Siemens ACUSON Freestyle User Manual

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ACUSON Freestyle Diagnostic Ultrasound System User Manual
US
Siemens Medical Solutions USA, Inc.
01230123
11002778_01 English
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Product Version 3.5
August 2014 Printed in the United States of America
ACUSON and ACUSON Freestyle are trademarks of Siemens Medical Solutions USA, Inc.
CE Declaration
This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC of June 14, 1993 concerning Medical Devices. The CE marking only applies to medical devices that have been put on the market according to the above reference Council Directive.
Unauthorized changes to this product are not covered by the CE marking and the related Declaration of Conformity.
Asepti-Wipe, Cidex, Gigasept, MetriCide, T-Spray, Wavicide-01, Metrizyme, Sani-Cloth, Sterrad, Sterrad 100S, Sterrad SealSure, and Tyvek are trademarks or registered trademarks of their respective owners.
Siemens reserves the right to change system
specications at any time
Global Business Unit and Legal Manufacturer
Siemens Medical Solutions USA, Inc. Ultrasound 685 East Middleeld Road Mountain View, CA 94043 U.S.A. Phone: +1-888-826-9702 www.siemens.com/healthcare
EU Authorized Representative
Siemens AG Medical Solutions Henkestrasse 127 91052 Erlangen Germany
Siemens Global Headquarters
Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany
Global Siemens Healthcare Headquarters
Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Phone: +49 9131 84-0 www.siemens.com/healthcare
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Contents
Chapter 1 Introduction
General overview of the ultrasound system.
Chapter 2 Safety and Care
Detailed information on system safety and how to care for and maintain the system and transducers.
Chapter 3 System Setup
Detailed instructions on system setup and menus.
Chapter 4 Patient Studies
Detailed instructions on how to add and manage patient studies.
Chapter 5 Scanning
Detailed information on scanning modes and controls.
Chapter 6 Wireless Probe Operation
Detailed information about best operating procedures when using a wireless probe.
Chapter 7 Batteries
Instructions for recharging and caring for probe and console batteries.
Chapter 8 Connectivity
Detailed information about conguring network and DICOM settings
ACUSON Freestyle User Manual iii
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iv ACUSON Freestyle User Manual
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About the User and Reference Manuals

The user and reference manuals consist of the following publications.
Publication Includes
User Manual ■ Intended Audience
■ Technical description of the ultrasound system
■ Safety and care information for the system and compatible transducers
■ Descriptions of system controls
■ Procedures for system setup and examination fundamentals
■ Acoustic output data
System Reference ■ Electromagnetic Compliance Information
■ Wireless specications, security, and quality of service information
Customer Information Note
■ Provides software release notes and updates to the User Manual
ACUSON Freestyle User Manual v
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Conventions

Read and understand these conventions used in this manual.
Warnings, Cautions, and Notes
WARNING: Warnings are intended to alert you to the importance of following the correct operating procedures where risk of injury to the patient or system user exists.
CAUTION: Cautions are intended to alert you to the importance of following correct operating procedures to prevent the risk of damage to the system.
Note: Notes contain information concerning the proper use of the system and/or correct execution of a procedure.
Probe and Transducer In accordance with ultrasound convention, these terms can be
interchangeable. For the ACUSON Freestyle, in this manual:
Probe typically refers to the entire assembly of the handheld
scanning module which includes the probe transducer, electronics, controls, and battery.
Transducer typically refers to the scanning array at the tip of the
probe.
Key Text There are two types of Soft Keys on the system and they are
formatted differently in this manual:
• Bottom Soft Keys and their menu and sub-menu items: for
example, SETUP, VIEW, SETTINGS (formatting: bold, all caps).
• Real-time Control Bar Soft Keys and their menus and sub-menu
items: for example Freeze, Save Exam, Vascular (formatting: bold, with gray bar).
vi ACUSON Freestyle User Manual
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Intended Audience

The intended audience for the user and reference manuals includes the following users.
User Interaction with Ultrasound Equipment Expected Experience and Other Characteristics
Sonographer or Nurse
Physician ■ Acquires diagnostic views of anatomy,
System Administrator and Customer Service Engineer
■ Acquires diagnostic views of anatomy,
blood ow, and related pathology
Performs measurements and analysis of
the acquired images
■ Performs ultrasound-guided procedures
■ Prepares exam data for review and
interpretation by a qualied physician
blood ow, and related pathology
Performs measurements and analysis of
the acquired images
■ Performs ultrasound-guided procedures
■ Writes and assembles exam ndings in a report
■ Congures the ultrasound system for use in a networked environment
■ Ranges from novices (for example students) to advanced practitioners with
certication in multiple specialties
Educated in anatomy, physiology, patient care, and identication of pathology in
ultrasound images
■ Expert in ultrasound guided procedures
■ Many sonographers and nurses have a Bachelor’s degree in related health care subjects
■ Medical doctor
■ Expert in diagnostic imaging, including computed tomography (CT), magnetic resonance imaging (MRI), X-ray, ultrasound, and nuclear medicine
■ Skilled in the interpretation of ultrasound exam data
■ Expert in ultrasound-guided procedures
■ A System Administrator is an individual within your organization who is designated to set up system parameters to connect the ultrasound system or workstation to a picture archiving and communication system (PACS)
■ Customer Service Engineers are
Siemens representatives who congure
the ultrasound system or workstation during software installation and support troubleshooting activities
ACUSON Freestyle User Manual vii
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Freestyle Contents
About the User and Reference Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Conventions ............................................................. vi
Intended Audience .......................................................vii
1 Introduction
System Overview ........................................................ 1-3
System Console ........................................................1-3
Console Front View .....................................................1-3
Console Rear View .....................................................1-4
Console Inputs/Outputs Panel ............................................. 1-5
Turning the System On and Off ............................................1-6
Turn the System On ...................................................1-6
Turn the System Off ...................................................1-7
Imaging Screen Layout ................................................... 1-8
Sample Imaging Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
2 Safety and Care
Operating Safety and Environment .........................................2-3
Labels ...............................................................2-3
System Symbols .......................................................2-3
Intended Use ...........................................................2-6
Indications for Use ....................................................2-7
Fetal ...............................................................2-7
Abdominal ..........................................................2-7
Intraoperative ........................................................2-7
Intraoperative Neurological .............................................2-7
Pediatric ............................................................2-8
Small Organs ........................................................2-8
Neonatal Cephalic ....................................................2-8
Cardiac ............................................................. 2-8
Peripheral Vessel (Vascular) ............................................2-8
Musculoskeletal ...................................................... 2-8
Transducers and Intended Use ............................................2-9
Biohazard Considerations ...............................................2-10
Acoustic Output ....................................................... 2-11
ALARA / Prudent Use ................................................. 2-11
Acoustic Output: Global Maximum Values .................................2-12
References: ........................................................2-12
Acoustic Terms and Denitions ......................................... 2-13
Accuracies ............................................................2-15
Measurement Accuracies .............................................2-15
Accuracy by Transducer Type .......................................... 2-15
Accuracy of Primary Measurements .....................................2-15
Distance ...........................................................2-15
Area .............................................................. 2-15
Potential Sources of Measurement Error During Scanning ....................2-16
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Electrical Safety ........................................................ 2-17
Level of Protection Against Electrical Shock for Probes ......................2-19
Debrillators ..........................................................2-19
Implantable Devices ....................................................2-20
Possible Combinations with Other Equipment and Peripheral Equipment ........ 2-21
Important Information for Maintaining Data Integrity .........................2-24
Caring for the Ultrasound System .........................................2-25
Daily Checklist ........................................................2-25
Maintenance .........................................................2-26
Repair ............................................................. 2-26
Cleaning and Disinfecting ...............................................2-27
Cleaning and Disinfecting Ultrasound System Surfaces ...................... 2-27
Approved Disinfectant Wipes for the Ultrasound System Surfaces ..............2-29
Caring for Documentation and Storage Devices ............................. 2-29
Caring for Probes ......................................................2-30
Protective Case .......................................................2-30
Storage ............................................................ 2-30
Repair ............................................................. 2-30
Cleaning and Disinfecting Probes ......................................... 2-31
Intraoperative Neurological Important Warnings ............................2-32
Probe General Cleaning (including Low Level Disinfection): ..................... 2-33
Probe High Level Disinfection ............................................ 2-34
Preparation ......................................................... 2-34
High-Level Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
Probe Sterilization ...................................................2-34
Sterilization Preparation ...............................................2-34
Probe Sterilization: Sterrad ............................................2-35
IPX8 Immersion Levels ...............................................2-36
Approved List of Disinfectants .......................................... 2-37
Caring for Probe Accessories ............................................2-38
Probe Sheaths ........................................................2-38
Storage .............................................................2-38
Recommended Use of the Probe Sheaths ..................................2-39
Application ......................................................... 2-39
Disposal ...........................................................2-39
Battery Safety .........................................................2-40
Good Ergonomic Practices ..............................................2-42
Interrupt Scanning ...................................................2-42
Positioning ......................................................... 2-42
Hand and Wrist ......................................................2-42
Exercise and Stretching ...............................................2-42
Moving the System ..................................................... 2-43
ACUSON Freestyle Rollstand Conguration .................................2-44
System Upgrades ......................................................2-45
Performing System Software Upgrades. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-45
Environmental Protection ................................................ 2-45
Product Recycling and Disposal ..........................................2-45
Recycling Batteries ....................................................2-46
ACUSON Freestyle User Manual ix
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Disposing of the Packaging Materials ...................................... 2-46
Disposing of Components and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47
Energy Conservation ...................................................2-47
Technical Description .................................................. 2-48
3 Setup
System Setup and Controls ...............................................3-3
Overview of the Setup Menu ..............................................3-3
How to Select Items from the Setup Menu .................................. 3-4
Setup Menu Options ....................................................3-5
Scan ..............................................................3-5
Probes .............................................................3-5
Settings ............................................................3-6
System .............................................................3-7
Study List ...........................................................3-9
New Patient Study .................................................... 3-9
Close Study .........................................................3-9
4 Patient Studies
Protecting Patient Health Information ....................................... 4-3
About Patient Studies ....................................................4-3
Patient Study Fields ..................................................... 4-4
Patient Soft Keys .......................................................4-5
Creating New Patient Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Using Patient Information from a DICOM Server ..............................4-6
Worklist Query ....................................................... 4-6
Study Exam Types ....................................................... 4-6
Factory Exam Types ...................................................4-7
User-Dened Exam Types ..............................................4-8
The Study List .......................................................... 4-9
Viewing the List of Patient Studies ..........................................4-9
Sorting the Study List ..................................................4-9
Scrolling through the Study List .........................................4-10
Selecting Multiple Studies for Export or Deletion ............................ 4-10
Viewing Images in a Study from the Study List .............................4-10
Managing Patient Studies ................................................ 4-11
Exporting Patient Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
How to Export Studies ................................................ 4-11
Export Parameters ...................................................4-12
Editing Patient Studies .................................................. 4-12
Deleting Patient Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
5 Scanning
Using the Probe ......................................................... 5-3
About the Probe ........................................................ 5-3
Probe Orientation ....................................................5-3
Overview of the Probe ................................................. 5-3
Probe Controls .......................................................5-4
Locking and Unlocking the Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
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Probe Shortcuts for Save and Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Connecting the Probe ...................................................5-5
Cabled Probe Operation ...............................................5-5
Wireless Probe Operation ..............................................5-6
The Real-Time Scanning Screen ........................................... 5-7
Overview of the Scanning Process .........................................5-8
Real-Time Scanning Controls .............................................5-9
Selecting an Exam Type from the List of Exams ........................... 5-11
Freezing an Image ................................................... 5-11
Scanning Soft Keys ..................................................5-12
B-Mode Scanning .....................................................5-13
B-Mode Tools ....................................................... 5-13
Color Flow Mode Scanning .............................................. 5-15
Color Flow Tools .................................................... 5-15
Measurements .........................................................5-16
Performing a Measurement ..............................................5-16
Deleting Measurements ..............................................5-16
Ellipse Measurement ...................................................5-16
Area Measurement ....................................................5-17
Adding Text Annotations to Studies .......................................5-18
Text Functions ........................................................5-18
6 Wireless Probes
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Antenna Locations ......................................................6-3
Equipment Setup for Optimal Scanning ...................................... 6-4
Connecting a Wireless Probe .............................................. 6-5
Problems Connecting .................................................. 6-5
Wireless Signal Quality ................................................... 6-6
Monitoring Wireless Signal Quality .........................................6-7
Wireless Signal Quality Meter ...........................................6-7
Average Noise Level Indicator ...........................................6-8
Wireless Noise Examples ...............................................6-10
B-Mode Wireless Noise ............................................... 6-10
Color Flow Wireless Noise .............................................6-10
Finding/Locating Wireless Probes ........................................ 6-11
Using Multiple Probes ................................................... 6-12
More than One Wireless Probe .........................................6-12
A Probe Connected via Adapter Cable .................................... 6-12
Powering Down the Probe ...............................................6-12
7 Batteries
Overview of the Probe Battery .............................................7-3
Charging the Probe Battery ............................................... 7-4
Checking the Status of Charging Batteries ...................................7-4
Inserting the Battery into the Probe .........................................7-5
Monitoring the Battery Charge Level while Scanning .........................7-5
Low Battery Alerts ......................................................7-6
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8 Connectivity
Overview of Connectivity .................................................8-3
Conguring the Network Settings ..........................................8-3
Ethernet Setup ......................................................... 8-3
Wireless Network Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Working with Multiple WiFi Networks ......................................8-4
Detecting WiFi Networks ...............................................8-4
Conguring the WiFi Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Conguring the DICOM Setup ............................................. 8-6
DICOM Setup Menu Soft Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Conguring a DICOM Storage Server ..................................... 8-7
Conguring a DICOM Storage Commitment Server ..........................8-8
Conguring a Modality Worklist Server ....................................8-9
Conguring the System DICOM Settings .................................. 8-10
Freestyle Mobile Link App ............................................... 8-11
Freestyle Mobile Link Settings ............................................ 8-11
Privacy and Security ...................................................8-12
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1 Introduction

A general overview of the ultrasound system and instructions on how to turn it on and off.
System Overview ........................................................ 1-3
System Console ........................................................1-3
Console Front View .....................................................1-3
Console Rear View .....................................................1-4
Console Inputs/Outputs Panel ............................................. 1-5
Turning the System On and Off ............................................1-6
Turn the System On ...................................................1-6
Turn the System Off ...................................................1-7
Imaging Screen Layout ................................................... 1-8
Sample Imaging Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Introduction
ACUSON Freestyle User Manual 1-1
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Introduction
1-2 ACUSON Freestyle User Manual
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System Overview

The ACUSON Freestyle ultrasound system is designed for ultrasound studies. The system offers a variety of scanning modes and probes. The system probes may be operated in wireless mode, or using a probe Cable Adapter. The system provides an intuitive and easy-to­operate user interface. It has a compact and portable design and offers DICOM archival and networking capability.

System Console

Console Front View

8
PATIENT NAME PATIENT ID
Nerve Gen
L13-5
2.5cm G 9
CG 10
SC 3 SF 6
PP 10
55dB CF 1
CP 1 Vel 1 Pri 4 20 Hz
XXX
XXX
XXX
XXX
XXX
XXX
XXX
XXX
Introduction
7
XXX XXX XXX XXX
1
2
3
System Console: Front View
1. ON/OFF Button
2. SETUP Soft Key
3. Bottom Soft Keys
4. Trackball and Trackball Left and Right keys
5. Rotary knobs
6. Real-time Control bar Soft Keys
7. Real-time Control bar labels
8. Image Settings area
4
ANL 0.0 dB
P S
6
5
ACUSON Freestyle User Manual 1-3
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Introduction

Console Rear View

10
1
2
3
4
5
6
System Console: Rear View
1. Hand grip
2. I/O panel
3. VESA mount locations
4. Probe holders
5. Power Cable connector
6. Tilt stand
7. Service Use Only
8. System label
9. Service Use Only
10. Probe battery charge bays
9
8
7
1-4 ACUSON Freestyle User Manual
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Console Inputs/Outputs Panel

1
2
3
4
Introduction
5
Inputs/Outputs Panel along right side of system console
1. Probe Adapter Cable connector
2. For Service Only
3. Network connector
4. USB ports
5. 15-pin Video connector
ACUSON Freestyle User Manual 1-5
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Introduction

Turning the System On and Off

The Power key is located in the bottom, left corner of the system console control panel.
Location of Console Power Key

Turn the System On

To turn the system on, press the POWER key, holding it down momentarily. You will hear a beep when power is started. The system will take a number of seconds to boot up.
NOTE: While the system is booting up, do not try to power down.
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Turn the System Off

To power the system down, press the POWER key, holding it down momentarily.
If you attempt to power the system down and the momentary pressing of the POWER key does not shut the system off, hold the POWER key down continuously for ve seconds to power down. If you repeatedly have problems powering down, contact your service representative.
NOTE: If the system does not boot up when it is not plugged into the AC Mains power outlet, it may be because the system battery is depleted. Plug the system into AC mains power outlet using the power cable.
WARNING: Do not power down until an archival transfer is complete. If the system is in the process of an archival transfer operation, such as saving a patient study to a removable storage medium or over a network, powering down will terminate the transfer and result in an unsuccessful transfer.
CAUTION: Do not power down during a software upgrade. Powering down during a system software upgrade will cause the upgrade to terminate and be unsuccessful.
Introduction
ACUSON Freestyle User Manual 1-7
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Introduction

Imaging Screen Layout

The console displays clinical images together with important operating parameters, patient data, and control commands.

Sample Imaging Screen

8
7
PATIENT NAME PATIENT ID
Nerve Gen
1
ANL 0.0 dB
2
XXX XXX XXX XXX
L13-5
2.5cm G 9
CG 10
SC 3 SF 6
PP 10
55dB CF 1
CP 1 Vel 1 Pri 4 20 Hz
XXX
XXX
XXX
XXX
XXX
XXX
XXX
XXX
5
P S
6
4
3
Sample ACUSON Freestyle Console Screen
1. Image area
2. Bottom Soft Keys
3. Wireless Signal Quality
4. Probe, System battery/power, Networking Status area
5. Frame Rate/Average Noise Level displays
6. Real-time Control Bar Soft Keys (e.g., Freeze, Save, Gain, etc.); controlled by touching the bar and using the Rotary knob.
7. Image Settings area
8. Patient Name and ID
1-8 ACUSON Freestyle User Manual
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2 Safety and Care

This chapter contains information regarding the safe operation of the ACUSON Freestyle Ultrasound System, including a technical description of the system. Please read and understand it prior to using the system in patient studies. Consult the System Reference section of the Manual for important information about Electromagnetic Compatibility (EMC), Wireless Security, and Wireless Quality of Service.
Operating Safety and Environment .........................................2-3
Labels ...............................................................2-3
System Symbols .......................................................2-3
Intended Use ...........................................................2-6
Indications for Use ....................................................2-7
Fetal ...............................................................2-7
Abdominal ..........................................................2-7
Intraoperative ........................................................2-7
Intraoperative Neurological .............................................2-7
Pediatric ............................................................2-8
Small Organs ........................................................2-8
Neonatal Cephalic ....................................................2-8
Cardiac ............................................................. 2-8
Peripheral Vessel (Vascular) ............................................2-8
Musculoskeletal ...................................................... 2-8
Transducers and Intended Use ............................................2-9
Biohazard Considerations ...............................................2-10
Acoustic Output ....................................................... 2-11
ALARA / Prudent Use ................................................. 2-11
Acoustic Output: Global Maximum Values .................................2-12
References: ........................................................2-12
Acoustic Terms and Denitions ......................................... 2-13
Denition of Acoustic Terms ........................................2-14
Acoustic Output Global Maximum Values: B-Mode ......................2-14
Acoustic Output Global Maximum Values: Color Doppler ..................2-14
Accuracies ............................................................2-15
Measurement Accuracies .............................................2-15
Accuracy by Transducer Type .......................................... 2-15
Accuracy of Primary Measurements .....................................2-15
Distance ...........................................................2-15
Area .............................................................. 2-15
Potential Sources of Measurement Error During Scanning ....................2-16
Electrical Safety ........................................................ 2-17
Level of Protection Against Electrical Shock for Probes ......................2-19
Debrillators ..........................................................2-19
Implantable Devices ....................................................2-20
Possible Combinations with Other Equipment and Peripheral Equipment ........ 2-21
Important Information for Maintaining Data Integrity .........................2-24
Caring for the Ultrasound System .........................................2-25
Daily Checklist ........................................................2-25
Perform the following each day before using the ultrasound system: ......... 2-25
Once the ultrasound system is powered on: ............................ 2-25
Maintenance .........................................................2-26
Repair ............................................................. 2-26
Siemens Authorized Care .......................................... 2-26
Safety and Care
ACUSON Freestyle User Manual 2-1
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Safety and Care
Cleaning and Disinfecting ...............................................2-27
Cleaning and Disinfecting Ultrasound System Surfaces ...................... 2-27
Approved Disinfectant Wipes for the Ultrasound System Surfaces ..............2-29
Caring for Documentation and Storage Devices ............................. 2-29
Caring for Probes ......................................................2-30
Protective Case .......................................................2-30
Storage ............................................................ 2-30
Repair ............................................................. 2-30
Cleaning and Disinfecting Probes ......................................... 2-31
Intraoperative Neurological Important Warnings ............................2-32
Probe General Cleaning (including Low Level Disinfection): ..................... 2-33
Probe High Level Disinfection ............................................ 2-34
Preparation ......................................................... 2-34
High-Level Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
Probe Sterilization ...................................................2-34
Sterilization Preparation ...............................................2-34
Probe Sterilization: Sterrad ............................................2-35
IPX8 Immersion Levels ...............................................2-36
Approved List of Disinfectants .......................................... 2-37
Caring for Probe Accessories ............................................2-38
Probe Sheaths ........................................................2-38
Storage .............................................................2-38
Recommended Use of the Probe Sheaths ..................................2-39
Application ......................................................... 2-39
Disposal ...........................................................2-39
Battery Safety .........................................................2-40
Good Ergonomic Practices ..............................................2-42
Interrupt Scanning ...................................................2-42
Positioning ......................................................... 2-42
Hand and Wrist ......................................................2-42
Exercise and Stretching ...............................................2-42
Moving the System ..................................................... 2-43
ACUSON Freestyle Rollstand Conguration .................................2-44
System Upgrades ......................................................2-45
Performing System Software Upgrades. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-45
Environmental Protection ................................................ 2-45
Product Recycling and Disposal ..........................................2-45
Recycling Batteries ....................................................2-46
Disposing of the Packaging Materials ...................................... 2-46
Disposing of Components and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47
Energy Conservation ...................................................2-47
Technical Description .................................................. 2-48
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Operating Safety and Environment

Do not operate the ultrasound system until you fully understand the safety considerations and procedures presented in this manual.
WARNING: Failure to comply with Warnings may pose a threat to patient and/or user safety.

Labels

For information regarding product labels, see the System Reference Manual.

System Symbols

Refer to this table to identify important symbols located on the ultrasound imaging system and transducers.
NOTE: Some symbols in this table may not be used in your system.
Safety and Care
Symbol Explanation
Caution: Risk of electric shock.
Consult instructions for use
Consult instructions for use
Caution
General Warning
(yellow and black illustration)
Standby — ON
USB Connection
Ethernet 10/100BaseT/1000BaseT Connection
Type B Applied Part
ACUSON Freestyle User Manual 2-3
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Safety and Care
xxxx
-20 C
60 C
Symbol Explanation
Do not dispose of by dumping in garbage. Use a separate collection for electrical and electronic equipment.
Products bearing this symbol are subject to the European Community directive 2002/96/EC on waste electrical and electronic equipment (WEEE), amended by directive 2003/108/EC. For collection and disposal of the product, its components, or its accessories, contact your local Siemens representative.
Federal Communications Commission
Manufacturer's declaration of product compliance with applicable EEC
directive(s) and the European notied body
Safety testing classied symbol for Canada and United States of America
IVK
(Installierte Volumen Komponente)
Identier of selected system components or parts for product traceability
Probe storage temperature range System storage temperature range
Fuse. Identies location of Fuse.
WARNING: Risk of Fire. Replace Fuse as marked.
Alternating Current (AC). Species the type of input voltage.
Transducer Connector port
Video Output. Connector for attaching video display monitor.
Electrostatic sensitive devices
Recyclable / Recoverable
Magnetic Field. WARNING: Keep battery-end of transducer at least 3 centimeters (1.3 inches) away from implanted cardiac rhythm devices.
Protective Earth Ground
IPX8
2-4 ACUSON Freestyle User Manual
Protected against the effects of continuous immersion in water
Page 25
Symbol Explanation
Bar Code
Manufacturer
Year of Manufacture symbol with the year below
Safety and Care
V~
AC (alternating current) voltage source
Indicates this side up
Do not allow to get wet
Fragile. Handle with care.
IEEE 802.11b/g (WiFi) connected
Battery (charge level)
Power Plug
I/O; for service use only.
Ethernet network
Study Storage Memory Used
ACUSON Freestyle User Manual 2-5
Page 26
Safety and Care

Intended Use

WARNING: The analysis of results from an ultrasound examination requires that you are
trained in the interpretation of diagnostic ultrasound studies and are qualied to make
clinical diagnoses.
Prescription Device Statement: In the United States of America, federal law restricts this device to sale or use by, or on the order of, a physician.
The ACUSON Freestyle ultrasound system supports the applications listed in this section.
WARNING: The ACUSON Freestyle ultrasound system is not intended for ophthalmic
studies.
WARNING: No claim is made regarding the safety or efcacy of ultrasound contrast
agents. It is important that you carefully follow the indications, instructions for use, warning, and cautions that are provided by ultrasound contrast agent manufacturers as part of the product labeling.
WARNING: Cardiac rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been observed in the diagnostic range of mechanical index (MI)
values. See the specic package insert for the contrast agent being used for details.
CAUTION: In performing fetal ultrasound studies, it is important to consult consensus statements and health care organization guidelines for the use of ultrasound imaging in pregnancy. Reference: Diagnostic Ultrasound Imaging in Pregnancy. NIH Consensus Statement 1984 Feb 6-8;5(1):1-16
WARNING: Use sterile, endotoxin-free sheaths in intraoperative neurological scanning. Disinfectant/sterilant residue left on the probe is neurotoxic and endotoxin is pyrogenic.
WARNING: Probe sheaths cannot be relied upon to prevent contamination of the probe when used intraoperatively on patients with known or suspected Creutzfeld-Jakob disease (CJD). A probe exposed to central nervous system tissue from know or suspected CJD or Variant CJD should be destroyed since it may not be possible to sterilize. (See http://www. cdc.gov/ncidod/qa_cid_infection_control.htm)
2-6 ACUSON Freestyle User Manual
Page 27

Indications for Use

The indications for use (intended use) for the ACUSON Freestyle include fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organs, neonatal cephalic, cardiac, peripheral vessel and vascular, and musculoskeletal.
Scanning modes may include B-mode, Color Doppler, and Amplitude Doppler. Not all modes may be activated on the system or available with all transducers or for all indicated uses. Consult the Transducer Intended Use Table in this section. The system and probe may be used in adult, pediatric, neonatal, and fetal patients.

Fetal

Fetal studies are performed to obtain images that can be used to: detect presence or absence of structural abnormalities, image and measure anatomic and physiologic parameters of the
fetus, and determine blood ow patterns and velocities.

Abdominal

Abdominal studies are performed to obtain images that can be used to: detect presence or absence of abdominal organ abnormalities, determine size, contour, and patency of vessels,
characterize obstructions, and determine blood ow patterns and velocities.
Safety and Care

Intraoperative

Intraoperative studies are performed during surgical or interventional procedures to obtain images that can be used to: identify organs and vessels, detect presence or absence of organ abnormalities, determine size, contour, and patency of vessels, characterize obstructions,
determine blood ow patterns and velocities, and provide guidance and imaging of surgical
devices or instruments, such as needles, catheters, or biopsy instruments

Intraoperative Neurological

Intraoperative Neurological studies are performed during surgical procedures to obtain images that can be used to: identify organs and vessels, detect presence or absence of organ abnormalities, determine size, contour, and patency of vessels, characterize obstructions,
determine blood ow patterns and velocities, provide guidance and imaging of surgical devices
or instruments, such as needles, catheters, or biopsy instruments.
ACUSON Freestyle User Manual 2-7
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Safety and Care

Pediatric

Pediatric studies are performed in pediatric patients to obtain images that can be used to:
detect presence or absence of organ abnormalities, detect abnormalities in supercial and bony structures, determine size, contour, and patency of vessels, and determine blood ow
patterns and velocities.

Small Organs

Small Organ studies are performed to obtain images of targets such as the breast, thyroid, testicles, and lymph nodes that can be used to: detect presence or absence of organ
abnormalities, determine size, contour, and patency of vessels, and determine blood ow
patterns and velocities.

Neonatal Cephalic

Neonatal cephalic studies are performed in neonatal patients to obtain images that can be used to: detect presence or absence of abnormalities, such as abnormal ventricle size or a shift
in the midline, or ow abnormalities.

Cardiac

Cardiac studies are performed to obtain images of the heart and associated vessels that can be used to: detect presence or absence of abnormalities in heart anatomy, determine the blood
ow patterns and velocities, and image and measure anatomic and physiologic parameters of
the heart.

Peripheral Vessel (Vascular)

Peripheral vessel (vascular) studies are performed to obtain images that can be used to: detect
size, contour, and vessel patency, characterize obstructions, determine blood ow patterns and
velocities, and image and measure anatomic and physiologic parameters of vessels.

Musculoskeletal

Musculoskeletal studies are performed to obtain images of supercial and deeper targets such
as tendons, ligaments, muscles, and bony structures that can be used to: detect presence of
absence of anatomical abnormalities, and determine blood ow patterns and velocities.
2-8 ACUSON Freestyle User Manual
Page 29

Transducers and Intended Use

NOTE: Certain probes may require features not available on your system.
Transducer Name and Array Type Modes Intended Use
L8-3 Linear B-Mode
Color Doppler
Amplitude Doppler
L13-5 Linear B-Mode
Color Doppler
Amplitude Doppler
C5-2 Curvilinear B-Mode
Color Doppler
Amplitude Doppler
Fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organs, neonatal cephalic, cardiac, peripheral vessel and vascular, and musculoskeletal.
Fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organs, neonatal cephalic, cardiac, peripheral vessel and vascular, and musculoskeletal.
Fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organs, neonatal cephalic, cardiac, peripheral vessel and vascular, and musculoskeletal.
Safety and Care
Technical Data Frequency Range Footprint
3.0 – 8.0 MHz
38.4 x 5 mm
5.0 – 13.0 MHz
25.6 x 4 mm
2.0 – 5.0 MHz
13.0 x 60.00 mm
ACUSON Freestyle User Manual 2-9
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Safety and Care

Biohazard Considerations

WARNING: Siemens makes every effort to manufacture safe and effective probes. You
must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. These precautions should be considered in the use of any application that may indicate the need for such care, for example, when scanning patients with open wounds.
WARNING: To eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials, always dispose hazardous or infectious materials according to local, state, and regional regulations.
WARNING: Probe Sheaths: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1.
WARNING: Ultrasound energy is transmitted more effectively through water than through tissue. When using a standoff device of any kind, for example, a waterpath or gel pad, the actual mechanical and thermal indices, MI and/or TI, may be higher than indicated in the output display on the ultrasound system.
The assessment of the biological effects of diagnostic ultrasound on humans is a subject of
ongoing scientic research. This ultrasound system, and all diagnostic ultrasound procedures,
should be used for valid reasons, for the shortest possible period of time, and at the lowest mechanical and thermal indices necessary to produce clinically acceptable images.
According to the principles of ALARA (As Low As Reasonably Achievable), the acoustic output should be the lowest level required to satisfactorily perform the examination.
The ultrasound imaging system complies with the standards of the American Institute of Ultrasound in Medicine (AIUM) and the National Electrical Manufacturers Association (NEMA), the guidelines of the United States Food and Drug Administration (FDA) and the standards of the International Electrotechnical Commission (IEC) in terms of safety and acoustic output levels. The ultrasound output levels are stated to permit the user to critically evaluate the
ultrasound system settings in the event of new research ndings being announced.
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Page 31

Acoustic Output

WARNING: Ultrasound procedures should be used for valid reasons, for the shortest
period of time, and at the lowest mechanical/thermal index setting necessary to produce clinically acceptable images.
NOTE: For ultrasound systems distributed in the United States of America, refer to the Medical Ultrasound Safety ultrasound education program brochure produced by the AIUM that is shipped with the system. This document explains the interaction of ultrasound and tissue, the possibilities and mechanisms of bioeffects, and it explains the terms used to describe acoustic output.
The ultrasound energy, frequency levels, and scanning times employed by the ACUSON Freestyle have not been associated with harmful effects. Nevertheless, it is advisable to minimize the patient’s exposure to ultrasound energy. This prudent use can be accomplished by following the ALARA (As Low as Reasonably Achievable) Principle, and by operating the system in a manner that reduces patient exposure to ultrasound energy. Acoustic Output tables for the ACUSON Freestyle are provided below.
The acoustic output for the ACUSON Freestyle has been measured and calculated in accordance with the “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD2-2004), and the “Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (NEMA UD3-2004.)
Safety and Care

ALARA / Prudent Use

Prudent use of ultrasound requires that patient exposure to ultrasound energy be limited to the lowest output for the shortest period of time needed to obtain acceptable diagnostic results. Techniques include:
1. Keep exams as brief as possible, consistent with diagnostic requirements.
2. Select the appropriate transducer for the patient body type and exam type in order to optimize imaging results.
3. Use overall gain or dynamic range or post processing settings, which have no effect on output, to optimize the image and obtain diagnostic results.
4. In general, as shown in the Acoustic Output Tables, Color Flow Doppler mode will have higher output levels than B-Mode (2D). Keep this in mind when scanning. New studies default to B-Mode.
ACUSON Freestyle User Manual 2-11
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Safety and Care

Acoustic Output: Global Maximum Values

No system/transducer combination is capable of exceeding either a Thermal Index (TI) of 1.0 or a Mechanical Index (MI) of 1.0, so, in accordance with relevant standards (NEMA UD3-2004), the system does not display MI or TI. The table below, Global Maximum Values, provides the mean of the global maximum of acoustic output values. The terms are described below.
Table entries have been obtained with the same operating conditions that create the maximum value.
Uncertainties associated with the values derive from transducer and system variability, measurement variability, and engineering approximations for real-time calculations. Measurement precision and uncertainty for quantities used to calculate the values in the table are 30% for intensity and 15% for MI.
Maximum surface temperatures are in accordance with IEC 60601-2-37.

References:

Ziskin MC: “Measurement of uncertainty in ultrasonic exposimetry”, Ultrasonic Exposimetry, M.C. Ziskin and P.A. Lewin, eds. (CRC Press, Boca Raton, FL) pp. 409-443, 1993.
Ziskin MC: “Specication of acoustic output level and measurement uncertainty in ultrasound
exposimetry,” IEEE Transactions Ultrasonics, Ferroelectrics, and Frequency Control, 50, 1023- 34, 2003
2-12 ACUSON Freestyle User Manual
Page 33
Acoustic Terms and Denitions
Translations for language other than English.
Term Denition
Acoustic Output
Global Maximum Values
Term
Denition
ISPTA.3 (Intensity, spatial­peal temporal average)
TI (Thermal Index)
TIC (Thermal Index Cranial)
TIS (Thermal Index Soft Tissue)
TIB (Thermal Index Bone)
MI (Mechanical Index)
IPA.3@Mimax (Intensity, pulse average at the maximum MI)
B-Mode
Transducer Model
Type
Value
Color Doppler
Safety and Care
ACUSON Freestyle User Manual 2-13
Page 34
Safety and Care
Denition of Acoustic Terms
Term Denition
ISPTA.3 Intensity, spatial-peak temporal average: The value of the temporal-
average intensity at the point in the acoustic eld where the temporal­average intensity is a maximum, or is a local maximum within a specied
region. Units: milliwatts/cm2.
TI Thermal Index: A quantity related to calculated or estimated temperature
rise under certain dened assumptions. The thermal index is the ratio
of total acoustic power to the acoustic power required to raise tissue
temperature by 1º C under dened assumptions. C: Cranial. S: Soft
tissue. B: Bone.
MI Mechanical Index: The spatial-peak value of the peak rarefactional
pressure, derated by 0.3 dB/cm-MHz at each point along the beam axis, divided by the square root of the center frequency.
IPA.3@MImax Intensity, pulse average at the maximum MI: The ratio of the pulse
intensity integral to the pulse duration at the maximum MI. Units W/cm2.
Acoustic Output Global Maximum Values: B-Mode
TRACK 3 Summary (for systems with no probes having global maximum index values exceeding 1.0)
Transducer Model ISPTA.3 TI Type TI Value MI IPA.3@MImax
L8-3 3.58 mW/cm
L13-5 1.15 mW/cm
C5-2 4.53 mW/cm
2
2
2
TIC 0.09 0.76 92.7 W/cm
TIS 0.02 0.33 31.74 W/cm
TIC 0.15 0.76 67.21 W/cm
2
2
2
Acoustic Output Global Maximum Values: Color Doppler
TRACK 3 Summary (for systems with no probes having global maximum index values exceeding 1.0)
Transducer Model ISPTA.3 TI Type TI Value MI IPA.3@MImax
L8-3 33.02 mW/cm
L13-5 54.49 mW/cm
C5-2 19.09 mW/cm
2
TIC 0.72 0.76 132.41 W/cm
2
TIC 0.86 0.38 86.44 W/cm
2
TIC 0.88 0.76 75.18 W/cm
2
2
2
2-14 ACUSON Freestyle User Manual
Page 35

Accuracies

Measurement Accuracies

The ACUSON Freestyle may be used to provide measurements and calculations derived from
ultrasound images. The quantied image data may be used along with other clinical information
to assist a physician in making a patient diagnosis.
The sole reliance on diagnostic ultrasound data to make a clinical diagnosis is not recommended. Numerous factors related to the accuracy of ultrasound image data must be taken into account. This section describes some of these factors. Measurement accuracies are
also inuenced by operator experience, scanning technique, interpreting physician experience, and the technical difculty of the patient. Many of these variables are not associated with the
ACUSON Freestyle system. This limits the ability to fully specify the clinical accuracy of the
measurements and calculations provided by the system.

Accuracy by Transducer Type

All transducer types have been veried for measurement accuracy in the modes appropriate to
each measurement type.
Because the moderate transducer frequency range of the system, measurement accuracies for
the system are not expected to vary signicantly based on transducer used.
Safety and Care

Accuracy of Primary Measurements

All reported accuracies are +/– one-half the least signicant digit.

Distance

The system assumes that the speed of sound in tissue is 1540 meters per second and that this speed is homogeneous in all tissues. The diagnostic ultrasound literature states that differences in the speed of sound in the body do exist because of the differing tissue types. In Clinical Sonography – A Practical Guide, (2nd Edition, Roger C. Sanders, ed., Little Brown and Company 1991) the range is cited as from 1500 to 1600 meters per second. These differences would produce an inaccuracy of up to +/– 4%.
The distance measurements on the system are veried using an AIUM standard phantom with a uid having an acoustic speed of approximately 1540 meters per second at room
temperature. The accuracy of this measurement is +/– 5%. The maximum range of this measurement is 24 cm (dependent on the probe).

Area

The accuracy of the area measurement is +/– 10%.
The maximum range of this measurement is 733 cm2 (dependent on the probe).
ACUSON Freestyle User Manual 2-15
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Safety and Care

Potential Sources of Measurement Error During Scanning

The table below identies potential sources of measurement error that may occur during
scanning. Awareness of these sources can help you avoid errors they may cause.
Potential Source of Error Explanation of Error
Patient Variability The technical difculty of patients in ultrasound imaging varies widely.
Greater care must be taken with technically difcult patients to obtain
the best images possible with the optimal transducer and system control settings.
Operator Variability The skill, care, and experience of the person conducting the scan is
one of the most critical factors in obtaining accurate measurements. Operator training should be consistent with the recommendations of the appropriate professional medical societies.
Speed of Sound The image processing and measurement algorithms of diagnostic
ultrasound assume that the speed of sound in body tissue is 1540 meters per second. Different body tissues have different sound speeds. In soft tissue there is approximately a 2% error; this may be as high as 5%, especially if fatty tissue is present in the area being measured.
Doppler Alignment When performing Doppler scans, try to align the Doppler sample as
close to parallel as possible.
Screen Pixel Resolution
WARNING
The display screen provided in the ACUSON Freestyle system is comprised of a rectangular array of square picture elements (pixels). Measurement pixel resolution is assumed to be +/– one pixel. The maximum potential error of this resolution accuracy is 0.4%
Occasionally, a pixel or a group of pixels of the display may enter a fault condition and become stuck in an on or off position. If stuck pixels occur at a place where a measurement value is displayed, it could cause the operator to misread the result. Pixels stuck in the on position may be detected by looking at the screen with a dark background. Pixels stuck in the off position will show up as dark against a bright video image. You should periodically examine your system for stuck pixels and be aware of this potential condition when reading measurements. If you believe your system has stuck pixels, contact your Service Representative.
2-16 ACUSON Freestyle User Manual
Page 37

Electrical Safety

WARNING: Explosion Hazard. Possible explosion hazard if used in the presence of
ammable anesthetics.
WARNING: To avoid electric shock, use a protective earth connection to connect the ultrasound system to the AC Mains power supply. The protective earth connection ensures that the mains circuit breaker will disconnect the power supply in the event of a short circuit.
WARNING: To ensure grounding reliability, only connect the system to a hospital-grade power outlet.
WARNING: The AC Mains power connector plug for the ultrasound system is a three prong grounded plug (in the U.S.A.) and should never be adapted to any two prong (non grounded) outlet, either by modifying the plug or by using an adapter. In the U.S.A., proper grounding requires the AC Mains power connector plug to be plugged into a hospital grade power outlet.
WARNING: Risk of re. Replace fuse as marked.
Safety and Care
WARNING: To avoid electrical shock, never modify the ultrasound system AC Mains power connector plug, as doing so may overload your facility’s power circuits. To ensure grounding reliability, connect the system only to an equivalent outlet.
WARNING: To avoid electrical shock, never use equipment or an AC Mains power cord that shows signs of wear or tampering, or that has a ground plug which has been bypassed by using an adapter.
WARNING: Equipment connected to the ultrasound system and in the patient zone must be powered from a medically isolated power source or must be a medically isolated device. Equipment powered from a non isolated source can result in chassis leakage currents exceeding safe levels. Chassis leakage current and patient leakage current created by an accessory or device connected to a non isolated outlet may add to the chassis leakage current of the ultrasound system.
WARNING: Using an extension cord or multi socket outlet setup to provide power to the ultrasound system, or to the system’s peripheral devices may compromise the system grounding and cause your system to exceed leakage current limits.
WARNING: To avoid electrical shock and damage to the ultrasound system, power off and unplug the equipment from the AC Mains power outlet before cleaning and disinfecting.
WARNING: To prevent excessive leakage current from contacting the patient, do not touch a user-accessible connector on the system while touching or scanning the patient. User-accessible connectors include connectors such as the USB connectors, and any other audio, video, or data transmission connectors.
ACUSON Freestyle User Manual 2-17
Page 38
Safety and Care
WARNING: Connecting peripheral devices to accessory outlets on the ultrasound system effectively creates a medical electrical system, resulting in a reduced level of safety.
WARNING: No modication of this equipment it allowed.
WARNING: Do not remove system covers. There are no operator serviceable parts
inside. Refer servicing to qualied personnel.
WARNING: To avoid the risk of electrical shock and re hazard, inspect the system
probes and console on a regular basis for any damage to the enclosure, controls, connectors or display, and do not use if damaged. Electrical safety tests must also be
performed at regular intervals as specied by local safety regulations, or as needed.
WARNING: To avoid the risk of electrical shock do not touch the probe battery recharging contacts on the system console.
CAUTION: To avoid the possibility of static shock and damage to the ultrasound system, avoid the use of aerosol spray cleaners on the monitor screens.
CAUTION: Do not use spray cleaners on the ultrasound system, as this may force
cleaning uid into the system and damage electronic components. It is also possible for the solvent fumes to build up and form ammable gases or damage internal components.
CAUTION: Do not pour any uid onto the ultrasound system surfaces, as uid seepage
into the electrical circuitry may cause excessive leakage current or system failure.
CAUTION: To ensure proper grounding and leakage current levels, it is the policy of Siemens to have an authorized Siemens representative or Siemens approved third party perform all on board connections of documentation and storage devices to the ultrasound system.
CAUTION: To avoid the risk of electrical shock and re hazard, inspect the system
probes and console on a regular basis for any damage to the enclosure, controls, connectors or display, and do not use if damaged. Electrical safety tests must also be performed at regular intervals as specied by local safety regulations, or as needed.
EMC Note: Proximity to sources of strong electromagnetic elds, such as radio
transmitter stations or similar installations may lead to interference visible on the monitor screen. However, the device has been designed and tested to withstand such interference and will not be permanently damaged.
CAUTION: Total system chassis risk current should not exceed 100 microamps.
CAUTION: Do not position the system to make it difcult to disconnect the power cable
connector/plug.
CAUTION: If the probe overtemp or probe battery overtemp message appears, the system will stop imaging and the image will be frozen. Unfreeze will not function until the overtemp condition terminates.
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Page 39

Level of Protection Against Electrical Shock for Probes

According to EN 60601-1 and IEC 60601-1, the assemblies for the probes provide a “Level of Protection Against Electrical Shock” of “Type B.”
The Type B icon is located on the probe and probe connector labels
Debrillators
WARNING: To avoid the risk of injury to the operator, remove the probe from patient
contact before the application of a high-voltage debrillation pulse.
For patient safety, be sure to use debrillators that do not have grounded patient circuits.
Safety and Care
ACUSON Freestyle User Manual 2-19
Page 40
Safety and Care

Implantable Devices

WARNING: Ultrasound systems, like other medical equipment, use high-frequency
electrical signals that can interfere with implantable devices such as pacemakers and
implantable cardioverter-debrillators (ICDs). If the patient has such an implantable
device, you should be aware of any interference in its operation and immediately power off the ultrasound system.
WARNING: The probe battery and probe adapter cable well at the back of the probe, away from the transducer end (see illustration) into which the probe battery or cable adapter are placed, contains magnets used to secure the probe battery and cable adapter. Keep this end of the probe at least 3 cm (1.3 inches) away from implanted cardiac rhythm devices.
1
2
Probe battery (showing connector side); insert with battery connectors facing down
1. Probe battery/cable adapter well
2. Location of magnets
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Safety and Care

Possible Combinations with Other Equipment and Peripheral Equipment

WARNING: Accessory equipment connected to the analog and digital interfaces must be
certied according to the respective EN and IEC standards (for example, EN 60950 and
IEC 60950 for data processing equipment and EN 60601-1 and IEC 60601-1 for medical
equipment). Furthermore, all congurations shall comply with the system standards EN
60601-1-1 and IEC 60601-1-1. Anyone who connects additional equipment to the signal
input or signal output port congures a medical system and is therefore responsible that
the system complies with the requirements of the system standards EN 60601-1-1 and IEC 60601-1-1. Siemens can only guarantee the performance and safety of the devices recommended by Siemens. If in doubt, consult the Siemens service department or your local Siemens representative.
WARNING: Do not use an accessory or peripheral device, such as an external monitor within 1.5 meters (1.83 meters [6 feet] in Canada and the U.S.A.) of a patient (beyond the perimeter of the bed — examination table, treatment surface, and the like) and extending
vertically 2.29 meters (7.5 feet) above the oor, unless the device receives power from an
isolation transformer that meets medical safety standards.
The ultrasound system supports a maximum of two documentation or storage devices connected to the system. Siemens recommends that you power off each device whenever the system is powered off.
CAUTION: Any on-board peripheral devices must be installed by an authorized Siemens representative or by a Siemens-approved third party. Devices installed by other people will be at the user’s risk and may void the system warranty.
In order to fulll EN 60601-1-1 and IEC 60601-1-1 (Medical Electrical Equipment, Part 1:
General Requirements for Safety) requirements, connection of peripheral equipment to your ultrasound system much adhere to one of the following conditions:
■ The peripheral equipment itself is a medical device approved according to EN 60601-1 and IEC 60601-1, or
■ Non-medical peripheral equipment approved according to any other EN or IEC standard (EN XXXXX or IEC XXXXX, e.g., equipment complying with EN 60348 and IEC 60348, EN 60950 and IEC 60950, etc.) must use the following setup for connection:
– The peripheral equipment is located at least 1.5 meters (1.83 meters [6 feet] in Canada and
the U.S.A.) outside the patient environment and extending vertically 2.29 meters (7.5 feet)
above the oor. A patient environment is dened as the area in which medical examination,
monitoring, or treatment of the patient takes place (examination table, treatment surface, and the like).
– The peripheral equipment is connected to a main outlet outside the patient environment but
still within the same room as the ultrasound system
– The peripheral equipment is connected to the ultrasound system using isolation adapters.
ACUSON Freestyle User Manual 2-21
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Safety and Care
1
2
4
5
6
7
8
Example of a peripheral equipment connection and patient environment
1. Patient environment represented by shading, extending exactly 1.5 meters (1.83 meters [6 feet] in Canada and in the U.S.A.) around patient and ultrasound system
2. Ultrasound system power cord
3. Medically-approved isolation transformer power cord
4. Medically-approved isolation transformer
5. Peripheral equipment power cord
6. Peripheral equipment (EN XXXXX and IEC XXXXX)
7. Peripheral equipment connections cable
8. Ultrasound system
3
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Safety and Care
1
2
Example of a peripheral equipment connection and patient environment
1. 2.29 meters
2. 1.5 meters (1.83 meters [6 feet] in Canada and the U.S.A.)
ACUSON Freestyle User Manual 2-23
Page 44
Safety and Care

Important Information for Maintaining Data Integrity

CAUTION: To prevent corruption of data stored on inserted media, do not interrupt the
exporting process. Do not delete exported patient data from the local database until the exporting process is complete and the inserted media is determined to be full (or no more exporting is planned for the inserted media).
■ To prevent the loss of data that results from power failures and other system “down” occurrences, you must archive important data, such as patient records, onto a network or an external recording medium, such as a USB, or DICOM storage device.
■ Loss of data is to be expected and its retrieval is not normally possible under the following conditions: loss of power to the ultrasound system, hard disk failure, CPU failure, system lockup, and other similar causes.
■ Should an abnormal system shutdown occur, retrieval of data not saved to the hard disk or not archived to an external recording media is not normally possible.
■ An abnormal system shutdown occurs if you do not power off the ultrasound system using the power on/off key located on the control panel. Other examples of abnormal system shutdown include:
– Equipment malfunction – Loss of power – Accidental removal of the power cord – Pressing and holding the power on/off switch longer than four seconds
■ Should an abnormal system shutdown occur, the system may initially require additional time to reboot or to respond to user input.
2-24 ACUSON Freestyle User Manual
Page 45

Caring for the Ultrasound System

It is the responsibility of the user to verify that the ultrasound system is safe for diagnostic operation on a daily basis. Each day, prior to using the system, perform each of the steps in the Daily Checklist.
All exterior parts of the ultrasound system, including the control panel, keyboard, system accessories, probes, and probe accessories, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect components to kill vegetative organisms and viruses.

Daily Checklist

WARNING: To minimize the risk of cross contamination and infectious diseases, a sterile,
non pyrogenic probe sheath must be in place during procedures requiring sterility.
WARNING: To avoid electrical shock, you must visually inspect a probe prior to use. Do not use a probe that has a cracked, punctured, or discolored casing or a frayed probe adapter cable.
Discoloration Exception: The use of the approved disinfectants, Cidex OPA and Gigasept FF, may cause discoloration of probe housings, including the face of the probe. You can continue
to use a probe if it is discolored due to the use of these specic disinfectants only.
Safety and Care

Perform the following each day before using the ultrasound system:

■ Visually inspect all probes. Do not use a probe that has a cracked, punctured, or discolored casing or a frayed probe adapter cable.
■ Visually inspect all power cords. Do not power on the ultrasound system if a cord is frayed or split, or shows signs of wear.
■ Verify that the Trackball, Rotary knobs, Soft Keys, and other controls on the control panel appear clean and free from gel or other contaminants.
Once the ultrasound system is powered on:
■ Visually check the on screen displays and lighting.
■ Verify that the monitor displays the current date and time.
■ Verify that the probe identication and indicated frequency are correct for the active probe.
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Safety and Care

Maintenance

CAUTION: Electrical safety tests must also be performed at regular intervals as specied
by local safety regulations, or as needed.

Repair

WARNING: No modication of this equipment is allowed.
For questions regarding repair or replacement of any equipment parts on your system, contact your Siemens service representative.
Siemens Authorized Care
Installers and operators must observe any statutory regulations that govern the installation, operation, inspection, and maintenance of this equipment.
Perform inspections and maintenance at the prescribed intervals to avoid worn and hazardous parts due to wear.
As manufacturers and installers of ultrasound equipment, Siemens cannot assume responsibility for the safety properties, reliability, and/or performance of the equipment, if:
■ Installations, extensions, readjustments, modications, additions, or repairs are carried out
by persons not specically authorized by Siemens.
■ Components that affect the safe operation of the system are replaced by parts not authorized by Siemens.
■ The electrical installation of the room where the equipment is located does not meet the power and environmental requirements stated in this manual.
■ The equipment is not used in accordance with the operating instructions.
■ The system is operated by personnel not adequately educated or trained.
Siemens suggests that you request any person who performs maintenance or repairs to
provide you with a certicate showing:
■ The nature and extent of the work performed
■ Changes in rated performance
■ Changes in working ranges
■ Date of service
■ Name of person or rm performing the service
■ Signature of person performing the service
Technical documentation pertinent to the ultrasound system is available at an additional charge. However, this does not in any way constitute an authorization to conduct repairs or maintenance. Siemens refuses all responsibility whatsoever for repairs that are performed without the express written consent of the Siemens service department.
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Cleaning and Disinfecting

You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. Use universal precautions when cleaning and disinfecting. You should treat all portions of the ultrasound system that come in
contact with human blood or other body uids as if they were known to be infectious.
All exterior parts of the ultrasound system, including the control panel, system accessories, probes, and probe accessories, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect components to kill vegetative organisms and viruses.

Cleaning and Disinfecting Ultrasound System Surfaces

WARNING: To avoid electrical shock and damage to the ultrasound system, power off
and unplug the equipment from the AC power outlet before cleaning and disinfecting.
WARNING: Disinfectants and cleaning methods listed are recommended by Siemens for compatibility with product materials, not for biological effectiveness. Refer to disinfectant
label instructions for guidance on disinfection efcacy and appropriate clinical uses.
WARNING: Do not immerse any part of the system console in Liquid.
Safety and Care
WARNING: Always wear protective clothing, including eye wear and gloves, when performing cleaning and disinfection.
WARNING: The use of any disinfectants other than those specied in the instructions for
use may damage the ultrasound system and accessory surfaces and, as a result, may create electrical hazards for the patients and/or users.
CAUTION: To avoid the possibility of static shock and damage to the ultrasound system, avoid the use of aerosol spray cleaners on the monitor screen.
CAUTION: Do not clean the ultrasound system with chlorinated or aromatic solvents, acidic or basic solutions, isopropyl alcohol or strong cleaners such as ammoniated products, as these can damage the surface of the system. Use of unapproved cleaners or disinfectants can result in severe damage to the ultrasound system components. Use the recommended cleaning procedure.
CAUTION: Do not use spray cleaners on the ultrasound system, as this may force
cleaning uid into the system and damage electronic components. It is also possible for the solvent fumes to build up and form ammable gases or damage internal components.
CAUTION: Do not pour any uid onto the ultrasound system surfaces, as uid seepage
into the electrical circuitry may cause excessive leakage current or system failure.
CAUTION: Do not use abrasive cloths or brushes when cleaning any part of the system. Use only soft cloths, gauze pads, or brushes. Apply solutions to the cloth, not the system.
CAUTION: To clean the lens cover of the system display monitor, use only a soft cloth lightly moistened with a mild lens or glass cleaner. Using other cleaners may damage the display and void the warranty.
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Safety and Care
The following instructions describe cleaning the surface of the ultrasound system, including the Trackball and probe holder. See also, “Approved Disinfectant Wipes for the Ultrasound System Surfaces” on page 2-29.
To Do This
Clean and disinfect the surface of the ultrasound system
Clean and disinfect the holders for probes
Clean and disinfect the Trackball
1. Power off the ultrasound system and unplug the power cord from the power outlet.
2. Use a clean gauze pad or lint-free cloth, lightly moistened with a mild detergent, to wipe the surface of the ultrasound system.
Take particular care to clean the areas near the Trackball, Soft Keys, and Rotary knobs. Ensure these areas are free of coupling agent (gel) and any other visible residue.
Ensure that cleaning solution does not seep into the control panel, or any other openings.
3. After cleaning, use a clean, lint-free cloth to dry the surface.
4. As required, use an approved disinfectant wipe to disinfect the ultrasound system and accessories.
5. Reconnect the ultrasound system power cord into the power outlet.
1. Remove the holder from the ultrasound system. a. Squeeze the tab at the top of the probe holder away from the system console
and pull the holder upward.
2. Clean the holder under running water, using a mild detergent, and dry with a lint free cloth.
3. As required, use an approved disinfectant wipe to disinfect the holder.
4. Reattach the holder to the ultrasound system pressing downward until the tab clicks into place.
CAUTION: Do not drop or place foreign objects inside the Trackball assembly because doing so may affect the Trackball operation and damage the ultrasound system.
1. Rotate the Trackball bezel counterclockwise and lift up to remove the Trackball bezel from the control panel.
2. Carefully remove the Trackball from the control panel.
3. Clean the bezel and Trackball with a cotton swab or lint free pad moistened with mild detergent solution.
4. Clean the inside of the Trackball assembly using a cotton swab moistened with mild detergent solution.
5. As required, use an approved disinfectant wipe to disinfect the Trackball, Trackball bezel, and Trackball assembly.
6. Allow the Trackball components to completely dry before reassembly.
7. Reinstall the Trackball and replace the Trackball bezel. a. Place the Trackball inside the Trackball assembly. b. Place the Trackball bezel over the Trackball. c. Rotate the Trackball bezel to tighten. Do not overtighten the Trackball bezel.
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Approved Disinfectant Wipes for the Ultrasound System Surfaces

The following matrix provides a list of approved disinfectant wipes for use on the ultrasound system and surfaces of the listed accessories.
Safety and Care
Sani-Cloth
Sani-Cloth
Ultrasound System
Probe Holders
Trackball Assembly
*or any bleach wipe with <1% sodium hypochlorite and no other active ingredients
= Compatible
Bleach Wipe*
Sani-Cloth HBSani-Cloth
Plus
Super Sani­Cloth

Caring for Documentation and Storage Devices

For information on the care of an optional documentation or storage device, refer to the manufacturer’s operating instructions that accompanied the device.
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Safety and Care

Caring for Probes

WARNING: During neurosurgical procedures, if a probe becomes contaminated with
tissue or uids of a patient known to have Creutzfeldt Jakob disease, the probe should be
destroyed as it cannot be sterilized.
CAUTION: Probes are sensitive instruments — irreparable damage may occur if they are dropped, knocked against other objects, cut, or punctured. Do not attempt to repair or alter any part of a probe, contact your local Siemens representative.
CAUTION: To avoid cable damage, do not roll the ultrasound system over probe adapter cables.
CAUTION: To avoid damage to the probe, do not use probe sheaths containing an oil based coating or petroleum or mineral oil based ultrasound coupling agents. Use only a water based ultrasound coupling agent.
CAUTION: Follow all instructions provided by manufacturers of sterile goods (probe sheaths) to ensure proper handling, storage, and cycling of all sterile goods.
CAUTION: Take extreme care when handling or storing probes. They must not be dropped, jarred, or knocked against other objects. Do not allow probes to come into contact with any sharp edged or pointed object.

Protective Case

Due to the mechanical sensitivity of probes, Siemens recommends that you always use the probe case when you ship a probe or transport it from one place of examination to another. The case is specially designed to protect the sensitive parts of the probe. Be sure that all parts of the probe are properly placed inside the case before you close the lid.

Storage

Store probes in a clean and dry environment. Extreme temperatures or humidity may damage a probe.

Repair

Do not attempt to repair or alter any part of the probe. Contact your service representative at Siemens immediately if a probe appears to be damaged or malfunctions in any way.
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Cleaning and Disinfecting Probes

WARNING: Before cleaning and disinfecting, you must read and understand the cleaning
and disinfecting topic, including the warnings and cautions for cleaning and disinfecting ultrasound system surfaces provided in this chapter.
WARNING: Follow the instructions in this chapter, and your institution’s procedures to avoid risk of infection.
WARNING: Probes used in semi-critical applications should be sterilized between uses whenever feasible though high level disinfection is minimally acceptable. In addition, the use of a sheath is recommended for every semi-critical use. Probes used in a semi-critical application should be cleaned and sterilized or at least receive high level disinfection after use, even if a sheath was used.
WARNING: Probes used in critical applications should be sterilized and the use of a sterile sheath is recommended. Probes used in critical applications should be cleaned and sterilized after use even if a sterile sheath was used.
NOTE: When sterilization is not possible, an accepted method of infection control for critical use is high-level disinfection and the use of a sterile gel and a sterile probe cover. (See US FDA Guidance document, “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” dated September 9, 2008 at www.fda.gov/downloads.) Use only sterile, legally marketed probe sheaths for semi-critical or critical applications.
Safety and Care
WARNING: ACUSON Freestyle probes may only be sterilized using the Sterrad method,
(Sterrad model 100S). Do not attempt to sterilize a transducer using steam, autoclaving, ultraviolet, gamma radiation, dry heat, ethylene oxide, or other methods.
WARNING: Unless explicitly stated otherwise, ACUSON Freestyle transducers are not indicated or intended for endo-scanning uses.
WARNING: Always wear protective clothing, including eye wear and gloves, when performing cleaning and disinfection.
WARNING: Clean the probe modules by hand. Do not use an ultrasonic cleaner or automatic washer.
WARNING: Inspect transducers for signs of wear or damage prior to use and prior to cleaning, disinfection, or sterilization. Do not process a probe that exhibits signs of wear or damage, such as cracks or fractures in the enclosure.
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Safety and Care

Intraoperative Neurological Important Warnings

WARNING: Use sterile, endotoxin-free sheaths in intraoperative neurological scanning.
Disinfectant/sterilant residue left on the probe is neurotoxic and endotoxin is pyrogenic.
WARNING: Probe sheaths cannot be relied upon to prevent contamination of the probe when used intraoperatively on patients with known or suspected Creutzfeld-Jakob disease (CJD). A probe exposed to central nervous system tissue from know or suspected CJD or Variant CJD should be destroyed since it may not be possible to sterilize. (See http://www. cdc.gov/ncidod/qa_cid_infection_control.htm)
WARNING: To avoid electrical shock and damage to the system, power down and disconnect the probe prior to cleaning or disinfecting.
WARNING: To avoid electrical shock and damage to the system, remove the probe battery or the probe adapter cable from the probe prior to cleaning or disinfecting.
WARNING: Disinfectants and cleaning methods listed are recommended by Siemens for compatibility with product materials, not for biological effectiveness. Refer to disinfectant
label instructions for guidance on disinfection efcacy and appropriate clinical uses.
CAUTION: Do not sterilize probes using hot steam, cold gas, or Ethylene Oxide (EO) methods. Before applying any other methods that might be recommended by manufacturers of sterilization equipment, please contact your Siemens representative.
CAUTION: To avoid damage to the probe, do not immerse or allow the probe adapter cable or connector of a probe to become wet.
CAUTION: The probes have been designed and tested to be able to withstand high level disinfection as recommended by the manufacturers of approved disinfectant products. Carefully follow the disinfectant manufacturer’s instructions. Do not immerse for more than one hour.
CAUTION: Do not use abrasive cleaning agents, organic solvents such as benzene, isopropyl alcohol, or phenol based substances, or cleaning agents containing organic solvents to clean or disinfect probes. These substances can damage the probes.
CAUTION: Prior to cleaning or disinfecting a probe, you must remove the probe battery and disconnect the probe adapter cable and remove the probe from the ultrasound system. To prevent the probe cleaners or disinfectants from contacting and damaging the ultrasound system surfaces, do not clean the probe on or near the ultrasound system. Approved probe cleaners and disinfectants are not approved for use on the ultrasound system surfaces. Unintended contact with approved probe cleaners and disinfectants can result severe damage to the ultrasound system components.
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All probes should be cleaned and disinfected prior to their use on each patient.

Probe General Cleaning (including Low Level Disinfection):

Clean probes (including low level disinfection) after every patient use, including non-critical
applications. Do not allow body uids, such as blood, to dry on the probe.
Routing cleaning steps are as follows:
1. Immediately after completing the exam, turn the probe off and remove the battery module. Process the pieces separately.
2. Wipe the gel off the probe with a soft cloth.
3. Use a soft brush, sponge, or gauze pad lightly moistened in an enzymatic detergent such as Metrizyme (in accordance with the manufacturer’s instructions) to remove all gel,
particulate matter, or bodily uids from all components and surfaces. Carefully clean any
crevices, corners or seams.
4. Rinse with quality running water, and dry with a soft cloth or gauze pad.
5. Thoroughly examine and visually inspect all surfaces that have been cleaned to make sure that they are clean. If visible debris is noticed, repeat Steps 3 and 4.
6. Immediately rinse the probe thoroughly with sterile water, then pat dry with a clean soft cloth or gauze pad.
Safety and Care
CAUTION: Do not run the probe Cable Adapter under water. Instead wipe with a lightly moistened sponge or gauze pad.
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Safety and Care

Probe High Level Disinfection

Preparation

Follow the Cleaning instructions above prior to high-level probe disinfection.

High-Level Disinfection

Soak the probe using a compatible disinfectant (listed below), following the manufacturer’s
instructions and specications.
CAUTION: When disinfecting probes, be careful to immerse only the top portion of the probe, up to two inches (5 cm) from the transducer face in the disinfecting solution. Do not immerse the entire probe and do not immerse the battery pack, probe battery well, or cable adaptor.
CAUTION: Strictly follow the instructions of the disinfectant manufacturer, and limit the time probes are soaked to the minimum time recommended by the disinfectant manufacturer. Follow the disinfectant manufacturer’s instructions for rinsing and drying after disinfection.
CAUTION: Do not use strong solvents such as acetone, Freon, and other industrial cleaners on transducers.

Probe Sterilization

CAUTION: The only sterilization methods compatible with ACUSON Freestyle probes
(including the probe battery pack) are those listed and described below. No other sterilization methods should be used.
CAUTION: Carefully follow the instructions provided with the sterilization system.
CAUTION: Use treated water that is of a quality that ensures hard water stains do not
occur. Failure to remove all organic materials or detergents may result in the formation of light-colored residue on the components. If residue is visible, you should clean, rinse, and dry and re-sterilize the items prior to use.

Sterilization Preparation

Thorough and effective cleaning is essential to successful sterilization. Follow the Cleaning instructions above prior to probe sterilization.
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Probe Sterilization: Sterrad

1. The probe main module and battery module must be keep disassembled from each other, and packaged separately for sterilization.
2. Carefully inspect the modules for cleanliness and dryness prior to packaging for Sterrad processing. If visible soil is present, the item must be re-cleaned and dried prior to sterilization. If moisture is present, dry the item thoroughly prior to sterilization.
3. Place the dry battery module into an ACUSON Freestyle charging bay and charge the battery fully before sterilizing. The modules can be either wrapped or peel pouched in compatible material. Only polypropylene wrap or Tyvek® pouches can be used in the Sterrad system. If you choose to wrap, secure the package with Sterrad SealSure® Chemical Indicator Tape.
4. Mark the tape or pouch used to package a battery with the expected expiration date of the battery’s charge. (For a fully charged battery, it is advisable to recharge the battery if it has been in a stored condition for over two months.) If you choose to place items in a peel pouch, use a Sterrad Chemical Indicator Strip marked with the expiration date of the battery’s charge placed on the inside of the pouch. If the pouch has an imprinted indicator strip you may alternatively write the date here.
5. Follow your facility’s procedures for labeling sterilized items.
6. Process the items in the Sterrad system in accordance with its instructions. The probe and battery modules have been validated with the following cycle parameters, for the Sterrad models listed below:
Safety and Care
Sterrad Model: Sterrad 100S
CYCLE DURATION
Pre-Plasma 10 minutes
Injection 6 minutes
Diffusion 2 minutes
Plasma 2 minutes
In the Sterrad 100S, two cycles of Injection/Diffusion/Plasma are performed
7. Batteries can be used immediately or stored in accordance with your facility’s procedures.
8. Rotate stock and recharge and re-sterilize batteries, as necessary.
CAUTION: The probe Cable Adapter is not sterilizable.
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Safety and Care

IPX8 Immersion Levels

CAUTION: To avoid damage to the probe, observe the continuous immersion levels
indicated for each probe type. When disinfecting probes, be careful to continuously immerse only the top portion of the probe, up to two inches (5 cm) from the transducer face in the disinfecting solution. The entire probe, battery pack, or probe battery will may be immersed for short periods of time (under three minutes). Do not continuously immerse the entire probe, battery pack, or probe battery well.
Example of continuous immersion level for each probe type
1. L8-3 probe (left)
2. L13-5 probe (middle)
3. C5-2 probe (right)
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Approved List of Disinfectants

The following matrix provides a list of approved disinfectants for all probes.
NOTE: The approved disinfectants, such as Cidex OPA, may discolor probe housings, including the face of the probe. There is no associated degradation of imaging performance or probe reliability.
Compatible Disinfectants for the System Console and Probe are listed below. Use of disinfectants not listed may cause damage to the system and void the warranty.
System Console
Name Description
abcoCIDE 14 Gluteraldehyde
abcoCIDE 28 Gluteraldehyde
Asepti-Wipe Quaternary Ammonia
Cidex Gluteraldehyde
Cidex OPA Ortho-phthaldehyde
Cidex Plus Gluteraldehyde
MetriCide 14 Gluteraldehyde
MetriCide 28 Gluteraldehyde
T-Spray Quaternary Ammonia
T-Spray II Quaternary Ammonia
Safety and Care
Probe
Name Description
abcoCIDE 14 Gluteraldehyde
abcoCIDE 28 Gluteraldehyde
Cidex Gluteraldehyde
Cidex Plus Gluteraldehyde
MetriCide 14 Gluteraldehyde
MetriCide 28 Gluteraldehyde
Wavicide-01 Gluteraldyhyde
Metrizyme Propylene glycol
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Safety and Care

Caring for Probe Accessories

Instructions are provided for the accessories.

Probe Sheaths

WARNING: There have been reports of severe allergic reactions to medical devices
containing latex (natural rubber). Health care professionals are advised to identify latex sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91 1. In the United States of America, for a single copy of a reference list on latex sensitivity write to LATEX, FDA, HFZ-220, Rockville, MD 20857.
WARNING: To minimize the risk of cross contamination and infectious diseases, a sterile, non pyrogenic probe sheath must be in place during procedures requiring sterility.
WARNING: Only a sterile probe sheath provides the sterile barrier required for surgical procedures. To ensure sterility of a procedure, always place a sterile sheath on a probe, as probes cannot be sterilized using hot steam, cold gas, or Ethylene Oxide (EO) methods.
CAUTION: Siemens recommends that you follow all instructions provided by manufacturers of sterile goods (probe sheaths) to ensure proper handling, storage, and cycling of all sterile goods.
Using a disposable probe sheath on a probe reduces the possibility of cross contamination. Always use a protective probe sheath when scanning an open wound or an area where the skin is not intact.

Storage

WARNING: Before use, examine sterile goods, such as sheaths, for any material aws.
Some packaging may list an expiration date. Any product showing aws, or whose
expiration date has passed, should not be used.
CAUTION: Do not store probe sheaths in direct sunlight, as ultraviolet damage can result.
Latex products have a limited shelf life, and should be stored in a cool, dry, dark place with an ambient temperature between -5°C and +40°C and up to 80% relative humidity at +40°C.
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Recommended Use of the Probe Sheaths

Siemens makes every effort to manufacture safe and effective probes. You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. These precautions should be considered in the use of any application that may indicate the need for such care, for example, when scanning patients with open wounds.
Probe sheaths are single use items used to ensure proper acoustic coupling and provide a prophylactic barrier for the intended ultrasound application. Sheaths are available for all probes. Use only market cleared probe sheaths.

Application

WARNING: After placing the sheath over the probe, visually inspect the sheath to ensure
there are no defects. Do not use the sheath if it has any holes or tears.
WARNING: Carefully follow the labeling instructions provided with the probe sheath.

Disposal

Safety and Care
While wearing protective gloves, remove the probe sheath from the probe and dispose of it according to local, state, and regional regulations for biohazardous waste.
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Safety and Care

Battery Safety

The ACUSON Freestyle contains rechargeable lithium ion batteries in the System Console. These batteries are not accessible by the operator and may only be replaced or serviced by a
qualied service technician.
The ACUSON Freestyle probe also utilizes a rechargeable lithium ion battery. This is enclosed in the removable battery pack.
To prevent the probe battery from bursting, igniting, or emitting fumes and causing personal injury or equipment damage, observe the following precautions.
WARNING: Use only batteries supplied by Siemens Medical Solutions USA, Inc. with the system and probe.
WARNING: Do not disassemble or alter the battery pack or remove the casing of the pack.
WARNING: The battery contains safety circuitry and features. Do not disassemble or alter the battery.
WARNING: Charge batteries only when the ambient temperature is between 0º and 40º C (32º and 104º F).
WARNING: Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects.
WARNING: Do not heat the battery or discard it in a re.
WARNING: Do not use a defective battery or a battery that appears to be malfunctioning
or not holding a charge. Replace such batteries.
WARNING: Do not expose the battery to temperatures over 60º C (140º F). Keep it away
from re and other heat sources.
WARNING: Do not leave the battery in direct sunlight.
WARNING: Do not pierce the battery with a sharp object, hit it, or step on it.
WARNING: Do not use a damaged battery, or a battery pack with cracks or damage to
the casing.
WARNING: Do not solder a battery
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WARNING: The polarity of the battery terminals is xed and cannot be switched or
reversed.
WARNING: Do not force the battery into its compartment in the probe.
WARNING: Do not connect the battery to an electrical power outlet.
WARNING: Do not continue to recharge a battery if it does not recharge properly after
two successive six hour charging cycles.
WARNING: If the battery leaks or emits an odor, remove it from all possible ammable
sources.
WARNING: Do not attempt to recharge non-rechargeable batteries, such as the batteries included on printed circuit boards. Recycle non-rechargeable batteries according to local, state, and regional regulations.
CAUTION: Remove the battery from the probe if the probe is not likely to be used for an extended period. Prior to storage charge or discharge the battery to approximately 50% of capacity.
Safety and Care
CAUTION: To avoid the battery bursting, igniting, or emitting fumes from the battery and causing equipment damage, observe the following precautions
CAUTION: Do not immerse the battery in liquid if it is damaged or the housing is cracked.
CAUTION: Do not immerse the battery in any liquid not listed in the chapter “Cleaning,
Disinfection, and Sterilization,” and do not submerge a battery beyond the time periods
specied in the instructions for recommended liquids.
CAUTION: If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal, immediately remove it from use.
CAUTION: Do not put the battery into a microwave oven or pressurized container.
CAUTION: Store the battery between 5º C and 60º C (41º and 140º F).
CAUTION: Use only Siemens-supplied batteries and charging devices.
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Safety and Care

Good Ergonomic Practices

WARNING: The operation of an ultrasound system may to linked to musculoskeletal
disorders (MSDs).
In ultrasound imaging, ergonomics may be dened as the physical interaction between the
operator, the system, and the transducer, in the course of conducting exams. It is important for the operator of the system to practice good ergonomic techniques to reduce the risk of injury. This chapter is intended to provide guidelines to help you work more comfortably in order to possibly reduce the risk of musculoskeletal disorders.
When using an ultrasound system, as with many similar physical activities, you may experience
occasional discomfort in your hands, ngers, arms, shoulders, eyes, neck, back, or other parts
of your body. If you experience symptoms such as constant or recurring discomfort, pain, throbbing, aching, tingling, numbness, burning sensation, or stiffness, you should promptly
consult a qualied health professional. These may be symptoms of MSD. MSDs can be painful
and may result in potentially disabling injuries to the nerves, muscles, tendons, joints, or other parts of the body. Examples of MSDs include carpal tunnel syndrome and tendonitis.
Steps you can take to guard against discomfort while scanning, or the risk of MSD are described here. It is also recommended that you consult the guidelines of professional medical societies concerned with ultrasound.

Interrupt Scanning

Interrupt scanning frequently, using breaks to rest and give soft tissue a chance to recuperate from the strained positions and repetitive movements of examinations.
While scanning, avoid maintaining the same body position for extended periods of time, by moving and varying head, neck, body, arm, and leg positions.

Positioning

Avoid bending or stooping.
Adjust the position of the ACUSON Freestyle such that viewing or reaching the controls does not require strained or awkward body positions.
Whenever possible, use an adjustable chair with good back support, and adjust chair height to promote good body posture. If possible, adjust the height of the patient bed to optimize body posture.
Maintain a comfortable and balanced body position with minimal stress on your joints, minimizing bending and twisting.
Keep elbows close to your side and relax your shoulders in a level position.

Hand and Wrist

Do not grasp the transducer with excessive force; hold it as lightly as possible.
Minimize the amount of pressure applied when pressing the transducer against the patient.
Avoid or minimize bending your wrist.

Exercise and Stretching

Targeted exercises and stretching may help avoid the risk of MSDs. Consult with a qualied health professional to dene a program suited to your needs and practices.
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Moving the System

The ultrasound system is a mobile unit. Before moving the system to another location, you must prepare for the move by powering off and securing the system.
Unplug the power cord plug from the wall outlet. Pull on the plug, not the cord. Disconnect the Ethernet cables from the ultrasound system.
Secure components such as the power cord, probes, and gel.
WARNING: When operating and transporting the ultrasound system using the ACUSON
Freestyle Rollstand, insure that the rollstand is congured according to the specications
provided in this manual. Failure to do so can cause the system to tip over and create a risk for injury to the user or patient and damage to the system.
WARNING: Do not tip the system in any direction more than 10 degrees. This action can cause the system to tip over and create a risk for injury to the user or patient and damage to the system.
WARNING: Preparations before moving the system are important to minimize potential damage to sensitive components and to avoid safety hazards. Review the moving instructions before moving the system.
Safety and Care
WARNING: Do not park or leave the ultrasound system unattended on a slope. Even when the brakes are engaged, the system may slide down a ramp.
WARNING: When using the system in a tabletop use, pull out the tilt stand on the rear of the unit to position it securely. Make sure the stand is placed securely on an even surface where the system will not be accidentally pushed.
CAUTION: When moving the ultrasound system, protect if from environmental changes including : moisture, winds, dirt and dust, and extreme heat or cold exposure.
CAUTION: Avoid moving the ultrasound system on outside surfaces with loose dirt, contaminants, or standing liquids.
CAUTION: Care should be taken to minimize shock and vibration of the ultrasound system. Avoid uneven surfaces that contain an abrupt height change or jarring surface irregularities.
CAUTION: After the move, make sure the ultrasound system has proper ventilation during operation. Do not position the system against walls or hard surfaces that would impede free ventilation around the system.
CAUTION: Do not allow linens, bedding, and/or hanging curtain partitions to block the ultrasound system’s ventilation.
CAUTION: When moving the ultrasound system over longer distances, or shipping it, place it in the protective shipping case provided by Siemens and pack it according to the instructions.
CAUTION: When moving the ultrasound system over longer distances, remove probe batteries from the probes.
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Safety and Care
ACUSON Freestyle Rollstand Conguration
WARNING: When operating and transporting the ultrasound system using the ACUSON Freestyle
Rollstand, insure that the rollstand is congured according to the specications provided
in this manual. Failure to do so can cause the system to tip over and create a risk for injury to the user or patient and damage to the system.
1
2
3
4
5
6
7
Rollstand Conguration
1. Quick Release Adaptor Plate: the top of the plate should be placed no higher than 48 in/122 cm. Do not place anything other than the Freestyle, probe batteries, and probes on this mount.
2. Handle: the top of the Handle should be placed no higher than 40 in/101 cm from the
oor.
3. Keyboard Shelf: should be placed no higher than 33 in/84 cm from the oor.
4. Rear Storage Basket: the top of the basket should be placed no higher than 30 in/76 cm
from the oor. Weight limit 4 lbs/1.8 kg.
5. Front Storage Basket: top of basket should be placed no higher than 24 in/61 cm from the
oor. Weight limit 4 lbs/1.8 kg.
6. Cable Wrap: should be placed no higher than 22 in/56 cm.
7. Video Printer Shelf: the shelf should be placed no higher than 12 in/30 cm from the oor. Weight limit 6 lbs/2.7 kg. Secure printer with straps.
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System Upgrades

Performing System Software Upgrades

When performing system software upgrades, carefully follow the installation instructions that accompany the software.
CAUTION: Back up or archive any patient studies that may be stored on the system prior to performing a software upgrade.
CAUTION: Do not terminate power during a software upgrade or otherwise interrupt a software upgrade. This may cause the system not to operate and may require system servicing. When conducting a software upgrade, operate the system on AC Mains power outlet and make sure the system battery is fully charged.
Consult your service representative or help desk contact with any questions you may have regarding software upgrades.

Environmental Protection

Safety and Care

Product Recycling and Disposal

Dispose of this product according to local, state, and regional regulations.
Batteries and electrical and electronic equipment can contain hazardous substances. If released, the hazardous substances can harm people and the environment.
Siemens provides disassembly instructions to treatment facilities for the safe and proper removal and recycling of electrical and electronic components in this product. For more information, contact your local Siemens representative.
To the extent required by local laws and regulations, Siemens has programs for the return of used products. For more information, contact your local Siemens representative.
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Safety and Care

Recycling Batteries

WARNING: Never dispose of batteries by burning or by ushing into any waste water
system, for example, a lavatory. Compromising the structural integrity of a battery can result in leakage or explosion and the potential for personal injury.
WARNING: Do not throw batteries into the trash. Collect and recycle used batteries separate from other waste.
The system does not contain alkaline batteries. Printed circuit boards may contain lithium batteries. If the system clock no longer keeps time, it could be time to replace the battery. Contact your local Siemens representative.
Recycle batteries according to local, state, and regional regulations. Use a battery collection program available in your country to recycle batteries.
To the extent required by local laws and regulations, Siemens will collect and recycle batteries for this product at no charge. Contact your local Siemens representative for battery shipment instructions.

Disposing of the Packaging Materials

Dispose of or recycle the packaging materials according to local, state, and regional regulations.
To the extent required by local laws and regulations, Siemens will collect and dispose of packaging materials for this product. For more information, contact your local Siemens representative.
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Disposing of Components and Accessories

WARNING: Observe local, state, and regional regulations for the disposal of the
ultrasound system components and accessories.

Energy Conservation

For improved energy conservation when the system is not in use, power off the system. Keep the system plugged into the power outlet.
For maximum energy conservation when the system is in storage, power off and unplug the system from the AC Mains power outlet.
NOTE: Unplugging the system from the AC mains power outlet can shorten the life of the system circuit board batteries.
Safety and Care
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Safety and Care

Technical Description

This Section provides a summary of important information regarding the specications and
safe operation of the ACUSON Freestyle Ultrasound System. Read this entire User’s Manual for important information on the safe installation and operation of the ACUSON Freestyle system, in particular, the Safety chapter.
Upon request, Siemens Medical Solutions USA, Inc. will make available circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist service personnel to repair those parts of the system which are designated by Siemens Medical Solutions USA, Inc. as repairable by non-Siemens personnel.
ACUSON Freestyle Ultrasound System Technical Description
Manufacturer Siemens Medical Solutions USA, Inc.
685 Middleeld Road Mountain View, CA 94043 USA
Electrical Power Requirements Input Voltage : 100 – 240 V
Frequency : 50/60 Hz Current : 1.5 – 0.7 A Fuse Rating : 250 V, 3 A Fuse Type: 5 x 20 mm Slo-Blo
Classications The ACUSON Freestyle is classied under IEC60601-1, UL 60601-1 as:
1. Class 1 protection against electrical shock. When probe and/or console are operated from battery power, Class is Internally Powered Equipment.
2. For continuous mode of operation
3. Equipment not suitable for use in the presence of ammable anesthetic
mixture with air or oxygen or nitrous oxide.
4. System: Ordinary equipment without protection against ingress of water.
5. Probe: IPX8
6. Probe : Applied part Type B.
Environmental Conditions Indoor Use Only
Operating: Temperature: 10º C to 40º C (50º F to 104º F) Humidity (Relative Humidity): 10% to 75% Pressure: 700 hPa to 1060 hPa (20.7 inHg to 31.3 inHg)
Transportation and Storage: Temperature: –20º C to 60º C (–40º F to 158º F) Humidity (Relative Humidity): 10% to 90%, Non-condensing Pressure: 500 hPa to 1060 hPa (14.8 inHg to 31.3 inHg)
Physical Specications Dimensions:
Console: 158 mm L x 373 mm W x 335 H Probe: 153 mm L x 65 mm W x 34 mm H
Weight: 10.5 pounds (System and one probe with probe battery)
Batteries Probe battery reorder number: 11002304
Battery Performance
(Figures approximate and will vary with operating conditions)
Charge Time (empty to full): Probe battery = 2 hours / System battery = 5 hours Run Time (full to empty): Probe battery = 1.5 hours / System battery = 1 hour Number of charge cycles before charge capacity reduced to < 70% of original
capacity: Probe battery = 500 / System battery = 300
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3 Setup

This section describes the functions of the Setup Menu that is used to specify system settings.
System Setup and Controls ...............................................3-3
Overview of the Setup Menu ..............................................3-3
How to Select Items from the Setup Menu .................................. 3-4
Setup Menu Options ....................................................3-5
Scan ..............................................................3-5
Probes .............................................................3-5
Locating the Active Probe ...........................................3-5
Connecting and Disconnecting Probes ................................. 3-5
Settings ............................................................3-6
User Exams ......................................................3-6
Network ......................................................... 3-6
DICOM .........................................................3-6
System .............................................................3-7
Getting Help and Service Support ....................................3-7
Closing the Active Page ............................................3-7
Setting Image Controls .............................................3-7
Removing Patient Information from Images ............................. 3-7
Administrative Options .............................................3-8
Study List ...........................................................3-9
New Patient Study .................................................... 3-9
Close Study .........................................................3-9
Setup
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Setup
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System Setup and Controls

This section explains how to setup the system. The Setup Menu includes patient data entry functions, patient study lists, system settings, and more.

Overview of the Setup Menu

To display the list of Setup options, press the SETUP Soft Key.
Setup
Location of SETUP Soft Key
Setup Soft Key Menu Options
Option Description
SCAN
PROBES
SETTINGS
SYSTEM
STUDY LIST
NEW PATIENT STUDY
CLOSE STUDY
Activates the real-time imaging screen
Connect and disconnect probes using this option.
Manage system settings, including:
User Exam proles
• Network settings
• DICOM settings
Activate the System information page that provides
information about hardware and software conguration, and
installed options. Includes:
• Setting image controls
• Patient anonymity settings
• Administrative options
• Contact information for service
• Battery status
Opens the list of studies.
Initiates data entry for a new patient study.
Closes the active study.
Each option is described on the following pages.
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Setup

How to Select Items from the Setup Menu

There are several ways to select an item from the SETUP menu list:
■ Turn the large, outer Rotary knob to highlight an item, then turn the small, inner Rotary knob to activate it.
■ To move left/right, back/forth turn the inner Rotary knob.
■ Use the Trackball which controls a pointer to highlight an option, and then touch the left Trackball key to activate it.
■ Use a compatible USB mouse for these controls (plug the mouse into one of the USB ports on the I/O Panel; for more information see “Console Inputs/Outputs Panel” on page 1-5).
If an item in the Setup list has sub-pages, a pop-up window will display the additional choices. Activate this pop-up window with the inner Rotary knob. The outer Rotary knob scrolls through this list, and the inner knob activates a selection.
XXX
XXX
XXX
XXX
XXX
XXX
XXX
Xxxx Xxxxxx Xxxxxxxx Xxxxxx Xxxxx Xxxx Xxx Xxxxxxx Xxxxx Xxxxx Xxxxx
XXX XXX XXX XXX
Xxxx Xxxxx Xxxxxxx XXXXX
XXXX Xxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxx
XXX
P S
Setup Menu and Sub-Menus; there are several ways to select items from the menus
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Setup Menu Options

Scan

Activates the real-time imaging screen. When you are in a Setup page or menu the SETUP Soft Key changes to SCAN.

■ To go to the real-time imaging screen from a Setup page, select SCAN.

■ To go to the real-time imaging screen when the Setup menu is displayed and Scan is highlighted, turn the small Rotary knob.

Probes

The Freestyle Probes page is a list of the most recently used probes by Name (type of probe), Serial Number and date Last Used.
Locating the Active Probe
If a probe is currently turned on and wirelessly connected to the system, pressing the IDENTIFY Soft Key causes the probe to beep. This can be useful when trying to locate a probe. To stop the probe from beeping, press the IDENTIFY Soft Key a second time.
NOTE: For the Identify function to operate, the probe must be: on, linked to the system, and within range of the Bluetooth radio.
Setup
Connecting and Disconnecting Probes
■ The CONNECT Soft Key connects the highlighted probe on the list if it is turned on and in a three meter range of the console, or plugged into the system console using the probe Cable Adapter.
■ The DISCONNECT Soft Key terminates the connection to the active probe.
For a description of the routine method of connecting probes, see the Scanning and Wireless Probe Operation chapters of this Manual.
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Setup

Settings

The Settings options are used to congure the system:
■ User Exams
■ Network
■ DICOM
User Exams
The ACUSON Freestyle comes pre-loaded with a variety of factory exam types (e.g., cardiac, vascular). This option lets you create custom User Exams with the parameters and settings
that you specify. Note that a “u” preface identies an Exam type as being user-dened.
For detailed instructions about Exam Types, see “Factory Exam Types” on page 4-7 and “User-Dened Exam Types” on page 4-8.
Network
The Network page includes information and the interface for establishing wired Ethernet or wireless connections with the system.
For detailed instructions about Connectivity settings and conguration, see the
Connectivity chapter of this Manual
DICOM
The DICOM page includes information and the interface for establishing and managing DICOM connections.
For detailed instructions about DICOM settings and conguration, see the Connectivity
chapter and the DICOM Conformance Statement of this Manual.
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System

The System page provides access to information about your product’s hardware and software
conguration as well as installed options, including the following:
■ Battery Status and Charge Levels for the system (console), left and right charger bays, and the active probe
■ System information including:
– System serial number – Software version number – License number – Installed options – Subsystem circuit board information
■ Image Controls (see “Setting Image Controls” and “Removing Patient Information from Images”).
■ Administrative Options: for more information see, “Administrative Options” on page 3-8.
Getting Help and Service Support
Press the HELPDESK Soft Key to enter contact information for your local Service support representatives. Your Siemens Service Representative may access additional system information from the Helpdesk page.
Setup
Closing the Active Page
To close the active page select the CANCEL option.
Setting Image Controls
Using the cursor and the Trackball, click on the slider tab using the left Trackball key to adjust the following:
Image Size: use the drop-down box to select the image size.
Cine Playback: set the length of time of multi-frame cine loops played back in real-time scroll memory.
Monitor Brightness: move the slider bar to adjust the brightness of the monitor.
Capture Quality: set the quality of JPEG-captured images.
– For higher quality images, move the slider bar to the right. – For lower quality images, move the slider bar to the left.
Removing Patient Information from Images
The Study Anonymity option allows you to remove patient information from images saved as either JPEG or DICOM. Make the scan anonymous by excluding either the Patient ID (Identication), the Patient Name, or both. Default setting: the anonymizing features are turned off; Patient Name and ID are displayed on saved images.
NOTE: These settings do not remove the Patient Name and ID from the DICOM data stored with the study.
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Setup
Administrative Options
The ADMIN Soft Key provides a list of administrative settings for the system as described in the following table.
Admin Soft Key Settings
Option Description
Automatic Freeze When enabled, allows the system to freeze during real-time scanning when
imaging is inactive.
Clip Storage When enabled, allows “clips” to be saved.
Use the drop-down menu to set the length, in seconds, of the saved clips. Clips of 10 seconds or longer will use a reduced Capture Quality setting.
Menu Time-outs When enabled, allows you to adjust the amount of time popup menus stay up
before automatically disappearing after inactivity. Use the drop-down menu to set a faster or slower time.
Sleep Mode When enabled, allows the console to go into a power saving “sleep” mode
when inactive for a specied time.
Set the inactive time by selecting a time from the drop-down menu.
Probe Localization When enabled, allows the wireless probe tracking feature to operate. For more
information see, “Finding/Locating Wireless Probes” on page 6-11.
Probe Keys Lock When enabled, the probe keys will come up in a locked state during scanning.
This prevents control changes due to unintended hits of the keys. The console will display a lock icon (a padlock) in the lower right corner of the system console.
To unlock the keys: move your nger along the probe slider the length of the
slider up and then down OR press the probe’s plus key, then the minus key, then the plus key (or the reverse: minus, plus, minus keys). Once unlocked, after a period of inactivity, the probe controls will lock again.
Probe Middle Keys When enabled, allows the operation of the probe middle keys.
Print with Save When enabled, also makes a print when you select SAVE. This feature only
operates with compatible video printers like the Sony UP-D897.
Area Measurement ­Continuous Trace
Hide Image Settings after…
Activate Scroll when freezing
Use international keyboard
Language Select a language for the screen display using the drop-down list.
Date and Time Adjust the date: Click on the Date eld and select the day from the displayed
When enabled, uses the continuous trace method for area measurements. When disabled, uses the multiple point-to-point trace method.
When enabled, hides the image settings after a selected amount of time following a controls change.
Set the time by using the drop-down menu.
Activates the Scroll key when image is frozen..
Adds special characters to the on-screen keyboard.
After changing the language, reboot the system to activate the new selection.
calendar.
• Adjust the time: Click on the up/down arrows to set the time. Check the AM/ PM checkbox to display time in 12-hour AM or PM mode; leave the box unchecked for a 24-hour clock. The system is designed to automatically adjust the date for leap years.
WARNING: The ACUSON Freestyle does not automatically adjust for changes to and from daylight savings time. If and when your locality changes the clocks to begin or end daylight savings time, you will need to manually adjust the system time.
NOTE: Be sure to check the time and date displayed on the system when you begin patient studies to make sure they are correct.
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Option Description
User Selected Keys Dene shortcut keys that will appear in the Real-time Control bar.
Two B-Mode and one Color shortcut can be dened. The function of the Probe middle keys can also be dened. Use the drop-down menus to specify the key
functions.
The Tools list can be used to access functions that are not specied for these
user-selected keys.
Mobile LInk When enabled, allows a Windows 8 mobile device running the Freestyle
Mobile Link App to connect to the system.

Study List

For details about the Study List, see the Patient Studies chapter of this Manual.

New Patient Study

For details about creating a New Patient Study, see the Patient Studies chapter of this Manual.
Setup

Close Study

Closes the active study.
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4 Patient Studies

This section describes how to create patient records and view, manage, and export patient studies.
Protecting Patient Health Information ....................................... 4-3
About Patient Studies ....................................................4-3
Patient Study Fields ..................................................... 4-4
Patient Soft Keys .......................................................4-5
Creating New Patient Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Using Patient Information from a DICOM Server ..............................4-6
Worklist Query ....................................................... 4-6
Study Exam Types ....................................................... 4-6
Factory Exam Types ...................................................4-7
User-Dened Exam Types ..............................................4-8
Creating a new User Exam Type .....................................4-8
Updating a User-Dened Exam with New Settings ....................... 4-8
The Study List .......................................................... 4-9
Viewing the List of Patient Studies ..........................................4-9
Sorting the Study List ..................................................4-9
Scrolling through the Study List .........................................4-10
Selecting Multiple Studies for Export or Deletion ............................ 4-10
Viewing Images in a Study from the Study List .............................4-10
Viewing Image Controls ...........................................4-10
Managing Patient Studies ................................................ 4-11
Exporting Patient Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
How to Export Studies ................................................ 4-11
Export Parameters ...................................................4-12
Editing Patient Studies .................................................. 4-12
Deleting Patient Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Patient Studies
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Patient Studies
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Protecting Patient Health Information

Storing patient data on the ACUSON Freestyle only temporarily, and then archiving the data to your institution’s secured archival systems can enhance protection of your patient’s Protected Health Information (PHI).
WARNING: Protected Health Information (PHI) such as patient records, is subject to privacy protection (such as is described in the US Health Insurance Accountability and Portability Act and the European Union Data Protection Directive, 95/46/EC.) Health care providers have a responsibility to protect PHI.
WARNING: Be aware that even a highly secured wireless network can be vulnerable to unauthorized access.

About Patient Studies

Only one patient study can be active at a time.
A patient study remains open until you:
■ close the current study,
■ create a new study, or
■ reboot the system.
Patient Studies
To reactivate a closed study, select STUDY LIST, highlight the desired study then select Edit/
Open.
The most recent Institution entry in the Patient Study page is retained in memory. The Institution name is displayed on the imaging screen.
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Patient Studies

Patient Study Fields

To display the Patient Study elds press the SETUP Soft Key, then NEW PATIENT STUDY. When entering data into the Patient Study eld, the [OK] key conrms an entry. The study information includes the elds described in the following table.
Patient Study Information Fields
Option(s) Description
Last Name, First Name, Middle Name
Patient ID A unique patient ID number.
Birth Date To enter data, use the number keys.
Gender Select either Male or Female.
Exam Select an Exam Type from the drop-down list.
Height, Weight To enter data, use the number keys.
Accession Type text into the eld.
Diagnosis Type text into the eld.
Institution Select from the drop-down menu.
Physician Select from the drop-down menu.
Operator Select from the drop-down menu.
Comments Enter any additional information or comments.
Patient name information. Note that the patient’s name can be removed from saved image scans using the
anonymity settings. For more information, see “Removing Patient Information from Images” on page 3-7.
NOTE: If you do not enter a Patient ID the system will generate one based on time and date.
To display values using the metric system, click the Metric checkbox.
The Institution name is displayed on the real-time imaging screen.
NOTE: Patient Name and ID elds are limited to 64 characters. If the eld is too long to be completely
displayed on the real-time scanning screen, the entry will be shortened in the display and followed by three dots.
NOTE: The system stores up to eight of the most recently used Institution, Physician, and Operator entries.
When using an external USB keyboard, quickly pressing the following key combinations allows you to enter special characters:
Press this key... then press this key Resulting character
(apostrophe)
(quotation mark)
` (accent grave)
~ (tilde)
^ (caret)
= (equals)
* (asterisk)
- (dash)
# (pound)
. (period)
, (comma)
/ (slash)
a, c, e, i, n, o, u, y, z á, ć, é, í, ń, ó, ú, ý, ź
a, e, i, o, u, y ä, ë, ï, ö, ü, ÿ
a, e, i, o, u à, è, ì, ò, ù
a, n, o ã, ñ, õ
a, e, i, o, u â, ê, î, ô, û
a, o æ, œ
a å
a, i, o, u ā, ī, ō, ū
c, s, z č, š, ž
e, z ė, ż
c, e, i ç, ę, į
l, o ł, ø
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Patient Soft Keys

Patient Soft Keys

Soft Key Description
SCAN
CANCEL
CLEAR
WORKLIST
Returns to the scan screen.
Closes the record without saving unconrmed entries.
Lets you start over by clearing information from all the elds.
Displayed if Worklist is congured for this system. For more
information see, “Worklist Query” on page 4-6.

Creating New Patient Studies

To enter Patient information:
1. Press the PATIENT Soft Key or select New Patient Study from the SETUP Soft Key menu to display the New Patient screen.
2. Use the Trackball to place the cursor in each entry eld, then press the left Trackball key to open the on-screen keyboard. You can also place the cursor over the keyboard symbol to the right of the entry box and press the left Trackball key to bring up the on-screen keyboard. You can also use an external USB-compatible keyboard.
3. Save the new patient record, by selecting [OK].
4. To then go directly to the real-time imaging screen select Scan from the SETUP Soft Key menu.
NOTE: If you start scanning a patient and save images without entering a patient name or ID, the
system will automatically create a Study le for that patient study. The patient name will be listed as
UNKNOWN, a machine-generated ID number will be created, and the date and time of the study will be recorded. This information will become a part of the image screen saved with the images. During or after the study, it is possible to modify the patient information that appears in the Patient Study Archive.
Patient Studies
NOTE: If a patient already has a study stored in the system, you will still need to enter new patient information at the time of a new study; the system does not provide patient folders with multiple studies.
NOTE: If the on-screen keyboard does not automatically activate as expected and you have a USB mouse or a wireless USB mouse connected, disconnect the USB mouse or use the pointer to select the on-screen typewriter symbol to activate the on-screen keyboard.
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Patient Studies

Using Patient Information from a DICOM Server

If your system has the Worklist option and is congured and connected to a DICOM server you
can obtain existing patient information (for more information, see “Overview of Connectivity” on page 8-3).

Worklist Query

This option provides a shortcut to entering patient information as you create new patient studies by accessing your DICOM Worklist Server (where patient information can be stored).
You can query the Worklist server using a variety of search terms or conditions, such as patient name or exam date. If the query returns a patient for whom you want to create a study, highlight the patient name in the response list, and select Create Study for this Patient. The data will be entered into the system and the study will be activated for that patient.
To access the Worklist server use the Soft Keys, SETUP / SETTINGS / DICOM / WORKLIST.

Study Exam Types

There are two kinds of study Exam types:
■ Factory/Standard exam types
■ User-created exam types
You can change the Exam Type during scanning using the Exams key in the real-time control window.
You can also specify which Factory/Standard Exam Types are available during scanning:
1. Select SETUP / SETTINGS / USER EXAMS.
2. Click the [+] box to display the lists of Exam types; to hide the lists, click the [–] box.
3. Use the checkboxes to select the desired Exam types.
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Factory Exam Types

The factory Exam Types provide real-time parameter presets optimized for specic types of exams (for information about creating user-dened exam types see “User Exams” on page
3-6). These standard exam types can help optimize imaging settings with minimal effort. Factory Exam Types are shown in the following table listed in alphabetical order. On the system they are displayed in the most-recently-used order.
Exam Types are organized in the following groups: Abdominal, General, Musculoskeletal, Nerve, Obstetrics/Gynecology, Small Parts, and Vascular.

Factory Exam Types

Screen Display Description
Abd Deep Abdominal Deep
Abd Gen Abdominal General
Abd Vasc Abdominal Vascular
Abd Renal Abdominal Renal
General General
MSK Deep Musculoskeletal Deep
MSK Elbow Musculoskeletal Elbow
MSK Foot/An Musculoskeletal Foot/Ankle
MSK Gen Musculoskeletal General
MSK Hand/Wr Musculoskeletal Hand/Wrist
MSK Hip Musculoskeletal Hip
MSK Knee Musculoskeletal Knee
MSK Shouldr Musculoskeletal Shoulder
MSK Spine MSK Spine
MSK Sup Musculoskeletal Supercial
MSK Tendon Musculoskeletal Tendon
Nerve Deep Nerve Deep
Nerve Gen Nerve General
Nerve Spine Nerve Spine
Nerve Sup Nerve Supercial
OB/Gyn Gyn Obstetrics/Gynecology Gynecology
OB/Gyn OB Obstetrics/Gynecology Obstetric
SP Breast Small Parts Breast
SP Deep Small Parts Deep
SP Gen Small Parts General
SP Sup Small Parts Supercial
SP Thyroid Small Parts Thyroid
V Arterial Vascular Arterial
V Carotid Vascular Carotid
V Gen Vascular General
V Vn Diff Vascular Venous Difcult
V Vn LwExtr Vascular Venous Lower Extremity
V Vn Sup Vascular Venous Supercial
V Vn UpExtr Vascular Venous Upper Extremity
Patient Studies
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Patient Studies
User-Dened Exam Types
User dened Exam Types are preceded by “u”. You can create up to 64 different user exams.
The User Exam page displays the list of User Exams that have been created, including the real-time settings by Probe type.
Display the list of User Exams that have been created on the User Exams page:
1. Press the SETUP Soft Key.
2. Select the SETTINGS option.
3. Select USER EXAMS.
You can display real-time settings by Probe type and create your own Exam Type with the system settings you prefer.
User Exam Soft Keys:
DELETE: deletes User Exams from the system.
RENAME: allows you to edit the name of the User Exam; names are limited to nine characters.
ACTIVATE: makes the highlighted Exam the active Exam Type.
Creating a new User Exam Type
1. During real-time scanning, select one of the pre-loaded factory Exam Types — not a User Exam Type; User Exams are prefaced with the letter “u” (for example, “u Cardio1”).
2. Change the system real-time control settings, such as Depth and Gain, that you prefer for the exam type you are creating.
3. When you have specied the settings you want, touch the Exams Soft Key, then select
Save Exam. The settings will be saved with the name “u Exam” followed by a number.
You can then rename the Exam in the SETUP / SETTINGS / USER EXAMS page.
NOTE: If you are unable to create new User Exams, you may have exceeded the number of User Exams the system allows. The system stores a total of 64 User Exams. Delete unused User Exams so new ones can be created.
Updating a User-Dened Exam with New Settings
1. During real-time scanning, use the Exams Soft Key to activate the User Exam you want to update.
2. Change any of the control settings (e.g., Gain, Depth).
3. Select Save Exam.
For information about saving images to a Patient Study, see the Scanning Chapter.
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The Study List

The Study List includes all the patient study les that have been imaged and stored on the
system. You can view studies from this list and send them (using the Export function) to a storage device such as a USB drive, or to a network destination such as a DICOM picture archival system (PACS).

Viewing the List of Patient Studies

To access the Study List,
1. Press the SETUP key.
2. Select STUDY LIST from the menu.
The Study List displays the studies in a tabular form, with column headers for Patient name, exam date, Patient ID, and export status. If a study has been archived (exported) to an external storage location an arrow appears next to the study. The study storage memory used symbol indicates the percentage of memory that has been used.
Patient Studies
1
Scan Delete Edit Export
The Studies List screen
1. List of studies
2. Thumbnail images from the highlighted study
3. Study Storage Memory Used symbol

Sorting the Study List

The default is to show studies sorted by their study date.
To change the sort to a different category, click on a column header.
2
3
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Patient Studies

Scrolling through the Study List

To scroll through the study list, use the outer Rotary knobs.
If a study contains saved images they are displayed as thumbnails. The inner knob highlights the images and allows you to view them full size.
To return to scrolling through the Study List, turn the inner knob so the thumbnail image is no longer highlighted.

Selecting Multiple Studies for Export or Deletion

To select multiple studies for exporting or deleting place the pointer in the space to the left of the name and press the left Trackball key. The selected studies will be marked with a checkmark (). To de-select, place the pointer over the checkmark and press the left Trackball key.

Viewing Images in a Study from the Study List

If a highlighted study has saved images, thumbnail versions of the images will be displayed at the right of the screen. To highlight an image, turn the small Rotary knob one click. To view the image in View mode, turn the small Rotary know a second time.
Viewing Image Controls
The VIEW Soft Key opens all the recorded clips from the active study. Studies may also be viewed by selecting them from SETUP / STUDY LIST.
When viewing study images:
Next cycles through the stored clips.
PANEL view displays multiple images on the same screen; then use these controls:
MORE makes thumbnails smaller – FEWER makes thumbnails bigger – DELETE highlight and delete selected thumbnails
DELETE removes the highlighted clip from the study.
Studies
Name Date Id Smith, John 05-FEB-2013 2013.02.0546 Jones, Jane 05-FEB-2013 2013.02.0545
Abbot, Steven 05-FEB-2013 2013.02.0544
White, Emma 05-FEB-2013 2013.02.0543 Patient, F 05-FEB-2013 2013.02.0542
Patient, E 05-FEB-2013 2013.02.0541 Patient, D 05-FEB-2013 2013.02.0540 Patient, C 05-FEB-2013 2013.02.0539 Patient, B 05-FEB-2013 2013.02.0538 Patient, A 05-FEB-2013 2013.02.0537
Scan More Fewer Delete
Scan More Fewer Delete
Panel views of study thumbnail images; left picture: fewer, larger thumbnails; right picture: more, smaller thumbnails
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Managing Patient Studies

Exporting Patient Studies

The Export function sends selected studies to a storage medium (on a network or a compatible USB drive).

How to Export Studies

To export patient studies, follow these steps:
1. Be sure you have the desired type of export hardware connected, e.g., a USB drive or a
congured DICOM network.
2. Open the study list by selecting STUDY LIST from the SETUP menu.
3. Select a study by placing the cursor over the checkbox to the left of the study and pressing the left Trackball key to check or uncheck the box. To export multiple studies at one time, check multiple boxes.
4. Press the EXPORT Soft Key.
5. Specify the Congure Export choices (see “Export Parameters” on page 4-12).
6. Click [OK] to begin the export. While the export is taking place, the Export List shows details about the study being exported and the status of the export, indicating how many clips have been stored out of the total. To terminate the export, click [CANCEL].
NOTE: Allow the status indication to complete and show no additional clips to store before removing the USB drive, otherwise the export may not be successful.
Patient Studies
When a study has been successfully exported, a curved arrow symbol is displayed to the right of the study.
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Patient Studies

Export Parameters

Pressing the EXPORT Soft Key opens the Congure Export list with the following elds:
Export Format: choose an export format: DICOM Network, DICOM Media, DICOM Media DSF (Decompressed Single Frame), or PC Viewable. DICOM Media and PC Viewable are used to store studies to a compatible USB external drive connected to the system. If no drive is connected, these options are not displayed.
Storage Destination: for detailed information see the Connectivity chapter of this Manual.
Storage Commitment Destination: for detailed information see the Connectivity chapter of this Manual

Editing Patient Studies

1. Open the study list by selecting STUDY LIST from the SETUP menu.
2. Press the EDIT Soft Key to activate the Studies page where you can edit patient information (name, birth date, etc.).
NOTE: Patient ID cannot be edited.

Deleting Patient Studies

The Delete function removes studies from the system.
1. Open the study list by selecting STUDY LIST from the SETUP menu.
2. Highlight a study in the Study List and press the DELETE Soft Key.
You will be prompted to conrm that you intend to delete the study before it is removed.
If you intend to archive a study to an external storage medium, do not delete the study prior to the archival being performed. Once a study has been deleted, it cannot be recovered from the system.
CAUTION: Conrm that an archival operation has been successful before deleting a
study from the system.
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5 Scanning

This section describes the real-time scanning operation.
Using the Probe ......................................................... 5-3
About the Probe ........................................................ 5-3
Probe Orientation ....................................................5-3
Overview of the Probe ................................................. 5-3
Probe Controls .......................................................5-4
Locking and Unlocking the Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Probe Shortcuts for Save and Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Connecting the Probe ...................................................5-5
Cabled Probe Operation ...............................................5-5
Wireless Probe Operation ..............................................5-6
Connecting More Than One Wireless Probe ............................5-6
The Real-Time Scanning Screen ........................................... 5-7
Overview of the Scanning Process .........................................5-8
Real-Time Scanning Controls .............................................5-9
Selecting an Exam Type from the List of Exams ...........................5-10
Freezing an Image ...................................................5-10
Scanning Soft Keys .................................................. 5-11
B-Mode Scanning .....................................................5-12
B-Mode Tools ....................................................... 5-12
Color Flow Mode Scanning .............................................. 5-13
Color Flow Tools .................................................... 5-13
Measurements .........................................................5-14
Performing a Measurement ..............................................5-14
Deleting Measurements ..............................................5-14
Ellipse Measurement ...................................................5-14
Area Measurement ....................................................5-15
Adding Text Annotations to Studies .......................................5-16
Text Functions ........................................................5-16
Scanning
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Scanning
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Using the Probe

About the Probe

Probe Orientation

The probe index marker is the side of the probe where the probe on/off symbol is located. This corresponds to the ACUSON “a” symbol next to the image display. The probe model numbers, such as “L8-3” also serve as index markers. For transducers in non-cardiac applications, the normal and default location of the on-screen index marker symbol is to the left of the image.

Overview of the Probe

1
2
Scanning
3
4
Controls on the probe include a slider, plus/minus keys, middle keys
1. Back of probe
2. Circular plus/minus keys and slider bar
3. Probe middle keys
4. Front (or “face”) of probe
NOTE: In wireless mode, press the two on-probe circular keys continuously to turn the probe on and off (see “Wireless Probe Operation” on page 5-6).
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Scanning

Probe Controls

Functions in the real-time Control Bar can be adjusted or selected using the controls on the probe. These controls include the slider, the two circular buttons, and the two buttons in the middle of the probe.
The slider mimics the function of the large Rotary knob on the console, moving the selection of the active item in the real-time control knob:
■ To move the highlight up the list, push upward on the slider, away from the transducer face.
■ To move the highlight down, push downward on the slider, toward the transducer face.
The button towards the rear of the probe (away from the transducer) represents Plus, the button towards the front of the probe (towards the transducer) represents Minus. These mimic the functions of the inner Rotary knob on the console.
■ Plus corresponds to clockwise rotation of the knob.
■ Minus corresponds to counterclockwise rotation of the knob.

Locking and Unlocking the Probe

Before using the probe controls, you may have to unlock these functions on the probe if you unchecked the Enable Probe Key and Slider selection in the SETUP / SYSTEM / ADMIN page.
NOTE: When the probe is locked, a padlock icon is displayed on the bottom right of the console screen.
There are two ways to unlock the probe:
■ Slide the probe slider the length of the slider in both directions
■ Press the plus key, then the minus key, then the plus key (or the reverse)
Once unlocked, the controls will lock again after a period of inactivity.

Probe Shortcuts for Save and Color

The two keys in the middle of the probe can be used as shortcuts for the function you select on the System Administration page. Tap either probe key three times to activate the function.
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Connecting the Probe

There are two ways to operate the probe with the system:
■ Cabled
■ Wireless

Cabled Probe Operation

To operate the probe with the removable probe Cable Adapter, plug the probe cable into the system I/O panel (see “Console Inputs/Outputs Panel” on page 1-5), and insert the probe end into the probe.
NOTE: Both ends are keyed to prevent improper connection. Do not use force to connect either end of the cable.
During cabled probe operation, the probe comes up with the image frozen. Select Unfreeze to go to real-time scanning.
NOTE: If a probe is already connected using the probe Cable Adapter you cannot connect another probe using the wireless connection. To make a wireless probe connection, unplug the probe Cable Adapter at the probe or system console.
Scanning
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Scanning

Wireless Probe Operation

To operate the system probe in wireless mode, insert a charged probe battery pack into the probe.
NOTE: The battery pack is keyed to prevent improper connection. Do not use force when inserting the probe battery pack.
Probe and battery; line up battery connectors with probe connectors
With the system power ON, turn the probe on by continuously pressing the two circular on­probe buttons. When power has been turned on for the probe, you will hear a beep from the probe. The system and the probe will automatically connect.
Connecting More Than One Wireless Probe
To use more than one probe in wireless mode during an exam:
1. Turn the rst probe off by continuously pressing the two circular on-probe buttons, thereby disconnecting it from the console.
2. Connect to the second probe.
NOTE: If a Probe is connected to the console with the probe Cable Adapter, you will need to disconnect it to make a wireless connection to another probe. You can disconnect it either at the probe or the console end.
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The Real-Time Scanning Screen

Scanning
1
2
Real-time Scanning
XXX XXX XXX XXX
5
L13-5
Nerve Gen
2.5cm
CG 10
SC 3 SF 6
PP 10
55dB CF 1
CP 1 Vel 1 Pri 4 20 Hz
ANL 0.0 dB
G 9
3
4
XXX
XXX
XXX
XXX
XXX
XXX
XXX
XXX
P S
1. Imaging Area
2. Soft Keys
3. ANL: Average Noise Level. A measure of wireless probe signal quality. See the Wireless Probe Operation chapter of the Manual for details about ANL.
4. Real-time Control Bar Soft Keys: touch the control bar to activate the Soft Key next to the bar (e.g., Freeze, Save, etc.).
5. The on-screen settings window is the area next to the image that displays the settings of controls including depth, gain, probe type, exams, etc.
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Scanning

Overview of the Scanning Process

Scanning is controlled using the Soft Keys, real-time Control Bar, and Rotary knobs.
Basic steps to complete a scan and save it to the Study List:
1. Press the console power button to turn the system on and allow it to boot up.
2. To enter a new Patient Name and create a new Patient Study, press the PATIENT Soft Key or SETUP / NEW PATIENT STUDY, then use the on-screen keyboard or an external keyboard to enter the patient Name, ID, etc (see “Creating New Patient Studies” on page 4-5).
3. Select an Exam Type (see “Study Exam Types” on page 4-6).
4. Press the SETUP / SCAN Soft Key to go to scanning mode and start imaging.
5. Make sure your probe is connected (either cabled or wirelessly) and turned on. To turn a probe on for wireless operation, press the probe Plus and Minus keys continuously until you hear the probe beep.
6. Make any adjustments using the real-time Control Bar Soft Keys.
7. Press the Freeze key to freeze an image.
8. Press Save to save frames or clips.
9. If desired, press the MEASURE Soft Key to make measurements (see “Measurements” on page 5-16).
10. Press the VIEW Soft Key to view saved frames or loops.
11. To export studies to an external drive or system, see “Exporting Patient Studies” on page 4-11.
12. To view a list of completed studies press SETUP / STUDY LIST (see “The Study List” on page 4-9).
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Real-Time Scanning Controls

The Real-time Control Bar along the right side of the screen provides Soft Keys for the functions described in the following table.
The larger, outer Rotary knob moves up or down the list, highlighting an active control. The smaller, inner Rotary knob adjusts the settings of the highlighted function. The probe controls also provide these functions. Additionally, the controls may be activated by pressing the button area next to the control on the front panel.

Real-Time Scanning Controls

Real-time Control Bar Keys Description
Freeze/Unfreeze Freezes and unfreezes the image. When the image is frozen, the light
on the probe will ash on and off.
When you press Freeze during real-time scanning, you can select Scroll and use the inner Rotary knob or probe keys to step frame-
by-frame through the image memory. The scroll memory is the immediate sequence of frames that were produced just prior to the freeze.
The Cine key plays the scroll memory in a repeating loop.
Save Stores a still-frame image to the Patient Study le in internal memory.
NOTE: During live scanning a circular symbol appears in the
upper right corner of the screen for the length of time the Save or Clip is taking place. A new Save or Clip cannot be started until the Save or Clip is completed.
Scanning
NOTE: If you select Save or Clip and the system does not have any study storage memory available, the study storage memory used symbol will appear showing 100%. Delete studies to make memory available.
Clip Stores a multi-frame image clip to the Patient Study le in internal
memory. In order for clips to be stored, the Enable Clip Storage checkbox on the Setup/System/System Admin page must be checked.
NOTE: During live scanning a circular symbol appears in the upper right corner of the screen for the length of time the Save or Clip is taking place. A new Save or Clip cannot be started until the Save or Clip is completed.
NOTE: If you select Save or Clip and the system does not have any study storage memory available, the study storage memory used symbol will appear showing 100%. Delete studies to make memory available.
Gain Adjusts the overall image gain.
Displayed in the on-screen settings window as G.
Depth Adjusts the scanning eld of view. Scale markers in centimeters are
displayed along the edge of the image. In the on-screen settings window, the bottom depth number is displayed in centimeters.
Note that for linear array probes, distance markers are also shown along the top of the image and the center of the probe is marked with an arrow.
When making changes to the depth setting, the displayed depth setting number turns blue until the actual image depth changes to the new setting.
Color Turns color ow mapping on and off. The region of interest is moved
up or down with the Color Box Soft Key. Displayed in the on-screen settings window as C Box.
N Gain Adjusts the near eld gain.
Displayed in the on-screen settings window as NG.
Tools Activates the Tools menu for additional image adjustment.
Exams Displays the list of factory and user-dened Exam Types.
For more information, see “Selecting an Exam Type from the List of Exams” on page 5-11.
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Scanning
Real-time Control Bar Keys Description
TGC (Time Gain Compensation)
Activates keys for Near, Mid, and Far Gain controls. “Auto” restores default settings and “Exit” closes the TGC control list.
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