SONOACE X6 Operation Manual Ver 1.00.00

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Operation Manual Version1.00.00

M349-E10000-00

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PROPRIETRAY INFORMATION AND SOFTWARE LICENSE The Customer shall keep confidential all proprietary information furnished or disclosed to the Customer by MEDISON, unless such information has become part of the public domain through no fault of the Customer. The Customer shall not use such proprietary information, without the prior written consent of MEDISON, for any purpose other than the maintenance, repair or operation of the goods. MEDISON’s systems contain MEDISON’s proprietary software in machine-readable form. MEDISON retains all its rights, title and interest in the software except that purchase of this product includes a license to use the machine-readable software contained in it. The Customer shall not copy, trace, disassemble or modify the software. Transfer of this product by the Customer shall constitute a transfer of this license that shall not be otherwise transferable. Upon cancellation or termination of this contract or return of the goods for reasons other than repair or modification, the Customer shall return to MEDISON all such proprietary information.

Safety Requirements * Classification: Type of protection against electrical shock: Class I Degree of protection against electrical shock (Patient connection): Type BF equipment Degree of protection against harmful ingress of water: Ordinary equipment Degree of safety of application in the presence of a flammable anesthetic material with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Mode of operation: Continuous operation

* Electromechanical safety standards met: IEC/EN 60601-1 Medical Electrical Equipment, Part 1, General Requirements for Safety. IEC/EN 60601-1-1 Safety requirements for medical electrical systems. IEC/EN 60601-1-2 Electromagnetic compatibility -Requirements and tests. IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. IEC 61157 Declaration of acoustic output parameters. ISO 10993-1 Biological evaluation of medical devices. UL 2601-1 Medical Electrical Equipment, Part 1, General Requirements for Safety. CSA 22.2, 601.1 Medical Electrical Equipment, Part 1, General Requirements for Safety.

* Declarations:

This is CSA symbol for Canada and United States of America

This is manufacturer’s declaration of product compliance with applicable EEC directive(s) and the European notified body. This is manufacturer’s declaration of product compliance with applicable EEC directive(s).

READ THIS FIRST ▐ How to Use Your Manual This manual addresses the reader who is familiar with ultrasound techniques. Only medical doctors or persons supervised by medical doctors should use this system. Sonography training and clinical procedures are not included here. This manual is not intended to be used as training material for the principles of ultrasound, anatomy, scanning techniques, or applications. You should be familiar with all of these areas before attempting to use this manual or your ultrasound system. This manual does not include diagnosis results or opinions. Also, check the measurement reference for each application’s result measurement before the final diagnosis. It is useless to make constant or complex adjustments to the equipment controls. The system has been preset at the factory to produce an optimum image in the majority of patients. User adjustments are not usually required. If the user wishes to change image settings, the variables may be set as desired. Optimal images are obtained with little difficulty. We are not responsible for errors that occur when the system is run on a user’s PC. Please keep this operation manual close to the product as a reference when using the system. For safe use of this product, you should read ‘Chapter1. Safety’ in this manual, prior to starting to use this system.

NOTE

Some features are not available in some countries. The features with options, and specifications that this manual present can be changed without notice. Government approval is still pending in some nations.

Conventions Used in This Manual DANGER

Describes precautions necessary to prevent user hazards of great urgency. Ignoring a DANGER warning will risk life-threatening injury.

WARNING

Used to indicate the presence of a hazard that can cause serious personal injury, or substantial property damage.

CAUTION

Indicates the presence of a hazard that can cause equipment damage.

NOTE

A piece of information useful for installing, operating and maintaining a system. Not related to any hazard.

System Upgrades and Manual Set Updates MEDISON Ultrasound is committed to innovation and continued improvement. Upgrades may be announced that consist of hardware or software improvements. Updated manuals will accompany those system upgrades. Verify that this version of the manual is correct for the system version. If not, please contact the Customer Service Department.

If You Need Assistance If you need any assistance with the equipment, please contact the MEDISON Customer Service Department or one of their worldwide customer service representatives, immediately.

Table of Contents

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Table of Contents Chapter 1 - Safety SAFETY SIGNS ... 1-2 SAFETY SYMBOLS ... 1-2 LABELS ... 1-4 ELECTRICAL SAFETY ... 1-5 PREVENTATION OF ELECTRIC SHOCK ... 1-5 ECG-RELATED INFORMATION ... 1-6 ESD... 1-7 EMI... 1-7 EMC ... 1-8 MECHANICAL SAFETY... 1-14 MOVING THE EQUIPMENT... 1-14 SAFETY NOTE... 1-14 BIOLOGICAL SAFETY ... 1-15 ALARA PRINCIPLE ... 1-15 ENVIRONMENTAL PROTECTION ... 1-26 WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT... 1-26

Chapter 2 – Introduction and Installation WHAT IS SONOACE X6?... 2-2 FEATURES AND ADVANTAGES OF SONOACE X6... 2-2 SPECIFICATIONS ... 2-3 PRODUCT CONFIGURATION AND INSTALLATION... 2-6 MONITOR ... 2-6 CONTROL PANEL... 2-8 CONSOLE ... 2-15 PERIPHERAL DEVICES ... 2-18 PROBE ... 2-21 ACCESSORY... 2-22 OPTIONS... 2-22

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SONOACE X6 Operation Manual

Chapter 3 – Setting SELECTING PROBE/APPLICATION...3-3 PROBE/APPLICATION SELECTION...3-3 APPLICATION CHANGE ...3-4 PROBE SETTING CHANGE...3-4 EDITING BODYMARKER ...3-4 CALC. SEQUENCE...3-6 ENTERING PATIENT DATA ...3-7 REGISTERING A NEW PATIENT ...3-7 FINDING PATIENT INFORMATION...3-8 MODIFYING PATIENT INFORMATION ...3-10 SETTING SYSTEM ...3-11 GENERAL ... 3-11 DISPLAY ...3-13 MISC. ...3-15 SETTING MEASUREMENTS...3-16 GENERAL ...3-16 OBSTETRICS MEASUREMENT SETUP ...3-20 FETAL ECHO MEASUREMENT SETUP ...3-24 CARDIAC MEASUREMENT SETUP ...3-25 UROLOGY MEASUREMENT SETUP ...3-26 VASCULAR MEASUREMENT SETUP ...3-27 SETTING DICOM (OPTIONAL) ...3-28 SETTING DICOM INFORMATION...3-28 NETWORK SETUP ...3-29 ADDING OR CHNAGING THE DICOM SERVER ...3-29 EDITING THE DICOM SERVER INFORMATION...3-34 DELETING DICOM SERVER ...3-34 TESTING DICOM SERVER ...3-34 DICOM LOG...3-34 SETTING OPTION ...3-36 SETTING PERIPHERAL DEVICES ...3-37 INFORMATION...3-38 UTILITIES ...3-39 BIOPSY ...3-39

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ECG ... 3-41 MONITOR CALIBRATION ... 3-42 PRESET ... 3-42 MISCELLANEOUS ... 3-43

Chapter 4 – Diagnosis modes DIAGNOSIS MODE TYPES AND CONTROL ... 4-3 DIAGNOSIS MODE TYPE... 4-3 BASIC USE... 4-4 BASIC MODES ... 4-8 2D MODE ... 4-8 M MODE ... 4-12 COLOR DOPPLER MODE ... 4-14 POWER DOPPLER MODE ... 4-18 SPECTRAL DOPPLER MODE... 4-20 COMBINED MODES... 4-25 2D/C/PW MODE ... 4-25 2D/PD/PW MODE... 4-25 2D/C/CW MODE... 4-26 2D/PD/CW MODE ... 4-27 2D/C/M MODE... 4-28 MULTI-IMAGE MODE... 4-29 DUAL-2D MODE... 4-29 DUAL-2D/C MODE ... 4-29 DUAL-2D/PD MODE... 4-30 3DMODE ... 4-31 3D ... 4-31 ACQUIRING A 3D IMAGE ... 4-32 3D VIEW ... 4-32

Chapter 5 – Measurements and Calculations MEASUREMENT ACCURACY ... 5-3 CAUSES OF MEASUREMENT ERRORS ... 5-3 OPTIMIZATION OF MEASUREMENT ACCURACY ... 5-4 MEASUREMENT ACCURACY TABLE... 5-7

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SONOACE X6 Operation Manual

BASIC MEASUREMENTS ...5-9 DISTANCE MEASUREMENT ... 5-11 CIRCUMFERENCE AND AREA MEASUREMENT...5-16 VOLUME MEASUREMENT ...5-18 CALCULATIONS BY APPLICATION ...5-20 THINGS TO NOTE...5-20 COMMON MEASUREMENT METHODS ...5-22 OB CALCULATIONS...5-26 GYN CALCULATIONS ...5-32 CARDIAC CALCULATIONS...5-34 VASCULAR CALCULATIONS...5-44 UROLOGY CALCULATIONS ...5-47 FETAL ECHO CALCULATIONS...5-51 REPORT...5-56 VIEWING REPORT...5-56 EDITING REPORT...5-57 COMMENT...5-57 PRINTING OUT REPORT...5-57 EXPORTING REPORT ...5-57 GRAPH FUNCTION ...5-58

Chapter 6 – Image Managements REVIEWING IMAGES (CINE/LOOP) ...6-2 ANNOTATING IMAGES ...6-5 TEXT ...6-5 BODY MARKER...6-7 INDICATOR ...6-9 SAVING AND TRANSFERRING IMAGES ...6-11 SAVING IMAGES ... 6-11 TRANSFERRING IMAGES... 6-11 PRINTING AND RECORDING IMAGES...6-12 PRINTING IMAGES ...6-12 RECORDING IMAGES ...6-12 SONOVIEWTM ...6-13 STARTING SONOVIEWTM ...6-13

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EXAM VIEW ... 6-14 EXAM REVIEW ... 6-19

Chapter 7 – Maintenance SYSTEM MAINTENANCE ... 7-2 INSTALLATION REQUIREMENTS... 7-2 CLEANING AND DISINFECTIONS ... 7-3 FUSE REPLACEMENT ... 7-5 CLEANING THE AIR FILTERS... 7-6 ACCURACY CHECK ... 7-7 ADMINISTRATION OF INFORMATION ... 7-8 USER SETTING BACK UP ... 7-8 PATIENT INFORMATION BACK-UP ... 7-8 SOFTWARE... 7-8

Chapter 8 – Probes PROBES ... 8-2 ULTRASOUND TRANSMISSION GEL... 8-4 SHEATHS ... 8-4 PROBE PRECAUTIONS ... 8-5 CLEANING AND DISINFECTING THE PROBE... 8-7 BIOPSY ... 8-12 BIOPSY KIT COMPONENTS ... 8-12 USING THE BIOPSY KIT ... 8-13 CLEANING AND DISINFECTING BIOPSY KIT ... 8-15 ASSEMBLING THE BIOPSY KIT ... 8-17

** Reference Manual MEDISON is providing an additional SONOACE X6 Reference Manual. GA tables and references for each application are included in the Reference Manual.

Chapter 1

Safety Safety Signs ... 2 Safety Symbols ... 2 Labels ... 4

Electrical Safety... 5 Prevention of Electric Shock... 5 ECG-Related Information ... 6 ESD... 7 EMI... 7 EMC ... 8

Mechanical Safety ... 14 Moving the Equipment ... 14 Safety Note ... 14

Biological Safety... 15 ALARA Principle ... 15

Environmental Protection ... 26 Waste Electrical and Electronic Equipment... 26

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SONOACE X6 Operation Manual

Safety Signs Please read this chapter before using the MEDISON ultrasound system. It is relevant to the ultrasound system, the probes, the recording devices, and any of the optional equipment. SONOACE X6 is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of the medical device.

Safety Symbols The International Electro Technical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify a connection or warn of potential hazards. The classifications and symbols are shown below. Symbols

Description AC (alternating current) voltage source

Indicates a caution for risk of electric shock. Isolated patient connection (Type BF applied part). Power switch (Supplies/cuts the power for product) OFF (Cuts the power to a part of the product) ON (Supplies power to a part of the product) Refer to the User Manual.

Identifies an equipotential ground.

Indicates dangerous voltages over 1000V AC or over 1500V DC.

Chapter 1. Safety

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Identifies the point where the system safety ground is fastened to the chassis. Protective earth connected to conductive parts of Class I equipment for safety purposes. VGA output port or Parallel port. ECG port. Input/Output (I/O) port used for RS232C Left and right Audio / Video input Left and right Audio / Video output Remote print output Foot switch connector ECG connector USB connector MIC input port Protection against the effects of immersion.

Protection against dripping water.

Probe connector

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SONOACE X6 Operation Manual

Labels To protect the system, you may see ‘Warning’ or ‘Caution’ marked on the surface of the product.

[Label 1. Marked on the sides of the product]

[Label 2. Marked on the bottom of the product]

[Label 3. Marked below OUTLET]

Chapter 1. Safety

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Electrical Safety This equipment has been verified as a Class I device with Type BF applied parts.

CAUTION

As for US requirement, the LEAKAGE CURRENT might be measured from a center-tapped circuit when the equipment connects in the United States to 240V supply system.

Prevention of Electric Shock In a hospital, dangerous currents are due to the potential differences between connected equipment and touchable conducting parts found in medical rooms. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of angled sockets to the equipotential bonding network in medical rooms.

[Figure 1-1. Equipotential bonding] Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3 Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above-mentioned requirements. If in doubt, consult your local representative or the technical service department.

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SONOACE X6 Operation Manual ■ Electric shock may exist result if this system, including and all of its externally mounted recording and monitoring devices, is not properly grounded. ■ Do not remove the covers on the system; hazardous voltages are present inside. Cabinet panels must be in place while the system is in use. All internal adjustments and replacements must be made by a qualified MEDISON Customer Service Department.

WARNING

■ Check the face, housing, and cable before use. Do not use, if the face is cracked, chipped, or torn, the housing is damaged, or if the cable is abraded. ■ Always disconnect the system from the wall outlet prior to cleaning the system. ■ All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to application of a high voltage defibrillation pulse. ■ The use of flammable anesthetic gas or oxidizing gases (N20) should be avoided. ■ The system has been designed for 100-120VAC and 200-240VAC; you should select the input voltage of monitor, printer and VCR. Prior to connecting an OEM power cord, verify that the voltage indicated on the power cord matches the voltage rating of the OEM device.

CAUTION

■ An isolation transformer protects the system from power surges. The isolation transformer continues to operate when the system is in standby. ■ Do not immerse the cable in liquids. Cables are not waterproof. ■ The operator does not contact the parts (SIP/SOP) and the patient simultaneously

ECG-Related Information ■ This device is not intended to provide a primary ECG monitoring function, and therefore does not have means of indicating an inoperative electrocardiograph.

WARNING

■ Do not use ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in burns to the patient. ■ Do not use ECG electrodes during cardiac pacemaker procedures or other electrical stimulators. ■ Do not use ECG leads and electrodes in an operating room.

Chapter 1. Safety

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ESD Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. During low humidity conditions, electrical charges naturally build up on individuals, creating static electricity. An ESD occurs when an individual with an electrical energy build-up comes in contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals. The static shock or ESD is a discharge of the electrical energy build-up from a charged individual to a lesser or non-charged individual or object. ■ The level of electrical energy discharged from a system user or patient to an ultrasound system can be significant enough to cause damage to the system or probes.

CAUTION

■ The following precautions can help to reduce ESD: -

Anti-static spray on carpets or linoleum

-

Anti-static mats

-

A ground wire connection between the system and the patient table or bed.

EMI Although this system has been manufactured in compliance with existing EMI(Electromagnetic Interference) requirements, use of this system in the presence of an electromagnetic field can cause momentary degradation of the ultrasound image. If this occurs often, MEDISON suggests a review of the environment in which the system is being used, to identify possible sources of radiated emissions. These emissions could be from other electrical devices used within the same room or an adjacent room. Communication devices such as cellular phones and pagers can cause these emissions. The existence of radios, TVs, or microwave transmission equipment nearby can also cause interference.

CAUTION

In cases where EMI is causing disturbances, it may be necessary to relocate this system.