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Table of Contents
Related Manuals for ARCHEON EOlife
Summary of Contents for ARCHEON EOlife
- Page 1 US INSTRUCTIONS FOR USE...
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Page 3: Table Of Contents
2. EOlife® device information screen........ -
Page 4: Symbols Used On Product Labelling
I. Symbols used on product labelling Symbol Definition Manufacturer’s lot number Part number Serial number Medical device Quantity CE marking Warning Manufacturer Date of manufacture Use by date Ingress protection against : • Intrusion of solid objects larger than 1 mm IP44 •... -
Page 5: Conditions Of Use
Only use the EOlife® device and its accessories if they do not show any visible damage ▶ The EOlife® device, its battery, its charger and the FlowSense® sensor must be stored and used as described in the instructions for use (see “IX Technical data”) - Page 6 ▶ Using a battery with a low charge at temperatures below 0°C (32 °F) greatly reduces the run time and can cause EOlife® to stop functioning after a short time If the device is used at low temperatures, the battery should be fully charged ▶...
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Page 7: Product Description
The ventilation interface and the self-inflating bag are accessories not supplied by ARCHEON Note Inlet and outlet ports of the device are compliant with the international standard EN/ISO 5356-1 EOlife® is then compatible with all type of ventilation interface and self-inflating bag... -
Page 8: Equipment
The equipment can be ordered from approved distributors VII. Quick start guide of the device This section gives a short step-by-step description of how to use the EOlife® device There is a more detailed description in the next section, “VIII Detailed product description and operating instructions”... - Page 9 ▶ Vt = tidal volume Ventilate the patient in ▶ Freq = ventilation frequency cardiopulmonary arrest for as long as necessary ▶ See “VIII 1 b) EOlife® Bar graph ventilation method” and “VIII 1 c) Visual signal” Visual signal display area Main screen Switch off EOlife®...
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Page 10: Detailed Product Description And Operating Instructions
FlowSense® is factory calibrated Once removed from its packaging FlowSense® is ready to be used Connect the FlowSense® sensor to the EOlife® unit, taking care not to expose the printed circuit board to dust or splash it with water First insert the part of the FlowSense®... -
Page 11: B) Eolife® Ventilation Method
EOlife® ventilation method EOlife® gives the user real-time feedback on the quality of the ventilation performed on the patient based on a cyclic analysis of inspiratory and expiratory flow rates It must therefore be positioned proximally to be able to... - Page 12 Medium 30 : 2 Rotate Freq. 420 mL 390 mL 11/min Good Ventilation Main screen Displays the patient’s height selected and quick access key to change the patient’s height 2. Displays the chosen ventilation mode and quick access key to change the ventilation mode 3.
- Page 13 ▶ Display in continious mode : In continuous ventilation mode, EOlife® generates a visual countdown to show the user when to ventilate to deliver 10 ventilations per minute When the green lung is displayed, the user must ventilate the patient ▶...
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Page 14: C) Visual Signals
9. Visual signal display area : • “Good ventilation” all the ventilation parameters calculated are within the appropriate range of values as defined in the international guidelines • “Insufficient volume” the volume of air insufflated to the patient is significantly lower than the values given in the international guidelines •... - Page 15 ▶ The ventilation frequency (Freq ) : Visual signal Ventilation frequency value Solution conditions Low frequency No insufflation during 9 seconds (continuous mode) Ventilate the patient at an appropriate frequency, as Low frequency No insufflation during 24 seconds recommended in the international (30 : 2 mode) guidelines High frequency...
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Page 16: D) Automatic Shutdown
EOlife® device failure If there is an EOlife® device failure or a loss of essential performances, the red LED in the top left of the screen comes on This red LED indicates a failure whatever the state of the device (on or off) Warnings Do not use the EOlife®... -
Page 17: Cleaning And Maintenance
Charging the battery Recharging the EOlife® battery : Note The battery must be removed from the EOlife® unit before recharging Turn off the device before battery removal 2. Plug the jack on the charger cable provided into the battery... -
Page 18: B) Cleaning Eolife® And Its Accessories
The FlowSense® sensor is a single-use component of EOlife® (see “VIII d) Disposal”) ▶ Electronic control unit and removable battery The electronic control unit and the removable battery are reusable EOlife® parts that must be cleaned after each use to avoid cross-contamination Caution The EOlife®... -
Page 19: C) Storing Eolife
(see “IX Technical data”) d) Disposal At the end of the EOlife® device’s lifetime (lifetime of the various parts specified in “IX Technical data”), it should be disposed of as follows: The EOlife® electronic control unit, battery and charger contain electronic components and must be disposed... -
Page 20: Technical Data
IP rating for protection against electric shock IP rating for protection against solids, IP44 (in use configuration, i e , EOlife®, its battery and FlowSense® connected) dust and ingress of water Electromagnetic compatibility The control parameters and threshold values can be obtained from the... -
Page 21: Technical Data Related To The Power Supply
ISO 10993-1: 2018 Under normal conditions of use, EOlife® must provide a reactive user interface (ex: bar graph in real time, no freeze of the screen) EOlife® must displays Essential performance requirements measured values (insufflated volume and ventilation frequency) without deviation Volume measurements are based on FlowSense®... -
Page 22: Technical Data Related To Consumable Flowsense
4. Technical data related to electromagnetic compatibility (EMC) Manufacturer statement and guidance - Electromagnetic interference EOlife® is designed to operate in an electromagnetic environment as defined below The user should ensure that the device is used in such an environment... - Page 23 RMF EOlife® has been tested for immunity to the radio services listed below If the field strength measured on the site where EOlife® is used exceeds the level of compliance below, it is advisable to monitor EOlife® to ensure that it is functioning properly If this is not the case, it may be necessary to take additional measures, such as changing the direction or location of EOlife®...
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Page 24: What To Do In The Event Of An Incident
X. What to do in the event of an incident If there is a persistent problem or a major adverse event occurs when using EOlife® (e g battery problem or sudden device failure), ask your approved distributor what procedure to follow and/or contact the manufacturer ARCHEON at this address: product-request@archeon-medical com Any incident occurring with the EOlife®... - Page 26 AUS00057-Rev05-21MAR2023...
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