Summary of Contents for Medical International Research Spirolab
- Page 1 Spirolab User manual User manual Rev. 1.4 Date issued 19.08.2015 Date approved 19.08.2015 Rev.1.4 Page 1 of 36...
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Page 2: Table Of Contents
1.5.2 Oximeter specifications ............................................12 1.5.3 Other features ................................................13 USING THE SPIROLAB ..............................................13 Turning the spirolab on and off ..........................................13 Saving energy ................................................14 Main screen ................................................14 Symbols and icons ..............................................15 Service menu ................................................15 2.5.1... - Page 3 The nose clip, mouthpiece and turbine with mouthpiece that come supplied with the device are to be treated as single-use disposable items. The accessories supplied are ticked on the cover of the "New spirolab device equipment", supplied with the device. Before using your spirolab…...
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Page 4: Introduction
If a spirolab user is a person who is incapable of looking after him or herself, the device must be used under the supervision and responsibility of the person who is legally in charge of that person. -
Page 5: Important Safety Warnings
The product must not be used if malfunctions or faults are detected or suspected as these may compromise results. WARNING When the spirolab device is used as an oximeter, it has a limited alarm system and for this reason the SpO2 and pulse rate shown on the display need to be checked frequently. -
Page 6: Mouthpiece
Reusable finger sensor for adults (Comfort Clip) 3044 Reusable finger sensor for adults These sensors require the use of an extension cable for connection with the spirolab device. Two lengths of extension cable are available: item code 919200 length 1.5 m Prolonged use of a sensor or the patient's condition may mean that the location of the sensor has to be changed periodically. -
Page 7: The Unit
The spirolab device should not be used close to or stacked with other equipment; if it must be used close to or stacked with other equipment, spirolab should be observed to verify normal operation in the configuration in which it will be used. -
Page 8: Ce Mark For Medical Devices
1.3.8 FCC certification label Spirolab complies with section 15 of the FCC standards. Operation of the device is subject to the following conditions: (1) This device must not cause harmful interference (2) This device can be subjected to all types of interference, including those which may cause undesired effects Any modifications made without the express approval of this company may compromise the use of the device by the user. -
Page 9: Electrostatic Discharge Symbol
Spirolab User manual Contact the supplier or radio/TV technician for expert advice. The symbols defined may be found on the device ID label. 1.3.9 Electrostatic discharge symbol This symbol, required by the EN 60601-1-2 International Standard, is used near every connector that has been excluded from the electrostatic discharge test. -
Page 10: Symbol For Reading The Operating Instructions
Spirolab is intended for use by medical specialists and it provides them with a powerful but compact tool that can process about 30 functional parameters. The device also provides a pharmacodynamic response, i.e. the % comparison of spirometric data measured before and after (PRE/POST) administration of a drug for bronchial provocation or bronchodilation. -
Page 11: Technical Specifications
User manual Spirolab performs FVC, VC & IVC and MVV tests and the ventilatory profile, as well as an acceptability (quality control) and reproducibility index of the spirometry test carried out by the patient. The automatic interpretation function uses 11 levels as per ATS (American Thoracic Society) classification. -
Page 12: Oximeter Specifications
Spirolab User manual Symbol Description U.m. Tidal Volume Minute ventilation at rest L/min Respiratory frequency Breaths/min Average inspiratory time at rest Average exhalation time at rest TV/tI Mean inspiratory flow at rest L/min tI/tTOT tI/(tI+tE) Maximum voluntary ventilation L/min Estimated Lung Age... -
Page 13: Other Features
Measurement of oximetry parameters with accuracy as defined in the table on page 13 USING THE SPIROLAB Turning the spirolab on and off To turn the spirolab on, press then release the button on the front of the unit. Rev.1.4... -
Page 14: Saving Energy
WARNING Spirolab does not turn off completely but enters an ultra-low standby mode; some features remain active to allow the device to keep the date and time updated and to be activated remotely if required. For this reason, the power key's symbol is corresponding to the standby mode. -
Page 15: Symbols And Icons
Spirolab User manual Symbols and icons The following table shows the icons displayed on the various screens and what they mean ICON DESCRIPTION To access initial settings (service menu) To enter new patient data To edit patient data/To rerun an archived patient test... - Page 16 Spirolab User manual Select the desired settings by tapping the white box; the selection is highlighted by an orange box. For the brightness of the display, move the orange cursor vertically until the desired brightness. To set the correct date and time, tap the box to bring up the cursor;...
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Page 17: Calibrating Turbines
Spirolab User manual In the "Incentive" section, you can configure the paediatric incentive to improve spirometric performance. The incentive may be enabled or disabled; should it be enabled, by selecting "ON" on the left, you must enter the age threshold up to which the incentive is displayed;... - Page 18 BTPS factor to be calculated. If a 3-litre syringe is used for the test and if the spirolab device is perfectly calibrated, the FVC (syringe) value measured will 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
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Page 19: Patient Data
Spirolab User manual FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20 °C, the correction coefficient will be: EXPIRATORY .00% INSPIRATORY .00% To repeat, this is NOT an error but the logical consequence of what was explained above. -
Page 20: Editing Patient Data
Spirolab User manual In the case of NHANES III standards: depending on the ethnic group set, different predicted formulae are taken into account (in accordance with the reference standard). Once the desired ethnic group has been selected, the device completes defining the patient parameters and returns automatically to the main screen. -
Page 21: Displaying The Last Test Session
This function acts like an actual laboratory-based real time spirometer connected to a PC. Connection to the PC can be performed by USB or by a wireless Bluetooth connection. Spirolab becomes an intelligent sensor for measuring volume and flow rate while the PC controls the functions, including turning on and off. -
Page 22: Performing A Spirometry Test
When the device is connected to a PC, it cannot be remotely operated. The settings on the PC are transferred to the device and remain active any other time you use the device remotely. For example, if you use spirolab connected to the PC and you set a particular turbine (disposable or reusable), this will remain the default turbine any other time you use the device remotely. -
Page 23: Vc Test
Remember that for accurate spirometry results, it is essential that all the air is expelled from the lungs. The test can be repeated as often as required without the mouthpiece having to be removed from the mouth. In this case, the spirolab will automatically recognise the longer cycle (longer FVC+FEV1) and present the relative readings. -
Page 24: Displaying And Reading Spirometry Results
Thanks to a mathematical analysis known as quality control that is applied to some indices and parameters calculated in FVC tests, the spirolab device can produce different comments that help to understand the reliability of tests carried out. The quality control system uses letters as described below:... -
Page 25: Performing Oximetry
MIR does not recommend any particular sensor; the decision is left to the doctor's discretion. During oximetry tests, the spirolab device cannot be turned off. To turn it off, you have to interrupt an on-going test. This system prevents unwanted interruptions that might compromise the reliability of data. - Page 26 Alarms can be set for oximetry tests as explained in section 2.5. If during a test, the %SpO2 or BPM rate goes above or below its threshold, the spirolab emits a beep (if set to do so in the service menu) for as long as this anomaly continues.
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Page 27: Instructions For Using The Sensor On Individual Adult Patients
The description of the following sensor serves solely as an example. Any of the sensors described in §1.2.4 can be used with the spirolab device MIR do not recommend any particular sensor; that decision is left to the doctor's discretion. -
Page 28: Data Transmission Via Bluetooth
User manual Data transmission via Bluetooth Spirolab can be connected as a "device" to any other "mater" device. Therefore, you can connect spirolab to a PC or a mobile phone and control it using special applications. The connection uses the SPP (Serial Port Profile) protocol. -
Page 29: Printing Data
Cleaning and checking reusable turbines The volume and flow turbine sensors usable with spirolab are of two types: disposable and reusable. These guarantee great accuracy and have the added benefit of not needing to be periodically calibrated. A simple clean before every use will ensure that the turbine keeps working as it should (only for reusable turbines). -
Page 30: Checking Correct Turbine Function
To charge the battery pack, only use the charger supplied by the manufacturer. When the spirolab device is turned on, an icon shows the condition of the battery in the top right hand corner: The maximum charge level is reached when the symbol is completely green. -
Page 31: Trouble Shooting And Solutions
Battery pack may be flat Charge the device using the charger unit The device may have lost Connect the device to a PC via USB and up-date spirolab doesn't turn on internal software the software; for further information, consult the online winspiroPRO User Manual... - Page 32 Spirolab User manual WARNING Before contacting the service centre, if possible, download the device archive to the PC using the winspiroPRO program. This is necessary as the data may be lost during repair activities and also to protect the patient's privacy, as neither the manufacturer nor authorised personnel are allowed to see such data.
- Page 33 (appendix II excluding para. 4) We declare that the following device: Type Spirometer/Oximeter Make MIR Medical International Research Name of Device spirolab Class conforms to the Essential Requirements of Directive 93/42 concerning Medical Devices, and its amendments, and its transposition in the Member States.
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Page 34: Guarantee Conditions
MIR Medical International Research reserves the right to replace the product or make any changes to it that the company deems necessary. -
Page 35: Appendix 3 Information About The Correct Use Of Device In An Electromagnetic Environment
ENVIRONMENT Manufacturer's recommendations and declarations - electromagnetic emissions The SPIROLAB device can be used in the following electromagnetic environments. The SPIROLAB customer or end user must ensure that the device is used in such an environment. Emission test Conformity Electromagnetic environment - guide... - Page 36 RF transmitter, you need to perform an electromagnetic scan of the site. If the intensity of the field where the SPIROLAB is used exceeds the applicable conformity level mentioned above, you will need to observe how the SPIROLAB works under normal conditions.
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