Vitalograph COMPACT 6600 Instructions For Use Manual
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Vitalograph COMPACT 6600 Instructions For Use Manual

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COMPACT
MODEL 6600
Instructions for Use
© Copyright Vitalograph 2020 Current Edition (Issue 2, 17-Jun-2020) Cat. No. 09240

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Summary of Contents for Vitalograph COMPACT 6600

  • Page 1 COMPACT MODEL 6600 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 2, 17-Jun-2020) Cat. No. 09240...
  • 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

    COMPACT - Instructions for Use 09240 Issue 2 Contents Main Components of the Vitalograph COMPACT ......4 1.1. Features of the Vitalograph COMPACT ........4 Setting Up the Vitalograph COMPACT ..........5 2.1. Vitalograph COMPACT Communications ........6 Operating Instructions ...............6 Power Management ................6 Cleaning &...

  • Page 4: Main Components Of The Vitalograph Compact

    A Global Leader in Respiratory Solutions 1. Main Components of the Vitalograph COMPACT Figure 1 Main components of the COMPACT Power Supply Power LED I/O Ports - 4 x USB, 2 x Ethernet, 2 x Serial, 1 x DVI Flowhead...

  • Page 5: Setting Up The Vitalograph Compact

    •  Maximum Voluntary Ventilation (MVV) Test 2. Setting Up the Vitalograph COMPACT 1. Attach the flowhead to the Vitalograph COMPACT using the dual silicone tubing (Flowhead Connection Tube). Ensure that the ribbed tapping on the flowhead is connected to the ribbed side of the connection in the housing.

  • Page 6: Vitalograph Compact Communications

    Alternatively a USB enabled keyboard may be used. 4. Power Management The Vitalograph COMPACT must be powered using the 19V low voltage Power Supply unit supplied with the device. When powered and switched ON the LED on the front of the device will be green. The Power Supply unit should be checked regularly and replaced when necessary.

  • Page 7: Cleaning & Hygiene

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

  • Page 8: Fault Finding Guide

    Possible Solutions:  Ribbed side of tubing should be connected (In probable order) to ribbed half of the connector on the Vitalograph device. Problem Fault Symptoms: • Incorrect or no volume measurements • Ensure tubing is connected correctly. Ribbed side of tubing should be connected to the ribbed half of connector on the Possible Solutions: ...

  • Page 9: Software Check

    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 10: Disposal

    A Global Leader in Respiratory Solutions 42084 Flow Conditioning Meshes (10) 67252 USB Cable 67181 COMPACT 19V Power Supply 61030 Flowhead Complete 42029SPR Flowhead Connection Tube 41530 Bluetooth Dongle Compatible 41300 12-Lead BT ECG (IEC) Devices 41303 12-Lead BT ECG (AHA) 70453 Pulse Oximetry Finger Probe USB 79400...

  • Page 11: Description Of The Vitalograph Compact

    11. Description of the Vitalograph COMPACT The Vitalograph COMPACT is a desktop medical workstation designed for use by trained medical professionals for physiological measurements in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centres.

  • Page 12: Indications For Use

    A Global Leader in Respiratory Solutions 11.1. Indications for Use Vitalograph COMPACT is intended for use by, or on the order of, a physician in a hospital or clinic setting. It is designed for use on both adult and paediatric patients.

  • Page 13: Contraindications, Warnings, Precautions And Adverse Reactions

    1. No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph COMPACT 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 COMPACT is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.

  • Page 14: Ce Notice

    Vitalograph Model 6600 COMPACT to the Medical Devices Directive of the European Community. The Vitalograph Model 6600 COMPACT 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 15 COMPACT - Instructions for Use 09240 Issue 2 The Model 6600 COMPACT has been tested in accordance with: EN 60601-1:2006 + A1:2013 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance EN 60601-1-2:2015-Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

  • Page 16: 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 17: Eu Declaration Of Conformity

    09240 Issue 2 16. EU Declaration of Conformity Product: 6600 Vitalograph Compact 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 18: 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 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.
  • Page 19 COMPACT - Instructions for Use 09240 Issue 2 Page of 20...

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