體外震波碎石機

The Sound Alternative to Surgery 1

 Shockwave Sources
Lightning
&
Thunder

Supersonic Airplane

Gun Shot

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Shock Waves Characteristics

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 Medispec 簡介
Market leader in development of state-of-the-art medical
systems based on shock wave technology
Non-invasive, reliable and effective medical systems

Founded in 1992

More than 2000 installations worldwide

80+ countries in 5 continents

Customers: From leading universities to private medical institutions

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 Medispec 儀器簡介
震波碎石機
1. 通過 FDA 及 CE (FDA Approval 、 CE
Approval)
2. 於 2006~2008 年在美國市場佔有率第一名 (No.1
in Lithotripter installations during 2006
to 2008 in the USA. )
3. 美國市場佔有率超過 35%
4. 在全球超過 1500 台 (1500 medical systems
installed worldwide and include)

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 Medispec 儀器簡介
能量及聚焦範圍 Power and
Focal Zone
1. 提供最佳聚焦範圍及最高震壓有效擊碎結石
The ESWL combines the power of spark gap technology with
a large focal zone and a high bar pressure to provide the most
effective stone breakage currently available.
2. 震壓 Bar Pressure = up to 910 bar

3. 聚焦範圍 Focal Zone = 13 x 60 mm F1

FOCAL ZONE ELECTRODE

HV Line

F2
MEMBRANE REFLECTOR

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 Electromagnetic
Shockwaves
When electricity is applied to the coil, the metallic
membrane is repelled to the opposing magnetic field,
creating shock waves.
The shock waves are transmitted to the focal point by
an acoustic lens or a parabolic reflector.
Lens Metal
Foil
Membrane

Focus

Coil
Water
Container

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 Shock Waves –
Clinical Consideration

Parameters to consider: Therapy Zone

• Energy density & range

5 Mpa Isobar
(treatment dependant) Limit of the Therapy
Focus Zone
Effect
• Total energy at the
therapeutic focal point
• Constant energy delivery Peak Pressure
• Precisely defined focus 100% Pressure

zone position Entrance Area

• Optimized therapy zone Skin

• Long lifetime
• Minimum consumables

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 EM1000 ESWL System
• High-voltage shockwave generator

• 4-axis treatment table

• Fluoroscopy X-Ray system

• Computerized console

• Ultrasound (optional)

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治療方式

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 Types of Shock Wave Sources
Electro hydraulic/Ellipsoid
Spark Gap technology: the shock waves are generated under
water using a spark electrode placed in an ellipsoid reflector.The
energy produced from the spark discharge is reflected, and
concentrated at a second focal point (F2)
Electromagnetic/Flat Coil (Lens)
When electricity is applied to the coil, the metallic
membrane is repelled to the opposing magnetic field,
creating shock waves. The shock waves are transmitted to
the focal point by an acoustic lens or a parabolic reflector.
Piezoelectric/Sphere
Ceramic elements are lined on a reflector dish. As these
elements are activated by high-voltage electric currents
they generate shock waves in a fluid medium. These shock
waves are reflected off the reflector dish and are localized
to a focal point.
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 Medispec 儀器簡介
臨床統計資料 Clinical Data

The system has been clinically proven to be one of

the most effective ESWL systems available:
Stone free at 3 months
83.3%
(no residual fragments)
Re-treatment rate 6–7%

Auxiliary procedure required <7%

* Source: FDA Clinical Study

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 Superior Clinical Results
• 78% of disintegrated stones could be excreted
spontaneously from the urinary system without
further treatment.
• Less than 8% re-treatment rate
• 3 optional levels of PPM 60 \ 90 \ 120

Stone Free
Fragments <=5mm
Fragments
Disintegration

Degree of Disintegration

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 Why Electrohydraulic is better?

• FDA Clinical studies prove that

better results are achieved Typical Average
through a larger focal zone. Electromagnetic Efficiency
during Lifetime
• Electromagnetic Technology Efficiency in %
Limitations. 100%

• While using the reflector head, 45%

energy decreases with time, until
there is a need to replace No. of Shocks 1,000,000
the unit.

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Focal Zone (F2) & Bar Pressure
Comparison*
* Based on SWL Update (Course 26 IC) from AUA 2006 Annual Meeting

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Siemens 網站資料

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 The Advantages of Medispec’s
Large Focal Zone
In Respiratory Movement
stone size movement of 0.5 cm movement of 1 cm

2 cm

1 cm

0.5 cm
Medispec
Focal zone

Competitors’ Respiratory gating NOT required due to large focal zone

Focal zone
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 規格
　 EM1000 E2000/E3000
震波產生方式 電磁式 火花放電 ( 電極棒 )
耗材 震波頭 ( 每 50 萬發更換 ) 電極棒每人使用一支
焦點深度 145mm 150mm
焦點範圍 6.8mm*68mm 13mm*60mm
震波壓力 85Bar~822Bar 425Bar~910Bar
噪音值 最低 62dB ，最高 73dB 　
震波電壓 12~20KV 15~22.5KV
頻率控制 非同步或同步 非同步或同步
治療床移動方向 4向 4向
治療床可承重 181 公斤 181 公斤
定位系統 X 光定位系統 X 光定位系統
影像增強器尺寸 9吋 9吋
控制台功能 (1) 可控制震波系統及定位系統的全程操作。
　 (2) 可控制震波釋放的能量及頻率。
　 (3) 可控制治療床的全程移動。
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 儀器性能比較
Electrohydraulic VS Electromagnetic
Electrohydraulic Electromagnetic
( 電極棒 ) ( 電磁式 )
Stone Free(at 3 months) 77%~65
82.9%
Re-Treatment Rate 7%~6 36%~24
Auxiliary Procedure 7% < 52%~11
Focal Zone 適中 (13x60mm) 小
( 不會因輕微的移動而 ( 容易因病人呼吸或輕微移
打不到結石 ) 動而造成降低效果 , 治療時
間變長 )
HVG( 震波產生器 ) ,每位病人更換電極棒 隨著使用時間增加 , 震波強
震波強度可維持一定 度跟著降低 , 影響治療效果
Reflector Head 不需更換 每 50 或 100 萬震波就必須更換
每位病人治療震波數 平均 3000 平均 4000

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 Medispec’s EM1000
ESWL System Advantages

• Best combination between largest focal zone in the

industry and bar pressure.
• Increased speed and treatment efficiency due to
large focal zone.
• Best clinical results with less complications.
• Cost effective, reliable, low maintenance &
consumable costs.
• Fully integrated, modular & compact systems.

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健保點值 - 門診

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健保點值 - 住院

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法規問題

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 ?Question

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