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bk3500 User Guide

(16-01410-EN-04)

Safety Information

39

Medical Equipment

If any other electrical equipment/accessory is connected to the system, the system

including

this equipment and/or accessory will become a medical system. Medical

systems must comply with EN/IEC 60601–1

,

ANSI/AAMI ES60601-1 or CAN/CSA

C22.2 No. 60601-1.

Non-Medical Equipment

WARNING

NME-w1

Follow the guidelines in EN/IEC 60601–1.

If you connect non-medical equipment (instruments that do not comply with safety
requirements for medical equipment, such as a video monitor, video recorder, endoscopic
camera control unit or other documentation device), this equipment must be placed
outside the patient environment (1.5m from the bed, for example). The equipment must
fulfill the relevant EN standard or other applicable national or international standard.

One of the following conditions must be fulfilled:

•

The system and other equipment are plugged into an external common isolation
transformer to control the leakage current during a ground connection fault.

or

•

The system is grounded with an additional safety ground connection (see “Additional
Protective Ground and Potential Equalization” on page 33).

If in doubt, contact your BK service representative.

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Содержание bk3500

Страница 1: ...16 01410 EN 04 April 2017 For Professional Users Only User Guide bk3500 Ultrasound System ...

Страница 2: ... 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 ...

Страница 3: ... Buttons 18 Monitor and Touch Screen Display 21 Battery 23 Charging the Battery 23 Battery Status 24 Information Available on the Monitor 24 Battery Life 25 Chapter 3 Safety Information 27 Safety Information 27 Safety Symbols and Information on the Equipment 27 General Safety Precautions 29 Mechanical Safety 30 Explosion Hazards 31 Electrical Safety 31 ESD Training 31 Interference 32 Electrical No...

Страница 4: ... Measurements 42 VFI Vector Flow Imaging 43 Puncture 43 Acoustic Output 44 General 44 Monitor Display 45 Thermal and Mechanical Indices 45 Acoustic Output Measurement 47 Functions Affecting Acoustic Output 48 Default Acoustic Output 48 Clinical Measurements Ranges and Accuracies 48 Geometric Measurements 50 Time Measurements 50 Doppler Measurements 50 Index 51 Appendix A Warnings and Cautions Disp...

Страница 5: ...ror of a displayed value which can be attributed to a physiological effect and which may alter the diagnosis The system displays correct numerical values associated with the diagnosis to be performed Document Information System User Guide Introductory information safety information getting started Quick Start Guide User interface basic operating instructions System Advanced User Guide Information ...

Страница 6: ...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 Emergency Medicine Anesthesia MSK Vascular Cardiology O...

Страница 7: ...dications for use 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 bk3500 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 ...

Страница 8: ... arthritis TEE should never be performed if there is any question about stability of cervical spine Patients who received extensive radiation to the mediastinum this can cause significant difficulty in probe manipulation within the esophagus and is a relative contraindication if the anatomy of the esophagus is not known Upper gastrointestinal bleeding significant dysphagia and odynphagia are also ...

Страница 9: ...etting Started The bk3500 System Monitor Control panel Transducer Touch screen Scan engine Transducer Battery cover Battery display Front handle with release handles Battery sockets holders compartment Endotransducer holder Baskets for accessories Lockable wheels ...

Страница 10: ...re may occur that requires technical support Make sure the battery is charged If it is not plug in the imaging system to use it or to charge the battery Figure 2 1 The power button on the scan engine To turn on Press the power button once then wait until startup screen disappears If the battery is empty it is not necessary to turn off the imaging system Plug the system into a power outlet to recha...

Страница 11: ...er on socket to the right 3 Remove plug from socket NOTE If more than one transducer is connected select a different transducer before you disconnect Otherwise the following message will be displayed on the touch screen Figure 2 3 Message if the active transducer is disconnected Barcode Reader To enter Patient Information with the barcode reader 1 Tap the touch screen Patient button 2 With the cur...

Страница 12: ...arcode Control Panel Figure 2 4 The control panel and touch screen WARNING SR w2 To avoid personal injury connecting disconnecting the barcode reader and or printer must be carried out only by BK personnel or authorized representatives Icon System Control Functionality Trackball Positions the mouse cursor measurement cursor and label QUICK ACCESS button Opens the quick exam start up workflow When ...

Страница 13: ...toggles between moving resizing the color box and selects sets measurements labels etc UPDATE Button Provides a wide variety of functions depending on the imaging state for example toggles between image views and image mode and rotates the transducer on the bodymark icon 1 Button Stores the current image FREEZE Button Freezes unfreezes live imaging A snowflake icon is displayed on the monitor when...

Страница 14: ...nter Patient information The Patient ID is filled in automatically with a timestamp but you can change this to a relevant ID or use a barcode reader See Barcode Reader on page 11 Figure 2 5 Patient window 3 Swipe the screen from right to left to enter additional patient information Figure 2 6 Second screen in Patient window ...

Страница 15: ...tarted 15 4 Tap the Exam Info button to add specific information relevant for the exam and tap Next Figure 2 7 Exam Info window 5 Select Transducer in this case 6C2 is selected Figure 2 8 List of available transducers those that are plugged in ...

Страница 16: ...ou intend to perform The applications available depend on the selected transducer in this case 6C2 Figure 2 9 List of available applications 7 Select imaging Preset The imaging presets available are dependent on the transducer and the application exam type selected Figure 2 10 Available presets ...

Страница 17: ...m When you are finished select End Exam WARNING Exam w2b If after beginning an exam without entering any Patient information you want to save an image you must verify that the system auto created a properly configured Patient ID before exiting the exam Whenever possible BK recommends that you also enter a complete Patient Name ...

Страница 18: ... Do as follows Tap the Patient button on the touch screen Enter patient information The Patient ID is filled in automatically with a timestamp but you can change this to a relevant ID or use a barcode reader See Barcode Reader on page 11 Figure 2 12 Patient window when using the touch screen buttons Swipe the screen from right to left if you need to add more information Add exam info by tapping th...

Страница 19: ...on on the connected transducer to select it Figure 2 13 Transducer window when using the touch screen buttons To use the application and preset already selected on the system continue the exam Otherwise continue your selection To select Application tap the application you want Figure 2 14 Application window when using the touch screen buttons ...

Страница 20: ...ady selected on the system continue the exam Otherwise continue your selection To select Preset tap the preset you want Figure 2 15 The preset window when using the touch screen buttons Figure 2 16 The touch screen in Basic layout during an exam The exam ends when you tap End Exam ...

Страница 21: ...N 04 GettingStarted 21 Monitor and Touch Screen Display Figure 2 17 Monitor clinical display Trans ducer Review tab with browser Exam type Patient Biopsy line Image data including battery status Measure ment data Hospital Operator ...

Страница 22: ...uch screen Basic layout Mode function buttons Image parameter buttons Touch screen dials Mode buttons Exam Management buttons Function buttons including the Home button Exam Management buttons Function buttons including the Home button Mode function buttons Image parameter buttons Touch screen dials Mode buttons ...

Страница 23: ... gauge so that the indication of how much charge is left in the battery is accurate Button Group Functionality Exam management buttons The exam management buttons follow the workflow to start an exam for a new patient or allow the user to change the transducer application or preset in an exam that has been started Mode buttons The mode buttons allow the user to select mode modes for the exam The m...

Страница 24: ... A message appears on the monitor when a battery reaches the end of its lifespan and needs replacing For information about the disposal of depleted batteries see page 40 Low Battery When battery capacity is very low An alarm sounds every 15 seconds A message appears on the monitor The on screen battery indicator turns red The display on the battery compartment blinks regularly Figure 2 21 Low batt...

Страница 25: ...ntinuous use With typical use which includes imaging and freezing a fully charged battery provides approximately 2 hours of operation With a fully charged battery pack you can scan continuously for approximately 1 hour 20 minutes Battery lifespan When a battery reaches the end of its lifespan the replace battery message appears on the monitor at start up On average a battery will need to be replac...

Страница 26: ...26 Chapter 2 April 2017 bk3500 User Guide 16 01410 EN 04 ...

Страница 27: ... the table may appear on the transducer BK Medical ApS disclaims all responsibility for the operating safety reliability and performance of the equipment if these symbols and warnings are disregarded in any way 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 d...

Страница 28: ... 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 Power button on side of scanner engine 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 ...

Страница 29: ...nd system read all the user documentation that accompanies it In addition if your system interacts with other equipment directly or indirectly you need to make sure the interactions are both safe and secure No further training is required but BK offers training in how to use the system Consult BK for information Equipment failure WARNING GS w2 If at any time the system malfunctions or the image is...

Страница 30: ...id 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 All parts must be stable WARNING MS w2 When ...

Страница 31: ...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 IEC60601 1 Part 1 General requirements for safety the impedance of the ground connection could exceed the limits specified in EN IEC 60601 1 Electrical shock WARNING ES w3 You riskelectrical shoc...

Страница 32: ...rtable 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 ...

Страница 33: ...d increased emission or decreased immunity of the system may result Installation safety requirement WARNING I w1 Toensuresafeperformance aqualifiedelectricianorhospitalsafetypersonnelmustverify 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 grou...

Страница 34: ...tain the IT network 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 42 System is unable to use the network due to faulty or overloaded...

Страница 35: ...equipment such as approved printers and video equipment are located on the rear of the system Do not use connectors that are not labeled Information about the correct cables to use is in Table 3 4 Figure 3 2 Transducer sockets and system connectors LAN Connector Composite Connector USB 2 0 Connector USB 3 0 Connector S video Out Microphone Audio In Audio Out DVI or VGA Monitor Wi Fi Dongle Transdu...

Страница 36: ...at gives the best image quality 2 VGA this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output 3 S video analog output 4 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 3 3 shows you which adapters can be used Symbol Connector Additional Information DV...

Страница 37: ...equirements cables attached to the system must be shielded and no longer than 5 m Cable Connectors in order of preference Adapter bk3500 Connector HDMI Adapter needed DVI I DVI D Not needed DVI I 15 pin VGA DVI to VGA adapter 2 views DVI I S video Not needed BNC Composite BNC female to Phono male Phono RCA Composite Not needed ...

Страница 38: ...ed with the system Connect the dongle to the extender cable and insert into one of the USB 3 0 connectors see Fig 3 3 on page 30 Connecting to a Wireless Network You must establish a secure wireless network at your hospital clinic or institution including a password for the network before you can use the system s Wi Fi for printing and archiving For setting up a wireless network see the bk3500 Adv...

Страница 39: ...alequipment suchasavideomonitor videorecorder endoscopic camera control unit or other documentation device this equipment must be placed outside the patient environment 1 5m from the bed for example The equipment must fulfill the relevant EN standard or other applicable national or international standard One of the following conditions must be fulfilled The system and other equipment are plugged i...

Страница 40: ...y for computer viruses from the network that may infect the system See Exporting Data in the bk3500 Advanced User Guide Printer Touch Screen WARNING BS w6 To ensure proper ventilation and avoid overheating keep both ends of the battery clear Check external media Caution CS c1 You must perform a virus check on any external storage medium USB device or DVD to make sure that it is virus free before y...

Страница 41: ... connecting disconnecting the barcode reader and or printer must be carried out only by BK personnel or authorized representatives Electrical shock WARNING T w1 The transducer sockets contain terminals with 3 3V Do not touch the patient while you are touching an uncovered socket Type B transducers WARNING T w2 When using Type B non isolated transducers carefully check all electrical equipment with...

Страница 42: ...ect Type number displayed must match number on transducer WARNING Exam w4 Before you start to image verify that the type number on the transducer matches the number displayed on the monitor In case of any inconsistency stop imaging turn off the system and contact your BK service representative Using Doppler curves WARNING M w2 Drawings of Doppler curves manual and automatic are meant as tools for ...

Страница 43: ...eal time volume flow measurement may not be precise Doppler gate large enough WARNING VFI w4 Check to make sure that the Doppler gate covers the entire vessel Otherwise the real time volume flow measurement may not be precise Doppler gate over only one vessel WARNING VFI w5 Checktomakesure that theDoppler gate only covers one vessel Otherwise the real time volume flow measurement may not be precis...

Страница 44: ...tain a satisfactory image If you switch from an application requiring high acoustic output levels see Functions Affecting Acoustic Output on page 48 to one that requires lower levels fetal imaging for example be sure to reset the levels before you image For example start in B mode Take into account all the types of tissue that may be affected For example when imaging a breast it may be appropriate...

Страница 45: ...ic output will not be evaluated on an application specific basis but the maximum derated Spatial Peak Temporal Average Intensity ISPTA must be 720mW cm2 the maximum Mechanical Index MI must be 1 9 and the maximum Thermal Index TI must be 6 All BK transducers for use with the bk3500 Ultrasound System are Track 3 Monitor Display The Mechanical Index MI and Thermal Index TI can be viewed in all imagi...

Страница 46: ...ferences EN60601 2 37 and AIUM NEMA standard but the formulas are given below MI Formula where the variables are defined in the table below TI Formula where the variables are defined in the table below Variable Definition Pr0 3 zsp Peak Rarefactional Pressure MPa derated by 0 3dB cm MHz measured at zsp the point on the beam axis where pulse intensity integral PII0 3 is maximum fc measured center f...

Страница 47: ...here the variables are defined in the table below It should be stressed that the in situ values given are only applicable when there is attenuating tissue between the transducer face and the focal point Possibility of Adverse Effects Although it is believed that diagnostic ultrasound causes no significant biological effects in mammalian tissue the user should be aware of the hypothetical possibili...

Страница 48: ... the acoustic output within it The user can set a Thermal Index limit This will provide an upper limit for acoustic output Default Acoustic Output After the system has been turned off the transducers will start in the default setup when the system is turned on again The default setup may be factory defined or defined by the user The factory defined default setup values of acoustic output for each ...

Страница 49: ...proximates an ellipse the circle being a special ellipse and when the structure is roughly symmetrical about the selected axis of rotation NOTE The choice of the axis of rotation is important for the calculation of the volume A vertical axis gives a different volume than a horizontal axis The minimum requirement is that the cross section outlined by the user should be convex If the user draws a no...

Страница 50: ...ded to the nearest 0 01s Accuracy 0 01 x t where t is the full time scale of the image field Doppler Measurements In measuring blood flow velocity it is assumed that the measured power spectral distribution of the Doppler signal equals the blood cell velocity distribution The measurement accuracy of blood flow velocity is heavily dependent on the angle between the ultrasound beam and the velocity ...

Страница 51: ...curacies 50 warnings 42 Doppler mode fetal imaging 48 E earth See ground electrical noise 32 electrical safety 33 electrical shock 31 electromagnetic compatibility See EMC electromagnetic interference 32 EMC attaching cables 37 data in BZ2100 5 noise checking for 32 precautions 32 equipment failure 29 ESD precautions 31 symbol 28 31 training 31 essential performance 5 explosion hazards 31 exposure...

Страница 52: ...ical 31 33 transducer 41 sealing symbol 28 security network See network security service and repair 41 standby symbol 28 system isolation from line voltage 29 malfunction 29 T Technical Data BZ2100 5 45 48 Thermal Index limit setting 48 Thermal Index limit setting 48 TI Thermal Index and ALARA 45 blood perfusion and 47 time measurements 50 tipping and overbalance warning 30 warning symbol 27 train...

Страница 53: ...he transducer malfunctions see Warning GS w2 on page 29 Warning text Action if necessary Current date and time s are before the scanner was last run s Check your system clock Failed to parse the prom received from the probe Try again Failed to read general settings from database Try again Failed to save bodymark catalog Try again Note that changing the time zone requires restarting the scanner Res...

Страница 54: ...e s Use valid result name A formula in the measurement contains an undefined measurement tool s Use a defined measurement tool A measurement cannot depend on itself Adjusting the guide s height Adjusting the guide s width Allavailablepropacksfor shasbeenhidden An error occurred while the patient archiving database was being copied Try again Another scanner is using this network drive for archiving...

Страница 55: ...configure the server Try again Failed to connect to SMTP server s s Try again Failed to copy file s To s s Try again Failed to copy Try again Failed to create Diagnostic Setup ID s Try again Failed to create new Pro Package s Try again Failed to delete catalog in database Try again Failed to delete curve in database Try again Failed to delete measurement in database Try again Failed to delete the ...

Страница 56: ... file Try again Failed to store curve in database Try again Failed to store general settings in the database Try again Failed to store key assignments in database Try again Failed to store the curve s Two curves cannot have the same Reference Name and the imported curve s Reference Name s is already used for the curve s Use a different reference name to store the curve Failed to update Pro Package...

Страница 57: ...d Do not leave the fields empty Fill in name and formula No available pro packages in database for transducer s No catalogs available Assign catalogs in setup window No default propackage available for the s transducer choose a default propackage No Preset name was specified nNothing will be saved Specify a preset name One or more batteries are wearing out Considerreplacingthefollowingbatteries s ...

Страница 58: ...rement must be unique Fillouttherequiredfieldsaccordingtotheon screen instructions The archived document s was not found on the network drive The connected transducer cannot be used because there is a problem with its PROM Please remove the transducer and contact a service technician The curve definition is not compatible with this software version Upgrade software The curve definition must contai...

Страница 59: ...e name The guide s vertical holes cm is invalid Use valid vertical holes cm setting The guide s vertical offset is invalid Use valid vertical offset setting The guide s width is invalid Use valid guide width setting The host name is invalid The license could not be removed The measurement cannot be edited The template contains errors Contact service technician The measurement contains an invalid p...

Страница 60: ...contact service technician The scanner s hardware does not support s The selected curve is invalid Use valid curve The system has not finished sending the last mail Please try again later The system must be restarted for changes to take effect The system must be restarted to fully implement the language change The tool attribute s is invalid Use valid tool attribute The transducer button d is stuc...

Страница 61: ...ce technician Transducer s cannot be used with this scanner Connect a compatible transducer See Product Data Sheet for more details Transducer s cannot be used with this scanner A hardware upgrade may solve the problem Connect a compatible transducer See Product Data Sheet for more details Transducer s is disabled for this scanner Unable to capture image Try again Unable to connect remote control ...

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