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Dräger Savina, Instructions For Use Manual

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Dräger Savina Instructions For Use Manual Download Page 5

For your safety and that of your patients

5

For your safety and that of your 
patients

Strictly follow the instructions for use  

Any use of the apparatus requires full understanding and strict 
observation of these instructions. The apparatus is only to be 
used for purposes specified here.

Maintenance  

This apparatus should only be inspected, serviced and 
maintained by trained service personnel.
We recommend that a service contract be obtained with 
DrägerService and that all repairs also be carried out by them. 
Only authentic Dräger spare parts may be used for 
maintenance. Observe chapter "Maintenance Intervals".

Accessories

Do not use accessory parts other than those in the order list.

Not for use in areas of explosion hazard 

This apparatus is neither approved nor certified for use in 
areas where combustible or explosive gas mixtures are likely 
to occur.

Safe connection with other electrical equipment 

Electrical connections to equipment which is not listed in 
these instructions for use should only be made following 
consultation with the respective manufacturer or an expert.

Liability for proper function or damage 

The liability for the proper function of the apparatus is 
irrevocably transferred to the owner or operator to the extent 
that the apparatus is serviced or repaired by personnel not 
employed or authorized by DrägerService or if the apparatus 
is used in a manner not conforming to its intended use. 
Dräger cannot be held responsible for damage caused by 
non-compliance with the recommendations given above. 
The warranty and liability provisions of the terms of sale 
and delivery of Dräger are likewise not modified by the 
recommendations given above. 

Dräger Medical AG & Co. KGaA

Summary of Contents for Savina

Page 1: ...D Dräger Medical Instructions for Use Software 2 n mt78799 Savina Intensive Care Ventilator ...

Page 2: ...halten Ausschalten des Medikamentenverneblers Taste O2 Y Absaug zum Starten Beenden des Oxyge nierungsprogramms Taste Insp hold für eine manuell ausgelöste Inspiration und eine Verlängerung der Inspiration Info Fenster im Bildschirm Während der Einstellung eines Beatmungsparameters errechnet Savina die neuen abgeleiteten Parameter und zeigt sie im Info Fenster am Bildschirm in der Hauptseite an Da...

Page 3: ...ection chart Dismantling Cleaning Maintenance Assembly Checking readiness for operation Description of ventilation modes Bibliography Display Abbreviations Symbols Environmental conditions Performance data Measured value displays Operating data Contents For your safety and that of your patients 5 Intended Use 7 Operating Concept 9 Operation 17 Configuration 47 Fault Cause Remedy 55 Care 67 Prepara...

Page 4: ...4 ...

Page 5: ...either approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur Safe connection with other electrical equipment Electrical connections to equipment which is not listed in these instructions for use should only be made following consultation with the respective manufacturer or an expert Liability for proper function or damage The liability for the prope...

Page 6: ...bove standards and therefore cause interference The following points should be noted if ventilating while travelling Do not place Savina on the bed while travelling Ensure the apparatus cannot fall or be knocked over Protect the apparatus from splashes and rain to avoid risk of malfunction Savina is not splashproof During transport conditions e g in an aircraft hoses may start to vibrate and thus ...

Page 7: ...7 Intended Use Intended Use 8 ...

Page 8: ...with positive airway pressure SB Spontaneous Breathing Spontaneous breathing ASB Assisted Spontaneous Breathing Pressure assisted spontaneous breathing BIPAP3 optional Biphasic Positive Airway Pressure Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle and adjustable pressure assist on CPAP level 1 Savina is a registered trade mark of Dräge...

Page 9: ... mode 10 Screen Operating Controls 11 Keys for routine and additional functions 12 Information window on screen 12 Power switch 12 Screen Pages 13 Structure of the screen pages 13 Main page 13 Settings screen page 14 Alarms screen page 14 Values screen page 14 Configuration screen page 15 Standby key 15 ...

Page 10: ...n parameter press the corresponding parameter key The yellow LED in the key lights up 3 To set the value of the ventilation parameter turn the rotary knob The value is displayed next to the parameter key 3 To confirm the value press the rotary knob The yellow LED in the key goes out The new value of the parameter becomes effective on confirmation Derived parameters are displayed in an information ...

Page 11: ...the alarm limits Values key for selecting the Measured values screen page in order to display the measured values Config key for selecting the Configuration screen page for system settings such as alarm volume screen brightness 2 Central turn and push rotary knob for selecting and setting the options displayed on the screen To select set turn the rotary knob to confirm press the rotary knob Changin...

Page 12: ... the left hand side of the front panel Neb key for switching the medicament nebuliser on off O2 Y suction key to start end the oxygen enrichment program Insp hold key for manually activated inspiration and for extending the inspiration time Information window on screen During setting of a ventilation parameter the Savina calculates the derived parameters and displays them in the information window...

Page 13: ...values display field 4 Measured values display field 5 Information bar Main page Displays a pressure curve and displays three measured values To configure combination of measured values see page 49 or Displays a flow curve and displays three measured values To configure combination of measured values see page 49 107 37261 1 2 3 4 5 075 37388 072 37388 ...

Page 14: ...e parameter for setting press rotary knob The active parameter appears light on a dark background To set parameter turn rotary knob to confirm press rotary knob For detailed instructions on setting the ventilation modes see pages 19 onwards Alarms screen page For displaying the alarm limits associated with the measured values For setting the alarm limits For detailed operating instructions see Set...

Page 15: ... to the next page press the same key again To change to another page press the corresponding key for that page To change to the main page for pressure curves press Curves key Detailed instructions for use see Configuration pages 47 onwards Standby key 1 Positioned at bottom right of the front panel To keep the apparatus operational e g after pre setting or to switch on ventilation To switch to stan...

Page 16: ...16 ...

Page 17: ... 31 Advisory 32 Suppressing the audible alarm 32 Displaying Curves and Measured Values 33 Displaying measured values 33 NIV Non invasive ventilation Mask ventilation optional 34 Special functions 37 Manual inspiration 37 Medicament nebulization 38 Oxygen enrichment for bronchial suction 40 Calibrating 42 Calibrating O2 sensors 43 At high ambient temperature 44 In the event of a power supply failur...

Page 18: ... associated ventilation parameters During the self test the start up page appears showing the software version After this the main page appears 2 Check the settings in the display fields next to the parameter keys and adjust as necessary To adjust ventilation parameters Either 2 Change the ventilation parameters after the Savina has started ventilation or 3 Press the Standby switch to set the Savi...

Page 19: ...s for the active ventilation mode do not become operative until confirmed If you fail to confirm the new settings within 15 seconds the previous settings will remain operative Extreme settings Certain ventilation parameters are limited by Savina to a threshold value Extreme values can only be set after confirmation by pressing the rotary knob Confirmation is not necessary when the values are returned ...

Page 20: ...s that are operative in the active ventilation mode Any change and confirmation of these parameters immediately affects the active ventilation mode 2 Press the relevant parameter key which has its LED constantly lit 3 Set the desired value turn the rotary knob confirm value press the rotary knob the yellow LED for that parameter key will go out 3 To activate ventilation mode press rotary knob If pa...

Page 21: ...tive end expiratory pressure PEEP If PEEP is greater than 0 the airway pressure remains constantly in the positive range CPPV Pressure limit Pmax The pressure peak can be avoided in IPPV and IPPVAssist by setting a pressure limit Thereby the PLV ventilation mode can be reached Pressure Limited Ventilation To set the pressure limit Pmax Set Pmax to ON see page 51 Set pressure limit value by means o...

Page 22: ...g press rotary knob A recommended start up setting for FlowAcc is 35 mbar s IPPV can be extended using the following ventilation parameters Trigger Sigh AutoFlow optional Trigger IPPVAssist To synchronize the mandatory ventilation strokes with the patient s efforts to breathe in The actual frequency may be higher than the ventilation frequency f set 1 The green LED lights up if the Savina detects ...

Page 23: ...trigger field OFF 2 To confirm press rotary knob The ventilation mode IPPV is displayed on the screen Sigh To prevent atelectasis Atelectasis can be prevented by activating the sigh function and setting the sigh in the form of an intermittent PEEP When the sigh function is activated the end expiratory pressure is increased by the set intermittent PEEP for 2 ventilation strokes every 3 minutes Acti...

Page 24: ...and pressure peaks are avoided Savina supplies additional inspiration flow when the patient breathes in restricted by the alarm limit VTi The patient can also breathe out during the inspiratory plateau phase The inspiratory pressure is limited by the Paw alarm limit To switch AutoFlow ON and OFF Press Settings key Select line AutoFlow on screen turn rotary knob To release AutoFlow for setting press...

Page 25: ...ventilation strokes on screen page Settings 1 1 Set flow metering by means of FlowAcc on screen page Settings 1 1 AutoFlow optional ON OFF Pressure limit Pmax The pressure peak can be avoided in SIMV and SIMV ASB by setting a pressure limit To set the pressure limit Pmax Set Pmax to ON see page 51 Set pressure limit value by means of Pinsp key When setting the pressure limit ensure that the tidal ...

Page 26: ...essure support PASB above PEEP For details see BIPAP description page 104 Set BIPAP by means of the ventilation parameter keys Inspiration time Tinsp Frequency f O2 concentration O2 Inspiration pressure Pinsp Positive end expiratory pressure PEEP The following can be set on the screen Sensitivity Trigger for synchronization with spontaneous breathing To set the trigger page 23 FlowAcc can be set o...

Page 27: ...nally for CPAP ASB Pressure support PASB above PEEP The following can be set on the screen FlowAcc for pressure support ASB on screen page Settings 1 1 Sensitivity Trigger for synchronising attempted spontaneous breathing with ASB pressure support on screen page Settings 1 1 CPAP CPAP ASB can be supplemented with the following ventilation parameters and ventilation modes Trigger By setting the tri...

Page 28: ...s key Screen page 1 1 appears If apnoea ventilation is activated the VTApnoea and fApnoea lines are visible In this case A apnoea ventilation standby appears at the right on the main screen page If apnoea ventilation is deactivated instead of the fApnoe line the display shows Apn Vent OFF To activate apnoea ventilation Select Apn Vent OFF line turn rotary knob Activate press rotary knob Set a valu...

Page 29: ...larm Reset key Savina carries on ventilating in the original ventilation mode and associated ventilation parameters During Savina settings the status of switched on apnoea ventilation is displayed for 6 seconds by a special information page where in principle apnoea ventilation is possible when changing over the ventilation mode when switching on Savina when reducing the frequency if the cycle tim...

Page 30: ... pressure Paw because it is automatically coupled to the PEEP setting The alarm limits do not have to be set for the O2 concentration These limits are automatically coupled to the O2 concentration setting Lower alarm limit Setting 4 vol at settings up to 60 vol Setting 6 vol at settings from 60 to 100 vol Upper alarm limit Setting 4 vol at settings up to 60 vol Setting 6 vol at settings from 60 to...

Page 31: ...certain alarm messages occur Warning Top priority message 1 Red LED flashes Warning messages are marked with three exclamation marks and appear white on a dark background Example Savina generates a five tone sequence that is sounded twice and repeated every 7 5 seconds Caution Medium priority message 1 Yellow LED flashes Caution messages are marked with two exclamation marks Example Check settings ...

Page 32: ... background on the screen and need to be acknowledged 2 Press the Alarm Reset key 3 The message is erased from the screen Suppressing the audible alarm for max 2 minutes 4 Press the key Its yellow indicator LED lights up and the alarm tone will be muted for about 2 minutes If the cause of the alarm has not yet been remedied the audible alarm will sound again after about 2 minutes If you wish to re...

Page 33: ...e line can be configured see page 49 Displaying measured values Press Values key The screen page Values1 2 appears or in Mask NIV mode Values 1 3 The airway pressure is indicated by a bar display The other measured values are displayed numerically Displaying other measured values Press Values key again The screen page Values2 2 appears or in Mask NIV mode Values 2 3 When ventilating without plateau...

Page 34: ...s to standby hold down Standby key for about 3 seconds Press Alarm Reset to switch off the audible alarm Select Patient Connection line press rotary knob Select Mask NIV line press rotary knob Confirm press rotary knob When masks are used the dead space increases Follow the mask manufacturer s directions For a detailed description of NIV see page 106 Never ventilate an intubated patient in the Mas...

Page 35: ... caused by the patient up to 25 L min Automatic compensation of set tidal volume Savina compensates up to 100 of the measured minute volume for leaks detected Monitoring in the Mask NIV mode To avoid artefacts in the case of very big leaks the following alarms may be switched off MV minute volume lower alarm limit VTi inspiratory tidal volume upper alarm limit TApnoea apnoea monitoring upper alarm...

Page 36: ...l the screen page Alarms 2 2 appears Activate the TDisconnect line to set Set TDisconnect turn the rotary knob confirm press the rotary knob Selecting Tube mode Switch apparatus to standby hold down Standby key for about 3 seconds Press Alarm Reset to switch off the audible alarm To select activate Patient Connection line press rotary knob Select Tube turn rotary knob Confirm press rotary knob The...

Page 37: ...e manually started ventilation stroke depends on the ventilation mode in use For IPPV SIMV volume controlled ventilation stroke defined by the VT and Tinsp settings For BIPAP pressure controlled ventilation stroke defined by the Pinsp and Tinsp settings For CPAP ASB pressure assisted ventilation stroke defined by the PASB above PEEP setting 1 Press and hold down the Insp hold key for as long as inspi...

Page 38: ...Prepare the medicament nebulizer in accordance with the accompanying instructions for use 1 Connect the nebulizer to the inspiratory side of the Y piece temperature sensor side 2 Connect the inspiration hose to the medicament nebulizer Swivel the medicament nebulizer to the vertical position Using clamps route the nebulizer hose back to the ventilator along the ventilation hose 3 Connect the nebul...

Page 39: ... On screen information Flow calibration Remove any left over medicament from the medicament nebulizer Follow the instructions for use of the medicament nebulizer Take into account the effect of aerosols on sensors and filters The measuring function of the flow sensor may be impaired The flow resistance of filters is liable to increase and may impair ventilation During medicament nebulization do not us...

Page 40: ...ring suction and for two minutes afterwards the lower alarm limit for the minute volume is disabled Connect your O2 supply 2 7 to 6 bar from the medical pipeline system or from the O2 cylinder to Savina Before suction 1 Hold down O2 Y suction key until the yellow lamp lights up In the set ventilation mode Savina ventilates with 100 Vol O2 In case PEEP has not been set higher than 4 mbar an automat...

Page 41: ...er reconnection After reconnection has taken place Savina ventilates once more in the set ventilation mode however for final O2 enrichment 120 seconds more with 100 Vol O2 Message in the information line on screen Final O2 enrichment 100 120 s The remaining time is continuously displayed on screen In case the O2 enrichment has to be interrupted 1 Press the O2 Y suction key again Automatic discontin...

Page 42: ...er changing the O2 concentration Savina uses a full inspiration phase for calibration Short inspiration times are extended to about one second Message in the information line on the screen Flow calibration in progress After calibration is complete the following message appears in the information line Flow calibration ok If calibration is unsuccessful the following message appears Flow calibration ...

Page 43: ... than 2 by volume when the air pressure changes by more than 200 hPa e g during transfer flights by helicopter when the temperature changes by more than 10 oC During automatic calibration the following message appears in the information line on the screen O2 calibration active After calibration is complete the following message appears O2 calibration ok The O2 sensor for O2 monitoring sensor 2 has...

Page 44: ... operational temperature sensor is used in the Y piece Savina will warn of breathing gas temperatures of 40 o C or higher by activating the alarm Breathing gas temp high In both cases Savina continues ventilating the patient Lower the ambient temperature In the event of a power supply failure If all external and internal power sources fail an intermittent audible alarm sounds Either immediately re...

Page 45: ... needs an inspiratory O2 concentration higher than 21 Vol reconnect the O2 supply without delay In the event of blower failure Savina cannot carry on ventilating Continue ventilating without delay using an independent ventilator ...

Page 46: ...46 ...

Page 47: ...ble alarm 48 Configuring the measured values line 49 Manual calibration for O2 sensor 2 49 FiO2 or flow monitoring ON OFF 50 Pmax ON OFF 51 Plateau ON OFF 52 Selecting the language 52 Setting the date and time 52 Configuring the MEDIBUS protocol 53 Displaying the device values 53 ...

Page 48: ...enance software version device identification number Setting the screen contrast Press Config key repeatedly until Configuration 1 4 appears Select the Contrast line turn the rotary knob activate press the rotary knob To set the contrast turn the rotary knob The contrast changes Confirm press the rotary knob The contrast set will now be activated Adjusting the volume of the audible alarm Display exa...

Page 49: ...wing alarms occur FiO2 high or FiO2 low or O2 measurement inop Manual calibration can be carried out in the respective ventilation mode Press Config key repeatedly until Configuration 2 4 appears Select O2 calib line turn rotary knob to release for setting press rotary knob To start O2 calibration turn rotary knob and select Start to confirm press rotary knob Message in the information line on scree...

Page 50: ...p or FiO2 low Replace O2 sensor see page 77 After replacing the O2 sensor Allow about 20 minutes warm up time to elapse then calibrate FiO2 or flow monitoring ON OFF For instance when a used O2 or flow sensor cannot be replaced immediately Use alternative monitoring as otherwise there will be a restricted monitoring function Press Config key repeatedly until Configuration 2 4 appears Select the desire...

Page 51: ...eactivated even when the device is switched on again Display in alarm line O2 monitoring off On acknowledging by pressing the Alarm Reset key display O2 monitoring off Reactivate the monitor function after replacing the sensor Pmax ON OFF To use the pressure limit Pmax in the IPPV IPPVAssist and SIMV SIMV ASB ventilation modes The pressure limit value is set by means of the Pinsp key Savina limits...

Page 52: ...ed Selecting the language Display example Press Config key until Configuration 3 4 appears Select Language line turn the rotary knob to release for setting press rotary knob The following languages can be selected German Japanese English Russian US English Greek French Romanian Italian Polish Spanish Portuguese Chinese Select language turn the rotary knob confirm press the rotary knob The new langua...

Page 53: ...nob Displaying the device values Press Config key repeatedly until Configuration 4 4 appears Savina displays SW Software version of the device Device ID specific device identification number Working hours the total number of hours the device has been operating and h since service the number of working hours since the last inspection and service by trained service personnel Release code Numerical cod...

Page 54: ...54 ...

Page 55: ...55 Fault Cause Remedy Fault Cause Remedy 56 ...

Page 56: ...ck ventilation pattern Correct alarm limit if necessary Ventilation hose kinked Check hose system and tube Airway pressure low Leaking cuff Inflate cuff and perform leak test Leak or disconnection Check hose system for tight connections Check that the expiration valve is properly engaged Ambient press meas inop Internal absolute pressure sensor faulty Due to a fault in the ambient pressure measurem...

Page 57: ...e VT and minute volume MV values on the basis of 1013 mbar in the absence of current measurements If the Airway pressure high alarm is correctly set and the incorrect tidal volume VT and minute volume MV values are tolerable Savina can continue to be used Keep a check on the patient s condition Call DrägerService Atmospheric pressure low The device is being used at too low atmospheric pressure Use...

Page 58: ...supply active Device operating with external battery Note capacity of external power source Ext DC high External battery voltage is too high Disconnect Savina from the external battery and connect to a battery with the permissible voltage FiO2 high Due to a low minute volume MV the mixer is not yet completely steady Message disappears after a short time O2 sensor not calibrated O2 sensor s faulty ...

Page 59: ...eld down longer than 15 seconds Release Insp hold key Int batt almost discharged Working time when running on the internal battery has almost expired mains power or external DC power supply not connected Immediately connect supply via mains external battery or a vehicle DC on board network Int batt almost discharged Mains power connected internal battery almost discharged Do not switch over Savina...

Page 60: ...is only a few minutes Do not switch over Savina to operation via internal battery Key xx failed xx key e g 2 min can no longer be pressed Disconnect patient from Savina and continue ventilation without delay using another independent ventilator Use PEEP and or an increased O2 concentration if necessary Call DrägerService Key xx overused Keys pressed very frequently within a short time e g 2 min ke...

Page 61: ...rägerService MEDIBUS COM inop The connector of the MEDIBUS cable has been unplugged during operation Reconnect the connector and secure against disconnection with the two screws MEDIBUS cable defective Use a new MEDIBUS cable Interface defective Ventilation with Savina can be continued Call DrägerService Microfilter blocked Microfilter clogged Change microfilter see page 75 Microfilter missing Microfil...

Page 62: ...na can be continued Call DrägerService No int battery Internal battery is missing defective or not connected or fuse has failed Call DrägerService This alarm can be acknowledged by the Alarm reset key Then it appears as advisory message No int battery Internal battery is missing defective or not connected or fuse has failed If there is a reliable mains supply ventilation with Savina can be continu...

Page 63: ...s Ventilation with Savina can be continued though the PEEP set will not be reached Observe the patient closely Call DrägerService Pressure meas inop Fluid in expiration valve Replace expiration valve then disinfect clean and dry see page 71 Pressure measurement malfunction Disconnect patient from Savina and continue ventilation without delay using another independent ventilator Use PEEP and or an ...

Page 64: ...necessary correct the alarm limit Leak or disconnection Check that the connections of the hose system are leakproof Tidal volume high After first breathing stroke The upper alarm limit of the applied inspiratory tidal volume VT has been exceeded during three consecutive ventilation strokes Check the condition of the patient Check the ventilation pattern If necessary correct the alarm limit Leak or ...

Page 65: ...nsp key After second breathing stroke in AutoFlow Because of pressure and time limitations the set tidal volume VT will not be applied Extend inspiration time Tinsp raise FlowAcc raise upper alarm limit for airway pressure Paw VTi high Alarm off Only in Mask NIV mode optional The inspiratory tidal volume upper alarm limit VTi has been switched off Reset alarm limit VTi to desired monitoring value ...

Page 66: ...66 ...

Page 67: ...ina Intensive Care Ventilator 73 Maintenance Intervals 74 Replacing the microfilter 75 Replacing the dust filter set 76 Replacing the O2 sensors 77 Using an external battery 77 Correct disposal of batteries and O2 sensors 78 Correct disposal of internal battery 78 Important when storing Savina 78 Correct disposal of apparatus 78 ...

Page 68: ... ventilation hoses Drain the water trap on the expiration valve 2 Drain the water container of the humidifier Ventilation hoses Remove ventilation hoses from the device ports Remove the water traps from the ventilation hoses Remove the water containers from the water traps and the expiration valve Prepare the ventilation hoses water traps and associated water jars and the Y piece for disinfection ...

Page 69: ...ebulizer and from the spigot on the device 2 Pull medicament nebulizer out of the adult hose set or 2 dismantle medicament nebulizer from the paediatric hose set 3 Pull catheter connector ISO cone ø15 ø11 out of the input 4 Pull spigot ISO cone ø22 ø11 out of the output 5 Pull corrugated hose out of the spigot Dismantle and prepare medicament nebulizer in accordance with the accompanying instructi...

Page 70: ...trap 4 Turn knurled sleeve to the left and 5 remove expiration valve 6 Remove diaphragm 7 Remove rubber bushing Do not disassemble the expiration valve any further The expiration valve together with the diaphragm rubber bushing and dismantled water trap collecting jar are suitable for disinfection and cleaning by autoclaving or sterilising Breathing gas humidifier Dismantle according to the relevan...

Page 71: ...published by mhp Verlag Wiesbaden also classifies each disinfectant by its active agents For countries where the DGHM list is not available we recommend the types of disinfectant given above Disinfectants often contain besides their main active agents additives that can also damage materials If in doubt ask the supplier manufacturer of the disinfectant cleaning agent Savina basic device with trolle...

Page 72: ...xpiration valve diaphragm Containers for water traps Temperature sensor are thermo stable and can be steam sterilised at 134 oC Prepare medicament nebulizer in accordance with the accompanying instructions for use Handle bacterial filter in accordance with the accompanying instructions for use ...

Page 73: ...ible hospital hygiene official remain unaffected Part How often How Reusable components Recommended cleaning intervals Disinfecting and cleaning Sterilising Autoclaving at 93 o C 10 minutes Wiping Bath immersion Steam 134 o C 10 minutes Savina basic device per patient no outside no no Trolley Hinged arm Medical gas hose per patient no outside no no Ventilation hoses Y piece Water traps and Collecti...

Page 74: ...nnel after 20 000 hours operation or after 8 years whichever is earlier Lead gel battery To be replaced by trained service personnel after 2 years Lead gel batteries should be disposed of as special waste see page 78 Filter in O2 inlet To be replaced by trained service personnel every 6 years Real time clock To be replaced by trained service personnel every 6 years Pressure reducer To be replaced ...

Page 75: ...e new microfilter into housing as far as it will go Dispose of used microfilter with domestic waste 4 Insert filter cover with two lugs into rear panel 5 Position power cable under filter cover 6 Push latches into housing until they engage Do not operate Savina without a microfilter as the inspiration side will get dirty 097 29 170 1 1 2 099 29 170 3 114 29 170 5 6 6 4 4 ...

Page 76: ... Fit new dust filter Dispose of used dust filter with domestic waste 4 Insert filter cover with two lugs into rear panel 5 Position power cable under filter cover 6 Push latches into housing until they engage Breathing air and cooling air are drawn in through the filter cover Do not cover do not place up against a wall risk of device overheating 097 29 170 1 1 2 098 29 170 3 3 3 114 29 170 5 6 6 4 ...

Page 77: ...ng Sensor 2 Allow not more than 20 minutes warm up time to elapse then calibrate manually see page 49 The internal battery supplies the two O2 sensors with current even when Savina is switched off This enables Savina to supply valid O2 measured values as soon as it is switched on If the internal battery is discharged Savina does not supply any O2 measured values for the first 20 minutes after switc...

Page 78: ...ains permanent batteries that contain harmful substances The permanent batteries containing harmful substances that are fitted in Savina should be removed and disposed of by Dräger Service Important when storing Savina If Savina is stored for longer than 1 month without power Remove fuse for internal battery This avoids undesirable total discharge of the internal battery which would otherwise cons...

Page 79: ...ratory bacterial filters 82 Note on the use of heat and moisture exchangers 82 Positioning the humidifier 83 For ventilating infants 83 Fitting the Aquapor humidifier 83 Fitting the Fisher Paykel humidifier 84 Electrical power supply 85 O2 supply 91 Expected operating time when using an O2 cylinder supply 91 Nurse call system 92 Checking readiness for operation 93 Checklist 96 ...

Page 80: ...e expiration valve 1 Attach diaphragm to expiration valve 2 Attach rubber bushing to port Inserting the expiration valve 3 Turn knurled sleeve to left as far as it will go 4 Insert expiration valve 3 Turn knurled sleeve to right 5 Fit container for water trap 052 37261 2 1 028 37261 3 4 5 ...

Page 81: ...unting and push it into the socket as far as it will go Then 3 Push flow sensor to the right as far as it will go into the rubber lip of the expiration valve Fitting the bacterial filter An inspiratory bacterial filter is necessary to protect the patient from contamination from the ambient air drawn in Push bacterial filter on to inspiration port 029 37261 2 1 3 034 37261 ...

Page 82: ...xchanger HME in the patient connection of the Y piece can considerably increase breathing resistance An increase in breathing resistance will in turn lead to greater effort in spontaneous breathing and or greater trigger effort during assisted ventilation Under unfavourable conditions an increase in breathing resistance can lead to an unwanted intrinsic PEEP This breathing resistance in the patien...

Page 83: ...e with the separate instructions for use Monitor the breathing gas temperature 1 Hang the Aquapor with a bracket to the mounting and tighten the screws 2 Insert elbow connector into Aquapor 3 Insert double nozzle into elbow connector Fill Aquapor tank with sterile distilled water to the upper level If using heated paediatric hoses with internal hot wires please note In the event of Savina failure ...

Page 84: ...r use 1 Hang the humidifier with bracket to the humidifier holder rail and tighten the screws DIN VDE 0750 Part 215 The use of anti static or electrically conductive material in the breathing system of the lung ventilator is not considered to contribute any improvement in safety On the contrary the use of these materials increases the danger of electric shock to the patient and of fire due to the p...

Page 85: ... of the humidifier and note their length in metres Electrical power supply The ventilator is designed for a mains voltage of 100 V to 240 V 50 60 Hz The built in power adapter of the Savina automatically adapts to the mains supply Insert the plug into the mains socket Do not use shorter ventilation hoses than specified to avoid the risk of overheating the breathing gas 036 37261 0 4m 1 1 1m 1 2m 10...

Page 86: ...able that plugs into the Savina is coded This enables Savina to detect whether an external battery or a DC on board network is connected Ensure polarity is correct black red If an external battery or DC on board network is wrongly connected the device will ignore it Insert plug into DC socket on rear of device Only rechargeable batteries should be used The charging function of the DC power supply ...

Page 87: ...tically prioritises the use of the power sources Mains supply If a mains supply is available Savina automatically switches to mains voltage and charges the internal and external batteries External battery or DC on board network In case of mains power failure if direct current voltage is connected Savina automatically switches to the external battery or DC on board network Internal battery If neith...

Page 88: ...e Savina charges the battery to counteract running down Operation with an external battery or DC on board network In the event of a mains power failure Savina seamlessly switches over to the external DC power supply connected This may take either of two forms Supply from external battery or Supply from DC on board network Savina detects whether an external battery or the DC on board network is con...

Page 89: ...ry first and then the external battery Immediately reconnect Savina to mains power supply to fully recharge the internal and external battery again Operation with the internal battery In the event of a mains power failure if no external battery is connected or if the external battery is discharged Savina seamlessly switches over to the internal battery Display 1 No mains supply top lamp N out 2 No ...

Page 90: ...avina with an internal battery Reconnect Savina to the mains voltage in order to charge the internal battery and if applicable the external battery again immediately When the power source is an external battery the internal battery is not charged Only trickle charging takes place When the power source is the DC on board network the internal battery is charged The charging time is around 5 hours Al...

Page 91: ...inder supply the maximum possible operating time depends on the O2 reserve as well as on the O2 concentration and the ventilation parameters For example Cylinder pressure measured at the pressure regulator on the O2 cylinder 200 bar O2 cylinder capacity 3 L O2 reserve 200 bar x 3 L 600 L Expected operating time with the following parameters Ventilation mode IPPV Frequency f 10 bpm Tidal volume VT ...

Page 92: ...Installation of the supplementary equipment should be carried out by experts The 6 pin round plug female should be connected to the clinic internal central alarm by experts When Savina displays an alarm message the connection 3 5 is closed and the nurse call system is active Expected operating time Gas reserve L O2 fraction 0 21 x MV L min 600 L 0 5 0 21 x 6 L min 600 0 29 x 6 approx 340 min appro...

Page 93: ...ntact Input voltage max 40 V Input current max 500 mA Switching power max 15 W Checking readiness for operation to be carried out after preparation The following functions are tested during this check Operation of lamps LEDs displays and the audible alarm Ventilation function PEEP function Expiratory volume measurement MV Measurement of inspiratory O2 concentration FiO2 Lower alarm limit MV Lower ...

Page 94: ...eters Checking the lamps and audible alarm At the end of the 12 second test phase the device activates all the LEDs all the lamps in the keys and the trigger and power supply lamps The audible alarm is tested briefly The lamp indicating the power source in use at any given time is lit continuously Testing the ventilation function 1 Ventilation mode IPPV 2 VT 800 mL 3 Tinsp 2 s 4 f 10 bpm 5 O2 60 vo...

Page 95: ...ect mains plug or disconnect DC supply plug The device switches over to the internal battery and continues ventilating Display Int battery activated Reconnect mains plug or DC supply plug Checking the O2 alarm Disconnect O2 compressed gas hose connector Intermittent audible alarm and display O2 supply down Savina ventilates with air Reconnect O2 compressed gas hose connector A warning FiO2 low may...

Page 96: ... stop simulation At the end of the apnoea alarm time TApnoea audible alarm sounds the warning Apnoea appears on the screen Press Alarm Reset PEEP high alarm Set ventilation mode IPPV set Paw to 100 mbar keep flow sensor tight Audible alarm sounds red lamp flashes the warning PEEP high appears on the screen Press Alarm Reset Airway pressure high alarm Set pressure limit Pmax to OFF set Paw below the ...

Page 97: ...ventilation 98 IPPV 98 Flow Acceleration 98 Pressure limiting 98 IPPVAssist 99 Sigh intermittent PEEP 99 AutoFlow optional 100 SIMV 102 ASB 103 BIPAP optional 104 Automatic leakage compensation 105 NIV Non invasive ventilation optional 106 Bibliography 108 ...

Page 98: ...e VT and flow acceleration The value for Tinsp is shown on Values screen 2 2 Savina establishes a minimum expiration time of 500 ms and limits the resulting I E ratio to max 4 1 Flow Acceleration With the parameter FlowAcc the pressure and flow increase can be influenced A greater Flow acceleration produces a steeper pressure and flow increase Flow acceleration and the inspiration time can be used to ...

Page 99: ...lung Since atelectatic alveoli have a longer time constant also caused by obstructed bronchioles increased airway pressure maintained over a longer period is required to open them In many cases the sigh function is achieved by increasing the ventilation stroke however due to the short time available this form of sigh only marginally improves the filling of the slow alveoli In Savina the sigh operat...

Page 100: ...tient breathes in or out during mandatory inspiration the plateau pressure Pplat is not changed for this ventilation stroke Only the inspiration and expiration flow are adapted to the patient s demand The individually applied tidal volume VT may differ from the set tidal volume VT in specific ventilation strokes but on average over time a constant tidal volume VT is supplied The exceeding increase o...

Page 101: ...athing stroke serves the function AutoFlow as starting value for the inspiration pressure Settings to suit the patient s needs The Start of the mandatory inspiration can be synchronized with the patient s inhalation effort with the help of the variable flow trigger The flow trigger can only be completely turned off in IPPV IPPVAssist IPPV The steepness of the pressure increase from PEEP level to the...

Page 102: ...esult in an undesirable increase in the effective IMV frequency Savina adds in the reduced SIMV time by prolonging the subsequent spontaneous breathing phase by the SIMV time difference T thus preventing an increase in SIMV frequency The frequency parameter f remains constant This parameter in combination with the tidal volume VT sets the minimum ventilation If the patient has breathed in a consid...

Page 103: ...ment of the patient The flow supply can be adjusted using FlowAcc to meet the individual needs of the patient In case of high flow acceleration Savina supports the insufficient spontaneous breathing of the patient with a high peak flow In case of low flow acceleration Savina begins smoothly with even inspiratory flow ASB is terminated when the inspiration flow returns to zero during phase I i e whe...

Page 104: ...tient s spontaneous breathing The frequency of the change over is kept constant even with patient synchronisation by defining a trigger time window with a fixed time constant This smooth adaptation to the patient s spontaneous breathing requires less sedation so that the patient returns to spontaneous breathing more rapidly As in all pressure controlled ventilation modes the patient is not prescribe...

Page 105: ...y f Automatic leakage compensation Savina determines the difference between the inspiratory metered flow and the expiratory measured flow The difference provides an indication of the extent of leakage and is designated leak minute volume MVleak The leak minute volume MVleak is taken into account for trigger detection for optimum synchronisation of the ventilator with the patient Automatic leakage co...

Page 106: ...ery big leaks it is often not possible to measure any expiratory minute volume If this alarm were not switched off the device would generate alarms all the time The following alarms can therefore be deactivated in Mask NIV mode Minute volume low Tidal volume high Apnoea detection Non invasive ventilation with the alarms switched off is only permissible if the patient s safety is not put at risk Th...

Page 107: ...ncreases the applied tidal volume VT by the amount lost due to leakage during inspiration If a tidal volume VT of 500 mL has been set and 50 mL are lost during inspiration Savina will automatically deliver 550 mL Because unlimited leakage compensation is not advisable Savina compensates for leakage up to 100 of the set tidal volume ...

Page 108: ... augmentierenden Beatmung Anaesthesist 38 1989 452 458 2 Vincent J L Yearbook of Intensive Care and Emergency Medicine Springer Verlag 1993 3 Sydow M Biphasic Positive Airway Pressure BIPAP und Airway Pressure Release Ventilation APRV in Kuhlen R Guttmann J Rossaint R Hrsg Neue Formen der assistierten Spontanatmung Urban Fischer 2000 ...

Page 109: ...109 What s what Control unit 110 Front connection block 111 Back panel 112 Abbreviations 113 Symbols 115 ...

Page 110: ...37388 D Savina IPPV Insp hold O2 Y Absaug Verneb Lock 2 min Standby Einstell Kurven Alarme Werte Konfig Trigger SIMV BIPAP O g CPAP ASB Alarm Reset VT mL L Pinsp mbar PASB über PEEP PEEP mbar Tinsp s f bpm O2 Vol 19 18 17 16 3 4 5 6 7 8 15 14 13 12 11 10 9 20 1 2 J J N int ext D Savina IPPV Insp hold O2 Y Suction Neb Settings Curves Alarms Values Config Trigger SIMV BIPAP O g CPAP ASB Alarm Reset ...

Page 111: ... block 1 Flow sensor 2 Expiration valve with expiration port 3 Socket for breathing gas temperature sensor plug 4 Inspiration port 5 Gas supply port for the medicament nebuliser 6 Protective cover for O2 sensors 088 37261 1 2 4 5 3 6 ...

Page 112: ...ptional 3 Power switch 4 Fuse for internal battery 5 Power unit socket 6 DC inlet external battery or DC on board network 7 Potential equilisation connector 8 Filter cover 9 Low pressure O2 inlet 10 In side panel connection for O2 pressure hose 089 37261 1 2 3 4 5 6 7 8 9 10 ...

Page 113: ...oea ventilation fspn spontaneous breathing frequency ftot total breathing frequency Fail to cycle Machines detects no inspiration FiO2 Inspiratory O2 concentration FlowAcc Flow acceleration Int PEEP Intermittent Positive End Expiratory Pressure Sigh IPPV Intermittent Positive Pressure Ventilation IPPVAssist Assisting Intermittent Positive Pressure Ventilation IRV Inversed Ratio Ventilation Ventila...

Page 114: ...IV mode Temp Inspiratory breathing gas temperature Te Expiration time Tinsp Setting for the inspiratory time Tplat Plateau time VT Setting for tidal volume VTApnoea Setting for tidal volume of apnoea ventilation VTe Expiratory tidal volume VTi Inspiratory tidal volume VTpat Leakage compensated inspiratory measured tidal volume Abbreviation Definition ...

Page 115: ...play measured values Switch between flow pressure curve Bright dark screen brightness setting Mute audible alarm for 2 minutes Acknowledge alarms Lock ventilation parameters and ventilation mode Standby Upper alarm limit Lower alarm limit Lower upper alarm limit Follow instructions for use Protection class Type B Protection class Type BF Insert flow sensor Neb O2 Y Suction Insp hold Settings Config ...

Page 116: ...116 ...

Page 117: ...117 Technical data Technical data 118 ...

Page 118: ...perature Pressure Saturated Measured values with reference to the conditions of the patient s lung body temperature 37 oC ambient pressure steam saturated gas Accuracy 10 of set value or 25 mL whichever is greater Inspiratory pressure Pinsp 0 to 99 mbar 1 mbar 100 Pa O2 concentration Accuracy 21 to 100 vol 3 vol The accuracy of the inspiratory O2 concentration is appreciably reduced when operating...

Page 119: ...adult patient hose system 2 mL mbar Inspiration resistance 2 3 mbar 60 L min Expiratory resistance 3 8 mbar 60 L min Equipment compliance with Fisher Paykel MR 730 humidifier and tubing system for paediatric use 1 mL mbar Inspiration resistance 4 1 mbar 30 L min Expiration resistance 4 1 mbar 30 L min Additional functions Inspiratory relief valve opens breathing system in case of failure Safety val...

Page 120: ...Vleak based on the inspiratory minute volume only in Mask NIV mode Range 0 to 100 Resolution 1 Accuracy 18 of measured value Measured expiratory tidal volume VTe Range 0 to 3999 mL BTPS Resolution 1 mL Accuracy 8 of measured value Leakage compensated inspiratory measured tidal volume VTpat only in Mask NIV mode Range 0 to 3999 mL BTPS Resolution 1 mL Accuracy 18 of measured value Frequency Measure...

Page 121: ... min steps Lower alarm limit alarm when MV falls below the lower alarm limit Setting range 0 5 to 40 L min in 0 1 L min steps Airway pressure Paw Upper alarm limit alarm when the Paw high value is exceeded Setting range 10 to 100 mbar Lower alarm limit alarm when the value PEEP 5 mbar coupled with the PEEP set value is not exceeded for at least 0 1 s in two successive ventilation strokes Delay tim...

Page 122: ...nternal battery Plug in fuse 1 SA 32 V Supply from DC on board network 12 to 36 V DC Supply from external batteries 12 or 24 V Input current DC 12 V battery typically 10 A max 20 A 24 V battery typically 5 A max 10 A Bridging time if mains supply is down with charged external battery and typical ventilation examples 12 V battery 36 Ah approx 4 hours e g with 1 lead gel battery 12V 36 Ah 24 V batte...

Page 123: ...y 15 Ah Charging time 12 V battery 10 hours about 5 hours at 80 charge 24 V battery 10 hours about 5 hours at 80 charge Charge current 12 V battery 4 A 24 V battery 2 A Internal battery Type Lead gel battery maintenance free sealed Charging time 5 hours including from external DC on board network about 1 5 hours at 80 charge Protection class Machine Class I Temperature sensor AWT01 sensor fitted Ty...

Page 124: ...pecial requirements for intensive care ventilators EN 60601 1 Medical electrical appliances Part 1 General safety rules IEC 601 1 1996 EN 60601 1 2 Medical electrical appliances Part 1 General safety rules Second supplementary standard Electromagnetic compatibility Requirements and testing IEC 601 1 2 1993 RTC DO 160D Environmental Conditions and Test Procedures for Airborne Equipment Section 21 E...

Page 125: ...125 Order List Order List 126 ...

Page 126: ...ed L Stl MX 02 652 Hose set paediatric Fisher Paykel comprising Hose heater 23 47 020 patient hoses water traps Y piece catheter connector 84 12 081 Bacterial filter disposable 84 09 716 Special accessories Pneumatic medicament nebulizer 84 12 935 Articulated bracket or Quick fit articulated bracket 2 84 09 609 2M 85 706 SavinaMobil trolley 84 14 335 For manual ventilation Resutator 2000 21 20 046 P...

Page 127: ...1 65 856 Corrugated hose flex 0 13 m 84 09 634 Catheter connector size 11 set of 10 M 19 490 Cap 84 01 645 Paediatric adapter 90o 84 03 075 Double cone 84 09 897 Temperature sensor inputs 84 11 044 Expiratory condensate trap 84 09 627 Hose heater 1 10 m 84 11 045 Hose heater adapter 84 11 097 Designation Description Part No Consumables Spirolog flow sensor set of 5 84 03 735 Microfilter 67 37 545 Set...

Page 128: ...schedule 73 Dismantling 68 Disposal 78 Dust filter set 76 Electrical power supply 85 Event of an alarm 31 Event of gas failure 44 Expiration valve 70 80 External battery 77 Extreme settings 19 Fault Cause Remedy 56 FiO2 50 Flow Acceleration 98 Flow Acceleration FlowAcc 22 Flow monitoring 50 Flow sensor 70 81 Front connection block 111 Heat and moisture exchanger 82 HME 82 Hose set adult 81 Hose se...

Page 129: ...upply 85 Power supply failure 44 95 Power switch 12 Preparation 80 Pressure limiting 98 Readiness for operation 93 Release code 53 Screen pages 13 Structure 13 Selecting the ventilation mode 10 Setting new parameters 20 Setting ventilation parameters 10 Settings 14 Sigh 23 24 99 SIMV 25 102 SIMV ASB 25 Special functions 37 Standby 15 Sterilising 71 Storing 78 Suction 40 Supply 85 SW 53 Switching o...

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Page 132: ...rmation only and are not intended for use with any specific machine or device 90 37 388 GA 5664 915 en Dräger Medical AG Co KGaA 1st edition March 2001 Subject to alteration Dräger Medical AG Co KGaA Germany z Moislinger Allee 53 55 D 23542 Lübeck y 49 451 8 82 0 x 26 80 70 FAX 49 451 8 82 20 80 http www draeger com ç Directive 93 42 EEC concerning Medical Devices ...

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