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E13C2 User Guide

 (16-01484-EN-01)

 

9

 

Puncture and Biopsy Facilities

Puncture and biopsy are possible with the E13C2 transducer. The needle guides are 
illustrated in the following pages with a brief description of their use and operating 
instructions.

The needle guide is intended for transrectal puncture and biopsy. 

You will need:

reusable needle guide UA1349 or single-use needle guide UA1339

17-gauge biopsy needles for use with both needle guides.

Needle guide UA1339 has an inner diameter of 1.7 mm and reusable needle 

guide UA1349 has an inner diameter of 1.5 mm, both of them suitable for up 

to 17-gauge needles. Needle guide UA1339 is supplied sterile and is for single 

use only.

The needle guide is angled 0° towards the long axis of the transducer (i.e. towards 
the mid-axis of the scan image with E13C2). The distance from the entrance to the 
needle guide and the first puncture line dot on the scan image is 166 mm, as shown 
in Fig. 4. The dots are 5 mm apart.

All parts of the UA1349 needle guide can be autoclaved or disinfected by immersion 
in a suitable solution.

Figure 2. Reusable needle guide UA1349.

Single-Use Sterile Needle Guide UA1339

Needle guide UA1339 is supplied sterile in peel packs and is for single-use only. 
Contents are sterile only if the package is intact. The needle guide must be discarded 
after use.

WARNING

Sterile-w1

Single-use components are packaged sterile and are intended for single-use only.

Do not use if:

Integrity of packaging is violated

Expiration date has passed

Package label is missing

Summary of Contents for E13C2

Page 1: ...16 01484 EN 01 June 2018 For Professional Users Only E13C2 Transducer User Guide ...

Page 2: ...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 Your opinions are important to us You are always welcome to contact us via your BK Medical representative or by contacting us directly 2018 BK Medical Information in this document may be subject to change without notice ...

Page 3: ...Starting Imaging 7 Connecting the Transducer 7 Changing Frequency 7 Using a Transducer Cover 7 Using the Transducer Control Button 8 Changing Orientation 8 Puncture and Biopsy Facilities 9 Single Use Sterile Needle Guide UA1339 9 Performing Puncture and Biopsy 10 Cleaning after Puncture and Biopsy 12 Disposal 12 English source version 16 01484 01 EN ...

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Page 5: ...uitable for contrast imaging and elastography Needle guide UA1339 provides needle guidance for biopsy Patient Population The patient population is adults Figure 1 E13C2 transducer General Information Product specifications acoustic output data and data about EMC electromagnetic compatibility for this transducer can be found in the Product Data Sheet and the Technical Data BZ2100 that accompany thi...

Page 6: ...s ortheimageisseverelydistortedordegraded 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 service representative or hospital technician WARNING AO w1 To avoid...

Page 7: ...ur area NOTE In the United States of America it is recommended to use transducer covers that have been market cleared In Canada use only licensed transducer covers In Europe transducer covers must be CE marked WARNING Reproc w2 Users of this equipment have an obligation and responsibility to provide the highest possible degree of infection control to patients co workers and themselves The instruct...

Page 8: ...s the button for more than one second to make a copy of the image The transducer makes a beep sound each time you press the button Changing Orientation To change the orientation of the image on the monitor refer to the applicable system user guide for instructions WARNING TC w1 Some transducer covers can contain latex Because of reports of severe allergic reactions to medicaldevicescontaininglatex...

Page 9: ...s for single use only The needle guide is angled 0 towards the long axis of the transducer i e towards the mid axis of the scan image with E13C2 The distance from the entrance to the needle guide and the first puncture line dot on the scan image is 166 mm as shown in Fig 4 The dots are 5 mm apart All parts of the UA1349 needle guide can be autoclaved or disinfected by immersion in a suitable solut...

Page 10: ...ironment and kept out of direct sunlight Large temperature changes during storage may cause condensation and violate the integrity of the packaging WARNING D w1 For disposal of contaminated items such as transducer covers or needle guides or other disposable items follow disposal control policies established for your office department or hospital WARNING P w1 Before you start imaging verify that t...

Page 11: ... tip echo will be seen as a bright dot on the screen To remove the puncture line from the scan image refer to the applicable system user guide for instructions Figure 4 Illustration of the puncture line for needle guides UA1339 and UA1349 WARNING P w4 The puncture line on the image is an indication of the expected needle path To avoid harming the patient the needle tip echo should be monitored at ...

Page 12: ...covery 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 drying on the surface Dried bioburden can lead to inefficient cleaning disinfection and sterilization causing a risk of cross contamination If pre and tho...

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