6T series User Manual Rev 01

Technical Publications 6T/6T-RS probes

User Manual KX192827 - English Rev. 01

Operating Documentation Copyright © 2014 By General Electric Co.

Manual status KX192827-01 2014 07 08 (YYYY MM DD) Manufacturer: GE VINGMED ULTRASOUND A/S Strandpromenaden 45 N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Regulatory Requirements

Conformance Standards Standard/Directive

Scope

IEC60601-1

Medical Electrical Equipment, Part 1; General Requirements for Safety

IEC60601-2-18

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

IEC60601-2-37

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

IEC1157/ EN61157

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

EN60601-1-2

Medical Electrical Equipment - part 1-2. Collateral standard: Electromagnetic compatibility - Requirements and tests.

Country specific approvals •

Japan MHLW Approved Number: •

6T Probe: 21700BZY00068000

•

6T-RS Probe: 21700BZY00067000

Original Documentation •

The original document was written in English.

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Chapter 1 TEE Probes Contents: ‘Introduction’ on page 1-2 ‘Getting started’ on page 1-5 ‘Safety’ on page 1-12 ‘Conducting an examination’ on page 1-21 ‘Cleaning and disinfection’ on page 1-26 ‘Storage’ on page 1-32 ‘Shipping and disposal’ on page 1-34 ‘Probe Specifications’ on page 1-35 ‘Accessories’ on page 1-37

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TEE Probes

Introduction

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

Imaging capability:

Transesophageal echocardiography

Probe

4D/Simultaneous Multi-plane

2D

6T

Adult

Yes

No

6T-RS

Adult

Yes

No

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, and be skilled in interpreting the echocardiographic data obtained from the transesophageal and transgastric positions.

Contraindications The TEE probes are NOT intended for fetal imaging.

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Introduction 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 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

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

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

Minor injury

•

Property damage

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TEE Probes

WARNING

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, Center of frequency, 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. (Not for China) Attention - Consult accompanying documents: alerts the user to refer to the user documentation when complete information cannot be provided on the label. (For China only) 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.

Manufacturing date (month/year)

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6T/6T-RS probes – User Manual KX192827 01

Getting started

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 1-7 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

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

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TEE Probes 5. Test the leakage current using the procedure outlined in ‘Safety Tests/Verification’ on page 1-17. 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

•

Bite Guards

•

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. 9.

Flexible shaft Articulation section Distal tip with transducer Deflection brake Deflection control wheels System cable System connector scan plane control switches Attachment ring

Figure 1-1.

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

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Getting started 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 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 1-8, 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

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.

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TEE Probes

6T/6T-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.

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.

. .

Operation of the deflection controls

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Getting started 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 1-3). 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 1-3.

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Operation of the deflection brake

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TEE Probes Buttons functionality 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 1-4.

Buttons functionality

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 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 1-5. 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 1-5.

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Scan plane angle indication

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Getting started 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 1-4). 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.

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TEE Probes

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 1-17) 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

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Safety sheath, be careful not to use excessive force on the probe tip. Otherwise permanent damage to the TEE Probe may occur. 9. Avoid forceful intubation pressure which can cause lacerations of the gastrointestinal tract with attendant and subsequent perforation. 10. 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 between the probe handle and the patient; 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.

11. Withdraw the TEE Probe only after verifying that the deflection brake is in the free position (refer to Figure 1-3 for details). 12. Clean and disinfect the probe using the recommended procedures only. Do not steam autoclave or Ethylene-Oxide sterilize the probe as permanent damage is likely to occur. 13. 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.

14. Safe and efficient data storage is crucial when doing transesophageal examination. To ensure optimal image storage during a transesophageal examination the user should consider: •

To create a new examination when using the TEE probe in order to limit the size of the examination.

•

To store the images on the local archive. Storage on a remote archive may be affected by network instability and traffic.

System Safety Patient safety is ensured only when a well-designed product is used in a safe and responsible manner. Maintaining and

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TEE Probes determining the mechanical and electrical integrity of the probe on a regular basis will keep the safety of the patient at a maximum. It is important that the user establishes and utilizes a check-out procedure to assure that the instrument is safe to use and functions properly prior to each use. If any irregularity, substandard functioning or unsafe condition is observed or suspected, the TEE Probe should not be used. Contact a GE service representative immediately.

Electrical Safety The TEE probe electrical safety is a result of sound system design, careful handling, and periodic testing of the instrument. GE recommends that leakage current measurements according to EN 60601-1 /IEC 60601-1 §19 are carried out frequently and on a regular basis, to obtain the best possible patient safety. National legislation may specify the testing intervals. As a minimum, tests according to EN 60601-1/IEC 60601-1 §19 must be performed once a year. The requirements for Body Floating (BF) have to be applied as described in ‘Electrical Leakage Current test’ on page 1-17.

WARNING

Measuring Electrical Leakage Current should only be done by qualified personnel. Take all necessary precautions to avoid contact with non-insulated parts that have applied voltages. In addition, a puncture inspection should be conducted as described on ‘Puncture detection’ on page 1-17, prior to use of the probe.This is particularly important if using the probe during a surgical procedure. Any significant changes in the observed values should cause further investigation.

Thermal Safety Maintaining a safe thermal environment for the patient has been a design priority at GE. It is generally agreed that in order to avoid damage to body tissues, for long term exposures, tissue contact probe tip temperatures should be less than 42-43°C. The ultrasound scanner incorporates an elaborate thermal safety system which informs the physician of the operating temperature of the probe, and prevents the operative temperature from exceeding given limits. Whenever the TEE

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Safety Probe is plugged into the system and selected, the probe tip temperature will be displayed on the system monitor. If the temperature sensor is not working properly when you plug the probe into the system, the probe will not be accepted and scanning will not be possible. The lower probe operation temperature limit is system dependent (as specified in the system user manual). If the probe tip temperature is below this limit scanning will not be possible (the system enters Freeze Mode). Scanning will resume after the probe tip temperature is above the lower probe operation temperature limit and the user presses the Full Freeze button. In environments with low temperature the tip can be warmed up in the palm of the hand to start the probe.

High temperature protection levels The temperature is always displayed on the system monitor. The system has two levels of upper thermal limit: the first high limit is set at 41.0°C, and the second high limit is set at 42.7°C. If the temperature of the probe tip reaches 41.0°C, the temperature display turns red, the system enters freeze mode, and a warning appears on the monitor, asking the user if he/she wishes to continue scanning up to a higher temperature limit. If the response is yes, the scanner will resume scanning. If the response is no, or no response is given, the system will remain in Freeze mode. If the temperature reaches 42.7°C, the system will freeze unconditionally. The user will not be allowed to start scanning until the temperature has decreased 0.5°C below the limit where the system entered Freeze mode. To restart scanning, the user must press the Full Freeze button. Please note that the system will also automatically enter a “time-out” Freeze Mode if no controls are touched for more than ten minutes, and this should not be misinterpreted as a high temperature safety shut-down. A “time-out” Freeze Mode can also be exited by pressing the Full Freeze button. NOTE:

During scanning, the displayed temperature is expected to be between the patient body temperature and 42.7°C.

Using the Bite Guard The use of bite guard during all TEE examinations is mandatory to protect the probe from possible damage. Damage to the probe, which results from the failure to utilize a bite guard will void the probe warranty. Biting the endoscope may cause severe, permanent damage to the probe, rendering it unusable

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