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Applies from S/N EO0700520050

102-36 revDB 12/2020

EO-70

Secretion Management Device

User Guide

Содержание EO-70

Страница 1: ...Applies from S N EO0700520050 102 36 revDB 12 2020 EO 70 Secretion Management Device User Guide ...

Страница 2: ...2 ...

Страница 3: ... device 13 Turning off the device 13 Device Auto Power off on batteries 14 End of batteries beeps 14 Starting and Stopping treatment 14 Turning on and off the docking station 15 Using the SMD module outside of the docking station click and go 15 The Home Screen 17 Using the Touch Pad 18 Navigating the Preferences Menu 19 Accessing the settings menu 20 Presets 21 Presets Configuration Access 21 Cha...

Страница 4: ...7 Connecting to mains power 37 Complete assembly with accessories 37 Running the EO 70 on internal battery 38 Battery run time 38 Storing and recharging 39 Prepare the battery for long term storage 39 Travelling with EO 70 39 Chapter 4 Alarms indicator 39 Chapter 5 Routine Cleaning and Maintenance 40 Instructions for hygienic reprocessing at patient change 41 Servicing 42 Maintenance Timetable 42 ...

Страница 5: ...5 Software versions 47 Guidance and Manufacturer s Declaration Electromagnetic Emissions Immunity 48 Standards compliance 52 Cybersecurity contact 52 Training and support 53 Limited warranty 53 ...

Страница 6: ...sive and non invasive interface This device is transportable but not intended for use during transport The EO 70 device may be used either with a mask mouthpiece or tracheostomy tube WARNING E0VE 70 is not for use with anaesthetic gases E0VE 70 is not for use in an oxygen enriched environment Do not use EO 70 device in an MRI equipment or in a barotherapy equipment Contraindications Barotrauma Pne...

Страница 7: ...nt for extended periods of time The EO 70 should be kept out of reach of children and domestic animals to ensure their safety and the safety of the patient and to avoid damage to the device and the accessories The battery and all machine parts of the device should be disposed of appropriately following correct regulations for waste management in order to minimize the risk for the environment They ...

Страница 8: ...ay screen 3 EO device housing unit 2 SMD module 4 Circuit Port 5 Keyboard Rear Panel 1 Air inlet outlet filters cover 5 USB 1 port 2 DC Power connector 6 SpO2 connector 3 Power button 7 Remote Control connector 4 USB 2 port Maintenance only 1 2 3 4 5 2 1 3 4 5 6 7 ...

Страница 9: ...without housing 1 USB port 2 DC Power connector 3 Connection to outer housing Keyboard 1 Power source indicator 2 Alarm indicators 3 Treatment start stop button 4 Power on off button 5 Battery level indicator 1 2 3 1 2 3 4 5 ...

Страница 10: ... Battery power indicator Power off button Calibration screen access User manual access Settings information Alarms screen access Maintenance menu access Preferences screen access Coaching screen access Export Data screen access Skip the current serie Adds one breath to the current serie Leak Indicator inactive Leak Indicator excessive interface leaks Leak Indicator acceptable interface leaks Breat...

Страница 11: ...standard 60529 Protection against ingress of water and foreign objects Date of manufacture This side up Complies with European legal requirements Manufacturer High and low temperature limitations Serial number Should not be disposed of in household waste Product reference number Keep dry Recyclable Danger of fire if damaged Copyright Fragile Handle with care Class II device Storage and transport h...

Страница 12: ...thcare provider or EOVE for assistance if any of the checks in the set up test fail If the EO 70 has been returned after servicing ensure it is clearly labelled as disinfected before starting the set up test or installing To perform a Set Up Test During a first patient installation it is recommended to check the correct operating status of the device 1 Connect the device to the AC power source and...

Страница 13: ...touch interface Main proceedings 1 From the Home screen or from the coaching screen of the touch interface press and hold until the circle becomes red 2 A confirmation message is displayed Validate 3 The device turns OFF CAUTION The EO 70 device cannot be powered off during treatment Unplugging from mains power does not power off the device It will continue to run on the internal battery The devic...

Страница 14: ...e will sound two beeps then below 10 the two beeps will sound every minute Starting and Stopping treatment Treatment can be started and stopped from either the touch screen or from the keyboard Various preset treatments may be installed on the device by your clinician to ensure the best therapy Use these presets according to the instructions provided by the clinician To START treatment using the k...

Страница 15: ...period of non use without power supply the docking station should be switched off To switch on and off the docking station and the touch screen when the SMD module is outside press the Power button for a few seconds Using the SMD module outside of the docking station click and go The SMD module can be used outside of the docking station To remove the module from the docking station 1 Turn off the ...

Страница 16: ...ly set parameters 6 To charge the module plug it back in the docking station and restore the mains connection WARNING The SMD module extraction from the station must not be performed by the patient Only trained persons are allowed to perform this operation To avoid contact with connectors do not put the hands in the docking station while the module is out Do not touch the inside of the station and...

Страница 17: ...nces menu 8 Time Indicates the time on 24hr clock This can be set up and changed from the Preferences menu 9 Airway pressure indicator Indicates the pressure in the circuit All inhalations are colored in blue all exhalations are colored in green all pause time are colored in white 10 Main settings bar Displays the main settings associated to the current mode can be adjusted when unlocked 11 Start ...

Страница 18: ...ouch Pad is not used the device is in pause state controlling PEEP pressure 2 Press the Touch Pad and slide to the right The device is starting an inspiration phase 3 Keep a finger on the pad to hold the inspiration 4 Without removing the finger from the Pad slide to the left The device is starting an exhalation 5 Keep a finger on the pad to hold the exhalation 6 Release the Touch Pad The device c...

Страница 19: ...splay the settings as list press the small circle The circle and the bar will become blue Luminosity Adjusts screen luminosity Transition beep Activates beeps at transitions from exhalation to inspiration INEX and IPPB modes and from inspiration to exhalation INEX mode only Current Date Sets the current day month and year To set the date click on the wheel and choose the date from the calendar Pre...

Страница 20: ...ss the settings Menu 1 Choose and hold down the lock button until it becomes red A confirmation message is displayed Validate 2 The settings button on the home screen is now available no lock on it 3 Click on the home page settings for adjustment of the main settings or access the settings menu to adjust any setting ...

Страница 21: ...n and how they should be used Presets Configuration Access Access the settings screen see instruction above From the upper band of the menu you can 1 Save the active mode as preset and rename the saved preset 2 Load a previously saved preset to visualize the settings contained in the preset 3 Suppress a preset displayed only if a preset is loaded NOTE To change a setting from a preset select the p...

Страница 22: ...the preset click on the preset you want to switch on Changing treatment mode From the settings menu click the mode bar on the upper left of the screen A pop up will be displayed to select the mode Click on the desired mode and validate If the treatment is in progress it is not possible to change the treatment mode 1 2 3 ...

Страница 23: ...ess Save to apply the changes Boxes display mode 1 From the settings menu click on one of the settings box 2 Adjust the settings with and in the setting pop up 3 Validate the settings Enabling the coaching function The user can switch to Coaching screen to perform a treatment previously saved as preset by the medical personal NOTE Coaching function is only available for preset with treatment in IN...

Страница 24: ...es no compatible preset is available contact your service provider Changing preset mode from Coaching screen To change the preset click on the preset you want to switch on If the treatment is in progress it is not possible to change the preset 1 Current preset Activated preset 2 Available preset 3 Inactive preset not available for Coaching 4 Empty preset 1 2 3 4 ...

Страница 25: ...cates the level of charge left in the battery or whether the battery is charging 8 Date indicates the date on YYYY MM DD format Time Indicates the time on 24hr clock This can be set up and changed from the Preferences menu 9 Skip button permit to stop the INEX serie on going 10 Chameleon Animation which will follow the treatment set up to help the patient 11 Start Stop button starts or stops treat...

Страница 26: ...utton during the last cycle Series counter is incremented at each start of treatment It is reset when changing preset or shutting down the devices Tidal volume is updated after each inhalation At the end of the serie or when stopping the treatment using the skip button a pop up will appears to ask the patient if a new serie will be performed or not The timer is indicative Click on skip pause to re...

Страница 27: ...nt time during treatment when a treatment time is set by the clinician Performing an IPPB treatment with Coaching function Select a preset with IPPB treatment and start the treatment Following the treatment set up inhalation can either be triggered by the patient or by using the dedicated button Volume shows the volume live evolution during the inhalation This monitoring stays to the final inhalat...

Страница 28: ...3 first inhalations It stays unchanged until end of the treatment During exhalation chameleon will gradually deflate until reaching the initial position and colour It stays like this until next inhalation The volume bargraph arrow will move following the proportion of the target volume reached It will stay to the maximum level reached until next inhalation ...

Страница 29: ...k orifice may not be enough to flush all patient CO2 depending on volume inspired and PEEP set For prolongated usage we strongly recommend setting a minimum PEEP of 4 cmH2O and exhal Slope 1 minimum to allow minimum CO2 flush and checking that the patient is well tolerating the treatment Patient Circuit installation The EO 70 SMD device can be used with 22 mm diameter circuit only It is recommende...

Страница 30: ...onnect the patient interface to the other end of the breathing tube IPPB mode 1 Attach the antibacterial filter to the inspiratory port of the device 2 Connect the breathing tube to the other side of the filter 3 Connect the leak accessory to the other side of the patient circuit 4 Perform a circuit calibration 5 Connect the patient interface to the other end of the breathing tube ...

Страница 31: ...ies without patient interface 2 Access the calibration menu 3 Unseal the patient circuit extremity and click on the blinking circle 4 Wait until the circle is completed 5 Seal the patient circuit extremity and click on the blinking circle 6 Wait until the circle is completed 7 Exit the calibration menu by clicking on Validate At any time calibration can be aborted if necessary by pressing on abort...

Страница 32: ...32 In case of error during the seal or unseal phases the following message will be displayed Click then on abort to restart the process ...

Страница 33: ...e or anti static air tubing Due to their resistance to flow accessories such as filters many decrease patient pressure during inspiration and increase patient pressure during exhalation WARNING To prevent the risk of cross contamination an antibacterial filter is mandatory if the device is to be used on multiple patients Regularly check the antibacterial filter for signs of moisture or other conta...

Страница 34: ...e in the sensor improperly applied sensor incorrect sensor type a sensor not at heart level poor pulse quality venous pulsations anemia or low hemoglobin concentrations cardiogreen or other intravascular dyes carboxyhemoglobin methemoglobin dysfunctional hemoglobin artificial nails or fingernail polish 1 Connect the SpO2 adaptor EO SPO2CBL connector at the rear of the device 2 Connect the sensor t...

Страница 35: ... cable pull firmly on the locking ring Do not twist Upright Bracket installation for a vertical position of the device 1 Insert the upright brackets into the guides located on the lower housing of the device NOTE Upright brackets are fully reversible and can be used on the right or left guide with the same feature Locking Ring ...

Страница 36: ...ce the device on its upright brackets to use it on the vertical position CAUTION Make sure to push the upright brackets until the contact with the lower housing to ensure good support for the device Be sure to check the positioning of the upright brackets after moving the device ...

Страница 37: ...er WARNING Ensure that the power cord does not pose a tripping or choking hazard Ensure that the home AC mains supply and connections are safe and comply with the applicable regulations Ensure that the device and its power charger are placed in a way that allows an easy disconnection from the mains To connect to mains power 1 Connect the DC plug of the supplied external power supply unit to the re...

Страница 38: ...ended periods will accelerate battery ageing This will not affect the safety of the battery or the device The internal battery of the EO 70 allows your SMD device to operate even when mains power is disrupted or when the device is not connected to the mains When the EO 70 is operating on internal battery power you are notified of the level of charge in the battery by the battery power source indic...

Страница 39: ...d be 100 2 Turn off the device 3 Remove the power cord from the device Travelling with EO 70 The EO 70 must be transported in its transport bag WARNING The EO 70 device should not be operated while in the Transport CAUTION Do not place any heavy or bulky objects in the zippered pocket on the inside front of the bag This could result in damage to the touch screen Chapter 4 Alarms indicator The EO 7...

Страница 40: ... such as Microzid sensitive liquid from Schülke or WILAsil from WILAmed For other product usage please contact our customer service Warning Proper cleaning and maintenance of your EOVE device is essential Cleaning described in this section should be carried out regularly Refer to the user guides of any accessories in use for detailed instructions specific to those devices Maintenance Method Freque...

Страница 41: ...sensitive liquid from Schülke or WILAsil from WILAmed The following basic products could be used IPA Iso Propyl Alcohol Ethanol 70 Hydrogen peroxyde Chlore 1000 ppm For other product usage please contact our customer service It is important to avoid the spilling of liquid on the electrical connector of the device User must ensure that the disinfectant is dry before turning on the device It is poss...

Страница 42: ...ice will provide safe and reliable functioning for 10 years provided that it is operated and maintained in accordance with the instructions given in this manual As with all electrical devices if any problem arises with your EO 70 device you should exercise caution and have it inspected by an authorized EOVE technician Servicing schedule from the date of first use Recommended Service Conducted by I...

Страница 43: ... Slope 3 Inh Time 3 s Trigger off Pause 1 s Peep 4 cmH2O Exh Pressure 30 cmH2O Exh Time 2 s Insp Oscillations I on Amp 2 Freq 10 Hz Exp Oscillations OFF In these conditions with a 22 mm tubing and a test lung Compliance 20 mL mbar Resistance 20 mbar L s Max volume 1000 mL monitoring should be the following Tidal Volume 700 ml 140 ml Peak Flow 125 l min 25 l min ...

Страница 44: ...on The Auto Mode delivers the therapy accordingly to the settings of Inhalation Pressure Exhalation Pressure Inhalation Time Exhalation Time Pause Time PEEP and Rise Time The therapy delivered will follow the sequence below for the Number of Cycles set or until the user stops the therapy PEEP if set during the Pause Time Inhalation Pressure during the Inhalation Time Exhalation Pressure during the...

Страница 45: ...tion Fall and Inhalation Trigger The therapy delivered will follow the sequence Inhalation flow during inhalation Exhalation Fall and PEEP during exhalation During the inhalation phase the device delivers the Inhalation Flow until the device reaches one of the two limits Pressure Max or Inhalation Max Time When Inhalation Slope is ON the device will decrease the Inhalation Flow as pressure is incr...

Страница 46: ...9 s Exhalation Time E Time 0 to 9 9 s Pause Time P Time 0 to 99 9 s SpO2 0 to 100 Heart Rate 0 to 300 bpm Peak Exhalation Flow 0 to 300 l min Rate 0 to 99 9 bpm A monitored value displayed as means that the measurement is not available or invalid Accuracy of monitoring data Inspired volume 10 ml 10 Time 0 2 s Peak Flow 5 l min 15 SPO2 according to manufacturer specifications Heart Rate according t...

Страница 47: ...7 A max Environmental Specifications Storage and transport conditions Ambient temperature From 20 C to 60 C Relative humidity From 10 to 95 non condensing Waiting time before usage after storage at extreme temperatures min or max 2 hours Operating conditions Ambient temperature From 5 C to 35 C after conditioning at 23 for 20 minutes Relative humidity From 10 à 95 non condensing Atmospheric pressu...

Страница 48: ...ts for medical electrical systems Any person undertaking this kind of addition shall be responsible to ensure that all requirements are complied with It is important to note that local laws take priority over the above mentioned requirements If in doubt consult an EOVE representative or the technical service department Interference may occur in the vicinity of equipment marked with the following s...

Страница 49: ... kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode For home health care environment and a professional health care establishment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 Ut for 0 5 cycle With 0 45 90 135 180 225 270 et 315 0 Ut for 1 cycles 70 Ut for 25 cycles at 50 Hz 0 Ut For 30 cycles at 60 Hz Monophased at ...

Страница 50: ...sional health care establishment Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 6 V in ISM band and from 0 15 MHZ to 80 MHZ amateur radio band included 80 MA at 1 KHz 6 Vrms 150 kHz to 80 MHz 6 V in ISM band and from 0 15 MHZ to 80 MHZ amateur radio band included 80 MA at 1 KHz For home health care environment and a professional health care establishment Electromagnetic fields Radiated RF IEC...

Страница 51: ...sional health care establishment Recommended separation distance EO70 device must be used in an electromagnetic environment in which the perturbations due to RF are controlled The user or installer of the device can help to prevent any electromagnetic interference by maintaining a minimum distance depending on RF emitter maximum power Portable RF devices included cables and antennas must not be us...

Страница 52: ...al requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances Requirements and tests IEC 60601 1 6 Medical Electrical Equipment Part 1 6 General requirements for basic safety and essential performance Collateral Standard Usability CEI 60601 1 11 General requirements for basic safety and essential performance Collateral standard Requirements for medical...

Страница 53: ... use of the Product Whatever the claim on the quality of the Product made by the Purchaser the latter remains liable for paying the corresponding amounts on their due date The condition of the supplied Products must be verified by the Purchaser upon receipt As such any claim from the Purchaser based on the quality of the Product must be made by written notice within THREE 3 days from the discovery...

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