EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY SYSTEM

Transcription

1 EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY SYSTEM LITHO3PTER LITHOARC Advanced Medical Systems

2 PCK has built a solid worldwide reputation as a leading lithotripsy manufacturer by uniquely offering high-tech, high quality systems at reasonable prices. The fifth addition to the popular Stonelith family is the extremely versatile LITHO3PTER Extracorporeal Shock Wave Lithotripter. The 3 in the name symbolizes the combining of the ESWL main unit, the patient treatment table, and an X-ray fluoroscopy U-arm into one integrated system. All of the LITHO3PTER models include motorized control of the treatment table in the vertical, longitudinal and transverse directions. These movements- as well as other control features- are made from the LITHO3PTER s mobile console, which can be placed next to the machine, behind a radiation barrier or even in an adjacent room, according to the requirements of the customer. The treatment table is X-ray transparent, allowing for other radiological procedures. The standard model of the LITHO3PTER includes an integrated U-arm X-ray with motorized oblique movements (manual control, optional). The operation of the U-arm is also made from the console s soft-touch control panel. A major advantage of the stable X-ray is that, unlike non-attached systems, the second focal point (F2) does not need to be checked prior to the treatment procedure, saving the operator time in the preparation process. The system can also be provided with an integrated C-arm replacing the U-arm, thereby providing an added orbital movement, and a convenient infrared remote controller. For those customers preferring to have localization made through an independent X-ray unit, the LITHO3PTER is available without the integrated U-arm. PCK can then meet this fluoroscopy requirement by means of their Polaris C-arm or Lithovision U-arm X-rays.

3 An optional feature of the LITHO3PTER is the PCK spherical ultrasound attachment. The doctor simply locates the position of the stone and then places the probe into the device s holder. Adjustment can be made as required. A major advantage of the attachment is it allows for both fluoroscopic and ultrasonic localization of the stone simultaneously. The LITHO3PTER s versatility is made evident by being able to meet the lithotripsy needs of medical establishments requiring more technically-advanced features. The PCK smart is a system control/database program functioning from a personal computer, allowing for more operating flexibility and data management tools. The LITHO3PTER + smart package can be further upgraded to include automatic stone localization. This includes locating the stone by use of fluoroscopy (X-lith), ultrasonography (Ultralith) or both types of imaging (Autolith).

4 The LITHO3PTER s user-friendly soft-touch panel places many special features at the operator s fingertips. It is divided into three main sections: The ESWL Section (right side of panel) Alphanumeric LCD Screen (describing current operating condition) Ellipsoid Fill/Drain Shock Counter Set/Clear Adjustable Shock Power Adjustable Frequency Control Choice of Single, Double or Triple Shocks Choice of Automatic, Remote, ECG or Respiratory Modes Start/Stop Arc Movement (optional) The Treatment Table Section (middle of panel) Vertical Adjustment Longitudinal Adjustment Transverse Adjustment The X-ray Section (left side of panel) LED Displays (indicating levels of kv, ma and minutes of use) Icon Buttons Controlling kv, ma and Timer Motorized Oblique Movement (manual control, optional) Manual and Automatic Mode Selection Image Control Buttons (providing normal view, horizontal flip, and vertical flip) System Warning Indicators

5 smart Program The optional smart software is a PCK-developed control program for the ESWL that works on a Pentium PC under Windows 95 and higher versions. With smart, all of the functions necessary for advanced stone treatment are conveniently at the command of the operator, including: ESWL controls, table movements, and X-ray and/or ultrasound operations. The real time fluoroscopy on the Stonelith SMART s PC-integrated control environment (ICE) monitor allows for easy viewing and manipulation of the image. Besides image manipulation and processing, smart also includes other special utilities, such as: remote diagnostics through a modem, ESWL shock counters for the treatments and generator, and permitting control of more than one function simultaneously. The software allows for easy installation of the system while minimizing downtime and service calls. Patient Database The smart s database stores patient information for statistical use and later recollection. Biographical, operator, diagnostic, stone and treatment information are recorded along with miscellaneous notes and comments. All of the data can be easily stored, searched, recalled, printed, and deleted. With a click of the mouse, treatment information including: date, biographical details of patient, operating mode, average kv applied, average frequency, number of shocks sent, and duration of treatment can be instantly stored for future reference. Graphics and real time snap-shot images from the treatment can also be attached to this database for later use. X-lith X-ray computer-controlled stone localization system Ultralith Ultrasound computercontrolled stone localization system Autolith X-ray & ultrasound computer-controlled stone localization system The LITHO3PTER + smart program option can be upgraded to include the primary feature of what may be referred to as highend lithotripsy systems: automatic stone localization. This includes locating the stone by use of fluoroscopy (X-lith), ultrasonography (Ultralith) or both types of imaging (Autolith). The X-lith allows the operator to locate the targeted stones in patients accurately and automatically. The Ultralith (and the other half of the Autolith) C 2 SLS options incorporate the PCK-developed robotic arm, which holds the convex or sector probe in place. The Ultralith s robotic arm can work in conjunction with a variety of different ultrasound

6 OLD SYSTEM PCK SYSTEM PCK s Long-Life Electrodes: Last approximately 50 sessions Are easy to adjust and replace Increase the effectiveness of the shock waves Have a very low cost Like earlier Stonelith versions, the LITHO3PTER is able to increase effectiveness while decreasing discomfort due in part to its unique long-life electrode system. In comparable machines, the traditional spark gap electrode is designed so two thick pieces of metal, that become thin towards the ends, face each other. After about 1,000 shocks the distance between the two metal ends gets wider, resulting in thicker parts of the metal pieces being used to translate the spark. The spark eventually loses its focus as a result of having to use the wider pieces of metal while traveling a greater spark distance between the two parts of the electrode. This degeneration continually increases the pain the patient feels while decreasing the treatment s effectiveness. PCK s electrode system avoids the problems of the traditional spark gap electrodes. The long-life electrodes have been designed so that they begin thin and stay thin throughout their lifetime. There is no thick part to disrupt the focusing efficiency of the spark to the second focal point. Even when the distance is greater, after approximately 1,000 shocks, the spark maintains its focusing strength much better than the traditional electrodes. The other major advantage of the LITHO3PTER s long-life electrodes is that they are adjustable. Without disrupting the treatment, the doctor can simply adjust the distance between the electrodes with an equally slight turn of both electrode handles, making the electrodes as good as new even after thousands of shocks have been administered. Each long-life electrode pair can last approximately 150,000 shocks, or 50 sessions of 3,000 shocks each. A new option to the well-proven PCK long-life electrodes is automatic motorized adjustment of the electrode pair. Besides long-life electrodes, another factor that increases effectiveness while decreasing discomfort is PCK s computer-designed ellipsoids. The size and shape of these reflectors, made from an especially strong alloy, have been chosen to maximize the amount of shock waves that reflect off the deep ellipsoid. This helps minimize the percentage of shock waves that are lost and not reflected towards the second focal point. Since lost waves contribute to the pain that patients feel during treatments, the V.5 s exceptionally large standard ellipsoid reduces unnecessary discomfort caused by improper mechanical design and use of inferior metal. The PCK spherical ultrasound attachment can be adjusted to a variety of different positions. The spherical ultrasound attachment maintains a proper F2 focus regardless of its position. Another optional feature available with the LITHO3PTER is inline ultrasound localization. A combination of inline and external ultrasound localization is also possible.

7 The standard model of the Stonelith Version 5 ESWL comes complete with a stable ellipsoid. However, the LITHO3PTER can be provided with a reflector that rotates inside a C-shaped mechanical device. This major model is known as LITHOARC. The basic unit includes a swing-away U-arm along with the integrated treatment table. However, like the LITHO3PTER, the LITHOARC can also be provided without the X-ray unit attached, or even have a C-arm replace the U-arm. The LITHOARC provides for the motorized movement of the ellipsoid in a semi-circle track. This flexibility provides the user with the ability to more accurately locate the stone s position, regardless of where it is in the urinary tract. By allowing the operator to locate even the traditionally hard-to-find stones, the doctor is allowed the opportunity to expand the lithotripsy procedure s practical applications.

8 In order to more fully appreciate the versatility of the LITHOARC, the system must be accompanied by some type of ultrasound localization. This need can be met by inline ultrasound or the Ultralith robotic arm, which is a part of the computercontrolled stone localization option of the smart. An important added application of the LITHOARC is for Extracorporeal Shock Wave Therapy, or ESWT. The therapeutic use of electro-hydraulic shock wave pulses is a rapidly expanding utilization of machines traditionally limited to stone-breaking procedures. The flexibility of the LITHOARC s ellipsoid allows for comfortable therapy in a variety of different locations.

9 LITHO3PTER Specifications ESWL Unit Energy source Electro-hydraulic spark gap system Focusing Ellipsoidal Patient coupling Dry patient coupling, water cushion with automatic pressure stabilization, elastic and soft hypoallergenic membrane Localization X-ray fluoroscopy and/or ultrasound system Operating voltage 7.5 to 24+ kv, adjustable Ellipsoid aperture 220 mm ( 8.66 ) Focal distance 130 mm ( 5.11 ) Focal pressure 0 to 1200 bar Water cushion capacity 10.5 lt ( 2.77 usgallon) Water tank capacity 13 lt ( 3.43 usgallon) Height 920 mm ( 36.5 ) Length 1070 mm ( 42.5 ) Width (wheel base) 780 mm ( 31 ) Weight 300 kg ( 661 lbs) with integrated treatment table and U-arm 250 kg ( 551 lbs) with integrated treatment table only Treatment Table Patient surface 190 cm x 50 cm ( 75 x 20 ) Height adjustment 30 cm (12 ) Longitudinal adjustment 15 cm (6 ) ; 20 cm (8 ), optional Transverse adjustment 15 cm (6 ) ; 20 cm (8 ), optional Patient size (max) 160 kg (353 lbs) Weight 150 kg (331 lbs) U-arm X-ray Tube power rating X-ray generator type Power rating kv range ma range Image Intensifier Monochrome Monitor kvp DC Half-wave silicium rectified; high frequency generator, optional kvp ma kv ma 6 (17 cm) 17 ; CCIR standard; medical grade; 850+ TV line; infinitely extendable; contrast, brightness, horizontal and vertical hold adjustments Power Requirements Power voltage 220V AC/50 Hz or 110 AC/60 Hz, 3kVA, single phase Power voltage fluctuation ± 10% Grounding 100V Ω or less in grounding resistance Electrical isolation Transformer protection, current leakage interrupter Safety standard IEC class 1, type B Quality standard ISO 9001 Environmental Conditions Operating temperature 10 C to 30 C (50 F to 86 F) Humidity 35% to 85% Non-operating temperature -15 C to +40 C (5 F to F) Space requirement 4 m x 3 m (13 x 10 ) Due to continued product innovation, specifications may change without notice. Electronic Industry and Trade Co., Ltd. Turan Günefl Blv., Konrad Adenauer Cad. 59/1 Sancak, Çankaya Ankara TURKIYE Phone: +90 (312) Fax: +90 (312) PCK Factory Division: Ankara Sanayi Odas 1. Organize Sanayi Bölgesi Orhan Ifl k Cad. No: 4 Sincan ANKARA Phone: +90 (312) Fax: +90 (312) intlsales@pckmed.com