MiniSpir
User manual
MINISPIR
Rev 1.9
page 1 of 18
User Manual Rev. 1.9
Issued on:
09.10.2020
Approved on:
Page 1: ...MiniSpir User manual MINISPIR User manual Rev 1 9 page 1 of 18 User Manual Rev 1 9 Issued on 09 10 2020 Approved on 09 10 2020...
Page 2: ...the PC The device can then be used with the winspiroPRO software Keep the original packaging In the event that your device requires attention then always use the original packaging to return it to th...
Page 3: ...n electromagnetic environments 7 1 3 Unforeseen errors 8 1 4 Labels and symbols 8 1 4 1 Identification label 8 1 4 2 ESD Electrostatic discharge sensitivity symbol 9 1 5 Product description 9 1 6 Tech...
Page 4: ...e for ensuring that the device is stored and used in appropriate environmental conditions as specified in paragraph 1 6 3 WARNING If the device is exposed to unsuitable environmental conditions this c...
Page 5: ...ned before each spirometry test and a new disposable mouthpiece must always be used for each subject The use of an anti bacterial filter is at the discretion of the doctor If a disposable turbine is u...
Page 6: ...rect functioning of the device and thus of incorrect test results and create inconvenience to the patient The user is responsible for obtaining the correct type of mouthpieces for the device Those req...
Page 7: ...igurable parameters should only be made by qualified personnel However an incorrect set up of the parameters does not put the patient at risk When connected to other devices to preserve the safety oft...
Page 8: ...nnect to other devices such as PC or printer Use only the USB cable supplied by the manufacturer and observe the safety regulations of IEC 60601 1 1 SpO2 Warning symbol for the SpO2 port for oximetry...
Page 9: ...ope 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 Dischar...
Page 10: ...from healthy subjects MiniSpir is connected to a PC trough a USB port Data measured by MiniSpir are transferred to the PC in real time The Windows winspiroPro software allows to view the spirometric...
Page 11: ...e mL FIVC Forced inspiratory volume L FIV1 Volume inspired in the 1st second of the test L FIV1 FIVC FIV1 FIVC x 100 PIF Peak inspiratory flow L s FIF25 Maximum flow at 25 of FIVC L s FIF50 Maximum fl...
Page 12: ...he analysis period BPM Recording time Total time measure of SpO2 hh mm ss Analysis Time Total time of analysis hh mm ss T90 Time passed with SpO2 90 hh mm ss T89 Time passed with SpO2 89 hh mm ss T88...
Page 13: ...liant with EN 60601 1 2005 A1 2012 Error of displayed numeric value Flow measurement percentage error 5 Oximetry parameters measuring with accuracy defined in table on 1 6 2 Emission limits CISPR 11 G...
Page 14: ...struction or restriction plus one level of normal spirometry as shown in the following table normal mild moderate moderately severe severe very severe Through an analysis applied to some of the indice...
Page 15: ...de by the individual doctor Re usable finger sensor This sensor is recommended for patients weighing 20 Kg with limited activity Carry out an oximetry test as follows Connect the sensor to the instrum...
Page 16: ...line runs across the mid axis of the fingertip Wrap the bottom adhesive around the digit being careful not to cover the nail Fold the sensor s top over the digit making sure the light source is direct...
Page 17: ...he turbine such as threads or hair Any such deposit could brake or block the rotation of the turbine blade and thus compromise the measurement accuracy To clean the reusable turbine remove it from its...
Page 18: ...le turbine included are specifically excluded from the terms of this guarantee This warranty is not valid at the discretion of the manufacturer in the following cases If the fault is due to an imprope...
