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

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ALPHA
MODEL 6000
Instructions for Use
© Copyright Vitalograph 2021 Current Edition (Issue 1, 27-Jan-2021) Cat. No. 09060

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Summary of Contents for Vitalograph Alpha 6000

  • Page 1 ALPHA MODEL 6000 Instructions for Use © Copyright Vitalograph 2021 Current Edition (Issue 1, 27-Jan-2021) Cat. No. 09060...
  • 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

    5.3. Power Save Mode ..............21 6. Cleaning & Hygiene ................21 6.1. Preventing Cross-Contamination of Subjects ......21 6.2. Inspection of the Vitalograph Model 6000 Alpha ....22 7. Fault Finding Guide ................23 7.1. Software Check ................24 7.2. Product Useful Life Checks .............24 8.

  • Page 4: Main Components

    A Global Leader in Respiratory Diagnostics 1. Main Components The main components are: Figure 1.a Figure 1.b Flowhead Touchscreen display Micro SD card connector On/Off button Printer door release button Printer USB connector Ethernet connector Power supply input Flowhead tubing connector (device) Flowhead tubing connector (flowhead) Page of 40...

  • Page 5: Features

    Alpha - Instructions for Use 09060 Issue 1 1.1. Features The features include: • Fleisch type pneumotachograph • Ambient temperature sensor • Colour touchscreen display • Sounds for audio feedback • Integral 4” thermal printer 2. Setting up the device Check that the contents of the packaging match the contents label inside the carton.
  • Page 6 A Global Leader in Respiratory Diagnostics 2. If defaults are acceptable, press the green arrow to move to the main menu. 3. The Main Menu offers three standard options - Subject, Quick Test and Configuration - and a fourth option Connect, if Connect is configured. Figure 2.a Figure 2.b The Calibration Verification prompt...

  • Page 7: Entering Subject Data

    Alpha - Instructions for Use 09060 Issue 1 All subject demographics may be added in the add subject screen. 5. Quick Test allows the user to select Spirometry or Reports Reports will always be blank for the Quick Test. Figure 3 Spirometry option includes VC, FVC and Post (see Sections 3.2 Conducting a Test).

  • Page 8: Conducting A Test

    A Global Leader in Respiratory Diagnostics separate pages. Enter details in subject information fields: Primary: ID , Date of Birth , Height , Birth Sex Population Secondary: Alternative ID , Forename , Surname Weight , Smoker and Pack years On the comments page, comments may be freeform or selected from a pre-defined list.
  • Page 9 Alpha - Instructions for Use 09060 Issue 1 VC test session a. Breathe normally until the end-expiratory lung volume is stable. Stability is defined as having at least three tidal breaths with end expiratory lung volume within 15% of the tidal volume (the device will alert a user when this has been achieved).
  • Page 10 A Global Leader in Respiratory Diagnostics eight. h. Check FEV1 and FVC repeatability and perform more manoeuvres as necessary. i. Click on for quality information and test acceptability. Note: A single-breath FVC technique may also be performed on the device. Results grading for FEV1 and FVC is shown below in Table 1.

  • Page 11: Reporting

    Alpha - Instructions for Use 09060 Issue 1 pressing the tabs There are additional options to add comments and information on session quality and session interpretation. The user may add comments of up to 250 characters to the results by clicking in the top right corner.
  • Page 12 If a permanent record is required, photocopy the thermal printout or send the report to the Device Studio Utility. 3.3.2. External Printer via Vitalograph Device Studio The device can print to an external printer using the Device Studio application.
  • Page 13 Alpha - Instructions for Use 09060 Issue 1 on and in the main screen. If the device is not already connected, click on the ‘Connect Device’ option in the menu. Figure 5.a 3. Device Studio will search for assessments on the device (see Fig 5.a).

  • Page 14: Calibration Verification

    A Global Leader in Respiratory Diagnostics Additional guidance on using Device Studio can be found in the Instruction for Use PN 09550 supplied on the USB flash drive PN 93002 and in the software help menu of the application. The settings option allows the user to configure information displayed on the session report.

  • Page 15: Connection To Electronic Medical Records (Emr) Via Vitalograph Connect

    If the error continues to show, contact the manufacturer using contact information at the start of this document. 3.5. Connection to Electronic Medical Records (EMR) via Vitalograph Connect Connection to an EMR system may be achieved using the Connect service.
  • Page 16 A Global Leader in Respiratory Diagnostics Figure 7 – Example set up for Connect Once the information is entered, select the appropriate tab: wireless or wired. a. Wireless Network 1. When the wireless tab is selected the device searches all available networks.
  • Page 17 Alpha - Instructions for Use 09060 Issue 1 6. When connected, a WiFi symbol displays in the status bar, top left. b. Wired Network 1. For a wired connection complete the required information in the ‘Wired Network’ tab, including: • MAC address •...
  • Page 18 A Global Leader in Respiratory Diagnostics Return Orders • Figure 9 3.5.2. New Orders To process a new order, go to the ‘New Orders’ tab, select the order required and press the ‘Start Testing’ button (see Figure 9). The subject information displays.

  • Page 19: Cybersecurity Considerations

    The OS has a configured firewall to protect against any unauthorised access over the communications ports, only Vitalograph PC based applications can access the device over a secure connection. No further controls are required to be applied by users to secure the device. The device will timeout and auto power down after 5 minutes of inactivity.

  • Page 20: Interfaces

    The recommended battery pack replacement interval is 3 years. Battery replacement should be carried out only by the manufacturer, the approved importer or by Service Agents approved by Vitalograph. Note: Powering the device or recharging the battery pack from the USB is not possible.

  • Page 21: Power Save Mode

    6.1. 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 the subject, the device and the user against cross contamination during spirometry manoeuvres.

  • Page 22: Inspection Of The Vitalograph Model 6000 Alpha

    ‘Cleaning and Hygiene’ on the Vitalograph website. 6.2. Inspection of the Vitalograph Model 6000 Alpha No inspection of the device is required by the subject. The device is used under the supervision of a healthcare professional.

  • Page 23: Fault Finding Guide

    Alpha - Instructions for Use 09060 Issue 1 7. Fault Finding Guide Problem Fault • Calibration verification variations > +/-3% Symptoms: • False readings suspected • The % error indicates the severity of the issue. Over 3%, repeat calibration verification. Over 6% may indicate the device requires cleaning or maintenance.

  • Page 24: Software Check

    7.1. Software Check Information about the device 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 , select ‘Configuration’ on the Main Menu and go to the second screen of options.

  • Page 25: Consumables And Accessories

    Alpha - Instructions for Use 09060 Issue 1 reported to Vitalograph or its Authorised Representative and the Regulatory Authorities of the country. Refer to the Vitalograph contact information at the start of this manual. 9. Consumables and Accessories Cat. No...

  • Page 26: Disposal

    A Global Leader in Respiratory Diagnostics 10. 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. BVFs are made from recyclable material and should be disposed of in line with local requirements.

  • Page 27: Description Of The Vitalograph Model 6000 Alpha

    Restricted to sale by, or on the order of a physician 12. Description of the Vitalograph Model 6000 Alpha The Vitalograph Model 6000 Alpha is a spirometer designed for lung function testing in a variety of professional healthcare environments, e.g., primary care, hospitals and occupational health centres.

  • Page 28: Technical Specification

    A Global Leader in Respiratory Diagnostics 13. Technical Specification Product Vitalograph Model 6000 Alpha Model 6000 Flow Detection Principal Fleisch type pneumotachograph Essential Performance Flow measurement output Essential Performance Flow Accuracy ±10% or ±20 L/min, Test Limits whichever is greater Back pressure Less than 0.1kPa/L/second @ 14 L/s...

  • Page 29: Contraindications, Warnings, Precautions And Adverse Reactions

    Reactions 1. No modification of this equipment is allowed. Any unauthorised changes to the 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 of 40...
  • Page 30 2. The device is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals. 3. 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 the subject, the device and the user against cross contamination during spirometry manoeuvres.
  • Page 31 Alpha - Instructions for Use 09060 Issue 1 the device and contact Vitalograph support. In case of leaking ensure the electrolyte does not get in the eyes or touch skin. If electrolyte gets into the eyes flush the area immediately with water for 15 minutes and seek medical attention.

  • Page 32: Ce Notice

    A Global Leader in Respiratory Diagnostics 15. CE Notice Marking by the symbol indicates compliance of the Vitalograph Model 6000 Alpha to the Medical Devices Directive of the European Community. The device is intended for and suitable for use in a variety of professional healthcare environments, e.g.
  • Page 33 Alpha - Instructions for Use 09060 Issue 1 EN 60601-1-2:2015 - Immunity tests Compliance level Immunity test Test level Reached Contact: ± 8 kV Contact: ± 8 kV Electrostatic discharge (ESD) Air: ± 2 kV,± 4 kV, Air: ± 2 kV,± 4 kV, EN 61000-4-2 ±...

  • Page 34: Fda Notice

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device including cables specified by Vitalograph. Otherwise, degradation of the performance of this equipment could result.

  • Page 35: Eu Declaration Of Conformity

    09060 Issue 1 17. EU Declaration of Conformity Product: Vitalograph Model 6000 Alpha 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: European Medical Devices Directive {MDD} 93/42/EEC, as amended.

  • Page 36: Guarantee & Free Five Year Warranty

    A Global Leader in Respiratory Diagnostics 18. Guarantee & Free Five Year Warranty Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its option 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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  • Page 38 A Global Leader in Respiratory Diagnostics Page of 40 DT_0006 Issue 15...
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