Transesophageal Echocardiography Instructions for Use

Coverage This user manual is intended to be used as an addition to the manual for the GE ultrasound systems and covers specifics for the Transesophageal Echocardiography (TEE) probes. The TEE probes carry the CE mark as follows:

Manual status KY092071-1EN-03 2022 06 23 (YYYY MM DD)

Table of Contents

Table of Contents Chapter 1 - Intended Purpose Intended Purpose Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Intended Patient Groups - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Intended Users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Intended Use Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Precautions in relation to patient condition - - - - - - - - - - - - - - - - - - - - - 1-3 Product Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Clinical benefit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Residual Risk - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5

Introduction Conventions used in this manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Device Labels- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8

Chapter 2 - Safety Safety Safety precautions for the TEE exam - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Safety precautions for the pre-procedure checkout - - - - - - - - - - - - - - - 2-3 Safety precautions for cross contamination and processing - - - - - - - - - 2-4 Emergency procedure in case of deflection section jamming- - - - - - - - - 2-4 Safety precautions during defibrillation - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Disposal and non-approved use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5

Chapter 3 - Getting Started Getting Started Unpacking and Inspecting the Contents - - - - - - - - - - - - - - - - - - - - - - - 3-2 Detailed Description of the TEE Probe and System Interface - - - - - - - - 3-3 Buttons functionality - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 How to Connect the TEE Probe to a System - - - - - - - - - - - - - - - - - - - 3-10 The Scan Plane Indicator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 The Orthogonal Rotation Function - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10

Chapter 4 - Conducting an Examination Conducting an Examination Patient Selection Precautions and Considerations - - - - - - - - - - - - - - - - 4-2 Probe Design - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Probe Inspection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 The Examination- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

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Chapter 5 - Cleaning and Disinfection Cleaning and Disinfection Probe Processing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Pre-Treatment at the Point of Use (patient contact area) - - - - - - - - - - - 5-4 Manual Cleaning- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Structural integrity testing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-6 Processing of handle, cable and connector - - - - - - - - - - - - - - - - - - - - - 5-7 Manual High-Level Disinfection (HLD) - - - - - - - - - - - - - - - - - - - - - - - - 5-9 Drying - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-12 Automated High-Level Disinfection (HLD) - - - - - - - - - - - - - - - - - - - - - 5-12 Automated Cleaning and High-Level Disinfection (HLD) - - - - - - - - - - - 5-13

Chapter 6 - Maintenance Maintenance System Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Basic Inspection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Structural Integrity Testing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Thermal Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-5 Using the Bite Guard- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-8 Using Sterile Sheath - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-8

Chapter 7 - Transportation and Storage Transportation and Storage Transportation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 Storage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3

Chapter 8 - Shipping and Disposal Shipping and Disposal Shipping - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Disposal- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2

Chapter 9 - Probe Specifications Probe Specifications TEE Probes General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Probes Specific - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3

Chapter 10 - Regulatory Conformance Regulatory Conformance Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2 Country Specific Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-4

Index

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Chapter 1 Intended Purpose

‘Intended Purpose’ on page 1-2 ‘Introduction’ on page 1-7

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Intended Purpose

Intended Purpose

Indications for Use The TEE probes are intended for Transesophageal Echocardiography (TEE). The TEE probes are medical devices. This manual provides information for the following TEE probes:

Probe

Indication for Use:

Imaging capability:

Transesophageal echocardiography

2D

4D/Simultaneous Multi-plane

6VT-D

Adult

Yes

Yes

6Tc

Adult

Yes

No

6Tc-RS

Adult

Yes

No

9T

Pediatric

Yes

No

9T-RS

Pediatric

Yes

No

9VT-D

Pediatric, Adult

Yes

Yes

10T-D

Neonatal, Pediatric, Adult

Yes

No

Not all the probes described in this manual may be supported by your GE ultrasound unit. Refer to the system’s user documentation for a complete list of supported probes.

Intended Patient Groups The minimum patient weight for 9T, 9T-RS, and 9VT-D is 5 kg. The minimum patient weight for 10T-D is 2.5 kg. These probes may be used on smaller patients based on physician's clinical judgment of benefit/risk for the individual patient. There is no known limitation in larger patients. The 6Tc probes and 6VT-D are intended for adults where minimal patient size depends on the anatomy of the individual patient and clinical judgment of the physician.

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Intended Purpose Intended Users The physician conducting the examination must exercise sound medical judgment in the selection of the most suitable probe for the patient and be skilled in interpreting the echocardiographic data obtained from the transesophageal and transgastric positions. The users must be familiar with applicable guidelines for performing TEE examinations and with the associated contraindications and potential complications. Examples of such guidelines are published by: •

American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists

•

European Association of Echocardiography, endorsed by the Echo Committee of the European Association of Cardiothoracic Anaesthesiologists

Personnel involved in processing and handling the TEE probes outside the clinical setting must be aware of the risks for cross contamination and toxicity resulting from improper preparation for the next exam.

Intended Use Environment The TEE probes are intended for use in Echo labs, Operating Room, Intensive Care Units and Cathlab.

Contraindications The TEE probes are NOT intended for fetal imaging.

Precautions in relation to patient condition TEE investigations should not be performed if the patient has esophagectomy or esophagogastrectomy, very significant strictures or trachea-esophageal fistulas, esophageal tumors, esophageal perforation, lacerations or esophageal diverticulum. Special care during intubation and manipulation is necessary if the patient has a history of esophageal surgery or radiation treatment to neck and mediastinum. Other patient conditions requiring special attention are dysphagia, esophageal varices, Barrett esophagus, hiatal hernia, active esophagitis, coagulopathy, thrombocytopenia, large descending aortic aneurysm (due to proximity and potential for overstimulation leading to dissection), suspected chemical burns, esophagus strictures, diverticula, external tumors compressing esophagus or tumors involving esophagus causing strictures. Care is also

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Intended Purpose required if patient has restricted neck mobility (severe cervical arthritis, atlantoaxial joint disease) or is being treated with anticoagulants. Finally, special care is needed when using TEE on small children due to potential for bronchial obstruction. Patient condition must be monitored continuously throughout the TEE procedure as the manipulations of the probe, or possibly the presence of the TEE probe in the esophagus, may rarely trigger cardiac arrhythmias. Additional situations requiring special attention must be addressed on case-by-case basis by qualified physician.

Product Description The TEE probe is an electronically steered phased array ultrasound transducer assembly, mounted in a sealed tip at the end of a conventional endoscope. It is designed to be used only with a GE ultrasound scanner with appropriate software and hardware installed. The TEE probes can generate a set of ultrasound images or slices within a cone from the same position in the esophagus. The rotation of the scan plane is controlled by push-buttons on the endoscope housing. The direction of the tip of the endoscope can be steered using the deflection control wheels on the handle of the instrument to allow exact positioning of the transducer in the esophagus. The 6VT-D and 9VT-D probes also have the ability to generate: •

Single and multi-beat volume data in real-time with volume rendering techniques for three-dimensional visualization of valves and structures.

•

Simultaneous multi-plane acquisition (Bi-plane and Tri-plane). The rotation of the scan-planes is controlled either from push-buttons on the handle of the probe or from a rotary on the scanner.

Clinical benefit The clinical benefits of using TEE probes include the opportunity to image the heart from closer proximity and from different views in relation to external probes. During cardiac resuscitation it is possible to continue interrogating the heart without interrupting chest compressions. Similarly, in the operating room imaging can continue during open chest surgery.

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Intended Purpose Clinical benefit of an ultrasound device used in echocardiography is to allow healthcare professionals provide an accurate diagnostic information that enhances the diagnostic and treatment care pathways of the patient for a variety of diseases and conditions. Typical examples include visualization of heart valves and thereby determine the severity and cause of valvular regurgitation.

Residual Risk TEE probes are optimized to ensure acceptable safety in terms of external atraumatic smoothness, probe size, trackability, steerability and pushability-stiffness while allowing adequate diagnostic imaging performance. The probes are also designed for robustness to foreseeable mishaps and processing throughout their service life. User attentiveness is still essential for safe operation of the TEE probes, as indicated by warnings and cautions in this manual. Special attention from users is required in the following situations:

Risks related to esophagus injury Injury to the esophagus, throat and mouth could occur if the users are not appropriately trained in endoscopic procedures and familiar with the probe at hand. The incidence, nature, and severity of complications, such as esophageal tears/perforations associated with endoscopic procedures are well characterized in literature. Mechanical injury to esophageal tract is an inherent risk due to the nature of the TEE procedure. Injuries vary from self-resolving (local minor bleeding), to life-threatening (perforation, major bleeding, infection, or death) requiring surgery or medical treatment. Significant injuries are uncommon when patient is low-risk and environmental risk factors are absent. This highlights the importance of carefully assessing the suitability of a TEE procedure for each patient (see ‘Precautions in relation to patient condition’ on page 1-3). The external surface of the probe could be damaged through impact, rupture of internal mechanisms or chemical wear. This could expose sharp edges or result in mechanical malfunction. Pre-procedure inspection of the probe for structural and functional defects is essential to minimize this risk. Indirect trauma of the gastro intestinal tract may be related to excessive or prolonged, continuous pressure at the TEE probe-mucosal interface, resulting in tissue ischemia and necrosis. The risk can be minimized by relaxing the pressure and moving the probe tip to a less sensitive area.

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Intended Purpose Risks related to procedures supported by TEE Hazardous situations can occur during procedures that cannot be safely aborted without TEE imaging guidance, such as MitraClip procedures, if the probe should fail due to prior un-noticed damage or internal component failure. Any electronic device can fail without warning signs. Risks are reduced if a backup probe and scanner are available for such procedures.

Risks related to cross contamination Cross contamination could occur if the probe is not properly transported, processed or stored, or is damaged or worn in such a way that micro-organisms or disinfection chemicals could collect inside the probe to be released when intubated. Chemical burns can occur if the probe is not completely rinsed from residue of harsh disinfectants.

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Introduction

Introduction

This manual aims to give the user information concerning: •

Probe operation

•

Probe care and maintenance

•

Probe safety inspection

This manual is a supplement to the ultrasound unit user manual and does not include instructions on how to operate the scanner.

Conventions used in this manual The following icons highlight safety issues:

CAUTION

WARNING

Indicates that a potential hazard may exist that, given inappropriate conditions or actions, can cause: •

Minor injury

•

Property damage

Indicates that a specific hazard exists that, given inappropriate conditions or actions, will cause: •

Severe or fatal personal injury

•

Substantial property damage

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Intended Purpose Device Labels Label

Purpose 6VT-D 9VT-D 6Tc 6Tc-RS 9T 9T-RS

Identification label: Model, Manufacturer, Part number, Serial number, Production date, Device listing, and Certification labels

10T-D

Label

Purpose Follow instructions for use. Read and understand all instructions in the User's Manual before attempting to use the probe. Attention - Consult accompanying documents: alerts the user to refer to the user documentation when complete information cannot be provided on the label. Equipment Type BF, in which protection against electric shock does not rely on basic insulation only. Provides additional safety precautions such as double insulation or reinforced insulation, because there is no provision for protective earthing or reliance upon installation conditions. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment.

CE mark. XXXX is replaced by either 0123 or 0459

XXXX Manufacturing date (Year-Month)

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Introduction Label

Purpose Manufacturer name and address

Unique Device Identification (UDI). Every device has a unique marking for identification. Scan or enter the UDI information into the patient health record as required by governing laws. Environment Friendly Use Period (EFUP). The number inside the circle indicates number of years.

This symbol indicates the item is a medical device.

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Intended Purpose

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Chapter 2 Safety

This chapter contains Safety Precautions.

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Safety

Safety

WARNING

All safety precautions in this section must be followed. Please contact a GE representative if a serious incident or hazardous situation occurs in relation to the use of the TEE probe.

Safety precautions for the TEE exam

WARNING

1. TEE examinations must only be performed by users that are trained in endoscopic techniques as dictated by current relevant medical practices and familiarize themselves with the workings of the current TEE probe. Familiarity with the deflection controls, deflection brake and how to recognize the neutral position is important for safe operation. 2. Avoid forceful intubation pressure which can cause lacerations of the gastrointestinal tract with attendant and subsequent perforation. 3. Withdraw the TEE probe only after verifying that the deflection brake is in the free position (refer to Figure 3-5 and Figure 3-6 on page 3-8 for details).

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Safety Safety precautions for the pre-procedure checkout

WARNING

1. TEE users must inspect patient contact areas prior to each exam, and particularly the endoscope and bending areas, for damage such as cuts and punctures where micro-organisms and remains from toxic cleaning agents could collect. Such damage could also result in compromised electrical safety and loss of function. A structural integrity check using leakage current should be incorporated as part of reprocessing, and bite guard should be used to reduce probe wear unless the patient has a medical condition preventing the use of bite guard. Damaged probes should not be used. 2. The user must inspect patient contact surfaces for sharp edges or corners that could cut esophagus. Such inspection should be performed by feeling the entire surface of the flexible shaft and deflection section both straight and deflected. The probe must be discarded if any metallic protrusions or severe dents are found. 3. Check for proper mechanical operation of the probe. Deflect the tip and make sure that the deflection control operates smoothly. Check that the neutral position of the deflection control reflects the probe tip’s neutral (undeflected) position and that the tip straightens under force also when the brake is applied. 4. In situations where the procedure may be difficult to abort safely without TEE imaging guidance, such as MitraClip procedures or atrial septal defect closure with Amplatzer Cribriform Occluder, it is prudent to have a backup system and probe, checked for good operation, available. Consider that trans-thoracic probes do not provide the same fidelity/plane images as TEE probes. Always follow the instructions of the manufacturers of the implantable medical devices. 5. Do not touch the acoustic window of the 10T-D unnecessarily.

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Safety Safety precautions for cross contamination and processing

WARNING

1. Efficient processing of the probe before first use and after each use is essential for safe operation and prevention of cross contamination. Requirements for high-level disinfection must be met for patient contact areas. The instructions for use include detailed instructions for several processing alternatives. These are validated for efficacy and residual toxicity when followed. Personnel involved in processing and handling the TEE probes must be aware of the risk of infections from cross contamination by pathogen residue and risk of contact reactions to insufficiently rinsed chemical residue resulting from improper preparation for the next exam. 2. In addition to the high-level disinfection, the use of a protective sheath may provide an even higher level of protection against contamination of the probe. 3. Do not steam autoclave or Ethylene-Oxide sterilize the probe as permanent damage is likely to occur.

Emergency procedure in case of deflection section jamming

WARNING

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The deflection mechanism is designed to provide safe operation during normal use. If the probe tip should get jammed in a deflected position inside the patient, and all attempts to release the deflected tip should fail, the following procedure can be utilized to assure a safe retraction of the probe: •

Disconnect the probe from the ultrasound unit.

•

At an accessible location, cut the entire endoscope shaft, including all internal wiring, using heavy duty cutting pliers or another suitable tool.

•

The deflection is now released and the probe may be safely retracted.

Transesophageal Echocardiography – Instructions for Use KY092071-1EN 03

Safety Safety precautions during defibrillation

WARNING

Disconnect the probe from the system before defibrillation. Make sure that: •

Nobody touches the connector during defibrillation.

•

The connector is not in direct contact with any conductive material during defibrillation.

Disposal and non-approved use

WARNING

1. Probes covered in this manual are not approved for veterinary use. Any probes that have been used on non-humans must be marked clearly “VET” or “Not for human use” and must not be returned to GE for service. Probes used on animals must not be placed back into service for humans. 2. There is no adequate means to disinfect a probe that has been contaminated by prions, such as Creutzfeldt Jacob’s disease. In this case, the contaminated device/probe MUST BE discarded in accordance with local biologic waste hazard procedures.

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Safety

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