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(1) A prospective study of non-ECG gated electroconductive lithotripsy: Holder monitoring during an alternance of
periods with and without R-wave triggering : T. Flam, D. Saighi, F. Legagneux, Z. Ounnoughene, D. Duboc, N.
Thiounn, M. Bourlion, M. Zerbib, B. Debré - Hôpital Cochin, Paris, France 14th World Congress on Endourology and
SWL, Melbourne, Australia, Nov. 1996.

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!
1. BASICS OF EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY ...............................................................2

2. DESCRIPTION OF SONOLITH® PRAKTIS.........................................................................................................3

2.1 GENERAL DESCRIPTION .........................................................................................................................................3
2.2 USER’S INTERFACES ..............................................................................................................................................4
3. SAFETY......................................................................................................................................................................5
3.1 STANDARDS ............................................................................................................................................................5
3.2 LABELS ..................................................................................................................................................................5
3.3 WARRANTY & MAINTENANCE ..................................................................................................................................5
4. PRECAUTIONS FOR USE ......................................................................................................................................7
4.1 PROTECTION AGAINST ELECTRIC SHOCK ..................................................................................................................7
4.2 DAILY CHECKING OF PRAKTIS C-ARM CALIBRATION.................................................................................................7
4.3 RISK OF CRUSHING .................................................................................................................................................8
4.3.1 Crushing with shockwave generator of ESWL module ................................................................................8
4.3.2 Crushing with modules interconnection.......................................................................................................8
5. TYPICAL INSTALLATION ..................................................................................................................................10
5.1 ESWL MODULE CABLE CONNECTIONS ...................................................................................................................11
6. COMMON PROCEDURES....................................................................................................................................13
6.1 ASSEMBLING/DISMANTLING THE SONOLITH® PRAKTIS ........................................................................................13
6.2 PREPARATION & SETTING UP OF THE C-ARM FLUOROSCOPE ..................................................................................14
6.2.1 Pre-adjustment of the movements...............................................................................................................14
6.2.2 Installation of the X-ray cross support.......................................................................................................16
6.2.3 Setting up the C-arm relative to the table ..................................................................................................17
6.3 PREPARATION OF THE SONOLITH® PRAKTIS ......................................................................................................18
6.3.1 Connecting the SONOLITH® Praktis to the C-arm...................................................................................18
6.3.2 Calibration of the fluoroscopic C-arm .......................................................................................................19
6.3.2.1 Laser beam method (only with GE-OEC 7900 equipped with laser beam option) ................................20
6.3.2.2 The X-ray method ..................................................................................................................................24
6.3.3 Switching on SONOLITH® Praktis............................................................................................................28
6.3.4 Installation of the electrode........................................................................................................................29
6.3.5 Validation of electrode installation............................................................................................................29
6.3.5.1 Reusing the old electrode .......................................................................................................................30
6.3.5.2 New electrode.........................................................................................................................................31
6.4 POSITIONING OF THE PATIENT ON THE TABLE ........................................................................................................35
6.5 POSITIONING OF THE CHILDREN FOR THE ESWL TREATMENT ................................................................................37
6.6 STONE LOCALIZATION ...........................................................................................................................................38
6.6.1 Stone localization with fluoroscopy ...........................................................................................................38
6.6.2 STONE LOCALIZATION WITH ULTRASOUND SCANNING ................................................................................41
6.6.2.1 Description of the localization system ...................................................................................................41
6.6.2.2 Description of localization method. .......................................................................................................43
7. ESWL TREATMENT COMPULSORY STEPS...................................................................................................46

8. APPENDIX ...............................................................................................................................................................47
8.1 LIST OF CURRENTLY CERTIFIED ULTRASOUND PROBES ..........................................................................................47
8.2 INDEX OF FIGURES ...............................................................................................................................................48

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 1. DESCRIPTION OF THE SONOLITH® PRAKTIS .................................................................................. 3
1.1 GENERAL DESCRIPTION ............................................................................................................................ 3
1.2 CONNECTION PLATE ................................................................................................................................. 4
1.3 REMOTE CONTROL ................................................................................................................................... 6
1.3.1 General description......................................................................................................................... 6
1.3.2 Description of the keys of the standard remote control................................................................... 7
1.3.3 General description of the optional remote control (for GE-OEC 7900 motorized C-arm only) ... 8
1.3.4 Description of the keys of the optional remote control ................................................................... 9
1.4 USE OF THE SOFTWARE .......................................................................................................................... 10
1.4.1 Menu display ................................................................................................................................. 10
1.4.2 Option selection ............................................................................................................................ 10
1.4.3 Input of a value.............................................................................................................................. 11
1.4.4 Control of the sub-menus .............................................................................................................. 11
1.5 SONOLITH® PRAKTIS SAFETY FEATURES............................................................................................. 12
1.5.1 Standards ...................................................................................................................................... 12
1.5.2 Labels ............................................................................................................................................ 12
1.5.3 Mains supply electrical fuses ........................................................................................................ 15
1.5.4 Front wheel brakes........................................................................................................................ 15
1.5.5 Generator's arm position .............................................................................................................. 15
1.5.6 Control of the 3 axis movements of the table ................................................................................ 16
1.5.7 Hardware & software design ........................................................................................................ 17
1.5.8 Test of the Liquid crystal display (LCD) ....................................................................................... 17
1.5.9 Software integrity test.................................................................................................................... 17
1.5.10 Test of the 4 major components..................................................................................................... 18
1.5.11 Test of a new Electrode ................................................................................................................. 19
1.5.12 Shocks delivery process................................................................................................................. 19
1.5.13 Pressure measurement and "Energy"............................................................................................ 20
1.5.13.1. “Automatic” power mode...................................................................................................... 21
1.5.13.2. "Used Electrode” power mode .............................................................................................. 22
1.5.13.3. “Manual” power mode"......................................................................................................... 23
2. SOFTWARE ALARMS AND INFORMATION MESSAGES............................................................... 26
2.1 ALARM MESSAGES : ORIGINS AND ACTIONS .......................................................................................... 26
2.2 INFORMATION MESSAGES AND REMINDERS ............................................................................................ 37
3. TECHNICAL SPECIFICATIONS............................................................................................................ 43
3.1 GENERAL ............................................................................................................................................... 43
3.2 CLASSIFICATION .................................................................................................................................... 43
3.3 SPECIFICATIONS FOR SHOCK WAVE GENERATOR .................................................................................... 43
3.4 DAILY EXPOSURE TO IONIZING RADIATION (X-RAY) .............................................................................. 44
3.5 DAILY EXPOSURE TO NOISE .................................................................................................................... 44
3.6 ENVIRONMENTAL CONDITIONS .............................................................................................................. 44
3.7 DIMENSIONS .......................................................................................................................................... 45
3.8 POWER SUPPLY AND ELECTRICAL SPECIFICATIONS ................................................................................ 45
4. DAILY & ROUTINE MAINTENANCE .................................................................................................. 46
4.1 DAILY MAINTENANCE ............................................................................................................................ 46
4.1.1 Membrane cleaning/ disinfection .................................................................................................. 46
4.1.2 Machine cleaning .......................................................................................................................... 46
4.2 MONTHLY MAINTENANCE ...................................................................................................................... 47
4.2.1 Demineralized water replacement................................................................................................. 47
4.2.2 Shock waves generator cleaning ................................................................................................... 49
4.3 IF NECESSARY ........................................................................................................................................ 49
4.3.1 Membrane replacement................................................................................................................. 49
4.3.2 Date and time adjustment.............................................................................................................. 50
4.3.3 Language selection........................................................................................................................ 51

! " ##
 4.4 ACCESSORIES AND EQUIPMENT LIST ...................................................................................................... 52
4.5 INDEX OF FIGURES ................................................................................................................................. 53

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