Technical Specification of ESWL integrated system with X-Ray and

Ultrasound

No Specification Requirements Shock Wave Generator

1.1 The shock wave generator to be of electromagnetic type.
1.2 Focussing of shockwave with or without focussing lens.
1.3 Single focus system
1.4 The therapy source should be under-table or over the table or both

1.5 Shockwave source, x-ray system should be one single fully integrated system
1.6 Effective focal energy for treatments of the stones. Energy in –6dB focal zone. Minimum 0.88
mJ/mm2 or as per FDA / CE norms
1.7 The peak pressure at therapy focus should be variable. The value at maximum energy level
should be as per FDA / CE norms
1.8 The minimum focal pressure at -6dB should be at least 5 Mpa or as per FDA / CE norms r
1.9 Selectable energy flux density in every focal zone. Range (minimum and maximum) in –6dB focal
zone. Maximum energy flux density should reach approved by FDA/ CE
1.10 Minimum energy flux density in -6 dB should be 0.42 mJ/mm² or as per FDA / CE norms
1.11 Selectable ECG and variable frequency triggering.
1.12 The shock wave penetration depth (measured from surface of shock wave coil to half-focal-
length) should be as per manufacturer specification and approved by FDA / CE
1.13 The focal area (-6dB focus) should be at least 120 mm² or as per FDA / CE norms
1.14 Shock wave frequency should be variable of at least 60 and above pulses per minute
1.15 State diameter of shockwave source, which should be at least 14 cm to 30cm
1.16 Coupling area of shockwave head should be at as per manufacturer design
1.19 Lithotripsy function can be operated from patient table or from remote control console.
1.21 The system provides a fast localization with low exposure to radiation.

No Specification Requirements
X-Ray Generator
2.1 Standard generator power: 3.5 kW or above
2.2 Digital Radiography 40 -120 KV /60mA
2.3 Fluoroscopic voltage range: 40-120 kV
Fluoroscopic current range: 0.2 – 5.0 mA, (upto 10 mA auto high penetration)
2.4 Automatic kV and mA control for optimal image quality.

No Specification Requirements
Image Intensifier/TV chain
3.1 Minimum field to be 14 cm diameter with the other fields 17 cm and 23 cm.
3.2 I.I. of 23cm.
3.3 3 definition imaging chain 1024 x 1024 pixels matrix
High

3.4 3 screen monitor(s) (TFT) with at least 46 cm (18”) diagonal

Flat
3.5 3
Remote controlled iris collimator.

No Specification Requirements
X-ray tube
4.1 X-ray tube of rotating anode compatible to the quoted generator and comprising:
4.2 Dual focal spots of maximum 0.3 mm and 0.6 mm for maximum geometric resolution
4.3 The heat storage capacity to be Housing -800KHU or less
4.4 In-line / Isocenteric X-ray in 0° and 30° projection
4.5

No Specification Requirements
Ultrasound system localization
5.1 The ultrasound system localization to be of digital technology. The ultrasound system shall
provided with localization arm
5.2 The system should provide b/w images on various modes of operation
5.3 A sector probe of 3.5 MHz to be included
5.4 Stone localisation should be performed in an in-line mode/ Real time / outline
5.5 Simultaneous X-ray and ultrasound imaging should be possible

No Specification Requirements
Treatment table
6.1 A highly radiolucent motorized in 3 axes patient table for the safe positioning of patients with
variable height adjustment
6.2 Table movement (without coupled shockwave source should be:
x-axis: 350 mm or more
y-axis: +/- 70 mm
6.3 Height adjustment at least from 80 cm to 114 cm or more
6.4 Width of the table top 72cm or better
6.5 The patient table should be accessible from all sides
6.6 Table movement during stone fragmentation treatment should be possible motorised without
interrupting the treatment.
6.7 Treatment of infants should be facilitated by supporting patient foil or any other means