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Summary of Contents for MedChip Solutions SpiroConnect
- Page 1 SpiroConnect Spirometer Operating Instructions Issue 1.2 Copyright © MedChip Solutions Ltd. All Rights Reserved...
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Page 2: Table Of Contents
Warnings and Cautions ........................... 5 Contraindications ............................ 5 Intended Use ............................6 Environment ............................6 Getting Started ............................7 Installing SpiroConnect Data Manager Software ................7 Operation ..............................9 Patient Selection: ..........................9 Unit Connection: ..........................9 Forced Spirometry: ........................... 10 Relaxed Vital Capacity: ........................ -
Page 3: Introduction
SpiroConnect Instructions for Use 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: Package Contents
SpiroConnect Instructions for Use 2 Package Contents SpiroConnect spirometer SpiroConnect Data Manager software on USB flash drive memory stick (May be supplied by distributor on alternative format) SpiroConnect dongle Carrying pouch 2 Alkaline AA cells Nose Clip MedChip Solutions Ltd. -
Page 5: Warnings And Cautions
SpiroConnect Instructions for Use 3 Warnings and Cautions Caution: Possibility of injury or serious damage Warning: conditions or practices that could result in personal injury. Please Note: Important information for avoiding damage to the instrument or facilitating operation of the instrument. -
Page 6: Intended Use
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 over 5. The SpiroConnect is intended to be used in doctors’ offices, hospitals and clinics. 6 Environment The SpiroConnect is designed for routine clinical use in an office environment. -
Page 7: 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: N.B. - Page 8 SpiroConnect Instructions for Use taken to a download page where he can download the installer for the newer version. This file should be downloaded and then run to complete the update. MedChip Solutions Ltd. Page 8 of 26 001.105 Issue 1.2...
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Page 9: Operation
SpiroConnect Instructions for Use 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. -
Page 10: Forced Spirometry
SpiroConnect Instructions for Use Once ‘Start’ is clicked to initiate a test, the LED shows solid green to show that the unit is ready for a blow. 8.3 Forced Spirometry: Press in the bottom right corner of the Spirometry Examination screen to initiate the test. - Page 11 SpiroConnect Instructions for Use the ‘Results’ tab will change the display to show detailed results, and an interpretation, if available. NEXT can be clicked in order that the current blow is accepted into the exam stage and a new blow is initiated. REJECT can be clicked to initiate a new blow without adding the last blow to the exam.
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Page 12: Relaxed Vital Capacity
SpiroConnect Instructions for Use 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 may contain messages similar to those below: Not Met: A minimum of 3 good quality tests are required An exam stage needs at least 3 blows that have a Quality Check of ‘Good Blow’... - Page 13 SpiroConnect Instructions for Use For the tidal breathing method instruct the patient to seal their lips around the mouthpiece and breathe normally. The device will beep on each beginning of inhalation and monitor tidal breathing until it has determined a stable tidal pattern has been recognised. At this point the unit will beep three times in very quick succession as well as change the graph border to a green colour, indicating that it is ready for the vital capacity manoeuvre.
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Page 14: Review Results
SpiroConnect Instructions for Use Forced tests (and subsequent post-BD tests) can be added using the buttons on the bottom right of the screen. 8.5 Review Results: From the main window, clicking the Review Examinations button will open the Exam Selector. This screen lists saved exams (the oldest exam at the top, newest at the bottom) which can be opened for review and printing, or the addition of post-BD tests. -
Page 15: 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 16 SpiroConnect Instructions for Use the should pause for approximately one second before withdrawing the plunger, again at a pace such that the trace remains within the green shaded area. Three consecutive cycles will be performed, each with a higher flow rate than the last. Once the final highest flow rate cycle has been performed, click ‘Done’...
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Page 17: Settings
The procedure for doing so is as follows: Open SpiroConnect Data Manager, and take note of the database path and name as shown in the title bar. Close SpiroConnect Data Manager, and use Windows Explorer to navigate to the database file. -
Page 18: Battery Management
SpiroConnect Instructions for Use 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. Remove the batteries if you do not intend to use the device for more than 3 months. -
Page 19: Cleaning
Re-assemble the transducer into the main body by reversing the steps shown for disassembly. 12 Accessories The following accessories are recommended for use with your spirometer. • SpiroConnect Dongle (for Bluetooth communications) • Replacement batteries (Energiser E91 x 2) • USB memory stick (with Operators Manual and Software) •... -
Page 20: Servicing
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. if you unit requires service or repair to obtain a Please contact service@medchipsolutions.com... -
Page 21: Software License Agreement
The software may not be rented or leased to others, but you may transfer your rights under this agreement in full provided that all copies of the software and written manuals are transferred, and that the recipient agrees to the terms of this agreement and notifies MedChip Solutions Ltd of the transfer of license. -
Page 22: Electromagnetic Compatibility (Emc)
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. Emissions test Compliance Electromagnetic environment –... - Page 23 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.
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Page 24: Symbols
SpiroConnect Instructions for Use 18 Symbols Type BF applied part. complying with the specified requirements of F-TYPE APPLIED PART EN60601-1:2006 to provide a higher degree of protection against electric shock than that provided by TYPE B APPLIED PARTS In accordance with Directive 93/42/EEC... -
Page 25: Classification
SpiroConnect Instructions for Use 19 Classification Protection against electric shock: Internally powered equipment. Mode of operation: Continuous 20 Specifications Transducer Type: Bi-directional high sensitivity turbine Measurements: FEV3/FVC FEV0.75 FEV0.75/FEV6 FEV1 FEV1/FEV6 FEV3 FEF50/VC FEV6 FEF50/FVC MMEF/FVC (FEF25-75/FVC) FIV1/FIVC (FIR) FEF25 (MEF75) - Page 26 Transport and Storage Conditions: C to 70 C, 15% to 95% RH, non condensing Lifetime: 5 years NOTE: There are no user serviceable parts in the SpiroConnect. WARNING: No modification of this equipment is allowed. Issued: 14 May 2015 MedChip Solutions Ltd.
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