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Spirobank II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rev.1.6 

Page 11 of 35 

User manual 

NOTE

: This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC 

Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment 
generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause 

harmful interference to radio communications. 
However,  there  is  no  guarantee  that  interference  will  not  occur  in  a  particular  installation.  If  this  equipment  does  cause  harmful 
interference to radio or television reception, which can be determined by simply turning the equipment off and on, the user is encouraged 
to try to correct the interference with one or more of the following ways: 

 

 

Reposition the receiving antenna. 

 

Increase separation between the equipment and receiver. 

 

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 

 

Consult the dealer or an experienced radio/TV technician for assistance. 

 

1.4.3

 

(ESD) Electrostatic discharge sensitivity symbol 

 

 

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. 

 

It  is  recommended  that  all  staff  involved  receive  an  explanation  of  the  ESD  warning  symbol  and  training  in  ESD  precautionary 
procedures. 
 
the electrostatic discharge is defined as an electric charge at rest. It is the sudden flow of electricity between two objects caused by 

contact,  an  electrical  short,  or  dielectric  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 increase significantly. Common 
plastics generally will create the greatest static charges.  
Typical electrostatic voltage values: 

 

Walking across a carpet 

1.500 

 35.000 volts

 

Walking over untreated vinyl floor 

250 

 12.000 volts 

Vinyl envelope used for work instructions 

600 

 7.000 volts 

Worker at a bench 

700 

 6.000 volts 

 
If two items are at different electrostatic charge levels, as they approach one another, a spark or Electrostatic Discharge (ESD) can 
occur. This rapid, spontaneous transfer of electrostatic charge can generate heat and melt circuitry in electronic components. 

A latent defect can occur when an ESD sensitive item is exposed to an ESD event and is partially degraded. It may continue to perform 
its intended function, so may not be detected by normal inspection. Intermittent or permanent failures may occur at a later time. 
Static dissipative material will allow the transfer of charge to ground or to other conductive objects. The transfer of charge from a static 
dissipative material will generally take longer than from a conductive material of equivalent size. Some well known insulators are common 

plastics, and glass. An insulator will hold the charge and cannot be grounded and conduct. the charge away. 
Both conductors and insulators may become charged with static electricity and discharge. Grounding is a very effective ESD control 
tool, however, only conductors (conductive or dissipative) can be grounded. 
The fundamental ESD control principles are: 

 

 

Ground all conductors including people 

 

Remove insulators, substitute with ESD protective versions 

 

neutralize with ionizers 

 

ESDS outside the EPA (ESD protected area) to be in packaging having ESD shielding property 

 

1.5

 

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.  

Summary of Contents for Spirobank II

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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