Technical Documentation
231 Pages
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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
Symbols and Definitions
9
Function Description 1
General
11
2
Basic Principle
14
For internal use only. Copyright reserved.
GBK5664800IECIVZ.fm
3
2.1
Evita 4 ...14
2.2
Evita 2 dura ... 16
2.3
Basic principle Evita 4 ... 18
2.4
Basic principle Evita 2 dura ... 19
CPU 68332 PCB
20
3.1
EEPROM ...21
3.2
Processor System ...21
3.3
RS232 Interface ...21
3.4
ILV Interface ...21
3.5
Driver ...21
3.6
Clock ...21
3.7
DUART ...21
3.8
DC/DC Converter ... 22
3.9
CAN ... 22
3.10 Bus Driver ... 22 3.11 Sound Generator ... 22 3.12 Reset Logic ... 22
5664.800 Evita 2 dura
Contents
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Contents 4
5
For internal use only. Copyright reserved.
23
4.1
Electrical Isolation ... 26
4.2
Power Failure Logic ... 26
4.3
Voltage Monitoring ... 26
4.4
Measurement of Temperature and Pressure ... 26
CO2 Measurement
27
5.1
CO2 Sensor ... 28
5.2
Processor Board PCB ... 30
5.3
Power Supply PCB ...31
6
Power Supply Unit
32
7
Graphics Controller PCB
33
8
GBK5664800IECIVZ.fm
CO2 Carrier PCB
7.1
Processor System ... 34
7.2
Uprog ... 34
7.3
Reset ... 34
7.4
Loudspeaker Monitoring ... 34
7.5
Keyboard Port and LED Driver ... 34
7.6
Display Control ... 34
7.7
CAN Interface ... 34
7.8
DC/DC Converter ... 35
Communication PCB (Optional)
36
8.1
Processor System ... 37
8.2
Uprog ... 37
8.3
Reset ... 37
8.4
CAN Interfaces ... 37
8.5
RS232 Interfaces ... 37
5664.800 Evita 2 dura
Contents
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Contents
9
10
8.6
Analog Outputs ... 37
8.7
DC/DC Converter ... 37
8.8
EEPROM ... 37
Paediatric Flow PCB (Optional)
38
9.1
Flow Measurement ... 39
9.2
Multiplexer ... 39
9.3
A/D Converter ... 39
Pneumatics Controller PCB
40
10.1 Pneumatics Controller PCB block diagram ...41 10.2 Pneumatics Controller PCB ... 42 10.3 Pressure Measurement ... 43 10.4 Flow Measurement ... 43 10.5 O2 Measurement ... 43 10.6 Fan Monitoring ... 43 10.7 Multiplexer ... 44 10.8 Solenoid Valves ... 44 10.9 PEEP Valve Control ... 44 10.10 HPSV Interface ... 44 10.11 CAN Interface ... 44 10.12 Processor System ... 44
For internal use only. Copyright reserved.
GBK5664800IECIVZ.fm
10.13 Serial EEPROM ... 44 11
HPSV-Controller PCB
45
12
Frontpanel PCB Evita 2 dura
47
12.1 Processor System ... 48 12.2 Loudspeaker Monitoring ... 48
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Contents
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Contents 12.3 Keyboard Port and LED Driver ... 48 12.4 Display Control ... 48 12.5 Flash VPP ... 48 12.6 Voltage Generation ... 48 12.7 CAN Interface ... 48 13
7-Segment PCB Evita 2 dura
49
14
Pneumatics
50
14.1 Gas Connection Block ...51 14.2 Parallel Mixer or Mixer Unit ... 54 14.3 Mixer Connection Block ... 54 14.4 Cartridge Valves or O2 and AIR HPS Valves ... 55 14.5 Pressure Sensors ... 57 14.6 Inspiratory Unit ... 58 14.7 Patient System ... 60 14.8 PEEP/PIP Valve ... 62 14.9 AIR Supply ... 63 14.10 O2 Supply ... 64 14.11 Inspiration ... 65 14.12 Paw High ... 66 14.13 Emergency Pressure Relief Mechanism ... 66
For internal use only. Copyright reserved.
GBK5664800IECIVZ.fm
14.14 Expiration ... 66 15
Ventilation Modes
67
15.1 Volume-Controlled Ventilation with PLV and Auto-Flow ... 67 15.2 Classic Constant-Volume Mandatory Breath ... 67 15.3 Manual Pressure Limitation Pmax ... 68
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Contents 15.4 Auto-Flow ... 68 15.5 Artificial Sighs ...71 15.6 SIMV (Synchronized Intermittent Mandatory Ventilation) ... 72 15.7 ASB (Assisted Spontaneous Breathing) ... 73 15.8 BIPAP (Biphasic Intermittent Positive Airway Pressure) ... 75 15.9 APRV (Airway Pressure Release Ventilation) ... 77 15.10 MMV (Mandatory Minute Volume) ... 78 15.11 Measurement Manoeuvres ... 80 15.12 Intrinsic PEEP ...81 15.13 Inspiratory O2 Concentration During Medicament Nebulization ... 82 16
Gas mixture
84
16.1 Operating principle ... 84 16.2 Correcting the oxygen HPSV ... 84 16.3 Dependence on the input pressure ... 84 16.4 BTPS/NTPD conversion ... 85 17
Function Diagram
86
17.1 Pneumatics function diagram ... 87
For internal use only. Copyright reserved.
GBK5664800IECIVZ.fm
Test List 1
Test Equipment Required
89
2
General Condition
90
2.1
Front Panel ... 90
2.2
CO2 Sensor (Optional) ...91
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Contents 2.3
Accessories (if available) ...91
2.4
Special Accessories (if available) ...91
3
Checking Accompanying Documents
92
4
Safety Check
92
5
4.1
Protective Conductor Resistance ... 92
4.2
Equivalent Device Leakage Current ... 92
Checking the Safety Valves 5.1
Checking the 10 mbar Safety Valve ... 93
5.2
Checking the 100 mbar Safety Valve ... 94
5.3
Checking the 10 mbar Safety Valve ... 95
5.4
Checking the Check Valve ... 96
6
Checking the Temperature Measurement
96
7
Checking the Optional CO2 Sensor
97
8
Power-On Test
97
8.1
Checking Using the Internal Device Checklist ... 97
9
Mains Failure Alarm Without the DC Module
98
10
Place fully functional unit at customer’s disposal.
98
11
Tested
98
For internal use only. Copyright reserved.
GBK5664800IECIVZ.fm
93
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Contents
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Contents Replacing Non-Repairable Items 1
Replacing the O2 Sensor 1.1
99
Replacing the Ambient-Air Filter ... 100
2
Replacing the Cooling-Air Filter
101
3
Replacing the Battery for Data Backup
101
4
Replacing the Real-Time Clock
104
5
Pressure Regulator
105
6
5.1
Replacing the AIR Pressure Regulator ... 105
5.2
Adjusting the AIR Pressure Regulator ... 108
5.3
Replacing the O2 Pressure Regulator ... 109
5.4
Adjusting the O2 Pressure Regulator ... 109
Replacing the Filters in the Gas Inlets
110
For internal use only. Copyright reserved.
GBK5664800IECIVZ.fm
Fault, Cause, Remedy 1
Alarm Messages
112
1
Service Diagnosis Mode (Optional)
117
1.1
Call-Up of Service Diagnosis Mode ... 118
1.2
“Front” Diagnosis ... 119
1.3
“Electronics” Diagnosis ... 120
1.4
“Pneumatics” Diagnosis ... 125
1.5
Error List ... 131
1.6
Error Number Definition ... 132
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Contents Schematics and Diagrams 1
Printed Circuit Boards Layout
135
2
Identification of the Printed Circuit Boards
136
Changes 1
Type of Changes
145
Appendix Spare parts list
146
For internal use only. Copyright reserved.
GBK5664800IECIVZ.fm
1
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General
This Service Manual conforms to the International Standard IEC 60601-1. Read each step in every procedure thoroughly before beginning any test. Always use the proper tools and specified test equipment. If you deviate from the instructions and/or recommendations in this Service Manual, the equipment may operate improperly or unsafely, or the equipment could be damaged. Use only original Dräger parts and supplies. The maintenance procedures described in this Service Manual may be performed by qualified service personnel only. These maintenance procedures do not replace inspections and servicing by Dräger Medizintechnik GmbH.
Strictly follow the Instructions for Use. This Service Manual does not replace the Instructions for Use. Any use of the product requires full understanding and strict observation of the product-specific Instructions for Use.
Unless otherwise stated, reference is made to laws, regulations or standards (as amended) applicable in the Federal Republic of Germany.
1
Symbols and Definitions − A dash (−) is used to identify items on a list.
For internal use only. Copyright reserved.
GBK5664800A01.fm 05.12.00
− A bullet (•) is used to identify a sentence that contains direct work instructions.
This symbol is used to provide important information that, if ignored, could lead directly to a patient’s or operator’s injury. It is also used to provide important information that, if ignored, could lead directly to equipment damage and, indirectly, to a patient’s injury.
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General
Page 9
This symbol is used to provide additional information, operating tips, or maintenance suggestions.
Inspection
=
examination of actual condition
Servicing
=
measures to maintain specified condition
Repair
=
measures to restore specified condition
Maintenance
=
inspection, servicing, and repair
For internal use only. Copyright reserved.
GBK5664800A01.fm 05.12.00
Definitions according to German standard DIN 31051:
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General
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Function Description
1
General
The Evita 4/Evita 2 dura is a time-cycled, constant-volume long-term ventilator for adults and children with a minimum body weight of 3 kg. The Evita 4/Evita 2 dura can be used for the following ventilation modes:
IPPV
Intermittent Positive Pressure Ventilation, controlled and assisted constantvolume ventilation with the following options: • CPPV = (Continuous Positive Pressure Ventilation) Controlled ventilation at a continuous positive airway pressure. • PLV = (Pressure Limited Ventilation) Pressure-limited, constant-volume ventilation. • AutoFlow® = for automatic optimizing of the inspiratory flow. • IRV = (Inversed Ratio Ventilation) Ventilation at a reversed I:E ratio.
SIMV
Synchronized Intermittent Mandatory Ventilation, weaning method for spontaneously breathing patients with the following options: • PLV = (Pressure Limited Ventilation) Pressure-limited, constant-volume ventilation. • AutoFlow® = for automatic optimizing of the inspiratory flow.
MMV
Mandatory Minute Volume Ventilation, spontaneous breathing with automatic synchronizing of mandatory ventilation and required minute volume of the patient. With the following options: • PLV = (Pressure Limited Ventilation) Pressure-limited, constant-volume ventilation.
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
• AutoFlow® = for automatic optimizing of the inspiratory flow.
SB
Spontaneous Breathing, spontaneous breathing at atmospheric pressure conditions.
CPAP
Continuous Positive Airway Pressure, spontaneous breathing at a positive airway pressure.
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ASB
Assisted Spontaneous Breathing, pressure-assisted spontaneous breathing.
BIPAP
Biphasic Intermittent Positive Airway Pressure, pressure-controlled ventilation combined with free spontaneous breathing during the entire respiratory cycle and adjustable pressure assistance on CPAP level.
APRV
Airway Pressure Release Ventilation, spontaneous breathing on two pressure levels with extended time ranges, independently variable.
Special methods:
ApnoeaFor automatic change-over to volume-cycled mandatory ventilation in the event Ventilation of apnoea. In this case the Evita 4 gives an alarm upon expiry of the set alarm time (Tapnoea >) and activates constant-volume ventilation.
ILV (optional)
Independent Lung Ventilation, bilateral, differentiated, synchronized ventilation with two Evita 4 units.
Intrinsic PEEP measurement
For determination of the intrinsic PEEP in air trapping.
Occlusion pressure measurement
For assessment of the respiratory drive during spontaneous breathing.
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GBF5664500T015664800.fm 05.12.00
Diagnosis:
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Monitoring: • Airway pressure (Paw) • Expiratory minute volume (MV) • Inspiratory O2 concentration (FiO2) • Inspiratory breathing gas temperature (T) • Expiratory CO2 concentration (etCO2) • Inspiratory tidal volume (V TI) • Apnoea time
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
• Tachypnoea monitoring to detect dead-space-intensive spontaneous breathing.
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2
Basic Principle
2.1
Evita 4
The Evita 4 consists of three components which communicate via a CAN (fast serial interface).
Control unit Evita 4
IPPV
E Störung O2-Messung Einstellung
30 100% O2
P FiO2
20 10
Insp. hold
0 -10 1
3
2
-----
MV
29
VT
669
P
26
i
Alarmgrenzen
Messw. Kurven
Messmanöver
21
,700
1,50
13,5
IPPV
27
40
10
CPAP
Reset Check
SIMV Kalibration
BPAP Konfiguration
Electronics
I O
CAN
UNOM 100...140 VAC 50/60 Hz INOM 3,2...1,2 A
COM1 RS 232C F1, F2 T5H 250 V IEC 127-21V
ILV Sync.
SpO2
Temp. CO2
Extensionbox
Pneumatics !
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
Exp.
Fig. 1: Basic components
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Function Description
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2.1.1
Control Unit
The control unit is the interface between the machine and the operator. The control unit serves to make adjustments, to display measured values and to activate alarms. In the control unit the display, membrane keypad, touch screen and Graphics Controller PCB are accommodated.
2.1.2
Electronics
The electronics is the central control unit of the Evita 4. It includes the CPU 68332 PCB, the CO2-Carrier PCB with the Processor Board PCB and Power Supply PCB and the power supply unit (Communication PCB, Paediatric Flow PCB and the optional SpO2 PCB). 2.1.3
Pneumatics
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
The pneumatics controls the pneumatic valves following preset ventilation parameters. It includes an independent microprocessor system and the valve control. In the pneumatics the Pneumatics Controller PCB, the HPSV Controller AIR/O2 PCB, the PEEP valve, the mixer, the pressure connection, the flow sensor and the O2 sensor are accommodated.
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2.2
Evita 2 dura
The Evita 2 dura has three components which communicate via a CAN (fast serial interface).
Front panel Evita 4
IPPV
Einstellung
P
30
SIMV + ASB 100% O2
hold
Exsp. hold
FiO2 MVtotal
40
4
2
ts
1
38
2
669
PEEP mbar
f 26 bpm
P
i Trigger L/min
Rampe s
Alarm Reset
Messw. Kurven
Pplat
PASB über PEEP
Messmanöver
Reset Check
Flow IPPV U/min
SIMV
Info. Bildstop aktiv
27 Ausdruck
Pinsp über PEEP
Tinsp s
VT 3
O2 Vol% Alarmgrenzen
29
Meß-
2
Pmean
VT ----L
MV
26 29 Zusätze ,700 I :1,50 E FiO2 13,5 Konfi1:2 35 guration 4 ts
21 0
10.2
mbar werte 45 Meß25 manöver
Ppeak
0
60 30 0 30 60
L/min Alarm14.5 grenzen
12.8
10
0
-10 Insp. hold
Erw.
P mbar 20
20 100% Insp. O2
Evita 2 dura
E Störung O2-Messung
Stop
40
CPAP
10
Kurven
Werte 1 2
IPPV
BPAP BIPAP
SIMV
Kalibration weitere Modi
Konfiguration
Electronics
I O
CAN
UNOM 100...140 VAC 50/60 Hz INOM 3,2...1,2 A
COM1 RS 232C F1, F2 T5H 250 V IEC 127-21V
ILV
Sync. SpO2
Temp. CO2
Extensionbox
Pneumatics !
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
Exp.
Fig. 2: Basic components
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Function Description
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2.2.1
Front Panel
The front panel is the interface to the user. The front panel allows the user to adjust the desired values. It displays the measured values and alarms. The front panel also contains the LCD, the membrane keyboard, the 7-segment displays, the Frontpanel PCB, and the 7–Segment PCB.
2.2.2
Electronics
The electronics is the central control unit of the Evita 2 dura. It contains the CPU 68332 PCB, the power supply unit, the CO2-Carrier PCB including the Processor Board PCB (optional), and the Power Supply PCB (optional). The Communication PCB, the Paediatric Flow PCB, and the SpO2 PCB are optional features. 2.2.3
Pneumatics
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
The pneumatics controls the pneumatic valves according to pre-set ventilation parameters. It has an independent microprocessor system and the control elements for the valves. The Pneumatic Controller PCB, the HPSV Controller AIR/O2 PCB, the PEEP valve, the mixer, the pressure connection, the flow sensor and the O2 sensor are part of the pneumatics.
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2.3
Basic principle Evita 4
P
P IPPV 30
E Störung O2-Messung
P FiO2
-----
MV
29
20 10
VT
0 -10 1
21
,700
3
2
1,50
P
669 26
O2
IPPV
13,5
5V
SIMV 27
40
CPAP
10
BPAP
4
5
10
25
11
12 13 14
9
3
18 19
20 21 2223 24
15
2
...
1
68 332 + TI 34010
6 7
68 332
16 17
68 332
Fig. 3: Basic principle
1 2 3 4
Keys Rotary knob including acknowledgement (by pressing knob) Touchscreen TFT display 640 x 480
5
Information LEDs and Alarm LEDs
6 7 8 9 10 11
CAN bus Graphics processor reset not applicabel Loudspeaker with sound chip Second loudspeaker (piezo) Voltage monitoring (activates reset of the processors and the piezo) Rechargeable battery (Goldcap capacitor)
15 Second inspiratory Paw 16 Reset pneumatics processor and venting 17 Electronics processor reset and second loudspeaker alarm 18 Inspiratory Paw 19 O2 sensor 20 FiO2 (HPSV mixer) 21 AIR (HPSV mixer) 22 Flow sensor 23 Expiratory valve with PEEP 24
Expiratory Paw
25 Loudspeaker with current monitoring
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
12
13 Supply voltages 14 Mains switch
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Function Description
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2.4
Basic principle Evita 2 dura
P
P SIMV + ASB
Erw.
!!! PAW hoch
P mbar
MVtotal
40
12.8
20
Ppeak
0
2
4
ts
60 30 0 30 60
38 Pmean
26 0
2
4
ts
L/min Alarm14.5 grenzen
10.2
Meß-
mbar werte 45 Meß25 manöver Pplat
I:E
FiO2
1:2
35 guration
O2
5V
29 Zusätze Konfi-
Info. Bildstop aktiv
4
5
25
10
11
12 13 14
9
3
Front panel
18 19
20 21 22 23 24
15
Electronics
Pneumatics
2
...
1
68020 + 68 332 + F 6554 x
6 7
68 332
16 17
68 332
Fig. 4: Basic principle
1 2 3 4
Keys Control knob with acknowledgment function (press) 7-segment displays LCD or TFT display, 640 x 480
5
Indicator LEDs and alarm LEDs
6 7 8 9 10 11
CAN bus Reset graphics processor Not applicable Loudspeaker with soundchip Second loudspeaker (piezo) Voltage monitoring (activates processors reset and the piezo) Battery (Goldcap capacitor)
15 Second Paw, inspiratory 16 Pneumatics processor reset and venting 17 Electronics processor reset and second loudspeaker alarm 18 Paw, inspiratory 19 O2 sensor 20 FiO2 (HPSV mixer) 21 Flow (HPSV mixer) 22 Flow sensor 23 Expiratory valve with PEEP 24 Paw, expiratory 25 Loudspeaker with current monitoring
For internal use only. Copyright reserved.
GBF5664500T015664800.fm 05.12.00
12
13 Supply voltages 14 Power switch
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Function Description
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