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Transport Ventilator Instructions for use...
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This also contains detailed information about the device design and function as well as its individual components. NOTE Fritz Stephan GmbH offers training on the safe and efficient use of the EVE ventilator. Training material can also be requested. Please contact info@stephan-gmbh.com for more information.
Functions in the System Settings menu ... 52 3.2.2 Measured value display ..........54 3.2.3 Function fields ............57 3.2.3.1 Measured value indicator switch ...... 57 3.2.3.2 Values .............. 57 3.2.3.3 Alarms .............. 59 3.2.3.4 Maneuver ............66 3.2.3.5 Graph ..............68 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Installing the SpO sensor ............ 121 Aerosol nebulization ............121 Operation ..................125 Test before every start-up ............ 125 6.1.1 Testing requirements ..........125 6.1.2 Test list ..............126 Switching the device on/off ..........127 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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........191 Functional description ..............193 Troubleshooting ................195 10.1 List of errors ................ 195 10.2 Selftest error ................ 208 10.3 Moisture in the PNT B (flow sensor) ........209 Care and maintenance ..............211 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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12.1 Electromagnetic emissions ..........235 12.2 Electromagnetic immunity........... 236 12.3 Recommended separation distance ........239 Accessory list ................. 241 Warranty ..................245 List of figures ................. 247 List of tables ................... 251 Notes ....................253 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
NOTE The applied parts of the EVE (CO sensor, SpO sensor and ventilator breathing system (VBS)) are protected against defibrillation. For the SpO and CO module, the recovery time is under 5 seconds. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Pneumatic medication nebulizer 22m/22f Manufacturer: GaleMed 2. Flow sensors Flow sensor, adults Manufacturer: Fritz Stephan GmbH Flow sensor, children Manufacturer: Fritz Stephan GmbH Pneumotachograph, preterm infants and newborns, type B for ventilator EVE Manufacturer: Fritz Stephan GmbH ...
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® General information 4. NCPAP patient interfaces EasyFlow NCPAP system Manufacturer: Fritz Stephan GmbH 5. Expiration valve Manufacturer: Fritz Stephan GmbH sensor Manufacturer: Masimo Masimo Rainbow Manufacturer: Masimo 7. Optiflow Junior Nasal Cannula Manufacturer: Fisher & Paykel 8. Optiflow + Nasal Cannula Manufacturer: Fisher &...
Do not throw the battery into a fire or open it with force! NOTE Before disposing of the device or any of its components, these must be cleaned and disinfected. Infectious disposable accessories must be disposed of as specified in the operating manual! Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The manufacturer does not accept any warranty claims resulting from Warranty incorrect operation or inadequate care and maintenance. The manufacturer only guarantees the safety and reliability of the device if it is operated in compliance with the operating manual. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Control knob for device operation Insp Inspiration (inhalation) Time period from the onset of the inspiration flow until the onset of the expiration flow Medium priority An alarm indicating that the user should intervene immediately. (IEC 60601-1-8). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Perfusion index PRVC Pressure regulated volume control Pressure-controlled and volume-regulated ventilation Pressure support ventilation Pressure support ventilation PVI™ Pleth Variability Index Plethysmographic variability index PEEP Positive End Expiratory Pressure Positive end expiratory pressure Pinsp Inspiratory pressure Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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VC-SIMV Volume-controlled synchronized Volume-controlled synchronized intermittent intermittent mechanical ventilation mechanical ventilation Packaging unit Tidal volume Breathing volume Expiratory breathing volume Expiratory tidal volume Central gas supply Volume Tab. 2: Abbreviations and technical terms Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Ventilation settings for adults pre-selected (see chapter 3.2.5) Ventilation settings for children pre-selected (see chapter 3.2.5) Ventilation settings for preterm infants and newborns preselected (see chapter 3.2.5) Non-invasive ventilation (see chapter 3.2.5) Invasive ventilation (see chapter 3.2.5) Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Ethernet port Type BF applied part, defibrillator-protected The instructions in the operating manual must be observed Read operating manual Equipotential bonding Hazard symbol for ESD-sensitive parts Push lever up to unlock Manufacturer Manufacturing date Serial number Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Humidity limits for storage and transport Atmospheric pressure limits for storage and transport Warning Do not use if the packaging is damaged Recyclable materials CE marking, indicates compliance with Directive 93/42/EEC concerning medical devices Tab. 3: Pictograms Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Dimensions (WxHxD) Weight Main device without 6.3 kg external battery Main device with 6.9 kg external battery Sound pressure level 46 dB (A) Sound power level 56 dB Maximum pressure 100 mbar (SFC) LIM, limit Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The battery life of the ventilator is reduced at extreme temperatures. Brackets Ambulance bracket Dimensions 380 x 360 x 118 mm (W x H x D) Weight 3.5 kg Connections: 12 – 28 V DC Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Spontaneous respiration with continuous positive airway pressure DUOPAP Ventilation support at two different pressure levels Volume-controlled continuous mandatory ventilation VC-CMV VC-SIMV Volume-controlled synchronized intermittent mechanical ventilation nPC-CMV Non-invasive pressure-controlled mandatory ventilation Non-invasive pressure-controlled synchronized nPC-SIMV intermittent mandatory ventilation Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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150 – 500 ml ventilation) 500 – 1000 ml 1000 – 2000 ml Flow limit Flow limitation 5 -30 / Off l/min Tinsp Inspiration time 0.2 – 30 s Texp Expiration time 0.2 – 30 s Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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: V = 4.0 ml +15%) (STPD, accuracy 0 – 3000 VTspon 0 – 3000 VTleak 0 – 100 l/min 0.01 0 – 999 MVspon l/min 0.01 0 – 999 Accuracy assumes an ambient temperature of 0 – 40° C. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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(see manufacturer data sheet for accuracy of MASIMO sensors) Pulse 0 – 239 (above "---") 0 – 100% 0.01 0.02 – 0.99 1 – 9.9% 10 – 20% SpM et 0 – 100 SpCO 0 – 100 SpOC ml/dl 0 – 35 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Identifies potentially dangerous situations that may result in minor or moderate injury to the patient or user or damage to the medical device if not avoided. NOTE Identifies additional information that is useful for device operation and intended to avoid problems during use. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Do not use any combustible or anesthetic gases. DANGER Use of the device in the vicinity of magnetic resonance imaging systems may degrade its functionality, which can potentially put the patient and operator at risk. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
If the ventilator is to be operated with additional O , the O supply pressure must be 2.8 – 6 bar (see chapter 1.9). WARNING The displayed O concentration is not a measurement. Instead, the gas concentration is calculated from the flow rates. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Therefore, do not use antistatic or electro-conductive patient tubing or lines. WARNING Never pull on patient tubing or electrical cables. This may cause the device to tip over or drop. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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PC-CMV in the case of suction. To prevent the occurrence of negative pressures, the PEEP must be set to a minimum of 4 mbar. WARNING Treat the individual parts carefully to avoid mechanical damage. Only use correctly prepared parts to operate the device. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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When adding system components or sub-assemblies to the ventilation system of the ventilator, the pressure gradient across the ventilation system, measured at the patient connection port, may negatively affect the performance data of the ventilator. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If adjacent or stacked use is necessary, the medical electrical equipment or system should be monitored to verify its intended operation in the configuration in which it is used. WARNING No modifications to the EVE are permitted without the manufacturer's authorization! Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Design and functional description Design and functional description Front view Fig. 1: Front view 1 Touchscreen display 4 Function buttons 2 Transport handle with alarm 5 Control knob indicator 3 Control panel 6 Removable display cover Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 2: Front view with display cover 3.1.1 Alarm indicator The alarm indicator in the transport handle notifies the user about alarm occurrences. It flashes yellow for medium priority alarms and red for high priority alarms. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
0.5 s will then start or switch to the selected ventilation mode. Pressing this key will start ventilation using the standard parameters for Fast tracking key for preterm infants and preterm infants and newborns (see chapter 6.6). newborns Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Pressing the key again after 5 s has passed will start a new 2 minute countdown. NOTE During therapeutic procedures, the acoustic alarm can be completely suppressed for 2 min by pressing the alarm suppression button before the occurrence of the first alarm. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The internal batteries are charged automatically as needed. The battery charge indicators tell you the current battery level. The indicator is green when an oxygen cylinder with sufficient fill Oxygen supply indicator pressure is connected. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
At the same time, the display for the set oxygen concentration changes to the pre-set “Preoxy” value. The alarm limits for oxygen concentration are adjusted automatically. The button is green while pre-oxygenation is in progress. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Pressing the control knob for three seconds will lock the touchscreen. Lock/unlock touchscreen Press the control knob again for three seconds to unlock the touchscreen. When you tap the locked touchscreen, a lock icon appears in the "System Settings" field (see chapter 3.2.7). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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It can be selected using the touchscreen or by pressing the control knob again. When changing a numeric parameter, the control knob must be used to confirm this in order to accept the modified value. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
8 Measurement value display (ventilation mode and flow sensor with alarm limits display and selection) 5 System field 9 Time display (Access system settings / touchscreen lock state indicator) 6 System field (Energy supply indicator) Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
When selected, the color of a function field/tab changes from green to white. In case of navigation, no further confirmation is necessary. For safety-relevant functions (e.g. when changing the ventilation mode), a second button appears for confirming the selection. Fig. 7: Selecting a function field Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Selecting a parameter field changes its color to yellow. The value can Parameter now be changed using the control knob. Pressing the control knob again will accept the value, and the field color changes back to gray. Fig. 9: Changing values Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 10: "Return" field Single drop-down box Pressing a drop-down box opens a list of possible options below the box. Use the control knob or touchscreen to make a selection. Fig. 11: Single drop-down box Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The change is discarded. Fig. 13: "Close" field NOTE Except for the menu for setting the ventilation parameters (see chapter 3.2.3.6), a menu can also be closed by selecting any other menu or a field on the touchscreen. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Five measured values are displayed. Three sets of 5 measured values each are available. Only one set can be displayed at a time. Use the function field to switch between the sets (see chapter 3.2.3.1). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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VTleak Leak Flow V´min Minimum flow l/min V´max Maximum flow l/min Time Tinsp Inspiration time Texp Expiration ftotal Total respiratory rate 1/min (mechanical + spontaneous respiratory rate) fspon Spontaneous respiratory rate 1/min Inspiration time ratio Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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(HP alarm) or yellow (MP alarm), depending on the alarm priority. In addition, an error message appears in the status, alarm, and info display. Fig. 15: Color change when alarm limits are breached Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(see chapter 3.2.2). The active set is indicated by a number in the function field. 3.2.3.2 Values Pressing this function field opens the "Values" sub-menu. This provides an overview of the measured values currently determined by the Values ventilator. Fig. 17: Values sub-menu Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The last 1000 values can be displayed on the monitor. In total up to 1100 entries can be saved in the device. If this value is exceeded, the oldest entries are automatically overwritten. NOTE The logbook data can be saved on the internal SD card (see chapter 4.4.9). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
If an inactive alarm recurs, it becomes current and appears in the alarm history. Manually deleting an inactive alarm from the alarm history moves the next internally stored alarm into the on-screen alarm history. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If limits are breached during the current ventilation, the corresponding parameter field turns yellow or red, depending on the alarm priority. Fig. 19: Alarms sub-menu 1 Name and unit 3 Current measured value 2 Upper limit 4 Lower limit Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Adult: Child: Child: (PC mode) Preterm infants Preterm infants and and newborns: newborns: 0.42 0.78 fspon 1/min Apnea mmHg EtCO Vol.% Set value −10% Set value +10% minimum maximum 100% Tab. 6: Preset alarm limits Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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4 – 60 Pulse 30 – 230 35 – 235/Off 1 Tab. 7: Adjustable alarm limits Auto Pressing the »Auto« field sets the PAW, MVe, VTe, EtCO and PEEP limits to the system's automatic alarm limit presets. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If configured in the setup menu, the alarm limits for FiO , PAW LOW and PEEP are always set automatically. Parameter Unit Lower limit Upper limit Set value −10 Set value +10 minimum 21% maximum 100% PEEP mbar Set value + 5 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The settings are automatically saved when shutting down the device and are retained when restarting the device. When the mainboard software is updated, all settings in the menu are reset and may need to be manually reactivated. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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NOTE The "Apnea alarm activated" setting switches on each time the device is started and cannot be saved as the default value. Fritz Stephan GmbH recommends supplementing patient monitoring with external monitoring if the apnea alarm is deactivated. Fritz Stephan GmbH...
EVE now automatically detects the spontaneous breathing effort by the patient, closes the system and measures the P0.1 value. When the measurement is complete, the determined value appears in the display. The three most recent measured values are saved and displayed for reference purposes. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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When the bar graph is completely filled, the SpHb measurement can be performed by pressing the »Start« field. When the measurement is complete, the measured value appears on the display. The three most recent measured values are saved and displayed for reference purposes. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 24: Configurable parameters for standard SIMV ventilation 1 Optionally selectable 2 Current ventilation mode additional functions for the indicator ventilation mode 3 Ventilation parameters Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 25: Parameter display for PC-CMV ventilation mode To change a parameter, select the corresponding field. The field then turns yellow. You can now change the value using the control knob. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
5 Patient type 3 Additional function for 6 Icon for non-invasive ventilation mode ventilation Selecting this field opens a ventilation menu (see chapter 6.8) where you can adjust the settings to the current ventilation scenario. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Pictogram Meaning Green Capacity between 75 – 100% Yellow Capacity between 40 – 74% Capacity between 1 – 39% Tab. 9: Charge level indicator Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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3.2.7 System settings Fig. 29: "System Settings" field Pressing this field opens the "System Settings" sub-menu (see chapter 4). NOTE This field contains a lock icon if the touchscreen is locked (see chapter 3.1.3). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Preoxygenation display corresponding icon, and the preset preoxygenation time starts to count down. Nebulization display Pressing the »Aerosol« button (see chapter 3.1.3) displays the corresponding icon, and the preset nebulization time starts to count down. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The top field of the graphic display always shows the pressure curve. The remaining fields can be freely configured by selecting them. NOTE The system automatically adapts the scaling of the curves and scales to the current measured values. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Select a measurement curve on the display to change it. Fig. 33: Graphic display, changing the display A window with all available measurement curves (volume, flow, CO plethysmogram) opens. You can now select the desired option. Fig. 34: Selecting the measurement curve Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Pressing the corresponding field lets you display the desired loop in the graphic display. Fig. 35: Selecting loops Pressing the »X« field closes the selection window and shows the loop including its measured values in the graphic display. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Design and functional description Fig. 36: Loop (here V‘(P)) 1 Loop If the »Trends« field is selected, available options are displayed on the Trends right. Fig. 37: Trends selection 1 Monitoring time setting 2 Trend selection Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Selectable trends Ppeak MVespon SPMet Pplat Vt spon ftotal Pulse SPMet Pplat/ PEEP Pmean Vt leak fspon SPCO Mve/ Mvespon PEEP SPOC ftotal/ fspon Tab. 11: Displayable trends Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The maximum load of the attachment hook is 15 kg. Attachment hook It can be used to attach the EVE a standard rail (10 x 25 mm) hospital beds (Ø 38 mm) Stretchers Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 39: Right side view 1 Insp. = gas outlet opening 3 SpO sensor connection Inspiration tube connection 4 CO sensor connection 2 Exp. = gas return opening 5 Flow sensor connection Expiration tube connection 6 Aerosol nebulizer connection Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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® Design and functional description Bottom view Fig. 40: Bottom view 1 Fan 2 Cover for the SD card slot Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Pressing the field shows the current charge level using LEDs. Reset button Pressing the Reset button causes the EVE to restart. However, it does not reset the ventilator to factory settings. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
3.7.1 Ambulance bracket Fig. 42: Ambulance bracket 1 EVE attachment hook 4 Lock/unlock latch 2 EVE bracket 5 EVE safety catch 3 EVE interface 6 12/24 V on-board power supply input Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(item 6) and then the bracket (item 2) lock into place with a click. To remove the ventilator, press the lock/unlock latch (item 5). The device releases and can be removed from the bracket. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
5 Bag for tube system and accessories 3 Manometer WARNING Only use the original carry system from F H, otherwise device RITZ TEPHAN damage may result. 3.7.3.1 Built-in pressure regulator NOTE Observe the manufacturer’s service and operating manuals! Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Sensors Display Setup They are described below. NOTE Changes are automatically saved when exiting a sub-menu and remain in effect when restarting the device, with the exception of the Masimo Rainbow SET® parameters. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
System Settings System This lets you access the following sub-menus: Info Display Time Function Fig. 46: System Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Settings made in the "Display" sub-menu are also used when switching manually between day/night mode in the function area (see chapter 3.1.3). 4.1.3 Time and Date This sub-menu lets you set the date and time. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Lets you set duration of the preoxygenation (10 – 180 s) that is triggered when the »Preoxy« button is pressed. Setting for the inspiratory oxygen concentration administered when the Preoxy % »Preoxy« button is pressed. You can select an inspiratory oxygen concentration between 21 and 100%. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The configured settings are used for the current ventilation process when exiting the menu. The user-defined configuration for the Masimo sensors is not permanently saved. Restarting the ventilator will reset it to the factory settings. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
This lets you switch the frequency of the sensor from 50 Hz (default Frequency setting value) to 60 Hz. Selecting this function enables the acoustic pulse signal. Otherwise, the Smart Tone Smart Tone is disabled. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The number of measurement parameters is optional and can be configured upon customer request. Parameters not contained in the package are grayed out and not selectable. NOTE The SpOC parameter can only be selected if SpHb is activated. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The signal averaging time can be set to 2 – 4, 4 – 6, 8, 10, 12, 14, or 16 s. Averaging Time The oximeter continuously measures the values over the preset time and then displays the mean value. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Medium (default), and Long. The oximeter continuously measures the values over the preset period and then displays the mean value. SpHb Precision This lets you set the signal precision to the following levels: 0.1 (default), 0.5, and 1.0. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(optional). Fig. 53: Capnometry In addition, you can select the unit (mmHg, kPa, and Vol.%) and choose to run zero calibration on the sensor (see chapters 8.1.5 and 8.2.5). Fig. 54: Running zero calibration Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 55: Configuring the flow sensor Select from the following settings for the flow sensor: Adult Infant (child) PNT B Furthermore, the flow trigger can be switched on or off here. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 56: Presetting for the patient tube system ATTENTION Fritz Stephan GmbH explicitly recommends that only patient tube systems included in the list of accessories are used. Otherwise, ventilator function may be impaired! If it is necessary to use a non-standardized tube system that has not been tested by H, select the "Other Tube System"...
This sub-menu lets you configure the measured value display. Fig. 57: Display sub-menu 4.3.1 Measured values The three sets of the measured value display (see chapter 3.2.2) can be freely configured by the user in this sub-menu. Fig. 58: Configuring the measured values Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The Setup menu lets you make changes and configure settings that directly affect the ventilator's therapy settings. For this reason, this area is protected by a 4-digit code 1948 to be entered on the touchscreen. Fig. 59: Entering the code Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The "I:E/Tinsp," "Language," "Touchscreen," "Factory Settings," "Service Software," "Deep Sleep," "Logbook," and "Pressure units" fields are only available in Standby mode. 4.4.1 Oxygen configuration Select this option when using oxygen with a concentration of 93%. Oxygen93 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 61: I:E/Tinsp configuration When you activate the "Display All Parameters" field, all current breathing cycling values are shown in the parameter display. Fig. 62: Parameter display with and without activated breathing cycling display Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
This sub-menu lets you reset the EVE to factory settings by pressing the corresponding field followed by a restart. 4.4.6 Service Software Pressing the Start button will start the service software from the SD card. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The alarm volume must be selected so it can be heard over ambient noise. Otherwise, the patient may be put at risk because the user may not be able to hear acoustic indicators for existing alarms. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
You can switch the protocol for the Patient Data Management System (PDMS) on or off here. 4.4.12 Pressure units The unit for the displayed pressure can be selected here. The following options are possible: mbar Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
CAUTION Immediately degrease equipment and facilities for oxygen that are contaminated by oil and grease using suitable solvents. Never work on oxygen equipment or facilities with dirty hands, gloves, or cloths. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Pressurized gas cylinders must be protected from dangerous heating (> 50° C), e.g. from heaters or open flames. CAUTION Handle the valves of oxygen cylinders manually only and open them slowly. Always point the valve opening and handwheel away from the body. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Except during use, oxygen cylinders may only be transported with an approved valve protector (e.g. cylinder cap) and if sufficiently protected against sliding or rolling. CAUTION Change the pressurized gas cylinder in time to ensure sufficient operating time. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Basic flow at 95% oxygen = 2 l/min The minute volume is calculated by multiplying the tidal volume with the respiratory rate: = ∗ = 500 ∗ 12 1/ = 6 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
At very high temperatures the basic flow may rise, but due to the blower module the EVE can provide ventilation without any added oxygen at any time. 5.1.3 Changing the oxygen cylinder NOTE Before changing the pressurized gas cylinder, refer to the operating manual of the pressure regulator. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The device can also be operated with an oxygen concentrator. Connect the O hose to the O quick coupling on the left side of device (see chapter ) and to the oxygen concentrator in accordance with the manufacturer instructions. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
12 V or 24 V using the ambulance or helicopter bracket. Connect the power plug to the 12/24 V socket on the back of the corresponding ambulance bracket (see chapters 3.7.1 and 3.7.2). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The specified run time assumes a new battery with a capacity of 100%. The operating time can be affected by the age of the battery, the charging cycles, and the charge level and can therefore deviate from specifications. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Installing additional components may cause increased dead space, resistance, and compliance in the ventilation tube system. CAUTION A patient filter (HME filter) should not be used together with an external patient gas humidification system because this causes increased resistance. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Preparation for use 5.3.2 EVE pediatric single-use tube system Fig. 67: EVE pediatric single-use tube system 1 Tube system 4 Distal expiration valve 2 Flow sensor for children 5 Flow sensor adapter 3 Patient filter (optional) Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Do not tilt the expiration valve or press it in with force. Danger of breakage! lets you use both distal (away from the patient) and proximal (close to the patient) expiration valves. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Flow sensor, adult 11 ml The flow sensor is connected between the expiration valve and the endotracheal tube (ETT). Fig. 69 and Fig. 70 show the additional connection of a CO sensor and a bacterial filter. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
"Sensors/Flow" menu (see chapter 4.2.3). Installing the patient filter CAUTION Using a patient filter (HME filter) may increase (airway) resistance. In addition, the increased dead space volume when connecting a filter must be taken into account. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Select the medication dose carefully. If the medication dose is too high, it may negatively affect the ambient air. CAUTION The accuracy of the ventilator may be impaired by the gas added by the nebulizer. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Aerosol nebulization is automatically synchronized with inspiration. NOTE In volume-controlled mode, the volume is automatically compensated for during nebulization. For medication nebulization, install the nebulizer as shown in Fig. 71 and fill according to the operating manual provided with the nebulizer. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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"Function" menu (see chapter 4.1.4) in the system configuration. The nebulization ends automatically at the end of the set time or when pressing the button again. NOTE Follow the operating manual provided with the nebulizer for installation and filling! Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The last safety check must have been carried out as scheduled. Visual check of the safety check sticker. The device is completely assembled and connected. The internal battery must be fully charged. DANGER Never operate device if it has failed one of the tests! Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
After 30 s, "O2 low!!" MP alarm level low set O level to 30%. appears Alarm: Connect test lung, set PAW UL to Airway pressure high!!! High pressure minimum, trigger peak pressure HP alarm appears. Tab. 13: Test list Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Sensor test External ADC channel 2 External ADC channel 9 External ADC channel 5 Difference between ADC channels 0 and 1 External ADC channel 7 Internal ADC channel 0 Test of the blower module Turbine test Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
A failed selftest means that the ventilator cannot currently be used. An error code appears. See chapter 10.2 for causes and information on troubleshooting. After the malfunction has been corrected, the selftest can be repeated. Fig. 73: Selftest failed Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(see chapter 3.1.2). These provide a quick and easy way to select the default ventilation parameters for preterm infants and newborns, children, and adults (see chapter 6.7.1). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Fig. 75: Selecting the patient type Press the »Confirm« button to save the settings and return the ventilator to the Standby screen. You can now select the »Start Ventilation« field. Press the »Mode Settings« field to change the ventilation mode. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Otherwise, ventilator function may be impaired! If it is necessary to use a non-standardized tube system that has not been tested by H, select the "Other Tube System" option. Then enter the tube RITZ TEPHAN system's parameters manually. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
12 mbar 12 mbar Psupp 1 mbar 10 mbar 10 mbar Ramp time 0.1 s 0.2 s 0.2 s 5 ml 200 ml 500 ml Trigger Flow limit 9 l/min Tab. 14: Default ventilation parameters Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
NOTE Volume alarms are not active during non-invasive ventilation methods. The "Mode Settings" menu first lets the user decide between invasive or non-invasive ventilation. Fig. 77: Mode Settings menu Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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License Neo mode required nDUOPAP License Neo mode required DUOPAP License Neo mode or NIV/DUOPAP required Spontaneous CPAP Standard nCPAP License Neo mode required Other therapy Standard High flow – O therapy Standard Tab. 15: Ventilation modes Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
For this purpose, the "Monitoring" field must be selected in the "Ventilation Settings" menu and the "SPO " field activated in the subsequent sub-menu. The Pleth and Pulse values are then displayed graphically. Fig. 78: Setting for SPO monitoring Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
This example uses invasive PC-SIMV to describe the selection of the ventilation mode. Proceed as follows: Press the »Invasive« field in the menu. All available ventilation modes are displayed. Select »PC-SIMV« and press the »Next« field. Fig. 79: Selecting the ventilation mode Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Select a parameter. The parameter turns yellow. The value can now be changed using the control knob. Press the control knob or the »Confirm« field to complete your entry. Proceed analogously to configure the other ventilation parameters. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Ending ventilation To end the current ventilation process and switch to Standby mode, press and hold the »On/Off/Standby« button for 3 s (see chapter 6.2). Pressing the button for another 3 s turns the ventilator off. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
A flow limit is available in NEO mode for non-invasive ventilation modes. The preset flow limit is 9 l/min. It can be set within a range of 5-30 l/min in the corresponding field or switched off completely. Fig. 82:Flow limit Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Additional options Some ventilation modes provide additional options, such as Pressure-regulated and volume-controlled ventilation (PRVC) Pressure support ventilation (PSV) Backup ventilation Tube compensation Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Spontaneous breathing is visualized in the curve display by a color Points to note in relation change in the ventilation curve. The color of the flow curve changes from to the visualization of magenta to orange. spontaneous breathing Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(optional). The "trigger threshold" is set in the »Trigger« field as flow in l/min. NOTE The internal flow trigger can be activated for all ventilation forms. The external flow sensor must first be switched off in the "Sensors/Flow" menu (see chapter 4.2.3). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The ETT positioned in the intubated patient's trachea prevents him from breathing. The smaller the diameter of the ETT, the more difficult it is to breathe in and out. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
"forces" the delivery of a preset inspiratory tidal volume. The ventilation pressure delivered changes with the mechanical parameters of the lungs. If compliance improves, the ventilation pressure needed to reach the selected tidal volume adjust to the lowest possible value. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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However, ETT leakage may prevent the total ventilator-delivered volume from reaching the lungs. Fig. 83: Volume-controlled ventilation VC-CMV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
In turn, too little distance to the respiratory gas flow signal can cause unintended triggering due to artifacts or leakage flows. For VC-SIMV, the EVE delivers a mandatory breath once an inspiratory flow reaches the preset trigger threshold. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The actual total breathing frequency is shown in the "ftotal" measured value display of the monitor. This also shows the minute volume measurement as "MVtotal". Fig. 84: VC-SIMV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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4.4.2) Positive end expiratory pressure (PEEP) Tidal volume (VT) Pressure support (Psupp) (relative set value with reference to PEEP) Expiration trigger sensitivity (ETS) Tab. 19: VC-SIMV with PSV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The lungs have now been filled within the time indicated on the time axis. The inspiratory pressure increase which can be set in the »Ramp time« field determines how the ventilation pressure reaches its maximum value within the inspiration time »Tinsp.«. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Ramp time Inspiration pressure (Pinsp) Tab. 20: PC-CMV NOTE The PC-CMV ventilation mode can be used with volume guarantee (PRVC) (see chapter 7.4.1). It also includes an option for tube compensation (see chapter 7.4.3). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Inspiration time (Tinsp) and breathing frequency (the parameters for breathing cycling can be configured, see chapter 4.4.2) Positive end expiratory pressure (PEEP) Ramp time Inspiration pressure (Pinsp) Flow limitation (in NEO mode only) Tab. 22: nPC-CMV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
As a result, the time by which the expiration time was reduced is added to the next following expiration times after each trigger event. This means that the average matches the mandatory base frequency set by the user. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Tab. 23: PC-SIMV NOTE The PC-SIMV ventilation mode can be used with volume guarantee (PRVC) or pressure support (PSV) (see chapters 7.4.1 and 7.4.2). It also includes an option for tube compensation (see chapter 7.4.3). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Inspiration pressure (Pinsp) Positive end expiratory pressure (PEEP) Ramp time Pressure support (Psupp) (relative set value with reference to PEEP) Trigger Expiratory trigger sensitivity (ETS) Tab. 25: PC-SIMV with PSV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Inspiration pressure (Pinsp) Positive end expiratory pressure (PEEP) Ramp time Pressure support (Psupp) (relative set value with reference to PEEP) Trigger Expiratory trigger sensitivity (ETS) Tab. 27: nPC-SIMV with PSV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Inspiration time (Tinsp) and breathing frequency (f) (the parameters for breathing cycling can be configured, see chapter 4.4.2) Inspiration pressure (Pinsp) Positive end expiratory pressure (PEEP) Ramp time Trigger Tab. 28: PC-ACV NOTE Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Inspiration time (Tinsp) and breathing frequency (the parameters for breathing cycling can be configured, see chapter 4.4.2) Positive end expiratory pressure (PEEP) Ramp time Trigger Flow (in NEO mode only) limitation Tab. 30: nPC-ACV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The change to the PEEP level takes place either upon expiration of the set inspiration time or is patient triggered at incipient expiration by the patient. As a result, the patient controls the beginning, progress, and volume of the mechanically supported breath. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
For this purpose, the »Trigger« field is used to set the trigger function. The flow trigger is used to initiate the changeover from the lower to the upper pressure level within a trigger window. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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This differentiates DUOPAP from other mixed ventilation modes where spontaneous and controlled breaths follow one after another. In addition, mechanical ventilation and spontaneous breathing can be combined simultaneously. Fig. 88: DUOPAP Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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4.4.2) Positive end expiratory pressure (PEEP) Ramp time Pressure support (Psupp) (relative set value with reference to PEEP) Trigger Expiratory trigger sensitivity (ETS) Tab. 34: DUOPAP with PSV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(f) (the parameters for breathing cycling can be configured, see chapter 4.4.2) Positive end expiratory pressure (PEEP) Ramp time Pressure support (Psupp) (relative set value with reference to PEEP) Trigger Tab. 36: nDUOPAP with PSV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
10 s opens. If an additional sufficient spontaneous breathing takes place during this time window, the respirator returns to normal CPAP ventilation. Ventilation mode Adjustable parameters O CPAP PEEP Trigger Backup Tab. 37: CPAP Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Tab. 38: CPAP with backup Fig. 89: CPAP NOTE The CPAP ventilation mode can be used with pressure support (PSV) (see chapters 7.4.1 and 7.4.2). It also includes an option for tube compensation (see chapter 7.4.3). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(PNT) in this mode. The pressure is measured proximally via the pressure measurement adapter set. Ventilation mode Adjustable parameters O nCPAP PEEP Trigger Backup Flow limitation (in NEO mode only) Tab. 40: nCPAP Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Tab. 41: High-Flow ATTENTION The operating pressure, not the patient's inspiration pressure, is displayed on the ventilator. If the operating pressure is decreased via the PAW alarm limit, the flow to the patient also decreases. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
»PEEP«, the inspiration time »Tinsp«, and the frequency »f« should be set as usual. In this case, however, the »VT« parameter field has special significance, because it is used to set the desired tidal volume. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If lung compliance deteriorates, the ventilation pressure increases at maximum to the automatically set »Pmax«. As of this pressure, it will no longer be possible to apply the set tidal volume in full. The ventilator now reverts to pressure-controlled-only ventilation. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The ventilator uses the selected trigger threshold to detect the patient's inhalation efforts and then triggers a mandatory breath using the selected pressure support (Psupp). Without patient triggering, however, the ventilator does not provide pressure support. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Expiration is initiated as soon as the flow has dropped to the previously set percentage for the inspiratory peak flow. The Expiration Trigger Sensitivity (ETS %) is used for this setting. Fig. 94: PC-SIMV with PSV parameter setting Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The pressure in the tube system is visualized as a filled curve, the tracheal pressure as a single black line. Additional pressure support can significantly reduce the breathing effort for the patient. The following parameters must be set: Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Ventilation modes Compensation (%) Adjustable parameters Tube diameter (mm) These settings can be configured directly in the respective ventilation menu. Fig. 96: Configuring tube compensation with PC-SIMV Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Data output The measuring data is output either numerically (see chapter 3.2.2) or graphically as curves on the display of the EVE (see chapter 3.2.9). Fig. 97: CO curve display Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The IRMA™ CO analyzer is not designed for use as a standalone patient monitoring device. It must always be used in combination with other systems for monitoring the vital signs and/or together with professional patient observation. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
It must always be used in combination with other systems for monitoring the vital signs. WARNING The IRMA™ probe may not be used with flammable anesthetics. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The IRMA™ CO analyzer is not designed for use in MRI environments. WARNING Do not use the IRMA™ airway adapter together with metered-dose inhalers or medication nebulizers because this impairs the translucency of the adapter's view ports. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The airway adapter must be replaced in case of moisture collection or condensation on the inside. WARNING Never make modifications to the device! WARNING Only use MASIMO brand IRMA™ airway adapters. WARNING Direct contact of the IRMA™ probe with the patient must be prevented. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
EVE monitor must be checked. Fig. 99: Airway adapter for adults/children and infants Secure the IRMA™ probe to the IRMA™ airway adapter. The probe audibly locks into place when secured properly. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Connect the socket of the airway adapter to the Y piece of the ventilation system. Fig. 102: Connecting the airway adapter's socket to the Y piece Connect the socket of the airway adapter to the ETT tube. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The gas section should be tested annually. NOTE After inserting the probe, a leakage test of the EVE patient system is recommended. WARNING The airway adapter must be replaced if moisture or condensation collect on the inside. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
4.2.2) to start the zero calibration. The probe's LED flashes green during zero calibration. Every zero calibration must be followed by a functional test. If zero calibration is immediately followed by a "CO sensor zero calibration!" alarm, the procedure must be repeated. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
MASIMO ISA™ detector via a thin tube. This is where the measurement occurs. The benefit of this approach is that the weight near the ETT is not increased, reducing the risk of extubation. For this reason, this technique is particularly popular in pediatric and neonatal settings. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
It must always be used in combination with other systems for monitoring the vital signs and/or together with professional patient observation. 8.2.2 Specifications NOTE For detailed specifications about the MASIMO ISA™ CO analyzer, see the documentation included with the product. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Used disposable sample collection tubes must be disposed of as medical waste according to local regulations. WARNING Do not lift the ISA™ CO analyzer at the sample collection tube. This may cause the tube connection to detach, and the analyzer could drop onto the patient. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Nomoline locking message appears on the EVE display. WARNING The ISA™ CO analyzer is not designed for use in MRI environments. During MRI scans, the analyzer must remain outside the MRI room. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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WARNING Do not create negative pressure in the Nomoline tube (e.g. using a syringe) to remove water condensation. WARNING Excessive positive or negative pressure in the patient system circuit. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Do not position the ISA™ analyzer in a way where it is at risk of dropping onto the patient. WARNING Position the ISA™ analyzer securely to avoid device damage. WARNING Do not put strain on the ISA™ analyzer's cable. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
"CO sampling line clogged!!" message appears on the EVE display. Fig. 106: Connecting the sample collection tube to the ISA™ CO analyzer 1 CO connection analysis adapter 2 Sample collection tube Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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The measured gas values should be checked regularly for accuracy by conducting comparative measurements. The gas section should be tested annually. NOTE After connecting the ISA™ CO analyzer, a leakage test of the EVE patient system is recommended. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The status indicator of the ISA™ probe indicates the following operating states: LED color Meaning Green System ready for use Flashing green Zeroing in progress Sensor fault Flashing red Check sample collection tube Tab. 43: Status indicator Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
CAUTION Do not sterilize the ISA™ CO analyzer or submerge it in liquids. CAUTION The Nomoline sample collection tubes are not sterile. To prevent damage, do not autoclave any part of the sample collection tube. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Optional MASIMO technology integration provides all Rainbow parameters. Furthermore, an optional non-invasive SpCO measuring procedure can be integrated. This allows immediate diagnosis of carbon monoxide poisoning and supports the user in patient treatment and monitoring tasks. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Functional description Fig. 108: EVE pneumatics design Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Alarm starts out as an MP alarm and becomes an HP alarm under defined conditions. HP alarms High priority alarm Flash frequency: 2 Hz Sequence Color code HP Notifications C-A-F-A-F C-A-F C2-B-A-G-F C2-B-A C2-C-C-C2-C C2-C-C C-C-C-C-C C-C-C Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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10 s. Run zero calibration for the CO sensor. Clean the CO sensor; if necessary, replace the adapter Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Check Δ Psupp setting Paw limited by Check Paw alarm Paw limited by PEEP PEEP settings Check PEEP setting PEEP limited by PEEP limited by Check PEEP setting PEEPlim upper pressure alarm limit Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Check Paw alarm limit Ramp time limited Check Pinsp setting Ramp limited by by Pinsp Pinsp Check ramp time setting Internal Contact RTC error communication RITZ TEPHAN error customer service team Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Check the settings and alarm limit for three adjust if necessary breaths Check the alarm limits Escalates to MP and adjust if necessary after 60 s Check the tube system for leakage or disconnected parts Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Battery 1 Check battery 1, replace Battery 1 temp. low undercooled if necessary Do not operate the device at temperatures outside ambient conditions (see chapter 1.9). Contact RITZ TEPHAN customer service Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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CO adapter Replace the CO adapter Replace CO adapter malfunction or contamination sampling line Sampling line is Check the sampling line contaminated or clogged Replace the sampling clogged line Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Check the CO sensor sensor error detected Replace the CO sensor CO sensor or if necessary adapter Use external CO contaminated. monitoring if necessary CO sensor possibly incorrectly attached to the cuvette Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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In case of larger limit value deviations, contact F RITZ TEPHAN customer service Parameter error Internal Contact communication RITZ TEPHAN error customer service Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If the blower frequency overheats, an HP Reduce flow for O alarm is triggered therapy Battery 1 and 2 Check the batteries, Battery 1 & 2 failure malfunction replace if necessary Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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PEEP level PAW alarm limit Check the patient's Airway tube kinked condition Check the pressure alarm limits Check the flow sensor and breathing tube Check the ETT or mask Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Check minute volume setting alarm limits Leak Check patient tube Flow sensor system and connections malfunction for leakage Check that the manual settings are correct, adjust if necessary Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Check expiration valve for proper connection Check mask and tube for proper connection P-Meas.: Check VBS Pressure Check patient tube measurement failure system Tab. 44: Troubleshooting Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Check system for leakage Check sealing plug on Y piece If the error cannot be corrected, contact RITZ TEPHAN customer service, providing the error code displayed Tab. 45: Selftest error Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
(see chapter 3.4) to let any moisture escape. Turn the measurement line connectors upward to prevent condensate Position the PNT from entering the measurement lines. Fig. 109: Turning the measurement line connectors upward Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
CAUTION Do not sterilize the device in an autoclave, under pressure, or using ethylene oxide (EO). This will damage the device. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
These agents can damage the device material and cause malfunctions. CAUTION Disinfectants based on amines and their derivatives can damage silicone parts (e.g. patient tubes) and are therefore not suitable for use on the device. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Load the automated cleaning and disinfection equipment in such a way that the inner and outer surfaces of the parts can be reached by the cleaning agent and no spots are missed. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If necessary, repeat the cleaning and disinfection process. After this, dry the treated parts thoroughly (in a drying cabinet if necessary). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
To manually clean the individual parts, pre-rinse them in warm water. Then clean the individual parts in the cleaning and disinfectant solution, if necessary using soft brushes or sponges. All secretions and other deposits and contamination must be completely removed. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
WARNING When using wipe disinfection, ensure that no liquid enters the device. Liquid ingress can impair the operation of the device and thereby pose a risk to the patient. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
The hot steam sterilizer must be loaded according to the manufacturer’s instructions for use and the corresponding program started. Temperature Hold/dwell time 134° C 3 – 18 min. Tab. 47: Standard procedure for steam sterilization* *All standard steam sterilization procedures can be used. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
5. Dry the disinfected parts (in a drying cabinet if necessary), unless this happens inside the automated cleaning and disinfection equipment. Further information on automatic cleaning can be found in chapter 11.3. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Further information on sterilization can be found in chapter 11.6. Storage After sterilization, store the system in the sterilization packaging, first ensuring it is dry and free of contamination. Additional information None Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
2. Carefully pull both vortex bodies out on both sides of the flow sensor using the assembly tool. Preparing the PNT B Fig. 110: Preparing the PNT B Pressure measurement line Vortex body Connector 1 Hook Connector 2 PNT B assembly tool Pneumotachograph Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
3. Attaching the vortex bodies to the assembly tool Post-treatment PNT B Fig. 111: Post-treatment PNT B 4 PNT housing 5 Vortex body O-ring of the vortex body 7 Assembly tool b Flat end of the assembly tool 8 Concentric tube system Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Preparation for use of connection (3) marked with "P" on the reusable flow sensor adapter. the flow measurement 4. Connect the second pressure measurement line to the second adapter (reusable) connection (4) on the reusable flow sensor adapter. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If this occurs, the measurement results for tidal volumes and minute volumes will be incorrect. Before using the flow sensor, leak and functional checks must be Function test performed (see chapter 7 of the operating manual). Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
1. Check for residual water and carefully purge with sterile compressed air if necessary. 2. Connect the tube adapter and tube sleeve to the silicone tube. 3. Connect the connection tube to the test lung together with the tube adapter and tube sleeve Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Storage After sterilization, store the system in the sterilization packaging, first ensuring it is dry and free of contamination. Additional information None Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Observe the manufacturer’s operating weekly manual! After every patient/ Test lung Neo with weekly tube adapter Reusable After every patient/ weekly expiration valve After every patient/ Reusable patient tube system weekly Type B After every patient/ weekly pneumotachograph Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
All maintenance Basic maintenance (annually) Major maintenance (every five years) must be performed according to maintenance instructions by the authorized F H customer service team. RITZ TEPHAN Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
TEPHAN ATTENTION Use only spare parts from F H for servicing, otherwise device RITZ TEPHAN damage may result. The following procedures must be performed regularly to ensure that the ventilator is operational at all times: Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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This involves completely discharging and recharging battery twice in a row Replacement after 500 load Authorized cycles, or if the battery capacity is RITZ TEPHAN below 50% after full charging customer service team Tab. 49: Servicing Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Remove the screw on the left side panel. Fig. 115: Removing the screw on the side panel Slightly lift the housing cover and remove. Replace the coarse filter. Fig. 116: Replacing the coarse filter Replace the housing cover. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Install the new HEPA filter. Replace side panel and coarse filter. 11.11.1.3 Replacing the fan filter Remove the screw on the right side panel. Fig. 118: Removing the screw on the side panel Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Fig. 119: Replacing the filter element NOTE When replacing the filter element, observe the correct installation direction. The filter has a slit on the front left side. Replace and screw on the fan cover. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
Replacing the external battery To replace the external battery 2 (optional), squeeze together the two tabs on the rear of the battery. This automatically releases the battery from the device for replacement. Fig. 120: Replacing the external battery Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
CISPR 11 low-voltage power supply network that also supplies Harmonics as defined in Class B buildings used for domestic purposes. IEC 61000-3-2 Voltage fluctuations/flicker as defined in IEC 61000-3-3 Tab. 50: Electromagnetic emissions (IEC 60601-1-2) Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
IEC 61000-4-4:2012 Surges as defined in +1 kV +1 kV Mains power quality should be IEC 61000-4-4:2012 Line-to-line Line-to-line that of a typical commercial or hospital environment. +2 kV +2 kV Line-to-earth Line-to-earth Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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ISM bands Conducted RF 10 V 10 V effective value effective value disturbances as 150 kHz to 80 MHz defined in in ISM bands IEC 61000-4-6 for 80 MHz to 800 MHz Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ventilator. Over the frequency range 150 kHz to 80 MHz, field strength is less than 10 V/m. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Tab. 52: Recommended separation distance (IEC 60601-1-2, Table 5) Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
107061360 Helicopter bracket with charging electronics 24 V DC 107061370 Docking station Light 107061660 EVE pressure regulator including connection tube 107063001 connection hose, 3 m, phthalate-free 110261270 DIN-NIST, EN 5359 safety tube, 2 m 170460434 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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O2 safety tube, 2 m 1 70460425 nasal cannula child, incl. O2 safety tube, 2 m 1 70060428 Headband for children's breathing mask 170060007 Headband for adult breathing mask 170060008 Small mask ring for breathing mask, size 0–1 170060005 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Air-Soft breathing mask, size 5 (large adult) 170060037 Pediatric test lung, silicone, 30 ml, including tube adapter for 170060092 connection to Y piece Test lung GaleMed with adapter (Fritz Stephan GmbH) 107061207 Description Art. no. EasyFlow_nCPAP system Prongs (PU: 5) ...
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Accessory list Description Art. no. 170161024 170161025 170161026 170161027 170161028 170161029 Headband complete with 2 fixing straps and forehead pad (PU:1) micro 170161040 mini 170161041 maxi 170161042 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
See the corresponding chapters in this operating manual for additional information. Only F H or authorized professionals are allowed to RITZ TEPHAN manipulate or repair the device. Non-compliance voids the warranty. Improper handling of the device also voids the warranty. Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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Fig. 116: Replacing the HEPA filter ............. 231 Fig. 117: Removing the screw on the side panel ........231 Fig. 118: Replacing the filter element ........... 232 Fig. 119: Replacing the external battery ..........233 Fritz Stephan GmbH GA-070T-0518V2.7-HAO-EN...
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