Vitalograph alpha 6000 User Manual
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Vitalograph alpha 6000 User Manual

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Vitalograph ALPHA User Manual
07368
Issue 2
Vitalograph
alpha
MODEL 6000

User Manual

l
Copyright Vitalograph 2007

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Summary of Contents for Vitalograph alpha 6000

  • Page 1: User Manual

    Vitalograph ALPHA User Manual 07368 Issue 2 Vitalograph alpha MODEL 6000 User Manual Copyright Vitalograph 2007...
  • Page 2 Vitalograph Inc., 13310 West 99 Street, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: vitcs@vitalograph.com Vitalograph (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: sales@vitalograph.ie Internet: www.vitalograph.com © Copyright Vitalograph 2007 Current Edition (Issue 2) Cat.

  • Page 3: Table Of Contents

    Table of Contents DESCRIPTION OF THE VITALOGRAPH ALPHA MAIN COMPONENTS OF THE VITALOGRAPH ALPHA FEATURES OF THE VITALOGRAPH ALPHA GETTING THE VITALOGRAPH ALPHA READY FOR USE POWER MANAGEMENT IN THE VITALOGRAPH ALPHA ATTERY ATTERY ETECT OPERATING THE VITALOGRAPH ALPHA NTERING...
  • Page 4 CUSTOMER SERVICE CONSUMABLES AND ACCESSORIES EXPLANATION OF SYMBOLS OTHER LABELS TECHNICAL SPECIFICATIONS CE NOTICE FDA NOTICE DECLARATION OF CONFORMITY GUARANTEE...
  • Page 5 Vitalograph ALPHA User Manual 07368 Issue 2 Figure 1 Copyright Vitalograph 2007...

  • Page 6: Description Of The Vitalograph Alpha

    LCD and printed and downloaded to a PC. There are a variety of backup and other configuration options. Information about the software can be obtained from the About box. This information can be used if any queries are made to Vitalograph or a service agent. To access the About box: 1.

  • Page 7: Getting The Vitalograph Alpha Ready For Use

    ALPHA R ETTING THE ITALOGRAPH EADY 1. Attach the flowhead to the Vitalograph ALPHA by the dual silicone tubing (Flowhead Connection Tube). Ensure that coloured/ribbed tapping on the flowhead is connected to the ribbed side of the connection in the housing.

  • Page 8: Battery Low Detect

    Battery Low Detect The Vitalograph ALPHA has a number of battery power detect messages: When the Battery Pack starts to run low the Battery Low icon will flash on and off on the Main Menu screen. You will be allowed to continue to use the device. It is advised that you plug in the 12V Power Supply to re- charge the batteries and continue testing.

  • Page 9: Performing A Test Session

    Perform the VC test as follows: 1. Select the ‘VC Test’ option from the Main Menu using the keypad. 2. Wait for the ‘Exhale to Begin’ icon to appear. This indicates that the Vitalograph ALPHA unit is ready to accept a blow.
  • Page 10 Note: You can view the results as either a Volume/time graph or a Volume bar graph: a. Press key 1 for Volume/time (V/t) graph. b. Press key 2 for Volume bar graph. 3. The VC test can be performed using two methods. Read either of the following instructions to the subject so that testing is performed properly: Method 1:...

  • Page 11: Performing An Fvc Test

    1. Select the ‘FVC Test’ option from the Main Menu using the keypad. 2. Wait for the ‘Exhale to Begin’ icon to appear. This indicates that the Vitalograph ALPHA unit is ready to accept a blow. Note: You can view the results as either a Volume/time (V/t) or a Flow/Volume (F/V) graph: a.

  • Page 12: Saving The Test Session

    d. Breathe in and out normally. This is called tidal breathing. When you are happy that the subject has achieved steady tidal breathing, continue with: e. Inhale as deeply as possible Exhale as much and as quickly as possible, and when fully exhaled g.

  • Page 13: Performing A Post Test Session

    Vitalograph ALPHA. The best three tests will be saved. Note: If a Compact Flash card is inserted into the Compact Flash connector at the right side of the device, then all test blows and not just the best three will be saved to the Compact Flash card.

  • Page 14: Clear Results

    The Vitalograph ALPHA has an internal printer. It can also be connected through the USB port at the side of the unit to the Vitalograph Reports Utility, so that the report can be written to a PC. The information printed on the session report can be configured to suit individual requirements.

  • Page 15: When To Check Accuracy

    Note: Note: Press the ‘Del’ key to exit the Accuracy Check screen and return to the Main Menu. The accuracy check will not be logged to the Vitalograph ALPHA memory in this case. 4. If an Accuracy Check report is required select the Report option.

  • Page 16: Deleting Stored Subjects/Test Results

    Printer This allows you to either print the test report to the Internal Printer or send it to the Vitalograph Reports Utility on a PC. Press key ‘1’ on the keypad to switch between the two options. Note: In order to send the report to the Vitalograph Reports Utility it...

  • Page 17: Date/Time

    PC and the Vitalograph ALPHA connected to your PC via a USB cable. Units This allows you to select the units as Metric or US (Imperial). Press key ‘2’ on the keypad to switch between the two options. Graph Type This allows you to select the graph type to be shown as default in the FVC test screen, Press key ‘3’...

  • Page 18: Report Settings

    The information printed on the session reports can be configured to suit individual requirements. The Vitalograph ALPHA can print to the internal printer or send the report to the Vitalograph Reports Utility. 1. Select ‘Report Settings’ from the Configuration screen using the keypad.
  • Page 19 Set Syringe Volume: Select Precision Syringe from the Syringe/Calibration screen using the keypad. ii. Follow on screen instructions to enter the volume of the calibrated syringe you are using. iii. Press ‘Enter’ to save the new volume entered and return to the Syringe/Calibration screen. Press Delete to cancel the changes made and return to the Syringe/Calibration screen.

  • Page 20: Sound Volume

    Configuration screen. Fitting a New Paper Roll The Vitalograph ALPHA is supplied with a roll of paper fitted into the printer. (Note: The outside of the roll will not give a strong print...

  • Page 21: Cleaning Instructions

    4. Lay the paper roll between the back of the Vitalograph ALPHA unit and the inside of the open door, with the paper coming out from the bottom of the roll and pointing toward the printer.
  • Page 22 It is recommended that the flowhead be regularly cleaned according to the guidelines of the user’s facility. In the event of visible contamination of the flowhead cones or flowhead element, they should be cleaned or disinfected as described in the accompanying table.
  • Page 23 134°C for 3 minutes or Meshes 120°C for 20 minutes. All external parts of the Vitalograph ALPHA require cleaning, i.e. the removal of visible particulate contamination. The parts of the Vitalograph ALPHA that make up the flowhead, which comes into...

  • Page 24: Disassembling The Fleisch Flowhead

    contact with subjects being tested, also require disinfecting. A spirometer is not designed as a ‘sterile’ device. Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Committee to Department of Health Medical Devices Directorate, 1996”.

  • Page 25: Reassembling The Fleisch Flowhead

    The flowhead body (7) does not require disinfection, but may be cleaned/disinfected with the rest of the flowhead for convenience. 5. Rinse all parts in clean water. 6. Disinfect by immersion in sodium dichloroisocyanurate (NaDCC) solution at 1,000 ppm concentration of free chlorine for 15 minutes. Prepare disinfectant solution as directed in the manufacturer’s guidelines.

  • Page 26: Fault Finding Guide

    When attaching the flowhead connection tube ensure that the matching coloured/serrated edge pressure tappings on the flowhead and the Vitalograph ALPHA are connected to each other. It is recommended that an accuracy check is carried out following reassembly to verify correct operation and accuracy.
  • Page 27 Possible Causes: (In probable side of the tubing should be connected to the order) ribbed half of the connector on the Vitalograph ALPHA device and the blue tapping on the flowhead connector • Ensure that the flowhead connecting tube is not pinched or trapped.

  • Page 28: Customer Service

    Service and repairs should be carried out only by the manufacturer, the approved importer or by Service Agents specifically approved by Vitalograph. For the names and addresses of approved Vitalograph Service Agents or to arrange spirometry workshops, please refer to the contact information at the start of this manual.

  • Page 29: Explanation Of Symbols

    Attention (reference relevant section in manual) THER ABELS Power input connector USB connector ECHNICAL PECIFICATIONS Product Vitalograph ALPHA Model 6000 Flow detection principle Fleisch type pneumotachograph Back pressure Less than 0.1kPa/L/second @ 14L/s, complies with ATS/ERS 2005 Volume detection Flow...

  • Page 30: Ce Notice

    Parameters measured Varies by country variant Printer Thermal Communications USB and Compact Flash Note: All values displayed by the Vitalograph ALPHA are expressed as BTPS values. CE N OTICE Marking by the symbol indicates compliance of the Vitalograph ALPHA to the Medical Devices Directive of the European Community.
  • Page 31 Guidance and manufacturer’s declaration – electromagnetic immunity The ALPHA is intended for use in the electromagnetic environment specified below. The customer or the user of the ALPHA should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment-...
  • Page 32 Guidance and manufacturer’s declaration – electromagnetic immunity The ALPHA is intended for use in the electromagnetic environment specified below. The customer or the user of the ALPHA should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment test...
  • Page 33 Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. 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 34: Fda Notice

    Portable and mobile RF communications equipment can affect medical electrical equipment. FDA N OTICE Caution: Federal Law restricts this device to sale by, or on the order of a physician.

  • Page 35: Declaration Of Conformity

    ECLARATION OF ONFORMITY Vitalograph alpha Product Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards: •  European Medical Devices Directive {MDD} 93/42/EEC.

  • Page 36: Guarantee

    UARANTEE 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.

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