Dräger Medical Savina Operating Instructions Manual
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Dräger Medical Savina Operating Instructions Manual

Intensive care ventilator
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M E D I C A L
Savina
Intensive Care Ventilator
Operating Instructions
Software 2.1n

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Summary of Contents for Dräger Medical Savina

  • Page 1 M E D I C A L Savina Intensive Care Ventilator Operating Instructions Software 2.1n...
  • Page 2 T T T T r r r r a a a a d d d d e e e e m m m m a a a a r r r r k k k k s s s s The Dräger name and logo are registered trademarks of Draeger. Savina® is a registered trademark of Draeger. AutoFlow® is a registered trademark of Draeger.
  • Page 3 3 Press »Stand by« key to set Savina to standby. 4 Press »Alarm Reset« key to confirm. 2 Change ventilation parameters and 3 press »Stand by« key to return to ventilation.
  • Page 4 Installed Options Installed Options...

  • Page 5: Table Of Contents

    Contents Contents Important Safety Information READ THIS FIRST! Safety considerations Intended Use Areas of use, restrictions of use, appropriate monitoring, back-up ventilation Operating Concept Controls, parameter setting, screen structure Preparation Assembly, installation, checks of readiness for operation AC Line Power and Battery Operation Power sources, priorities, battery level display Operation Ventilation modes, alarm limits and alarm priorities, waveforms,...
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  • Page 7: Important Safety Information Read This First

    Important Safety Information READ THIS FIRST! Important Safety Information READ THIS FIRST! Operator's Responsibility for Patient Safety ....... . 8 Limitation of Liability .

  • Page 8: Operator's Responsibility For Patient Safety

    Important Safety Information Operator's Responsibility for Patient Safety Limitation of Liability Important Safety Information Operator's Responsibility for Patient Safety Limitation of Liability Draeger Medical, Inc.'s liability, whether arising out of or WARNING ! related to manufacture and sale of the goods, their installation, demonstration, sales representation, use, performance, or Strictly follow this Operator's Instruction Manual otherwise, including any liability based upon Draeger Medical,...

  • Page 9: Warranty

    Important Safety Information Warranty Warranty Application of this warranty is subject to the following All Draeger products are guaranteed to be free of defects for a conditions: period of one year from date of delivery. The following are exceptions to this warranty: 1.

  • Page 10: Definitions

    Important Safety Information Definitions Definitions WARNING ! A WARNING statement refers to conditions with a possibility of personal injury if disregarded. CAUTION ! A CAUTION statement designates the possibility of damage to equipment if disregarded. N N N N O O O O T T T T E E E E : : : : A NOTE provides additional information intended to avoid inconveniences during operation.

  • Page 11: Summary Of Warnings And Cautions

    WARNING ! a risk of patient injury. The Savina ventilator must only be used under the super- vision of qualified medical personnel in order to provide WARNING ! immediate corrective action in case of a malfunction.
  • Page 12 If a fault is detected in the Savina ventilator, so that its life-support functions are no longer assured: WARNING! start ventilation using an independent ventilation...
  • Page 13 Draeger cannot warrant or endorse the safe performance Connecting other devices to the same extension power of third party humidifiers for use with the Savina ventila- strip may, in the event of grounding failure, cause the tor. Specifically, the user has to assess the risks of deliv-...
  • Page 14 Always use ventilator that has been cleaned and disin- hospital (e. g. inside the Savina nurse call electronics, the fected and has been successfully tested to be ready for Savina power supply, or the hospital alarm equipment) operation.
  • Page 15 Do not use a heat/moisture exchanger (HME) while — Avoid high airway pressures. Risk of aspiration. nebulizing pharmaceutical aerosols. — Never operate Savina without a water trap on the expi- Risk of increased breathing resistance. ratory valve - overcompensation for leakage might cause unintentionally high airway pressure and mis-trig- gering might occur.
  • Page 16 WARNING ! WARNING ! Sterilization of parts in ethylene oxide (EtO) may lead to a In the event of a failure of the turbine blower, Savina is patient health risk: not able to continue ventilation. Immediately continue Patients may become exposed to EtO that may have ventilation using an independent manual ventilation diffused into components.
  • Page 17 Draeger standards. It cannot withstand high temperatures and would be Draeger cannot warrant or endorse the safe performance destroyed. of third party replacement parts for use with the Savina ventilator. CAUTION ! Do not disassemble expiratory valve beyond removing...
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  • Page 19: Intended Use

    Intended Use Intended Use Intended Medical Applications ......... . 20 Intended Areas of Use .

  • Page 20: Intended Medical Applications

    **** Please refer to FAA or other pertinent regulations regarding the ® Savina is a registered trade mark of Dräger required permits for mobile use of the Savina ventilator ® ** AutoFlow is a registered trademark of Dräger (in aircraft, etc.)

  • Page 21: Restrictions Of Use

    Using high frequency electrosurgery equipment, defibril- WARNING ! lators, or short-wave treatment equipment in the vicinity The Savina ventilator must only be used under the super- of the ventilator may interfere with its operation and pose vision of qualified medical personnel in order to provide a risk of patient injury.

  • Page 22: Appropriate Monitoring

    WARNING ! Back-up ventilation with an independent manual ventilation device If a fault is detected in the Savina ventilator, so that its life-support functions are no longer assured: start ventilation using an independent ventilation device (resuscitation bag) without delay, if necessary with PEEP and / or increased inspiratory O concentration.

  • Page 23: Operating Concept

    Operating Concept Operating Concept Ventilation Controls ........... . 24 Setting Ventilation Parameters .

  • Page 24: Ventilation Controls

    Setting Ventilation Parameters Selecting the Ventilation Mode Operating Concept Ventilation Controls 1 Keys for selecting the ventilation modes: –CMV A/C –SIMV Savina –CPAP/PS –PCV+ 2 Keys for selecting / setting ventilation parameters: – Tidal volume V – Inspiration time T insp –...

  • Page 25: Screen Operating Controls

    Operating Concept Screen Operating Controls Screen Operating Controls 1 Screen operating keys: Savina — » « key for setting screen and display brightness (bright or dim), — »Waveforms « key for selecting the main screen page to display pressure and flow waveforms, ∆∆...

  • Page 26: Keys For Routine And Auxiliary Functions

    — »Insp. hold« key for manually activated inspirations and for manually extending inspiratory time. On Screen Information Window During setting of a ventilation parameter, Savina re-calculates derivative parameters (marked with an asterisk) and displays them in the information window on the main screen page.

  • Page 27: Structure Of The Screen Pages

    Operating Concept Structure of the Screen Pages Structure of the Screen Pages 1 Ventilation mode display field 2 Alarm message display field 3 Waveforms and measured values display field 4 Measured values display field 5 Information bar Main page Displays a pressure curve as well as three measured values. To configure the combination of measured values to be displayed, see page 87.

  • Page 28: Settings" Screen Page

    Operating Concept "Settings" Screen Page "Alarms" Screen Page "Values" Screen Page "Settings" Screen Page — Analog bar display of the airway pressure Paw. — Setting menu for setting the supplementary ventilation parameters »Trigger«, »FlowAcc«, »AutoFlow« (optional). — Setting menu for setting apnea ventilation, with the parameters »VT «, »f «.

  • Page 29: Configuration" Screen Page

    For detailed instructions for use, see "Configuration", beginning on page 86. »Stand by« Key 1 Positioned at bottom right of the front panel. Savina — To keep the ventilator ready for operation, e.g. after pre-setting. — to switch on ventilation.
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  • Page 31: Preparation

    Preparation Preparation Assembly of Components ..........32 Assembling the Expiratory Valve .

  • Page 32: Assembly Of Components

    3 Hand-tighten knurled knob clockwise. 5 Install water trap collecting jar. WARNING ! Never operate Savina without a water trap on the expira- tory valve – overcompensation for leakage might cause unintentionally high airway pressure and false triggering might occur.

  • Page 33: Installing The Flow Sensor

    Preparation Installing the Flow Sensor Installing a Bacteria Filter Installing the Flow Sensor 1 Slide flow sensor receptacle all the way to the left. 2 Insert flow sensor into its receptacle (plug facing the ventilator) and push into its socket as far as it will go. Then: 3 Slide flow sensor fully to the right into the rubber grommet of the expiratory valve.

  • Page 34: Precautions When Using Expiratory Bacteria Filters

    Preparation Precautions When Using Expiratory Bacteria Filters Precautions When Using Expiratory Bacteria Filters Expiratory bacteria filters may be used. Use of bacteria fiters in the expiratory side of the patient circuit can cause an undesirable increase in breathing resistance. Particularly when nebulizing aerosols or humidifying the breathing gas, resistance caused by a bacteria filter may slowly increase, leading to increased work of breathing and to intrinsic PEEP.

  • Page 35: Precautions When Using Heat/Moisture Exchangers

    (HME)! WARNING! Draeger cannot warrant or endorse the safe performance of heat/moisture exchangers with the Savina ventilator. The user has to verify that the heat/moisture exchanger is covered by a technical safety certificate which guaran- tees its complete suitability for its intended use.

  • Page 36: Installing A Heated Humidifier

    Installing a Heated Humidifier WARNING! Draeger cannot warrant or endorse the safe performance of third party humidifiers for use with the Savina ventila- tor. Specifically, the user has to assess the risks of delivery of breathing gas not maintained at a proper temperature associated with different humidifier designs.
  • Page 37 Preparation Installing a Heated Humidifier When ventilating infants Always use a humidifier suitable for ventilating small patients Always use appropriately sized patient circuits. NOTE: When using heated pediatric circuits with internal heating wires, please note: In the event of a ventilator failure, the patient can continue breathing through the inspiratory relief valve.

  • Page 38: Supplies And Connections

    Electrical Power Supply The ventilator is designed for a line voltage of: 100 V to 240 V AC, 50/60 Hz. Savina is equipped with an auto-switching power supply that adapts to the local line voltage. Insert plug into the power outlet.
  • Page 39 Please refer to "Technical Data", page 137, for external battery specifications) WARNING ! Use rechargeable batteries ONLY. Because of the charging feature of the Savina DC power supply, connecting non-rechargeable batteries might lead to a risk of explosion when operating the ventilator from line power.

  • Page 40: Connecting The O 2 Supply

    Expected operating time when using an O cylinder supply When using an increased O concentration (above 21 Vol. %), Savina ventilates with a mixture of air (delivered by its blower) and O When supplying O from a cylinder, the maximum possible...

  • Page 41: Before Using The Ventilator On A New Patient

    Preparation Before Using the Ventilator on a New Patient The ventilator takes into account the O concentration of 21 Vol. % in the air. Expected operating time = Gas reserve [L ] fraction – 0.21) x MV [L/min] 622 L (0.5 –...

  • Page 42: Nurse Call System (Available Option)

    Preparation Nurse Call System (Available Option) Nurse Call System (Available Option) Connection on the rear panel of Savina intended for the transmission of alarm signals to a central hospital alarm system. WARNING ! Installation of the Savina nurse call kit should only be performed by DraegerService or factory trained and authorized service personnel.

  • Page 43: Checking Readiness For Operation

    Savina now performs a power-on self test Wait for the 12 second test to complete. Savina automatically adapts its blower speed to the gas requirements of the patient. When starting a ventilation or adjusting ventilation parameters, a slight whining noise may be...
  • Page 44 O/s (on screen page »Settings 1/1«) »FlowAcc« 35 cmH »Pmax« (on screen page »Configuration 2/4«) »Plateau« (on screen page »Configuration 2/4«) Savina now ventilates the test lung with the set ventilation pattern. ∆∆ 8 Select »Values 1/2« with »Values « key.
  • Page 45 Pull quick connect of O2 supply hose from gas outlet: Intermittent audible alarm and display message: !!! O supply down Savina will ventilate with Air only. Reconnect quick connect to the O source. A warning message !!! FiO may appear briefly.

  • Page 46: Checklist

    Preparation Checklist Checklist Perform checks before each use. Ventilator is completely assembled and ready for operation, test lung is connected. What Target Function of lights/LEDs Switch ventilator on: All lights and LED digits light up, the audible and audible alarm alarm starts sounding.

  • Page 47: Ac Line Power And Battery Operation

    AC Line Power and Battery Operation AC Line Power and Battery Operation Displaying the Active Power Supply ........48 Operation from AC Line Power .

  • Page 48: Displaying The Active Power Supply

    Savina automatically switches to AC line power when available and charges the internal and external batteries. WARNING ! Leave Savina connected to AC line power only in well ventilated rooms (minimum air circulation: 1.2 m /h). Charging batteries generates hydrogen that, with suffi- cient concentration, could cause an explosion with the risk of personal injury.

  • Page 49: Operation From Ac Line Power

    Operation From an External Battery or an On- Board DC Power Source In case of AC line power failure, Savina will switch, without interruption, to an available DC source. The supply may be one of two different types: —...

  • Page 50: Operation From The Internal Battery

    See “Operation From the Internal Battery” on page 50 When AC line power is restored, Savina will automatically switch back to AC power and will charge both batteries. NOTE: The on-board DC system will only charge the internal battery while Savina is switched on.
  • Page 51 WARNING ! If the WARNING "!!! Int. batt. almost discharged" appears, Savina could stop working at any moment. Immediately reconnect Savina to AC line power, a charged external battery, or DC on-board system in order to prevent any interruption of ventilation.
  • Page 52 Reconnect Savina to AC power in order to fully recharge the internal battery (and the external battery if connected). While Savina is switched on, the internal battery is charged by the external battery or the on-board network. When Savina is switched off, charging only takes place if connected to AC line power.

  • Page 53: Operation

    Operation Operation Precautions During Operation ......... . 54 Starting Up .

  • Page 54: Precautions During Operation

    WARNING ! Do not place containers of liquids (such as infusion bottles) on top of or above the Savina ventilator. In case of a fault in any of the built-in monitoring a substi- Liquids getting into the ventilator can cause equipment tute has to be provided in order to maintain an adequate malfunction with the risk of patient injury.

  • Page 55: Starting Up

    Savina 2 Change ventilation parameters after Savina has started ventilation 3 Press »Stand by« key to set Savina to standby. 4 Press »Alarm Reset« key to confirm. 2 Change ventilation parameters and 3 press »Stand by« key to return to ventilation.

  • Page 56: Setting Ventilation Modes

    Settings outside the standard range Certain ventilation parameter settings are initially limited by Savina to not exceed certain threshold values. Values exceeding the threshold can only be set after confirmation by pressing the dial knob (see above).
  • Page 57 The yellow LED for that parameter key will go out. 3 To activate ventilation mode, press dial knob. NOTE: If the setting of parameters is interrupted, Savina will not reset parameters that have been preset and confirmed. To protect settings against modification 4 Press »...

  • Page 58: Cmv, Cmv Assist

    If AutoFlow (option) is not active: Set pressure limit with »Pinsp« key. When setting the pressure limit, take care that the required tidal volume V is still delivered. Otherwise Savina will display the message: !! Tidal volume low If this happens: Increase pressure limit increase inspiratory time »Tinsp.«...
  • Page 59 Used to synchronize mandatory ventilator breaths with a patient’s spontaneous breathing efforts. The actual breath rate may be higher than the set ventilator rate. 1 The green LED will light up whenever Savina has detected a spontaneous breathing effort. Savina The trigger may be switched off if no synchronization with a patient’s spontaneous breathing is expected or desired.
  • Page 60 On screen, the ventilation mode CMV is now displayed. Assist 3 The green LED will light up whenever Savina has detected a spontaneous breathing effort. NOTE: When switching from CMV (no assist) to SIMV, PCV+, or CPAP/PS, the last trigger sensitivity setting used will be in effect.
  • Page 61 Savina supplies additional inspiratory flow during spontaneous > inspirations – limited by the alarm threshold V The patient can also exhale during the inspiratory plateau phase.

  • Page 62: Simv, Simv / Ps

    Operation SIMV, SIMV / PS SIMV, SIMV / PS Synchronized Intermittent Mandatory Ventilation Pressure Support Fixed mandatory minute volume MV set with tidal volume V without with and ventilator rate (frequency). Between mandatory ventilator pressure support pressure support breaths, the patient can breathe spontaneously, thereby contributing to the minute volume.

  • Page 63: Pcv+ (Bipap), Pcv+ / Ps (Bipap/Ps)

    Operation PCV+ (BIPAP), PCV+ / PS (BIPAP/PS) PCV+ (BIPAP), PCV+ / PS (BIPAP/PS) (Available Option) Biphasic Positive Airway Pressure Pressure Support Pressure-controlled ventilation combined with free without spontaneous breathing with spontaneous breathing spontaneous breathing during the complete breathing cycle, supported by adjustable additional pressure at CPAP level. FlowAcc FlowAcc pressure support...

  • Page 64: Cpap, Cpap / Ps

    Operation CPAP, CPAP / PS CPAP, CPAP / PS Continuous Positive Airway Pressure Pressure Support Used for patients with adequate spontaneous breathing. Spontaneous breathing at an elevated pressure level, to increase a patient’s functional residual capacity FRC. Spontaneous breathing can be assisted with additional pressure support.

  • Page 65: Apnea Ventilation

    > Apnea Start of — PCV+ (option) apnea ventilation — PCV+/PS (option) If the patient stops breathing, Savina activates an alarm after Flow the set alarm time (T ) and starts volume-controlled Apnea mandatory ventilation. Apnea ventilation employs the mode SIMV with the following parameter settings: —...
  • Page 66 6 seconds in all those cases where apnea ventilation would be possible in principle: — when switching between ventilation modes, — when switching Savina on, — when, by reducing the ventilator frequency, the cycle time becomes longer than the current value of T Apnea To set alarm limits, see page 67.

  • Page 67: Setting Alarm Limits

    Operation Setting Alarm Limits Setting Alarm Limits ∆∆ Press »Alarms « key. Example display: screen page »Alarms 1/1« This page displays all alarm limits that can be set. = lower alarm limit = upper alarm limit Alarm Setting Range 10 to 100 cmH 2.0 to 41 L/min 0.5 to 40 L/min 15 to 60 sec...

  • Page 68: In The Event Of An Alarm

    = Warning (red LED flashes) = Caution (yellow LED flashes) = Advisory (yellow LED lights up and remains continuously lit) NOTE: Savina will display a message for operator guidance in the information line when certain alarm messages have occurred. Alarm Categories Warning Top priority message 1 Red LED flashes.

  • Page 69: Silencing Audible Alarms

    1 Yellow LED lights up and remains lit. Advisory messages are marked with one exclamation mark. Example: ! Flow monitoring inactive Savina generates the corresponding audible alarm as a two-tone sequence that sounds only once. To remedy any faults, please refer to the "Troubleshooting"...

  • Page 70: Displaying Waveforms And Measured Values

    Operation Displaying Waveforms and Measured Values Displaying Measured Values Displaying Waveforms and Measured Values On the main page airway pressure waveform or flow waveform and three relevant measured values are displayed To change the waveform display Press »Waveforms « key. Example: flow waveform The combination of measured values to be displayed in the measured values screen field is configurable, see page 87.

  • Page 71: Niv - Non-Invasive Ventilation

    — Avoid high airway pressures. Risk of aspiration. — Never operate Savina without a water trap on the expi- ratory valve – overcompensation for leakage might cause unintentionally high airway pressure and mis-trig- gering might occur.
  • Page 72 25 L/min. See page 149 for further details. Automatic compensation of set tidal volume When Savina determines the presence of a leak, it will compensate lost volume for up to 100 % of measured minute ventilation.
  • Page 73 Operation NIV – Non-invasive Ventilation, Mask Ventilation (Available Option) WARNING ! Never operate Savina without a water trap on the expira- tory valve - overcompensation for leakage might cause unintentionally high airway pressure and false triggering might occur. Leak compensation disabled If the flow sensor is missing or flow monitoring has been...
  • Page 74 An advisory message to check alarm limits appears briefly. WARNING ! Always check alarm limits after changing from »Mask/NIV« to »Tube« mode. When switching over to »Tube« mode, Savina automatically selects the default alarm limits for the alarms previously switched off in »Mask/NIV« mode.

  • Page 75: Special Functions

    »∆ Psupp. above PEEP« setting. 1 Press and hold down »Insp. hold« key for as long as inspiration is desired. Savina Either an automatic ventilator breath that has just begun will be prolonged or a new ventilator breath is initiated.

  • Page 76: Nebulizing Pharmaceutical Aerosols

    Since Savina uses pure oxygen for nebulizing pharmaceu- tical aerosols, an increase of the set inspiratory O con- centration may be caused Due to the inability of Savina to measure this increase in the concentration, an incorrect O reading will be displayed. Connect your O supply of 39 to 87 psi (2.7 to 6 bar) –...
  • Page 77 If nebulization needs to be stopped prematurely: 4 Press » Nebul.« key again. The yellow light goes out, the nebulizer is switched off. Savina will then automatically heat-clean and calibrate the flow sensor. On-screen information: Flow calibration Remove any leftover medication from the nebulizer.

  • Page 78: Pre-/Post-Oxygenation For Bronchial Suction

    To prevent hypoxia during bronchial suction, Savina is provided with an oxygenation program to be used when removing of secretions. After the program has started, Savina ventilates in the selected ventilation mode for up to 180 seconds with 100 Vol.% oxygen as a pre-oxygenation phase.
  • Page 79 The time remaining for pre-oxygenation is continuously displayed on screen. Pre-oxygenation lasts for a maximum of 180 seconds. During this time, Savina waits for a disconnection associated with the begin of suction. NOTE: For small tidal volumes, the patient may not immediately...

  • Page 80: Calibrations

    — after using the pneumatic nebulizer — after bronchial suction — after changing the O concentration NOTE: Savina uses a full inspiratory phase for calibration. Short inspiratory times are extended to approximately one second. Message in the information line on the screen:...

  • Page 81: Calibrating O 2 Sensors

    Always use a reliable independent O supply during calibration that contains 100% O . In case the calibration procedure is based on a diluted oxygen source, Savina may deliver inaccurate oxygen concentrations without further notification. During automatic calibration, the following message will...

  • Page 82: Operation At High Ambient Temperature

    C Savina displays an advisory message: ! Temperature high To prevent the breathing gas from becoming too hot, Savina reduces the maximum speed of the built-in blower as the ambient temperature rises. If high inspiratory pressures are set at the same time, e.g. beyond 80 cmH O, the result may be that high flows, e.g.
  • Page 83 In the event of a blower failure WARNING ! In the event of a failure of the turbine blower, Savina is not able to continue ventilation. Immediately continue ventilation using an independent manual ventilation device (resuscitation bag) in this case.
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  • Page 85: Configuration

    Configuration Configuration Setting the Screen Contrast ..........86 Adjusting the Volume of the Audible Alarm .

  • Page 86: Setting The Screen Contrast

    Configuration Setting the Screen Contrast Configuration The following user preferences can be selected in »Configuration« mode: — Screen contrast — Audible alarm volume — Measured values field — Manual calibration for O sensor 2 — FiO and flow monitoring ON / OFF —...

  • Page 87: Adjusting The Volume Of The Audible Alarm

    Configuration Adjusting the Volume of the Audible Alarm Configuring the Measured Values Field Adjusting the Volume of the Audible Alarm Display (example): ∆∆ Press »Config. « key repeatedly until »Configuration 1/4« appears. Turn dial knob to select item »Vol.«. Press dial knob to activate. Turn dial knob to adjust volume.

  • Page 88: Manual Calibration For O 2 Sensor 2

    Savina ventilates again using the original settings. NOTE: Disconnection during the calibration procedure would activate a number of alarms. For this reason, Savina turns the respective alarms off during calibration. If the patient is not reconnected within 30 seconds, Savina continues ventilation with the original settings and all alarms become active again.

  • Page 89: Fio 2 - Or Flow Monitoring On / Off

    Configuration FiO2- or Flow Monitoring ON / OFF If the following alarm appears after calibration: !!! O measurement failure Replace O sensor, see page 108. If the following alarm appears after calibration: !!! FiO Make sure, that the O source in use contains 100 % O (see WARNING on page 88).

  • Page 90: P Max On / Off

    Sensor 1 for accurate O control, otherwise the blending of O and Air would be impaired. monitoring should only be deactivated when Savina is supplied with air only. NOTE: O monitoring remains deactivated even when the ventilator is switched on again.

  • Page 91: Pressure Plateau On / Off

    A setting of inspiratory time T will not be applied. insp Savina establishes a minimum expiratory time of 500 ms and limits the resulting I:E ratio to a maximum of 4:1. ∆∆ Press »Config.

  • Page 92: Setting Date And Time

    Press dial knob to confirm. Displaying Ventilator Data ∆∆ Press »Config. « key repeatedly until »Configuration 4/4« appears. Savina displays: — SW Software version of the ventilator — Device-ID device-specific identification number of the ventilator — Operation hours the total number of hours the device has been operating —...

  • Page 93: Configuring Remote Service (Option)

    — Call Savina calls the remote server. — Listen Savina waits for a call from the remote server. — Task This parameter is only available if »Call« or »Listen«” has been selected under Remote Service. Remote Service use mode, with the following values: —...
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  • Page 95: Care

    Disinfecting / Cleaning / Sterilizing ........99 Disinfecting / Cleaning / Sterilizing Schedule for the Savina Intensive Care Ventilator .

  • Page 96: Dismantling Components

    Care Dismantling Components Care Clean and prepare the ventilator after each patient. WARNING ! To avoid risks to hospital staff and patients, disinfect and clean ventilator after use. Always use ventilator that has been cleaned and disin- fected and has been successfully tested to be ready for operation.
  • Page 97 Care Dismantling Components CAUTION ! When removing a reusable patient circuit, always grasp hoses by their sleeve, never by the hose itself, to avoid possibly tearing the hose at the sleeve or ripping it out of the sleeve. Nebulizer (available option)* 1 Remove nebulizer hose from the nebulizer and from the ne- bulizer port on the ventilator.
  • Page 98 Care Dismantling Components Flow sensor 1 Push flow sensor to the left as far as it will go Savina 2 pull out. CAUTION ! Flow sensor is not compatible with parts washer equipment and may not be autoclaved or steam-sterilized.

  • Page 99: Disinfecting / Cleaning / Sterilizing

    Follow all accepted hospital procedures for disinfecting parts contaminated by body fluids (protective clothing, eyewear, etc.). — Savina ventilator with mobile stand — hinged circuit support arm — gas supply hoses Wipe disinfect with a disinfectant based on the suggested active ingredients.
  • Page 100 Care Disinfecting / Cleaning / Sterilizing — Reusable patient circuit — reusable patient wye — water traps and collecting jars — expiratory valve body — expiratory valve diaphragm — expiratory valve collecting jar May be disinfected in a moisture saturated environment at C (200 F) for 10 minutes.

  • Page 101: Disinfecting / Cleaning / Sterilizing Schedule For The Savina Intensive Care Ventilator

    Care Disinfecting / Cleaning / Sterilizing Schedule for the Savina Intensive Care Ventilator Re-assembly Disinfecting / Cleaning / Sterilizing Schedule for the Savina Intensive Care Ventilator Applicable for use with non-infectious patients. For infectious patients, all parts that conduct breathing gas must be additionally sterilized after disinfecting and cleaning.
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  • Page 103: Maintenance

    Maintenance Maintenance Maintenance Intervals ..........105 User Replaceable Parts .
  • Page 104 When servicing the ventilator, always use replacement parts that are qualified to Draeger standards. Draeger cannot warrant or endorse the safe performance of third party replacement parts for use with the Savina ventilator. CAUTION ! Never operate the ventilator without a microfilter at the air intake.

  • Page 105: Maintenance Intervals

    Maintenance Maintenance Intervals Maintenance Intervals sensors Replace when the following message is displayed: !!! O measurement failure when calibration is no longer possible. For disposal of spent sensor capsules, see page 109. Microfilter Replace every year, see page 106. Disposal with normal domestic waste. Dust filter set Replace every year, see page 107.

  • Page 106: User Replaceable Parts

    Maintenance User Replaceable Parts User Replaceable Parts Replacing the microfilter — Filter should be replaced every year. 1 Hold down both latches, 2 Lift filter cover and remove. 3 Remove used microfilter from its housing. Slide new microfilter into housing as far as it will go. Dispose of used microfilter together with domestic waste.
  • Page 107 Maintenance User Replaceable Parts Replacing the dust filter set — Inspect for soiling every 4 weeks, clean or replace as necessary. 1 Hold down both latches. 2 Lift filter cover and remove. 3 Remove used dust filters from filter cover. Install new dust filters.

  • Page 108: Using An External Battery

    Savina is switched off. This enables Savina to measure valid O values as soon as it is switched on. If the internal battery is discharged, Savina does not supply any O values for the first 20 minutes after switching on.

  • Page 109: Disposal Of Batteries And O 2 Sensors

    Considerations for Extended Storage If Savina is stored for longer than 14 days without power: Remove fuse for internal battery. This will prevent an unde- sirable deep discharge of the internal battery, which other- wise would continue to supply current to the O sensors.
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  • Page 111: Troubleshooting

    Troubleshooting Troubleshooting Troubleshooting ............112...
  • Page 112 Advisory Message with low priority Savina displays a help text in the information field when certain alarm messages occur. In the table below, messages are listed in alphabetical order. This table is intended to help identifying possible causes of an alarm and to assist with prompt corrective action.
  • Page 113 V and minute ventilation MV on the basis of 1013 mbar ambient pressure. You may continue to use Savina if the "Airway pressure high" alarm is set correctly and uncompensated values for and MV can be tolerated. Check patient condition closely.
  • Page 114 Breathing gas temperature above 40 C. Turn humidifier off. Use longer inspira- tory patient circuit. Check settings Due to an internal data loss, Savina ope- This alarm can be acknowledged by rates with factory dfault settings. pressing the »Alarm Reset« key. Check settings and adjust as necessary.
  • Page 115 Take note of the capacity of DC power source. !!! Fan failure Fan failure. Savina uses the fan to cool the interior of the ventilator and to avoid an increased risk of fire in the event of an O leak.
  • Page 116 10 %. Savina is about to stop working. Int. batt. almost discharged AC line power or external DC connected; Do not switch Savina over to operate internal battery almost discharged. from its internal battery. Charge battery Int. battery activated...
  • Page 117 Remedy Int. battery failed Internal battery has failed. If a reliable line power supply is available, ventilation with Savina may be continued. Call DraegerService. Int. battery low Time for operation from internal battery Restore AC line power or supply from a will soon have expired.
  • Page 118 Mains switch inop. Savina has not clearly detected the Acknowledge message by pressing »Alarm Reset« key. switch position. If Savina has to be switched off: First turn power switch to » «, then switch off Savina. If message appears again: Ventilation with Savina may be continued.
  • Page 119 Nebulizer for pharmaceutical aerosols is switched on. !!! No int. battery Internal battery discharged. Do not switch Savina over to operate from its internal battery. Charge battery Internal battery missing, faulty, or not This alarm can be acknowledged by connected, or fuse has failed.
  • Page 120 Check bacteria filter. Replace if necessary. !!! PEEP failure Set PEEP is not reached. Check system for leaks. Ventilation with Savina may be continued although the set PEEP may not be reached. Observe patient closely. Call DraegerService. !!! Pressure meas. failure Fluid in expiratory valve.
  • Page 121 Press »Alarm Reset« to confirm Remote Remote Service mode. service mode. To continue ventilation with Savina: Disconnect cable from serial interface. Then switch Savina off and on again. !!! Standby activated Savina has been switched to standby. Confirm standby mode by pressing »Alarm Reset«.
  • Page 122 Troubleshooting Message Cause Remedy Tidal volume low Because of pressure or time limitations, Extend inspiration time »T « insp the set tidal volume V has not been Raise »FlowAcc«. applied in four consecutive ventilator Raise pressure limitation with the »P «...

  • Page 123: What's What

    What’s What What’s What Control Unit ............124 Front Connection Block .

  • Page 124: Control Unit

    What's What Control Unit What's What Control Unit Savina Trigger Alarm Nebul. insp Silence mL L ∆P insp. Alarm Suction Supp Reset above PEEP Insp. Rate PEEP hold Lock Vol.% Waveforms Settings Alarms Values Config. ext. ∆∆ ∆∆ ∆∆ ∆∆...

  • Page 125: Front Connection Block

    What's What Front Connection Block Front Connection Block 1 Flow sensor 2 Expiratory valve with expiratory connector port 3 Socket for breathing gas temperature sensor plug 4 Inspiratory connector port 5 Nebulizer gas supply port 6 Bacteria filter 7 Protective cover for O sensors...

  • Page 126: Rear Panel

    What's What Rear Panel Rear Panel 1 RS232 serial interface 2 Nurse call socket (optional) 3 Power switch 4 Fuse for internal battery 5 AC input receptacle 6 DC inlet (external battery or on-board DC system) 7 Equipotential bonding connection (grounding pin) 8 Filter cover 9 ID label/rating plate 10 In the side panel:...

  • Page 127: Labels

    WARNING ! ALWAYS USE A RELIABLE INDEPENDENT SUPPLY DURING CALIBRATION. IN CASE THE CALIBRATION PROCEDURE IS BASED ON A DILUTED OXYGEN SOURCE, SAVINA MAY DELIVER INACCURATE OXYGEN CONCENTRATIONS WITHOUT FURTHER NOTIFICATION. 5 CSA-label LR 95701 ® Conform with devices using...

  • Page 128: Abbreviations

    What's What Abbreviations Abbreviations Abbreviation Definition Assist Control, Assisted Mandatory Ventilation ® AutoFlow Ventilation mode extension automatically adjusting inspiratory flow to changes in lung conditions and spontaneous breathing breath per minute, unit for ventilation/breathing rate BTPS Body Temperature, Pressure, Saturated Measured values based on the conditions of the patient’s lungs, with body temperature 37 C, atmospheric pressure, water-...
  • Page 129 What's What Abbreviations Abbreviation Definition high Airway pressure high Pressure Controlled Ventilation plus PCV+ (BIPAP) Ventilation mode for spontaneous breathing at continuous positive airway pressure with two different pressure levels PEEP Positive End-Expiratory Pressure Setting of the upper pressure level in PCV+ insp Maximum airway pressure Mean airway pressure...

  • Page 130: Symbols

    What's What Symbols Symbols Symbol Explanation Switch nebulizer on / off Nebul. Activate / deactivate oxygenation program for bronchial suction Suction Start manual inspiration and hold Select settings page ∆∆ Configure system settings ∆∆ Display alarm limits ∆∆ Display measured values ∆∆...

  • Page 131: Technical Data

    Technical Data Technical Data Environmental Conditions ..........132 Settings .

  • Page 132: Environmental Conditions

    21 to 100 vol.% **** Accuracy ±3 vol.% The accuracy of the inspiratory O concentration is noticeably reduced when operating Savina without O sensors. Positive end-expiratory pressure PEEP or interm. PEEP 0 to 35 cmH Trigger sensitivity 1 to 15 L/min...

  • Page 133: Performance Data

    30 minutes, in the inspiratory flow phase, (with O supply only) 2 bar (29 psi), max. 10 L/min, Savina takes the nebulizer flow into account to keep the minute-ventilation constant. Oxygenation program for bronchial suction (with O supply only)

  • Page 134: Measured Value Displays

    Technical Data Measured Value Displays Measured Value Displays Airway pressure measurement (Resistive differential pressure transducer) Max. airway pressure Peak Plateau pressure Plat Pos. end-exp. pressure PEEP Mean airway pressure Mean Range 0 to 99 cmH Resolution 1 cmH Accuracy ±2 cmH Inspiratory O measurement (maintenance-free electrochemical sensor)
  • Page 135 Technical Data Frequency measurement Spontaneous breathing frequency f Total breathing frequency f Range 0 to 150 /min Resolution 1 /min Accuracy ±1 /min approx. 35 s 0...90 Inspiratory/expiratory ratio I:E Range 0 : 150 to 150 : 1 Resolution Accuracy ±6 % of measured value Inspiratory time T insp...

  • Page 136: Monitoring

    Technical Data Monitoring Monitoring Expiratory minute volume MV Upper alarm limit alarm when MV exceeds the upper alarm limit. Setting range 41 to 2 L/min, in 0.1 L/min increments 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 increments Airway pressure Paw...

  • Page 137: Operating Data

    CAUTION ! Do n n n n o o o o t t t t use batteries that use chemical systems other than lead/acid (such as NiCd, NiMH) Battery charging: Savina automatically detects the voltage of the external battery connected. Charge current for the external battery: 12 V battery approx. 4 A 24 V battery approx.
  • Page 138 Technical Data Operating Data Charging times Charging times indicated refer to immediate charging of the external battery after discharge. Several successive partial discharges without charging from AC may extend the necessary charging time for a full charge. Type lead-gel battery, maintenance-free, sealed Minimum capacity 12 V battery 33 Ah...

  • Page 139: Materials Used

    Technical Data Classifications / Standards Materials Used Classifications / Standards EC Classification Class IIb as per EC Directive 93/42/EEC Appendix IX UMDNS-Code 17 – 429 Universal Medical Device Nomenclature System – classification for medical products Electrical protection classification Ventilator Class I Temperature sensor AWT01 (installed sensor) Type BF Electromagnetic compatibility EMC...
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  • Page 141: Theory Of Operation

    Theory of Operation Theory of Operation Ventilation Modes - Volume Controlled Ventilation ......142 PCV+ (BIPAP) (Available Option) ........148 Automatic Leak Compensation .

  • Page 142: Ventilation Modes - Volume Controlled Ventilation

    , as well as SIMV, SIMV/PS Assist The »Pinsp« ventilation parameter is used to set the limit. The value of Pinsp remains in effect until Savina has applied the insp set tidal volume V or until the set inspiratory time has elapsed.
  • Page 143 filling of the »slow« alveoli only marginally due to the short time available. In the Savina ventilator, the sigh operates during expiration with an intermittent PEEP. It is set as a pressure relative to PEEP (∆ sigh).
  • Page 144 »V «. If the set alarm limit is exceeded just once, Savina displays an advisory message (!); if, however, the alarm limit is exceeded three times, Savina PLAT issues a warning message (!!!). The volume is actively limited to PEEP the value of the alarm threshold »V...
  • Page 145 Theory of Operation Ventilation Modes – Volume Controlled Ventilation Start-up behavior of AutoFlow Upon switching AutoFlow on, Savina applies the set tidal volume V using a volume-controlled ventilator breath. The plateau pressure P derived from this ventilator breath plat serves AutoFlow as a starting value for the inspiratory pressure.
  • Page 146 Synchronization of mandatory ventilator breaths by itself effectively reduces SIMV time, which would result in an undesirable increase in the effective IMV rate. Savina therefore extends the subsequent time allowed for spontaneous breathing by the missing time difference ∆T – thus preventing an increase in SIMV rate.
  • Page 147 Savina supports the insufficient spontaneous breathing of the patient with a high peak flow. — In case of low flow acceleration: Savina begins gently with an even inspiratory flow. Pressure support is terminated: — when the inspiratory flow returns to zero during phase I, i.e.

  • Page 148: Pcv+ (Bipap) (Available Option)

    Theory of Operation PCV+ (BIPAP) (Available Option) PCV+ (BIPAP) (Available Option) Pressure Controlled Ventilation plus Biphasic Positive Airway Pressure PCV+ is a pressure controlled/time cycled ventilation mode which allows the patient to breathe spontaneously at any time. PCV+ is therefore often described as a time cycled alternation between two CPAP levels.

  • Page 149: Automatic Leak Compensation

    "recover" from this temporary state within 1-2 breaths. Leak monitoring If Savina detects a major leak in the system while in »Tube« mode, the advisory message ! Leakage appears. In this case, tube and patient circuit should be checked for tight...

  • Page 150: Niv - Non-Invasive Ventilation (Available Option)

    Theory of Operation NIV – Non-invasive Ventilation (Available Option) NIV – Non-invasive Ventilation (Available Option) With the NIV option, Savina offers an application mode optimized for non-invasive ventilation using a nose or face mask. Greater leakage generally occurs with non-invasive ventilation than with ventilation via a tube.
  • Page 151 Tpat deviate. Automatic volume compensation If volume-controlled ventilation modes (CMV, SIMV) are applied in »Mask/NIV« mode, Savina increases the applied tidal volume V by the amount lost to leaks during inspiration. If a tidal volume V of 500 mL has been set and 50 mL are lost during inspiration, Savina will automatically deliver 550 mL.
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  • Page 153: Ordering Information

    Ordering Information Ordering Information Ordering Information ..........154...
  • Page 154 Ordering Information Ordering Information Name/Description Order No. Basic ventilator Savina 84 13 600 Options ® Option AutoFlow 84 14 130 Option PCV+ 84 14 131 Option NIV 84 14 072 Nurse call system 84 13 631 Plug for the connection of nurse call system...
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  • Page 156: Index

    Index Index Configuration ........86 Abbreviations .
  • Page 157 Index Front connection block ......125 disposal ........109 Functions replacing .
  • Page 158 Index Schedule Valve, expiratory ........98 for disinfecting / cleaning / sterilizing .
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  • Page 160 These Instructions for Use apply only to Savina with Serial No.: If no Serial No. has been filled in by Draeger, these Instructions for Use are provided for general information only and are not intended for use with any specific machine or device.

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