Operators Manual
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GE Healthcare
MAC™ 7 Resting ECG Analysis System Operator's Manual Version 1
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Keep this manual with your Regulatory and Safety Manual and equipment at all times, and periodically review it.
MAC™ 7 Resting ECG Analysis System Operator's Manual English © 2020-2021 General Electric Company All Rights Reserved.
Publication Information
Publication Information The information in this manual applies only to 1.00 of MAC™ 7 Resting ECG Analysis System. It does not apply to earlier product versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. 12SL, CASE, CardioSoft, InSite ExC, MAC, MACCRA, MARS, MUSE, Marquette, MobileLink, and MULTI-LINK 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 - 2020. For more information about compliance, refer to the Regulatory and Safety Guide for this product. 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
6 March 2020
Customer Release
B
3 July 2020
Update legal manufacturer and registration information
C
11 December 2020
Update content for Software SP02
D
9 April 2021
Update content for Software SP03
E
10 September 2021
Update cleaning and disinfection information
Access other GE Healthcare Diagnostic Cardiology documents at the Customer Documentation Portal. Go to https:// www.gehealthcare.com/en/support/support-documentation-library and scroll to the bottom of the page. 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)
•
OpenSSH (https://www.openssh.com/)
•
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)
•
Yocto project packages (https://www.yoctoproject.org)
•
Freedesktop.org (https://www.freedesktop.org)
•
Busybox project (https://busybox.net)
•
bzip.org (http://www.bzip.org)
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•
FreeType project (https://www.freetype.org)
•
OpenBSD Project (https://www.openbsd.org)
•
netfilter.org project (http://www.netfilter.org)
•
netcat (http://netcat.sourceforge.net/)
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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)
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rsyslog (https://www.rsyslog.com)
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sshpass (https://sourceforge.net/projects/sshpass/)
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. This document describes the MAC™ 7 Resting ECG Analysis System, also referred to as the” product”, “system”, or “device”. This document is intended to be used by an operator of the MAC™ 7 Resting ECG Analysis System system. The MAC™ 7 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. 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. 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. For more self-paced course offerings, tools, and reference guides you may find useful, visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.
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Table of Contents Publication Information... 2
1: Product Overview... 7 Front View...7 Side and Rear View...8 Acquisition Screen Overview...9 User Menu Options Description... 12 Battery Status... 14 Show Battery Status... 15 Show Network Connection Status... 16 Change the Brightness of the Screen... 17
2: Login and Security... 18
Power On the ECG Device... 18 Power Off the ECG Device... 18 User Authentication... 19 Log On to the Device... 20 Log On the Device as a STAT User... 22 Access the Device using a Technician ID...22 Log Out of the Device...22 Change the User Password...23 Activate or Deactivate Privacy Mode... 23 Lock the Device...24 Unlock the Device... 24 Put the Device on Standby...24 Perform System Reset... 25
3: Patient Information...26 Patient Information Screen Overview... 26 Start a Test for a New Patient...28 Enter Patient Information...29 Update Patient Information with a Barcode Reader... 29 Query Orders or ADT for Patient Demographics...30 Enter or Edit Patient Information Using the Software Keyboard...36
4: Record an ECG or Rhythm... 38
Hookup Advisor Overview...38 Acquire an ECG based on the Hookup Advisor status in Post-Acquisition Mode...41 Acquire an ECG based on the Hookup Advisor status in Pre-Acquisition Mode... 41 Change Lead Sets and Lead Formats... 41 Enable ACS Interpretation...42 Change Speed, Gain, and Filter...43 ECG Acquisition Overview... 44 Automatically Acquire an ECG...44 Manually Start an ECG recording...45 Cancel an ECG...47 Accept or Reject an ECG Patient Report...47 Review an ECG Patient Report... 51
Automatically Print an ECG Patient Report... 53 Record a Rhythm...54 Review a Digital Rhythm Report...56 Transmit a Patient Report to a Configured Destination... 57 Print a Patient Report...60 Edit Patient Information in a Patient Report...62 Delete a Patient Report...62 View the Patient Report... 63 Close a Patient Report...63 Full Disclosure Overview...64 Record a Full Disclosure ECG... 64 Review a Full Disclosure Report...66
5: Work with Orders...68 Automatically Update the Orders List...71 Manually Update the Orders List...71 Sort Orders in the Orders List... 72 Filter Orders in the Orders List... 72 Attach an Order when the Patient Test is Not Started... 75 Attach an Order to a New Patient Test...75 Attach an Order when the Patient Test is Completed...76 Attach an Order that is Attached to a Different Patient Test...77 Change the Order Attached to a Patient Test...78 Detach an Order from a Patient Test...78 Order Status...79
6: Work with the Files List... 81
Review a Stored Patient Report... 83 Transmit a Stored Patient Report to a Configured Destination... 85 Print a Stored Patient Report... 88 Print a List of Stored Records... 90 Edit Patient Information in a Stored Patient Report...90 Delete Stored Patient Reports from the Files List...91
7: Work with the Queue List...93
Display the Report Queue...95 Delete Jobs from the Queue... 96 Retry Transmission of a Patient Report... 96
8: Work with the Patients List...98
Open the Patients List...100 Select a Patient from the Patients List...100
9: Maintenance...101 Adjust the Paper Tray for Paper Size...101 Store Thermal Paper... 103 Clean the Printhead...104 Charge the Battery... 104 Replace the Battery...105
10: Cleaning and Disinfection... 108
Inspect the Device... 108 Care at the Point of Use... 108
Preparation for Cleaning...108 Clean and Disinfect Guidelines... 108 Visual Inspection, Cleaning and Disinfection Frequency...109 Clean and Disinfect the Device and Trolley...110 Pre-Clean Inspection and Functional Test...110 Clean the Device and Trolley...110 Post-Clean Inspection...111 Disinfect the Device and Trolley...111 Clean and Disinfect Leadwires and Reusable Electrodes... 112 Storage...112 Other Cleaning and Disinfection Agents... 112 Additional Information... 113
11: Troubleshooting...114 System Errors...114 ECG Acquisition Errors...115 Printing Errors...116 Report Transmission Errors... 119 Wireless Network Connectivity Errors... 120
A: Report Formats... 123
ECG Report Formats...123 Rhythm Report Format... 128 Full Disclosure (FD) Report Format...131
B: Patient Preparation... 134
Prepare the Patient’s Skin... 134 Electrode Placement... 135 Standard 12–Lead Electrode Placement...135
C: Patient Information Fields...137
Patient Information Text Box Names...137
D: Technical Specifications... 147
System Specifications...147 ECG Specifications...149 Environmental Specifications...150 Safety Specifications...151 Network Specifications... 151
Glossary... 153
Product Overview
1 Product Overview The MAC 7 Resting ECG Analysis System, (referred to as "the device" throughout this document), supplies 12-lead ECG measurement and interpretative analysis, prints 12-leads of ECG, and transmits ECG data to and from a central ECG cardiovascular information system.
Front View
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Item
Name
Description
1
Display and Touchscreen
Displays waveform and text data. The touchscreen enables you to interact directly with the device through touch gestures.
2
Power button
Turns the device on or off.
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Product Overview
Item
Name
Description
3
Power on LED
Shows if the device is on or off.
4
5
Battery LED
AC Power LED
•
Green light - on.
•
No light - off.
•
Flashing green light - standby mode.
Battery status: •
Flashing amber light at two-second intervals - battery is charging.
•
Flashing amber light at a one-second interval - battery is critically low.
•
Flashing amber light at a half-second interval - battery has a communication failure.
•
No light - battery is fully charged, not installed, or discharging.
AC power status: •
Green light - the device is plugged in and receiving power.
•
No light - the device is not plugged into AC power.
Side and Rear View
8
Item
Name
Description
1
ECG Patient Cable Connector
D-sub 15–pin female connector for the acquisition cable.
2
USB Slot B
•
Used to connect a USB flash drive or USB cable. You can connect a USB flash drive for a software update, backup/restore or export operations, or a barcode reader USB cable.
•
Standard USB connector for USB devices, for example, the external barcode reader, USB memory stick, USB keyboard and USB mouse.
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Item
Name
Description
3
USB Slot A
•
Used to connect a USB flash drive or USB cable. You can connect a USB flash drive for a software update, backup/restore or export operations, or a barcode reader USB cable.
•
Standard USB connector for USB devices, for example, the external barcode reader, USB memory stick, USB keyboard and USB mouse.
4
KISS Pump Connector
Used to connect a KISS pump cable.
5
Ethernet/LAN Port
Used to connect an Ethernet cable.
6
Battery Compartment
Used to insert the battery.
7
Equipotential Grounding Plug
Used to connect non-grounded peripheral devices.
8
Label
Product label.
9
AC Power Inlet
Used to connect the AC power cord.
Item
Name
Description
10
Printer Door
Used to pull out the paper tray.
Acquisition Screen Overview The Acquisition screen is the main screen that displays when you first log on to the device. You can acquire an ECG from the Acquisition screen. 2109599-001E
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Product Overview
Table 1: Acquisition Screen Item Name
Description
1
Live tab
Displays the live waveform for the current patient connected to the device.
2
Full Disclosure tab
Displays a full disclosure ECG. NOTE: The Full Disclosure tab displays after you buy and enable the full disclosure function.
3
Patient Information Banner
Displays selected Patient Information such as the patient first name, surname, and gender. Select anywhere on the banner to add or edit patient information.
4
ECG tab
Displays the ECG recorded for a patient. The tab is titled ECG: <Time_of_Acquisition>. ECG previews and/or accepted ECGs are displayed on this tab.
5
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 7 Resting ECG Analysis System Setup and Configuration Manual.
6
Rhythm tab
Displays the rhythm recorded for a patient. The tab is titled Rhythm: <Time_of_Acquisition>.
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Item Name
Description
7
•
The Orders tab displays when you enable order management. Select Orders to open the Orders list and view a list of the available orders.
•
The Orders tab does not display if you disable order management, the Patients tab displays. Select Patients to open the Patients list. View a list of the last 500 patients display with ECGs that were acquired on the device.
•
Select Files to open the Files list and view the list of stored patient reports.
•
Select Queue to open the Queue list to view the list of reports in the queue to be transmit to a configured destination.
Orders/Patients, Files, and Queue tabs
8
Brightness Icon
Select to adjust the screen brightness.
9
Battery or AC Power Icon
Displays the battery status.
10
Network Status Icon
Displays the wireless or LAN connection status.
11
User Menu
Displays the name of the user logged on to the device. When you select the name, the user menu expands and displays the available menu options. You do not have access to some menu options. Your administrator can assign the proper privileges. If you disable user authentication or configure with Technician ID access, the Default user must to log on as a user with sufficient privileges to access a menu option.
12
Start New Patient icon
Select to enter patient data for a new patient test.
13
Expand icon
Select the tab (Orders/Patients, Files, or Queue) that you want to expand, and select the Expand icon to open the list.
14
Electrode Placement Picture
Select the arrow to expand and view the picture that shows the placement of electrodes and the electrode quality of each lead. Each lead quality indicator on the picture changes to yellow, red, or green, based on its connection status. You can enable or disable the auto-expansion of the picture. If auto-expansion of the picture is enabled:
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The picture automatically expands if the Hookup Advisor Lead Quality Indicator is yellow or red.
•
The picture automatically collapses if the Hookup Advisor Lead Quality Indicator is consistently green for a few seconds.
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Product Overview
Item Name
Description
15
Displays messages:
Notification Area
•
printing status and progress
•
report transmission status
•
Hookup Advisor lead quality status
The messages display one at a time in the sequence of occurrence. The messages do not display when a patient is connected and hookup advisor is evaluating the waveform. 16
Hookup Advisor Lead Quality Status Indicator
Displays the lead quality status indicator in three circles that change to yellow, red, or green, based on the lead quality.
17
Filter, Speed and Gain
Displays the default waveform filter, speed, and gain. 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 and during the recording of a rhythm. NOTE: A change to the filter, speed or gain is applicable to the current patient. For a new patient, the values are reset to default settings.
18
Start Rhythm icon
Select to print or digitally record the rhythm report.
19
Start ECG icon
Select to record an ECG.
20
Lead Set and Display Format
Displays the default test type and display format. 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 and 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 User Menu is 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>
Displays the name of the user logged into the device 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. The 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 is 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 is prompted to log on as a user with sufficient privileges.
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Product Overview
Item
Option
Description
4
Service Snapshot
The user can get a service snapshot without the Service privileges. Complete the snapshot to help identify a problem on the device.
5
Change Password
The Admin user or a local user can change their password. Displays only if you enable full user authentication.
6
Lock
Locks the device. Displays only if you enable full user authentication.
7
Log Out
Logs off the user. Displays only when you are logged on to the device.
8
Standby
Puts the device in standby mode to save battery power without turning it off.
9
Power Off
Powers off the device. NOTE: Pressing the Power button on the front panel can also stop the device.
10
About
Displays the device software information.
11
Help
Displays help information about the device.
Battery Status The battery icon shows the stored power of the battery. The power levels are shown in 10% increments. The color of the icons change to show the level of battery life. You can operate the device connected to the AC Mains power when the batteries are removed. The device can also operate with a single battery installed to allow hot swapping of the battery without plugging into AC Power. Table 3: Examples of Battery and Power Icon Status
14
Icon
Status
Description
Green
Connected to AC The device is connected to the AC Mains power and the Mains battery is charging.
White
Operating on Battery
The device is only using the battery and the battery is discharging. The device is not connected to the AC Mains power.
White
Battery – Fully Charged and Disconnected from AC Mains
The battery is fully charged and the device is disconnected from the AC Mains power. When the device is connected to the AC Mains power and the battery icon is solid green, shows that the battery is fully charged.
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Product Overview
Icon
Status
Description
Red
Battery – Low or The battery is at low capacity and the device is disconnected Critically Low from the AC Mains power. If the charge level is below 15%, an error tone sounds. If the charge level is below 10%, the error tone is louder, longer, and sounds every minute. A message opens that tells you the battery is critically low and you should connect to AC power immediately.
No color with red X
Battery Not Present, AC Mains Power
The battery is not in the device and the AC Mains power is connected. If you select the battery icon, a message opens that tells you the battery is not present.
The image illustrates the battery in the battery compartment:
Show Battery Status
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1.
Select the battery icon on the Status Bar of the Acquisition screen.
2.
An image opens showing the battery life.
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Product Overview
Show Network Connection Status When the wireless and wired connection is set to Enable, the device uses a wired connection when you connect a Local Area Network (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 LAN or Wireless Local Area Network (WLAN), perform the procedure as follows: 1.
Select the Network Status icon on the status bar.
2.
Review the tables for the description of the network status icon when connected to a LAN or WLAN network. Table 4: 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.
LAN Disconnected
The device is not connected to a LAN; no LAN (Ethernet) cable is attached to the device.
Table 5: 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.
For more information about wireless certificate errors, see Wireless Network Connectivity Errors on page 120. 16
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Product Overview
3.
Close the Network Status window by selecting something on the screen outside of the window.
Change the Brightness of the Screen To change the brightness of the screen, select the brightness icon on the Status Bar of the Acquisition screen.
Follow one of the steps to change the brightness level of the screen from 10% to 100%: • To increase the brightness of the screen, press +. • To decrease the brightness of the screen, press -. 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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Login and Security
2 Login and Security Power On the ECG Device 1.
Press the Power button on the keyboard for a few seconds to start the device. The device is powered on. The Power on LED on the front panel is green. A notification message displays, if it is configured by the administrator.
2.
Click Accept. • If user authentication is enabled, you are prompted to log on to the device. • If user authentication is disabled, you are automatically logged on to the device as the Default User. • If the user authentication mode is Technician ID, enter the Technician ID to log on as a Default User.
Power Off the ECG Device 1.
Before you Power Off the device, complete pending tasks, for example, acquire an ECG and save configuration settings.
2.
Do one of these steps to remove power from the ECG device: a)
From the User Menu on the screen, select Power Off. The Power off window opens and displays a message. Select Power Off. The device is off. The Power on LED on the front panel is off.
b)
Press the Power button on the front panel for a few seconds: The Power Options window opens with Cancel, Standby, Log Out, Privacy Mode, and Power Off options. Select Power Off.
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Login and Security
The device is off. The Power on LED on the front panel is off.
User Authentication The device supports different modes of user authentication. Table 6: Supported User Authentication Modes User Authentication Mode Description Full authentication with STAT login
The Login screen displays with these fields when the device is powered on or unlocked.
The users below can log on to the device:
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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 button is selected. The user can configure the text for this button.
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Login and Security
User Authentication Mode Description Technician ID login
The Login screen displays when the device is powered on or unlocked.
A technician can access the device by entering the Technician ID. No authentication
A Login screen does not display when you power on the device. You are automatically logged on as the Default User. The Default User cannot access the device if user authentication is enabled.
Log On to the Device Enter the user name and password on the Login screen to enable User authentication to allow users to log on to the device. Table 7: Type of Users Type of User
Description
Admin user
The username is Admin. The default password to log on as the Admin user is admin123. The Admin user is prompted to change the default password immediately after the first login.
Service user The username is Service. This username is intended for use by Service personnel. A user with the user management privilege can set the password for the Service user. Local users
The local user profiles are managed by the device administrator. Obtain your username and password from the device administrator.
LDAP users
LDAP user authentication is available only if you configure the device to support LDAP. The LDAP server administrator manages the LDAP user profiles. Obtain your username and password from the LDAP server administrator. Your privileges are based on the user role assigned to the LDAP group to which your user profile belongs.
1.
Do one of these steps: • If the device is shutdown, power on the device. See Power On the ECG Device on page 18. • If the device is locked, unlock the device. See Unlock the Device on page 24.
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