Dräger Savina 300 Technical Documentation Manual
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Dräger Savina 300 Technical Documentation Manual

Intensive care ventilator
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Technical Documentation IPM
Savina 300
Intensive Care Ventilator
Warning
All servicing and/or test procedures on the
device require detailed knowledge of this docu-
mentation. Use of the device requires detailed
knowledge and observance of the relevant
Instructions for Use.

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Summary of Contents for Dräger Savina 300

  • Page 1 Technical Documentation IPM Savina 300 Intensive Care Ventilator Warning All servicing and/or test procedures on the device require detailed knowledge of this docu- mentation. Use of the device requires detailed knowledge and observance of the relevant Instructions for Use.
  • Page 2 – This page has been intentionally left blank – Savina 300...

  • Page 3: Table Of Contents

    Replacing the consumables in the O2 gas inlet ........Annex Savina 300...
  • Page 4 – This page has been intentionally left blank – Savina 300...

  • Page 5: General

    General This chapter contains general notes and definitions that are important for the use of this documentation. General notes ............................ Savina 300...

  • Page 6: General Notes

    NOTE A NOTE provides additional information intended to avoid inconvenience during operation and/or servicing. Inspection Identification of actual condition Maintenance Measures to maintain the speci- fied condition Repair Measures to restore specified condition Servicing Inspection, maintenance, repair Savina 300...
  • Page 7 The device may transmit pathogens following use on the patient. – Before carrying out any servicing, ensure that the device and its com- ponents have been handed over by the user cleaned and disinfected. – Service only cleaned and disinfected devices and device components. Savina 300...
  • Page 8 Where reference is made to legislation, regulations and standards, in respect of devices used and serviced in Germany they are based on the laws of Germany. Users and technicians in other countries must comply with their national laws and/or international standards. Savina 300...

  • Page 9: Function Descriptions

    Function descriptions This chapter contains descriptions of the device's technical functions. Block diagram and functional principle ....................Electronic assembly ........................... Control panel with TFT colour display....................Pneumatic assembly .......................... Savina 300...

  • Page 10: Block Diagram And Functional Principle

    Function descriptions Block diagram and functional principle Block diagram and functional principle Introduction The following text sets out the block diagram and the functional principle of the Savina 300. Block diagram Fig. 1 Block diagram Savina 300 Savina 300...
  • Page 11 Sensors, the electronics and the valve block meter the oxygen concentration. Main components The device consists of the following main components: – Elektronic assembly – Control unit – Pneumatic assembly Savina 300...

  • Page 12: Electronic Assembly

    The output voltages are generated according to the following priority, depen- dent on the input voltages: Input voltage Priority Action AC voltage Charge external and internal batteries, and maintain the charge. External battery/batteries Charge internal batteries, and maintain the charge. Internal batteries Savina 300...
  • Page 13 Control of the ventilation – Monitoring of the front processor The master processor data are cached in the RAM. The EEPROM of the master processor system stores the calibration data of the sensors and set values such as volume. Savina 300...
  • Page 14 If the mains power fails, the device switches to the internal batteries which supply the device with power. If the internal batteries are discharged and the device has no external batteries, an acoustic alarm is sounded with a Gold- Cap and a horn. Savina 300...
  • Page 15 Central Control Board. The „actual value signal“ is 6 pulses per rotation. In the event of discrepancies in the rotation speed the Central Control Board adjusts the speed according to the deviation. Fig. 3 Block diagram of the motor actuator Savina 300...
  • Page 16 Central Control Board stores the calibration data of the sensors. The refer- ence voltage for the O2 sensors is generated from the voltage of the rechargeable batteries. The supply voltages for the O2 Diaphragm PCB are +5 V and +15 V. Fig. 5 O2 Diaphragm PCB block diagram Savina 300...
  • Page 17 The air flow removes excess oxygen from the device. The supply voltage for the fan is +24 V. The Central Control Board regulates the speed of the fan. Fig. 6 Fan control Item Designation Supply voltage Target speed Speed signal Sensor supply voltage Ground Savina 300...

  • Page 18: Control Panel With Tft Colour Display

    The rotary knob is used to set and acknowledge the ventilation parameters. The shaft encoder transmits square signals to the processor system as it rotates, and the signals are then evaluated by the Central Control Board. The voltage supply is +5 V. Savina 300...
  • Page 19 The Central Control Board controls the communication between the proces- sor system and the touch-screen. The correct position is determined with the aid of the relevant software drivers. The analog touch-screen works very pre- cisely, and provides a high resolution. Savina 300...

  • Page 20: Pneumatic Assembly

    Functional diagram Fig. 9 Functional diagram Item Designation Micro-filter (AIR) Filter (O2) Filter (inspiratory flow sensor) Filter (Filter element) Volume Mixing chamber Suction sound insulator Sound insulator Supply pressure regulator (Oxygen) Gebläse Blower Kühler Cooler Reduction valve Expiratory valve Savina 300...
  • Page 21 Metering unit for O2 measurement (0,2 L/min at 30 mbar, Sensor 3.2) Main components The pneumatic assembly consists of the following components: – Plug-in unit – Valve block – Inspiratory block – Pressure measuring block – Patient system – Flow sensors Savina 300...
  • Page 22 V1 is reduced. During the expiratory phase all the blower gas flows through the bypass valve V1. The cooler reduces the respiratory gas temperature down to a permissible range. Savina 300...
  • Page 23 S1. The oxygen is metered in a closed con- trol loop. In the process, the inspiratory O2 concentration is measured by the O2 sensor S 3.1. Fig. 11 Detail view of functional diagram; O2 mixture with O2 high pres- sure Savina 300...
  • Page 24 Detail view of functional diagram; O2 mixture with O2 low pressure When no O2 low pressure source is connected to the unit, the non-return valve D6 prevents gas from escaping during normal operation. NOTE In „LPO“ mode, the valve block in the O2 supply is not actuated. Savina 300...
  • Page 25 2 bar.During the nebulizing phase the solenoid valve V5 operates in an “inspi- ration” (open position) and “expiration” (closed position) cycle. When the neb- ulizer function is inactive the nebulizer switching valve V5 is closed. Fig. 14 Detail view of functional diagram; drug nebulier Savina 300...
  • Page 26 S3.1 during ventilation. The oxygen sensor S3.2 must be calibrated man- ually (patient disconnected). Fig. 15 Detail view of functional diagram; O2 calibration function O2 sensor detection The device has an oxygen sensor detector which is necessary for the „LPO“ option. Savina 300...
  • Page 27 Detail view of functional diagram; pressure sensors and oxygen sensor The airway pressure sensor S4.1 measures the pressure in the inspiratory branch. The airway pressure sensor S4.2 measures the pressure in the expi- ratory branch. The output signals of the airway pressure sensors are needed Savina 300...
  • Page 28 The calibration valves V6.1 and V6.2 enable calibration of the inspiratory and expiratory airway pressure sensors. During calibration, the corresponding calibration valve interrupts the connection to the ventilation circuit and switches the airway pressure sensor to ambient pressure. Fig. 18 Detail view of functional diagram; calibration valves Savina 300...
  • Page 29 Detail view of functional diagram; flow sensor Expiration is executed with the directly actuated expiratory valve V3. The expiratory valve has the following functions: – PEEP control during the expiratory phase – Close the breathing system during the inspiratory phase. Savina 300...
  • Page 30 – This page has been intentionally left blank – Savina 300...

  • Page 31: Maintenance Instructions

    Replacing the microfilter ........................Replacing the dust filters........................Replacing the O2 sensors........................Replacing the diaphragm of the expiratory valve ................Replacing the internal batteries ......................Replacing the external batteries ......................Replacing the consumables in the O2 gas inlet ................. Savina 300...

  • Page 32: Disassembling/Assembling The Device

    Rear panel Removing/fitting the Savina 300 from/into the trolley Preconditions – The O2 and mains power supply to the Savina 300 have been cut. – The tubing system and fitted units have been removed. Removal 1. Loosen the nuts (Fig.
  • Page 33 Maintenance instructions Disassembling/assembling the device 3. Lift the Savina 300 out of the trolley. Installation 1. Place the Savina 300 in the trolley. 2. Use the screws (Fig. 22/3) to secure the Savina 300 to the trolley. 3. Push the locking devices (Fig.
  • Page 34 23/1) of the filter cover into the rear panel until they lock in place. Fig. 24 Detail view of filter cover; tabs and recesses 2. Lay the power cable (Fig. 23/2) around the filter cover guide, as shown in the illustration. Fitting of the filter cover is complete. Savina 300...
  • Page 35 Removal 1. Pry the tab fuse (Fig. 25/2) from its holder using a small screwdriver or similar tool. 2. Remove the connectors and tubing listed below from the Savina 300, if fitted: Fig. 25 View of device rear; connections Item...
  • Page 36 26/1) towards A and take it out of the rear panel. Fig. 26 View of right rear of device; cable retainer 4. Remove the Savina 300 from the trolley, see section headed „Remov- ing/fitting the Savina 300 from/into the trolley“. 5. Remove the screws (9x) (Fig.
  • Page 37 Savina 300 from/into the trolley“. 4. Re-attach removed connectors and tubing to the Savina 300. 5. Fit the filter cover on the Savina 300, see section headed „Filter cover“. 6. Plug the tab fuse for the internal batteries into the holder on the power supply unit.

  • Page 38: Replacing The Microfilter

    28/1) is located on the rear of the device. Fig. 28 Device rear; microfilter Removal Preconditions – Savina 300 is switched off. Procedure 1. Reach into the openings in the filter cover on both sides, press the catches concealed behind them (Fig. 29/1) simultaneously towards A slightly, move the filter cover back slightly and take the filter cover out of the rear panel.
  • Page 39 30/2) by the tab (Fig. 30/1) out of its mount and dispose of it in the domestic waste bin. Fig. 30 Savina 300 rear; microfilter Removal of the microfilter is complete. Fitting 1. Insert the new microfilter (Fig. 30/2) into its mount as far as it will go.

  • Page 40: Replacing The Dust Filters

    32/1) simultaneously towards A slightly, move the filter cover back and take the filter cover out of the rear panel. 2. Withdraw the power cable (Fig. 32/2) from filter cover guide. Fig. 32 Savina 300 rear; filter cover Savina 300...
  • Page 41 32/1) press the filter cover into the rear panel until it locks in place. Fig. 34 Detail view of filter cover: Fitting 3. Lay the power cable (Fig. 32/2) around the filter cover guide, as shown in the illustration. Fitting of the dust filters is complete. Savina 300...

  • Page 42: Replacing The O2 Sensors

    The following section provides a view of the O2 sensors and describes how to remove, fit and calibrate them. View The O2 sensors (Fig. 35/1) are located behind the cover plate on the front of the Savina 300. Fig. 35 Device front; O2 sensors Savina 300...
  • Page 43 Maintenance instructions Replacing the O2 sensors Removal Preconditions – The Savina 300 is switched off and disconnected from the mains power supply. Service equipment – Screwdriver required Procedure 1. Swivel the inspiratory port (Fig. 36/1) down. 2. Loosen the screw (Fig.
  • Page 44 2. Swivel the inspiratory port (Fig. 39/1) down. 3. Use the screw (Fig. 39/2) to secure the cover plate (Fig. 39/3) on the Savina 300. Fig. 39 Device front; cover plate Fitting of the O2 sensors is complete. Savina 300...
  • Page 45 „HPO“ mode NOTE To be able to calibrate the Savina 300 correctly, you must wait for the device to warm up. If the blade fuse was removed, it may take as long as 20 minutes for the device to warm up.
  • Page 46 During the 10-minute warm-up phase after switching on the Savina 300 b) Up to one hour after the Savina 300 has been subjected to a major temperature change, such as being transported from a cold room to a heated room or due to extreme ventilation settings.

  • Page 47: Replacing The Diaphragm Of The Expiratory Valve

    41/2) to the left as far as it will go. 3. Turn the locking ring (Fig. 41/3) of the expiratory valve to the left towards B as far as it will go. Fig. 41 Detail view of Savina 300; removing the expiratory valve Savina 300...
  • Page 48 Removal of the expiratory valve diaphragm is complete. Fitting 1. Clip the new diaphragm (Fig. 43/1) onto the rim of the expiratory valve (Fig. 43/2) so that it engages on the expiratory valve rim all the way round. Fig. 43 Expiratory valve; fitting the diaphragm Savina 300...
  • Page 49 Maintenance instructions Replacing the diaphragm of the expiratory valve 2. Push the expiratory valve into the mount on the Savina 300 until you feel a resistance and turn the locking ring (Fig. 44/3) of the expiratory valve all the way to the right towards B until you feel it lock in place.

  • Page 50: Replacing The Internal Batteries

    Rear of device; cover plate Removal Preconditions – The Savina 300 has been switched off and disconnected from the mains power supply. – The fuse link for the internal batteries has been removed from its holder on the power supply unit.
  • Page 51 (Fig. 46/1). 2. Remove the cover plate (Fig. 46/2). Fig. 46 Rear of device; cover plate 3. Pull on the tab (Fig. 47/1) and withdraw the battery slightly out of the device. Fig. 47 Rear of device; tab Savina 300...
  • Page 52 Fig. 49 Rear of device; cable connector (3x) NOTE Batteries are special waste. When disposing of them, observe local waste disposal regulations. 8. Dispose of batteries according to local waste disposal regulations. Removal of the batteries is now complete. Savina 300...
  • Page 53 Maintenance instructions Replacing the internal batteries Fitting 1. Place the new batteries in front of the Savina 300, paying attention to their orientation (the lugs of the batteries point upwards towards the O2 supply). 2. Push the cable connectors (Fig.

  • Page 54: Replacing The External Batteries

    The following section provides a view of the external batteries and describes how to remove and fit them. View The external batteries are located behind the cover of the battery pack (Fig. 50/1). Fig. 50 Trolley; cover (battery pack) Savina 300...
  • Page 55 Replacing the external batteries Removal Preconditions – The Savina 300 has been switched off and disconnected from the mains power supply. – The connector of the DC battery cable has been disconnected from the power supply unit of the Savina 300.
  • Page 56 53/1) initially just two turns. Fig. 53 View of external batteries; screw (strap) CAUTION Danger of injury by falling battery! When removing the batteries there is a risk that the upper battery might fall out. – Hold the top battery during removal. Savina 300...
  • Page 57 8. Remove used batteries and place them aside. 9. Remove the mounting brackets (Fig. 55/2) from the used batteries and fit them to the new batteries. NOTE Used batteries are special waste. Dispose of used batteries in accordance with local waste disposal regulations. Savina 300...
  • Page 58 – Check the condition of the insulating strip before fitting the batteries. 1. Check that the insulating strip (Fig. 56/1) is not damaged; replace it as necessary. Fig. 56 Battery pack for external batteries; insulating strip Savina 300...
  • Page 59 57/2) in the battery pack, holding the battery firm while fitting it. 6. Insert the locating pin (Fig. 58/1) of the strap in the upper support as shown in the illustration. Fig. 58 View from above of battery pack; locating pin Savina 300...
  • Page 60 Maintenance instructions Replacing the external batteries 7. During fitting, hold the upper battery (Fig. 59/1) and screw in the screw with bar (Fig. 59/2) a few turns. Fig. 59 View of external batteries; screw with bar Savina 300...
  • Page 61 Risk of device failure due to electrical short-circuit! If the electrical wires of the batteries contact the housing, an electrical short-circuit may occur and cause a device failure. – Screw the wires onto the batteries so that no contact with the housing is possible. Savina 300...
  • Page 62 Cable with red marking on positive terminal (Fig. 61/2) (+) of top bat- tery b) Cable with no marking on negative terminal (Fig. 61/3) (--) of bottom battery Fig. 61 View of external batteries; electrical connections Savina 300...
  • Page 63 12. Place the cover on the battery pack so that the groove (Fig. 62/2) of the cover and the tongue engage. 13. Make sure the end profile (Fig. 63/1) is sealed off from the column. Fig. 63 View from above of battery pack; end profile Savina 300...
  • Page 64 Detail view of trolley; screw 15. Insert the connection socket of the DS battery cable for the external bat- teries in the connector on the rear of the Savina 300. Fitting of the external batteries is complete. 16. Perform the „function test“ and „electrical safety test“ as per the test instructions.

  • Page 65: Replacing The Consumables In The O2 Gas Inlet

    Fig. 65 Rear of device; fitting location of consumables Removal Preconditions – Savina 300 has been disconnected from the mains power supply and the O2 supply. – ESD precautions have been taken. – The Savina 300 has been removed from the trolley, see „Disassem- bling/assembling the device“...
  • Page 66 1. Using a torque spanner and an insertion tool (size 22 mm), unscrew the connection (Fig. 66/1) anti-clockwise. Fig. 66 View of O2 gas inlet; screw connection 2. Push the seal (Fig. 67/1) off of the connector plate. Fig. 67 View of O2 gas inlet; seal Savina 300...
  • Page 67 68/1) and dispose of it in accordance with local waste disposal regulations. Fig. 68 View of O2 gas inlet; washer 4. Remove the screws (Fig. 69/1) and detach the connector plate (Fig. 69/2). Fig. 69 View of O2 gas inlet; screws Savina 300...
  • Page 68 View of O2 gas inlet; sealing ring 6. Take out the gas inlet filter (Fig. 71/1) and dispose of it in accordance with local waste disposal regulations. Fig. 71 View of O2 gas inlet; gas inlet filter Removal of the consumables is complete. Savina 300...
  • Page 69 7. Fit the rear panel, see also „Disassembling/assembling the device“ sec- tion headed „Rear panel“. 8. Re-attach removed tubing and connectors to the appropriate connections on the Savina 300. 9. Fit the filter cover, see also „Disassembling/assembling the device“ sec- tion headed „Filter cover“.
  • Page 70 – This page has been intentionally left blank – Savina 300...

  • Page 71: Annex

    Annex Parts catalog This chapter contains a list of the device's orderable parts. Test Instructions This chapter contains the measures required to determine the actual condi- tion of the device. Savina 300...
  • Page 72 – This page has been intentionally left blank – Savina 300...
  • Page 73 Parts catalog Savina 300 Revision: 01 2010-07-23 5664.920...
  • Page 74 Parts catalog Equipment affected Item Remark Order No. Description Qty. Qty.unit 8417800 Savina 300, System 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 2/37...
  • Page 75 1.000 8418922 Flat cable,O2-Measuring Module 1.000 D04766 PACKING RING 1.000 1340727 OVAL HEAD SCR.DIN7985-M3X6-A2 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 3/37...
  • Page 76 1.000 19 8412952 CREW 1.000 20 8419303 O-ring 16x1.25 1.000 21 8411147 Non-return valve 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 4/37...
  • Page 77 Lip seal (gray) 1.000 8413661 Membrane, complete 1.000 8416204 Pot (grey) 1.000 M20622 O-RING SEAL 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 5/37...
  • Page 78 1.000 8416370 Cable harness flow switch 1.000 8413610 Valve actuator 1.000 8417921 Pba FrontPneuBoard 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 6/37...
  • Page 79 Insertion Strip NL 1.000 22 8417872 Insertion Strip BG 1.000 23 8417873 Insertion Strip SE 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 7/37...
  • Page 80 32 8417830 Pressing foot 1.000 33 8417852 Swivel axis 1.000 34 8417853 Spacer bolt 2.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 8/37...
  • Page 81 1.000 8418783 PCB Support hinge pivoting 1.000 8417911 Pba BackPneuBoard 1.000 8418817 EMC Gasket-D3 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 9/37...
  • Page 82 Order No. Description Qty. Qty.unit 8413579 TSI-sensor 1.000 8418793 TSI tube 1.000 8413700 CABLE HARNESS 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 10/37...
  • Page 83 1.000 1841416 Lead-acid battery 12V/3.5AH 1.000 8416370 Cable harness flow switch 1.000 8408197 SOCKET 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 11/37...
  • Page 84 Valve actuator 1.000 1339958 COUNTER SUNK SCREW M4X8 DIN965 4.000 10 8413748 FILTER TSI 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 12/37...
  • Page 85 6737545 MICROFILTER 1.000 8413609 MAINS SWITCH 1.000 8418932 Cover 184_206 1.000 8418931 Cover 150-175 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 13/37...
  • Page 86 13 8417753 Ground cable -85 1.000 14 CH09932 RUBBER BUFFER 1.000 15 8418789 Grommet 9.5mm 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 14/37...
  • Page 87 1.000 23 8418788 O_Ring 2.8x1.8 1.000 24 M12701 O-RING 1.000 25 8410713 O-RING SEAL 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 15/37...
  • Page 88 8410713 O-RING SEAL 1.000 D04766 PACKING RING 1.000 6804141 Isolate socket 1.000 8400964 SOCKET 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 16/37...
  • Page 89 Rebound strap 1.000 10 8417896 Rebound strap pin 2.000 11 8418783 PCB Support hinge pivoting 4.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 17/37...
  • Page 90 Hexagon bolt M5 DIN985 2.000 13 8418933 Device retaining sheet 2.000 14 1329235 Hexagon bolt M5X12 DIN933 2.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 18/37...
  • Page 91 17 8418818 Back plane, compl. 1.000 18 8417880 Unit feet 1.000 19 8418780 Cable holder 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 19/37...
  • Page 92 Flat cable, Valve bench 1.000 8418757 Cable backend 1.000 8417937 Interface Cable RS232 1.000 8418758 Cable frontend 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 20/37...
  • Page 93 1.000 15 8416370 Cable harness flow switch 1.000 16 8414028 Cable harness spirolog sensor 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 21/37...
  • Page 94 Cable harness motor electronic 1.000 8413582 CABLE POWERPACK 1.000 8413584 Cable power supply, akku 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 22/37...
  • Page 95 HOSE 2X1-SIGN BL 1.000 1204823 HOSE 2X1-SIGN ORANGE 1.000 1198912 HOSE 12X3-SI NF M29909 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 23/37...
  • Page 96 1.000 1198912 HOSE 12X3-SI NF M29909 1.000 10 8401083 T-PIECE 1.000 11 8406909 DIODE 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 24/37...
  • Page 97 Claw 160 1.000 1843303 Lead-acid battery 12V/17AH 2.000 8417321 Accu mounting bracket 2.000 8418810 DC-Akku-Cable 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 25/37...
  • Page 98 O-RING SEAL 1.000 8414137 Closure (LPO) 1.000 8415745 Retainer cap 1.000 8418824 Label LPO 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 26/37...
  • Page 99 Monitor Item Remark Order No. Description Qty. Qty.unit 8418819 Monitor bracket Savina 300 1.000 1343319 Countersunk screw M5X12 DIN7991 1.000 8417510 Monitor mounting Evita XL 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts...
  • Page 100 Qty. Qty.unit 8418924 Nurse call shield 1.000 8418826 Option Nurcecall 1.000 8417941 PBA RelaisBoard 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 28/37...
  • Page 101 Software Item Remark Order No. Description Qty. Qty.unit 8418925 CD Software 3.51 Savina 300 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 29/37...
  • Page 102 Parts catalog Savina 300, yearly Item Remark Order No. Description Qty. Qty.unit MX08859 Savina 300 Service Set 1y 1.000 8417898 Set dust filter 1.000 8413661 Membrane, complete 2.000 6737545 MICROFILTER 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts...
  • Page 103 Parts catalog Savina 300, 2-yearly Item Remark Order No. Description Qty. Qty.unit MX08860 Savina 300 Service Set 2y 1.000 8417898 Set dust filter 1.000 8413661 Membrane, complete 2.000 1841416 Lead-acid battery 12V/3.5AH 2.000 6737545 MICROFILTER 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts...
  • Page 104 Parts catalog Savina 300, 6-yearly Item Remark Order No. Description Qty. Qty.unit MX08861 Savina 300 Service Set 6y 1.000 8417898 Set dust filter 1.000 8416117 Filter Gas Inlet 1.000 M09257 PACKING RING 3.000 M19311 WASHER 3.000 1845527 REAL TIME CLOCK DIL24 RoHS 1.000...
  • Page 105 Engine-blower-unit kit Item Remark Order No. Description Qty. Qty.unit 8413643 Spare Parts (Blow.Engine Unit) 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 33/37...
  • Page 106 SET OF SPARE BRACKETS 1.000 8414698 Aquapor EL, Humidifier 1.000 8412935 MED. NEBULIZER EVITA 4 (PNEU) 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 34/37...
  • Page 107 Qty.unit MK01900 SpiroLife 1.000 10 8405371 TEMPERATURE SENSOR 1.000 11 2M85446 Connecting hose holder 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 35/37...
  • Page 108 TORQUE WRENCH, 5 - 50 NM 1.000 7910132 TORQUE WRENCH, 20-100 NM 1.000 7901204 WRENCH, SPECIAL OPEN-ENDED, WAF 17 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Savina 300 Revision: 01 36/37...
  • Page 109 1190520 HOSE 4X1,5-SI 50 SH A NF 1.000 1197851 SILICONE HOSE 6X2,5 NF M29907 1.000 Items that are shown in the illustration but are not listed below the illustration are not available as spare parts Revision: 01 Savina 300 37/37...
  • Page 110 - This page has been intentionally left blank -...
  • Page 111 Test instructions / Service Card IPM Savina 300 NOTE – Prior to using these test instructions, check that they are the latest revi- sion (compare revision with current service documentation). – All results and inputs must be documented in the „Test Report“ or „Result Sheet“, as applicable.
  • Page 112 – This page has been intentionally left blank – 2 / 50...
  • Page 113 Condition tests .......................... 30 4.1.1 Accompanying documents ..................30 4.1.2 Device labelling ......................30 4.1.3 General condition (Savina 300, accessories and special accessories)...... 31 4.1.4 „O2“ compressed gas connecting tube ..............31 4.1.5 Option, trolley (general condition) ................31 4.1.6 Option, LPO (external oxygen supply) ...............
  • Page 114 Table of contents 4.2.2 Safety valve (D1) ......................34 4.2.3 Emergency respiratory valve (D2) ................35 4.2.4 Power supply unit ....................... 36 4.2.5 Emergency expiratory valve ..................37 4.2.6 Testing the ventilation....................38 4.2.7 O2 control (VC-CMV/VC-AC) ..................40 4.2.8 Paw pressure regulation (VC-CMV/VC-AC) ...............

  • Page 115: Device Configuration

    1 Device configuration This chapter is used to record the device configuration. Savina 300..........................6 5 / 50...

  • Page 116: Savina 300

    Software version and operating hours Action • Switch on the Savina 300. • Set the Savina 300 to „Standby“ mode. • Press the „Alarm Reset” key to reset the acoustic alarm. • Press the „System configuration“ softkey. • Select the „Options“ submenu.

  • Page 117: Reading Out Customer-Specific Settings

    [________h] 1.1.4 Reading out customer-specific settings Prerequisites Savina 300 is connected to the mains power supply and is switched on. Savina 300 is in „Standby“ mode. NOTE After completion of the test procedure, re-enter the customer-specific set- tings before handing the unit over to the customer/owner.
  • Page 118 Device configuration Savina 300 Entry MV high [________txt] Entry MV low [________txt] Entry [________txt] Entry V Ti [________txt] Entry [________txt] Entry T apn [________txt] Action • Press the „System configuration“ softkey. • Select the „Ventilation“ submenu. • Read and note down the following parameters from the display:...
  • Page 119 2 Maintenance parts This chapter contains interval-related maintenance parts, measures, and tests that can only be performed on an open device. Maintenance and inspection ..................... 10 Maintenance parts, yearly ......................10 Maintenance parts, 2-yearly ..................... 11 Maintenance parts, 6-yearly ..................... 12 Maintenance parts, 8-yearly, but at the latest after 20000 operating hours......

  • Page 120: Maintenance Parts Maintenance And Inspection

    12000 operating hours, whichever occurs first. Then yearly or af- ter 6000 operating hours, whichever occurs first. Maintenance parts, yearly 2.2.1 Savina 300 service set The service set (quantity 1) with the number MX08859 includes the following items: Quan-...

  • Page 121: Maintenance Parts, 2-Yearly

    Maintenance parts Maintenance parts, 2-yearly Maintenance parts, 2-yearly 2.3.1 Service set for Savina 300 The service set (quantity 1) with the number MX08860 includes the following items: Quan- Designation Number Location/Remark tity Microfilter 6737545 Filter mount / Trained person- Set of dust filters S...

  • Page 122: Maintenance Parts, 6-Yearly

    Maintenance parts Maintenance parts, 6-yearly Maintenance parts, 6-yearly 2.4.1 Service set for Savina 300 NOTE After replacing the real-time clock make the following settings on the device: – Current date and time – User/operator ventilation settings and alarm limits. The service set (quantity 1) with the number MX08861 includes the following...

  • Page 123: Maintenance Parts, 8-Yearly, But At The Latest After 20000 Operating Hours

    Blower Quan- Designation Number Location/Remark tity Blower with spare 8413643 Savina 300 / Trained person- parts set nel with product-specific Drä- gerService training Entry Next replacement: [________dat] 2.5.2 Service set for Savina 300 The service set (quantity 1) with the number MX08860 includes the following...
  • Page 124 Maintenance parts Maintenance parts, 8-yearly, but at the latest after 20000 operating hours – This page has been intentionally left blank – 14 / 50...
  • Page 125 3 Electrical safety This chapter contains tests that need to be performed in order to verify that the medical elec- trical system is operational. Electrical safety to EN 62353 ....................16 Electrical safety according to IEC 60601-1................24 15 / 50...

  • Page 126: Electrical Safety Electrical Safety To En 62353

    Electrical safety Electrical safety to EN 62353 Electrical safety to EN 62353 NOTE The device conforms to the conditions of protection class I. When the airway temperature sensor is connected it conforms to type BF. Introduction The following subsections provide descriptions of device checks, recurrent testing and testing after servicing of medical electrical (ME) devices.

  • Page 127: Protective Conductor Resistance

    Electrical safety Electrical safety to EN 62353 3.1.2 Protective conductor resistance Test set-up Fig. 1 Protective conductor resistance Item Designation Tester Device under test Tester probe cable Conductor Neutral conductor Protective earth conductor Action • Prepare the test setup. • Switch the tester on. •...

  • Page 128: Protective Earth Conductor Resistance Measurement Points

    Electrical safety Electrical safety to EN 62353 3.1.3 Protective earth conductor resistance measurement points Action • Scan the following measurement points for protective earth conductor resistance measurement one after the other using the tip of the probe cable: – Power supply unit potential equalization pin –...

  • Page 129: Applied Parts For Measurement Of The Device Leakage Current

    Electrical safety Electrical safety to EN 62353 NOTE The test must be performed twice! The second test is performed with the plug rotated 180° in the socket. In many test devices the mains plug rotation is simulated by means of a built-in selector switch. The higher measured val- ue must be documented.

  • Page 130: Leakage Current, Mains On Applied Part With Airway Temperature Sensor Awt 01, If

    Electrical safety Electrical safety to EN 62353 3.1.6 Leakage current, mains on applied part with airway temperature sen- sor AWT 01, if installed NOTE In the following test the leakage current is measured at the airway tempera- ture sensor AWT01. The expected value is very low (the typical measured value is 1.5 μA to 2 μA).

  • Page 131: Leakage Current On Applied Part With Test Adapter (Normal Condition)

    Electrical safety Electrical safety to EN 62353 NOTE The test must be performed twice! The second test is performed with the plug rotated 180° in the socket. In many test devices the mains plug rotation is simulated by means of a built-in selector switch. The higher measured val- ue must be documented.
  • Page 132 Electrical safety Electrical safety to EN 62353 Action • Prepare the test setup. • (applied part) Connect the device-specific test adapter on one end to the device under test and on the other end to the tester's configurable socket „A“ for applied parts (paying attention to the configuration!). •...

  • Page 133: Optional Multiple Socket Strip On Trolley

    Electrical safety Electrical safety to EN 62353 3.1.8 Optional multiple socket strip on trolley Power fuse links Action • Compare the power fuse links with rated values on the multiple socket strip. Test The power fuse-links match the specifications on the multiple socket strip. Result [________OK] Protective conductor resistance...

  • Page 134: Electrical Safety According To Iec 60601-1

    3.2.1 Visual check Prerequisites Savina 300 is switched off and not connected to the mains power supply. Action • Check the following items for damage: – Power supply cord of the device –...

  • Page 135: Protective Conductor Resistance

    Electrical safety Electrical safety according to IEC 60601-1 3.2.2 Protective conductor resistance NOTE The protective earth conductor resistance is measured with the power cable connected. Test set-up Fig. 5 Test setup for protective earth conductor resistance Item Designation Tester, e.g. SECUTEST Device under test Test probe with tip Conductor...

  • Page 136: Earth Leakage Current

    Electrical safety Electrical safety according to IEC 60601-1 3.2.3 Earth leakage current NOTE In order to avoid incorrect measurement, set up the device under test so that it is insulated. Test set-up Fig. 6 Earth leakage current test setup Item Designation Tester, e.g.

  • Page 137: Patient Leakage Current

    Electrical safety Electrical safety according to IEC 60601-1 Entry Normal condition (N.C.) [________μA] Test Single fault condition (S.F.C.): The value must not exceed 1000 μA. Entry Single fault condition (S.F.C.) [________μA] 3.2.4 Patient leakage current Test set-up Fig. 7 Patient leakage current test setup Item Designation Tester, e.g.

  • Page 138: Optional Multiple Socket Strip On Trolley

    Electrical safety Electrical safety according to IEC 60601-1 Action • Plug the power supply connector (inverted, if possible) into the test socket of the test device. (In many test devices the power supply connector inver- sion can be simulated by means of a built-in selector switch.) Test Normal condition (N.C.) AC: The value must not exceed 100 μA.
  • Page 139 4 Function and condition test This chapter contains tests that need to be performed in order to verify that the function and condition of the device and the accessories used meet the specifications according to the Instructions for Use. Condition tests .......................... 30 Function tests ...........................

  • Page 140: Function And Condition Test Condition Tests

    Function and condition test Condition tests Condition tests 4.1.1 Accompanying documents Action • Check that the following accompanying documents are available: – Instructions for use – Medical Products Logbook (applicable to Germany only) Entry All accompanying documents are available (according to user/operator). [________OK] 4.1.2 Device labelling...

  • Page 141: General Condition (Savina 300, Accessories And Special Accessories)

    Function and condition test Condition tests 4.1.3 General condition (Savina 300, accessories and special accessories) Action • Check that the following device components, the accessories and the spe- cial accessories are not damaged. Device components – Savina 300 – Tubing system according to instructions for use/accessories list –...

  • Page 142: Option, Lpo (External Oxygen Supply)

    Function and condition test Condition tests 4.1.6 Option, LPO (external oxygen supply) O2 supply connector socket Action • Check the O2 supply „LPO“ connector socket. Test The O2 supply „LPO“ connector socket is undamaged. Entry [________OK] Protective cap 8415745 for connector socket Action •...

  • Page 143: Function Tests

    Function and condition test Function tests Function tests 4.2.1 Non-return valve in expiratory valve Prerequisites The expiratory valve(s) has/have been removed. Action • Prepare the following test setup: Test set-up Fig. 8 Test setup; non-return valve in expiratory valve Item Designation Syringe 60 mL Pressure gauge...

  • Page 144: Safety Valve (D1)

    Function and condition test Function tests 4.2.2 Safety valve (D1) Prerequisites The Savina 300 is not connected to the mains power supply or to the „O2“ compressed gas supply. Savina 300 is switched off. Action • Prepare the following test setup: Test set-up Fig.

  • Page 145: Emergency Respiratory Valve (D2)

    Function tests 4.2.3 Emergency respiratory valve (D2) Prerequisites The Savina 300 is not connected to the mains power supply or to the „O2“ compressed gas supply. Savina 300 is switched off. Action • Prepare the following test setup: Test set-up Fig.

  • Page 146: Power Supply Unit

    – „Mains power supply“ LED out; „External battery“ LED out – „Interne battery“ LED lit „green“ or lit „yellow“ Action • Press the „Start/Standby“ key and switch the Savina 300 to „VC-CMV/VC- AC“ mode. Entry The blower runs up to speed. Ignore the error messages and alarms during this test.

  • Page 147: Emergency Expiratory Valve

    [________OK] 4.2.5 Emergency expiratory valve Prerequisites The Savina 300 is connected to the mains power supply and to the „O2“ com- pressed gas supply. Savina 300 is switched on. Action • Press the „Ventilation settings“ softkey and select „VC-CMV/VC-AC” mode.

  • Page 148: Testing The Ventilation

    Function and condition test Function tests 4.2.6 Testing the ventilation Prerequisites The Savina 300 is connected to the mains power supply and to the „O2“ com- pressed gas supply and switched on. Action • Prepare the following test setup: Test set-up Fig.
  • Page 149 • Press the „Ventilation“ softkey and set the following parameters: – Pressure limitation: Off – Plateau: On – LPO: Off • Start ventilation with the Savina 300. O2 calibration Action • Select the „Sensoren/Parameter” menu. • Press the O2 calibration „Start“ softkey and confirm with the rotary knob.

  • Page 150: O2 Control (Vc-Cmv/Vc-Ac)

    • After the tidal volume measurement (Vt) perform a flow calibration. 4.2.7 O2 control (VC-CMV/VC-AC) Prerequisites The Savina 300 is connected to the mains power supply and to the „O2“ com- pressed gas supply and switched on. Action • Prepare the following test setup: Test set-up Fig.

  • Page 151: Paw Pressure Regulation (Vc-Cmv/Vc-Ac)

    • Set specified O2 value to 21 % by volume O2. 4.2.8 Paw pressure regulation (VC-CMV/VC-AC) Prerequisites The Savina 300 is connected to the mains power supply and to the „O2“ com- pressed gas supply and switched on. The Savina 300 is set to „VC-CMV/VC- AC“ mode. Action •...
  • Page 152 Function and condition test Function tests The displayed value of the external pressure gauge is in a range from 3 mbar to 7 mbar (3.1 cmH2O to 7.1 cmH2O). Entry Expiratory phase, 5 mbar (external pressure gauge) [________mbar] Action • Set PEEP to 25 mbar (25 cmH2O) The displayed value of the external pressure gauge is in a range from 23 mbar to 27 mbar (23.5 cmH2O to 27.5 cmH2O).

  • Page 153: Options

    Options 4.3.1 AWT 01 temperature sensor Prerequisites The Savina 300 is connected to the mains power supply and to the „O2“ com- pressed gas supply and switched on. Action • Connect the AWT 01 temperature sensor to the Savina 300.

  • Page 154: External Battery Or Dc Onboard Power

    4.3.3 External battery or DC onboard power Prerequisites The Savina 300 is connected to the mains power supply and not to the exter- nal battery or the DC onboard power. Savina 300 is in „Standby“ mode. Test The „External battery“ LED on the front of the Savina 300 is unlit.

  • Page 155: Lpo (External Oxygen Supply)

    Options 4.3.4 LPO (external oxygen supply) Prerequisites Savina 300 is switched off. Action • Using an approximately 40 cm silicone tube (4 x 1.5), connect the Savina 300 connecting port („LPO“ connection) to the cross-piece 7901504. • Using an approximately 40 cm silicone tube (4 x 1.5), connect the manom- eter 7910722 (Fig.

  • Page 156: User-Specific Settings

    4.4.1 Input of user-specific settings Action • Re-enter all recorded user-specific settings from the „Device configuration“ section (test item: Input of user-specific settings) in the Savina 300. Result The user-specific settings have been re-entered into the Savina 300. [________OK] Final action Prerequisites –...
  • Page 157 5 Test equipment This chapter lists the service equipment required to perform the tests specified in these test instructions. Test equipment list ........................48 47 / 50...

  • Page 158: Test Equipment Test Equipment List

    Test equipment Test equipment list Test equipment list NOTE Use the following test equipment or equivalent aids. 5.1.1 Test equipment subject to mandatory calibration Designation Part number Comments Electrical safety tester, e.g. GMC 7910596 Secutest Multimeter 7901021 Oxygen analyzer, e.g. MiniOx 3000 7911610 Temperature and humidity meter 7910980...

  • Page 159: Test Equipment Not Subject To Mandatory Calibration

    Test equipment Test equipment list Designation Part number Comments Flowmeter, 3-block set 7901161 Flowmeter 7900718 Torque wrench 7900909 Torque grasp 7911766 No illustration available Entry Test equipment calibrated in a valid manner used. [________OK] 5.1.2 Test equipment not subject to mandatory calibration NOTE Use the following test equipment or equivalent aids.
  • Page 160 Test equipment Test equipment list Designation Part number Comments Y-piece, adult, Luer-Lock M33278 Einsteckwerkzeug-Maul, 22 mm 7911877 No illustration available Rubber plug 18/20 DIN 12871 1294105 Rubber plug 22/25 7901665 Cross-piece, plastic 7901504 T-piece, plastic 6800187 Syringe, 60 mL 7910745 Tube 6 x 2.5, silicone 1197851 Tube 4 x 1.5, silicone...
  • Page 161 1.1.2.5 Option, Nurse call (YES / NO) 2.5.2 Service set for Savina 300 1.1.2.6 Option, Savina 300 trolley (YES / NO) 3 Electrical safety 1.1.2.7 Option, external battery on trolley (YES / NO) 3.1 Electrical safety to EN 62353 1.1.3 Software version and operating hours 3.1.1...
  • Page 162 Recurrent test 4 Function and condition test Condition tests 4.1.1 Accompanying documents 4.1.2 Device labelling 4.1.3 General condition (Savina 300, accessories and special accessories) 4.1.4 O2 compressed gas connecting tube 4.1.5 Option, trolley (general condition) 4.1.6 Option, LPO (external oxygen supply) 4.1.6.1...
  • Page 163 Report: Test has been performed according to the test instructions. Name: ......__________________________________________________________ Date/Signature:....__________________________________________________________...
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  • Page 166 Manufacturer: Dräger Medical GmbH Moislinger Allee 53 – 55 23542 Lübeck Germany +49 1805 3723437 FAX +49 451 882 - 3779 http://www.draeger.com Subject to change without notice Will not be replaced in the event of modifications. © Copyright 2010 by Dräger Medical GmbH, Lübeck, Germany. Revision 3.0 9036766 5664.920...

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