Stephanie

Pediatric Ventilator

Technical Manual
Vorwort

F. Stephan GmbH
- Medizintechnik -
Kirchstrasse 19

56412 Gackenbach

Technische Änderungen vorbehalten.

Stand: März 2006

Version: V2.2

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Table of contents

Table of contents
Table of contents ........................................................................................3
1 Basic principles..................................................................................7
1.1 Structure...................................................................................7
1.1.1 Control unit module ....................................................8
1.1.2 Electronic module .......................................................8
1.1.3 PC module .................................................................12
1.1.4 Electric power supply module...................................13
1.1.5 Battery module ..........................................................14
1.1.6 Pneumatics module ...................................................15
1.1.7 Patient component .....................................................16
1.1.8 Test module ...............................................................16
1.1.9 Valve actuation..........................................................17
1.2 Functional operation ..............................................................18
1.2.1 Gas supply .................................................................18
1.2.2 Electric power supply................................................20
1.2.2.1 General description ..........................................20
1.2.2.2 Transformer......................................................20
1.2.2.3 Generating supply voltages ..............................20
1.2.2.4 Charging circuit, switch-over to battery
operation...........................................................21
1.2.2.5 Heating control.................................................22
1.2.2.6 Control .............................................................22
1.2.2.7 Power failure ....................................................24
1.2.2.8 Safety controls..................................................24
1.2.3 Generation of the ventilation pattern.........................24
1.2.4 Heating and humidifying ventilatory gases...............25
1.2.5 Monitoring.................................................................25
1.2.6 Control.......................................................................26
2 Mechanical structure........................................................................27
2.1 General...................................................................................27
2.2 Assembly and disassembly ....................................................28
3 Pneumatics .......................................................................................31
3.1 General...................................................................................31

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Table of contents

3.2 Pneumatics module................................................................31

3.2.1 Pneumatics plans .......................................................32
3.2.1.1 Signal designation ............................................34
3.2.1.2 Operating function ...........................................34
3.2.2 Assembly and disassembly........................................36
3.3 Test block ..............................................................................38
3.3.1 General ......................................................................38
3.3.2 Assembly and disassembly........................................40
3.4 Patient component .................................................................40
3.4.1 General ......................................................................40
3.4.2 Functional operation..................................................41
3.4.3 Assembly and disassembly........................................43
3.5 Patient Hose System ..............................................................44
3.6 Measurement of pressure and volume flow...........................44
3.7 Aerosol System......................................................................45
3.8 Ventilatory-gas humidifying..................................................46
4 Electronic .........................................................................................46
4.1 General...................................................................................46
4.2 Control unit............................................................................47
4.2.1 Therapy control module ............................................47
4.2.2 Monitor control module.............................................48
4.3 PC module .............................................................................48
4.3.1 PC circuit boards .......................................................48
4.3.2 VGA card ..................................................................48
4.3.3 PC interface ...............................................................48
4.3.3.1 Signal designations ..........................................49
4.3.3.2 Operational functioning ...................................50
4.4 Electronics block ...................................................................51
4.4.1 Microcomputer ..........................................................51
4.4.1.1 Signal designations ..........................................51
4.4.1.2 Operational functioning ...................................53
4.4.2 Monitoring (watchdog) .............................................54
4.4.2.1 Signal designations ..........................................54
4.4.2.2 Functional operation ........................................56
4.4.3 Sensor module ...........................................................58
4.4.3.1 Signal designations ..........................................59

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Table of contents

4.4.3.2 Operational functioning ...................................60

4.4.4 Power amplifier .........................................................62
4.4.4.1 Signal designations ..........................................62
4.4.4.2 Operational function ........................................63
4.5 Power supply .........................................................................66
4.5.1 Power supply module ................................................66
4.5.1.1 Signal designations ..........................................67
4.5.1.2 Operational function ........................................68
4.5.2 Battery module ..........................................................69
4.6 Valve actuation ......................................................................70
5 Safety concept..................................................................................71
5.1 General...................................................................................71
5.2 Safety design of the ventilators..............................................71
5.3 Mandatory parameters to be monitored and tested................72
5.4 Adjustment and treatment of limit valves..............................72
5.4.1 General ......................................................................72
5.4.2 Pressure .....................................................................72
5.4.3 Respiratory minute volume .......................................73
5.4.4 Insp. O2 concentration: .............................................73
5.4.5 Temperature ..............................................................74
5.5 Alarm Response.....................................................................74
5.5.1 General ......................................................................74
5.5.2 Alarm suppression.....................................................75
5.5.3 Status graphic of the alarm system............................75
5.5.4 Alarm table................................................................77
6 Failure mode analysis ......................................................................81
6.1 Control unit............................................................................81
7 List of figures...................................................................................83
8 List of tables.....................................................................................85
9 Appendix: Circuit diagramms..........................................................87
10 Notices .............................................................................................89

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1.1 Structure

1 Basic principles
1.1 Structure

Using the modular structure, this section will briefly deal the individual
functional modules and their interaction.. Detailed descriptions and
explanations of the individual functionalities of the modules are given in
the sections that follow.As shown in the Appendix (modular display,
Stephanie), theStephanie consists of several components or modules :

Control unit module,

Electronic module,
PC module,
Pneumatics module,
Electric power supply module,
Patient component,
Actuator for the ventilator valve.

Fig. 1: Block Diagram

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1 Basic principles

1.1.1 Control unit module

Fig. 2: Control Unit Module

The control unit module is positioned on the front side of the Stephanie
unit. It is lectern-shaped and is comprised of all the adjustment and
settings elements in the form of switches, potentiometers and keys (push-
buttons). Furthermore, these are grouped for the various therapy settings
and for monitoring. The control unit module, ie. the control elements,
transmits the information to the central controller in the electronic block
module.

On a 9.4" TFT flat screen, all monitoring results are displayed in

alphanumerical form of all ventilation parameters being monitored; time
functions of ventilatory pressure, volume flow and volume are displayed
in graphical form. The screen display is directly controlled by the PC
module.

1.1.2 Electronic module

The electronic module consists of the circuit boards, sensor circuit

boards, central processing unit, monitoring (watchdog) as well as the
power amplifier..

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1.1 Structure

Fig. 3: Electronic module

The sensor circuit board has two pressure sensors for regulating and
Sensor circuit board monitoring ventilatory pressure, one differential pressure sensor that,
together with the pneumotachograph head, carries out volume
measurement, and three amplifiers for evaluating thermistor signals for
ventilatory-gas humidifying.

Fig. 4: Sensor circuit board, top view

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1 Basic principles

Fig. 5: Sensor circuit board, front view

Microcomputer The Microcomputer (MC) is the essential core of the unit controlling all
therapy functionalities provided by the Stephanie unit. It processes the
information given via the control module received from the adjustment
and settings elements and transfers these on to the serial port interface RS
232 to the PC module.

Fig. 6: Microcomputer

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1.1 Structure

The microcomputer generates the digital control algorithms for pressure

regulation and volume regulation. For doing this, it receives information
from the pressure and volume flow sensors of the sensor ciruit board as
actual values and compares these to the pre-set or target values of the
ventilatory pattern generator.

As a result of the control algorithm, a corrective signal is generated,

which – amplified by the power amplifier – activates the valve actuation.
This changes the pistion position of the inspiration/expiration valve until
the target and pre-set values precisely correspond to each other.

The microcomputer also takes on the regulation of respiratory-gas

humidifying. Temperature signals provided by the sensor circuit board
serve as actual values, and the target value is generated by the
temperature control algorithm. Depending on regulating deviations,
power transistors located in the electric power module switch on or off
the heating element in the humidifier and/or hose.

Power amplifier The power amplifier amplifies the analogue signal generated by the
microcomputer which, in turn, activates the valve actuation. By means of
feedback of the path signal of a positional transducer coupled with the
valve actuation, a path control loop is created, which greatly improves the
dynamic of the valve actuation.

Fig. 7: Power amplifier

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1 Basic principles

Circuit board Circuit board monitoring / supervision (watchdog) serves functionality

monitoring / supervision monitoring, and oversees the microcomputer as well as the PC module. It
contains the so-called watchdogs, that are rhythmically activated by both
units, and if failure occurs, switches the entire unit over to an emergency
mode, in which the safety valve is activated and the patient can at least
spontaneously breathe ambient air.

If the alarm limit is exceeded, it activates an audible alarm.In addition,

this circuit board contains the power transistors for activation of the
magnetic valve (solenoid) of the pneumatics module.

Fig. 8: Circuit board monitoring / supervision

1.1.3 PC module

The PC Module houses a complete personal computer, 486 DX 66.

It fulfills two tasks:
Monitoring of the microcomputer,
Monitoring of ventilatory parameters and pre-set alarm limits.

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1.1 Structure

Fig. 9: PC module

The sensor signals generated by the sensor circuit board are evaluated
independent of the microcomputer and the monitoring parameters are
alphanumerically displayed in a dedicated field on the monitor display
screen.. It coordinates the visual alarm with the alarm statuses, that are
recognized either by the PC module itself or by the microcomputer. In
addition, the PC module generates the screen display of ventilatory
pressure, volume and volume flow as a function of time.

1.1.4 Electric power supply module

The electric power supply module supplies the electric current necessary
for the operation of the ventilation unit. It contains all monitoring
switching devices as well as power transistors for switching on/off the
heating elements of the respiratory-gas humidifier and ventilation hoses.

Fig. 10: Electric power supply module

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1 Basic principles

1.1.5 Battery module

Fig. 11: Battery module

The battery module contains a 24 V lead storage battery, which, in the

event of power failure, ensures continued operation of the ventilation unit
for a short period of time.

Fig. 12: Battery module

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1.1 Structure

1.1.6 Pneumatics module

The pneumatics module contains all the pneumatic components that are
necessary for processing the respiratory gas, including respiratory gas
mixer, valves, pressure regulator, etc. It is pneumatically connected to the
patient component via a plug coupling.

Fig. 13: Pneumatic module

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1 Basic principles

1.1.7 Patient component

The patient component contains all the pneumatic components of the

patient circuit (loop), which must be sterilised. In particular, these are: the
inspiration/expiration valve housed in a ventilation valve unit, safety
valve as well as an injector.

Fig. 14: Patient component

1.1.8 Test module

The test module contains an electromagnet via which the safety valve of
the patient component is activated; it also contains a lever for switching
the ventilator over to manual operation, as well as for calibration for
Compliance and Resistance, for testing the entire system during the unit
system selftest.

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1.1 Structure

Fig. 15: Test module

1.1.9 Valve actuation

The valve actuation is carried out by an electrodynamic converter. It is

activated by the power amplifier and is coupled with the ventilatory valve
unit by means of magnetic force.

Fig. 16: Valve actuation

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1 Basic principles

1.2 Functional operation

Fig. 17: "Operational diagram, entire system"

1.2.1 Gas supply

The gas supplies, compressed air (CA) and oxygen (O2) are fed in the
pneumatics module via magnetic valves (solenoids) to the oxygen/air
mixer and can be used either for mechanical or manual ventilation. The
current (actual) oxygen concentration is monitored by the oxygen sensor
and evaluated by the PC module.

Pressure sensors, together with the central processor, monitor supply

pressures for CA and O2.

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1.2 Functional operation

Technical modifications The F. Stephan GmbH has carried out advanced technical modifications
on pediatric-ventilator STEPHANIE, affecting the handling/operation of
the ventilator.

The following points must be observed:

The position of the medical gas connections for Oxygen and Compressed
Caution Air as well as the position of the Oxygen-sensor have been changed. The
gas connection ports are coded with “NIST”-threads. The gas connections
are equipped with safety valves, releasing pressures higher 6,5 bar to
atmosphere

Fig. 18: “NIST-threads“

Because of the electronic mixing unit the function “Manual Ventilation”

is available only when STEPHANIE is switched on. During breakdown or
power outrage, the function “Manual Ventilation”is not possible.
Caution

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1 Basic principles

1.2.2 Electric power supply

Technical documentation power pack/mains

power

1.2.2.1 General description

The power pack module of the STEPHANIE provides the equipment

with the necessary supply voltage 5 V, +/- 12 V and 24 V, and regulates
the charging of the internal battery as well as the switch-over from mains
power supply to battery operation. Furthermore, it generates monitoring
signals including re-set signals for the controller of the STEPHANIE.

All voltages are generated with switching regulators from a unstabilized

intermediate circuit voltage in the range of 22 – 28 V, that is taken either
from rectified secondary voltage of a transformer, or from the internal
battery of the equipment.

1.2.2.2 Transformer

A safety transformer from the company Marek is used to generate the

secondary voltage. The transformer can be operated on 230 V or 110 V
respectively, and provides secondary 22 V at 7 A. Compliance with the
requirements of EN 60601 for equipment with a protective rating of 1 has
been tested. In addition, the transformer is equipped with an over-heating
safety device.

The rectified secondary voltage serves as intermediate circuit voltage for

generating other supply voltages as well as directly providing power
supply for the heating system.

1.2.2.3 Generating supply voltages

The supply voltages necessary for the STEPHANIE (5V / 4A and +/-
12/2A) are taken from the intermediate circuit voltages with switching
regulators (see circuit diagram, sheet 1). Types LM2679 from National
Semiconductor (NSC) were used.

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1.2 Functional operation

Voltages of 5V and 12V are generated by the downwards adjustment

control, the 12 voltage by means of inversion of the +12V voltage. The
load on the 12V regulator does not increase in this case, because the 12V
supply is essentially only alternately loaded. The design of the switching
and the selection of additional components is in accordance with the
circuit recommendations of NSC. Cooling of the regulator is effected by
means of a copper surface on the printed circuit board. The maximal
measured temperature in immediate proximity of the 5V regulator
(having the most load) amounted to approximately 70ºC. (maximal
permissible temperature, 115ºC).

The thermal load on the other components is lower. Additionally, all

voltages are filtered through a LC module. Because of a special
sensitivity of the power amplifier to interference of the –12V supply
(leads to noise at the patient component), a significantly greater
inductivity (4mH) was used than that for the other voltages. The 5V and
12V regulators can be switched off via a shut-down input (STB2) (see
"Control").

1.2.2.4 Charging circuit, switch-over to battery operation

For maintaining voltage supply in the event of mains power failure,

the STEPHANIE is equipped with two series connected batteries
(each 12V/1.3 ampere hour). A voltage of approximately 27.6V is
necessary to charge the batteries which slightly difffers according to
temperature.

As the intermediate circuit voltage from the mains can lie below as well
as above this value, a regulator is used for battery charging that operates
both upwards and downwards (component at U5, Circuit Diagram,
sheet 1). The circuit is similar to an application of the company Linear
Technologies.

The maximal output current of the charging circuit is limited to a value

of approximately 0.3A via R16 and Q3. Battery charging can also be
switched on or off via a shut-down signal (AK-SHDN).
The switch-over between mains power supply and battery operation is
effected by a relay (K1, Circuit Diagram, sheet 1). By means of this relay,
the equipment can also be switched off in the event of error or
malfunctioning, by using the Re-set key S1. This forces the relay into the
mains position. If the mains power is also switched off, the
STEPHANIE software shuts the equipment down.

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1 Basic principles

1.2.2.5 Heating control

The circuit breaker for the two heating systems of the STEPHANIE are
also built in to the power pack module. They are Profets from the
company, Infineon: (U6, U7, Circuit Diagram, sheet 1). They are Mosfets
with protective and monitoring functions.

The components are short-circuit proof and equipped with thermal

overload protection. They switch the intermediate circuit voltage over to
heating resistors.

1.2.2.6 Control

Monitoring of the power pack and the generation of the control signals
for the controller is via the microprocessor (Motorola 68HC11, ICI,
Circuit Diagram, sheet 2).

Because of practicality, the processor is used as the use of assembled

discrete components is somewhat costly. The possibility of programming
proves to be useful as well, because the temporal control of the signals
has proven to be critical. The program is written in Assembler and filed
(stored) in the program memory of the processor. Generated and
evaluated are the following signals:

Outputs: Two power OK signals (POK1/2) These signals are set when all supply
voltages lie within the default limits.These are:

5V :4.8 – 5.2V
12V :11 – 13V
-12V :-11 – -13V
Intermediate circuit voltage : 18- 37V

The voltages are led through voltage multipliers to the A/D converter
inputs of the processor and the processor controls the compliance with the
limit values. The POK signals are logical HIGH (5V) for correct
functioning, and LOW (0V) for malfunctioning. POK1 is used as RESET
for the controller of the STEPHANIE. A correct start of the controller
was only achieved, when this signal was set with a delay of 200 ms.

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1.2 Functional operation

Two signals for battery check (BATOK, BATLOW) These signals

serve as watchdog for the battery. BATOK becomes HIGH, when the
battery voltage is at least 22V. BATLOW becomes LOW, when the
voltage fall below 18V.

A mains power failure signal (PFAIL) This output becomes LOW,

when the secondary voltage of the transformer falls below 18V.

Inputs: Mains switch-off/shut-down (SHDN) This signal causes the

STEPHANIE to shut down the power supply unit. The mains/battery
switch-over relay is put into battery operation mode, in this mode
battery charging is switched off. SHDN is used to briefly switch over
to battery operation during the test routine after starting up the
equipment to test the flawless functioning of the battery.

Standby operation (STB) In standby mode, all functions of the

equipment, apart from battery charging, are deactivated. Input
corresponds to a software shutdown. The switch-over mains/battery is
put into mains position, the voltage regulator for supply voltages are
switched off (the internal control signal STB2 is set to LOW). Battery
charging mode remains on. Evaluation of standby signal proved to be
problematic, because the STEPHANIE switching circuit generated no
clearly defined signal. During normal operational mode, there is a
voltage of approximately 4V, that drifts to smaller values after switch-
over to standby, without a clear switch-over. Therefore, the evaluation
takes place also with a A/D converter. If the voltage exceeds 3V,
normal operation is switched off. Switch-over to standby takes place
when the voltage falls below 2V.

Inputs for heating control (HZ1ON, HZ2ON, HZDIS). HIGH signals

at HZ1ON, HZ2ON switch on the respective heating, under the
condition that HZDIS is not activated and the unit is being operated
on mains power. In battery operation, the heating systems are
switched off to increase operation time.

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1 Basic principles

1.2.2.7 Power failure

If the processor detects a fall in secondary voltage below 18V, there is an

automatic switch-over to battery-powered operation via the switching of
relay K1. Here, a relay can be used, because of the large supportive
condensator at the input (C22, 10000uf), the intermediate circuit voltage
only falls slowly. As soon as mains power has been restored, switch-over
to mains power takes place and battery charging is switched on once
again.

1.2.2.8 Safety controls

For protection against transient interruptions, all voltage outputs are

equipped with voltage surge diodes. Secondary and battery voltages are
secured with 47V protection diodes, the +/-12V voltages with 15V diodes
and the 5V with 6.8V diodes. Problems with reversed polarity are kept
below approximately 0.7V.

1.2.3 Generation of the ventilation pattern

The central control regulates the pressure, volume flow regulating circuits
for generating the ventilation pattern desired. It receives from the control
elements of the control unit the desired ventilation parameters and from
these generates, via the controller program, all the analogue and digital
control signals necessary for carrying out the tasks involved in the
therapy.

For this purpose, actual values of ventilation pressure and volume flow
are collected by the analogue-digital converter (ADUs) of the central
control (microcomputer) and are via control algorithms converted into
an analgoue control signal for the power amplifier. This regulates, via the
valve actuation, the control valve in the patient loop.Mandatory
monitoring of the ventilation pressure is carried out by the PC module
via a second pressure sensor.

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1.2 Functional operation

To ensure a high quality of performance of monitoring the pressure and

volume flow regulator circuits, a high valve actuation dynamic is of
absolute necessity. For this, there is the path control circuit, in which the
position of the control valve is tracked by means of an optical positional
transducer, and is fed back to the input of the power amplifier.

For reasons of safety, the positional transducer is a dual system and the
position signal is fed to the central control by System 2. By comparing
the pre-set (target) valve (output DAC1 of the central control) with the
actual position, a complex monitoring of the ADU – DAU path of the
central control is obtained including power amplifier, actuator and control
valve.

1.2.4 Heating and humidifying ventilatory gases

Heating and humidifying ventilatory gases are also coordinated by the

central control. A temperature sensor at the exit side of the humidifying
chamber and one at the exit side of the inspiration hose heating element
provide the actual temperature valve to the central control. The central
control generates, according to a pre-set temperature value and according
to a temperature control algorithm, the control signal, from which the
power transistors for both heating circuits are switched. A third
temperature sensor serves as monitor. For safety reasons, it is also
evaluated by the PC module.

1.2.5 Monitoring

Together with the display screen, the PC module serves and supports:

monitoring of the proper functioning of the central control, and

monitoring of the ventilation pattern
alphanumerical display of measured ventilation parameters as well as
alarm statuses.

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1 Basic principles

Fig. 19: Monitoring

The PC is coupled with the central control via a serial interface port and
receives the setting parameters of the control unit, including those of the
alarm statuses of the central control, and also transmits its own alarm
statuses as well as the monitoring parameters to the central control..

1.2.6 Control

The central control and PC module take on, independent of one another,
the monitoring of safety-relevant parameters and statuses in line with
current standards.Both units classify alarm statuses via independent alarm
systems, into alarms of high and medium priority and then feed these data
to the circuit board. This triggers an audible alarm and, should the
situation or error be endangering, switches off the emergency air valve
for reasons of patient safety.

Monitoring the central control and PC module themselves is carried out

by watchdogs, that, in the event of malfunctioning or failure, also lead to
shut-down followed by appropriate corrective action.The audible warning
system has a backup system so that in the event of failure of the first
audible system, the second system will trigger the alarm.

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2.1 General

2 Mechanical structure

2.1 General

Fig. 20: Housing

The Stephanie consists of the housing, in which a rack is inserted.

Positioned on this rack are the PC module, pneumatics module and
electric power supply module arranged as plug-ins. The circuit boards of
the electronic module are individually inserted in the lower tier of the
rack. The latter are covered at the rear side of the unit by the battery
module.

Fig. 21: Rack

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2 Mechanical structure

The control unit serves as the front cover of the housing unit.
Con0nections between the individual electronic units are in the form of
wiring backplane, ie circuit boards, and connection cables. A specific of
the Stephanie is the drive of the oxygen/air mixer positioned in the
pneumatics module. As the setting element belonging to it is positioned
on the control unit, a toothed-belt drive serves as a mechnical coupling to
both components.

All functional units of the patient circuit such as valve actuation, patient
component and the test module are mounted to a robust mounting plate
on the right-hand sidewall of the Stephanie. The valve actuation is
positioned inside the patient component and the test module on the
exterior of the housing.

Below the lowest tier insert, there are two blowers mounted for providing
cooling of the inside of the unit. RPMs of the blowers and therewith the
cooling performance, are regulated by thermistors that are positioned at
temperature-critical points in the unit.

2.2 Assembly and disassembly

The housing consists of an L-shaped basic body, formed by the right

sidewall and the base plate, the left sidewall and the housing cover.
Normally, it need not be completely disassembled for servicing. If it is
necessary to gain access to the backplane or to the control unit, only the
cover need be removed.

Fig. 22: Remove cover

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2.2 Assembly and disassembly

To remove the cover, loosen the two long hexagon socket screws (3mm)
that are accessible through the large bores on the rear wall of the cover.
The cover is carefully pulled forward approximately 3 mm, so that the
tongues located on the underside of the cover can be freed from the pins
mounted to the housing. Following this, the cover can be lifted from the
housing. Make sure that the control unit does not tip forward. After
loosening M4 countersunk screws on the lowerside of the control unit,
the control unit is carefully pulled forwards and hung in the hing pins of
the unit. Now the control unit can be swung forward and all components
of the backplane as well as the control unit are accessible.

Assembly is carried out in reverse order. Only make sure that while
inserting the control unit, the potentiometer axis of the FiO2- drive must
be inserted into the correct sleeve.

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3.1 General

3 Pneumatics

3.1 General

The pneumatic system of the Stephanie consists of three main

componnents, the pneumatics module, patient component together with
the patient loop, and the test block.

3.2 Pneumatics module

Fig. 23: Pneumatics module, top view

The pneumatics module is an insert that contains all the pneumatic

elements that do not directly belong to the patient loop. In addition,
sensors are located in the pneumatics module. These sensors measure the
pressures of the supply gases, the inspiratory oxygen concentration as
well as the inner temperature of the module.

Structurally, the pneumatics module is a hermetically closed unit within

the ventilation unit.Should it, in the event of malfunctioning or failure,
result in an unacceptably high oxygen concentration within the module,
the high oxygen concentration cannot escape to other parts of the unit.
Such concentrations can escape through a number of wide slits in the
front plate of the pneumatics module.

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3 Pneumatics

Technical modifications The F. Stephan GmbH has carried out advanced technical modifications
on Pediatric-ventilator STEPHANIE, affecting the handling/operation of
the ventilator. (See chapter 1.2.1)

Because of the electronic mixing unit the function “Manual Ventilation”

is available only when STEPHANIE is switched on. During breakdown or
power outrage, the function “Manual Ventilation”is not possible.
Caution

3.2.1 Pneumatics plans

Fig. 24: Pneumatics plan (new version)

32 GA-123-0306V2.2-HAO-DE © F. Stephan GmbH

 ®

3.2 Pneumatics module

O2-Zelle M5

R cksclagventil OV10/DN8
V2
O,3
NC
NW 0.8
Drucksensor
V1 M5 2.8 bar V3
Air
Duese NC
R1/8 NW 0.8
Injektor M5
Air
V1
NC V4 NC
O2-Kalb.21%
NW 2
D1 NW 0.8

R1/8 O2

Pilot Druck V6 NC O,5

V2-V7 M5 NW 0.8
Aerosol M5

P=min ca.2.8bar

Mischer Mischer Flow = 1-40 l/min D2

V7
R1/8 R1/8 NW 0.8
NO
Handbeatmung M5
ca 10 l max.

Mischerausgang
R1/8 V5 NC
Druckregler 150 mbar R1/8
NW 2
V1 V2 V3 V4 V5 V6 Ventile stromlos geschlossen
V7 Ventil stromlos ge”ffnet
24 Volt 2 WATT
Druckbereich 2.5 - 6bar

Maást ab
Wer k s t of f / Hal bz eug
Hal bf er t i gt ei l
Roht ei l
Dat um Name ( Benennung)
ng)
Bear b. 6.10.00 Mainusch Pneumatic-Block
Gepr .
Nor m Stephanie
A NA E S T H E S I E ( Ar t i kel nummer ) Bl at t
S t e ph an P Ž DI A T R I E
A T E MT H E R A P I E
1 035 65 053
Bl .
Zus t . Žnder ung Dat um Name ( Ur spr . : ( Er s . f : )

Fig. 25: Pneumatics plan (old version)

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 33

3 Pneumatics

3.2.1.1 Signal designation

Operating voltages
SV_P12LV
SV_P12
SV_N12
Control signals
/ÜW_VPL Actuation of compressed-air valve (-12V)
/ÜW_VO2 Actuation of oxygen valve (-12V)
/ÜW_VINJ1 Actuation of injector valve 1(-12V)
/ÜW_VINJ2 Actuation of injector valve 2 (-12V)
/ÜW_VSubst Actuation of substitution valve (-12V)
/ÜW_VAerosol Actuation of aerosol valve (-12V)
Outlet signals
PM_UP120 Pressure sensor 120 mbar admission pressure
PM_UPl Pressure sensor, compressed-air admission
pressure
PM_UO2 Pressure sensor, oxygen admission pressure
PM_UFiO2 FiO2 sensor signal
PM_UTemp Temperature-sensor signal
Tab. 1: Signal destination

3.2.1.2 Operating function

The electronics integrated in the pneumatics module is made up of

sensors for measuring:

Oxygen concentration (FiO2),

Temperature inside the pneumatics module.
Supply pressure of compressed air,
Supply pressure of oxygen,
Admission pressure of ventilatory-gas mixture.

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3.2 Pneumatics module

All sensors apart from the oxygen sensor and their respective electronic
components are fitted to a circuit board. This circuit board is located
inside the pneumatics module in such a way, that a SUB-D plug
connector mounted to the rear side of the circuit board – hermetically
sealed – protrudes through the rear side of the pneumatics module. This
allows all electrical connections to be effected outside the pneumatics
module.

Fig. 26: All electrical connections to be effected…

Fig. 27: …outside the pneumatics module.

Oxygen partial pressure and thus oxygen concentration of the ventilatory-

gas mixture (after pressure regulator PR2) is converted by means of a
sensor KE25 (Unitronic) into an electric current that is amplified by the
amplifier U1 by a factor of 100 and held as signal PM_UFiO2 at the
outlet.

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 35

3 Pneumatics

The thermistor amplifier U2 is, together with thermistor R4, located on

the circuit board, a temperature voltage converter, and serves to
determine the inner temperature of the pneumatics module. Its output
signal PM_UTemp is evaluated by the central control. If the limit value
for the inner temperature of 50°C is exceeded an audible and a visual
alarm are triggered.

The pressure sensors for the admission pressure of the compressed air and
oxygen as well as the ventilatory-gas mixture are sensors with integrated
electronic, that directly provide the pressures of the assigned currents
PM_UPl, PM_UO2 and PM_UP120 at the outlet.

3.2.2 Assembly and disassembly

Removing the pneumatics module is effected in the following way:

1. Remove the supply hoses for compressed air and oxygen,

2. Position Hand/Ventilator, switch in Ventilator position,
3. Remove patient component,
4. Loosen pneumatic connection sleeve for patient component from the
right sidewall with hexagon socket wrench,
5. Open housing (see Pt. 2.2),
6. Remove toothed belt from toothed gear of the pneumatics module,
7. Remove SUB-D plug from the rear side of the pneumatics module,
8. Remove plug-coupling hose for nebulizer outlet from the inner right
sidewall,
9. Loosen the 4 screws on the front plate of the pneumatics module,
10. Pull out the pneumatics module.

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3.2 Pneumatics module

After loosening the screws and removing the cover, all components of the
module are now accessible.

Fig. 28: Pneumatic module

If only an inspection of the pneumatics module is to be carried out during

ooperation, the entire module need not be pulled out. It is only necessary
to remove the cover and to unscrew the upper module rails. After that, the
module cover can be opened as described above and the inner parts of the
pneumatic module are accessible.

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 37

3 Pneumatics

3.3 Test block

3.3.1 General

The so-called test block is mounted on the right sidewall of the basuc
unit. On the underside of the test block there is a screw-on bottle attached
filled with copper wool that serves as test Compliance. Via a pneumatic
resistance, it is connected to a connecting union (pipe) found on the rear
side of the test block. When the unit is not in operation or when running
the test program, the Y-piece of the ventilation hose is attached to this
connecting union.

Fig. 29: Test block, side view

Using the lever „Hand / Resp“, the unit can be switched over between
manual ventilation and ventilator operation. When the lever is in „Resp“
position, the ventilatory-gas mixture reaches the patient via the patient
component and the patient is mechanically ventilated. When the lever is
in the „Hand“ position, a tappet rod found in the pneumatics module
switches the unit over to manual ventilation. The ventilatory-gas mixture
is then provided at the connecting union below this lever and is led via a
hose to the manual ventilation bag. By using a screwdriver, the volume
flow for manual ventilation can be adjusted at the flow control valve.
This becomes visible when the lever is in the „Hand“ position.
Otherwise, it is covered by the lever.

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3.3 Test block

Fig. 30: Test block

1 Resp. lever for changeover to 2 Airflow rotary knob for manual

manual ventilation ventilation
3 Connection for manual
ventilation bag

When the lever is in the „Hand“ position, an electric contact is

simultaneously activated. Once activated the optical message "Attention
Manual Ventilation!" appears on the display screen.!“. In addition, the
emergency air valve as well as the injectors in the patient component are
switched off, whereby the patient can, generally, spontaneously breathe
ambient air.

Furthermore, the test block is equipped with an electric lifting magnet.

When activated, this closes, via a valve reed, the emergency air valve of
the patient component. (see. Patient component).

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 39

3 Pneumatics

3.3.2 Assembly and disassembly

The test block can be disassembled by loosening the hexagon socket

screws that are accessible at the side. After loosening the screws the test
block can be pulled off and the plug connection between the test block
and housing removed.

When re-assemblying, make sure that the tappet rod of the switch-over
"Hand/Ventilator" is centrally positioned on the tappet of the pneumatics
module.When replacing the electromagnet (solenoid), loosen the ring nut
between the patient component and the test block by using box or socket
spanner (wrench).

3.4 Patient component

3.4.1 General

Fig. 31: Patient component

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3.4 Patient component

The patient component is the actual connection (interface) between the

ventilator and the patient. It is attached on the sidewall of the basic unit in
front of the test block and locked in using a lever.

All pneumatic components of the patient loop are found in the patient
component; all these components must undergo sterilisation.

Fig. 32: Patient component

3.4.2 Functional operation

The ventilatory-gas mixture in the pneumatics module is pressurized to
approximately 110 mbar. It is led via a plug coupling, hermetically sealed
with o-rings, through the inlet of the patient component. The ventilatory
gas flows through the humidifying bottle filled with water, and then,
warmed and humidified, proceeds to the inspiration valve Vin and from
there is led via the inspiration outlet through the inspiration hose to the
Y-piece. The exhaled ventilatory gas flows through the expiration hose
and the expiration inlet to the expiration valve Vex and from there into
the ambient air via an injector.

Valves V1, V2, V3, V4 and V5 form the safety system within the patient
component and prevent, in the event of mechanical malfunctioning, any
endangering of the patient.

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 41

3 Pneumatics

By means of the excess pressure safety valve V1, the maximum possible
excess pressure at the inspiration outlet is mechanically limited. Here, the
opening pressure of valve V1 is adjustable in the range from 20 mbar to
approximately 80 mbar by using the toggle found on the front side of the
patient component.

The negative pressure safety valve V4 limits the maxium negative

pressure at the expiration inlet to approximately -10 mbar. It is pre-set by
the manufacturer and the opening pressure cannot be adjusted by the user.

The inspiration outlet and the expiration inlet are connected to the
emergency air valve via the check valves V2 and V3. During normal
operation of the ventilator, a lifting magnet (solenoid) in the test block
presses a valve head against the outlet of V5. This disables V2 and V3. In
the event that the unit detects an operational disturbance, the solenoid is
deactivated, the valve head opens the emergency air valve, and the patient
can inhale via valve V2 and exhale via valve V3, whereby the effective
dead space is less than 2.5 ml.

The inspiration valve Vin and the expiration valve Vex structurally form
a single unit, in that the inspiration valve opens when the expiration valve
closes, and vice versa. This valve unit is actuated by a valve actuation
that is found in the basic unit. The mechanical connection between
actuation and valve unit is by means of magnetic forces. Here, a small
magnetic clamp is attached to the actuation and the side of the valve
pistion facing the actuation is equipped with a thin soft iron plate. When
the patient componenet is locked onto the right side of the housing, the
magnetic clamp attracts the valve piston above the soft iron plate and in
this way forms a tight (free of play) connection between actuation and
valve unit. Through a slight crowned design of the soft iron plate, slight
tilting of the patient component can be compensated for, without
endangering the safety of the mechanical connection.

When the patient component is separated from the basic unit, the moving
part of the valve actuation found in the basic unit is pulled against a stop
until it overcomes the maximum magnetic force, and the connection
between actuation and valve is mechanically broken.

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3.4 Patient component

3.4.3 Assembly and disassembly

The patient component can be completely disassembled. The bell-shaped
valve and the safety valve can be unscrewed by using a coin to loosen the
screws.

Fig. 33: Patient component

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 43

3 Pneumatics

3.5 Patient Hose System

Fig. 34: Patient hose system, complete

The patient hose system, consisting of heated inspiration hose and

expiration hose, is attached to the ventilatory-gas connection pipes found
on the front side of the patient component.

Here, it must be ensured that the red hose sleeve coupling of the
inspiration hose is on the red inspiration outlet. At the end of the
inspriation hose, a nebulizer pot can be attached, which then can be
connected via an additional hose with the Y-piece.

At the patient end, the temperature sensor is also inserted in to the bore
marked red. The plugs for heating and temperature sensor are pluged into
the respective sockets located in the connection block for heating,
pressure measurement and aerosol.

3.6 Measurement of pressure and volume flow

The measurement of pressure and volume flow takes place near the
patient between Y-piece and tube connector. For this, a
pneumotachograph head is inserted between both parts. The differential
pressure resulting above the resistor of the PNT-head is a rate for the
volume flow. The differential pressure is led, via two thin tubes, to the
pressure sensors (ventilation pressure) of the sensor circuit board found in
the basic unit, and to the differential pressure sensor (volume flow). The
mechanical connection of these hoses to the basic unit is via a Luer Lock
coupling.

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3.7 Aerosol System

For reasons of safety, the measurement of ventilation pressure is via two

pressure sensors. Via valves, the pressure measurement ports of the
differential pressure transducer can be intermittently switched over to
ambient air, and during this short time period a zero set compensation of
the volume flow can be carried out. A precise explanation of this
calibration procedure can be found in subpoint 4.3.3 (Sensor Module)

3.7 Aerosol System

Fig. 35: Connection pipe for aerosol

On the right sidewall there is also a connection union (pipe) for aerosol
(see also Pneumatics Module). When the nebulizer function is activated
the therapy ventilatory-gas mixture at this connection is under a pressure
of approximately 2 bar. It is fed to the nebulizer chamber via a hose
attached to this connection. This is to be placed, near the patient, on the
end of the inspiration hose (see also Hose System).

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 45

4 Electronic

3.8 Ventilatory-gas humidifying

Humidifying the ventilatory gas takes place by means of a state-of-the-art

procedure, in that humidifying and warming of the ventilatory gas is done
in two steps and via two separate loops.

4 Electronic

4.1 General
The entire electronic system is housed in the basic unit. It can be broken
down in to the following.

Control unit,
Monitor,
Electric power supply,
Pneumatics module,
Actuator

The operational functioning of the individual electronic components can

best be described using the following logic diagrams.
The signal designations are based on the following principle:
The first two letters refer to the signal sources. They are followed by a
sub-hyphen and the subsequent characters that should, if possible,
identify the significance of the signal. Serving as signal sources:
MC : Microcomputer (central control),
PC : PC Module,
ÜW : Monitoring,
LV : Power amplifier,
SM : Sensor module,
PM : Pneumatics module,
SV : Electric power supply module,
AM : Battery module,
RV : Backplane circuit board,
GG : Basic unit.

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4.2 Control unit

4.2 Control unit

The control unit is the communications level (interface) between the user
and the equipment.

On the one hand it contains all control elements necessary for the
therapeutic operation of the Stephanie (Therapy Control Module), on the
other hand, it also contains the monitor, consisting of a display screen and
its control elements (Monitor Control Module), via which the user can
access all information pertaining to the patient and equipment.

4.2.1 Therapy control module

Setting and adjustment elements for the individual parameters are:

Potentiometer: Tins, Trigger, Vt, Pmax, PEEP, Temp, FiO2,

V’osz, fosz, Rv und Ev,
Switch: Operation mode, inspiration pattern,
Incre. transmitter: Tex.
Keys: Insp. Hold, Aerosol, NVI, PVI,

The switches are equipped with resistor networks, so that their position,
including that of the potentiometer, is recorded and transmitted to the
microcomputer by an analogue-digital converter via a 16 ibt databus
(MC_D0..MC_D15).

The switching state of the keys is stored in a switching circuit and also
transmitted via the databus.

The control signals from the microcomputer for the temporal

coordination of the query of the control elements as well as signalling the
LEDs are transmitted via the same databus. The logic necessary for this is
carried out by two programmable logic arrays (PAL).

A failure mode analysis of the control unit is discussed in Section 5.

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 47

4 Electronic

4.2.2 Monitor control module

The following belong to the Monitor Control Module:

Incremental transmitter for menu control of the monitor, as well as the
Keys for Stop, Print, LFD1, Reserve, Alarm Mute.
These signals are evaluated by the PC module and the central control
(MC).

4.3 PC module

The PC module contains a complete industrial standard PC, consisting of

the PC circuit board, a VGA card, floppy-disk drive, harddisk and a bus
card as interface between the processor and the PC. All circuit boards are
mounted on a backplane.

4.3.1 PC circuit boards

The PC circuit boards supply a PC (486 -33 DX2) and contain all
necessary drives and interfaces for the keyboard and storage systems.

The actual monitoring program is stored on a semiconductor memory

(silicon disk). As the PC card is a commerically manufactured circuit
board that is not subject to servicing, its functioning will not be detailed
in this technical manual.

4.3.2 VGA card

The VGA card contains the entire electronics necessary to drive TFT-
VGA display screen. For detailed information, refer to manufacturer's
technical data..

4.3.3 PC interface

The PC provides the interface between the PC and the ventilator.

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4.3 PC module

4.3.3.1 Signal designations

Operating voltages
SV_P5, SV_0V

Input signals
AIN0...AIN7 8 Analogue inputs
DI0...DI15 16 digital inputs
IGRa, IGRb Inputs for an incremental
transmitter

Output signals
DAC0...DAC3 4 Analogue outputs
D01...D15 16 digital outputs

Bus signals
D0...D15 16 Databus signals
A0...A10 11 Addressbus signals
OSC,/IOW, /IOR, BALE, AEN, Controlbus signals
RESET.DRV, /IOCS16

Tab. 2: Signal designations

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4 Electronic

4.3.3.2 Operational functioning

The PC interface card provides the connection between the address bus
and the databus of the PC as well as analogue and digital input/output
signals of the processor.

The analogue-to-digital converter (A3 and A4) allows the AD conversion

of 8 analogue signals with a word size of 12 bits in a voltage range of +/-
12V.

Two digital-to-analogue converters (A1, A2) generate four analogue

output signals in a voltage range of +/- 5V using a word size of 12 bits.
The exact setting of the reference voltage is effected via the settings
control R1.

Via circuits D6 and D7, 16 digital inputs can be read and via D8 and D11
an additional 16 digital outputs can be recorded.
The sequential and combinational control logic for these processes is
provided by PALs D3, D4 and D5.

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4.4 Electronics block

4.4 Electronics block

4.4.1 Microcomputer
4.4.1.1 Signal designations

Opreating voltage: SV_P5; SV_0V

Analogue input signals 10bit (0.5V)

SM_UTemp1 Ventilatory gas conditioning,
Temperature 1
SM_UTemp2 Ventilatory gas conditioning,
Temperature 2
SM_UTemp3 Ventilatory gas conditioning,
Temperature 3
PM_Upl Supply pressure, compressed air
PM_UO2 Supply pressure, O2
PM_Utemp Temperature in pneumatics module
RV_UP4 Battery voltage 4V
LV_Usumm1 Positional transducer: cumulative
voltage 1
LV_Usumm2 Positional transducer: cumulative
voltage 2
Tab. 3: Analogue input signals 10bit (0.5V)

Analogue input signals12 bit (+/-10V)

SM_UP1 Pressure, near patient sensor
SM_UP2 Pressure, near unit sensor
SM_Uflow Volume flow of PNT
PM_UP120 Admission pressure 120 mbar
LV_Us2 Positional transducer: path 2
PM_UFiO2 FiO2 sensor signal
Tab. 4: Analogue input signals12 bit (+/-10V)

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4 Electronic

Analogue output signals 12 bit (+/- 12V)

MC_ UDAC1, Analogue output 1
MC_UDAC2 Analogue output 2

Tab. 5: Analogue output signals 12 bit (+/- 12V)

Digital input signals

/ÜW_RSTMC Restart Microcomputer
SV_PGLV Power amplifier
/NMI Not assigned
/ÜW_5VBFail
/ÜW_PCWD watchdog for PC fail
/RV_SMan Switch, manually switched on
Tab. 6: Digital input signals

Digital output signals

MC_SD Shut down signal for power supply
MC_INSP Inspiration phase for mechanical
ventilation
MC_Heiz1 Heating, humidifier chamber, ON
MC_Heiz2 Heating, hose, ON
MC_RSTAus Blocking of Restart function of ÜW
MC_LVEin Relay on power amplifier, ON
MC_Spk1Ein Signal transmitter 1 on ÜW, ON
MC_NL Emergency air magnet, normal
operation
MC_WD Control signal for watchdog on ÜW
MC_HP Alarm, high priority
MC_MP Alarm, medium priority
Tab. 7: Digital output signals

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4.4 Electronics block

Bus signals
MC_D0...MC_D15 16 Databus signals
MC_A0...MC_A7 8 Address bus signals
MC_RD, MC_WR, MC_CLK, Control bus signals
MC_SEL
Tab. 8: Bus signals

Serial interface ports

TXD0, RXD0, TXD1, RXD1 Interface port signals
Tab. 9: Serial interface ports

4.4.1.2 Operational functioning

The circuit board of the microcomputer is made up of the following

components:
The actual microcontroller (80C166 from Siemens) with an integrated
10 bit ADU,
12 bit ADU, 8 channels (D ),
12 bit DAU, 2 channels (D ),
PAL (D ),
ROMs (D ),
RAMs (D ),
2 Latch (D ),
Bi-directional bus driver (D ).

The analogue input signals are collected by the two ADUs and together
with the digital input signals further processed by the microcomputer in
line with the program. At its outputs, it furnishes the corresponding
digital control signals and provides the DAU the information for its
analogue output data.

Address bus and databus signals are transmitted via the respective drivers
to the outside. Coordination of the internal processes is ensured by the
processor, and by the PAL. In particular, it generates control signals for
the peripheral components.

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 53

4 Electronic

By means of the adjusting rheostat R1, the reference voltage of the DAU
and by means of R6 that of the 10 bit ADU can be set.

The microcomputer is equipped with two ports for serial data

transmission RS232.

Fig. 36: Serial ports

4.4.2 Monitoring (watchdog)

4.4.2.1 Signal designations

Operating voltage: RV_P12, SV_0V, SV_N12LV

Analogue input signals:

SA_SPEECH Tone signals for voice output
(not yet installed)
Tab. 10: Analogue input signals:

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4.4 Electronics block

Digital input signals

SV_AkkLOw Battery LOW signal (Ubatt < 21 V)
SV_PG Power good for processor voltage
SV_PGLV Power good for LV voltage

/MC_RSTAus Blocking of Restart function of ÜW

MC_Spk1Ein Signal transmitter 1 on ÜW ON
MC_NL Emergency air magnet, normal
operation
MC_WD Control signal for watchdog on ÜW
MC_HP Alarm, high priority
MC_MP Alarm, medium priority

PC_RSTEin Restart_function enable

PC_RSTDrive
SV_AkkLOw Battery LOW signal (Ubatt < 21 V)
Tab. 11: Digital input signals

Digital output signals

/ÜW_5VBFail Internal voltage 5V fail
/ÜW_5VB1fail Internal voltage 5VB1 fail
/ÜW_RSTMC Restart Microcomputer
/ÜW_RSTPC Restart PC
/ÜW_PCWD PC watchdog responded
/ÜW_MCWD MC watchdog responded
/ÜW_NL Emergency air signal, normal
operation
ÜW_Spk1_1 Output voltage 1 for speaker 1
ÜW_Spk1_2 feedback input signal 2 from
speaker 1
ÜW_SPK2 Output signal for speaker 2

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 55

4 Electronic

Tab. 12: Digital output signals

Valve control signals
/ÜW_V0.../ÜW_V10 Negative control signals for the
valves
Tab. 13: Valve control signals

Bus signals
MC_D0...MC_D15 16 data bus signals
MC_A7 Address bus signal
MC_RD, MC_WR, MC_SEL Control bus signals
Tab. 14: Bus signals

4.4.2.2 Functional operation

The watchdog circuit board has the following tasks to fulfil:

Monitoring the proper functioning of PC and MC by processing and

evaluating watchdog signals,
Generating audible signal sequence for alarm,
Generating the actuation signal for the emergency air,
Actuating all magnetic valve in the pneumatics module and basic
unit.

Internal power supply For reasons of safety, the internal voltages for 5V are doubled and the
DC-DC transformer converts the externally supplied voltage RV_P12
into IC21 (5VB) and IC22 (5VB1).

Watchdog monitoring The PC module and the controller independently transmit, in the course
of properly processing their respective program and at intervals of approx
100..200 ms, watchdog signals PC_WD and MC_WD, that are evaluated
by the watchdog for the PC signal (IC8) and that for MC signal (IC9). In
the event of errors in the program run, the watchdog signal cease and the
PC and/or MC are restarted. During this time a HP (high priority) alarm
is triggered, and the patient has the possibility to spontaneously breathe
ambient air via the emergency air valve.

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4.4 Electronics block

The precise time for running this routine can be read from the status
graphs for the watchdog automaton. It is identical for both the PC and
MC systems.

The normal state is state 1, the emergency air valve is closed

(/ÜW_NLok). If there is no watchdog signal within the set time-window,
the status graph goes over to state 2: the emergency air valve opens and
the PC or MC are restarted via signals /ÜW_RSTPC or /ÜW_RSTMC. If
restartup is successful, the automaton goes over to 3, in which the
emergency air remains open. Only when the next proper WD signal is
received, will state 1 be activated again. If restart was unsuccessful, the
WD automaton goes over to state 4, which can only be exited again by
switching the unit off: the emergency air valve remains open and the HP
alarm remains activated.

Generating the audible The audible alarm signal is also generated in an alarm automaton. The
alarm signal signal sequence is stipulated according EN 475 and for alarms of medium
priority (PC_MP, MC_MP) is distinct from those alarms of high priority
(PC_HP, MC_HP). The alarm automaton is made up of the PALs IC1
and IC2 in connection with a clock generator (IC5).

The output signal of the automaton activates the signal generator SPK1
via the power amplifier (IC10). This is found in the basic unit and is
electrically switched between outputs ÜW_SPK1_1 and ÜW_SPK1_2.
This allows, via the signal (ÜW_SPK1_2) to determine whether current
is actually flowing through the signal generator SPK1 on request/prompt
for audible signaling.. In this respect, signal ÜW_SPK1_2 is actually an
input signal and serves towards monitoring the audible signal routing
from input of watchdog switching down to signal generator SPK1.

In the event of any error within this routing, alarm automaton 2 kicks in
and triggers the audible alarm (ÜW_SPK2) via signal generator 2.

Valve actuation The magnetic valves (solenoids) in the pneumatics system are actuated by
bus signals (MC_D0..MC_D10) and the respective control. Both registers
IC11 and IC12 store the databytes sent by the MC and control, on their
part, the MOSFET power transistors T2..T11 via the optical coupler
IC15..IC17. Via their outputs, they switch (ÜW_V0.../ÜW_V10) the
solenoids to - 12V (SV_N12LV). In high-impedance state of the
transistors, the valves are switched off.

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Here, there is also a check as to whether the desired switching operation

has been at least electrically executed, or not. For this, there are, in
parallel to the outputs of transistors T0...T10, the control inputs of the
optical couplers (IC 18...IC20) are switched via RLC components. When
the transistors are in off status low current flows through each solenoid,
which, however, suffices to activate the optical coupler. This signal is
transmitted via the bus drivers IC13 and IC14 and the MC bus signals
(MC_D0 ...MC_D10) to the MC.

When the MC generates a control signal for actuating the solenoids, a

check is run by the MC after a transient period of about 10 ms, whether
the respective valve has actually been switched. This provides
information on the electrical functional capability of the path, MC - ÜW -
valves – MC, including the respective software.

The emergency air valve is of particular importance among the solenoid

valves, as it is not activated via the bus, but by the alarm automaton and
the WD automaton. The emergency air valve can only be actuated when
all units are functioning properly and do not signal a malfunctioning. The
logic equations for activating the emergency air valve can be found in the
operational diagram.

4.4.3 Sensor module

The sensor module is a circuit board on which all sensors necessary for
the proper functioning of the Stephanie are mounted, including their
respective electronic components. They are the following:

1 Differential pressure sensor for measuring volume flow

2 Pressure sensors for ventilatory pressure (HCMX100)
3 Thermistor amplifier for measuring ventilatory-gas temperature
1 Instrument amplifier
2 Amplifier

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4.4 Electronics block

4.4.3.1 Signal designations

Operating voltages: SV_P12LV, SV_P12, SV_N12, SV_0V

Input signals
MC_UDAC2 MC: DAC-Signal 2
/ÜW_VPNT ÜW: zero point valve PNT ON
GG_UIn1 GG: analogue input 1
GG_UIn2 GG: analogue input 2
GG_Ures1 GG: analogue reserve input 1
GG_Ures2 GG: analogue reserve input 2
GG_Rth11 GG: Thermistor 1, terminal1
GG_Rth12 GG: Thermistor 1, terminal2
GG_Rth21 GG: Thermistor 2, terminal1
GG_Rth22 GG: Thermistor 2, terminal2
GG_Rth31 GG: Thermistor 3, terminal1
GG_Rth32 GG: Thermistor 3, terminal2
Tab. 15: Input signals

Output signals
SM_UP1 SM: voltage, pressure 1
SM_UP1Out SM: k. fixed voltage, pressure 1
SM_MP1 SM: measuring pt. 1 (refer. voltage 1.23 V)
SM_UP2 SM: voltage, pressure 2
SM_UFlow SM: voltage, volume flow
SM_UFlowOut SM: k. fixed voltage volume flow
SM_UOut1 SM: output voltage 1
SM_UOut2 SM: output voltage 2
SM_UTemp1 SM: voltage, temperature sensor 1
SM_UTemp2 SM: voltage, temperature sensor 2
SM_UTemp3 SM: voltage, temperature sensor 3
SM_Ures SM: voltage, reserve

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Tab. 16: Output signals

4.4.3.2 Operational functioning

The functioning of the sensor module is discussed in the following on

hand of the operational diagram FP_SM.

Differential pressure Determining the volume flow is carried out pneumotachographically,

sensor whereby the volume flow to be measured flows through a
pneumotachograph head (PNT) and the resulting fall in pressure above
the PNT (the difference between proximal and distal pressure) is
converted into an electrical signal by a piezoresistive differential pressure
sensor. The differential pressure sensor as well as the two sensors for
measuring the ventilatory pressure are, from a pneumatic view,
symmetrically arranged. This is necessary so that the ventilatory pressure
does not impede the measurement of the volume (common mode pressure
suppression).

The proximal supply pressure P1 reaches, via a distributing manifold, to

the proximal pressure sensor (sensor 2) and via the solenoid valve (valve
2), to the pressure inlet of the differential pressure sensor (sensor 1).

In the same way the distal supply pressure P2 reaches, via a second
distributing manifold, the distal pressure sensor (sensor 3) and via the
solenoid valve (valve 1), the second pressure inlet of the differential
pressure sensor.

The output signal of the differential sensor (sensor 1) is amplified by the

instrument amplifier U1 and is resident at the output as signal
SM_UFlow.

A second amplifier A1D provides a short circuit-proof signal

SM_UFlowOut for connecting external equipment.

Bridge supply current for the differential pressure sensor is generated by

the reference voltage source (A1A) in connection with amplifier A1B.

Solenoid valves Valve1 and Valve 2 are electrically actuated in order and
switch in deactivated state a respective pressure inlet of the differential
pressure sensor to ambient air. During normal operation the valves are
switched on (/ÜW_VPNT= -12V) and connect the pressure inlets of the

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4.4 Electronics block

differential pressure sensor with the pressure port for the proximal and
distal pressure.

During a periodical zero point correction, the valves, via the signal
/ÜW_VPNT, are switched off for the duration of approximately 50 ms
and the pressure inlets of the differential pressure sensor are switched
over to ambient air. The microcomputer measures the ouput voltage
SM_UFlow and in a compensating procedure, via the control signal
MC_UDAC2, the bridge zero point is modified until SM_UFlow Null
reaches zero.

Pressure sensors for The output signal of the proximal pressure sensor (sensor 2) is amplified
ventilatory pressure via amplifier A2B ( V=2) to signal SM_UP1 and via a second amplifier
A2A (V=1) short circuit-proof to signal SM_UP1Out.
The distal pressure signal of sensor 3, however, is only converted via
amplifier A2C (V=2) to signal SM_UP2.

The pressure voltage transfer function is:

U/V = 1 + 0.04 * P/mbar.

Thermistor amplifier The instruments amplifiers U3 to U5 form, in connection with the

(temperature measurement) reference voltage source (MP1) and the bridge resistors R11..R15, a
resistive voltage converter by means of which the signals of the
externally located temperature sensors (thermistors) are converted to
electical voltages (SM_UTemp1, SM_UTemp2, SM_UTemp3).

The temperature voltage transfer funtion is:

U/V = 2 + 0.1 *(T/°C - 20°C).

Discrete amplifier The instruments amplifier U2 enables the amplification of a random

(Reserve) signal by the factor V=100. (use for the measurement of FiO2 in
Pulmostar) Both amplifiers A1C (V=2) and A2D (V=1) are for reserve
purposes.

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4.4.4 Power amplifier

4.4.4.1 Signal designations

Voltages
SV_P12, SV_N12, SV_P12LV, Operating voltages
SV_N12LV
Tab. 17: Voltages

Input signals
WM_I1PSD1 WM: current 1 from PSD 1
WM_I2PSD1 WM: current 2 from PSD 1
WM_I1PSD2 WM: current 1 from PSD 2
WM_I2PSD2 WM: current 2 from PSD 2
MC_UDAC1 MC: Analogue voltage 1
MC_LVEin MC: power amplifier ON
Tab. 18: Input signals

Output signals
LV_USum1 LV: cumulative voltage of
positional transd. 1
LV_USum2 LV: cumulative voltage of
positional transd. 2
LV_Us1 LV: voltage, path 1
LV_Us2 LV: voltage, path 2
LV_UEDA1 LV: output voltage 1 for EDA
LV_UEDA2 LV: output voltage 2 for EDA
Tab. 19: Output signals

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4.4 Electronics block

4.4.4.2 Operational function

The power amplifier amplifies the analogue signal supplied by the

microcomputer (MC) and through that controls the moving-coil
(electrodynamic) actuation (EDA) for the ventilatory valve.

In addition, electronic components are on the circuit board for two

positional transducers, by means of which the exact position of the valve
piston is determined and with that, via path feedback, the natural
frequency of the EDA can be significantly increased.

Explanatory note on the The actual positional transducer system is found on the right sidewall of
positional transducer the Stephanie. It consists of two position measurement paths, each of
system which are formed by a luminescence diode (LED), an optic system and a
position sensitive device (PSD).

Fig. 37: Positional transducer system

The lightband generated by the LED and optic is covered by the PSD
opposite a crevice located on the valve piston, so that at the point of the
crevice only a narrow light spot appears on the PSD. This spot of light
generates two photoelectric currents, the strength of which both in
intensity as well as the position of the spot of light on the active surface
of the PSD can be determined.

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The following explains the principle of signal processing. Definitions are;

l: Length of the active path of the PSD

x: Position of the lightspot on on the PSD with reference to the initial
starting point
I1: Current 1
I2: Current 2,
L: Photo-current of the lightspot.

Equations for the photo-currents:

I1 = k * L * x/l; I2 = k * L * (1-x)/l (Eq1)

Resulting cumulative currents:

Is=I1 + I2 = k * L * 1/l (Eq2)

and the differential current:

Id = I1 - I2= k * L * (1-2*x)/l (Eq3)

When the quotients are formed from Id and Is, one receives
S = Id/Is = 1 - 2*x. (Eq4)

According to this, the Eq. 4 signal obtained is only proportional to path x

and within a certain range independent of photo-current and physical
properties of the PSD.

The following description of circuit design refers to positional transducer

system WMS 1. The operational function of WMS2 is the same.

The photo-currents WM_I1PSD1 and WM_I2PSD1 are converted by

amplifiers A1A and A1B, in connection with resistors R1 and R2, into
current-proportional voltages. A1C forms the sum Us and A1D the
difference Ud of these currents. The analogue division curcuit A2 then
realises Eq.4 by quotient formation of Us and Ud. Its output signal
LV_Us1 is a measurement for the position of the lightspot on the PSD
and is therefore proportional to the path travel (position) of the piston..

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4.4 Electronics block

Signal LV_Usumm1 corresponds to the 0.33 fold cumulative voltage after

A1C. It serves to monitor the optical path of the WMS. By means of the
adjuster ER1, the electrical zero point of WMS can be shifted.

The setting of the transfer function of WMS is fixed at U/V = 2 * s/mm,

i.e. 1mm travel difference corresponds to a voltage difference of 2 V.

Power amplifier The actual power amplifier (LV) is realised by a TDA 2050 (A6). In
connection with the feedback resistors (R33, R41) it has for the input
signal an amplification of V=13.6. Input resistor R33 is, via relay REL1
in its activated state, switched to control input MC_UDAC1 and in
deactivated state, via R40, switched to the output of A6.

The activation of REL1 is by means of transistor T1 and the control

signal MC_LVEin. The sense of this circuit is that for reasons of load, the
LV and therewith the EDA are only activated when necessary. In certain
emergency situations or when using the Stephanie as a pulmonary-
function unit, the LV is switched off by the MC via the signal
MC_LVEin=LOW.

This means that the LV can no longer be activated via its input, and the
output current through EDA sinks to values less than 30 mA, which no
longer create thermal load.

Travel feedback The output signal of positional transducer 1 is led via a transfer link with
PD behaviour (A5A, A5B) to a further control input for the power
amplifier. Der P-part carries back a travel-proprtional part, and the D-part
a speed-proportional part. Via the travel-proportional part, the overall
transfer factor of LV and EDA, concerning travel, and via the speed-
proportional part (ER3) the attenuation can be stipulated. Due to the high
loop amplification of this system, the transfer function LV-EDA is
practically only dependent on that of the positional transducer system,
and results

s / Uein = 1 / KWMS = 0.5 mm/V.

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This achieves, that, independent of intraindividual parameter fluctuations

between the individual moving-coil actuators, a constant transfer
behaviour of the valve actuator is ensured. That is to say, a change in
voltage of MC_UDAC1 by 1 V leads to a change in position of the EDA
of 0.5 mm. By means of the ER4, an additional stability of the system can
be influenced at high frequencies.

Safety observations Since the positional transducer system is designed as a dual system, one
system is for the feedback, a second is for checking the system.. Thanks
to the good coordination between the control voltage of the MC
(MC_UDAC1) and the position of the control valve, a check can be run,
via the second positional transducer system, as to whether the desired
position has actually been achieved. This comparison check takes place in
the MC. This monitoring check is very complex and entails the entire
path MC - LV - actuator – control valve - MC. Its operational function
is: within a certain temporal and voltage error span, the MC checks
whether the generated control voltage of the MC agrees with the voltage
of positional transducer system 2. In the case of deviation, an alarm with
high priority is triggered along with activation of the emergency air
system.

4.5 Power supply

4.5.1 Power supply module

Fig. 38: Power supply module, top view

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4.5 Power supply

Fig. 39: Power supply module, rear view

4.5.1.1 Signal designations

Voltages:
SV_P5, SV_P12, SV_N12 Operating voltages for the
computers
SV_P12LV, SV_N12LV Operating voltages for power
amplifier and valves,
SV_P24 Intermediate circuit voltage
(24...28V)
SV_HEIZ1 Activated voltage for heating and
humidifier,
SV_Heiz2 Activated voltage for hose heating
Tab. 20: Voltages

Monitoring signals:
SV_PG Power good signal of computer
voltages
SV_PGLV Power good signal of LV voltages
SV_Netzok Mains voltage is OK
SV_Akkok Battery voltage is OK
SV_AkkLow Battery voltage is less than 20 V
Tab. 21: Monitoring signals

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Control voltage:
MC_SD MC: Shut down
/BE_SBER BE: switch position not ready
MC_HEIZ1 MC: Heating 1 ON
MC_HEIZ2 MC: Heating 2 ON
/UW_NL ÜW: emergency air valve not
activated
Tab. 22: Control voltage

Switch signals
SV_S1a, SV_S1b Switch contact of mains power
switch
Tab. 23: Switch signals

4.5.1.2 Operational function

The input voltage of 220 V is led, via the fuses and the mains power
Voltage generation switch to a primary voltage regulator. If the signal is MC_SD=LOW, it
generates an intermediate circuit voltage of 24 V...28 V (otherwise it is
zero). At the same time the charging current for the 24 V lead battery is
generated and the battery is charged.In the case of /BE_SBER =HIGH,
the secondary voltage regulators for the computer voltages and the power
amplifier are switched on. A contact of the mains power switch is on the
outside.

Substitution switch of If there is a power failure during operation on mains power supply
the battery voltage (SV_Netzok=LOW), the intermediate circuit voltage through the primary
regulator becomes zero, and the battery voltage (24V) is switched via a
MosFet to the intermediate circuit. This ensures that there continue, with
no break, all output voltages of the power supply. Only the heating is not
supplied with current during a power failure.

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4.5 Power supply

Heating voltage The battery voltage is monitored for compliance within certain voltage
generation parameters and its state is determined via the respective signals.
The voltages for respiratory gas humidifier and hose heating are obtained
via the power-MosFets directly from the intermediate circuit voltages.
Prerequisite for provision of these heating voltages is that the mains
power is on and the systems monitor does not detect an emergency air
situation (SV_Netzok * /UW_NL=HIGH). If this is the case, heating
voltages 1 and 2 from the MC can be switched via signals MC_Heiz1,2.

4.5.2 Battery module

Fig. 40: Battery module

The battery module is made up of a 24 V rechargeable lead battery, of

which the output voltage (AM_P24) is secured by a 4 A fuse, and is led
to the identical inputs of the power supply module.

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4.6 Valve actuation

The valve actuation is realised by a moving-coil converter similar to that
of a loudspeaker. The drive coil is held by two centering diaphams and is
frictionlessly guided. This drive coil is closed in the direction of the
ventilation valve unit by a plate, on which a small magnetic clamp
(D=8.5 mm) is stuck. This magnet forms, in connection with the soft-iron
plate on the valve piston, the mechanical coupling between the valve
actuator and the ventilation valve unit.

When the patient component is connected to the housing, both parts come
into magnetic contact and form a tight hysteresis-free mechanical
coupling.The executed positional feedback, in connection with the valve
actuator, has already been explained in Section 4.3.4. In addition, it
allows to check the integrity of the connection between the valve
actuation and the valve piston.The assembly of the valve actuation is
carried out within the unit, whereby using an adjustment gauge, the
adjustment of the position of the positional transducer and the ventilation
valve unit can be conducted.

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5.1 General

5 Safety concept
5.1 General

The safety concept for the Stephanie is so designed, that it detects a

simple error and even in the case of a double error, switches the ventilator
over to a status where the patient is not at all endangered. At this stage of
development we understand the status of "fail save"; that means that the
patient is secured by the safety valve being activated and this allows the
patient to spontaneously breathe ambient air.

Depending on the cause of the error or malfunctioning, and in line with

EN 475, the unit introduces various forms of visual and audible error
signalling and corrective action. Causes of error and malfunctioning are
various. These can be:

Unit defect of the ventilator des Ventilators (break-down),

Faulty use of the unit (e.g. disconnection),
Threatening situation on the patient's side (e.g. apnea),

5.2 Safety design of the ventilators

Concerning safety design, the Stephanie is structured as a dual-channel

system. The diagram shows that the microcomputer (central control) and
the PC module almost completely, but independent of one another, take
over the mandatory monitoring parameters of the unit and patient, and
when errors are detected trigger audible alarms as well as introduce
corrective action.In addition, many functional units such as actuator,
audible alarming, valve control, etc., are subject to very complex
selftests, the functioning of which has been described in the respective
sections.

Furthermore, the test function of the Stephanie, that must be conducted

before using the unit on the patient, provides a very comprehensive test of
the unit. After the test has been successfully carried out, the unit, based
on reliability predictions, can be classified as being new equipment
(prerequisite: constant failure rate).

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5.3 Mandatory parameters to be monitored and

tested
According to DIN EN 794, the mandatory parameters to be monitored
and tested are:

1. 1.Functional capability of the equipment.

2. 2.Operating voltages
3. Gas pressure of the central respiratory gas supply
4. Alternative or reserve power supply
5. Inspiratory oxygen concentration
6. Air-passage pressure
7. Minute volume
8. Disconnection
9. Apnea
10. Respiratory gas temperature

5.4 Adjustment and treatment of limit valves

5.4.1 General

The mandatory limit values to be monitored are preferably set by hand

(see Operating Instructions). This has the disadvantage of being time-
consuming compared with automatically set defaults dependent on the
preset ventilation parameters. On the other hand, it has the advantage that
a mistakenly false setting of these parameters triggers an alarm, thus
avoids any endangering of the patient. After the unit has been switched
on, limit values are set according to the setup routine.

5.4.2 Pressure

During machine ventilation, the respective peak pressure is monitored in

relation to upper and lower limit values. During proper functioning of the
pressure loop, the upper limit value will normally not be reached.
Pressure falling below the lower limit value, in the case of disconnection
or in comparison to the preset value of Pmax and VT, will result in "soft
lung".

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5.4 Adjustment and treatment of limit valves

Setting Limit Value Setting the limit value is carried out manually.
Setup: Pgob = 30 mbar,
Pgun = 10 mbar.

Error corrective action Pgob-Alarm:

Visual: "Peak pressure too high !!!"
Audible: HP-Warning tone
Technical: opening of safety valve

Pgun-Alarm: Visual: "Peak pressure too low, Disconnection ?"

Audible: Warning tone
Technical: no response.

5.4.3 Respiratory minute volume

The expiratory minute volume V'ex is monitored in all modes of

operation. Approximately 15 s are selected as a monitoring timeframe.

Setting limit values Manual setting,

Setup: V’max = 2 l/min,
V’min = 0.2 l/min

Error corrective action Visual: "Minute volume too low ! Disconnection?"

"Minute volume too high !"
Audible: HP- or MP alarm,
Technical: none

5.4.4 Insp. O2 concentration:

Since a pneumatic mixer is used, the actual preset value is recorded by

coupling the mixer rotary head with an transmitter (Potentiometer).

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5 Safety concept

The voltage value, corresponding to the potentiometer setting, is the

target value, and is compared to the actual value which is measured by
the O2 sensor.

Setting limit values Manual setting,

Setup: FiO2 ob = 50%
FiO2un = 20 %.

5.4.5 Temperature

Setting limit values Setting limit values is carried out manually.

Setup: Tun = 33 °C,
Tob = 38 °C.

Error corrective actions Visual: " Respiratory gas temperature too high!"
„ Respiratory gas temperature too low!“
Audible: MP - Alarm for a temperature >= 40°C

Technical: For excess temperature > 41 °C longer than 2 min., heater is

switched off.

5.5 Alarm Response

5.5.1 General
The individual alarm ratings correspond to, in line with DIN EN 475, the
various alarm responses regarding the audible and visual alarm signals as
well as the response of the safety system. In line with this, there is a
distinction between alarms of medium priority and those of high priority.
An alarm of at least medium priority (MHP) means that the alarm begins
as medium priority and then goes over to an alarm of high priority.

The safety system responds by switching off the emergency air valve (
/ÜW_NL), the two valves for compressed air (/ÜW_VPL) and oxygen
(/ÜW_VO2), the central gas supply as well as the injector valve
(/ÜW_VInj1, /ÜW_VInj2). In this event the patient can at least
spontaneously breathe ambient air.

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5.5 Alarm Response

Visual alarm signalling is via alphanumeric display on the monitor

screen. In the event of an alarm of low and medium priority, it is yellow,
alarms of high priority are displayed in red. Alarm situations that have
ended, but have not yet been acknowledged, are displayed in green.

5.5.2 Alarm suppression

The audible components of alarms of high and medium priority can be

suppressed for the duration of 2 minutes by pressing the "Alarm mute"
key. This suppression applies, however, only for current alarms. When
the cause triggering the has been, in the meantime, remedied, but recurs
before this suppression elapses, it is treated as a new alarm. This also
applies to alarms arising due to other causes.The status of the audible
alarm suppression is visually displayed.

5.5.3 Status graphic of the alarm system

The behaviour of the alarm automation can best be described by means of

a status graphic. This also applies to those of the MC and PC.

MPALneu MPALneu
MP-OptAnzeige MP-OptDisplay
Gelb Yellow
Grün green
MP-Signalton MP-Signal tone
Kein Alarm No alarm
MPALneu MPALneu
Tab. 24: Alarm automation graphic glossar

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Fig. 41: Status graphic of the alarm system

The status graphic describes the transitions between the individual

states/statuses depending on the kind of (MP, MHP, HP) as well as
temporal occurance and the effect of T-Mute key. The designations in the
nodes denote which action is taken during a particular status. The edge
lines represent the condition under which a status transition occurs.

In detail:

HPAL: presence of a HP-Alarm condition

MPAL: presence of a MP-Alarm condition,
MHPAL: presence of a MHP-Alarm condition,
Tmute: Alarm-Mute duration has elapsed,
Mute: Activation of Mute key
Tmhp: Time for transition from a MP-Alarm to HP-Alarm.

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5.5 Alarm Response

5.5.4 Alarm table

The following is a table of Alarm Events evaluated by the Stephanie.

To apply this table:

The alarm designation is identical to the visual alarm message.

The category designates the priority of the alarm (MP, MHP, HP)
including the kind of audible signalling.
Columns 5 and 6 refer to the particular monitoring unit.
The column "Condition" refers to the condition that triggered the
alarm event.

The various responses of the safety system are listed in the last column.
Definitions:

Safety status 1:
the switching off of all valves, including the emergency air valve, so that
the patient can breathe ambient air or be manually ventilated.

Safety status 2:
For CMV ventilation with standard values for CPAP mit PEEP = 2mbar

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No. Alarm designation Rating Monitoring Condition Safety system

response
Primary energy supply
1 „Mains power failurel“ MHP MC PC /SV_Netzok
2. „Compressed air failure“ MHP MC PC P_Pl < 2.8 bar
3. „Oxygen failure“ MHP MC PC P_O2 < 2.8 bar
4. „Primary gas failure“ HP MC PC (P_Pl < 2.8 bar) & Stage 1 (all valves
( P_O2 < 2.8 bar) OFF)
5. „Respiratory gas failure“ HP MC PC P_120 < 70 mbar Stage 1
6. „Battery discharge“ HP MC PC RV_AkkuLow & Stage 1
/SV_NetzOk

Ventilatory parameters
7. „Peak pressure“ When Plim_max MC switches after
is reached for 0.1 s to PEEP level.
longer than 0.1 s PC switches off
for MC and for emergency air after
longer than 0.2s 0.2s
for PC
8. „Cont. high pressure“ HP MC PC Pmean > Pmean /V_NL for 1sec.
lim for longer than After that start of
15 s new inspiration.
Max. 3 attempt, then
/V_NL,/V_PL,
/V_O2,
9. „pressure low, MHP MC PC Pendinsp < Pmax
Disconn ?“ during machine
inspiration
10. „AMV high“ MP MC PC Amv > AMV lim
max
11. „AMV to low“ MHP MC PC AMV < AMV lim
min
12. „Apnea“ MHP MC PC no inspiration start
within 15 s

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5.5 Alarm Response

No. Alarm designation Rating Monitoring Condition Safety system

response
Respiratory gas
conditioning
13. „FiO2 too high“ MP MC PC FiO2 > FIO2 lim
max
14. „FiO2 too low“ MP MC PC FiO2 < FiO2 lim
min
15. „ Temperature too high“ MP MC PC Temp > Temp lim
max
16. „ Temperature too low“ MP MC PC Temp < Temp lim
min
17. „Temperature > 41°C“ MHP MC PC Temp > 41°C Heating OFF

Hardware error
20. „Controller error “ HP ÜW PC watchdog error Safety status 1
21 „PC error „ almost HP ÜW MC watchdog error Safety status 1
imposs..
21. „Valve error n “ MHP MC No electrical
response of valve
n
22. „Potentiometer n“ HP MC Potentiometer Safety status 2
makes no contact
23. „power supply error“ HP MC, PC /SV_PG + Safety status 1
ÜW /SV_PGLV

Tab. 25: Alarm table

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 79

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6 Failure mode analysis

6 Failure mode analysis

6.1 Control unit

The failure mode analysis for the control unit is found in the following
table.

No. Failure/error type Detec.. Explanation

F_BE1 Contact error of the yes see 1 and 2

contact of the Pot. und
Schalter
F_BE2 LED defect yes Detection during unit
selftest
F_BE3 Incr. transmitter Tex ja no reaction of expiration
defect time to change in IGR.
Detection also during unit
selftest.
F_BE4 Line break in databus yes see 3.
F_BE5 Keys defect yes see 4.
F_BE6 Incr. transmitter monitor yes No reaction of menu bar to
defect change in IGR. Detection
also during unit selftest.
F_BE7 Display screen defect yes Detection during operation
and during unit selftest.
Tab. 26: Failure mode analysis for the control unit

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 81

6 Failure mode analysis

1. The potentiometer and switch receive a primary voltage that is 90%

that of the reference voltage. In addition, all ADU inputs are
connected, via high-impedance resistors, with the reference voltage.
In the case of line break or interruption in the contact, the ADU
measures the primary voltage, which is evaluated as a nonplausible
setting and thus as an error. In this event, the new value is not
accepted, the unit continues to operate with the old value, however, it
triggers a HP alarm with error description.
2. During the unit selftest, all settings of the potentiometer and switch
are displayed in a menu item. These settings are to be confirmed by
the tester.
3. Only the databus lines MC_D0...MC_D9 are used. During the unit
selftest all LEDs are switched on and off, and the numeric display is
activated. Thus, and in connection with point 2, the entire databus is
tested. This must be confirmed by the tester.
4. During the unit selftest all keys must be tested and the response of
each checked by the illumination of the respective LED. In this
fashion, a complete check, including the respective component of the
microcomputer necessary for this function, is carried out.

By means of this test, all errors possibly occuring in the control unit can
be detected.

82 GA-123-0306V2.2-HAO-DE © F. Stephan GmbH

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7 List of figures

7 List of figures

Fig. 1: Block Diagram............................................................................... 7

Fig. 2: Control Unit Module...................................................................... 8
Fig. 4: Electronic module.......................................................................... 9
Fig. 5: Sensor circuit board, top view ....................................................... 9
Fig. 6: Sensor circuit board, front view................................................... 10
Fig. 7: Microcomputer ............................................................................ 10
Fig. 8: Power amplifier ........................................................................... 11
Fig. 9: Circuit board monitoring / supervision........................................ 12
Fig. 10: PC module ................................................................................. 13
Fig. 11: Electric power supply module ................................................... 13
Fig. 12: Battery module........................................................................... 14
Fig. 13: Battery module........................................................................... 14
Fig. 14: Pneumatic module ..................................................................... 15
Fig. 15: Patient component ..................................................................... 16
Fig. 16: Test module ............................................................................... 17
Fig. 17: Valve actuation .......................................................................... 17
Fig. 18: "Operational diagram, entire system" ........................................ 18
Fig. 19: “NIST-threads“ .......................................................................... 19
Fig. 20: Monitoring ................................................................................. 26
Fig. 21: Housing...................................................................................... 27
Fig. 22: Rack ........................................................................................... 27
Fig. 23: Remove cover ............................................................................ 28
Fig. 24: Pneumatics module, top view .................................................... 31
Fig. 25: Pneumatics plan (new version) .................................................. 32
Fig. 26: Pneumatics plan (old version).................................................... 33
Fig. 27: All electrical connections to be effected…................................ 35
Fig. 28: …outside the pneumatics module.............................................. 35
Fig. 29: Pneumatic module ..................................................................... 37
Fig. 30: Test block, side view ................................................................. 38

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 83

7 List of figures

Fig. 31: Test block................................................................................... 39

Fig. 32: Patient component ..................................................................... 40
Fig. 33: Patient component ..................................................................... 41
Fig. 34: Patient component ..................................................................... 43
Fig. 35: Patient hose system, complete ................................................... 44
Fig. 36: Connection pipe for aerosol....................................................... 45
Fig. 37: Serial ports ................................................................................. 54
Fig. 38: Positional transducer system...................................................... 63
Fig. 39: Power supply module, top view................................................. 66
Fig. 40: Power supply module, rear view................................................ 67
Fig. 41: Battery module........................................................................... 69
Fig. 42: Status graphic of the alarm system ............................................ 76

84 GA-123-0306V2.2-HAO-DE © F. Stephan GmbH

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8 List of tables

8 List of tables

Tab. 1: Signal destination........................................................................ 34

Tab. 2: Signal designations ..................................................................... 49
Tab. 3: Analogue input signals 10bit (0.5V)........................................... 51
Tab. 4: Analogue input signals12 bit (+/-10V) ....................................... 51
Tab. 5: Analogue output signals 12 bit (+/- 12V) ................................... 52
Tab. 6: Digital input signals .................................................................... 52
Tab. 7: Digital output signals .................................................................. 52
Tab. 8: Bus signals .................................................................................. 53
Tab. 9: Serial interface ports ................................................................... 53
Tab. 10: Analogue input signals: ............................................................ 54
Tab. 11: Digital input signals .................................................................. 55
Tab. 12: Digital output signals ................................................................ 56
Tab. 13: Valve control signals ................................................................ 56
Tab. 14: Bus signals ................................................................................ 56
Tab. 15: Input signals.............................................................................. 59
Tab. 16: Output signals ........................................................................... 60
Tab. 17: Voltages .................................................................................... 62
Tab. 18: Input signals.............................................................................. 62
Tab. 19: Output signals ........................................................................... 62
Tab. 20: Voltages .................................................................................... 67
Tab. 21: Monitoring signals .................................................................... 67
Tab. 22: Control voltage ......................................................................... 68
Tab. 23: Switch signals ........................................................................... 68
Tab. 24: Alarm automation graphic glossar ............................................ 75
Tab. 25: Alarm table ............................................................................... 79
Tab. 26: Failure mode analysis for the control unit ................................ 81

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 85

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9 Appendix: Circuit diagramms

9 Appendix: Circuit diagramms

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 87

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10 Notices

10 Notices

© F. Stephan GmbH GA-123-0306V2.2-HAO-DE 89

F. Stephan GmbH
- Medizintechnik -
Kirchstrasse 19
56412 Gackenbach

(+)49 (6439) 9125 – 0

(+)49 (6439) 9125 – 111
[email protected]
www.stephan-gmbh.com