F 120 GLOBETROTTER “GT”
PAEDIATRIC VENTILATOR
Operating instructions
F. STEPHAN GmbH Medizintechnik D-56412 Gackenbach Kirchstr. 19 Tel. (06439) 9125-0 Fax (06439) 9125-11 info@stephan-gmbh.com www.stephan-gmbh.com
Reanimator F 120 GT |
Operating instructions |
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Realisation:
Bernd Höhne
Edited John Hussen
F. Stephan GmbH -Medizintechnik- Gackenbach
Subject to technical changes
Status: February 2006
Rev.: 2.1
Reanimator F 120 GT |
Operating instructions |
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Content |
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1. NOTICE...................................................................................................................................................... |
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2. PREFACE .................................................................................................................................................. |
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Optional Monitoring ................................................................................................................................................... |
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3. RANGE OF APPLICATION....................................................................................................................... |
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4. SPECIFICATIONS OF THE REANIMATOR F 120 GT............................................................................. |
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5. PRINCIPLE OF PERFORMANCE........................................................................................................... |
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6. DESCRIPTION OF PERFORMANCE. .................................................................................................... |
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External Oxygen Supply – Incubator...................................................................................................................... |
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7. DESCRIPTION OF CONTROL ELEMENTS AND ELEMENTS ............................................................. |
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7.1 |
Twin flowmeter.................................................................................................................................................... |
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7.2 |
O2- Monitor ....................................................................................................................................................... |
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7.3 |
Control component and indicators .................................................................................................................... |
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7.4 |
Monitor................................................................................................................................................................. |
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7. 5 Patient component P1 ....................................................................................................................................... |
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7.6 |
Patient tube system.............................................................................................................................................. |
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8. TESTING PRIOR TO OPERATION......................................................................................................... |
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8.1 |
Monitoring ........................................................................................................................................................... |
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8.2 |
Inspiratory pressure (Plateau), expiratory pressure (PEEP).......................................................................... |
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8.3 |
Tightness .............................................................................................................................................................. |
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8.4 |
Heater and tube heating system ......................................................................................................................... |
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8.5 |
O2-Monitor .......................................................................................................................................................... |
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8.6 |
Intake filter .......................................................................................................................................................... |
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9. DESCRIPTION OF MODES OF VENTILATION ..................................................................................... |
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9.1 |
Controlled ventilation, IMV ............................................................................................................................... |
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Reanimator F 120 GT |
Operating instructions |
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9.2 |
Manual ventilation and inflation........................................................................................................................ |
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9.3 |
CPAP - ventilation............................................................................................................................................... |
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10. CLEANING AND STERILIZATION ....................................................................................................... |
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11. INSPECTION AND MAINTENANCE..................................................................................................... |
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12. ACCESSORIES LIST / SPARE PARTS F 120 GT .......................................................................... |
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F120GT Ventilator Replacement Part..................................................................................................................... |
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NeoSid Monitor Accessories + disposables.............................................................................................................. |
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Reanimator F 120 GT |
Operating instructions |
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1. NOTICE
1.Pursuant to Medical Device Directive 93/42, the apparatus must only be operated by trained personnel. Prerequisite is an exact knowledge of the operating instructions.
2.The apparatus is only intended for use as specified in the operating instructions.
3.The apparatus must be inspected periodically by trained personnel.
4.The F. STEPHAN GmbH prescribes a semi-annual inspection and maintenance by an authorised service technician.
5.A performance test has to be carried out prior to each putting into service.
6.The F. STEPHAN GmbH will not be liable for damages resulting from faulty operation due to non-observance of the operating-instructions or from use, for which the apparatus is not
earmarked.
7.If possible, neither antistatic nor electrically conductive tubes should be used.
8.Prior to each putting into service a performance test has to be carried out by activating the key „AUTO TEST“. In doing so, all luminous fields must illuminate, an intermittent audible alarm must sound five times and the valve must be activated five times.
9.An apparatus for manual ventilation, independent from the Reanimator F 120 GT must be close at hand.
10.The Reanimator F 120 GT must only be operated with the genuine by-pack spare-parts of STEPHAN or with those parts, which are recommended by the manufacturer.
11.The conveying capacity of the built-in compressor changes with 12 V (DC) operation.
WARNING
The Reanimator must not be used with, respectively in connection with inflammable anaesthetic agents.
If the ambient temperature rises above 41°C the humidifier heater should be switched off
The Reanimator F 120 GT is provided with an internal battery. To guarantee an optimum charge of the battery, the apparatus must always be connected to the current supply and mains switch on the apparatus plug must be in „ON“-position during stand-by periods.
With an optimum charge of the battery, an operating time of at least 2 hours is secured. The time to recharge the discharged battery takes at least 20 h.
NOTE:
An external 12v supply can be connected using the external dc cable.
Reanimator F 120 GT |
Operating instructions |
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2. Preface
The STEPHAN Reanimator is a ventilator unit for neonatal and perinatal short-term ventilation. It operates time-controlled, flow-constant and pressure-limited for controlled IMV-ventilation as well as flow-constant and pressure-limited for CPAP-ventilation and manual ventilation.
Inspiration time is adjustable from 0.25 to 2 seconds; expiration time is adjustable from 0.25 to 30 seconds. Flow is adjustable from 0 to 20 l/min; respiratory pressure is adjustable from 15 to 60 cmH2O
The frequency indicator (digital) indicates, according to the setting, with controlled ventilation (IMV) the respiratory rate of 2 to 120 breaths per minute (BPM). In operating mode CPAP the display shows three bars (---).
Oxygen and air are mixed in the attached twin flowmeter. Oxygen concentration is adjustable from 21 to 100% O2. An O2-monitor with adjustable minimumand maximum alarm-value monitors the oxygen concentration with visual and audible signals.
The monitor supervises visually and audibly failure of mains power and gas supply as well as disconnection and stenosis. As well as the Auto-Test system the electronics of the respirator are permanently supervised by a Watchdog system.
The apparatus is provided with a heater for warming the respiratory gas. The heater consists of the heater cartridge for humidification of the respiratory gas as well as of the heated tube system to stabilise temperature and to prevent forming of condensate water. The heating system can be switched on and off.
The patient component P 1 consists of the heated humidifier for the respiratory gas, PEEPand inspiration-pressure valve and can be autoclaved at up 134°C. A compressor is integrated in the Reanimator F 120 GT, making a self-supporting supply with compressed air possible. It directly and permanently supplies the F 120 GT so that no external supply with compressed air need be connected. In addition to the 230 V mains supply it is possible to connect the F 120 GT to an external electric board network and to operate the Reanimator on 12V (DC). An internal battery provides the power supply, when no mains supply, respectively board network is available. Switching over to the available power supply ensues automatically and is indicated.
Reanimator F 120 GT |
Operating instructions |
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Optional Monitoring
The F 120 GT can be equipped with an optional Monitor NeoSid plus. This monitor is able to measure heartand respiration signs of the patient during transportation.
The EKGand respiratory signals and are detected due to electrodes attached to the body of the patient.
By using the unique Massimo technology oxygen saturation of the patient is detected and controlled.
The large, backlit display is able to show digital information as well as graphical indication by means of SpO2-, EKGand respiration-impedance curves.
Reanimator F 120 GT |
Operating instructions |
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3. Range of application
The Reanimator F 120 GT is a ventilator for short-term and emergency ventilation of premature infants, neonates and infants.
It is used in the case of insufficiency in the lungs of neonates due either to immaturity, disease or failure of the respiratory system.
Due to the independence of any distribution voltage the Reanimator F 120 GT is designed to be operated as part of the TI 5000 Globe Trotter Neonatal Transport System.
The internal battery provides an operation-time of at least 2 hours independent from distribution voltage at max loading capacity.
Caution:
The Reanimator F 120 GT is not designed for long term intensive care ventilation.
Reanimator F 120 GT |
Operating instructions |
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4. Specifications of the Reanimator F 120 GT
Modes of operation: |
-IMV (controlled ventilation) |
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-CPAP (spontaneous respiration) |
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Possible settings: |
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Inspiration time adjustable |
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0,25 to 2 seconds |
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Expiration time adjustable |
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0,25 to 30 seconds |
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O2-flow (constant) adjustable |
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0 to 10 l/min |
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Air-flow (constant) adjustable |
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0 to 10 l/min |
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Oxygen concentration adjustable |
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21 to 100% O2 |
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Patient component |
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Expiratory pressure (PEEP) adjustable |
0 to 15 cmH2O |
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Inspiratory pressure (Plateau) adjustable |
15 to 60 cmH2O |
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Heated humidification |
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12 V 10 Watt |
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Heated tube system |
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Power consumption |
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12 V 10 Watt |
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Monitor |
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Disconnection |
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Visual and audible alarm in case 12 cmH2O are not |
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reached after expiration time + maximum |
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inspiration time |
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Stenosis |
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Visual and audible alarm if respiratory pressure |
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does not fall below 12 cmH2O |
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2,2 seconds after end of inspiration time |
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Failure of power supply: |
Audible alarm for 120 seconds |
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Fault of Reanimator-electronics: |
Visual and audible alarm until fault has been |
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eliminated. |
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Distribution voltage: |
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Indication of the actual distribution voltage |
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Testing program „AUTO-TEST“: |
Performance test of all indicators, alarms and of the |
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valve. |
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Mute of alarm: |
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2-min suppression of audible alarm |
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Reanimator F 120 GT |
Operating instructions |
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Oxygen-monitor |
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Digital display: |
21 to 99% O2 of the respiratory gas |
Maximum O2-limitation adjustable: |
21 to 99% O2, visual and |
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Audible warning in case of exceeding. |
Minimum O2-limitation adjustable: |
21 to 99% O2, visual and audible warning in |
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case of falling below. |
Automatic calibration: |
Only in case of saturation with compressed air. |
Indicators: |
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Respiratory pressure, gauge |
-10 to 60 cmH2O |
Frequency with IMV (digital) |
2 to 120 respirations per minute (BPM) |
Power supply: |
230V/50 mains |
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12V (DC) external |
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12V (DC) internal by battery |
Protective transformer: |
Single phase separating transformer, power |
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consumption 70 VA |
Protective class: |
I Type B |
Protective category: |
IP2O |
Weight: |
app. 18 kg |
Measurements: |
L 120 x H 300 x D 210 mm |
Reanimator F 120 GT |
Operating instructions |
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5. Principle of performance
The Reanimator F 120 GT primarily works time-controlled and pressure-limited according to the continuous-flow-principle. The fresh gas, as set on the flowmeter unit, flows during inspiration and expiration. To avoid unintended adjustments of the gas flow the knobs of the flow control valves are different due to the gas type and are covered by a metal frame.
The filling of the lungs during inspiration is accomplished by closing of the expiration valve. For manual ventilation, the expiration valve can be closed by hand pushing the red button of the expiratory valve. If the set inspiratory pressure limit - inspiratory pressure plateau - is reached prior to the end of the selected inspiration time, the surplus gas is evacuated via the mechanical inspiratory pressure valve.
A second safety valve to avoid excessive patient gas pressures is positioned at the rear of the F 120 GT. It is set to 40 cmH2O at a gas flow of 5 l/min.
Expiration is effected by opening the expiration valve. Hereby the lungs evacuate due to the decrease of pressure. Expiratory gas and fresh gas together are evacuated via the expiration valve. From this results the following important consistency, common to all constant-flow-appliances:
The set continuous gas flow bypasses even during the expiration cycle the y-piece of the patient. That bypass flow washes out the exhaled carbon dioxide (CO2) of the patient.
The rate of the gas flow should be adjusted minimum to the inspiratory peak flow of the patient (approx. 2-5 l/min ). Excessive gas flows will increase the work of breathing of the patient, as does too low a gas flow.
The minute volume as set on the flowmeter unit is the maximum quantity of fresh gas available to the patient for the period of one minute. Dependent on the set respiratory cycle (inspiration time + expiration time, respiratory time ratio) the patient receives only part of the set minute volume, since part of the fresh gas is lost during expiration and when the pressure plateau has been reached and consequently is no longer available to the patient. From this follows, that the set minute volume on the flowmeter unit must always be higher than the inspiratory minute volume that the patient is supposed to receive.
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