Samsung | SONOACE X6 | Samsung SONOACE X6 User Manual (Sonoace X6 USER Manual)

Chapter 8
Probes
Probes .........................................................................................................................3
Ultrasound transmission Gel ..................................................................................................... 6
Sheaths ..................................................................................................................................... 7
Probe Precautions .................................................................................................................... 8
Cleaning and Disinfecting the Probe ........................................................................................ 9
Biplane Probe ........................................................................................................................... 18
Biopsy..........................................................................................................................20
Biopsy KIT Components ........................................................................................................... 20
Using the Biopsy Kit .................................................................................................................. 21
Cleaning and Disinfecting Biopsy Kit ........................................................................................ 23
Assembling the Biopsy Kit ........................................................................................................ 25
Chapter 8. Probes
8-3
Probes
The probe is a device that sends and receives ultrasound for acquiring image data. It is also
called a Transducer or Scanhead.The ultrasonographic image scanner uses the image data
received by the probe to display the images of each organ on the screen. For best quality
images, select the appropriate probe for the each application.
The system limits patient contact temperature to 43 degrees Celsius, and acoustic power values
to their respective U.S. FDA limits. A power protection fuse circuit protects against over-current
conditions. If the power monitor protection circuit senses an over-current condition, then the
drive current to the probe is shut off immediately, preventing overheating of the probe surfaces
and limiting acoustic output. Validation of the power protection fuse circuit is performed under
normal system operation. For invasive probes, additional protections are designed to keep
patient contact surface temperature under 43 degrees Celsius in the event of a single fault
failure.
▐ Probe List
The ultrasound image scanner uses probes to obtain graphic data of the human body and
then displays it on the screen. Always use application-specific probes in order to obtain the
best quality images. It is also important to configure the probe with the best settings for the
particular organ being scanned.

Probe Application and Preset
Probes, applications and settings available for this product are as follows:
Product
Applications
C2-5EP
General, OB, Gynecology, Abdomen, Fetal Heart, Renal
C2-4ES
General, Abdomen
C2-8
General, OB, Gynecology, Abdomen, Fetal Heart, Renal
C3-7EP
General, OB, Gynecology, Abdomen, Fetal Heart, Renal
C4-9ED
General, Pediatric, Vascular, Neonatal
HL5-12ED
L3-8
General, Breast, Small Parts, Vascular, Musculoskeletal
General, Small Parts, Vascular
L5-12EP
General, Breast, Small Parts, Vascular, Musculoskeletal
L5-12/50EP
General, Breast, Small Parts, Vascular, Musculoskeletal
LN5-12
General, Breast, Small Parts, Vascular, Musculoskeletal
8-4
SONOACE X6 Operation Manual
Product
Applications
ER4-9/10ED
General, OB, Gynecology, Urology
EV4-9/10ED
General, OB, Gynecology, Urology
NER4-9ES
General, OB, Gynecology, Urology
NEV4-9ES
General, OB, Gynecology, Urology
BCC4-9
General, Urology
P2-4AH
General, Abdomen, Cardiac, Pediatric, TCD
P3-7AC
General, Cardiac, Pediatric
CW2.0
General, Cardiac
CW4.0
General, Pediatric, Cardiac
NOTE

Besides, user can have or select own preset between User1-5.

Refer to ‘Chapter3. Setting’ for how to set probe and its preset.
▐ TI Table
TI (Thermal Index) is displayed on the title of the screen and shows the estimate of the
temperature increase in specific body tissues. The thermal index consists of the following
indices: soft tissue (TIs), bone (TIb), and cranial bone (Tic). This product will show the TI
automatically by the probe and application. See the following table.
C2-5EP
TIs TIb TIs TIs TIs TIb
C2-4ES
TIs
C2-8
TIs
TIs
TIs TIb TIs TIs TIs TIb
TIs
Musculoskeletal
TCD
Pediatric
Neonatal
Small Parts
Renal
Urology
Vascular
Breast
Cardiac
Fetal Heart
Abdomen
Gynecology
OB Early
Obstetrics
Probe
General
Application
Chapter 8. Probes
8-5
Musculoskeletal
TCD
Pediatric
Neonatal
Small Parts
Renal
Urology
Vascular
Breast
Cardiac
Fetal Heart
Abdomen
Gynecology
OB Early
Obstetrics
Probe
General
Application
C3-7EP
TIs TIb TIs TIs TIs TIb
TIs
C4-9ED
TIs
TIs
HL5-12ED
TIs
TIs TIs
TIs
L3-8
TIs
TIs
TIs
L5-12EP
TIs
TIs TIs
TIs
TIs
L5-12/50EP
TIs
TIs TIs
TIs
TIs
LN5-12
TIs
TIs TIs
TIs
TIs
TIc TIs
ER4-9/10ED
TIs TIb
TIs
TIs
EV4-9/10ED
TIs TIb
TIs
TIs
NER4-9ES
TIs TIb
TIs
TIs
NEV4-9ES
TIs TIb
TIs
TIs
BCC4-9
TIs
P2-4AH
TIs
P3-7AC
TIs
TIs
TIs
TIs
TIs TIs
TIs
TIs
TIs
CW2.0
TIs
TIs
CW4.0
TIs
TIs
TIs
8-6
SONOACE X6 Operation Manual
Ultrasound transmission Gel
Using an inappropriate ultrasound gel may damage the probe. For proper transmission of the
acoustic beam, only use ultrasound transmission gel only approved by MEDISON. Refer to the
table of ‘Cleaning and Disinfecting the Probe’ section in ‘Appendix A Maintenance’ for detail.
■ Do not use mineral oil, oil-based solutions, or other non-approved
material as they may cause damage to the probe.
■ Do not use gels that contain any of the following agents:
WARNING
-
Acetone
Methanol
Denatured Ethyl Alcohol
Mineral Oil
Iodine
Lanoline
Any lotions or gels containing perfume
Chapter 8. Probes
8-7
Sheaths
Sheaths are recommended for clinical applications of an invasive nature, including
intraoperative, transrectal, transvaginal, and biopsy procedures. MEDISON does not supply
sheaths so that you should purchase appropriate ones on your own.
■ Always keep sheaths in a sterile state.
■ Sheaths are disposable. Do not reuse them.
■ If sheaths are torn or soiled after use, wash and disinfect the probe.
■ In neurosurgical applications, a disinfected probe must be used with
sterile gel and a sterile pyrogen-free sheath.
WARNING
■ If the sterile sheath becomes compromised during neurosurgical
applications involving a patient with Creutzfeldt-Jakob disease, the probe
cannot be successfully sterilized by any disinfection method.
■ Some sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Please refer to the FDA Medical
Alert released on March 29, 1991.
▐ Installing the Sheath
1.
Use sterile gloves.
2.
Unpack the sheath and fill it with acoustic coupling gel.
3.
Insert the probe into the sheath and pull the latex tip to cover the probe completely. If
possible, cover the probe cable as well.
4.
Ensure that there is no air bubble within the ultrasound gel.
5.
If necessary, secure the sheath to the probe and the probe cable.
6.
Dispose of the sheath after use.
8-8
SONOACE X6 Operation Manual
Probe Precautions
The probe can easily be damaged by improper use or by contacting certain chemical
substances. Always follow the instructions in the user manual to inspect the probe cable, case
and lens before and after each use.
Check for cracks, broken parts, leaks and sharp edges. If there is any damage, immediately
stop using the probe and contact the MEDISON Customer Support Department. Using
damaged probes may result in electric shocks and other hazards to the patients and/or users.
■ Do not apply mechanical shock to the probe.
CAUTION
■ Do not place the probe cable on the floor where the cable can be run
over by equipment wheels, etc. Do not apply excessive force to bend or
pull the cable.
■ Do not immerse the probe into any inappropriate substances such as
alcohol, bleach, ammonium chloride, and hydrogen peroxide.
■ Do not expose the probe to temperatures of +50°C or higher.
▐ Use and Infection Control of the Probe
WARNING
No neurosurgical treatments or examinations should be carried out on a
patient with Creutzfeldt-Jakob disease (critical brain disease caused by
virus). If the probe has been used on such a patient, it cannot be sterilized by
any method whatsoever.
CAUTION
Sufficient washing and disinfecting must be carried out for preventing
infection. This is the responsibility of the user who manages and maintains
the disinfection procedures for the equipment. Always use legally approved
detergents and sheaths.
The ultrasonographic image scanner uses ultrasound, and it makes direct contact with the
patient when in use. Depending on the types of examinations, such contact can be made to
a wide variety of locations including the ordinary skin or the location of blood transfusion
during a surgery.
The most effective method to prevent infection among patients is to use each probe only
once. However, probes may need to be re-used as they are complex in design and
expensive. Consequently, protective devices such as sheaths must be used, and the safety
instructions must be followed carefully in order to minimize the risk of infection among
patients.
Chapter 8. Probes
8-9
▐ Electric Shocks
The probe uses electrical energy. If it touches conductive materials, there are risks of
electric shocks to the patient or the user.
■ Regularly receive short-circuit examination from the MEDISON Customer
Support Department.Do not immerse the probe into liquid.
■ Do not immerse the probe into liquid
■ Do not drop the probe or apply mechanical shocks.
■ Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem before and after each use.
WARNING
■ Do not apply excessive force to twist, pull or bend the probe cable. It may
result in a short circuit.
■ The power protection fuse protects the probe and the product from excess
current. If the power monitoring protection circuit detects excess current,
it immediately shuts off the current to the probe in order to prevent the
probe surface from overheating and to restrict the ultrasound power
output.
■ The temperature of the product for making contact with patients is limited
under 43°C. The ultrasound power output (AP&I) is in compliance with US
FDA standards.
Cleaning and Disinfecting the Probe
Using an inappropriate detergent or disinfectant may damage the probe.

WARNING

Always use protective eyewear and gloves when cleaning and
disinfecting probes.
Inspect the housing, strain relief, lens and seal for damage, and check
for any functional problem after cleaning and disinfecting the probe.
8 - 10
SONOACE X6 Operation Manual
▐ Information of Detergent, Disinfectant, and Ultrasound Gel
Use an appropriate one with following tables. All probes are under tested in IPX 7 Criteria.
Sani-Cloth Active
Setptiwipes
Clieanisept Wipes
Ster-Bac Blu
Trasneptic Spray
Incidin Foam
Super Sani-Cloth
Sani-Cloth
Germicidal
Asepti-Wipes
Asepti-Wipes II
CaviWipes
MetriWipes
Cidex 2%
S
W
W
W
W
W
L
S
S
W
W
W
W
W
L
C2-5EP
C2-4ES
●
C2-8
C3-7EP
C4-9ED
HL5-12ED
L3-8
L5-12EP
L5-12/50EP
LN5-12
ER4-9/10ED
EV4-9/10ED
NER4-9ES
NEV4-9ES
BCC4-9
P2-4AH
P3-7AC
CW2.0
CW4.0
◆
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
◆ ◎
★
●
●
IPA
Active Ingredient
W
NA
Sani-Cloth Plus
S
Quaternary
Ammonium
(N-Alkyl)
Sani-Cloth HB
Type
T-Spray
Names
T-Spray II
Disinfectants
●
●
▣ ▲
●
●
▣
●
●
●
●
Chapter 8. Probes
8 - 11
Sekusept Plus
Milton
Bleach 5.25%
L
L
L
L
L
L
L
L
S
L
L
L
C2-5EP
C2-4ES
C2-8
C3-7EP
C4-9ED
HL5-12ED
L3-8
L5-12EP
L5-12/50EP
LN5-12
ER4-9/10ED
EV4-9/10ED
NER4-9ES
NEV4-9ES
BCC4-9
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
x
●
●
●
●
◇ ▣
●
●
●
●
●
Nonionic
surfactant
Active Ingredient
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
▣
●
●
●
Sodium
Hypochlorite
Surfaces Hautes
L
3)
Steranios 2%
CW4.0
Salvanios pH10
●
●
Salvanios pH 7
★
Sekusept Extra
CW2.0
Wavicide-01
x
Nuclean
★
L
Glutaraldehyde
P3-7AC
Omnicide - FG2
●
●
P2-4AH
●
★
●
●
●
●
●
●
●
●
●
●
●
●
▲
●
Omnicide 14NS
L
Omnicide (28)
L
2)
Type
Metricide
Cidex Plus
2)
Names
Cidex OPA
2,3)
Disinfectants
●
★
●
●
★
●
●
●
●
Virkon
Sporox
Sporox Ⅱ
Type
L
L
L
Active Ingredient
C2-4ES
C2-8
L3-8
LN5-12
NER4-9ES
NEV4-9ES
P2-4AH
P3-7AC
CW2.0
CW4.0
x
●
C2-5EP
●
C3-7EP
x
C4-9ED
x
HL5-12ED
L5-12EP
L5-12/50EP
BCC4-9
x
x
PeraSave
L
P
Chlorhexidine
gluconate solution
x
●
x
x
x
★
◎
x
x
◎
★
●
◎
●
●
ER4-9/10ED
EV4-9/10ED
●
●
●
●
Klenzyme
Isopropyl
alcohol(70%)
Isopropyl
alcohol(80%)
●
●
L
L
L
L
●
●
x
●
●
●
●
●
●
●
●
●
Alcohol
Proteolytic Enzymes
Disinfectants
Cidezyme
Alkazyme
Enzol
Hibitane
L
Peracetic Acid
Dodecylphenolethoxyl
ate, Sodium Xylene
Sulfonate
NA
Gigasept FF
L
Bersteinsaure
3)
Gigasept AF
x
Gigasept
●
L
Succindialdehyde,
formaldehyde
Hydrogen Peroxide
Names
NA
8 - 12
SONOACE X6 Operation Manual
Cleaner
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
x
●
x
●
●
●
x
●
●
▲
x
x
Chapter 8. Probes
Gel
Metrizyme
McKesson
Natural Image
Aquasonics 100
GE Ultrasound
Contact Gel
Clear Image
Kendall
Scan
Wavelength
Sonogel
L
L
L
G
G
G
G
G
G
G
G
Active Ingredient
Propylene
Glycol
PCMX
(Chloroxylenol)
Ammonium
Chlorides
Names
C2-5EP
C2-4ES
●
●
●
C2-8
C3-7EP
C4-9ED
HL5-12ED
L3-8
L5-12EP
L5-12/50EP
LN5-12
ER4-9/10ED
EV4-9/10ED
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
NER4-9ES
NEV4-9ES
BCC4-9
P2-4AH
P3-7AC
CW2.0
CW4.0
●
●
●
●
NA
Ethanol 75%
Type
Alcohol
3)
Cleaner
8 - 13
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
8 - 14
SONOACE X6 Operation Manual
※ Symbols
(1)
Compatible but no EPA Registration
(2)
FDA 510(k) qualified
(3)
Has CE mark
(4)
Discontinued
(5)
Under Development
S
Spray
W
Wipe
L
Liquid
P
Powder
G
Gel
x
Not compatible(DO NOT USE)
●
Compatible
★
Staining may occur on housing parts; however, the acoustic performance
and image quality are not affected.
■
Must not be used longer than 5 minutes.
◐
Must not be used longer than 10 minutes.
▲
Must not be used longer than 15 minutes.
◆
Must not be used longer than 20 minutes.
◇
Must not be used longer than 25 minutes.
◎
Must not be used longer than 30 minutes.
▣
Must not be used longer than 50minutes.
Blank
Untested (DO NOT USE)
Chapter 8. Probes
Following is information about manufacturer (or Distributor)
of
8 - 15
Detergent, Disinfectant, and
Ultrasound Gel.
Product
Manufacturer or Distributor
Aquasonics
Parker Co.
Cidex
CIVCO Co.
Enzol
CIVCO Co.
Telephone number
+1-800-631-8888(USA)
+1-800-445-6741(USA)
+1-319-656-4447(Worldwide)
+1-800-445-6741(USA)
+1-319-656-4447(Worldwide)
GIgasept AF
S&M(Schulke&mayr) Co.
+44-114-254-3500(UK)
Gigasept FF
S&M(Schulke&mayr) Co.
+44-114-254-3500(UK)
Local drugstore
None
Klenzyme
Steris Co.
+1-800-548-4873(USA)
Metricide
CIVCO Co.
+1-800-445-6741(USA)
+1-319-656-4447(Worldwide)
Metrizyme
Metrex Research Corp.
+1-800-841-1428(USA)
Product & Gamble Australia Pty. Ltd.
+61-1800-028-280(Australia)
Nuclean
Nation Diagonostics Co.
+1-800-526-3867(USA)
+44(0)-148-264-6020(UK)
Omnicide
Cottrell Ltd.
+1-800-843-3343 (USA)
Sani-cloth
PDI Nice/Pak Products Co.
+1-914-365-1602(USA)
Henkel Hygiene GmbH.
+49-0211-797-0(Germany)
Sporox II
Sultan Chemist Inc.
+1-800-637-8582(USA)
T-Spray
CIVCO Co.
+1-800-445-6741(USA)
+1-319-656-4447(Worldwide)
Antec International LTD.
+1-403-286-1771(USA)
Wave Energy System Inc.
+1-800-252-1125(USA)
Isoproppyl alcohol (70%)
Milton
Sekusept Extra
Virkon
Wavicide
▐ Cleaning
Cleaning is an important procedure that is carried out before disinfecting the probe. The
probe must be cleaned after each use.
■ Do not use a surgical brush when cleaning probes. The use of even
brushes can damage the probe.
CAUTION
soft
■ During cleaning and disinfection, keep the parts of the probe that must
remain dry higher than the other parts during wetting until all parts are dry.
This will help prevent liquid from entering non-liquid-tight areas of the
probe.
8 - 16
SONOACE X6 Operation Manual
1.
Disconnect the probe from the system.
2.
Remove any biopsy adapters or biopsy needle guides. (Biopsy adapters are re-usable
and can be disinfected).
3.
Discard sheaths. (Sheaths are single-use items).
4.
Use a soft cloth lightly dampened with mild soap or compatible cleaning solution to
remove any particulate matter and body fluid that remain on the probe or cable.
5.
To remove remaining particulates, rinse with water up to the immersion point.
6.
Wipe with a dry cloth.
7.
If necessary, wipe first with a water-dampened clothe to remove soap residue.
▐ Disinfection
-6
Only disinfect vaginal and rectal probes. A 10 reduction in pathogens should be reached
following the disinfection procedures in this Manual and using the following MEDISON
recommended solutions.
WARNING
CAUTION
1.
 If a pre-mixed solution is used, be sure to observe the solution expiration
date.
 The type of tissue it will contact during use dictates the level of disinfection
required for a device. Ensure that the solution strength and duration of
contact are appropriate for disinfection.

Using a non-recommended disinfectant or not following the recommended
disinfection method can damage and/or discolor the probe and will void the
probe warranty.

Do not immerse probes for longer than one hour, unless they are
sterilizable.

Only sterilize probes using liquid solutions. Avoid using autoclave, gas
(EtO), or other non-MEDISON-approved methods.
Follow the instructions on the disinfectant label for storage, use and disposition of the
disinfectant.
2.
Mix the disinfectant compatible with your probe according to label instructions for
solution strength.
3.
Immerse the probe into the disinfectant as shown in the illustration below.
Chapter 8. Probes
4.
Using the instructions on the disinfectant, rinse the probe after the immersion process
is complete.
5.
8 - 17
Air dry the probe or towel it dry with a clean cloth.
[Figure 8.1 Disinfection]
8 - 18
SONOACE X6 Operation Manual
Biplane Probe
The Biplane probe allows you to scan two objects simultaneously using two elements. It is
mainly used in urology.
▐ Configuration
The following illustration shows the Biplane probe with its two elements.
① Horizontal element
② Vertical element
[Figure 8.2 Biplane Probe]
NOTE
The biopsy function is only available using the vertical element.
▐ Connecting and Removing
The Biplane probe is connected using a probe connector and a dedicated Biplane probe
connector.
① Main connector
② Sub connector
[Figure 8.3 Connecting Biplane Probe]
Chapter 8. Probes
CAUTION

You must observe the following instructions for connecting and removing the
probe. Otherwise, you may cause serious damage to the probe.
Connecting the Probe
First, connect the sub connector (②) and then connect the main connector (①).

8 - 19
Removing the Probe
First remove the main connector, and then remove the sub connector.
8 - 20
SONOACE X6 Operation Manual
Biopsy
A biopsy is an examination method that surgically extracts tissue from the patient for
examination. The probe and the biopsy kit are used together when conducting a biopsy with the
ultrasonographic image scanner.
The ultrasound system shows the needle, which penetrates through the skin surface and veins,
along with the examination location, minimizing the risk to the patient.
Biopsy KIT Components
The biopsy kit consists of the adaptor, needle guide and needle. The components vary
depending on the probe type. The components and accessories can be purchased from
MEDISON.
[Figure 8.2 Biopsy Kit Components]
-
Adaptor: Secures the needle guide to the probe tightly.
-
Needle Guide: Guides the angle (direction) of the needle so that it can reach the
examination location accurately. It also secures the needle so that the needle is not
loose.
-
Needle: This is the needle that is inserted into the patient’s body.
-
Sheath: Prevents the probe and adaptor from getting soiled by any unwanted
substances during the examination (blood and other body fluids).
-
Ultrasound Gel: The space between the probe and the sheath is filled with the
ultrasound gel to obtain images of the best quality.
Chapter 8. Probes
8 - 21
Using the Biopsy Kit
■
Verify the condition of the biopsy needle before use. Do not use a bent
biopsy needle.
■
The biopsy needle may bend during tissue penetration. The precise
location of the needle must be checked by monitoring the echo generated
from the needle.
■
Never use the biopsy kit to biopsy prostate tissue.
■
Verify the condition of the biopsy needle before use. Do not use a bent
biopsy needle.
WARNING
▐ Before Using Biopsy Kit
Ultrasonographic scanning using the biopsy kit must be conducted by medical doctors or
experienced medical staff with appropriate qualifications. Always, without fail, verify all
safety prevention procedures and disinfection.
Use only MEDISON-approved biopsy kits. Other bands may not properly fit MEDISON
probes. Improper installation may result in patient discomfort.
Inspect all components. Ensure that the biopsy kit you are using is the correct one for the
probe, the system, and system software.
■ Do not attempt to use the biopsy until you read the instructions for
installing the sheath and verifying alignment of the needle guide.
WARNING
■ Always ensure that the probe and the needle guide are secured on both
the left and the right.
■ Do not use in IVF, CVS, or PUBS procedures.
▐ Biopsy Procedure
The system generates a needle guideline though the displayed real-time ultrasound images
to indicate the anticipated path of the needle. You can use this guideline to ensure that the
needle or instrument is following the correct path.
1.
Ready the patient according to the procedure appropriate for the examination
objectives.
2.
Install the sheath and the biopsy kit.
8 - 22
SONOACE X6 Operation Manual
3.
Set the system controls for the biopsy procedure.If necessary, apply acoustic gel to
the patient.
4.
Begin scanning the patient. Adjust the patient so that the location for examination fits
into the needle guideline on the screen.
5.
Insert the needle into the needle guide. Perform the puncture by sliding the needle
through the groove in the guide until the needle intercepts the target.
To keep the needle securely in the needle guide, press down on the top of the biopsy
adapter with your index finger.
6.
When the examination location is reached, take the needle out of the needle guide.
7.
Detach the needle guide, adapter and sheath from the probe.
8.
Dispose of the components that are not designed for reuse.
▐ Needle Guide Alignment
Alignment of the needle guide displayed on the system is for the purpose of verifying
whether the needle and the needle guide are properly installed. This must be done prior to
the biopsy examination. Do not use the needle guide if the needle is not following the
intended path. Contact MEDISON Customer Service Department for service.
Reverberation or other tissue artifacts may produce false needle images which can cause
confusion. Ensure the needle path is along the guideline, and that you are not using a false
needle image to locate the needle.
WARNING
■ The needle used for this alignment verification must not be used for the
actual procedure. Always use a new, sterile needle for each biopsy
procedure.
■ To assist in accurate projection of the needle, use a straight, new needle
for each alignment procedure.
1. Attach the biopsy kit.
2. Set the system depth for the procedure to be performed and select the Biopsy menu.
3. Immerse the probe into the water bath, and insert the needle into the needle guide.
4. Confirm that the needle image is on the needle guidelines. If so, the needle guide is
properly aligned.
5.
If the needle image is out of the needle guideline, check the needle guide or the probe adapter.
Chapter 8. Probes
8 - 23
Cleaning and Disinfecting Biopsy Kit
-6
Wash and disinfect the biopsy kit to reduce pathogens to the level of 10 . Some components of
the biopsy kit may be disposable. Please read the biopsy kit user manual carefully before use.
Refer to the table of ‘Cleaning and Disinfecting the Probe’ section in this chapter for detail.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting
biopsy kit.
▐ Cleaning and disinfection of stainless steel biopsy kit


Cleaning
1.
After use, remove the biopsy kit from the probe.
2.
Disassemble the biopsy kit into its component parts, if applicable.
3.
Using a small brush and water, scrub each part to remove trapped material from
the biopsy kit.
4.
Rinse with water to remove remaining particulates.
Disinfection
1.
Disinfect the adapter by autoclaving (Steam) or using gas (Ethylene Oxide).
2.
After disinfection, follow the proper post-disinfection procedure for the disinfection
method used. (Please refer to the disinfection user manual, etc.)
3.
Inspect the biopsy kit for damage such as cracks, rust or breakage. If damage is
evident, discontinue use of the biopsy kit and contact MEDISON Customer
Service Department.
▐ Cleaning and Disinfection of plastic biopsy kit

Cleaning
1. After use, remove the biopsy kit from the probe.
2. Disassemble the biopsy kit into its component parts, if applicable. Discard the
single-use parts. These parts cannot be disinfected.
3. Using a small brush and water, scrub each part to remove trapped material from
the reusable components.
4. Rinse with water to remove remaining particulates.
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SONOACE X6 Operation Manual

Disinfection
CAUTION
Plastic biopsy kits can only be disinfected using a chemically
compatible cold-disinfectant. Disinfection by autoclaving or by using
gas or radiation will cause damage to these parts.
Please refer to the user manual of the disinfectant for storage, use, and disposition of
the disinfectant.
1. Check the disinfection duration (generally 10 hours) and temperature of the
disinfectant.
2. After disinfection, follow the proper post-disinfection procedure for the disinfection
method used.
3. Inspect the components for damage such as cracks, rust or breakage. If damage
is evident, discontinue use of the biopsy kit and contact MEDISON Customer
Service Department.
Chapter 8. Probes
8 - 25
Assembling the Biopsy Kit
▐ C2-5EP Biopsy Guide
■
Specifications
Model name
Component
Material
Available Gauges
■
BP-KIT-021
Biopsy Adapter
1 EA
Needle Guide
8 EA
Polyurethane
16G, 18G, 22G
Installation
1. Mount the Biopsy Adapter onto the probe.
2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
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SONOACE X6 Operation Manual
3. Secure the Needle Guide Clip.
4. Choose a needle guide of the desired gauge and secure it to the adapter.
5. Insert the needle into the needle guide for use.
Chapter 8. Probes
8 - 27
▐ C2-8Biopsy Guide

Specification
Model name
Component
Material
Available Gauges
BP-KIT-035
Biopsy Bracket
1 EA
Needle Guide
24 EA
Acetal Copolymer
16G, 18G, 22G
 Installation
1. Mount the adapter onto the probe.
2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
3. Secure the Needle Guide Clip.
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SONOACE X6 Operation Manual
4. Insert the needle into the needle guide for use.
Chapter 8. Probes
8 - 29
▐ C3-7EP Biopsy guide
■ Specification
Model name
BP-KIT-025
Adapter
1EA
Needle Guide Kit (Odd & Even Gauge Clip)
2EA
Box
1EA
User Manual
1EA
Component
Material
Available Gauges
Stainless
15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G
■ Installation
1. Mount the adapter onto the probe.
2. Fill the sheath with the ultrasound gel and place the sheath all the way down to
the Adapter.
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SONOACE X6 Operation Manual
3. Secure the Needle Guide Clip.
4. Insert the needle into the needle guide for use.
Chapter 8. Probes
8 - 31
▐ BCC4-9 Biopsy Guide
NOTE

The biopsy function is only available using the vertical element.
Specification
Model name
BP-KIT-031
Component
Adapter
Material
Available Gauges
1EA
ABS
16 ~ 18G
 Installation
1.
Fill the sheath with the ultrasound gel and place the sheath all the way down to the
probe.
2.
Mount the adapter onto the probe.
3.
Place the sheath all the way down to the probe and adapter.
4.
Insert the needle into the needle guide for use.
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SONOACE X6 Operation Manual
Chapter 8. Probes
8 - 33
▐ HL5-12ED Biopsy guide
■ Specifications
Model name
BP-KIT-022
Adapter
1EA
Component
Needle Guide Kit (Odd & Even Gauge Clip)
3EA/Each
Body: Acetal Copolymer
Material
Screw: 303 Stainless
Available Gauges
16G, 18G, 22G
※ You can buy a pack of Adapter or needle guide kit. One pack is consisted of 24ea per
each gauge.
■ Installation
1. Mount the Adapter onto the probe.
2. Insert gel into probe cover. And cover it.
3. Install the needle guide onto the Adapter.
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SONOACE X6 Operation Manual
4. Lock the needle guide like (a), and do like (b).
(a)
(b)
(c)
5. Press the needle guide like (c), and install the needle into the needle guide.
Chapter 8. Probes
8 - 35
▐ L3-8 Biopsy Guide

Specification
Model name
BP-KIT-036
Adapter
Component
Material
Available Gauges
Needle Guide
1EA
24EA
Acetal Copolymer
16G, 18G, 22G
 Installation
1. Mount the adapter onto the probe.
2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
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SONOACE X6 Operation Manual
3. Secure the Needle Guide Clip.
4. Insert the needle into the needle guide for use.
Chapter 8. Probes
8 - 37
▐L5-12EP Biopsy Guide

Specifications
Model name
Component
Material
Available Gauges

BP-KIT-023
Biopsy Adapter
1 EA
Needle Guide
8 EA
Polyurethane
16G, 18G, 22G
Installation
1. Mount the adapter onto the probe.
2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
adapter.
3. Secure the Needle Guide Clip.
4. Choose a needle guide of the desired gauge and secure it to the adapter.
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SONOACE X6 Operation Manual
5. Insert the needle into the needle guide for use.
Chapter 8. Probes
▐ L5-12/50EP Biopsy Guide
NOTE
To purchase this biopsy kit, please contact the local office.
■ Specifications
Model name
BP-KIT-020
Biopsy Adapter
1EA
Needle Guide
8EA
Component
Material
Available Gauges
Polyurethane
16G, 18G, 20G
■ Installation
1. Insert gel into the cover for the Kit and cover the adapter completely.
2. Mount the needle guide for the desired gauge onto the adapter.
3. Lock the needle guide.
4. Insert the needle into the needle guide for use.
8 - 39
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SONOACE X6 Operation Manual
▐ LN5-12 Biopsy Guide

Specification
Model name
BP-KIT-040
Biopsy Adapter
1 EA
16Ga disposable needle guide/probe cover KIT
8EA
18Ga disposable needle guide/probe cover KIT
8EA
22Ga disposable needle guide/probe cover KIT
8EA
Component
Material
Available Gauges

Acetal Copolymer
16G, 18G, 22G
Installation
1. Mount the adapter onto the probe.
2. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter.
Chapter 8. Probes
3. Secure the Needle Guide Clip.
4. Insert the needle into the needle guide for use.
8 - 41
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SONOACE X6 Operation Manual
▐ EV4-9/10ED, ER4-9/10ED Biopsy Guide
■
Specifications
Model name
BP-KIT-024
Biopsy Adapter
1 EA
Sheath
2 EA
Component
Material
Available Gauges
■
Stainless
16G
Installation
1. Fill the sheath with the ultrasound gel and place the sheath all the way down to the
Adapter. And then tie with rubber band.
2. Mount the adapter onto the probe
3. Place the sheath again and tie with the rubber band again. Tie the lower part than 1.
4. Insert the needle into the needle guide for use.
Chapter 8. Probes
8 - 43
▐ NER4-9ES, NEV4-9ES Biopsy guide (Disposable Type)
■ Specifications
Model name
Component
Material
Available Gauges
BP-KIT-018
Package
24 EA
Biopsy Adapter
1 EA
Sheath
2 EA
Plastic
16G
■ Installation
1. Fill the sheath with ultrasound gel and insert the probe.
2. Mount the Adapter onto the probe.
3. Place the thin sheath on the adapter again and insert the needle into the needle
guide for use.
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SONOACE X6 Operation Manual
▐ NER4-9ES, NEV4-9ES Biopsy guide (Reusable Type)
■ Specifications
Model name
BP-KIT-019
Biopsy Adapter
1 EA
Cleaning Brush
5 EA
Component
Material
Available Gauges
Stainless
16G
■ Installation
1. Fill the sheath with ultrasound gel and insert the probe.
2. Mount the adapter to the probe and insert the needle.
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