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Spirobank II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rev.1.6 

Page 8 of 35 

User manual 

If any of these rules are not followed then MIR will decline all responsibility for any direct or indirect damages, however 
caused. 
To supply power to the device use only the battery type indicated in the § Technical specifications. 

The device may be powered through a PC by a USB cable. By this means, the device works both on line with the PC, or 
individually powered by the PC. 
Keep the device out of reach of children and of any person with mental handicap. 

 

1.2.7

 

Warnings for use in electromagnetic environments 

 

Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.) medical devices may be 
subject to electromagnetic interference caused by other equipment. 

Such electromagnetic interference could cause the medical device to malfunction, such as a lower measurement accuracy 
than stated, and create a potentially dangerous situation. 
Spirobank  II  complies  with  the  EN  60601-1-2:2015  standard  on  electromagnetic  compatibility  (EMC  for  electromedical 
devices) both in terms of immunity and emissions. 

For the correct operation of the device, however, it is necessary not to use Spirobank II near other devices (computers, cordless 
phones, cell phones, etc.) that generate strong magnetic fields. 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. 

Do not use the instrument in the presence of MRI equipment, which can generate an induced current in the sensor to measure 
oximetry, causing injury to the patient. 
 

1.3

 

Lithium-ion battery pack warning 

 
The device is powered by a rechargeable lithium-ion battery pack with a supply voltage of 3.7 V. 
For proper use of the battery pack please read carefully the warning below   
 

 

WARNING

 

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. 
 
Please read the following instructions carefully. 

 
DANGER 
Do not disassemble or modify the battery pack. The battery pack comes with an internal safety sensor; which if tampered 
with may cause acid leakage, overheating, smoke, breakage an explosion and/or fire. 

 
Do not short-circuit the po) and negative (-) poles with any metal objects. 
Do not carry the battery pack in your pocket or in a bag with other metallic objects like necklaces, hairpins, coins or screws. 
Do not store the battery pack near any such objects. 

 
Do not warm-up or throw the battery pack in a fire. 
 
Do not use or store the battery pack near a fire or in a vehicle where the temperature may reach 60°C or higher 

 
Do not immerge the battery pack in water or salt-water, and do not leave it wet. 
Such  events  may  damage  the  internal  battery  safety  sensor,  thus  causing  the  battery  to  be  charged  at  a  higher  voltage, 
triggering abnormal chemical reactions leading to acid leakage, overheating, smoke, an explosion and/or fire 

 
Do not charge the battery pack near a fire or in an extremely hot environment. High temperature may activate the internal 
battery safety sensor thus inhibiting the charge. The high temperature may also damage the internal battery safety sensor 
causing extremely high current surge; and consequently causing abnormal chemical reactions in the battery pack triggering 

acid leakage, overheating, smoke breakage, an explosion and/or fire. 
 
Use only the battery charger who comply with the characteristics defined in point 1.6.3 of this manual to recharge the battery 
pack. Recharging with an unsuitable charger in unconforming conditions may cause the battery pack  to overcharge or the 

charging current to be extremely high thus causing abnormal chemical reactions in the battery pack triggering acid leakage, 
overheating, smoke breakage an explosion and/or fire.  
 
Do not puncture the battery pack with sharp objects such as a nail. 

Do not hammer, step-on, throw or cause a forceful impact to the battery-pack. 

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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