Stephan GmbH
Short Term and Transport Ventilation
F120 mobil Reanimator Operating Manual V2.3 Sept 2008
Operating Manual
70 Pages
Preview
Page 1
F 120 mobil Reanimator
Operating manual
®
1
Preface
This manual answers your questions about the operation and care of reanimator F 120 MOBIL. The manual does not contain any information about repairs and installation. If any malfunctions occur while operating the device, please contact an authorized Customer Service of F. STEPHAN GMBH or the authorized specialist dealer who supplied the device and who familiarized you with its function and operation. The manufacturer only guarantees the safety and reliability of F 120 MOBIL.when it is operated according to the operation manual
Cooperation
The hygienic procedures in chapter 9 of this user manual were written by: Hygiene-ArGe Joachim Höfner Gerhart-Hauptmann-Strasse 31 47058 Duisburg www.hygiene-arge.de
F. Stephan GmbH - Medizintechnik Kirchstrasse 19 56412 Gackenbach Subject to technical alterations. as of:
September 2008
Version:
2
V2.3
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© F. Stephan GmbH
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1.1
Product combination
Contents Contents ...3 1
2
3
General information ...5 1.1
Product combination...5
1.2
Device name and manufacturer ...5
1.3
Intended purpose...6
1.4
Packaging and waste disposal...6
1.5
Introduction ...7
1.6
Abbreviations and definitions...8
1.7
Technical data...10
Safety instructions...13 2.1
Danger warnings...14
2.2
Warnings...15
Structure and functional description ...19 3.1
General...19
3.2
Functional principles ...20
3.3
Front view...22 3.3.1
Description of control elements ...24
3.3.1.1 Ventilation forms ...24 3.3.1.2 Heating system...25 3.3.1.3 Auto test ...25 3.3.1.4 Alarm suppression...25 3.3.1.5 Timer for setting the respiration times ...26 3.3.2
Alarm and monitoring displays ...26
3.3.2.1 Alarm displays ...26 3.3.2.2 High pressure alarm ...27 3.3.2.3 Monitoring the power supply ...28 3.3.2.4 O2 monitor ...29
3.4 4
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3.3.3
Double flow meter...30
3.3.4
Patient component ...31
3.3.5
Patient tubing system ...34
Side- and rear view ...35
Preparing for operation ...37
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1
5
6
7
4.1
Gas supply ...37
4.2
Power supply ...38
Test list...40 5.1
Checklist ...40
5.2
Daily checks every time before starting the device ...41
Operation ...43 6.1
Switching on ...43
6.2
Select ventilation form...43
6.3
Short operation description...44
Forms of ventilation...47 7.1
Intermittent mandatory ventilation ...47
7.2
Spontaneous respiration with positive end-expiratory pressure (CPAP) ...49
7.3
Hand ventilation ...50
8
Troubleshooting ...51
9
Care and maintenance ...53 9.1
4
Disinfection and sterilization...53 9.1.1
Device housing, gas supply tubes, power cables...54
9.1.2
Patient tubing...55
9.1.3
Patient component ...56
9.1.4
Subsequent treatment ...58
9.1.5
Assembly...58
9.1.6
How to react to damage...58
9.2
Disinfection and sterilization table ...59
9.3
Safety checks ...60
9.4
Maintenance...60
10
Accessories list...61
11
Guarantee ...63
12
List of figures...65
13
List of tables...67
14
Notes………………….. ...69
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1.1
1
General information
1.1
Product combination
Product combination
F. STEPHAN GMBH rules out any warranty in the event that inadmissible device combinations are used with products which have not been permitted or certified as compatible by the manufacturer.
Only use the spare parts listed in chapter 10.
1.2
Device name and manufacturer Device name
F 120 MOBIL
Manufacturer
F. Stephan GmbH - Medizintechnik Kirchstrasse 19 56412 Gackenbach (+)49 (6439) 9125 – 0 (+)49 (6439) 9125 – 111 [email protected] www.stephan-gmbh.com
© F. Stephan GmbH
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1
General information
1.3
Intended purpose The Reanimator F 120 MOBIL is a ventilator for short-term and emergency ventilation of premature infants, neonates and infants. It is used in case of insufficiency of the lungs due to immaturity of lungs of neonates, of insufficiency due to a disease or failure of the respiratory mechanism. Due to the independance of any distribution voltage the Reanimator F 120 MOBIL can be operated at the incubator or in the emergency car as well as in intensive care stations or birth rooms for first accomodation. The internal accu provides an operation-time of at least 40 minutes with heating and ca. 120 min without heating-independent from distribution voltage at max loading capacity Contraindication:
1.4
The Reanimator F 120 MOBIL is not suitable for the long-term ventilation and the intensive care ventilation of patients of with a severe lung disease.
Packaging and waste disposal
Packaging materials
The packaging used for the device consists essentially of recyclable or reusable materials. The carton packaging can be reused or disposed of with used paper. The secondary packaging consists of CFC-free padding which can be disposed of together with the foil as recyclable plastic waste.
Return / Disposal
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F. STEPHAN GMBH warrants that used devices will be taken back and disposed of correctly by our company free of charge, thus making a contribution to the environment.
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1.5
1.5
Introduction
Introduction Legislation
The Medical Devices Law (MPG), the Medical Devices Operator Ordinance (MPBetreibV) and the law on technical working equipment stipulate that the operator must be informed of the following: The device must only be operated by skilled staff. Precise knowledge of the user manual is prerequisite. Only use the device for the intended purpose described in the user manual. Read the user manual carefully and comply with its instructions, because lasting safety for patient and operator is only warranted when the device is handled correctly. The user manual must be constantly available where the device is being used. Inadequate care and operating errors can cause failure of the device and accidents. A performance test has to be carried out prior to each putting into service. Therefore activate the „AUTO TEST“-Button. In doing so, all luminous fields must illuminate, an intermittent audible alarm must sound five times and the valve must be activated five times. An device for manual ventilation, independent from the Reanimator F 120 MOBIL must be close at hand. The Reanimator F 120 MOBIL must only be operated with the genuine spare-parts of the F. STEPHAN GMBH or with those parts, which are recommended by the manufacturer. The conveying capacity of the built-in compressor changes with 12 V (DC) operation.
Warranty
The manufacturer does not accept any warranty claims resulting from incorrect operation, inadequate care and maintenance. The device must be inspected regularly by correspondingly trained staff. F. STEPHAN GMBH stipulates six-monthly intervals for inspection and maintenance. The manufacturer only guarantees the safety and reliability of the device when it is operated in compliance with the operating instruction.
© F. Stephan GmbH
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General information
1.6
Abbreviations and definitions
Abbreviation/term
Definition
Meaning
A
amp
Unit of measurement for electric current
Fig.
Figure
AC
Alternating current
AIR
Medical compressed air
Bat
Battery
Bar Bpm
Unit of measurement for pressure breath per minute
cmH2O CPAP
Breathing rate Unit of measurement for pressure
Continuous Positive Airway Pressure
Spontaneous respiration with continued positive airway pressure
DC
Direct current
DIN
German standardization institute
Disc.
Disconnection
Interruption (pneumatic) of a connection
EN
European standard
ETT
Endotrachial tube
Exp.
Expiration
Breathing out
HPa
Hecto-Pascal
Unit of measurement for pressure
Flow
Flow rate
Volume flow
Hz
Unit of measurement for frequency
Insp.
Inspiration
Breathing in
KPa
Kilo Pascal
Unit of measurement for pressure
Connection
Connection
Cont.
Continuous
LED l/m
8
Device for storing electrical energy in the form of electrical energy
Light Emitting Diode
Light emitting diode Liters per minute
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1.6
Abbreviation/term
Definition
Mbar min.
Abbreviations and definitions
Meaning Unit of measurement for pressure
Minutes
Unit of measurement for time
MPG
Medical Devices Law
O2
Oxygen
PEEP
Positive End Expiratory Pressure
Positive end expiratory pressure
PIP
Peak Inspiratory Pressure
Peak inspiratory pressure
Resp.
Respiration
S
Seconds
Unit of measurement for time
IMV
Intermittent Mandatory Ventilation
Combination of spontaneous respiration and machine ventilation
Standby
Device is ready
Temp.
Temperature
V
Volt
Unit of measurement for voltage
VE W
Packaging unit Watt
Unit of measurement for power
ZGA
Central gas system
Tab. 1: Abbreviations and technical terms
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General information
1.7
Technical data
Ambient conditions
Operation
Temperature
10 – 40°C
Rel. humidity
10 – 80 %
Air pressure
500 – 1060 hPa
Let the device reach room temperature before starting operation. Storage
Temperature
5 – 40 °C
Rel. humidity
10 – 80 %
Air pressure
500 – 1060 hPa
Store protected from moisture, free of dust and free of frost
General
MPG class
II b
Protection class
I type B as per DIN EN 60601-1 : March 1996
Inspection/ maintenance cycle
every six months
Dimensions (WxHxD)
120 x 300 x 240 mm plus patient component 80 mm
Weight
Forms of ventilation
14 kg
IMV
Intermittent mandatory ventilation. Combination of spontaneous respiration and machine ventilation
CPAP
Spontaneous respiration with continuous positive airway pressure.
Manual ventilation
Manual ventilation
Test
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1.7
Power supply
Mains power
Technical data
Connection
230 V AC 50 – 60 Hz (100/115/ 250 V possible on request)
Power consumption
55 VA
Device fuse
2 x 2 AT
Vehicle power supply
12 V DC external (The device tolerates a voltage range from 11 to 14 V DC) 120 VA
Battery
Rated voltage
12 V DC
Rated capacity
17 Ah
Fuse
6.3 AT
Operating time with heating:
40 min
Operating time without heating
120 min
Protection transformer: Single-phase 170 VA separating transformer
Parameters
© F. Stephan GmbH
Current consumption
70 VA
Supply lead
Earthed plug with device jack
Inspiration time
adjustable from 0.25 to 2 s
Expiration time
adjustable from 0.25 to 30 s
O2 flow
adjustable from 0 to 10 l/min
AIR flow
adjustable from 0 to 10 l/min
Oxygen concentration
adjustable from 21 to 100 % O2
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1
General information
Patient component
O2 monitor
Monitoring
Positive end expiratory pressure (PEEP):
adjustable from 0 to 10 cmH2O
Inspiratory ventilation pressure (pressure plateau):
adjustable from 15 to 60 cmH2O
Heated humidifier:
12 V DC/10 W
Heated tube system:
12 V DC/10 W
Digital display:
20 to 99 % O2 of the ventilation gas
Upper O2 limit:
adjustable from 20 to 99 % O2 visible and acoustic alarm when for high level
Lower O2 limit:
adjustable from 20 to 99 % O2 visible and acoustic alarm when for low level
Manual calibration
Only for 21% O2 concentration (compressed air)
Disconnection
Visual and audible alarm in case 12 mbar are not reached after expiration time + maximum inspiration time
Stenosis
Visual and audible alarm if 2,2 seconds after the end of inspiration time the respiratory pressure does not fall below 12 mbar
High Pressure
Visual and audible alarm if the manual adjusted alarmlimit is exceeded.
Failure of power supply
Audible alarm for 120 seconds
Fault of reanimatorelectronics
Visual and audible alarm until fault has been eliminated
Distribution voltage
Indication of the actual distribution voltage
Testing program „AUTO- Performance test of all indicators, alarms and TEST“ of the valve.
12
Mute of alarm
2-min supression of audible alarm
Ventilation pressure gauge
-10 to 60 cmH2O
Breathing rate for IMV (digital)
2 to 120 breaths per minute (bpm)
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1.7
2
Technical data
Safety instructions Refers to instructions drawing attention to important facts.
The following safety instructions are repeated at relevant points in the user manual and must always be heeded.
Refers to dangers which, if not heeded, can result in life-threatening injuries to the patient and/or operator. Danger
Warning
Refers to warnings which, if not heeded, can result in malfunctions, damage or defects in the device, which can possibly also put the patient at danger.
Refers to precautions which, if not heeded, can result in damage to the device and its accessories. Caution
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2
Safety instructions
2.1
Danger warnings
Danger
Danger
The device must only be operated by authorized and well trained skilled staff. The device must be operated according to the instructions in this user manual.
The device must be inspected at regular intervals by correspondingly trained staff. F. STEPHAN GMBH specifies six-monthly inspection and maintenance by an authorized technician.
The device must always be tested before use by pressing the »Auto Test« button. Danger
The device is not certified for use in explosion-risk areas. Danger Explosion risk! Do not use flammable or anesthetic gases. Danger
Use of the device in the vicinity of MIR scanners can have a negative impact on its function and thus endanger both patient and user. Danger
Always keep an independent hand breathing bag at the ready. Danger
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2.2
Danger
2.2
Warnings
At a room temperature higher than 32 °C, the heater of the F 120 MOBIL must be switched off. Since the heater of the Reanimator is not regulated, respiratory gas at the tube may reach a temperature of more than 41°C.
Warnings
Warning
The use of antistatic or electrically conductive patient tubing can result in burns when using electrical high-frequency surgical devices at the same time. Therefore do not use any antistatic or electrically conductive patient tubing or leads.
Handle individual parts carefully to avoid mechanical damage. Warning Only use Reanimator F 120 MOBIL with original or authorized spare parts supplied by the manufacturer. Danger
Only use original patient tubing systems by F. STEPHAN GMBH. Warning Only use dry compressed air! Moisture in the gas lines can cause technical failure of the device. Warning
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2
Safety instructions
Warning
Short-wave therapy devices, HF diathermy devices, defibrillators etc. in the vicinity of the device can impair its operational reliability. Constant supervision of patient and device is required in this case.
Only use correctly prepared and treated parts for operating the device. Warning
Warning
In the case of a power failure, the internal battery takes over the power supply for the device for a period of 40 min when the heating is on and 120 min when the heating is off. To keep the battery charged up to the optimum level, the device must always be connected to the mains power supply with the power switch on when not in use. It takes at least 20 hours to recharge the flat battery, this time is reduced the higher the charge status. A protective circuit prevents the battery from being overcharged. The device cannot be operated when the battery is flat!
The battery type used in F 120 MOBIL does not reach its optimum capacity until it has been recharged and discharged five times. Warning
Warning
Warning
16
If the battery is in a state of total discharge, it may be possible that it cannot be recharged. Only the customer service authorized by F. STEPHAN GMBH is allowed to replace the battery.
Compliance is required particularly with DIN EN 60601-1 resp. VDE 0751-1 for medical technical devices with an electrical connection. Accordingly, these devices must only be repaired by the manufacturer or by an authorized representative.
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2.2
Warning
Warning
Warnings
The provisions of DIN EN 60601-1 must be heeded when connecting external electrical devices: all devices must be connected via a separating transformer (4 kV test voltage, available from F. STEPHAN GMBH).
Only the authorized customer service for F. STEPHAN GMBH is allowed to alter, modify, repair or open the device or replace the battery. This does not include dismantling the patient component in accordance with the intended purpose of the device as stipulated in the user manual.
Caution is required if the incubator temperature exceeds a value of 39°C. Warning When changing oxygen supply or oxygen cylinder the Oxygen flow knob should be set to the lowest acceptable oxygen flow rate. Warning
Please watch the oxygen cylinder content and do not increase Flow Rate to compensate for failing oxygen supply. Warning
© F. Stephan GmbH
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®
3.1
General
3
Structure and functional description
3.1
General The Reanimator F 120 MOBIL is a ventilator for short-term and emergency ventilation of premature infants, neonates and infants. The Reanimator operates volume-time-controlled, flow-constant and
pressure-limited for controlled IMV-ventilation as well as flowconstant and pressure-limited for CPAP-ventilation and manual ventilation. The following settings can be made: Inspiration time:
0,25 - 2 sek
Expiration time:
0,25 bis 30 sek
Flow:
0 bis 30 1/min
Respiratory pressure:
15 bis 60 mbar.
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 minimum- and maximum value monitors the oxygen concentration with visual and audible signals. The monitor supervises visually and audibly failure of mains power, gas supply and high pressure as well as disconnection and stenosis. Electronics of the respirator are controlled for one by self-testing and for the other a „Watch-dog“ has been installed, which permanently supervises the hardware of the respirator. The device 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 switched on and off. The patient component P 1 consists of the heated humidifier for the respiratory gas, PEEP- and inspiration-pressure valve and can be autoclaved at up 140 °C.
© F. Stephan GmbH
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3
Structure and functional description
A compressor is integrated in the F 120 MOBIL, making a self-supporting supply with compressed air possible. It directly and permanently supplies the reanimator 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 MOBIL 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.
3.2
Functional principles The fresh gas, as set on the flowmeter unit, flows during inspiration and expiration. 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. 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 mechanic inspiratory pressure valve.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 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. Dependent on the system this results, according to the set flow, in an increase of the end-expiratory pressure, indicated on the pressure gauge.
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3.2
Functional principles
Due to the danger of hyperextension of the lungs of babies and infants, ventilation with pressure limitation is decisive. To administer a sufficient volume of gas under this limitation, a constant flow is offered. This may be more than the patient is able to take in. Therefore, different respiratory patterns may result.
Fig. 1: Respiratory patterns High flow offer
With an increased offer of flow, the pressure limit is reached fast, here the airway resistance caused by the development of turbulences becomes specially perceptible. Flow in the trachea remains on a uniform high level only for a short period of time, since the lungs with low compliance keep filling.
Low flow offer
With a low offer of gas flow the set pressure limit is reached later. Here the compliance of the lungs is decisive. It takes a longer time until the pressure limit is reached and the flow, which in this case develops less turbulences, remains almost constant through a long period of the inspiration time.
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