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E14CL4b User Guide

 (16-01277-EN-02)

 

5

 

Introduction

This is the user guide for the E14CL4b transducer, and it must be used together with 
the 

Care and Cleaning

 user guide which contains important safety information.

Intended use

The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis 
of the human body.

Indications for use

E14CL4b is suitable for transrectal imaging, transvaginal imaging, guidance of 

all transperineal interventional procedures including brachytherapy and 

cryotherapy treatments. It is also suitable for elastography

1

 and contrast imaging

2

.

E14CL4b contains two arrays — a curved array for transverse (T) imaging, and 
a linear array for sagittal (S) imaging. Both arrays can be used separately or they 
can be used simultaneously. When using the simultaneous biplane feature, you 
are able to view two planes at once with a single transducer, and this helps 
determine the true position of the needle and its tip during puncture and biopsy.

Patient Population

The patient population is adults.

Imaging Plane

Figure 1. E14CL4b

Physicians

only

Caution 

Rx-c1

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

1. Elastography on the bk5000 has not been licensed by Health Canada.

2. Contrast imaging on the bk3000/bk5000 has not been licensed by Health Canada. In the USA, 
contrast-enhanced ultrasound has not been market cleared by the FDA, with the exception of 
only select cardiac imaging applications.

Sagittal Button

Transverse Button

Summary of Contents for E14CL4b

Page 1: ...16 01277 EN 02 September 2015 For Professional Users Only E14CL4b Transducer User Guide ...

Page 2: ...gram 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 directl...

Page 3: ...ing a Transducer Cover 8 Using the Transducer Control Button 8 Changing Orientation 8 Endorectal Imaging with E14CL4b 9 Adjusting Image Area and Using Expanded Sector Trapezoidal View 9 Puncture and Biopsy Facilities 9 Puncture Attachment UA1232 9 Performing Puncture and Biopsy 11 Prostate Volume Determination 12 Radioactive Source Implantation 12 Cleaning after Puncture and Biopsy 13 Disposal 13 ...

Page 4: ...4 ...

Page 5: ... and a linear array for sagittal S imaging Both arrays can be used separately or they can be used simultaneously When using the simultaneous biplane feature you are able to view two planes at once with a single transducer and this helps determine the true position of the needle and its tip during puncture and biopsy Patient Population The patient population is adults Imaging Plane Figure 1 E14CL4b...

Page 6: ...rdegraded oryou 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 has been checked Do not try to repair the system yourself Contact your BK Medical representative or hospital technician WARNING AO w1 To avoid tissue damage always keep the e...

Page 7: ...01 1 IEC 60601 1 Changing Frequency The multifrequency imaging MFI control enables you to select the imaging frequency See the applicable system user guide for instructions The selected frequency is displayed on the monitor WARNING Reproc w2 Usersofthisequipmenthaveanobligationandresponsibilitytoprovidethehighestdegree of infection control possible to patients co workers and themselves To avoid cr...

Page 8: ...ure attachment place it gently over the cover and secure it following the instructions for the puncture attachment Verify that the cover has not been damaged in the process If it has repeat the procedure with a new transducer cover Using the Transducer Control Button The transducer has two control buttons one for the sagittal array and one for the transverse array Fig 1 Pressing the button activat...

Page 9: ...psy Facilities Puncture and biopsy are possible with the E14CL4b transducer The puncture attachment is illustrated in the following pages with a brief description of its use and operating instructions Puncture Attachment UA1232 Puncture attachment UA1232 Fig 4 is designed for transperineal puncture and biopsy It consists of A needle guide and a mounting ring with a lock screw The needle guide comp...

Page 10: ...To mount UA1232 1 Loosen the lock screw and slide the attachment over the tip of the transducer until the lock screw pressure pad meets the steel stud on the side of the transducer 2 The puncture attachment should be correctly positioned Fig 5 before the lock screw is tightened 3 No force should be used when attaching the puncture attachment to the transducer Figure 5 E14CL4b with puncture attachm...

Page 11: ...To remove the puncture line from the scan image refer to the applicable system user guide for instructions WARNING P w1 Before you start imaging verify that the type number of the transducer and the type number or description of the puncture attachment you are using match the number displayed on the monitor Also make sure that the needle guide is positioned correctly If they do not match or if the...

Page 12: ... mounted and locked in the stepping unit The volume study of the prostate is performed the radiation dose planned and the needles loaded To superimpose the source matrix on to the monitor refer to the system user guide for further details Before starting source implantation anchor the prostate to the matrix using thread or needles to prevent it moving during needle placement Always place the needl...

Page 13: ...vant material in each individual land must be followed Within the EU when you discard the transducer you must send it to appropriate facilities for recovery and recycling WARNING Reproc w3 Immediately after use you must pre clean the device until visually clean including device lumens if existing Conduct the thorough cleaning process as soon as possible after use in order to prevent bioburden dryi...

Page 14: ...14 September 2015 E14CL4b User Guide 16 01277 EN 02 ...

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