MedChip Solutions SpiroConnect Operator's Manual

MedChip Solutions SpiroConnect Operator's Manual

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SpiroConnect
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 Reserved
1

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Summary of Contents for MedChip Solutions SpiroConnect

  • Page 1 SpiroConnect 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 Reserved...
  • Page 2: Table Of Contents

    Warnings and Cautions ..........................6 Relative Contraindications for Spirometry ....................7 Intended Use ............................. 7 Environment ............................. 7 Getting Started ............................8 Installing SpiroConnect Data Manager Software ................. 8 Operation ..............................9 Patient Selection: ..........................9 Unit Connection: ..........................9 Forced Spirometry: ..........................10 Relaxed Vital Capacity: ........................
  • Page 3: Introduction

    SpiroConnect Operators Manual 1 Introduction Thank you for choosing the SpiroConnect from MedChip Solutions. Please take a moment to familiarise yourself with the instructions for use detailed in this manual and for further information please refer to our website: www.medchipsolutions.com.
  • Page 4 (e.g. opening windows). Ideally this should be in the region of 6 room air changes per hour The MedChip Solutions Covid-19 Response is based ATS guidance and on the ARTP document “Risk minimisation in spirometry re-start” by Martin Allen .
  • Page 5: Package Contents

    SpiroConnect Operators Manual 2 Package Contents Your SpiroConnect comes complete with 2 Alkaline AA (LR6) batteries, quick start guide, calibration certificate and the following items: SpiroConnect spirometer SpiroConnect Data Manager software on USB flash drive memory stick (May be supplied by distributor on alternative format)
  • Page 6: Warnings And Cautions

    Do not use excessive force. WARNING: If you use multiple turbines in the same SpiroConnect then the calibration should be checked each time the turbine is swapped and the calibration updated in line with the recommendations on screen.
  • Page 7: Relative Contraindications For Spirometry

    The intended use of the SpiroConnect is to provide spirometry measurements used for the diagnosis of common respiratory diseases such as asthma and COPD in adults and children aged 3 and older. The SpiroConnect is intended to be used in doctors’ offices, hospitals and clinics.
  • Page 8: Getting Started

    WARNING: do not touch the patient when the battery cover is removed. 7.1 Installing SpiroConnect Data Manager Software The SpiroConnect DM software is supplied on a USB flash drive memory stick together with this user manual. Install the software as follows:...
  • Page 9: Operation

    SpiroConnect Operators Manual 8 Operation WARNING: Do not attempt to connect the SpiroConnect to the PC using the USB socket on the SpiroConnect device via USB cable. WARNING: Keep the patient away from the PC during use. Start the SpiroConnect Data Manager software by clicking on the desktop icon, or from the Windows Start Menu under All Programs->MedChip Solutions Spirometry.
  • Page 10: Forced Spirometry

    SpiroConnect Operators Manual 8.3 Forced Spirometry: After clicking the Forced Spirometry icon on the main screen, a screen with a start button and temperature reading is displayed. This temperature reading is the ambient room temperature as measured by the unit. If the operator wishes to modify the temperature value, he may do so by clicking on the displayed temperature, and he will then be given the opportunity to enter a temperature to over-ride the automatic temperature.
  • Page 11 SpiroConnect Operators Manual All parameters that have been selected for display in Settings are shown, along with the predicted value (if available), best baseline value (*Base) and percentage change from Best Base blow (if the blow is a Post blow), blow quality assessment, ATS/ERS 2019 FEV1 and FVC acceptability status for this blow, ATS/ERS 2019 exam grade for the exam as a whole, overall examination quality assessment and interpretation.
  • Page 12 SpiroConnect Operators Manual you wish to end the current exam stage and review results. After DONE is clicked, no further blows can be added to the current exam stage. Post1 or Post2 blows can be added at a later stage if they do not exist already.
  • Page 13 SpiroConnect Operators Manual 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:...
  • Page 14 SpiroConnect Operators Manual Summary section - this reports the variability between the blow being observed and the Best Blow in the same exam stage for FEV1 and FVC, in both percentage and millilitres. The ATS/ERS 2019 update also introduces the concept of Exam Grade. This is an overall grade that is given to an exam based upon how many FEV1 and FVCs were acceptable/usable/not usable and what the reproducibility between the best values was.
  • Page 15 SpiroConnect Operators Manual Standardised Operator Comments can be elected for addition to Exam Notes by selecting the ‘Standardised Operator Comments’ tab: NOTE: All timing calculations 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)
  • Page 16: Relaxed Vital Capacity

    SpiroConnect Operators Manual 8.4 Relaxed Vital Capacity: *Please note: Relaxed Vital Capacity tests MUST be added as the first test in any exam stage. If Forced Spirometry is performed first, there will be no option to add a Relaxed Spirometry...
  • Page 17: Review Results

    SpiroConnect Operators Manual Once this has been done, the patient can remove the device from their lips and the results will be displayed. Forced tests (and subsequent 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 8.5 Review Results:...
  • Page 18: General Information Pertaining To The Reviewing Of Examinations

    The normal values therefore will not change with time, and even if SpiroConnect Data Manager has been configured to use a different Normal Value set to that used at the time the exam was created, the original Normal Value Set in use at the time of exam creation will always be used when reviewing or adding post bronchodilator blows to that exam.
  • Page 19: Calibration

    SpiroConnect Operators Manual 8.7 Calibration: Calibration mode can be entered by clicking the icon. A 3 litre syringe should be connected to the device, and the plunger fully withdrawn prior to commencement of calibration. The unit should be in a vertical orientation or inverted by 180degrees –...
  • Page 20: Settings

    8.10 Patient Database: The location of the currently used database is displayed in the SpiroConnect Data Manager title bar. The database can support thousands of patients (each with numerous exams) up to a maximum database size that is limited only by the amount of disk space available.
  • Page 21: Android Application

    “SpiroConnect Mobile”. This application is a simplified version of the full PC software and may be used, with your SpiroConnect, to collect spirometry results and upload to the PC. Patient details may also be downloaded from the PC to the mobile phone or tablet. Please refer to the Android application instruction manual for further details.
  • Page 22: Battery Management

    9 Battery Management The SpiroConnect is designed to use 2 alkaline AA size primary cells. Note: To ensure maximum lifetime of the batteries the unit will automatically turn off approximately 5 minutes after a measurement is made.
  • Page 23: Looking After Your Spiroconnect

    Re-assemble the transducer into the main body by reversing the steps shown for disassembly. CAUTION: When removing or replacing the turbine, the mouthpiece holder must be facing away from the SpiroConnect product name as shown above. Do not use excessive force. 11.3 Soft Carry Case Cleaning Local infection control guidance should be followed.
  • Page 24: Accessories

    13 Servicing Routine maintenance consists of regular calibration checks and cleaning of the transducer. The SpiroConnect should be returned to the supplier every 2 years for transducer inspection and accuracy check unless local guidelines require a more frequent check. Please contact your authorised dealer if you unit requires service or repair.
  • Page 25: Software License Agreement

    Guidance and manufacturer’s declaration – electromagnetic emissions The SpiroConnect is intended for use in the electromagnetic environment specified below. The customer or the user of the SpiroConnect should assure that it is used in such an environment. MedChip Solutions Ltd.
  • Page 26 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SpiroConnect is used exceeds the applicable RF compliance level above, the SpiroConnect should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SpiroConnect.
  • Page 27: Network

    The SpiroConnect is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SpiroConnect can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and SpiroConnect as recommended below, according to the maximum output power of the communications equipment.
  • Page 28: Symbols

    Range of atmospheric pressure to which the instrument can be safely exposed to during transport The symbol indicates the orientation of the turbine for removal/replacement and use: Unlocked – the turbine can be removed and replaced Locked – the SpiroConnect can be used 21 Classification Protection against electric shock: Internally powered equipment.
  • Page 29: Specifications

    SpiroConnect Operators Manual 22 Specifications Transducer Type: Bi-directional high sensitivity turbine Measurements: VT (TV) FEV0.75 FEV1 FEV3 FEV6 Vext FEV0.75/VC FEF25 (MEF75) FEV0.75/FVC FEF50 (MEF50) FEV1/VC FEF75 (MEF25) FEV1/FVC (FER) FEF25-75 (MMEF) FEV3/VC FIV1 FEV3/FVC FIVC FEV0.75/FEV6 FEV1/FEV6 FIF25 (MIF75)
  • Page 30 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 no user serviceable parts in the SpiroConnect. WARNING: No modification of this equipment is allowed. MedChip Solutions Ltd. Chislehurst Business Centre 1 Bromley Lane, Chislehurst Kent, BR7 6LH, U.K.
  • Page 31 SpiroConnect Operators Manual Notes: MedChip Solutions Ltd. Page 31 of 31 001.105.GBR Issue 1.12...

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