Spirobank II User manual Spirobank II Bluetooth low energy User manual rev. 1.1 Rev.1.1 Issue date Approval date 20.11.2014 20.11.
Spirobank II User manual INDEX 1. INTRODUCTION .............................................................................................................................................................................................. 4 1.1 Intended use ............................................................................................................................................................................................ 4 1.1.1 User category ..........................................
Spirobank II User manual Thank you for choosing a MIR product MEDICAL INTERNATIONAL RESEARCH Spirobank II is sold in three different configurations; the following table describes these three configuration and the relevant functions: Spirobank II ® Basic Advanced Advanced Plus Additional parameters POST Bronchodilator test Bluetooth 2.
Spirobank II User manual Copying this manual in whole or in part is strictly forbidden. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN 1. 1.1 INTRODUCTION Intended use The SPIROBANK II spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician.
Spirobank II User manual 1.1.5 Patient effect on the use of the device A spirometry test should only be carried out when the patient is at rest and in good health, in suitable testing conditions. A spirometry test requires the full collaboration of the patient since she/he must perform a complete forced expiration, in order to obtain a reliable test result. 1.1.
Spirobank II User manual 1.2.2 Turbine Disposable turbine WARNING For spirometry testing with a disposable turbine it is important to use a new turbine for each new patient. The accuracy and hygiene of the disposable turbine can only be guaranteed if it has been conserved beforehand in its original sealed packaging. The disposable turbine is made of plastic and its disposal after use should adhere to the local regulations and norms in force.
Spirobank II User manual WARNING Dyes introduced into the bloodstream (for example; to perform a diagnostic tests) such as methylene blue, indocyanine green, indigo carmine, patent blue V (PBV), and fluorescein may adversely affect the accuracy of the oximetry reading. Any condition that restricts blood flow, such as the use of a blood pressure cuff or a device for systemic vascular resistance, may cause the inability to determine accurate pulse rate and SpO2 readings.
Spirobank II User manual Use only battery packs supplied by MIR Improper use of the battery pack may cause acid leakage, overheating, smoke, breakage an explosion and/or fire. Consequently the battery pack may be damaged or suffer a drop in overall performance. The internal battery pack safety sensor could also be damaged as well by any of the above events. Furthermore the user of the device could be harmed and other nearby appliances could be damaged as well.
Spirobank II User manual If the battery pack gives off a bad smell, if it generates heat, if it fades/deformes or if anything abnormal happens during storage, usage and recharging immediately remove the battery pack from the device or the battery charger and do not use it any longer, as any of these events may cause acid leakage, overheating, smoke, breakage and/or fire. NOTE The battery pack includes an internal safety protector.
Spirobank II User manual 1.4.3 Electrical safety symbol In accordance with the IEC 60601-1 Standard, this product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity. 1.4.4 Warning symbol for the USB To connect to other devices such as PC or printer. Use only the USB cable supplied by the manufacturer and observe the safety regulations of IEC 60601-1-1. 1.4.5 Warning symbol for the SpO2 port for oximetry SpO2 1.4.
Spirobank II User manual WARNING Pins of connectors identified with the ESD warning symbol should not be touched and the connections should not be made to these connectors unless ESD precautionary procedures are used. Precautionary procedures are the following: Environmental procedures as: air conditioning, humidification, conductive floor coverings, non-synthetic clothing User procedures as: discharging one’s body to a large metal object, using wrist strap connected to earth.
Spirobank II User manual The device is specifically designed to measure a range of respiratory parameters and to monitor the saturation of oxygen in the blood and the heart beat. A quality control check is carried out internally on the measured parameters and the device has an internal memory sufficient for approximately 10.000 spirometry tests or at least 900 hours of oximetry monitoring.
Spirobank II User manual 1.6.1 Features of the spirometer Measured parameters: Symbol *FVC *FEV1 *PEF FVC FEV1 FEV1/FVC PEF FEF2575 *= best values Description Best FVC Best FEV1 Best PEF Forced Vital Capacity Volume expired in the 1st second of the test FEV1/FVC x 100 Peak expiratory flow Average flow between 25% and 75% of the FVC Flow/volume measurement system Temperature sensor Measurement principle Volume range Flow range Volume accuracy Flow accuracy Dynamic resistance at 12 L/s 1.6.
Spirobank II User manual The specifications for both the oximetry and for the cardiac pulse are the same regardless of which of the above mentioned oximetry sensors is used. 1.6.
Spirobank II User manual The second screen shows the information as in the image beside. He key allows to visualize the service menu; with these voices it is possible to configure the device in the correct way. If any keys are touched, then the device goes to the main screen. To switch off the device push . WARNING SPIROBANK II does not switch off completely but goes in stand by status with a very low power consumption.
Spirobank II User manual ICON 2.5 DESCRIPTION To search a test starting from a specific date onwards..
Spirobank II User manual WARNIG Password Error Press OK to try again If the user fails to enter the correct password three consecutive times the device will automatically turn off. If instead the password was properly inserted the message below will be displayed: WARNIG Please wait erasing memory After approximately 30 seconds the following message will appear: WARNIG Memory deleted Press to return to the service menu.
Spirobank II User manual Alarms setting Access to this function allows to setup the parameters linked to the oximetry First parameter is the alarm intensity: it can be possible to set the type and volume. Use e and to switch from a parameter to the other, then are useful to set the desired value: the select icon is the grey one. Press to change screen. Step following steps allow to set the threshold value for %SpO2 and BPM.
Spirobank II User manual Turbine calibration is performed with a calibration syringe to simulate a FVC test for the expired parameters and a FIVC test for the inspired parameters. To enter the calibration function, select the “Turbine Calibration” option from the Service Menu (as explained in paragraph 2.5). To enter the new calibration values choose the item “Modify calibration” in the submenu, enter the password and insert the new calibration values.
Spirobank II User manual 2.6.1 Inserting data of a new patient Press and insert the patient information in the required sequence. First screen (date of birth, weight, height and sex) Use and to set the correct value; use instead and to switch from one to another parameter. Set the day, month, year of birth, height and weight of the patient.
Spirobank II User manual Database by date of testing: requires the insertion of the date when the test was performed; once all the date information has been inserted press . The data returned by the device are all the test sessions performed during that specific day. Complete database: shows data starting from the most recent session. The end of the database is signalled by a double beep. The database search is resumed from the last session. 2.7.
Spirobank II User manual FVC spirometry testing VC type spirometry test MVV type spirometry test test with broncodilator (POST) Once a test is selected the screen will display information concerning the type of turbine in use including the necessary information to complete the test in the correct manner. To end a test press 2.9.
Spirobank II User manual 2.10 Viewing the spirometric results Following a FVC test, the spirometry test results are shown. The first screen displays a Flow/Volume graph of the Forced Vital Capacity pressing it is be possible visualize the best value of FVC, FEV1, FEV1% and PEF with the percentage change compared to the predicted values. By scrolling with 2.10.1 and it is possible to view all the parameters next to the chosen predicted values.
Spirobank II User manual Between tests, the SPIROBANK II checks the repeatability of the following parameters: If FVC is > 1.0 L then: FEV1 repeatable when the difference between the two largest FEV1 is ≤ 150 mL; FVC repeatable when the difference between the two largest FVC is ≤ 150 mL; if FVC is ≤ 1.0 L then: FEV1 repeatable when the difference between the two largest FEV1 is ≤ 100 mL; FVC repeatable when the difference between the two largest FVC is ≤ 100 mL; 2.
Spirobank II User manual Low battery level Press the key to exit the test, otherwise after a seconds will start the test. In the event that a test is interrupted due to a complete battery discharge, the next time the device is turned on the following message is displayed: WARNING Wrong interruption of last oximetry test At the same time an intermittent beep is emitted for 4 seconds. Subsequently the SPIROBANK II returns to the main screen.
Spirobank II User manual To end an oximetry test press 2.11.5 key. Instructions for Adult Single 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.
Spirobank II User manual functioning of the sensor according to the previous instructions. WARNING Do not twist the cable or use excessive force when using, connecting, disconnecting, or storing the sensor. Avoid over tightening the adhesive tape; a sensor wrapped too tightly can produce inaccurate saturation measurements. To reduce chances of entanglement it is recommended to fasten the cable to the wrist with a bandage. 3.
Spirobank II User manual The sensor included with the SPIROBANK II is made with latex free material. 4.2 Changing the adhesive wrap sensor The disposable adhesive tape is made with latex-free material. Gently remove the used adhesive tape from the sensor and dispose of it. The back of the sensor has alignment pins. Place the sensor with the alignment pins facing the adhesive part of the tape and align the pins to the holes on the tape.
Spirobank II User manual PROBLEM Spirometry test results are unreliable Certain spirometry and/or oximetry parameters are not shown at the end of a test. During an oximetry test values are returned at irregular intervals, intermittent or simply wrong. During oximetry testing the screen is barely readable Problem during battery pack recharging Unforseeable error of the memory The device has frozen due to an unforseeable event MESSAGE \ \ \ \ \ \ Damaged battery pack Error in memory \ POSSIBLE CAUSES REME
Spirobank II User manual Via del Maggiolino 125, 00155 Roma - ITALY DECLARATION OF CONFORMITY CE (annex II excluding par.4) We hereby declare that the following device: Type Brandname Device name Class Spirometer/Oximeter MIR Medical International Research spirobank II IIa Complies with the Essential Requirements of directive 93/42/EC concerning Medical Devices, and its amendments, and its transposition in the Member States. This statement is made on the basis of the CE Certificate n.
Spirobank II User manual LIMITED WARRANTY CONDITIONS SPIROBANK II, together with its standard accessories is guaranteed for a period of: 12 months if intended for professional use (doctors, hospitals, etc.) 24 months if the product has been purchased directly by the end user. The warranty is effective from the date of purchase shown on the relevant sales invoice or proof of purchase. The warranty is effective from date of sale which must be shown on the relevant sales invoice or proof of purchase.
Spirobank II User manual ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer’s declaration – electromagnetic emissions The SPIROBANK II is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIROBANK II should assure that it is used in such an environment.
Spirobank II User manual Guidance and manufacturer’s declaration – electromagnetic immunity The SPIROBANK II is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIROBANK II should assure that it is used in such an environment.
Spirobank II User manual For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
