This document provides technical specifications for a lithotripsy system, including over 60 parameters for the shockwave generator, imaging fluoroscopy system, ultrasound system, and patient table. Key requirements include FDA/CE clearance; one shockwave head; ECG and automatic triggering; localization using inline motorized localization or C-arm; penetration depth over 160mm; dual focus X-ray tube; digital fluoroscopy and radiography; 12-inch or larger monitor; and automated electro-hydraulic patient table movement.
This document provides technical specifications for a lithotripsy system, including over 60 parameters for the shockwave generator, imaging fluoroscopy system, ultrasound system, and patient table. Key requirements include FDA/CE clearance; one shockwave head; ECG and automatic triggering; localization using inline motorized localization or C-arm; penetration depth over 160mm; dual focus X-ray tube; digital fluoroscopy and radiography; 12-inch or larger monitor; and automated electro-hydraulic patient table movement.
This document provides technical specifications for a lithotripsy system, including over 60 parameters for the shockwave generator, imaging fluoroscopy system, ultrasound system, and patient table. Key requirements include FDA/CE clearance; one shockwave head; ECG and automatic triggering; localization using inline motorized localization or C-arm; penetration depth over 160mm; dual focus X-ray tube; digital fluoroscopy and radiography; 12-inch or larger monitor; and automated electro-hydraulic patient table movement.
1 UNIVERSAL ESWL SYSTEM FOR THERAPHY PROCEDURE WITH A SINGLE SHOCK WAVE HEAD WITH FLOUROSCOPIC AND US LOCALIZATION. 2 FDA/CE CLEARANCE Yes 3 SHOCK-WAVE GENERATOR 4 Focal Dimensions, mm Specify 5 Type Specify 6 Focusing technique Specify 7 X- ray Locating Specify : ( Inline Motorized Localization or Motorized C-arm & Automatic Stone Positioning ) 8 Number of shock wave heads One 9 Triggering ECG & Automatic 10 Physiological monitoring for ECG triggering. Required with NIBP and SPO2 included 11 Pulse frequency / min (Specify the Value) 12 Penetration depth > 160 mm approx. 13 Pressure at focus, MPa (Specify the Value) 14 Dynamic Range (Min- Max), MPa (Specify the Value) 15 Coupling method Dry or Water cushion (specify) 16 Coupling Cushion Diameter, mm Specify 17 Pressure Level Specify 18 Therapy Head Aperture Angle specify 19 Guaranteed life time for shock wave Coil or Electroconductive Electrode > 2.000.000 shocks approx.. 20 Table side SW control Specify 21 Screen Operation in Treatment Room Specify 22 Control console SW control Yes 23 Localization Mode Auto positioning (Localization) 24 Ultrasound locating system Yes, (specify) - inline Motorized Localization or Free Line Localization 25 IMAGING fluoroscopy digital system 26 Generator High frequency 27 Nominal Voltage .9DSSUR[ 28 Radiation dose reduction measures Yes needed 29 output , KW .:DSSUR[6SHFLI\ 30 Kvp output 40 To 120 Kvp 31 Cine memory Up to 1300 images or more
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Kingdom of Saudi Arabia ΔϳΩϮόδϟΔϴΑήόϟΔϜϠϤϤϟ Ministry Of Health ΔΤμϟΓέίϭ General Directorate of Equipment Supplies ΔϴΒτϟΕΰϴϬΠΘϟΓέΩ· Department Of Specs. & Development ήϳϮτΘϟϭΕΎϔλϮϤϟΓέΩ·
TECHNICAL & PERFORMANCE SPECIFICATION FOR MEDICAL EQUIPMENTS
# TECHNICAL PARAMETERS SPECIFIED RESULT
32 mA Range Up to 630 mA 33 Digital fluoroscopy Yes 34 Digital Radiography Yes 35 Pulse Fluoroscopy specify 36 AEC Yes 37 X-Ray Tube 38 Dual Focus Yes 39 Focal spot size, mm Specify 40 Anode heat storage capacity .+8$SSUR[ 41 Multileaf collimator Yes 42 large Image intensifier Yes , Specify 43 Grid Specify 44 Fluoroscopy function Yes 45 Reference image display Yes 46 Image Matrix 1024 x 1024 47 Volatile image memory LIH & 100 images / storage on USB stick or image archiving system should be possible 48 Ultrasound 49 Transducer Yes, Micro convex 50 Central Frequency Mhz. 3.5 approx. 51 Modes B, M, B/M, B/B 52 Monitor size > 12 Inch or more 53 US Transducer Movement Yes, (Specify) - Inside (Inline) / Outside (Outline) therapy head or Freeline 54 US Transducer can get in contact with patient body Yes 55 Built in Storage 999 images in compact Flash 56 Cine Memory 1300 images or more 57 Beam Formation 12 bit Digital system 58 PATIENT TABLE 59 Automated Movement Yes , Electro Hydraulic- other specify 60 Vertical movement, cm. Specify 61 Longitudinal movement, cm Specify 62 Lateral movement, cm Specify 63 Trendelenburg Yes 64 Treatment of Pediatric Patients Yes 65 Max patient weight in Kg. 66 Table Cut-Off Specify 67 CONTROL CONSOLE 68 Number of monitors 2 TFT/LCD 69 Reporting functionality yes 70 Monitor size, diagonal, cm 45 or more 71 Touch Screen Control Yes
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Kingdom of Saudi Arabia ΔϳΩϮόδϟΔϴΑήόϟΔϜϠϤϤϟ Ministry Of Health ΔΤμϟΓέίϭ General Directorate of Equipment Supplies ΔϴΒτϟΕΰϴϬΠΘϟΓέΩ· Department Of Specs. & Development ήϳϮτΘϟϭΕΎϔλϮϤϟΓέΩ·
TECHNICAL & PERFORMANCE SPECIFICATION FOR MEDICAL EQUIPMENTS
# TECHNICAL PARAMETERS SPECIFIED RESULT
72 Patient monitoring features ECG, patient ID, patient Demographics, Specify others if available 73 Image storage Size, pixels x bits 1024 x 1024 x 10 or more 74 Number of images Specify 75 Number of images storage on HD >100.000 in 1024 x 1024 76 Display of X-ray & endoscopic Specify 77 Image post-processing Specify 78 Integrated Lithotripsy Database Specify 79 APPLICATIONS 80 ESWL Yes 81 ESWT Yes 82 Urological diagnosis and endourology Specify 83 Prostatic therapy Yes 84 Cystoscopy Yes 85 DICOM 3.0 Yes, full DICOM 3.0 Please supply your DICOM Conformance Statement 86 DICOM Print Yes 87 DICOM Send Yes 88 DICOM query/retrieve Yes 89 DICOM Worklist Yes 90 DOCUMENTATION Yes 91 CD writer or USB Key Yes 92 B&W Thermal Printer For US Doc 93 Network Connection Available 94 Laser paper printer For report documentation 95 ACCESSORIES 96 Endoscopy interface integrated in the unit Specify 97 Head wedge for patient Yes 98 Compression belt Yes 99 Patient leg knee and foot support Yes, for adult 100 Patient arm rests Yes, for both arms 101 Patient shoulder supports Yes 102 Patient wrist restraints Yes 103 Patient elbow supports Yes 104 Endoscopy shelf Specify 105 foot switches Yes, for fluoroscopy / radiography / table movement. 106 18 TFT color monitors or x-ray diagnostic monitors suspended from the unit Yes 107 Drain pan for perineal table end Yes 108 Holder for plastic drain bag for the perineal table end Yes 109 Infusion bottle holder Yes, 110 OTHER SPECIFICATIONS 111 All access. needed 112 X-ray protection apron with wall stands. Yes, 4
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Kingdom of Saudi Arabia ΔϳΩϮόδϟΔϴΑήόϟΔϜϠϤϤϟ Ministry Of Health ΔΤμϟΓέίϭ General Directorate of Equipment Supplies ΔϴΒτϟΕΰϴϬΠΘϟΓέΩ· Department Of Specs. & Development ήϳϮτΘϟϭΕΎϔλϮϤϟΓέΩ·
TECHNICAL & PERFORMANCE SPECIFICATION FOR MEDICAL EQUIPMENTS
# TECHNICAL PARAMETERS SPECIFIED RESULT
113 PRE-INSTALLATION WORK Required 114 Mild site preparation Site visit is recommended 115 WARRANTY 116 SW Coil Or Electroconductive Electrode Replacement Free of charge during Warranty period 117 After Warranty Service Contract Not more than 7% annually of the system value including spare parts and to be valid for at least 3 years. 118 TRAINING Yes, Required 119 VISUAL THERAPY (Pictures should be choices by hospital administrator ) One ceiling mural approx (2-3) m / Two well mural approx (1.5-2) m 120 HIPPA Compliance Specify 121 5 years warranty and operational maintenance include both the update and upgrade (includes Yes HW/SW) 122 Maintenance and Service Contract Value with Spare Parts for the First Year after Warranty Specify the Value 123 Maintenance and Service Contract Value with Spare Parts for the Second Year after Warranty Specify the Value 124 Maintenance and Service Contract Value with Spare Parts for the Third Year after Warranty Specify the Value 125 Maintenance and Service Contract Value with Spare Parts for the Fourth Year after Warranty Specify the Value 126 Maintenance and Service Contract Value with Spare Parts for the Fifth Year after Warranty Specify the Value