Technical Documentation
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Evita 2 Intensive Care Ventilator Technical Documentation
Copyright by Dräger Medizintechnik GmbH, Lübeck, Federal Republic of Germany Copying is prohibited for commercial purposes. No replacement in event of modification. Attention is to be paid to the Operating Manual. This technical documentation does not replace the Operating Manual. The warranty and liability conditions of the general terms and conditions for business transactions of Dräger Medizintechnik GmbH are not extended by this technical documentation. Safety Regulations: Reference is hereby made to the observance of the relevant safety provisions, such as the Medical Equipment Ordinance (Medizingeräteverordnung), the Pressure Container Ordinance (Druckbehälterverordnung), the Technical Rules for Pressurised Gases (Technische Regeln Druckgase) or the Occupational Health and Safety Provisions (Unfallverhütungsvorschriften). Insofar as reference is made to laws, regulations or standards, these are based on the legal system of the Federal Republic of Germany. Follow your local laws and regulations.
Contents General 1
2
About this Service Manual 1.1
Safety precaution ...8
1.2
Maintenance ...8
1.3
Power connection ...8
1.4
Not for use in areas of explosion hazard ...8
1.5
Safe connections with other electrical equipment ...8
1.6
Liability for proper function or damage ...9
Intended Use 2.1
3
8
10
Adequate monitoring of the ventilation ...12
Technical Data
13
For internal use only. Copyright reserved.
GBK5664300IECIVZ.fm
Function description 1
Overview of the pneumatic control
20
2
Pneumatics Function Description
22
2.1
Gas supply ... 22
2.2
Air ... 22
2.3
O2 ... 23
2.4
Switch over ... 23
2.5
Inspiration IPPV ... 24
2.6
Paw high ... 24
2.7
„Emergency hammer“ ... 25
2.8
Expiration IPPV ... 25
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Contents 2.9
CPPV (PEEP) ... 25
2.10 PLV ... 25 2.11 PCV ... 26 2.12 IRV ... 26 2.13 IPPV/Assist Trigger ... 26 2.14 Sigh ... 26 2.15 ASB/Spont. (CPAP) ... 27 2.16 ASB ... 27 2.17 Flow trigger ... 27 2.18 Apnoea-Ventilation ... 28 2.19 SIMV ... 28 2.20 BIPAP ... 29 2.21 BIPAP-SIMV ... 29 2.22 BIPAP-APRV ... 29 2.23 MMV ... 30 2.24 Volume monitoring ... 30 2.25 Monitoring of rapid shallow respiration ... 30 2.26 Medicament nebulizer ... 30 2.27 Flow calibration ...31 2.28 O2-calibration ...31 2.29 Zero-calibration of pressure sensors ... 32 2.30 Stand-by air ... 32
For internal use only. Copyright reserved.
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2.31 Measuring manoeuvre occlusion pressure ... 33 2.32 Intrinsic PEEP ... 33
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Contents 3
Supply block
35
4
HPS valve with high pressure sensor
35
4.1
Mixer connection block ... 35
4.2
Cartridge valve HPSV - O2 and cartridge valve HPSV - Air ... 35
4.3
Position sensor system ... 36
4.4
High pressure sensors ... 36
5
Inspiration block
38
6
Patient unit
39
7
PEEP/PIP valve
40
8
Pressure measurement
41
9
Pneumatics interface
41
10
Overview of the pneumatic control
42
11
Mains supply
43
12
Front Panel
44
12.1 Function description of the individual components ... 44 13
PCB HPSV (Version 1: 83 05 821, version 2: 83 06 351)
49
For internal use only. Copyright reserved.
GBK5664300IECIVZ.fm
13.1 Functional description of the individual components ... 49 13.2 PCB connector (83 06 021) ... 50 13.3 PCB transistor (83 06 041) ...51
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Contents 13.4 Messages on the 7-segment display ...51 13.5 Status messages ...51 13.6 Error messages: ... 52 13.7 Error messages ... 52 14
PCB Valve Control (8306111)
53
14.1 General ... 53 14.2 Function description ... 53 14.3 Simplified diagram PCB Valve control ... 55 15
PCB Flowmeter
56
15.1 General ... 56 15.2 Function Description ... 56 15.3 Cleaning/glowing the flow sensor ... 56 15.4 Flow output 0 - 150 L/min ... 57 15.5 Inop identification ... 57 15.6 Zero calibration ... 57 15.7 Block diagram PCB FLowmeter ... 57 16
PCB Pressure, O2, temperature (83 06 381)
58
16.1 General ... 58 16.2 Function description ... 58 16.3 Airway temperature sensor ... 58
For internal use only. Copyright reserved.
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16.4 Device temperature ... 59 16.5 PCB Pressure, O2 Temperature ... 60 16.6 PCB Pressure, O2 ...61
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Contents 17
PCB monitoring
62
17.1 General ... 62 17.2 Function description ... 62 18
PCB monitoring
63
18.1 General ... 63 18.2 Function description ... 63 18.3 PCB Monitoring ... 64 18.4 PCB Monitoring ... 65 18.5 PCB DW-Bus ... 66 18.7 Functional Description ... 66
For internal use only. Copyright reserved.
GBK5664300IECIVZ.fm
Test List 1
Test Equipment Required to Perform the Steps in the Test List
68
2
Accompanying Documents
69
3
General Appearance of the Evita 2
69
4
Tests According to VDE 0751, Part 1 (Follow the national and international laws, standards and regulations applicable in your country) 70
5
4.1
Evita 2 ... 70
4.2
Socket Strip (Optional) ... 70
Functional Tests
71
5.1
Testing the Emergency Air Valve ...71
5.2
Testing the Pressure Relief Valve ... 72
5.3
Testing the Check Valves ... 73
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Contents 5.4
Testing the Pneumatic Safety Valve ...74
5.5
Testing the Power Failure Alarm ... 75
5.6
Testing the Flow and the O2 Calibration ... 76
5.7
Testing the Gas Failure Alarm ... 77
5.8
Adult Hose System Leak Test ... 78
5.9
Paediatric Hose System Leak Test ... 79
5.10 Testing Adult Ventilation ... 80 5.11 Testing the PEEP Pressure ... 82 5.12 Testing the Paediatric Ventilation ... 83 5.13 Testing the Pressure Limitation (Pmax) ... 85 5.14 Testing the CPAP/ASB ... 86 5.15 Testing the Pressure Relief Function ... 87 6
Humidifier
88
8
Tested
88
7
Assemble the Evita 2 Ready for Use.
88
For internal use only. Copyright reserved.
GBK5664300IECIVZ.fm
Replacing Non-repairable Items 1
O2 sensor capsule
89
2
Ambient-air filter
91
3
Cooling-air filter
92
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Contents 4
Timekeeper RAM on PCB CPU
93
5
NiCd battery on PCB „monitoring“
95
6
Pressure reducers in the pneumatics unit
98
7
Testing and setting pressure reducers
101
Changes 1
Type of Changes
103
1
Explanation of abbreviations and symbols
104
2
Spare parts list
109
For internal use only. Copyright reserved.
GBK5664300IECIVZ.fm
Appendix
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Contents
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General
1
About this Service Manual
1.1
Safety precaution
For correct and effective use of the apparatus and to avoid hazards it is essential to read the following recommendations and to act accordingly: (Insofar as reference is made to laws, regulations or standards, these are based on the legal system of the Federal Republic of Germany.) Strictly follow the instructions for use. Any use of the apparatus requires full understanding and strict observation of the Instruction for use. The apparatus is only to be used for purposes specified here.
1.2
Maintenance
The apparatus must be inspected and serviced by experts at regular 6 month intervals (and a record kept). Repairs and general overhaul of the apparatus may only be carried out by experts. We recommend that a service contract is obtained with DrägerService and that all repairs are also carried out by them. Only original Dräger spare parts may be used for maintenance.
1.3
Power connection
The apparatus is to be used only in rooms with mains power supply installations complying with national safety standards (such as in F.R. of Germany: VDE 0107). The requirements laid down in IEC 601-1 "Safety of Medical Electrical Equipment" are applicable for electrically powered equipment.
1.4
Not for use in areas of explosion hazard
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
This apparatus is neither approved nor certified for use in areas where combustible or explosive gas mixture are likely to occur.
1.5
Safe connections with other electrical equipment
Electrical connections to equipment which is not listed in the instructions for use should only be made following consultations with the respective manufacturers or an expert.
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1.6
Liability for proper function or damage
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
The liability for the proper function of the apparatus is irrevocably transferred to the owner or operator to the extent that the apparatus is serviced or repaired by personnel not employed or authorized by DrägerService or if the apparatus is used in a manner not conforming to its intended use.
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2
Intended Use
Time-controlled, volume-constant long-term ventilator for use in intensive care. For adults and infants from a weight of 3 kg. The unit includes the following ventilation modes:
IPPV
Intermittent Positive Pressure Ventilation, controlled and assisted volume-constant ventilation. Including the following modes:
− CPPV (Continuous Positive Pressure Ventilation) − PLV (Pressure Limited Ventilation) − PCV (Pressure Controlled Ventilation)
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
− IRV (Inversed Ratio Ventilation). SIMV
Synchronized Intermittent Mandatory Ventilation, respirator weaning method for spontaneously breathing patients.
MMV
Mandatory Minute Volume Ventilation spontaneous breathing with automatic adaptation of the mandatory ventilation to the minute volume required by the patient.
SB
Spontaneous Breathing Spontaneous breathing at ambient pressure.
CPAP
Spontaneous breathing with positive airway pressure.
BIPAP
Biphasic Positive Airway Pressure Spontaneous breathing on two different CPAP levels and adjustable pressure increase with automatic synchronisation in the event of CPAP level changeover.
BIPAP-SIMV
Spontaneous breathing on two pressure levels (like BIPAP, but with SIMV time pattern and ASB pressure support.
BIPAP-APRV
Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels (like BIPAP) with large time intervals, which can be adjusted individually.
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Apnea-ventilation
Spontaneous breathing with safety ventilation after expiry of an adjustable apnea period.
ILV (optional)
Independent Lung Ventilation Bilateral, differentiated, synchronised ventilation with two Evita 2 units.
With monitoring for:
− airway pressure Paw − minute volume *E − insp. O2-concentration FiO2 − insp. breathing gas temperature Automatic gas changeover. If the supply of one gas fails it is automatically changed over to the other supply gas.
Do not use flammable gases or anaesthetic agents in this unit, danger of fire!
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
Classification according to MedGV, device of group 1
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2.1
Adequate monitoring of the ventilation
(recommendation of the DGAI)* * DGAI = German Association for Anaesthesia and Intensive Care Medicine The monitoring system to be used for ventilation serves the adequate monitoring of the ventilatory situation and thus the identification of undesired changes of the ventilation parameters:
− airway pressure − inspiratory oxygen concentration − expiratory minute volume − if required, inspiratory breathing gas temperature Changes of these paramters might be caused by:
− acute changes of the patient’s condition − errors in adjustment and handling − device errors − failure of the power and gas supply Evita 2 includes monitoring systems for airway pressure, inspiratory oxygen concentration, expiratory minute volume, as well as inspiratory breathing gas temperature.
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
In the event of a failure in these systems separate measuring instruments (e.g. PM 8030, Oxydig, AWT 01) must be used.
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3
Technical Data
Environmental conditions For operation: temperature atmospheric pressure rel. humidity
15 to 40 °C 530 to 1100 hPa 0 to 90 %
For storage: temperature atmospheric pressure rel. humidity
-20 to 60 °C 530 to 1100 hPa 0 to 90 %
Set values Ventilation frequency for IPPV Ventilation frequency for IMV Ventilation frequency for BIPAP
5 to 100/min 0 to 60/min 2 to 100/min
I:E ratio TI:TE
6:1 to 1:6
Tidal volume VT paediatric accuracy
0.04 to 0.3 L ± 10 % of set value or ± 10 mL, whichever the greater value.
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
adult accuracy
0.1 to 2.0 L ± 10 % of set value or ± 25 mL, whichever the greater value.
Inspiratory flow * max paediatric adult
6 to 30 L/min 6 to 120 L/min
Inspiratory pressure-limitation Pmax
0 to 100 mbar
O2 Concentration accuracy
21 to 100 Vol.-% ± 5% of set value or ± 2 Vol.-%, whichever the greater value.
Positiv endexpiratory pressure PEEP or continuous positive airway pressure CPAP or interm. PEEP
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0 to 35 mbar
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Trigger sensitivity ý ptr (differential pressure below PEEP) for IPPV and for SIMV
0.7 mbar, fixed trigger
Pressure support ASB rise time for increase in pressure support Trigger sensitivity Sensitivity of patient synchronisation on BIPAP mode
3 to 80 mbar 64 ms to 2 s 1 to 15 L/min 1 to 15 L/min
BIPAP pressure levels Plow, Phigh level times Tlow, Thigh
0 to 35 mbar, 0 to 80 mbar 200 ms to 60 s
Apnoea ventilation Apnoea time
15 to 60 s
Independant lung ventilation (optional) Master Slave
with trigger/without trigger sync./nonsync./ inverse I:E
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GBK5664300A01.fm 09.09.99
Performance Data Control principle
time-cycled, volume-constant pressure controlled
Intermittent PEEP frequency
2 cycles every 3 minutes
Medikament nebulization
for 10 minutes during inspiratory flow phase
Bronchial suction disconnection detection reconnection detection oxygen enrichment active suction phase final oxygen enrichment
automatic automatic max. 3 minutes max. 2 minutes 2 minutes
Valve response time
T 0...90 ≤ 5 ms
Supply system for spontaneous breathing and ASB max. flow rate
Adaptable CPAP system with high initial flow 2 L/s in 8 ms
Machine compliance (with Aquapor and patient tubing system)
≤ 2 mL/mbar
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Additional functions: Inspiratory relief valve
Opens if compressed air supply fails (pressure < 1.2 bar), enables spontaneous breathing with filtered ambient air.
Safety valve
Opens the breathing system at 100 mbar
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
Measured value display O2 concentration accuracy
5 to 99 Vol.-% ± 3 Vol.-%
Expiratory minute volume *E accuracy t 0...90
0 to 99 L/min ± 8 % of measured value about 35 s
Tidal volume VTe accuracy
0 to 3999 mL ± 8 % of measured value
Frequency f accuracy t 0...90
0 to 150/min ± 1/min about 35 s
Insp. breathing gas temperature accuracy
18 to 51 °C ± 1 °C
Airway pressure-data During ventilation peak pressure plateau pressure pos. endexp. pressure mean pressure
0 to 99 mbar max plat PEEP mean
During spontaneous breathing max. airway pressure continuous positive airway pressure min. airway pressure
max CPAP min
During BIPAP max. airway pressure continuous positive airway pressure min. airway pressure mean pressure
max CPAP min mean
accuracy
± 2 mbar
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Spontaneous breathing-data spont. breathed minute volume accuracy spontaneous breathingfrequency accuracy Computed value displays compliance accuracy resistance accuracy Graphic displays airway pressure resolution
MVspo f-spo
C R
Paw (T)
0 to 99 L/min ± 8 % of measured value 0 to 80/min ± 1/min
1 to 250 mL/mbar ± 10 % of measured value 1 to 200 mbar/L/s ± 10 % of measured value
-10 to 100 mbar 1 mbar
Monitoring Expiratory minute volume *E alarm upper alarm limit setting range
when upper alarm limit has been exceeded OFF, 41 to 0.1 L/min
alarm lower alarm limit Setting range
when lower alarm limit has been crossed OFF, 0.1 to 41 L/min
The two alarm limits cannot overlap. Airway pressure Paw alarm upper alarm limit
when the pmax value (set on the rotary knob for pmax/pins) is exceeded by more than 10 mbar
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GBK5664300A01.fm 09.09.99
alarm lower alarm limit (effective for all mandatory ventilation strokes except MMV)
given when the PEEP value (set on the rotary knob for PEEP) has not been exceeded by more than 4.5 mbar during 96 msec and 2 successive breathing strokes
range
both alarm limits are automatically allocated to the set values pmax and PEEP
Insp. O2 concentration FiO2 alarm upper alarm limit
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when the upper alarm limit has been exceeded for more than 20 seconds
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alarm lower alarm limit
when the lower alarm limit has been crossed for more than 30 seconds
range
both alarm limits are automatically allocated to the set value: below 60 Vol.-% - ± 4 Vol.-% 60 Vol.-% and above - ± 6 Vol-%
Insp. breathing gas temperature alarm upper alarm limit
when 40 °C has been reached. Evita 2 can also be operated without temperature sensor, if it was not connected when switching on.
Tachypnoea monitoring alarm
when, during spontaneous breathing the breathing frequency has been exceeded for a certain time (alarm time)
setting ranges frequency alarm time
5 to 120/min 15 s to 10 min
Volume warning alarm
when the set tidal volume VT has not been supplied.
The alarms are visual and audible; the audible alarm can be switched off for 2 minutes.
Operating data
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
Mains power connection
Range: 220 V to 240 V or : 100 V to 127 V 50/60 Hz
Current at 230 V at 100 V
max. 1.2 A max. 2.2 A
Power consumption
about 125 W
Machine fuses range 100 V to 127 V range 220 V to 240 V
M 4 A DIN 41571 (2x) M 2 A DIN 41571 (2x)
Gas supply O2 gauge pressure O2 connection thread air gauge pressure
3 bar -10% to 6 bar M 12 x 1 female 3 bar -10% to 6 bar
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air connection thread
M 20 x 1,5 male Gas must be dry and free from oil and dust.
Gas consumption of control system
Compressed air or O2 about 2.0 L/min
Supply for pneumatic medicament nebulizer
Compressd air (or O2 if compressed air is not available) max. 2 bar max. 10 L/min
Sound pressure level (for free field measurement over a reflecting surface)
max. 47 dB (A)
Dimensions (W x H x D) basic machine machine with trolley
530 x 270 x 400 mm 580 x 1315 x 660 mm
Weight basic machine basic machine with trolley incl. cabinet 8 H
ca. 23 kg ca. 65 kg
Machine outputs analogue output Drägerbus (optional)
with additional p.c.b. for output of analogue data and digital status messages
digital output (optional)
with additional p.c.b. for output and receipt via an RS 232 C interface
Automatic gas switch-over
during gas failure (inlet pressure < 1,5 bar) the machine switches to the other gas
For internal use only. Copyright reserved.
GBK5664300A01.fm 09.09.99
Central alarm (optional) Built -in plug on the back of Evita 2 for connection to house telephone system to trigger a central alarm Operating voltage
max. 24 V =
Current
max. 250 mA
Power consumption
max. 3 W
Potential-free make-and-break contact Manufacturer’s guarantee of radio interference suppression
We guarantee that Evita 2 is radio-screened in accordance with the guidelines laid down in the German Instruction 1046.
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