wait longer Version 03.00 • Date 19FEB2020 Cont.
MasterScope - Instructions for Use Note: The volume signal must run horizontally after the measurement was started (subject not yet breathing into device). If you observe curves going up or down (see example) during a measurement, the pneumotach has not been properly zeroed. In order to fix this, press “Result“ to enter the Result phase and then press “Zero“ to start zero adjustment again. Make certain that the pneumotach is not moved and the subject is not breathing through the mouthpiece.
MasterScope - Instructions for Use IC - Inspiratory Capacity The measurement starts with tidal breathing (establishing a stable baseline may require more than 5 tidal breaths). From tidal breathing the subject takes in a maximum inspiration to total lung capacity (TLC). When TLC is achieved, the subject‘s exhalation should be relaxed and the subject should come back to tidal breathing (no maximal expiration to ERV). Version 03.
MasterScope - Instructions for Use VCEx or VEX - Expiratory Vital Capacity The measurement starts with tidal breathing (establishing a stable baseline may require more than 5 tidal breaths). From tidal breathing the subject takes in a maximum inspiration to total lung capacity (TLC). When TLC is achieved, a full but relaxed exhalation to residual volume (RV) should occur, followed by an inspiration back to tidal breathing to record EVC or VCex.
MasterScope - Instructions for Use VCin or IVC - Inspiratory Vital Capacity The measurement starts with tidal breathing (establishing a stable baseline mayrequire more than 5 tidal breaths). From tidal breathing the subject exhales fully to residual volume (RV), followed by a full inspiration to total lung capacity (TLC) and back to tidal breathing to record IVC or VCin. The Time Ex (expiration time) of the maneuver should last at least 6 seconds.
MasterScope - Instructions for Use This traffic light indicates the repeatability of the trial: Less than 3 efforts were performed. Red: Yellow: 3 or more accepted efforts were performed and the repeatability criteria were not met. Green: 3 or more accepted efforts were performed and the repeatability criteria were met. A green traffic light does not imply that all ATS criteria for the test are met. The green light only signifies that repeatability has been established.
MasterScope - Instructions for Use 9.4 Forced Spirometry Measurement Parameter Definition FEV1 FVC PEF FEF25-75 FEV3 FEV6 FEV1/FVC FEV1/FEV6 Version 03.
MasterScope - Instructions for Use 9.5 Perform a Forced Spirometry Measurement Please observe the instructions for hygiene of your system. To ensure optimal subject safety, we recommend only the use of accessories which are distributed with the MasterScope. Make the proper preparations. (see “Basic Conditions prior to starting a Measurement“) Start Spirometry by pressing the icon. Page 108/233 Version 03.
MasterScope - Instructions for Use Please follow the notes on the screen. Please check and, if necessary, correct the ambient conditions shown on the screen. Put your finger on the fingerprint sensor to continue. As an alternative, click the
MasterScope - Instructions for Use Any measurement starts with a zero adjustment of the pneumotach. Continue with . Do not breathe through the pneumotach and do not move the pneumotach during zero adjustment. If the zeroing fails, a corresponding message will be displayed. When the zero adjustment is complete, instruct the subject to close his/her nose with the nose-clip and to approach the mouthpiece. Make sure his/her lips seal around the mouthpiece.
MasterScope - Instructions for Use The results of the Spirometry measurement depend on the subject’s cooperation. Explain the breathing exercise to your subject thoroughly. Version 03.
MasterScope - Instructions for Use Start with . The subject should breathe normally until stable tidal breathing is shown. From tidal breathing, the subject is instructed to inhale as deeply as possible. Without interruption, the subject should now immediately exhale as fast and as much (FEV1) and as long (FVC) as possible. The maneuver is usually completed by a maximal inhalation (VC IN) and continue to normal breathing.
MasterScope - Instructions for Use Screen display after pressing “Result”. Explanation of icons from left to right: • Show expiration only • Show inspiration only • Show F/V loop • Switch to Tiffeneau • Show quality errors The quality of the flow-volume curve depends on the subject‘s cooperation.In order to assess reproducibility (repeatability) and thus the quality of cooperation, it is recommended to perform at least 3 trials.
MasterScope - Instructions for Use Screen display after three reproducible trials: This traffic light indicates the repeatability of the trial: Less than 3 efforts were performed. Red: Yellow: 3 or more accepted efforts were performed and the repeatability criteria were not met. Green: 3 or more accepted efforts were performed and the repeatability criteria were met. A green traffic light does not imply that all ATS criteria for the test are met.
MasterScope - Instructions for Use With mouse over on the effort number (here 3rd effort) the date/time of the measurement will be displayed and if the effort was deselected by the system or by the user (if applicable). Colors above the effort number matching the color of the flow/volume loop for easy identifing the loop vs. the parameters. Dashed color indicates the effort was deselected while a solid colored line indicates the effort is valid.
MasterScope - Instructions for Use Forced Spirometry: Repeatability of test set • No repeatability: Less than 3 acceptable measurements recorded • FEV1 repeatability is unacceptable Difference in FEV1 from best to second best is greater than 150 mL. • FVC repeatability is unacceptable Difference in FVC from best to second best is greater than 150 mL. • PEF repeatability is unacceptable Difference in PEF from best to second best is greater than 0.67 L/sec.
MasterScope - Instructions for Use 9.7 Unacceptable Efforts Immediately after each effort, messages are displayed, which indicate whether the last effort should be disregarded (not accepted) by the operator and how to prevent such errors in the future.
MasterScope - Instructions for Use Depending on the study setup the system either allows the user to decide if the efforts should be kept or it will not allow to deselect the effort for the following errors: • Expiration time shorter than 6 sec. • No plateau at end of expiration detected Page 118/233 Version 03.
MasterScope - Instructions for Use The automatic removal of unacceptable efforts is based on ATS/ERS guidelines. The investigator can accept an effort again if indicated by clicking on the deselected dot with the left mouse button. To disregard an effort, click on the colored dot with the left mouse button. Discarded efforts are not counted for the minimum three efforts. 9.
MasterScope - Instructions for Use 9.9 Measurement Summary Result and Comments After acceptable efforts have been obtained and no additional efforts are indicated, proceed by pressing . The Summary screen shows the best and predicted values of the parameters FEV1 and FVC.
MasterScope - Instructions for Use 9.10 Review Results and Edit Comments At any time, measurement details can be reviewed by clicking on the corresponding tab and Info icon in the Visit Summary screen. Typical information provided with the measurement results are: 1. Parameter values from measurements 2. Flow Volume curves 3. ATS error codes for single measurements and best test. 4. Comments for this test, which can be amended. Version 03.
MasterScope - Instructions for Use 9.11 Amending Spirometry Measurements Once a spirometry test has been saved, it can be reopened and amended if no other workflow steps (inclusion, randomization, data transfer) have been completed. In order to amend the last test, click the icon . The spirometry module will allow performing additional measurements. Amending PFT is only applicable until the measurement results have been transfered via Data Transfer to the ERT Backend Center.
MasterScope - Instructions for Use 10. Resting ECG MasterScope ECG allows to record a 12-lead resting ECG measurement. Click the icon. Version 03.
MasterScope - Instructions for Use Following screen appears: Please follow the notes on the screen. Put your finger on the fingerprint sensor to continue. As an alternative, click the
MasterScope - Instructions for Use 10.1 Information on ECG Recording An electrocardiogram (ECG) is a graphic recording of the changes occurring in the electrical potentials (millivolt changes) at defined sites on the skin. The continuously changing electrical fields are the result of depolarization and polarization of the heart and are distributed in the body without any delay. The electrical fields are caused by the cardiac cells, which are electrically polarized.
MasterScope - Instructions for Use 10.1.2 ECG Leads To minimize artifacts, the skin of the defined lead positions has to be prepared thoroughly. Preparing the subject‘s skin: 1. Identify the (10) electrode sites on the torso by referring to the picture and description below. 2. Remove any hair from the electrode site using a razor. 3. Wipe oils from the electrode sites with an alcohol prep pad. 4. Remove any dead skin from the electrode sites with an abrasive cleaner.
MasterScope - Instructions for Use 10.1.
MasterScope - Instructions for Use The different measurement setups are commonly referred to as leads. For a standard 12-lead ECG, four electrodes are placed at the limbs and six at the chest.
MasterScope - Instructions for Use 10.1.5 Basic Conditions for ECG Recording For high-quality ECG recording, certain criteria have to be met: Mentally prepare the subject for the examination in order to eliminate pain and consequently tachycardia and muscle tremor. Ambient temperature should be at least 23 °C to avoid shivering; make sure that the subject is lying comfortably on a suitable couch or bed and eliminate all sources of noise.
MasterScope - Instructions for Use 10.2 Performing an ECG Recording A screen displaying the correct placement of the electrodes for the ECG recording will appear. 10.2.1 Electrode Test Before an ECG recording is started, an automatic electrode contact measurement is performed. This measurement is started by pressing . The electrode test program automatically checks whether the electrodes are in good contact with the skin.
MasterScope - Instructions for Use To enable an easy check of the electrode placement, the system will illuminate the electrodes in a fixed sequence. Depending on the used ECG, the electrodes are visually checked (“running lights“), starting with “V1“ and ending with “LL“: Chest ECG electrode sequence: Limb ECG electrode sequence: “e“ shape mirrored “S“ shape Pressing will start the recording of the ECG signals. Version 03.
MasterScope - Instructions for Use 10.2.2 ECG Recording The recorded ECG waveforms are displayed on the screen. Scaling and Filter Press to change between the scalings 5 mm/mV and 10 mm/mV. Press to turn on/off the notch filter. Turn this on if there is noise seen on the ECG signal. Before using the notch filter ensure there is no other interference causing the noise, e.g. electric interference next to the ECG amplifier. Page 132/233 Version 03.
MasterScope - Instructions for Use 10.2.3 ECG Evaluation Inspect the recording quality of the signals. If the signals are free of drift and noise, press to analyse the last 10 seconds of the recording and halt the aquisition. HES® Interpretation will be performed and the results will be displayed on the screen. Interpretation according to HES® MasterScope ECG provides the Hannover ECG System HES®, which has been developed together with leading cardiologists all over the world.
MasterScope - Instructions for Use It is extremely important that the ECGs submitted have clean baselines and are free of any drifts. See “Recording Quality ECGs“ on the next page. If the quality of the recorded data is not sufficient, a new ECG recording should be started prior to pressing (= save and exit ECG recording). For this, press to delete the recorded data and restart ECG recording. Press to save the current ECG recording and exit the program. Enter a comment and click .
