bk3000 Ultrasound System User Guide Jan 2015

LEGAL MANUFACTURER BK Medical Aps Mileparken 34 2730 Herlev Denmark Tel.:+45 4452 8100/Fax:+45 4452 8199 www.analogicultrasound.com Email: [email protected]

The serial number label on a BK Medical product contains information about the year of manufacture. BK Medical Customer Satisfaction

Input from our customers helps us improve our products and services. As part of our customer satisfaction program, we contact a sample of our customers a few months after they receive their orders. If you receive an email message from us asking for your feedback, we hope you will be willing to answer some questions about your experience buying and using our products. Your opinions are important to us. You are of course always welcome to contact us via your BK Medical representative or by contacting us directly. If you have comments about the user documentation, please write to us at the email address above. We would like to hear from you. •

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System Software NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. BK Medical HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON BK Medical TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR USE. EXPORT RESTRICTIONS. You acknowledge that Windows 8 Embedded is of US-origin. You agree to comply with all applicable international and national laws that apply to Windows 8 Embedded, including the U.S. Export Administration Regulations, as well as end-user, end-use and country destination restrictions issued by U.S. and other governments. For additional information on exporting Windows 8 Embedded, see http:// www.microsoft.com/exporting/ The bk3000 Ultrasound System is closed. Any modification of or installation of software to the system may compromise safety and function of the system. Any modification of or installation of software without written permission from BK Medical will immediately void any warranty supplied by BK Medical. Such changes will also void any service contract and result in charges to the customer for restoration of the original bk3000 Ultrasound System.

Trademarks: DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries.

bk3000 = Ref. Type 2300 © 2015 BK Medical Information in this document may be subject to change without notice.

Contents Chapter 1

General Information... 5 Essential Performance... 5 Intended Use... 6 Modes of Operation... 6 Indications for Use... 7 Contraindications... 7

Chapter 2

Safety Information... 9 Safety Information... 9 Safety Symbols and Information on the Equipment... 9 General Safety Precautions... 10 Mechanical Safety... 12 Explosion Hazards... 12 Electrical Safety... 13 ESD Training... 13 Interference... 13 Electrical Noise... 13 Electromagnetic Interference... 14 RF (Radio Frequency) Interference... 14 Installation... 15 Connecting Other Equipment... 15 Network Connection... 16 Network Security... 16 Network Printing... 16 Connectors... 16 EMC Requirements... 20 Isolation of DICOM Network... 21 Wireless Networks... 21 Medical Equipment... 23 Non-Medical Equipment... 24 Computer Security... 24 Service and Repair... 25 Transducers... 25 During an Examination... 25 Checking the Date... 25 Verifying the Transducer Type... 26 Measurements... 26 VFI - Vector Flow Imaging... 27 Puncture and Brachytherapy... 27 3D... 28 Picture in Picture... 29 Acoustic Output... 29 General... 29 Monitor Display... 30 Thermal and Mechanical Indices... 30

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Acoustic Output Measurement... 31 Functions Affecting Acoustic Output... 32 Default Acoustic Output... 32 Clinical Measurements: Ranges and Accuracies... 33 Geometric Measurements... 34 Time Measurements... 35 Doppler Measurements... 35

Chapter 3

Getting Started... 37

Index... 39 Appendix A English source version 16-01249-EN-01

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Warnings and Cautions Displayed on the System... 43

Chapter 1 General Information This user guide is for the bk3000 ultrasound system. NOTE: Some of the functionality and options described in this guide may not be

available with your version of the system. Before using the equipment, please make yourself familiar with the information in the accompanying user information documents. Some documents are printed. Make sure that you also read the transducer user guide and specifications for each transducer that you use. Document

Information

System User Guide

Introductory information, safety information, getting started.

Getting Started

User interface, basic operating instructions. Note: this book is part of the system user guide.

System Advanced User Guide

Information about advanced functions, glossary.

Product Data for system

Specifications for the system, including disinfection methods that can be used. Indications for use for each transducer that can be used with the system.

Technical Data (BZ2100)

Acoustic output data, clinical measurements (ranges and accuracies), factory default power levels and data about EMC (electromagnetic compatibility) for all transducers. Pro Package calculation formulas.

Care and Cleaning

Cleaning, disinfection, sterilization, checking, storing and disposing of BK Medical equipment. Includes environmental limits.

Transducer User Guide

Specific instructions for the transducer and puncture attachments.

Product Data for each transducer

Specifications for the transducer, including disinfection methods that can be used.

Table 1-1. User information documentation that accompanies the equipment. Improper use

Failure to follow safety instructions or use for purposes other than those described in the user manuals constitutes improper use.

Essential Performance The system can provide 2D and 3D ultrasound echo and flow imaging systems as an aid in diagnosis, data processing and -transfer, and guidance of puncture and biopsy. The system can perform simple geometric measurements and calculations. The system can guide biopsy- and puncture needles. The system is free from artefacts or distortion in the image or error of a displayed value, which can be attributed to a physiological effect and which may alter the diagnosis.

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The system displays correct numerical values associated with the diagnosis to be performed. The As Low As Reasonably Practicable (ALARP) principle is used and safety related indications (MI, TIS, TIB, etc) are displayed as worst-case values. The system does not generate unintended or excessive ultrasound output or transducer surface temperature. There is no unintended or uncontrolled motion of transducer assemblies intended for intra-corporeal use.

Intended Use The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: •

Urology

• • •

Vascular Cardiology OB/GYN

Modes of Operation • • • • • • • •

B-Mode (including Tissue Harmonic imaging) M-Mode PWD Mode CFM Mode Power Doppler Contrast Imaging1 CW Doppler2 Elastography3

1. In the USA, contrast-enhanced ultrasound has not been market cleared by the FDA, with the exception of select cardiac imaging applications. 2. CW Doppler on the bk3000 has not been market cleared by the FDA or licensed by Health Canada. 3. Elastography on the bk3000 has not been market cleared by the FDA or licensed by Health Canada.

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Indications for Use The system is intended for use by qualified physicians for ultrasound evaluation. Specific clinical applications and exam types include: • • • • • • • • • • •

Fetal (including Obstetrics) Abdominal Pediatric Small Organ (also known as Small Parts) Adult Cephalic (also known as Adult Transcranial) Neonatal Cephalic Intraoperative* Intraoperative (Neuro)* Transrectal Transvaginal Transurethral*

• • •

Musculoskeletal (Conventional and Superficial) Cardiac Adult Peripheral Vessel (also known as Peripheral Vascular)

Indicated uses are different for different transducers. The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system.

Contraindications • •

The bk3000 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.

* This application currently not for sale

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Chapter 2 Safety Information The system can be used for continuous operation, but imaging duration for individual patients must not exceed 60 minutes. We recommend, however, that you turn off the system at the end of each workday.

Safety Information This user guide contains cautions, warnings and other information about what you must do to ensure the safe and proper performance of the ultrasound system. You must also follow local government rules and guidelines at all times. WARNING Warnings contain information that is important for avoiding personal injury.

Caution Cautions contain information and instructions that must be followed to avoid damaging equipment, data, or software. NOTE: Notes contain information that you should be aware of.

Safety Symbols and Information on the Equipment Table 2-1 contains brief explanations of the symbols and information used to label the equipment. (Some labels in the table may appear on the transducer.) BK Medical disclaims all responsibility for the operating safety, reliability and performance of the equipment if these symbols and warnings are disregarded in any way. Symbol

Name

Description

Caution or Warning

Consult accompanying user guides when you encounter this sign on the instrument, to avoid reducing its safety.

Consult instructions Consult user guide or other instructions. for use Follow instructions for use

Consult user guide or other instructions.

Pushing prohibited

Do not use excessive force to push the system. Excessive force when pushing over uneven surfaces can cause the system to overbalance and tip.

Table 2-1. Symbols and information on the equipment.

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Symbol

3D56

Name

Description

Keep hands clear

Show caution when you adjust the system monitor.

Manufacturer

Legal manufacturer.

UL Classification for Canada and US

UL requirements are met for special conditions.

Rx only

Federal law in North America restricts this device to sale to, or on the order of, a physician.

Potential Equalization

Terminal connected to the chassis. Should be connected to corresponding terminals on other equipment to eliminate potential differences.

Ground (earth)

Additional protective ground (earth).

Type BF

BF: Isolated from ground. Maximum patient leakage current under • Normal condition 100A • Single-fault condition  500A

Type BF

BF, defibrillator-proof

Type B

B: Maximum patient leakage current under • Normal condition 100A • Single-fault condition  500A

Sealing

Dust- and immersion-protected according to EN 60529.

Standby

Symbol on ON/Standby button on back of scanner unit – used to turn system on and off.

ESD (electrostatic discharge)

Do not touch pins in connectors with this symbol unless you follow ESD precautionary procedures.

WEEE waste

Within the EU, when you discard the equipment, you must send it to appropriate facilities for recovery and recycling.

China ROHS 25 Years Environmentally Friendly Use Period for ROHS is 25 Lifetime years. Table 2-1. Symbols and information on the equipment. (continued)

General Safety Precautions The ultrasound system is designed and tested in accordance with EN/IEC 60601-1 (2006) (Part 1: General requirements for basic safety and essential performance) and EN 60601–2–37 (2007) (Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment).

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The system also complies with ANSI/AAMI ES60601-1 (2005) and CAN/CSA C22.2 No.601.1 (2008). It fulfills the requirements for dust protection (IP20) for ordinary equipment specified in EN 60529. Caution Rx-c1 Physicians only

Federal law in North America restricts this device to sale to, or on the order of, a physician.

WARNING GS-w1 Proper Training

Before you attempt to use BK Medical equipment, you should be trained in ultrasonography or be under the supervision of someone who is trained in ultrasonography. You should also be thoroughly familiar with the safe operation of your ultrasound system: read all the user documentation that accompanies it. No further training is required, but BK Medical offers training in how to use the system. Consult your BK Medical representative for information.

WARNING GS-w2 Equipment failure

If at any time the system malfunctions, or the image is severely distorted or degraded, or you suspect in any way that the system is not functioning correctly: • Remove all transducers from contact with the patient. • Turn off the system. Unplug the system from the power source. • Do not try to repair the system yourself. • Contact your BK Medical representative or hospital technician.

WARNING GS-w3 Isolating the system

The power supply cord connects the equipment to the line voltage. To isolate the equipment, you must unplug the power supply cord from the power source. Do this before you try to make any repairs to the system.

Caution S-c2 Spilled liquids

Do not spill liquids on the equipment.

Caution S-c3 Condensation

Large variations in temperature or humidity may cause water to condense inside the system. If this happens, the system may fail to operate properly. Always let the system come to room temperature before you plug it in. • Wait at least 2 hours after the system has been subjected to major changes in temperature or humidity. • If there is visible evidence of condensation, wait at least 8 hours.

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Before you use the equipment, make sure that all the safety requirements described in this chapter have been satisfied.

Mechanical Safety Mechanical failure or unintended use of ultrasound equipment can result in physical injury to patients or operators. WARNING MS-w1 Mechanical injury

Be careful to avoid the following potential sources of injury: • Parts of the body can be pinched by moveable parts of the equipment, such as the control panel. • Tilting the system can cause it to be unstable and injure someone. Do not lean or sit on the control panel or any other part of the system. The control panel or monitor can break if subjected to heavy weights or impact.

WARNING MS-w2 All parts must be stable

When parts of the equipment can be mounted individually (for example, for use in an operating room) each part must be securely mounted to a stable support so that it does not tip, fall or come loose and injure someone.

WARNING MS-w3 Don’t drop the scanner unit

To avoid personal injury or damage to the system, if you handle the scanner unit by itself, make sure you have a firm grip so that you do not drop it. Note that it may be hot.

WARNING MS-w4 Don’t push too hard

To avoid injury and equipment damage, do not push the system too hard, especially when you roll the system over an uneven surface. Applying excessive force near the top could cause the system to overbalance and tilt.

Explosion Hazards WARNING EH-w1 Explosion hazards

The equipment is not designed to be used in potentially explosive environments. It should not be operated in the presence of flammable liquids or gases, or in oxygen-enriched atmospheres. There is a possible explosion hazard if the equipment is used in the presence of flammable anesthetic. The system should be placed at least 25cm (10 inches) from the patient. The ultrasound system contains a lithium battery. Never remove or replace this battery. The lithium battery must not be removed except by a BK Medical service representative.

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Electrical Safety WARNING ES-w1 Do not use a power strip

Do not plug the equipment into an ordinary power strip. If the ground connection fails, this is dangerous because • the total leakage current for all the connected equipment can exceed the limits specified in EN/IEC 60601-1 (Part 1: General requirements for safety). • the impedance of the ground connection could exceed the limits specified in EN/IEC 60601-1.

WARNING ES-w3 Electrical shock

You risk electrical shock if you try to get inside the equipment (other than opening a cover to access connectors or batteries described in the user guide). Do not allow anyone but qualified service personnel to service the equipment.

ESD Training The ESD Symbol Anyone using the equipment must be able to recognize the ESD symbol and understand how to take the necessary precautionary procedures, as described in the caution below. Caution ESD-c1 ESD

Do not touch pins in connectors that have the ESD symbol . Do not connect anything to them unless you follow these ESD (electrostatic discharge) precautionary procedures: • Discharge your body to ground before you touch the pins with your hand or a tool. For example, touch an unpainted metal part of the system cover. • You can use a wrist strap connected to the additional protective ground or potential equalization terminal on the system if that is more convenient.

Interference The 2300 Ultrasound System is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Electrical Noise WARNING EN-w1 Electrical noise

Electrical noise from nearby devices such as electrosurgical devices – or from devices that can transmit electrical noise to the AC line – may cause disturbances in ultrasound images. This could increase the risk during diagnostic or interventional procedures.

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Electromagnetic Interference Medical electrical equipment requires special precautions regarding EMC (electromagnetic compatibility). You must follow the instructions in this chapter when you install the system and put it into service. If the image is distorted, it may be necessary to position the system further from sources of electromagnetic interference or to install magnetic shielding. WARNING EMC-w1 Other equipment nearby

Do not use this equipment adjacent to other equipment. If you must place it next to or stacked with other equipment, verify that it operates normally there and neither causes nor is affected by electromagnetic interference.

EMC noise can reduce the usable image depth. Therefore, to avoid having to repeat an ultrasound examination, you must make sure beforehand that the ultrasound system can be used for the examination. Repeating an examination can be regarded as a potential risk that should be avoided, especially if the examination involves transducers used intracorporeally or transducers used for puncture.

RF (Radio Frequency) Interference Portable and mobile RF (radio frequency) communication equipment can affect the system, but the system will remain safe and meet essential performance requirements. An ultrasound system intentionally receives RF electromagnetic energy for the purpose of its operation. The transducers are very sensitive to frequencies within their signal frequency range (0.3MHz to 80MHz). Therefore RF equipment operating in this frequency range can affect the ultrasound image. However, if disturbances occur, they will appear as white lines in the ultrasound image and cannot be confused with physiological signals. Caution Inter-c1 Possible interference sources

Other equipment may interfere with the system, even if that other equipment complies with CISPR (International Special Committee on Radio Interference) emission requirements.

Caution Inter-c2 Use specified equipment only

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Caution: If you use accessories, transducers or cables with the system, other than those specified, increased emission or decreased immunity of the system may result.

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Installation WARNING I-w1 Installation safety requirement

To ensure safe performance, a qualified electrician or hospital safety personnel must verify that the equipment is correctly installed and that it complies with the following safety requirements: • Use only the original power supply cord. In the USA, this is fitted with a hospital grade three-prong grounded power plug. Never try to remove or change the plug on the power supply cord. • All equipment must only be connected to a grounded AC power supply (or wall outlet) that meets EN/IEC/NEC requirements or applicable local regulations. The examination room’s grounding system should be checked regularly by a qualified electrician or hospital safety personnel. • Never use extension cords. The increased length of the cord will increase the resistance of the protective ground conductor and may increase the equipment’s leakage current beyond an acceptable level. • Keep power cords, sockets and plugs clean and dry at all times. • Make sure that the power supply cord cannot be accidentally disconnected from the power source or the equipment.

Original power cords

If the original power cords are missing or damaged, you must order new ones from your local BK Medical representative.

Additional Protective Ground and Potential Equalization An additional protective ground can be connected to the control panel, see Fig 2-1.

terminal underneath the

The potential equalization terminal underneath the control panel is connected to the system chassis. It can be connected to corresponding terminals on other equipment to eliminate potential differences. Do NOT use it for additional protective grounding.

Figure 2-1. The terminals for potential equalization are underneath the control panel.

and additional protective ground

Connecting Other Equipment For connection to other equipment, BK Medical systems have a communication protocol on top of TCP/IP

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WARNING C-w1 Connection guidelines

Follow the guidelines in EN60601-1-1 (Safety requirements for medical electrical systems) when you connect the system to other equipment.

Network Connection BK Medical’s range of ultrasound systems comply with the DICOM standard for handling, storing, printing and transmitting information in medical imaging. DICOM includes a file format definition and a network communication protocol which facilitates the exchange of data between electronic medical systems. For detailed information about: • • • • •

network requirements network configuration workflow between devices technical specifications safety specifications

see BK Medical’s DICOM conformance statement at www.analogicultrasound.com/support/bk-medical/DICOM

Network Security It is the responsibility of the on-site personnel or technician to maintain the ITnetwork and identify, analyze, evaluate and control new risks caused by a change in the network configuration. If the applicable network connection does not meet the required characteristics of the IT-network, the following hazardous situations may occur: • •

Corrupt patient data due to network errors, see Warning Exam-w3 on page 26 System is unable to use the network due to faulty or overloaded network, see Warning GS-w1 on page 11

System overloads the network causing other equipment to fail. NOTE: If your system interacts with other equipment directly or indirectly you must ensure that your network is properly dimensioned and that critical equipment is placed on a separate network. Otherwise you could risk overloading the network and your equipment failing. •

Network guidelines

Network Printing For printing on network printers, BK Medical supports protocols PCL 5, PCL 6 and PS (Post Script).

Connectors PC connectors for connecting the system to other equipment such as approved printers and video equipment are located on the rear of the system. See Fig 2-3.

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Some connectors are used by the system. Do not use connectors that are not labelled in Fig 2-3. More information about the connectors is in Table 2-2. Information about the cables to use is in Table 2-4. The bk3000 ultrasound system has four transducer sockets on the side of the system. See Fig 2-2.

Figure 2-2. Transducer sockets.

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Power supply cord goes here

Figure 2-3. System connectors.

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Symbol

Connector

Additional Information

DVI-I

Connector for auxiliary DVI or VGA monitor.

Composite/S-video Out

7-pin S-video connector (see Table 2-3 for pin layout) that can be adapted to a composite video output (see Table 2-3).

Microphone

Microphone connector

Audio In Audio Out 4 USB 2.0 connectors, A-type

500mA current limit on each.

10/100/1000 Ethernet

LAN: 10/100/1000 LAN connector, RJ45.

Table 2-2. System connectors.

Video Output Although 4 different video output signal formats are available, the image quality is not the same for all of them. DVI gives best image quality

To get the best image quality possible, connect your monitor or other video equipment using the output signal that gives the highest quality image. See the list below. Output signal types (in order of quality, with digital DVI highest)

1 2 3 4

DVI - digital output that gives the best image quality. VGA – this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output. S-video – analog output Composite – signal with the most loss of information

If you must use a cable that does not have a DVI connector, you may need to use an adapter. Table 2-3 shows you which adapters can be used.

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Cable Connectors (in order of preference)

Adapter

2300 Connector

HDMI

Adapter needed

DVI-I

Not needed

DVI-I

DVI-D

DVI to VGA adapter (2 views)

15-pin (VGA)

DVI-I

7-pin S-video to Composite + BNC (female) to Phone (male)

BNC (Composite)

+

Phono RCA (Composite)

7-pin S-video to Composite

2 connectors (S-video and composite)

7-pin S-video to S-video/Composite

(same view on both connectors) Table 2-3. Video connectors and adapters.

EMC Requirements To fulfill EMC requirements, cables attached to the system must be shielded and no longer than 5 m.

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