MIR Spirobank II User Manual
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Summary of Contents for MIR Spirobank II
- Page 1 Spirobank II User manual Spirobank II User manual rev. 1.6 Issue date 20.01.2021 Approval date 20.01.2021 Page 1 of 35 Rev.1.6...
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Page 2: Table Of Contents
1.6.3 Oximetry alarms description ................................15 1.6.4 Other features ....................................16 FUNCTIONING OF THE Spirobank II ................................17 Switch on and switch off the device ..............................17 Energy saving ...................................... 18 Main screen ......................................18 Symbols and Icons ....................................18 Service menu ....................................... - Page 3 MIR accepts no responsibility for any loss or damage caused by the user of the device due to instructions contained in this Manual and/or due to incorrect use of the product.
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Page 4: Introduction
no Intended use The Spirobank II spirometer and pulse oximeter is intended to be used by a physician, by a licensed healthcare professional or by a patient under the instruction of a physician or of a licensed healthcare professional. -
Page 5: Patient Effect On The Use Of The Device
Important safety warnings Spirobank II has been examined by an independent laboratory which has certified the compliance of the device to the European Safety Standards EN 60601-1 and guarantees the EMC Requirements within the limits laid down in the European Standard EN 60601- 1-2. -
Page 6: Turbine
Reusable hard finger sensor (adults) 919020 These sensors, with the exception of the sensor MIR code 919020 which has the MIR connector with orange arrow, require the use of an extension cable for a proper connection to Spirobank II. Two cable lengths are available: •... -
Page 7: Usb Connection Cable
Do not use cables that appear to be or are damaged. If a new cable is required, contact your local distributor. Use only cables supplied by MIR, specifically designed to be used with Spirobank II. The use of other types of cables can lead to inaccurate measurements. -
Page 8: Lithium-Ion Battery Pack Warning
Keep these devices at a minimum distance of 30 centimeters. If it is necessary to use it at shorter distances, Spirobank II and the other devices must be kept under observation to verify that they work normally. - Page 9 Spirobank II User manual A damaged or deformed battery pack may cause internal short-circuits thus creating the possibility for acid leakage, overheating, smoke, breakage and/or fire. Do not use a heavily scratched or deformed battery back as this may be cause for acid leakage, overheating, smoke, breakage and/or fire.
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Page 10: Labels And Symbols
1.4.2 FDA and FCC Warnings Spirobank II complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions: (1) this device must not cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired operation. -
Page 11: Esd) Electrostatic Discharge Sensitivity Symbol
Product description The Spirobank II is a pocket spirometer, with an optional pulse oximetry module. It can operate either in stand-alone mode or it can be connected to a PC or to a printer using any one of several methods: USB, Bluetooth. - Page 12 10.000 spirometry tests or at least 900 hours of oximetry monitoring. Spirobank II is a powerful and compact measurement device, intended for use by a respiratory specialist or by a suitably trained general practitioner. The spirometer calculates up to 30 functional respiratory parameters providing the pharmacodynamic effects, i.e. the data comparison after the administration of a drug (PRE/POST) for a bronchodilator test or for a bronchial challenge test.
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Page 13: Technical Specification
Spirobank II User manual This measurement principle ensures accuracy and reproducibility, without requiring regular calibration. The oximetry sensor can be disinfected with isopropilic alcohol. Technical specification A comprehensive description of the main features of the device, the flow and volume measurement turbine and also of the oximetry sensor follows: 1.6.1... -
Page 14: Oximeter Features
Spirobank II User manual *= best values Parameters for BASIC version: Symbol Description Units *FVC Best FVC *FEV1 Best FEV1 *PEF Best PEF Forced Vital Capacity FEV1 Volume expired in the 1 second of the test FEV1/FVC FEV1/FVC x 100... -
Page 15: Oximetry Alarms Description
Oximetry alarms description Spirobank II is equipped with audio and visual alarm indicators to alert the operator to provide prompt patient attention or to abnormal device conditions. Spirobank II detects both patient and equipment alarms. Both, patient alarms and equipment alarms are identified medium priority as defined in IEC 60601-1-8 standard. -
Page 16: Other Features
Spirobank II User manual Patient Alarm Description Factory default Adjustment Options Increment High Alarm Limit 85-99% Low Alarm Limit 85-99% Pulse Rate High Alarm Limit 120 bpm 30-240 bpm 1 bpm Pulse Rate Low Alarm Limit 60 bpm 30-235 bmp... -
Page 17: Functioning Of The Spirobank Ii
MIR will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist service personnel to repair those part of the device that are designated by MIR as repairable by service personnel. FUNCTIONING OF THE Spirobank II... -
Page 18: Energy Saving
User manual Spirobank II does not switch off completely but goes in stand by status with a very low power consumption. Some functions are ready and the device updates date and hour or to switch on the device using other remote controllers when required. For this the symbol in use is corresponding to the stand by status. -
Page 19: Service Menu
Spirobank II User manual ICON DESCRIPTION Male sex patient selection Female sex patient selection To access all oximetry test options / To perform an SpO2/BPM test To access spirometry testing type to perform a forced vital capacity test FVC/search FVC tests in memory... - Page 20 Spirobank II User manual If the second or the third option are selected, then in the bottom of the screen the device shows the Bluetooth PIN. Select language Select the desired item using the keysand press , the language is now set and the device will return to the Service Menu.
- Page 21 Spirobank II User manual required to access this option;insert the following password starting from left to right: The item “factory defaults” erases the previous calibration values and restores the two percentage corrections to zero percent correction factor; in this case a password is required as explained above.
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Page 22: Reusable Turbine Calibration
Make three manoeuvres with a syringe as described by the screen on the device, then Spirobank II calculates the FVC and FIVC values. Press The screen requires to insert the volume of the syringe in use; Spirobank II so calculates the correction percentage between the reference and the calculated value. -
Page 23: Patient Data
BTPS values are thus calculated. If a 3L syringe is used to make the calibration and if the Spirobank II is calibrated correctly then the FVC (syringe) value will 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS). -
Page 24: Patient Data Modification
Spirobank II User manual opt for “without correction”); Standard ATS/ERS Standard NAHNES III Group % correction Without correction 100% Caucasian Caucasian 100% Mexican-American Oriental 100% Afro-American Hong Kong Chinese 100% Other Giapanese Polinesian North Indian South Indian Pakistani African descendant... -
Page 25: Pc On Line Mode (Connected To A Pc)
• Place the noseclips on the nose so as not to let any air out of the patient’s nostrils. • Hold the Spirobank II with both hands or grasp it like a mobile phone. The display must always face the patient taking the test. -
Page 26: Fvc Test
To end the test press During the test the Spirobank II emits "beeps", the frequency of which are directly proportional to the inspired and expired velocity of the air. This helps the doctor understand when the velocity of the air is approaching zero, and the patient has almost exhausted all of the inspired or expired volume. -
Page 27: Post Test, After Drug Administration
Through the use of a mathematical analysis applied to certain indices and parameters calculated in the FVC test , the Spirobank II is capable of producing a list of quality control comments useful to assess the quality and reproducibility of the manouvers performed. -
Page 28: Oximetry Testing
F= No acceptable FEV1 manoeuvres An acceptable manoeuvre means: good start and satisfactory exhalation (duration and flow) Several comments related to the single test are calculated, however Spirobank II will only point out the most relevant to facilitate the test interpretation. - Page 29 The first few seconds are used to find the best signal possible; after which the Spirobank II timer resets itself and the device starts recording data.
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Page 30: Instructions For Adult Patient Sensor
WARNING The oximetry sensor used in the manual is only one of the different types of sensors which can be used with Spirobank II listed in paragraph 1.2.4. MIR does not recommend any one particular sensor, the decision is left to the doctor who will choose the sensor which she/he believes to be more suitable. -
Page 31: Data Transmission Via Bluetooth
Spirobank II can be connected as a “device” to another product which performs the “master” function. It is possible to connect Spirobank II to a PC or mobile phone and with application the two devices can operate together. The connection uses the SPP protocol (Serial Porto Profile). -
Page 32: Cleaning And Checking The Reusable Turbine
Cleaning and checking the reusable turbine Two types of turbines can be used with Spirobank II. The disposable turbine or the reusable turbine. Both guarantee precise measurements and have the advantage of requiring no periodic calibration. In order to maintain the default characteristics of the reusable turbine a simple cleaning procedure is required before use. -
Page 33: Cleaning Of The Device
The sensor included with the Spirobank II is made with latex free material. Battery charging Turn on Spirobank II and the following icon will appear on the main screen showing the charge level of the battery pack: The maximum charge level is displayed with all 6 bars inside the battery. -
Page 34: Problem Solving
Contact a technical service center inserted in the device The device may have lost its internal software Connect the device to the PC with the Spirobank II does not USB cable and update the internal software; turn on For more detailed information please... -
Page 35: Limited Warranty Conditions
Any device or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found. If units are to be returned to the manufacturer then written or verbal permission must be received before any devices are returned to MIR.
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