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Spirobank II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rev.1.6 

Page 32 of 35 

User manual 

 

Changing the disposable turbine before each test. 

 

Cleaning of the device 

 

Cleaning the oximetry sensor 

 

Recharging the internal battery pack. 

 

The maintenance operations described in the User’s Manual must be carried out with extreme care. Failing to 

observe the instructions 

may cause errors in measurement or the  misinterpretation of the measured values. 
Modifications, adjustments, repairs, and reconfigurations must be carried out by the manufacturer or by qualified personnel. 
In the unlikely event of a problem do not attempt to repair the unit. 
The  parameter  configuration  setup  must  be  carried  out  by  qualified  personnel.  In  any  case  the  risks  pertaining  to  an  incorrect 

configuration setting in no way endangers the patient.

 

 

4.1

 

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.  
Cleaning of the disposable turbine

 

is not required, as it is supplied clean in a sealed plastic bag. It must be disposed of after use. 

 

 

WARNING 

Periodically check the inside of the turbine to ensure that there are no impurities, corpuscles, or any foreign matter like hairs 
which could inadvertently block or even slow down the mobile equipment in the turbine and as a consequence compromise 
spirometry measurement accuracy. 

 
Before use perform the test described in paragraph 4.1.1 which allows to the check the efficiency of the turbine. If the test result is 
negative perform the following procedure. 
To clean the 

reusable 

turbine remove it from its housing by rotating it counter-clockwise and apply slight pressure with a finger from 

the bottom of the turbine to lift it out of its housing. 
Immerse the turbine in a cold 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 turbine please do not use any alcoholic or oily detergent solutions, and do not 
immerge the turbine in hot water or hot liquids. 
Do not place the turbine under a direct water jet or other liquid. If no detergent solution is available, clean the turbine in clean 
water. Do not use compressed air to clean the turbine. 

 
Rinse the turbine by immerging it in clean water (

not hot

). 

Shake off the excess water from the turbine and let it dry, position the turbine vertically on a dry surface. 
 

Before inserting the reusable turbine in the device it is good practice to visually check that the rotor inside turns freely. Hold the turbine 
horizontally and slowly move it left and right and vice versa. You should be able to see the mobile equipment (blade) rotate  freely. If 
this is not the case then the measurement accuracy can no longer be guaranteed and as such the turbine must be replaced. 
 

Having completed the turbine cleaning procedure, insert the turbine in its housing making sure to turn it clockwise as shown  by the 
symbol of the lock printed on 

Spirobank II.

 

 
The turbine is inserted properly by pushing it all the way in and subsequently rotating it clockwise until it stops; this bayonet mechanism 

ensures that the turbine is blocked inside the plastic casing.  
 
To  be  absolutely  certain  that  the  turbine  is  functioning  properly  perform  the  checklist  in  paragraph  4.1.1;  if  the  turbine  is  still 
malfunctioning please replace it with a new one. 

 

 

WARNING

 

Do not carry out any cleaning procedures when using disposable turbines, a new disposable turbine must be used for every 
new patient. 

 

4.1.1

 

Proper turbine operation check 

 

Turn on 

Spirobank II

  

 

setup the device to perform a spirometry test (for example 

FVC

). 

 

Hold the 

Spirobank II

 with one hand and move it slowly sideways, having the air pass through the turbine. 

 

If the rotor spins properly the device will emit a series of acoustic signals “beeps”

. The beeping frequency is a function of the air 

flow passing through the turbine. 

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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