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Summary of Contents for Medisoft Micro 6000
- Page 1 HARDWARE USER MANUAL Micro 6000 Version 2.2 H17-EN 30/12/2019...
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Page 2: Table Of Contents
5.4.2 Checking the pneumotachograph calibration ................21 Maintenance ......................23 Foreword ........................23 Maintenance planning ....................24 Maintenance procedures for the user ..............25 6.3.1 Cleaning ............................25 6.3.2 Replacement of the pneumotachograph mesh ................25 H17-EN Micro 6000 2/26... - Page 3 Revision Date Version Modifications 21/02/2016 1.0 Creation 01/06/2018 2.0 New design 14/05/2019 2.1 Modification of the CE marking 30/12/2019 2.2 Removing redundant information’s H17-EN Micro 6000 3/26...
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Page 4: Foreword
The handheld spirometer is suitable for spirometry in clinical context, pharmacology and epidemiology studies. The Micro 6000 is operated by ExpAir, a software program developed by Medisoft S.A. that functions on Windows based PC systems. -
Page 5: Description Of Available Tests
1.2 Description of available tests The Micro 6000 device allows the spirometry measurement. The conventional spirometry includes: • Slow spirometry with measurement of lung-volume subdivisions (VC, IC, ERV, Vt, RR, • Forced expiratory maneuver (FEV1, FVC, PEF, intermediate flows, FEF25-75…) •... -
Page 6: Warnings
2.1 Location of the device Location of the Micro 6000 The Micro 6000 module should not be located on wet or dusty conditions. The cooling ventilator on the rear panel must not be obstructed which could lead to an overheating inside the module. -
Page 7: General Overview
General overview 3.1 Front panel Front panel Power LED Handheld spirometer Lilly type pneumotachograph Combined tubing for handheld spirometer Upstream flow connector (+, red) Downstream flow connector (-, blue) Heated wire connector Holder for pneumotachograph H17-EN General overview 7/26... -
Page 8: Rear Panel
3.2 Rear panel Rear panel Reset button USB port (connected to computer) Thermometer sensor Humidity sensor Power switch (ON/OFF) Power supply entry H17-EN General overview 8/26... -
Page 9: Handheld Pneumotachograph
3.3 Handheld pneumotachograph Pneumotachograph front part (patient facing) Heated wire and plug Pneumotachograph mesh Handle Pneumotachograph back part (to ambient) Antibacterial/viral filter Upstream flow line and connector (+, red) Downstream flow line and connector (-, blue) H17-EN General overview 9/26... -
Page 10: Connections
Connections 4.1 Connections on the front panel Insert the plug-in connectors to the upstream (red)/downstream (blue) ports Secure the connection by clockwise rotation of the plug-in connectors Plug the heated wire H17-EN Connections 10/26... -
Page 11: Connections On The Rear Panel
4.2 Connections on the rear panel Power supply cable USB cable H17-EN Connections 11/26... -
Page 12: Calibration
After a calibration, it is possible to perform a check (which is recommended by ATS-ERS guidelines) in order to verify the quality of the calibration and the accuracy of the measurement. The table below summarises the calibrations which have to be performed on Micro 6000 module. Calibration Min. -
Page 13: Initializing The Calibration Mode
5.3 Initializing the calibration mode On main menu of Expair, select the calibration menu Click on New Check ambient conditions and correct if necessary Define operator’s name H17-EN Calibration 13/26... - Page 14 The ambient conditions are used to calculate BTPS correction factor. It is essential that ambient conditions are measured or encoded correctly for accurate volume measurement: • Temperature: in degrees Celcius • Relative humidity: in % • Barometric pressure: in mmHg Important information on barometric pressure The barometric pressure used by the software is the actual barometric pressure, not barometric pressure corrected at sea level.
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Page 15: Volume Calibration
5.4 Volume calibration 5.4.1 Calibrating the pneumotachograph Calibration process H17-EN Calibration 15/26... - Page 16 Select the Volume tab. Select the device (if there are several modules connected to the same computer). Define the calibration syringe volume (by default, it is set to 3 liters). Click on Calibrate. Wait for the zero measurement (red cross). When the green check mark is displayed, the device is ready to calibrate.
- Page 17 Analysis of the volume calibration results Analysis of the calibration results is essential to ensure an accurate volume measurement by the system. Flow-volume loop During the calibration process, the flow-volume loops are displayed, the volume is on the horizontal axis and the flow is on the vertical axis. There should be no drift on the horizontal axis as shown below.
- Page 18 Verification of the system If one or two traffic lights are yellow or red, the operator has to perform a verification of the system described below. 1. Verify the connection of the tubing to the module (red and blue connectors). 2.
- Page 19 3. Verify the pneumotachograph is assembled correctly and fitted securely to the handle. 4. Verify the correct syringe volume (indicated on a label on the syringe) is the same volume entered into the software. 5. Verify the calibration syringe is not damaged and has no leak. Calibration syringes should ideally be checked and calibrated annually by a calibration laboratory.
- Page 20 Deviation between 5 and 10%. The calibration is acceptable and the system can be used. The deviation could be a sign that device maintenance is necessary. Please contact your Medisoft representative. Deviation greater than 10%. The calibration is not acceptable. A verification of the system by a field service technician is required.
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Page 21: Checking The Pneumotachograph Calibration
5.4.2 Checking the pneumotachograph calibration As the respiratory flow patterns are made up of many different flows, an individual flow error will affect the overall result. The calibration can be verified at multiple flow rates with the use of the Check button. This allows the operator to check different flow rates and to ensure the quality of the volume measurement linearity or that the readings are good over the full operating range of the pneumotachograph. - Page 22 ATS-ERS criteria. The system can be used. Accuracy greater than 3.5%. The linearity of the volume measurement is not good and does not meet ATS-ERS criteria. A verification of the system linearity by a field service technician is required. Please contact your Medisoft representative. H17-EN Calibration...
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Page 23: Maintenance
Maintenance 6.1 Foreword All Medisoft devices are designed to have a lifetime of 10 years minimum, which entails a regular maintenance to be performed by the manufacturer or its representative. The device requires a preventive maintenance once a year, along with a recommended bi-annual control visits in order to validate the calibration. -
Page 24: Maintenance Planning
6.2 Maintenance planning Table below shows the list of actions to be performed for a full preventive maintenance. Each action has to be performed by the user or a technician approved by Medisoft or its representative. The highlighted actions have to be performed by the user by following the procedures described in the next paragraphs. -
Page 25: Maintenance Procedures For The User
6.3 Maintenance procedures for the user 6.3.1 Cleaning See dedicated manual for cleaning and disinfection. 6.3.2 Replacement of the pneumotachograph mesh Remove the pneumotachograph from the handle. Take the pneumotachograph from the lower part and turn counter clockwise the upper part in order to disassemble the pneumotachograph. Carefully remove the mesh. - Page 26 Medisoft S.A. www.medisoft.be P.A.E. de Sorinnes info@medisoft.be 1, Route de la Voie Cuivrée T: +32 (0)82 22 30 20 5503 Dinant – Sorinnes (Belgium) F: +32 (0)82 22 33 34...
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