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FINAPRES NOVA
BASIC USER MANUAL
Document ID: 0283-02-001-EN (910700)
Version 1.9
Version date: 04 April 2016

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Summary of Contents for FINAPRES NOVA

  • Page 1 FINAPRES NOVA BASIC USER MANUAL Document ID: 0283-02-001-EN (910700) Version 1.9 Version date: 04 April 2016...
  • Page 2  Additional manuals of optional hardware modules and software applications Copyright © Finapres Medical Systems B.V. All rights reserved. No part of this publication may be reproduced, stored in database or retrieval system, or published, in any form or in any way, electronically, mechanically, by print, photo print, microfilm or any other means without prior written permission from the manufacturer.
  • Page 3 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 4: Customer Support

    The year of manufacture of the Finapres Nova is mentioned on the identification plate at the back side of the device. An example of a Finapres Nova identification plate is shown below. Figure C-1: Identification plate of the Finapres Nova If accessories for Finapres Nova are needed, such as extra cuffs please contact the Finapres Medical Systems B.V Sales Department:...
  • Page 5 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 6: Warranty

    Warranty Finapres Medical Systems B.V. issues a 12 month guarantee on the Finapres Nova. This guarantee is only valid if the Finapres Nova is operated in accordance with the specifications and the instructions for use and maintenance. The guarantee of the Finapres Nova is void in the event of: ...
  • Page 7 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 8: Disclaimer

    Finapres Medical Systems B.V. is not liable for unsafe situations, accidents and injury or damage which are caused by:  Neglecting warnings or prescriptions as shown on the Finapres Nova or stated in this Basic User Manual and/or additional hardware and software manuals. ...
  • Page 9 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 10: Preface

    This Basic User Manual informs the user about the safe operation and everyday maintenance of the Finapres Nova. Read this Basic User Manual carefully before starting to use the Finapres Nova. Only then optimal safety can be obtained. Operation (and everyday maintenance) of the Finapres Nova may only be done by qualified personnel.
  • Page 11 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 12: Table Of Contents

    Package contents ..................... 23 3.2 Installation....................... 23 3.2.1 Finapres Nova ....................23 Finapres Nova description ............25 4.1 Description of the Finapres Nova ................ 25 4.2 Connections and controls ..................25 4.2.1 Accessories ...................... 26 4.3 Graphical user interface ..................27 Operation ..................
  • Page 13 Basic user manual Finapres Nova 5.4.4 Actions during a measurement ................. 33 5.4.5 Stopping the measurement ................34 5.4.6 Disconnecting the patient .................. 34 5.5 Reviewing a measurement ................... 35 5.6 Selecting a user profile..................37 5.7 Measurement settings ................... 37 5.8 File management ....................
  • Page 14 Basic user manual Finapres Nova A3.1.3 Cuff application ....................94 A3.2 Connecting the height correction unit ................. 95 Version date: 04 April 2016...
  • Page 15 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 16: Introduction

    Finapres Nova Introduction Finapres Nova The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject’s finger. The Finapres NOVA...
  • Page 17: Intended User

    The Finapres Nova is used in a professional medical environment (i.e. hospitals, clinics and research institutions etc.). The Finapres Nova is suitable for use in an operating room in the non-sterile zone. The Finapres Nova is not intended for use in an oxygen rich environment.
  • Page 18: Accessories

    Finapres Nova  The Finapres Nova has a protection degree against harmful ingress of water or particulate matter of IP31. This means that the Finapres Nova is protected against ingress of solid foreign objects having a diameter of ≥2,5 mm and against harmful effects of dripping water per IEC 60529.
  • Page 19 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 20: Warnings And Safety Precautions

    Basic user manual Finapres Nova Warnings and safety precautions Safety and precautionary symbols Suggestion to carry out tasks easier. Draws attention to potential problems. Draws attention to the danger of serious injuries to the user or patient if the instructions are not carried out carefully.
  • Page 21: Warnings And Cautions

    Damaged or defective parts should always be replaced before putting the Finapres Nova into use again It is not allowed to make modifications to the Finapres Nova or its software without prior written approval of Finapres Medical Systems B.V.
  • Page 22 Basic user manual Finapres Nova To avoid the Finapres Nova to fall, make sure it is placed on a flat surface. The Finapres Nova should be moved from one location to another using a trolley or similar means After a patient connected to the Finapres Nova is defibrillated, the Finapres Nova needs 5 seconds recovery time.
  • Page 23 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 24: Installation

    Unpacking the Finapres Nova Always check the packing of the Finapres Nova for damage before starting to unpack. In case of damage of the packing contact Finapres Medical Systems B.V. before continuing. 3.1.1 Package contents Verify the contents of the package with the delivery note.
  • Page 25 3. When the Finapres Nova is used in combination with other ME equipment, it is recommended to connect the potential equalization pin to a potential equalization busbar. After installing, always check the functioning of the Finapres Nova before performing a measurement. Version date: 04 April 2016...
  • Page 26: Finapres Nova Description

    Description of the Finapres Nova Figure 4-1: The Finapres Nova Connections and controls On the front, back and on the right side of the Finapres Nova several connections and controls are positioned. Controls on the front On the front of the touch screen you will find the touch ON/OFF touch button:...
  • Page 27: Accessories

    Basic user manual Finapres Nova Connection on the right side The connection of the Frontend Unit can be found on the right side of the Finapres Nova. Figure 4-3: Connection for the Frontend Unit Controls and connections on the back On the back of the housing general connections and the mains switch of the Finapres Nova can be found (Figure 4-4).
  • Page 28: Graphical User Interface

    3. Height correction unit Graphical user interface The Finapres Nova is mainly controlled via its graphical user interface using the touch screen. The graphical user interface allows the operator to set up the Finapres Nova, to perform measurements and to review stored data.
  • Page 29 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 30: Operation

    4. The “MAIN MENU” appears. …or… 5. The “HARDWARE CONFIGURATION” screen will appear when one or more additional modules report an important error 6. To start the Finapres Nova, press the “CONTINUE” button to open the “MAIN MENU” Version date: 04 April 2016...
  • Page 31: Switching Off

    Finapres Nova to “0” Disconnecting from the mains supply If the Finapres Nova will not be used for a longer period or maintenance has to be performed, the Finapres Nova must be disconnected from the mains supply. To disconnect the Finapres Nova from the mains supply:...
  • Page 32: Measuring

    If a measurement is started without a finger in the finger cuff, the finger cuff may be damaged. 5.4.2 Connecting the Frontend Unit To connect the Frontend Unit to the Finapres Nova: Push the plug of the Frontend Unit into the socket on the right side of the Finapres Nova marked with “FRONT END”.
  • Page 33: Starting A Measurement

    START MEASUREMENT” button on the “MAIN MENU” screen. If the HCU is connected for the first time after the Finapres Nova is started up the “ZERO HEIGHT CORRECTION UNIT” screen appears: 2. Follow the instructions on the screen and wait for the status “ZEROED”...
  • Page 34: Actions During A Measurement

     The measurement data is stored on the hard disk of the Finapres Nova. During the measurement all available signals, even those that are not visible on the screen, are recorded. 5.4.4 Actions during a measurement Figure 5-1: “MEASUREMENT” screen with a running measurement While in measurement mode several actions are possible by means of the buttons at the bottom of the screen (e.g.
  • Page 35: Stopping The Measurement

    5.4.6 Disconnecting the patient After the measurement is finished the patient can be disconnected from the Finapres Nova by removing all accessories from the patient. To disconnect the Frontend Unit to the Finapres Nova: Version date: 04 April 2016...
  • Page 36: Reviewing A Measurement

    Basic user manual Finapres Nova 1. Unlatch the plug by pulling the ribbed part a few millimeter backwards 2. Pull the plug of the Frontend Unit out of the socket. When disconnecting, pull on the plug itself, not on the cable.
  • Page 37 Basic user manual Finapres Nova 2. Select a file. 3. Press the “OPEN” button.  The “REVIEW MEASUREMENT” screen is opened and the data of the selected file is loaded. Figure 5-2: “REVIEW MEASUREMENT” screen with a measurement loaded When a measurement is opened it is fully zoomed out so that the entire measurement is visible.
  • Page 38: Selecting A User Profile

    Basic user manual Finapres Nova Selecting a user profile The appearance of the measurement and review screen is stored in user profiles. For creating, copying, renaming and deleting user profiles see A1.4.2. 1. Press the “MANAGE USER PROFILES” button of the “MAIN MENU”.
  • Page 39: File Management

    Basic user manual Finapres Nova In the “MEASUREMENT SETTINGS” screen, settings for “WAVEFORM GRAPHS”, “TREND GRAPHS”, “NUMERIC VALUES”, “SIGNAL SETTINGS” and “MARKER DEFINITIONS” can be made (A1.4.4). If the measurement settings are changed, the new settings will be stored to the currently active user profile and will immediately be visible in the “MEASUREMENT”...
  • Page 40: Maintenance & Cleaning

    Cleaning The Finapres Nova should be cleaned after each day of use. The Finapres Nova can be cleaned by whipping its surface using a soft, slightly moistened cloth. Cleaning fluid or any liquid should not be sprayed directly onto the device or its units.
  • Page 41 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 42: Transport And Storage

    Use, if possible, the original cardboard box and protection buffers to avoid damage during transport. If this is not available make sure that the used box is compatible with the Finapres Nova and packed securely to help assure safe transportation, keeping in mind ordinary care in handling by couriers.
  • Page 43 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 44: Appendix 1 Graphical User Interface

    Basic user manual Finapres Nova Appendix 1 Graphical user interface A1.1 General screen description Figure A1-1: General screen description All screens of the graphical user interface consist of a STATUS BAR (1) on top of the screen and a CONTENTS BOX (2) in the middle (see Figure A1-1).
  • Page 45: A1.2 On-Screen Keypad

    MAIN MENU loaded. A1.2 On-screen keypad To be able to enter text in text fields, the Finapres Nova graphical user interface is provided with an on-screen keypad. This on-screen keypad shows up automatically after a text box is touched (see Figure A1-3).
  • Page 46 Opens the SYSTEM SETTINGS SCREEN. Refer to A1.4.6 for more information. When additional applications are available on the Nova, these are accessible via an additional button. When only one application is available, this button is replaced by the button specific for that application.
  • Page 47: A1.4 Setup And Start Measurement

    Basic user manual Finapres Nova A1.4 Setup and start measurement The SETUP AND START MEASUREMENT option on the MAIN MENU SCREEN opens the first preparation screen of the measurement procedure. The procedure starts with showing the “ZERO HEIGHT CORRECTION UNIT”...
  • Page 48 Continues to the next step of the measurement preparation procedure. When no Height Correction Unit is connected to the Finapres Nova, the “ZERO HEIGHT CORRECTION UNIT (HCU)” screen will instruct the user to keep the hand of the patient at heart level during the measurement.
  • Page 49 Basic user manual Finapres Nova Figure A1-7: The “PREPARE MEASUREMENT” screen The elements of the second “PREPARE MEASUREMENT” screen have the following meaning: Item Description Measurement settings Opens the MEASUREMENT SETTINGS screen that allows the user to review and change the measurement settings (these are automatically stored in the user profile).
  • Page 50 Basic user manual Finapres Nova Patient data PATIENT, PHYSICIAN, PROCEDURE, GENDER, AGE, WEIGHT, LENGTH, REFERENCE, COMMENTS Fields in which the patient related data is to be entered. The on-screen keypad will appear as soon as a text field is tapped.
  • Page 51 Basic user manual Finapres Nova Figure A1-8: The “MEASUREMENT” screen The “MEASUREMENT” screen is divided into four parts (see Figure A1-8): Trend Graphs In this area the trend graphs defined in the “MEASUREMENTS SETTINGS” screen (refer to A1.4.3) are shown.
  • Page 52 Basic user manual Finapres Nova Item Description The marker will appear on the time index the MARKER LIST button was pressed. In review mode the marker can be renamed if desirable. SCREEN SHOT Takes a screen shot. The picture will be saved with the actual date and time as filename in the subfolder Screenshots in the measurement data folder.
  • Page 53 Basic user manual Finapres Nova Item Description QUICK MENU TOGGLE A selection menu that allows the operator quick access to several functions and settings The controls of the “QUICK MENU TOGGLE” have the following functionality: Item Description MAIN MENU Opens the “MAIN MENU” screen...
  • Page 54 Basic user manual Finapres Nova Item Description NIBP FINGER STOP Stops the finger blood pressure measurement. This action does not affect the state of recording. NIBP ARM START Starts the upper arm blood pressure measurement. NIBP ARM STOP Stops the upper arm blood pressure measurement.
  • Page 55: A1.4.1 Review Measurement

    Basic user manual Finapres Nova A1.4.1 Review measurement Figure A1-9: The “REVIEW MEASUREMENT” screen The “REVIEW MEASUREMENT” is divided into four parts: Trend Graphs In this area the trend graphs defined in the “MEASUREMENTS SETTINGS” screen (refer to A1.4.4) are shown.
  • Page 56 Basic user manual Finapres Nova Item Description MARKER LIST Shows a list of the present markers. Enables the user to alter the marker descriptions and to delete markers. MARKER LIST BUTTONS By means of the buttons the user can quickly move to the previous or next marker in the recording without having to zoom out.
  • Page 57: A1.4.2 Manage User Profiles

    Basic user manual Finapres Nova Item Description HIGHLIGHT LIST Shows a list of the highlights. Enables the user to alter the highlight descriptions and to delete highlights. By means of the button one can move quickly from highlight to highlight.
  • Page 58 MEASUREMENT SETTINGS Opens the “MEASUREMENT SETTINGS” screen that allows the user to review and change the user bound measurement settings. CHOOSE APPLICATION Some Finapres NOVA applications require application-specific Version date: 04 April 2016...
  • Page 59: A1.4.3 Finger Cuff Settings

    Basic user manual Finapres Nova Item Description settings. These can be accessed by selecting the application and then pressing the button MEASUREMENT SETTINGS. Application-specific settings will be addressed in their respective manuals. General settings can be altered by selecting NovaScope and pressing the MEASUREMENT SETTINGS button.
  • Page 60: A1.4.4 Measurement Settings

    Basic user manual Finapres Nova The elements of the “CUFF SETTINGS” screen have the following meaning: Item Description SINGLE CUFF OR DUAL CUFF MEASUREMENT Allows the operator to choose between single and dual cuff measurements CUFF SELECTION Only visible when a single cuff measurement is selected.
  • Page 61 Basic user manual Finapres Nova Figure A1-12: The “MEASUREMENT SETTINGS” screen, waveform tab Item Description WAVEFORM GRAPH Shows the different waveform graphs that will be visible on the MEASUREMENT screen and REVIEW MEASUREMENT screen. With the buttons it is possible to add and remove graphs to the screen.
  • Page 62 Basic user manual Finapres Nova Item Description AVAILABLE SIGNALS Shows all signals that can be displayed in the waveform graphs. The signals are sorted per available module or application. Moves the selected signals from the available signals to the visible signals...
  • Page 63 Basic user manual Finapres Nova Figure A1-13: The “MEASUREMENT SETTINGS” screen, trend graph tab Item Description TREND GRAPH Shows the different trend graphs that will be visible on the MEASUREMENT SCREEN and REVIEW MEASUREMENT SCREEN. With the buttons it is possible to add a graph to the screen.
  • Page 64 Basic user manual Finapres Nova Item Description AVAILABLE SIGNALS Shows all signals that can be displayed in the trend graphs. The signals are sorted per available module or application. Moves the selected signals from the available signals to the visible signals...
  • Page 65 Basic user manual Finapres Nova Item Description NUMERIC VALUES Shows the different signals that will be shown as numeric values. AVAILABLE NUMERIC VALUES Shows all values that can be displayed as numeric values. The signals are sorted per available module or application.
  • Page 66 Basic user manual Finapres Nova Figure A1-15: The “MEASUREMENT SETTINGS” screen, signal settings tab Item Description AVAILABLE SIGNALS Shows how the available signals will be represented on screen and after printing. When selecting a signal, the settings can be changed in the SIGNAL PROPERTIES window below.
  • Page 67 Basic user manual Finapres Nova Item Description linked to the first one and only one y-scale will appear in the graph) COLOR and STYLE Allows the user to select the color and style of the selected signal both on screen and for printing Figure A1-16: The “MEASUREMENT SETTINGS”...
  • Page 68: A1.4.5 File Management

    Item Description setting the marker when pressing that key. A keyboard and mouse can be connected to the Finapres NOVA using a USB hub. USB ports can be found at the back side of the device. A1.4.5 File management By means of the “FILE MANAGEMENT” screen the files containing the measurement data can be opened for reviewing or deletion.
  • Page 69 Basic user manual Finapres Nova Item Description Controls of the panes BROWSE Opens a pop-up that allows the user to select the directory to be shown in the pane. When needed, a new directory can be created by pressing the button .
  • Page 70: A1.4.6 System Settings

    Basic user manual Finapres Nova A1.4.6 System settings Figure A1-18: The “SYSTEM SETTING” screen The items of the SYSTEM SETTINGS SCREEN have the following meaning: Item Description REGIONAL SETTINGS Opens the “REGIONAL SETTINGS” screen. HARDWARE Opens the “HARDWARE” screen. SOFTWARE Opens the “SOFTWARE”...
  • Page 71 Through the tab column of the “HARDWARE” screen gives the user access to:  Status The “STATUS” tab of the “HARDWARE” screen shows the presence and status of the (optional) hardware of the Finapres Nova.  Network The network tab displays the network information and allows the user to setup the network connection.
  • Page 72 Basic user manual Finapres Nova  Maintenance Gives access to the maintenance screens of the Finapres Nova. The “Maintenance” screen is restricted to Finapres Service personnel. Via the maintenance tab a user can download logfiles if so requested for by service personnel.
  • Page 73 Basic user manual Finapres Nova Item Description SYSTEM NAME Displays the name with which the Finapres Nova will appear on the network WEBSERVICE When the webservice checkbox is selected, it becomes possible to remotely access the Finapres Nova to download measurement data via the indicated web address and port.
  • Page 74 Finapres Nova are  Canon MX520 series  Canon MX530 series  HP Envy 5640 series Other printerdrivers can be created by Finapres Medical Systems upon request Uninstalls the selected printerdriver Version date: 04 April 2016...
  • Page 75 Displays the current and previous version of the installed software, and allows the user to install new versions.  License Displays the license information of the software of the Finapres Nova and enables the user to enter a new license code to unlock software functions.  Company Logo...
  • Page 76 Basic user manual Finapres Nova Figure A1-24: The “SOFTWARE” screen – current version tab Item Description Shows software installation files available on a connected USB drive Refreshes the list of available software installation files Installs the selected software installation file.
  • Page 77 Basic user manual Finapres Nova Figure A1-25: The “SOFTWARE” screen – license tab Item Description INSTALL LICENSE Allows the user to install a new license code from a license file to unblock software functions. When the button is pressed a location on an external drive can be selected in which the license file is located.
  • Page 78 USB drive Refreshes the list of available logo picture files on USB disk Installs the selected logo Sets the default Finapres Medical Systems logo Allows the user to enter the company name, which is used for printing...
  • Page 79 Basic user manual Finapres Nova Figure A1-27: The “SOFTWARE” screen – encryption tab Item Description Allows the user select the drive to create an encrypted drive on (if not present) or to mount (if the drive has an encrypted partition)
  • Page 80: A1.5 Basic Warnings And Error Messages

    A1.5 Basic warnings and error messages This paragraph describes the warnings and error messages that might be shown on the display of the Finapres Nova: The following warnings will appear in the “HARDWARE CONFIGURATION” screen or in the status bar.
  • Page 81 If the error persists, have the device checked by Finapres Medical Systems B.V.. The module is connected Please reconnect Finapres Nova is in an  Reconnect the Frontend Frontend Unit error state that can only Unit. be resolved by If the error persists, have...
  • Page 82 Basic user manual Finapres Nova Status Description Action Zeroing Failed HCU zero-ing failed  Try again  Try another HCU If the error persists, have the device checked by Finapres Medical Systems B.V. The following warnings and error messages will appear in the STATUS BAR.
  • Page 83 Basic user manual Finapres Nova Warnings Description Action  Warm the hand. Temperature high High internal temperature  Turn off the device.  Make sure the rear end of the device has access to fresh air (i.e. don't use the device inside a closed cabinet).
  • Page 84 If the error persists, have stable enough. the device checked by Finapres Medical Systems B.V. Reconnect Frontend Finapres Nova is in an  Reconnect the Frontend error state that can only Unit. be resolved by If the error persists, have...
  • Page 85 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 86: Appendix 2 Technical Specifications

    Cuff pressures on the finger up to 350 mmHg are practically painless and do no harm unless applied for long periods. Electrical circuits of the Finapres Nova do not touch the skin, and are not in contact with body fluids. The following measures are taken for the safety and comfort of the patient monitored and the convenience of the operator.
  • Page 87: A2.2.3 Cuff Pressure

     Fully contracted finger arteries do not allow pressure monitoring. A warning is send to the Finapres Nova and the finger cuff is depressurized when this is detected. The Finapres Nova waits maximally 100 s and starts up again. A2.3 Signals The table below gives an overview of the available signals.
  • Page 88: A2.4 Technical Description

    USB port. When a USB drive has caching enabled and has been removed improperly from a computer/device it may no longer be recognized by the Finapres NOVA. Please ensure that the used USB storage device has caching turned  ...
  • Page 89: A2.4.3 Electrical

    Basic user manual Finapres Nova A2.4.3 Electrical Power cord: IEC 60320 C13 to local mains plug AC power: 100 - 240 Vac, 50 / 60 Hz, 2A - 1A Protection against electric According EN 60601-1 shock: Degree of protection: Finger cuff, HCU, type B applied part...
  • Page 90: A2.4.5 Emc Guidance And Manufacturer's Declaration Tables

    Guidance and manufacturer's declaration - electromagnetic emissions The Finapres Nova is intended for use in the electromagnetic environment specified below. The customer or the user of the Finapres Nova should assure that it is used in such an environment. Emissions test...
  • Page 91 Guidance and manufacturer's declaration - electromagnetic immunity The Finapres Nova is intended for use in the electromagnetic environment specified below. The customer or the user of the Finapres Nova should assure that it is used in such an environment. Immunity test...
  • Page 92 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Finapres Nova is used exceeds the applicable RF compliance level above, the Finapres Nova should be observed to verify normal operation.
  • Page 93 Basic user manual Finapres Nova Version date: 04 April 2016...
  • Page 94: Appendix 3 Connecting The Patient

    Appendix 3 Connecting the patient A3.1 Using finger cuffs Proper finger cuff application is critical to the success of the Finapres Nova finger arterial pressure measurement. Therefore read the following sections about finger cuff selection, handling and application with care! A3.1.1...
  • Page 95: A3.1.2 Notes On Cuff Handling

    Don't remove the finger cuff from a finger before stopping the measurement or before disconnecting the air hose from the Frontend Unit. You may damage the finger cuff even though Finapres Nova automatically takes pressure away when the finger cuff unwraps.
  • Page 96 Basic user manual Finapres Nova Figure A3-3: Connecting the finger cuffs to the Frontend Unit 7. Repeat step1 to 6 for a second finger, when finger switching measurement mode has been selected. Make sure to connect a finger cuff to the air and electrical connections that are positioned above each other on the Frontend Unit.
  • Page 97 Basic user manual Finapres Nova 3. The other ending of the height correction unit, the transducer ending, should be fixed to one of the finger cuffs. Version date: 04 April 2016...
  • Page 98 Basic user manual Finapres Nova Cleaning ......39 height correction unit....95 Connecting the patient .... 93 Maintenance ......39 Disclaimer ......7 measurement ....16, 21 Error message Status bar ..81 Measuring ......31 Check air supply ....82 Connecting the Frontend Unit 31 Error messages hardware ..

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