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Spirobank II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rev.1.6 

Page 12 of 35 

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 

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. A comparison 
of data is made between POST (after-drug) and PRE (before drug administration). 
 
The flow and volume measurement sensor is a digital turbine, based on the infrared interruption principle. This transducer ensures the 

accuracy and the reproducibility of the measurements, without requiring periodic calibration.  
The sensor features are listed below: 
 

 

Accurate measurement even at very low flow rates (end of expiration) 

 

Not affected by relative humidity and air density  

 

Shockproof and unbreakable 

 

Inexpensive to replace. 

 

The turbine flow measurement sensor is available both in reusable and in single-patient disposable versions. 
 

 

 

REUSABLE TURBINE 

DISPOSABLE TURBINE 

 
The following precautions must be observed to ensure that the characteristics of the turbine remain unaltered over time: 
 

 

for the disposable turbine: must always be substituted from one patient to the other. 

 

for the reusable turbine: always disinfect the turbine for testing from one patient to the next, to ensure the maximum level of hygiene 
and safety. 

 
For a correct interpretation of a spirometry test, the measured values must be compared either to the so-called 

normal or predicted 

values

 which are calculated from the anthropometric details of the patient or, alternatively, to the 

personal best values

 from the clinical 

history of the subject. 

The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects.

 

 

Spirobank II

 can also be connected to a PC (or to another computerised system) to configure the instrument. All spirometry test data  

including the related patient details stored inside the device can be transferred from the device to the PC and then viewed on the PC 
(Flow/volume curves, spirometry parameters, plus optional oximetry parameters). 
The connection to the winspiroPRO can be made via USB connection. 

 

Spirobank II

 can perform FVC, VC & IVC, MVV and breathing profile tests, and calculates an index of test acceptability (quality 

control) plus the reproducibility of the spirometry tests carried out. The automatic test interpretation follows the latest 11 level ATS 
(American Thoracic Society) classification. Each test can be repeated as required. The best parameters are always available for review. 

The normal (predicted) values can be selected fr

om several normal “sets”. For example, within the European Union the majority of 

doctors use the ERS (European Respiratory Society) predicted values. 
 
Oximetry function (on request) 

The oximetry sensor has two light emitting diodes  (LEDs), one emits in the visible spectre and one infrared. Both lights then pass 

through the finger and are “read” by the receiver. As these lights pass through the finger, a proportion of the light is abso

rbed by the 

blood and by the soft tissue, in function of the concentration of heamoglobin. The quantity of light absorbed, at each frequency, depends 
on the degree of oxygenation of the haemoglobin inside the soft tissue.  

Содержание Spirobank II

Страница 1: ...Spirobank II Rev 1 6 Page 1 of 35 User manual Spirobank II User manual rev 1 6 Issue date 20 01 2021 Approval date 20 01 2021...

Страница 2: ...HE Spirobank II 17 2 1 Switch on and switch off the device 17 2 2 Energy saving 18 2 3 Main screen 18 2 4 Symbols and Icons 18 2 5 Service menu 19 2 5 1 Reusable turbine calibration 22 2 6 Patient Dat...

Страница 3: ...al packaging In the unlikely event that you have a problem with your device please use the original packaging and return it to the distributor or manufacturer Should this be the case please follow the...

Страница 4: ...he patient by the doctor WARNING The manufacturer cannot be held responsible for any damage caused by the user of the device failing to follow instructions and warnings in this manual If the user of t...

Страница 5: ...Spirobank II is continuously checked during manufacturing and therefore the product complies with the established security levels and quality standards laid down by the Council Directive 93 42 EEC for...

Страница 6: ...spirometer are only to be used as a reference guide to purchase the correct size mouthpiece required These mouthpieces are clean but not sterile To purchase appropriate mouthpieces generally either pa...

Страница 7: ...vent safety hazards for the user 1 2 5 USB connection cable Incorrect use or application of the USB cable may produce inaccurate measurements wich will show very inaccurate values of the patient s con...

Страница 8: ...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 har...

Страница 9: ...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 protec...

Страница 10: ...ed against vertically falling drops of water Antenna symbol for devices that include RF transmitters FCC ID FCC Identification code indicating traceability to FCC compliance Rx ONLY Reference to US FD...

Страница 11: ...ielectric breakdown ESD can be caused by a buildup of static electricity by tribocharging or by electrostatic induction At lower relative humidity as the environment is drier charge generation will in...

Страница 12: ...nt to the next to ensure the maximum level of hygiene and safety For a correct interpretation of a spirometry test the measured values must be compared either to the so called normal or predicted valu...

Страница 13: ...y Flow at 75 of FVC L s FEV05 Volume expired after 0 5 seconds L FEV05 FEV05 FVC x 100 FEV075 Volume expired after 0 75 seconds L FEV075 FEV075 FVC x 100 FEV2 Volume expired in the first 2 seconds of...

Страница 14: ...usable soft sensor for adults Reusable paediatric soft sensor Range SpO2 Arms Range SpO2 Arms Range SpO2 Arms 70 100 1 19 70 100 1 470 70 100 1 390 70 80 0 554 70 80 1 626 70 80 1 851 80 90 1 32 80 90...

Страница 15: ...octor 1 6 3 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 Spiro...

Страница 16: ...h of the above mentioned oximetry sensors is used 1 6 4 Other features Memory Memory capacity for over 10000 spirometric tests The precise number depends on the individual configuration so it cannot b...

Страница 17: ...discharge protection 8kV contact 15kV air Magnetic field immunity 30 A m Radio Frequency Immunity 3V m 80 2700 MHz MIR will make available on request circuit diagrams component part lists description...

Страница 18: ...displayed with a reduction of the indicators 2 3 Main screen On the main screen the following areas can be accessed patient data management area spirometry area oximetry area archive area archive are...

Страница 19: ...e key and then the key The service menu shows the following list of items Change date time LCD settings Bluetooth settings Select language Delete memory Select standard Select predicted Select turbine...

Страница 20: ...standard to be used ATS ERS or NHANES III with the keys and then press the setting takes effect and the device returns to the Service Menu WARNING If the NHANES III standard is selected it is not pos...

Страница 21: ...hreshold or rise above the maximum threshold of the SpO2 and BPM values previously set Use keys and to decrease increase the values and select moving the arrow with the keys and At the end press to re...

Страница 22: ...g of the turbine is necessary The disposable turbine is check before the application of the external packaging for this reason it doesn t requires a periodic calibration If a calibration must be perfo...

Страница 23: ...robank II is calibrated correctly then the FVC syringe value will be 3 00 FVC x 1 026 BTPS 3 08 L FVC at BTPS If the ambient temperature is 20 C the FIVC syringe value will be 3 00 FIVC x 1 102 BTPS 3...

Страница 24: ...en without modifying any data WARNING A new patient is not created from the previous patient when selecting this function Patient info however can be modified Future tests will be associated to the pa...

Страница 25: ...efault settings of the PC software will be transferred to the device and will remain in the device even when used in stand alone mode for example when the Spirobank II is connected to the PC and the u...

Страница 26: ...results of the best 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...

Страница 27: ...rst 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 v...

Страница 28: ...argest FVC is 100 mL 2 11 Oximetry Testing WARNING Check if the oximetry function is available in the device this function is an option in some models This is not available in BASIC version WARNING Th...

Страница 29: ...the Spirobank II timer resets itself and the device starts recording data For any type of oximetry test if the sensor is not properly connected the following message will be displayed on screen after...

Страница 30: ...ct to biocompatibility tests Choose an application site on the patient s finger or toe where the light source will be directly over and in line with the detector The preferred sites are the forefinger...

Страница 31: ...manage Spirobank II The user can perform on line wireless tests of spirometry or oximetry and the tests will be directly stored in the database of winspiroPRO software 3 2 PC connection via USB port W...

Страница 32: ...liquid solution and shake it so as to remove any impurities Leave the turbine immersed for the time specified in the instruction of the solution WARNING To avoid irreparable damage to the reusable tur...

Страница 33: ...an the sensor WARNING Do not sterilize by irradiation steam or by using ethylene oxide Unplug the sensor from the device before cleaning or disinfecting it The sensor included with the Spirobank II is...

Страница 34: ...t was not performed correctly Repeat the test and follow closely the indications shown on the screen Certain spirometry and or oximetry parameters are not shown at the end of a test Personalized param...

Страница 35: ...n If the product is utilised differently from the use described in the User s Manual If any alteration adjustment modification or repair has been carried out by personnel not authorised by the manufac...

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