Vitalograph 6000 Instructions For Use Manual
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Vitalograph 6000 Instructions For Use Manual

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ALPHA Touch
MODEL 6000
Instructions for Use
© Copyright Vitalograph 2019 Current Edition (Issue 1, 26-Nov-2019) Cat. No. 09100

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  • Page 1 ALPHA Touch MODEL 6000 Instructions for Use © Copyright Vitalograph 2019 Current Edition (Issue 1, 26-Nov-2019) Cat. No. 09100...
  • Page 2 Tel: +353 65 6864111 Technical Support Email: technical.support@vitalograph.ie Tel: +353 65 6864111 Email: technical.support@vitalograph.ie Vitalograph GmbH Rellinger Straße 64a Vitalograph Ltd, Hong Kong/China D-20257 Hamburg P.O. Box 812 Germany Shatin Central Post Office Tel: +49 40 547391-40 Hong Kong Fax: +49 40 547391-40 E-mail: sales@vitalograph.cn...

  • Page 3: Table Of Contents

    ALPHA Touch - Instructions for Use 09100 Issue 1 Contents Main Components of the Vitalograph ALPHA Touch ......4 1.1. Features of the Vitalograph ALPHA Touch ......5 Setting Up the Vitalograph ALPHA Touch ........5 2.1. Fitting a New Paper Roll ............6 Operating Instructions ...............7...

  • Page 4: Main Components Of The Vitalograph Alpha Touch

    A Global Leader in Respiratory Solutions 1. Main Components of the Vitalograph ALPHA Touch Figure 1 Main components of ALPHA Touch Note: Computer not supplied Display Internal Thermal Printer Flowhead Flowhead Connection Tubing Medically Approved Power Supply BVF™ USB Cable...

  • Page 5: Features Of The Vitalograph Alpha Touch

    • Compatible with Spirotrac software (purchased separately) 2. Setting Up the Vitalograph ALPHA Touch 1. Connect one end of the flowhead connection tubing to the Vitalograph ALPHA™ Touch base. Ensure that the coloured/ribbed tapping on the flowhead is connected to the ribbed side of the tubing in the connector housing.

  • Page 6: Fitting A New Paper Roll

    Note: To make fitting easier, create a point in the middle of the paper by tearing or cutting the two corners of the leading edge of the paper. Note: The Vitalograph logo should be facing you on the right edge of the paper. 4. Clip the paper cartridge back into place between the back of the ALPHA and the inside of the open door.

  • Page 7: Operating Instructions

    ALPHA Touch - Instructions for Use 09100 Issue 1 Figure 3 – Fitting a new paper roll. Warning: The paper tear bar has sharp edges. Take care not to cut fingers. 3. Operating Instructions Turn on the ALPHA Touch (The On/Off switch is at the back of the device). 3.1.
  • Page 8 A Global Leader in Respiratory Solutions 2. Select a subject and ensure the required demographic information is entered. 3. Wash hands (operator and subject). 4. Fit a new Bacterial Viral Filter (BVF) to the flowhead for each test subject. The use of a disposable noseclip is recommended. 5.
  • Page 9 The Post Mode screen also offers the option to save and recall test sessions to and from a permanent storage location on the device. This permanent storage does not get deleted when test sessions are sent to Vitalograph Reports or Spirotrac. To access this option select ‘Permanent Storage’. ...
  • Page 10 A Global Leader in Respiratory Solutions 3.2.3. Bronchodilator Responsiveness Testing A Bronchodilator Responsiveness Test session can be performed on an FVC test session following the administration of drugs. Post drug delivery performance is measured versus pre delivery. • To start bronchodilator responsiveness testing select ‘Post Mode’ from the Main Menu.

  • Page 11: Reporting

    • All Test Sessions: It is possible to select to print all test sessions for the current subject via a PC using Vitalograph Reports software. It is not possible to automatically print all test sessions for a subject from the internal printer.

  • Page 12: Calibration Verification

    • If an Accuracy Check report is required, select the Report option. • Press the ‘C’ key to exit the Accuracy Check screen and return to the Main Menu. The accuracy check will not be logged to the Vitalograph ALPHA Touch memory in this case.
  • Page 13 Calibration Calibration is not required for normal use. Calibration should only be conducted by, or under the guidance of Vitalograph Service Agents. See contact details on p. 2. 1. Select ‘Calibration’ from the Calibration screen. 2. Pump air through the flowhead to bring it to ambient temperature. ...
  • Page 14 A Global Leader in Respiratory Solutions 3. Press the ‘Enter’ key to bring you into the Calibration screen and follow the on-screen instructions.  4. If a Calibration report is required select the Report option. Press the ‘C’ key to exit the Calibration screen. Note: An Accuracy check must be done on the same day as the device is calibrated.
  • Page 15 ALPHA Touch - Instructions for Use 09100 Issue 1 Accuracy Log 1. Select ‘Accuracy Log’ from the Calibration screen. The accuracy log contains a record of all the accuracy checks done on the device. 2. There are three options: a. To print the complete accuracy log press ‘Print All’. b.
  • Page 16 A Global Leader in Respiratory Solutions 1. Select the incentive device to be used in testing using the drop down list. A preview of the incentive will appear on the screen. 2. Modify the % of predicted using the on-screen keyboard. The value entered must be between 80-150.
  • Page 17 ALPHA Touch - Instructions for Use 09100 Issue 1 FIF 25 Forced inspiratory flow at 25% of the FVC (L/sec) FIF 50 Forced inspiratory flow at 50% of the FVC (L/sec) FIF 75 Forced inspiratory flow at 75% of the FVC (L/sec) Maximum voluntary ventilation indirectly MVVind calculated from the FEV1 (L/min)
  • Page 18 A Global Leader in Respiratory Solutions Vext/FVC Ratio extrapolated volume of FVC PIF L/min Peak inspiratory flow (L/min) Lung age will be displayed if the date of birth, height, population group and smoking information have been entered.  Lung age will Lung Age only be shown if the measured FEV1 value is less than the lower limit of the predicted normal value...

  • Page 19: Power Management

    (print via a PC) and off for black & white. Note: In order to send the report to the Vitalograph Reports utility it is necessary to have the Vitalograph Reports Utility installed on the user’s PC and the ALPHA Touch connected to the PC via a USB cable.

  • Page 20: Battery Pack

    5.1. Preventing Cross-Contamination of Subjects A spirometer is not designed or supplied as a ‘sterile’ device. Vitalograph intends that a new Bacterial Viral Filter (BVF) be used for every subject to prevent cross contamination. Using a new BVF provides a significant level of protection of for the subject, the device and the user against cross contamination during spirometry manoeuvres.

  • Page 21: Inspection Of The Vitalograph Alpha Touch

    ALPHA Touch - Instructions for Use 09100 Issue 1 5.2. Inspection of the Vitalograph ALPHA Touch Visual inspection is recommended on a routine basis; Remove flowhead cone and flowhead end cap from the flowhead (figure 5). Examine flow conditioning mesh filters for damage or contamination. If they are damaged or blocked, discard and replace with new parts.

  • Page 22: Fault Finding Guide

    A Global Leader in Respiratory Solutions 6. Fault Finding Guide Problem Fault • Accuracy check variations > +/-3% Symptoms: • False readings suspected. • Recheck Calibration with reference to section Checking Accuracy. • Was the correct syringe volume selected? • An accuracy check is required after cleaning/ disinfecting the flowhead Fleisch element assembly.

  • Page 23: Software Check

    • Main PCB failure – contact support. 6.1. Software Check The software version and issue can be determined from the About screen. Please quote this, and the serial number of the Vitalograph ALPHA Touch, to an approved manufacturer’s support desk when requesting further advice or assistance.

  • Page 24: Customer Service

    Service and repairs should be carried out only by the manufacturer, or by Service Agents approved by Vitalograph. Contact information for approved Vitalograph Service Agents may be found at the start of this manual. Any serious incident that has occurred in relation to the device should be reported to Vitalograph or its Authorized Representative and the Regulatory Authorities of the country.

  • Page 25: Disposal

    ALPHA Touch - Instructions for Use 09100 Issue 1 9. Disposal The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste. Used BVFs constitute minimally soiled waste from human healthcare and should be disposed of in line with local requirements.

  • Page 26: Description Of The Alpha Touch

    MVV. It is designed for desktop use. The Fleisch flowhead is used for testing and has a resting location on the device. 11.1. Indications for Use The indications for use of the Vitalograph ALPHA Touch is in the assessment of lung function through the measurement of dynamic lung volumes, i.e. spirometry.
  • Page 27 Design limits: 10–40ºC Operating humidity range 30%–75% Ambient pressure range 850hPa–1060hPa Performance standards the ATS/ERS 2019, ISO 23747:2007 & Vitalograph ALPHA Touch ISO 26782:2009 meets or exceeds Safety standards EN 60601-1:2006 EMC Standards EN 60601-1-2:2007 EN ISO 23747:2007, EN ISO 26782:2009 &...

  • Page 28: Contraindications, Warnings, Precautions And Adverse Reactions

    1. No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph ALPHA Touch device may compromise product safety and/ or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.
  • Page 29 Vitalograph support. In case of leaking ensure the electrolyte does not get in the eyes or touch skin. If electrolyte contacts the eyes flush the area immediately with water for 15 minutes and seek medical attention.

  • Page 30: Ce Notice

    Model 6000 ALPHA Touch to the Medical Devices Directive of the European Community. The Vitalograph Model 6000 ALPHA Touch is intended for use in a variety of professional healthcare environments, e.g. primary care, hospital wards and occupational health centres, except for near active high frequency surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high.
  • Page 31 EN 60601-1-2:2007 - Emissions tests Electromagnetic environment - Emissions test Compliance guidance The Model 6000 ALPHA Touch uses RF energy only for its internal function. Therefore, its RF RF emissions CISPR 11 Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment.

  • Page 32: Fda Notice

    It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

  • Page 33: Eu Declaration Of Conformity

    09100 Issue 1 16. EU Declaration of Conformity Product: Model 6000 ALPHA Touch Vitalograph hereby ensures and declares that the above product associated with these instructions for use, is designed and manufactured in accordance with the following QMS regulations and standards: •...

  • Page 34: Guarantee

    A Global Leader in Respiratory Solutions 17. Guarantee Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its opinion replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials.
  • Page 35 ALPHA Touch - Instructions for Use 09100 Issue 1 Page of 36...

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