Siemens Modularis Uro Plus Function Description

Page 1

MODULARIS Uro Plus

Function Description

LITHOSTAR MODULARIS

The reproduction, transmission or use of this document or its contents is not permitted without express written authority. Offenders will be liable for damages. All rights, including rights created by patent grant of registration of a utility model or design, are reserved.

English Print No.: SPL1-130.041.01.01.02 Doc. Gen. Date: 09.98

Replaces: n.a.

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Table of Contents 0 - 3

Seite

1 _______Introduction ___________________________________________________ 1 - 1

The first step. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 - 1

Components of a MODULARIS Uro Plus system . . . . . . . . . . . . . . . . . . . . 1 - 2

LITHOSTAR MODULARIS overview . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 3

Manual control with LCD display and selection keys . . . . . . . . . . . . . . . . . . 1 - 4

Menu displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 5

Selection Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 6

2 _______Function Overview _____________________________________________ 2 - 1

Using menus in the display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 1

System start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 1

The therapy menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 2

The selection menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 3

The service menu (English only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 4

Summary: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 6

3 _______Blockschaltbild ________________________________________________ 3 - 1

Main system functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1

4 _______System start-up ________________________________________________4 - 1

Internal tests (initialization) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1

External tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 - 2

Start-up after download and new control board D3 . . . . . . . . . . . . . . . . . . . 4 - 2

5 _______The shock wave system _________________________________________ 5 - 1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 - 1

The shock wave head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 2

The cooling and coupling circuit hydraulics . . . . . . . . . . . . . . . . . . . . . . . 5 - 3

The cooling circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 4

The coupling circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5

Electrical circuit diagram of the cooling and coupling circuit: . . . . . . . . . . . . . . 5 - 6

The charging and high voltage circuit . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 8

Interface between D3 and M12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 12

6 _______Patient table operation and interfaces _____________________________ 6 - 1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 - 1

7 _______SIREMOBIL ISO-C Interface ______________________________________ 7 - 1

8 _______The chip card system ___________________________________________ 8 - 1

Goldcard system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 1

Pay per use system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 1

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Introduction 1

The first step 1

This introduction provides an overview of the most important components of the MODULARIS Uro Plus system. It describes the function of the LITHOSTAR MODULARIS therapy unit and the MODULARIS Uro patient table.

The supplied operating instructions contain information on operating the system. This chapter contains only the most important information.

The objective of this document is to describe all system functions, from the beginning of the function (e.g. via the manual control) to the end (e.g. motor starts running). Understanding all of these functions will provide faster service (shorter repair times).

An important issue which has emerged from the many courses on older LITHOSTAR systems, is the fact that it is essential to understand how the system should operate under normal conditions. This way, if the system should malfunction, it will be easier to recognize "what is different", and to come up with an appropriate strategy for troubleshooting.

1 - 1

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1 - 2 Introduction

Components of a MODULARIS Uro Plus system 1

LITHOSTAR MODULARIS

SIREMOBIL Iso-C

Fig. 1

Imaging module:

A: SIREMOBIL ISO-C basic unit with X-ray generator B: Sirecon 23-3 HDR image intensifier C: X-ray tube with integrated collimator D: Trolley with monitor and Memoskop digital memory

Table mo dule:

E: MODULARIS Uro patient table

ESWL module:

F: LITHOSTAR MODULARIS G: Shock wave head with shock wave system C H: Manual control

Options: (not shown)

SIRECUST ECG triggering SONOLINE Prima ultrasound device (general monitoring) e.g. Multispot 2000 multi-format camera / laser camera connection)

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Introduction 1 - 3

LITHOSTAR MODULARIS overview 1

LITHOSTAR MODULARIS

1. Shock wave head

Report Menu

___0

P Energy

0,1

2. Supply line

3. Support arm

4. Basic unit with

- control unit with chip card reader

- shock wave generator

- cooling unit with hydraulic control

- power supply

- control cable to SIREMOBIL Iso-C

- control cable to MODULARIS Uro table

- control cable to SIRECUST ECG unit

5. Manual control with LCD display

6. Focus measurement device (focus phantom)

7. C-arm angulation motor (+/- 20 degrees)

8. Coupling and locking unit to the SIREMOBIL ISO-C

Options: (not shown)

- SIRECUST ECG triggering

- ultrasound general monitoring

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1 - 4 Introduction

Manual control with LCD display and selection keys 1

Multifunctional use

depending on the display

Move table upward

Move table left

Move table towards head-end or foot-end (dep. on position)

Move table down

Report Menu

___0

0,1

Energy

Multifunctional use

Patient position*

LCD display

Multifunctional use

depending on

the display

Shock wave release

Move table towards head/foot end

Litho basic position

Move table right

C-arm angulation -20°

The manual control comprises the LCD display with buttons for controlling the shock wave system, and buttons for controlling the table movement or C-arm for localization. There are additional buttons for radiation release and image storage.

* Orientation: At the beginning of the treatment, the user determines the "patient position" in the display. The shock wave head is the point of reference. The travel direction of the table then depends on the kidney to be treated. Headward or footward can be reversed, depending on the table orientation.

C-arm angulation +20° C -arm 0° position

Image memory

Release fluoroscopy

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Introduction 1 - 5

Menu displays 1

After system startup

Select

“Report”

Report Menu

Shock wave

count

Display

“Coupling Pressure”

Select

“Coupling Pressure”

Coupling pressure: 5 levels are selectable. Gel position if none are selected.

Energy levels: selectable from 0.1 to 8.0. After level 4, a warning appears

___0

0,1

Coupling pressure is continuously adjustable after switching to the selection menu.

"kidney application exceeded!"

Energy

Select “Menu”

Display "maximum

energy level or pulse/min for kidney application

exceeded"

Display

shock wave

energy

Select

“Energy Level”

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1 - 6 Introduction

Selection menu 1

Example: select “position”

Back Back

Selection

> Position

Pulse/min ECG-Trig. P-control

Back Back

Selection

...

Rinsing

> Brightness

 

The selection menu is used to select and set the parameters displayed above.

- patient position - shock wave release frequency - ECG triggering

- P regulation - rinse coupling circuit -brightness set (LCD display)

Refer to the next chapter for additional service-specific details on the menus.

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Function Overview 2

Using menus in the display 2

2 - 1

Chipcard not ok, return by means of Cardchange or. I chipcard is acceppted

Chipcard-

Status

Therapydata

These Menues are only accessable for Service Technic.

Error table

Pulse counter

Fig. 1

After Turn on

Chipmenu

Chipmenu f.

Goldcard

Startup

Chipcard

okay

Therapymenu

Selection

Service-Menu

System dataDate

Once the system successfully starts up, the therapy menu is displayed. If this is a pay-per-use system, the user can access the chip menu in order to check the current chip data. For Goldcard systems, the chip menu is only accessible in service mode. (Service mode: switching S2 on board D3.)

System start-up 2

SIEMENS

MODULARIS

S3 + S4

Fig. 2

If the system uses the Siemens configuration, the above will be displayed once the LITHOSTAR MODULARIS is switched on. The keys on the manual control unit are

S5 + S6

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2 - 2 Function Overview

blocked and cannot be activated until the start-up process is completed. After an automatic water circulation cycle in the coupling circuit (length of time approx. 18 sec), the chip card interface is checked. If the chip card is in order, the therapy menu will appear. If the chip card is empty, invalid, or defective, the user must take appropriate action (refer to chip card interface).

The therapy menu 2

Report Menu

___0

0,1

Fig. 3

Energy

Functions:

Í Increase or decrease the energy level (refer to shock wave system). Í Increase or decrease the coupling pressure (refer to shock wave system).

Report: Press this key to display the therapy data. Pressing the Reset key for more than one second resets the therapy data, and returns to the therapy menu.

Reset Back

Average value

E E Pulse

Ø max

3,8 4,7 3712

Only with a pay per use system

remaining units: 211 196

Fig. 4

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Function Overview 2 - 3

e 1

e 2

The selection menu 2

There are two display pages for this menu.

Goldcard Pay-per-use or Service on

Back Back

Selection

Position

Pulse/min ECG-Trig . P-control

Back Back

Selection

> Brightness

Fig. 5

Functions:

...

Rinsing

Back Back

Selection

Position Pulse/min > ECG-Trig. P-control

Back OK

Auswahl

Chipcard >Rinsing Brightness Service

Pag

| 0

Pag

Í Pulse/min: 60/90120 shock waves per minute selectable (USA 2Hz fixed). Í ECG - triggering: select on/off (option). Í P-regulation: in steps or continuously selectable (refer to shock wave system).

The chip card menu depends on the chip card being used. .

Goldcard

Return Eject

Chipcard

Return Eject

Type: LITHOCARD Gold INIT-Counter: 1

Fig. 6

LITHOCARD 250 000 Remaining units: 122 234

Pay per use

Chipcard

Refer also to chip card interface.

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2 - 4 Function Overview

The service menu (English only)

Back Next

Service

> Set clock Cooling unit Coupling circuit System data

Fig. 7

Back returns to the "selection menu".

Back Back

Service

Set clock

⇓

> Cooling unit Coupling circuit System data

fill empty

Functions:

Í Set clock: set the time and date. Refer to control board D3 Í Cooling unit and coupling circuit: fill/empty the cooling circuit and the coupling cir-

cuit; use arrow keys to activate. Refer to shock wave system.

Í System data: also refer to control board D3, shock wave system, C-arm angula-

tion

Back Next

System data

Error table Language

> Pulse counter

C-arm 0-Pos. SW: VA00A / VA001

Fig. 8

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Function Overview 2 - 5

Í Error log

Back Help

Error table

E14: xxxxxxxxxxxxxxxx E56: xxxxxxxxxxxxxxxx > E35: xxxxxxxxxxxxxxxx E23: xxxxxxxxxxxxxxxx E86: xxxxxxxxxxxxxxxx

Fig. 9

The error log lists the errors in the order of their occurrence, with the most recent at the top of the list. Press Help for more detailed information. The last 100 errors are listed.

Back Reset

⇓

Pulse counter

system unit 1 543 846 shockwave head 534 357

⇓

Back Back

E35: Temperature of shock head too

high, please wait!

E14: xxxxxxxxxxxxxxxx E56: xxxxxxxxxxxxxxxx > E35: xxxxxxxxxxxxxxxx E23: xxxxxxxxxxxxxxxx E86: xxxxxxxxxxxxxxxx

Yes OK? No

Pulse counter

system unit 1 543 846 shockwave head 534 357

> capacitor 1 543 846

spark gap 488 634

Fig. 10

Check the shock wave counter: displays the shock waves released with respect to the individual components of the shock wave system.

Reset procedure: after pressing the reset key, a reconfirmation query appears (yes/no).

The total shock wave counter (system unit) cannot be reset.

> capacitor 0

spark gap 488 634

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2 - 6 Function Overview

Summary: 2

This chapter describes the most important system operations for service with respect to the therapy, selection, and service menu, and categorizes the various main functions.

Í increase or decrease the energy level (refer to shock wave system) Í increase or decrease the coupling pressure (refer to shock wave system). Í Pulse/min: 60/90120 shock waves per minute selectable (USA 2Hz fixed). Í ECG - triggering: select on/off. Í P-regulation: in levels or continuously selectable (refer to shock wave system). Í Set clock : set the time and date (refer to control board D3) Í Cooling unit and coupling circuit: filling or emptying the cooling circuit and the

coupling circuit, activated via the arrow keys (refer to shock wave system).

The main functions of the system will now be illustrated and discussed using a block diagram.

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Block diagram 3

3 - 1

M15

Keyboard LCD-display

M17

Chipcard modul

power supply

D3/PC104

µP-control

M12

Shockwave generator

M14

Cooling and coupling control

Shockwave head

C-arm angulation motor

MODULARIS Uro

Examination table

M18

ECG-unit (Option)

SIRECUST

LITHOSTAR MODULARIS

Fig. 1 Block diagram of the LITHOSTAR MODULARIS

SIREMOBIL ISO-C

Main system functions 3

• The operating and menu functions (already discussed in chapter 2 ) are extremely

important, since they affect almost all of the system functions. Location is M15 and controller D3/PC104. The PC104 piggy-back board realizes a PC-based system.

• The main function of the system is to generate a shock wave starting with the release

key, and up to the point where the shock wave enters the patient’s body. Components involved are: M15, controller D3/PC104, the shock wave generator with high voltage generation M12, the shock wave head M3, the cooling and coupling system M14, and M18 for ECG-triggered shock waves with the SIRECUST.

• Stone localization in the urological tract is achieved via motorized movement of the C-

arm M2 and the MODULARIS Uro table. The imaging system is the SIREMOBIL ISO-C (FL or DR, etc.).

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3 - 2 Block diagram

• The chip card module enables "pay per use" operation; in other words, it contains a

certain number of shock waves which the user can release. A goldcard system is also available. The chip card module is covered, so that the card is not accessible from the outside.

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System Start-up 4

4 - 1

internal

Tests

external

Tests

Power on

Initialisation of

control board

Activating pumps

for 2 seconds

Checking of

control switches

Coupling circuit

rinsing (18 sec)

HW-version test

RAM and power

supply test

Software check

System startup

SIEMENS

LITHOSTAR MODULARIS

start up

display

D3/PC104

µP

Stand by mode

Bericht Menü

___0

0,1

Therapy menue

Internal tests (initialization) 4

After switching on the software initializes the internal register, counters, I/O ports, interface circuits, etc. The system also checks the validity and functionality of the hardware and software versions, the power supply, the memory circuits, the user software, and much more. It also initializes the manual control.If an error occurs during this phase, an error message will appear on the 7 segment display on the control board. Immediately after switching on the system, the manual control displays "system start-up".

Energie

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4 - 2 System Start-up

External tests 4

During this phase of the start-up process, the manual control displays "start-up display". To tear off (start up) the cooling and coupling circuit pumps, they are switched on for approximately 2 seconds. Then the program activates the water circulation cycle in the coupling circuit, which takes approximately 18 seconds. This procedure removes any air bubbles which may be present in the coupling bellows.

The "therapy menu" is displayed, indicating that the system start-up is complete. If there are no more activities, the system is in normal mode.

In normal mode, the processor system checks functions such as: power supply, correct pump function, water temperature and water pressure, etc. Any errors will be displayed on the manual control display.

Start-up after download and new control board D3 4

The service switch on D3 is set to "on". After approximately 20-30 seconds, "0" is displayed on the 7-segment display. The switch-on message is "E00".

The following error messages are normal:

E53,E80,E81,E82,E83,E86 internal data invalid, initialized at the first start-up.

These messages will no longer appear once another reset is performed, and the system will start normally, as described above.

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The shock wave system 5

Overview 5

5 - 1

M15

Keyboard

M11/D1

power supply

Fig. 1 Circuit diagram of the shock wave system

M13/D3/PC104

µP control board

M12

Shockwave generator

Temperature / Pressure

M14

Cooling and coupling circuit

The shock wave system comprises the following components:

• the shock wave components M12 and M3.

• the cooling circuit M14.

• the coupling circuit M14.

Shockwave head

Cooling

Coupling

• the controller D3/PC104

• the release switch on manual control M15.

The objective is to generate a shock wave in shock wave head M3, which then enters the patient’s body. The stone must be positioned in the focus of the shock wave head, and is fragmented as a result of the shock wave pressure. Shock wave generation is based on the electrodynamic principle. The discharge current of a 1.2 µF capacitor flowing in a primary coil causes the metal membrane in the secondary coil to deflect in the axial direction. This creates an acoustic wave which is focused via a synthetic lens. The shock wave passes through a water-filled coupling bellows and then enters the patient’s body. The water pressure and flow rate determine optimal coupling. The water pressure in the coupling circuit is constantly monitored.

Generating shock waves creates heat which must be cooled via a cooling circuit so that the coupling water does not overheat and burn the patient’s skin. Furthermore, the static and dynamic water pressure in the cooling circuit presses the metal membrane (secondary coil) onto the primary coil, in order to provide optimized energy transfer. The shock wave intensity is varied (pressure at the focus) in the primary coil of the shock wave head.

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5 - 2 The shock wave system

Fokus

120.3**

Aperturwinkel

55.2° **

Ø164.5*

Ø125.2*

(The shock wave head 5

Wasseranschluß

Kühlkreis Water connector Cooling circuit

Wasseranschluß

Gewicht Stoßwellenkopf C incl. Wasserfüllung: 5,0 kg

Focus

Kühlkreis Water connector Cooling circuit

Koppelbalg Coupling bellows

Ankoppelbereich

Linse

Plastic Lense

Membrane (secundary coil)

Vorlaufstrecke

Stoßwellen quelle

shock wave source

ceramic body with primary coil

Hochspannungsanschluß

hightension connector

Fig. 2 Layout of the shock wave head and coupling bellows (does not correspond to the original MODULARIS shock wave

head)

coupling circuit water support

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The shock wave system 5 - 3

The cooling and coupling circuit hydraulics 5

Fig. 2 shows the principle construction of the shock wave head. The following provides

additional information on the shock wave head with respect to the cooling and coupling circuit.

Shockwave

head(SWK)

Coupling

circuit

blue

max

S50

red

green

yellow

Normal duty cycle

Filling duty cycle

S51

min

Cooling

circuit

S52

min. water level

Fig. 3 Circuit diagram of the cooling and coupling circuit

1) Druckschalter/Pressure switch (p min) 6 Druckausgleichsbehälter / Pressure balance container

2 Druckschalter /Pressure switch(p max) 7 Wasserfilter / Water filter

3a Schlauchpumpe / Peristaltic pump

(Cooling circuit)

3b Schlauchpumpe / Peristaltic pump

(Coupling circuit)

8 Kugelhahnventil / Ball valve (emp-

tying cooling circuit) manual

9 Magnetventil / Solenoid valve (Fill-

ing cooling circuit)

4 Schwimmerschalter / Floating switch 10 Wasserbehälter / Water supply

5 Belüftungsventil / Degassing valve

11 Entlüftungsventil / Degassing valve

(Coupling bellows) n.a. 12 Kühlgerät / Cooling unit

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5 - 4 The shock wave system

The cooling circuit 5

Objective:

• to cool the shock wave source; the water temperature in the coupling system may not

exceed 41°C under any circumstances.

• to generate static water pressure in the cooling circuit, which presses the membrane

(secondary coil) against the primary coil (embedded in the ceramic body), in order to provide optimal energy transfer. Note: The shock wave head is designed so that the water flow causes dynamic pressure to build up, therefore supply and return hoses must not be interchanged.

For temperature monitoring, two temperature sensors enclosed in a metal housing are pressed against the ceramic body of the shock wave head by a compression spring. Controller board D3 monitors the signal forwarded via an A/D converter in the µP microprocessor-controlled system. The cooling circuit pump switches on: "with the start of shock wave release, or if the temperature is too high".

Temperature cooling pump

Temp<5°C release blocked, error message "Sensor defective"

5°C<Temp<40°C cooling pump on: velocity 60%

40°C<Temp<60°C cooling pump on: velocity 70%

60°C<Temp<80°C cooling pump on: velocity 80%

Temp>80°C cooling pump on: velocity 80%, shock wave release

blocked, error "shock wave head overheated

Function: (refer to Fig.3/5-3)

Normal mode: the peristaltic pump 3a forces the warmed water coming from the shock

wave head (SWK) through the cooling unit 12 and then back through the shock wave head, etc. The pressure balance container 6 equalizes the pressure variations in the cooling circuit. Pressure switches 1 and 2 monitor the acceptable pressure values. Degassing valve 11 removes small air bubbles from the cooling circuit. If the maximum pressure (780mbar) is exceeded for more than 3 s, the µP sends an error message. If the minimum pressure is not reached, the 3-way valve 9 will switch to fill for 1s. In other words, water flows from water supply 10, through water filter 7, into the cooling circuit. After a pause of 2s, the µP checks the min switch. If the switch is not activated yet, the filling process repeats, otherwise the filling process is completed. If the minimum pressure is still not reached after 20 fill processes, the µP emits an error message: "leak in system".

Filling and emptying: "possible in service mode only" Ball valve 8 must be opened manually. In the service menu, select either fill cooling circuit or empty cooling circuit. 3-way valve 9 switches over. Activate the pump via the manual control. During the filling process, pump water into the cooling circuit until there are no more air bubbles visible in the water return. The pump stops if the pressure switch reaches max 2. If the pressure switch responds while the circuit is emptying, the pump will continue to run.

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The shock wave system 5 - 5

The coupling circuit 5

Objective:

The shock wave passes into the patient’s body via the flexible front part of the shock wave head; the coupling bellows. It is extremely important that contact with the patient’s skin surface is not interrupted, and that there are no air bubbles (due to total reflection).

Coupling can be done manually or automatically in five pressure levels, and is selected via the manual control. Automatic means that a pressure sensor monitors the working range of the selected pressure level and regulates the water fill in the coupling bellows.

3200mV

2800mV

2400mV

1700mV

950mV

750mV Gelposition

pressure sensor (mV)

750mV Gelposition

pressure sensor (mV)

pressure steps

Fig. 4 Pressure levels selectable either continuously or in 5 levels. (pressure sensor output values in mV)

pressure manual

Function: (refer to Fig.3/5-3)

Normal mode: If automatic mode is selected, the peristaltic pump 3b pumps water into

the coupling bellows until the selected pressure level is reached (fill level of the shock wave head). In manual mode, the user selects the fill level of the coupling bellows by activating the appropriate keys on the manual control. Pressing the key longer than 3 seconds changes the pump velocity from v1 to v2. When the water supply is pumped out, the electronics switch off the pump and an error message is transmitted. Degassing valve 5 is closed. Note: "rinse the coupling circuit" can be selected via the manual control. This removes air bubbles from the coupling bellows.

Filling and emptying: "only in service mode" During filling, peristaltic pump 3b pumps via water filter 7. Degassing valve 5 is opened. The filling process is completed when no more air bubbles are visible in the return. A small hose is located in the coupling bellows, which is attached to the coupling bellows and suctions out air bubbles. Emptying follows the same principle; the motor is reversed and water is suctioned out.

Siemens AG SPL1-130.041.01 Page 5 of 12 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 26

5 - 6 The shock wave system

Electrical circuit diagram of the cooling and coupling circuit: 5

X2.3

1,6AT

230V

X2.5

M11

M14

X55 3

X52.1

X51.2

circuit

Cooling

pump

X53.1

pump

circuit

Coupling

filling

circuit

Cooling

Coupling

ventilation

Water

F> min

S52

container

filling level

0,78 bar

P max

S50

Cooling

switches

pressure

circuit

P min

0,18 bar

S51

X56.1

Cooling and coupling circuit

X7.

MK-

MK+

M13

J51

Motor

Driver

3,15AT

+24V

Fig. 5 Circuit diagram of the shock wave system

MA-

MA+

Motor

Driver

3,15AT

+24V

J52

+Y1

-Y1

3,15AT

+24V

+Y2

-Y2

X3.

P max

P min

Control board

MODULARIS Uro Plus SPL1-130.041.01 Page 6 of 12 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Page 27

The shock wave system 5 - 7

M1, M2: The two 24V pump motors are controlled via pulse-width modulation. That is,

motor output can be controlled between 0% and 100%. The temperature, control, and starting current are monitored.---> refer to error messages.

Startup: Via the motor drive, the µP switches on pumps M1 and M2 at 100% for 2 seconds. After that, M2 runs for 18 seconds at 70% in order to remove air bubbles from the coupling circuit (only in normal mode).This time is omitted in service mode.

Fuses F2, F3, F4: are monitored by the µP system.

Displays: MK+, MK-, MA+, MA- clockwise or counter-clockwise.

Measurement points: n.a.

Siemens AG SPL1-130.041.01 Page 7 of 12 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 28

5 - 8 The shock wave system

The charging and high voltage circuit 5

230 V~

power

supply

evaluation

peak value

High tension charger

Idisch_max

KVact

KVact/2

CH0

CH1

10 Bit

control

error

CH2

ADC

max

I charge

KVnom

CH3

CH4

monitoring

CH5

Trigger-

U>Umax

230V~ 19 kV

elektronik

head

shockwave

Trigger

disch.

Cap/2

Cap

act

generator

shock wave

capacitor

spark gap

230 V~

cooling unit

1,2µF

valve control

temp.sensor 1

temp.sensor 2

water level switch

motor control

STW

(HW)

230 V~

release

shock wave

Trigger

M13/D3

µP control

M15

keyboard

CLK

Shockwave

counter

Reset

energy steps

Din

Dout

HVon

HVset

Fig. 6 Circuit diagram: high tension charger and discharge circuit

MODULARIS Uro Plus SPL1-130.041.01 Page 8 of 12 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Page 29

The shock wave system 5 - 9

gap

Function: (refer to Fig.6/5-8)

Prior to releasing a shock wave

the following parameters must be set via the manual con-

trol:

energy level release frequency ECG triggering on/off

For "pay-per-use" systems, a valid chip card must be available.

The shock wave release key on manual control M15 activates relay K1 on controller board D3. There, the switch signal is coupled with the hard-wired software-controlled process.

This provides added protection against unintentional shock wave release in cases of malfunction.

Objective: charging the 1.2µF capacitor in the shock wave generator with the energy level corresponding to the KV value, and then discharging it via the primary coil of the shock wave head. The HVon (high voltage on) and the frequency coded HVset (nominal KV) begin the charging process (charge start). The 1.2 µF capacitor is charged to this nominal value. Control D3 constantly monitors the KV nominal voltage via the A/C converter. The charging process is complete when the KV nominal value is reached.

act

primary coil

secundary coil

charge start

Spark gap

1,2 µF Capacitor

= KV

act

nom

charge end > tri

Focus

Shock wave head

time

er to spark

Fig. 7 Shock head and charging principle

Siemens AG SPL1-130.041.01 Page 9 of 12 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 30

5 - 10 The shock wave system

Control board D3 now begins the discharge process, and generates a trigger signal to ignite the spark gap. Its function is similar to an electrical switch. During the abovedescribed charging and discharging process, control board D3 constantly monitors such important parameters as:

• the total capacitor voltage KVact

• half of the capacitor voltage KVact/2

• the charging current I charge

• the discharge current I discharge

Using these values, the µP immediately recognizes a short in the capacitor, a loss in capacitance or an error in igniting the spark gap.

Special note:

After 500 shock waves, the µP automatically stops the release, in order to remind the user to check the focus. Continuation is only possible by opening and closing the release switch.

Shock wave release is interrupted when exiting the main menu.

The energy level value ranges from 0.1 to 8.0. The maximum required energy for treatment of the kidneys is 4.0; therefore a warning appears on the display for levels above this value. The auto-repeat function is not available between 4.0 and 4.2.

In free-running mode , the shock wave frequency can be set to 60, 90, and 120 pulse/min.

In the kidney area, the frequency can be set only up to 90 P/min. If 120 P/min is set, it will be automatically reduced (fixed to 120 P/min in the USA).

In service mode, the release rate is limited to 15 shock waves/minute, and a chip card is not required.

The ECG triggered shock wave release depends on the patient’s QRS signal. The shock wave is released when the heart muscle enter the diastolic phase. The release rate must not exceed the set free-running rate.

If a QRS signal is no longer detected for more than 2 seconds, the system will emit an error message.

MODULARIS Uro Plus SPL1-130.041.01 Page 10 of 12 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Page 31

The shock wave system 5 - 11

Stoßwellenkopf /

Shock wave head

and

M12

1,2µF Spark Gap

charging control

for shock wave head

High tension power supply

X2.1

X2.2

M13

8AT

230V

Fig. 8 Circuit diagram of the charging / energy unit

M11

FOC

(fibre optic cables)

out

set

Trigger

CLK

about temperature and pressure

see service program for more information

Siemens AG SPL1-130.041.01 Page 11 of 12 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 32

5 - 12 The shock wave system

Interface between D3 and M12 5

The control signals between D3 and M12 are galvanically separated by routing them via fiber optic cables. "Active high" indicates that the transmission diode (LED) for the receiver is active.> LED on

Explanation (with respect to M12):

Input

HV on: switch-on signal for the charging current circuit; high voltage on; LED

HV set nominal voltage frequency encoded; (1KHz = 1 KV) max 19.3 KV

Trigger trigger pulse to the ignition transformer; LED on

CLK synchronization of A/C converter and µP system

CS chip select; start A/C conversion; LED on.

D in data input A/C converter

Output:

D out data output A/C converter.

General:

For the charging/energy unit, only the spark gap can be replaced; all other malfunctions require a complete replacement.

MODULARIS Uro Plus SPL1-130.041.01 Page 12 of 12 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Page 33

Table operation and interface 6

Overview 6

6 - 1

Middle part

for Shockwave

application

Head end side

Base frame

Foot pedal

Insert

Tilting control

Hand control

Lifting column

Foot end side

Radiolucent

middle part

Foot switch

Base frame extension

Fig. 1 Overview of table operation

The MODULARIS Uro patient table is used for the following medical applications:

• urological diagnostics and endourology

• extracorporeal shock wave lithotripsy

• prostate therapy

Four movement axes are available for positioning the patient:

• patient table toward the head-end, foot-end

• transverse patient movement

• upward and downward movement

• table tilt

Siemens AG SPL1-130.041.01 Page 1 of 4 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 34

6 - 2 Table operation and interface

Manual control

table in litho basic position

lithotripsy mode on/off

on: lithotripsy mode selected flashing: table not in

litho basic position

Fig. 2 Overview of patient table operation

Lithotripsy mode on/off: the system limits the table’s range of motion, due to the fact that in the working position, the shock wave head could collide with the tabletop. Millimeter step mode is also possible in this operating mode .

Litho basic position: After selecting the lithotripsy mode, pressing this key causes the tabletop to move into the basic position. The display light flashes until the basic position is reached. The same key is also on the LITHOSTAR MODULARIS manual control. As long as the LED is flashing, the basic position is not reached yet.

Prostate therapy mode: all table movements are blocked in this operating mode.

prostate therapy mode on/off

on: prostate therapy mode selected

MODULARIS Uro Plus SPL1-130.041.01 Page 2 of 4 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Page 35

Table operation and interface 6 - 3

Interface between LITHOSTAR and patient table

mains

power supply

X27 X1

Fig. 3 Block diagram of table control

Hand control

Foot switch

LITHOSTAR

interface

Table control

Drive AM1/S1

vertical movem.

Drive AM2/S2

longitudinal

movement

Drive AM3/S3

table transverse

Drive AM4/S4

table tilt

The patient table movement is controlled with the LITHOSTAR MODULARIS manual control via the connection X27-X1 from D3 to D1. The signals for the table movement for each axis (one motor) are encoded via two logical lines.

Line 1 Line Movement

00stop

10forward

01backward

11stop

Tab. 1

In addition, there is also a toggle line, which must change its logical status every 40 ms if the table is activated. If there is no change within 100 ms, movement will stop. Each motor is encapsulated and water resistant. There is a limit switch for each end stop. In case of error, the entire drive must be replaced. In addition, micro switches S1, S2, S3, and S4 are available for the litho basic position. A, B, C are equal-access plug-in positions on the table operating panel. They can be replaced for troubleshooting. 1, 2, 3 and 4 are the outputs for the motor. 5 and 6 are the limit switch inputs for the basic position.

Siemens AG SPL1-130.041.01 Page 3 of 4 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 36

6 - 4 Table operation and interface

M15 Keyboard

M13

Fig. 4 Circuit diagram of table control with M15

serial

data

trans-

mission

Circuit diagram:

Measurement points:none

EPLD

X27

MODULARIS

Uro(Table)

Control

Note: For more

details see table

wiring diagram.

In case of function errors, first check the various controls (M15, tableside control or footswitch) to determine whether it is an operating or motor function error.

MODULARIS Uro Plus SPL1-130.041.01 Page 4 of 4 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Page 37

SIREMOBIL ISO-C Interface 7

Circuit diagram

7 - 1

D30

SW release

K6 K13

V84 GN

V82 GN

N11 SIREMOBIL ISO-C

X11.2

xray on

X34.2

+15V

X11.3

X34.3

X11.4

X34.4

M13

V83 GN

X11.1

ATB

X34.6

+24V

K11

Angulationsbremse/

X11.5

X34.8

+24V

Angulation brake

mb2

X11.6

X34.9

1 KOhm

X38.4

X38.3

X38.2

X36.2

X36.3

MC -MC

+24V

X5.6

X5.7

serial data

transmission

+20°

0°

-20°

M15

Fig. 1 Block diagram: ISO-C interface

Siemens AG SPL1-130.041.01 Page 1 of 2 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 38

7 - 2 SIREMOBIL ISO-C Interface

Docking mechanism: Prior to docking the LITHOSTAR MODULARIS to the SIREMOBIL

ISO-C, two micro switches were activated, which are not included in the block diagram (refer to ISO-C block diagram G5464 p.10/switch S4 and S.11/switch S3). The switches block all brakes on the ISO-C. Moving the lifiting column is only possible after opening the docking bracket for decoupling.

Start-up: if the "X-ray on" key is pressed during start-up, a warning and error message will be transmitted. Shock wave release will be blocked until the key is released.

Functions:

Radiation release: The key on manual control M15 is marked with a fluoroscopy symbol, but basically all available modes are usable. Software release signal K13 and hand signal K6 (dual protection) are activated via relay K2 on board D30. K8 deactivates the hand

switch on the ISO-C.

Save fluoro image: K3 responds, as well as K11 on D30, whose contact activates the ATB (Auf Tastendruck Bild) function on control board D1 on the ISO-C.

C-arm angulation (+20/-20°): pressing the key releases the angulation brakes (via relay K4), and activates the angulation motor in M2. The µP on D3 receives an actual value

position message from the 1 Kohm potentiometer. For purposes of testing, the angulation motor can also be checked in the uncoupled position. After switch-on, the brakes remain released until there has been motorized movement.

C-arm adjustment: adjustments are only possible in service mode. The movement velocity is reduced. When the adjustment mode is de-selected, the current actual value of the potentiometer is saved and used as the new mean position, as long as it is within the permissible tolerance range (short beep). Otherwise the default value will be used, and an error message will be transmitted (C-arm out of adjustment).

Default value 5V. Tolerance +/- 1.0 V.

MODULARIS Uro Plus SPL1-130.041.01 Page 2 of 2 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Page 39

The chip card system 8

Goldcard system 8

When a goldcard system is started for the first time, a counter is activated and a code is set so that the card cannot be used in other systems. The card is checked during start-up and at specific intervals during operation. The user cannot see the Goldcard, i.e., no counter status and no messages with respect to the card.

Pay per use system 8

The system can be started without the chip card. The card is checked during start-up or after insertion. Counter status is displayed in the main menu. The chip card can be ejected via the menu. During therapy, the counter status is decremented. When the chip card counter reaches less than 5000, a message is displayed, and the counter status flashes. If the user inserts a new card, all remaining units from the old card will be transferred to the new one.

The counter status is updated before the card is ejected.

Service

8 - 1

Follow the specified procedure when replacing the D3 (PC 104) board (refer to Service Instructions).

Chip card trace (available with future software versions)

A log of the last 50 chip cards in case:

...the chip card has an invalid status due to a defect, and the remaining units need to be calculated.

...the customer questions the units logged.

The following data is required, and can be called up with the service PC:

number of logged units, serial number of the card, number of units the last time it was ejected, date it was last ejected, and shot count for the system.

The chip card interface

Serial interface RS 232. COM 1 of the PC 104 board is used and connected via flat cable to control board D3. During system start-up and operation, a function test is performed. In case of error, the entire reading unit must be replaced.

Siemens AG SPL1-130.041.01 Page 1 of 2 MODULARIS Uro Plus Medical Engineering Rev. 01 09.98 TD SD 24

Page 40

8 - 2 The chip card system

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MODULARIS Uro Plus SPL1-130.041.01 Page 2 of 2 Siemens AG Rev. 01 09.98 TD SD 24 Medical Engineering

Siemens Modularis Uro Plus Function Description

Specifications and Main Features

Frequently Asked Questions

User Manual

Introduction 1

The first step 1

Components of a MODULARIS Uro Plus system 1

LITHOSTAR MODULARIS overview 1

Manual control with LCD display and selection keys 1

Menu displays 1

Selection menu 1

Function Overview 2

Using menus in the display 2

System start-up 2

The therapy menu 2

The selection menu 2

The service menu (English only)

Summary: 2

Block diagram 3

Main system functions 3

System Start-up 4

Internal tests (initialization) 4

External tests 4

Start-up after download and new control board D3 4

The shock wave system 5

Overview 5

(The shock wave head 5

The cooling and coupling circuit hydraulics 5

The cooling circuit 5

The coupling circuit 5

Electrical circuit diagram of the cooling and coupling circuit: 5

The charging and high voltage circuit 5

Interface between D3 and M12 5

Table operation and interface 6

Overview 6

SIREMOBIL ISO-C Interface 7

The chip card system 8

Goldcard system 8

Pay per use system 8