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M E D I C A L ™ NeoFlow Neonatal Patient Mode Addendum to Operating Instructions Evita These Operating Instructions apply also to Evita 4 with the XL option...
Important Safety Information Operator's Responsibility for Patient Safety Limitation of Liability Important Safety Information Limitation of Liability Operator's Responsibility for Patient Safety 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,...
Important Safety Information Warranty Warranty All Draeger products are guaranteed to be free of defects for a Application of this warranty is subject to the following period of one year from date of delivery. conditions: The following are exceptions to this warranty: 1.
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.
WARNING ! flammable gases or anesthetics. This device is neither approved nor certified for use in Installation of the NeoFlow option into Evita ventilators areas where combustible or explosive gas mixtures are may only be performed by factory trained and authorized likely.
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Important Safety Information Summary of WARNINGS and CAUTIONS WARNING! CAUTION ! Effect of aerosols on sensors, filters, Do not ventilate larger pediatric patients with serious and heat and moisture exchangers! infections and a severe cough using the neonatal flow The measuring function of the flow sensor may be sensor.
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Important Safety Information Summary of WARNINGS and CAUTIONS Precautions during maintenance WARNING ! To avoid any risk of infection, clean and disinfect ventila- tor and accessories before any maintenance according to established hospital procedures - this applies also when returning ventilators or parts for repair. WARNING ! Preventive Maintenance work on the Evita ventilators...
Intended Use Restrictions of Use Intended Use NeoFlow – neonatal mode with base flow. Extends the patient range of the Evita intensive care ventilator to infants and premature babies with a minimum body weight of 1.1 lbs (0.5 kg). Extends the range of flow monitoring with Evita during pediatric and neonatal ventilation employing a proximal flow...
Before Using for the First Time Preparation Before Using for the First Time Installing the NeoFlow option WARNING ! Installation of the NeoFlow option into Evita ventilators may only be performed by factory trained and authorized service personnel. Follow installation instructions in the respective documentation.
Preparation Preparing for Use Preparing for Use Installing the neonatal flow sensor Prepare patient circuit – see chapter "Ventilating Infants" in the Evita Operating Instructions. Only the neonatal flow sensor (84 11 130) may be used. WARNING ! Do not use the Y-piece with integral flow sensor (part no.
Preparation Device Check Device Check The NeoFlow option expands the Evita pre-use check procedure by the following function: — Calibration neo. flow sensor...
Starting calibration for EvitaXL Press » Sensor Parameter« key. The »Sensor Parameter«, menu is displayed. Select »NeoFlow« menu, flow monitoring is activated. Start calibration: Touch »Start« screen key. The screen key turns green, the ventilator now calibrates the flow sensor.
Preparation Replacing the Neonatal Flow Sensor Calibration procedure Remove ET-tube connector, Remove neonatal flow sensor from Y-piece, Insert patient ET-tube connector directly into the Y-piece for the duration of the calibration. WARNING ! The operator of the ventilator must still assume full responsibility for proper ventilation while flow monitoring is not available during calibration.
Operation Selecting Neonatal Mode Operation Selecting Neonatal Mode The required patient mode can be selected from the Evita menu immediately after switching on or while in standby mode: Adult« » = Adult » Ped.« = Pediatric » Neo.« = Neonatal The menu ranges can be configured, see "Configuring Ventilation, Setting the patient range", on page 28.
Operation Volume Controlled Ventilation in Neonatal Mode Volume Controlled Ventilation in Neonatal Mode ® The AutoFlow ventilation mode supplement is always active when using volume controlled ventilation (CMV, SIMV, MMV) in neonatal mode. ® AutoFlow – for automatic regulation of "Insp.
Operation Back-up Ventilation in Neonatal Mode Pressure Support Ventilation (PSV) Back-up Ventilation in Neonatal Mode during volume-controlled neonatal ventilation Volume-controlled ventilation during neonatal ventilation is only possible with intact flow monitoring. If neonatal flow monitoring fails or has been switched off during volume- controlled ventilation, Evita automatically switches over to pressure-controlled back-up ventilation.
Operation Apnea Ventilation in Neonatal Mode Apnea Ventilation in Neonatal Mode Unlike in adult or pediatric ventilation, pressure controlled apnea ventilation is started after the set alarm time > ) if an apnea occurs in Apnea ventilation modes with activated apnea ventilation.
Operation NIV (Mask Ventilation) NIV (Mask Ventilation) See Evita Operating Instructions for details on Non Invasive Ventilation (NIV). Set ventilation parameters As described for »Tube« application mode. An additional screen knob »T « is insp displayed for CPAP/P Supp In patient modes »Pediatric« or »Neonate«, Evita limits the maximum duration of a pressure support breath to...
Evita displays the »Sensor Parameter« menu. Touch screen key for the sensor to be deactivated, in this case »NeoFlow«. Touch »Off« screen key, the screen key turns yellow. Press dial knob to confirm, the screen key turns green. Neonatal flow monitoring is deactivated, and the corresponding measured values disappear from the screen.
Operation Flow Monitoring During Pediatric Ventilation Flow Monitoring During Pediatric Ventilation If the neonatal flow sensor is present and intact during ventilation in pediatric patient mode, it will perform the function of pediatric flow monitoring if neonatal flow monitoring is activated. If the neonatal flow sensor is defective or if neonatal flow monitoring is deactivated, flow monitoring is performed by the expiratory flow sensor installed in Evita...
Operation Nebulizing Pharmaceutical Aerosols Nebulizing Pharmaceutical Aerosols In neonatal mode, it is only possible to nebulize pharmaceutical aerosols during pressure controlled ventilation. WARNING! Effect of aerosols on sensors, filters, and heat and moisture exchangers! The measuring function of the flow sensor may be impaired.
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Operation Nebulizing Pharmaceutical Aerosols Removing the neonatal flow sensor WARNING! The wires of the flow sensor are hot. If the neonatal flow sensor is left in the patient circuit for some time during nebulizing without being cleaned, deposits from the medicated aerosols may build up and impair flow measu- rement.
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Operation Nebulizing Pharmaceutical Aerosols 1 Remove corrugated silicone tubing of the patient circuit from the inspiratory adapter of the Y-piece and re-connect it to the input adapter of the nebulizer. 2 Using the Y-piece inspiratory adapter, connect the free end of the corrugated tubing to the nebulizer.
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Operation Nebulizing Pharmaceutical Aerosols Starting nebulization Deactivate neonatal flow monitoring, page 21. Touch »Special Procedure...« screen function key, Evita opens the »Additional Function« menu. Touch » Nebulizer« screen key, the key turns yellow. Press dial knob to confirm, the screen key turns green. The nebulizer is in operation.
Operation O2 Concentration When Using Nebulizer Oxygenation for Bronchial Suction Concentration When Using Nebulizer The nebulizer for medication aerosols operates continuously, when activated in the neonatal range. During nebulizer treatment, the base flow is increased from 6 L/min to 9 L/min. Depending on the set O concentration, the nebulizer is supplied with medical compressed air, oxygen, or a mixture of...
Configuration of Ventilation Setting the Patient Range Configuration of Ventilation Setting the Patient Range Select the required patient mode from the list on the configuration page, see Evita Operating Instructions. The following ranges are available: Adults only Pediatrics only Neonates only Adults or Pediatrics Pediatrics or Neonates Adults, Pediatrics, or Neonates...
Configuration of Ventilation Start-up Defaults for Ventilation Parameters and Alarm Limits Start-up Defaults for Ventilation Parameters and Alarm Limits Start-up default values, i.e. the values for tidal volume V and ventilator rate f activated whenever Evita is switched on, may be defined as a function of either ideal body weight or of the patient mode.
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Configuration of Ventilation Start-up Defaults for Ventilation Parameters and Alarm Limits To select the initial values for V and f as a function of the ideal weight, the Radford nomogram has been extended to an ideal weight of 0.5 kg: Factory-set default Hospital-set default Weight...
Configuration of Ventilation Defining Start-up Defaults for Tube Compensation (ATC) Defining Start-up Defaults for Tube Compensation (ATC) Press » System Setup« function key. Touch »Therapy« screen key. Touch »Mode & Settings« screen key and enter access code 3032. Touch »Add. settings...« screen key. Touch the respective screen key to switch ATC on or off.
Care Dismantling the Neonatal Flow Sensor Disinfecting/Cleaning/Sterilizing Care Dismantling the Neonatal Flow Sensor 1 Unplug flow sensor cable from both the sensor and the back panel of Evita 2 Remove the sensor element: Press the buttons on both sides while pulling the sensor out of the housing at the same time.
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Care Disinfecting/Cleaning/Sterilizing Flow sensor cable Disinfect by wiping with disinfectant based on the recommended active ingredients. Follow instruction labels with respect to prescribed concentrations and the necessary exposure times. CAUTION ! Do not allow any liquid into the connector of the flow sensor cable.
Evita ventilators. Maintenance Intervals Preventive maintenance Every 6 months by trained and factory authorized service personnel. The Evita NeoFlow option is serviced as part of the scheduled preventive maintenance of the Evita ventilator every six months.
In the table below, the additional messages specific to order of priority. NeoFlow are listed in alphabetical order. The table can be used as reference for rapidly identifying and remedying the For example, if two faults are detected at the same time, the cause of any alarm.
Technical Data Neonatal Settings Technical Data For neonatal mode, supplements Technical Data section in the Evita Operating Instructions. Neonatal Settings Tidal volume V Range 3 to 100 mL, BTPS* Resolution 1 mL Accuracy greater of ±8 % of set value or 1 mL Trigger sensitivity Range 0.3 to 5 L/min...
Technical Data Performance Data Display of Measured Values Performance Data Control principle Base flow with demand system, pressure-controlled, time-controlled Base flow 6 L/min (this can be changed by DraegerService to 9 L/min) Base flow during medicament nebulisation 9 L/min Insp. Flow up to 30 L/min Exp.
Technical Data Monitoring Materials Used Tidal volume V Range 0 to 999 mL, BTPS 1000 to 4000 mL, BTPS Resolution 0.1 mL 10 mL Accuracy greater of ±8 % of the measured value or 1 mL Tidal volume V Range 0 to 999 mL, BTPS 1000 to 4000 mL, BTPS Resolution...
Theory of Operation – Special Features of Neonatal Ventilation Measuring Leakage Flow Theory of Operation – Special Features of Neonatal Ventilation Measuring Leakage Flow A small amount of respiratory gas almost always escapes between the tracheal wall and endotracheal tubes when ventilating newborns and infants with uncuffed tubes.
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Theory of Operation – Special Features of Neonatal Ventilation Measuring Leakage Flow Patient flow and tidal volume are then calculated as follows: Inspiration: Flow = Flow – Flow Patient, insp insp Leak ∫ Flow Patient, insp Expiration: Inspiratory flow Flow = Flow + Flow Patient, exp...
Theory of Operation – Special Features of Neonatal Ventilation Airway Pressure Measurement Airway Pressure Measurement Evita measures airway pressure indirectly by means of two internal pressure sensors in the apparatus. The sensors are installed in the inspiratory and expiratory lines, thereby eliminating the need for an external pressure measuring line between the Y-piece and the ventilator.
Theory of Operation – Special Features of Neonatal Ventilation Trigger Response Trigger Response In neonatal mode, Evita detects a patient's spontaneous breathing using the neonatal flow sensor proximal to the patient. When spontaneous inspiration is detected, a synchronized, mechanical, and pressure controlled breath, or a pressure support breath is triggered according to the selected mode of ventilation.
Theory of Operation – Special Features of Neonatal Ventilation ® AutoFlow ® AutoFlow AutoFlow is a ventilation mode extension that optimizes flow control during mandatory breaths in the volume constant > ventilation modes CMV, SIMV, and MMV. In neonatal mode, AutoFlow is always active in all volume = f (V insp controlled ventilation modes (CMV, SIMV, MMV).
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Theory of Operation – Special Features of Neonatal Ventilation ® AutoFlow > Tidal volume V can be limited by the alarm limit »V V V V «. If the set alarm limit is exceeded once, Evita will generate an > advisory message (!).
Glossary Abbreviations Glossary Abbreviations Abbreviation Explanation Mechanical ventilation frequency (setting) Spontaneous breathing rate (measured value) Flow Displayed real-time waveform, patient flow (measured value), with correction for leak Flow Flow through the expiratory valve during inspiration Flow Base flow (system setting), see technical data page 36 Flow Inspiratory flow, without correction for leak...
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These Instructions for Use apply only to Evita with Serial No.: If no Serial No. has been filled in by Dräger, these Instructions for Use are provided for general information only and are not intended for use with any specific machine or device.