Flex Focus Type 1202 Users Guide Jan 2010

WORLD HEADQUARTERS Mileparken 34 DK-2730 Herlev Denmark Tel.:+45 44528100 / Fax:+45 44528199 www.bkmed.com Email: [email protected] If you have comments about the user documentation, please write to us at the email address above. We would like to hear from you. BK Medical Customer Satisfaction Input from our customers helps us improve our products and services. As part of our customer satisfaction program, we contact a sample of our customers a few months after they receive their orders. If you receive an email message from us asking for your feedback, we hope you will be willing to answer some questions about your experience buying and using our products. Your opinions are important to us. You are of course always welcome to contact us via your BK Medical representative or by contacting us directly.

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Scanner 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 XP Embedded is of US-origin. You agree to comply with all applicable international and national laws that apply to Windows XP Embedded, including the U.S. Export Administration Regulations, as well as end-user, enduse and country destination restrictions issued by U.S. and other governments. For additional information on exporting Windows XP Embedded, see http://www.microsoft.com/exporting/ The Flex Focus 1202 Ultrasound Scanner 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 Flex Focus 1202 system.

Trademarks: Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries. FireWire is a trademark of Apple Computer, Inc. © 2010 BK Medical Information in this document may be subject to change without notice.

Contents Chapter 1

General Information... 5

Chapter 2

Safety Information... 7 Safety Information... 7 Safety Symbols on the Scanner... 7 CE Marks on Electrical Devices... 8 General Safety Precautions... 8 Mechanical Safety... 9 Explosion Hazards... 10 Electrical Safety... 10 ESD Training... 11 Interference... 11 Electrical Noise... 11 Electromagnetic Interference... 12 RF (Radio Frequency) Interference... 12 Installation... 13 Connecting Other Equipment... 14 Connectors... 14 EMC Requirements... 17 Network Connection... 17 Medical Equipment... 18 Non-Medical Equipment... 19 Using the Scanner with a Lithotriptor... 19 Computer Security... 20 Service and Repair... 20 Transducers... 20 During an Examination... 21 Checking the Date... 21 Verifying the Transducer Type... 21 Measurements... 21 Puncture and Brachytherapy... 22 3D... 23 Acoustic Output... 23 General... 23 Monitor Display... 24 Thermal and Mechanical Indices... 25 Acoustic Output Measurement... 26 Functions Affecting Acoustic Output... 26 Default Acoustic Output... 27 Clinical Measurements: Ranges and Accuracies... 27 Geometric Measurements... 29

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Time Measurements... 29 Doppler Measurements... 30 References... 30 Chapter 3

Getting Started... 33

Chapter 4

Specifications and Indications for Use... 35 Indications for Use... 35 Contraindications... 35

Index... 37

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Chapter 1 General Information This user guide is for all versions of the Flex Focus 1202 Ultrasound Scanner from BK Medical, including the Flex Focus and the Flex Focus Solo. Intended use

The scanner is a 2D and 3D ultrasound echo and flow imaging system for diagnosis, data processing and transfer and guidance of puncture and biopsy. NOTE: Some of the functionality and options described in this guide may not be

available with your version of the scanner. Before using the scanner, make yourself familiar with the information in the accompanying user information documents. Make sure that you also read the transducer user guide and specifications for each transducer that you use. Improper use

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

Information

Scanner User Guide

Introductory information, safety information, getting started.

Getting Started

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

Scanner Advanced User Guide

Information about advanced functions, glossary.

Product Data sheet for scanner

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

Technical Data CD

Acoustic output data and data about EMC (electromagnetic compatibility) for all transducers

Care, Cleaning and Safety Cleaning, disinfection, sterilization, checking, storing and disposing of BK Medical equipment. Includes environmental limits. Transducer User Guide

Specific instructions for using the transducer and puncture attachments

Product Data sheet for each transducer

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

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

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General Information

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Chapter 2 Safety Information The scanner can be used for continuous operation, but scanning duration for individual patients must not exceed 60 minutes. We recommend, however, that you turn off the scanner 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 scanner. 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 on the Scanner Table 2-1 contains brief explanations of the symbols used to label the scanner. (Some labels in the table may appear on the transducer rather than the scanner itself.) 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.

Potential Equalization

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

Ground (earth)

Additional protective ground (earth). BF: Isolated from ground. Maximum patient leakage current under

Type BF

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Normal condition ≤100μA

•

Single-fault condition ≤500μA

Table 2-1. Symbols on the scanner.

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Symbol

Name

Description

Type BF

BF, defibrillator-proof B: Maximum patient leakage current under

Type B

•

Normal condition ≤100μA

•

Single-fault condition ≤500μA

Sealing

Dust- and immersion-protected according to EN 60529 [1].

Standby

Standby switch on back of scanner unit– used to turn scanner on and off.

Not watertight

Plug may not be immersed (unless it is covered with a special watertight plug cover).

ESD (electrostatic discharge)

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

WEEE waste

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

Table 2-1. Symbols on the scanner. (continued)

CE Marks on Electrical Devices The European Union has introduced directives requiring b marks on devices. Non-medical devices marked with b comply with relevant directives, for example EEC Council Directive 89/336/EEC of 3 May 1989 concerning Electromagnetic Compatibility. BK Medical devices marked with b or c comply with EEC Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices. b applies to Class I medical devices. c applies to Classes Im, IIa, IIb and III. BK Medical defines classes assuming scanning duration for individual patients does not exceed 60 minutes.

General Safety Precautions The ultrasound scanner is designed and tested in accordance with EN/IEC 60601-1 [2] (Part 1: General requirements for safety) and EN 60601–2–37 [3] (Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment). It complies with requirements for Class 1 (protective earth) devices of EN/IEC 60601-1. It also complies with UL 60601-1 [4] and CSA C22.2 No. 601.1– M90 [5]. It fulfills the requirements for dust protection (IP20) for ordinary equipment specified in EN 60529 [1].

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Physicians only Proper training

Caution: Federal law in North America restricts this device to sale to, or on the order of, a physician. WARNING GS-1 Before you attempt to use BK Medical equipment, you should be trained in ultrasonography or be under the supervision of someone who is trained in ultrasonography. You should also be thoroughly familiar with the safe operation of your ultrasound system: read all the user documentation that accompanies it. No further training is required, but BK Medical offers training in how to use the system. Consult your BK Medical representative for information.

Equipment failure

WARNING GS-2 If at any time the scanner malfunctions, or the image is severely distorted or degraded, or you suspect in any way that the scanner is not functioning correctly:

Isolating the scanner

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Remove all transducers from contact with the patient.

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Turn off the scanner. Unplug the scanner from the power source (wall outlet or UPS (uninterruptible power supply)) and make sure it cannot be used until it has been checked.

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Do not remove the scanner cover.

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Contact your BK Medical representative or hospital technician.

WARNING GS-3 The power supply cord connects the scanner to the line voltage. To isolate the scanner, you must unplug the power supply cord from the power source (wall outlet or UPS). Do this before you try to make any repairs to the system.

Spilled liquids

Caution: Do not spill liquids on the scanner.

Condensation

Caution: Large variations in temperature or humidity may cause water to condense inside the scanner. If this happens, the scanner may fail to operate properly. Always let the scanner come to room temperature before you plug it in. •

Wait at least 2 hours after the scanner has been subjected to major changes in temperature or humidity.

•

If there is visible evidence of condensation, wait at least 8 hours.

Before you use the scanner, 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.

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Mechanical injury

WARNING MS-1 Be careful to avoid the following potential sources of injury:

All parts must be stable

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Parts of the body can be pinched by moveable parts of the scanner, such as the control panel.

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Tilting the scanner can cause it to be unstable and injure someone.

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Do not lean or sit on the control panel or any other part of the scanner. The control panel or monitor can break if subjected to heavy weights or impact.

WARNING MS-2 When parts of the scanner can be mounted individually (for example, for use in an operating room) each part must be securely mounted to a stable support so that it does not tip, fall or come loose and injure someone.

Explosion Hazards Explosion hazards

WARNING EH-1 The ultrasound scanner is not designed to be used in potentially explosive environments. It should not be operated in the presence of flammable liquids or gases, or in oxygen-enriched atmospheres. There is a possible explosion hazard if the scanner is used in the presence of flammable anesthetic. The scanner should be placed at least 25cm (10 inches) from the patient. The ultrasound scanner contains a lithium battery. Never remove or replace this battery. The lithium battery must not be removed except by a BK Medical service representative.

Electrical Safety Do not use a power strip

WARNING ES-1 Do not plug the scanner into an ordinary power strip. If the ground connection fails, this is dangerous because

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the total leakage current for all the connected equipment can exceed the limits specified in EN/IEC 60601-1 [2] (Part 1: General requirements for safety).

•

the impedance of the ground connection could exceed the limits specified in EN/IEC 60601-1.

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Leakage current

WARNING ES-2 When the equipment is used with 230V (and you believe the leakage current would be within the UL limit if you were using 120V), power to the equipment must come from an installation or supply unit with a center-tapped, 240V single-phase circuit. This will make sure that chassis leakage current during single fault condition fulfills the requirements specified in UL60601-1 [4] (limit of 300µA). If power is not supplied in the way specified, the leakage current can be as high as 500µA, the limit specified in EN/IEC 60601-1 [2] (Part 1: General requirements for safety).

Electrical shock

WARNING ES-3 You risk electrical shock if you try to get inside the scanner (other than opening a cover to access connectors described in the user guide). Do not allow anyone but qualified service personnel to service the scanner.

ESD Training 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 warning below. Caution: Do not touch pins in connectors that have this symbol. Do not connect anything to them unless you follow these ESD (electrostatic discharge) precautionary procedures: ESD

•

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 scanner cover.

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You can use a wrist strap connected to the additional protective ground or potential equalization terminal on the scanner if that is more convenient.

Interference The Flex Focus 1202 Ultrasound Scanner is suitable for use in all establishments, other than domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Electrical Noise Electrical noise

WARNING EN-1 Electrical noise from nearby devices such as electrosurgical devices – or from devices that can transmit electrical noise to the AC line – may cause disturbances in ultrasound images. This could increase the risk during diagnostic or interventional procedures.

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Electromagnetic Interference Medical electrical equipment requires special precautions regarding EMC (electromagnetic compatibility) [6]. You must follow the instructions in this chapter when you install the scanner and put it into service. If the image is distorted, it may be necessary to position the scanner further from sources of electromagnetic interference or to install magnetic shielding. Other equipment nearby

WARNING EMC-1 Do not use this equipment adjacent to other equipment. If you must place it next to or stacked with other equipment, verify that it operates normally there and neither causes nor is affected by electromagnetic interference.

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

RF (Radio Frequency) Interference Portable and mobile RF (radio frequency) communication equipment can affect the scanner, but the scanner will remain safe and meet essential performance requirements. An ultrasound scanner 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 picture and cannot be confused with physiological signals. Possible interference sources

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

Use specified equipment only

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

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Installation Installation safety requirements

Original power cords

WARNING I-1 To ensure safe performance, a qualified electrician or hospital safety personnel must verify that the ultrasound scanner is correctly installed and that it complies with the following safety requirements: •

Use only the original power supply cord. In the USA, this is fitted with a hospital grade three-prong grounded power plug. Never try to remove or change the plug on the power supply cord.

•

All equipment must only be connected to a grounded AC power supply (or wall outlet) that meets EN/IEC/NEC requirements or applicable local regulations. The examination room’s grounding system should be checked regularly by a qualified electrician or hospital safety personnel.

•

Never use extension cords. The increased length of the cord will increase the resistance of the protective ground conductor and may increase the equipment’s leakage current beyond an acceptable level.

•

Keep power cords, sockets and plugs clean and dry at all times.

•

Make sure that the power supply cord cannot be accidentally disconnected from the power source or the scanner.

If the original power cords are missing or damaged, you must order new ones from your local BK Medical representative. Additional Protective Ground and Potential Equalization An additional protective ground can be connected to the control panel, see Fig 2-1.

terminal underneath the

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

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

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and additional protective ground

Safety Information

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Connecting Other Equipment Connection guidelines

WARNING C-1 Follow the guidelines in EN60601-1-1[7] (Safety requirements for medical electrical systems) when you connect the scanner to other equipment.

Connectors PC connectors for connecting the scanner to other equipment such as printers and video equipment are located in the neck of the scanner. To access them, unscrew the screw on the bottom of the neck and remove the connector cover. See Fig 2-2.

Connector cover

Unscrew here to remove connector cover

Figure 2-2. Flex Focus connector cover.

Some connectors are used by the scanner. Do not use connectors that are not labelled in Fig 2-3. More information about the connectors is in Table 2-2. Information about the cables to use is in Table 2-5.

Auxiliary power outlet - for approved printers only

DVI-I Power supply cord goes here

Figure 2-3. Connectors in the neck of the Flex Focus scanner.

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Symbol DVI-I

Connector

Additional Information

DVI-I

Connector for auxiliary DVI or VGA monitor.

Composite/S-video In Composite/S-video Out

7-pin S-video connector (see Table 2-3 for pin layout) that can be adapted to a composite video output (see Table 2-4).

Audio In Audio Out 4 USB 2.0 connectors, A-type 500mA current limit on each

FireWireTM

Not currently supported. For future use.

10/100/1000 Ethernet

LAN: 10/100/1000 LAN connector, RJ45

Table 2-2. Connectors in the neck of the Flex Focus scanner. S-Video connector pin layout

7-pin S-video MINI-DIN Female

Pin

Name

Description

1

GND

Ground (Y)

2

GND

Ground (C)

3

Y

Intensity (Luminance)

4

C

Color (Chromaticity)

6

V

Composite Video

7

VGND

Composite Ground

5

Table 2-3. S-video connector pin layout.

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

To get the best image quality possible, connect your monitor or other video equipment using the output signal that gives the highest quality image. See the list below.

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Output signal types (in order of quality, with DVI highest)

DVI - digital output that gives the best image quality. 2 VGA – this analog output from the DVI connector gives slightly poorer image quality. 3 S-video – analog output 4 Composite – signal with the most loss of information If you must use a cable that does not have a DVI connector, you may need to use an adapter. Table 2-4 shows you what adapters can be used. 1

Cable Connectors (in order of preference)

Adapter

Flex Focus Connector

Not needed.

DVI

DVI

15-pin (VGA)

DVI to VGA adapter (2 views) DVI

4-pins (S-video) Not needed

BNC (Composite)

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

Phono RCA (Composite)

7-pin S-video to Composite

2 connectors (S-video and composite)

7-pin S-video to Composite/Composite

(same view on both connectors) Table 2-4. Video connectors and adapters.

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

Cable type

Type and length

DVI-I

Dual link

Shielded, 5 m

S-video/composite In

S-video

Shielded, 5 m

S-video/composite Out

S-video

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

USB, 2.0

Shielded, 5 m

USB 2

USB, 2.0

Shielded, 5 m

USB 3

USB, 2.0

Shielded, 5 m

USB 4

USB, 2.0

Shielded, 5 m

FW400

FireWire

Shielded, 5 m

10/100/1000 Ethernet

Network, CAT6E

Shielded, 5 m

Table 2-5. List of cables used in testing for EMC compliance

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

Network Connection The scanner must not be galvanically connected to a computer network (DICOM®) that has not been isolated. If the network is not isolated, the scanner must be connected via a network isolator DP0925 (see Accessories in Product Data sheet).

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Medical Equipment Power source

WARNING ME-1 Follow the guidelines in EN60601–1–1 [7] (Safety requirements for medical electrical systems). Equipment that complies with the requirements of EN/IEC 60601–1 [2] (Part 1: General requirements for safety), UL 60601-1 [4] or CSA C22.2 No. 601.1–M90 [5] can be connected to the scanner, but one of the following conditions must be fulfilled: •

Each piece of equipment is plugged directly into an independent wall power outlet. or

•

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

If in doubt, contact your local BK Medical representative.

Printers and auxiliary power outlet

WARNING ME-2

Standby switch does not turn off outlet

The auxiliary power outlet is still live even when the standby switch on the scanner is turned off. In order to remove voltage from this outlet, you must unplug the power supply cord from the power source (wall outlet or UPS).

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An approved printer, specified in the Product Data sheet, can be connected to the internal auxiliary power outlet on the scanner. Do not use the auxiliary power outlet on the Flex Focus 1202 for any other equipment.

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Non-Medical Equipment WARNING NME-1 Follow the guidelines in EN60601–1–1 [7] (Safety requirements for medical electrical systems). If you connect non-medical equipment (instruments that do not comply with safety requirements for medical equipment, such as a video monitor, video recorder, endoscopic camera control unit or other documentation device), this equipment must be placed outside the patient environment (1.5m from the bed, for example). The equipment must fulfill the relevant EN standard or other applicable national or international standard. One of the following conditions must be fulfilled: •

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

or •

The scanner is grounded with an additional safety ground connection (see “Additional Protective Ground and Potential Equalization” on page 13).

If in doubt, contact your local BK Medical representative.

Using the Scanner with a Lithotriptor Special considerations apply if you are using a lithotriptor with the scanner. The lithotriptor must comply with the guidelines in EN60601–1–1 [7] (Safety requirements for medical electrical systems). You must have a license installed in order to use a lithotriptor with the scanner. You must always follow instructions in the manufacturer’s user guide for the lithotriptor. Power Connections Do NOT connect a lithotriptor to the auxiliary power outlet. Plug the scanner and the lithotriptor directly into independent wall power outlets. Connecting the Scanner to the Lithotriptor Connect the lithotriptor to a USB connector on the scanner. If necessary, use a USB RS-232 adapter cable. Follow the connection instructions in the manufacturer’s user guide for the lithotriptor system. The connections must follow the guidelines given in EN 60601– 1–1 [7] (Safety requirements for medical electrical systems).

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Computer Security When the Flex Focus is connected to a hospital network, BK Medical does not take any responsibility for computer viruses from the network that may infect the Flex Focus. Check external media

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

Service and Repair Authorized personnel

WARNING SR-1 Service and repair of BK Medical electromedical equipment must be carried out only by the 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 Electrical shock

WARNING T-1 The transducer sockets contain terminals with 5V. Do not touch the patient while you are touching an uncovered socket.

Type B transducers

WARNING T-2 When using Type B (non-isolated) transducers, carefully check all electrical equipment within the patient area. Also, consider using additional protective grounding.

Electrical burns

WARNING T-3 Do not leave transducers in contact with the patient when using HF electrosurgical equipment.

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

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WARNING T-4 Do not turn the transducer on and allow it to scan into mid-air without scanning gel applied to the surface of the array. Doing so may cause the surface temperature on the array to heat up to 27 °C above room temperature (measured according to EN60601– 2–37 [3]). To avoid this, freeze the image when the transducer is not used for scanning. January 2010

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