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10

 November 

2018

N13C5 User Guide

 (16-01270-EN-06)

Puncture and Biopsy Facilities

The N13C5 transducer can be used for puncture and biopsy. The appropriate 

puncture attachments are illustrated on the following pages with a brief description 

of their use and operating instructions.

Single-Use Needle Guide UA1345 for N13C5

Needle guide UA1345 is supplied sterile in peel packs and is for single-use only. 
Contents are sterile only if the package is intact. The needle guide, inserts, and 
palettes must be discarded after use.

The sterile-packed needle guide must be stored at a temperature range from +5 ºC 
(+41 ºF) to +25 ºC (+77 ºF) and a storage humidity of 0% to 80%.

WARNING

TC-w5

If the transducer cover is damaged during interventional procedures, follow the policies of 
the hospital or clinic for treatment of the patient under such circumstances.

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

WARNING

Sterile-w2

Sterile-packed components must be stored in a safe environment 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.

Содержание N13C5

Страница 1: ...For Professional Users Only 16 01270 EN 06 November 2018 N13C5 Transducer User Guide...

Страница 2: ...ufacture of a product please contact your BK Medical representative or write to us at the email address above including the product s serial number SN number BK Medical Customer Satisfaction Input fro...

Страница 3: ...er Cover 8 Using the Transducer Control Button 9 Changing Orientation 9 Neurosurgical Imaging with N13C5 9 Puncture and Biopsy Facilities 10 Single Use Needle Guide UA1345 for N13C5 10 Assembling and...

Страница 4: ...4...

Страница 5: ...aniotomy Patient Population The patient population is neonates2 infants children adolescents and adults Physicians only Caution Rx c1 United States law restricts this device to sale by or on the order...

Страница 6: ...ns 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 sys...

Страница 7: ...nd repair of BK 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 l...

Страница 8: ...da use only licensed transducer covers In Europe transducer covers must be CE marked WARNING GS w4a It is essential for the patient s safety that only the correct equipment is used Do not use other ma...

Страница 9: ...lowing 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 Bu...

Страница 10: ...e humidity of 0 to 80 WARNING TC w5 If the transducer cover is damaged during interventional procedures follow the policies of the hospital or clinic for treatment of the patient under such circumstan...

Страница 11: ...ith free angle inserts The 3 angle inserts each contain three channels These channels allow the needle to be positioned at 25 45 or 65 to the image axis of N13C5 The free angle inserts are slotted to...

Страница 12: ...unt of imaging gel to the tip of the transducer and carefully cover the transducer with a sterile cover 2 Select the required needle guide insert by breaking it off the palette see Figure 2 3 Find the...

Страница 13: ...a LEYLA arm NOTE Ensure that the transducer cable is secured so that it cannot move and pull the transducer out of position WARNING P w9 Ensure that the channel bracket and needle guide are correctly...

Страница 14: ...ith a new transducer cover before reattaching the needle guide WARNING Exam w5 Be careful not to lose any parts of the needle guide inside the patient WARNING P w1 Before you start imaging verify that...

Страница 15: ...e use needle guide UA1345 when mounted on N13C5 transducer You must take extra care when taking a free angle biopsy because the expected needle path is not shown on the screen image Cleaning after Pun...

Страница 16: ...is scrapped at the end of its life national rules for the relevant material in each individual land must be followed Within the EU when you discard the transducer you must send it to appropriate faci...

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