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g GE Medical Systems

Technical
Publications

Specialty Probes
0470

User’s Manual

GEVU #: KZ192871
GEVU Rev. 01
Operating Documentation
Copyright  2004 By General Electric Co.
g GE Medical Systems
MANUAL STATUS  GE Medical Systems. All rights reserved. No part of this
KZ192871-01 manual may be reproduced, stored in a retrieval system, or
28/10/2004 transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise,
without the prior written permission of GE Medical
Systems.

COMPANY DATA GE VINGMED ULTRASOUND A/S


Strandpromenaden 45, N-3191 Horten, Norway
Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350
Table of Contents

Table of Contents
Table of Contents
Introduction
The intention with this manual..................................................... 1
Convention used in this manual .................................................. 2

Chapter 1
TEE Probes
Introduction.................................................................................... 5
Description of the TEE Probe ............................................... 5
Intended Use of the TEE Probe............................................ 6
Contraindications .................................................................. 7
Regulatory information.......................................................... 7
Getting started ............................................................................... 8
Unpacking and Inspecting the Contents ............................... 8
Detailed description of the TEE Probe and system interface 9
Operating and checking TEE probe controls ...................... 11
The Scanplane Rotation Control......................................... 15
The Scanplane Indicator..................................................... 16
Biplane Functionality........................................................... 17
How to connect the TEE Probe to a system ....................... 18
Safety............................................................................................ 21
Safety Precautions.............................................................. 21
System Safety..................................................................... 22
Electrical Safety .................................................................. 22
Thermal Safety ................................................................... 23
Using the Bite Guard .......................................................... 24
Using sterile Sheath............................................................ 25
Safety Tests/Verification ..................................................... 26
Conducting an examination ....................................................... 30
Patient Selection Precautions and Considerations............. 30
Probe Inspection................................................................. 30
The Examination................................................................. 31
Operation of Deflection Controls......................................... 32

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Table of Contents

Cleaning and Disinfecting ........................................................... 34


Cleaning and Disinfecting Solutions.................................... 34
Instructions .......................................................................... 34
Storage................................................................................ 35
Shipping .............................................................................. 35
Disposal............................................................................... 36
Probe Specifications.................................................................... 37
6T/6Tv/6T-RS probes.......................................................... 37
9T probe .............................................................................. 39
Accessories .................................................................................. 41
TEE Probe Wall Rack and Disinfection Column.................. 41
Scanhead protection cover.................................................. 41

Chapter 2
Intraoperative Probes
Introduction .................................................................................. 45
Description the IO probes.................................................... 45
Intended Use ....................................................................... 45
Contraindications................................................................. 46
Regulatory information ........................................................46
Getting Started .............................................................................47
Unpacking and Inspecting the Contents.............................. 47
How to connect the Intraoperative Probe to a scanner ....... 48
Patient Safety ............................................................................... 50
Contamination and Infection Risks...................................... 50
Acoustical Output Levels..................................................... 50
Electrical Safety................................................................... 51
Electromagnetic compatibility.............................................. 52
Biocompatibility ................................................................... 52
Use of Latex Protective Sheaths ......................................... 52
General Safety Precautions ................................................ 53
Conducting an examination ........................................................54
Preparation of Probe for use with Sterile Sheath ................ 54
Conducting the Examination ............................................... 55
Proper Handling ........................................................................... 56
Decontamination and Cleaning ........................................... 57
Sterilization procedures....................................................... 59
Recommended Processing and Materials........................... 63

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Probe Storage..................................................................... 64
Preparation for Shipping ..................................................... 64
Probe disposal .................................................................... 65
Electrical Leakage Current Test................................................. 66
Electrical Leakage Current Test Setup ............................... 66
Probe Specifications ................................................................... 68
i8Lv/i8L Probe..................................................................... 68
i13Lv/i13L Probe................................................................. 69
Index

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iv Specialty Probes User's Manual


KZ192871-01
Introduction

Introduction
This manual provides user information on the Transesophageal
(TEE) and intra-operative (IO) probes available on the GE
ultrasound scanning systems supporting such probes.
The probes are:

Probe Probe type

6T/6Tv/6T-RS Adult TEE

9T Pediatric TEE

i8L/i8Lv IO

i13L/i13Lv IO

The 6T, 6Tv and 6T-RS probes differ only by their connectors.
The i8L and i8Lv probes differ only by their connectors. The
i13L and i13Lv probes differ only by their connectors.
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 TEE and IO
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 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.

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KZ192871-01
Introduction

Convention used in this manual


The following icons highlight safety issues:
Indicates that a potential hazard may exist that, given inappropriate
conditions or actions, can cause:
CAUTION • Minor injury
• Property damage

Indicates that a specific hazard exists that, given inappropriate


conditions or actions, will cause:
WARNING • Severe or fatal personal injury
• Substantial property damage

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Chapter 1
TEE Probes
Contents:

• Introduction ................................................................................... ...... 5


• Description of the TEE Probe ....................................................... 5
• Intended Use of the TEE Probe ................................................... 6
• Contraindications ......................................................................... 7
• Regulatory information ................................................................. 7
• Getting started .............................................................................. ...... 8
• Unpacking and Inspecting the Contents ...................................... 8
• Detailed description of the TEE Probe and system interface ....... 9
• Operating and checking TEE probe controls ............................. 11
• The Scanplane Rotation Control ................................................ 15
• The Scanplane Indicator ............................................................ 16
• Biplane Functionality .................................................................. 17
• How to connect the TEE Probe to a system .............................. 18
• Safety ............................................................................................. .... 21
• Safety Precautions ..................................................................... 21
• System Safety ............................................................................ 22
• Electrical Safety ......................................................................... 22
• Thermal Safety ........................................................................... 23
• Using the Bite Guard .................................................................. 24
• Using sterile Sheath ................................................................... 25
• Safety Tests/Verification .............................................................. .... 26
• Electrical Leakage Current test .................................................. 26
• Temperature Calibration test ...................................................... 28
• Conducting an examination ......................................................... .... 30
• Patient Selection Precautions and Considerations .................... 30
• Probe Inspection ........................................................................ 30
• The Examination ........................................................................ 31

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• Operation of Deflection Controls .................................................32


• Cleaning and Disinfecting ........................................................... ..... 34
• Cleaning and Disinfecting Solutions ........................................... 34
• Instructions ................................................................................. 34
• Storage ....................................................................................... 35
• Shipping ...................................................................................... 35
• Disposal ...................................................................................... 36
• Probe Specifications .................................................................... ..... 37
• 6T/6Tv/6T-RS probes ................................................................. 37
• 9T probe ..................................................................................... 39
• Accessories .................................................................................. ..... 41
• TEE Probe Wall Rack and Disinfection Column ......................... 41
• Scanhead protection cover ......................................................... 41

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Introduction
This chapter provides information for the following probes:
• 6T/6Tv adult TEE probes
• 6T-RS adult TEE probes
• 9T Pediatric TEE probes
Unless specified otherwise “the probe” or “the TEE probe”
means either of these probes.

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 Medical Systems scanner with appropriate
software and hardware installed.
The TEE Probe is used to generate a set of ultrasound images
or slices within a cone from the same position in the
esophagus. The rotation of the scanplane is driven by a motor
in the endoscope handle, controlled by push-buttons on the
endoscope housing.
For orientation purposes the user may choose to start scanning
in one of the transverse planes, for instance the standard
monoplane indicated as 0° on the system monitor. After
rotating the scanplane 90°, scanning occurs in the longitudinal
plane, sweeping through two opposite quadrants of the cone.
When the scanplane rotates 90° further in the same direction,
scanning occurs in the mirror image of the first transverse
plane. The only two planes that are equivalent are the two
transverse planes; one being the mirror image of the other. As
shown in Figure 1 a 180° rotation of the scanplane fills all four
quadrants of the conic imaging volume.
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.

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1. 90° rotation Sagittal


to mirror image of
transverse plane
2. 90° rotation
Transverse to
Longitudinal plane
3. Conic Imaging
volume
4. Quadrants filled by
first 90° rotation
5. Quadrants filled by
second 90° rotation

Figure 1-1: Multiplane imaging

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.
As with any procedure of this sort, 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.
The 6T, 6Tv and 6T-RS probes are intended to be used on
adults.
The 9T 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 child, the appraisal of the need to perform an
TEE investigation and the physician's clinical judgement.
All probes are designed for imaging, color flow and Doppler
examinations by applying ultrasound energy through the
esophagus or stomach of the patient into his heart.
Backscattered ultrasound energy from the patient’s heart is
used to form images of the heart (2D-Mode or M-Mode) to
detect abnormalities in structure or motion, to evaluate the

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velocity of blood flowing within the heart (Pulsed or CW


Doppler) and to obtain a color depiction of the velocities of
blood flowing in the heart (Color Flow Mode or Color M-Mode).

Contraindications
The TEE probes are NOT intended for fetal imaging.

Regulatory information
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.

0470
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 60601-1 (1988) Medical Electrical Equipment, Part 1; General


Requirements for Safety

IEC 1157/ EN 61157/ Requirements for the declaration of the acoustic output of
(1994) medical diagnostic ultrasonic equipment.

EN 60601-1-2 (2001) Medical Electrical Equipment - part 2. Collateral standard:


Electromagnetic compatibility - Requirements and tests.

The probes should be disinfected before use according to


national/local regulations. The use of a sheath is
recommended.

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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 11 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.
Never deflect the probe tip by using finger pressure directly on
the tip, as this may permanently damage the internal control
CAUTION wires.

5. Test the leakage current using the procedure outlined in


’Safety Tests/Verification’ on page 26.
A written log should be kept of the results.

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6. Notify your service representative immediately of any


damage or discrepancies.

Figure 1-2: Shipping case with TEE Probe

The case contains:


• The TEE Probe
• User Manual
• Bite Guards
• Leakage current test connector
• Certificate of Cleanliness
• Product locator 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 1-3 shows
the different probe features.

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1. Flexible shaft
2. Articulation section
3. Distal tip with
transducer
4. Deflection brake
5. Deflection control
wheels
6. System cable
7. System connector
8. Scanplan control
switches
9. Attachment ring

Figure 1-3: Main features of the TEE Probe (here 6T probe)

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Operating and checking TEE probe


controls
The endoscope is designed for one-hand operation of the
deflection and scanplane controls.

Tip Deflection
6T/6Tv/6T-RS probes
The 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 1-4, page 13, 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.
Maximum deflection:
• Up: 120° minimum
• Down: 40° minimum, 60° maximum
• Left and right: 40° minimum, 60° maximum
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 in the range of 120° to 130° with reference to the
endoscope shaft. In the counterclockwise extreme position the
angle should be in the range of 40° to 60°.
If during this checkout procedure a sharp “U-turn” of the probe
tip is observed, i.e. that the probe tip angle exceeds the
CAUTION maximum deflection angles given above, do not use the probe.
Please contact a GE Medical Systems service representative.

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9T probe
The TEE probe endoscope has one control wheel for deflection
of the tip. The deflection wheel controls the up/down tip
deflection (see Figure 1-5, page 14).
• Clockwise rotation of the wheel will deflect the tip up.
• Counterclockwise rotation of the wheel will deflect the tip
down.
Maximum deflection:
• Up: 120° minimum
• Down: 40° minimum, 60° maximum

If during this checkout procedure a sharp “U-turn” of the probe


tip is observed, i.e. that the probe tip angle exceeds the
CAUTION maximum deflection angles given above, do not use the probe.
Please contact a GE Medical Systems service representative.

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6T/6Tv/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 1-4: 6T/6Tv/6T-RS Probes: Operation of the deflection


controls

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9T
1. Turn deflection
wheel clockwise to
move up, 90° min.
2. Turn upper wheel
counterclockwise to
move down, 60° min.
3. Deflection control
wheel

Figure 1-5: 9T Probe: Operation of the deflection controls

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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 brake for the Up/Down deflection is a handle under the
deflection wheel (see Figure 1-6). There is no friction brake for
the sideways deflection.

1. Deflection brake for


up/down in Free
position
2. Deflection brake for
up/down in fixed
position
3. Wheel position
marker
4. Neutral position
marker

Figure 1-6: Operation of the deflection brake

The Scanplane Rotation Control


The scanplane rotation is driven by a motor located in the
endoscope handle. The scanplane rotation is controlled by the
two outer push buttons on the handle (see Figure 1-7,
page 16).
When pushing the button closest to the probe tip, the
scanplane rotates counterclockwise (scanplane angle
increases).
The scanplane 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.

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6T/6Tv/6T-RS
1. Probe tip
2. Counterclockwise
3. Clockwise

9T
1. Probe tip
2. Counterclockwise
3. Clockwise

Figure 1-7: Scanplane rotation control

The Scanplane Indicator


For orientation purposes, a scanplane indicator has been
incorporated on the system display.
The actual scanplane angle is indicated by a marker and the
value is also displayed as shown in Figure 1-8. The display
shows the angle referred to the standard monoplane, displayed
as 0° on the system. The angle will be in the range from 0° to
180°.

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Figure 1-8: Scanplane angle indication

Biplane Functionality
The middle button on the endoscope handle (Figure 1-9,
page 18) rotates the scanplane at full speed to the orthogonal
position (e.g. if the present position is 22°, the scanplane
rotates to 112°. If the present position is 162°, the scanplane
rotates to 72°). If the center button is pressed again, the
scanplane rotates back to the original position.

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6T/6Tv/6T-RS
1. Push center button
for rotation to
orthogonal position

9T
1. Push center button
for rotation to
orthogonal position

Figure 1-9: Biplane functionality

How to connect the TEE Probe to a


system
The TEE Probe is delivered with a System connector. Below is
a description of how to connect the probe to the system.

Connecting 6T/6Tv
Release the locking handle on the connector of the probe by
rotating it counterclockwise until it makes an angle of 90° with
the connector housing. Align the probe connector with one of
the receptacles in the system’s connector panel. Push the
connector into the receptacle, and lock it by rotating the handle
clockwise until it aligns with the connector housing.

Connecting 6T-RS
Release the locking handle on the system. Align the probe
connector with the receptacle on the system. Push the

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connector into the receptacle, and lock it by rotating the handle


on the system.

All probes
The probe is now connected to the system and may be
selected. For details on how to select the probe, please refer to
the System User Manual.
After the probe has been selected, the scanplane 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.
In case the initialization of the probe fails, (no response from
the scanplane buttons after initialization), re-select the probe to
repeat the initialization routine.

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6T/9T

6Tv

6T-RS

Figure 1-10: System connectors

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Safety
Safety Precautions
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. 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 Medical Systems service representative.
Make sure that the TEE Probe tip is straight during application
and removal of the sheath. During removal of the sheath, be
CAUTION careful not to use excessive force on the probe tip. Otherwise
permanent damage to the TEE Probe may occur.
For USA: Please re- 6. In addition to the high level disinfection, the use of a
fer to the U.S. Food protective sheath may provide an even higher level of
and Drug Adminis- protection against contamination of the probe. An
tration's March
29,1991, “Medical
applicator for protective sheath can be ordered through
Alert on Latex your GE Medical Systems representative.
Products” for fur- 7. Avoid forceful intubation pressure which can cause
ther information re- lacerations of the gastrointestinal tract with attendant and
garding the use of
latex sheaths.
subsequent perforation.

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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
CAUTION 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.

8. Withdraw the TEE Probe only after verifying that the


deflection brake is in the free position (refer to Figure 1-6 for
details).
9. 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.
Remove the probe from the patient when heart starters are used.

CAUTION

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

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GE Medical Systems recommends that leakage current


measurements according to EN 60601-1 /IEC 601.1 §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.
The test requires access to the ultrasound scanner and to
standardized test equipment. The probe has to be immersed in
a Normal Saline solution (50g NaCl per liter water) to above the
40 cm mark (but below the handle).
Measuring Electrical Leakage Current should only be done by
qualified personnel. Take all necessary precautions to avoid
WARNING contact with non-insulated parts that have applied voltages.

In addition, a bite-hole inspection should be conducted as


described on page 26, prior to use of the probe in any 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 Medical Systems. 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 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 17.5°C. If the
probe tip temperature is below this limit, the temperature
display turns red and scanning will not be possible (the system
enters Freeze Mode). Scanning will resume after the probe tip
temperature is above 18.0°C and the user presses the Full
Freeze button.

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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.

Using the Bite Guard


Damage to the The use of bite guard during all TEE examinations is
probe due to biting mandatory to protect the probe from possible damage.
is not covered under Damage to the probe, which results from the failure to utilize a
the probe's warran-
ty or any service
bite guard will void the probe warranty. Biting the endoscope
contract may cause severe, permanent damage to the probe, rendering
it unusable in the future, and unsafe in the present by creating
electrical and mechanical failure mechanisms.
Each TEE probe from GE Medical Systems is delivered with
three bite guards. Use of a bite guard is mandatory. There are
several manufacturers of bite guards for adult and pediatric
TEE probes. Please contact a local GE Medical Systems
representative if you need help in ordering more bite guards.
Re-use, cleaning, and sterilization of the bite guards should be
done according to instructions given by the manufacturer of the
bite guard.

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1. Side view
2. Front view

Figure 1-11: The bite guard

Using sterile Sheath


There are different sterile sheaths available which eliminate the
direct contact between the patient and the endoscope. Follow
the user instructions for the particular sheath when applying
and removing it from the TEE Probe. Please contact a local GE
Medical Systems representative if you need help in obtaining
sterile sheaths.
Both Latex and latex free sheaths are available.
Make sure that the TEE Probe tip is straight during application
and removal of the sheath. During removal of the sheath, be
CAUTION careful not to use excessive force on the probe tip. Otherwise
permanent damage to the TEE Probe may occur.

Applicator for the sterile Sheath


An applicator for the sterile Sheath can be ordered from a GE
Medical Systems representative.

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Safety Tests/Verification
Electrical Leakage Current test
GE Medical Systems scanners with accessories are designed
to meet the requirements for patient safety laid out in IEC
60601-1. To maintain patient safety it is important to have a low
electrical leakage current in the product. Each TEE Probe is
tested for electrical isolation and leakage current before it is
shipped to a customer.
The endoscope shaft has no electrically conducting surfaces,
and is covered with a layer of material, which permits neither
fluids nor electricity to pass through it. Electrical safety is
maintained for the probe by keeping this material intact.
Do not use the probe if the insulating material has been
punctured or otherwise compromised.
WARNING

Checking the integrity of the insulating material cannot always


be accomplished by visual inspections, and a program for
measuring the electrical leakage current on a regular basis
should be established.
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. The test requires
access to the ultrasound scanner and to standardized test
equipment. The probe has to be immersed in a Normal Saline
solution (50g NaCl per liter water) to above the 40 cm mark (but
below the handle).
Measuring Electrical Leakage Current should only be done by
qualified personnel. Take all necessary precautions to avoid
WARNING contact with non-insulated parts that have applied voltages.

Bite-hole inspection
Bite-holes or other damages of the endoscope surface can
alternatively be detected by a simplified test without the access
to the ultrasound scanner, by using the procedure described
below. The objective of this test is to detect bite holes. It is safe
and easy to perform, but is not an isolation or leakage current

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test as described in EN 60601-1. The test equipment is shown


below.

>10MΩ OK
MΩ

V/Ω Com

50 g NaCl/1000g H2O

>25 cm 2
Cu

Figure 1-12: Equipment used to detect bite-holes in the endoscope


shaft

The setup is as follows and as shown in Figure 1-12:


1. The TEE probe with the endoscope shaft submersed in
liquid to above the 40 cm mark (but below the handle)
connected to the multimeter as described in step 2:
2. Multimeter set to measure resistance (range > 40 MOhms).
The multimeter can • The positive lead is connected to the bare metal of the
be connected to system connector housing.
probe and copper
sheet using alliga- • The negative lead is connected to the copper plate in the
tor clips. salt-water bath.
3. A copper or aluminum sheet of at least 25 cm2.
4. A water bath with a 1 Normal saline solution (50g
NaCl/1 liter water).

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Procedure
If there is a bite hole, 1. Insert the probe shaft in the saline solution beyond the 40
the resistance may cm mark (but below the handle).
vary considerably
during the mea- 2. Connect the multimeter as described above, and set the
surement and be- measuring range to > 40 MOhms, wait 2 seconds before
tween different making the measurement.
multimeters. This
3. Check that the resistance is more than 10 MOhms.
test has been veri-
fied using the fol-
lowing
multimeters:
Fluke 89 IV,
Fluke 12, Fluke 87
and Tectronix TX3.
If the value is less than 10 MOhms, the endoscope insulation may
be damaged. Do not use the probe until a GE Medical Systems
WARNING service representative has inspected and released it for further
use.

GE Medical Systems recommends that leakage current


measurements be carried out on a regular basis to obtain the
WARNING best possible patient safety. In addition, a bite-hole inspection
should be conducted prior to the use of the probe in any surgical
procedure.

Temperature Calibration test


The temperature measurement function should be verified to
be according to the specifications (’Thermal Safety’ on
page 23) at least once pr year.
To perform a temperature calibration test the following
equipment is required:
• A temperature stabilized water bath
• A temperature gauge with accuracy of +/- 0.1°C
Procedure
1. Adjust the water bath temperature to 42 +/- 0.1°C and
monitor the temperature with the gauge. If an accurate and
stable water bath is not available the added inaccuracy
must be taken into account when the temperature is read
from the ultrasound unit. Deviation of more than +/- 0.5°C is
not acceptable. Beware that this accuracy without
temperature regulation may prove difficult to achieve.
2. Plug the TEE probe in the system and select the probe.

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3. Press Freeze.
4. Put the probe tip in the water bath.
At least 10 cm of the distal end must be submerged.
5. Observe the temperature indicated on the system monitor.
Wait until the temperature display is stabilized at
42 +/- 0.5°C plus/minus any water bath temperature
deviation.
6. Observe that the Warning pop-up window is displayed.
If both step 5 and 6 are passed the temperature shutdown
works as stated. If not contact your local GE Medical Systems
service provider.

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Conducting an examination
Patient Selection Precautions and
Considerations
The listed consider- While echocardiographs from the transesophageal or
ations do not con- transgastric position will provide important clinical data not
stitute a complete available from any other view, there are a number of conditions
list of all possible
factors the examin-
which call for special consideration in patient selection for safe
ing physician must use of the probe. The ability of the patient to swallow or
take into account accommodate the probe is the most obvious of these
before commencing conditions. Any history of gastroesophageal diseases must be
the examination. determined and considered, as well as the possible effects of
They are presented
other therapies the patient may be undergoing.
here as typical ex-
amples. Gastroesophageal abnormalities such as diverticuli, peptic
ulcers, hiatal hernia, esophageal webs and rings, and the like
will need to be considered as well.

Probe Inspection
Prior to each use 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, or
severe dents are found, the instrument should not be used.
Also examine the distal end probe tip for any holes or severe
dents.
Check for proper mechanical operation of the probe. Deflect
the tip in the two directions 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 (see Figure 1-4, page 13(6T/6Tv/6T-RS
probes) and Figure 1-5 (9T probe)).
During the deflection test, carefully observe the deflection
angle of the tip. Turning the up/down deflection wheel
clockwise to its extreme position, the tip angle should be in the
range of 120° to 130° with reference to the endoscope shaft. In
the counterclockwise extreme position the angle should be in
the range of 40° to 60°.

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If during this checkout procedure, a sharp “U-turn” of the probe


tip is observed, i.e. that the probe tip angle exceeds the
CAUTION maximum deflection angles, do not use the probe. Please
contact a GE Medical Systems service representative.

Electrical leakage current test should be conducted as outlined


in ’Electrical Leakage Current test’ on page 26.

The Examination
The actual techniques for introduction of the TEE Probe into
the patient is beyond the scope of the manual. There are
numerous medical texts and articles which very thoroughly
address this topic. There are, however, a number of specific
cautions that should be considered.
1. Maintenance of an unobstructed airway is a prime
consideration for all patients.
2. Prolonged pressure on the esophagus by the tip of the
probe may lead to a Pressure Necrosis condition. Thus, in
OR monitoring applications, the tip should be removed from
the esophagus wall when not scanning, by releasing it in
the neutral position. If continuous monitoring is required,
the probe tip should be re-positioned often.
3. Long term exposure to ultrasound should be minimized.
Although there have never been any bioeffects
demonstrated at the acoustic output levels of the TEE
Probe, it is prudent to minimize patient exposure to
ultrasound according to the principle of ALARA (As Low As
Reasonably Achievable). Please refer to the ultrasound
system User Manual.
4. In consideration of points 2 and 3 above, the user should
freeze the image, which turns the power to the transducer
off, and allow the endoscope deflection controls to be
disengaged whenever active scanning is not desired.
5. Proper patient preparation is essential for successful
examinations. This includes restrictions on food and liquid
intake as well as a thorough explanation of the examination
procedure and other instructions as the particular situation
warrants.
6. The use of a bite guard during all TEE examinations is
mandatory to protect the probe from possible damage.

Specialty Probes User's Manual 31


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7. The use of protective gloves during the examination is


encouraged. Please refer to the U.S. Food and Drug
Administration’s Medical Alert on Latex Products (FDA
1991).

Operation of Deflection Controls


The endoscope is designed for one-hand operation.
Figure 1-13 shows the operator holding the endoscope handle
in his left hand. Thumb, first and second fingers interact with
the deflection and scanplane controls.

Figure 1-13: Holding the probe

6T/6Tv/6T-RS probes
There are two wheels for controlling the probe tip deflection.
The lower wheel has brake and freely-moving modes. In the
braked mode, the movement of the deflection wheel is
restrained. This is used to hold the tip in a certain position.

9T probe
There is one wheel for controlling the probe tip deflection. The
wheel has brake and freely-moving modes. In the braked
mode, the movement of the deflection wheel is restrained. This
is used to hold the tip in a certain position.

All probes
Special care should be taken when inserting and removing the
probe:
1. Excessive force during insertion, positioning, or withdrawal

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may cause trauma to the stomach or esophagus.


2. When inserting or withdrawing the probe, the control wheel
must be in the freely moving, un-braked state (Figure 1-14).
3. Never deflect the distal tip of the probe by direct application
of force, use only the deflection wheels for this task.

1. Deflection brake for


up/down in Free
position

Figure 1-14: Operation of the deflection brake.

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Cleaning and Disinfecting


Cleaning and Disinfecting Solutions
Cleaning and disinfection is required for TEE probes. In order
to provide users with options in choosing a germicide, GE
Medical Systems routinely reviews new medical germicides for
compatibility with the materials used in the transducer housing,
cable and lens. Although a necessary step in protecting
patients and employees from disease transmission, liquid
chemical germicides must also be selected to minimize
potential damage to the transducer.
Refer to the Probe Care Card enclosed in the probe case or to
"http://www.gemedicalsystems.com/rad/us/probe_care.html"
for the latest list of compatible cleaning solutions and
disinfectants.
Use only germicides that are listed in the Probe Care Card
enclosed with the probe. In addition, refer to the local / national
WARNING regulations.
The manufacturer’s instructions for preparation and use of the
recommended solutions must be carefully followed.
The probe must not be exposed to the solutions for a longer time
than specified by the manufacturer.

Do not immerse the system connector or adapter in any fluid.

WARNING
DO NOT immerse the probe in solutions containing: alcohol,
bleach, ammonium chloride compounds or hydrogen peroxide.
Do not steam autoclave or subject the probe to Ethylene Oxide
(ETO).

Instructions
Follow the procedures below to clean and disinfect the probe.

Cleaning procedure
1. Immerse the flexible shaft of the TEE probe in one of the
recommended enzymatic solutions for the time duration
specified by the manufacturer (see also the Probe Care
Card).
The handle is sealed and may be immersed if necessary.

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2. Rinse thoroughly in lukewarm running water the parts of the


probe that have been exposed to the enzymatic solution.
3. Perform the disinfection procedure described below.

Disinfection procedure
1. Immerse the flexible shaft of the cleaned TEE probe in one
of the recommended germicides for the time duration
specified by the manufacturer (see also the Probe Care
Card).
The handle is sealed and may be immersed if necessary.
2. Rinse thoroughly the parts of the probe that have been
exposed to the germicide with water in a quality suited for
the following use of the probe.
3. Wipe dry with a soft towel or air dry the probe.

Storage
1. Following the last procedure and cleaning/disinfection of
the day, take extra care to dry the TEE Probe with a clean
cloth.
2. Do not use the shipping case for other than short term
storage or to ship the probe from one place to another.
When the shipping case is used for these purposes, avoid
damage to the probe by allowing nothing to protrude
beyond the case when closing the lid.
3. The probe should preferably be stored in a vertical
orientation on a wall rack. Avoid direct sunlight, and
exposure to x-rays. Recommended storage temperature
range: Between 0°C and +45°C.
4. When a wall mounted rack is employed for storage, be sure
that it is securely mounted, that the storage slots do not mar
the scope and are sized to prevent the instrument from
inadvertently falling.

Shipping
To reduce the risk of spreading diseases, the following safety
precautions must be followed carefully:
1. Shipping temperature range: between -40°C and +70°C.
2. The shipping container in which the TEE Probe was
delivered, must never come in contact with a
non-disinfected probe.

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3. To disinfect a probe, use the procedure described in


’Cleaning and Disinfecting’ on page 34.
4. Before returning a probe to manufacturer or distributor,
always disinfect the probe. This disinfection must be
documented on the “Certificate of Cleanliness”, and
attached to the packing list.
Shipments without the above mentioned certificates will be
returned to sender.

Disposal
The probe shall not be destroyed by incinerating or burning.
The probe connector contains a battery which may explode if
exposed to very high temperatures. Please return the probe to
your local GE Medical Systems representative for disposal.

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Probe Specifications
6T/6Tv/6T-RS probes

Endoscope: External Diameter: 10.5 mm


Length: 110 cm

Steering Orientation: Clockwise rotation of the inner deflection control wheel


will deflect the tip up. Counterclockwise rotation of the
deflection wheel will deflect the tip down.
Clockwise rotation of the outer deflection control wheel
will deflect the tip to the right.
Counterclockwise rotation of the deflection wheel will
deflect the tip to the left.

Maximum deflection: Up: 120° min.


Down: 50° ±10°
Right and Left: 50° ±10°

Scanplane Rotation: The probe scans images in any plane within a 180
(nominal) cone from a transverse plane, through the
longitudinal plane and ending at the mirror of the first
transverse plane.
The scanplane rotation is motor-driven, with speed and
direction selected with buttons on the endoscope handle.
Max. speed: 180 in approx. 5 sec.

Scan Angle: 90° max.

Probe tip dimensions: Length: 40 mm1)


Cross-section max.: 14 mm x 12.5mm

Electrical Safety: Conforms to applicable UL, CSA, IEC requirements for


class BF.

Temperature Accuracy: ±0.5°C within the range of 35°C to 45°C

Probe tip temperature Upper: 42.7°C


limits: Lower: 17.5°C

Transducer: 5.0 MHz

Acoustic Output: Dependent on system software. Refer to System User


Manual for information.

Cable length: 2m

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Weight: Complete probe: 1.5 kg


Handle: 0.5 kg
Connector: 0.6 kg
Packet probe: 5.5 kg

Biocompatibility: All patient contact materials of the TEE Probe/endoscope


system comply with ISO 10993-1/
The probe is latex free.

Shipping temperature: Between -40 and +70°C

Storage temperature: Between 0 and +45°C

1): Defined as the length of the inflexible distal part of the probe

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9T probe

Endoscope: External Diameter: 7.2 mm


Length: 80 cm

Steering Orientation: Clockwise rotation of the deflection control wheel will


deflect the tip up. Counterclockwise rotation of the
deflection wheel will deflect the tip down.

Maximum deflection: Up: 120° ±10°.


Down: 90° ±10°

Scanplane Rotation: The probe scans images in any plane within a 180
(nominal) cone from a transverse plane, through the
longitudinal plane and ending at the mirror of the first
transverse plane.
The scanplane rotation is motor-driven, with speed and
direction selected with buttons on the endoscope handle.
Max. speed: 180 in approx. 5 sec.

Scan Angle: 90° max.

Probe tip dimensions: Length: 35.2 mm1)


Cross section: 10.9 x 8.4 mm

Electrical Safety: Conforms to applicable UL, CSA, IEC requirements for


class BF.

Temperature Accuracy: ±0.5°C within the range of 35°C to 45°C

Probe tip temperature Upper: 42.7°C


limits: Lower: 17.5°C

Transducer: Center Frequency: 6.0 MHz

Acoustic Output: Dependent on system software. Refer to System User


Manual for information.

Cable length: 2m

Weight: Complete probe: 1.5 kg


Handle: 0.5 kg
Connector: 0.6 kg
Packet probe: 5.5 kg

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Biocompatibility: All patient contact materials of the TEE Probe/endoscope


system comply with ISO 10993-1/
The probe is latex free.

Shipping temperature: Between -40 and +70°C

Storage temperature: Between 0 and +45°C

1): Defined as the length of the inflexible distal part of the probe

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Accessories
The accessories can be ordered through your GE Medical
Systems representative.

TEE Probe Wall Rack and Disinfection


Column
The TEE Probe wall rack securely stores the probe and
protects it from physical damage when not in use. Combined
with the Disinfection column it creates an easy, convenient
means to disinfect the probe between procedures.

Figure 1-15: The TE Probe Wall Rack

Scanhead protection cover


The Scanhead protection cover is a polyester foamed plastics
for protection of the distal end/scanhead of the endoscope. It is
intended to enclose and protect the scanhead from being
exposed to mechanical strain during transportation and
storage.

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The Scanhead protection cover is a single use device. Discard


after use.
CAUTION

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Intraoperative Probes

Chapter 2
Intraoperative Probes
Contents:

• Introduction ................................................................................... .... 45


• Description the IO probes .......................................................... 45
• Intended Use .............................................................................. 45
• Contraindications ....................................................................... 46
• Regulatory information ............................................................... 46
• Getting Started .............................................................................. .... 47
• Unpacking and Inspecting the Contents .................................... 47
• How to connect the Intraoperative Probe to a scanner .............. 48
• Patient Safety ................................................................................ .... 50
• Contamination and Infection Risks ............................................. 50
• Acoustical Output Levels ............................................................ 50
• Electrical Safety ......................................................................... 51
• Electromagnetic compatibility ..................................................... 52
• Use of Latex Protective Sheaths ................................................ 52
• General Safety Precautions ....................................................... 53
• Conducting an examination ......................................................... .... 54
• Preparation of Probe for use with Sterile Sheath ....................... 54
• Conducting the Examination ...................................................... 55
• Proper Handling ............................................................................ .... 56
• Decontamination and Cleaning .................................................. 57
• Sterilization procedures .............................................................. 59
• Recommended Processing and Materials ................................. 63
• Probe Storage ............................................................................ 64
• Preparation for Shipping ............................................................ 64
• Probe disposal ........................................................................... 65
• Electrical Leakage Current Test .................................................. .... 66
• Electrical Leakage Current Test Setup ...................................... 66

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• Probe Specifications .................................................................... ..... 68


• i8Lv/i8L Probe .............................................................................68
• i13Lv/i13L Probe ......................................................................... 69

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Introduction
This chapter provides information for the 8Lv/i8L and the
i13Lv/i13L intraoperative (IO) probes. Unless specified
otherwise “the probe” means either of these probes.

Description the IO probes


The Intraoperative Probe (Figure 2-1) is an electronically
steered linear ultrasound array transducer intended for
intraoperative use with a GE ultrasound scanner with
appropriate software and hardware installed.
It is equipped with a saleable connector enabling the complete
probe to be submerged in fluid (see Figure 2-2, page 49).
Both 2D imaging and color flow modes are supported.
The probe may be sterilized with STERIS System 1 or
STERRAD 100 Sterilizer equipment.

1. Probe cable
2. Scanhead

Figure 2-1: The scanhead

Intended Use
The intraoperative probe is intended for use by surgeons who
have received appropriate training in intraoperative ultrasound
techniques as well as in proper operation of the scanner.
The probe is intended for epicardial use in accordance with the
indications for use specified in the ultrasound system user
manual.

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When used with appropriate ultrasound scanner, the probe can


be used to:
• visualize and perform measurements on anatomical
structures during surgical procedures.
• visualize blood flow and quantify velocities during surgical
procedures.
As with any procedure of this sort, the physician conducting the
examination must exercise sound medical judgement in
interpreting the echocardiographic data.
The i8Lv/i8L probe is optimized for depths in the range from 10
to 50 mm. The i13Lv/i13L is optimized for a 0 to 10 mm range.
For USA only:
United States law restricts this device to sale or use by, or on the
CAUTION
order of a physician.

Contraindications
The probe is NOT intended for intraoperative use in neurology.

Regulatory information
The i8Lv/i8L and the i13Lv/i13L probes are Class III products.
The probes carry the CE mark and comply with regulatory
requirements of the European Directive 93/42/EEC concerning
medical devices.

0470

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Getting Started
Unpacking and Inspecting the Contents
The probe is delivered in a non-sterile state from the
manufacturer.
CAUTION

Case content:
• Intraoperative Probe
• User Manual (this document)
• Leakage current test connector
• Certificate of Cleanliness
• Product Locator Card
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.
To avoid damage, handle the probe with upmost care. Avoid
shock on a hard surface.
CAUTION

1. Visually examine the shipping case and the intraoperative


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 intraoperative probe.
4. Following the above procedure 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 intraoperative probe should
not be used.
5. Visually examine and feel the surface of the probe and
cable. If any protrusions, holes, rough spots, cracks, or
severe dents are found, the probe should not be used.

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6. Test the leakage current using the procedure outlined in


’Electrical Leakage Current Test’ on page 66. A written log
should be kept of the results.
7. Notify your service representative immediately of any
damage or discrepancies.

How to connect the Intraoperative


Probe to a scanner
Follow the established clinical safety procedures in order to
preserve sterile environment.
CAUTION

The intraoperative probe is delivered with a special system


connector. This connector is sealed for immersion in fluids
when the connector cap is properly in place. The connector cap
is attached to the cable by a flexible rubber band.
Below is a description of how to connect the probe to the
ultrasound unit.
1. Release the locking handle on the connector of the probe,
by rotating it counterclockwise and pull away the sealing
cap.
Let the cap be hanging free on the cable.
2. Align the probe connector to one of the receptacles in the
unit's connector panel, with the cable pointing upwards.
3. Push the connector into the receptacle, and lock it by
rotating the handle clockwise.
Do not apply force. The connector shall slide into position
without any noticeable resistance.
The probe is now connected to the ultrasound unit and may be
selected. For details on how to select the probe, please refer to
the ultrasound unit user manual.

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Figure 2-2: System connector with cap for sealing

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Patient Safety
Contamination and Infection Risks
These probes are designed for intraoperative use and
represent a serious risk of infection if not properly cleaned and
sterilized or high-level disinfected between each patient use.
To prevent patient infection and disease transmission,
intraoperative probes must be:
CAUTION • Decontaminated and thoroughly cleaned after each patient use,
and prior to each patient use be, either Sterilized by one of the
methods specified below, or High-level disinfected and used
with a sterile probe sheath.
If the probe is to be used with a sterile sheath, the probe must, as
a minimum, be high-level disinfected. Sterilization is highly
recommended for thoracic surgery, even when used with a
sterile sheath.

Although not intended for veterinary use the intraoperative


probes are also suitable for research scanning on small rodents.
CAUTION The user must in such cases take every precaution including
complete sterilization of the probes to avoid possible transfer of
diseases between humans and animals.
It is recommended that dedicated probes for use on humans only
or animals only. Clearly identify probes dedicated for animal use
with special labels.
Observe any national rules and regulations for handling
equipment used on both animals and humans. There may be
restrictions prohibiting the use of probes on both animals and
humans.

Acoustical Output Levels


The maximum acoustical output levels follow the U.S. Food
and Drug Administration’s recommendations for Track 3. The
acoustical output is dependant on both the probe and
ultrasound unit software revision. The measured values are
given in the ultrasound unit manual.

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ALARA (As Low As Reasonably Achievable)


Principle
Long term exposure to ultrasound should be minimized.
Although there have never been any bioeffects demonstrated
at the acoustic output levels of the intraoperative probe, it is
prudent to minimize patient exposure to ultrasound.
When using an ultrasound system it is recommended that the
practitioner use the lowest possible acoustic energy setting to
achieve the required clinical information. Similarly, limitation of
the duration of insonation to the minimum necessary for
diagnosis is recommended. This means that when controlling
the amount of acoustic transmit power, in either Imaging,
Doppler, Color Doppler or M-mode, one should use only the
amount necessary to obtain the clinical information required to
aid diagnosis.
The ultrasound system will default (based on probe and
selected Application Mode) to nominal acoustic power setting
which should be used whenever possible unless when clinical
indications require a higher setting. Whenever possible, the
practitioner should lower the acoustic power if the ultrasound
system default appears to provide more than required for a
given patient.

Electrical Safety
The intraoperative probe is classified as a CF (Cardiac
Floating) device. The CF labeling is found on the connector.
The electrical safety is based on prudent system and probe
design, careful handling, and periodic testing of the probe.

Figure 2-3: The CF (Cardiac Floating) label

The most common reasons for failing an electrical leakage test


are:
• Cuts and abrasion on the cable or transducer. The
transducer lens is particularly vulnerable. Instruments like
scalpels and scissors will easily damage the probe.
• Deviations from approved cleaning, disinfection and

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sterilization procedures.
• Use of non-approved cleaning and disinfection agents.
• Shock from being dropped on a hard surface.
GE Vingmed recommends that the probe is tested for leakage
current before every surgery procedure. The test must be
performed before any disinfection or sterilization procedure.
The complete probe with connector should as a minimum be
inspected carefully before disinfection or sterilization. Prior to
each use visually examine and feel the surface of the probe
and cable. If any protrusions, holes, severe dents or other
suspicious changes to the probe are found, the instrument
should not be used.
The probe must not be used without passing a current leakage
test if any sign of damage to the probe like cuts and cracks,
even very minor ones, are detected. Refer to *** 'Electrical
Leakage Current Test' on page 66 *** for further information on
testing of leakage current.
GE Vingmed Ultrasound recommends that inspections and
tests are logged and performed as a routine on a scheduled
basis. Any significant changes in the observed values should
be cause for further investigation.

Electromagnetic compatibility
The i8Lv/i8L and i13Lv/i13L probes comply with regulatory
requirements of the European Directive 93/42/EEC concerning
medical devices. They also comply with emission limits for
Group 1, Class B as stated in EN 55011.

Biocompatibility
All materials that are exposed to the patient have passed
relevant biocompatibility tests. Observe that deviations from
recommended cleaning, disinfection and sterilization agents
and procedures may compromise the biocompatibility or cause
toxic remnants to remain on the probe.

Use of Latex Protective Sheaths


Due to reports of severe allergic reactions to medical devices
containing latex (natural rubber), the FDA advises health-care

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professionals to identify latex-sensitive patients, and be


prepared to treat allergic reactions promptly.
For more details regarding allergic reaction to latex, refer to
FDA Medical Alert MDA91-1, March 29, 1991.
Non-latex sterile sheaths are available. Please contact your
local GE representative for further information.

General Safety Precautions


• Intraoperative probes shall be handled only by trained
personnel. The probe is a precision instrument and can be
inadvertently damaged.
• Intraoperative examinations and procedures should be
performed only by personnel with adequate training.
Consult the medical literature regarding techniques,
complications, and hazards prior to introducing the
equipment for intraoperative examinations and procedures.
• Study this manual thoroughly prior to performing epicardial
examinations and procedures.
• 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 probe should not be used. Contact a GE
Ultrasound service representative.
• 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 intraoperative probe should not
be used. Contact a GE Ultrasound service representative
immediately.

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Conducting an examination
Preparation of Probe for use with
Sterile Sheath
Follow established clinical safety and infection control
procedures in order to preserve the sterile environment. These
CAUTION procedures are to be carried out prior to each patient use.

Use only FDA (USA) or CE (EU) cleared sterile probe sheaths


for intraoperative use.
The probe must be thoroughly cleaned and either sterilized by
one of the methods described below or, as a minimum,
high-level disinfected prior to insertion into a sterile probe
sheath. After sterilization or high-level disinfection, the probe is
to be inserted into a sterile sheath as follows:
1. Fluid coupling must be maintained between the sheath and
the active face of the probe. Before inserting the probe, fill
the end of the sheath with sterile water, or sterile gel
cleared for intraoperative use.
2. Insert the probe into the sheath, making sure there is
coupling medium between the probe face and the sheath
(see Figure 2-4).
3. Press the probe surface against the sheath to remove any
visible air bubbles between the active face and the sheath
before using.
4. Position a sterile rubber band tightly around the sheath just
above the cable-probe transition in order to hold fluid/gel in
place and ensure acoustic coupling during the examination.
Make sure that the rubber band is still in place at the end of the
examination.
CAUTION

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1. coupling medium
2. Sterile rubber band
3. Sterile sheath

Figure 2-4: Scanhead with sterile sheath

Conducting the Examination


The actual techniques for application of an intraoperative probe
is beyond the scope of the manual. There are numerous
medical texts and articles addressing this topic.

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Proper Handling
Patient injury or probe damage may result from improper
handling.
WARNING

The most common reasons for probe malfunction are:


• Cuts and abrasion on the cable or transducer. The
transducer lens is particularly vulnerable. Instruments like
scalpels and scissors will easily damage the probe.
• Deviations from approved cleaning, disinfection and
sterilization methods and procedures
• Use of cleaning, disinfection and sterilizing agents other
than those recommended by GE Vingmed.

Permanent probe damage and unsafe use may result. Use only
the STERIS or STERRAD methods described below for
CAUTION sterilization. Other methods including autoclaving or the use of
ethylene oxide (ETO) will damage the probe. Do not use lacquer
thinner, organic solvents, caustic or abrasive chemicals for
cleaning as these may cause deterioration of the probe surface.

• Use of non water soluble gel of gel substitutes.


• Dropping the transducer on a hard surface.
• Pinching of the cable. A typical cause is rolling over the
probe cable by heavy equipment wheels. Observe that use
of edgy and powerful clamps may also harm the cable.
• Immersion of the probe connector in a fluid without the
protective cap applied to the connector. Any spill or splash
on the uncovered connector may cause harm.

Electric shock hazard. Do not use a probe where the connector


has been immersed in a liquid without the protective cap
CAUTION mounted. Contact GE Service personnel.

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Decontamination and Cleaning


It is necessary to decontaminate and clean the probe following
each patient use:
• Decontamination is done to protect users and other
personnel that are likely to handle a soiled or infected probe
after use. It includes disassembly, pre-cleaning and proper
disposal of consumable items to eliminate blood-borne
pathogens and other possible sources of infection.
• Cleaning is done to remove all debris and organic matter in
preparation for high-level disinfection or sterilization.
Cleaning with soap and water alone provides a low-level
disinfection only.

Decontamination and Cleaning Procedure


Complete and thorough cleaning is vital to achieve sterilization
or high-level disinfection. This may be achieved by the
following process:
1. Disconnect the probe from the ultrasound system.
2. Attach the protective cap to the probe connector.
3. Remove the probe sheath and elastic bands or O-rings
used for fastening the sheath and dispose of in accordance
with established clinical safety and infection control
procedures.
For the health and safety of personnel, decontaminate and clean
the probe immediately after each procedure. The probe and all
CAUTION disposables must be handled in accordance with infection
control standards for the isolation of blood borne pathogens and
other potentially infectious material (i.e. OSHA Title 29 CFR
1910.1030). Examination gloves must be worn during this
procedure. Whenever there is a risk of splashing or splatter of
potentially infectious material, wear a face shield and gown as
well.

4. Scrub the probe with a soft brush or a gauze pad soaked in


Klenzyme ® enzymatic cleaning solution according to their
instructions. Make sure that all external surfaces of the
probe body and cable have been scrubbed at least three
times and be sure that the brush or gauze penetrates any
undercut slots or recesses.

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Probe damage may result. Do not immerse the probe connector


in this procedure even if the protective cap is in place. Do not
CAUTION leave the probe immersed in Klenzyme ® for more than two
minutes.

5. Thoroughly rinse the probe and cable under running water


using gauze pads or a soft brush.
6. Carefully inspect to assure that all debris has been
removed, checking any recessed areas and the interface
between the probe handle and the lens for debris. Repeat
steps 4 and 5 as needed to remove all debris.
7. Wipe exterior surfaces of the probe with a soft pad to
remove all moisture. Residual moisture can impair effective
sterilization or high-level disinfection.

High-level Disinfection procedure


Prior to intraoperative use, the probe must either be sterilized
or high-level disinfected and used with a sterile probe sheath.
The following procedure describes the high-level disinfection
procedure.
1. Ensure that the probe has been thoroughly washed and
dried according to the above cleaning process before
conducting the disinfection.
2. Submerge the clean probe in the recommended liquid
chemical disinfectant, up to but not including the connector.
Keep the probe in contact with the liquid chemical
disinfectant for the time and under the conditions specified
by the manufacturer of the disinfectant.
To assure safe and effective high-level disinfection:
• Always use an FDA (USA) or CE (EU) cleared, high-level
CAUTION disinfectant.
• Be sure to carefully follow the disinfectant manufacturer's
instructions for preparation, use, storage and disposal.
• Prevent glutaraldehyde from contacting exposed skin or eyes
by wearing protective clothing and eye protection.
• Use only in a well ventilated area and thoroughly rinse all
glutaraldehyde residue from the probe.

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3. Remove the probe from the germicide and thoroughly rinse


with sterile water. Do not rinse the connector.

Recommended Germicide

Generic Type: Buffered glutaraldehyde with oxidizing agent

Brand Name: Cidex™ (FDA clearance K924434, CE


compliant, CE 0086)

Manufacturer: Advanced Sterilization Products


Division of Johnson & Johnson Medical.

The manufacturer’s instructions for preparation, use, storage


and disposal of the recommended solution should be carefully
followed.

Sterilization procedures
The i8Lv/i8L and i13Lv/i13L intraoperative probes are designed
to be fully sterilized only by either the STERIS or STERRAD
process described below. Both methods provide rapid, cold
processing to allow sterilization just prior to patient use (also
known as just-in-time sterilization).
Permanent probe damage and unsafe use may result. Use only
the STERIS or STERRAD methods described below for
CAUTION sterilization. Other methods including autoclaving or the use of
ethylene oxide (ETO) will damage the probe. Never use
ultraviolet light for sterilization nor caustic solutions, such as
chlorine bleach.

Sterilization using the STERIS® System 1


Process
The STERIS System 1 Process sterilizes by total immersion
and forced circulation of liquid chemical sterilant. This process
takes place inside the STERIS System 1 Processor with
STERIS 20™ sterilant concentrate. The sterilization cycle
attains a 50-55 C temperature for approximately 12 minutes

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Intraoperative Probes

and is followed by multiple sterile water rinses. A complete


cycle takes about 30 minutes.

Sterilization Process

Generic Type: Liquid chemical, Peracetic acid

Brand Name: STERIS System 1

Manufacturer: STERIS Corporation, Mentor, Ohio, USA


Phone: 440-354-2600

1. Ensure that the probe has been thoroughly washed and


dried according to the above process before conducting the
sterilization.
2. Verify that the protective cap is in place on the end of the
connector.
Permanent damage to the probe may result. Sterilization using
the STERIS System 1 requires complete immersion of the probe,
CAUTION including the probe connector. Verify that the protective
connector cap is ON, covering the electrical contacts. The probe
warranty is voided if the connector is immersed in any liquid
without the protective cap in place. If the connector has been
immersed without the protective cap in place, do not plug the
connector into the ultrasound unit. Call a GE Ultrasound service
representative to arrange for return.

3. Lay the cleaned probe gently into deep end of the STERIS
C1221 cassette. Lay the cable into the cassette using large
loops and place the connector in the middle of the cassette
with the cap next to the shaft (See Figure 2-5).
4. Include process controls according to established infection
control procedures and close the cassette. Follow all
instructions provided by STERIS for sterilization using the
STERIS System 1.
5. If the STERIS System 1 read out does not indicate any error
after the sterilization cycle is complete, remove the cassette
and transport it to the point of use.
6. Using sterile procedure open the cassette and allow the
probe, cable, and connector to be passed into the sterile
field. Dry the connector and cap with a sterile towel.
7. Remove the connector cap just before the probe is plugged
into the ultrasound system. This may be done by a person

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from the sterile field, but it is recommended that the


connector be passed out of the sterile field to be plugged
into the imaging system to avoid inadvertent contact with
the non sterile imaging system console or non-sterile
surfaces inside the cap and on the portion of the connector
which was covered during sterilization.
The inside of the connector cap and the portion of the connector
which was covered by the connector cap are not sterile. It is
CAUTION recommended that the cap be removed from the connector after
the connector is passed out of the sterile field.

Figure 2-5: Placement of the probe into the STERIS C1221 cassette

Sterilization using STERRADTM Process


The STERRAD Process is a low moisture and low temperature
process offering rapid sterilization based on the germicidal
effects of hydrogen peroxide acted upon by a radio frequency
field producing gas plasma, UV radiation and numerous free
radicals. The process takes place inside a sealed sterilization
chamber and includes a 50 minute H2O2 diffusion cycle

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followed by a 15 minute plasma cycle, attaining a maximum


temperature of 50 C.

Sterilization Process

Generic Type: Hydrogen Peroxide Gas Plasma

Brand Name: STERRAD™ 100

Manufacturer: Advanced Sterilization Products


Division of Johnson & Johnson Medical
Irvine, California, USA
Phone: 714-581-5799

1. Ensure that the probe has been thoroughly washed and


dried according to the above cleaning process before
conducting the sterilization.
2. Do not attach the protective cap to the probe connector.
This is a dry process and allows the entire connector to be
sterilized.
3. Place the cleaned and dried probe inside hydrogen
peroxide gas plasma compatible sterilization pouch for
processing.
4. Follow the STERRAD instructions, loading the sterilization
chamber, including appropriate process controls according
to established infection control procedures and initiate the
sterilization cycle.
5. When the cycle has finished, remove the sterile pack and
transport to the point of use.
6. Using sterile procedure open the sterile pack and allow the
probe, cable, and connector to be passed into the sterile
field. The sterile connector is then passed out of the sterile
field to be plugged into the ultrasound system.

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Recommended Processing and


Materials

Cleaning and Decontamination

Generic Type: Enzymatic presoak

Brand Name: Klenzyme®

Manufacturer: STERIS Corporation, Mentor, Ohio, USA


Phone: 440-354-2600

High-level Disinfectant

Generic Type: Buffered glutaraldehyde with oxidizing agent

Brand Name: Cidex™

Manufacturer: Advanced Sterilization Products


Division of Johnson & Johnson Medical
Irvine, California, USA
Phone: 714-581-5799

STERIS Sterilization Process

Generic Type: Liquid chemical, Peracetic acid

Brand Name: STERIS 20™ sterilant concentrate

Manufacturer: STERIS Corporation, Mentor, Ohio, USA


Phone: 440-354-2600

STERRAD Sterilization Process

Generic Type: Hydrogen Peroxide Gas Plasma

Brand Name: STERRAD™ 100 sterilant

Manufacturer: Advanced Sterilization Products


Division of Johnson & Johnson Medical
Irvine, California, USA
Phone: 714-581-5799

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Probe Storage
When the intraoperative probe is not in use nor being
processed for use, it should be stored under the following
conditions.
1. Ensure that the probe has been thoroughly cleaned and
disinfected as described above prior to storage.
2. Store in a manner that protects the probe from shock and
mechanical damage. For prolonged storage, place the
probe in its original protective case and loosen or remove
the protective cap from the probe connector.
3. Store at room temperature.
4. Avoid direct sunlight, and long term exposure to x-rays.
5. Prior to reuse, inspect the probe and perform safety tests.
If necessary, clean the probe. Always complete a high-level
disinfection or sterilization process prior to intraoperative
use.

Preparation for Shipping


If the intraoperative probe is to be transported or returned to
the manufacturer, the following conditions must be observed.
1. Ensure that the probe has been thoroughly cleaned and
disinfected as described above prior to shipping.
To reduce the risk of spreading diseases, the intraoperative
probe must be disinfected prior to shipment. This must be
CAUTION documented on the “Certificate of Cleanliness” provided with
each probe. Attach the certificate to the return packing list.
Shipments without the certificate of cleanliness will not be
accepted by the manufacturer

2. Place the probe in its original protective case and loosen or


remove the protective cap from the probe connector. The
protective case must never come in contact with an infected
probe.
3. The allowable temperature range for shipping is from - 25 C
to 55 C.

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Probe disposal
The probe shall not be destroyed by incinerating or burning.
Dispose the probe according to international rules and
regulations or return the probe to your local GE Vingmed
Ultrasound representative for disposal.

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Electrical Leakage Current Test


To maintain patient safety it is important to have a low electrical
leakage current in the product. Each intraoperative probe is
tested for electrical isolation before it is sent to a customer. This
is done according to requirements in International Standards
for CF classification.
The probe has no electrically conducting surfaces, and is
covered with a layer of material that permits neither fluids nor
electricity to pass through it. Electrical safety is maintained on
the probe by keeping this material intact. In the event that the
insulating material has been punctured or otherwise
compromised, electrical safety (insulation) is maintained by the
ultrasound unit’s AC-power supply.
Checking the integrity of the insulating material cannot always
be accomplished by the visual inspections that should be
carried out prior to each examination. This is best done by
including the probe in part of a normal electrical leakage
current checking program.
GE Vingmed Ultrasound recommends that leakage current
testing is carried out on a regular basis to obtain the best
possible patient safety. Also, a leakage current test should be
conducted prior to its use in any surgical procedure.

Electrical Leakage Current Test Setup


1. A special test connector is needed, and is supplied with the
probe. The test connector combines all the wires in the
system connector to one common wire. This wire is
connected to the leakage current tester as shown in
Figure 2-6.
2. Immerse the transducer with 20 cm of the cable, in Normal
Saline.
Immersion of a larger part of the probe cable will cause the
measured current to increase and possibly exceed the limit for
CAUTION CF. Only the portion of the cable that can be in contact with the
patient shall be included. This is determined to be 20 cm for
these probes.

3. A copper or aluminum foil electrode with a surface area on


each side of approximately 625 cm2 is immersed in the

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saline along with the probe. The electrode must have a lead
attached for connecting to the leakage current tester.
4. With both the electrode and the probe in the saline and both
connected to the test equipment, turn on the test voltage.
Increase the test voltage slowly and observe the current.
On an intact probe the measured current should be less
than 50 µA when the applied voltage is 265 VAC. If the
measured current exceeds 50 µA under these conditions,
the probe should not be used, and your service
representative should be contacted.

µA Voltage

OUT HV

1. Normal saline: 50g NaCl to 1 liter water 3. Electrode, 625 cm2


2. Leakage Current Tester 4. Test connector

Figure 2-6: Leakage current test set-up

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Probe Specifications
i8Lv/i8L Probe

Materials: All external materials of the probe have passed relevant


cytotoxicity, acute systemic toxicity and intracutaneous
tests.

Probe dimensions: Width: 16 mm


Length: 44 mm

Current Leakage: Conform to applicable UL, CSA, IEC requirements for


class CF

Transducer type: Linear

Frequency: 5 - 8 MHz 1)

Acoustic Output: Dependent on ultrasound unit software. Refer to the


system manual for information.

Shipping/Storage Between -25 and +50C


temperature:

1): The upper frequency limit is dependent of the ultrasound


unit and software version.

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i13Lv/i13L Probe

Materials: All external materials of the probe have passed relevant


cytotoxicity, acute systemic toxicity and intracutaneous
tests.

Probe dimensions: Width: 10 mm


Length: 28 mm

Current Leakage: Conform to applicable UL, CSA, IEC requirements for


class CF

Transducer type: Linear

Frequency: 7.5 - 12 MHz 1)

Acoustic Output: Dependent on ultrasound unit software. Refer to the


system manual for information.

Shipping/Storage Between -25 and +50C


temperature:

1): The upper frequency limit is dependent of the ultrasound


unit and software version.

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70 Specialty Probes User's Manual


KZ192871-01
Index

Index

A
Accessories ................................................................................................................................41

B
Biplane Functionality..............................................................................................................17
Bite Guard ...................................................................................................................................24

C
Cleaning
IO probes ...............................................................................................................................57
TEE probes ...........................................................................................................................34
Connecting
IO probes ...............................................................................................................................48
TEE probes ...........................................................................................................................18
Contraindications
IO probes ...............................................................................................................................46
TEE probes .............................................................................................................................7

D
Decontamination
IO probes ...............................................................................................................................57
Deflection brake
6T/6Tv probes ................................................................................................................15, 32
9T/9Tv probes ......................................................................................................................32
Deflection controls ..................................................................................................................32
6T/6Tv probes ...................................................................................................................... 11
9T/9Tv probes ......................................................................................................................12
Disinfecting Solutions
IO probes ...............................................................................................................................63
TEE probes ...........................................................................................................................34
Disinfection
IO probes ...............................................................................................................................58
TEE probes ...........................................................................................................................34
Disinfection Column ...............................................................................................................41
Disposal
IO probes ...............................................................................................................................65

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Index

TEE probes ...........................................................................................................................36

I
IO probe examination ............................................................................................................54

L
Leakage Current Test
IO probes ...............................................................................................................................66
TEE probes ...........................................................................................................................26

P
Patient Safety
IO probes ...............................................................................................................................50
TEE probes ...........................................................................................................................21
Probe inspection
IO probes ...............................................................................................................................47
TEE probes ...........................................................................................................................30

R
Regulatory information
IO probes ...............................................................................................................................46
TEE probes .............................................................................................................................7

S
Safety Tests
TEE probes ...........................................................................................................................26
Scanplane Indicator ...............................................................................................................16
Scanplane Rotation Controls.............................................................................................15
Sheath
IO probes ...............................................................................................................................54
TEE probes ...........................................................................................................................25
Shipping
IO probes ...............................................................................................................................64
TEE probes ...........................................................................................................................35
Specifications
IO probes ...............................................................................................................................68
TEE probes ...........................................................................................................................37
Sterilization
IO probes ...............................................................................................................................59
Sterilization Solutions

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Index

IO probes ...............................................................................................................................63
Storage
IO probes ...............................................................................................................................64
TEE probes ...........................................................................................................................35

T
TEE examination .....................................................................................................................31
Temperature Calibration test .............................................................................................28
Temperature control ...............................................................................................................23

W
Wall Rack ....................................................................................................................................41

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Index

74 Specialty Probes User's Manual


KZ192871-01

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