Operators Manual
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GE Healthcare
MAC™ VU360 Resting ECG Analysis System Operator's Manual Version 1.01 2088531-001D
Familiarize yourself with this information before attempting to use this system. Keep this manual with your Regulation and Safety Manual and equipment at all times, and periodically review it.
MAC™ VU360 Resting ECG Analysis System Operator's Manual English © 2017-2018 General Electric Company. All Rights Reserved.
Publication Information This document describes version 1.01 of MAC™ VU360 Resting ECG Analysis System, also referred to as the “product” or "system" or "device". It does not apply to earlier product versions. Due to continuing product innovation, specifications in this document are subject to change without notice. MUSE, MAC, MARS, CASE, CardioSoft and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners. This product complies with the requirements concerning medical devices from the following regulatory bodies.
Date of first CE mark - 2018. The MAC VU360 Resting ECG Analysis System is intended to be used, under the direct supervision of a licensed healthcare practitioner by trained operators in a hospital or facility providing patient care. This document provides information required for the proper use of the system. Familiarize yourself with this information and read and understand all instructions before attempting to use this system. Keep this document with the Regulatory and Safety manual, and with the equipment at all times, and periodically review it. NOTE: Illustrations in this document are provided as examples only. Depending on system configuration, screens in the document may differ from the screens on your system. Patient names and data are fictitious. Any similarity to actual persons is coincidental. The document part number and revision are on each page of the document. The revision identifies the document’s update level. The revision history of this document is summarized in the following table. Revision
Date
Comment
A
30 August 2017
Initial Release
B
15 January 2018
Customer Release
C
22 February 2018
Updated ECG specifications
D
30 March 2018
Updated the following information: •
Support to open multiple applications via the Citrix server
•
Displaying institution name on ECG reports
•
Printing barcode on ECG reports
•
User-initiated system restore to reset Admin password
•
User privileges to restrict access to view network details
To access other GE Healthcare Diagnostic Cardiology documents, go to the Common Documentation Library (CDL), located at http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library, and click Cardiology. To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website. Third-party Licenses This product includes software developed by: •
Linux Kernel organization (https://www.kernel.org)
•
NXP Semiconductors (https://www.nxp.com)
•
Apache Software Foundation (http://www.apache.org)
•
OpenSSL.org (http://www.openssl.org)
•
GNU Foundation packages (https://www.gnu.org)
•
Gentoo software (https://packages.gentoo.org)
•
Boost Libraries (http://www.boost.org)
•
POCO Project (https://pocoproject.org)
•
Debian packages (https://packages.debian.org)
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Yocto project packages (https://www.yoctoproject.org)
•
Freedesktop.org (https://www.freedesktop.org)
•
Busybox project (https://busybox.net)
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bzip.org (http://www.bzip.org)
•
FreeType project (https://www.freetype.org)
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OpenBSD Project (https://www.openbsd.org)
•
netfilter.org project (http://www.netfilter.org)
•
OpenLDAP Project (https://www.openldap.org)
•
ws4d.org (http://ws4d.org/projects)
•
JS Foundation (https://js.foundation)
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ANGULARJS (https://angularjs.org)
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QT-labs (https://github.com/qt-labs)
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Massachusetts Institute of Technology (https://web.mit.edu)
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Cyrus IMAP org (https://www.cyrusimap.org)
License details of the software used in the product can be viewed in the online help in the Open Source Licenses section. Contact GE Service to obtain the source code of the open-source software used in the product, if required. Support GE Healthcare maintains a trained staff of application and technical experts to answer questions and to respond to issues and problems that may arise during the installation, maintenance, and use of this product. If you require additional assistance, contact your GE Healthcare representative or GE Healthcare support at one of the following numbers: •
North America: 1-800-558-7044
•
Europe: +49 761 45 43 -0
•
Asia: +86 21 3877 7888
Training This document is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the use of the product, you should request training assistance from GE Healthcare. To see available training, go to the GE Healthcare training website (www.gehealthcare.com/training). Select Education > Product Education-Technical > Diagnostic Cardiology. For more self-paced course offerings, tools, and reference guides you may find useful, please visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.
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Contents Publication Information... 2 1
Product Overview... 7
2
Login and Security... 19
3
Patient Information...28
4
Recording an ECG or Rhythm...37
5
Working with Orders... 60
Front and Rear View... 7 Keyboard... 8 Acquisition Screen Overview... 10 User Menu Options Description... 12 Displaying Battery Status...14 Viewing Status of Network Connection...16 Changing the Brightness of the Screen... 17
Turning On the ECG Device...19 Turning Off the ECG Device...19 User Authentication... 20 Changing the User Password...24 Activating or Deactivating Privacy Mode... 25 Locking the Device... 25 Unlocking the Device...25 Putting the Device on Standby...26 Performing System Restore...26
Patient Information Screen Overview... 28 Starting a Test for a New Patient... 30 Updating Information in the Patient Information Screen... 31
Hookup Advisor Overview...37 Changing Lead Sets and Lead Formats... 41 Enabling ACS Interpretation...41 Changing Speed, Gain, and Filter...42 ECG Acquisition Overview... 43 Recording a Rhythm... 51 Transmitting a Patient Report to a Configured Destination... 54 Printing a Patient Report... 56 Editing Patient Information in a Patient Report... 57 Deleting a Patient Report...58 Viewing the Patient Report...59 Closing a Patient Report...59
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Automatically Updating the Orders List...63 Manually Updating the Orders List...63 Sorting Orders in the Orders List...63 MAC™ VU360 Resting ECG Analysis System
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Filtering Orders in the Orders List...64 Attaching an Order when the Patient Test is Not Started...65 Attaching an Order to a New Patient Test... 65 Attaching an Order when the Patient Test is Completed... 66 Attaching an Order that is Attached to a Different Patient Test... 67 Changing the Order Attached to a Patient Test...68 Detaching an Order from a Patient Test... 68 Order Status...69
6
Working with the Files List... 71
7
Working with the Queue List... 82
8
Working with the Patients List... 87
9
Working with Remote Applications...90
10
Maintenance...92
11
Cleaning and Disinfection...98
12
Troubleshooting...106
Reviewing a Stored Patient Report...72 Transmitting a Stored Patient Report to a Configured Destination... 74 Printing a Stored Patient Report...76 Editing Patient Information in a Stored Patient Report... 78 Deleting Stored Patient Reports from the Files List...80
Displaying the Report Queue... 84 Deleting Jobs from the Queue... 84 Retrying Transmission of a Patient Report...85
Opening the Patients List... 88 Selecting a Patient from the Patients List...89
Launching a Remote Application... 90 Viewing a PDF in a Remote Application...91
Adjusting the Paper Tray for Paper Size... 92 Storing Thermal Paper...94 Cleaning the Printhead...95 Charging the Battery... 95 Replacing the Battery...96
Cleaning and Disinfecting Guidelines...98 Inspecting the Device...98 Care at the Point of Use...99 Preparation for Cleaning... 99 Visual Inspection, Cleaning and Disinfection Frequency...99 Cleaning and Disinfecting the Acquisition Module...100 Cleaning and Disinfecting the Device and Trolley...101 Cleaning and Disinfecting Leadwires and Reusable Electrodes... 103 Storage...104 Other Cleaning and Disinfection Agents... 104 Additional Information... 105
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System Errors...106 ECG Acquisition Errors...107 MAC™ VU360 Resting ECG Analysis System
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Printing Errors...108 Report Transmission Errors... 110 Wireless Network Connectivity Errors... 112
A: Appendix A: Report Formats...114
ECG Report Formats...114 Rhythm Report Format... 121
B: Appendix B: Patient Preparation...124
Preparing the Patient’s Skin... 124 Electrode Placement... 125
C: Appendix C: Patient Information Fields... 131 Patient Information Fields... 131
D: Technical Specifications... 140
System Specifications...140 ECG Specifications...142 Environmental Specifications...144 Safety Specifications...144 Network Specifications... 145
Glossary... 147
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1 Product Overview The MAC™ VU360 Resting ECG Analysis System, (referred to as "the device" throughout this document), provides 12-lead or 15-lead ECG measurement and interpretative analysis, prints 12-leads or 15-leads of ECG, and provides transmission of ECG data to and from a central ECG cardiovascular information system.
Front and Rear View
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Item
Part Name
Description
1
Acquisition Module
Used to acquire, digitize, and transmit analog ECG signals to the ECG device.
2
Display and Touchscreen
Presents waveform and text data. The touchscreen enables you to interact directly with the device through touch gestures without the use of the keyboard.
3
Standard Keyboard
Used to enter data on the screen or perform functions such as recording or printing an ECG or rhythm. MAC™ VU360 Resting ECG Analysis System
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Product Overview
Item
Part Name
Description
4
Sliding Tray
Used for storage.
5
Integrated Trolley
Used to move the device from one location to another.
6
Front Bin
Used for storage.
7
Front Wheels and Lock
Used to mobilize and lock the trolley in position. The front wheels are fixed wheels and non-conductive.
8
Acquisition Module Cable
Connects the Acquisition Module to the device.
9
Leadwire Cables
Connects the leadwires to the Acquisition Module.
10
AC Power Inlet
Slot to connect the AC power cord.
11
Rear Bin Mounting Bracket
Used to mount the rear bin.
12
Accessory Track
Used to change the position of the rear bin.
13
Rear Wheels and Lock
Used to mobilize and lock the trolley in position. The rear wheels are swivel wheels and conductive.
Keyboard
8
Item Name of Key
Description
1
Powers the device on or off.
Power button
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Product Overview
Item Name of Key
Description
2
ECG
Records an ECG.
3
Rhythm
Starts recording or printing a real-time, continuous rhythm.
4
Stop
Stops printing an ECG or rhythm report.
5
Trimpad
Provides movement through menus and windows.
6
Enter
Use to advance the focus in a window or to select items from the screen.
7
Shift
Use to type a capital letter. For example, press Shift + p to type a capital P.
8
Space bar
Enters a space in the text.
9
Alt
Switches between different international methods of entry (IME) for the Chinese keyboard language.
10
Caps Lock
Capitalizes the letters in a text.
11
Tab
Moves to the next field in a screen. Shift + Tab key moves to the previous field in a screen.
12
Esc
Closes a window on a screen.
13
Battery LED
Indicates various battery states:
14
15
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AC Power LED
Power on LED
Backspace
•
Flashing amber light at two-second intervals indicates that the battery is charging.
•
Flashing amber light at one-second intervals indicates that the battery is critically low.
•
Flashing amber light at half-second intervals indicates that the battery has a communication failure.
•
No light indicates the battery is fully charged, not present, or discharging.
Indicates various AC power states: •
Green light indicates the device is plugged in and receiving power.
•
No light indicates the device is not plugged into AC power.
Indicates if the device is powered on or off: •
Green light indicates the device is powered on.
•
No light indicates the device is off.
•
Flashing green light indicates the device is in standby mode.
Deletes characters or text.
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Product Overview
Acquisition Screen Overview The Acquisition screen is the main screen that displays when you first log into the device, and enables you to obtain an ECG.
Table 1: Acquisition Screen
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Item Name
Description
1
Live tab
Displays the live waveform for the current patient connected to the device.
2
Date and Time
Current local date and time in the configured date and time format. To configure a date and time format, refer to the MAC™ VU360 Resting ECG Analysis System Setup and Configuration Manual.
3
Patient Information Banner
Displays selected Patient Information such as first name, last name, and gender. Select anywhere on the banner to add or edit patient information.
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Product Overview
Item Name
Description
4
•
If order management is enabled, the Orders tab is displayed. Select Orders to open the Orders collapsed list and display a list of currently available orders.
•
If order management is disabled, the Orders tab is not displayed, the Patients tab is displayed. Select Patients to open the Patients collapsed list and display a list of the last 500 patients whose ECGs were taken on the device.
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Select Files to open the Files collapsed list and display the list of stored patient reports.
•
Select Queue to open the Queue collapsed list to see the list of reports in the queue to be transmitted to a configured destination.
Orders/Patients, Files, and Queue tabs
5
Battery or AC Power Icon
Indicates the status of the batteries.
6
Network Status Icon
Indicates the status of the wireless or LAN connection.
7
User Menu
Displays the name of the user logged into the device. When you select the name, the user menu expands and displays the available menu options. Depending on the privileges assigned to your user role, you may or may not have access to some options. If user authentication is disabled or configured with Technician ID access, the Default user will be prompted to log in as a user with sufficient privileges if the user does not have access to a menu option.
8
Start New Patient icon
Allows you to enter patient data for a new patient test.
9
Expand icon
Select the tab (Orders/Patients, Files, or Queue) that you want to expand, and select the Expand icon to open its expanded list.
10
Electrode Placement Image
Select the arrow to expand and view the image that shows the placement of electrodes and the electrode quality of each lead. Each lead quality indicator represented on the image changes to yellow, red or green, based on its connection status. You can enable or disable the auto-expansion of the image. If auto-expansion of the image is enabled:
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Hookup Advisor Lead Quality Status Indicator
•
The image automatically expands if the Hookup Advisor Lead Quality Indicator is yellow or red.
•
The image automatically collapses if the Hookup Advisor Lead Quality Indicator is consistently green for a few seconds.
Displays the overall lead quality status indicator in three circles that change to yellow, red, or green, based on the overall lead quality.
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Product Overview
Item Name
Description
12
Notification Area
Displays messages, such as printing status and progress, report transmission status, and Hookup Advisor lead quality status. Messages are displayed one at a time in the order of occurrence except when a patient is connected and hookup advisor is evaluating the waveform.
13
Remote Applications Panel
Displays remote applications, if they have been configured. If you select the buttons, you will launch the application.
14
Filter, Speed and Gain
Displays the default waveform filter, speed, and gain. To change, select anywhere around the ellipsis icon and select a different value. You can only make a change before you record an ECG. You can make a change before or during the recording of a rhythm. NOTE: Any change to the filter, speed or gain is applicable to the current patient. For a new patient, the values are reset to default settings.
15
Start Rhythm icon
Allows you to print or digitally record a rhythm report.
16
Start ECG icon
Allows you to start recording an ECG.
17
Lead Set and Display Format
Displays the default test type and display format. To change, select anywhere around the ellipsis icon and select a different value. You can only make a change before you record an ECG. You can make a change before or during the recording of a rhythm. NOTE: Any change to the test type and display format only applies to the current patient. For a new patient, the values are reset to the default settings.
User Menu Options Description The following figure illustrates the User Menu located at the top right corner of the Acquisition screen.
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Product Overview
Table 2: User Menu Options Item
Option
Description
1
<User>
Display Name of the currently logged-in user as configured by your administrator. Pre-defined users display as follows:
2
Settings
•
Admin
•
STAT
•
Service
•
Default
Displays the Settings screen used to configure the device. Your administrator must grant you privileges to access this screen. If the user does not have access to the screen and if user authentication is disabled or configured with Technician ID access, the Default user will be prompted to log on as a user with sufficient privileges.
3
Service
Displays the Service screen used to service the device. Your administrator must grant you privileges to access this screen. If the user does not have access to the screen and if user authentication is disabled or configured with Technician ID access, the Default user will be prompted to log on as a user with sufficient privileges.
4
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Service Snapshot
Saves service information used for troubleshooting.
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Product Overview
Item
Option
Description
5
Change Password
Allows the Admin user or a local user to change your password. Displays only if full user authentication is enabled.
6
Lock (Alt+L)
Locks the device. Displays only if full user authentication is enabled.
7
Log Out
Logs out the current user. Displays only when you are logged into the device.
8
Standby
Puts the device in standby mode. This mode helps the device to conserve power without powering it off.
9
Power Off
Powers off the device. NOTE: You can also power off the device by pressing the Power button on the keyboard.
10
About
Displays the device software information.
11
Help
Displays help information about the device.
Displaying Battery Status To display the status of the two batteries, select the battery icon located on the Status Bar of the Acquisition screen.
The battery icons display the discharge and charge rates of each battery. The color of the icons change to indicate the level of battery life. The power level is displayed in 10% increments when the batteries are charging or discharging. The device can be connected to the AC Mains power and operated with the batteries removed. The device can also operate with a single battery installed to allow hot swapping of the batteries without plugging into AC Power. Table 3: Color Indicator on Battery Icons
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Icon Color
Battery is Present
AC Power Status
Description
Green
Yes
On
The battery is charging or fully charged and the device is connected to AC power.
MAC™ VU360 Resting ECG Analysis System
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Product Overview
Icon Color
Battery is Present
AC Power Status
Description
White
Yes
Off
The battery is sufficiently charged and device is operating on battery.
Red
Yes
On or Off
The battery is low or critically low. If the power icon displays next to the battery icons, the devcie is connected to AC power.
No color but crossed out
No
On
The battery is not present.
Table 4: Examples of Battery and Power Icon Status Icon
Status
Description
Connected to AC Displays that the device is connected to the AC Mains power Mains and the batteries are charging. Operating on Battery
Displays that the device is only operating on batteries and the batteries are discharging. Indicates that the device is not connected to the AC Mains power.
Batteries – Fully Charged
Displays that the batteries are fully charged and the device is disconnected from the AC Mains power.
Disconnected from AC Mains
When the device is connected to the AC Mains power and the battery icon is solid green, a message displays indicating that the battery is fully charged.
Batteries – Low or Critically Low
Displays that the batteries are at low or critically low capacity and the device is disconnected from the AC Mains power. If the total charge level drops below 15%, an error tone notifies you and a message displays indicating that the battery is low. If the total charge level drops below 10%, the error tone is louder, longer, and sounds every minute, and a message displays indicating that the battery is critically low and you should connect to AC power immediately.
Battery Not Present, AC Mains Power
Displays that battery B is not in the device and the AC Mains power is connected. A message displays indicating that the battery is not present.
The following image illustrates the batteries A and B in the battery compartment:
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Product Overview
Viewing Status of Network Connection If you have enabled the wireless and wired connection, the device automatically switches to the wired connection when you connect the LAN cable. If you remove the LAN cable, the device uses the wireless connection. To view the status of your device's connection to your Local Area Network (LAN) or Wireless Local Area Network (WLAN), perform the following procedure. 1.
Locate the Network Status icon on the status bar.
2.
Review the following tables that describe the network status icon when connected to a LAN or WLAN network. Table 5: LAN Icons Network Status Icon
Status
Description
LAN Active
The device is connected to a LAN.
LAN Connected
The device is connected to a remote server through a LAN and is in the process of obtaining an IP address. If this icon is blinking, the device is acquiring an IP address from DHCP.
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Product Overview
Network Status Icon
Status
Description
LAN Disconnected
The device is not connected to a LAN; no LAN (Ethernet) cable is attached to the device.
Table 6: WLAN Icons Icon
Status
Description
WLAN Active
The device is connected to a WLAN and has a valid IP address. The icon shows a number of wireless bars to indicate the strength of the wireless signal.
WLAN Connected
The device is connected to an access point and is in the process of obtaining an IP address. If this icon is blinking, the device is acquiring an IP address from DHCP.
WLAN Disconnected
The device is not connected to a WLAN.
3.
To view network information, select the Network Status icon. A drop-down list opens and displays the network status (and signal strength and wireless certificate errors, in the case of a wireless network). To troubleshoot wireless certificate errors, see "Wireless Network Connectivity Errors" on page 112.
4.
To collapse the Network Status window, select somewhere on the screen outside of the window.
Changing the Brightness of the Screen Perform one of the following steps to change the brightness level of the screen from 10% to 100%: • To increase the brightness of the screen, select Alt + Arrow up keys on the keyboard. • To decrease the brightness of the screen, select Alt + Arrow down keys on the keyboard. Continue to select the keys to reach the desired level of brightness.
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Product Overview
Table 7: Brightness Level Condition
When the device is powered by A/C Power
When the device is powered by the battery
Brightness level on initial power up
80%
50%
Brightness level when you change the power source when the device is on
Resets to the saved brightness value when the device was last used on AC Power.
Resets to the saved brightness value when the device was last used on the battery.
The changes you make are automatically saved to your device and will not change when you turn the device on or off.
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2 Login and Security Turning On the ECG Device 1.
Press the Power button on the keyboard for a few seconds to turn on the device:
The device is turned on. The Power on LED on the keyboard turns green. A notification message displays, if it is configured by your administrator. 2.
Click Accept. • If user authentication is enabled, you are prompted to log into the device. • If user authentication is disabled, you are automatically logged into the device as the Default User. • If the user authentication mode is Technician ID, you are prompted for a Technician ID before being automatically logged in to the device as the Default User.
Turning Off the ECG Device 1.
Complete any pending tasks, such as acquiring an ECG or saving configuration settings, before turning off the device.
2.
Perform one of the following steps to turn off the ECG device: • From the User Menu on the screen, select Power Off. • Press the Power button on the keyboard for a few seconds:
The Power Options window opens with Power Off, Log Out, and Standby options. Select Power Off.
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Login and Security
The device is turned off. The Power on LED on the keyboard turns off.
User Authentication The device supports the following modes of user authentication: Table 8: Supported User Authentication Modes User Authentication Mode Description Full authentication with STAT login
The following Login screen displays when the device is powered on or unlocked.
The following users can log into the device:
Technician ID login
•
Pre-defined users (Admin, Service)
•
LDAP users (If LDAP-based user authentication is configured)
•
Local users (If user profiles are locally managed on the device)
•
STAT User if STAT login is enabled
The following Login screen displays when the device is powered on or unlocked:
A technician can access the device by entering the Technician ID. No authentication
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A login screen is not displayed when you power on the device. You are automatically logged in as the Default User. The Default User cannot access the device if user authentication is enabled.
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