Dräger Savina 300 Technical Documentation Manual Download Page 134

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Electrical safety

Electrical safety according to IEC 60601-1

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3.2

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

– Power switch

– Power fuse link for mains power supply

– Fuse link for internal battery

Test

The items mentioned above are undamaged. The fitted power fuse-links
match the values specified on the labels.

Result

Visual check completed.

[________OK]

NOTE

The medical product to be tested conforms to the requirements of protection
class I, type B with an airway temperature sensor type BF connected.

NOTE

An optional multiple socket-outlet, if any, must be included in the individual
tests (medical electrical system).

NOTE

With devices that are connected to other devices by means of a data cable,
this connection must be disconnected prior to performing the electrical safe-
ty check, in order to avoid incorrect measurements.

Summary of Contents for Savina 300

Page 1: ...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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Page 3: ...Control panel with TFT colour display 18 Pneumatic assembly 20 Maintenance instructions 31 Disassembling assembling the device 32 Replacing the microfilter 38 Replacing the dust filters 40 Replacing the O2 sensors 42 Replacing the diaphragm of the expiratory valve 47 Replacing the internal batteries 50 Replacing the external batteries 54 Replacing the consumables in the O2 gas inlet 65 Annex 71 ...

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Page 5: ...Savina 300 No 1309_0000001227_Publication 5 General This chapter contains general notes and definitions that are important for the use of this documentation General notes 6 ...

Page 6: ...ole or in part be modified copied dis tributed reproduced republished displayed transmitted or sold without the prior written consent of Dräger Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION A CAUTION statement provides important information about a potentially hazar...

Page 7: ...räger standards Dräger cannot guarantee or confirm the operational safety of third party replacement parts used on the device Use only replacement parts certified to Dräger standards for servicing of the device otherwise the proper functioning of the device may be compromised Pay attention to the Servicing section of the Instructions for Use WARNING Non conforming test values If test values do not...

Page 8: ...d to the device before starting main tenance or repair work NOTE 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 ...

Page 9: ...ublication 9 Function descriptions This chapter contains descriptions of the device s technical functions Block diagram and functional principle 10 Electronic assembly 12 Control panel with TFT colour display 18 Pneumatic assembly 20 ...

Page 10: ...nction 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 ...

Page 11: ...th the blower to reg ulate the pre set ventilation parameter The non return valve opens or closes according to the pre set ventilation parameters To increase the oxygen con centration in the ventilation gas an external oxygen source can be connected to the device Sensors the electronics and the valve block meter the oxygen concentration Main components The device consists of the following main com...

Page 12: ...or on board power supply and Internal battery LEDs The LEDs are mounted on the membrane keypad of the control panel and indicate the respective operat ing status The device includes two internal rechargeable batteries 2 x 12 V which enable uninterrupted operation in the event of a mains power failure The internal rechargeable batteries supply the O2 sensors with power even when the device is switc...

Page 13: ...r Three processor systems save the changeable non volatile data to EEPROMs Fig 2 Block diagram of the Central Control Board Master processor The master processor has the following tasks Activation of the actuators valves valve block blower Reading of the measured values from the sensors Control of the ventilation Monitoring of the front processor The master processor data are cached in the RAM The...

Page 14: ...ocessor stores user specific display settings such as measured value positions Flash EEPROMs The device s operating system program software is stored in Flash EEPROMs rewritable memory modules Real time clock The real time clock generates the time and date information The real time clock has an internal battery The Central Control Board incorporates the following functions Processing of the signal...

Page 15: ...erial interface Via the CAN interface the control unit can communicate with the electronic and pneumatic assemblies The transmission rate is 800 kbit s Motor actuator The motor actuator controls the blower motor The motor actuator is located in a self contained housing The supply voltage for the motor actuator is 48 V and is protected by a fuse 6 3AT The input voltage range of the motor actuator i...

Page 16: ...he nebulizer valve can be operated separately by an electronic switch They are actuated by the Central Control Board Fig 4 Block diagram of the O2 Valve PCB O2 Diaphragm PCB The O2 Diaphragm PCB amplifies the signals from the O2 sensors and mea sures the temperature of the O2 sensors and of the respiratory gas in the inspiration block The temperature of the O2 sensors is required to compen sate fo...

Page 17: ...nt air through the cooler and cools the blower motor 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 1 Supply voltage 2 Target speed 3 Speed signal 4 Sensor supply voltage 5 Ground ...

Page 18: ... keypad The keypad features the control keys and the associated LEDs TFT colour display The 12 1 TFT colour display comprises the actual display and the backlight converter The TFT colour display has a resolution of 800 x 600 pixels The backlight converter generates a high voltage for the display backlighting Rotary encoder The rotary knob is used to set and acknowledge the ventilation parameters ...

Page 19: ... dots which ensure the two layers are kept separate In 8 wire systems the touch screen has eight wires routed to the controller four for each axis When the touch screen is touched at a certain point where the two ITO layers are located an electrical contact is produced The resistance of this contact results in a different voltage at each point The change in voltage is then used to define the x and...

Page 20: ... diagram Fig 9 Functional diagram Item Designation F1 Micro filter AIR F2 Filter O2 F4 Filter inspiratory flow sensor F5 Filter Filter element Volume Mixing chamber SD1 Suction sound insulator SD2 Sound insulator DR1 Supply pressure regulator Oxygen Gebläse Blower Kühler Cooler V1 Reduction valve V3 Expiratory valve ...

Page 21: ...S4 1 Inspiratory airway pressure sensor located in inspiratory branch S4 2 Expiratory airway pressure sensor located in expiratory branch S5 Supply pressure sensor oxygen S6 Pressure sensor 1 absolute pressure S7 Pressure sensor 2 absolute pressure D1 Safety pressure limitting valve passive approx 120 mbar D2 Emergency air valve 3 mbar to 6 mbar D3 Expiratory non return valve D4 Inspiratory non re...

Page 22: ...ntroller operates the blower motor during a breath at a constant speed The bypass valve regulates the inspiratory pressure The combination of the blower motor and bypass valve V1 provides a pressure source Fig 10 Detail view of functional diagram ventilation function The sound insulators SD1 and SD2 on the inlet and outlet sides of the blower motor reduce the sound level The bypass valve V1 is ope...

Page 23: ...r F2 With the aid of the digital valve block consisting of 8 digital solenoid valves oxygen is metered into the volume mixing chamber The amount of metered oxygen depends on the pre set O2 concentration and on the inspiratory flow rate measured by the flow sensor 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 Fi...

Page 24: ... particles The oxygen flows from the non return valve D6 into the volume mixing chamber In the volume mixing chamber it is mixed with the drawn in and filtered fresh air Fig 12 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 Connect only O2 low p...

Page 25: ... stenosis if the pressure cannot be relieved through the expiratory valve To do so the electric emergency vent valve pilot valve V8 actuates the emergency vent valve V9 accordingly Fig 13 Detail view of functional diagram pneumatic safety devices Drug nebulizer The drug nebulizer is operated with 100 oxygen The pressure regulator DR1 ensures in the case of widely varying supply pressure 2 7 to 6 0...

Page 26: ...iratory side and the oxygen sensor is open During oxygen sensor calibration oxygen passes to the oxygen sensor This layout permits online calibration of the oxygen sen sor 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...

Page 27: ... pressure S6 The oxygen sensor S3 1 generates the signal for the dis played FiO2 measured value and the signal to control the inspiratory oxygen concentration The oxygen sensor S3 2 monitors the oxygen sensor S3 1 Fig 16 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 ...

Page 28: ...re sensor in the respective no flow branch Fig 17 Detail view of functional diagram airway pressure sensors 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 Det...

Page 29: ... measure the inspiratory gas temperature Fig 19 Detail view of functional diagram flow sensor The flow sensor S2 measures the gas flow through the expiratory valve The flow sensor is a temperature compensated hot wire anemometer with no flow direction detector With this signal the patient is monitored e g the minute volume Fig 20 Detail view of functional diagram flow sensor Expiration is executed...

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Page 31: ...specified con dition of the device Disassembling assembling the device 32 Replacing the microfilter 38 Replacing the dust filters 40 Replacing the O2 sensors 42 Replacing the diaphragm of the expiratory valve 47 Replacing the internal batteries 50 Replacing the external batteries 54 Replacing the consumables in the O2 gas inlet 65 ...

Page 32: ...m into the trolley Filter cover 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 21 1 on the left and right sides of the trolley slightly and push the two locking devices Fig 21 2 inwards towards A as far as they will go 2 Re...

Page 33: ...t 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 22 2 on the left and right sides of the trol ley outwards towards B as far as they will go and tighten the nuts Fig 22 1 Fig 22 View from below of trolley mount screws ...

Page 34: ...ack slightly and take the filter cover out of the rear panel Fig 23 View of device rear filter cover Removal of the filter cover is complete Installation 1 Slot the tabs Fig 24 1 of the filter cover into the recesses Fig 24 2 in the rear panel swivel the filter cover upwards and press the catches Fig 23 1 of the filter cover into the rear panel until they lock in place Fig 24 Detail view of filter...

Page 35: ...ic discharge have been established The filter cover has been removed see section headed Filter cover 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 Designation 1 Connection external battery 2 Tab fuse 3 Mains connection 4 Connectio...

Page 36: ... cable retainer Fig 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 27 1 Fig 27 View of device rear screws 6 Remove the rear panel Removal of the rear panel is now complete ...

Page 37: ... rear panel 3 Fit the Savina 300 into the trolley see section headed Removing fitting the 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 7 Perform the electrical safety test and function tests ...

Page 38: ...g 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 2 Withdraw the power cable Fig 29 2 fro...

Page 39: ...plete Fitting 1 Insert the new microfilter Fig 30 2 into its mount as far as it will go 2 Close the tab Fig 30 1 against the microfilter 3 Slot the pegs on the underside of the filter cover into the recesses in the rear panel swivel the filter cover upwards and with the catches Fig 29 1 press the filter cover into the rear panel until it locks in place 4 Lay the power cable Fig 29 2 around the fil...

Page 40: ...t it View The dust filters Fig 31 1 are located in the device s filter cover Fig 31 Device rear dust filters 3x Removal 1 Reach into the openings in the filter cover on both sides press the catches concealed behind them Fig 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 Fi...

Page 41: ...ng 1 Insert the new dust filters Fig 33 1 in the recesses in the filter cover 2 Slot the pegs Fig 34 1 on the underside of the filter cover into the recesses Fig 34 2 in the rear panel swivel the filter cover upwards and with the catches Fig 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 f...

Page 42: ...g 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 NOTE Replace the O2 sensors if calibration is no longer possible or if the alarm message FiO2 measurement failed is displayed ...

Page 43: ...quipment required Screwdriver Procedure 1 Swivel the inspiratory port Fig 36 1 down 2 Loosen the screw Fig 36 2 using a screwdriver or similar and detach the cover plate Fig 36 3 Fig 36 Device front cover plate 3 Take the O2 sensors Fig 37 1 out of their mounts Fig 37 Device front removing the O2 sensors NOTE O2 sensors are special waste When disposing of them observe local waste disposal regulati...

Page 44: ...te Fitting 1 Push the O2 sensors with the arrows on the oxygen cells pointing upwards as shown in the following illustration into their mounts until you feel a resistance Fig 38 Device front fitting the O2 sensors 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 com...

Page 45: ...ina 300 calibrates O2 sensor 2 During calibration the alarms which would normally occur due to the disconnection and the changed O2 concen tration are disabled After about 60 seconds the prompt Reconnect patient is displayed 7 Immediately fit the inspiratory tube on the inspiratory socket If the display indicates O2 calibration OK calibration is complete NOTE To be able to calibrate the Savina 300...

Page 46: ...nspiratory tube from the inspiratory socket and if necessary continue ventilation with an independent ventilator The display indicates O2 calibration in progress The Savina 300 calibrates the O2 sensors During calibration the alarms which would normally occur due to the disconnection and the changed O2 concentration are disabled After about 60 seconds the prompt Reconnect patient is displayed 6 Im...

Page 47: ...hragm and describes how to remove and fit it View The diaphragm Fig 40 1 is located on the expiratory valve Fig 40 Detail view of expiratory valve diaphragm Removal 1 Push the flow sensor flap Fig 41 1 up to position A 2 Push the flow sensor Fig 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 vi...

Page 48: ...phragm 6 Dispose of the old diaphragm according to local waste disposal regula tions 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 NOTE Diaphragms are classified as special waste When disposing...

Page 49: ...ng Fig 44 3 of the expiratory valve all the way to the right towards B until you feel it lock in place Fig 44 Detail view of Savina 300 fitting the expiratory valve 3 Check that the expiratory valve is securely locked in place by pulling on it lightly 4 Slide the flow sensor Fig 44 2 to the right into the flow sensor sleeve 5 Push the flow sensor flap Fig 44 1 down towards A Fitting of the expirat...

Page 50: ... 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 The Savina 300 has been removed from the trolley see Disassem bling assembling the device section headed Removing fitting the Savina 300 from into the trolley The filter cover has been remov...

Page 51: ... instructions Replacing the internal batteries Procedure 1 Remove the screws 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 ...

Page 52: ... link Fig 49 1 to bring the second battery out of the compartment 6 Push the cable connectors Fig 49 1 off of the battery lugs 7 Disconnect the cable connector Fig 49 2 from the battery lug Fig 49 Rear of device cable connector 3x 8 Dispose of batteries according to local waste disposal regulations Removal of the batteries is now complete NOTE Batteries are special waste When disposing of them obs...

Page 53: ... Disassem bling assembling the device section headed Rear panel 9 Fit the filter cover on the Savina 300 see Disassembling assembling the device section headed Filter cover 10 Fit the Savina 300 on the trolley see Disassembling assembling the device section headed Removing fitting the Savina 300 from into the trolley 11 Insert the fuse link in the holder on the power supply unit 12 Connect the Sav...

Page 54: ...ternal batteries Replacing the external batteries Introduction 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 ...

Page 55: ...Actuate all locking brakes on the double wheel castors 2 Remove the screw Fig 51 1 lift off the cover and place it aside Fig 51 Detail view of trolley screw 3 Remove the screws and split washers Fig 52 1 2 of each and discon nect the electrical cable with integrated tab fuse 25 A 32 V Fig 52 3 Fig 52 View of external batteries screws split washers and electrical cable 4 Remove the screws and split...

Page 56: ...he external batteries 5 Loosen the screw Fig 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 ...

Page 57: ...iew of external batteries screw with bar 7 Take the strap out of the upper support Fig 55 1 Fig 55 View of external batteries upper support 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 ...

Page 58: ...s is complete Fitting 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 CAUTION Risk of device failure due to damaged insulating strip If the insulating strip is damaged a short circuit may occur in the battery pack and result in device failure Check the condition of the insulating strip before fitting the ...

Page 59: ...Fig 57 Fig 57 View of external batteries batteries and cables 4 Place the electrical cables Fig 57 4 on the bottom battery so they are not trapped as shown in the illustration 5 Pay attention to the polarity of the top battery the positive terminal is at the top see Fig 57 and insert the battery Fig 57 2 in the battery pack holding the battery firm while fitting it 6 Insert the locating pin Fig 58...

Page 60: ...tion 60 Savina 300 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 ...

Page 61: ...ies and tighten the screw Fig 60 1 with a torque of 3 Nm Fig 60 View of batteries strap and screw CAUTION 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 ...

Page 62: ...tteries 9 Connect the cables by one screw and one spring washer each to the bat teries as follows a 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 ...

Page 63: ...rackets 11 Check the fitting position of the end profile Fig 62 1 of the cover see following illustration Correct the position of the end profile as necessary Fig 62 Detail view of cover end profile and groove 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 abo...

Page 64: ...n 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 17 Fully charge the external batteries for time taken see instructions for use CAUTION Batteries not fully charged If the batteries are not fully charged the running time of the device in the event of a mains power failure may be reduced co...

Page 65: ...ation 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 section headed Removing fitting the Savina 300 from into the trolley The filter cover has been removed see Disassembling assembling the device section heade...

Page 66: ... the consumables in the O2 gas inlet Procedure 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 ...

Page 67: ...ng the consumables in the O2 gas inlet 3 Take out the washer Fig 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 ...

Page 68: ...he sealing ring Fig 70 1 and dispose of it in accordance with local waste disposal regulations Fig 70 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 ...

Page 69: ...7 1 onto the connector plate 6 Screw the connection Fig 66 1 onto the O2 supply block with a tighten ing torque of 20 Nm 2 Nm using a torque spanner and insertion tool size 22 mm 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 Disas...

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Page 71: ...9_0000001227_Publication 71 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 ...

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Page 73: ...Parts catalog Savina 300 5664 920 Revision 01 2010 07 23 ...

Page 74: ...escription Qty Qty unit Remark 8417800 Savina 300 System 1 000 St Revision 01 Equipment affected Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 2 37 ...

Page 75: ... 4 R31296 O RING SEAL 1 000 St 5 8410713 O RING SEAL 1 000 St 6 8351201 PCB O2 DIAPHRAGM 1 000 St 7 8418922 Flat cable O2 Measuring Module 1 000 St 8 D04766 PACKING RING 1 000 St 9 1340727 OVAL HEAD SCR DIN7985 M3X6 A2 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 3 37 ...

Page 76: ... Color ring Exp 1 000 St 10 8417077 Elbow fitting 22 Insp 1 000 St 11 8417831 Plug 1 000 St 12 8410713 O RING SEAL 1 000 St 13 8410181 DIAPHRAGM 1 000 St 14 M06763 VALVE SPRING 1 000 St 15 8412993 ELECTROVALVE 1 000 St 16 R22363 O ring 1 000 St 17 8410307 SEALING WASHER 1 000 St 18 2M12034 SPRING 1 000 St 19 8412952 CREW 1 000 St 20 8419303 O ring 16x1 25 1 000 St 21 8411147 Non return valve 1 000...

Page 77: ...2 8416203 Flow sensor sleeve compl gray 1 000 St 3 8415864 Expiration valve flutter seal 1 000 St 4 8416201 Lip seal gray 1 000 St 5 8413661 Membrane complete 1 000 St 6 8416204 Pot grey 1 000 St 7 M20622 O RING SEAL 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 5 37 ...

Page 78: ...t XL 1 000 St 4 8414028 Cable harness spirolog sensor 1 000 St 5 8417845 Connector housing Exp 1 000 St 6 8416370 Cable harness flow switch 1 000 St 7 8413610 Valve actuator 1 000 St 8 8417921 Pba FrontPneuBoard 1 000 St Revision 01 Connector housing exp Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 6 37 ...

Page 79: ... 1 000 St 10 8417860 Insertion Strip FR 1 000 St 11 8417861 Insertion Strip CN 1 000 St 12 8417862 Insertion Strip RU 1 000 St 13 8417863 Insertion Strip JP 1 000 St 14 8417864 Insertion Strip IT 1 000 St 15 8417865 Insertion Strip ES 1 000 St 16 8417866 Insertion Strip PT 1 000 St 17 8417867 Insertion Strip RO 1 000 St 18 8417868 Insertion Strip GR 1 000 St 19 8417869 Insertion Strip PL 1 000 St ...

Page 80: ...17878 Insertion Strip SK 1 000 St 29 8607597 trim knob Cockpit 1 000 St 30 8607479 color ring MoBi Primus IE 1 000 St 31 8418700 Rotary encoder complete 1 000 St 32 8417830 Pressing foot 1 000 St 33 8417852 Swivel axis 1 000 St 34 8417853 Spacer bolt 2 000 St Revision 01 Operating device Parts catalog Items that are shown in the illustration but are not listed below the illustration are not availa...

Page 81: ...er 1 000 St 4 Valve unit 1 000 St 5 PAW Pressure sensor unit 1 000 St 6 8418783 PCB Support hinge pivoting 1 000 St 7 8417911 Pba BackPneuBoard 1 000 St 8 8418817 EMC Gasket D3 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 9 37 ...

Page 82: ...emark 1 8413579 TSI sensor 1 000 St 2 8418793 TSI tube 1 000 St 3 8413700 CABLE HARNESS 1 000 St Revision 01 TSI sensor Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 10 37 ...

Page 83: ...4 125GR 1 000 St 1 Blower unit 1 000 St 2 1841416 Lead acid battery 12V 3 5AH 1 000 St 3 8416370 Cable harness flow switch 1 000 St 4 8408197 SOCKET 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 11 37 ...

Page 84: ...7 SOCKET 1 000 St 5 8413710 GASKET 1 000 St 6 8410181 DIAPHRAGM 1 000 St 7 8414081 REP SET DIAPHRAGM 1 000 St 8 8413610 Valve actuator 1 000 St 9 1339958 COUNTER SUNK SCREW M4X8 DIN965 4 000 St 10 8413748 FILTER TSI 1 000 St Revision 01 Blower unit Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 12 37 ...

Page 85: ...holder 1 000 St 2 6737545 MICROFILTER 1 000 St 3 8413609 MAINS SWITCH 1 000 St 4 8418932 Cover 184_206 1 000 St 5 8418931 Cover 150 175 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 13 37 ...

Page 86: ...e 1 000 St 6 8413755 FILTER TUBE 1 1 000 St 7 8413754 FILTER TUBE 2 1 000 St 8 8413666 Pressure regulator 1 000 St 9 8418792 dosage insert 1 000 St 10 8416272 O ring 2x1mm 1 000 St 11 8412993 ELECTROVALVE 1 000 St 12 M09257 PACKING RING 1 000 St 13 8417753 Ground cable 85 1 000 St 14 CH09932 RUBBER BUFFER 1 000 St 15 8418789 Grommet 9 5mm 1 000 St Revision 01 Valve unit Parts catalog Items that ar...

Page 87: ...SURE SENSOR 1 000 St 18 1865862 Pressure Sensor 7bar absolute 1 000 St 19 2M03646 slide washer 1 000 St 20 1340727 OVAL HEAD SCR DIN7985 M3X6 A2 1 000 St 21 D04766 PACKING RING 1 000 St 22 8418787 Spout 1 000 St 23 8418788 O_Ring 2 8x1 8 1 000 St 24 M12701 O RING 1 000 St 25 8410713 O RING SEAL 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the...

Page 88: ... Sensor 120mbar difference 1 000 St alternativ 3 8412993 ELECTROVALVE 1 000 St 4 8410713 O RING SEAL 1 000 St 5 D04766 PACKING RING 1 000 St 6 6804141 Isolate socket 1 000 St 7 8400964 SOCKET 1 000 St Revision 01 PAW Pressure sensor unit Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 16 37 ...

Page 89: ...IME CLOCK DIL24 RoHS 1 000 St 4 8418799 Insulation holder 4 000 St 5 8413620 Enginedrive compl 1 000 St 6 8417822 Oxygen seal 1 000 St 7 8414518 HORN CPL 1 000 St 8 8418763 Loudspeaker complete 1 000 St 9 8417857 Rebound strap 1 000 St 10 8417896 Rebound strap pin 2 000 St 11 8418783 PCB Support hinge pivoting 4 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not ...

Page 90: ...design bottom part right 1 000 St 8 G93118 Bumper basic complete 1 000 St 9 G93107 Castor 551 125 Steinco 1 000 St 10 G93203 Label 5 degrees 1 000 St 11 1346806 Counters Srew ISO10642 M5X16 2 000 St 12 1335618 Hexagon bolt M5 DIN985 2 000 St 13 8418933 Device retaining sheet 2 000 St 14 1329235 Hexagon bolt M5X12 DIN933 2 000 St Revision 01 Trolley Parts catalog Items that are shown in the illustr...

Page 91: ...t 9 8417492 Safety sign 1 000 St only for USA 10 8418832 Toggle screw 1 000 St 11 8418831 Label US Caution Note 1 000 St only for USA 12 8418824 Label LPO 1 000 St 13 8418823 Label nursecall 1 000 St 14 8417837 Filter cover 1 000 St 15 8418769 Cable conduit 1 000 St 16 2M30555 Importer Label TR 1 000 St only for Turky 17 8418818 Back plane compl 1 000 St 18 8417880 Unit feet 1 000 St 19 8418780 Ca...

Page 92: ... Cable harness motor electronic 1 000 St 3 8413582 CABLE POWERPACK 1 000 St 4 8418754 Cable backlight 1 000 St 5 8418755 Cable collection board 1 000 St 6 8413621 Flat cable Valve bench 1 000 St 7 8418757 Cable backend 1 000 St 8 8417937 Interface Cable RS232 1 000 St 9 8418758 Cable frontend 1 000 St Revision 01 Cables Parts catalog Items that are shown in the illustration but are not listed belo...

Page 93: ...Cable RS232 1 000 St 9 8418758 Cable frontend 1 000 St 10 8413700 CABLE HARNESS 1 000 St 11 8418826 Option Nurcecall 1 000 St 12 8418922 Flat cable O2 Measuring Module 1 000 St 13 8417936 Cable Harness Temp Sensor 1 000 St 14 8414519 Cable harness AWT01 1 000 St 15 8416370 Cable harness flow switch 1 000 St 16 8414028 Cable harness spirolog sensor 1 000 St Revision 01 Parts catalog Items that are ...

Page 94: ...ins cable SA 3m C13W GY RoHS 1 000 St 0 1856626 Power cord USA 3m 10A C13W 1 000 St 0 1859706 Power cable 10A 3m black China 1 000 St 0 1850377 FUSE 5A 1 000 St 0 1851810 Cabel Australia 3m 10A C13W 1 000 St 1 8417856 Power Supply 1 000 St 2 1850369 FUSE 15A 1 000 St 3 8417939 Cable harness motor electronic 1 000 St 4 8413582 CABLE POWERPACK 1 000 St 5 8413584 Cable power supply akku 1 000 St Revi...

Page 95: ...807 HOSE 2X1 SIGN GREEN 1 000 m 5 1204793 HOSE 2X1 SIGN RED 1 000 m 6 1204815 HOSE 2X1 SIGN BROWN 1 000 m 7 1204785 HOSE 2X1 SIGN BL 1 000 m 8 1204823 HOSE 2X1 SIGN ORANGE 1 000 m 9 1198912 HOSE 12X3 SI NF M29909 1 000 m Revision 01 Hoses Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 23 37 ...

Page 96: ...E 2X1 SIGN GREEN 1 000 m 5 1204793 HOSE 2X1 SIGN RED 1 000 m 6 1204815 HOSE 2X1 SIGN BROWN 1 000 m 7 1204785 HOSE 2X1 SIGN BL 1 000 m 8 1204823 HOSE 2X1 SIGN ORANGE 1 000 m 9 1198912 HOSE 12X3 SI NF M29909 1 000 m 10 8401083 T PIECE 1 000 St 11 8406909 DIODE 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as sp...

Page 97: ...300 Tension belt 1 000 St 4 8417317 Set dowel pins 1 000 St 5 8416191 Claw 160 1 000 St 6 1843303 Lead acid battery 12V 17AH 2 000 St 7 8417321 Accu mounting bracket 2 000 St 8 8418810 DC Akku Cable 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 25 37 ...

Page 98: ...515 NONRETURN VALVE FOR 8411848 1 000 St 3 M16201 SIEVE 1 000 St 4 D18400 O RING SEAL 1 000 St 5 8414137 Closure LPO 1 000 St 6 8415745 Retainer cap 1 000 St 7 8418824 Label LPO 1 000 St Revision 01 LPO Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 26 37 ...

Page 99: ...Monitor bracket Savina 300 1 000 St 2 1343319 Countersunk screw M5X12 DIN7991 1 000 St 3 8417510 Monitor mounting Evita XL 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 27 37 ...

Page 100: ...8418924 Nurse call shield 1 000 St 1 8418826 Option Nurcecall 1 000 St 2 8417941 PBA RelaisBoard 1 000 St Revision 01 Nurse call Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 28 37 ...

Page 101: ...der No Description Qty Qty unit Remark 8418925 CD Software 3 51 Savina 300 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 29 37 ...

Page 102: ...9 Savina 300 Service Set 1y 1 000 St 2 8417898 Set dust filter 1 000 St 3 8413661 Membrane complete 2 000 St 4 6737545 MICROFILTER 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 30 37 ...

Page 103: ...7898 Set dust filter 1 000 St 3 8413661 Membrane complete 2 000 St 4 1841416 Lead acid battery 12V 3 5AH 2 000 St 5 6737545 MICROFILTER 1 000 St Revision 01 Savina 300 2 yearly Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 31 37 ...

Page 104: ...s Inlet 1 000 St 4 M09257 PACKING RING 3 000 St 5 M19311 WASHER 3 000 St 6 1845527 REAL TIME CLOCK DIL24 RoHS 1 000 St 7 8413661 Membrane complete 2 000 St 8 1841416 Lead acid battery 12V 3 5AH 2 000 St 9 6737545 MICROFILTER 1 000 St Revision 01 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 32 37 ...

Page 105: ...n Qty Qty unit Remark 1 8413643 Spare Parts Blow Engine Unit 1 000 St Revision 01 Engine blower unit kit Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 33 37 ...

Page 106: ...12344 PAED HOSE SET AQUAPOR 1 000 St 0 8413146 HOSE SET E2 BLUE 1 000 St 0 8412860 HOSE SET HME 1 000 St 0 MP02400 SelfTestLung 1 000 St 0 8403201 TEST LUNG 1 000 St 0 MP01579 Mask NovaStar NIV w SE S 1 000 St 0 MP01580 Mask NovaStar NIV w SE M 1 000 St 1 2M85706 Quickstop hinged arm 2 1 000 St 2 8409609 Hinged arm 1 000 St 3 MP00690 Infinity ACS hinged arm 1 000 St 4 G93110 Cylinder Support compl...

Page 107: ...SpiroLife 1 000 St 10 8405371 TEMPERATURE SENSOR 1 000 St 11 2M85446 Connecting hose holder 1 000 St Revision 01 Accessories consumables Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 35 37 ...

Page 108: ...ALE 1 000 St 7901808 TEST CABLE RS232 EXTENSION 1 000 St 7901482 TEST PRESSURE REDUCER O2 1 000 St 7910342 TEST PRESS RED O2 PIN INDEX 1 000 St 7900930 INJECTOR 1 000 St 1294105 PLUG 1 000 St 7901161 FLOWM BL 0 02 14 L MIN 1 000 St 7900718 FLOWM 10 120 L MIN O2 AIR 1 000 St 7910385 CHARGE TESTER EVITA COMPLETE 1 000 St 7910387 Cable for charge tester 1 000 St 7910426 POWER SUPPLY UNIT 3 18 VDC 2 3...

Page 109: ... 000 St 7902275 Leak detection spray 1 000 St 1180614 HOSE 2X1 SI NF M17749 1 000 m 1198343 HOSE 7X2 5 SI NF M29908 1 000 m 1190520 HOSE 4X1 5 SI 50 SH A NF 1 000 m 1197851 SILICONE HOSE 6X2 5 NF M29907 1 000 m Revision 01 Tools Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts 37 37 ...

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Page 111: ...d higher Conversion table 1 bar 14 504 PSI 1 mbar 1 01973 cm H2O 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 NOTE Do not use these test instructions for testing after a repair procedure ...

Page 112: ...No 0208_0000002533_Publication 2 50 6DYLQD 5HYLVLRQ This page has been intentionally left blank ...

Page 113: ...ective earth conductor resistance measurement points 18 3 1 4 Device leakage current 18 3 1 5 Applied parts for measurement of the device leakage current 19 3 1 6 Leakage current mains on applied part with airway temperature sensor AWT 01 if installed 20 3 1 7 Leakage current on applied part with test adapter normal condition 21 3 1 8 Optional multiple socket strip on trolley 23 3 2 Electrical saf...

Page 114: ...ressure regulation VC CMV VC AC 41 4 3 Options 43 4 3 1 AWT 01 temperature sensor 43 4 3 2 Nurse call 43 4 3 3 External battery or DC onboard power 44 4 3 4 LPO external oxygen supply 45 4 4 User specific settings 46 4 4 1 Input of user specific settings 46 4 5 Final action 46 4 5 1 Device handover with test label 46 5 Test equipment 47 5 1 Test equipment list 48 5 1 1 Test equipment subject to ma...

Page 115: ... 6DYLQD 5HYLVLRQ No 0208_0000002533_Publication 5 50 1 Device configuration This chapter is used to record the device configuration 1 1 Savina 300 6 ...

Page 116: ...he rating plate on the rear of the device Entry AutoFlow Yes No ________txt Entry PC SIMV PC BIPAP YES NO ________txt Entry NIV mask breathing YES NO ________txt Entry Option LPO YES NO ________txt Entry Option Nurse call YES NO ________txt Entry Option Savina 300 trolley YES NO ________txt Entry Option external battery on trolley YES NO ________txt 1 1 3 Software version and operating hours Actio...

Page 117: ...mode and read off and note down the following parameters from the display Entry O2 ________txt Entry VT ________txt Entry Ti ________txt Entry f ________txt Entry FlowAcc ________txt Entry PEEP ________txt Action Select the Advanced settings submenu Read and note down the following parameters from the display Entry Sigh ON or OFF ________txt Entry Flow trigger ON or OFF ________txt Entry AutoFlow ...

Page 118: ... Press the System configuration softkey Select the Ventilation submenu Read and note down the following parameters from the display Entry Pressure limitation ON or OFF ________txt Entry Plateau ON or OFF ________txt Entry LPO ON or OFF ________txt Action Press the Sensors Parameters softkey Read and note down the following parameters from the display Entry O2 monitoring ON or OFF ________txt Entry...

Page 119: ... related maintenance parts measures and tests that can only be performed on an open device 2 1 Maintenance and inspection 10 2 2 Maintenance parts yearly 10 2 3 Maintenance parts 2 yearly 11 2 4 Maintenance parts 6 yearly 12 2 5 Maintenance parts 8 yearly but at the latest after 20000 operating hours 13 ...

Page 120: ... replacement ________dat NOTE Carry out maintenance and inspection for the first time after 2 years or at the latest after 12000 operating hours whichever occurs first Then yearly or af ter 6000 operating hours whichever occurs first Quan tity Designation Number Location Remark 1 Microfilter 6737545 Filter mount Trained person nel 1 Set of dust filters S 8417898 Rear panel Trained person nel 2 Dia...

Page 121: ...includes the following items Entry Next replacement ________dat Quan tity Designation Number Location Remark 1 Microfilter 6737545 Filter mount Trained person nel 1 Set of dust filters S 8417898 Rear panel Trained person nel 2 Diaphragm com plete 8413661 Expiratory valve for 2 expira tory valves Trained person nel 2 Lead acid accumu lator 12 V 3 5 Ah 1841416 Compartment for the internal battery Tr...

Page 122: ...and alarm limits Quan tity Designation Number Location Remark 1 Microfilter 6737545 Filter mount Trained person nel 1 Set of dust filters S 8417898 Rear panel Trained person nel 2 Diaphragm com plete 8413661 Expiratory valve for 2 expira tory valves Trained person nel 1 Filter Gas inlet 8416117 O2 inlet Trained personnel 2 Lead acid accumu lator 12 V 3 5 Ah 1841416 Compartment internal bat tery Tr...

Page 123: ...the following items Entry Next replacement ________dat Quan tity Designation Number Location Remark 1 Blower with spare parts set 8413643 Savina 300 Trained person nel with product specific Drä gerService training Quan tity Designation Number Location Remark 1 Microfilter 6737545 Filter mount Trained person nel 1 Set of dust filters S 8417898 Rear panel Trained person nel 2 Diaphragm com plete 841...

Page 124: ...No 0208_0000002533_Publication 6DYLQD Maintenance parts Maintenance parts 8 yearly but at the latest after 20000 operating hours 14 50 6DYLQD 5HYLVLRQ This page has been intentionally left blank ...

Page 125: ...cation 15 50 3 Electrical safety This chapter contains tests that need to be performed in order to verify that the medical elec trical system is operational 3 1 Electrical safety to EN 62353 16 3 2 Electrical safety according to IEC 60601 1 24 ...

Page 126: ...e tester e g SECUTEST must be correctly configured for all measure ments If implausible measurement results are obtained such as a leakage current of 0 0 μA check the tester configuration in addition to the test setup NOTE In testing to IEC 62353 the medical electrical device ME device or the medical electrical system ME system must be tested ME systems must be treated like ME devices An ME system...

Page 127: ...ng the entire length during the measurement The resistance must not change when you do so Test The protective conductor resistance of devices with detachable but con nected mains power cables must not exceed 0 3 Ohm in each case Entry Maximum measured value of device with power cable ________Ohm Test If other optional power cables are fitted the respective protective conductor resistance must not ...

Page 128: ...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 Follow the instructions on the tester NOTE The device leakage current can be tested by the differential measure ment method or the direct measurement method In direct measurement set u...

Page 129: ...lead 2 pin temperature sensor if installed Test Measure leakage current at temperature connection 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 NOTE The reference value initial measured value must...

Page 130: ...e under test and on the other end by a test clip with measuring lead and the tester configurable socket A for applied parts paying attention to the configuration Follow the instructions on the tester 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 Item Designation 1 Tester...

Page 131: ... 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 NOTE The reference value initial measured value must always be transmitted NOTE If the measured values are between 90 and 100 of the permissible limit value the reference value and the previously measured values of the recur rent ...

Page 132: ... The recurrent test value must not exceed 10 μA IAC Entry Recurrent test IAC ________μA Test The recurrent test value must not exceed 100 μA IDC Entry Recurrent test IDC ________μA 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 meas...

Page 133: ...ntacts of all sockets on the multiple socket strip with tester probe Test The value of the protective earth conductor resistance must not exceed 0 3 ohms in each case Entry Document the highest protective conductor resistance measurement in the Test Report ________Ohm Equivalent device leakage current Test The initial value must not exceed 100 μA Entry Initial value ________μA Test The recurrent t...

Page 134: ...tery Test The items mentioned above are undamaged The fitted power fuse links match the values specified on the labels Result Visual check completed ________OK NOTE The medical product to be tested conforms to the requirements of protection class I type B with an airway temperature sensor type BF connected NOTE An optional multiple socket outlet if any must be included in the individual tests medi...

Page 135: ...nts on the device under test move the power supply cord section wise while doing so Power supply unit earth pin Screws on the housing Oxygen connection Optional rails on side of Savina LPO option connector Test The protective conductor resistance must not exceed 0 2 Ohm including mains power cable in each case Entry Enter the highest measured value of the protective conductor resistance ________Oh...

Page 136: ...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 The value must not exceed 500 μA NOTE In order to avoid incorrect measurement set up the device under test so that it is insulated Item Designation 1 Tester e g SECUTEST 2 Device under test L Conductor N Neutral conduct...

Page 137: ...ondition N C DC ________μA Test Single fault condition S F C DC The initial value must not exceed 500 μA Entry Single fault condition S F C DC ________μA Item Designation 1 Tester e g SECUTEST 2 Device under test 3 Measuring line 2 pin temperature 4 Sockets for applied parts L Conductor N Neutral conductor PE Protective Earth conductor NOTE For symmetrical mains plugs that have no preferential pos...

Page 138: ...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 Action Check the protective conductor contacts of all sockets on the multiple socket strip with tester probe Test The value of the protective earth conductor resistance must not exceed 0 3 ohms in each case Entry...

Page 139: ...ntains 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 4 1 Condition tests 30 4 2 Function tests 33 4 3 Options 43 4 4 User specific settings 46 4 5 Final action 46 ...

Page 140: ...ot dirty or damaged ________OK Device label Order number Fitting location Option nurse call 8418823 Rear panel filter cover LPO option 8418824 Rear panel filter cover Safety symbol 8416324 Rear panel filter cover 5 degrees label G29203 Trolley Device label Order number Fitting location Option nurse call 8418823 Rear panel filter cover LPO option 8418824 Rear panel filter cover Safety symbol 841632...

Page 141: ...orementioned device components the accessories and the special accessories are undamaged ________OK 4 1 4 O2 compressed gas connecting tube Action Check the O2 compressed gas connecting tube the connector and the screw fitting Entry The O2 compressed gas connecting tube conforms to the accessory list and to national regulations The O2 compressed gas connecting tube the connector and the screw fitt...

Page 142: ...al 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 Check protective cap on connecting port Test The protective cap on the connecting port is undamaged Entry ________OK ...

Page 143: ...ction Using the syringe slowly permissible pressure change less than 1 mbar s build up a pressure of 2 0 to 3 mbar at the outlet of the expiratory valve Expiratory valve 1 Test The volume injected from the syringe in one minute must not exceed 35 mL Result ________OK Action Repeat the test for expiratory valve 2 Expiratory valve 2 Test The volume injected from the syringe in one minute must not ex...

Page 144: ...2 compressed gas supply Savina 300 is switched off Action Prepare the following test setup Test set up Fig 9 Test setup pneumatic safety valve Action Using a test pressure regulator set a flow of 2 to 3 L min Test The measured pressure is in a range from 80 mbar to 120 mbar Entry ________OK Item Designation 1 Test pressure regulator 2 Flowmeter 3 Pressure gauge 4 T piece 5 Silicone tube 6 Connecti...

Page 145: ...epare the following test setup Test set up Fig 10 Emergency respiratory valve test setup Action Using the test pressure regulator set a flow of 57 to 63 L min Test The measured pressure is in a range from 3 mbar to 6 mbar Entry ________OK Item Designation 1 Test pressure regulator 2 Injector 3 Silicone tube 4 Connecting sleeve 5 ISO socket 6 Flowmeter 7 Adult ventilation tube tube length 0 9 to 1 ...

Page 146: ...following operating states 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 ________OK Action Connect the Savina 300 to the mains power supply Power failure alarm Action Remove the fu...

Page 147: ...C AC mode Set the following parameters O2 21 VT 500 mL Ti 5 0 s f 6 min PEEP 5 mbar Action Press the Alarms softkey Airway pressure limit high Paw high Set 10 mbar above peak pressure Action Prepare the following test setup Fig 11 Test setup emergency expiratory valve Test After three cycles the Savina 300 builds up a pressure up to the airway pres sure limit Paw high Then the pressure is briefly ...

Page 148: ...are the following test setup Test set up Fig 12 Test setup testing the ventilation Action Press the Ventilation settings softkey and select VC CMV VC AC mode Set the following parameters O2 21 VT 500 mL Ti 2 0 s f 12 min PEEP 5 mbar Press the Advanced settings softkey and set the following parameters Sigh Off Flow trigger Off AutoFlow Off Item Designation 1 Pressure gauge 2 Test lung 3 Y piece adu...

Page 149: ...inspiratory socket Test The display shows O2 calibration in progress and then Reconnect patient Action Reconnect the ventilation tube to the inspiratory socket Test The following message is displayed O2 calibration OK Entry ________OK VT flow control and VT measurement Action While the test lung is being ventilated push the Spirolog sensor to the left hand end position and back to the right hand e...

Page 150: ...n Action Prepare the following test setup Test set up Fig 13 Test setup O2 regulation Action Set the O2 concentration to the following value Note The comparative measurement with the reference O2 analyzer is carried out when the dis played O2 measured value corresponds to the O2 specification Set specified O2 value to 60 by volume Test The oxygen concentration is rising and is in a range from 57 t...

Page 151: ...ed gas supply and switched on The Savina 300 is set to VC CMV VC AC mode Action Prepare the following test setup Test set up Fig 14 Test setup Paw pressure regulation Action Press the Ventilation settings softkey and set the following parameters Ti 2 0 s f 6 min PEEP 5 mbar Item Designation 1 Pressure gauge 2 Test lung 3 Y piece adult Luer Lock 4 Adult ventilation tubing 5 O2 analyzer 6 O2 adapter...

Page 152: ...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 Entry Expiratory phase 25 mbar external pressure gauge ________mbar ...

Page 153: ...est The measured value of the reference thermometer matches the Savina 300 reading and is within a tolerance of 2 C Entry ________OK 4 3 2 Nurse call Prerequisites The Savina 300 is connected to the mains power supply and to the O2 com pressed gas supply and switched on Test set up Fig 15 Test setup central alarm Action Set VC CMV VC AC mode Set the following parameters O2 21 VT 500 mL Ti 2 0 s f ...

Page 154: ...board power Savina 300 is in Standby mode Test The External battery LED on the front of the Savina 300 is unlit Action Plug the connector of the external battery or of the DC onboard power sup ply into the Savina 300 s power supply unit Test The External battery LED on the front of the Savina is lit green or yellow Action Cut the mains power supply to the Savina 300 Switch the Savina 300 to any ve...

Page 155: ...imately 30 cm silicone tube 4 x 1 5 connect the syringe 7901541 Fig 16 6 to the cross piece Using an approximately 40 cm silicone tube 4 x 1 5 connect the connect ing sleeve M13506 Fig 16 1 to the cross piece Into the connecting sleeve Fig 16 1 slot the ISO connector M25647 Fig 16 2 Fit the ventilation tube 1 20 metres Fig 16 3 onto the ISO connector Fig 16 2 Seal off the free end of the ventilati...

Page 156: ...onfiguration 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 4 5 Final action Prerequisites The test instructions have been performed as specified All tests performed were passed successfully 4 5 1 Device handover with test label Action Attach a test label to the device Supply the user owner w...

Page 157: ...DYLQD 5HYLVLRQ No 0208_0000002533_Publication 47 50 5 Test equipment This chapter lists the service equipment required to perform the tests specified in these test instructions 5 1 Test equipment list 48 ...

Page 158: ...E Use the following test equipment or equivalent aids Designation Part number Comments Electrical safety tester e g GMC Secutest 7910596 Multimeter 7901021 Oxygen analyzer e g MiniOx 3000 7911610 Temperature and humidity meter 7910980 Pressure gauge 7910722 Test pressure regulator hose connec tion or 7901482 Test pressure regulator pin index 7910342 No illustration available ...

Page 159: ...set 7901161 Flowmeter 7900718 Torque wrench 7900909 Torque grasp 7911766 No illustration available Designation Part number Comments NOTE Use the following test equipment or equivalent aids Designation Part number Comments Breathing bag with 7 mm catheter con nector set 8403201 Measuring line 2 pin temperature 7910364 Patient connection adapter 7910195 ISO socket M25647 Connecting sleeve M13506 Inj...

Page 160: ...ble 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 1190520 Nebulizer tube 8412985 Suction tube M25780 Tube 1 x 2 5 silicone 1198343 No illustration available Tube 2 x 1 silicone 1180614 No illustration available Designation Part number Comments ...

Page 161: ...OFF txt 1 1 4 19 Plateau ON or OFF txt 1 1 4 20 LPO ON or OFF txt 1 1 4 21 O2 monitoring ON or OFF txt 1 1 4 22 Flow monitoring ON or OFF txt 2 Maintenance parts 2 1 Maintenance and inspection 2 2 Maintenance parts yearly 2 2 1 Savina 300 service set dat 2 3 Maintenance parts 2 yearly 2 3 1 Service set for Savina 300 dat 2 4 Maintenance parts 6 yearly 2 4 1 Service set for Savina 300 dat 2 5 Maint...

Page 162: ...eturn valve in expiratory valve 4 2 1 1 Expiratory valve 1 OK 4 2 1 2 Expiratory valve 2 OK 4 2 2 Safety valve D1 OK 4 2 3 Emergency respiratory valve D2 OK 4 2 4 Power supply unit 4 2 4 1 Electrical supply display OK 4 2 4 2 Internal supply voltage internal battery OK 4 2 4 3 Power failure alarm OK 4 2 5 Emergency expiratory valve OK 4 2 6 Testing the ventilation 4 2 6 1 O2 calibration OK 4 2 6 2...

Page 163: ...6DYLQD Test has been performed according to the test instructions Name __________________________________________________________ Date Signature __________________________________________________________ Report ...

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Page 166: ... 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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Summary of Contents for Savina 300

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Dräger Savina 300, Technical Documentation Manual, Page: 134 / 166

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