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Spirobank II

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rev.1.6 

Page 16 of 35 

User manual 

 

 

 

 
 
 

Equipment (technical) Alarms  

- Sensor is unplugged 
- Finger is not inserted 
- Low battery level 
 

Visual Alarm Indicator  

When the alarm is activated through over limitation of physiological alarm, corresponding data area will view in reverse (video) mode. 
When the alarm is activated by more than one physiological alarm condition, each parameter will be displayed in reverse mode. 
If the alarm is triggered by a technical condition, the relevant warning message is displayed, for example: 

 

WARNING  

FINGER is not inserted 

 

Auditory Alarm Indicator  

Audible alarms can be heard in a quiet environment. The medium priority audible alarm has a "du-du-du" tone that repeats every 5 
seconds. The acoustic alarm signal can be temporarily disabled while an alarm condition is in progress. The duration of the paused audio, 
the time interval in which the alarm system or part of the alarm system does not generate an audible alarm signal, is a maximum of 2 

minutes. 
The sound pressure level of the alarm tone is about 55 dB, in complies with the standard. 
 

Other beeps (acoustic signals): 

 

Pulse tone, beeps at frequency depending on Pulse Rate 

 

Sounds the next time the device is turned following an interrupted test due to low battery 

 
 
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. 
 

1.6.4

 

Other features 

 

Memory 

Memory capacity for over 10000 spirometric tests 
The precise number depends on the individual configuration, so it cannot be determined 
more closely

 

keyboard 

membrane keyboard with 6 keys  

Display 

Display LCD  160x80 monochromatic  

Interface 

USB, Bluetooth 

Bluetooth interface 

frequenzy range = 2402-2480 MHz 
rated RF power output = 0.001 W 
frequency tolerance = 20 ppm 
type of antenna = permanently attached 

gain of antenna = 0 max dBi 

Duration of the 3,7V lithium battery 

Approx 500 charge cycles, under normal conditions of use 

Power supply 

Battery pack Li-ion 3.7 V 1100mAh 

Battery charger 

Voltage = 5VDC 
Current = 500 mA or higher 
Connector = micro USB type B 

Dimensions 

160x55.2x25mm;  

Weight 

Central unit 140g (including batteries) 

Type of electrical protection 

Internally powered 

Degree of electrical protection 

BF 

Grade of protection against water ingress 

IPX1 device, protected against water drops 

Safety level in the presence of 
inflammable anaesthetic gas, oxygen or 
nitrogen 

Device not suitable

 

Conditions of use 

Device for continuous use

 

Storage conditions 

Temperature: MIN -20 °C, MAX + 60 °C 
Humidity :MIN 10% RH; MAX 95%RH 
Athmospheric pressure: 50kPa, 106 kPa 

Transport condition 

Temperature: MIN -20 °C, MAX + 60 °C 
Humidity :MIN 10% RH; MAX 95%RH 

Patient Alarm Description 

Factory default 

Adjustment Options 

Increment  

SpO

High Alarm Limit 

99% 

85-99% 

1% 

SpO

Low Alarm Limit 

85% 

85-99% 

1% 

Pulse Rate 

 

High Alarm Limit 

120 bpm 

30-240 bpm  

1 bpm 

Pulse Rate 

 

Low Alarm Limit 

60 bpm 

30-235 bmp  

1 bpm 

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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