N13C5 Transducer

Introduction

This is the user guide for the N13C5 transducer and it must be used together with the Care and Cleaning user guide which contains important safety information.

Caution Rx-c1
United States law restricts this device to sale by or on the order of a physician.

Intended use

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

Indications for Use

System          Indications for Use

bk3000, bk3500

• Neonatal cephalic imaging
• Pediatric imaging

bk5000

• Intraoperative (neuro) imaging (neurosurgery)
• Neonatal cephalic imaging
• Intraoperative imaging
• Pediatric imaging

N13C5 is also suitable for elastography1. Needle guide UA1345 provides needle guidance for biopsy and drainage (following craniotomy).

Patient Population

The patient population is neonates2 , infants, children, adolescents and adults.

1. Use of N13C5 for elastography has not been CE-marked.
2. Neonatal cephalic and pediatric imaging only.

Figure 1. N13C5 transducer

Contraindications

WARNING T-w6: To avoid causing injury to the eye, do not use this transducer for ophthalmic use, or any application that causes the acoustic beam to pass through the eye.

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.

WARNING GS-w2: If at any time the system malfunctions, or the image is severely distorted or degraded, or you 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 tissue damage, always keep the exposure level (the acoustic output level and the exposure time) as low as possible.

WARNING AO-w3: To reduce the risk of thermal damage to tissues, be sure to keep the acoustic output as low as possible when you expose the head, brain, or spine of any neonate or fetus to diagnostic ultrasound.

Service and Repair

WARNING SR-w1: Service and 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 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.

Caring for the Transducer

The transducer may be damaged during use or reprocessing, so it must be checked before use for cracks or irregularities in the surface, following the procedure in Care and Cleaning. It should also be checked thoroughly once a month following the same procedure.

Reprocessing

To ensure the best results when using BK Medical equipment, it is important to maintain a strict cleaning routine.
Complete details and procedures can be found in Care and Cleaning that accompanies this user guide. A list of reprocessing methods that the transducer can withstand are listed in the Product Data Sheet.
Sterile covers are available. See the Product Data Sheet for more information.

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 instructions in this book are meant as a guide. To avoid cross-contamination, follow all infection control policies (including for reprocessing, packing and storage) for personnel and equipment that have been established for your office, department or hospital.

Starting Imaging

Before use, all equipment must be reprocessed according to expected use.

WARNING T-w5: To prevent electrical shock and damage to the transducer, the connector pins in the transducer plug must always be completely dry before you connect to a system.

Connecting the Transducer

The transducer is connected to the system using the array transducer socket on the system. To connect, flip the system’s locking lever to the right. Align the transducer plug to the system socket and insert securely. Flip the system’s locking lever to the left to lock it.
When connected, the transducer complies with Type BF requirements of EN60601-1 (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.

Using a Transducer Cover

BK recommends the use of a sterile transducer cover to reduce the risk of crosscontamination. See the Product Data Sheet for a list of available transducer covers. Follow local guidelines for the use of transducer covers in your 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.
Apply sterile gel to the tip of the transducer or fill the cover with 1 to 2 ml of sterile water. This improves screen imaging by preventing image artifacts caused by air bubbles.
Pull the transducer cover over the transducer. Check for air bubbles between the cover and the transducer and even out if necessary before proceeding.

For Intraoperative Applications:

• Irrigate the organ to be imaged with 0.9% sterile physiological saline solution while imaging.

For Surface Use:

• Gel also creates a good acoustic contact between the skin and the transducer: Therefor, apply a small amount to the outside of the cover prior to imaging and reapply frequently.

Follow these precautions when putting sterile covers on a transducer:

• Wear sterile gloves.
• When using a puncture 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 control button on the transducer controls the imaging.
Press the button to Start or Stop imaging (freeze frame). Press the button for more than one second to make a copy of the image.

Changing Orientation

To change the orientation of the image on the monitor, refer to the applicable system user guide for instructions.

Neurosurgical Imaging with N13C5

WARNING C-J-w1: Do not use a transducer for neurosurgical applications if the patient is suspected of having Creutzfeldt-Jakob disease. If a neurosurgical transducer has been used on a patient suspected of or diagnosed as being Creutzfeldt-Jakob positive, the transducer must be destroyed, following approved procedures for your hospital.

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.

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.

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.

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 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.

Figure 2. Two needle-guide insert palettes together with needle guide UA1345.

Figure 3. Needle Guide UA1345 for N13C5; the numbered steps refer to the procedure on the following pages describing how to mount the needle guide.

Single-use Needle Guide UA1345 (see Figure 3) is for use with N13C5 and is supplied together with two needle guide insert palettes (see Figure 2). Each palette contains a set of 9 needle guide inserts; one palette with 3-angle inserts and one palette with 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 allow positioning of the needle at any angle between 25° and 65° to the image axis of N13C5 while making sure that the needle follows the plane of the image.

Puncture lines indicate expected needle path
The puncture line on the scan image is an indication of the expected needle path (see Figure 7). The distance from the guide channel entrance of the puncture attachment to the first dot on the scan image puncture line is approximately 7.5 mm (0.3 in) for 25°, 12 mm (0.5 in) for 45°, and 19 mm (0.7 in) for 65°. The distance between the dots is 5 mm (0.2 in).

Assembling and Mounting the Needle Guide

To assemble and mount a needle guide on N13C5:

1. Apply a small amount 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 wedge-shaped channel in the needle guide, and slide the insert into the channel in the needle guide until it clicks into place and aligns with the needle guide.

4. Hold the assembled needle guide with the bracket pointing down.

5. Align the two grooves on the transducer with the two ridges on the needle guide.

6. Carefully smooth and stretch the transducer cover along the face of the array and apply pressure until the needle guide clicks into place over the end of the transducer. Figure 4 below shows the needle guide mounted on the transducer.
   
   __ Figure 4. UA1345 mounted on N13C5 (shown here without transducer cover).

7. Carefully insert the needle into the needle channel.

Attaching N13C5 and UA1345 to a LEYLA Arm

Needle guide UA1345 (for use with N13C5) has a tab that can be used to secure it to a LEYLA arm (see Figure 5).
Figure 5. N13C5 transducer with needle guide can be attached to a LEYLA arm.

NOTE: Ensure that the transducer cable is secured so that it cannot move and pull the transducer out of position.

Releasing the Needle During Biopsy

You can release the needle during biopsy so that the needle guide and transducer can be removed from the patient, leaving only the needle in place.
How to release the needle guide on N13C5 :

1. Hold the transducer with your left hand. With your right hand, carefully push the needle guide insert sideways until it opens up (see Figure 6).
   
   Figure 6. Push to release the needle guide on the N13C5.

2. Carefully move the transducer and needle guide away from the needle.

Performing Puncture and Biopsy

If the transducer cover is damaged when attaching the puncture attachment, replace it with a new cover. See the Product Data Sheet for a list of available transducer covers.
Press the Puncture or Biopsy control on the system to superimpose a puncture line on the scan image.
If more than one puncture line is available, refer to the applicable system user guide for instructions on how to change which one appears.
Move the transducer until the puncture line transects the target. Insert the needle and monitor as it moves along the puncture line to the target. The needle tip echo will be seen as a bright dot on the screen.

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.

To remove the puncture line from the scan image, refer to the applicable system user guide for instructions.

WARNING P-w5: Avoid unnecessary tissue damage. When performing a biopsy, always make sure that the needle is fully drawn back inside the needle guide before moving the probe.

_ Figure 7. Illustration of the puncture lines for single-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 Puncture and Biopsy

Use a suitable brush to make sure that biological material and gel are removed from all channels and grooves. See Care and Cleaning for cleaning instructions.

Disposal

When the transducer 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 facilities for recovery and recycling.

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.

BK Medical N13CP Transducer User Manual – Optimized PDF
BK Medical N13CP Transducer User Manual – Original PDF

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