MasterScope - Instructions for Use Click to open the user confirmation window. Use your fingerprint again to confirm your identity. The DCR will be electrically submitted with the next data transfer to ERT data management for processing. Make sure to print one version of the Data Correction Form for your source documentation. The form can be printed using the MasterScope.
MasterScope - Instructions for Use 16.2 DCR Overview Refer to the following steps: 1. Click on in the menu bar on the right-hand side of the screen. 2. Select the tab. 3. Click to get an overview of the created DCRs. The following screen will appear: Select the appropriate DCR and confirm with
MasterScope - Instructions for Use The selected DCR will be displayed in detail: Click to exit the screen. Version 03.
MasterScope - Instructions for Use 17. Troubleshooting Resolving problems will be much easier if you follow these guidelines: • Immediately stop when you recognize a problem exists. Further action may result in incorrect data, data loss or damage. • Print a copy of the screen . The troubleshooting tools should be used only by instructed staff. The investigator should use these tools only if requested by the CRA or the ERT Customer Care.
MasterScope - Instructions for Use 17.2 Backup Medium The back-up produces an error message referring to an invalid medium. • Replace the medium. In case the problem persists, contact the ERT Customer Care or the CRA. 17.3 Notebook The computer does not start. • The battery may be discharged completely. • Check the connection to AC power. Make sure that the cord is firmly connected to the computer and a power outlet. In case the problem persists, contact the ERT Customer Care or the CRA.
MasterScope - Instructions for Use Power light and Resume light are flashing • Printer may have a paper jam. Remove paper from the tray. Open the lid and remove any pieces of paper that may be stuck in the printer. Power light is on and Resume light is flashing • Printer is out of paper. Refill the paper tray, and then press the Resume button.
MasterScope - Instructions for Use 18. Hygiene Wireless Spirometry Sensor Unit In the course of lung function testing, certain parts of the equipment can be contaminated by germs, which creates the risk that these germs can be transferred to the next test subject. For cross-contamination to occur, the test subject would need to be in direct contact with the contaminated object or transport media such as droplets or aerosols.
MasterScope - Instructions for Use 18.3 Wiping disinfection Surface Cleaning and Disinfection The surface disinfection of the wireless spirometry sensor unit and charging station must be performed on a regular basis. If there has been direct contact with the skin or if the case history/diagnosis of the patient requires it, a surface disinfection has to be performed directly after the application. If the patient’s history shows a dangerous infectious disease (e.g.
MasterScope - Instructions for Use The manufacturer’s information on the cleaning of accessories provided separately must be observed! With suspected tuberculosis or other resistant germs, the use of an appropriate disinfectant (CaviWipes, Reaction time >3 minutes) is required. Avoid contaminated fluids (e.g. blood) to get into the wireless spirometry sensor unit. In case of ingress of contaminated fluids, do not use the wireless spirometry sensor unit anymore. 18.
General Safety Precautions MasterScope - Instructions for Use 19. General Safety Precautions The Instructions for Use is regarded to be a part of the instrument, and should always be kept on hand. The Instructions for Use describes the present state of the device/system, including software and accessories, with regard to the fundamental requirements of the MDD 93/42/EEC. Exact adherence to the instructions issued is a prerequisite for perfect and intended functioning of ERT instruments.
General Safety Precautions MasterScope - Instructions for Use Valid for all ERT devices: The connection of further power-operated units to your ERT unit may cause all the leakage currents to add-up and the safety of the subject is reduced. Due to this, the connection of further units may only be carried out on consultation with the ERT Customer Care. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN standards (e.g.
MasterScope - Instructions for Use General Safety Precautions Portable RF communication equipment (transmitters) (including their accessories, such as antenna cables and external antennas) should be operated with a minimum distance of 30 cm (21 inch) to the MasterScope’s components and cables specified by the manufacturer. Non-observance may lead to a reduction of the device’s performance.
General Safety Precautions MasterScope - Instructions for Use Contraindications and possible adverse effects: According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be physically demanding for a minority of subjects. It is recommended that subjects should not be tested within 1 month of a myocardial infarction.
MasterScope - Instructions for Use General Safety Precautions Maintenance No part of the medical device may be replaced by the customer. Use only ERT approved accessories and spare parts for this medical device. If applied parts (e.g. handle/Sensor Unit) have been exposed to extreme mechanical stress, a function test (e.g. calibration check) has to be performed. If function is lost, the defective part is to be replaced. Damaged parts, e.g.
General Safety Precautions MasterScope - Instructions for Use 19.1 Graphical Symbols The typeplate on the Wireless Spirometry Sensor Unit is positioned at the left side. The typeplate of the Charging Station can be found at the bottom side. Alternating current Direct current Stand by Note Instructions for Use Caution! Consult accompanying documents.
General Safety Precautions MasterScope - Instructions for Use Separate collection for waste of electrical and electronic equipment Protection against intrusion of solid objects with a diameter ≥ 12,5mm; no protection against liquid intrusion 1 Protection against intrusion of solids ≥ 12,5mm diameter; protection against dripping water Serial Number Catalogue Number Batch code Fragile, handle with care Keep dry Temperature limitation Up Manufacturer logo CE mark with code number of the Notified Bod
General Safety Precautions MasterScope - Instructions for Use UDI UDI (Unique Device Identifier) MD Medical Device 19.2 Safety Precautions for Lithium Ion Rechargeable Batteries The Wireless Spirometry Sensor Unit is powered by an internal Lithium-Ion Polymer battery. The following safety precautions are valid for Lithium-Ion batteries: • Dispose of Lithium-Ion batteries according to local regulations. • Do not shortcut the battery.
General Safety Precautions MasterScope - Instructions for Use USA “This device complies with Part 15 of the FCC Rules. Operation is subjected to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including that may cause undesired operation.
General Safety Precautions MasterScope - Instructions for Use Notes on EMC according to EN60601-1-2 The use of accessories not recommended by ERT may result in an increased electromagnetic radiation or a reduced interference immunity of the MasterScope. Guidance and Manufacturer‘s Declaration – Electromagnetic Emissions and Immunity The MasterScope and its components use RF energy for internal function.
MasterScope - Instructions for Use Return of Goods in Medical Institutions Recommendations for action for all staff members having contact with potentially contaminated returns. Returns or returned goods are all products returned to the producer or the supplier, irrespective of whether or not they have been used, e.g. due to complaints, repair or maintenance. Those products might have had contact with biological substances or highly active pharmaceuticals (e.g.
MasterScope - Instructions for Use The following applies to products that are potentially contaminated by biological working substances of risk group 3 and 2 according to the regulation on biological substances and that are thus classified as Transport Category B: Please contact ERT before returning the goods and observe the regulations for the transport of dangerous goods. 2.
MasterScope - Instructions for Use 5. Labeling If a concrete risk of infection (e.g. HIV, Hepatitis B or C) is known to be present, this risk has to be noted on the packing of the returned goods and/or in the accompanying documents. For “Packaging and labeling of non-contaminated products“: see point 6. 6.
MasterScope - Instructions for Use Certificate of Hygiene This certificate must be attached to ANY product complaint, ANY return of medical products and accessories, ANY repair order and ANY return of studies. Name of product: REF (ERT item no.): LOT (batch no.): It is herewith confirmed by signature that (please mark appropriate box): the enclosed medical product had no contact with blood or other body fluids so that it is hygienically safe.
MasterScope - Instructions for Use Technical Data Calibration Syringe Calibration Syringe: Volume: Accuracy: 3L +/- 12 mL Technical Data Wireless Spirometer Sensor Unit & Charging Station Measuring Range: PEF: FEV1 and FVC: 0.1 to 16 L/s 0.1 to 8 L Resolution: PEF: FEV1 and FVC: < 5 mL/s 1 mL Accuracy: PEF: FEV1 and FVC: 0.1 to 16 L/s: 0.1 to 8 L: Resistance Spirometer: max. 135 Pa/L/s at 14 L/s Instantaneous Flow: 0.1 – 14 L/s: +/- 5% or 0.
MasterScope - Instructions for Use Technical Data Ruuvitag Ambient Sensor RuuviTag (https://ruuvi.com) is an open-source sensor platform that can measure temperature, relative air humidity, airpressure and acceleration. Bluetooth: BLE 4.
MasterScope - Instructions for Use System Requirements Operating System: Windows 10 or higher Software is pre-installed on laptop included in the MasterScope package.
MasterScope - Instructions for Use Index A Acceptability ......................................................... 115 Accessories ............................................................. 16 Ambient conditions ............................................... 216 Ambient Conditions and Calibration Check ............. 75 Ambient Room Conditions ...................................... 75 Amending Spirometry Measurements ................... 122 ATS Criteria ..................................................
MasterScope - Instructions for Use P Parameter Definition ............................................. 107 Password ....................................................... 17, 209 Pneumotach ......................................................... 102 Precleaning .................................................. 212, 213 Printer ................................................................... 210 Printing Reports .................................................... 144 Printing Screenshots ..........
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