E8C Type Probe/E8C-RS Type Probe User Manual

Regulatory Requirement The E8C Type probe complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices for the ultrasound system.

The E8C-RS Type Probe complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices for the ultrasound system.

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

June 1st, 2001

Initial Release

Rev. 1

Aug. 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

Rev. 6

April 17, 2008

Remove the applicable system description from Page 1.

Rev. 7

Nov. 6, 2008

Revise Eu Rep and List 3 of Storing the probe.

Rev. 8

July. 17, 2009

Add EURep symbol and Alter the manufacturer name.

Rev. 9

Dec. 25, 2009

Remove system name from Regulatory requirement description.

List of Effective Pages

PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev.9

Table of Contents

Rev.9

Revision History

Rev.9

1 thru 16

Rev.9

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on MyWorkshop/ePDM (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.

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Table of Contents

Table of Contents

Instructions General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1 Composition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1 Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1 Outside Dimensions and Construction - - - - - - - - - - - - - - - - - - - - - - - - - 2 Operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3 Cleaning and Disinfecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - 6 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9 Storing the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10 Contact Information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Instructions

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

Specifications Scanning Method

Micro-convex, 11R

Frequency

6.5MHz

Field of View

133 degrees

Number of elements

128

Weight

Approximately 140g (not including the cable and connector)

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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Outside Dimensions and Construction

Figure -1. Probe dimensions

2

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Instructions 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.

WARNING

Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals. Failure to follow these precautions can result in serious injury and equipment damage. •

Do not immerse the probe into any liquid beyond the level specified for that probe. Never immerse the transducer connector 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 inappropriate coupling or cleaning agents:

•

•

Do not soak or saturate transducers with solutions containing alcohol, 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 to the housing, strain relief, lens and seal. Do not use a damaged or defective probe.

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.

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Remove the filling

3

1. Fill the probe sheath with acoustic coupling gel as shown in Figure 3.

Figure -3. Ultrasound gel placement 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.

Figure -4. Probe sheath application

CAUTION

Do not use pre-lubricated condoms as a sheath. In some cases, they may damage the probe. Lubricants in these condoms may not be compatible with probe construction.

CAUTION

DO NOT use an expired probe sheath. Before using probe sheaths, verify whether the term of validity has expired.

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

4

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Instructions 4. Figure 5 shows the relationship between the displayed image direction during an axial scan compared to the probe and probe position.

Figure -5. Scan plane orientation

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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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. Disconnect the probe from the ultrasound console and remove all coupling gel from the probe by wiping with a soft cloth and rinsing with flowing water. 2. Wash the probe with mild soap in lukewarm water. 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 clean potable water to remove all visible soap residue. 4. Air dry or dry with a soft cloth.

CAUTION

6

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.

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Instructions Disinfecting probes Ultrasound probes can be disinfected using liquid chemical germicides. The level of disinfection is directly related to the duration of contact with the germicide. Increased contact time procedures a higher level of disinfection. 2% Glutaraldehydebased 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.gehealthcare.com/ usen/ultrasound/products/probe_care.html.

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.

CAUTION

CREUTZFIELD-JACOB DISEASE Neurological use on patients with this disease must be avoided. If a probe becomes contaminated, there is no adequate disinfecting means.

Biological Hazard

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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High Level Probe Disinfection

Figure -6.

CAUTION

8

Probe immersion level

•

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.

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Instructions Coupling gels

WARNING

Applying

CAUTION

Precautions

Do not use unrecommended gels (lubricants). They may damage the probe and void the warranty.

In order to assure optimal transmission of energy between the patient and probe, a conductive gel or couplant must be applied liberally to the patient where scanning will be performed.

Do not apply gel to the eyes. If there is gel contact to the eye, flush eye thoroughly with water.

Coupling gels should not contain the following ingredients as they are known to cause probe damage: •

Methanol, ethanol, isopropanol, or any other alcohol-based product

•

Mineral oil

•

Iodine

•

Lotions

•

Lanolin

•

Aloe Vera

•

Olive Oil

•

Methyl or Ethyl Parabens (para hydroxybenzoic acid)

•

Dimethylsilicone

•

Polyether glycol based

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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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 be stored or transported within the parameters outlined below. Table 1:

2D Probe Environmental Requirements Operational

Storage

Transport

Temperature

10° - 40° C 50° - 104° F

-10° - 60° C 14° - 140° F

-40° - 60° C -40° - 140° F

Humidity

30 - 85% non-condensing

30 - 90% non-condensing

30 - 90% non-condensing

Pressure

700 - 1060hPa

700 - 1060hPa

700 - 1060hPa

The following maintenance schedule is suggested for the system and probes to ensure optimum operation and safety.. Table 2: Do the Following Inspect the probes

Planned Maintenance Program

Daily

After Each Use

X

Clean the probes

X

Disinfect the probes

X

Sterilize probes

10

As Necessary

X

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Instructions Contact Information Contacting GE Healthcare Ultrasound For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages: INTERNET

http://www.gehealthcare.com http://www.gehealthcare.com/usen/ultrasound/products/ probe_care.html USA

Clinical Questions

GE Healthcare TEL: (1) 800-437-1171 Ultrasound Service Engineering FAX: (1) 414-721-3865 9900 Innovation Drive Wauwatosa, WI 53226 For information in the United States, Canada, Mexico and parts of the Caribbean, call the Customer Answer Center TEL: (1) 800-682-5327 or (1) 262-524-5698 In other locations, contact your local Applications, Sales or Service Representative.

Service Questions

For service in the United States, call GE CARES TEL: (1) 800-437-1171 In other locations, contact your local Service Representative.

Accessories Catalog Requests

To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center TEL: (1) 800-643-6439 In other locations, contact your local Applications, Sales or Service Representative.

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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Contacting GE Healthcare Ultrasound (continued) Placing an Order

To place an order, order supplies or ask an accesory-related question in the United States, call the GE Access Center TEL: (1) 800-472-3666 In other locations, contact your local Applications, Sales or Service Representative.

CANADA

GE Healthcare TEL: (1) 800-664-0732 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Customer Answer Center TEL: (1) 262-524-5698

LATIN & SOUTH AMERICA

GE Healthcare TEL: (1) 262-524-5300 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Customer Answer Center TEL: (1) 262-524-5698

EUROPE

GE Ultraschall TEL: 0130 81 6370 toll free Deutschland GmbH & Co. KG TEL: (33) 130.831.300 Beethovenstrasse 239 FAX: (49) 212.28.02.431 Postfach 11 05 60 D-42655 Solingen

ASIA

GE Ultrasound Asia (Singapore) TEL: 65-291 8528 Service Department - Ultrasound FAX: 65-272-3997 298 Tiong Bahru Road #15-01/06 Central Plaza Singapore 169730

JAPAN

12

GE Healthcare Japan Corporation TEL: (81) 42-648-2910 Customer Service Center FAX: (81) 42-648-2905

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

Instructions Contacting GE Healthcare Ultrasound (continued) ARGENTINA

GEME S.A. TEL: (1) 639-1619 Miranda 5237 FAX: (1) 567-2678 Buenos Aires - 1407

AUSTRIA

GE GesmbH Medical Systems Austria TEL: 0660 8459 toll free Prinz Eugen Strasse 8/8 FAX: +43 1 505 38 74 A-1040 WIEN TLX: 136314

BELGIUM

GE Healthcare BVBA TEL: +32 0 2 719 72 04 Kouterveldstraat 20 FAX: +32 0 2 719 72 05 B-1831 Diegem

BRAZIL

GE Sistemas Medicos TEL: 0800-122345 Av Nove de Julho 5229 FAX: (011) 3067-8298 01407-907 Sao Paulo SP

CHINA

GE Healthcare - Asia TEL: (8610) 5806 9403 No. 1, Yongchang North Road FAX: (8610) 6787 1162 Beijing Economic & Technology Development Area Beijing 100176, China

DENMARK

FRANCE

GERMANY

GREECE

ITALY

LUXEMBOURG

GE Medical Systems TEL: +45 4348 5400 Fabriksparken 20 FAX: +45 4348 5399 DK-2600 GLOSTRUP GE Medical Systems TEL: 05 49 33 71 toll free 738 rue Yves Carmen FAX: +33 1 46 10 01 20 F-92658 BOULOGNE CEDEX GE Ultraschall TEL: 0130 81 6370 toll free Deutschland GmbH & Co. KG TEL: (49) 212.28.02.207 Beethovenstrasse 239 FAX: (49) 212.28.02.431 Postfach 11 05 60 D-42655 Solingen GE Medical Systems Hellas TEL: +30 1 93 24 582 41, Nikolaou Plastira Street FAX: +30 1 93 58 414 G-171 21 NEA SMYRNI GE Medical Systems Italia TEL: 1678 744 73 toll free Via Monte Albenza 9 FAX: +39 39 73 37 86 I-20052 MONZA TLX: 3333 28 TEL: 0800 2603 toll free

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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Instructions Contacting GE Healthcare Ultrasound (continued) UNITED KINGDOM

OTHER COUNTRIES

GE Medical Systems TEL: 0800 89 7905 toll free Coolidge House FAX: +44 753 696067 352 Buckingham Avenue SLOUGH Berkshire SL1 4ER NO TOLL FREE TEL: international code + 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 Healthcare Japan Corporation 7-127, Asahigaoka 4-Chome Hino-Shi Tokyo, 191-8503 JAPAN

E8C Type Probe/E8C-RS Type Probe User Manual 2302323-100 Rev.9

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