GE Medical Systems

Biopsy Guide Attachment for Use

With the MTZ/MZ/E721/E72 Type Probe

OPERATION MANUAL

2373241-100
Revision 0
Regulatory Requirement

The Biopsy Guide Attachment for use with the MTZ/MZ/E721/E72 Type probe complies with regulatory
requirements of the following European Directive 93/42/EEC.
 PRECAUTIONS FOR USE
When using this attachment, please take the following precautions.
1. Precautions for use
(1) Be careful not to damage the probe when you install or remove this attachment.
(2) Be careful when installing or removing the attachment. If this attachment is dropped
or damaged, the biopsy positions and angles will be warped or operations will not be
able to be performed smoothly.
2. How to use a guide line
The guide line on the screen can be used as a reference mark for inserting the biopsy
needle in the proper direction.
3. Others
Do not use if any accident or abnormal condition occurs in the ultrasound diagnostic
system main frame, probe or attachment.

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B
 TABLE OF CONTENTS
PRECAUTIONS FOR USE A
OVERVIEW- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
CONFIGURATIONS- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
SPECIFICATIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
DIMENSIONS (mm) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -2
PROCEDURES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -3
5-1. How to install - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3
5-2. Displaying a biopsy guide line - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4
5-3. Choosing a biopsy target and insertion route - - - - - - - - - - - - - - - - - - - - - - - - - - 5
5-4. Confirming the biopsy needle and needle point echo - - - - - - - - - - - - - - - - - - - - 6
CLEANING AND DISINFECTING THE ATTACHMENT - - - - - - - - - - - - - - - - - - -7
6-1. Attachment cleaning process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7
6-2. High level attachment disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7
Disinfecting process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7
Sterilizing Process- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8
STORAGE THE ATTACHMENT - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9
Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9
1. OVERVIEW
This attachment has been installed on the Convex prove (MTZ, MZ, E721 and E72
types) by GE Medical Systems to assist you in conducting biopsy procedures. Using this
attachment allows a biopsy position to be selected along the guide line while monitoring
the Convex image in real-time.
The attachment is easy to install and remove. This allows the probe to be rapidly
configured for the remainder of the study or the next exam. This attachment may be used
to carry out transvaginal or transrectal biopsies.

2. CONFIGURATIONS
• Attachment (made of stainless steel) ..........1
• Filling remover tool ......................................1
• Clamps ........................................................5
• Operation Manual ........................................1

3. SPECIFICATIONS
1. Available probes: MTZ, MZ, E721 and E72 type probes
2. Biopsy angle and depth: See Illustration 1.
3. Applicable biopsy needle: 16G or thinner, effectual length 22cm or longer
4. Weight: Approximately 16g (main frame only)
5. Application: For transvaginal and transrectal biopsies

INSERTION ROUTE OF CENTER OF THE

THE BIOPSY NEEDLE ULTRASOUND BEAM
1.5cm

Illustration-1. MTZ/MZ/E721/E72 TYPE PROBE

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4. DIMENSIONS (mm)

212

9 30
3.1
6.6

ATTACHMENT
CONNECTION HOOK

Illustration-2.

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5. PROCEDURES

5-1. How to install

Before installing the attachment, the filling must be removed from the probe head
where the biopsy guide attachment will be installed. This is only for first time
installation. See illustration 3.

FILLING REMOVER TOOL

AREA WHERE THE BIOPSY GUIDE

ATTACHMENT IS INSTALLED

PROBE HEAD

Illustration-3.

1. Fill the sterilized medical probe sheath with sterilized ultrasound gel, and
insert the probe in the medical probe sheath provided.
2. Install and fix the sterilized biopsy attachment on the covered probe.
3. Use the clamp to secure the biopsy attachment and probe sheath.
See Illustration 4.

ATTACHMENT CLAMP

PROBE HANDLE
STERILIZED PROBE SHEATH

MAIN FRAME OF PROBE

Illustration-4.

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5-2. Displaying a biopsy guide line

The guide line indicating the needle insertion route is stored in the operating
software of the ultrasound system.
1. Refer to the Users Manual of the ultrasound system for details on selecting
and enabling the guide line.
2. Press the Measurement key once to display the integrated biopsy depth
cursor while the guidelines are present. Use the Trackball to position the
depth marker.

DISPLAY ON MONITOR
(ASSUMING THAT THE REVERSE FUNCTION IS ON)

Illustration-5.

CAUTION Confirm that the biopsy guide line type is “TV0°“ for the LOGIQTM 500/
LOGIQTM 400/LOGIQTMα100/LOGIQTMα200 system. Refer to the Users
Manual for details.

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5-3. Choosing a biopsy target and insertion route

NOTE: Illustration shows a transvaginal scan only.

Insert the probe into the vaginal (rectal) cavity, and display the biopsy target on
the image. After the biopsy target has been confirmed, move the probe, to set the
position and angle with the target positioned on the guide line.(See Illustration 6.)
Verify that the insertion route is the optimum path to the biopsy target. Ensure
that there are no serious obstructions along the insertion route.
Hold the probe steady so that the biopsy target remains along the needle
insertion route.

PR

PL

A = Anterior
P = Posterior A
PL = Patient Left
PR = Patient Right

PR

Illustration-6. Transvaginal Scanning

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5-4. Confirming the biopsy needle and needle point echo

This attachment can be used with biopsy needles of 16G or thinner.

NOTE • The needle point echoes on the image appear slightly outside the actual
position.
• In some cases, the needle echo may appear as a needle inserted from the
opposite side just after the needle is displayed on the image. This is a side-
lobe virtual image which occurs when the needle point echo is specially
strong. If this occurs, reconfirm the attachment holder position and the probe
direction, and check whether the image direction is correctly displayed.
Continue the biopsy operation. (See Illustration 7.) As the needle point is
pushed away from the probe tip, the side-lobe will diminish and the virtual
image will disappear.

ACTUAL NEEDLE VIRTUAL

POINT ECHO IMAGE

CONDITION JUST AFTER THE BIOPSY DISPLAY ON THE MONITOR

NEEDLE APPEARS ON THE IMAGE

Illustration-7.

If you are using a fine needle according to the application, the needle may be
bent along the insertion route and not meet the guide line. Therefore, fine
needles should be inserted carefully.

Illustration-8.

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6. CLEANING AND DISINFECTING THE ATTACHMENT

6-1. Attachment cleaning process

To avoid the cross contamination, follow all infection control policies established
by your office, department or hospital as they apply to personnel and equipment.
1. After each use, disconnect the attachment from the probe and remove all
coupling gel from the probe by wiping with a soft cloth and rinsing with
flowing water.
2. Wash the attachment with mild soap in lukewarm water (below 80°F[26°
C] is recommended). Scrub the probe as needed using a soft sponge,
gauze, or cloth to remove all visible residue from the probe surface.
Prolonged soaking or scrubbing with a soft bristle brush (such as a
toothbrush) may be necessary if material has dried onto the probe surface.
3. Rinse the probe with enough potable water to remove all visible soap
residue.
4. Air dry or dry the probe with a soft cloth.

CAUTION Do NOT clean any portion of the attachment with methanol, ethanol,
isopropanol, or any other alcohol based cleaner. Such substances can cause
irreparable damage to the attachment.
Do NOT clean the attachment by immersing in an alcohol solution.

6-2. High level attachment disinfection

Disinfecting process

CAUTION The attachment can be disinfected using Ethylene oxide gas, cold plasma and
liquid chemical germicides.
Proceed appropriate disinfection and sterilization following regulatory
requirements depending on each countries.

Disinfection with The level of disinfection is directly related to the duration of contact with the
Germicide germicide. Increased contact time produces a higher level of disinfection, and
sterilization effect.
Cidex and Sporox are the only germicides approved by GE Medical Systems for
Ultrasound probe disinfecting purposes. 2% Glutaraldehyde-based solutions
have been shown to be very effective for disinfecting. Cidex (2% Glutaraldehyde-
based germicide) and Sporox (an alternative germicide with non–glutaraldehyde-
based chemicals) have been evaluated for compatibility with the material used to
construct the probes.

WARNING The following FDA cleared, high–level disinfectant chemicals are

recommended for this attachment.
• Cidex
• Cidex OPA
• Sporox
NOTE : Sporox is not allowed in Germany.

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Disinfecting process(Cont.)

CAUTION In order for liquid chemical germicides to be effective, all visible residue must
be removed during the cleaning process. Thoroughly clean the attachment, as
described earlier before attempting disinfection.

1. Prepare the germicide solution according to the manufacturer’s instructions.

Be sure to follow all precautions for storage, use and disposal.
2. Follow the direction for use, recommendations and precautions provided by
the manufacturer to achieve a germicide level of sterilant and / or disinfectant
required for infection control of the attachment.
3. After removing from the germicide, rinse the attachment following the
germicide manufacturer’s rinsing instructions. Flush all visible germicide
residue from the probe, guide sleeve and stopper and allow to air dry.

Sterilizing Process

Gas Sterilization 1. Rinse the attachment with flowing water.

2. Wash the attachment in water and remove all visible residue from the surface
by wiping with a soft sponge, gauze or cloth.
3. Proceed with gas sterilization using ethylene oxide gas. Follow the
instructions, recommendations and precautions provided by the
manufacturer of the sterilization equipment and gas supplier.

Cold Plasma 1. Rinse the attachment with flowing water.

Sterilization 2. Wash the attachment in water and remove all visible residue from the surface
by wiping with a soft sponge, gauze or cloth.
3. Proceed with cold plasma sterilization following the instructions,
recommendations and precautions provided by the manufacturer of the cold
plasma sterilization equipment.
NOTE: Sterrad is the recommended Cold Plasma Sterilization method.

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7. STORAGE THE ATTACHMENT
1. After cleaning and disinfection, store the attachment in it’s case for
protection.
2. The attachment should not be stored or transported within the parameters
outlined below.

Storage Transport

Temperature -10 ～ 60 ℃ -10 ～ 60 ℃

Humidity 30 ～ 95% 30 ～ 95%

non-condensing non-condensing

Pressure 700 ～ 1060hpa 70 ～ 1060hpa

The following maintenance schedule is suggested for the attachment to ensure

optimum operation and safety.

Do the following Everyday After use As necessary

Inspect the attachment X

Clean the attachment X

Disinfect the attachment X

Sterilize the attachment X

8. Manufacturer
GE YOKOGAWA MEDICAL SYSTEMS
4-7-127, Asahigaoka, Hino-shi
Tokyo 191-8503
JAPAN

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