Common Reusable Biopsy Attachment User Manual Rev1 March 2020

Regulatory Requirement E8C Reusable Biopsy Guide Attachment and ERB7/ERB Biopsy Guide Attachment complies with the following European Regulation (EU) 2017/745.

Original Documentation •

The original document was written in English.

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

European registered place of business: GE Medical Systems SCS 283 rue de la Minière 78530 BUC, France Tel: +33 (0) 1 30 70 4040

Revision History Reason for change Rev.

Date

Rev.1

March, 2020

Reason for change Initial Release

List of Effective Pages Page Number

Revision

Page Number

Revision

Title page

Rev.1

Revision History Page

Rev.1

Regulatory Requirement

Rev.1

Page 4-34

Rev.1

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... 2 Safety Precautions ... 3 Biopsy Overview ... 9 E8C Reusable Biopsy Guide Attachment Instructions ... 12 ERB7/ERB Biopsy Attachment ... 20 Instructions ... 20 Cleaning, disinfection and Sterilization ... 29 Storage and Transport ... 33 Regular Maintenance... 34

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Safety Precautions 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

CAUTION

NOTE:

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

Severe personal injury

•

Substantial property damage.

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

Minor personal injury

•

Property damage.

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

Maintaining an optimum system environment

•

Using this Manual

•

Notes to emphasize or clarify a point.

General Warning Sign

Clinical benefits The clinical benefit of a diagnostic ultrasound device is to help healthcare professionals provide an accurate diagnostic information (visualize human tissue/internal structure) that enhances the diagnostic and treatment care pathways of the patient for a variety of diseases and conditions.

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Biological Hazards on 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, probes 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.

WARNING

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.

WARNING

To minimize the risk of infection from blood-borne pathogens, you must handle products which have contacted blood, other potentially infectious materials, mucous membranes, and non-intact skin in accordance with infection control procedures.

WARNING

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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Using protective sheath WARNING

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. If the sheath becomes damaged during a procedure, stop immediately and replace.

WARNING

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

WARNING

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.

WARNING

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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Mechanical hazards on Handling Devices WARNING

WARNING

Ultrasound products 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 product. Failure to follow these precautions can result in serious injury and equipment damage. When using this attachment, please take the following precautions: •

Be careful not to damage products when you install or remove the attachment.

•

If the 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. Guideline use - The guideline on the screen can be used a reference mark as for inserting the biopsy needle in the proper direction.

• •

WARNING

Do not use if any accident or abnormal condition occurs with the ultrasound system, probe or attachment.

DO NOT use the needle with the catheter (soft tube). There is a possibility of breaking the catheter in the body.

CAUTION

WARNING

Probes for transvaginal and transrectal applications require special handling. Transvaginal/transrectal examinations and probe with biopsy guide attachment insertions should be performed only by personnel with adequate training. Excessive force can cause patient injury or probe damage. •

Observe depth markings and do not apply excessive force when inserting or manipulating intercavitary probes.

•

Inspect external appearance for sharp edges or rough surfaces that could injure sensitive tissue

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Important Safety Consideration The following topic headings (Patient Safety, and Equipment and Personnel Safety) are intended to make the equipment user aware of particular hazards associated with the use of this equipment and the extent to which injury can occur if precautions are not observed. Additional precautions may be provided throughout the manual.

WARNING

Improper use can result in serious injury. The use of the system outside the described conditions or intended use, and disregarding safety related information is considered abnormal use. The user must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device. Training assistance is available from GE if needed. Disregarding information on safety is considered abnormal use.

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Hazard Symbols Potential hazards are indicated by the following icons. Table 1-1: Potential Hazards Icon

Potential Hazard Biological Hazard Describes precautions necessary to prevent the risk of disease transmission or infections. • Patient/user infection due to contaminated equipment.

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Usage • Cleaning and care instructions • Sheath and glove guidelines

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Biopsy Overview Introduction This manual provides information for the following biopsies: •

E8C Reusable Biopsy Guide Attachment

•

ERB7/ERB Biopsy Attachment Unless specified otherwise “the biopsy” means either of these biopsies. Not all the biopsies described in this manual may be working with your GE ultrasound unit. Refer to the system’s user documentation for a complete list of available biopsies.

The intention with this manual This manual aims to give the biopsy user the information necessary to become a confident user of the biopsies. It also includes suggestions on how to care for the biopsy at all stages of handling. As an aid in safeguarding the patient and ensuring reliable biopsy operation, we recommend that this manual is kept close at hand during all stages of biopsy handling. This manual does 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.

Ergonomics Probes and Biopsy guides 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.

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Labeling Each Biopsy is labeled with the following information:

Figure1-1: Sample design of product rating plate

1. GE LOGO 2. Biopsy Model Name 3. UDI Symbol and Data Matrix 4. UDI Human Readable Label Text: (01) Global Trade Item Number (11) Manufacturing Date (21) Serial Number 5. Electronic instructions for use 6. Chinese RoHS Hazardous Substance Symbol 7. CE Mark of Conformity indicates this equipment conforms 8. Medical Device 9. REF: Catalog/Model number 10. Serial Number: 6 digits plus " YP" and 1 digit 11. Country of Origin 12. Legal Manufacturer's Name and Address 13. Date of Manufacturer, as YYYY-MM 14. European authorized representative

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Labeling (continued) Information of Symbols on Carrying Case is labeled with the following information:

Figure1-2: Sample design of environment label

Information of Symbols Fragile, handle with care

Humidity limitation

Keep Dry

Atmospheric pressure limitation

Universal recycling symbol

Temperature limit

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E8C Reusable Biopsy Guide Attachment Instructions

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Overview This attachment has been installed on the probe listed below by GE Healthcare to assist you in conducting biopsy procedures. Using this attachment allows a biopsy position to be selected along the guideline while monitoring the Convex image in real-time. This 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

•

Cleaning Brush

•

Operation Manual x1

Applicable Probe (As of 2020 March) • • • • • • • •

E8C Probe E8C-RS Probe E8CS Probe E8CS-SC Probe E8Cs-RS Probe E8CS-RC Probe IC5-9H Probe IC5-9-D Probe

For detail, Refer to Console Manual for applicable probes

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Specifications Available probe

Refer to the ultrasound system documentation for further information. See Figure 2-1. 16G or thinner Approximately 39g (main frame only) Approximately more than 18cm For transvaginal and Transrectal biopsies

Biopsy angle and depth Applicable biopsy needle Weight Length Application

CAUTION

Use this attachment only with an Ultrasound system that supports the E8C reusable biopsy guide. For technical support, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center.

Center of the image Insertion route of the biopsy needle

1.57cm

Figure 2-1. Biopsy angle and depth for E8C

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How to Install Before installing the attachment, if the probe head is still filled some silicone filling, the filling must be cleanly removed from the probe head where the biopsy guide attachment will be installed. This is only for first time installation. See Figure 2-2.

a. Probe Head b. Area where the biopsy guide attachment is installed. c.

Filling Remover Tool or equivalent Figure 2-2. Remove the filling

WARNING If the silicone filling is not completely removed, there is a possibility of physical injury as the attachment may not be properly sealed and secure.

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Fill the sterilized medical probe sheath with sterilized ultrasound gel and insert the probe in the medical probe sheath provided.

1. Install the sterilized biopsy attachment on the covered probe and fix firmly with a fastening screw. See Figure 2-3. a.

b.

d.

c. a. Attachment b. Main frame of probe c. Medical probe sheath d. Probe handle Figure 2-3. Probe with the attachment and medical sheath

WARNING Make sure that the biopsy attachment is sterilized as necessary.

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Displaying a biopsy guideline The guideline indicating the needle insertion route is stored in the operating software of the ultrasound system. 1.

Refer to the User Manual of the ultrasound system for details on connecting and selecting the probe.

2.

Press the Biopsy kit key on the Touch Panel and select the appropriate biopsy guideline type (for example, “E8C-RU”). The biopsy guideline depends on the ultrasound system and displays on the monitor. Verify that the biopsy guide attachment type is the same as indicated on the system. WARNING

NEVER use TR5 disposable biopsy guide attachment guideline. Refer to the User Manual of the ultrasound system for details on the biopsy guideline.

Display on the monitor (Assuming that reverse function is on) Figure 2-4. Displaying a biopsy guideline

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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 guideline. (See Figure 2-5.) 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.

A = Anterior P = Posterior PL = Patient Left PR = Patient Right Figure 2-5. Transvaginal Scanning

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