B-K Medical Convex Array 8803 Manual de usuario

English

BB0335-J

August 2007

8803

Convex Array Transducer

ser Guide

WORLD HEADQUARTERS

Mileparken 34

DK-2730 Herlev

Denmark

Tel.:+45 44528100 / Fax:+45 44528199

www.bkmed.com

Email: info@bkmed.dk

B-K Medical Customer Satisfaction

Input from our customers helps us improve our products and services. As part of our customer

satisfaction program, 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 B-K Medical

representative or by contacting us directly.

Information in this document may be subject to change without notice.

Convex Array Transducer Type 8803

Introduction 1

Scanning Plane 1

General Information 1

Caring for the Transducer 2

Cleaning and Disinfection 2

Starting Scanning 2

Connecting the Transducer 3

Changing Frequency 3

Using a Transducer Cover 3

Using the Transducer Control Button 3

Changing Orientation 4

Puncture Facilities 4

UA1250 4

Performing Puncture and Biopsy 5

Cleaning after Puncture and Biopsy 6

Disposal 7

BB0335-J

August 2007

Convex Array Transducer Type 8803

Introduction

This is the user guide for Convex Array Transducer Type 8803 and must be used together

with Transducer Care, Cleaning & Safety which contains important safety information.

8803 is an abdominal transducer suitable for intercostal examinations.

Fig. 1. Convex Array Transducer Type 8803

A small diode on the transducer’s handle indicates whether the transducer is active. An

orange light indicates that the transducer is connected to the scanner. A green light

indicates that the transducer is scanning.

Scanning Plane

The scanning plane for 8803 is shown in Fig. 2.

Fig. 2. Convex Array Transducer Type 8803 showing scanning plane

General Information

Product specifications for this transducer can be found in the Product Data sheet that

accompanies this user guide.

8803 • Cleaning and Disinfection

Acoustic output data and data about EMC (electromagnetic compatibility) for this

transducer are on the Technical Data CD that accompanies this user guide. A full

explanation of acoustic output is given in your scanner user guide.

Caring for the Transducer

The transducer may be damaged during use or processing, so it must be checked before use

for cracks or irregularities in the surface. It should also be checked thoroughly once a month

following the procedure in Transducer Care, Cleaning & Safety.

Cleaning and Disinfection

To ensure the best results when using B-K Medical equipment, it is important to maintain

a strict regular cleaning routine.

Full details of cleaning and disinfection procedures can be found in Transducer Care,

Cleaning & Safety that accompanies this user guide. A list of disinfectants and disinfection

methods that the transducer can withstand are listed in the Product Data sheet.

Sterile covers are available. See the Product Data sheet for more details.

Caution

Keep all plugs and sockets absolutely dry at all times.

Starting Scanning

All equipment must be cleaned and disinfected before use.

WARNING

If at any time the scanner malfunctions, or the image is severely distorted or degraded, or

you suspect in any way that the scanner is not functioning correctly:

• Remove all transducers from contact with the patient.

• Turn off the scanner. Unplug the scanner from the wall and make sure it cannot be

used until it has been checked.

• Do not remove the scanner cover.

• Contact your B-K Medical representative or hospital technician.

WARNING

Always keep the exposure level (the acoustic output level and the exposure time) as low as

possible.

WARNING

Users of this equipment have an obligation and responsibility to provide the highest degree

of infection control possible to patients, co-workers and themselves. To avoid cross contami-

nation, follow all infection control policies for personnel and equipment established for your

office, department or hospital.

8803 • Starting Scanning

Connecting the Transducer

The transducer is connected to the scanner using the array Transducer Socket on the

scanner. To connect, the transducer plug’s locking lever should first be in a horizontal

position. Align the plug to the scanner socket and insert securely. Turn the locking lever

clockwise to lock in place.

When the transducer is attached to the scanner, the diode light is orange.

When connected the transducer complies with Type B requirements of EN60601-1 (IEC

60601-1).

Changing Frequency

The Multi-Frequency Imaging (MFI) facility enables you to select the scanning frequency.

See the applicable scanner user guide for instructions. The selected frequency is displayed

at the top of the screen.

Using a Transducer Cover

The transducer should be enclosed in a transducer cover or a standard condom. See the

Product Data sheet for a list of available transducer covers.

Apply gel to the tip of the transducer. This improves the screen images by preventing image

artifacts caused by air bubbles.

Pull the transducer cover over the transducer.

Gel also creates a good acoustic contact between the skin and the transducer; therefore,

apply a small amount to the outside of the cover prior to scanning. Re-apply the gel

frequently to ensure good screen images.

Using the Transducer Control Button

The transducer has a control button that you can press to Start or Stop scanning (freeze

frame). Press the button for more than one second to make a copy of the image.

Note: Transducer buttons cannot be used to copy images using the Mini Focus 1402

Ultrasound Scanner.

Each time the button is pressed, a “beep” is emitted.

When the transducer is scanning, the diode light is green. When scanning stops, the light is

orange.

WARNING

Keep all plugs and sockets absolutely dry at all times.

WARNING

Because of reports of severe allergic reactions to medical devices containing latex (natural

rubber), FDA is advising health-care professionals to identify their latex-sensitive patients

and be prepared to treat allergic reactions promptly.

WARNING

Use only water-soluble agents or gels. Petroleum or mineral oil-based materials may harm

the cover material.

8803 • Puncture Facilities

Changing Orientation

To change the orientation of the image on the monitor, refer to the applicable scanner user

guide for instructions.

Puncture Facilities

Puncture and biopsy is possible with Type 8803. The puncture attachment is illustrated in

the following pages with a brief description of its use and operating instructions.

UA1250

The puncture attachment (see Fig. 3.) comprises an attachment bracket, an attachment lock

screw (item A in Fig. 4.), a needle guide, a needle-guide lock screw (item B in Fig. 4.) and a

variable diameter holder for fine needles (0.6mm or 24 gauge) and large bore needles

(2.4mm or 13 gauge). The guide channel is angled at 18°to the transducer’ s image axis.

Fig. 3. Puncture attachment UA1250

To mount biopsy attachment UA1250 ready for use:

Note: When mounted the attachment lock screw (item A in Fig. 3.) should be on the side of

the transducer handle opposite to the transducer’s control button.

1. Mount the attachment bracket on the transducer. Fit the indentations in the sides of

the bracket over the raised metal knobs on either side of the transducer handle.

2. Fix the attachment bracket in position by tightening the attachment lock screw (item

A in Fig. 3.). Tighten the screw up to its “locking point”, after which it will not be pos-

sible to tighten the screw anymore.

3. The biopsy attachment should now be fixed solidly to the transducer’s handle.

4. Using the needle guide locking screw (item B in Fig. 3.), adjust the needle guide

according to the size of needle to be used.

WARNING

It is essential for the patient’s safety that only the correct puncture attachment is used with

Type 8803. Never use unauthorized combinations of transducers and puncture attachments

or other manufacturers’ puncture attachments.

8803 • Performing Puncture and Biopsy

The distance from the guide channel entrance of the puncture attachment to the first dot on

the scan image puncture line is 52mm. The distance between the dots is 10mm, see Fig. 5.

for details.

Fig. 4. Type 8803 with UA1250 mounted

All parts of the puncture attachment can be autoclaved or disinfected by immersion in a

suitable solution.

Performing Puncture and Biopsy

Cover the transducer with a sterile transducer cover.

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 scanner Puncture or Biopsy control button to superimpose a puncture line on the

scan image.

WARNING

It is essential for the patient’s safety that only the correct puncture attachments, as described

in this guide, are used. Never use unauthorized combinations of transducers and puncture

attachments or other manufacturers puncture attachments.

Before beginning a puncture or biopsy procedure, always check that the type number of the

transducer and the type number or description of the puncture attachment match exactly

those displayed on the scanner monitor.

WARNING

The puncture line on the scan image is an indication of the expected needle path. The needle

tip echo should be monitored at all times so any deviation from the desired path can be cor-

rected.

8803 • Performing Puncture and Biopsy

If more than one puncture line is available, refer to the applicable scanner 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 it as it moves along the puncture line to the target. The needle 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 scanner user guide

for instructions.

Fig. 5. Puncture line for UA1250 with 8803

The transducer and puncture attachment can be removed without disturbing the position of

the needle during puncture.

Cleaning after Puncture and Biopsy

If biological materials are allowed to dry on the transducer or puncture attachments,

disinfection and sterilization processes may not be effective. Therefore, you must clean

puncture attachments and transducers immediately after use.

Use a suitable brush to make sure that biological material and gel are removed from all

needle guides and other channels and grooves. See Transducer Care, Cleaning & Safety for

cleaning instructions.

WARNING

If the needle guide is detached from the transducer during interventional procedures, cover

the transducer with a new transducer cover.

WARNING

When performing a biopsy, always make sure that the needle is fully drawn back inside the

needle guide before moving the probe.

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