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Chapter 8

Probes

Probes .......................................................................................................................... 3
Ultrasound transmission Gel ................................................................................................. 12
Sheaths ................................................................................................................................. 13
Probe Precautions ................................................................................................................ 14
Cleaning and Disinfecting the Probe .................................................................................... 15
MPTEE Probe (Optional) ...................................................................................................... 24

Biopsy......................................................................................................................... 28
Biopsy KIT Components ....................................................................................................... 28
Using the Biopsy Kit .............................................................................................................. 29
Cleaning and Disinfecting Biopsy Kit .................................................................................... 31
Assembling the Biopsy Kit .................................................................................................... 33
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 system limits patient contact temperature to 43 degrees Celsius, and acoustic output
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:

Probe Application Preset

Abdomen General, Aorta, Appendix, Renal, ContrastAgent

C2-5EL Gynecology General, Adnexa, Endometrium, Uterus

OB General, Early, Fetal Heart

Abdomen General, Aorta, Appendix, Renal, ContrastAgent

C2-5EP Gynecology General, Adnexa, Endometrium, Uterus

OB General, Early, Fetal Heart

Abdomen General, Renal, Aorta, Appendix


C2-8
Gynecology General, Adnexa, Endometrium, Uterus
8-4 SONOACE X8 Operation Manual

Probe Application Preset

OB General, Early, Fetal Heart

Abdomen General, Aorta, Appendix, Renal


C3-7EP
Gynecology General, Adnexa, Endometrium, Uterus

C3-7EP OB General, Early, Fetal Heart

Pediatric General, Abdomen, Neo head, Hips

C4-9/10ED Appendix General, Appendix

Vascular General, Arterial, Carotid, Venous

Musculoskeletal General, Elbow/Wrist, Hand/Foot, Shoulder/Knee

Pediatric General, Abdomen


L4-7EL
Small Parts General, Breast, Superficial, Testicle, Thyroid

Vascular General, Arterial, Carotid, Venous

Musculoskeletal General, Elbow/Wrist, Hand/Foot, Shoulder/Knee

Pediatric General, Abdomen


HL5-12ED
Small Parts General, Breast, Superficial, Testicle, Thyroid

Vascular General, Arterial, Carotid, Venous

Musculoskeletal General, Elbow/Wrist, Hand/Foot, Shoulder/Knee

Pediatric General, Abdomen


L5-12EC
Small Parts General, Breast, Superficial, Testicle, Thyroid

Vascular General, Arterial, Carotid, Venous

Musculoskeletal General, Elbow/Wrist, Hand/Foot, Shoulder/Knee

Pediatric General, Abdomen


L5-12EP
Small Parts General, Breast, Superficial, Testicle, Thyroid

Vascular General, Arterial, Carotid, Venous


Chapter 8. Probes 8-5

Probe Application Preset

Musculoskeletal General, Elbow/Wrist, Hand/Foot, Shoulder/Knee

Pediatric General, Abdomen


L5-12/50EP
Small Parts General, Breast, Superficial, Testicle, Thyroid

Vascular General, Arterial, Carotid, Venous

Musculoskeletal General, Elbow/Wrist, Hand/Foot, Shoulder/Knee

Pediatric General, Abdomen


LN5-12
Small Parts General, Breast, Superficial, Testicle, Thyroid

Vascular General, Arterial, Carotid, Venous

P2-4AH Abdomen General, Aorta, Renal

Cardiac General, Aortic arch

P2-4AH Pediatric Cardiology General, Aortic arch

TCD General

Abdomen General, Aorta, Renal

Cardiac General, Aortic arch


P2-4AA
Pediatric Cardiology General, Aortic arch

TCD General

Abdomen General, Aorta, Renal

Cardiac General, Aortic arch


P3-5AC
Pediatric Cardiology General, Aortic arch

TCD General

Abdomen General, Aorta, Renal

P3-7AC Cardiac General, Aortic arch

Pediatric Cardiology General, Aortic arch


8-6 SONOACE X8 Operation Manual

Probe Application Preset

TCD General

MPT4-7 Cardiac General, Aortic arch

Gynecology General, Adnexa, Endometrium, Uterus

ER4-9/10ED OB General, Cervix, Fetal Heart

Urology General, Bladder, Prostate

Gynecology General, Adnexa, Endometrium, Uterus

EV4-9/10ED OB General, Cervix, Fetal Heart

Urology General, Bladder, Prostate

Gynecology General, Adnexa, Endometrium, Uterus

NER4-9ES OB General, Cervix, Fetal Heart

Urology General, Bladder, Prostate

Gynecology General, Adnexa, Endometrium, Uterus

NEV4-9ES OB General, Cervix, Fetal Heart

Urology General, Bladder, Prostate

3D2-6ET Abdomen General, Aorta, Appendix, Renal

Gynecology General, Adnexa, Endometrium, Uterus


3D2-6ET
OB General, Early, Fetal Heart

Abdomen General, Aorta, Appendix, Renal

3D4-8EK Gynecology General, Adnexa, Endometrium, Uterus

OB General, Fetal Heart, Cervix

Abdomen General, Aorta, Appendix, Renal


3D4-8ET
Gynecology General, Adnexa, Endometrium, Uterus
Chapter 8. Probes 8-7

Probe Application Preset

OB General, Early, Fetal Heart

Gynecology General, Adnexa, Endometrium, Uterus

3D4-9ES OB General, Fetal Heart, Cervix

Urology General, Bladder, Prostate

Gynecology General, Adnexa, Endometrium, Uterus

3D5-9EK OB General, Early, Fetal Heart

Urology General, Bladder, Prostate

Abdomen General, Aorta, Appendix, Renal

3DC2-6 Gynecology General, Adnexa, Endometrium, Uterus

OB General, Early, Fetal Heart

CW2.0 Cardiac General

Cardiac General
CW4.0
Pediatric Cardiology General

 Besides, user can have or select own preset between User1-5.


NOTE
 Refer to ‘Chapter3. Setting’ for how to set probe and its preset.
8-8 SONOACE X8 Operation Manual

■ Function list

Some functions depend on probe and its application. See following table.

Probe Application Q Scan Har PI PPI TDI CM ECG Biopsy

Abdomen ●
C2-5EL Gynecology x ● ● ● x x x ●

OB ●

Abdomen ●
C2-5EP Gynecology x ● ● ● x x x ●

OB ●
Abdomen ●

C2-8 Gynecology ● ● ● ● x x x ●

OB ●

Abdomen ●
C3-7EP Gynecology x ● ● ● x x x ●

OB ●

Pediatric
C4-9/10ED Appendix x x x x x x x

Vascular x

Musculoskeletal x

Pediatric x
L4-7EL x x x x x x ●
Small Parts ●

Vascular ●

Musculoskeletal x

Pediatric x
HL5-12ED ● x x x x x ●
Small Parts ●

Vascular ●

Musculoskeletal x

Pediatric x
L5-12EC ● x x x x x ●
Small Parts ●

Vascular ●
L5-12EP Musculoskeletal x x x x
● x x ●
L5-12EP Pediatric x x x x
Chapter 8. Probes 8-9

Probe Application Q Scan Har PI PPI TDI CM ECG Biopsy

Small Parts ● x x x

Vascular ● x x ●

Musculoskeletal x

Pediatric x
L5-12/50EP ● x x x x x ●
Small Parts ●

Vascular ●

Musculoskeletal x x x x

Pediatric x x x x
LN5-12 ● x x ●
Small Parts ● x x x

Vascular ● x x ●

Abdomen x x x x

Cardiac ● ● ● ●
P2-4AH ● ● ● x
Pediatric Cardiology x ● ● ●

TCD x x x x

Abdomen x x x x

Cardiac ● ● ● ●
P2-4AA ● ● ● x
Pediatric Cardiology x ● ● ●

TCD x x x x

Abdomen x x x x

Cardiac ● ● ● ●
P3-5AC ● ● ● x
Pediatric Cardiology x ● ● ●

TCD x x x x

Abdomen x x x x

Cardiac x ● ● ●
P3-7AC ● ● ● x
Pediatric Cardiology ● ● ● ●

TCD x x x x
MPT4-7 Cardiac ● ● ● ● ● ● ● x
Gynecology ● x x x
ER4-9/10ED OB x x x x x ● x ●
Urology x x x x
Gynecology ● x x x
EV4-9/10ED x x x ●
OB x x ● x
8 - 10 SONOACE X8 Operation Manual

Probe Application Q Scan Har PI PPI TDI CM ECG Biopsy

Urology x x x x

Gynecology ●
NER4-9ES OB x x x x x x x ●

Urology x

Gynecology ●

NEV4-9ES OB x x x x x x x ●

Urology x

Abdomen ●

3D2-6ET Gynecology x ● ● x x x x ●

OB ●

Abdomen ●

3D4-8EK Gynecology x ● ● x x x x ●

OB ●

Abdomen ●

3D4-8ET Gynecology x ● ● x x x x ●

OB ●

Gynecology ●

3D4-9ES OB ● ● X X X X X ●

Urology ●

Gynecology ●

3D5-9EK OB x ● ● x x x x ●

Urology x

Abdomen ●

3DC2-6 Gynecology ● ● ● x x x x ●

OB ●

CW2.0 Cardiac x x x x x x x x

Cardiac x
CW4.0 x x x x x x x
Pediatric Cardiology x
Chapter 8. Probes 8 - 11

▐ Thermal Index (TI) Tables


TI values displayed on the screen title bar can change depending on probes and
applications. SONOACE X8 decides automatically which TI value will be displayed out of
TIs, TIb, and TIc. The TI values are as follows,

Application

PediatricCardiology

Musculoskeletal
Gynecology

Small Parts
Obstetrics

Abdomen

Appendix
Pediatric

Vascular
Urology
Cardiac
Probe

TCD
C2-5EL TIb TIs TIs

C2-5EP TIb TIs TIs

C2-8 TIs TIs TIs

C3-7EP TIb TIs TIs

C4-9/10ED TIs TIs TIs

L4-7EL TIs TIs TIs TIs

HL5-12D TIs TIs TIs TIs

L5-12EC TIs TIs TIs TIs

L5-12EP TIs TIs TIs TIs

L5-12/50EP TIs TIs TIs TIs

LN5-12 TIs TIs TIs TIs

P2-4AH TIs TIs TIs TIs

P2-4AA TIs TIs TIs TIs

P3-5AC TIs TIs TIs TIs

P3-7AC TIs TIs TIs TIs

MPT4-7 TIs

ER4-9/10ED TIb TIs TIs

EV4-9/10ED TIb TIs TIs

NER4-9ES TIb TIs TIs


8 - 12 SONOACE X8 Operation Manual

Application

PediatricCardiology

Musculoskeletal
Gynecology

Small Parts
Obstetrics

Abdomen

Appendix
Pediatric

Vascular
Urology
Cardiac
Probe

TCD
NEV4-9ES TIb TIs TIs

3D2-6ET TIb TIs TIs

3D4-8EK TIb TIs TIs

3D4-8ET TIb TIs TIs

3D4-9ES TIs TIs TIs

3D5-9EK TIb TIs TIs TIs

3DC2-6 TIs TIs TIs

CW2.0 TIs

CW4.0 TIs TIs

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.

■ 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:
- Acetone
WARNING - Methanol
- Denatured Ethyl Alcohol
- Mineral Oil
- Iodine
- Lanolin
- Any lotions or gels containing perfume
Chapter 8. Probes 8 - 13

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.

▐ Installing the Sheath

■ Always keep sheaths in a sterile state.

■ Sheaths are disposable. Do not reuse them.

■ If sheaths are torn or soiled after use, clean 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.

1. Put on sterile gloves. Unpack the sheath and fill it with acoustic coupling gel.
2. Insert the probe into the sheath and pull the latex tip to cover the probe completely. If
possible, cover the probe cable as well.
3. Ensure that there is no air bubble within the ultrasound gel. If necessary, secure the
sheath to the probe and the probe cable.
4. Dispose of the sheath after use.
8 - 14 SONOACE X8 Operation Manual

Probe Precautions
■ Do not apply mechanical shock to the probe.

■ 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
CAUTION 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.

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.

▐ Use and Infection Control of the Probe

No neurosurgical treatments or examinations should be carried out on a patient


with Creutzfeldt-Jakob disease (critical brain disease caused by virus). If the
WARNING
probe has been used on such a patient, it cannot be sterilized by any method
whatsoever.

Sufficient washing and disinfecting must be carried out for preventing infection.
This is the responsibility of the user who manages and maintains the disinfection
CAUTION
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 reused, 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 - 15

▐ 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 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.
■ Do not apply excessive force to twist, pull or bend the probe cable. It may
WARNING
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.

 Always use protective eyewear and gloves when cleaning and


disinfecting probes.
WARNING
 Inspect the housing, strain relief, lens and seal for damage, and check
for any functional problem after cleaning and disinfecting the probe.

▐ Information of Detergent, Disinfectant, and Ultrasound Gel


Use an appropriate one with following tables. All probes are under tested in IPX 7 Criteria.
8 - 16 SONOACE X8 Operation Manual

Disinfectants

Clieanisept Wipes
Sani-Cloth Active

Trasneptic Spray

Super Sani-Cloth
Sani-Cloth Plus

Asepti-Wipes II
Sani-Cloth HB

Asepti-Wipes
Incidin Foam
Ster-Bac Blu
Setptiwipes

MetriWipes
Germicidal

CaviWipes
Sani-Cloth
T-Spray II

Cidex 2%
T-Spray
Names

Type S S W W W W W L S S W W W W W W L

Ammonium
Quaternary

(N-Alkyl)

IPA

NA
Active Ingredient

C2-5EL ● ● ●
C2-5EP
C2-8
C3-7EP ● ●
C4-9/10ED ● ●
L4-7EL ● ● ●
HL5-12D
L5-12EC ● ● ●
L5-12EP
L5-12/50EP ● ●
LN5-12 ● ● ●
P2-4AH ● ★ ●
P2-4AA ● ● ● ● ●
P3-5AC ● ● ●
P3-7AC ● ● ●
MPT4-7
ER4-9/10ED ● ● ●
EV4-9/10ED ● ● ●
NER4-9ES ● ● ●
NEV4-9ES ● ● ●
3D2-6ET ● ● x
3D4-8EK
3D4-8ET ● ● x
3D4-9ES ● ● ●
3D5-9EK
3DC2-6
CW2.0 ● ● ●
CW4.0 ●
Chapter 8. Probes 8 - 17

Disinfectants

Surfaces Hautes
Salvanios pH10
Omnicide - FG2
Omnicide 14NS

Sekusept Extra

Salvanios pH 7

Sekusept Plus
3)
2,3)

Bleach 5.25%
Steranios 2%
2)

2)

Wavicide-01
Omnicide
Cidex Plus

Nuclean
Cidex OPA

Metricide

Milton
Names

Type L L L L L L L L L L L L S L L L

Glutaraldehyde

Hypochlorite
surfactant
Nonionic

Sodium
Active Ingredient

C2-5EL ● ● ● ● ● ● ● ●
C2-5EP
C2-8
C3-7EP ● ● ● ●
C4-9/10ED ● ● ● ● ●
L4-7EL ● ● ● ● ● ● ●
HL5-12D
L5-12EC ★ ● ● ● ● ●
L5-12EP
L5-12/50EP ● ● ● ●
LN5-12 ● ● ● ● ● ●
P2-4AH ● ● ● ●
P2-4AA ● ● ● ● ● ● ● ● ●
P3-5AC ★ ● ● ● ● ● ★
P3-7AC ★ x ● ● ★ ● ★
MPT4-7 ● ● ●
ER4-9/10ED ● ● ● ● ● ●
EV4-9/10ED ● ● ● ● ● ●
NER4-9ES ● ●
NEV4-9ES ● ●
3D2-6ET ● ● ● ●
3D4-8EK
3D4-8ET ● ● ● ●
3D4-9ES ● ●
3D5-9EK
3DC2-6
CW2.0 ★ ● ● ●
CW4.0 ● ● ●
8 - 18 SONOACE X8 Operation Manual

Disinfectants Cleaner

3)

alcohol(70%)

alcohol(80%)
Gigasept FF

Isoproppyl

Isoproppyl
Gigasept AF
Sporox Ⅱ

Cidezyme

Klenzyme
Alkazyme
Gigasept

PeraSafe
Hibitane
Sporox
Virkon

Enzol
Names

Type L L L L L L L P L L L L

Succindialdehyde,

Dodecylphenoleth
Xylene Sulfonate
oxylate, Sodium
Peracetic Acid
Bersteinsaure
Chlorhexidine
formaldehyde

Proteolytic
gluconate
Hydrogen

Enzymes
Peroxide

solution

Alcohol
NA

NA
Active Ingredient

C2-5EL ● ● ● ● ● ● ●
C2-5EP
C2-8
C3-7EP x ● ●
C4-9/10ED x ● ● x
L4-7EL ● ● ● ● ●
HL5-12D
L5-12EC x x x ● ● ● x
L5-12EP
L5-12/50EP x ● ● x
LN5-12 ● ● ● ●
P2-4AH ★ ● ●
P2-4AA ● ● ●
P3-5AC x x x ★ ● ● x
P3-7AC x x x ★ ● ● x
MPT4-7 ●
ER4-9/10ED ● ● ●
EV4-9/10ED ● ● ●
NER4-9ES ●
NEV4-9ES ●
3D2-6ET x ● ●
3D4-8EK
3D4-8ET x ● ●
3D4-9ES ●
3D5-9EK
3DC2-6
CW2.0 ● x x ● ● ● x
CW4.0 ●
Chapter 8. Probes 8 - 19

Cleaner Gel

3)

GE Ultrasound
Aquasonics 100
Natural Image
Ethanol 75%

Clear Image
Contact Gel

Wavelength
KcKesson
Metrizyme

Sonogel
Kendall

Scan
Names

Type L L L G G G G G G G G

Propylene Glycol

(Chloroxylenol)

Ammonium
Chlorides
Alcohol

PCMX

NA
Active Ingredient

C2-5EL ● ●
C2-5EP
C2-8
C3-7EP ● ● ●
C4-9/10ED ● ●
L4-7EL ● ●
HL5-12D
L5-12EC ● ●
L5-12EP
L5-12/50EP ● ● ●
LN5-12 ● ● ●
P2-4AH ● ● ●
P2-4AA ● ●
P3-5AC ● ●
P3-7AC ● ●
MPT4-7 ●
ER4-9/10ED ● ● ●
EV4-9/10ED ● ● ●
NER4-9ES ●
NEV4-9ES ●
3D2-6ET ● ●
3D4-8EK
3D4-8ET ● ●
3D4-9ES ●
3D5-9EK
3DC2-6
CW2.0 ● ●
CW4.0 ●
8 - 20 SONOACE X8 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 8 - 21

Following is information about manufacturer (or Distributor) of Detergent, Disinfectant, and


Ultrasound Gel.

Product Manufacturer or Distributor Telephone number

Aquasonics Parker Co. +1-800-631-8888(USA)


+1-800-445-6741(USA)
Cidex CIVCO Co.
+1-319-656-4447(Worldwide)
+1-800-445-6741(USA)
Enzol CIVCO Co.
+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)
Isopropyl alcohol (70%) Local drugstore None
Klenzyme Steris Co. +1-800-548-4873(USA)
+1-800-445-6741(USA)
Metricide CIVCO Co.
+1-319-656-4447(Worldwide)
Metrizyme Metrex Research Corp. +1-800-841-1428(USA)
Milton Product & Gamble Australia Pty. Ltd. +61-1800-028-280(Australia)
+1-800-526-3867(USA)
Nuclean Nation Diagonostics Co.
+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)
Sekusept Extra Henkel Hygiene GmbH. +49-0211-797-0(Germany)
Sporox II Sultan Chemist Inc. +1-800-637-8582(USA)
+1-800-445-6741(USA)
T-Spray CIVCO Co.
+1-319-656-4447(Worldwide)
Virkon Antec International LTD. +1-403-286-1771(USA)
Wavicide Wave Energy System Inc. +1-800-252-1125(USA)
8 - 22 SONOACE X8 Operation Manual

▐ 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 soft
brushes can damage the probe.

■ During cleaning and disinfection, keep the parts of the probe that must
CAUTION
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.

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.


Chapter 8. Probes 8 - 23

▐ 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.

 If a pre-mixed solution is used, be sure to observe the solution expiration


date.
WARNING  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.
CAUTION  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.

1. 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 lavel instructions for
solution strength.

3. Immerse the probe into the disinfectant as shown in the illustration below.

4. Using the instructions on the disinfectant, rinse the probe after the immersion process
is complete.

5. Air dry the probe or towel it dry with a clean cloth.

[Figure 8.1 Disinfection]


8 - 24 SONOACE X8 Operation Manual

MPTEE Probe (Optional)

Multi planr transesophageal echocardiography (MPTEE) probe is one of the intracavity probes.
You should read the following information before you use the MPTEE probe.

▐ Usage of MPTEE Probe

[Figure 8.2 Dials of MPTEE Probe]

- Angle of lens: Use dial ①. The lens can be controlled in –5~180˚.


Counterclockwise rotation makes large angle. There is the white line on the side of
dial for the convenience of user. If you make it meet the center line of the handle,
the angle of the lens become 90˚. The status of -5˚is following figure.

[Figure 8.3 Angle arrangement; in case of -5˚]

- Scan Head Tilting: Use dial ②. Clockwise rotation makes scan head bend to
forward of the lens. Counterclockwise rotation makes scan head bend to backward
of the lens. If you make the white line meet the centerline of the handle, the scan
head become a straight line.
Chapter 8. Probes 8 - 25

[Figure 8.4 Scan Head Tilting]

- Locked Mode: It makes the action of the Head and lens unnaturally while using the
probe. To Lock the probe, turn the silver handle until the red sign is displayed.

[Figure 8.5 Lock Status]

▐ Safety precautions

Never use MPTEE probe, if the surface temperature is under 25℃ or over
DANGER
42℃. It can be very harmful for human body.

 Do not move the system with MPTEE probe on the probe holder.
MPTEE probe can fall down because it is not set.
WARNING
 To protect the patient and the probe, unlock the deflection control when
inserting or withdrawing the probe.
8 - 26 SONOACE X8 Operation Manual

If the temperature of surface temperature is over 40℃, the warning message will be appeared.

- 40℃: Estimated surface temperature of 40degrees C


- 41℃: Estimated surface temperature of 41degrees C
- 42℃: Estimated surface temperature of 42degrees C
- 43℃: Approaching thermal limit; currently 43 degrees C
- 44℃: Critical scanhead temperature (MPTEE probe will be Lock up, and Probe
selection window will be displayed.)

Keep MPTEE probe clean because this is intracavity probe. Do not put
CAUTION MPTEE probe on the floor.

 Put MPTEE probe on the left holder of system. The right probe holder is
NOTE not fit for MPTEE probe.
 A pyrogen-free sheath is recommended to use with MPTEE probe.

▐ Maintenance
Adequate cleaning and, if necessary disinfection are carried out to prevent disease
transmission. It is the responsibility of the user to verify and maintain the effectiveness of the
procedure used.

Keep the handle and probe connector out of any cleaning or disinfection
solutions. The handle and cable may be cleaned with a damp cloth, but only
CAUTION the end of the probe up to the 100cm marker on the shaft may be placed into
a disinfection solution.

■ Cleaning

Do not clean any portion of the probe with methanol or ethanol. Such
CAUTION substance can cause irreparable damage to the probe.

1. Clean the scan head and flexible shaft with gauze pads soaked in mild soapy
lukewarm water (below 26°C is recommended). Remove any materials that could
interfere with the disinfection procedure.

2. Rinse the scan head and shaft with lukewarm water, in which one can hold one's
hand without pain. Proceed until all visible soap residue has been removed.

3. Air-dry or dry with a soft cloth.


Chapter 8. Probes 8 - 27

■ Disinfection

WARNING Do not use other disinfection methods like ethanol, Iodine, Steam, Heat or
Ethylene Oxide.

 The probe should never be left in the disinfection solution for more than
CAUTION 1 hour.
 Do not forget to rinse the probe directly after disinfection.

When necessary ultrasound probes can be disinfected using liquid chemical


germicides. Cidex, Cidex-OPA, Metricide, Omnicide and Gigasept solutions have been
tested for compatibility with the materials used to construct the probe. Follow the
disinfectant manufacturer's recommendations for solution preparation, immersion time
and rinsing.

1. Place the cleaned and dried probe surface (the end of probe and up to the
100cm marker only) in contact with the disinfection solution.

2. Rinse the scan head and shaft with water and dry prior to storage.
8 - 28 SONOACE X8 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 adapter, needle guide and needle. The components vary depending
on the probe type. The components and accessories can be purchased from MEDISON.

[Figure 8.6 Biopsy Kit Components]

- Adapter: 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 adapter 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 - 29

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
WARNING location of the needle must be checked by monitoring the echo
generated from the needle.
■ Never use the biopsy kit to biopsy prostate tissue.

▐ 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.

3. Set the system controls for the biopsy procedure.If necessary, apply acoustic gel to
the patient.
8 - 30 SONOACE X8 Operation Manual

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.

■ 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.
WARNING
■ 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 - 31

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.

Always use protective eyewear and gloves when cleaning and disinfecting
WARNING
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.
8 - 32 SONOACE X8 Operation Manual

▐ 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.

■ Disinfection

Plastic biopsy kits can only be disinfected using a chemically


CAUTION 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 - 33

Assembling the Biopsy Kit


▐ C5-2EL Biopsy guide

■ Specifications

Model name BP-KIT-010


Biopsy Adapter 1 EA
Component
Box 1 EA
Material Acetal Copolymer

Available Gauges 14G, 16G, 18G, 20G, 22G

■ Installation
1. Mount the Biopsy Adapter onto the probe.

2. Place the Probe Cover all the way down to the Adapter.

(a) (b)
8 - 34 SONOACE X8 Operation Manual

(c) (d) (e)


3. Choose a needle guide of the desired gauge and secure it to the adapter.

4. Secure the Needle Guide Clip.

5. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 35

▐ C2-5EP Biopsy Guide


■ Specifications

Model name BP-KIT-021

Biopsy Adapter 1 EA
Component
Needle Guide 8 EA

Material Polyurethane

Available Gauges 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.

3. Secure the Needle Guide Clip.


8 - 36 SONOACE X8 Operation Manual

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 - 37

▐ C2-8Biopsy Guide

■ Specification

Model name BP-KIT-035

Biopsy Bracket 1 EA
Component
Needle Guide 24 EA

Material Acetal Copolymer

Available Gauges 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.


8 - 38 SONOACE X8 Operation Manual

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 39

▐ C3-7EP Biopsy Guide

■ Specifications

Model name BP-KIT-025


Adapter 1EA
Needle Guide Kit 8EA
Component
BVerufucation kit 1EA
User Manual 1EA
Material Polyurethane

Available Gauges 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.
8 - 40 SONOACE X8 Operation Manual

3. Secure the Needle Guide Clip.

4. Insert the needle into the needle guide for use.


Chapter 8. Probes 8 - 41

▐ L4-7EL Biopsy Guide

■ Specifications

Model name BP-KIT-014


Biopsy Adapter 1 EA
Component Needle Guide Pack
Box 1 EA
Material Polyurethane

Available Gauges 14G, 16G, 18G, 20G, 22G, 25G

■ Installation

1. Mount the adapter onto the probe.

2. Fill the sheath with ultrasound gel and insert the adapter fully into it.
8 - 42 SONOACE X8 Operation Manual

3. Mount the needle guide onto the adapter.

4. Mount the needle guide clip on the adapter to provide a desired gauge.

5. Insert a needle into the needle guide for use.


Chapter 8. Probes 8 - 43

▐ L5-12EP Biopsy Guide


■ Specifications

Model name BP-KIT-023

Biopsy Adapter 1 EA
Component
Needle Guide 8 EA

Material Polyurethane

Available Gauges 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.


8 - 44 SONOACE X8 Operation Manual

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 - 45

▐ HL5-12ED Biopsy Guide


■ Specifications

Model name. BP-KIT-022

Biopsy Adapter 1EA


Needle Guide Kit (Odd & Even Gauge Clip) 3EA/Each
Component
(Needle Guide Kit is composed with Sheath, Ultra Sound
Gel, and Needle Guide Straw.)

Material Body: Acetal Copolymer


Screw: 303 Stainless

Available Gauges 16G, 18G, 22G

※ Adapters and the needle guide kits (24 different gauge types per pack) are available for
sale in packs.

■ Installation

1. Mount the Biopsy adapter onto the probe.

2. Insert gel into sheath. And cover it.

3. Choose a needle guide of the desired gauge and secure it to the adapter.
8 - 46 SONOACE X8 Operation Manual

4. Lock the needle guide like following (a), (b). and (c)

(a) (b) (c)


5. Press the needle guide like (c), and install the needle into the needle guide.
Chapter 8. Probes 8 - 47

▐ L5-12EC Biopsy Guide


■ Specifications

Model name BPL-75/40-AC

Biopsyadapter 1EA
Component
Box 1EA
Material Stainless (re-usable)
Available Gauges 8G, 14G, 16G, 18G, 20G, 22G

■ Installation
1. Mount the adapter onto the probe.

2. Choose a needle guide of the desired gauge and secure it to the adapter.

3. Insert the needle into the needle guide for use.


8 - 48 SONOACE X8 Operation Manual

▐ L5-12/50EP Biopsy Guide

NOTE To purchase this biopsy kit, please contact the local office.

■ Specification

Model name BP-KIT-020


Biopsy Adapter 1EA
Component
Needle Guide 8EA

Material Polyurethane

Available Gauges 16G, 18G, 22G

■ Installation

1. Insert gel into the cover for the Kit and cover the adapter completely.
Chapter 8. Probes 8 - 49

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 - 50 SONOACE X8 Operation Manual

▐ LN5-12 Biopsy Guide

 Specification

Model name BP-KIT-040

Biopsy Adapter 1 EA
16Ga disposable needle guide/probe cover KIT 8EA
Component
18Ga disposable needle guide/probe cover KIT 8EA
22Ga disposable needle guide/probe cover KIT 8EA

Material Acetal Copolymer

Available Gauges 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.


Chapter 8. Probes 8 - 51

4. Insert the needle into the needle guide for use.


8 - 52 SONOACE X8 Operation Manual

▐ EV4-9/10ED, ER4-9/10ED Biopsy guide

■ Specifications

Model name BP-KIT-024

Biopsy Adapter 1 EA
Component
Sheath 2 EA

Material Stainless

Available Gauges 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 - 53

▐ NER4-9ES, NEV4-9ES Biopsy guide (Disposable Type)

■ Specification

Model name BP-KIT-018


Package 24 EA
Component Biopsy Adapter 1 EA
Sheath 2 EA
Material Plastic

Available Gauges 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.
8 - 54 SONOACE X8 Operation Manual

▐ NER4-9ES, NEV4-9ES Biopsy guide (Reusable Type)

■ Specification

Model name BP-KIT-019

Biopsy Adapter 1 EA
Component
Cleaning Brush 5 EA

Material Stainless

Available Gauges 16G

■ Installation
1. Fill the sheath with ultrasound gel and insert the probe.

2. Mount the adapter to the probe and insert the needle.


Chapter 8. Probes 8 - 55

▐ 3D2-6ET, 3D4-8ET Biopsy Guide

■ Specification

Model name BP-KIT-033

Biopsy Adapter 1 EA
Component
Needle Guide 1 EA

Material Ticona-Acetal

Available Gauges 14G ~ 23G

■ Installation

1. Place the biopsy adapter onto the probe.

2. Fill the sheath with ultrasound gel and insert the probe.

3. Mount the needle guide on the adapter.


8 - 56 SONOACE X8 Operation Manual

4. Install the needle into the needle guide for use.


Chapter 8. Probes 8 - 57

▐ 3D4-9ES Biopsy guide


■ Specifications

Model name BP-KIT-027

Component Adapter 1 EA

Material Stainless

Available Gauges 16~22G

■ Installation

1. Fill the sheath with ultrasound gel and insert the probe.

2. Mount the adapter to the probe and insert the needle.


8 - 58 SONOACE X8 Operation Manual
Chapter 8. Probes 8 - 59

▐ 3D4-8EK Biopsy guide

■ Specifications

Model name PEC-51

Adapter 1 EA
Guide 1 EA
Component
Case 1 EA
User Manual 1 EA
Material Stainless

Available Gauges 16G, 18G, 22G

■ Installation
1. Mount the Biopsy adapter onto the probe.

2. Install the needle guide onto the adapter.

3. Insert the needle into the needle guide for use.


8 - 60 SONOACE X8 Operation Manual

▐ 3D5-9EK Biopsy guideSpecifications


■ Specifications
Model name PEC-47

Adapter 1 EA
Guide 1 EA
Component
Case 1 EA
User Manual 1 EA

Material Stainless
Available Gauges 16G, 18G, 22G

■ Installation
1. Mount the Biopsy adapter onto the probe.

2. Turn the knob to fix the adapter on the probe.

3. Install the needle into the needle guide for use.


Chapter 8. Probes 8 - 61

▐ 3DC2-6 Biopsy Guide


■ Specifications

Model name BP-KIT-026

Biopsy Adapter 1 EA
Component
Needle Guide 24 EA

Material Acetal Copolymer

Available Gauges 16G, 18G, 22G

■ Installation
1. Place the biopsy adapter onto the probe.

2. Fill the sheath with ultrasound gel and insert the probe.

3. Mount the needle guide on the adapter.


8 - 62 SONOACE X8 Operation Manual

3. Install the needle into the needle guide for use.

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