STEPHANIE Pediatric Ventilator Operating Instructions

Table of Contents

1 2 3 3.1 3.2 3.3 4 4.1 4.2 5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.3 5.4 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 8 8.1 8.2 8.3 8.4 9 9.1 9.2 10 11 11.1 11.2 12

Preface... Introduction... Combination of products... List of abbreviations and technical terms... General data... Equipment designation and manufacturer... Field of application and performance... Technical data... Safety instructions... Danger warnings... Notes... Description... Equipment components... Ventilator... Control panel... Special funktion section... Monitor... Patient component... Patient circuit system... Preparing ventilator for use... Setting up the ventilator... Connecting gas and power supply... Filling respiratory gas humidifier... Performing equipment test, calibrating... Operation... Selection of form and type of ventilation... Setting ventilatory parameters and alarm limits... Ventilation... Manual ventilation... Monitoring display during ventilation... Alarms during ventilation... Acoustic alarm suppression... Switching off of Stephanie... Disinfection and sterilisation... Disassembling patient circuit system and patient component... Cleaning and sterilisation of the pneumotachographen... Procedural instructions, hygienic treatment... Assembly for further use... Notes on mafuntions... Equipment malfunctions / technical alarms... Maintenance and safety checks... Accessories list / replacement parts... Options... Medication nebulizer... Respiratory mechanics diagnostics module... Alphabetical index...

Operating Instructions STEPHANIE, March 2002

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Preface

The present Operating Instructions are intended to answer for you, in lucid form, questions on the operation, running and upkeep of the Pediatric Ventilator Stephanie. These Operating Instructions contain no information on repairs or assembly work. Should malfunctions occur during operation, please refer to the authorized Technical Support department of F. STEPHAN GmbH. The manufacturer guarantees the safety and reliability of the Pediatric Ventilator Stephanie, only if the equipment is operated in accordance with the Operating Instructions.

Use of these Operating Instructions: Chapter

Contents

Table of Contents List of abbreviations and technical terms General data

Medical application and brief technical information

Safety instructions

General safety instructions for operation

Description

Description of components and controls elements

Preparing the ventilator for use

Connecting the ventilator and conducting equipment test

Operation

Operation and running the ventilator

Disinfection and sterilisation

Sterilisation Overview and Servicing

Troubleshooting

Table of alarms and corrective action

Alphabetical index

Glossary

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Operating Instructions STEPHANIE, March 2002

Introduction The Medical Equipment Regulations (MPG), the Medical Products Operations Act (MPBetreibV) and the law governing technical working materials stipulate that the attention of the operator must be drawn to the following: -

Make yourself familiar with the Operating Instructions.

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Read the Operating Instructions carefully and follow the instructions, as only proper operation of the pediatric ventilator guarantees permanent safety for the patient and for the operator .

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Use the Pediatric Ventilator STEPHANIE solely for the purpose described in the Operating Instructions.

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Inadequate upkeep and operating errors may lead to operational failures and accidents.

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The STEPHANIE pediatric ventilator must be operated and run solely by trained medical personnel.

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The Operating Instructions must always be available where the ventilator is in use.

Warranty claims arising from improper operation, insufficient upkeep and servicing will not be acknowledged by the manufacturer. The manufacturer guarantees the safety and dependability of the pediatric ventilator, only when it is operated in accordance with these Operating Instructions. The STEPHANIE pediatric ventilator was developed in co-operation with the Children’s Hospital, Neonatology and Pediatric Intensive Care Unit, Carl Gustav Carus Faculty of Medicine, Dresden Technical University.

Operating Instructions STEPHANIE, March 2002

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1 Combinations of Products F.STEPHAN GmbH will entertain no warranty claim in the event that inadmissible equipment combinations are operated with products not licensed by the manufacturer or authorized for compatibility. Authorized product combinations: 1. Stephan medication nebulizer set, autoclaveable, Article-No: 1710-60-120 The following accessories are to be used: Pneumatic medication nebulizer, Article-No: 8405000, Dräger AG, Lubeck, Germany 2. Equipment for regulating dosage of NO for respiratory air, Pulminox mini, Manufacturer: Messer, Austria. Available from Mallinckrodt-Nellcor-Puritan-Benett. The following accessories are to be used: -Flowbox for NO measurement and dosaging, for connection to patient component with RS 232 interface port for dead space reduction incl. PNT, Article-No: 1705-61-000 -Adjustable, heated patient circuit tubing system with Y-piece and pressure gauge line for NO operation, Article-No: 1007-61-700 -Pneumotachograph Neonatology STEPHANIE with plug and silicon hoses, autoclaveable 134ºC, Type B for NO operation -NO-suction adapter, Article-No. 1007-61 022 3. Equipment for regulating dosage of NO for respiratory air, Inovent, Manufacturer: Datex Ohmeda 4. Stephan Respiratory Mechanics Diagnostic Module, Article-No: 1035-61-700 The following accessories are to be used: -Pressure absorption gauge DPT-6003, pvb medizintecknik gmbh & co kg -Pressure absorption gauge DPT-8001, pvb medizintecknik gmbh & co kg -Biotrans BT-201, Biosensors international Pte., Ltd., Singapore -Combitrans Transducer green, B. Braun Mellsungen AG

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Operating Instructions STEPHANIE, March 2002

2 List of abbreviations and technical terms Abbreviations used Technical terms

Term in full

Meaning of term

ADC

Analog-digital-controller

Analog-digital converter, assembly in basic equipment

Aerosol

Nebulization of medication

Aqua dest.

Aqua destilata (Latin)

Ass./contr.

Assist-control (patient triggered)

ATPD

Ambient temperature pressure dry

Type of ventilation In this type of ventilation, the ventilator supplies mechanical ventilation, whenever an inspiratory volume flow exceeds a preset trigger threshold. Patient triggered ventilation using Alternatively, differential pressure the assist control mode trigger

bar

Battery

Distilled, demineralised water

Measurement of all volumina under ATPD conditions Unit for air pressure, 1mbar corresponds to approx. 1 cm H2O

Battery

Battery for storage of electrical power in form of chemical energy

Calibration

Calibration of measuring instruments

cm H2O

Unit interface port

COM

Serial interface port

contr.

Controlled Time cycled, pressure controlled mechanical ventilation Time cycled, volume controlled mechanical ventilation

Type of ventilation In the controlled ventilation mode, the ventilator controls the positive pressure at the Y-piece and the change over time of this pressure. Time controlled, pressure controlled. Time controlled, volume controlled.

CPU

Central Processing Unit

Central unit comprising processor, clock unit and system control

CPAP

Continuous positive airway pressure

Spontaneous breathing under positive respiratory system pressure. In the CPAP type of ventilation the ventilator maintains the pressure constant on the connectingpiece of the endotracheal tube.

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2 List of abbreviations and technical terms Abbreviations used Technical terms

Term in full

Meaning of term

Decelerating

Here: curve type

Default settings

Standard set values

Diag.

Diagnostics

Optional function: use of Stephanie as pulmonary function monitor Treatment in which highfrequency currents warm tissue the body Quantity by which amounts differ

Diathermy Here: HF diathermy

High-frequency diathermy

Diff.

Difference

DIN

German Industrial Standards

Abbreviation for German Standards Institute

Disc.

Disconnection

Interruption (pneumatic) of a connection

Dist.

Distal

Here: Farthest from the patient

ES

European Standards

Abbreviation for European Standards

Engl.

English

Exp.

Expiration

1) Exhalation

2) Designation of rotary knob

see 5.2.1 FHFO

Frequency

Designation of FHFO rotary knob, see 5.2.1

FiO

Fraction of inspired oxygen

Designation of FiO rotary knob, see 5.2.1

Flow, Symbol

Volume flow

Inspiratory volume flow Expiratory volume flow

HF

High-frequency

Here: see HF diathermy

HP

Hewlett Packard

Hardware manufacturer

HFO

High-frequency oscillation

1) method of ventilation therapy 2) Designation of rotary knob see 5.2.1

2

8

high-frequency oscillatiory ventilation

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Operating Instructions STEPHANIE, March 2002

2 List of abbreviations and technical terms

Abbreviations used Technical terms impedance

Term in full

Meaning of term

IMV

Intermittent mandatory ventilation Combined form of mechanical ventilation and spontaneous respiration. The patient can spontaneously breathe at regular pauses. Necessary ventilation is provided intermittently by mandatory ventilation.

Insp

Inspiration

Here: resistance of a pneumatic/ mechanical system

Calibration

1) Inhalation 2) Designation of rotary knob, see 5.2.1 Calibration of measuring instruments

Communic. Connection

communication

Here: menu fields, see 5.2.3 Connection

Cont.

continuous

See alarms during ventilation 7.6

kV

kilovolt

Unit of measurement for electric current.

lat.

Latin

LED

1) light emitting diode Display, see 5.2.1

low

weak, low

max.

maximal

Very high, the most

MAX

maximum

Highest degree

mbar

millibar

Unit used for air pressure

MHP

Mean high priority

Alarm signals: An alarm at least of mean priority is rated as an alrm of mean priority (MP) on the occurrence of the alarm situation to switch over to an alarm of high priority (HP) after seconds (as per DIN EN 475)

Alarm at least of mean priority

min

minutes

Basic unit of time

MEAN PMEAN PMAP

Mean

Here: Mean airway pressure Mean airway pressure

Mean airway pressure

Operating Instructions STEPHANIE, March 2002

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2 List of abbreviations and technical terms Abbreviations used Technical terms

Term in full

Meaning of term

MP

Mean priority

msec

millisecond

Alarm signals: A signal of mean, low priority is an attention signal to indicate that the user‘s attention is required. Basic unit of time

NVI

Negative ventilator impedance

Negative impedance respiratory assist

Off

1) machine is not in operation position of mode switch, see 5.2.1

OCCL

Occlusion

1) seal at tubing exit of Y-piece designation of key, see 5.2.3

PAV

Proportional assist ventilation

Assist mechanical ventilation using resistive and elastic unloading

PC

Personal computer

Personal computer

PEEP

Positive end expiratory pressure

1) positive end expiratory pressure 2) designation of rotary knob, see 5.2.1

PMAX / Pmax

Maximal presure

1) peek pressure 2) PMAX designation of display, see 5.2.3 3) Pmax designation 3a) rotary knob, see 5.2.1 3b) relief safety valve, see 5.3

PNT

Pneumotachograph

Flow-Sensor, see 5.4

Potentiometer

Voltage divider

PRINT

1) produce in printed form 2) designation of key, see 5.2.3 Here: situated near patient

prox.

Proximal

Resistiv Resp.

10

Forming a pneumatic resistance Respiration

Here: Designation of lever for manual ventilation, see 7.4

Operating Instructions STEPHANIE, March 2002

2 List of abbreviations and technical terms Abbreviations used Technical terms

Term in full

Meaning of term

sec

Seconds

Basic unit of time

Setup S-IMV

Basic settings Synchronised intermittent mandatory ventilation

Type of ventilation, see 7.2

sine

Here: Curve pattern

Half-sine

Here: Curve pattern

Stand-by

Equipment state: readiness

Temp.

Temperature

Degree of heat of a substance, repiratory gas temperature

Vt.

Tidal volume

1) volume of air moving in and out of lungs during normal breathing 2) designation of rotary knob, see 5.2.1 time monitoring circuit

Water bath

Here: Humidifier bottle/chamber with filling of water

Watchdog WB

Operating Instructions STEPHANIE, March 2002

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3 General Data 3.1 Equipment designation and manufacturer STEPHANIE pediatric ventilator Manufacturer: F. STEPHAN GmbH Medizintechnik Kirchstr. 19 D-56412 Gackenbach Germany Tel: +49 (0) 6439 / 9125-0 Fax: +49 (0) 6439 / 9125-11 Email: [email protected] 3.2 Field of application and performance The STEPHANIE ventilator is designed for the mechanical ventilation of premature babies, infants and small children weighing up to 20 kg, in particular for infants of very low weight. Therapeutic capabilities: The STEPHANIE ventilator can be used to perform all licensed conventional types of ventilation: CPAP (continuous positive airway pressure), S-IMV (synchronized intermittent mandatory ventilation), Controlled (controlled ventilation) Assist-control (assist-control ventilation, patient triggered ventilation) As well as high-frequency oscillatory ventilation HFO in combination with all types of ventilation. The STEPHANIE ventilator provides a new form of ventilation: To assist breathing in CPAP and S-IMV, the STEPHANIE ventilator allows proportional assist ventilation (PAV) as a particularly subtle form of assist ventilation. With this type of assist, there is elastic and/or resistive unloading of the spontaneously breathing infant, so that the infant‘s efforts of breathing can be considerably reduced. The functional mode of „resistive loading“ of the spontaneously breathing child in order to train respiratory muscles and the mechanics of breathing is deactivated. This function can only be reactivated by the Technical Support Team of F. Stephan GmbH.

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Operating Instructions STEPHANIE, March 2002

3 General Data 3.3 Technical Data Ambient conditions: Storage:

- dust-free - frost-free - protected from humidity - allow ventilator to warm up to ambient temperature before use

Operation:

- Temperature: 15 – 40 ºC - rel. Humidity: 10 – 95 ºC - air pressure: 500 – 1060 hPa

Electrical power supply: MedGV – group Protection rating:

II b I, Type B DIN EN 60601-1 max. permissible Earth leakage current 0.5 mA

Mains feed line (shock-proof plug) with equipment socket Electrical mains connection Power consumption Current supply Equipment fuse Battery, internal Battery, module fuse

can be selected from between 115 V (AC) or 230 V (AC) 50 Hz approx. 250 VA approx. 0.75 A 4.0 AT DIN 41571 2 x 12V 1.2 Ah 4.0 AT DIN 41571

Gas supply: Operating positive pressure O2 Connection thread O2, on equipment Angular plug for gas socket

3.2 – 6.0 bar M 12 x 1 internal, nickel steel as per DIN 13260

Operating positive pressure AIR Connection thread AIR, Angular coupling for gas socket

3.2 – 6.0 bar M 20 x 1.5 external, nickel steel as per DIN 13260

The gases must be dry, oil-free and dust-free ! Control system gas consumption Aerosol gas consumption Respiratory gas comsumption

approx. 4 l/min approx. 3 l/min approx 4 l/min + respiratory minute volume (max. 25 l/min.)

Dimensions (W x H x D): Basic equipment

410 x 350 x 400 mm

Basic equipment

approx. 42 kg

Weight:

Operating Instructions STEPHANIE, March 2002

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3 General Data Performance characteristics: Effective parameters:

control principle

volume-controlled or pressure controlled electrodynamically driven, magnetically coupled respiratory valve, pressure controlled, time controlled

inspiratory time expiratory time tidal volume Vt insp. O2 concentration pressure relief valve max. pressure limitation min. pressure limitation positive end expiratory pressure PEEP or continuous, positive airway pressure CPAP respiratory gas temperature high-frequency oscillation FHFO oscillation amplitude HFO Ventilatory mode:

0.1 – 2 seconds 0.1 – 2 seconds 2 – 150 ml 21 – 100 vol. % O2 20 – 70 cmH2O (positive pressure safety regulator) 150 cmH2O (regulated), set internally from -7 cmH2O, set internally 0- 30 cmH2O 30 – 39 ºC, can be switched off 5 –15 Hz (300 – 900 l/min) 1 – 6, infinitely variable

volume control insp. Pressure limitation Pmax

square wave, sine, decelerating 5- 60 cmH2O

pressure control peak pressure Pmax pressure control without flow measurement

linear, half-sine, square wave 5 – 60 cmH2O half-sine, square wave

triggering flow triggering, if respiratory mode rotary knob is in the black zone trigger flow range between 0.1 – 2.9 l/min pressure triggering, if respiratory mode rotary knob is in the red zone trigger pressure range between 0.1 – 2.9 mbar for PEEP Ventilation type: contr. ass. contr. S-IMV CPAP

Controlled mechanical ventilation Assist-control mechanical ventilation synchronised intermittent mandatory ventilation spontaneous breathing under continuous positive airway pressure

PAV / respiratory mechanics (mechanics of breathing) Unloading Loading Elastance Resistance

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unloaded breathing loaded breathing – deactivated! (can only be activated by the Technical Support Team of F.Stephan GmbH) 0 – 4 cmH2O/ml 0 – 200 cmH2O/l/s

Operating Instructions STEPHANIE, March 2002

3 General Data Digital data display: Respiratory pressure

Volume

Frequency Time relationship Insp. – Exp. O2 concentration Temperature Impedance

Peak pressure Pmax Mean pressure Pmean Positive end expiratory Pressure PEEP or continuous Positive respiratory system Pressure CPAP Display error P

(-20) –99 cmH2O (-20) –99 cmH2O

(-20) –99 cmH2O P = + (2% * P + 1 cmH2O + 1 digit)

Respiratory minute volume V’ Exp. Tidal volume VTE Display error V Volume measurement

0 – 999 l/min 0 – 999 ml V = + (10% * V + 1 ml + 1 digit) ATPD

Frequency f

0 – 99 /min

Rel. inspiratory duration %

0.1 – 100%

Insp. Oxygen fraction FiO2

0 – 100 % ± 5 vol. %

Respiratory gas temperature

0 - 50 ºC

Resistance R Compliance C

0 – 999 cmH2O/l/s 0 – 999 ml/cmH2O

Display of curves: Curves are displayed on an active LCD monitor Respiratory curves Respiratory LOOPS

ventilation pressure, volume and volume flow curves volume pressure, volume flow-volume and volume flow-pressure loop

Scaling

Operating Instructions STEPHANIE, March 2002

direct from parameters

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3 Gerneral data Monitoring: Peak pressure Pmax upper limit lower limit

upper and lower limit, adjustable within range 10 – 70 cmH2O 0 – 60 cmH2O

Continuous peak pressure Pcont upper limit

upper limit, adjustable within range 0 – 60 cmH2O

Respiratory minute volume MV upper limit lower limit

upper and lower limit, adjustable within range 0.5 – 20 l/min 0.01 – 9.9 l/min

Tidal volume VTE/TI lower limit

lower limit, adjustable within range 0.0 – 150 ml

insp. O2 fraction of FiO2 upper limit lower limit

upper and lower limit, adjustable within range 21 – 100 % 18 – 99 %

Respiratory gas temperature T upper limit lower limit

upper and lower limit, adjustable within range 36 – 41 ºC 18 – 40 ºC

Data output: Serial interface port for data transmission The STEPHANIE pediatric ventilator can be adapted to the Central Monitoring System from Hewlett Packard (HP), VueLink Open Interface. For this, however, the HP monitor must be made compatible. The connection module of HP must be adapted for recognizing external equipment with Open Interface Format. Parallel interface port for connection to printer Recommended type of printer: HP deskjet, or standard printer (use only DOS compatible printer) Analog signal outputs: Positive pressure respiration, volume flow of respiration, optionally selectable analog signal of the digitally displayed respiratory parameters. All connected external equipment must be operated via an isolating transformer according to DIN VDE 0550 Sensors: Two pneumotachographs (PNT) are available for measuring the volume flow PNT head, type B: volume flow range –10 to +10 l/min, dead space 0.6 ml PNT head, type C volume flow range –25 to+25 l/min, dead space 0.9 ml

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Operating Instructions STEPHANIE, March 2002

3 General data Manufacturer‘s certificate on interference suppression: The STEPHANIE pediatric ventilator meets the requirements on electromagnetic compatibility in the Guidelines of the Council of Ministers of May 3, 1989, on the harmonisation of the statutory regulations on electromagnetic compatibility (89/336/EU) The STEPHANIE pediatric ventilator complies with DIN 13254 „Ventilators“ as well as EN 794 „Lung Aeration Equipment“. Packaging/waste disposal: The equipment packaging consists mainly of materials which can be recycled and reused. Cardboard packaging can be reused or be disposed of as waste paper. The surrounding, inner packaging consists of CFC-free lining. The lining can be disposed of together with the foil in a bin designated for such materials.

Operating Instructions STEPHANIE, March 2002

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4 Saftey instructions The following safety instructions are repeated at relevant points in the Operating Instructions and must be heeded at all times: Marks danger warnings which, if ignored, may lead to life-threatening injuries to the patient and/or the operator.

Marks notes which, if ignored, may lead to malfunctions, damage or defects of the equipment and also endanger the patient, in certain circumstances. 4.1

Danger warnings

Do not operate the pediatric ventilator in areas where there is an explosion hazard. Never occlude the respiratory outlet downstream of the noise reducer. This might lead to malfunctioning of the equipment with a high risk for the patient ! Never unscrew the humidifier chamber during operation. The humidifier chamber is pressurized at 150 cmH2O! Make absoulutely sure that when a syringe is used to top up the water level, the syringe plunger is not forced out of the syringe by the pressure. Remove the syringe after filling Do not use inflammable or anaesthetic gases! Danger of explosion! Always keep an independent, manual ventilation bag close by! The connection point is on the test module. The patient‘s tubing as well as the tubing for measuring that lead to the pneumotachograph must be neither electrically conductive nor antistatic! When an aerosol nebulizer is used to deliver medication, an expiratory filter must be connected to the expiratory limb of the circuit! If an alarm message is displayed on the monitor or in the LED display fields (e.g., „SWITCH OFF“), which requires a remedy or action: „Switch off ventilator/call Technical Support)“: disconnect patient from the equipment start manual ventilation switch off equipment later (mains power switch)

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Operating Instructions STEPHANIE, March 2002

4 Saftey instructions

Make sure the pressure-measuring tube is properly connected (2nd connection from bottom, see also 5.4 Patient tubing system). Check that no condensation water collects and obstructs the inspiratory tube near the Y-piece. This might cause the pneumotachograph to malfunction. Check that no water droplets are present in the pressure-measuring tubes. After the pneumotachograph has been properly prepared, check that the correct swirls have been placed at both sides to avoid errors in measuring volume (type B or type C). Every time prior to putting the ventilator into operation, perform the equipment test (see also 6.4 Performing equipment test). Prior to every use on the patient, check whether the correct pneumotachograph head has been selected for the patient. Also check that the differential pressure measuring tubes are correctly connected. If incorrectly connected, the flow-curve is negative during inspiration. It leads to PNT error (see 8.2.8) Check to make sure that the hose connections at the pneumotachograph are pointing upwards, in order to prevent droplets from running into the measuring tubes. When using the special status of alarm suppression (point 7.7), make absolutely sure that before leaving the child, the alarm system has be re-activated. 4.2

Notes

Do not place the ventilator on a foam-rubber mat! This restricts air circulation. Use only parts which have been properly treated (see Chapter 8, Disinfection and Sterilisation) Use only dry oxygen and compressed air labelled as medical gas! Humidity in the gas pipes can lead to technical failure of the ventilator. Use only original patient tubing systems supplied by F. STEPHAN GmbH. Carefully handle individual components to avoid mechanical damage.

Operating Instructions STEPHANIE, March 2002

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4 Saftey instructions

During manual ventilation, there is no mechanical ventilation! If there is a failure of the power supply, the 24 V battery provides the ventilator with current for a maximum duration of 5 minutes. The battery must always be charged. For this purpose, even if the ventilator is not in use: keep the ventilator connected to the power supply, keep the ‘mains switch’ switched on, keep the mode switch in the “OFF” position. If this is not possible, the battery must be charged for 24 hours at least every 14 days. For this purpose, proceed as described above. A protective system prevents overcharging of the battery. The ventilator cannot be operated if the battery is discharged! Caution! A totally discharged battery cannot be recharged and must be exchanged. Only the authorized Technical Support of F. STEPHAN may perform this replacement. If the ventilator is not connected to the power supply: the mains switch must be switched off and the mode switch must be in the “OFF” position. Failure to comply, results in a totally discharged and thus inoperative battery. Failure to comply with this safety instruction counts as an operator error.

When the ventilator is set up, make sure that it stands centrally on its placement area on the equipment trolley, so that the cover flap can be opened. When moving the equipment trolly, make sure that the wheel brakes are disengaged, that the wheel brakes are engaged again for setting up the ventilator. The „STEPHANIE“ ventilator has an overall weight of 42 kg. If the ventilator is mounted to a wall rail, the latter must be secured by a supporting bracket. Turn the mode switch to the „OFF“ position before disconnecting th mains plug from the ventilator. In a pressure controlled type of ventilation without pneumotoachograph (red zone of mode rotary knob), monitoring of the respiratory minute volume is disengaged. In this type of ventilation, observe the patient closely. In this type of ventilation, the occlusion test and ventilator impedance functions are also disabled. The setting of the mechanical positive pressure safety valve Pmax must always be higher than the inspiratory peak pressure set with the rotary knob Pmax.

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Operating Instructions STEPHANIE, March 2002

4 Saftey instructions

If the composition of respiratory gas is to be analysed for research purposes, bear in mind that: the respiratory gas outlet downstream of the noise reducer must not be closed! The equipment must only be operated under continuous supervision by trained personnel. The evacuation tube must have a diameter of ≥ 1 cm and of length of 20 cm or less. Short-wave therapy equipment, defibrillators, HF diathermy equipment and suchlike standing in the proximity of the ventilator may impair its functional safety. In this case, continuous supervison of patient and equipment is required. Coupling with electrical equipment: When external electrical equipment is connected up, DIN EN 60601-1-1 specifications must be complied with. External equipment must be connected up via an isolating transformer (4 kV testing voltage, obtainable from F. STEPHAN) Maintenance and repair: Changes, modifications, repairs or opening of the ventilator, replacement of the battery or removal of the racks may only be carried out by persons authorised by F. Stephan (Technical Support). This does not include, disassembly of the patient component, as foreseen in the Operating Instructions. Use only F. STEPHAN spare parts for maintenance. Always carefully clean the pneumotachographs under flowing water. Do not put in equipment washer.

Operating Instructions STEPHANIE, March 2002

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