MTZ and MZ and E 721 Type Probe User Manual Rev 1

Regulatory Requirement.

The MTZ, MZ and E721 probe complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices as included in the following systems. MTZ Probe: LOGIQ™ 400, LOGIQ™ 500, LOGIQ™ 200 PRO series, LOGIQ™α200 series MZ Probe: RT fino E721 Probe: LOGIQ™ 400, LOGIQ™ 500

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

Feb. 26, 2004

Initial Release (Change from Parts# P9893YN Rev.7)

Rev. 1

Dec. 4th, 2006

Revise Manufacturer description. Remove RT4600/8000/x400 from the second page. Remove CE mark on the front page.

Table i-2: List of Effective Pages PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 1

Table of Contents TOC-1 thru 2

Rev. 1

Revision History i-1 and i-2

Rev. 1

1 thru 15

Rev. 1

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.

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

i -1

This page intentionally left blank.

i -2

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

Table of Contents

Table of Contents

Instructions... 1 General... 1 Composition... 1 Specifications... 2 High level disinfection/sterilization... 2 Outside Dimensions and Construction... 3 Operation... 4 How to install... 4 Tilting the grip... 6 Procedure... 6 Cleaning and Disinfecting the Probe... 7 Probe Cleaning Process... 7 Disinfecting probes... 8 Probe Immersion Level... 10 Storing the Probe... 11

Who To Contact... 12 Contacting GE Medical Systems Ultrasound... 12 Manufacturer... 15

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

TOC-1

Table of Contents

TOC-2

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

MTZ/MZ/E721 Type Probe

Instructions

General The probe is a 6.5MHz micro-convex device for conducting transvaginal and transcrectal scans. The probe grip is designed so that the handle can be adjusted straight or at an angle. This means that the probe can be used with its grip straight during a scan or with its grip tilted during a biopsy. Thus, the probe can be applied to a wide range of tasks.

Composition 1. Probe body, including • Head-Assy

• Knob

• Grip-Left

• Grip-Right

• Carrying Case

2. Operation Manual 3. Caution Sheet 4. Filling remover tool

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

1

MTZ/MZ/E721 Type Probe Specifications Scanning Method

Micro-convex, 10R

Frequency

6.5MHz

Field of view

MTZ/E721 Type Probe: 120° MT Type Probe: 122°

Number of elements

128

Weight

Approximately 170g (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

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

MTZ/MZ/E721 Type Probe

Outside Dimensions and Construction Biopsy guide recess

Right grip

Head-Assy Transducer

Left grip Knob Connector

346 150

136.9

FOV

50°

Figure 1-1.

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

Probe Dimensions

3

MTZ/MZ/E721 Type Probe 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.

4

Ultrasound Gel Placement

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

MTZ/MZ/E721 Type Probe 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 the probe sheath at the Transducer location for scanning. 4. Figure 5shows the relationship between the displayed image direction during an axial scan compared to the probe and probe position.

Patient’s foot

Patient’s head Display Monitor

Figure-5.

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

Scan Plane Orientation

5

MTZ/MZ/E721 Type Probe Tilting the grip The grip can be tilted within a range of 0° to 50° as shown in Figure 6.

Figure-6.

Handle Adjustment

Procedure 1. Loosen the screw by turning the knob on the probe body counterclockwise. 2. Set the grip to the desired angle and securely tighten the screw by turning the knob clockwise. 3. Apply the probe sheath to the probe follow the instructions on Page 4 and 5. CAUTION

6

If you attempt to tilt the grip or change the grip angle after putting the probe sheath on the probe, the probe sheath may break if it gets caught in the grip. To avoid this, be sure to tilt the grip before place the probe sheath.

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

MTZ/MZ/E721 Type Probe 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 7 on page-10. 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.

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

7

MTZ/MZ/E721 Type Probe

Da ily W ee k M ly on th ly O th er

Disinfecting probes

After Each Use

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% 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.

8

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

MTZ/MZ/E721 Type Probe 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.

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

9

MTZ/MZ/E721 Type Probe Probe Immersion Level Relief

Figure-7.

10

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.

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

MTZ/MZ/E721 Type Probe

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% non-condensing

30-90% 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 Inspect the probe

Everyday

After use

As necessary

X

Clean the probe

X

Disinfect the probe

X

Sterilize the probe

X

Table 2: Probe Planned Maintenance Program

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

11

MTZ/MZ/E721 Type Probe

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:

12

USA GE Medical Systems Ultrasound Service Engineering 4855 W.Electric Avenue Milwaukee, WI53219

TEL: (1) 800-437-1171 FAX: (1) 414-647-4090

Customer Answer Center

TEL: (1) 800-682-5327 (1) 262-524-5698

CANADA GE Medical Systems Ultrasound Service Engineering 4855 W.Electric Avenue Milwaukee, WI53219

TEL: (1) 800-664-0732

Customer Answer Center

TEL: (1) 262-524-5698

LATIN & SOUTH AMERICA GE Medical Systems Ultrasound Service Engineering 4855 W.Electric Avenue Milwaukee, WI53219

TEL: (1) 305-735-2304

Customer Answer Center

TEL: (1) 262-524-5698

EUROPE GE Ultraschall Deutschland GmbH & Co.KG Beethovenstraße 239 Postfach 11 05 60 D-42655 Solingen

TEL: 0130 81 6370 toll free TEL: (49) (0) 212.28.02.208 FAX: (49) (0) 212.28.02.28

ASIA On-Line Center (OLC), Asia

TEL: 65-6277-3512 FAX: 65-6272-3997

Japan Customer Call Center

TEL:0120-055-919 FAX: (81) 426-48-2905

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

MTZ/MZ/E721 Type Probe UNITED KINGDOM GE Medical Systems Coolidge House 352 Buckingham Avenue SLOUGH Berkshire SL1 4ER

TEL: 0800 89 7905 toll free FAX: +44 753 696067

OTHER COUNTRIES NO TOLL FREE

TEL: international code + 33 1 39 20 0007

Manufacturer MTZ Probe

LOGIQ™ 400, LOGIQ™ 500 including MTZ Probe GE Yokogawa Medical Systems 4-7-127, Asahigaoka, Hino-shi Tokyo, 191-8503 JAPAN LOGIQ™ 200 PRO series, LOGIQ™α200 series including MTZ Probe GE Healthcare Korea 65-1, Sangdaewon-Dong, Chungwon-ku Sungnam-Si, Kyunggi-Do Korea 462-120

MZ Probe

E721 Probe

RT fino including MZ Probe Wipro GE Medical Systems Plot No 4,Kadugodi Industrial area Sadaramangala Whitefield Bangalore 560067 INDIA

LOGIQ™ 400, LOGIQ™ 500 including E721 Probe GE Yokogawa Medical Systems 4-7-127, Asahigaoka, Hino-shi Tokyo, 191-8503 JAPAN

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1

15

MTZ/MZ/E721 Type Probe

16

MTZ/MZ/E721 Type Probe User Manual Direction 2406392-100 Rev. 1