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Available with disposable turbines or re-usable turbine Power supply Spirolab main unit Complete with: • Spirolab main unit • MiniFlowmeter sensor Re-usable turbine • Re-usable turbine or (Optional) disposable turbines • Power supply unit • Mouthpiece • Single use nose clip •...
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Contents Product Description Overview Getting Started Calibration Check Customise View Results Patients Perform Test Maintenance Technical Specification Troubleshooting Appendix: Information about the correct use of device in an electromagnetic environment...
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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.
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2,000 spirometric tests or a maximum of 900 hours of oximetry data. Spirolab is intended for use by medical specialists and it provides them with a powerful but compact tool that can process approximately 30 functional parameters. The device also provides a pharmacodynamic response, i.e.
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• Accurate readings even with low air flow rates (end of exhalation) • Not affected by humidity and gas density • Inexpensive to replace The turbine volume and flow sensor is available in disposable and reusable versions. MIR Spirolab (UK version) | User Manual...
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Overview The Spirolab uses a high resolution touch screen with individual icons to represent each function available. When the Spirolab device is turned on, the battery icon located in the top right-hand corner of the screen shows the charge remaining.
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Spirolab is charging. The LED indicator will illuminate green once charging is complete. The Spirolab can be used on mains power supply whilst the battery is being charged providing that the battery has sufficient charge for it to operate. The battery will continue to charge even when in use.
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Calibration Check The Spirolab can be verified as per local guidelines using a single flow or calibrated using a multi flow. Tap the “Cal. Check” icon from the home screen. Tap the “Syringe Verification” icon to enter the verification screen.
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If the volume is within 3.5% of the syringe volume then the calibration is unchanged. If the volume is over 3.5% of the syringe volume then the Spirolab is recalibrated to these new values. MIR Spirolab (UK version) | User Manual...
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Customise The Spirolab can be fully configured to the users own specification. Tap the “Customise” icon from the home screen. Enter the password (1223) to access the settings menu which is divided into the following sections. Each section has sub-sections which allow the user to navigate easily through the options.
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Parameter selection, test type, test beep, print curves, interpretation, units of measurement, incentive Oximetry Min/Max SpO2, Min/Max BPM Reference Predicted value selection Database Management Memory used, format database INFORMATION The default password is 1223 MIR Spirolab (UK version) | User Manual...
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Tap on the desired patient and tap “Select” and you will see all of the patient details as well as their previous results. By highlighting the desired result the option to view results, perform a test or perform a POST test becomes available. MIR Spirolab (UK version) | User Manual...
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When the patient details are complete you have the option to either save them for use at a later date/time or tap “Perform test” to continue to the test screen. MIR Spirolab (UK version) | User Manual...
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You will then have the options displayed below: Note: Oximetry is available as an optional add-on. Button will display if installed. MIR Spirolab (UK version) | User Manual...
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At the end of the test the results screen will be shown. The best result will be shown with % predicted as well as the graph. Options to add notes, print results, finish test or perform a forced VC test will be available. MIR Spirolab (UK version) | User Manual...
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The best results of the active indices will be shown with % predicted. Interpretation is shown and is based on the ATS/ERS guidelines. Options to add notes, print results, finish test or perform a post test will be available. MIR Spirolab (UK version) | User Manual...
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At the end of the test the results screen will be shown displaying the PRE and POST best indices for comparison. Options to add notes, print results, finish test or perform an additional POST test will be available. Oximetry The Spirolab allows the user to perform oximetry (optional extra). MIR Spirolab (UK version) | User Manual...
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Performing an oximeter test Select a patient and from the perform test screen tap the “Oximetry” icon in the bottom right hand corner. The oximetry test screen will appear. MIR Spirolab (UK version) | User Manual...
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During the test if the %SpO2 or HR rate goes above or below the threshold as set in the customise menu then the Spirolab emits a beep (if set to do so in the customise menu) for as long as this anomaly continues.
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To tear off the through the roller. You excess paper pull towards will have the option to you and to the right or manually adjust the roll as left as shown required. MIR Spirolab (UK version) | User Manual...
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Maintainance WARNING It is recommended that only MIR thermal printer paper is used with the Spirolab to avoid damage to the printer head. Please contact Intermedical (UK) Ltd to re-order on 01732 522444 Cleaning the turbine To clean a reusable turbine, remove it from its housing in the MiniFlowmeter by turning it anti-clockwise and pulling gently.
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Maintainance Servicing The Spirolab does not require any routine servicing as standard. If the Spirolab is damaged or requires servicing please contact Intermedical (UK) Ltd on 01732 522444. Consumables/Supporting Products PART NUMBER DESCRIPTION MR-911082E1 MIR Intermedical Spirolab Spirometer with re-usable turbine...
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BF and therefore offer protection against electrical shocks. USB port warning label For connecting the device to a PC. Only use cables supplied by the manufacturer and observe the IEC 60601-1 safety standards. MIR Spirolab (UK version) | User Manual...
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Technical Specification 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.
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Where applied, the symbol refers the user to this manual for the persistent damage can occur even after a long time. correct use of the device. With ESD materials, charges go to ground or to another conductive object that the material contacts. MIR Spirolab (UK version) | User Manual...
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Electro Magnetic Compatibility IEC 60601-1-2 Key performance Accuracy in measuring spirometry parameters in accordance with the ATS standard (in accordance with EN 60601-1: 2007) Measurement of oximetry parameters with accuracy as defined in oximetry specifications MIR Spirolab (UK version) | User Manual...
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Technical Specification IMPORTANT SAFETY WARNINGS Spirolab devices have been examined by an independent laboratory that has certified their conformity with EN60601-1 safety standards and guaranteed that their electromagnetic compatibility is within the limits laid out in EN 60601-1-2. Spirolab devices are subject to continuous checks during production and therefore comply with the safety and quality standards laid down in Council Directive 93/42/EEC for Medical Devices.
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FEV2/FVC x 100 Maximum voluntary ventilation L/min FEV3 Volume exhaled in the first 3 seconds of the test FEV3/FVC FEV3/FVC x 100 FEV6 Volume exhaled in the first 6 seconds of the test MIR Spirolab (UK version) | User Manual...
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18 – 300 BPM Resolution of pulse rate 1 BPM Pulse rate accuracy 2 BPM or 2% of highest value Interval for calculating median pulse 8 seconds rate Signal quality 0 - 8 display segments MIR Spirolab (UK version) | User Manual...
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Time with SpO2 less than 89% %-hh:mm:ss Time with SpO2 less than 5% of the mean value %-hh:mm:ss T<40BPM Time passed with Pulse rate <40 BPM %-hh:mm:ss T>120BPM Time passed with Pulse rate <120 BPM %-hh:mm:ss MIR Spirolab (UK version) | User Manual...
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The brightness level of the display automatically dims 5 The display is not very bright No message minutes after a test starts. This None during tests function extends battery life. MIR Spirolab (UK version) | User Manual...
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Press the on button 3 times; wait The device will freeze when No message a few seconds and the device will unforeseen events occur reset then turn itself on. MIR Spirolab (UK version) | User Manual...
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Information about the correct use of device in an electromagnetic 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 SPIROLAB uses RF energy for internal functions only.
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Information about the correct use of device in an electromagnetic environment Manufacturer’s recommendations and declarations - electromagnetic immunity 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. Test level Level of...
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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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Recommended separation distance between mobile radio-communication appliances and devices Spirolab devices are designed to work in electromagnetic environments in which radiated RF disturbances are controlled. The device customer or end user can contribute towards preventing electromagnetic interference by providing a minimum distance between mobile RF communication devices (transmitters) and the unit as recommended below in relation to the maximum power output of the radio-communication devices.
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MIR Spirolab (UK version) | User Manual...
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Please can you tell us how to set up our spirolab so that it shows the Z-scores on the results
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