GE E8 User Manual

GE Medical Systems
Technical
Publications
2302323-100
Revision 5
E8C Type Probe

0459
E8C-RS Type Probe

0459
User Manual
Copyright© 2001, 2002, 2003, 2004 By General Electric Co.
Operating Documentation
Regulatory Requirement
The E8C probe complies with regulatory requirements of the following European Direc-
tive 93/42/EEC concerning medical devices for the LOGIQ™3, LOGIQ™5, LOGIQ™7,
LOGIQ™9 and Vivid 7 systems.
0459
The E8C-RS probe complies with regulatory requirements of the following European
Directive 93/42/EEC concerning medical devices for the LOGIQ Book only.
0459
GE Medical Systems
GE Medical Systems: Telex 3797371

P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
(Asia, Pacific, Latin America, North America)
GE Ultraschall: TEL: 49 212.28.02.208

Deutschland GmbH & Co. KG: FAX: 49 212.28.02.431
Beethovenstraße 239
Postfach 11 05 60
D-42655 Solingen GERMANY
Revision History
Table i-1: Reason for Change
REV DATE REASON FOR CHANGE
Rev. 0 June 1st, 2001 Initial Release

Rev. 1 August 10, 2001 Add the applicable system
Rev. 2 May 14, 2002 Add E8C-RS Probe
Rev. 3 Dec. 25, 2002 Add the applicable system
Rev. 4 May 27, 2003 Add the manufacturer and the applicable system
Rev. 5 Feb. 26, 2004 Add the description of a removal tool and Cidex Opa
Table i-2: List of Effective Pages
REVISION REVISION
PAGE NUMBER NUMBER PAGE NUMBER NUMBER
Title Page Rev. 5 Table of Contents TOC-1 thru 2 Rev. 5
Revision History i-1 and i-2 Rev. 5 1 thru 13 Rev. 5
Please verify that you are using the latest revision of this document. Information
pertaining to this document is maintained on GPC (GE Medical Systems Global
Product Configuration). 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.
E8C, E8C-RS Type Probe User Manual i-1

2302323-100 Rev. 5
This page intentionally left blank.
i -2 E8C, E8C-RS Type Probe User Manual

2302323-100 Rev. 5
Table of Contents
Table of Contents
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Composition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
High level disinfection/sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Outside Dimensions and Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Transvaginal Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Cleaning and Disinfecting the Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Probe Cleaning Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Disinfecting probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
High Level Probe Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Storing the Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Who To Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Contacting GE Medical Systems Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
E8C, E8C-RS Type Probe User Manual TOC-1

2302323-100 Rev. 5
Table of Contents
TOC-2 E8C, E8C-RS Type Probe User Manual

2302323-100 Rev. 5
E8C, E8C-RS Type Probe
Instructions
General
The probe is 6.5MHz micro-convex device for conducting transvaginal

scan.
Composition
1. Probe body, including:
• Head-Assy
• Grip
• Carrying Case
2. Operation Manual
3. Filling remover tool
E8C, E8C-RS Type Probe User Manual 1

2302323-100Rev 5
Specifications
Applicable System
E8C Probe LOGIQ™3
LOGIQ™5
LOGIQ™7
LOGIQ™9
Vivid 7
E8C-RS Probe LOGIQ Book
Scanning Method Micro-convex, 11R
Frequency 6.5MHz
Field of view 133°
Number of elements 128
Weight Approximately 140g (not including the cable

and connector)
High level disinfection/sterilization
By immersing into a germicide for plastic medical instruments. 2%(w/v)

glutaraldehyde solutions without surfactants are recommended.
Ethylene Oxide is recommended if gas sterilization is required. To avoid

probe damage, do not use process cycles that exceed 60° C or
pressuresthat difer normal atmosphere.
Follow the germicidi or gas manufacturer’s instructions regarding

concentration, time of contact, storage and disposal for high level
disinfection or sterilization.
2 E8C, E8C-RS Type Probe User Manual

2302323-100 Rev 5
Outside Dimensions and Construction
BIOPSY GUIDE Recess GRIP
Transducer Head Assy
323
149 129
FOV
unit:mm
Figure-1. Probe dimensions

2302323-100Rev 5
Operation
Refer to the section entitled Connecting the probe in the ultrasound

system user manual and connect the probe to the probe connector
provided on the control console.
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 2.
Filling remover tool
Area where the biopsy guide

attachment is installed
Probe head
Figure-2. Remove the filling
1. Fill the probe sheath with acoustic coupling gel as shown in Figure 3.
Probe sheath
ACOUSTIC
COUPLING GEL
Figure-3. Ultrasound gel placement

2302323-100 Rev 5
2. Place the gel-filled probe sheath on the transducer face and bring it up
the probe body so that the adjustment knob of the probe is completely
covered with the probe sheath as shown in Figure 4.
Probe sheath
Figure-4. Probe sheath application
3. Apply gel to outer surface of theprobe sheath at the transducer

location for scanning.
4. Figure 5 shows the relationship between the displayed image
direction during an axial scan compared to the probe and probe
position.
B
Patient’s Foot
A
B C
Patient’s Head
1/2 FOV
Display on Monitor
A
FOV
Figure-5. Scan plane orientation

2302323-100Rev 5
Cleaning and Disinfecting the Probe
The probe is driven with electrical energy that can injure the patient or
user if live internal parts are contaced by conductive solution:
CAUTION DO NOT immerse the probe into any liquid beyond the level indicated
by the immersion level in Figure 6 on page-9. Never immerse the
probe connector or probe adaptors in any liquid.
Probe Cleaning Process
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 probe from the ultrasound console and
remove all coupling gel from the probe by wiping with the soft cloth
and rinsing with flowing water.
2. Wash the probe with mild soap in lukewarm water(below 80° F[26° C]
is recommennded). 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
tooth brush)may be necessary if material has dried onto the probe
surface.
3. Rinse the probe with enough clean 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 probe with methanol, ethanol,
isopropanol, or any other alchol based cleaner.Such substances can
cause irreparable damage to the probe.

2302323-100 Rev 5
Disinfecting probes
Ultrasound probes can be disinfected using liquid chemical germicides.
ly
M ly The level of disinfection is directly related to the duration of contact with
th
k
er
ily
ee
on
th
Da
W
O the germicide. Increased contact time procedures a higher level of

After Each Use disinfection. 2% Glutaraldehyde-based solutions have been shown to be
very effective for this purpose. Cidex and Cidex Opa are the germicide
that have been evaluated for compatibility with the material used to
construct the probes.
Refer to the Probe Care Card or http://www.gemedicalsystems.com/rad/

us/probe_care.htm for more information.
CAUTION In order for liquid chemical germicides to be effective, all visible

residue must be removed during the cleaning process.Thoroughly
clean the probe 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. Place the cleaned and dried probe in contact with the germicide for
the time specified by the germicide manufacturer. High-level
disinfection is recommended for surface probes and is required for
endocavitary and intraoperative probes (follow the germicide
manufacturer’s recommended time).
Probes for neuro surgical intra-operative use must not sterilized with
liquid chemical sterilants because of the possibility of neuro toxic
residues remaining on the probe. Neurological procedures must be
done with the legally marketed, sterile, pyrogenfree probe sheaths.
3. After removing from the germicide, rinse the probe following the
germicide manufacturer’s rinsing instructions. Flush all visible
germicide residue from the probe and allow to air dry.

2302323-100Rev 5
WARNING Ultrasound transducers can easily be damaged by improper handling

and by contact with certain chemicals. Failure to follow all these
precautions can result in serious injury and equipment damage.
• DO NOT imerse the probe into any liquid beyond the level
specified for hat probe. Never immerse the transducer connector,
relief or probe adapters into any liquid.
• Avoid mechanical shock or impact to the transducer and do not
apply excessive bending or pulling force to the cable.
• Transducer damage can result from contact with inapropriate
coupling or cleaning agents:
• Do not soak or saturate transducers with solutions containing
alchol, bleach, ammonium chloride compounds or hydrogen
peroxide.
• Avoid contact with solutions or coupling gels containing
mineral oil or lanolin.
• Avoid temperatures above 60° C.
• Inspect the probe prior to use for damage or degeneration t the
housing, strain relief, lens and seal. Do not use a damaged or
defective probe.

2302323-100 Rev 5
High Level Probe Disinfection
RELIEF
Figure-6. Probe immersion level
CAUTION • DO NOT attempt to disinfect or sterilize the probe with an

autoclave or steam sterilization.
• DO NOT clean the probe by immersing in an alcohol solution.
• DO NOT soak, disinfect, or sterilize the connector and relief.
• DO NOT immerse the grip part of the probe.

2302323-100Rev 5
Storing the Probe
1. After cleaning and disinfection, store the probe in it’s carrying case for
protection.
2. Store the probe even when traveling for short distances in its carrying
case or in the system probe holder.
3. The probe should not be stored or transported within the parameters
outlined below.
Storage Transport
Temperature -10°−60° C -40° −60° C
Humidity 30-90% 30-90%

non-condensing non-condensing
Pressure 700-1060hPa 700-1060hPa
Table 1: Probe Environmental Requirements
The following maintainance schedule is suggested for the probe to ensure

optimum operation and safety.
Do the following Everyday After use As necessary
Inspect the probe X
Clean the probe X
Disinfect the probe X
Sterilize the probe X
Table 2: Probe Planned Maintenance Program

2302323-100 Rev 5
Who To Contact
Contacting GE Medical Systems Ultrasound
For additional information or assistance, please contact your local

distributor or the appropriate support resource listed below:
USA TEL: (1) 800-437-1171

GE Medical Systems FAX: (1) 414-647-4090
Ultrasound Service Engineering
4855 W.Electric Avenue
Milwaukee, WI53219
Customer Answer Center TEL: (1) 800-682-5327

(1) 262-524-5698
CANADA TEL: (1) 800-664-0732

GE Medical Systems
Milwaukee, WI53219
LATIN & SOUTH AMERICA TEL: (1) 305-735-2304

GE Medical Systems
Milwaukee, WI53219
EUROPE TEL: 0130 81 6370 toll free

GE Ultraschall TEL: (49) (0) 212.28.02.208
Deutschland GmbH & Co.KG FAX: (49) (0) 212.28.02.28
Postfach 11 05 60
D-42655 Solingen
ASIA TEL: 65-6277-3512

On-Line Center (OLC), Asia FAX: 65-6272-3997
Japan TEL:0120-055-919
Customer Call Center FAX: (81) 426-48-2905

2302323-100Rev 5
ARGENTINA TEL: (1) 639-1619

GEME S.A FAX: (1) 567-2678
Miranda 5237
Buenos Aires - 1407
AUSTRIA TEL: 0660 8459 toll free

GE GesmbH Medical Systems Austria FAX: +43 1 505 38 74
Prinz Eugen Strasse 8/8 TLX: 136314
A-1040 WIEN
BELGIUM TEL: 0 800 11733 toll free

GE Medical Systems Benelux FAX: +32 0 3 320 12 59
Gulkenrodestraat 3 TLX: 72722
B-2160 WOMMELGEM
BRAZIL TEL: 0800-122345

GE Sistemas Médicos FAX: (011) 3067-8298
Av Nove de Julho 5229
01407-907 São Paulo SP
DENMARK TEL: +45 4348 5400

GE Medical Systems FAX: +45 4348 5399
Fablicsparken 20
DK-2600 GLOSTRUP
FRANCE TEL: 05-49-33-71 toll free

GE Medical Systems FAX: +33 1 46 10 01 20
738 rue Yves Carmen
F-92658 BOULOGNE CEDEX
GERMANY TEL: 0130 81 6370 toll free

GE Ultraschall TEL: (49) (0) 212.28.02.208
Deutschland GmbH & Co.KG FAX: (49) (0) 212.28.02.28
Postfach 11 05 60
D-42655 Solingen
GREECE TEL: +30 1 93 24 582

GE Medical Systems Hallas FAX: +30 1 93 58 414
41, Nikolaou Plastira Street
G-172 21 NEA SMYRNI
ITALY TEL: 1678 744 73 toll free

GE Medical Systems Italia FAX: +39 39 73 37 86
Via Monte Albenza 9 TLX: 3333 28
1-20052 MONZA
LUXEMBOURG TEL: 0800 2603 toll free

2302323-100 Rev 5
MEXICO TEL: (5) 228-9600

GE Sistemas Médicos de Mexico S.A. de C.V FAX: (5) 211-4631
Rio Lerma #302, 1º y 2º
Colonia Cuauhtémoc
06500-México, D.F.
NETHERLANDS TEL: 06 022 3797 toll free

GE Medical Systems Nederland B.V. FAX: +31 304 11702
Atoomweg 512
NL-3542 AB UTRECHT
POLAND TEL: +48 2 625 59 62

GE Medical Systems Polska FAX: +48 2 615 59 66
Krzywickiego 34
P-02-078 WARSZAWA
PORTUGAL TEL: 05 05 33 7313 toll free

GE Medical Systems Portuguesa S.A. FAX: +351 2 2084494
Rua Sa da Bandeira, 585 TLX: 22804
Apartado 4094
P-4002 PORTO CODEX
RUSSIA TEL: +7 095 956 7037

GE VNIIEM FAX: +7 502 220 32 59
Mantulinskaya UI. 5A TLX: 613020 GEMED SU
123100 MOSCOW
SPAIN TEL: 900 95 3349 toll free

GE Medical Systems España FAX: +34 1 675 3364
Hierro 1 Auturo Gimeno TLX: 22384 A/B GEMDE
Poligono Industrial I
E-28850 TORREJON DE ARDOZ
SWEDEN TEL: 020 795 433 toll free

GE Medical Systems FAX: +46 87 51 30 90
PO-BOX 1243 TLX: 12228 CGRSWES
S-16248 KISTA
SWITZERLAND TEL: 155 5306 toll free

GE Medical Systems (Schweiz) AG FAX: +41 41 421859
Sternmattweg 1
CH-6010 KRIENS
TURKEY TEL: +90 212 75 5552

GE Medical Systems Turkiye A.S. FAX: +90 212 211 2571
Mevluk Pehliran Sodak
Yilmaz Han, No 24 Kat 1
Gayretteppe
ISTANBUL

2302323-100Rev 5
UNITED KINGDOM TEL: 0800 89 7905 toll free

GE Medical Systems FAX: +44 753 696067
Coolidge House
352 Buckingham Avenue
SLOUGH
Berkshire SL1 4ER
OTHER COUNTRIES TEL: international code +

NO TOLL FREE 33 1 39 20 0007
Manufacturer
GE Medical System (China) Co., Ltd.
No. 19, Changjiang Road
WuXi National Hi-Tech Development Zone
Jiangsu, P.R. China 214028
TEL: +86 510 5225888; FAX: +86 510 5226688
GE YOKOGAWA MEDIDCAL SYSTEMS

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

2302323-100 Rev 5

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What models of ultrasound systems is the E8C probe compatible with?

What models of ultrasound systems is the E8C probe compatible with?

GE Medical Systems

E8C Type Probe

E8C-RS Type Probe

Copyright© 2001, 2002, 2003, 2004 By General Electric Co.

GE Medical Systems: Telex 3797371

GE Ultraschall: TEL: 49 212.28.02.208

Table i-1: Reason for Change

REV DATE REASON FOR CHANGE

Rev. 0 June 1st, 2001 Initial Release

Table i-2: List of Effective Pages

Title Page Rev. 5 Table of Contents TOC-1 thru 2 Rev. 5

Revision History i-1 and i-2 Rev. 5 1 thru 13 Rev. 5

E8C, E8C-RS Type Probe User Manual i-1

i -2 E8C, E8C-RS Type Probe User Manual

Who To Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

E8C, E8C-RS Type Probe User Manual TOC-1

TOC-2 E8C, E8C-RS Type Probe User Manual

The probe is 6.5MHz micro-convex device for conducting transvaginal

E8C, E8C-RS Type Probe User Manual 1

Scanning Method Micro-convex, 11R

Field of view 133°

Number of elements 128

Weight Approximately 140g (not including the cable

High level disinfection/sterilization

By immersing into a germicide for plastic medical instruments. 2%(w/v)

Ethylene Oxide is recommended if gas sterilization is required. To avoid

Follow the germicidi or gas manufacturer’s instructions regarding

2 E8C, E8C-RS Type Probe User Manual

Outside Dimensions and Construction

BIOPSY GUIDE Recess GRIP

Transducer Head Assy

Figure-1. Probe dimensions

E8C, E8C-RS Type Probe User Manual 3

Refer to the section entitled Connecting the probe in the ultrasound

Filling remover tool

Area where the biopsy guide

Figure-2. Remove the filling

Figure-3. Ultrasound gel placement

4 E8C, E8C-RS Type Probe User Manual

Figure-4. Probe sheath application

3. Apply gel to outer surface of theprobe sheath at the transducer

Figure-5. Scan plane orientation

E8C, E8C-RS Type Probe User Manual 5

Cleaning and Disinfecting the Probe

Probe Cleaning Process

Avoid cross contamination. Follow all infection control policies established

6 E8C, E8C-RS Type Probe User Manual

Ultrasound probes can be disinfected using liquid chemical germicides.

O the germicide. Increased contact time procedures a higher level of

Refer to the Probe Care Card or http://www.gemedicalsystems.com/rad/

CAUTION In order for liquid chemical germicides to be effective, all visible

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

E8C, E8C-RS Type Probe User Manual 7

WARNING Ultrasound transducers can easily be damaged by improper handling

8 E8C, E8C-RS Type Probe User Manual