MedChip Solutions SpiroConnect, Operator'S Manual

Page 1: ...onnect Spirometer Operators Manual Issue 1 12 Note This issue of the Operators Manual Issue 1 12 is applicable to SDM 1 12 when used with FW 3 02 July 2022 Copyright MedChip Solutions Ltd All Rights R...

Page 2: ...Results 17 8 6 General information pertaining to the reviewing of examinations 18 8 7 Calibration 19 8 8 Settings 20 8 9 Menu Bar options 20 8 10 Patient Database 20 8 11 Android application 21 8 12...

Page 3: ...o avoid damage the following precautions should be taken Clean or sterilise the turbine in accordance with the instructions See section 11 Do not immerse the turbine in sterilising solution for more t...

Page 4: ...he ARTP document Risk minimisation in spirometry re start by Martin Allen3 Which includes PCRS Spirometry in Primary Care Guidance on reinstating spirometry in England ARTP Statement for the NHS NATIO...

Page 5: ...lete with 2 Alkaline AA LR6 batteries quick start guide calibration certificate and the following items 1 SpiroConnect spirometer 2 SpiroConnect Data Manager software on USB flash drive memory stick M...

Page 6: ...ld not be disposed of as unsorted waste Please utilise your local WEEE collection facilities for the disposal of this product WARNING No modification of this equipment is allowed CAUTION Read the manu...

Page 7: ...r suspected transmissible respiratory or systemic infection including tuberculosis Physical conditions predisposing to transmission of infections such as hemoptysis significant secretions or oral lesi...

Page 8: ...at user however the database can be shared between users if it is configured to be in an accessible area for all users Run SpiroConnectDataManagerSetup_v1 XX exe There is no need to run any of the oth...

Page 9: ...ove From this screen a forced spirometry test or relaxed vital capacity test may be selected 8 2 Unit Connection Before Start is clicked to initiate a test the unit needs to be powered on and connecte...

Page 10: ...beep to indicate that it is ready At this point the operator can select a tab for a single graph or the Incentive tab if he wishes to view the FV graph VT graph or Child Incentive graphic as an altern...

Page 11: ...the exam the VC result for the Relaxed test will be displayed within the Forced Spirometry results directly underneath FVC for convenience sake Note The values used for the interpretation are always t...

Page 12: ...full Low Volume FVC less than max previous FVC Take the deepest breath possible and keep going until completely empty Incomplete Insp before Exp FIVC after FVC FVC Fill your lungs completely before b...

Page 13: ...ust be within 150mL 100mL if FVC 1L of each other The two largest FEV1 values must be within 150mL 100mL if FVC 1L of each other The two largest VC values must be within 150mL of each other ATS ERS 20...

Page 14: ...n the best values was The operator should always aim to get the highest exam grade possible The grading system goes as follows from best to worst A B C D E U F The Exam Grade is displayed on screen in...

Page 15: ...ulations are performed with reference to Tzero which is determined by locating the steepest rising point on the volume time graph which is the point of peak flow and back extrapolating a line drawn th...

Page 16: ...mouthpiece and exhale at a comfortable rate until they have completely emptied their lungs The expiratory volume time curve will be displayed For Inspiratory Vital capacity instruct the patient to ful...

Page 17: ...uent post BD tests can be added using the buttons on the bottom right of the screen When performing Relaxed Spirometry Variability is shown on screen for VC 8 5 Review Results From the main window cli...

Page 18: ...nt buttons on the lower button bar 8 6 General information pertaining to the reviewing of examinations Please note that when reviewing an existing exam the patient details used for determination of no...

Page 19: ...ow rate cycle has been performed click Done and the calibration check results dialog will be shown possible outcomes of the Calibration Check are PASS No change to the stored calibration is required P...

Page 20: ...on this PC Help About displays the version number of the PC software Check for Updates if the PC is connected to the Internet will check for a later version of software Check for Firmware Update will...

Page 21: ...tails 8 12 ArtiQ AI Functionality ArtiQ provides artificial intelligence based report generation for quality control of an examination as well as a report that presents their interpretation of a lung...

Page 22: ...oaded once and saved alongside the examination in the database so that they can be automatically displayed the next time the exam is reviewed without requiring a connection to the internet 9 Battery M...

Page 23: ...or servicing To clean or disinfect the transducer it may be removed by means of the following procedure 1 Remove the transducer by rotating the mouthpiece holder assembly anti clockwise by 90o and gen...

Page 24: ...age is suitable for your specific requirements or usage The warranty does not extend to any damage or corruption to the supplied media or documentation subsequent to your receipt of the product howeve...

Page 25: ...se 16 Trouble Shooting Information Should you encounter problems operating the SpiroConnect consult the table below Problem Possible cause Solution 1 Unit does not turn on Batteries flat Replace batte...

Page 26: ...or to application of the test level Guidance and manufacturer s declaration electromagnetic immunity The SpiroConnect is intended for use in the electromagnetic environment specified below The custome...

Page 27: ...om structures objects and people Changes or modifications to the SpiroConnect that are not expressly approved by MedChip Solutions can cause EMC issues with this or other equipment The SpiroConnect is...

Page 28: ...onsult the instructions for use Caution consult the accompanying documents Date of manufacture Manufacturer Serial number Range of humidity to which the instrument can be subjected to during transport...

Page 29: ...m age that a Normal Value Set supports or the patient s age 30 years whichever is greater Lung Age is not calculated for patients younger than 20 years old Accuracy To ISO26782 and ATS 2005 standards...

Page 30: ...mum resolution Recommended 1280x800 or greater USB One free USB port is required OS Win XP Win 7 Win 8 and Win 10 BT Radio Equipment Frequency Bands 2 402 2 480 GHz Maximum Power 2 mW NOTE There are n...

Page 31: ...SpiroConnect Operators Manual MedChip Solutions Ltd Page 31 of 31 001 105 GBR Issue 1 12 Notes...