Instruction Manual

PIEZOLITH

3000

GA--A 175 / en / Index: 11--01--3.0 / ÄM: KG 01--120

 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 unit to be used or sold, except under the supervision of a medical doctor.

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.: (001)--847--913 1113 Tel.: (..44)--(0)181--944--7447
MANUFACTURER Fax: (001)--847--913 1489 Fax: (..44)--(0)181--944--1311

BELGIUM FRANCE AUSTRIA

N.V. Endoscopie RICHARD WOLF France S.A.R.L. RICHARD WOLF Austria
RICHARD WOLF Belgium S.A. Rue Daniel Berger Ges.m.b.H.
Industriezone Drongen S Landegemstraat 6 Z.A.C. La Neuvillette Lederergasse 32
B--9031 Gent --Drongen F--51100 Reims A--1082 Wien
Tél.: (..32)--(0)9--2808100 Tél.: (..33)--(0)3--26--870289 Tel.: (..43)--(0222)1--405 6219
Fax: (..32)--(0)9--2829216 Fax: (..33)--(0)3--26--876033 Fax: (..43)--(0222)1--408 7084

0 GA--A 175
 Contents
1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Use in urology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.3 Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.4 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.5 Positioning examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4.1 Device combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4.2 Product / component requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2 Illustration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Equipment trolley with X--ray and ultrasound devices and treatment table . . . . . . . . . . 6
2.1.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Device trolley with articulated arm and compact ultrasound device . . . . . . . . . . . . . . . . 7
2.2.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3 Connections of ”device trolley” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.3.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.4 ”Water treatment” controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5 Display and control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.5.1 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.6 ”Therapy source” control field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.7 ”Articulated arm” control field (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.1 Parking brakes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.1.1 Parking brakes of device trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3 Water treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.3.1 Removing the coupling membrane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.3.2 Installing the coupling membrane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.3.3 Information on water preservative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.3.4 Transducer position for filling/emptying/deaerating the system . . . . . . . . . . . . . . . . . . . . 13
3.3.5 Filling the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.3.6 Emptying the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.3.7 Deaerating the system / evacuating air bubbles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.1 Daily checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.2 Weekly checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.3 Monthly checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.4 Checking the transducer performance (energy) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

5 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1 Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1.1 Piezoelectric principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1.2 Locating system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

GA--A 175 I
5.2 Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.2.1 Basic instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.2.2 Movable table top . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2.3 Treatment with X--ray and ultrasound location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2.4 Treatment steps with ultrasound location and articulated arm . . . . . . . . . . . . . . . . . . . . . 20
5.2.5 Shock wave therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.3 Evaluating the shock wave therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.3.1 Mean intensity value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.3.2 Shock wave statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

6 Reprocessing and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.1 Reprocessing of device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.2 Reprocessing of coupling membrane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.3.1 Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.3.2 Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

7 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7.1.1 Status/error messages on the ”shock wave counter” display . . . . . . . . . . . . . . . . . . . . . . 25
7.1.2 Device malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7.2 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7.2.1 Locating systems*) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
7.3 Operating, storage, transport and shipping conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
7.4 Transport of device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
7.5 Spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
7.6 Replacement of parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.6.1 Replacing device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.6.2 Disposal of product, packaging material and accessories . . . . . . . . . . . . . . . . . . . . . . . . 29

8 Locating systems and attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

8.1 Ultrasound location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8.1.1 Connection between ultrasound device and device trolley . . . . . . . . . . . . . . . . . . . . . . . . 30
8.1.2 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8.1.3 Connection of compact ultrasound unit on rotating support of device trolley . . . . . . . . . 31
8.1.4 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.1.5 Checking the ultrasound targeting cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
8.2 Attaching the X--ray C--arc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
8.2.1 Connecting the stand for the therapy source to the X--ray C--arc . . . . . . . . . . . . . . . . . . 33
8.2.2 Adjusting the X--ray C--arc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
8.2.3 Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
8.2.4 Checking the X--ray targeting cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

9 Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

II GA--A 175
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

GA--A 175 1
 Symbols Meaning

“Enable articulated arm” button

”Enable joint 1” button

”Enable joint 2” button

”Enable joint 3” button

Cable--linked remote control for shock wave triggering

Video In

Video Out

Data transfer

CAUTION: LASER BEAM. DO NOT LOOK INTO THE BEAM.

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)

1.2 Intended use

Find a description of the intended use for application in section 1.3.

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.

2 GA--A 175
1.3 Use in urology
1.3.1 Indications
Extracorporeal shock wave lithotripsy
D Extracorporeal shock wave lithotripsy is indicated for the treatment of
any kind of stone in the urinary tract with the exception of immobile
asymptomatic diverticulum stones or complicated staghorn calculi in
the renal calyx.

1.3.2 Contraindications
Acute urinary obstruction without previous release.
Blood coagulation diseases and/or administration of anticoagulants.
1.3.3 Complications
Discharge of disintegrates and consecutive urinary obstruction, colics
and fever. Acute macro haematuria. Subcapsular haematoma have rarely
been observed.
1.3.4 Side effects
Effects on neighboring organs are only possible with incorrect focusing.
EPL--induced hypertonia hasn’t been proved so far.
Even in long--term studies renal insufficiencies have not occurred. So far
no effects on the cardiac or circulatory system have been observed.
1.3.5 Positioning examples

Z Kidney stones
' Positioning: Dorsal position

Z Middle and high ureterolith

' Positioning: Dorsal position

Z Deep ureterolith
' Positioning: Prone position slightly rotated to the side

GA--A 175 3
1.4 Combinations

. IMPORTANT!
In addition to this instruction manual also observe the manuals of the
products used in combination with the main product.
Electromagnetic interference or other influences between this product
and other products can cause failures or malfunctions.

. IMPORTANT!
Do not use any devices transmitting radio waves, such as mobile phones,
in the vicinity of this device as this can impair the performance. Particular
caution is necessary if strong sources of radiation are used in the vicinity,
such as HF surgical devices. In this case do not arrange the cables par-
allel to each other. In case of doubt, contact the manufacturer.

1.4.1 Device combinations

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 ex-
tension.

. IMPORTANT!
When selecting the system components make sure that they are in con-
formity with the requirements for the medical environment the system is
used in, in particular EN 60601--1--1 / IEC 601--1--1 K.
Persons combining products in such a way that they form a system are
responsible for compliance with the performance and the safety require-
ments, e.g. the requirements of EN 60601--1--1 / IEC 601--1--1. In case of
doubt ask the manufacturer(s) of the system components.
Do not touch electrical connections between the different components
(e.g. signal input and output connections for video signals, data ex-
change, control circuits etc.), and the patient at the same time.
KUnder normal conditions, for products marked UL -- when jointly connected via one (single)
power cable -- this system must have an earth leakage current value of no more than 300 mA.

4 GA--A 175
1.4.2 Product / component requirements
The requirements depend on whether the products / components are within or
outside the patient’s environment.

R = 1.5 m Patient environment

h = 2.5 m

Patient environment

Acc. to UL-- 2601: R = 1.83 m (6 feet) ; h = 2.29 m (71/2 feet)

Within Complies with:

patient EN 60601 / IEC 601
Product Component
environment UL--2601
Yes No CSA C22.2 No.601
Extracorporeal shock wave therapy device
F PIEZOLITH F
' Type B applied part

F Ultrasound device Ultrasound device 'Type BF applied part F

F X--ray device X--ray device 'Type B applied part F
F Treatment table Treatment table 'Type B applied part F
Video devices e.g. Video devices F
' Monitors or
' Recorders
' Printers or in accordance with the product--specific
F EN / IEC / UL / CSA standards in connection with:
a) additional protective earth connection
(contact the device manufacturer)
b) earth--free power supply
c) additional safety isolating transformerKK
KK R. Wolf video trolley with isolating transformer
F F
Extracorporeal shock wave therapy device
F PIEZOLITH F
' Type B applied part

F Ultrasound device Ultrasound device ' Type BF applied part F

F X--ray device X--ray device ' Type B applied part F
F Treatment table Treatment table ' Type B applied part F
Video devices e. g.
' Monitors in accordance with the product--specific
F ' Recorder EN / IEC / UL / CSA standards
' Printer
Uninterruptible
in accordance with the product--specific
F Power Supply
EN / IEC / UL / CSA standards
System (UPS)

GA--A 175 5
2 Illustration

2.1 Equipment trolley with X-- ray and ultrasound devices and treatment table

9 5

4 6

1.1
1

10.10 7

10

2.1.1 Legend
1 Therapy source 6 Remote control for shock wave triggering
1.1 Connection of therapy source 7 Ultrasound device
2 Stand for therapy source 9 X--ray C--arc
3 Display and control panel 10 Treatment table
4 Power on/off switch of device trolley 10.10 Extension for treatment table
5 Device trolley

6 GA--A 175
2.2 Device trolley with articulated arm and compact ultrasound device

8 3 7

11

1
6

2.2.1 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 device trolley 8 Articulated arm
5 Device trolley 11 Rotating support

GA--A 175 7
2.3 Connections of ”device trolley”

19

Service

14

15

13
18
17 16

2.3.1 Legend
13 Equipotential connector 17 Power input socket with fuse holder
14 BNC“Video Out“ socket (option) 18 Identification plate
15 Socket for laser 19 Service connector
16 Interface for ultrasound unit

2.4 ”Water treatment” controls

12.1 ”Empty system” button

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

12.2

8 GA--A 175
2.5 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

2.5.1 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

GA--A 175 9
2.6 ”Therapy source” control field

1.4
1.3
1.2
1.1

1.1 ”Retract ultrasound probe” button

1.1 1.2 ”Extend ultrasound probe” button
1.2 1.3 ”Reduce membrane pressure” button
1.3 1.4 ”Increase membrane pressure” button
1.4

2.7 ”Articulated arm” control field (option)

8.1
8.2
8.3 8.1 ”Enable articulated arm” button
8.4 8.2 ”Enable joint 1” button
8.3 ”Enable joint 2” button
8.4 ”Enable joint 3” button

10 GA--A 175
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 ex-
plosion.

. NOTE!
Check supply voltage is the same as the voltage specified on the identifi-
cation plate.

3.1 Parking brakes

3.1.1 Parking brakes of device trolley

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 trig-
gering in socket and tighten collar.
Z Connect the locating system(s) to the device trolley as shown in the
connection diagrams, chapter 8.
Z Connect the power supply/mains plug of the device trolley.
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 11
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 re-
cess 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 dam-
age.
' Clean and disinfect the transducer and coupling membrane.
. IMPORTANT!
Replace coupling membrane after 8 weeks at the latest.

1.5 1.6 1.5

1.6
M 1.7
1.6 B

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 con-
tact 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 en-
tire 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.

12 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.
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. 8 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 con-
tainer.
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 13
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 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 wa-
ter 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.

14 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 connection hose to therapy source for damage
' Check coupling membrane for damage and cleanliness.
' Check connection cable(s) of locating device(s) for damage.
' Check device and connection hose to therapy source for water
leakage.

4.2 Weekly checks

Z X--ray location.
' Check system using the X--ray target cross, see chapter 8.

4.3 Monthly checks

Z Check locating device(s), see chapter 8.
Z Check lettering for completeness and good legibility.
Z Check that monthly water treatment has been carried out.
Z Check transducer surface for damage.

4.4 Checking the transducer performance (energy)

. IMPORTANT!
The power output of the transducer can only be determined correctly if the water
is free of air bubbles and clean. Air bubbles and micro particles can cause the
power output to decrease. If necessary start a new water treatment routine and
deaerate the system.
Z Fully retract the ultrasound probe.
Z Fully retract the membrane using the ”reduce membrane pressure”
button.
Z Move the therapy source to horizontal position (see fig. 3.3.4).
Z Open locking collar of therapy source approx. one full turn, rotate the
therapy source to vertical position. Then retighten the locking collar.
' Releasing the locking collar approx. one turn releases the toothing to
allow the therapy source to be rotated. In this position the therapy
source can be rotated, but cannot fall down.

Z Place test cylinder (1.8) onto therapy source and fasten with Phillips
1.8 screws.
Z Lubricate seal on test cylinder with instrument oil.
Z Press the ”increase membrane pressure” button to couple the mem-
brane to the test cylinder, until the membrane makes a good seal
against the test cylinder.

GA--A 175 15
 Z Use the “extend ultrasound probe” button to extend the ultrasound
probe about halfway.
Z Fill tap water into the test cylinder (1.8) under ultrasound control

10cm
(approx. 300 ml) until the target cross is on the water surface.
Z Set device to shock wave intensity 15.
Z Trigger a shock wave.
' If the height of the water jet generated is more than 10 cm, the trans-
ducer has sufficient power.
' If the water jet is lower than 10 cm, contact our service department.
Z Uncouple and remove the test cylinder (1.8) from the membrane.
' Empty out the water before uncoupling the test cylinder.

Z Turn the therapy source back to horizontal and retighten the locking
collar (see fig. 3.3.4).
' Ensure that the toothing engages properly.

16 GA--A 175
5 Application

5.1 Operating principle

5.1.1 Piezoelectric principle

The scientific basis for the generation or 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 form in the focus.
In the PIEZOSON the piezo elements are arranged like a mosaic in a
spherical cup, and they are all activated simultaneously by a pulse gener-
ated. The spherical design with a large active surface and the large aper-
ture 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.

5.1.2 Locating system

Ultrasound location
The ultrasound locating system allows precise localization of the indica-
tions that can be visualized sonographically as well as permanent sono-
graphic 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--
arc via the stand allows X--ray location of the area to be treated. Location
is carried out in 2 fluoroscopy projections (AP (0_) and 30_projection).
A treatment table with electrically operated sliding table top allows verti-
cal and horizontal positioning of the patient relative to the therapy focus.

GA--A 175 17
5.2 Treatment

5.2.1 Basic instructions

CAUTION!
Careful if high pulse rates are used!
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, in-
testine). Use adequate entry window for therapy source, i.e. position the pa-
tient accordingly.
CAUTION!
Pressure pulses can cause undesirable heart reactions.
ECG monitoring for patients with pacemaker.
. 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.
Attach the table top extension to the corresponding end of the table.

18 GA--A 175
5.2.2 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.

5.2.3 Treatment with X--ray and ultrasound location

Preparation:
-- Move X--ray C--arc in AP (0_) position
-- Treatment table top to center position
-- Reduce membrane bulging (by reducing the membrane pressure).
Z Set the therapy source to the optimum therapy position for the indica-
tion.
' To adjust the therapy source release the locking mechanism by
pushing in the direction indicated by the arrow.
Z Position the patient on the treatment table in such a way that he is
stable relative to the therapy source.
Z Apply ultrasound gel evenly and free of air bubbles to the coupling
membrane and patient.
Z Couple the patient to the therapy source by pressing the ”increase
membrane pressure” button.
Z Perform AP fluoroscopy.
Z Position the patient horizontally by moving the table top.
' Repeat AP fluoroscopy and horizontal positioning until the therapy
field coincides with the target cross.
Z Turn the X--ray C--arc laterally to the 30_ position.
' Avoid collision with the patient or the treatment table.
' Perform 30_ fluoroscopy.
Z Position the patient on the table top in vertical direction.
' Repeat AP fluoroscopy 30_ and vertical positioning until the therapy
field coincides with the target cross.
Z Turn X--ray C--arc laterally to the AP position.
' Fluoroscopy check and horizontal readjustment if necessary.
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.
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 increase the membrane pressure excessively not to
move the patient.
' 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.

GA--A 175 19
 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.

5.2.4 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 fluoroscopy and reposi-
tion the treatment table if necessary.
Good ultrasound image = good transmission of the shock wave energy =
highly successful treatment!

20 GA--A 175
 . NOTE!
Rotate the ultrasound probe between 0° and 80° 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.

5.2.5 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.

GA--A 175 21
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 s (”E” is displayed on the ”membrane pressure”
display of the field.
' 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.

22 GA--A 175
6 Reprocessing and maintenance

6.1 Reprocessing of device

CAUTION!
If humidity penetrates into the device:
Danger of electrical shock.
Before reprocessing the device must be switched off and the power
supply disconnected.
The device may be cleaned with a soft cloth moistened with surface dis-
infectant, alcohol or spirit.
Follow the disinfectant manufacturer’s instructions.

. IMPORTANT!
Make sure that no humidity penetrates into the device. Do not use any
cleaning or scouring agents or solvents for the care of the device!

6.2 Reprocessing of coupling membrane

Z 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.

GA--A 175 23
6.3 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.

6.3.1 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.

6.3.2 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 60601--1 / IEC 601--1
Z Function check as described in the instruction manual.
Z Check of the attached locating device(s) in accordance with chapter 8.

24 GA--A 175
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 deaerated Status message
FFFF System is being emptied Status message
Let water cool down
A001 Water supply too hot ( > 40°C)
(wait approx. 30 min.)
A002 Float switch ”S2” in degassing tank defective 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
A010 System water too hot ( > 40°C) Contact service department
A020 Voltage of HV generator too high/too low Contact service department
A040 Error in HV 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 ”function” key
Check setting of laser monitoring on
laser reflection mark of X--ray C--arc,
A400 Shock wave triggering inhibited
if adjustment not possible contact
service department
Check suction filter, carry out new
A800 Suction filter clogged or insufficient water supply
water treatment cycle

7.1.2 Device malfunctions

Error Possible cause Remedy

Power switch not switched on Switch on the power supply
Power cable not connected Connect the power supply cable
Device has no function
No power supply Check in--house power supply
Fuse in device defective Change mains/power fuse
No targeting cross on ultrasound
No video connection Connect video cable
monitor
Connect video cable, check whether
No ultrasound image on monitor No video connection
video cables have been mixed up
Cable--linked remote control not con-
No shock wave Connect/replace remote control
nected/defective
Empty system and restart water treat-
ment
Insufficient membrane pressure Not enough water in the system or
Check device for water leakage --
(i.e. insufficient bulging) water circuit leaking
switch off device immediately and
contact the service department
Excessive membrane pressure Too much water in system or air in wa- Deaerate system or empty system
(i.e. excessive bulging) ter circuit and refill

GA--A 175 25
7.2 Technical data
Piezolith Piezolith Voltage Frequency Power Current Fuse
(without articulated (with articulated consumption rating
arm) arm) Vµ Hz VA A A

3000.001 3000.011 220 -- 240 50 / 60 1000 4 T 5,0 L

3000.021 3000.031 220 -- 240 50 / 60 1000 4 T 5,0 L
3000.002 3000.012 110 -- 120 50 / 60 1000 8 T 10,0 L
3000.022 ------ 110 -- 120 50 / 60 1000 8 T 10,0 L
3000.003 3000.013 100 50 / 60 1000 9 T 10,0 L
3000.023 ------ 100 50 / 60 1000 9 T 10,0 L

Electrical safety to EN 60601--1 / IEC 601--1

Electromagnetic compatibility (EMV) to EN 60601--1--2 / IEC 601--1--2
Medical devices directive 93/42/EEC Class II b
Protection class to EN 60601--1 / IEC 601--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 mixtures (Do not operate this device in areas where explosive
substances are present)
Weight of device trolley approx. 220 kg (approx. 483 lbs)
Dimensions of device trolley LxWxH 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

Shock wave source Piezoelectric self--focusing spherical cup

Aperture angle 80°
Energy flow density (positive) 0.1 to 1.8 mJ/mm2
Pressure range 17 to 132 MPa
Focal zone (medium energy):
Fx(--6dB) = Fy(--6dB) 2.5 mm
Fz(--6dB) 16.0 mm
Volume of focal zone 52.5 mm3
Pulse rate 0 to 2 Hz
Energy dosage 20 steps
Energy (--6 dB) 2.1 to 7.5 mJ
Position of targeting mark Center of --6dB zone
Depth of penetration 0 to 150 mm

26 GA--A 175
7.2.1 Locating systems*)
Inline ultrasound probe 3.5 MHz and 5.0 MHz
Ultrasound 0° to 180° rotation,
80 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 + 40°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 ma-
terial.

7.4 Transport of device

General notes:
. IMPORTANT!
For device trolleys with ultrasound device it is necessary to separate the ultra-
sound unit form the device trolley for any transport.
Transport all components separately.
Transport outside the hospital premises (e.g. by van or truck) is only allowed by
specially trained technical personnel.
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

Z Acceleration / deceleration± 3 G

Device trolley with articulated arm:

For transport/shipment the therapy source remains connected to the ar-
ticulated arm.

Device trolley with stand for therapy source:

For transport/shipment the therapy source is disconnected from the
stand.
Z Empty the system
1.1 Z Open the therapy source connection (1.1).
Z Pull the therapy off the connector.
Z Place the therapy source onto the device trolley and fasten.

GA--A 175 27
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 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 64 265.010 Testing device for targeting cross
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
' further accessories on request

28 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 29
8 Locating systems and attachments

8.1 Ultrasound location

8.1.1 Connection between ultrasound device and device trolley

8.3

8
8.4

8.5 GN
RD
8.7

BU 8.6

8.1.2 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.

30 GA--A 175
8.1.3 Connection of compact ultrasound unit on rotating support of device trolley

8.3 8.1
8

1
8.2

8.6

8.4

8.1.4 Legend
1 Therapy source 8.2 Probe plug
8 Ultrasound device 8.3 Power supply for ultrasound device
8.1 BNC--sockets ”Video In” , ”Video Out” 8.4 Ultrasound probe
8.6 Jumper cable (ultrasound operation without
Piezolith)

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

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

GA--A 175 31
8.1.5 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).
' Make sure that none of the clamps rests against the control foil.
' 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 until the membrane encloses 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.

“Freeze” “Run”

32 GA--A 175
8.2 Attaching the X--ray C--arc

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 Piezolith 3000
device trolley).

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

2.3

2 2.1

2.2

9.3
2.2

GA--A 175 33
8.2.2 Adjusting the X--ray C--arc

. NOTE!
The X--ray C--arc may only be adjusted by adequately trained technical
personnel.

9.2 9.1

8.2.3 Legend
9.1 Laser reflection mark 9.2 Laser beam

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

Z Set lateral tilt to 0°.

Z Set lateral rotation to 0_ and lock.
Z Set orbital movement 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.
' If the laser beam is not properly adjusted to the laser reflection mark
on the X--ray C--arc shock wave triggering is inhibited, the display
field reads the message “A400” and an alarm is sounded.

34 GA--A 175
8.2.4 Checking the X--ray targeting cross

. 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 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).
' Make sure that none of the clamps rests against the control foil/mem-
brane.
' Close the clamps clearly over dead center to ensure that they are
locket.
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.
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.
. 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.

GA--A 175 35
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

Z Extracorporeal Shock Waves in Orthopaedics

W. Siebert, M. Buch
1997 , Springer--Verlag , ISBN 3--540--63092--9

36 GA--A 175