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SpiroConnect Operators Manual 

MedChip Solutions Ltd. 

Page 13 of 31 

001.105.GBR Issue 1.12  

Note: If an older exam is being reviewed and it was conducted with SDM software < 1.12 or 
unit    firmware  <  V3.02,  the  exam  will  be  presented  with  quality  messages  from  ATS/ERS 
2005 guidelines instead of ATS/ERS 2019, and could be one of the following messages: 
 

Slow Start:

 

The  patient  appeared  to  have  paused  slightly  at  the  beginning  of  the 
manoeuvre.  He/she  should  blast  air  out  as  hard  as  possible  from  the 
very beginning of test 

Abrupt End:

 

The  patient  appeared  to  stop  blowing  suddenly.  The  patient  should 
continue to squeeze every last bit of air out of their lungs at the end of 
exhalation. A good guideline is that they should not stop before they have 
exhaled  for  6  seconds  at  least  (the  graph  border  turns  green  after  6 
seconds to indicate this time has elapsed) 

Possible Cough:

 

A possible cough has been detected.  

Good Blow:

 

The blow is of good quality 

 
The ACCEPTANCE CRITERIA messages for the current exam are shown below the Results 
area. These messages report on the overall quality of the current and existing exam stages 
(Base, Post1, Post2) and depend upon the criteria selected as follows: 
 

ARTP (Association for Respiratory Technology and Physiology

At least 3 good quality blows must exist within the exam stage 
The two largest FVC values must 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 2019 

At least 3 acceptable FEV1 and 3 acceptable FVC must exist within the exam stage 
The two largest FVC values must be within 150mL of each other, or for patients aged 6 or 
younger, 100mL or 10% of largest FVC, whichever is greater. 
The two largest FEV1 values must be within 150mL of each other, or for patients aged 6 or 
younger, 100mL or 10% of largest FEV1, whichever is greater. 
The  two  largest  VC  values must  be  within 150mL of  each other  or  10%  VC  (whichever  is 
smaller)  for  patients  older  than  6  years;  and  100mL  or  10%  of  largest  FVC,  whichever  is 
smaller (for patients aged 6 or younger). 
 
 

BTS 

At least 3 good quality blows must exist within the exam stage 
The two largest FVC values must be within 100mL or 5% (whichever is larger) of each other 
The two largest FEV1 values must be within 100mL or 5% (whichever is larger) of each other 
The two largest VC values must be within 100mL or 5% (whichever is larger) of each other 
 

CUSTOM 

You can select CUSTOM and set up your own set of acceptance criteria if desired 
 
 
Please note that one can select either ATS/ERS 2019, BTS, ARTP or CUSTOM acceptance 
criteria to be used for this assessment, from the Settings tab. 
 
Whilst seeking to attain ‘Criteria Met’ for the Acceptance Criteria summary, it is useful to know 
what  the  current  variability  status  is.  A  VARIABILITY  result  is  presented  within  the  Test 

Содержание SpiroConnect

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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