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ACUSON

 Freestyle User Manual

Safety and Care

Definition of Acoustic Terms

Term

Definition

ISPTA .3

Intensity, spatial-peak temporal average: The value of the temporal-

average intensity at the point in the acoustic field where the temporal-

average intensity is a maximum, or is a local maximum within a specified 

region. Units: milliwatts/cm

2

.

TI

Thermal Index: A quantity related to calculated or estimated temperature 

rise under certain defined assumptions. The thermal index is the ratio 

of total acoustic power to the acoustic power required to raise tissue 

temperature by 1º C under defined 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/cm

2

.

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

2

TIC

0.09

0.76

92.7 W/cm

2

L13-5

1.15 mW/cm

2

TIS

0.02

0.33

31.74 W/cm

2

C5-2

4.53 mW/cm

2

TIC

0.15

0.76

67.21 W/cm

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

2

TIC

0.72

0.76

132.41 W/cm

2

L13-5

54.49 mW/cm

2

TIC

0.86

0.38

86.44 W/cm

2

C5-2

19.09 mW/cm

2

TIC

0.88

0.76

75.18 W/cm

2

Summary of Contents for ACUSON Freestyle

Page 1: ...ACUSON Freestyle Diagnostic Ultrasound System User Manual Siemens Medical Solutions USA Inc 11002778_01 English US 0123 0123 ...

Page 2: ...043 U S A Phone 1 888 826 9702 www siemens com healthcare 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 ...

Page 3: ... 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...

Page 4: ...iv ACUSON Freestyle User Manual ...

Page 5: ...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 specifications security and quality of service information Customer Information Note Provides software release notes and updates to t...

Page 6: ...xecution 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...

Page 7: ...lated health care subjects Physician Acquires diagnostic views of anatomy blood flow and related pathology Performs measurements and analysis of the acquired images Performs ultrasound guided procedures Writes and assembles exam findings in a report Medical doctor Expert in diagnostic imaging including computed tomography CT magnetic resonance imaging MRI X ray ultrasound and nuclear medicine Skil...

Page 8: ... 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...

Page 9: ...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 ...

Page 10: ... 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 Defined 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 L...

Page 11: ...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 Findi...

Page 12: ... 8 4 Detecting WiFi Networks 8 4 Configuring the WiFi Network 8 5 Configuring the DICOM Setup 8 6 DICOM Setup Menu Soft Keys 8 6 Configuring a DICOM Storage Server 8 7 Configuring a DICOM Storage Commitment Server 8 8 Configuring a Modality Worklist Server 8 9 Configuring the System DICOM Settings 8 10 Freestyle Mobile Link App 8 11 Freestyle Mobile Link Settings 8 11 Privacy and Security 8 12 ...

Page 13: ...ystem 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 ...

Page 14: ...1 2 ACUSON Freestyle User Manual Introduction ...

Page 15: ...rface It has a compact and portable design and offers DICOM archival and networking capability System Console Console Front View PATIENT NAME PATIENT ID XXX XXX XXX XXX XXX XXX XXX XXX L13 5 Nerve Gen 2 5cm G 9 CG 10 SC 3 SF 6 PP 10 55dB CF 1 CP 1 Vel 1 Pri 4 20 Hz ANL 0 0 dB XXX XXX XXX XXX 2 3 4 5 6 1 7 8 P S System Console Front View 1 ON OFF Button 2 SETUP Soft Key 3 Bottom Soft Keys 4 Trackba...

Page 16: ... Console Rear View 7 1 2 3 4 5 6 8 9 10 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 ...

Page 17: ...anual 1 5 Introduction Console Inputs Outputs Panel 1 2 3 4 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 ...

Page 18: ...t 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 ...

Page 19: ... 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 ...

Page 20: ...erve Gen 2 5cm G 9 CG 10 SC 3 SF 6 PP 10 55dB CF 1 CP 1 Vel 1 Pri 4 20 Hz ANL 0 0 dB XXX XXX XXX XXX 1 3 7 2 4 5 6 8 P S 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 ba...

Page 21: ...hazard 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 Definitions 2 13 Definition 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 Prim...

Page 22: ...ion 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 S...

Page 23: ... 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 Symbol Explanation Caution Risk of electric shock Consult instructions for use Consult instructions for use Caution General Warning yellow an...

Page 24: ...nd the European notified body Safety testing classified symbol for Canada and United States of America IVK Installierte Volumen Komponente Identifier of selected system components or parts for product traceability 20 C 60 C Probe storage temperature range System storage temperature range Fuse Identifies location of Fuse WARNING Risk of Fire Replace Fuse as marked Alternating Current AC Specifies t...

Page 25: ...0xx Year of Manufacture symbol with the year below 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 ...

Page 26: ... rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been observed in the diagnostic range of mechanical index MI values See the specific 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 imagi...

Page 27: ...in 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 flow patterns and velocities 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 ...

Page 28: ...e or absence of abnormalities such as abnormal ventricle size or a shift in the midline or flow 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 flow patterns and velocities and image and measure anatomic and physiologic parameters of the hear...

Page 29: ...natal cephalic cardiac peripheral vessel and vascular and musculoskeletal 3 0 8 0 MHz 38 4 x 5 mm L13 5 Linear B Mode Color Doppler Amplitude Doppler Fetal abdominal intraoperative intraoperative neurological pediatric small organs neonatal cephalic cardiac peripheral vessel and vascular and musculoskeletal 5 0 13 0 MHz 25 6 x 4 mm C5 2 Curvilinear B Mode Color Doppler Amplitude Doppler Fetal abdo...

Page 30: ...h 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 scientific research This ultrasound system and all diagnostic ult...

Page 31: ...anner 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...

Page 32: ...um 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 Meas...

Page 33: ... Definition Acoustic Output Global Maximum Values Term Definition ISPTA 3 Intensity spatial peal 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 ...

Page 34: ...erated 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 Transd...

Page 35: ...e 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 significantly based on transducer used Accuracy of Primary Measurements All reported accuracies are one half the least significant digit Distance The system assumes that the speed of sound in tissue is 1540 meters per second and t...

Page 36: ...ody 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 ...

Page 37: ...utlet 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 isolat...

Page 38: ...components CAUTION Do not pour any fluid onto the ultrasound system surfaces as fluid 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 s...

Page 39: ...e a Level of Protection Against Electrical Shock of Type B The Type B icon is located on the probe and probe connector labels Defibrillators WARNING To avoid the risk of injury to the operator remove the probe from patient contact before the application of a high voltage defibrillation pulse For patient safety be sure to use defibrillators that do not have grounded patient circuits ...

Page 40: ...rence 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 cardia...

Page 41: ...wo 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 fulfill EN 606...

Page 42: ... 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 ...

Page 43: ...ACUSON Freestyle User Manual 2 23 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 ...

Page 44: ... 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 sh...

Page 45: ... 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 specific disinfectants only Perform the following each day befo...

Page 46: ...ed out by persons not specifically 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 opera...

Page 47: ...rforming cleaning and disinfection WARNING The use of any disinfectants other than those specified 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 s...

Page 48: ...he 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 Clean and disinfect the Trackball CAUTION Do not drop o...

Page 49: ...isted accessories Sani Cloth Sani Cloth Bleach Wipe Sani Cloth HB Sani Cloth Plus Super Sani Cloth Ultrasound System Probe Holders Trackball Assembly or any bleach wipe with 1 sodium hypochlorite and no other active ingredients Compatible Caring for Documentation and Storage Devices For information on the care of an optional documentation or storage device refer to the manufacturer s operating ins...

Page 50: ...ION 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 sensiti...

Page 51: ...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 sh...

Page 52: ...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 ...

Page 53: ... 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 fluids 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 ...

Page 54: ...low 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 ...

Page 55: ...tion 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...

Page 56: ...ly 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 p...

Page 57: ...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 Probe Nam...

Page 58: ...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...

Page 59: ... 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 o...

Page 60: ... 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...

Page 61: ...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 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 th...

Page 62: ... 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 positio...

Page 63: ...ystem 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...

Page 64: ...an 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 floor 3 Keyboard Shelf should be placed no higher than 33 in 84 cm from the floor 4 Rear Storage Basket the top of the basket should be placed no higher than 30 in 76 cm from the floor Weight limit 4 lbs 1 8 kg ...

Page 65: ...y is fully charged Consult your service representative or help desk contact with any questions you may have regarding software upgrades Environmental Protection 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 peopl...

Page 66: ... 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 f...

Page 67: ...ccessories 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 batteri...

Page 68: ...tection 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 flammable 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 Enviro...

Page 69: ...tems 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 ...

Page 70: ...3 2 ACUSON Freestyle User Manual Setup ...

Page 71: ...ging screen PROBES Connect and disconnect probes using this option SETTINGS Manage system settings including User Exam profiles Network settings DICOM settings SYSTEM Activate the System information page that provides information about hardware and software configuration and installed options Includes Setting image controls Patient anonymity settings Administrative options Contact information for ...

Page 72: ...ouse 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 P S XXX XXX X...

Page 73: ...irelessly 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 Connecting and Disconnecting Probes The CONNECT Soft Key connect...

Page 74: ...d instructions about Exam Types see Factory Exam Types on page 4 7 and User Defined 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 configuration see the Connectivity chapter of this Manual DICOM The DICOM page includes information...

Page 75: ...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 ...

Page 76: ...r 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 When enabled uses the cont...

Page 77: ...ecify the key functions The Tools list can be used to access functions that are not specified 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 ...

Page 78: ...3 10 ACUSON Freestyle User Manual ...

Page 79: ...tudy Exam Types 4 6 Factory Exam Types 4 7 User Defined Exam Types 4 8 Creating a new User Exam Type 4 8 Updating a User Defined 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 ...

Page 80: ...4 2 ACUSON Freestyle User Manual Patient Studies ...

Page 81: ...ability 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...

Page 82: ...metric system click the Metric checkbox Accession Type text into the field Diagnosis Type text into the field Institution Select from the drop down menu The Institution name is displayed on the real time imaging screen Physician Select from the drop down menu Operator Select from the drop down menu Comments Enter any additional information or comments NOTE Patient Name and ID fields are limited to...

Page 83: ...ve 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 file for that patient study The patient name will be listed as UNKNOWN a machine generated ID number will be created and the da...

Page 84: ... 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 Stand...

Page 85: ...inal 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 Superficial MSK Tendon Musculoskeletal Tendon Nerve Deep Nerve...

Page 86: ... 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 specified the settings you want touch the Exams Soft Key then select Save Exam The settings will be saved with the ...

Page 87: ...DY 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 3 1 Scan Delete Edit Export 2 The Studies List scree...

Page 88: ...age 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 t...

Page 89: ... 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 Configure 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 cli...

Page 90: ...l 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 stud...

Page 91: ...ireless 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 Measu...

Page 92: ...5 2 ACUSON Freestyle User Manual Scanning ...

Page 93: ...s 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 2 3 4 1 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 prob...

Page 94: ... 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 ...

Page 95: ...n 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 connect...

Page 96: ...ircular on probe 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 first probe off by continuously pressing the two circular on probe buttons thereby disconnecting it from the console 2 Connect to the...

Page 97: ...anning 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 in...

Page 98: ...dy 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 i...

Page 99: ...lete studies to make memory available Clip Stores a multi frame image clip to the Patient Study file 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...

Page 100: ...Freestyle User Manual 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 ...

Page 101: ...tiple pages of Exam Type lists if there are more than can be displayed in the real time control window Exam Types e g Vascular Abdominal the list of Exam Type groups are in the most recently used order Selecting an Exam Type group will display the individual Exam Types available for that group Freezing an Image When you press the Freeze Soft Key during real time scanning the current image freezes ...

Page 102: ...tive study Studies may also be viewed by selecting them from SETUP STUDY LIST When Viewing study images To cycle through the stored clips press Next on the real time Control Bar To display multiple thumbnail images on the same screen press the PANEL Soft Key To display a larger number of thumbnails press MORE To display a smaller number press FEWER To display the highlighted clip in full screen mo...

Page 103: ...age Lower values will have softer appearance higher values will have a more contrasty appearance Displayed in the on screen settings window as PP Dyn Range Image Dynamic Range Displayed in decibels dB Displayed in the on screen settings window as numerical units followed by dB Compound Spatial Compounding Selects different levels of spatial compounding Spatial compounding combines different scan s...

Page 104: ...th steep angle ON needle entering from the side of probe with the index marker with shallow angle OFF ON needle entering from opposite the side of probe with the index marker with shallow angle ON needle entering from opposite the side of probe with the index marker with steep angle ON needle enhancement without steering angle When one of the ON settings is active a graphic overlay will appear on ...

Page 105: ...ext to the real time image Vel Invert Velocity Invert Shifts the color map orientation from the default of red towards the transducer to blue towards the transducer When invert is selected the color map graphic bar will invert Displayed in the on screen settings window as Vel WARNING It is important to pay careful attention to the color flow invert status of the system The non inverted state is re...

Page 106: ...t to the drawing 5 Press Save to save an image with measurements Deleting Measurements Press DELETE to delete the last completed measurement To skip to an earlier measurement for deleting use Next To delete all measurements press DELETE ALL Ellipse Measurement To perform an ellipse measurement 1 Activate the ellipse function by selecting ELLIPSE from the MEASURE sub menu This brings up a cross hai...

Page 107: ...he right Trackball key to back up and delete parts of the trace If you have selected the point to point method in the SETUP SYSTEM ADMIN page by disabling Continuous Trace use the Trackball to position the cursor and the left Trackball button to set multiple points 4 To complete the measurement leave at least a small gap between your finishing point and the starting point and press the left Trackb...

Page 108: ...the Text menu Clear Clears all text labels on the current image Pointer Use the pointer to select a location for the text label Provides an arrow point to place in an area of interest Use the Trackball to position the pointer then press the left Trackball button to place it in the area of interest The small inner Rotary knob may be used to rotate the orientation of the arrow in Annotation mode Tex...

Page 109: ...uality 6 6 Monitoring Wireless Signal Quality 6 7 Wireless Signal Quality Meter 6 7 Number of Bars in the Wireless Signal 6 7 Average Noise Level Indicator 6 8 Wireless Noise Examples 6 10 B Mode Wireless Noise 6 10 Reasons for a Low Wireless Signal in B Mode 6 10 Color Flow Wireless Noise 6 10 Reasons for a Low Wireless Signal in Color Flow 6 10 Finding Locating Wireless Probes 6 11 Using Multipl...

Page 110: ...6 2 ACUSON Freestyle User Manual Wireless Probes ...

Page 111: ...d System Reference manual for important information about the ACUSON Freestyle wireless probe specifications electromagnetic compatibility considerations and security features Antenna Locations The probe antennas are located towards the back of the probe the back is the part with the probe controls If possible keep your hand away from this area for optimal operation Additional antennas are also lo...

Page 112: ... facing the location of the transducer with a clear line of sight The quality of the wireless link is weakened if the co location of the two is too far out of plane horizontally or vertically The antennas in the console that communicate with the probe are located in the upper left corner of the front of the display Do not block these console locations they must form a clear line of sight with the ...

Page 113: ...nnecting to Probe with the unique probe ID number and sends a return signal which establishes the connection 3 When the connection is made the console screen displays this message Wireless connection established 4 Next the message Configuring System is displayed and the console will beep The console screen will show the probe battery symbol You can now begin real time scanning This process normall...

Page 114: ... XXX XXX XXX XXX XXX XXX L13 5 Nerve Gen 2 5cm G 9 CG 10 SC 3 SF 6 PP 10 55dB CF 1 CP 1 Vel 1 Pri 4 20 Hz ANL 0 0 dB XXX XXX XXX XXX P S The Wireless Signal Quality Meter indicates the wireless probe link quality best signal quality is six bars The number of bars on the wireless signal quality meter has been empirically correlated to the potential for artifact to be introduced into the image becau...

Page 115: ...rformance without noise being introduced because of wireless link quality 3 Very reliable wireless probe performance this noise is typically imperceptible but there is a possibility of low levels of noise artifacts being introduced into the image because of a compromised wireless probe link Reorient the probe console to within 3 meters of each other in a line of sight without obstructions between ...

Page 116: ...ayed in dB An ANL value of 0 0 represents the optimal setting and indicates that the signal quality is very good and free of errors that might introduce noise into the image Be alert to the ANL level in accordance with the guidance below To insure optimal wireless imaging use the information from both the wireless signal quality meter and the ANL PATIENT NAME PATIENT ID XXX XXX XXX XXX XXX XXX XXX...

Page 117: ... 0 Very reliable wireless probe performance but there is a possibility of low levels of noise being introduced into the image because of a compromised wireless probe link This noise is typically imperceptible Reorient the probe console to within 3 meters of each other in a line of sight without obstructions between the probe and the console Signal less than 1 0 There is an increased possibility of...

Page 118: ...here is an obstruction between the probe antennas and the console antennas Some combination of these Color Flow Wireless Noise In Color Flow Doppler mode if the wireless signal quality is compromised excess background noise as demonstrated in the simulated phantom flow image here may occur If you experience such noise reposition to improve the link quality Color Flow Doppler wireless noise simulat...

Page 119: ...aration distance is greater than is normally used for scanning It may also mean that the probe is being unintentionally separated from the console In this situation the probe will beep and the system will display a message on the screen advising you to locate and secure the identified probe 3 Press OK or Silence to acknowledge this message With a probe turned on and connected wirelessly you can al...

Page 120: ...ng Down the Probe When you have finished scanning with the connected probe and are ready to either clean it or store it power it down by continuously pressing both circular buttons on the probe until it beeps When the probe is turned off the battery symbol will disappear from the display Removing the battery also powers the probe down Before trying to scan with a new probe be sure to power the act...

Page 121: ...garding the battery operation of the system and wireless probes 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 ...

Page 122: ...7 2 ACUSON Freestyle User Manual Batteries ...

Page 123: ...probe or charger bays are dry and free of liquids CAUTION Verify that the probe battery pack and either the probe battery receptacle or the System charging bays are free of any liquid gels or contaminants before inserting the battery Inserting a battery into the probe or charger bays when liquid gel or contaminants could cause harm to the probe and or system 2 3 1 The probe battery is recharged in...

Page 124: ...t flashing NOTE The probe s battery pack is keyed to prevent improper insertion CAUTION The battery pack is keyed to fit into the charging bay in the proper orientation Do not use excessive force in inserting the pack into the charging bay Make sure that you have lined it up properly when inserting 3 Confirm the status of the probe batteries in the charging bays by checking the Battery page in the...

Page 125: ...e Battery Charge Level while Scanning During live scanning monitor the charge level status of the probe battery by observing the probe battery P symbol and the system console battery S on the screen The green portion of the battery symbol represents the estimated charge remaining Typically a fully charged probe battery will provide approximately one hour of scanning NOTE The estimated charge remai...

Page 126: ...y you can begin using the probe cable connector or proceed to promptly complete the exam When the system battery approaches 10 the battery alert message will be repeated Shortly following that the probe will automatically shut down When the 10 remaining charge message appears you should take action so as not to interrupt the exam When the system is plugged into AC Mains power if the console batter...

Page 127: ...Wireless Network Setup 8 4 Working with Multiple WiFi Networks 8 4 Detecting WiFi Networks 8 4 Configuring the WiFi Network 8 5 Configuring the DICOM Setup 8 6 DICOM Setup Menu Soft Keys 8 6 Configuring a DICOM Storage Server 8 7 Configuring a DICOM Storage Commitment Server 8 8 Configuring a Modality Worklist Server 8 9 Configuring the System DICOM Settings 8 10 Freestyle Mobile Link App 8 11 Fre...

Page 128: ...8 2 ACUSON Freestyle User Manual Connectivity ...

Page 129: ...may be options which are not provided on every system Configuring the Network Settings To configure your system for connectivity go to SETUP SETTINGS NETWORK This takes you to the Network page Ethernet Setup This defines the network identification of the system using the IP address Subnet Mask and Gateway to give the ACUSON Freestyle a unique identifier on a specific network Check the Auto IP Enab...

Page 130: ...urity and consult with your IT administrator when configuring the system for WiFi connectivity Even secured WiFi networks may be the subject of unauthorized access The system can be configured to store multiple wireless network configurations Working with Multiple WiFi Networks If multiple WiFi networks have been set up use the options described in Configuring the WiFi Network on page 8 5 to manag...

Page 131: ... Use the drop down menu to select the security method used by the WiFi network See the Safety chapter of this Manual for information about 802 11 b g security Use the data entry fields in the security box to enter security data To import Enterprise WiFi Certificate data select IMPORT CERTIFICATE Copy the certificate to a USB drive then plug the USB drive into the Freestyle Select the certificate f...

Page 132: ...hat a study has been received and stored by the target device Worklist When supported by your PACS system and configured on the ultrasound system manages the ACUSON Freestyle s communication with a DICOM Worklist Server to download patient information System Sets the DICOM AE Title the name the system provides to the DICOM server and the port to use DICOM Setup Menu Soft Keys In the DICOM setup me...

Page 133: ...estyle The alphanumeric characters entered in this field must exactly match including case the Application Entity name assigned to the server application Limited to 16 characters cannot include the period character Port Number The remote port on the server that is to receive the connection request and the patient studies The default setting is 104 Test Used to test the connection once you have ent...

Page 134: ... 16 characters cannot include the period character Port Number The remote port on the server that is to receive the storage commitment messages The default is port 104 Test Used to test the connection once you have entered the configuration data You can test using either Ping or C Echo DICOM Verify Ping tests the connection across the network C Echo additionally tests that the DICOM server is acti...

Page 135: ...tion Entity name assigned to the server application Limited to 16 characters cannot include the period character Port Number The remote port on the server that is to receive the worklist messages The default is port 104 Test Used to test the connection once you have entered the configuration data You can test using either Ping or C Echo DICOM Verify Ping tests the connection across the network C E...

Page 136: ... SETTINGS DICOM SYSTEM 2 Enter the system information as described in the following table DICOM System Settings Fields Field Description Freestyle AE Title Identifies the AE Title assigned to the system Limited to 16 characters cannot include the period character Freestyle Port Number The port on the system used for DICOM messages The default is port 104 ...

Page 137: ... App is Enabled the mobile symbol appears on the console imaging screen To disable the Mobile Link uncheck the box Set Security PIN Code Note that the PIN code specified here must also be entered on the Windows mobile device in order to link to the Freestyle Select SETUP SETTINGS NETWORK Go to the Mobile Link section Select PIN Code Enter a four digit PIN Code After entry the PIN code is not displ...

Page 138: ...k to the Freestyle using the Mobile Link App uncheck disable the box on the SETUP SYSTEM ADMIN page If a mobile device is connected through the Mobile Link App the mobile symbol will be displayed on the console screen Protect the security of the PIN code used to allow devices to link Change the PIN code if necessary to improve security To prevent the patient name and ID from being displayed on sav...

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