B-K Medical Type 8553 Bedienungsanleitung

English

BB0101-H

August 2006

Type 8553

Convex Array Transducer

User Guide

WORLD HEADQUARTERS

Mileparken 34

DK-2730 Herlev

Denmark

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

www.bkmed.com

Email: [email protected]

If you have comments about the user documentation, please write to us at the email address above.

We would like to hear from you.

BK 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 BK Medical

representative or by contacting us directly.

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

Convex Array Transducer Type 8553

Introduction 1

Scanning Plane 1

General Information 1

Caring for the Transducer 2

Cleaning and Disinfection 2

Starting Scanning 2

Connecting a Transducer 3

Changing Frequency 3

Using a Transducer Cover 3

Using the Transducer Control Button 3

Changing Orientation 3

Puncture Facilities 4

UA0940 4

UA1217 5

Performing Puncture and Biopsy 6

Cleaning after Puncture and Biopsy 7

Disposal 7

BB0101-H

August 2006

8553 • Introduction

Convex Array Transducer Type 8553

Introduction

This is the user guide for Convex Array Transducer Type 8553 and must be used together

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

8553 is an abdominal transducer suitable for transcutaneous scanning of the bladder and

kidney, and for intercostal examinations.

Fig. 1. Convex Array Transducer Type 8553

Scanning Plane

Fig. 2. Scanning plane of Type 8553

General Information

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

accompanies this user guide.

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

ducer are on the Technical Data CD that accompanies this user guide. A full explanation of

acoustic output is given in your scanner user guide.

8553 • Cleaning and Disinfection

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 the Transducer Care,

Cleaning & Safety booklet that accompanies this user guide. A list of disinfectants and dis-

infection 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.

• 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.

8553 • Starting Scanning

Connecting a Transducer

Unscrew the connector plug cover on the transducer (if attached). On the connector plug,

make sure that the red arrow is aligned with the red dot on the transducer socket. Pull back

the outer locking mechanism and insert the plug in the socket. Release the locking mecha-

nism to secure in place.

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 scanning gel to the tip of the transducer. This improves the screen images by prevent-

ing 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 fre-

quently 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.

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

Changing Orientation

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

detailed instructions.

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.

8553 • Puncture Facilities

Puncture Facilities

Puncture and biopsy is possible with Type 8553. The puncture attachments are illustrated

in the following pages with a brief description of their uses and operating instructions.

UA0940

Fig. 3. Puncture Attachment UA0940

The stainless steel puncture attachment is shown in Fig. 3.; it comprises an attachment lock

screw, a needle guide, a needle-guide lock screw and a variable diameter holder for needles

with diameters from (0.6mm or 24 Gauge) and up to a maximum of (2.1mm or 14 Gauge).

The guide channel is angled at 18°to the transducer’s image axis.

Before mounting the puncture attachment, loosen the needle-guide lock screw, extend the

needle-guide to the 15mm setting and lock in position. Attach the puncture attachment to

the transducer. Tighten the lock screw and check the UA0940 is secure. See Fig. 4..

When the puncture attachment is at the 0mm setting, the distance from the guide channel

entrance of the puncture attachment to the first dot on the scan image puncture line is

65mm for the 8553. See Fig. 6. The distance between the dots is 10mm.

To fit the required needle, turn the variable-diameter holder counterclockwise and insert the

needle. Turn the holder clockwise until tight enough to hold the needle firmly.

WARNING:

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

Type 8553. Never use unauthorized combinations of transducers and puncture attachments or

other manufacturers’ puncture attachments.

WARNING:

Use only metal needles with this puncture attachment.

8553 • Puncture Facilities

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

a suitable solution.

Fig. 4. Puncture attachment UA0940 mounted on the 8553

UA1217

Fig. 5. Puncture attachment UA1217

The puncture attachment (see Fig. 5.) is recommended for use with catheters and large

diameter needles from 1.2 mm and up to 3.6 mm. It comprises an attachment lock screw, a

needle guide, a needle-guide lock screw and a variable diameter holder for needles (1.2mm

or 18 Gauge) and large bore needles (3.6mm or 9 Gauge). The guide channel is angled at 18°

to the transducer’s image axis.

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

the scan image puncture line is 65 mm for the 8553. The distance between the dots is 10mm.

These distances are the same as the UA0940, see Fig. 6. for details.

All parts of the puncture attachment can be disinfected by immersion, or can be autoclaved.

8553 • Performing Puncture and Biopsy

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.

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 mon-

itor 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. 6. The distance from the top of UA0940 to the first dot in the puncture line is indicated.

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.

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.

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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