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Vitalograph ALPHA 6000 Instructions For Use Manual

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ALPHA
MODEL 6000
Instructions for Use
Rx Only
© Copyright Vitalograph 2025 Current Edition (Issue 9, 13-Feb-2025) Cat. No. 09060

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Summary of Contents for Vitalograph ALPHA 6000

  • Page 1 ALPHA MODEL 6000 Instructions for Use Rx Only © Copyright Vitalograph 2025 Current Edition (Issue 9, 13-Feb-2025) Cat. No. 09060...
  • Page 2 E-mail: contact@vitalograph.com Technical Support www.vitalograph.com Telefon: +49 40 547391-14 Technical Support E-mail: technical.support@vitalograph.de Tel: (913) 730-3205 Email: technical.support@vitalograph.com © Copyright Vitalograph 2025 Current Edition (Issue 9, 13-Feb-2025) Vitalograph is a registered trademark. Cat. No. 09060 Page 2 of 48 TMP-10002-20...

  • Page 3: Table Of Contents

    10. Customer Service ................35 11. Consumables and Accessories ............35 12. Disposal Instructions ................36 13. Explanation of Symbols ..............36 14. Description of the Vitalograph Model 6000 Alpha ......37 15. Technical Specifications ..............38 16. Electromagnetic Compatibility (EMC) Standards ......40 17. FDA Notice ...................42 18.

  • Page 4: Indications For Use

    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. 2. The device is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.
  • Page 5 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 6 22. 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. 23. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

  • Page 7: Main Components Of The Vitalograph Model 6000 Alpha

    Alpha - Instructions for Use 09060 Issue 9 3. Main Components of the Vitalograph Model 6000 Alpha The main components are: Figure 1 Figure 2 Flowhead Touchscreen display Micro SD card connector On/Off button Printer door release button Printer USB connector...

  • Page 8: Features Of The Vitalograph Model 6000 Alpha

    A Global Leader in Respiratory Diagnostics 3.1. Features of the Vitalograph Model 6000 Alpha The features include: • Fleisch type pneumotachograph • Ambient temperature sensor • Colour touchscreen display • Sounds for audio feedback • Integrated 4” thermal printer 4. Setting up the Vitalograph Model 6000 Alpha Check that the contents of the packaging match the contents label inside the carton.

  • Page 9: Operating Instructions

    Alpha - Instructions for Use 09060 Issue 9 5. Operating Instructions On all screens: the (blue) arrow at the top left goes back one step, the (green) arrow at the top right moves forward one step. 1. After turning on the device for the first time, the Start-up Wizard opens giving 2 options: Device Config allows the user to change audio level, haptic feedback, screen brightness, enable/disable passcode, units and language.
  • Page 10 A Global Leader in Respiratory Diagnostics Figure 4 The Calibration Verification prompt displays in the centre of the screen when the device has just been powered on if a calibration verification has not been completed that day. To complete a calibration verification, press the green button (see Section 5.5). If a calibration verification is not required press 5. Subject allows the user to select a current subject by ID , forename or surname (see Section 5.2 Conducting a Test) or to add/create a new subject (see...

  • Page 11: Entering Subject Data

    Alpha - Instructions for Use 09060 Issue 9 Spirometry option includes VC, FVC and Post (see Section 5.2 Report option allows printing of a subject’s report to the internal printer (see Section 5.3). 7. Configuration - allows the user to: • carry out a calibration verification (Section 5.5), • configure reports (Section 5.3), •...
  • Page 12 A Global Leader in Respiratory Diagnostics Testing 1. Select ‘VC Test’ or ‘FVC Test’ from ‘Spirometry’ in the Main Menu. 2. Select how the results should be presented by scrolling across the screens or pressing the circles at the top of the screen: •...
  • Page 13 Alpha - Instructions for Use 09060 Issue 9 k. Click on for quality information and test acceptability. Acceptability may be changed from ‘Auto’ to ‘Accepted’ or ‘Rejected’. Click again to exit. Note: A single-breath VC technique may also be performed on the device. FVC test session: a.
  • Page 14 A Global Leader in Respiratory Diagnostics ≥ 2 acceptable OR 1 > 0.250 L N/A > 0.200 L* N/A acceptable 0 acceptable AND ≥ 1 usable 0 acceptable and 0 usable Table 1 – Grades *Or 10% of the highest value, whichever is greater; applies for age ≥5yr and ≤6yr. Saving the Test Session The device has capacity to store at least 20,000 tests, with a maximum of 8 blows allowed for each test session.
  • Page 15 Alpha - Instructions for Use 09060 Issue 9 3. A warning prompt will appear on screen advising on the next steps in the redesignation process. Select the green arrow to continue with redesignation of the test or go back to select a different test. Note: If Test 1 of a Pre test is selected to be redesignated to a Post test, then all tests in that session will be redesignated.
  • Page 16 A Global Leader in Respiratory Diagnostics from pre-defined comments as per ATS/ERS 2019. Select again to save and close. The icon in the top right corner displays the session information, quality, and interpretation. Select again to close. GOLD ATS/ERS Interpretation Gold 2019: Global strategy for the diagnosis management and prevention of COPD. Base FVC Interpretations algorithm. Page 16 of 48 TMP-10002-20...
  • Page 17 Alpha - Instructions for Use 09060 Issue 9 Post FVC interpretation algorithm. Page 17 of 48...

  • Page 18: Reporting

    If a permanent record is required, photocopy the thermal printout or send the report to the Device Studio Utility. 5.3.2. External Printer via Vitalograph Device Studio The device can print to an external printer using the Device Studio application.
  • Page 19 Alpha - Instructions for Use 09060 Issue 9 Figure 7 3. Device Studio will search for assessments on the device (see Figure 7) Available assessments are shown on screen and may be selected and printed and/or saved (see Figure 8). Page 19 of 48...

  • Page 20: Deleting Stored Subjects

    A Global Leader in Respiratory Diagnostics Figure 8 4. Device Studio may also be used to print/save calibration verification reports and to update device firmware. 5. When finished with Device Studio click on the ‘Disconnect Device’ option in the application menu before disconnecting the USB cable/ device. Note: If the USB cable/device is disconnected prior to clicking the ‘Disconnect Device’ option the device will restart. Additional guidance on using Device Studio can be found in the Instruction for Use 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...

  • Page 21: Calibration Verification

    3% (2.5% for the device with an additional 0.5% allowed for the syringe). 1. Attach flowhead to the syringe with a BVF fitted as per figure 9. Note: If using a Vitalograph syringe, adaptors are supplied with the syringe for connection between BVF and syringe, if required. Figure 9 2.

  • Page 22: Connection To Electronic Medical Records (Emr) Via Vitalograph Connect

    EMI (Electromagnetic Interference) is suspected or possible. 5.6. Connection to Electronic Medical Records (EMR) via Vitalograph Connect Connection to an EMR system may be achieved using the Connect service. This is available on the Flash Drive PN 93002 supplied with the device.
  • Page 23 Alpha - Instructions for Use 09060 Issue 9 • Connect Configuration On the main menu select ‘Connect Config’ The following information is required: Address: URL for the Connect service http://{host}[:{port}]/connect Network information: Three options – disabled, wired or wireless. Figure 10 Page 23 of 48...
  • Page 24 A Global Leader in Respiratory Diagnostics 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. 2. Select the required network and enter passkey. The ‘Advanced’ option allows the user to add/edit the advanced network details if required. The wireless security measures will be determined by the local IT infrastructure, the available options for the Alpha are None (open network), WPA-PSK, WPA-EAP, IEEE8021X 3.
  • Page 25 Alpha - Instructions for Use 09060 Issue 9 Figure 11 2. When connected, a wired Ethernet symbol displays in the status bar, top left. Once Connect is configured, the Main menu offers Subject, Quick Test, Configuration and Connect options. (See Section 5, Figures 3 and 4).

  • Page 26: Passcode

    A Global Leader in Respiratory Diagnostics c. New Orders To process a new order, go to the ‘New Orders’ tab, select the order required and press the ‘Start Testing’ button (see Return Unsolicited). The subject information displays. Review and press the green forward button to proceed with a test. The main test menu displays. Select ‘Spirometry’...

  • Page 27: Incentives

    Note: Ensure the version of Spirotrac running is 6.7 or later and device is updated to v1.07 or later. Once switched on and in main screen, the Vitalograph Alpha device is ready for use with Spirotrac. Uploading subject(s) from Spirotrac to Vitalograph Model 6000 Alpha Note: Ensure the device is on the main screen.
  • Page 28 Create new Subject – this will add a new subject to the device. c. Skip – no subject demographics is transferred to the device. Downloading subject(s) from Vitalograph Model 6000 Alpha to Spirotrac Note: Ensure the device is on the main screen.

  • Page 29: Cybersecurity Considerations

    The application runs on top of the OS and is the only user interface to the device. 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 30: Battery Pack

    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 31: Cleaning & Hygiene

    8. Cleaning & Hygiene 8.1. 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. The interior of a Vitalograph flowhead does...

  • Page 32: Inspection Of The Vitalograph Model 6000 Alpha

    A Global Leader in Respiratory Diagnostics 8.2. 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. For the healthcare professional a visual inspection is recommended on a routine basis. Examine cone and flow conditioning mesh filter for damage or contamination. If it is damaged or blocked, it should be replaced with a new part.

  • Page 33: Fault Finding Guide

    Alpha - Instructions for Use 09060 Issue 9 9. Fault Finding Guide • Calibration verification variations > +/-3% Problem Fault 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. Over 25%, the user should contact technical support.

  • Page 34: Software Check

    Reference Section 5.5 Calibration Verification for details on how to check the device flowhead. As the main battery pack ages, the required charging frequency will increase, and the battery life will decrease. Vitalograph recommend changing the battery pack every 3 years or when the product useful life checks indicate it is required. Page 34 of 48 TMP-10002-20...

  • Page 35: Customer Service

    Any serious incident that has occurred in relation to the device should be 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.

  • Page 36: Disposal Instructions

    A Global Leader in Respiratory Diagnostics 12. Disposal Instructions 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.

  • Page 37: Description Of The Vitalograph Model 6000 Alpha

    MR Unsafe – Do not use this device in an MRI environment. 14. 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 38: Technical Specifications

    A Global Leader in Respiratory Diagnostics 15. Technical Specifications Product Vitalograph Model 6000 Alpha Flow Detection Principal Fleisch type pneumotachograph Volume detection Flow integration sampling @ 100Hz Maximum test duration 90 seconds Power supply: Voltage/Frequency Input 100-240V, 50/60Hz, 0.5A Output 12V, 1.5A Battery: 7.2V, 2.2Ahr Volume Accuracy ±2.5% ATS/ERS 2019, ISO 26782...
  • Page 39 Alpha - Instructions for Use 09060 Issue 9 WiFi 802.11bgn Module: WL1831MOD Wi-Fi Texas Instruments Certified/ approved FCC, IC, ETSI/CE, Japan MIC. FCC ID: Z64-WL18SBMOD Wireless Technology IC: 451I-WL18SBMOD MIC (Japan): 201-135370 Frequency 2.4-GHz (2412 – 2484 MHz). Maximum RMS output power measured at 1dB: 17.3dBm Power Supply 12V, 1.5A DC power supply 7.2V, 2.2Ahr NiMh battery Essential Performance Flow measurement output Essential Performance Flow Accuracy ±10% or ±20 L/min, whichever is greater...

  • Page 40: Electromagnetic Compatibility (Emc) Standards

    Vitalograph Model 6000 Alpha to the Medical Devices Directive of the European Community. The Vitalograph Model 6000 Alpha was tested in accordance with: EN 60601-1:2006 + A1:2013 + A2:2021with US deviations - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
  • Page 41 Alpha - Instructions for Use 09060 Issue 9 EN 60601-1-2:2015 + A1:2021 - Immunity tests Compliance level Immunity test Test level Reached Electrostatic discharge Contact: ± 8 kV Air: ± 2 kV,± Contact: ± 8 kV (ESD) 4 kV, Air: ± 2 kV,± 4 kV, EN 61000-4-2 ±...

  • Page 42: Fda Notice

    Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. Loss or degraded performance due to EMI that exceeds the test levels in immunity test tables above will result in a failed calibration verification.

  • Page 43: Regulatory Information

    09060 Issue 9 18. Regulatory Information 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 44: Guarantee & Free Five-Year Warranty

    A Global Leader in Respiratory Diagnostics 19. 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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