Probe_UM_KZ192871_1_00
Probe_UM_KZ192871_1_00
Probe_UM_KZ192871_1_00
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.
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
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
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
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:
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.
Chapter 1
TEE Probes
Contents:
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.
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
IEC 1157/ EN 61157/ Requirements for the declaration of the acoustic output of
(1994) medical diagnostic ultrasonic equipment.
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.
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
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.
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
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
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
6T/6Tv/6T-RS
1. Probe tip
2. Counterclockwise
3. Clockwise
9T
1. Probe tip
2. Counterclockwise
3. Clockwise
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.
6T/6Tv/6T-RS
1. Push center button
for rotation to
orthogonal position
9T
1. Push center button
for rotation to
orthogonal position
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
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.
6T/9T
6Tv
6T-RS
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.
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.
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.
1. Side view
2. Front view
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
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
>10MΩ OK
MΩ
V/Ω Com
50 g NaCl/1000g H2O
>25 cm 2
Cu
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.
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.
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°.
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.
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
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.
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.
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.
Probe Specifications
6T/6Tv/6T-RS probes
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.
Cable length: 2m
1): Defined as the length of the inflexible distal part of the probe
9T probe
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.
Cable length: 2m
1): Defined as the length of the inflexible distal part of the probe
Accessories
The accessories can be ordered through your GE Medical
Systems representative.
Chapter 2
Intraoperative Probes
Contents:
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.
1. Probe cable
2. 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.
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
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
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.
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.
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.
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.
1. coupling medium
2. Sterile rubber band
3. Sterile sheath
Proper Handling
Patient injury or probe damage may result from improper
handling.
WARNING
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.
Recommended Germicide
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 Process
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
Figure 2-5: Placement of the probe into the STERIS C1221 cassette
Sterilization Process
High-level Disinfectant
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.
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.
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
Probe Specifications
i8Lv/i8L Probe
Frequency: 5 - 8 MHz 1)
i13Lv/i13L Probe
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
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
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