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E8C Reusable Biopsy Guide Operation Manual

Copyright© 2003, 2009, 2010 By General Electric Co.

Regulatory Requirement

The E8C Reusable Biopsy Guide for use with the E8C probe complies with
regulatory requirements of the following European Directive 93/42/EEC.

GE Healthcare Japan Corporation

7-127, Asahigaoka 4-chome, Hino-shi, Tokyo
191-8503, JAPAN

GE Medical Systems Information Technologies GmbH

(GEMS IT GmbH)
Munzinger Strasse 3, D-79111 Freiburg, GERMANY
Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233
Revision History
Reason for change

Rev. Date Reason for change

Rev.0 November, 2003 Initial Release

Rev.1 April 20, 2009 Add Gas sterilization detail.

Rev.2 Jan. 20, 2010 Add EU Rep. symbol and Alter the manufacturer name.

List of Effective Pages

Page Number Revision Page Number Revision

Title page Rev.2 Table of Contents Rev.2

Revision History Rev.2 Page 1-12 Rev.2

Please verify that you are using the latest revision of this document. Information
pertaining to this document is maintained on MyWorkshop (GE Healthcare electronic
Product Data Management). If you need to know the latest revision, contact your
distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical
Answer Center at 1 800 682 5327 or 1 262 524 5698.

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 Table of Contents

Table of Contents

PRECAUTIONS FOR USE

Instructions
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2
Configurations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2
Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3
Outline view - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4
Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5
Cleaning and disinfecting the attachment - - - - - - - - - - - - - - - - - - - - - - - 9
Storage the attachment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12
Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12

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TOC-2 E8C Reusable Biopsy Guide Operation Manual
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 PRECAUTIONS FOR USE

When using this attachment, please take the following precautions:

1. Be careful not to damage the probe when you install or remove
this attachment.
2. If this attachment is dropped or damaged, the biopsy positions
and angles will warp and/or the attachment will not perform as
required. Discontinue use under these circumstances.
3. Guideline use - The guide line on the screen can be used as a
reference mark for inserting the biopsy needle in the proper
direction.
4. Others
Do not use if any accident or abnormal condition occurs with the
ultrasound system, probe or attachment.

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 Instructions

Instructions

Overview
This attachment has been installed on the E8C probe 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.

Configurations
• Attachment (made of stainless steel) x1
• Filling remover tool x1
• Cleaning Brush （10 inch) x1
• Operation Manual x1

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Specifications

Available probe Refer to the ultrasound system

documentation for further information.

Biopsy angle and depth See Figure 1 on page 3

Applicable biopsy needle 16G or thinner

Weight Approximately 39g (main frame only)

Application For transvaginal and transrectal

biopsies

CAUTION Please use this attachment only with the ultrasound diagnosis
system which the guideline of E8C Reusable biopsy guide is
supported. If you need to know the support situation, contact your
distributor, local GE Sales Representative or in the USA call the
GE Ultrasound Clinical Answer Center.

Center of the
ultrasound beam
Insertion route of
the biopsy
needle 1.57cm

Figure 1. Biopsy angle and depth

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 Instructions

Outline view

Figure 2. Outline view

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Procedures

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 Figure 3.

Filling remover tool

Area where the biopsy guide

attachment is installed

Probe head

Figure 3. Remove the filling

1. Fill the sterilized medical probe sheath with sterilized ultrasound

gel, and insert the probe in the medical probe sheath provided.
2. Install the sterilized biopsy attachment on the covered probe and
fix firmly with a fastening screw. See Figure 4.

Attachment Probe handle

Main frame of probe Medical probe sheath

Figure 4. Probe with the attachment and medical sheath

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 Instructions

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 connecting and selecting the probe.
2. Press Biopsy kit key on the Touch Panel and select the biopsy
guide line type “E8C-RU”. The biopsy guide line displays on the
monitor.
Refer to the Users Manual of the ultrasound system for details
on the biopsy guideline.

Display on the monitor

(Assuming that reverse function is on)

Figure 5. Displaying a biopsy guide line

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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.
Hold the probe steady and insert the applicable biopsy needle.

PR

PL

A = Anterior A
P = Posterior
PL = Patient Left
PR = Patient Right
PR
Figure 6. Transvaginal Scanning

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 Instructions

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 especially 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 Figure 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 image

point echo

Condition just after the biopsy Display on the monitor

needle appears on the image
Figure 7. Virtual image display

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.

Figure 8. Fine needle insertion

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Cleaning and disinfecting the attachment

Attachment cleaning process

To avoid 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 attachment 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 attachment as
needed using a soft sponge, gauze, or cloth to remove all visible
residue from the attachment surface. Prolonged soaking or
scrubbing with a soft bristle brush (such as a toothbrush) may be
necessary if material has dried onto the attachment surface.
3. Wash inside of the attachment with the provided cleaning brush.
4. Rinse the attachment with enough potable water to remove all
visible residue.
5. Air dry or dry the attachment with a soft cloth.
6. Store the attachment in a hygienic way.
7. Wash and dry the provided cleaning brush after the attachment
cleaning.

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.

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 Instructions

High level attachment disinfection

CAUTION The attachment can be disinfected using Ethylene oxide gas and
liquid chemical germicides.
Proceed with the appropriate disinfection and sterilization
procedures by following the regulatory requirements for your
country.

Disinfection The level of disinfection is directly related to the duration of contact

with Germicide with the germicide. Increased contact time produces a higher level
of disinfection, and sterilization effect.

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

recommended for this attachment
• Cidex
• Cidex PLUS
• Cidex OPA
• Sterihyde

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 directions 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 attachment and
allow to air dry.

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Sterilizing Process

Gas 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 gas sterilization using ethylene oxide gas. Follow
the instructions, recommendations and precautions provided by
the manufacturer of the sterilization equipment and gas supplier.

Table 1: Example of Sterilization condition

Gas used Ethylene oxide gas 20% (wt)

Carbon dioxide gas 80% (wt)

Gas concentration 300 - 400mg/L

Gas pressure 810 - 1215hPa

Sterilization temperature 26°C

Humidity 30 - 50%RH

Length of effectiveness 8 hours

Aeration more than 16 hours

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 Instructions

Storage the attachment

1. After cleaning and disinfection, store the attachment in it's case
for protection.
2. The attachment should be stored or transported within the
parameters outlined below.
Table 2: Environmental Requirements

Storage Transport

Temperature -10° - 60° C -40° - 60° C

14° - 140° F -40° - 140° F

Humidity 30 - 95% 30 - 95%

non-condensing non-condensing

Pressure 700 - 1060hPa 700 - 1060hPa

The following maintenance schedule is suggested for the

attachment to ensure optimum operation and safety.
Table 3: Planned Maintenance Program

Before After As
Do the Following Each Use Each Use Necessary

Inspect the attachment X X

Clean the attachment X

Disinfect the attachment X

Sterilize the attachment X

Manufacturer
GE Healthcare Japan Corporation
7-127 Asahigaoka 4-chome, Hino-shi
Tokyo, 191-8503
JAPAN

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