MTZ and MZ and E 721 Type Probe User Manual Rev 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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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. 2. 3. 4. 5.

Available probes: Biopsy angle and depth: Applicable biopsy needle: Weight: Application:

MTZ, MZ, E721 and E72 type probes See Illustration 1. 16G or thinner, effectual length 22cm or longer Approximately 16g (main frame only) For transvaginal and transrectal biopsies

INSERTION ROUTE OF THE BIOPSY NEEDLE

CENTER OF THE ULTRASOUND BEAM

1.5cm

Illustration-1.

MTZ/MZ/E721/E72 TYPE PROBE

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4. DIMENSIONS (mm)

9

212 9

30

3.1

6.6

CONNECTION HOOK

ATTACHMENT 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.

A

PR

P

PL

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

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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

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The needle point echoes on the image appear slightly outside the actual position.

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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 sidelobe 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 POINT ECHO

CONDITION JUST AFTER THE BIOPSY NEEDLE APPEARS ON THE IMAGE

VIRTUAL IMAGE

DISPLAY ON THE MONITOR

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 Germicide

The level of disinfection is directly related to the duration of contact with the 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% Glutaraldehydebased germicide) and Sporox (an alternative germicide with non–glutaraldehydebased 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

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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 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 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% non-condensing

30 ～ 95% 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

Inspect the attachment

After use

As necessary

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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