Probe User Manual

Regulatory Requirements Conformance Standards The following classifications are in accordance with the IEC60601-1: 1988 + AMD1 + AMD2: 6.8.1 & IEC60601-1: 2005: 7.9 •

According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device.

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According to IEC/EN 60601-1, Equipment is Class I, Type B with BF or CF Applied Parts. According to IEC 60529,

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Probe head (immersible portion) and cable are IPX7 Probe connector is not waterproof.

Certifications •

General Electric Medical Systems is ISO 9001 and ISO 13485 certified.

Original Documentation •

The original document was written in English.

Revision History Reason for Change REV

DATE

Rev. 1

June 13, 2012

Rev. 2

April 25, 2014

Rev. 3

October 31, 2018

Rev. 4

October 31, 2021

List of Effective Pages PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 4

Regulatory Requirements

Rev. 4

Revision History

Rev. 4

Chapter 1-32

Rev. 4

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Chapter 1 Probes This chapter consists of the information of each probe and describes some special concerns.

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Probes

Probe Overview

Introduction This manual provides information for the following probes: • • • • • •

BE9C Probe E8C Probe ERB Probe I739/I739-RS Probe T739/T739-RS Probe IC5-9H Probe

Unless specified otherwise “the probe” means either of these probes. Not all the probes described in this manual may be working with your GE ultrasound unit. Refer to the system’s user documentation for a complete list over available probes.

The intention with this manual This manual aims to give the probe user the information necessary to become a confident user of the probes. It also includes suggestions on how to care for the probe at all stages of handling. As an aid in safeguarding the patient and ensuring reliable probe operation, we recommend that this manual is kept close at hand during all stages of probe handling. This manual do not include instructions on how to operate the system or how to evaluate clinical data. For such information, please consult the system user manual and other appropriate literature. The manual does not give clinical guidance for use. This manual is a supplement to the user manual of the ultrasound system.

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Probe Overview Ergonomics Probes have been ergonomically designed to: • • • • •

Handle and manipulate with ease Connect to the system with one hand Be lightweight and balanced Have rounded edges and smooth surfaces. Stand up to typical wear by cleaning and disinfectant agents, contact with approved gel, etc.

Cables have been designed to: •

Connect to system with appropriate cable length

Cable handling Take the following precautions with probe cables: • • •

Keep free from wheels Do not bend the cable acutely Avoid crossing cables between probes.

Labeling Each probe is labeled with the following information: • • • • • •

Probe User Manual 5458933-100 Rev. 4

Seller's name and manufacturer Operating frequency (not shown on all probes) GE part number Probe serial number Month and year of manufacture Probe designation-provided on the probe grip or the top of the connector casing, so it is easily read when mounted on the system and is also automatically displayed on the screen when the probe is selected.

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Probes

Probe Safety

Precaution Levels Various levels of safety precautions may be found on the equipment and different levels of concern are identified by one of the following flag words and icons which precede the precautionary statement. WARNING

Indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause: • •

CAUTION

Indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause: • •

NOTE:

Minor injury Property damage.

Indicates precautions or recommendations that should be used in the operation of the ultrasound system, specifically: • • •

Probe User Manual 5458933-100 Rev. 4

Severe personal injury Substantial property damage.

Maintaining an optimum system environment Using this Manual Notes to emphasize or clarify a point.

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Probe Safety Probe handling and infection control This information is intended to increase user awareness of the risks of disease transmission associated with using this equipment and provide guidance in making decisions directly affecting the safety of the patient as well as the equipment user. Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient by direct physical contact. Depending on the type of examination, this contact occurs with a variety of tissues ranging from intact skin in a routine exam to recirculating blood in a surgical procedure. The level of risk of infection varies greatly with the type of contact. One of the most effective ways to prevent transmission between patients is with single use or disposable devices. However, ultrasound transducers are complex and expensive devices that must be reused between patients. It is very important, therefore, to minimize the risk of disease transmission by using barriers and through proper processing between patients. CAUTION

Adequate cleaning and disinfection are necessary to prevent disease transmission. It is the responsibility of the equipment user to verify and maintain the effectiveness of the infection control procedures in use.

CAUTION

To minimize the risk of infection from blood-borne pathogens, you must handle the probe and all disposables which have contacted blood, other potentially infectious materials, mucous membranes, and non-intact skin in accordance with infection control procedures. You must wear protective gloves when handling potentially infectious material. Use a face shield and gown if there is a risk of splashing or splatter.

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Probes Using protective sheaths CAUTION

Protective barriers may be required to minimize disease transmission. Probe sheaths are available for use with all clinical situations where infection is a concern. Always use a legally marketed, sterile probe sheaths for intracavitary and intra-operative procedures. For neurological intra-operative procedures, use of a legally marketed, sterile, pyrogen free probe sheath is REQUIRED. If the sheath becomes damaged during a procedure, stop immediately and replace.

CAUTION

Devices containing latex may cause severe allergic reaction in latex sensitive individuals. Refer to FDA's March 29, 1991 Medical Alert on latex products.

CAUTION

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

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

Some pictures in this manual are shown without a sterile sheath for ease of understanding. Make sure to use a sterile sheath.

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Probe Safety Handling precautions WARNING

Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling. Use care when handling and protect from damage when not in use. DO NOT use a damaged or defective probe. Failure to follow these precautions can result in serious injury and equipment damage.

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. Refer to the Probe Care Card enclosed in the probe case. Use only disinfectants that are listed in the Probe Care Card enclosed in the probe case or listed on below website. http://www.gehealthcare.com/transducers

WARNING

Probes for transvaginal and transrectal applications, DO NOT use the needle with the catheter (soft tube). There is a possibility of the breaking the catheter in the body.

CAUTION

Probes for transvaginal and transrectal applications require special handling. Transvaginal/transrectal examinations and probe insertions should be performed only by personnel with adequate training.

Mechanical hazards CAUTION

A defective probe or excessive force can cause patient injury or probe damage: • • •

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Observe depth markings and do not apply excessive force when inserting or manipulating intercavitary probes. Inspect probes for sharp edges or rough surfaces that could injure sensitive tissue. DO NOT apply excessive force to the probe connector when inserting into the probe port.

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Probes Electrical shock hazard Electrical Hazard

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The probe is driven with electrical energy that can injure the patient or user if live internal parts are contacted by conductive solution: •

DO NOT immerse the probe into any liquid beyond the level indicated by the immersion level diagram. Refer to the immersion illustration in the Probe Cleaning Process section. Never immerse the probe connector or probe adaptors into any liquid.

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DO NOT drop the probes or subject them to other types of mechanical shock or impact. Degraded performance or damage such as cracks or chips in the casing may result.

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Prior to each use, visually inspect the probe lens and case area for cracks, cuts, tears, and other signs of physical damage. DO NOT use a probe which appears to be damaged until you verify functional and safe performance. You must perform a more thorough inspection, including the cable, strain relief, and connector, each time you clean the probe.

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DO NOT kink, tightly coil, or apply excessive force on the probe cable. Insulation failure may result.

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Electrical leakage checks should be performed on a routine basis by GE Service or qualified hospital personnel. Refer to the service manual for leakage check procedures.

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Care and Maintenance

Care and Maintenance

Planned maintenance CAUTION

Improper handling can lead to early probe failure and electric shock hazards. DO follow the specific cleaning and disinfection procedures provided in this chapter and the disinfectant manufacturers instructions. Failure to do so will void probe warranty. The following maintenance schedule is suggested for the system and probes to ensure optimum operation and safety. It is recommended to keep a maintenance log and note all probe malfunctions, along with a picture of any probe malfunction. Table 1-1:

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Planned Maintenance Program

Do the Following

Before Each Use

After Each Use

As Necessary

Inspect the Probes

X

X

X

Clean the Probes

X

X

Disinfect the Probes

X

X

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Probes Inspecting probes CAUTION

If any damage is found, DO NOT use the probe until it has been inspected and released for further use by a GE service representative.

Before each use 1. Inspect the probe's lens, cable, casing, and connector for cracks, cuts, tears, and other signs of physical damage. 2. Test the functionality of the probe.

Figure 1-1. 1. 2. 3. 4. 5.

Probe parts - example

Casing Strain relief Lens Cable Probe connector

After each use 1. Inspect the probe's lens, cable, casing, and connector for cracks, cuts, tears, and other signs of physical damage. 2. Look for any damage that would allow liquid to enter the probe.

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Care and Maintenance Storing the Probe After cleaning and disinfection, store the probe in it's carrying case for protection.

Transporting probes Store the probe even when traveling for short distances in its carrying case or in the system probe holder.

Environmental Requirements The probe should be operated, stored, or transported within the parameters outlined below. Table 1-2:

BE9C/I739/I739-RS/T739/T739-RS Probe Environmental Requirements Operational

Storage

Transport

Temperature

10° - 40° C 50° - 104° F

0° - 55° C 32° - 131° F

0° - 55° C 32° - 131° F

Humidity

30 - 85% non-condensing

30 - 85% non-condensing

30 -85% non-condensing

Pressure

700 - 1060hPa

700 - 1060hPa

700 - 1060hPa

Table 1-3: E8C/ERB/IC5-9H Probe Environmental Requirements Operational

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Storage

Transport

Temperature

10° - 40° C 50° - 104° F

-10° - 60° C 32° - 131° F

-40° - 60° C 32° - 131° F

Humidity

30 - 85% non-condensing

30 - 90% non-condensing

30 -90% non-condensing

Pressure

700 - 1060hPa

700 - 1060hPa

700 - 1060hPa

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Probes Cleaning and disinfecting probes Read instruction ref. 5661328 on below website or contact your GE representative. https://www.gehealthcare.com/en/support/support-documentation-library

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Care and Maintenance Coupling gels WARNING

Do not use unrecommended gels (lubricants). They may damage the probe and void the warranty. Recommended gels are listed in the Probe Care Card enclosed in the probe case or listed on below website. http://www.gehealthcare.com/transducers

Applying 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. CAUTION

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

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Probes Returning/Shipping Probes and Repair Parts US Department of Transportation and GE Medical Systems policy requires that equipment returned for service MUST be clean and free of blood and other infectious substances. When you return a probe or part for service (Field Engineer or customer), you need to clean and disinfect the probe or part prior to packing and shipping the equipment. Ensure that you follow probe cleaning and disinfection instructions provided in the Basic User Manual. This ensures that employees in the transportation industry as well as the people who receive the package are protected from any risk.

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BE9C Probe

BE9C Probe

Transrectal Scanning without Water Path 1. Remove the probe from the probe case and carefully examine it for any damage. 2. Clean and then disinfect the BE9C probe. 3. Inspect a sterile/sanitary sheath. Place a small amount of ultrasound gel inside the sheath tip (the gel is between the sheath inner surface and the probe aperture).

Figure 1-2.

Ultrasound Gel Placement

a. Probe sheath b. Ultrasound gel 4. Place the sheath tip over the probe aperture and then pull the sheath end toward the probe handle. 5. Place a rubber band over the sheath at the end of the probe shaft. Ensure the rubber band is tight around the sheath. Rub your finger over the tip of the probe to ensure all air bubbles have been eliminated. 6. Place a small amount of ultrasound gel on the gel-filled sheath tip outer surface.

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Probes Transrectal Scanning with Water Path (optional) 1. Remove the probe from the probe case and carefully examine it for any damage. 2. Clean and then disinfect the BE9C probe. 3. Fill the syringe with degassed water. 4. Attach tubing to the syringe and remove the air bubbles. 5. Inspect a sterile/sanitary inner sheath (finger cot). Put inner sterile sheath (finger cot) on the probe and secure it tightly with a rubber band. Double looping of the rubber band is suggested. NOTE:

6. Attach the tubing to the probe and inject water. The Water Path Inlet for BE9C probe is a luer lock form.”Luer Lock Extension” is available to adapt handle end luer lock and luer lock of syringe or extension tube. Please contact GE Medical Systems.

Figure 1-3. a. Optional Water Path Inlet (Luer lock) 7. Tilt the probe and withdraw water, forcing the air bubbles out first. Repeat as necessary to remove all air bubbles. 8. Inspect a sterile/sanitary outer sheath. Put a small amount of gel into the outer sterile sheath. 9. Place the sheath tip over the probe aperture and pull the sheath end down toward the probe handle

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BE9C Probe System Preparation 1. Connect the BE9C probe connector to the Ultrasound system’s probe port (refer to the system Users Manual). 2. If needed, display the needle placement guide line (refer to the system Users Manual). NOTE:

Sterile/sanitary sheaths are to be used on the probe during its actual use with patients. Wearing gloves protects the patient and operator.

Patient Preparation for Transrectal Imaging 1. Prepare the patient. An enema is recommend one hour before the exam. 2. Transrectal imaging is best performed in the flank or lithotomy position.

Changing Scan Method Changing scan methods between two micro-convex: Press the switch on the BE9C probe. See the system Users Manual for details.

Figure 1-4. a. Switching button

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