User Guide

bk3000 & bk5000 Ultrasound Systems

16-01249-EN-08
March 2019 For Professional Users Only
 LEGAL MANUFACTURER

BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 4452 8100/Fax:+45 4452 8199
www.bkmedical.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. You are always welcome to
contact us via your BK Medical representative or by contacting us directly.

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 2300 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 2300 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 either registered trademarks or trademarks of Microsoft Corporation in the United States
and/or other countries.

bk3000 & bk5000 = Ref. Type 2300

© 2019 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
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Explosion Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
ESD Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Electrical Noise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
RF (Radio Frequency) Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Connecting Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Network Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Network Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Network Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
EMC Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Isolation of DICOM Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Wireless Networks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Medical Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Non-Medical Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Battery Support System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Computer Security. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Service and Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
During an Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Checking the Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Verifying the Transducer Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Contrast Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
VFI - Vector Flow Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Puncture and Brachytherapy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
bkFusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3
 3D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Picture in Picture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Acoustic Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Thermal and Mechanical Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Acoustic Output Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Functions Affecting Acoustic Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Default Acoustic Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Clinical Measurements: Ranges and Accuracies. . . . . . . . . . . . . . . . . . . . . . . . . 36
Geometric Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Time Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Doppler Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Chapter 3 Battery Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Before You Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Imaging with Battery Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Battery Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Plugging in the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Charging the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Battery Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Information Available on the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Power Save Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Battery Life. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Battery Support Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Chapter 4 Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
The Remote Control and Its Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Pairing the Remote Control with the System . . . . . . . . . . . . . . . . . . . . . . . . 45
Calibrating the Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Mouse Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Replacing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Chapter 5 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Appendix A Warnings and Cautions Displayed on the System . . . . . . . . . . . . . . . . . . . . . . . . . 55

English source version

16-01249-EN-08

4
 Chapter 1
General Information

This user guide is for all versions of the bk3000 and bk5000 ultrasound systems.
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 artifacts 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.

bk3000 & bk5000 User Guide (16-01249-EN-08) General Information 5

 The system displays correct numerical values associated with the diagnosis to be
performed.
The As Low as Reasonably Achievable (ALARA) 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
• Emergency Medicine
• Surgery
• Anesthesia

Environment
The bk3000 and bk5000 Ultrasound systems are suitable for use in the professional
healthcare facility environment (e.g. hospitals, physician offices).

Modes of Operation
• B-Mode (including Tissue Harmonic imaging)
• M-Mode
• PWD Mode
• CFM Mode
• Power Doppler
• Contrast Imaging
• CW Doppler
• Elastography
• Fusion

6 Chapter 1 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 Indications for Use
The system is a diagnostic ultrasound imaging system used by qualified and trained
healthcare professionals for ultrasound imaging, human body fluid flow analysis and
puncture and biopsy guidance.
The 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
• Intra-operative1
• Intra-operative (Neuro)1
• Trans rectal
• Trans-vaginal
• Trans-urethral
• Musculo-skeletal (Conventional and Superficial)
• Cardiac Adult
• Peripheral Vessel (also known as Peripheral Vascular)
Indications 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 bk3000 and bk5000 ultrasound systems are 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.

1. bk5000 only.

bk3000 & bk5000 User Guide (16-01249-EN-08) General Information 7

8 Chapter 1 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
 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
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.
Keep hands clear Show caution when you adjust the system monitor.

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

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 9

 Symbol Name Description
SAFE WORKING The weight in kilos of the system including
LOAD transducers.
Manufacturer Legal manufacturer.
UL Classification for UL requirements are met for special conditions.
E351094
Canada and US
UL Recognized UL recognizes this as part of a UL-approved apparatus
Component for
Canada and US

Rx only United States Federal Law restricts this device to

sale or use by or on the order of a physician.
Potential Terminal connected to the chassis. Should be
Equalization connected to corresponding terminals on other
equipment to eliminate potential differences.
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

No Pacemakers or EM Transmitter may interfere with pacemakers and/or

Defibrillators cardioverter defibrillators.
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 Do not touch pins in connectors with this symbol
discharge) unless you follow ESD precautionary procedures.
Specified Radio (On remote control) This equipment conforms to
Equipment Japanese Radio Law regulations concerning
frequency and power.
WEEE waste Within the EU, when you discard the equipment, you
must send it to appropriate facilities for recovery and
recycling.
Battery waste (On the battery.) Dispose of used batteries properly.
When you dispose of the batteries you must follow
national rules. Within the EU, you must send them to
LI-ION appropriate facilities for recovery and recycling.
Table 2-1. Symbols and information on the equipment. (continued)

10 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 Symbol Name Description
Battery recycle (On the battery.) Recycle used batteries properly.

China ROHS 25 Years Environmentally Friendly Use Period for ROHS is 25

Lifetime years.
Mains (On back of scanning engine.) Indicates that system
can be powered by 100-240 V ac, 50/60 Hz, Max power
consumption 900 VA.

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
(2012) (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).
The system also complies with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
and CAN/CSA C22.2 No.60601-1 (2014).
It fulfills the requirements for dust protection (IP20) for ordinary equipment
specified in EN 60529.

Caution Rx-c1
Physicians United States Federal law restricts this device to sale to, or on the order of, a physician.
only

WARNING GS-w1
Proper To ensure safe and proper use of the equipment, before you attempt to use BK Medical
Training 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 offers training in how to use the
system. Consult your BK representative for information.

WARNING GS-w2
Equipment If at any time the system malfunctions, or the image is severely distorted or degraded, or
failure 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 wall and make sure it cannot be used
until it can be checked.
• Do not try to repair the system yourself.
• Contact your BK service representative or hospital technician.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 11

 WARNING GS-w3
Isolating the The power supply cord connects the equipment to the line voltage. To isolate the
system 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 The keyboard panel of the ultrasound system is not watertight. Be careful not to spill any
liquids liquids, gels or moist substances on the keyboard.

Caution S-c3
Conden- Large variations in temperature or humidity may cause water to condense inside the
sation 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.

Caution S-c4
Never unplug the system from the wall while it is running. Turn off the system and wait for
the light on the keyboard and the ON/Standby button to go out before unplugging.

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

12 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 WARNING MS-w3
To avoid personal injury, be aware that the scan engine can become hot after prolonged
use.

WARNING MS-w4
Don’t push To avoid injury and equipment damage, do not push the system too hard, especially when
too hard 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 The equipment is not designed to be used in potentially explosive environments. It should
hazards 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 service representative.

Electrical Safety
WARNING ES-w1
Do not use a Do not plug the equipment into an ordinary power strip. If the ground connection fails,
power strip 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 You risk electrical shock if you try to get inside the equipment (other than opening a cover
shock to access connectors described in the user guide). Do not allow anyone but qualified
service personnel to service the equipment.

Caution F-c1
With Fusion sensor mounted, the transducer only complies with type B requirements of
IEC 60601-1

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 13

 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-c1a
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 potential equalization terminal on the system
if that is more convenient.

Interference
The emission characteristics of this ultrasound system makes it suitable for use in
industrial areas and hospitals (CISPR 11 Class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-orienting the system.

Electrical Noise

WARNING EN-w1
Electrical Electrical noise from nearby devices such as electrosurgical devices – or from devices that can
noise transmit electrical noise to the AC line – may cause disturbances in ultrasound images. This
could increase the risk during diagnostic or interventional procedures.

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

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 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 Portable RF communication equipment (including peripherals such as antenna
interference cables and external antennas) should be used no closer than 30 cm (12 inches) to any
sources part of the ultrasound system, including cables specified by BK Medical. Otherwise,
degradation of the performance of this equipment could result.

Caution Inter-c2
Use specified If you use accessories, transducers or cables with the system, other than those specified,
equipment increased emission or decreased immunity of the system may result.
only

Installation
WARNING I-w1
Installation To ensure safe performance, a qualified electrician or hospital safety personnel must verify
safety that the equipment is correctly installed and that it complies with the following safety
requirement 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 If the original power cords are missing or damaged, you must order new ones from
power cords your local BK Medical representative.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 15

 Potential Equalization
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 terminal for potential equalization is located underneath the control panel.

Connecting Other Equipment

For connection to other equipment, BK systems have a communication protocol on
top of TCP/IP.

WARNING C-w1
Connection Follow the guidelines in EN/IEC60601-1 when you connect the system to other
guidelines equipment.

Network Connection
BK’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 the DICOM conformance statement at
www.bkultrasound.com/support/bk/resources/DICOM

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 Network Security
It is the responsibility of the on-site personnel or technician to maintain 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 27
• 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.
Network NOTE: If your system interacts with other equipment directly or indirectly you must
guidelines 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 Printing
For printing on network printers, BK supports protocols PCL 5, PCL 6 and PS (Post
Script).

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 17

 Connectors
As seen in Fig 2-2, the bk3000/bk5000 ultrasound system has four transducer sockets
on the side of the system.
PC connectors for connecting the system to 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 2-4.

Transducer Sockets

USB 3.0 (7) USB 2.0 (8)

Figure 2-2. Transducer sockets and keyboard USB connectors.

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 LAN Connector

Composite
Connector
USB 3.0 JTAG
Do Not Use
(1 - 2)

Battery Communication.
DVI
Connector Do Not Use on non-battery
models.

USB 2.0
Micro Sub-D
Connectors
Do Not Use
(3 - 6)
S-video Out

Microphone Audio In Audio Out

Wi-Fi Dongle

Figure 2-3. Connectors on the back of the system.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 19

 Symbol Connector Additional Information
DVI-I Connector for auxiliary DVI or VGA
monitor
Composite Out RCA/Phono
S-video Out 4-pin S-video connector
Microphone Microphone connector
Audio In
Audio Out
5 x USB 2.0 connectors and 3x USB 2.0: 500mA current limit on each
USB 3.0 connectors (A-type) USB 3.0: 900mA current limit on each
10/100/1000 Ethernet LAN: 10/100/1000 LAN connector, RJ45

Table 2-2. System connectors.

Connectors Not in Use

Mini display
1&2

HDMI

DVI 2

NOTE! These
connectors are
not supported

Figure 2-4. Connectors that are not supported.

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 To get the best image quality possible, connect your monitor or other video
image quality 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 DVI – digital output that 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

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 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.

Cable Connectors Adapter bk3000/bk5000

(in order of preference) 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

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.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 21

 Connector name Cable type Type and length
DVI-I Dual link Shielded, 5 m
Audio In Stereo, 3.5 mm jack Shielded, 5 m
Audio Out Stereo, 3.5 mm jack Shielded, 5 m
USB 1 (Engine) USB, 3.0 Shielded, 5 m
USB 2 (Engine) USB, 3.0 Shielded, 5 m
USB 3 (Engine) USB, 2.0 Shielded, 5 m
USB 4 (Engine) USB, 2.0 Shielded, 5 m
USB 5 (Engine) USB, 2.0 Shielded, 5 m
USB 6 (Engine) USB, 2.0 Shielded, 5 m
USB 7 (Neck) USB, 3.0 Shielded, 5 m
USB 8 (Keyboard) USB, 2.0 Shielded, 5 m
10/100/1000 Ethernet Network, CAT6E Shielded, 5 m

Table 2-4. List of cables used in testing for EMC compliance. Note that all connectors not
listed in this table are for service use only.

Do not attach transducers and other accessories unless the user guide for the
transducer or accessory states that it can be used with this system. Attaching other
equipment may cause an increase in electromagnetic emissions or may cause the
system to be more sensitive to electromagnetic interference.

Isolation of DICOM Network

The system must not be galvanically connected to a computer network (DICOM®)
that has not been isolated. If the network is not isolated, the system must be
connected via a network isolator DP0925 .

Wireless Networks
The system can be connected to a wireless network for printing and archiving data.
A Wi-Fi dongle and a 30 cm USB 3.0 extender cable are supplied with the system.
Connect the dongle to the extender cable and insert into one of the USB 3.0
connectors (see Fig 2-3 on page 19).

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.

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 Figure 2-5. Position of the Wi-Fi symbol on the screen.

To connect to a wireless network, click the Wi-Fi logo, choose the appropriate
network, and type in the password.

Figure 2-6. Wi-Fi connection window.

You only have to type in a password the first time you connect to a specific network.
When you turn on the system an attempt is made to reconnect to the network that the
system was connected to before it was turned off.
The bars in the Wi-Fi logo represents the signal strength. The more lit bars in the
Weak vs. logo, the stronger the signal.
strong signal
When the system is not connected to a wireless network, the Wi-Fi logo has a red ‘X’
over it.
No wireless
connection An advanced Wi-Fi setting option is available on the system using Windows
configurations. Always follow the security procedures that have been established for
your hospital, clinic or institution, as well as national guidelines. Contact your BK
service representative for more information.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 23

 Additional characteristics
Frequency band 2.412~2.4835 GHz
Data throughput Max. 150 Mbps
Latency Depends on network setup
Integrity Full integrity of archiving operations
Security characteristics Support for WEP, WPA and WPA2 encryption.
Enterprise encryption (802.1x) requires
assistance from an authorized BK Medical
technician.
Spectrum management None required

Table 2-5. Additional characteristics.

When you transmit data over a wireless network, some special considerations apply.
In particular, the network connections must be set up correctly. See Warning GS-w1
on page 11.
NOTE: The system only supports one network at a time.
If the system loses connection with the network while transmitting (for example,
because it is moved out of range of the network during a transmission), the pending
data is stored temporarily and re-transmitted when the connection is re-established.
For information on saving and printing using the DICOM protocol, see the DICOM
chapter in the Advanced User Guide for the relevant system.

Caution: Wifi-c1
The network must be set up correctly so that data is sent to the correct location. Otherwise
data can be lost or accessed by unauthorized people.

Caution: Wifi-c2
A safe encrypted protocol for data transmission, approved by the hospital, must be used.
This is to prevent unauthorized people from getting access to the data.

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/EIC 60601-1, ANSI/AAMI ES60601-1 or CAN/CSA
C22.2 No. 60601-1.

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 WARNING ME-w2
Printers and An approved printer, specified in the Product Data sheet, can be connected to the internal
auxiliary auxiliary power outlet on the system. Do not use the auxiliary power outlet on this BK system
power outlet for any other equipment.
The auxiliary power outlet is still live even when the ON/standby button on the system is
ON/Standby turned off. To remove voltage from this outlet, you must unplug the power supply cord
button does from the power source.
not turn off
outlet

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.
The system and other equipment must be plugged into an external common isolation
transformer to control the leakage current during a ground connection fault.
If in doubt, contact your BK service representative.

Remote Control
Before you use a wireless remote control with the system, read the remote control
chapter of this user guide.
The remote control uses short wave radio waves to communicate with the system.

WARNING RC-w2
The remote control is active at a distance of at least 10 meters from the system, even if the
system is in a different room.

This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions:
Caution: RC-c1
The remote control can be disrupted by other equipment operating at the same
frequency of 2.5 GHz.

1 This device may not cause harmful interference

2 This device must accept any interference received, including interference that
may cause undesired operation

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 25

 Battery Support System
If you use a battery to supply power to the system, read the battery support chapter
of this user guide.
Also observe the following warning for the battery:

WARNING BS-w6
To ensure proper ventilation and avoid overheating, keep both ends of the battery clear.

Battery When you dispose of the batteries, you must follow national rules. Within the EU,
disposal you must send them to appropriate facilities for recovery and recycling.

Computer Security
When BK systems are connected to a hospital network, BK Medical does not take
any responsibility for computer viruses from the network that may infect the system.

Caution: CS-c1
Check You must perform a virus check on any external storage medium (USB device or DVD)
external to make sure that it is virus-free before you connect it to the system.
media

Printer
Caution: Print-c1
The quality of a printed ultrasound image may vary, depending on the printer.

Service and Repair

WARNING SR-w1
Authorized Service and repair of BK electromedical equipment must be carried out only by the
personnel manufacturer or its authorized representatives. BK Medical reserves the right to disclaim
all responsibility, including but not limited to responsibility for the operating safety,
reliability and performance of equipment serviced or repaired by other parties. After
service or repairs have been carried out, a qualified electrician or hospital technician
should verify the safety of all equipment.

Transducers
WARNING T-w1
Electrical The transducer sockets contain terminals with 3.3V. Do not touch the patient while you
shock are touching an uncovered socket.

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 WARNING T-w2
Type B When using Type B (non-isolated) transducers, carefully check all electrical equipment
transducers within the patient area. Also, consider using additional protective grounding.

WARNING T-w3
Electrical Do not leave transducers in contact with the patient when using HF electrosurgical
burns equipment.

BK Medical transducers fulfill EMC requirements when they are outside as well as
inside the patient’s body.

WARNING T-w4
Surface Do not turn the transducer on and allow it to scan into mid-air without ultrasound gel
temperature applied to the surface of the array. Doing so may cause the surface temperature on the
on array array to heat up to 27 °C above room temperature (measured according to EN 60601–2–
37 [3] (Particular requirements for the safety of ultrasonic medical diagnostic and monitoring
equipment)). To avoid this, freeze the image when the transducer is not used for imaging.

WARNING C-J-w1
Creutzfeldt- Do not use a transducer for neurosurgical applications if the patient is suspected of having
Jakob Creutzfeldt-Jakob disease. If a neurosurgical transducer has been used on a patient
disease suspected of or diagnosed as being Creutzfeldt-Jakob positive, the transducer must be
destroyed, following approved procedures for your hospital.

During an Examination

Checking the Date

Before you start imaging, verify that the date and time displayed on the monitor are
correct.

WARNING Exam-w1
Date An incorrect date or time will make documentation of the image incorrect and may also
cause some calculated values to be incorrect.

WARNING Exam-w2
Patient ID You must enter a new patient ID or check that the system has entered a timestamp before
required you image a new patient. Otherwise, the documentation will not contain the correct
patient identification, and you will not be able to capture images and clips. We
recommend that you enter the complete name of the patient.

WARNING Exam-w3
Verify Verify that the patient name and ID are correct.
patient ID

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 27

 Verifying the Transducer Type

WARNING Exam-w4
Type Before you start to image, verify that the type number on the transducer matches the
number number displayed on the monitor. In case of any inconsistency, stop imaging, turn off the
displayed system, and contact your BK service representative.
must match
number on
transducer

Measurements
Pay careful attention when you position cursors to make measurements on a scanned
image or on a Doppler curve.

WARNING M-w1
Polygon To prevent wrongful diagnosis, you must be aware that:
measuring • When you use the polygon measuring tool, if the sides of the polygon intersect
tool (as in forming a curve like a figure eight, for example), the area calculation is
incorrect. In this case, the calculated area of the polygon is the area of the bigger
loop minus the area of the smaller loop.

WARNING M-w2
Using Drawings of Doppler curves, manual and automatic, are meant as tools for positioning
Doppler cursors so that measurements based on the curves can be calculated automatically. The
curves system has no facilities for checking whether the automatic measurements are
reasonable. Curves drawn on very noisy spectra may lead to misplacement of
measurement cursors. Make sure that measurement cursors are positioned so that the
results are reasonable. If they are not, you must adjust the position of the cursors manually.

Nuchal Translucency

Caution NT-c1
Nuchal You must be adequately trained before you attempt to make nuchal translucency
translucency measurements.

Contrast Imaging

Caution Exam-c6
When you turn on Bubble Burst, the acoustic output limits are increased to 1.9 (MI).
This change overrides any limits you have set. During Bubble Burst, the acoustic
output will exceed normal contrast imaging values and may approach the higher
(Bubble Burst) limits.

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 VFI - Vector Flow Imaging

WARNING VFI-w1
Artifacts Before you turn on VFI, check the B-mode image to make sure there are no artifacts visible
in the blood vessel. If there are strong artifacts in the B-mode image, the arrows in VFI may
be pulled to point in a more axial direction (toward or away from the transducer),
especially in low flow situations with correspondingly low PRF. These artifacts will not
affect the color mode (CFM) image, so it is important to check in B-mode.

WARNING VFI-w2
Arrow Check to make sure the VFI arrows are not aliasing before you activate the assisted
aliasing Doppler gate placement. Otherwise, the Doppler gate will not be positioned correctly.

WARNING VFI-w3
Diameter Check to make sure that the diameter markers correspond to the inner vessel wall and that
markers the connecting line between the markers is perpendicular to the direction of the vessel.
Otherwise, the real-time volume flow measurement may not be precise.

WARNING VFI-w4
Doppler gate Check to make sure that the Doppler gate covers the entire vessel. Otherwise, the real-
large time volume flow measurement may not be precise.
enough

WARNING VFI-w5
Doppler gate Check to make sure that the Doppler gate only covers one vessel. Otherwise, the real-time
over only volume flow measurement may not be precise.
one vessel

WARNING VFI-w6
Doppler Check to make sure that the Doppler spectrum does not alias. Otherwise, the real-time
spectrum volume flow measurement may not be precise.
aliasing

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 29

 Puncture and Brachytherapy

WARNING P-w1
Verify Before you start imaging, verify that the type number or name of the transducer and the
transducer type number or description of the puncture attachment you are using match the number
type number displayed on the monitor. Also make sure that the needle guide is positioned correctly. If
the numbers do not match, or if the needle guide position is not correct, the puncture line
on the monitor may not correspond to the true puncture path in the tissue. In case of any
inconsistency, stop imaging, turn off the system, and contact your BK service
representative.

WARNING P-w2
Verify Verify that the type number of the puncture guide displayed on the monitor corresponds
puncture to the puncture guide that you are actually using. If the number is incorrect, the puncture
guide type line on the monitor may not correspond to the true puncture path in the tissue.
number

WARNING P-w4
Watch the The puncture line on the image is an indication of the expected needle path. To avoid
needle tip harming the patient, the needle tip echo should be monitored at all times so any deviation
from the desired path can be corrected.

NOTE: If the image depth is set very low (to see tissue close to the transducer with
high magnification), the needle tip echo can be outside the displayed image area. To
see the needle tip in this case, zoom out so the full needle path is visible or pan the
image to the side (to keep the high magnification).

WARNING P-w3
Offset Changes you make to the offset of a programmable puncture guide or brachy matrix will
changes affect ALL programmable puncture guides and brachy matrixes. This could lead to
incorrect puncture lines or matrix positions for a different guide than the one you wanted
to change.

Brachytherapy and Prostate Transperineal Biopsy

WARNING B-w1
Verify matrix Verify that the matrix type and coordinates displayed on the monitor agree with the actual
type and matrix template you are using.
coordinates

WARNING B-w2
Verify user- If you create a user-defined matrix, it is your responsibility to verify that the matrix that
defined appears on the monitor corresponds to the physical matrix you are using.
matrix

30 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 WARNING B-w3
Verify matrix Before you use the matrix for seed implantation or biopsy, check the matrix offset value to
alignment verify that it corresponds with the chosen matrix. Then check the matrix alignment.

WARNING B-w4
To avoid harming the patient, check the needle alignment (and recalibrate if necessary)
before each use.

bkFusion

WARNING F-w1
High Do not operate bkFusion hardware if you or the patient have an implanted pacemaker or
magnetic cardioverter defibrillator. The high magnetic field generated by the EM Transmitter can
field cause implanted heart pacemakers and cardioverter defibrillators to cease operation.

WARNING F-w2
Patient Maintain a distance of at least 18cm between the patient and the EM transmitter for
distance Fusion (International Commission on Non-Ionizing Radiation Protection guidelines). The
from EM Transmitter radiates a low-frequency magnetic field (modulated 80 Hz). Magnetic
Transmitter radiation at 18cm is <100 uT. The 50/60 Hz radiation from the mains power system is
typically 10-100 uT.

Caution F-c1
With Fusion sensor mounted, the transducer only complies with type B requirements of
IEC 60601-1

bkFusion Articulated Arm

Head
Component

Central Anterior
Clamp Segment

NOTE: The fixation of the articulated arm is based on the principle of friction.
Changing the position without loosening the clamping mechanism can cause damage
and will shorten the lifespan of the articulated arm. The articulated arm can be
adjusted with little force. Turn the central clamp in a clockwise direction to tighten
the arm and anti-clockwise to loosen the arm.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 31

 WARNING MS-w5
Accidental The articulated arm can move unintentionally if the central clamp is released.
clamp Always hold the head component on the anterior segment with one hand and manipulate
release the central clamp with your other hand.

WARNING Check-w1
Do not use To ensure safe operation, do not use the equipment if you find any signs of damage.
damaged Contact your BK service representative.
equipment
If a transducer is dropped, and even if it shows no visible signs of damage, BK recommends
that a High Voltage test is conducted before the transducer is used again.

WARNING MS-w2
All parts When parts of the equipment can be mounted individually (for example, for use in an
must be operating room) each part must be securely mounted to a stable support so that it does
stable not tip, fall or come loose and injure someone.

3D
Pay particular care to the following safety issues when operating the 3D system.

WARNING 3D-w1
3D Measurements obtained with the 3D system and used in diagnosis must be carefully and
measure- thoughtfully performed to ensure accurate quantitative assessment. Before you perform
ments a calculation, make sure that all necessary calibrations and measurements are made.
If you suspect that the 3D system’s calibration is inaccurate (that is, the measurements are
not as expected), contact your BK service representative to check and confirm the system’s
proper operation.

WARNING 3D-w2
Untracked You cannot make accurate measurements on a 3D data set acquired using the untracked
freehand freehand method.

If you start to make a measurement on a 3D data set acquired using the untracked
freehand method, the following warning appears on the monitor:

Warning on Symbol Description

monitor
Measurement will not be accurate.

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 Picture in Picture

WARNING PIP-w1
PiP must not When you use Picture in Picture, do not cover critical information (such as TI or MI) on the
cover monitor. Make sure that all important information will appear if you print or save the
important ultrasound image.
information

Acoustic Output

General
Medical research has yet to prove whether or not ultrasound causes biological
effects. Therefore, prudent use considerations require you to follow certain
guidelines; see EN60601-2-37 (Particular requirements for the safety of ultrasonic
medical diagnostic and monitoring equipment).

Prudent Use

WARNING AO-w1
Exposure To avoid tissue damage, always keep the exposure level (the acoustic output level and the
level exposure time) as low as possible.

• Image patients only when clinical reasons make it necessary.

• Keep exposure time as short as possible.
• Be careful to prepare the patient correctly so that you get the best possible
image.
• Start imaging at a low acoustic output level (see “Thermal and Mechanical
Indices” on page 34) and increase the level only as much as necessary to obtain
a satisfactory image.
• If you switch from an application requiring high acoustic output levels (see
“Functions Affecting Acoustic Output” on page 35), 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 to monitor the TI in bone rather than in
soft tissue because the ribs will be subjected to ultrasound.

WARNING AO-w2
Appropriate To avoid tissue damage, always use the transducer best suited to the examination.
transducer

Acoustic output data for transducers used with the system are given in the Technical
Data (BZ2100) that accompanies this user guide. The uncertainty level for each
parameter is also listed. For definitions of the parameters, refer to the Food and Drug

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 33

 Administration (FDA) Guide as well as EN 60601-2-37 (Particular requirements for
the safety of ultrasonic medical diagnostic and monitoring equipment) and
AIUM/NEMA standards.
The routes (or tracks) available for clearance by the FDA are well-defined. Track 3
is for diagnostic ultrasound systems that follow the Output Display Standard. Under
Track 3, acoustic output will not be evaluated on an application-specific basis, but
the maximum derated Spatial Peak–Temporal Average Intensity (ISPTA) must be
720mW/cm 2, the maximum Mechanical Index (MI) must be  1.9, and the
maximum Thermal Index (TI) must be  6. All BK Medical transducers for use with
bk3000 and bk5000 are Track 3.

Monitor Display
The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging
modes.

Thermal and Mechanical Indices

The MI and TI indices are intended to allow users to implement the ALARA (As
Low As Reasonably Achievable) principle using an indicator related to a potential
bioeffect.
The full details of the indices are given in references EN60601-2-37 and
AIUM/NEMA standard, but the formulas are given below.

MI Formula
P r0,3  z sp 
MI = ------------------------
fc
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 frequency (in MHz)

TI Formula
W0
TI = ------------
-
W deg
where the variables are defined in the table below.

Variable Definition
W0 time-averaged acoustic power of the source or other power parameter (W)
Wdeg estimated power necessary to raise the temperature of the target tissue one
degree Celsius (W/°C)

34 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 Blood As a rule of thumb, the Thermal Index (TI) indicates the highest expected
perfusion and temperature increase in degrees Celsius. It is based on an average level of blood
TI
perfusion. The displayed TI may underestimate the temperature rise in poorly
perfused tissues; you must take this into account when deciding on the maximum TI
you will allow. Conversely, in areas with a rich perfusion of blood the temperature
increase will be less than the displayed TI indicates.
Fever A temperature increase of one degree Celsius increase in a patient with fever may
cause complications in certain circumstances; it may be safer to delay the
investigation.

Acoustic Output Measurement

All values are measured in water according to the EN 60601-2-37 and AIUM/NEMA
display standards. For some of the acoustic parameters, an estimated in situ derated
value is given. This is derived assuming a tissue attenuation of 0.3 dB/(cm·MHz)
when the estimated in situ derated value (I) is described by the following equation:
I formula I = I w exp  – 0,069fz 

where the variables are defined in the table below.

Variable Definition
IW Intensity in water at the position where I is maximum
f transducer frequency (in MHz)
z distance (in cm) from the transducer face to the position where I is maximum

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
possibilities of adverse effects.
Fetal imaging Current scientific and clinical concern over possible adverse effects is particularly
focused on fetal ultrasound imaging. It is due to the increased sensitivity of
mammalian cells and organs at this phase of their development and the fact that such
a risk could have profound implications on public health. If you use high acoustic
output levels for some reason (see “Functions Affecting Acoustic Output”, below),
be sure to return to B-mode alone and turn down the power level before you do any
fetal imaging.

Functions Affecting Acoustic Output

The system has a control function that ensures that neither the ISPTA nor MI nor TI
value exceeds the maximum allowable value. When necessary, the system will
reduce the output voltage and/or PRF (pulse repetition frequency) to the transducer
to comply with requirements.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 35

 Some of the system functions can affect the acoustic output, as listed here.
(Instructions for using these functions are given in the relevant sections of this user
guide.)
• Sizing functions such as ROI (region of interest) – in general, smaller size
results in higher acoustic intensity because the pulse repetition frequency (PRF)
is higher or the ultrasound beam is more strongly focused.
• Focus – in general, strongly focusing the beam makes the acoustic intensity
higher.
• Frame rate – higher frame rate results in higher acoustic intensity.
• Range – increasing the Doppler range increases the acoustic intensity by
increasing the PRF.
• CFM Resolution – higher resolution increases the acoustic output.
• Color box size – narrowing the color box generally increases 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 transducer are
listed in the Technical Data (BZ2100).
These setups have been optimized to give the best compromise between low acoustic
output and enough power to obtain the image features as quickly as possible. The
factory default setup for all transducers is B-Mode to ensure the lowest acoustic
output when you start imaging.
When you enter a new patient ID, by default the transducer setup will be reset to the
factory setup.
Fetal imaging When you use transducers intended for fetal imaging, it is important to make sure
that the default settings are appropriate and to reset to the default setting before
imaging a new patient.

Clinical Measurements: Ranges and Accuracies

This section states the accuracies for measurements made using the BK Medical
range of ultrasound systems. A table containing accuracies for specific transducers
can be found in the Technical Data (BZ2100) that accompanies this user guide.

36 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 The measurement accuracies are based on the assumption of “ideal” tissue, that is, a
tissue characterized by a sound velocity of 1540 m/s. When making clinical
measurements with ultrasound, errors may arise which are not taken into account in
this section. For example,
• The sound velocity may vary from approximately 1450 m/s in fatty tissue to
1585 m/s in muscle. This can, in simple cases, give rise to errors of up to 6% for
linear measurements. This inaccuracy may be further increased by refraction
occurring at tissue boundaries.
• The user can introduce errors when using approximate formulas, when
positioning the system’s calipers with respect to the ultrasound image and when
outlining structures in the image.
• The ellipsoid volume approximation, described in this user guide, is only
applicable when the cross section of the structure being studied approximates 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 non-convex outline, an inaccuracy is introduced which is
not taken into account in this section. In this case, the system calculates and displays
the convex hull of the figure, that is, the smallest convex figure containing the non-
convex figure outlined by the user (see Fig 2-7). The system bases the calculation of
the ellipsoid volume on the convex hull.

Figure 2-7. The dotted line indicates the convex hull of the non-convex figure.

Measuring volume using a stepping method produces an approximation caused by

the finite number of steps in the measurement. The user must always try to assess
how large an inaccuracy is introduced by the selected step size, that is, the distance
between organ cross sections.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 37

 Geometric Measurements

2D Measurements
The geometric measurements performed by BK Medical ultrasound systems are
distance, perimeter, area and ellipsoid volume. The accuracy of these measurements
is influenced by the following factors:
• Transducer geometry
• Rounding of results
• Resolution of digital image memory

3D Measurements
The 3D volume is found by summing the marked area in the individual slices and
multiplying by a factor that includes the distance between the slices and their relative
orientation.
To obtain the accuracies listed in the table in the Technical Data (BZ2100), you must
ensure that the calculation is based on contributions from at least 10 slices for very
regular shapes and more for irregular shapes. It must also be possible to discriminate
the boundary of the object from the surrounding tissue.
Volume The volume accuracy in the table is given as a percentage of the captured 3D volume
accuracy starting with the first slice and ending with the last slice that intersects the object of
interest.
If the 2D ROI (region of interest) is set to be much larger than the object, the accuracy
as a percentage of the object volume can be much worse (higher percent).
NOTE: To ensure that the accuracy of your volume measurement is as high as
possible, make sure that the object you are interested in fills the region of interest as
much as possible.
Distance and The accuracy of a distance measurement on a 3D image will never be better than 6%;
area accuracy the accuracy of an area measurement on a 3D image will never be better than 6%.
In the table in the Technical Data (BZ2100), the overall measurement accuracy for a
full range measurement is given in the right-hand column for each measurement. The
footnote below the table states the digital image resolution.

Time Measurements
In M-mode and spectral Doppler mode, data is displayed along a time axis. It is
possible to measure time differences. The accuracy for a time difference
measurement is
• Rounded to the nearest: 0.01s
• Accuracy: 0.01 x t
where t is the full time scale of the image field.

38 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 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 vector of the blood cells. The
velocity accuracies given in the Technical Data (BZ2100) are valid for  = 55. To
find the percentage accuracy for other angles, multiply the stated accuracy by
cos  – cos   + 1,8  
 ------------------------------------------------  100 + 0,5
 cos  

If the blood velocity exceeds the selected velocity range, aliasing occurs,
corresponding to an overload condition of the measurement system.

bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information 39

40 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
 Chapter 3
Battery Support

This chapter is only relevant if your system has battery support.

The battery enables you to operate the system while it is not connected to an external
electrical supply.

Before You Start

Read the battery support warning in “Battery Support System” on page 26. Also read
the rest of this chapter before you use the battery support system.
To setup and customize the battery operation, see the Advanced User Guide relevant
for your system.

Imaging with Battery Support

This is an overview of the steps for using the battery support system to power the
imaging system.
1 Make sure the battery is charged.
(If not, plug in the imaging system to use it or to charge the battery.)
2 Turn on the system.
3 When the battery is empty, you do not have to turn off the imaging system. Plug
it into a power outlet to recharge the battery while you run on power from the
normal power supply.

Battery Location
The battery is located in the battery compartment on the wheel base of the system.

Battery compartment

Figure 3-1. Battery in the wheel base.

bk3000 & bk5000 User Guide (16-01249-EN-08) Battery Support 41

 Power Supply

Plugging in the System

On systems with a battery, the power supply cord plugs into the battery compartment.

Charging the Battery

The battery automatically begins charging when the system is plugged into the power
outlet.
There is a battery charge display on the battery compartment. The battery will be
fully charged after approximately 4 hours.

May need to If the Battery Appears Not to Charge to 100%

discharge
and recharge After repeated use, the battery may require a full discharge, full charge, and full
fully discharge in order to recalibrate the electronic fuel gauge so that the indication of
how much charge is left in the battery is accurate.

Battery Status
While the system is operating, battery status is visible both on the monitor (in the
bottom right-hand corner) and on the display on the battery compartment.
• When the system is plugged into a power outlet, battery status is shown as
percent (%) of capacity remaining.
• When the system is running on the battery, battery status is shown as time
remaining in “hours:minutes”.
NOTE: The time displayed is an estimate based on typical use; for continuous
imaging, the actual time available will be less than indicated on the display.

Information Available on the Monitor

The battery status indicator appears in the bottom right-hand corner of the monitor.

Figure 3-2. Battery level shown as % or as time available.

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 26.
Low Battery
When battery capacity is very low,
• A message appears on the monitor
• The on-screen battery indicator turns red
• The display on the battery compartment blinks regularly

42 Chapter 3 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 Figure 3-3. Low battery message.

The low-battery message informs you that the battery level is low and that the system
will shut down when the system monitor clock matches the time stamp in the
message (shown here as 13:18:58).
The display on the battery compartment begins to blink regularly when the low
battery threshold is met, and it continues to blink even after the critical low battery
threshold is met and the system has shut down.

Caution BS-c1
If the battery reaches the auto-shutdown level, plug in the system and keep it
plugged in until the battery recharges to at least 10 %.

To set the level for the low battery message, see the Battery Support Setup section
in the Advanced User Guide relevant for your system.

Critical Low Battery

The setting for critical low battery is set to 3 minutes by default. When the battery
reaches the critical level, the system shuts down immediately.
To set the level for the critical low battery message, see the Battery Support Setup
section in the Advanced User Guide relevant for your system.
When the system is plugged in, the display on the battery compartment is lit.

Caution BS-c2
Never shut down a system with a battery module simply by unplugging it from the
wall. To preserve battery power, shut down the system properly.

Power Save Mode

Power save With power save mode, you can conserve battery power and reduce energy
mode consumption when the system is not in active use. A message appears on the monitor
to notify you when the system is about to go into power save mode.

bk3000 & bk5000 User Guide (16-01249-EN-08) Battery Support 43

 Figure 3-4. Power save message.

To exit power save mode and restore the system to normal power, you can do one of
the following:
• Press a key on the keyboard
• Press the transducer button
• Move the trackball
To enable and configure power save mode, see the Battery Support Setup section
in the Advanced User Guide relevant for your system.

Battery Life
Typical vs. With typical use (which includes imaging and freezing), a fully charged battery
continuous provides approximately 2 hours of operation. With a fully charged battery pack, you
use
can scan continuously for approximately 1 hour 20 minutes.
Battery When a battery reaches the end of its lifespan, the replace battery message appears
lifespan on the monitor at start-up.
On average, a battery will need to be replaced after approximately 300 recharge and
discharge cycles – the battery lifespan. Contact you BK Service technician for
replacement of batteries.
For information about the disposal of depleted batteries, see page 26.

Battery Support Setup

To customize the operation of the battery, see the Battery Support Setup section in
the Advanced User Guide relevant for your system.

Cleaning and Disinfection

The cleaning and disinfection instructions for the system in Care and Cleaning apply
to the battery compartment.

44 Chapter 3 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 Chapter 4
Remote Control

A wireless remote control is available for use with the bk5000 system. It uses
Bluetooth to communicate with the system and control many of its functions.

The Remote Control and Its Functions

Battery cap

Blue diode. Blinks to show Battery level. Blinks to warn that

remote control is awake batteries must be replaced soon
Change exam type (list Capture an image to the
will appear on monitor) system hard disk or print it.
(User-definable)

Select Start/Stop imaging

Adjust value or size of zoom

box, etc. Holding down the
key repeats the action
In B-mode, adjust Depth. If Adjust gain for one mode only,
Doppler is on, adjust Doppler the first in this list that is active:
PRF. If Color is on but not Doppler, Color, Power, B-mode
Doppler, adjust Color PRF

Toggle imaging modes:

Start a default measurement B > Color > Doppler > B ...
(User-definable) (User-definable)
User-defined Optimize image and Doppler
settings

Hold down P and AUTO for

three seconds when pairing
with the system

Figure 4-1. The remote control, with the location of its various functions.

Pairing the Remote Control with the System

1 Plug the Mini Bluetooth Adapter into a USB connector on the system (using the
adapter that came with the remote control) and restart the system.
2 Press any key on the remote control to wake it up.
3 Hold down the P and AUTO keys on the remote control for three seconds.
The remote control emits two beeps.
4 Release the keys after the second beep.
The blue diode starts blinking rapidly.
A dialog box appears on the monitor. This may take up to two minutes.

bk3000 & bk5000 User Guide (16-01249-EN-08) Remote Control 45

 5 Click Accept to pair the system with the remote control (indicated by its serial
no.).
The pairing process takes up to one minute.
When pairing is done, the remote control emits a beep and the blue diode blinks
to show the remote control is awake.
NOTE: The pairing process may time out. Try again if this happens.
A remote control will remain paired to a specific system, even when the remote
control is removed for disinfection/reprocessing. If you have more than one
remote control, make sure you know the specific system the remote control is
paired with. A remote control will remain paired to a system until it is paired
with another, separate system.

Calibrating the Remote Control

When using the remote control for the first time, the cursor might start drifting on the
monitor. To fix this issue, place the remote control on the tray in front of the
transducer holders and leave it for two minutes to calibrate.
If the remote has been reprocessed or has been shaken so that the cursor starts drifting
on the monitor, it needs recalibration. To recalibrate, repeat the process mentioned
above.
Before use, verify that the remote control is working correctly.

Sleep
If the remote control is not used or moved for 5 minutes, it goes to sleep to save
battery power. To wake it up, press any key.

Mouse Function
You can use the remote control as an air-tracking mouse to operate controls on the
system monitor.
To move the cursor, tilt the remote control; move the front end up, down, or side-to-
side. The mouse will not respond if you keep it level.
NOTE: You do not need to point the remote control at the monitor. The cursor
responds to changes in the position of the remote control.
To select an object on the monitor, move the remote control so that the cursor is on
the object, then press Select.

46 Chapter 4 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 Replacing Batteries
1 Remove the battery cap.
2 Insert two LR6 size AA 1.5 volt batteries.
3 Screw the battery cap on tight until the arrow on the remote
control points to the arrow on the battery cap.
When the battery cap is screwed on tight, the remote control is
watertight and can be immersed.

Cleaning and Disinfection

For details of cleaning and disinfecting the remote control, see Care, Cleaning &
Safety.

WARNING RC-w1
Remote The remote control requires surface disinfection or sterilization as a minimum. The inside
Control battery compartment cannot be classified as disinfected or sterile. Follow procedures
established for your hospital, clinic or institution to avoid cross-contamination when
inserting or removing batteries.

bk3000 & bk5000 User Guide (16-01249-EN-08) Remote Control 47

48 Chapter 4 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
 Chapter 5
Getting Started

Getting Started with bk3000 & bk5000 forms part of this user guide.

bk3000 & bk5000 User Guide (16-01249-EN-08) Getting Started 49

50 Chapter 5 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
Index
Numerics Creutzfeldt-Jakob warning 27
3D
measurements warning 32
D
warning about untracked freehand and measure- DICOM
ments 32 conformance statement 16
connection if network is not isolated 22
A network isolator 22
accuracy standard 16
2D geometric measurements 38 disposing of the system 10
3D distance 38 distorted image 14
3D measurements 38 Doppler measurements
3D volume 38 accuracies 39
clinical measurements explained 36 warnings 28
Doppler measurements 39 Doppler mode
time difference measurements 38 fetal imaging 36
acoustic output
default 36
E
factors affecting 35–36 electrical noise 14
measurement 35 electrical safety 15
ALARA principle 6, 34 electrical shock 13
electromagnetic compatibility. See EMC.
B electromagnetic interference 14
batteries and remote control EMC
battery level 45 attaching cables 21
replacing 47 data in BZ2100 5
battery noise, checking for 14
battery life 44 precautions 14
charging new battery 42 equipment failure 11
disposal 26 ESD
power save mode 43 precautions 14
recycling 26 symbol 10, 14
status 42 training 14
battery and battery compartment essential performance 5
warnings 26 examination, performing basic. See Getting Started.
battery compartment examination, viewing. See Getting Started.
cleaning and disinfection 44 explosion hazards 13
biopsy. See puncture. exposure level 33
brachytherapy extension cord, do not use 15
warning about checking matrix 31
warning about user-defined matrixes 30
F
warning to verify matrix type and coordinates 30 fetal imaging, acoustic output settings for 36
brightness, adjusting monitor. See Getting Started.
H
C height, adjusting. See Getting Started.
caution or warning, symbol 9 HF electrosurgical equipment, warning 27
Cautions
about 9
I
displayed on the system 55 image distortion 11, 14
center frequency 34 indications for use 7
charging battery 42 installation 15
connectors for other equipment intended use 6
accessing 18 isolation from line voltage 12
location 18
consult instructions for use (symbol) 9
K
contraindications 7 keys (basic), overview. See Getting Started.

51
L warning about changing offset of programmable
leakage current 13, 25 puncture guides or brachy matrixes 30
liquids, do not spill on system 12 warning to verify puncture guide number 30
pushing prohibited, symbol 9
M
magnetic shielding 14
R
manufacturer (symbol) 10 radio frequency interference. See RF interference.
measurements, Doppler warnings 28 remote control
MI (Mechanical Index) cleaning and disinfection 47
and AFA 34 keys and indicators 45
formula 34 mouse function 46
Mini Bluetooth Adapter 45 pairing 45
modes of operation 6 replacing batteries 47
monitor brightness, adjusting. See Getting Started. sleep and waking up 46
RF interference 15
N
network
S
guidelines 17 safety
isolator 22 electrical 13, 15
printing, protocols for 17 transducer 26
network security saving to USB. See Getting Started.
guidelines 17 screen controls, basic, overview. See Getting Started.
responsibility for 17 sealing (symbol) 10
noise security, network. See network security.
electrical 14 service and repair 26
EMC 14 Specified Radio Equipment, symbol (Japan) 10
non-medical equipment, connecting to system 25 standby (symbol) 10
standby button. See Getting Started.
O system
on and off, turning system. See Getting Started. isolation from line voltage 12
ON/Standby button malfunction 11
symbol on 10
overbalance and tipping
T
warning 13 Technical Data (BZ2100) 5, 33, 36, 38
warning symbol 9 Thermal Index limit
setting 36
P Thermal Index limit, setting 36
pairing remote control 45 TI (Thermal Index)
patient ID and AFA 34
verifying 27 blood perfusion and 35
Peak Rarefactional Pressure 34 time measurements 38
potential equalization tipping and overbalance
symbol 10 warning 13
terminal 16 warning symbol 9
power cord training before using equipment 11
keep clean and dry 15 transducer sockets, warning about covering 26
original 15 transducer, electrical safety 26
power plug 15 transperineal biopsy
power strip, do not use 13 warning about checking matrix 31
power supply cord warning about user-defined matrixes 30
accidental disconnection 15 warning to verify matrix type and coordinates 30
use original 15 turning system off and on, See Getting Started.
prostate transperineal biopsy Type B (non-isolated) transducers, warning about 27
warning about checking matrix 31 Type B (symbol) 10
warning about user-defined matrixes 30 Type BF (symbol) 10
warning to verify matrix type and coordinates 30 Type BF, defibrillator-proof (symbol) 10
prudent use 33
puncture
U
UL (symbol) 10

52
USB, saving to. See Getting Started. displayed on the system 55
waste disposal symbol 10
V WEEE waste (symbol) 10
VFI (Vector Flow Imaging), warnings about 29 Wi-Fi
viewing an examination. See Getting Started. connecting to 22
virus correct setup and safe protocol required (cautions)
checking external storage media 26 24
from network 26 network characteristics 23
password 23
W signal strength 23
Warnings using 22
about 9 wireless network. See Wi-Fi.

53
54
 Appendix A
Warnings and Cautions Displayed on the System

This appendix contains a list of warnings and cautions that may appear on the system
if you perform an undesirable action or e.g. type in a wrong setting value. Contact a
service technician if you encounter a persistent problem that can not be solved by the
suggested action(s) below.
This list covers all warnings and cautions on systems bk3000, bk3500 and bk5000,
so it may include warnings that are not relevant to your specific system.
The list also covers potential system and transducer malfunctions. Always contact a
service technician if the system or the transducer malfunctions, see Warning GS-w2
on page 11.

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 Try again.
probe.
Failed to read general settings from database. Try again.
Failed to save bodymark catalog. Try again.
Note that changing the time zone requires Restart the system.
restarting the scanner.
Probe prom read failed.
Sensor data from probe is not received.
Scanning is stopped.
The probe could not be connected.
The Probe FW is obsolete.
The read probe prom has a wrong CRC.
The read probe prom was empty.
The system time is invalid and has been
changed to %s %s. The system time can be set
in the setup menu.
The system time %s is invalid and setting it to
%s failed. The system time can be set in the
setup menu.
Parking of the transducer %s failed. Try again.

bk3000 & bk5000 User Guide (16-01249-EN-08) 55

 Caution text Action (if necessary)
%d text(s) has been truncated to %d
characters.
"%s" is not a unique name. Type in a unique name.
"%s" is not a valid number. Type in a valid number.
A 3D volume was not acquired because no
mover is connected. Please connect a mover.
A 3D volume was not acquired because the Make sure that connected mover matches the
connected mover does not match the selected mover.
selected mover. The connected mover is %s
and the selected mover is %s. \n
A curve cannot have itself as parent curve.
A formula in the measurement contains an Use valid device attribute.
invalid device attribute "%s.%s".
A formula in the measurement contains an Use valid result name.
invalid result name "%s".
A formula in the measurement contains an Use a defined measurement tool.
undefined measurement tool "%s".
A measurement cannot depend on itself.
Adjusting the guide's height.
Adjusting the guide's width.
All available pro packs for %s has been hidden
An error occurred while the patient archiving Try again.
database was being copied.
Another scanner is using this network drive
for archiving. This can cause problems. For
independent backups, each scanner must use
a separate subdirectory.
Changes not in effect until transducer(s) has
been reconnected.
Click Yes to clear the patient archive. All
patients in the patient archive will be lost.
Click No to cancel.
Could not create temporary subdirectory for Try again.
outgoing mail data.
Curve name, x-axis and y-axis are required. Do Fill out required fields.
not leave the fields empty.
Default LCD backlight has not been adjusted. Adjust default LCD backlight.

56 Appendix A March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

 Caution text Action (if necessary)
Empty volume name is not allowed. Type in volume name.
Engine configuration validation failed. One or
more Engine item versions are not valid.
Error opening database %s. %s
Error. The file did not contain a user-defined Include user-defined puncture guide.
puncture guide.
Failed to acquire 3D volume. %s
Failed to calculate expression "%s": %s. Try again.
Failed to calculate measurement. Syntax error Check formula.
in formula.
Failed to clear patient archive. Please contact
a service technician.
Failed to clear the patient dialog cache.\n%s
Failed to 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 server. Try again.
Failed to export table "%s". %s Try again.
Failed to import license keys from ""%s"". It is
not a valid license file.
Failed to import table "%s".\n%s Try again.
Failed to open file "%s". \n%s Try again.
Failed to process 3D volume.
Failed to read catalog from database. Try again.
Failed to read deleted Presets. Try again.
Failed to read key action definitions from Try again.
database.

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 Caution text Action (if necessary)
Failed to read key assignments from Try again.
database.
Failed to read key definitions from database. Try again.
Failed to read measurement list from Try again.
database.
Failed to restore factory default catalogs in Try again.
database.
Failed to restore factory default general Try again.
settings.
Failed to restore factory default measurement Try again.
groups.
Failed to save 3D volume.
Failed to save configuration "%s" in database. Try again.
Failed to save measurement in database. Try again.
Failed to send SMTP message (%s). Try again.
Failed to store catalog in database. Try again.
Failed to store clip in file. Try again.
Failed to store curve in database. Try again.
Failed to store general settings in the Try again.
database.
Failed to store key assignments in database. Try again.
Failed to store the curve "%s". Two curves Use a different reference name to store the
cannot have the same Reference Name, and curve.
the imported curve's Reference Name "%s" is
already used for the curve "%s".
Failed to update Pro Package: %s. Try again.
Failed to update the ICM file.
Failed to validate database %s. Reverting to
the latest backup from %s.
Hard disk space on %s is critically low. Please
clear some space on the hard disk or contact
a service technician before proceeding.
Hard disk space on %s is getting low. Free up hard disk space.
Import of license keys from "%s" completed. Try again.
The following license keys could not be
imported: %s

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 Caution text Action (if necessary)
Incorrect settings for HistoScanning
acquisition. Data will be rejected by
HistoScanning. Please adjust the scanner
settings.
Invalid %s. Empty names are not allowed. Fill out the required fields according to the on
Names must be shorter than %d characters. screen instructions.
Names must not contain any of the following
characters: %s
License already in use.
License key ""%s"" is invalid.
Licenses missing: No available pro packs for
%s has valid licenses
Login error. Please try again.
Name and description are required. Do not Fill in name and description.
leave the fields empty.
Name and formula are required. Do not leave Fill in name and formula.
the fields empty.
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 Specify a preset name.
be saved.
One or more batteries are wearing out.
Consider replacing the following batteries: %s
(where 1 is the top battery).
Only %d fields can be selected for the Patient
window. Deselect some of the fields.
Please disconnect all transducers, restart the
scanner, and start the import again.
Please enter a number
Please enter an SMTP Server Address. It must
be entered as a name or an IP address.
Please insert the archive disc labeled "%s" and
try again.
Pro Package %s could not be deleted because
it would leave some transducers without a
Pro Package.

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 Caution text Action (if necessary)
Staging area is not ready. Try again later.
System restarts now.
The '%s' curve could not be found in the Try again.
database.
The 3D volume is too big for the scanner
memory. Please reduce the capture area or
extent and try again.
The AE title is invalid.
The alias "%s" for the measurement "%s" is Fill out the required fields according to the on
invalid. 1: Aliases cannot be empty. 2: Aliases screen instructions.
must not contain any of the following
characters: %s . 3: Aliases in each
measurement must be unique.
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 Upgrade software.
this software version.
The curve definition must contain x and y
values.
The Display Controller Board has no ICM file.
The document cannot be displayed because Contact BK service technician.
document data is corrupted
The document cannot be displayed. Try again.
The document cannot be displayed. Currently Install a viewer.
there is no viewer available.
The entered license key has expired: %s.
The entered license key is invalid. Type in valid license key.
The field must not be empty.
The file \\"%s\\" is too large to open. Max size If possible, reduce the file size.
is %d bytes.
The file does not contain a valid curve. Use valid curve.
The file does not contain a valid Use valid measurement.
measurement.
The file size is too large to display on scanner

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 Caution text Action (if necessary)
The following licenses have expired:\n%s. Install new license.
The formula exceeds the maximum length of Reduce length.
%d characters.
The guide's height is invalid. Use valid height setting.
The guide's horizontal holes/cm is invalid. Use valid horizontal holes/cm setting
The guide's horizontal offset is invalid. Use valid horizontal offset setting.
The guide's name is invalid. Use valid guide 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 Contact service technician.
template contains errors.
The measurement contains an invalid Use valid procedure name.
procedure name "%s".
The measurement could not be found in the Try again.
database.
The measurement definition is not Upgrade software.
compatible with this software version.
The measurement requires an unsupported Install supported measurement device type.
measurement device type "%s".
The measurement type is invalid. Use valid measurement type.
The media was not burned: %s
The name ""%s"" is already used.
The name is invalid.
The port number is invalid
The procedure "%s" takes %d parameters.
The report cannot be saved before a patient
ID is entered.
The report file cannot be generated: "%s" Try again.
The same CD cannot contain both archived
and non-archived documents.

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 Caution text Action (if necessary)
The scanner cannot communicate with the
battery system. If you want to run the scanner
using battery power, we recommend that you
contact a service technician.
The scanner is ready to enter service mode.
The next time it starts, the PC will start in
Windows mode. Please press the standby
switch to turn off the scanner.
The scanner is unable to communicate with Use appropriate communication port(s). See
other equipment through a COM port. %s System User Guides or 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 stuck on the
transducer connected to connector %s.
The two passwords you have typed are not
identical.
The USB Device cannot be safely removed. Try
again.
The user already exists. Enter a different
username.
The value "%s" (%s) contains the invalid Type in valid characters.
character(s) "%s".
The value "%s" (%s) is outside the legal range Keep value (s) within legal range.
(%.2f - %.2f).
The volume name is already used in the
patient archiving system. Please enter
another name.
The volume name is not valid. It contains only
illegal character(s). Please enter the new
volume name.
The volume name is too long. The name must
be no longer than %d characters.

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 Caution text Action (if necessary)
The width and height must be numbers
between %d and %d.
There are no files to be burned to a CD.
There is no mail receiver (SMTP To-address)
configured.\nTechnical service must
configure this service before it can be used.
There is no USB Device connected to the
scanner.
There was a problem saving the Diagnostic Try again.
Setup %s.
This scanner does not support CW Doppler. Try again or contact BK service technician.
(This may be because of the power supply
version.)
Transducer "%s" cannot be used with this Connect a compatible transducer. See
scanner. Product Data Sheet for more details.
Transducer "%s" cannot be used with this Connect a compatible transducer. See
scanner. A hardware upgrade may solve the Product Data Sheet for more details.
problem.
Transducer ""%s"" is disabled for this scanner.
Unable to capture image. Try again.
Unable to connect remote control.
Unable to connect to the network drive.
Check server (UNC path), username and
password.
Unable to connect to the network drive. %s
Unable to create backup of database because
of %s. If the error persists, contact a service
technician.
Unable to launch application ("%s") Try again.
You must end the on-going exam before you
can clear the patient archive.
You must restart the scanner after you enable
or disable the OEM interface.
Your old password is not valid. Create new password.

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64 Appendix A March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)