TEE probes User Manual Rev 14 Oct 2020

Technical Publications TEE probes 0123

User Manual KZ192871 - English Rev. 14

Operating Documentation Copyright © 2020 By General Electric Co.

Manual status KZ192871-14 2020 10 09 (YYYY MM DD) Manufacturer: GE VINGMED ULTRASOUND Strandpromenaden 45 3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Regulatory Requirements

Conformance Standards The TEE probes conform to the Medical Device Directive 93/42/ EEC. According to the Medical Device Directive 93/42/EEC the TEE probes are of class IIA. The TEE probes carry the CE mark.

0123 Year of first CE mark Probe

Year

6Tc

2008

6Tc-RS

2008

6VT-D

2011

9T

2010

9T-RS

2010

To fulfill the requirements of relevant EC directives and/or European Harmonized/International standards, the following documents/standards have been used: Standard/Directive

Scope

93/42/EEC

Medical Devices Directive (MDD)

IEC/EN 60601-1

Medical Electrical Equipment, Part 1; General Requirements for Safety

IEC/EN 60601-2-18

Medical electrical equipment - Part 2-18. Particular requirements for the safety of endoscopic equipment.

IEC/EN 60601-2-37

Medical electrical equipment - Part 2-37. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

IEC/EN 61157

Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment.

TEE probes – User Manual KZ192871 14

i-1

Standard/Directive

Scope

IEC/EN 60601-1-2

Medical Electrical Equipment - part 1-2. General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

2012/19/EU

Waste Electrical and Electronic Equipment (WEEE).

2011/65/EU

Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS).

Country specific approvals •

Japan MHLW Approved Number: •

6VT-D probe: 224ABBZX00001000

•

6T Probe: 21700BZY00068000

•

6T-RS Probe: 21700BZY00067000

•

6Tc/6Tc-RS Probe: 220ABBZX00191000

•

9T Probe: 21700BZY00069000

•

9T-RS Probe: 218ABBZX00110000

Importer Information •

TURKEY Türkiye İthalatçısı / Turkish Importer

GE Medical Systems Türkiye Ltd. Şti. Esentepe Mah. Harman Sok. No: 8 34394 Şişli İstanbul Türkiye

Original Documentation •

i-2

The original document was written in English.

TEE probes – User Manual KZ192871 14

Chapter 1 TEE Probes

Contents: ‘Introduction’ on page 1-2 ‘Getting started’ on page 1-6 ‘Safety’ on page 1-15 ‘Conducting an examination’ on page 1-26 ‘Cleaning and disinfection’ on page 1-31 ‘Storage’ on page 1-36 ‘Shipping and disposal’ on page 1-38 ‘Probe Specifications’ on page 1-39 ‘Accessories’ on page 1-43

TEE probes – User Manual KZ192871 14

1-1

TEE Probes

Introduction

This chapter provides information for the following probes: Indication for Use:

Imaging capability:

Transesophageal echocardiography

Probe

4D/Simultaneous Multi-plane

2D

6VT-D

Adult

Yes

Yes

6Tc

Adult

Yes

No

6Tc-RS

Adult

Yes

No

9T

Pediatric

Yes

No

9T-RS

Pediatric

Yes

No

6T*

Adult

Yes

No

6T-RS*

Adult

Yes

No

* This document covers the 6T and 6T-RS probes with manufacturing date prior to 22 July 2014.

Unless specified otherwise “the probe” or “the TEE probe” means either of these probes. 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 over supported probes.

CAUTION

For USA only: United States law restricts this device to sale or use by, or on the order of a physician.

Intended Use of the TEE Probe The TEE Probe is intended for use by a duly licensed physician who has received appropriate training in endoscopic techniques as dictated by current relevant medical practices, as well as in proper operation of the ultrasound scanner and the probe. The physician conducting the examination must exercise sound medical judgment in the selection of patients for these probes,

1-2

TEE probes – User Manual KZ192871 14

Introduction and be skilled in interpreting the echocardiographic data obtained from the transesophageal and transgastric positions. The 9T/9T-RS probe is intended to be used on children. The suggested lower patient weight limit is 5 kg. The probe may also be used on smaller patients depending on the anatomy of the individual patient and the appraisal of the need to perform an TEE investigation and the physician's clinical judgement.

Contraindications The TEE probes are NOT intended for fetal imaging.

Description of the TEE Probe 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 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 6VT-D probe has also 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.

The direction of the tip of the endoscope is easily steered using the deflection control wheels on the handle of the instrument to allow exact positioning of the transducer in the esophagus.

The intention with this manual This manual aims to give the user information concerning: •

Probe operation

•

Probe care and maintenance

•

Probe safety inspection

TEE probes – User Manual KZ192871 14

1-3

TEE Probes 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 TEE Probe handling. The 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 ultrasound unit user manual.

Convention 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

Device label Label

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

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.

1-4

TEE probes – User Manual KZ192871 14

Introduction Label

Purpose 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

0123 Manufacturing date (Year-Month)

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. For China only: Marking for the Restriction of the use of Hazardous Substances in Electrical and Electronic Products according to SJ/T 11364-2014,

TEE probes – User Manual KZ192871 14

1-5

TEE Probes

Getting started

Unpacking and Inspecting the Contents Proper care and maintenance is paramount for safe and efficient operation of sophisticated medical/surgical equipment. We recommend careful inspection of all equipment upon receipt and prior to each use as a safeguard against possible injury to the patient or operator. 1. Visually examine the shipping carton and the TEE Probe for any damage. Any breakage or other apparent damage should be noted, the evidence retained, and the carrier or shipping agency notified. 2. Verify that the shipping carton contains the components listed on the packing list. 3. To avoid inadvertent damage, study this manual thoroughly before handling and cleaning the TEE Probe. 4. Following the same procedure as prior to each examination, check out the operation and physical integrity of the probe. If any irregularity, substandard function or unsafe condition is observed or suspected, the TEE Probe should not be used. Visually examine and feel the entire surface of the flexible shaft and deflection section with the instrument both straight and deflected. If any metallic protrusions, holes, rough spots, cracks, or severe dents are found, the instrument should not be used. Check for proper mechanical operation of the probe. Deflect the tip in all four directions and make sure that the deflection control operates smoothly. (Refer to ‘Tip Deflection’ on page 1-8 for details). Check that the friction brake operates both in the Up/Down direction and in the Right/Left direction. In particular check that the tip straightens easily when the friction brakes are off. CAUTION

1-6

Never deflect the probe tip by using finger pressure directly on the tip, as this may permanently damage the internal control wires.

TEE probes – User Manual KZ192871 14

Getting started 5. Test the leakage current using the procedure outlined in ‘Safety Tests/Verification’ on page 1-20. A written log should be kept of the results. 6. Notify your service representative immediately of any damage or discrepancies. The case contains: •

The TEE Probe

•

User Manual

•

Certificate of Cleanliness

•

Product locator card

•

Probe Care Card

Detailed description of the TEE Probe and system interface The TEE Probe consists of an electronically steered phased array ultrasound transducer assembly, mounted in a sealed tip at the end of a conventional endoscope. It is connected to the system via a cable with a suitable connector. Figure 1-1 shows the different probe features. 1. 2. 3. 4. 5. 6. 7. 8.

Flexible shaft Articulation section Distal tip with transducer Deflection brake Deflection control wheels System cable System connector scan plane control switches 6VT-D probe: configurable 9. Attachment ring

Figure 1-1.

Main features of the TEE Probe (here 6T probe)

TEE probes – User Manual KZ192871 14

1-7

TEE Probes Operating and checking TEE probe controls The endoscope is designed for one-hand operation of the deflection and scan plane controls.

Tip Deflection The adult probes The adult TEE probe endoscope has two control wheels for deflection of the tip. The deflection wheels control up/down and left/right tip deflection. In Figure 1-2, page 1-10, the deflection wheels are shown in the neutral (undeflected) position. Deflection control of distal tip (endoscope orientation: control wheels up): •

Clockwise rotation of the lower wheel will deflect the tip up.

•

Counterclockwise rotation of the lower wheel will deflect the tip down.

•

Clockwise rotation of the upper wheel will deflect the tip to the right.

•

Counterclockwise rotation of the upper wheel will deflect the tip to the left.

Deflection angles: •

Up: 120° minimum

•

Down: 40° minimum

•

Left and right: 40° minimum

When checking the deflection of the probe tip, carefully observe the deflection angle of the tip. Turning the Up/Down deflection wheel clockwise to its extreme position, the tip angle should be at least 120° with reference to the endoscope shaft. In the counterclockwise extreme position the angle should be at least 40°.

CAUTION

1-8

If during this checkout procedure a sharp “U-turn” of the probe tip is observed, i.e. that the probe tip angle exceeds the maximum deflection angles given above, do not use the probe. Please contact a GE service representative.

TEE probes – User Manual KZ192871 14

Getting started The pediatric probes The pediatric TEE probe endoscope has one control wheel for deflection of the tip. The deflection wheel controls the up/down tip deflection (see Figure 1-3, page 1-11). •

Clockwise rotation of the wheel will deflect the tip up.

•

Counterclockwise rotation of the wheel will deflect the tip down.

Deflection angles:

CAUTION

•

Up: 110° minimum

•

Down: 40° minimum

If during this checkout procedure a sharp “U-turn” of the probe tip is observed, i.e. that the probe tip angle exceeds the maximum deflection angles given above, do not use the probe. Please contact a GE service representative.

TEE probes – User Manual KZ192871 14

1-9

TEE Probes

6VT-D/6T/6Tc/6T-RS/6Tc-RS 1. Turn upper wheel counterclockwise to move left, 40° min 2. Turn upper wheel clockwise to move right, 40° min 3. Turn lower wheel clockwise to move up, 120° min

.

4. Turn lower wheel counterclockwise to move down, 40° min 5. Lower deflection control wheel 6. Upper deflection control wheel

Figure 1-2.

1-10

.

. .

Adult Probes: Operation of the deflection controls

TEE probes – User Manual KZ192871 14

Getting started

9T/9T-RS 1. Turn deflection wheel clockwise to move up, 110° min

.

2. Turn upper wheel counterclockwise to move down, 40° min 3. Deflection control wheel

Figure 1-3.

Pediatric Probes: Operation of the deflection controls

TEE probes – User Manual KZ192871 14

.

1-11

TEE Probes Tip deflection brake To be able to retain the tip in a deflected position, friction can be applied to the Up/Down deflection control. The TEE deflection brake will hold the up-down deflection position if no force is applied to the scanhead. It is important to note that this is a friction brake and in no way a lock. This is to ensure that the endoscope will straighten if the probe is rapidly pulled out of the patient in a crisis situation. The brake for the Up/Down deflection is a handle under the deflection wheel (see Figure 1-4). There is no friction brake for the sideways deflection.

1. 2. 3. 4.

Deflection brake for up/down in Free position Deflection brake for up/down in fixed position Wheel position marker Neutral position marker

Figure 1-4.

Operation of the deflection brake

Buttons functionality 6VT-D probe The three buttons on the 6VT-D probe handle are configurable on the system. Refer to the system user manual for more information about the button configuration. The default configuration in Live mode is as shown in Figure 1-5 below.

1-12

TEE probes – User Manual KZ192871 14

Getting started

1. Button 1 (closest to the probe tip): counterclockwise scan plane rotation 2. Button 2: Image store 3. Button 3: clockwise scan plane rotation

Figure 1-5.

6VT-D default button configuration (Live mode)

All probes except 6VT-D The three buttons have the following functions (not configurable):

1. Button 1 (closest to the probe tip): counterclockwise scan plane rotation 2. Button 2: orthogonal scan plane rotation 3. Button 3: clockwise scan plane rotation

Figure 1-6.

Buttons functionality (all probes except 6VT-D)

When pushing the button closest to the probe tip (button 1), the scan plane rotates counterclockwise (the scan plane angle increases). The scan plane rotates 180° from a standard transverse plane (short axis) to the longitudinal plane (long axis) and ending at the mirror image of the first transverse plane (short axis). The angular position is displayed on the System monitor. The 0° short axis reference position is defined as follows: when viewing the transducer through the acoustic

TEE probes – User Manual KZ192871 14

1-13

TEE Probes window of the probe tip, the transducer is in the extreme clockwise position.

The Scan plane Indicator For orientation purposes, a scan plane indicator has been incorporated on the system display. The actual scan plane angle is indicated by a marker and the value is also displayed as shown in Figure 1-7. The display shows the angle referred to the standard monoplane, displayed as 0° on the system. The angle is in the range from 0° to 180°.

Figure 1-7.

Scan plane angle indication

The Orthogonal rotation function The Orthogonal rotation function rotates the scan plane at full speed to the orthogonal position (e.g. if the present position is 22°, the scan plane rotates to 112°. If the present position is 162°, the scan plane rotates to 72°). The 90° offset function is controlled from the center button (button 2 Figure 1-6) – configurable on the 6VT-D probe. If the center button is pressed again, the scan plane rotates back to the original position. NOTE:

If the original position is 180°, the scan plane will rotate to 0° when pressing the center button twice.

How to connect the TEE Probe to a system Refer to the system user manual for probe connection and selection. After the probe has been selected, the scan plane positioning system automatically calibrates. This calibration cycle lasts 5 to 10 seconds. After the calibration is completed, the probe temperature sensor is activated, and the probe temperature is displayed. A message appears on the system display to remind the user of the importance of using a bite guard when conducting a TEE examination. When the message disappears and the calibration cycle is completed, the probe is ready for operation.

1-14

TEE probes – User Manual KZ192871 14

Safety

Safety

Safety Precautions

WARNING

The safety precautions listed below must be followed.

1. The TEE Probe shall be handled only by trained personnel. The TEE Probe is a precision instrument and can be inadvertently damaged. 2. Transesophageal examinations and probe insertions should be performed only by personnel with adequate training. 3. Consult the medical literature regarding techniques, complications, and hazards prior to transesophageal procedure. 4. Study this manual thoroughly prior to performing transesophageal procedure. 5. A puncture inspection (see page 1-20) should be conducted prior to the use of the probe. This is particularly important when planing to use a diathermic knife. Serious injury to the patient could occur if the probe isolation is impaired. 6. Check the probe prior to each use to assure that it is safe to use and functions properly. If any irregularity, sub-standard functioning, or unsafe condition is observed or suspected, the TEE Probe should not be used. Contact a GE service representative. 7. 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. An applicator for protective sheath can be ordered through your GE representative. NOTE:

For USA: Please refer to the U.S. Food and Drug Administration's March 29,1991, “Medical Alert on Latex Products” for further information regarding the use of latex sheaths 8. Make sure that the TEE Probe tip is straight during application and removal of the sheath. During removal of the

TEE probes – User Manual KZ192871 14

1-15