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E13C2 User Guide

 (16-01484-EN-01)

 

5

 

Introduction

This is the user guide for E13C2 and 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

E13C2

1

 is suitable for transrectal prostate and transvaginal uterus imaging. It is 

also suitable 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 this user guide.

Physicians

only

Caution 

Rx-c1

United States Federal law restricts this device to sale by or on the order of a physician.

1. E13C2 has been licensed by Health Canada for use on the bk3000 and bk3500 only.

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 ...

Page 4: ...4 ...

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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