Stephan EVETR Instructions For Use Manual Download Page 80

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3 Design and functional description

GA-070T-0518V2.7-HAO-EN



Fritz Stephan GmbH

3.4

Right side view

Fig. 39: Right side view

1 Insp. = gas outlet opening

Inspiration tube connection

3 SpO

sensor connection

4 CO

sensor connection

2 Exp. = gas return opening

Expiration tube connection

5 Flow sensor connection
6 Aerosol nebulizer connection

Summary of Contents for EVETR

Page 1: ...EVETR Transport Ventilator Instructions for use...

Page 2: ...zed you with its function and operation The manufacturer only guarantees the safety and reliability of the EVETR when it is operated according to the manual NOTE For information about the maintenance...

Page 3: ...s 16 1 9 Specifications 22 2 Safety instructions 33 2 1 Danger 34 2 2 Warning 35 3 Design and functional description 41 3 1 Front view 41 3 1 1 Alarm indicator 42 3 1 2 Control panel 43 3 1 3 Function...

Page 4: ...Right side view 80 3 6 Rear view 82 3 7 Brackets 83 3 7 1 Ambulance bracket 83 3 7 2 Helicopter bracket 84 3 7 3 Carry system 85 Built in pressure regulator 85 3 7 3 1 4 System Settings 87 4 1 System...

Page 5: ...on 113 5 2 1 Mains power supply 113 5 2 2 12 24 V mains power supply 113 5 2 3 Internal energy supply 114 5 2 4 Charging the external battery 115 5 3 Connecting the patient tube system 115 5 3 1 EVE a...

Page 6: ...Volume controlled ventilation 144 Volume controlled continuous mandatory 7 3 1 1 ventilation VC CMV 144 Volume controlled synchronized intermittent 7 3 1 2 mandatory ventilation VC SIMV 146 7 3 2 Pres...

Page 7: ...ent optional 173 8 1 Measurement using the mainstream technique 174 8 1 1 Intended use 174 8 1 2 Specifications 175 8 1 3 Warnings 175 8 1 4 Installing the CO2 measuring probe 178 8 1 5 Running zero c...

Page 8: ...he PNT B 220 11 7 1 1 Post treatment 221 11 7 1 2 11 7 2 Test lung Neo with tube adapter 224 11 8 Treatment table 226 11 9 Safety checks 227 11 10 Maintenance 227 11 11 Servicing 228 11 11 1Procedure...

Page 9: ...ng a suitable patient monitoring system that provides reliable data about the correct functioning of the medical device and the condition of the patient lies with the user of the ventilator Different...

Page 10: ...VE Manufacturer Fritz Stephan GmbH Pressure measuring adapter nCPAP Manufacturer Fritz Stephan GmbH 3 Disposable patient tube systems EVE adult emergency Manufacturer Fritz Stephan GmbH EVE paediatric...

Page 11: ...z Stephan GmbH 5 Expiration valve Manufacturer Fritz Stephan GmbH CO2 sensor Manufacturer Masimo 6 Masimo Rainbow Manufacturer Masimo 7 Optiflow Junior Nasal Cannula Manufacturer Fisher Paykel 8 Optif...

Page 12: ...ACV nACV art no 107061452 1 2 2 Hardware components The EVETR can optionally be equipped with a CO2 measurement using the mainstream or sidestream technique see chapter 8 as well as a pulse oximeter...

Page 13: ...lts weighing up to 200 kg It is also possible to ventilate preterm infants and newborns The EVETR supports the following types of ventilation Ventilation mode Standard Optional PC CMV X PC SIMV X PC A...

Page 14: ...terials The cardboard packaging can be reused or disposed of as used paper FRITZ STEPHAN GMBH will accept the return of any used devices from our company free of charge and dispose of these correctly...

Page 15: ...l carefully and comply with its instructions lasting safety for the patient and user is only ensured when the device is operated correctly The operating manual must be kept readily available at the pl...

Page 16: ...tient DUOPAP Ventilation support at two different pressure levels ETT Endotracheal tube Exp Expiration exhalation Time period from the onset of the expiration flow until the onset of the inspiration f...

Page 17: ...n invasive pressure controlled assist control ventilation with expiration trigger nDUOPAP Non invasive ventilation support at two different pressure levels NIST Non interchangeable screw thread Non in...

Page 18: ...el in arterial blood SpOC Oxygen level measurement Index for oxygen level in arterial blood Standby The device is ready for use STPD Standard temperature pressure dry Measuring condition at standard t...

Page 19: ...rge indicator for battery 2 see chapter 3 1 2 Inspiration hold see chapter 3 1 3 Pre oxygenation see chapter 3 1 3 Activate aerosol nebulization see chapter 3 1 3 Day Night toggle switch see chapter 3...

Page 20: ...ed see chapter 3 2 7 Mains power see chapter 3 2 6 Charge level for battery 1 see chapter 3 2 6 Charge level for battery 2 see chapter 3 2 6 Contains conventional or rechargeable batteries and must no...

Page 21: ...ry Keep away from sunlight Temperature limits for storage and transport Humidity limits for storage and transport Atmospheric pressure limits for storage and transport Warning Do not use if the packag...

Page 22: ...3 42 EEC II b Protection type IP 44 Protection against contact with tools conductive parts with a diameter 1 0 mm protection against foreign objects with a diameter 1 0 mm Protected against splash wat...

Page 23: ...Ah Operating time with optional external battery new batteries fully charged Max 6 hours min 3 5 hours Battery 1 internal Max 3 hours Battery 2 external optional Max 3 hours Charge time battery 1 App...

Page 24: ...CMV Pressure controlled continuous mandatory ventilation PC SIMV Pressure controlled synchronized intermittent mandatory ventilation PC ACV Pressure controlled assist control ventilation PC ACV Press...

Page 25: ...180 s 1 Pre oxygenation concentration 21 100 1 Insp Hold Max 15 s 1 Aerosol 5 30 min 5 Parameter Meaning Setting range Resolution PEEP Positive end expiratory pressure 0 25 mbar 1 Pinsp Inspiratory p...

Page 26: ...70 1 Tube compensation Intensity of tubus compensation 0 100 1 Tube Tube diameter 2 12 mm 0 5 Ensured by using a redundant pressure measurement and limitation Measured value Unit Resolution Display ra...

Page 27: ...level from 21 to 90 58 s VT 30 ml 37 s VT 150 ml 22 s VT 500 ml EtCO2 see manufacturer data sheet for sensor accuracy EtCO2 Vol 0 1 0 90 mmHg 1 0 12 kPa 0 1 0 999 Lung dynamics R mbar l s 1 0 1000 C m...

Page 28: ...at PEEP MVe MVespon ftotal fspon NOTE The EVE ventilator features a multi computer design with mutual monitoring and redundancy In addition ventilation pressures are limited by the hardware Parameter...

Page 29: ...990 500 2000 10 EtCO2 Vol 0 0 11 9 0 1 12 0 1 mmHg 0 89 1 90 1 kPa 0 0 11 9 0 1 12 0 1 O2 Vol 18 99 22 100 1 SpO2 88 98 91 99 Off 1 Pulse bpm 30 230 35 235 Off 1 PI 0 03 0 1 Off 0 04 0 1 0 01 0 1 1 0...

Page 30: ...airway adapter Dead space Preterm infants and newborns 1 ml Adults children 6 ml HME filter Children Air filter volume 8 ml Connections 15f patient side 15m machine side Luer lock Pressure drop at 5...

Page 31: ...l min Insp resistance 15 l min 0 022 hPa l min Insp resistance 2 5 l min 0 016 hPa l min Exp resistance 30 l min 0 06 hPa l min Exp resistance 15 l min 0 0743 hPa l min Exp resistance 2 5 l min 0 068...

Page 32: ......

Page 33: ...not avoided WARNING Identifies potentially dangerous situations that may result in death or serious injury if not avoided CAUTION Identifies potentially dangerous situations that may result in minor o...

Page 34: ...tructions in this operating manual DANGER The device is not certified for use in potentially explosive environments DANGER The device must not be used in areas with contaminated air DANGER Risk of exp...

Page 35: ...FRITZ STEPHAN GMBH for maintenance WARNING Do not operate the device outside the specified ambient conditions see chapter 1 9 Otherwise device functionality may be impaired WARNING The ventilator suc...

Page 36: ...s 1 2 Product combination and 12 List of accessories Using other patient tubing or accessories not intended for use with the ventilator may impair device performance and safety WARNING When operating...

Page 37: ...ventilation a CO2 monitor for measuring the expiratory CO2 level must be used The EVETR can be optionally equipped with an internal CO2 measuring unit Otherwise an external measuring unit must be used...

Page 38: ...measurement lines WARNING After using the special alarm suppression state make sure that the alarm is reactivated before leaving the patient WARNING FRITZ STEPHAN GMBH recommends that the ventilator...

Page 39: ...nal components may result in increased emission or decreased immunity of the medical electrical equipment or system WARNING Medical electrical equipment or systems should not be used adjacent to or st...

Page 40: ......

Page 41: ...tephan GmbH GA 070T 0518V2 7 HAO EN 41 3 Design and functional description 3 1 Front view Fig 1 Front view 1 Touchscreen display 4 Function buttons 2 Transport handle with alarm indicator 5 Control kn...

Page 42: ...2 7 HAO EN Fritz Stephan GmbH 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 medi...

Page 43: ...uppression Press this button to switch the EVETR on off or in the case of ongoing ventilation to switch it to Standby mode see chapter 6 2 To prevent operator errors the desired fast tracking key must...

Page 44: ...t ventilation using the standard parameters for adults see chapter 6 6 Pressing this key will suppress acoustic alarms for 2 min If the key is pressed again within 5 s the alarm suppression is cancele...

Page 45: ...the external battery 2 optional Green Capacity between 75 100 Yellow Capacity between 40 74 Red Capacity between 1 39 Flashing red Capacity 0 or error When connected to the energy supply the mains pow...

Page 46: ...reen Press the Preoxy button to administer a pre adjustable inspiratory oxygen concentration for a certain preset interval These settings can be configured in the System Settings Function menu see cha...

Page 47: ...ay and night mode Press the Aerosol button to switch on aerosol nebulization The medication nebulization duration can be set to between 5 and 30 min in the System Settings Function menu see chapter 4...

Page 48: ...Confirming parameter settings Turn the control knob clockwise or counterclockwise to scroll through the available menus function fields and parameter fields You can also use the touchscreen When usin...

Page 49: ...alarm indicators and notifications Change to alarm limits preoxygenation trigger 2 Function fields 3 Adjustable parameter display 4 Ventilation menu ventilation mode and flow sensor display and selec...

Page 50: ...der to accept the modified value Selecting a function field 3 2 1 1 When navigating the display using the control knob the focus is indicated by an orange border The field is in focus and can be selec...

Page 51: ...d places a green checkmark This will select the corresponding option Fig 8 Option deselected selected Selecting a parameter field changes its color to yellow The value can now be changed using the con...

Page 52: ...in the System Settings menu 3 2 1 3 The Return field takes you to the higher menu level Fig 10 Return field Pressing a drop down box opens a list of possible options below the box Use the control knob...

Page 53: ...uchscreen to make a selection Fig 12 Multiple drop down box Select the X field to close a menu window This field is always located at the top left corner of the open menu If a parameter is selected an...

Page 54: ...Fig 14 Measured value display 1 Function field for toggling between the measured value display and the display of the active measured value block 4 Name of measured value including unit 2 Time display...

Page 55: ...e determined by the ventilator and can be displayed Category Measured value Description Unit Pressure Ppeak Inspiratory peak pressure mbar Pplat Plateau pressure mbar Pmean Mean airway pressure mbar P...

Page 56: ...e constant Product from resistance and compliance s RSB Quotient from frequency and VT Rapid shallow breathing index 1 min l Masimo SpO2 Oxygen saturation Pulse bpm PI Perfusion index PVI Pleth Variab...

Page 57: ...6 Parameters Measured value indicator switch 3 2 3 1 Pressing this function field toggles between the three sets of measured values see chapter 3 2 2 The active set is indicated by a number in the fun...

Page 58: ...nd minutes This data can be viewed by selecting the Logbook field The following events are saved Start Stop Standby Settings and change to the settings Execution of special actions and maneuvers Occur...

Page 59: ...e date and time when the alarm occurred the category P patient alarm T technical alarm and the alarm text The color indicates the priority red HP alarm yellow MP alarm white alarm no longer active All...

Page 60: ...case energy is supplied by the internal battery NOTE In case of a total power failure all entries are deleted from the alarm history Pressing the Limits 1 3 fields lets you view all the alarm limits a...

Page 61: ...ollowing preset alarm limits Parameter Unit Lower limit Upper limit PAW mbar Pinsp 10 maximum 60 mbar PEEP mbar Set value 2 Set value 2 VTe VC mode ml Set value VT 30 Set value VT 30 VTe PC mode ml Ad...

Page 62: ...mbar 11 60 1 PEEP mbar 0 29 1 30 1 VTe ml 0 100 1 100 1 100 490 100 500 5 490 990 500 2000 10 EtCO2 Vol 0 0 11 9 0 1 12 0 0 1 mmHg 0 89 1 90 1 kPa 0 11 9 0 1 12 0 0 1 PI Off 0 03 0 1 0 04 0 1 0 01 0 1...

Page 63: ...ximum 35 mbar PAW PC mode PRVC mbar No Auto button available No Auto button available PEEP mbar Set value 2 Set value 2 VTe mbar 30 30 EtCO2 mbar 10 minimum 35 mmHg 10 maximum 45 mmHg Tab 8 Automatic...

Page 64: ...nually If you activate the FiO2 Follow option the FiO2 alarm limits are automatically updated However they can also be manually set If you deactivate this function it is only possible to make the sett...

Page 65: ...yed in the status alarm and info display see chapter 3 2 8 Fig 21 Status alarm and info display Apnea alarm deactivated NOTE The Apnea alarm deactivated symbol is only displayed if alarm suppression i...

Page 66: ...arameter of the patient s respiratory drive It is an index for the inspiration breathing effort by the patient against a closed system in the first 100 ms Fig 22 Maneuver P0 1 1 Start field 3 Measured...

Page 67: ...Start field 4 Current measured value 2 Bar graph 5 Measured value history 3 Remaining SpHb measurements The sensor requires a brief warm up phase indicated by the black bar graph When the bar graph is...

Page 68: ...er 3 2 9 Parameter 3 2 3 6 Pressing this function field opens a sub menu with all configurable parameters and additional functions for the currently active ventilation mode Fig 24 Configurable paramet...

Page 69: ...e ventilation mode these can also be activated from this menu Press the Confirm field to save the new settings and close the sub menu 3 2 4 Parameter display The display provides an overview of the fi...

Page 70: ...tilation mode causes the display to turn orange In addition the icon for non invasive ventilation appears Fig 26 Invasive ventilation mode Fig 27 Non invasive ventilation 1 Flow sensor type 4 Ventilat...

Page 71: ...battery charge indicator both the internal and external battery must be calibrated every six months see chapter 11 11 To allow for battery changes during operation the EVETR can be equipped with two i...

Page 72: ...battery indicators when mains power is connected The icon disappears from the display when mains power is disconnected Tab 10 Mains power indicator NOTE If mains power is not connected the battery pro...

Page 73: ...3 3 If there are no active alarms but a non acknowledged alarm history exists the corresponding icon appears on the alarm display The icon disappears after deleting the alarm history Pressing the Alar...

Page 74: ...re configured in the system settings see chapter 4 1 2 Three different layout versions are available 1 Display of three curves 2 Display of two curves 3 Display of one curve loop or trend Fig 32 Graph...

Page 75: ...the measurement curves 3 2 9 1 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 CO2 and pl...

Page 76: ...Stop field or automatically after 20 s have passed Configuration of loops and trends 3 2 9 2 Layout 3 provides the option of displaying loops and trends The lower field of the graphic display must be...

Page 77: ...ption Fritz Stephan GmbH GA 070T 0518V2 7 HAO EN 77 Fig 36 Loop here V P 1 Loop If the Trends field is selected available options are displayed on the right Fig 37 Trends selection 1 Monitoring time s...

Page 78: ...72 h Pressing the arrow key in the second window opens a dropdown menu Here you can select the required trend Up to two trends can be displayed at the same time for pressure minute volume and frequenc...

Page 79: ...side view Fig 38 Left side view 1 Attachment hook 3 O2 input 2 O2 input quick coupling 4 Air filter grille coarse and HEPA filter The maximum load of the attachment hook is 15 kg It can be used to at...

Page 80: ...Stephan GmbH 3 4 Right side view Fig 39 Right side view 1 Insp gas outlet opening Inspiration tube connection 3 SpO2 sensor connection 4 CO2 sensor connection 2 Exp gas return opening Expiration tube...

Page 81: ...3 Design and functional description Fritz Stephan GmbH GA 070T 0518V2 7 HAO EN 81 3 5 Bottom view Fig 40 Bottom view 1 Fan 2 Cover for the SD card slot...

Page 82: ...ry 2 optional 7 Adjustable bracket 4 External battery charge level indicator The charge level indicator lets you check the external battery optional even when the device is switched off Pressing the f...

Page 83: ...the bracket Otherwise injuries due to crushing may result Make sure the device locks into place CAUTION The safety catch of the brackets must be checked at least every four weeks for intactness and co...

Page 84: ...nd can be removed from the bracket 3 7 2 Helicopter bracket Fig 43 Helicopter bracket 1 EVETR attachment hook 5 Lock unlock latch 2 EVETR bracket 6 Standard rail bracket 3 EVETR interface 7 12 24 V on...

Page 85: ...arry system 1 Safety guard 4 Oxygen cylinder 2 Pressure regulator 5 Bag for tube system and accessories 3 Manometer WARNING Only use the original carry system from FRITZ STEPHAN GMBH otherwise device...

Page 86: ......

Page 87: ...vated Turn the control knob to change the parameters Complete your input by pressing the control knob or touching the field again The System Settings menu is divided into the following sub menus Syste...

Page 88: ...4 System Settings 88 GA 070T 0518V2 7 HAO EN Fritz Stephan GmbH 4 1 System This lets you access the following sub menus Info Display Time Function Fig 46 System...

Page 89: ...Battery SW Bootloader PSU Akkupack1 SW battery pack 1 Bootloader battery 4 1 2 Display This sub menu lets you separately adjust the display brightness for day and night operation in the range of 20 10...

Page 90: ...ets you set the aerosol nebulization time 5 30 min Aerosol nebulization is triggered by pressing the Aerosol button Lets you set duration of the preoxygenation 10 180 s that is triggered when the Preo...

Page 91: ...ry and flow The tube system used is configured here Fig 48 Sensor sub menu 4 2 1 Pulse oximetry This sub menu lets you configure the sensors for pulse oximetry NOTE The configured settings are used fo...

Page 92: ...1 1 Fig 49 Settings sub menu Turns the SpO2 sensor on off This lets you switch the frequency of the sensor from 50 Hz default value to 60 Hz Selecting this function enables the acoustic pulse signal O...

Page 93: ...rn on off the measurement of the Pulse PI SpHb SpMet SpCO SpOC and PVI parameters Fig 50 Activating the measured values NOTE The number of measurement parameters is optional and can be configured upon...

Page 94: ...vity levels if the sensor becomes detached from the patient This lets you activate deactivate FastSat mode This function monitors rapid changes of the arterial O2 level NOTE When FastSat mode is activ...

Page 95: ...the units for the SpHb value The following settings are available g dl default mmol l The signal averaging time can be set to the following levels Short Medium default and Long The oximeter continuou...

Page 96: ...mbH 4 2 2 Capnometry This lets you activate deactivate CO2 monitoring optional Fig 53 Capnometry In addition you can select the unit mmHg kPa and Vol and choose to run zero calibration on the sensor s...

Page 97: ...7 HAO EN 97 4 2 3 Flow This sub menu lets you configure the flow sensor Fig 55 Configuring the flow sensor Select from the following settings for the flow sensor Adult Infant child PNT B OFF Furtherm...

Page 98: ...orresponding tube system must be selected for this based on the type designation or a pictogram Fig 56 Presetting for the patient tube system ATTENTION Fritz Stephan GmbH explicitly recommends that on...

Page 99: ...Display 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 configure...

Page 100: ...he arrow buttons to select and the touchscreen or control knob to activate the desired field which is immediately added to the measured value bar Repeat as necessary until configuration is complete Ch...

Page 101: ...ns the following sub menu Fig 60 Setup menu NOTE The I E Tinsp Language Touchscreen Factory Settings Service Software Deep Sleep Logbook and Pressure units fields are only available in Standby mode 4...

Page 102: ...reathing time ratio frequency I E Frequency Inspiration time frequency Tinsp Frequency The settings remain stored and are only overwritten when resetting the device to factory settings Fig 61 I E Tins...

Page 103: ...or the language change to take effect Fig 63 Setting the system language 1 Language selection 2 Save button 4 4 4 Touchscreen calibration This sub menu lets you calibrate the touchscreen by pressing t...

Page 104: ...ins supply in order to be powered on 4 4 8 Sound This sub menu lets you separately adjust the alarm volume for day and night operation in the range of 30 100 You can also determine a start time for bo...

Page 105: ...the size of the data to be transferred are displayed Fig 65 Logbook 4 4 10 License This menu displays which optional software licenses have been purchased see chapter 1 2 1 4 4 11 Protocol You can sw...

Page 106: ......

Page 107: ...ed rooms CAUTION Particles such as adhesive residue from band aids may ignite flowing oxygen CAUTION Keep equipment fittings and valves for oxygen free from oil and grease this includes not using oint...

Page 108: ...rs only with a pressure regulator approved for oxygen look for Oil and grease free labeling Only approved pressure regulators according to DIN EN ISO 10524 or ones with special approval may be used to...

Page 109: ...ase rubbing alcohol hand lotion or band aids may cause explosive reactions CAUTION Keep valves of pressurized gas cylinders closed while no gas is used Handle the valves of pressurized gas cylinders m...

Page 110: ...rized gas cylinder O2 content is calculated by multiplying the oxygen cylinder pressure Pcyl with the oxygen cylinder volume Vcyl For EVETR the basic flow for the adult and pediatric range is at 2 l m...

Page 111: ...iplying the tidal volume with the respiratory rate 10 40 1 0 4 3 2 20 9 79 1 0 4 3 0 1 1 0 4 1 1 95 20 9 79 1 2 43 2000 2 43 823 NOTE At very high temperatures the basic flow may rise but due to the b...

Page 112: ...e fastening buckles Fit the O2 NIST screw connector to the O2 input on the EVETR Open the pressurized gas cylinder s valve This completes the cylinder replacement CAUTION After changing the pressurize...

Page 113: ...mains 80 240 V and switch on the power supply unit WARNING According to IEC 60601 1 1 the energy supply must only be connected to energy supply grids with adequate protective conductor connection WAR...

Page 114: ...only be replaced by the authorized FRITZ STEPHAN GMBH customer service team The primary supply of the ventilator is mains voltage In case of a power failure or if the device is disconnected from the...

Page 115: ...y changes to remaining run time in minutes 5 2 4 Charging the external battery The external battery optional can be charged directly inside the device or externally using a separate power supply NOTE...

Page 116: ...ay be impaired WARNING The patient tube systems are labelled with an expiration date The expiration date must be checked before use 5 3 1 EVE adults emergency single use tube system Fig 66 EVE adult e...

Page 117: ...GmbH GA 070T 0518V2 7 HAO EN 117 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 senso...

Page 118: ...e system 6 Flow sensor adapter 3 Decoupling tube 7 Distal expiration valve 4 Applicator 5 4 Installing the expiration valve CAUTION Carefully insert the expiration valve in the corresponding connectio...

Page 119: ...valve is connected to the expiration outlet of the device using an adapter see Fig 66 5 5 Installing the flow sensor EVETR measures pressure and flow via the flow sensor PNT The measurement is taken...

Page 120: ...r measurement line connectors upward to prevent condensate from entering the measurement lines The flow sensor settings can be pre selected in the system configuration in the Sensors Flow menu see cha...

Page 121: ...flow the minute and breathing volume displayed during medication nebulization may differ significantly from the actual values As a result FRITZ STEPHAN GMBH recommends using a pressure controlled ven...

Page 122: ...a result the Aerosol button see chapter 3 1 3 should be pressed only when a medication nebulizer is connected Otherwise the resulting breathing volume is too low NOTE Aerosol nebulization is only poss...

Page 123: ...n aerosol nebulization The aerosol nebulization duration can be set to between 5 and 30 min in the Function menu see chapter 4 1 4 in the system configuration The nebulization ends automatically at th...

Page 124: ......

Page 125: ...staff carrying out the tests must be well acquainted with the operating manual 6 1 1 Testing requirements The last safety check must have been carried out as scheduled Visual check of the safety check...

Page 126: ...onal Connected properly Check the flow sensor PNT Connected properly Check the expiration valve Connected properly Manual breathing bag Self filling present within reach Functions correctly Bracket Fu...

Page 127: ...switching on the device the EVETR performs an automatic selftest If the selftest is successful the EVETR automatically switches to Standby mode The following functions are checked during the selftest...

Page 128: ...ext field to open the standby screen 6 3 2 Selftest failed A failed selftest means that the ventilator cannot currently be used An error code appears See chapter 10 2 for causes and information on tro...

Page 129: ...ation Press the New Patient field to create a new patient To switch to Standby mode from a current ventilation process press and hold the On Off Standby button for 3 s see chapter 6 2 6 5 Using fast t...

Page 130: ...settings for preterm infants and newborns children and adults This selection corresponds to the function of the fast tracking keys see chapter 6 5 After selecting the patient type the system suggests...

Page 131: ...s based on the type designation or a pictogram If no new patient is displayed the presetting for the tube system of the last ventilation is adopted Fig 76 Presetting for the patient tube system ATTENT...

Page 132: ...pe They can be adapted to the corresponding patient in the Mode Settings menu Parameter Preterm infants and newborns optional Child Adult Apnea 4 s 4 s 4 s ETS 25 25 25 O2 21 21 21 f 40 20 12 I E 1 2...

Page 133: ...only if the tube system is disconnected from the device If the patient interface is disconnected prong mask or has a leakage the disconnection alarm will not be triggered NOTE For safety reasons the...

Page 134: ...tandard X X nPC SIMV License Neo mode required X PC ACV Standard X X PC ACV License ACV nACV required X X nPC ACV License Neo mode required X nPC ACV License ACV nACV required X PC CMV Standard X X nP...

Page 135: ...the EVE are not required the device can also be used as a pulse oximeter For this purpose the Monitoring field must be selected in the Ventilation Settings menu and the SPO2 field activated in the sub...

Page 136: ...entilation mode 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 display...

Page 137: ...PSV and tube compensation are listed on the left side The relevant configurable ventilation parameters are listed on the right side After the user selects the desired PC SIMV option the corresponding...

Page 138: ...tilation to activate the ventilation NOTE See chapter 7 for a detailed description of all the ventilation modes and configurable ventilation parameter settings provided by the EVETR 6 9 Ending ventila...

Page 139: ...on invasive ventilation modes nCPAP nPC SIMV nPC ACV nPC ACV nDUOPAP and nPC CMV are used for the ventilation of preterm infants and newborns In this case ventilation is carried out without a flow sen...

Page 140: ...ative side effects However it requires sufficient spontaneous breathing of the patient NIV ventilation is contraindicated in the following cases No spontaneous breathing Fixed or functional airway obs...

Page 141: ...Overview of selectable additional options When selecting a ventilation mode the available additional options appear as fields along the right edge of the screen see Fig 80 Select the corresponding fi...

Page 142: ...ion is preset in the device and cannot be changed by the user It is independent of the setting for inspiration flow detection The present trigger levels are approx 10 l min adults approx 2 l min child...

Page 143: ...during which pressure between the lungs and ventilator is equalized The exhaled expiratory breathing volume is called the tidal volume and measured by the flow sensor PNT and shown on the display The...

Page 144: ...ility is significant for the quality of the ventilator Depending on the selected ventilation mode pressure or volume controlled ventilation the inner resistance can also be used to specifically react...

Page 145: ...than the target volume set by the user The ventilation pressure limit and or respiratory rate may then have to be adjusted to maintain an adequate respiratory minute volume If the patient breathes ag...

Page 146: ...erse effects syncing between a spontaneously breathing patient and the ventilator is especially important The EVETR uses the flow sensor s patient gas flow signal as a synchronization trigger The flow...

Page 147: ...he second phase of the expiration time the EVETR now delivers a mandatory breath Selecting the inspiration and expiration time or frequency lets the user specify a mandatory base frequency that does n...

Page 148: ...V ventilation mode can be used with optional pressure support PSV see chapter 7 4 2 It also includes an option for tube compensation see chapter 7 4 3 Ventilation mode Adjustable parameters VC SIMV wi...

Page 149: ...atory peak pressure Pinsp is reached during this time The magnitude of the tidal volume depends on the compliance of the patient s lungs and results from the PEEP and Pinsp settings Spontaneous breath...

Page 150: ...athing frequency f the parameters for breathing cycling can be configured see chapter 4 4 2 Positive end expiratory pressure PEEP Ramp time Inspiration pressure Pinsp Tab 20 PC CMV NOTE The PC CMV ven...

Page 151: ...7 3 2 2 nPC CMV The nPC CMV corresponds to the behavior of the PC CMV It is only available in non invasive Neo mode The device is operated without a flow sensor PNT in this mode The pressure is measur...

Page 152: ...to breathe in to activate the trigger In turn too little distance to the respiratory gas flow signal can cause unintended triggering due to artifacts or leakage flows For PC SIMV the EVETR delivers a...

Page 153: ...able parameters PC SIMV O2 Inspiration time Tinsp and breathing frequency f the parameters for breathing cycling can be configured see chapter 4 4 2 Positive end expiratory pressure PEEP Ramp time Ins...

Page 154: ...xpiratory pressure PEEP Ramp time Target volume VT Tab 24 PC SIMV with PRVC Ventilation mode Adjustable parameters PC SIMV with PSV O2 Inspiration time Tinsp and breathing frequency f the parameters f...

Page 155: ...iration time Tinsp and breathing frequency f the parameters for breathing cycling can be configured see chapter 4 4 2 Positive end expiratory pressure PEEP Ramp time Inspiration pressure Pinsp Trigger...

Page 156: ...et trigger threshold with a mechanical breath This triggers the patient s mandatory inspiration but its characteristic is controlled by the device The patient cannot trigger a new mandatory breath unt...

Page 157: ...p time Target volume VT Trigger Tab 29 PC ACV with PRVC Non invasive pressure controlled assist control ventilation nPC 7 3 2 6 ACV The nPC ACV corresponds to the behavior of the PC ACV It is only ava...

Page 158: ...r breathing cycling can be configured see chapter 4 4 2 Positive end expiratory pressure PEEP Ramp time Target volume VT Trigger Flow limitation in NEO mode only Tab 31 PC ACV Non invasive pressure co...

Page 159: ...ntegrated turbine the flow is regulated when spontaneous breathing activity of the patient is detected This is to keep the selected airway pressure constant while simultaneously allowing spontaneous b...

Page 160: ...first phase Texpspon 50 of Texp the patient can only breathe spontaneously Even when the trigger threshold is crossed there is no mandatory support from the ventilator If the patient breathes spontane...

Page 161: ...parameters for breathing cycling can be configured see chapter 4 4 2 Inspiration pressure Pinsp Positive end expiratory pressure PEEP Ramp time Target volume VT Tab 33 DUOPAP with PRVC Ventilation mo...

Page 162: ...P O2 Inspiration time Tinsp and breathing frequency f the parameters for breathing cycling can be configured see chapter 4 4 2 Positive end expiratory pressure PEEP Ramp time Trigger Flow limitation i...

Page 163: ...an apnea alarm CPAP can be combined with backup ventilation The user can set the maximum desired apnea duration in the Apnea field If there is no spontaneous breathing during this time the ventilator...

Page 164: ...stable parameters CPAP with backup Ramp time Trigger Apnea Backup Phigh Tinsp f PEEP O2 Tab 38 CPAP with backup Fig 89 CPAP NOTE The CPAP ventilation mode can be used with pressure support PSV see cha...

Page 165: ...PEEP Pressure support Psupp relative set value with reference to PEEP Expiratory trigger sensitivity ETS Tab 39 CPAP with PSV nCPAP 7 3 3 2 The ventilation form nCPAP corresponds to the behavior of th...

Page 166: ...set maximum flow 6 l min should not be exceeded 7 3 5 High flow O2 therapy High flow O2 therapy is available only in Neo mode and is actually not a form of ventilation instead it serves as ventilatory...

Page 167: ...nd volume controlled ventilation This option lets the user select a target volume that guarantees a tidal volume with minimum required pressure during breaths Depending on the patient s spontaneous br...

Page 168: ...it However to ensure a minimum pressure it is not possible to reduce the inspiration pressure below the minimum limit of PEEP 5 mbar The EVETR now selects the ventilation pressure for every inspiratio...

Page 169: ...ts of pressure controlled ventilation with the patient s spontaneous breathing activity It helps better adapt the ventilation control to the patient s physiological needs and helps the patient overcom...

Page 170: ...been filled completely This effect can be used for better syncing of the ventilation process as follows With PSV enabled the ventilator stores the inspiratory peak flow during inhalation Expiration is...

Page 171: ...importance However during spontaneous breathing it makes breathing more difficult and requires more breathing effort Fig 95 Tube compensation NOTE If tube compensation is activated the calculated trac...

Page 172: ...GA 070T 0518V2 7 HAO EN Fritz Stephan GmbH Compensation Tube diameter mm These settings can be configured directly in the respective ventilation menu Fig 96 Configuring tube compensation with PC SIMV...

Page 173: ...measurement principle is based on infrared spectroscopy This means that infrared light is absorbed by CO2 molecules The higher the CO2 level in the patient gas the weaker the measurable infrared ligh...

Page 174: ...yzer 8 1 1 Intended use The IRMA CO2 analyzer can be connected to a patient ventilation system for real time measurement of the CO2 concentration The probe is designed for use both in EMS and ICU sett...

Page 175: ...8 1 3 Warnings WARNING Before using the IRMA CO2 analyzer carefully read the documentation provided with the product and observe the usage instructions and warnings it contains WARNING The IRMA probe...

Page 176: ...h adults because this may cause excessive flow resistance WARNING Mobile and RF communication devices may impair the measurements It must be ensured that the probe is used in an electromagnetic enviro...

Page 177: ...measurements WARNING Only use the IRMA CO2 analyzer in the upright position with the LED pointing up to prevent secretions and moisture from collecting on the sensor windows WARNING The airway adapte...

Page 178: ...ied ambient temperature CAUTION Do not expose the cable of the IRMA probe to tensile forces 8 1 4 Installing the CO2 measuring probe To install the CO2 measuring probe Connect the IRMA connecting cabl...

Page 179: ...status indicator see chapter 8 1 6 points up The CO2 analyzer is ready for use when the status indicator is green Fig 101 Status indicator of the CO2 analyzer Connect the socket of the airway adapter...

Page 180: ...ator The HME filter protects the airway adapter from secretions and water vapor so that the adapter does not have to be replaced NOTE The measured gas values should be checked regularly for accuracy b...

Page 181: ...y adapter you have to wait at least 10 s before you can perform the zero calibration For highest measurement accuracy the following recommendations for zero calibration should be followed For zero cal...

Page 182: ...70 CAUTION Do not sterilize the IRMA probe or submerge it in liquid CAUTION The IRMA airway adapter is a non sterile device Do not autoclave it otherwise it will be damaged 8 2 Measurement using the s...

Page 183: ...and suitable emergency medicine and emergency transport settings Fig 104 MASIMO ISA CO2 analyzer with connected communication cable shown shortened The ISA CO2 analyzer is not designed for use as a s...

Page 184: ...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...

Page 185: ...o the patient system circuit WARNING Do not use the sample collection tube configuration for infants with adults because this may cause excessive flow resistance WARNING The Nomoline sample collection...

Page 186: ...r s authorization If authorized modifications are made to the device the device must be tested accordingly WARNING Mobile and RF communication devices may impair the measurements It must be ensured th...

Page 187: ...lection point is located in the middle of the adapter WARNING Excessive scavenger system pressure may impact gas sample flow WARNING Waste gas must be returned to the patient system circuit or a scave...

Page 188: ...the EVETR see Fig 39 using the adapter Connect a Nomoline sample collection tube to the ISA analyzer s input connector Fig 105 Nomoline sample collection tube NOTE The Nomoline sample collection tube...

Page 189: ...lection tube to the patient tube system Attach the sample collection tube to the airway adapter Fig 107 Connecting the sample collection tube to the airway adapter 1 CO2 connection analysis adapter 2...

Page 190: ...and not to breathe in the vicinity of the analyzer before and during zero calibration The ISA CO2 runs zero calibration automatically For this purpose gas sample collection switches from ventilation...

Page 191: ...alcohol 70 for cleaning While cleaning the analyzer the Nomoline sample collection tube must remain connected to prevent cleaning liquid or dust from entering the analyzer via the CO2 connection CAUTI...

Page 192: ......

Page 193: ...ystems are available EVE adult emergency single use tube system EVE pediatric single use tube system All tube systems are pre fitted with a flow sensor and expiration valve and can be equipped with an...

Page 194: ...9 Functional description 194 GA 070T 0518V2 7 HAO EN Fritz Stephan GmbH Fig 108 EVETR pneumatics design...

Page 195: ...ical alarm PA Patient alarm HW Notifications MP MP alarms Medium priority alarm Flash frequency 0 625 Hz HW MP HW MP alarms Alarm starts out as a notification and becomes an MP alarm after 30 seconds...

Page 196: ...an 500 times Replace battery 2 Alarm speaker failure HW Speaker malfunction Only an acoustic auxiliary alarm sounds Piezo Check speaker replace if necessary Contact FRITZ STEPHAN GMBH customer service...

Page 197: ...HEPA filter exhibits increased resistance Change the filter Pressure limit HW The inspiration pressure needed to reach the preset tidal volume is higher than the PAW alarm limit setting Check the pat...

Page 198: ...d by upper or lower limit pressure Check Pinsp setting Pinsp limited by Paw HW Pinsp limited by upper alarm limit Check Paw setting Pinsp limited by PEEP HW Pinsp limited by PEEP Check Pinsp setting C...

Page 199: ...g Check oxygen supply connect if necessary Maintenance required HW Maintenance interval reached Perform service Contact FRITZ STEPHAN GMBH customer service VTe high HW MP PA The inspiratory breath vol...

Page 200: ...ce if necessary Keep the device away from direct sunlight or other heat sources Contact FRITZ STEPHAN GMBH customer service Battery 2 temp high MP TA Battery 2 has overheated Check battery 2 replace i...

Page 201: ...athing at a respiratory rate above the alarm limit setting Check the patient s condition Check the alarm limits Check the trigger threshold and correct if necessary Airway pressure low MP PA Volume me...

Page 202: ...setting Check the patient s condition Check the EtCO2 upper limit and adjust if necessary Check the ventilation settings Calibrate the CO2 sensor if necessary Clean the CO2 sensor cuvette if necessary...

Page 203: ...Check the oxygen delivery pressure and replace the O2 cylinder if necessary Check the oxygen pressure in CGS O2 high Alarm delay 30s MP PA Calculated O2 value is above the automatic alarm limit value...

Page 204: ...an if necessary Replace the CO2 adapter if necessary Standby MP TA Device has been switched to Standby mode No action necessary Temp Gasoutlet high MP TA The temperature at the blower module s gas out...

Page 205: ...if necessary Keep the device away from direct sunlight or other heat sources Contact FRITZ STEPHAN GMBH customer service Battery 1 2 cal HP TA Both batteries require calibration Calibrate the batteri...

Page 206: ...nnected parts Check that the manual settings are correct and plausible adjust if necessary EEPROM failure HP TA EEPROM malfunction Contact FRITZ STEPHAN GMBH customer service Measurement system error...

Page 207: ...pressure to PEEP level and then opens the expiration valve so that the patient can breathe freely Check the airway tube Check the ETT PEEP low HP PA PEEP measured value is below lower PEEP alarm limit...

Page 208: ...STEPHAN GMBH customer service providing the error code displayed Error during sensor test HW Sensor system malfunction Check secure connection of the patient tube system If the error cannot be correc...

Page 209: ...Standby mode or switch off the flow sensor in the system settings see chapter 4 2 3 Remove the pneumotachograph from the Y piece and disconnect the plug from the side panel Press the Aerosol button Ho...

Page 210: ......

Page 211: ...list personnel CAUTION The processes for the treatment of this medical product as described in this manual are recommendations only The requirements regarding hygiene and workplace safety must always...

Page 212: ...the cleaning agent CAUTION When using agents other than those specified please contact the manufacturer of the disinfectant to confirm its compatibility with ventilation and inhalation systems safety...

Page 213: ...ts can damage the material and cause malfunctions CAUTION Do not use any rinse aids or other drying agents 11 3 Automated cleaning and disinfection For automated cleaning configure the automated clean...

Page 214: ...ngal spores AB Same as A and for the inactivation of viruses Efficacy range A Efficacy range AB Ao 600 3000 Disinfection at 80 C 10 min 50 min Disinfection at 85 C 3 2 min 15 8 min Disinfection at 90...

Page 215: ...iologie German Society of Hygiene and Microbiology mhp Verlag Wiesbaden are recommended for users in the Federal Republic of Germany CAUTION Do not use disinfectants in automated cleaning and disinfec...

Page 216: ...fectant that is used must be proven Products based on the following are not suitable because they could possibly damage materials Highly alkaline solutions Petroleum or acetone Oxygen releasing or chl...

Page 217: ...h as Bacillol wipes or tissues made by Paul Hartmann AG Heidenheim or Mikrozid PAA wipes made by Sch lke Norderstedt 11 6 Sterilization Components labeled in this operating manual as suitable for ster...

Page 218: ...a disinfectant solution and carefully remove the impurities using pointed tweezers Do not damage or bend the centrally positioned tubes or the spacer plate Further information on preparation can be fo...

Page 219: ...t protrude over the edge of the outer cone The visible ring face of the proximal vortex body must be flush with the indentation in the PNT housing The vortex bodies must sit tightly in the housing and...

Page 220: ...ressure measurement lines off the PNT connectors 2 Carefully pull both vortex bodies out on both sides of the flow sensor using the assembly tool Fig 110 Preparing the PNT B 1 Pressure measurement lin...

Page 221: ...tem held by three webs on each side Check that the tube system is securely seated in the housing 2 connectors 2 Carefully purge the parts with compressed air so that there is no water in the connector...

Page 222: ...pressure measurement line to connection 2 Fig 112 Connecting the pressure measurement lines on the PNT 1 Connection 1 for proximal pressure measurement line 2 Connection 2 a Reusable pressure measurem...

Page 223: ...4 Connection 2 CAUTION Ensure that all pressure measurement lines are mounted in the correct position Any confusion between different pressure measurement lines may result in inverted measurements If...

Page 224: ...he manufacturer s instructions for use and start the program for anesthesia materials 5 Dry the disinfected parts in a drying cabinet if necessary unless this happens inside the automated disinfection...

Page 225: ...ial can be used for the packable parts The bag must be large enough for all components so that there is no strain on the seal Sterilization All test lung parts can be autoclaved with steam at 134 C Lo...

Page 226: ...connection tubes After every patient weekly No Surfaces No Touchscreen After every patient weekly No Surfaces No Docking station After every patient weekly No Surfaces No Ambulance bracket If contami...

Page 227: ...rve the manufacturer s operating manual Mobile stand brackets After every patient weekly No Surfaces No Tab 48 Treatment table 11 9 Safety checks Safety checks must be carried out annually by the manu...

Page 228: ...alter modify repair or open the device or to replace the battery This does not include the intended dismantling of the patient component according to the operating instructions Only use spare parts f...

Page 229: ...h the internal and external battery must be calibrated every six months This involves completely discharging and recharging battery twice in a row Replacement after 500 load cycles or if the battery c...

Page 230: ...11 11 1 Procedure Replacing the coarse filter 11 11 1 1 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 coar...

Page 231: ...er as described in chapter 11 11 1 1 Pull out the HEPA filter by carefully puncturing it using a sharp object or screwdriver Fig 117 Replacing the HEPA filter Install the new HEPA filter Replace side...

Page 232: ...Slightly lift the housing cover and remove Replace the filter element Fig 119 Replacing the filter element NOTE When replacing the filter element observe the correct installation direction The filter...

Page 233: ...AO EN 233 Replacing the external battery 11 11 1 4 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...

Page 234: ......

Page 235: ...The customer or user of the EVE ventilator should ensure that it is used in such an environment Emissions Compliance Electromagnetic environment guideline RF emissions as defined in CISPR 11 Group 1 T...

Page 236: ...ensure that it is used in such an environment Immunity test IEC60601 test level Compliance level Electromagnetic environment guideline Electrostatic discharge ESD as defined in IEC 61000 4 2 2008 6 k...

Page 237: ...ic field as defined in IEC 61000 4 8 2009 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment UT is the...

Page 238: ...MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5...

Page 239: ...0 1 0 11 m 0 38 m 0 19 m 0 38 m 0 76 m 1 0 35 m 1 2 m 0 6 m 1 2 m 2 4 m 10 1 1 m 3 8 m 1 9 m 3 8 m 7 6 m 100 3 5 m 12 m 6 m 12 m 24 m For transmitters without a rated output listed in the table above...

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Page 241: ...nebulizer set 22M 22F with O2 safety tube 170460422 Disposable EVE distal expiration valve 107061072 EVE replacement battery pluggable 107061037 EVE external power supply 107061041 EVE carry system 10...

Page 242: ...5 107060058 T airway adapter PU 25 107060059 Masimo Rainbow Masimo Rainbow DCI SC 200 sensor adult reusable SpHb SpO2 SpMet 107060512 Masimo Rainbow ReSposable R2 25 sensor system adult SpO2 SpHb SpMe...

Page 243: ...170060037 Pediatric test lung silicone 30 ml including tube adapter for connection to Y piece 170060092 Test lung GaleMed with adapter Fritz Stephan GmbH 107061207 Description Art no EasyFlow_nCPAP sy...

Page 244: ...7 HAO EN Fritz Stephan GmbH Description Art no XXL 170161024 3XL 170161025 4XL 170161026 5XL 170161027 6XL 170161028 7XL 170161029 Headband complete with 2 fixing straps and forehead pad PU 1 micro 17...

Page 245: ...ular safety checks and device maintenance by the manufacturer or by personnel authorized by FRITZ STEPHAN GMBH See the corresponding chapters in this operating manual for additional information Only F...

Page 246: ......

Page 247: ...13 Close field 53 Fig 14 Measured value display 54 Fig 15 Color change when alarm limits are breached 56 Fig 16 Function fields 57 Fig 17 Values sub menu 57 Fig 18 Alarm History sub menu 59 Fig 19 Ala...

Page 248: ...ght side view 80 Fig 40 Bottom view 81 Fig 41 Rear view 82 Fig 42 Ambulance bracket 83 Fig 43 Helicopter bracket 84 Fig 44 EVETR carry system 85 Fig 45 System field 87 Fig 46 System 88 Fig 47 Function...

Page 249: ...l expiration valve 120 Fig 71 Nebulizer connection 123 Fig 72 Selftest passed 128 Fig 73 Selftest failed 128 Fig 74 Standby mode 129 Fig 75 Selecting the patient type 130 Fig 76 Presetting for the pat...

Page 250: ...moline sample collection tube 188 Fig 105 Connecting the sample collection tube to the ISA CO2 analyzer 188 Fig 106 Connecting the sample collection tube to the airway adapter 189 Fig 107 EVETR pneuma...

Page 251: ...Tab 9 Charge level indicator 71 Tab 10 Mains power indicator 72 Tab 11 Displayable trends 78 Tab 12 Operating time 115 Tab 13 Test list 126 Tab 14 Default ventilation parameters 132 Tab 15 Ventilatio...

Page 252: ...39 CPAP with PSV 165 Tab 40 nCPAP 165 Tab 41 Status indicator 182 Tab 42 Status indicator 190 Tab 43 Troubleshooting 207 Tab 44 Selftest error 208 Tab 45 Efficacy ranges according to EN ISO 15883 1 2...

Page 253: ...17 Notes Fritz Stephan GmbH GA 070T 0518V2 7 HAO EN 253 17 Notes...

Page 254: ...Fritz Stephan GmbH Medizintechnik Kirchstra e 19 56412 Gackenbach 49 0 6439 9125 0 49 0 6439 9125 111 info stephan gmbh com www stephan gmbh com...

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