Instruction Manual

PIEZOLITH

3000

from SN 0300

GA--A 175 / en / Index: 10--04--8.0 / ÄM: KG 04--158

 Important general instructions for use
Ensure that this product is only used as intended and described in the instruction manual, by ade-
quately trained and qualified personnel, and that maintenance and repair is only carried out by
authorized specialized technicians.
Operate this product only in the combinations and with the accessories and spare parts listed in
the instruction manual. Use other combinations, accessories and wearing parts only if they are
expressly intended for this use and if the performance and safety requirements are met.
Reprocess the products before every application and before returning them for repair as required
by the instruction manual in order to protect the patient, user or third parties.
Subject to technical changes!
Due to continuous development of our products, illustrations and technical data may deviate
slightly from the data in this manual.

CAUTION -- USA only:

Federal law restricts this device to sale, distribution, and use only upon the lawful order of
a physician trained and/or experienced in the use of this device as outlined in the required
training program.

Safety instructions and levels of danger

Symbol Level of danger
WARNING!
Failure to observe can result in death or severe injury.
CAUTION!
Failure to observe can result in slight injury or damage to the product.
IMPORTANT!
. Failure to observe can result in damage to the product or surrounding.
NOTE!
. Tips for optimum use and other useful information.

GERMANY USA UK
RICHARD WOLF GmbH RICHARD WOLF RICHARD WOLF UK Ltd.
D--75438 Knittlingen Medical Instruments Corp. Waterside Way
Pforzheimerstr. 32 353 Corporate Woods Parkway Wimbledon
Tel.: (..49)--(0)7043--35--0 Vernon Hills, Illinois 60061 SW 17 0HB
Fax:(..49)--(0)7043--35300 Tel.: 847--913 1113 Tel.: 020--8944 7447
MANUFACTURER Fax: 847--913 14 88 Fax: 020--8944 1311

E--mail: info@richard--wolf.com E--mail: sales&marketing@richardwolfusa.com E--mail: admin@richardwolf.uk.com

Internet: www.richard--wolf.com Internet: www.richardwolfusa.com Internet: www.richardwolf.uk.com

BELGIUM FRANCE AUSTRIA

N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
B--9031 Gent --Drongen
Tel.: +32 9.280.81.00
Fax: +32 9.282.92.16
RICHARD WOLF France S.A.R.L. RICHARD WOLF Austria
Rue Daniel Berger Ges.m.b.H.
Z.A.C. La Neuvillette Wilhelminenstraße 93 a
F--51100 Reims A--1160 Wien
Tel.: +33 3.26.87.02.89 Tel.: +43 1-- 405 51 51
Fax: +33 3.26.87.60.33 Fax: +43 1-- 405 51 51--45

E--mail: endoscopy@richard--wolf.be E--mail: endoscopes@richardwolf.fr E--mail: info@richard--wolf.at

Internet: www.richard--wolf.at

0 GA--A 175
 Contents
1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.1 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.2 Piezoelectric principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.3 Locating systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 Indications and usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.5 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5.1 Patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5.2 Pretreatment set--up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5.3 Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5.4 Post--treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5.5 Device maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.6 Adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.6.1 Potential Adverse Events with Extracorporeal Shock Wave Lithotripsy . . . . . . . . . . . . . 7
1.7 Patient selection and treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.8 Safe radiation practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.9 Positioning examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.10 Use in gastroenterology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.10.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.10.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.10.3 Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.10.4 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.10.5 Positioning examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.11 Use in orthopedics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.11.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.11.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.11.3 Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.11.4 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.11.5 Indication examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.12 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.12.1 General requirements on products/components of a combination . . . . . . . . . . . . . . . . . 12
1.12.2 Specific requirements on the products/components of a combination . . . . . . . . . . . . . . 13
1.13 Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2 Illustration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.1 PIEZOLITH with LITHOARM, X--ray, ultrasound device and treatment table . . . . . . . . 15
2.1.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.2 PIEZOLITH with stand, X--ray, ultrasound device and treatment table . . . . . . . . . . . . . 16
2.2.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3 PIEZOLITH with articulated arm and compact ultrasound device . . . . . . . . . . . . . . . . . . 17
2.3.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.4 Connections of PIEZOLITH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.4.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.5 ”Water treatment” controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.6 Display and control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.6.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.7 Therapy source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

GA--A 175 I
2.7.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1 Parking brakes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.1.1 Parking brakes of Lithotripter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.3 Water treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.3.1 Removing the coupling membrane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.3.2 Installing the coupling membrane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.3.3 Information on water preservative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.3.4 Transducer position for filling/emptying/deaerating the system . . . . . . . . . . . . . . . . . . . . 24
3.3.5 Filling the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.3.6 Emptying the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.3.7 Deaerating the system / evacuating air bubbles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.4 Disassembling and assembling the therapy source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.4.1 Disconnecting and connecting the therapy source connection . . . . . . . . . . . . . . . . . . . . 27

4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.1 Daily checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.2 Monthly checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.3 Checks after transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.4 Checking the Shock Wave Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

5 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5.1 General instructions for safe and effective use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5.2 Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.2.1 Movable table top . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.2.2 Treatment steps with X--ray and ultrasound location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.2.3 Treatment steps with ultrasound location and articulated arm . . . . . . . . . . . . . . . . . . . . . 32
5.2.4 Shock wave therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.3 Evaluating the shock wave therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.3.1 Mean intensity value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.3.2 Shock wave statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

6 Reprocessing and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

6.1 Reprocessing of device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
6.2 Reprocessing of water system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
6.3 Reprocessing of coupling membrane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
6.4 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6.4.1 Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6.4.2 Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

7 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
7.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
7.1.1 Status/error messages on the ”shock wave counter” display . . . . . . . . . . . . . . . . . . . . . . 37
7.1.2 Device malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
7.2 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
7.2.1 Pressure pulse characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
7.2.2 Locating systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
7.3 Operating, storage, transport and shipping conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

II GA--A 175
 Contents
7.4 Considerations for transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.4.1 General notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.4.2 Preparation of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.4.3 Stowage of the system in a vehicle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.4.4 Set up after Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.5 Spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.6 Replacement of parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.6.1 Replacing device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.6.2 Disposal of product, packaging material and accessories . . . . . . . . . . . . . . . . . . . . . . . . 44

8 Locating systems and attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

8.1 Ultrasound location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
8.1.1 Connection ultrasound device (Kretz C401 / Medison Sonoace 5500) . . . . . . . . . . . . . 45
8.1.2 Connection of compact ultrasound unit (Aloka SSD--900) . . . . . . . . . . . . . . . . . . . . . . . . 46
8.1.3 Connection ultrasound device (Aloka SSD--1000 / SSD--3500) . . . . . . . . . . . . . . . . . . . . 47
8.1.4 Checking the ultrasound targeting cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
8.2 Attaching the X--ray C--arc to the stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.2.1 Connecting the stand for the therapy source to the X--ray C--arc . . . . . . . . . . . . . . . . . . 49
8.2.2 Adjusting the X--ray C--arc to the stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
8.3 Using the X--ray C--arc with LITHOARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
8.4 Checking the X--ray targeting cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
8.4.1 Version LITHOARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
8.4.2 Version Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
8.5 Using the X--ray U--arc with LITHOARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

9 Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

GA--A 175 III

1 General information

1.1 Symbols

Symbols Meaning

Attention, consult ACCOMPANYING DOCUMENTS

Off (power: disconnection from mains/power supply)

On (power: connection to mains/power supply)

Equipotentiality

TYPE B APPLIED PART

Mains/line power fuse

µ Alternating current (AC)

”Empty system” button

”Fill system” button

”Stop” button

”Reset shock wave counter” button

”Mean intensity ” button

”Reduce shock wave intensity” button

”Increase shock wave intensity” button

”Reduce pulse rate” button

”Increase pulse rate” button

”Deaerate system” button

”Function” button

”Reduce membrane pressure” button

”Increase membrane pressure” button

”Retract ultrasound probe” button

”Extend ultrasound probe” button

1 GA--A 175
 Symbols Meaning

“Enable articulated arm” button

”Enable joint 1” button

”Enable joint 2” button

”Enable joint 3” button

Release button “swiveling of therapy source”

Cable--linked remote control for shock wave triggering

Video In

Video Out
L Signal input lithoarm or laser

Data transfer

Therapy source

CAUTION LASER BEAM: Do not look into the beam.

A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as

Medical Electrical Equipment to standard CAN/CSA C 22.2 No. 601.1 (c) and UL 60601--1 (us)

Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or
packaging marked with this symbol. Products of category IIa and above, as well as
sterile products or products with measuring function pertaining to category I, are additionally marked
with the code number of the notified body (0124)

GA--A 175 2
1.2 Device description

1.2.1 General description

The PIEZOLITH consists of the device trolley, the therapy source with
inline ultrasound location, separate Ultrasonic device and X--ray unit.
A treatment table with electrically operated sliding table top allows verti-
cal and horizontal positioning of the patient relative to the therapy focus.

The PIEZOLITH 3000 is available in 3 versions:

-- with LITHOARM:
The LITHOARM is mounted to the X--ray device with a swivel slide that
permits individual adjustment of the therapy source for all therapy posi-
tions.
-- with stand:
The therapy source with swivel slide is mounted on a separate stand
and connected to the X--ray unit.
-- with articulated arm:
The therapy source is mounted with an articulated arm to the Lithriptor.
The articulated arm allows free adjustment of the therapy source for
individual treatment positions with ultrasound location.

1.2.2 Piezoelectric principle

The scientific basis for the generation of piezoelectric shock waves is the
spontaneous expansion of ceramic particles, driven by a short--term high
voltage pulse. This expansion of the ceramic material generates a pres-
sure wave in the water that causes a shock wave to be formed in the
focus.
In the PIEZOLITH the piezo elements are arranged like a mosaic in a
spherical cup, and they are all activated simultaneously by a pulse
generator. The spherical design with a large active surface and the large
aperture of the spherical cup result in a precisely defined focal zone with
high sound pressure in the focus.
The large--area energy coupling reduces the energy density at the sur-
face of the skin and considerably reduces pain -- particularly important
when shallow penetration is required. The precisely defined focal zone
allows accurate treatment while providing the best possible protection for
surrounding regions.
The system allows single pulse and continuous pulse modes. The power
of the shock waves is selectable with 20 intensity levels to suit the re-
quirements of the patient.

3 GA--A 175
1.2.3 Locating systems
The isocentric arrangement of the location systems guarantees that there
is no deviation between the target cross and shock wave focus even
when the direction of the shock wave is changed.

Ultrasound location
The inline ultrasound locating system allows precise localization of the
indications that can be visualized sonographically as well as permanent
sonographic control during therapy. For this purpose an ultrasound probe
is located in the therapy source and is rotatable inline and movable along
its longitudinal axis.

X--ray location
Fixed assignment of the therapy source to the isocenter of the X--ray
C--arm via LITHOARM or the laser--monitored stand allows X--ray loca-
tion by confocal adjustment of the piezo power source with X--ray C--arm
from AP to oblique view +/-- 30_. X--ray can not be used with articulated
arm.

1.3 Indications and usage

The PIEZOLITH 3000 is intended to fragment urinary stones in the
kidney (renal pelvis and renal calyces) and ureter (upper, middle, and
lower ureter).
More indications see chapter 1.10 and following.

On the basis of the patient’s general condition the physician in charge

must decide whether the planned use is possible or not. For further infor-
mation please refer to the current medical literature.

1.4 Contraindications
Do not use the PIEZOLITH 3000 in patients with:
Z Confirmed or suspected pregnancy.
Z Coagulation abnormalities (as indicated by abnormal prothrombin time,
partial thromboplastin time, or bleeding time) or those currently recei-
ving anticoagulants (including aspirin).
Z Arterial calcification or vascular aneurysm in the lithotripter’s shock
wave path.
Z Urinary tract obstruction distal to the stone.
Z Anatomy which precludes focusing the device at the target stone, such
as severe obesity or excessive spinal curvature.
Z Immobile asymptomatic diverticulum stones or complicated staghorn
calculi in the renal calyx.

GA--A 175 4
1.5 Warnings and precautions

1.5.1 Patient selection

WARNING
Anticoagulants: Patients receiving anticoagulants (including aspirin)
should temporarily discontinue such medication prior to extracorporeal
shock wave lithotripsy to prevent severe hemorrhage.
CAUTION
Impacted or embedded stones: The effectiveness of extracorporeal
shock wave lithotripsy may be limited in patients with impacted or em-
bedded stones. Alternative procedures are recommended for these pa-
tients.
Staghorn stones: The effectiveness of extracorporeal shock wave litho-
tripsy may be limited in patients with either staghorn or large (> 20 mm in
largest dimension) stones. Alternative procedures are recommended for
these patients.
Small ureteral stones: Small middle and lower ureteral stones, 4 to 6
mm in largest dimension, are likely to pass spontaneously. Therefore, the
risks and benefits of extracorporeal shock wave lithotripsy should be
carefully assessed in this patient population.

1.5.2 Pretreatment set--up

WARNING
Cardiac monitoring: If necessary perform cardiac monitoring during li-
thotripsy treatment, since the use of extracorporeal shock wave litho-
tripsy has been reported to cause ventricular cardiac arrhythmias in some
individuals. This warning is especially important for patients who may be
at risk of cardiac arrhythmia due to a history of cardiac irregularities or
heart failure.
Pacemaker or implantable defibrillator: To reduce the incidence of
malfunction to a pacemaker or implantable defibrillator, the pulse genera-
tor should be programmed to a single chamber, non--rate responsive
mode (pacemakers) or an inactive mode (implantable defibrillators) prior
to lithotripsy, and evaluated for proper function post--treatment. Do not
focus the lithotripter’s shock wave through or near the pulse generator.
Infected stones: Prophylactic antibiotics should be administered prior to
treatment whenever the possibility of stone infection exists. Extracorpo-
real shock wave lithotripsy treatment of pathogen--harboring calculi could
result in systemic infection.
Cardiac disease, immunosuppression, and diabetes mellitus:
Prophylactic antibiotics should be administered prior to extracorporeal
shock wave lithotripsy treatment to patients with cardiac disease (includ-
ing valvular disease), immunosuppression, and diabetes mellitus, to pre-
vent bacterial and/or subacute endocarditis.

5 GA--A 175
1.5.3 Treatment
WARNING
Bilateral stones: Do not perform bilateral treatment of kidney stones in a
single treatment session, because either bilateral renal injury or total uri-
nary tract obstruction by stone fragments may result. Patients with bilat-
eral kidney stones should be treated using a separate treatment session
for each side. In the event of total urinary obstruction, corrective pro-
cedures may be needed to assure drainage of urine from the kidney.
Air--filled interfaces in shock wave path: Do not apply shock waves to
air--filled areas of the body, i.e., intestines or lungs. Shock waves are
rapidly dispersed by passage through an air--filled interface, which can
cause bleeding and other harmful side effects.
Cardiac arrhythmia during treatment: If a patient experiences cardiac
arrhythmia during treatment reduce the shock wave intensity and the rep-
etition rate. If necessery, the shock wave therapy should be terminated.
As a general practice, patients with a history of cardiac arrhythmia should
undergo extracorporeal shock wave lithotripsy using an ECG--monitoring.

CAUTION
Renal injury: To reduce the risk of injury to the kidney and surrounding
tissues, it is recommended that:
1. the number of shock waves administered during each treatment
session be minimized;
2. retreatment to the same kidney/anatomical site occur no sooner than
1 month after the initial treatment;
3. each kidney/anatomical site be limited to a total of three treatment
sessions.
Use of fluoroscopy: While fluoroscopy must be used during the pro-
cedure, caution should be used to minimize the exposure.
Electromagnetic interference: If electromagnetic interference between
the extracorporeal shock wave lithotripter and near by electronic equip-
ment is suspected (as evidenced by erratic behavior with either device), it
is recommended that their distance be increased until proper operation
resumes. If it is necessary to operate an electronic device in close prox-
imity to the lithotripsy system during treatment, the device and the litho-
tripter should be tested for proper simultaneous operation prior to clinical
use.

1.5.4 Post--treatment
CAUTION
Radiographic follow--up: All patients should be followed radiographi-
cally after treatment until stone--free or there are no remaining stone frag-
ments which are likely to cause silent obstruction and loss of renal func-
tion.

1.5.5 Device maintenance

CAUTION
Electrical shock hazard: Never remove any of the cabinet covers to the
system’s electronics. The high voltage power supply circuits utilized by
extracorporeal shockwave lithotripters use voltages that are capable of
causing serious injury or death from electric shock.

GA--A 175 6
1.6 Adverse events
Potential adverse events associated with the use of extracorporeal shock
wave lithotripsy include those listed below, categorized by frequency and
individually described:

1.6.1 Potential Adverse Events with Extracorporeal Shock Wave Lithotripsy

Commonly reported (> 20% of patients)
D Hematuria
D Pain/renal colic
D Skin redness at shock wave entry site
Occasionally reported (1--20% of patients)
D Urinary tract infection
D Urinary obstruction/steinstrasse
D Skin bruising at shock wave entry site
D Fever (> 38_C)
D Nausea/vomiting
Infrequently reported (< 1% of patients)
D Cardiac arrhythmia
D Hematoma (perirenal/intrarenal)
D Renal injury
Hematuria: Hematuria occurs following most treatments, is believed to
be secondary to trauma to the renal parenchyma, and usually resolves
spontaneously within 24 to 48 hours of treatment.
Pain/renal colic: Pain/renal colic commonly occurs during and immedi-
ately after treatment, and typically resolves spontaneously. Temporary
pain/renal colic may also occur secondary to the passage of stone frag-
ments, and can be managed with medication.
Skin redness at shock wave entry site: Skin redness at the shock
wave entry site commonly occurs during and immediately after treatment,
and typically resolves spontaneously.
Urinary tract infection: Urinary tract infection (UTI) occurs in 1--7% of
patients following extracorporeal shock wave lithotripsy as a result of the
release of bacteria from the fragmentation of infected calculi, and infre-
quently results in pyelonephritis or sepsis. The risk of infectious complica-
tions secondary to extracorporeal shock wave lithotripsy can be mini-
mized through the use of prophylactic antibiotics in patients with UTI and
infection stones.
Urinary obstruction/steinstrasse: Urinary obstruction occurs in up to
6% of patients following lithotripsy due to stone fragments becoming
lodged in the ureter, and may be the result of either a single stone frag-
ment or the accumulation of multiple small stone particles (i.e., stein-
strasse). Patients with urinary obstruction typically present with persistent
pain, and may be at risk of developing hydronephrosis with subsequent
renal failure if the obstruction is not promptly treated. Intervention is nec-
essary if the obstructing fragments do not pass spontaneously.
Skin bruising at shock wave entry site: Skin bruising at the shock
wave entry site occasionally occurs after treatment, and typically resolves
spontaneously.
Fever (> 38_C): Fever is occasionally reported after lithotripsy, and may
be secondary to infection.
Nausea/vomiting: Transient nausea and vomiting are occasionally re-
ported immediately after lithotripsy, and may be associated with either
pain or the administration of sedatives or analgesia.

7 GA--A 175
 Cardiac arrhythmia: Cardiac arrhythmias, most commonly premature
ventricular contractions, are generally reported during extracorporeal
shock wave lithotripsy at fixed shock wave delivery in < 1% of patients.
These cardiac disturbances rarely pose a serious risk to the healthy pa-
tient, and typically resolve spontaneously by reducing shock wave inten-
sity and the repetition rate or terminating treatment.
Hematoma (perirenal/intrarenal): Clinically significant intrarenal or per-
irenal hematomas occur in < 1% of lithotripsy treatments. These patients
typically present with severe, chronic flank pain. Although clinically signifi-
cant hematomas often resolve with conservative management, severe
hemorrhage and death have been reported. Management of severe renal
hemorrhage includes the administration of blood transfusions, percuta-
neous drainage, or surgical intervention.
Renal injury: Extracorporeal shock wave lithotripsy procedures have
been known to cause damage to the treated kidney. The potential for in-
jury, its long--term significance, and its duration are unknown.

1.7 Patient selection and treatment

Specific patient populations:
Children: The safety and effectiveness of this device in the treatment of
urolithiasis in children have not been demonstrated. Although children
have been treated with shock wave therapy for upper urinary tract
stones, experience with lithotripsy in such cases is limited. Studies indi-
cate that there are growth plate disturbances in the epiphyses of develop-
ing long bones in rats subjected to shock waves. The significance of this
finding to human experience is unknown.
Women of childbearing potential: The treatment of lower ureteral
stones should be avoided in women of childbearing potential. The ap-
plication of shock wave lithotripsy to this patient population could possibly
result in irreversible damage to the female reproductive system and to
the unborn fetus in the undiagnosed pregnancy.

1.8 Safe radiation practices

Notice the following information if work with radiation:
D use the minimum technique factors and fluoroscopy duration which is
necessary for adequate stone imaging and localization;
i.e. minimum exposure durations and dosage for neccessery
adequate stone imaging and localization;
D do not exceed the maximal exposure duration of 5 minutes;
D in addition to this instruction manual also observe the manual of the
X--ray unit and the national regulations and guidelines how to mini--
mize radiation exposure to the device operator and other health care
staff;
D to keep the radiation load during radioscopy as low as possible push
the therapy source out of the beam path towards the rear as far as
possible.
We recommend for X--ray systems the standard fluoro operating mode
that is automatically entered by the X--ray system at power on with the
following parameters:
-- Fluoroscopy, 0.2 mA to 3 mA maximum
-- Auto Technique (Automatic Dose Rate Control)
-- Last Image Hold
-- Auto Window (optimizes monitor image brightness/contrast)

GA--A 175 8
1.9 Positioning examples

Z Kidney stones
' Positioning: Dorsal position
' Therapy source: from underneath

Z Middle and high ureterolith

' Positioning: Dorsal position
' Therapy source: from underneath

Z Deep ureterolith
' Positioning: Dorsal position
' Therapy source: from above

9 GA--A 175
1.10 Use in gastroenterology
1.10.1 Indications
Extracorporeal shock wave lithotripsy:
D In the gallbladder.
D In the bile duct.
D In the pancreatic duct.

. IMPORTANT!
It is often impossible to determine the actual degree of disintegration im-
mediately after treatment. To determine whether there are still major frag-
ments, sonographic (bile duct calculi) or if necessary endoscopic (stones
in the pancreatic duct) control is necessary.
In many cases multiple treatment is recommend to achieve optimum fine
fragmentation, as this will allow spontaneous discharge of the fragments
or facilitate additional endoscopic measures (bile duct calculi and calculi
in the pancreatic duct) or accompanying drug treatment (gallstones).

1.10.2 Contraindications
Coagulation diseases; administration of anticoagulants; pregnancy; unre-
liable stone location.

1.10.3 Complications
If fragments are discharged into the small intestine colic pain and feverish
inflammations can occur in rare cases. Occasionally fragments can be
jammed in the bile duct causing obstructions or germ transmission into
the blood stream.

1.10.4 Side effects

Very rarely shock wave induced bleeding or injury of the organs sub-
jected to ultrasound or neighboring organs (liver, gallbladder, intestine,
kidney, skin) as well as cardiovascular disorders are observed.

1.10.5 Positioning examples

Z Gallbladder stones, bile--duct stones and pancreatic stones

' Positioning: Lateral or prone position
' Therapy source: from underneath

Z In exceptional cases of bile--duct stones and pancreatic stones

(if prone position will not yield adequate location)
' Positioning: Dorsal position
' Therapy source: from above or lateral

. NOTE!
Documented explanations for the patient on ESWL--gastroenterology is available from Perimed
Compliance Verlag, D--91058 Erlangen, Weinstr. 70.

GA--A 175 10
1.11 Use in orthopedics
1.11.1 Indications
Extracorporeal shock wave therapy:
D In soft tissue near bones of the postural and locomotor system.
D Enthesiopathies (tennis or golfer’s elbow, painful stiffness of the
shoulder, plantarfasciitis (heel spur), achillodyna).
D Tendopathies with ectosteal calcareaous deposits (tendinosis
calcarea).
1.11.2 Contraindications
Infections; tumors; clotting disorder (prior coagulation analysis neces-
sary); use of hemodiluting medication; pregnancy; lung tissue in the
shock wave path; children under the age of 14.
1.11.3 Complications
Serious complications have not yet been observed.
1.11.4 Side effects
Occurrence of:
-- Local haematoma, petechiae
-- Local irritation of the skin
-- Local edemas

1.11.5 Indication examples

Z Shoulder (tendinosis calcarea)

' Positioning: Sitting or lying

Z Fasciitis (plantar or dorsal)

' Positioning: Lying (Prone position)

11 GA--A 175
1.12 Combinations
. IMPORTANT
In addition to this instruction manual follow the manuals of the products used in
combination with this product.

1.12.1 General requirements on products/components of a combination

The general requirements depend on whether the products/components are in-
side or outside the patient environment.

R = 1.5 m Patient environment

h = 2.5 m

Patient environment

Acc. to UL 60601-- 1: R = 1.83 m (6 feet) ; h = 2.29 m (71/2 feet)

Medically used room Non--medically Requirements / measures

Inside the patient environment outside the patient used room Leakage currents to clause 19
environment IEC/EN 60601--1--1 *

MP MP
-- -- --
µ µ

MP NMP

µ µ

MP NMP
a) additional protective earth connection
** -- -- (to be clarified with manufacturer),
µ
or

MP
b) with additional separating transformer **
NMP

MP NMP
-- --
µ µ

MP or a) common protective earth connection, or

MP NMP b) additional protective earth connection
(to be clarified with manufacturer), or
µ c) additional separating device (to avoid
µ earth/ground loops in the case of a
potential difference)

additional separating transformer additional separating device Functional µ power supply grid
according to IEC/ EN 60601--1--1 ** according to IEC/ EN 60601--1--1 connection

MP = medical electrical device according to IEC/ EN 60601--1, UL 60601--1, CSA C22.2 No. 601
NMP = non-- medical electrical device in accordance with the relevant product--specific IEC/ EN/ UL/ IEC standards

* If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 µA
(300 µA for systems in acc.with UL 60601--1).
** e.g. Richard Wolf Video Trolley with ”separating transformer”.

GA--A 175 12
1.12.2 Specific requirements on the products/components of a combination
. IMPORTANT!
Persons combining products to form a system are responsible for not impairing the system’s compliance with
the performance and safety requirements, and that the technical data and the intended use are adequately
fulfilled.
Electromagnetic interference or other types of interference occurring between this product and other products
can cause failures or malfunctions.
When selecting the system components ensure that they meet the requirements for the medical environment
they are used in, in particular IEC/ EN 60601--1--1. In case of doubt contact the manufacturer(s) of the system
components.
Do not touch connecting devices for electrical connections between the different components (such as signal
input and output connections for video signals, data exchange, control circuits, etc.) and the patient at the
same time.

CAUTION!
Possible parting of protective earth cable in mobile multi- socket outlet or extension.
Danger for patient and user due to inadmissible increase in leakage current.
Connect each system component individually to a wall socket.
Do not connect the components to a mobile multi- socket outlet or extension.

1.13 Electromagnetic compatibility (EMC)

NOTE: The device or system in the following called product always relates to the PIEZOLITH 3000

Guidance and manufacturer’s declaration -- electromagnetic emissions

The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Emissions measurement/test Compliance Electromagnetic environment -- Guidance
The product uses HF energy for its internal function.
HF emissions to CICPR 11 Group 1 The HF emission level is extremely low and it is not likely to cause any
interference in nearby electronic equipment.
HF emissions to CISPR 11 Class B
The product is suitable for use in all establishments, including domestic
Harmonic emissions to IEC 61000--3--2 Class A
establishments and those directly connected to the public low--voltage
In conformity with IEC 61000--3--3 “Voltage fluctuations / flicker power supply network that supplies buildings used for domestic purposes.
emissions”

Guidance and manufacturer’s declaration -- electromagnetic immunity

The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Immunity tests IEC 60601 test level Compliance Electromagnetic environment -- guidance

± 6 KV contact Floors should be wood, concrete or ceramic tile.

Electrostatic Discharge (ESD)
Yes If the floors are covered with synthetic material, the
to IEC 61000--4--2 ± 8 KV air releative humidity should be at least 30%.
Electrical fast transients, bursts ± 2 KV for power supply lines Mains/line power quality should be that of a typical
Yes
to IEC 61000--4--4 ± 1 KV for input/output lines commercial or hospital environment.
Surge ± 1 KV differential mode Mains/line power quality should be that of a typical
Yes
to IEC 61000--4--5 ± 2 KV common mode commercial or hospital environment.
Voltage dip for 0.5 cycle
> 95% UT * Mains/line power quality should be that of a typical
Voltage dips, short interruptions and Voltage dip for 5 cycles commercial or hospital environment.If the user of
voltage variations on power supply > 60% UT * the product requires continued operation during
Yes
input lines Voltage dip for 25 cycles power mains/line interruptions it is recommended
to IEC 61000--4--11 > 30% UT * that the product be powered from an uninterruptible
Voltage dip for 5 sec power supply or battery.
< 5% UT *
Power frequency (50/60 Hz) magnetic Power frequency magnetic fields should be at
field, 3 A/m Yes levels characteristic of a typical location in a
to IEC 61000--4--8 commercial or hospital environment.
* NOTE: UT is the line/mains voltage prior to application of the test level.

13 GA--A 175
Guidance and manufacturer’s declaration -- electromagnetic immunity for products that are not life--supporting
The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Compliance
Immunity test IEC 60601 test levels Electromagnetic environment -- guidance
level

Portable and mobile RF communications equipment should be

Conducted HF interference
to IEC 61000--4--6
Radiated HF interference
to IEC 61000--4--3
used no closer to any part of the product, including cables,
than the recommended separation distance calculated from
equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1.2 p P
d = 1.2 p P for 80 MHz to 800 MHz
3 Vrms d = 2.3 p P for 800 MHz to 2.5 GHz
150kHz to 80 MHz
P = Nominal power output rating of the transmitter in watts (W)
Yes (according to the transmitter manufacturer)
3 V/m d = recommended separation distance in meters (m)
80 MHz to 2.5 GHz
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey1, should be less than the
compliance level in each frequency range2.
Interference may occur in the vicinity of devices with the
following symbol:

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies.
These guidelines may no apply in all situations, as the propagation of electromagnetic waves is affected by absorption and
reflexion from buildings, objects and people.
1 = The field strength of fixed transmitters (e.g. base stations for radio telephones, land mobile radios, amateur radio, radio broadcast and
TV broadcast, ...), cannot be predicted theoretically with accuracy. To assess the EMC environment due to fixed transmitters an
electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds
the applicable compliance level above, the product should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product.
2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

The recommended separation distances between portable and mobile HF telecommunication devices and
devices which are not life--supporting
The product is intended for use in an electromagnetic environment with HF disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
HF telecommunications equipment and the product.
Separation distance as a function of transmitter frequency (m)
Rated nominal output power of the
transmitter (Watts) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 p P d = 1.2 p P d = 2.3 p P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can
be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W).
REMARKS: At 80 MHz and 800 MHz the higher frequency range applies.
These guidelines may no apply in all situations. Electromagnetic propagation is affected by absorption and reflexion
from buildings, objects and people.

GA--A 175 14
2 Illustration

2.1 PIEZOLITH with LITHOARM, X--ray, ultrasound device and treatment table

5
9 4 6

10.10 7

10

2.1.1 Legend

1 Therapy source 6 Remote control for shock wave triggering

2 LITHOARM 7 Ultrasound device
3 Display and control panel 9 X--ray device
4 Power on/off switch of lithotripter 10 Treatment table
5 Lithotripter 10.10 Extension for treatment table

15 GA--A 175
2.2 PIEZOLITH with stand, X-- ray, ultrasound device and treatment table

9 5

4 6

10.10 7

10

2.2.1 Legend
1 Therapy source 6 Remote control for shock wave triggering
2 Stand for therapy source 7 Ultrasound device
3 Display and control panel 9 X--ray device
4 Power on/off switch of lithotripter 10 Treatment table
5 Lithotripter 10.10 Extension for treatment table

GA--A 175 16
2.3 PIEZOLITH with articulated arm and compact ultrasound device

8 3

1
6

2.3.1 Legend
1 Therapy source 6 Remote control for shock wave triggering
3 Display and control panel 7 Ultrasound device
4 Power on/off switch of lithotripter 8 Articulated arm
5 Lithotripter

17 GA--A 175
2.4 Connections of PIEZOLITH

19

Service

14

15
MODEM
L
13
18

17 20 16

Federal law restricts this device to sale, distribution,

CAN/CSA C22.2 NO. 601.1 and use only upon the lawful order of a physician
UL 60601-- 1 trained and/or experienced in the use of this device
as outlined in the required training program.

2.4.1 Legend
13 Equipotential connector 17 Power input socket with fuse holder
14 BNC “Video Out“ socket (option) 18 Identification plate
15 Connection for LITHOARM or Laser 19 Service connector
16 Interface for ultrasound unit 20 Modem connector (option)

2.5 ”Water treatment” controls

12.1 ”Empty system” button

12.1 12.3 12.2 ”Stop” button
12.3 ”Fill system” button

12.2

GA--A 175 18
2.6 Display and control panel

3.2

3.3
3.1
3.5

3.4 3.6
3.8

3.7 3.9
3.11
3.12
3.10
3.13
3.14

2.6.1 Legend
3.1 ”Shock wave counter” display 3.8 ”Reduce pulse rate” button
3.2 ”Reset shock wave counter” button 3.9 ”Increase pulse rate” button
3.3 ”Mean intensity” button 3.10 ”Membrane pressure” display
3.4 ”Shock wave intensity” display 3.11 ”Reduce membrane pressure” button
3.5 ”Reduce shock wave intensity” button 3.12 ”Increase membrane pressure” button
3.6 ”Increase shock wave intensity” button 3.13 ”Deaerate system” button
3.7 ”Pulse rate” display 3.14 ”Function” button

19 GA--A 175
2.7 Therapy source

1.6

1.7

8.1 8.2 8.3 8.4

1.5

1.4 1.3 1.2

1.1

2.7.1 Legend
”Therapy source” control field ”Articulated arm” control field
1.1 ”Retract ultrasound probe” button 8.1 ”Enable articulated arm” button
1.2 ”Extend ultrasound probe” button 8.2 ”Enable joint 1” button
1.3 ”Reduce membrane pressure” button 8.3 ”Enable joint 2” button
1.4 ”Increase membrane pressure” button 8.4 ”Enable joint 3” button

1.5 Release button “swiveling of therapy source”

1.6 Locking button
1.7 Safety lever

GA--A 175 20
3 Setup

. NOTE!
First instructions are given to the person responsible for the device either
by the manufacturer or a person authorized by him.

WARNING!
The device is not protected against explosions.
Explosion hazard!
Do not operate this device in areas where there is a danger of
explosion.

. NOTE!
Check that the line voltage is the same as the voltage specified on the
identification plate. Connect the device only with the supplied power
cable or a power cable meeting the same specifications.

CAUTION!
Danger of faults and malfunctions.
To guarantee the safety of the user, the patient and others use only
accessories and spare parts specified by the manufacturer of this
product.
Other accessories or spare parts can cause the emission of
increased electromagnetic radiation or reduced immunity against
interference.

. IMPORTANT!
Medical devices are subject to special precautions with regard to electro-
magnetic compatibility (EMC).
Make sure you observe the notes on EMC for installation and operation.
Medical electrical devices can be influenced by mobile HF communica-
tion devices.
If it is necessary to stack the devices or place them next to each other
and HF interference is observed, make sure you observe the intended
use of the devices.

. IMPORTANT!
Never pull, pinch, squeeze or overbend the cables and flexible tubes.
This may lead to failure of the device.
Failure to follow this requirement voids the warranty for the product.

21 GA--A 175
3.1 Parking brakes

3.1.1 Parking brakes of Lithotripter

The two parking brakes of the front wheels serve to lock the device in
place.
. NOTE!
During treatment both brakes must be locked (engaged).

3.2 Preparation
Z Insert plug of cable--linked remote control button for shock wave
triggering in socket and tighten collar.
Z Connect the locating system(s) to the lithotripter as shown in the
connection diagrams, chapter 8.
Z Connect the power supply/mains plug of the lithotripter.
Z Switch on the power switch.
' The lamp in the power switch is lit.
Z Equipotentiality of the device and the equipotential bonding point of the
room can be achieved via a potential equalization cable.

GA--A 175 22
3.3 Water treatment

3.3.1 Removing the coupling membrane

Z Empty the water system.
Z Use special tool (M) to remove the membrane ring (1.5) evenly at the
4 recesses.
' Insert the short end of the special tool as far as it will go into the
recess of the membrane ring and push downward.
Z Remove coupling membrane (1.6).
Z Check coupling membrane (1.6) and transducer surface (1.7) for
damage.
' Clean and disinfect the transducer and coupling membrane.
. IMPORTANT!
Replace coupling membrane after 8 weeks at the latest.

1.5 1.5
1.6
1.6
M
1.6 B
1.7

3.3.2 Installing the coupling membrane

Z Place coupling membrane (1.6) onto therapy source.
Z Slightly lubricate the coupling membrane with instrument oil in the
contact area of the membrane ring (B).
Z Place the membrane ring (1.5) onto the coupling membrane and push
down evenly until the membrane ring is locked in place around its
entire circumference.
Z Fill the system.

3.3.3 Information on water preservative

CAUTION!
Follow the manufacturer’s instructions for use and safety. The safety data
sheet is available from the manufacturer on request.
Extract from the safety data sheet:
Wear waterproof protection gloves and goggles when dealing with the water
preservative.
In the case of skin or eye contact, skin or eye irritations are possible.
After skin contact: Clean skin with a lot of water and soap.
After eye contact: Rinse eyes for several minutes under the tap with
the palpebral fissure open.
If swallowed: Rinse mouth and drink a sufficient amount of water.
Do not stimulate vomiting.
' After contact or if swallowed, consult your physician and submit package
or label.

23 GA--A 175
3.3.4 Transducer position for filling/emptying/deaerating the system

Z For filling/emptying/deaerating, position the therapy source in accor-

dance with the illustration.

3.3.5 Filling the system

. NOTE!
The system must be completely emptied.
Z Switch on the device.
' Position the therapy source as shown in the section 3.3.4.
' For filling, the membrane must be in place.
Z Fill a container with approx. 10 liters of water (the PIEZOLITH requires
approx. 9 liters of water).
' Drinking water quality, water temperature between 10°C and 40°C
(preferably 30°C to 35°C).
Z Add the required amount of water preservative to the water in the
container.
C
Z Immerse filling hose with suction filter (C) in the container.
Z Actuate the ”fill system” button
' During the filling procedure the ”shock wave counter” display will
read “FFFF”.
' After approx. 20 minutes the system is full. Any air bubbles inside
the therapy source require deaeration of the system.
' The ”fill system” routine has been completed when the ”shock wave
counter” display switches from the display of letters to the display of
numbers only.
' If you want to stop the ”fill system” procedure prematurely, press the
”stop” button (before starting a new filling procedure empty the sys-
tem).

GA--A 175 24
3.3.6 Emptying the system
Z Position the therapy source in accordance with section 3.3.4.
Z Place the drain hose (D) without suction filter in a empty container of at
least 10 liters capacity.
D Z Actuate the ”empty system” button.
' During the emptying procedure the ”shock wave counter” display will
read “EEEE”.
' After approx. 20 minutes the system is empty.
' The ”empty system” procedure is completed when the ”shock wave
counter” display switches from letters to numbers only.
' If you want to stop the ”empty system” routine prematurely, press the
”stop” button.

. IMPORTANT!
Empty the water system every 4 weeks at the latest, refill with fresh
water and add the required water preservative.

3.3.7 Deaerating the system / evacuating air bubbles

Z Position the therapy source in accordance with section 3.3.4.

Z Move the coupling membrane forward and backward several times
(2 to 3 times).
' This helps to move the air bubbles inside the hoses of the device
towards the therapy source.

Z Actuate the ”deaerate system” button.

' While the system is deaerated the ”shock wave counter” display
reads “CCCC”.
' Slight knocking on the coupling membrane helps to evacuate the air
bubbles from the therapy source.
' The ”deaerate system” routine is completed after approx. 3 minutes.
Repeat the procedure if required.
' The ”deaerate system” routine is completed when the ”shock wave
counter” display displays only numbers and not series of letters any
longer.
' If you want to stop the ”deaerate system” procedure prematurely,
actuate the ”deaerate system” button once more.

. NOTE!
There must be no visible air bubbles in the therapy system.

25 GA--A 175
3.4 Disassembling and assembling the therapy source

. NOTE!
Make sure that you do not damage the cables and plugs when disassem-
bling and assembling the therapy source.

Positioning on the LITHOARM or stand:

Z Move the therapy source into the lowest therapy position.

Positioning on the articulated arm:

Z Position the articulated arm as shown in the figure.
' The therapy source is facing upwards.

Removal of therapy source:

Z Fully retract the ultrasound probe and membrane.
Z Switch off all devices and disconnect the power plug.
Z Disconnect the connection for the therapy source on the PIEZOLITH
and the Scanner plug on the ultrasound unit (is not necessary if you
move the therapy source only from the LITHOARM or the stand to the
articulated arm).
Z Unlock the safety lever (1.7) by pushing down and releasing it
completely.
Z Hold the therapy source firmly with both hands.
Z Actuate both locking buttons (1.6) and carefully remove the therapy
source.

1.7 1.6

1.6 1.7

GA--A 175 26
 Connecting the therapy source to the LITHOARM or stand:
Z The holding device should be in the lowest therapy position.
' When placing the therapy source onto the holding device, mind the
position of the guide pins (1.8) and actuate both locking buttons
(1.6).
Z After assembly check the therapy source for secure connection and
fully lock the safety lever (1.7) (it must engage in the locked position).
Z Connect the plug for the therapy source to the PIEZOLITH (see chap-
ter 3.4.1) and the scanner plug to the ultrasound device.
Z Check X--ray target cross (see chapter 8).

Connecting the therapy source to the acticulated arm:

1.8 Z Position the articulated arm in accordance with the drawing ensuring
that the holding device is straight and that the therapy source can be
inserted from the top.
' When the therapy source is placed onto the holder mind the position
of the guide pins (1.8) and actuate both locking buttons (1.6).
1.7
Z After assembly check the therapy source for secure connection and
fully lock the safety lever (1.7) (it must engage in the locked position).
Z Connect the plug for the therapy source to the PIEZOLITH (see chap-
ter 3.4.1) and the scanner plug to the ultrasound device.

3.4.1 Disconnecting and connecting the therapy source connection

WARNING!
Residual water can get onto the contacts.
Danger of electrical short- circuit.
Always ensure that the electrical contacts are dry.

. IMPORTANT!
Always secure the plug with a steel cable loop when disconnected.
Never let it trail or fall down.
5.1
Disconnecting the connection:
Z Before you disconnect the connection make sure that the PIEZOLITH
is switched off and disconnected from the power supply/mains.
Z Disconnect the connection by pulling the lever (5.1) upward, then fully
5.1 disconnect the plug.
' After disconnecting hold the plug downward to allow any residual
water to be drained, then dry again using a cloth.

Connecting the plug for the therapy source:

Z Position the plug in such a way that the markings (dots) are aligned,
then carefully insert the plug (observing the mounting pin) and lock
using the lever (5.1).
Z After connecting the connector to the system, bleed / vent the system.

IMPORTANT!
If the PIEZOLITH is ON and the plug is not connected, status message “A500” is
displayed (see 7.1.1). If you disconnect the connection during the filling or empty-
ing process it is necessary to empty the system and fill it once more.

27 GA--A 175
4 Checks
. NOTE!
For technical safety checks see chapter 6.

4.1 Daily checks

Z Visual check for proper condition of device and accessories
' Check device and connection hose to therapy source for damage
and for water leakage.
' Check coupling membrane for damage and cleanliness.
' Check connection cable(s) of all device(s) for damage.
Z X--ray location with LITHOARM.
' Check X--ray target cross (see chapter 8.4.1).
Z X--ray location with stand for therapy source.
' Check X--ray target cross (see chapter 8.4.2).
Z Check ultrasound target cross (see chapter 8.1.4).

4.2 Monthly checks

Z Check lettering for completeness and good legibility.
Z Check that monthly water treatment has been carried out.
Z Check transducer surface for damage.

4.3 Checks after transport

Z Use same checks as daily checks.
Z Check target cross of X--ray and ultrasound locating systems (see
chapter 8.1.4, 8.4.1 and 8.4.2).

GA--A 175 28
4.4 Checking the Shock Wave Energy
. IMPORTANT!
The shock wave energy can only be determined correctly if the system water is
free of air bubbles and clean. Air bubbles and microparticles can cause a reduc-
tion in performance. If necessary carry out a new water treatment cycle or deaer-
ate the system.

1.8 Z Fully retract the ultrasound probe.

Z Fully retract membrane bulge using the ”reduce membrane pressure”
button.
Z Turn therapy source completely downward (see Fig.).
Z Place test cylinder (1.8) onto therapy source and lock in place with the
3 quick--action clamps.
Z Use the ”increase membrane pressure” button to couple the mem-
brane to the test cylinder until the membrane seals tightly against the
test cylinder.
Z Fill in water up to almost the overflow capacity (approx. 300 ml)
1.9 1.10 1.11
Z Fully extend the probe using the “extend ultrasound probe” button.
Z Adjust the ultrasound probe (1.9) in such a way that the ultrasound
image is horizontally aligned with the water surface (1.11).
' As a viewing aid for adjusting the water level to the targeting cross
you may place a paper strip (1.12) in longitudinal direction onto the
water surface (1.11) in the test cylinder (1.8).
Z Fully retract the ultrasound probe.
Z Select shock wave intensity 15.
1.8 1.12 Z Trigger shock wave.
' The therapy source still has sufficient energy if the hight of the water
jet is more than 10 cm.
' If the hight of the water jet is less than 10 cm contact the service de-
10cm

partment.
Z Upon completion of the test, remove the water from the test cylinder.
' For this purpose hold a container under the test cylinder and care-
fully return the therapy source to horizontal position.
Z Fully retract the membrane bulge using the ”reduce membrane pres-
sure” button, then remove the test cylinder.

29 GA--A 175
5 Application

5.1 General instructions for safe and effective use

CAUTION!
Careful if high amount of shock waves are applied.
Possible tissue damage.
Do not apply more than 4000 shock waves during one therapy session.
CAUTION!
Patients with infectious diseases require the following measures:
Before treatment cover open wounds in such a way that no body fluents can
leak out.
Disinfect the device after treatment. Follow the disinfectant manufacturer’s
instructions.
CAUTION!
Do not apply pressure pulses to organs which include air (such as lung,
intestine). Use adequate entry window for therapy source, i.e. position the
patient accordingly.
CAUTION!
Pressure pulses can cause undesirable heart reactions.
ECG monitoring is recommended for patients with a history of cardiac
arrhythmia.

CAUTION!
Use of the PIEZOLITH 3000 for the treatment of urinary stones in the middle
and lower ureter should be performed using x- ray localization.
. IMPORTANT!
Should the coupling membrane be damaged and system water leak from the ther-
apy source, stop the treatment immediately, switch off the device and install a new
coupling membrane. Then refill the system.
. IMPORTANT!
Before any treatment disinfect the coupling membrane with surface disinfectant
which has been approved for patients.
Use only ultrasound gels certified as suitable for the use on patients.
Follow the gel manufacturer’s instructions.
. IMPORTANT!
During lithotripsy fine cavitation movements in the target area are visible during
ultrasound location indicating that the therapy focus is the same as the ultrasound
target cross.
. IMPORTANT!
If shock wave triggering is inhibited and the display reads “A400” immediately
check the position of the X--ray target cross.
. IMPORTANT!
Check stone position during treatment as often as necessary to ensure correct
treatment.
. NOTE!
Cushioning of the pressure pulse when it passes tissue and additional energy
absorption in bones.
. NOTE!
Avoid trapped air between the coupling membrane and the patient’s body.
Make sure that you choose an anatomically suitable entry window for the shock
waves. Move the therapy source to the required therapy position. If this is not ob-
served energy losses may occur.
During treatment the parking brakes of all system components used must be
locked.

GA--A 175 30
5.2 Treatment

5.2.1 Movable table top

Position the patient correctly with the help of the positioning buttons of
the manual control of the treatment table.
CAUTION!
Danger of getting caught while moving the treatment table top.
Actuate movement of table top only under visual control to ensure that nei-
ther the patient nor others are endangered. Ensure that the movement of the
table top is not obstructed by any object.

5.2.2 Treatment steps with X--ray and ultrasound location

Preparation:
-- X--ray C--arc in AP (0_) position
-- Treatment table to center position
-- Retract membrane (reduce membrane pressure)

Z Adjust therapy source to optimum therapy position as required by the

indication.
' To adjust the therapy source, actuate the release button.
Z Make sure the patient on the treatment table is in a stable position rel-
ative to the therapy source.
Z If during fluoroscopy the therapy source shades off the ray path, push
the therapy source back to position (B).
Z Perform AP fluoroscopy.
Z Position patient with treatment table horizontally.
' Keep repeating AP fluroscopy and horizontal positioning until the
therapy field coincides with the targeting cross.
Z Turn the X--ray C--arc laterally to the 30_ position.
B A ' Be aware of possible collision with the patient or treatment table.
' Perform 30_ fluoroscopy.
Z Position patient with treatment table vertically.
' Keep repeating 30_ fluoroscopy and vertical positioning until the
therapy field coincides with the targeting cross.
Z Turn X--ray C--arc laterally to the AP position.
' Perform a fluoroscopy check and readjust horizontal position if nec-
essary.
Z Apply ultrasound gel evenly and free of air bubbles to the coupling
membrane and to the patient.
Z Slide the therapy source forward to therapy position (A).
' Locking mechanism must engage.
Z Carefully couple the patient to therapy source using the ”increase
membrane pressure” button.
Z To keep the radiation exposure for patient and user as low as possible
the therapy zone should continuously observed with ultrasound loca-
tion.
' The ultrasound probe is vertically and radially adjustable.
' Retract the ultrasound probe as far as possible to keep energy ab-
sorption as low as possible.

31 GA--A 175
 Z If the ultrasound image is poor apply further ultrasound gel to the cou-
pling membrane or the patient. Increase the membrane coupling pres-
sure until good contact is established between the membrane and the
patient. Do not move the patient by increasing the membrane pressure
excessively.
' If the patient has moved, stop the shock wave therapy and reposition
under ultrasound and X--ray control until the therapy field again coin-
cides with the target cross.
Z After 1000 shock waves at the latest perform fluoroscopy and reposi-
tion the treatment table if necessary.
Good ultrasound image = good transmission of the shock wave energy =
highly successful treatment!
Therapy zone visible in the ultrasound targeting cross = high accuracy =
quick success of treatment
Z In the case of deep therapy zones set the penetration depth of the
therapy focus into the body to maximum focal depth by pressing the
”reduce membrane pressure” button (fully retract the membrane).
' The bulging of the coupling membrane determines the depth of pen-
etration of the therapy focus.

5.2.3 Treatment steps with ultrasound location and articulated arm

Preparation:
-- Move treatment table top to center position
-- Set ultrasound probe to 0_ or 90_position
-- High penetration: low membrane pressure (and bulging) and ultrasound
probe retracted
-- Low penetration: high membrane pressure (and bulging) and ultra--
sound probe extended
Z Stabilize the patient on the treatment table.
Z Apply ultrasound gel evenly and free of air bubbles to the coupling
membrane and the patient.
Z Position the therapy source relative to the patient in such a way that
the therapy field is visible in the ultrasound monitor; for this purpose
actuate the articulated arm or the individual joints, respectively.
Z Adjust the required depth of penetration of the therapy focus in the
body using the ”increase membrane pressure” or ”decrease membrane
pressure” buttons.
' The bulging of the coupling membrane determines the depth of pen-
etration of the therapy focus.
Z Carefully move the operating table horizontally and vertically until the
therapy field coincides with the targeting cross.
' Move the ultrasound probe radially to once more check the align-
ment of therapy field and targeting cross.
Z If the ultrasound image is poor apply further ultrasound gel to the cou-
pling membrane or the patient.
' If the patient has moved, stop the shock wave therapy and reposition
under ultrasound control until the therapy field again coincides with
the target cross.
Z After 1000 shock waves at the latest perform ultrasound localization
and reposition the treatment table if necessary.
Good ultrasound image = good transmission of the shock wave energy =
highly successful treatment!

GA--A 175 32
 . NOTE!
Rotate the ultrasound probe to adjust the optimum image angle.
For location, the ultrasound probe can be moved axially in direction of the therapy
focus to achieve direct coupling of the ultrasound probe via the coupling mem-
brane with the patient’s skin. This prevents multiple reflections and an optimum
ultrasound image.
To avoid energy losses during shock wave therapy the ultrasound probe should
be retracted as far as possible.

5.2.4 Shock wave therapy

CAUTION!
Trigger the shock wave only if the focus lies in the target area, otherwise
more frequent side effects are possible.
Shock waves may only be applied if the target area has been clearly identi-
fied and after having evaluated possible negative effects on the regions the
shock wave is applied to or through.

Z Simultaneous actuation of the two ”shock wave intensity” buttons

resets the intensity to zero.
Z Start at a low shock wave intensity and then slowly increase the inten-
sity as required by the indication.
' For single pulse mode set the pulse rate to ”0”.
' For continuous pulse mode set the required pulse rate.
Z Trigger the shock wave by pressing the button on the cable--linked
remote control
Z Slight movements in the focal area on the ultrasound image indicate
the activity of the shock wave. It is also possible that a white line ap-
pears on the ultrasound image when a shock wave is triggered.
Z The target area may change if the patient moves. It is therefore neces-
sary to continuously monitor the procedure on the screen to prevent
treatment of unaffected tissue.
Z When treating larger therapy areas it is advantageous to position the
focus at various points:
. NOTE!
Automatic shock wave stop.
After 1000 shock waves, shock wave triggering is automatically disabled.
To reenable shock wave triggering, actuate the ”function” button.

33 GA--A 175
5.3 Evaluating the shock wave therapy
5.3.1 Mean intensity value
Z The mean (average) shock wave intensity value per treatment is dis-
played when you press the ”mean intensity” button on the shock wave
counter display field (e.g. ”C 10.5”).
' Pressing the ”reset shock wave counter” button deletes the ”mean
intensity value”

5.3.2 Shock wave statistics

Z The shock wave statistics mode is called by actuating the ”function”
button for more than 3 seconds (”E” is displayed on the ”membrane
pressure” display).
' For the selected intensity level, the number of emitted shock waves
is displayed on the ”shock wave counter” display.
' Press any key (except the ”shock wave intensity”, ”mean intensity
”and ”F” buttons) to exit the shock wave statistics mode.
' Shock wave statistics are deleted by pressing the ”reset shock wave
counter” button.

GA--A 175 34
6 Reprocessing and maintenance

6.1 Reprocessing of device

WARNING!
Make sure that no humidity enters the device.
Danger of electric shock.
Before reprocessing switch off the device and disconnect it from
the power supply.

Clean the device with a soft cloth moistened with surface disinfectant,
alcohol or spirit.
Follow the disinfectant manufacturer’s instructions.

. IMPORTANT!
Make sure that no humidity enters the device. Do not use any cleaning
agents, scouring agents or solvents on this device.

6.2 Reprocessing of water system

Z Empty the water system after 4 weeks at the latest, refill with tap
water and the prescribed water preservative (see chapter 3.3).

6.3 Reprocessing of coupling membrane

Z Clean and disinfect the coupling membrane and membrane ring by
rubbing or spraying it with disinfectant before each use.
' Use only disinfectants suitable for silicone rubber which are ap-
proved in your country.
Follow the disinfectant manufacturer’s instructions.

Z Replace the coupling membrane after 8 weeks at the latest.

35 GA--A 175
6.4 Maintenance
. IMPORTANT!
In your inquiries or correspondence please always indicate the model and
serial number on the identification plate. Further documentation is avail-
able from the manufacturer on request.

6.4.1 Maintenance intervals

. IMPORTANT!
To prevent incidents caused by aging and wear of the device or the ac-
cessories perform maintenance at adequate intervals.
At least every 12 months the functional and operational safety must be
checked by an expert as required by the maintenance schedule.

6.4.2 Safety checks

. IMPORTANT!
Safety checks and tests may only be carried out by the manufacturer or
persons with specialized technical knowledge.
Document the test results and include them in the device record.
The device must not be used if the specified values are not displayed or
functions are not fulfilled.

Test intervals:
Every 12 months the safety check must be carried out as follows
Z Visual check for completeness, soiling and aging.
' Lettering and labels.
' All electrical lines and connections for damage and proper position/
firm connection.
' Leakage test of the water system.
Z Check of electrical safety to EN / IEC 60601--1
Z Function check as described in the instruction manual.
Z Check of the attached locating device(s) in accordance with chapter 8.

GA--A 175 36
7 Technical description

7.1 Troubleshooting
. IMPORTANT!
If the fault or errors cannot be eliminated with the help of this table,
please contact our service department or send in the device for repair.
' Do not attempt to do any repairs yourself.

7.1.1 Status/error messages on the ”shock wave counter” display

Error code Cause Remedy

CCCC System is being deaerated Status message
EEEE System is being emptied Status message
FFFF System is being filled Status message
Let water cool down
A001 Water supply too hot ( > 40°C)
(wait approx. 30 min.)
A002 Sensor “S2” in degassing tank defective Contact service department
A003 Sensor “S2” defective or degassing tank is not emptied Contact service department
A004 Float switch ”S3” in degassing tank defective Contact service department
A008 Float switch ”S4” in degassing tank defective Contact service department
Confirm with key ”F”.
A010 System water too hot (> 40_C) The heating remains off until the system
water has cooled down.

A020 Voltage of high voltage generator too high Contact service department
A030 Voltage of high voltage generator too low Contact service department
A040 Error in high voltage generator Contact service department
A080 Parting of pressure sensor cable in therapy source Contact service department
A100 Weight monitoring Contact service department
Perform locating check and acknowl-
A200 Shock wave stop after 1000 shock waves
edge with ”F” key
No shock wave transmission possible,
A300 Empty / fill device
system not ready for use
Check position monitoring of X--ray
A400 Shock wave triggering inhibited arc, if adjustment not possible
contact service department
A500 Plug for therapy source not connected Connect plug to socket
A700 Water change deadline exceeded by more than 2 weeks Carry out a water change
Check suction filter, carry out new
A800 Suction filter clogged or insufficient water supply
water treatment cycle
A900 Error in high voltage control to therapy source Contact service department

37 GA--A 175
7.1.2 Device malfunctions
Error
Device has no function
No targeting cross on ultrasound
monitor
No shock wave
Insufficient membrane pressure
(i.e. insufficient bulging)
Excessive membrane pressure
(i.e. excessive bulging)
GA--A 175
Possible cause
Power switch not switched on
Power cable not connected
No power supply
Fuse in device defective
No interface connection
Cable--linked remote control not con-
nected/defective
Not enough water in the system or
water circuit leaking
Too much water in system or air in
water circuit
Remedy
Switch on the power supply
Connect the power supply cable
Check in--house power supply
Change mains/power fuse
Connect interface cable;
Switch lithotripter and ultrasound off,
first switch on lithotriptor than ultrasound
Connect/replace remote control
Empty system and restart water treat-
ment
Check device for water leakage -- switch
off device immediately and contact the
service department
Deaerate system or empty system and
refill
38
7.2 Technical data

Voltage Frequency Power Current Fuse

PIEZOLITH PIEZOLITH consumption rating
(with articulated arm)
Vµ Hz VA A A
3000.001 3000.011 220 -- 240 50 / 60 1000 4 T 5,0 L
3000.002 3000.012 110 -- 120 50 / 60 1000 8 T 10,0 L
3000.003 3000.013 100 50 / 60 1000 9 T 10,0 L
3000.004 3000.014 200 50 / 60 1000 5 T 5,0 L

Electrical safety to EN / IEC 60601--1

Electromagnetic compatibility (EMC) to EN / IEC 60601--1--2
Medical devices directive 93/42/EEC Class II b
Protection class to EN / IEC 60601--1 ;
I
(UL 2601--1 / CSA C22.2 No.601.1 -- for USA)
Protection against electric shock Type B applied part
Degree of protection against the ingression of liquids Device trolley: IP 20 (not protected)
Mode of operation (duty factor) Continuous operation
Noise level 72 dB(A)
This device is not protected against explosions
Degree of protection in the presense of flammable
(Do not operate this device in areas where explosive
mixtures
substances are present)
Weight of lithotriptor (without / with articulated arm) approx. 210 kg (460 lbs) / 240 kg (530 lbs)
Dimensions of device trolley L x W x H approx. 1000 mm x 700 mm x 1000 mm
Water volume of system 10 liters
Required floor space with ultrasound (without X--ray) approx. 6 m2
Required floor space with ultrasound and X--ray approx. 9 m2

39 GA--A 175
7.2.1 Pressure pulse characteristics

Shock wave source Piezoelectric self--focusing spherical cup

Aperture angle 74°
0 Hz to 2 Hz: Step 1 to 20
Pulse rate / Intensity steps 3 Hz: Step 1 to 15
4 Hz: Step 1 to 10
Position of targeting mark Center of --6dB zone plus tolerances (see below)
Tolerance between geometric focus
(indicated by iron ball of the target cross test device) and xg , yg , zg (ultrasound) ≤ 1 mm
target location
(indicated by the target cross on the monitor of the respective xg , yg , zg (X--ray) ≤ 2 mm
locating system)
Depth of penetration 0 to 150 mm

minimum energy medium energy maximum energy

Tolerance between acoustic focus and geometric focus (za) 0 mm ≤ 1 mm ≤ 2 mm
Z--distance of acoustic focus to the proximal --6dB point (z1) 15 mm 7 mm 16 mm
Z--distance of acoustic focus to the distal --6dB point (z2) 13 mm 10 mm 21 mm
Peak compressional acoustic pressure (p+) 20 MPa 76 MPa 120 MPa
Peak rarefactional acoustic pressure (p-- ) -- 8.2 MPa -- 14 MPa -- 20 MPa
Positive energy flow density 0.12 mJ/mm2 0.48 mJ/mm2 1.7 mJ/mm2
Temporal integration limits (T)
positive temporal integration limits (TP): according IEC 61846 clause 3.23.1
total temporal integration limits (TT): according IEC 61846 clause 3.23.2
Total energy (--6 dB) per pulse at radius R = 1/2 fx/y 1.8 mJ 2.2 mJ 7.3 mJ
Focal zone : fx/y (--6dB) x fz (--6dB) 3.9 x 28 mm 2.1 x 17 mm 2.3 x 37 mm
Volume of focal zone Vf (--6 dB) 225 mm3 39 mm3 103 mm3
fz = z1 + z2
z1 z2

fx = fy
proximal zg distal
x g , yg
z axis
toward shock za target location away from
wave source shock wave source
acoustic focus
geometric (max. p+)
focus
--6 dB tolerance between geometric
contour x/y axis focus and target location

Definitions:
Target Location is the location in space where the manufacturer intends the operator to locate the calculi.
Acoustic focus is the location in the pressure pulse field of the maximum peak--positive acoustic pressure.
Focal volume is the volume in space contained within the surface defined by the --6 dB (relative to the value at the
focus) peak--positive acoustic pressure contour measured around the focus.
fz is the focal extent, defined as the shortest distance along the z axis that connects points on the --6 dB contour of
peak--positive acoustic pressure in the x--z plane on either side of the focus.
fx is the maximum focal width, defined as the maximum width of the --6 dB contour of peak--positive acoustic pressure
around the focus in the x--y plane that contains the focus.
fy is the orthogonal focal width, defined as the width of the --6 dB contour of peak--positive acoustic pressure around the
focus, in the x--y plane that contains the focus, in the direction perpendicular to fx

GA--A 175 40
7.2.2 Locating systems

Inline ultrasound probe 3.5 MHz

Ultrasound *)
120 mm vertical travel
Mobile digital X--ray location,
X--ray *)
range of rotation ±30° to the sides
*) For further information please see separate data sheet of the corresponding locating system

7.3 Operating, storage, transport and shipping conditions

+ 10°C to + 35°C , 30% to 75% rel. humidity
Operating conditions
atmospheric pressure 700 hPa to 1060 hPa
+ 5°C to + 40°C , 10% to 90% rel. humidity
Storage, transport and shipping conditions
atmospheric pressure 700 hPa to 1060 hPa

. NOTE!
To prevent damage during transport or shipment of the products we recommend using the original packaging
material.

41 GA--A 175
7.4 Considerations for transport

7.4.1 General notes

. IMPORTANT!
For device trolleys with ultrasound device it is necessary to separate
the ultrasound unit form the device trolley for any transport.
Transport all components separately.
Transport outside the hospital premises (e.g. by vehicle) is only allowed
by specially trained technical personnel.
The system must be stored and transported in watertight locations.

Z After transport/shipment always apply the parking brakes to keep the

device in place.
Z When passing over obstacles (e.g. edges, uneven surfaces etc.) that
are higher than 1.0 cm provide suitable ramps (e.g. wedges, boards,
etc.).
Z For recommended transport directions see figure.

7.4.2 Preparation of the system

Z Fully retract the ultrasound probe and membrane.
Z Empty the system.
' Not neccessary if using an heated vehicle with temperature control.
Z Remove the therapy source as described in chapter 3.4 and secure it.
Z Move all parts to the most compact position and tighten / lock all move-
able assemblies.
Z Disconnect all devices from mains/line
Z Disconnect all devices and transport separately.

7.4.3 Stowage of the system in a vehicle

Z Specification of vehicle:
' Fixing elements and belts to prevent damage during transport for all
devices of the system.
' Minimal dimensions of the load room:
-- length 3,0 m x width 1,8 m x hight 1,8 m
' Minimum loading capacity: 1500 kg
' Loading aids (e.g. hydraulic loading plattform) with minimum lifting
capacity: 500 kg
' We recommend a temperature controlled transport (see chapter 7.3).

7.4.4 Set up after Transport

Z Connect all devices (see chapter 3 and 8).

Z Check system (see chapter 4).

GA--A 175 42
7.5 Spare parts and accessories

Units Model/Type Designation

1 64 268.016 Device fuse T 5.0 AL (pack of 10)
1 64 268.021 Device fuse T 10.0 AL (pack of 10)
1 2440.03 Mains/power cable (Europe) 3.0 m
1 72 325.319 Mains/power cable (US Hospital Grade) 3.6 m
1 64 100.038 Coupling membrane
1 64 057.303 Membrane ring
1 64 207.003 Disassembly tool (for membrane ring)
1 74 011.050 Suction filter
1 64 235.157 Cable--linked remote control for shock wave triggering
1 64 230.002 Test cylinder
1 64 265.014 Testing device for targeting cross (FB27/74)
1 72 325.093 Equipotential cable
1 64 235.165 Instrument oil (pack of 2)
1 9500.061 Water preservative
1 9500.059 Ultrasound gel
1 9500.026 Set of allen wrenches/keys
' further accessories on request

43 GA--A 175
7.6 Replacement of parts

7.6.1 Replacing device fuses

CAUTION!
The device fuse values must correspond to the fuse specifications
on the identification plate.
Only use fuses listed in the spare parts list.

L Power input connector with fuse holder

4 4
5
3 2

Z Switch off the device and disconnect the power cable from the wall
socket and from the power input connector of the device.
Z Use a screwdriver [6] to take out the fuse housing [1].
Z Push the locking ledge [2] upward until the fuse holder is free and pull
out the fuse holder [3].
Z Remove the fuses [4] from their seats [5] and replace.
Z Reinsert the fuse holder into the fuse housing until it clicks into place.
Z Reinsert the fuse housing into the device and push until it clicks into
place.

7.6.2 Disposal of product, packaging material and accessories

For the disposal observe the relevant regulations and laws valid in your
country.
' For further information please contact the manufacturer.

GA--A 175 44
8 Locating systems and attachments

8.1 Ultrasound location

8.1.1 Connection ultrasound device (Kretz C401 / Medison Sonoace 5500)

8.3

8
8.4

8.5 GN
RD
8.7

BU 8.6

Legend
1 Therapy source 8.4 Ultrasound probe
8 Ultrasound device 8.5 Connection cable between device trolley and ultrasound device
8.3 Probe connector 8.6 Jumper cable (ultrasound operation without PIEZOLITH)

Z Switch off the power/mains switch of the devices.

' Connect the plugs in current--free (”cold”) condition.

. NOTE!
For additional instructions for use please refer to the instruction manual of
the ultrasound device used.

45 GA--A 175
8.1.2 Connection of compact ultrasound unit (Aloka SSD--900)

8.3
8.2

8.1
1

8.4

Legend
1 Therapy source 8.2 Probe plug
8 Ultrasound device 8.3 Power supply for ultrasound device
8.1 Connecting cable between Ultrasound device -- PIEZOLITH 8.4 Ultrasound probe

Z Switch off the power/mains switch of the device(s).

' Connect the plugs in current--free (”cold”) condition.

. NOTE!
For additional instructions for use please refer to the instruction manual of
the ultrasound device used.

GA--A 175 46
8.1.3 Connection ultrasound device (Aloka SSD--1000 / SSD--3500)

8.3
8.4

8.5

Legend
1 Therapy source 8.4 Ultrasound probe
8 Ultrasound device 8.5 Connecting cable between Ultrasound device -- PIEZOLITH
8.3 Probe connector

Z Switch off the power/mains switch of the devices.

' Connect the plugs in current--free (”cold”) condition.

. NOTE!
For additional instructions for use please refer to the instruction manual of
the ultrasound device used.

47 GA--A 175
8.1.4 Checking the ultrasound targeting cross
. IMPORTANT!
Proper checking of the ultrasound targeting cross is only possible with air--
bubble--free and clean system water. Air bubbles and microparticles can reduce
the power output. Run new water treatment cycle if necessary or deaerate the
system.
Z Move the therapy source to horizontal.
Z Retract coupling membrane (reduce membrane pressure) and ultra-
sound probe.
Z Place test device for targeting cross onto therapy source and fasten
with the 3 clamps (D).
' Close the clamps clearly over dead center to ensure that they are
locked.
Z Apply ultrasound gel to the test device in the area of the targeting
mark.
Z Press the ”increase membrane pressure” button to couple the mem-
brane to the targeting mark.
Z Press the “extend ultrasound probe” button to move the probe forward
as far as it will go.
' The targeting mark must lie within the ultrasound targeting cross.
' Rotate the ultrasound probe for better image adjustment.
. IMPORTANT!
If the targeting mark is not aligned with the targeting cross do not use the
device for therapy. ' Contact the service department.

Z Upon completion of the targeting cross check, proceed as follows.

' Fully retract the scanner.
' Retract the membrane half--way.
' Clean test device and membrane from ultrasound gel.
' Fully retract the membrane (by reducing the membrane pressure).
' Remove test device.

D D

GA--A 175 48
8.2 Attaching the X--ray C--arc to the stand
. NOTE!
For additional instructions for use please refer to the instruction manual of
the X--ray device used.

8.2.1 Connecting the stand for the therapy source to the X--ray C--arc

Z Move the X--ray C--arc to the intended treatment position and apply the
parking brakes.
' Ensure that the front wheel (9.3) is in transversal position or is facing
towards the rear.
Z Slide stand (2) completely onto the 2 locating cones (2.1).
Z Push clamping mechanism (2.2) upward and tighten hand wheel.
' Ensure that the nose of the clamping mechanism engages behind
the metal foot of the C--arc.
Z Adjust feet (2.3) of stand until they rest firmly against the floor.
Z Connect the laser connection cable (for monitoring the connection be-
tween the therapy source and the X--ray C--arc to the lithotripter).

CAUTION!
Laser radiation.
Do not look into the laser beam.
Class 2 laser.

2.1 2.2

2.3
9.3

49 GA--A 175
8.2.2 Adjusting the X--ray C--arc to the stand

9.1
9.2

Legend
9.1 Laser reflection mark 9.2 Laser beam

CAUTION!
Laser radiation.
Do not look into the laser beam.
Class 2 laser.

Adjustment of laser position control

Z Set horizontal tilt (”wig--wag”) to 0°.
Z Set lateral rotation to 0_ and lock.
Z Set orbital movement to 90_ and lock.
Z Adjust the laser reflection mark (9.1) to the laser beam (9.2) by moving
the X--ray C--arc horizontally and vertically.

Adjustment of shock wave focus to X--ray targeting cross

Z Follow instructions as described in chapter 8.4.2.

Final check of laser position control

Z Turn the C--arc laterally to the 0_ and 30_ position to check if the laser
beam matches the reflection mark.
' Shockwave triggering is inhibited if the laser beam is not correctly
adjusted to the laser reflection marking on the X--ray C--arc (the ther-
apy unit must be locked in the therapy position), “A400” is displayed
on the display field and an alarm is sounded.

. NOTE!
If the laser position control does not match laser beam adjustment may
only be performed by adequately trained technical personnel.

GA--A 175 50
8.3 Using the X--ray C--arc with LITHOARM
. NOTE!
For additional notes and instructions for use please refer to the manual of
the corresponding X--ray device.
To lock / unlock the LITHOARM, pull out / push in the locking button
(11.3) while pushing the LITHOARM briefly towards the C--arc.
If the therapy source is not in therapy position (the LITHOARM must be
locked in the therapy position) the error message „A 400“ will appear and
a brief alarm is sounded. Shock wave triggering is inhibited.
To check the X--arc targeting cross, proceed as described in section 8.4

11
11.3
11.3

11.1 11.2

11.2

B A

Caution:
Retract the therapy source and reduce the
membrane pressure before you swivel the LITHOARM!

Legend
11 X--ray C arc A Therapy position
11.1 LITHOARM B X--ray position
11.2 Unlocking button for sliding unit C Diagnosis position
11.3 Locking mechanism for LITHOARM

51 GA--A 175
8.4 Checking the X--ray targeting cross

8.4.1 Version LITHOARM

. NOTE!
The functions image inversion, image magnification (zoom), and image
rotation must not be selected or activated.

Z Position the therapy source to horizontal.

Z Retract coupling membrane (reduce membrane pressure) and ultra-
sound probe.
Z Place test device for targeting cross onto therapy source and fasten
with the 3 clamps (D).
' Close the clamps clearly over dead center to ensure that they are
locked.
Z Perform fluoroscopy in AP (0_) position.
' The X--ray targeting cross must be aligned with the targeting mark:
-- the difference may be not more than 2 mm
(observe zoom factor; the diameter of targeting mark is 4 mm)
Z Turn C--arc laterally to the 30_position and perform fluoroscopy.
' The X--ray targeting cross must be aligned with the targeting mark
-- the difference may be not more than 2 mm
(observe zoom factor; the diameter of targeting mark is 4 mm)

. IMPORTANT!
If the X--ray targeting cross does not match (i.e. if there is a deviation be-
tween the targeting mark and the X--ray targeting cross) do not use the
device for therapy. ' Contact the service department.

Z Upon completion of the targeting cross check:

' Remove test device.

D D

GA--A 175 52
8.4.2 Version Stand
. NOTE!
After checking or adjusting the X--ray targeting cross all levers except the
lever for lateral rotation on the C--arc, must be closed/locked.
The functions image inversion, image magnification (zoom), image rota-
tion and height adjustment must not be selected or activated.

Z Check correct attachement of stand to the C--arm according to chapter

8.2.1.
Z Position the therapy source to horizontal.
Z Retract coupling membrane (reduce membrane pressure) and ultra-
sound probe.
Z Place test device for targeting cross onto therapy source and fasten
with the 3 clamps (D).
' Close the clamps clearly over dead center to ensure that they are
locked.
Z Perform fluoroscopy in AP (0_) position.
' If the X--ray targeting cross is not aligned with the targeting mark,
move the X--ray C--arc horizontally until the X--ray targeting cross
coincides with the targeting mark:
-- the difference may be not more than 2 mm
(observe zoom factor; the diameter of targeting mark is 4 mm)
Z Turn C--arc laterally to the 30_position and perform fluoroscopy.
' If the X--ray targeting cross is not aligned with the targeting mark,
move the X--ray C--arc vertically until the X--ray targeting cross coin-
cides with the targeting mark:
-- the difference may be not more than 2 mm
(observe zoom factor; the diameter of targeting mark is 4 mm)

. IMPORTANT!
If the X--ray targeting cross cannot be adjusted (i.e. if there is a deviation
between the targeting mark and the X--ray targeting cross) do not use the
device for therapy. ' Contact the service department.

Z Upon completion of the targeting cross check:

' Remove test device.

D D

53 GA--A 175
8.5 Using the X--ray U--arc with LITHOARM
. NOTE!
For additional notes and instructions for use please refer to the manual of
the corresponding X--ray device.
When using an X--ray U--arc the therapy unit is located directly on the
X--ray device.
The error message “A 400” is displayed if the therapy source is not in
therapy position (therapy unit must be locked in therapy position) and a
brief alarm is sounded. Shock wave triggering is inhibited.
The position of the X--ray targeting cross is checked as described in
section 8.4

11

B C 11.3
A 11.4

11.2

11.1

Legend
11 X--ray U--arm A Therapy position
11.1 LITHOARM for therapy source B X--ray position
11.2 Release knob for sliding unit C Diagnosis position
11.3 Locking mechanism for diagnosis position
11.4 Locking mechanism for therapy position

GA--A 175 54
9 Literature
. IMPORTANT!
We do not guarantee that this literature index is complete. Users should
therefore always ensure that they keep themselves informed about the
latest findings in this field of use.

Z Die Stoßwelle , Forschung und Klinik

2. Konsensus Workshop der Deutschen Gesellschaft für Stoßwellen--
lithotripsie in Zusammenarbeit mit dem Arbeitskreis ”Minimal--invasive
Techniken” der Deutschen Gesellschaft für Urologie
C. Chaussy, F. Eisenberger, D. Jocham, D.Wilbert
1995 , Attempo Verlag Tübingen , ISBN 3--89308--228--X

Z High Energy Shock Waves in Medicine

Clinical Application in Urology, Gastroenterology and Orthopedics
C. Chaussy, F. Eisenberger, D. Jocham, D.Wilbert
1997 , Georg Thieme Verlag , ISBN 3--13--104831--X

55 GA--A 175