Technical Documentation
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Technical Documentation Savina Intensive Care Ventilator
Revision 8.0 5664.900 9036060
Emergency Care • Perioperative Care • Critical Care • Perinatal Care • Home Care
Because you care
Contents General 1
Notes 1.1
3
Symbols and Definitions ... 4
Function Description 1
7
1.1
Working principle ... 7
1.2
Monitoring ... 7
Principal components
9
2.1
Electronics ... 10
2.2
Control panel ... 14
2.3
Pneumatics ... 17
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General
I
Contents Maintenance Procedures 1
General notes
25
2
Replacing the microfilter
25
3
Replacing the dust filter set
27
4
Replacing the O2 sensors
28
5
Replacing the filter in the O2 inlet
29
6
Replacing the lead-gel battery (internal battery)
34
Schematics and Diagrams 1
Front view, Savina
41
2
Rear view, Savina
43
3
Identification of PCBs
46
3.1
O2 Valve PCB ... 46
3.2
Control PCB ... 48
3.3
Front Panel PCB ... 49
3.4
O2 Diaphragm PCB ...50
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II
Contents 4
Pneumatic diagrams
52
5
Tubing diagram
54
Annex Parts catalog Test List
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Technical Information
III
Contents
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All rights reserved. Copyright reserved.
IV
General
1
Savina 1
Notes
General This Technical Documentation conforms to the IEC 60601-1 standard. 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 Technical Documentation, 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 Technical Documentation may be performed by qualified service personnel only. These maintenance procedures do not replace inspections and servicing by the manufacturer. The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of the manufacturer.
Strictly follow the Instructions for Use manual / Operating Instructions! This Technical Documentation does not replace the Instructions for Use manual / Operating Instructions. Any use of the product requires full understanding and strict observation of the product-specific Instructions for Use manual/ Operating Instructions.
Reference is hereby made to the observance of the relevant safety provisions, for example in Germany, the Medical Product Law (MPG), the Medical Device Operator Ordinance (MPBetreibV), the Pressure Container Ordinance (Druckbehälterverordnung), the Technical Rules for Pressurized Gases (Technische Regeln Druckgase), or the Occupational Health and Safety Provisions (Unfallverhütungsvorschriften). Unless otherwise stated, reference is made to laws, regulations or standards (as amended) applicable in the Federal Republic of Germany.
Observe protection mark DIN 34. Copyright reserved.
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Follow the laws and regulations applicable in your country.
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General 1.1
Savina
Symbols and Definitions This symbol indicates a warning.
This symbol indicates tips and useful information.
This symbol is used to alert against unsafe practices when handling electrostatic sensitive devices (ESD).
= examination of actual condition
Maintenance
= measures to maintain specified condition
Repair
= measures to restore specified condition
Servicing
= inspection, maintenance, and repair
Observe protection mark DIN 34. Copyright reserved.
Inspection
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Definitions according to German standard DIN 31051:
Function Description
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Savina General
Savina is a long-term ventilator unit designed for patients with a tidal volume of 50 mL and above, and for the following applications: –
Intensive care unit
–
Recovery room,
–
Secondary transportation from hospital to hospital,
–
Patient transfer within the hospital,
–
Transfer flights.
1.1
Working principle
Savina generates the compressed air for ventilation with a blower, which means Savina is able to ventilate without any connection of compressed air or oxygen. A controllable valve is switched in parallel with the blower to regulate the pre-set ventilation parameters. The valve opens or closes according to the pre-set ventilation parameters. To increase the oxygen concentration in the ventilatory gas, an oxygen concentrator, such as Permox SilentCare, can be connected. If compressed oxygen is connected to Savina, the oxygen concentration of the ventilating gas can be precisely metered. The oxygen concentration is then metered internally with sensors, the associated electronics, and a bank of valves.
1.2
Monitoring
Savina has the following monitoring system:
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Function Description
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Measured values
Additional information
Measurement of the airway pressure (Paw)
Pressure curve is pT1-filtered. (T1 = 100 ms) The bargraph is additionally smoothed.
Measurement of insp. and exp. flow
---
Measurement of peak flow (FlowPeak)
---
Measurement of the inspiratory O2 concentration (FiO2)
PT1-filtered T1 = 2 s
Measurement of airway peak pressure (Ppeak)
---
Measurement of plateau pressure (Pplat)
---
Measurement of airway mean pressure (Pmean)
---.
Measurement of the positive endexpiratory pressure (PEEP)
---
Measurement of the expiratory volume (Vte)
Using the phase information from the ventilation control, the measured value is determined over one mandatory breath.
Measurement of the expiratory minute volume (MV)
Determined over 1 minute and filtered.
Measurement of the spontaneous minute volume (MVspon)
Determined over 1 minute and filtered.
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Function Description
Savina
Measurement of the total frequency (Ftot)
Determined over 1 minute and filtered.
Measurement of the spontaneous frequency (Fspn)
Determined over 1 minute and filtered.
Measurement of the inspiratory-expi- Using the phase information from ratory ratio (I:E). the ventilation control, the inspiratory time Tinsp and the expiratory time Texp of one respiratory cycle are determined. They are used to calculate I:E = Tinsp/Texp. The measured I:E-ratio is available as output value until the next inspiration is completed. A measurement is not carried out when an ASB breath changes into to a mandatory breath. The output values become invalid when the measurement is inactive, when a new value has not been determined for 15 s, or when more than 45 s have elapsed since the start of inspiration. Measurement of the plateau time (Tplat) Measurement of the inspiratory time (Tinsp)
Using the phase information from the ventilation control, the inspiratory time Tinsp and the plateau tiem Tplat are determined. The measured times are available as output values until the next inspiration is completed. A measurement is not carried out when an ASB breath changes into to a mandatory breath.
---
Measurement of the compliance (C)
---
Measurement of the temperature at the Y-piece (Temp.)
---
Only if optional NIV is enabled
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Measurement of the airway resistance (R)
For internal use only. Copyright reserved.
The output values become invalid when the measurement is inactive or when no new values have been determined for 15 seconds.
Savina
Function Description
Leakage volume in percent (MVleak) The patient flow and the patient flow clamped towards zero are totalized in two flow totalizers and their average is determined over 400 ms. These average values are filtered using a Bessel filter of the fourth order each and are then used as values for the leakage volume MVleak and the inspiratory minute volume MVinsp. This results in the MVleak readout according to: MVleak [%] = 100% * MVleak / MVinsp. Patient volume (VTpat)
---
Alarm limits / monitoring Apnea detection is adjustable (monitoring can be switched off in NIV). Detection of dead space-intensive spontaneous breathing (tachypnea monitoring). Airway pressure monitoring adjustable. Monitoring of minimum and maximum minute volumes is adjustable. Monitoring of maximum tidal volume is adjustable (monitoring can be switched off in NIV). The minimum and maximum limits for FiO2 are adjustable in (optional) LPO mode. A disconnection time, by which the “!!! Airway pressure low” warning is additionally delayed, is only adjustable in NIV.
For internal use only. Copyright reserved.
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Principal components
Savina consists of the electronics, the operator control unit and the pneumatic system, containing the following principal components:
Electronics
Control panel
Pneumatics
Power pack
Front Panel PCB
Plug-in unit
Control PCB
Display
Valve block
Motor Commutation PCB
Membrane keypad
Inspiratory block
O2 Valve PCB
Control knob
Pressure measuring unit
O2 Diaphragm PCB
Patient system
Fan
Flow sensors
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Function Description Electronics
2.1.1
Block diagram of the electronics with operator control
Power pack
The power pack delivers the supply voltages for Savina. The input voltage range of the power pack is 100 V to 240 V AC and 50 Hz to 60 Hz. However, the power pack can also be operated with an external rechargeable battery (12 V or 24 V) or with an external on-board - ambulance/helicopter - power supply (10.5 V to 36 V). The connection for the alternating voltage is made by a power cable. The connection for the external rechargeable battery or the external on-board power supply is made by a coded plug. The power pack actuates the three “Mains power”, “External battery or onboard power supply” and “Internal battery” LEDs. The LEDs are mounted on the membrane keypad of the operator control, and indicate the current operating status.
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Figure 1
For internal use only. Copyright reserved.
2.1
Savina
Savina
Function Description Savina includes 2 internal rechargeable batteries (2 x 12 V) which enable uninterrupted operation in the event of a complete failure of external power. The internal rechargeable batteries supply the O2 sensors with power, even when the Savina is switched off. As a result, valid O2 values are available immediately on power-up. The power pack supplies the following output voltages: –
+5 V
–
-15 V
–
+15 V
–
+24 V
–
+48 V
The output voltages are short-circuit-proof and stable at no-load. The output voltages are generated according to the following priority, dependent on the input voltages:
Input voltage
Priority
Action
AC voltage
1
Charge external and internal batteries, and maintain the charge.
External on-board power supply
2
Charge internal batteries, and maintain the charge.
External battery/batteries
3
Charge internal batteries, and maintain the charge.
Internal batteries
4
The fan cools the power pack. The heated air removes excess oxygen from the control unit and warms the patient system.
Control PCB
The Control PCB is the central “control and monitoring unit” of the Savina. It includes two separate processor systems: the master and front processors. The program memories are Flash-EPROMs. The Flash-EPROMs can be programmed with a laptop connected to the serial port of the Savina (software download). An EEPROM is provided for each processor system for storage of changeable, non-volatile data. The EEPROM of the master stores the calibration data of the sensors, fan, etc. The EEPROM of the front processor stores safety parameters, settings such as contrast, sound volume, etc., as well as a “backup copy” of the operating hours. The EEPROM of the front processor is plugged in and, if the board needs to be replaced, must be mounted on the new board.
For internal use only. Copyright reserved.
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2.1.2
The board is provided with a real-time clock which is used to display the time and to store the software options, the unit identification and the operating hours. The real-time clock is buffered by a battery which is integrated in the real-time clock. The real-time clock also holds the logbook. The real-time clock is plugged in and, if the board needs to be replaced, must be mounted on the new board.
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Function Description
Savina The control PCB contains the following functions:
–
Control of the blower and valves
–
Monitoring of the unit functions and the supply voltages
–
Actuation of the displays
–
Keypad interpretation
–
Delivery of the internal and external interfaces.
Block diagram: Control PCB
Motor Commutation PCB
The motor commutation PCB controls the motor of the blower. The entire control functionality is located in a self-contained housing. The supply voltage is +48 V, and is delivered by the power pack. The +48V on the Motor Commutation PCB are protected with a fuse (6.3AT). The input voltage range of the Motor Commutation PCB is 12 to 52.5V. The rotation speed is set by the Control PCB. The control voltage for the rotation speed is 0 to +5.00 V, corresponding to a rotation speed of 0 to 12,000 rpm. The rotation speed range is 4000 to 12.000 rpm.
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2.1.3
Processing of the signals from the sensors (O2, flow, pressure, temperature),
For internal use only. Copyright reserved.
Figure 2
–
Savina
Function Description The Motor Commutation PCB delivers the “actual rotation speed signal” to the Control PCB. The “actual value signal” is 6 pulses per rotation. In the event of discrepancies in the rotation speed the Control PCB adjusts the speed according to the deviation.
Figure 3
2.1.4
O2 Valve PCB
Block diagram of the Motor Commutation PCB
The O2 Valve PCB holds the pressure sensors (2x absolute pressure S6 and S7, 1x O2 supply pressure S5), the actuator for the O2 calibrating valve and the nebulizer valve, and the actuator for the valve bank. The signals from the pressure sensors are amplified and passed to the control PCB. The +5 V voltage supply to the pressure sensors is generated on the O2 valve PCB.
For internal use only. Copyright reserved.
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The valves in the valve bank, the O2 calibrating valve and the nebuliser valve can be operated individually by an electronic switch. They are actuated by the control PCB.
Figure 4 5664.900
Block diagram: O2 valve PCB
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Function Description 2.1.5
O2 Diaphragm PCB
Savina The O2 Diaphragm PCB amplifies the signals from the O2 sensors and measures the temperature of the O2 sensors and of the respiratory gas in the inspiration block. The temperature of the O2 sensors is required to compensate for the temperature-sensitive O2 measurements. The calibration data from the sensors are stored on the control PCB in an EEPROM. The reference voltage of the O2 sensors is generated from the voltage of the rechargeable batteries, and so is also available when the unit is switched off. The operating voltages of the O2 diaphragm PCB are +5 V and +15 V.
Figure 5
2.1.6
Fan
O2 amplifier block diagram
The fan takes in ambient air through the cooler of the blower and cools the blower. The air flow also removes excessive oxygen from the device.
2.2
14
Control panel
Fan control
The operator control is the interface between the unit and the user. It is used to enter and display the ventilation parameters.
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Figure 6
For internal use only. Copyright reserved.
The voltage supply to the fan is +24V. The rotation speed of the fan is controlled by the Control PCB.
Savina
Function Description
Figure 7
For internal use only. Copyright reserved.
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2.2.1
Front Panel PCB
Figure 8
2.2.2
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Control panel block diagram
The Front Panel PCB contains the 7-segment displays for the pre-set ventilation parameters, the drivers for the key LEDs, the drivers for interpretation of the keys and the shaft encoder, and the voltage generator for backlighting of the display. The voltage generation for the backlighting can be switched on and off from the control PCB.
Front Panel PCB block diagram
Display
The display shows the patient parameters and the warning messages. The display is actuated by the Control PCB; the display backlighting is actuated by the Front Panel PCB. The display resolution is 240 x 128 pixels. The voltage supply is +5 V and -15 V.
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Savina
Membrane keypad
The membrane keypad contains the keys, with associated LEDs, to operate the Savina.
2.2.4
Control knob
The control knob is used to set and confirm changeable ventilation parameters. The control knob transmits square signals to the Front Panel PCB as it rotates, and the signals are then evaluated by the Control PCB. The voltage supply is +5 V.
For internal use only. Copyright reserved.
2.2.3
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Function Description
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Savina
2.3
Figure 9
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Function Description
Pneumatics
Pneumatic diagram 8412996, revision 23
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