E1 Series Basic User Manual Jan 2018 PDF download

Statement SonoScape Medical Corp. (hereinafter called SonoScape) owns the intellectual property rights to this manual, and also maintains the contents of this manual as confidential information. This manual is a reference for the operation, maintenance and cleaning of this product and does not convey any license under the patent rights of SonoScape, nor the rights of others. This manual contains the information protected by copyrights or patents. Reproduction, amendment or translation of this manual in any manner whatsoever without the written permission of SonoScape is strictly prohibited. All information contained in this manual is believed to be correct. SonoScape shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this manual. SonoScape does not assume any liability arising out of any infringements of patents or other rights of third parties. This manual is based on the maximum configuration and therefore some contents may not apply to your product. This manual is subject to change without prior notice and legal obligation.

Manufacturer’s Responsibility SonoScape is responsible for the effects on safety, reliability and performance of this product, only if all the following requirements are met. ●

All installation operations, expansions, changes, modifications and repairs of this product are conducted by SonoScape authorized personnel.

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The use or application of the product or the use of parts or accessories is approved by SonoScape.

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The electrical installation of the relevant room complies with the applicable national and local requirements.

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The product is used in accordance with the instructions for use.

Documentation SonoScape provides the documentation consisting of various manuals: ●

The basic user manual (this manual) describes the basic functions and operating procedures of the system.

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The advanced user manual provides information about the measurements and calculations available in each mode.

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Compact Disc (CD) provides the acoustic output data related to the system.

Understand the meanings of the following items clearly before reading this manual. Item

Meaning Indicates a potentially hazardous situation which, if not avoided, could result in

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death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in malfunction or damage of the system. Indicates a potentially biological hazardous situation which, if not avoided, may result in disease transmission.

NOTE

Indicates precautions or recommendations that should be used in operating the system.

Boldfaced Word

Indicates controls on the control panel, or on-screen objects such as menu items

Click

Move the cursor to the controls on the display and press the confirm key on the

or keys.

control panel. >

Select a menu item or a key following the path.

Contact Information Manufacturer: SonoScape Medical Corp. Address: 4/F, 5/F, 8/F, 9/F & 10/F, Yizhe Building, Yuquan Road, Nanshan, Shenzhen, 518051, Guangdong, China Tel: +86 755 2672 2890 Fax: +86 755 2672 2850 http://www.sonoscape.com E-mail: [email protected]

EU Representative: SonoScape Europe S.r.l. Address: Via Luigino Tandura, 74-00128 Rome, Italy Tel: +39 06 508 2160 Fax: +39 06 508 4752 http://www.sonoscapeurope.com

Contents 1 Safety�� 1 1.1 Intended Use��2 1.2 Safety Precautions��2 1.2.1 Electrical Safety��2 1.2.2 Mechanical Safety��4 1.2.3 Accessories Caring��4 1.2.4 Biohazard Considerations��5 1.3 Acoustic Power Principle��5 1.3.1 Biological Safety��6 1.3.2 ALARA��6 1.3.3 Mechanical and Thermal Indices��6 1.3.4 Probe Surface Temperature Limits��7 1.3.5 Imaging Functions that Change Acoustic Output��8 1.4 Safety Symbols��8

2 System Overview�� 11 2.1 System Configuration��12 2.2 Physical Specifications��12 2.3 System Components��12 2.3.1 Front Panel��13 2.3.2 Side View��14 2.3.3 Back View��15 2.3.4 Bottom View��15 2.3.5 Control Panel��16 2.3.6 Key Panel��19 2.3.7 Basic Screen��21

3 Preparing the System�� 23 3.1 Positioning the System ��24 3.2 Powering the System��24 3.2.1 Using the Adaptor��24 3.2.2 Using the Battery��25

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Contents

3.2.3 Installing/Removing the Battery��26 3.2.4 Status Indicator ��27 3.3 Powering On/Off the System��28 3.3.1 To Power On the System��28 3.3.2 To Activate Screen Saver��28 3.3.3 To Enter the Standby Mode��28 3.3.4 To Power Off the System��29 3.4 Adjusting the Brightness of the Monitor��29 3.5 Connecting the Probe��29 3.6 Connecting the Peripheral Device��29 3.6.1 Connecting the Foot Switch (optional)��29 3.6.2 Connecting the Printer��30

4 Customizing Your System�� 33 4.1 General System Settings��34 4.1.1 General Settings��34 4.1.2 Display Settings��36 4.1.3 Save Settings��38 4.1.4 Biopsy Settings��39 4.2 Exam Preset Settings��41 4.3 Annotation Settings��42 4.3.1 Tools Settings��42 4.3.2 List Settings��43 4.4 Body Mark Settings��44 4.5 Measurement Settings��45 4.5.1 General Measurement Settings��45 4.5.2 Application Settings��47 4.5.3 List Settings��50 4.6 Report Settings��51 4.7 Peripheral Devices Settings��53 4.7.1 Basic Settings��53 4.7.2 Network Settings��54 4.8 DICOM Settings��55 4.8.1 DICOM Service Settings��55 4.8.2 DICOM Local Settings��64 II

Contents

4.9 Help Settings��65 4.10 Defining System Defaults��65 4.10.1 Loading System Defaults��65 4.10.2 Creating System Defaults��66 4.10.3 Exporting or Importing System Defaults��66 4.11 Viewing System Information��67

5 Preparing for an Exam�� 69 5.1 Acquiring Patient Information��70 5.1.1 Beginning a New Patient��70 5.1.2 Retrieving Archived Information��72 5.1.3 Using DICOM Worklist��73 5.1.4 Using Query/Retrieve List��73 5.2 Pausing/Resuming/Completing an Exam��73 5.2.1 To Pause an Exam��73 5.2.2 To Resume an Exam��73 5.2.3 To Complete an Exam��74

6 Acquiring Images�� 75 6.1 Selecting a Probe and an Exam Type��76 6.1.1 To Customize a Preset��76 6.1.2 To Arrange the Presets Display��77 6.2 Acquiring B-Mode Images��78 6.2.1 Entering B Mode��78 6.2.2 Optimizing B-Mode Images��78 6.3 Acquiring M-Mode Images��83 6.3.1 M Mode��83 6.3.2 Optimizing M-Mode Images��85 6.4 Acquiring Spectral Doppler Images (Optional)��87 6.4.1 PW Mode��87 6.4.2 Optimizing Spectral Doppler Images��89

7 Working with Images�� 93 7.1 Imaging Features��94 7.1.1 Imaging Reverse��94 7.1.2 Split Screen Display��94

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Contents

7.1.3 Auto Optimization��95 7.1.4 Harmonic Imaging ��96 7.1.5 Panoramic Imaging��96 7.2 Magnifying an Image��97 7.2.1 Filling the Full Screen��97 7.2.2 Magnifying the Whole Image��98 7.2.3 Magnifying the ROI��98 7.3 Freezing an Image��99 7.4 Using Cine��99 7.4.1 Reviewing Cine ��99 7.4.2 Cutting Cine��99 7.5 Annotations and Body Marks��100 7.5.1 Annotating an Image with Typed Words��100 7.5.2 Annotating an Image with Arrows��100 7.5.3 Body Mark��101 7.5.4 Deleting Annotations and Body Marks��101 7.6 ECG Module��102

8 Managing Images/Data�� 105 8.1 Storing an Image/Cine��106 8.1.1 Storing an Image ��106 8.1.2 Storing a Cine��106 8.2 Viewing an Image/Cine��106 8.2.1 Viewing a Current Image/Cine��106 8.2.2 Retrieving an Image��108 8.3 Backing up Data��108 8.4 Importing Data to the System��109

9 Working with DICOM��111 9.1 Verifying Connectivity��112 9.2 DICOM Storage��112 9.3 DICOM Print��113 9.4 DICOM Worklist��113 9.5 Query/Retrieve List��114 9.6 MPPS��116 9.7 Storage Commitment��117 IV

Contents

9.8 DICOM Queue��117

10 Probes and Biopsy Brackets �� 119 10.1 Probe��120 10.1.1 Available Probes��120 10.1.2 Probe Usage��121 10.1.3 Cleaning the Probe��123 10.1.4 Disinfecting or Sterilizing the Probe��124 10.1.5 Sterilizing the Probe��127 10.1.6 Disinfecting and Sterilizing the Probe Cable��127 10.1.7 Storage and Transportation��128 10.2 Biopsy��129 10.2.1 Available Biopsy Brackets��129 10.2.2 Assembling the Biopsy Bracket��130 10.2.3 Preparing for a Biopsy��133 10.2.4 Verifying the Biopsy Bracket��133 10.2.5 Performing a Biopsy��134 10.2.6 Cleaning the Biopsy Bracket��135 10.2.7 Sterilizing the Biopsy Bracket��135 10.2.8 Storage��136

11 System Maintenance�� 137 11.1 Cleaning the System��138 11.1.1 To Clean the System Surface��138 11.1.2 To Clean the Trackball��138 11.2 Maintenance Checks��139 11.2.1 Electrical Safety��139 11.2.2 Battery Safety ��139 11.2.3 Mechanical Safety��139 11.2.4 Image Recording��139 11.3 Troubleshooting��139 11.4 Equipment Disposal��140 11.5 Customer Service��140

Appendix A Specifications�� 141 Appendix B EMC Guidance and Manufacturer’s Declaration�� 142 V

Contents

B.1 Electromagnetic Emissions��142 B.2 Electromagnetic Immunity��142 B.3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Equipment��145

Appendix C In Situ, Derated, and Water Value Intensities�� 146 Appendix D Recommended Coupling Gel, Cleaner and Disinfectant�� 147 D.1 Coupling Gel��147 D.2 Cleaner��148 D.3 Disinfectant��149

Appendix E Acoustic Output Data�� 150

VI

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Safety

This chapter describes the important information for operating this system. To ensure the safety of both operator and patient, please read the relevant details in this chapter carefully before using this system. You should be thoroughly familiar with the precautions provided in this manual. Otherwise, the manufacturer is not responsible for the effects on safety, reliability and performance of the system.

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1 Safety

1.1 Intended Use The system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology. The system also provides the measurement and calculation packages used for clinical diagnosis purposes. For details, please refer to the advanced user manual. Contraindication: The system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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Precautions must be considered in the use of any application. Otherwise, it may result in system damage or serious injury.

1.2 Safety Precautions Read and understand all precautions in this manual before attempting to use the system. Keep this manual with the system at all times. Periodically review the procedures for operation and safety precautions.

1.2.1 Electrical Safety

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Only qualified physicians or sonographers can perform ultrasound scanning on human subjects for medical diagnostic reasons.

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Any unauthorized personnel should not tamper with the main unit of the system.

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Do not service or maintain the system while it is in use with a patient.

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Do not position the system to make it difficult to disconnect the system from the mains supply.

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Do not use the system with flammable anaesthetics (category AP) or flammable anaesthetics with oxidants (category APG).

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Do not use the system with other equipment such as an electric knife, high-frequency therapy equipment, or a defibrillator. Otherwise, electrical shock may occur.

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Connect the protective earth conductor only before powering on the system. Disconnect the ground wire only after powering off the system. Otherwise, electrical shock may occur.

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Connect the system to the other electrical equipment by using the potentialequalization lead wire before connecting the power plug of the system to an electrical outlet.

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Do not place the multiple socket-outlet on the floor.

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The video printer should be connected to the specific interface by using the cable provided by the manufacturer. Otherwise, electrical shock may occur.

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Within the environment that is 1.8 meters (6 feet) around a patient, connect peripherals to the auxiliary power outlet which is capable of isolation protection; or, power the peripherals by the auxiliary output cable or the isolation transformer complied with EN/IEC 60601-1, or the power input of the same safety level.

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Within the patient environment, when removing the covers or the connectors from the non-medical electrical equipment without tools during maintenance, calibration or other operations, do not touch the parts of the non-medical electrical equipment and the patient simultaneously.

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Use only the probes provided by the manufacturer. Otherwise, the system will not perform, and an accident such as a fire may result in the worst case.

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Only the peripherals and accessories provided or recommended by the manufacturer can be used. Using other devices or accessories may degrade the system performance and even cause electrical shock.

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Do not pour any fluid onto the system surfaces, as fluid seepage into the electrical circuitry may cause excessive electrical current leakage or system failure. If any water is spilled onto the system carelessly, stop using the system and contact the local distributor immediately.

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The AC power plug for the system is a three-prong grounded plug and should never be adapted to any two-prong outlet or by using an adapter. Connect the AC power plug of the multiple socket-outlet to a hospital-grade power outlet.

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If the system is transported to the operating environment with a great temperature change, leave it for approximately 4 hours before powering it on. Ensure that the temperature and humidity inside and around the system are equivalent before an operation.

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Do not use the system around a strong electric field, a strong electromagnetic field, or the devices which generate radio waves, such as a radio, cellular telephones, or transceivers. Using the system in an improper environment may result in malfunction or damage.

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Select the conformed multiple socket-outlet with protective grounding, and ensure that its maximum output power exceeds the requirement of the system.

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The multiple socket-outlet can only be used to provide power to the recommended peripherals of the system.

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Do not connect other devices to the multiple socket-outlet. Otherwise, the rated output power of the multiple socket-outlet may be exceeded, and it may result in failure.

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Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN/IEC standards (for example, EN/IEC 60950 for data processing equipment and EN/IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standards EN/IEC 60601-1.

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Do not use an endocavitary probe on the body surface of a patient. Otherwise, the electromagnetic compatibility of the probe may be degraded.

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If the non-medical electrical equipment used with the system is supplied by a multiple socket-outlet with separating transformer, connect the AC power plug of the multiple socket-outlet to a hospital-grade power outlet. Consult a professional to ensure that the connection complies with the safety standards.

1.2.2 Mechanical Safety

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To avoid possible personnel injury and system damage, move the system slowly and carefully.

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Do not place other objects on top of the control panel. Do not sit on the control panel or any other part of the system.

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Disconnect the foot switch and the power cable before moving the system.

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Do not knock or shake the system.

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Always use the handle to move the system.

1.2.3 Accessories Caring

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●● Do not use the foot switch in the operating room. ●● Use the probe carefully. If any part of the transducer surface is scratched, stop using the probe immediately. Otherwise, electrical shock may occur. ●●

After disinfecting the accessories, wash out chemicals or discharge gases thoroughly from the accessories. Residual chemicals or gases could result in damage to the accessories, and be harmful to human bodies.

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Only trained physicians or sonographers under ultrasound guidance can handle the biopsy needle guides. During the operation, the operator must observe proper needle insertion sequencing with the needle guide to avoid undue discomforts, unnecessary risks or injuries to the patient.

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Use the legally marketed probe sheath. Refer to package labeling to determine latex content. Natural rubber latex may cause anaphylactic reactions in some individuals. Avoid contact with items containing natural rubber latex. Refer to the FDA Medical Alert, March 29, 1991.

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Use the legally marketed coupling gel in accordance with relevant local regulations. Read and understand all precautions in the relevant manual of the coupling gel before use.

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Prepare, use, store and dispose the cleaner, disinfectant and sterilant according to the instructions provided by manufacturers.

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Do not disconnect the probe during the real-time scan. Otherwise, it may damage the probe and the system.

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Disconnect the probe from the system after freezing an image or powering off the system. Otherwise, the system or the probe could be damaged.

1.2.4 Biohazard Considerations ●●

To minimize the risk of cross-contamination or infectious diseases when performing a biopsy, the operator should wear disposable gloves, protective clothing or protective goggles if it is needed. Follow the working regulations strictly in case the skin contacts the samples.

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Some disinfectants or sterilants are acid or alkaline. Use them with caution, and prevent hands or clothing from coming into direct contact with them. Wash hands or eyes immediately in case of any contamination by disinfectants.

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Dispose of cleaners, disinfectants or solutions in accordance with local standards or regulations.

1.3 Acoustic Power Principle

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Perform ultrasound procedures prudently under the guidance of the ALARA (as low as reasonably achievable) principle. Only expose the patient to the lowest practical transmit power levels in the shortest possible period to achieve a satisfactory diagnosis.

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Freeze the image at any time if you are not operating the system for a long period of time.

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Do not scan the same part of an patient continuously or expose the patient to prolonged scanning. Doing so may harm the patient.

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Do not expose the fetus to prolonged scanning in the Doppler mode.

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Although the output power is automatically controlled for the selected applications, high TI values should be kept to a minimum or avoided in obstetric applications.

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You should be familiar with the performances and operations of the system, observe the ultrasound output parameters on the screen at all times.

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1.3.1 Biological Safety Diagnostic ultrasound is recognized as being safe, but the possibility of biological effects exists when using it in high exposure levels and long exposure times. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

1.3.2 ALARA It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures that the total energy level is controlled below a low enough level at which bioeffects are not generated while diagnostic information is being accumulated. The total energy is controlled by output intensity and total radiation time. The output intensity necessary for examinations differs depending on the patient and the clinical case. Not all examinations can be performed with an extremely low level of acoustic energy. Controlling the acoustic level at an extremely low level leads to low-quality images or insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However, increasing the acoustic power more than necessary does not always contribute to an increase in quality of information required for diagnosis, rather increasing the risk of generating bioeffects. The operator must take responsibility for the safety of the patients and utilize the ultrasound deliberately. Deliberate use of the ultrasound means that output power of the ultrasound must be selected based on ALARA. Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound is available in a document from the AIUM (American Institute of Ultrasound Medicine) title “Medical Ultrasound Safety”.

1.3.3 Mechanical and Thermal Indices The display of the system consists of two parts: Thermal Index (TI) and Mechanical Index (MI). ■ MI/TI Explanation In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med.,Sept. 1988: Vol. 7, No. 9 Supplement), sometimes referred to as the StoweReport, which reviewed available data on possible effects of ultrasound exposure. Another report “Bioeffects and Safety of Diagnostic Ultrasound” dated January28, 1993, provides more current information. ●●

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Mechanical Index (MI)

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Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with different types of tissue. The potential mechanical bioeffects varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. There is no specific MI value that means that a mechanical effect is actually occurring. The MI should be used as a guide for implementing the ALARA principle. ●●

Thermal Index (TI) The TI value informs the operator about the conditions that might lead to an increase in temperature on the surface of the body, within the body tissue, or at the point of focus of the ultrasound beam on bone. That is, the TI value informs the operator about the potential temperature rise in body tissue. It is an estimate of temperature increase in body tissue with specific properties. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, mode of operation and others. The TI value should be used as a guide for implementing the ALARA principle. Depending on the examination and type of tissue involved, TI could be one of three types: −− Soft Tissue Thermal Index (TIS) is used when imaging soft tissue only, it provides an estimate of potential temperature rise in soft tissue. −− Bone Thermal Index (TIB) is used when bone is near the focus of the image as in the trimester, it provides an estimate of potential temperature rise in the bone or adjacent soft tissue. −− Cranial Bone Thermal Index (TIC) is used when bone is near the skin surface as in transcranial examination, it provides an estimate of potential temperature rise in the bone or adjacent soft tissue.

■ MI/TI Display TI and MI values are displayed in the real time scan on the screen. The operator should observe these index values during examinations and ensure that exposure time and output values are maintained at the minimum amounts needed for effective diagnosis. The MI and TI precision is 0.1.

1.3.4 Probe Surface Temperature Limits For probes intended for internal applications, e.g. the endocavitary probe or transesophageal probes, the surface temperature of the probe may change by adjusting system parameters.

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1 Safety

The maximum surface temperature of the endocavitary probes is 43°C. To protect the patient against the harm of excessive temperature, the probe stops working automatically when its temperature reaches the limit. The surface temperature of the probe is displayed on the screen. TIP <28°C

Transducer Tip Temperature

PAT 37°C

Patient Temperature

1.3.5 Imaging Functions that Change Acoustic Output The qualified operator may use the system controls to limit the ultrasound output and to adjust the quality of the images. The operator should observe the acoustic output display for possible effects. There are three categories of system controls relative to output. They are controls that have direct effect on the output, controls that indirectly control output and controls that are receiver controls.

1.4 Safety Symbols The following table is provided for your identification of important symbols located in labels on the system. Symbol

Meaning Caution Dangerous voltage

Risk of explosion if used in the presence of flammable anesthetics. 0197

This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC Authorized representative in the European community Type BF Applied Part Power On/Off button

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Symbol

Meaning Alternating current Direct current Degree of IP protection Non-ionizing electromagnetic radiation.

Manufacturer

Date of manufacture

Follow instructions for use

Network Port

USB Port Fragile

AUDIO output

Keep dry

Maximum stacking limit of packages Maximum of two layers allowed for the system

Keep this way upward

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1 Safety

Symbol

Meaning Serial Number

Use it in ventilated and dry indoor environment (for AC adaptor only)

Rechargeable (for battery only) This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

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Basic User Manual

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System Overview

This system adopts advanced ultrasonic Doppler technologies. To ensure the performance and availability of this system, you should be thoroughly familiar with the operations of system components, the control panel, the key panel and the basic screen.

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2 System Overview

2.1 System Configuration The standard system configuration mainly consists of the followings items: ●●

Main unit

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Probes

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Others: See the Packing List in the packaging box.

2.2 Physical Specifications ●●

LCD monitor: 15.6’’ color display

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System dimensions: approx. 378mm(W) × 352mm(H) × 114mm(D)

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System weight: approx. 6.5kg (at most, including battery)

2.3 System Components

Figure 2-1 System Overview

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Basic User Manual

SonoScape

Ultrasound Systems

E1 Series Basic User Manual Jan 2018