MONIVENT Neo100 User Manual
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MONIVENT Neo100 User Manual

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Monivent Neo100
User Manual
N100-SY

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Summary of Contents for MONIVENT Neo100

  • Page 1 Monivent Neo100 User Manual N100-SY...
  • Page 3 Regnbågsgatan 8B info@monivent.se 417 55 Göteborg, Sweden www.monivent.se Trademark Monivent® is a registered trademark of Monivent AB, Sweden. Declaration of Conformity Monivent Neo100 conforms to European Medical Directive 93/42/EEC and meets applicable health, safety and 0402 environmental requirements. The number in conjunction with the CE-mark, is the identification number of the notified body involved in the conformity assessment procedure.

  • Page 4: Table Of Contents

    Table of Content 1. Introduction ................4 1.1 Intended use ....................4 1.2 Information for safe use ................4 1.3 Information for effective use ..............4 1.4 Contraindications ..................5 1.5 System overview ..................... 5 1.6 Principles of operation ................7 2.
  • Page 5 5. Service and support ............29 5.1 Warranty ...................... 29 5.2 Service life ....................29 5.3 Service ......................29 5.4 Troubleshooting ..................30 6. Symbols Used ..............31 7. Specifications ..............32 8. Safety and compliance ............34 9. Technical Description ............35 10.

  • Page 6: Introduction

    1. Introduction The Monivent Neo100 is a monitoring device designed to provide continuous, real-time feedback and guidance on several parameters, to support the gentle and effective ventilation of newborns in need of respiratory support at birth. The system shall be used to support decisions and as an adjunct to the established assessments of neonatal resuscitation.

  • Page 7: Contraindications

    1.4 Contraindications • Monivent Neo100 is only intended for short-term use and is not intended for continuous monitoring. • Monivent Neo100 shall not be used on patients other than newborns. 1.5 System overview The Monivent Neo100 system comprises of a Monitor (display and charger) and Sensor Modules integrated into a single-use Sensor Mask or Mask Adapter.
  • Page 8 WARNING – Only use Monivent AB original parts or connecting parts that have been specified as compatible with the system supplied by Monivent AB. WARNING – If Monivent Neo100 is to be used with a humidifier, the following conditions should be met: •...

  • Page 9: Principles Of Operation

    1.6 Principles of operation The Sensor Mask and Mask Adapter has a fixed constriction that generates a differential pressure relative to the flow through the Sensor Mask or Mask Adapter. The Sensor Module measures the differential pressure during ventilation and converts it to flow from which the tidal volume is calculated.

  • Page 10: Setup

    2. Setup 2.1 Delivery items The Monivent Neo100 system is supplied in a box containing the following items: • User Manual • Monitor • Power supply • Sensor Modules (3 pcs) • Sensor Mask Starter Kit • Screws for mounting the Monitor •...

  • Page 11: Setting Up

    2.2 Setting up The Monitor should be mounted adjacent to a resuscitation table intended for stabilization of newborns, using the standard VESA MIS-D (75 × 75 mm) mount interface. Mounting screws are provided for connector of choice. Connect the Monitor to a power outlet using the power supply provided.

  • Page 12: Charging The Sensor Modules

    2.3 Charging the sensor modules Place the Sensor Modules in the charger. Whilst the Sensor Modules are in the charger, the LED will indicate charging status: • Charging – Pulsing red-green • Fully charged – Steady green Full charging takes a maximum of 3 hours. The battery life of the Sensor Module during use is at least 1 hour.

  • Page 13: System Configuration

    An example using the set format is presented under the regional format drop-down. Set date, time and time zone Set the time zone where the Monivent Neo100 is located. Set the date and time to the current date and time.

  • Page 14: Functionality Check

    Set tidal volume target Tidal volume target should be set according to hospital guidelines. Measured volumes within the target range will be indicated by a green color on the cylindrical display and green LED on the Sensor Module. The green color is used to guide the operator in delivering appropriate tidal volumes.

  • Page 15: Usage

    3. Usage 3.1 Stand-by mode The Monitor should be connected to a power outlet using the power supply provided and left on at all times. Display brightness is reduced while in stand-by. The Sensor Modules should be placed in the charger when not used, otherwise batteries may deplete and the device may be unavailable for use.

  • Page 16: Start New Feedback Session

    3.3 Start new feedback session To initiate a new session, follow the steps below: Remove a Sensor Module from the charger and attach to a Sensor Mask of appropriate size. If the Sensor Module is pre-assembled with a Sensor Mask, remove the Sensor Module and Sensor Mask assembly from the charger.
  • Page 17 WARNING – The Sensor Mask needs to be exchanged if there is blood, vomit or meconium in the flow path of the Sensor Mask, to reduce the risk of incorrect measurements. NOTE – Monivent Neo100 is used for guidance. Clinical judgement shall be used for regular assessment of the patient's condition.

  • Page 18: Feedback View

    3.4 Feedback view Selected weight Message Elapsed time Message/-s Some specific warning text that can span sev- Quit session 2500g 00:00 eral lines if its really, really, really necessary, or maybe we have many errors? LEAK Upper and lower limit of PEEP RATE tidal volume...
  • Page 19 Feedback on ventilation The feedback view displays the following ventilation parameters in real time. Displayed parameter Abbreviation Unit Expiratory Tidal Volume mL/kg Peak Inspiratory Pressure Mask leakage LEAK Percent % Ventilation rate RATE Ventilations/minute Positive End-Expiratory Pressure PEEP All parameters are updated simultaneously on the display immediately after a ventilation cycle is registered.

  • Page 20: Disconnection During Procedure

    Too high leakage High mask leakage may affect tidal volume measurement accuracy with an underestimation of the value. High leakage is indicated by: • flashing leakage value in red 2500g 00:00 Reduce leakage • tidal volume cylinder and value in gray LEAK •...

  • Page 21: Led On Sensor Module

    3.6 LED on Sensor Module During ongoing session LED on Sensor Module Description Flashing blue Waiting to connect to Monitor Steady blue Connected, awaiting weight Connected and inactive (if another Sensor Module active) Steady white No new ventilation detected during the last 5 seconds Steady green VTe within target range...

  • Page 22: Messages In Feedback View

    3.8 Messages in feedback view Messages displayed during an ongoing session appear next to the symbol on the top of the display. Message Description and recommended use action Flashing High leakage may cause reduced volume Reduce leakage red/green/ measurement accuracy. Reduce leakage by orange changing mask position or mask size.

  • Page 23: Compromised Measurement Accuracy

    3.9 Compromised measurement accuracy In certain situations, the accuracy of a measured parameter may be compromised. This is indicated as follows: 2500g 00:00 Volume accuracy compromised If measurement accuracy for tidal volume is LEAK reduced, tidal volume cylinder and value are displayed in gray.

  • Page 24: Configuration Menu - Change Tidal Volume Target

    3.10 Configuration menu – Change tidal volume target Go to the CONFIGURATION menu via the CONFIGURATION symbol on the start screen. Use the + and − Tidal volume target Sensor Modules Paired Non-paired symbols to change the upper and lower limit of ADA-053 ADA-050 8 mL/kg...

  • Page 25: Sensor Modules Menu

    Battery capacity reduced. Sensor Module is defective. removed from charger. The flow check provides Please contact local distributor Please contact local or Monivent AB. distributor or Monivent AB. the possibility to test the flow measurement Flow check Measured air flow L/min L/min L/min functionality (see section "4.6 Functionality...

  • Page 26: Other Messages

    3.13 Other messages Defective Sensor Module The Sensor Module is defective and needs to be replaced with another Sensor Module. The Sensor Module defective. Replace. message will disappear once connection is established to a new Sensor Module. Communication error Ensure the USB cable is properly mounted. If Communication error.

  • Page 27: Maintenance

    4. Maintenance 4.1 Cleaning and disinfection Sensor Masks and Mask Adapters Sensor Masks and Mask Adapters are designed for single use only. Dispose of single use items in accordance with local practices. Do not attempt to clean or reuse. WARNING – Do not reuse the Sensor Mask or Mask Adapter. Cleaning and sterilizing may affect the measuring function causing measurement error.

  • Page 28: Disposal

    Cleaning Monitor 1) Clean all outer surfaces of the Monitor with sanitizing wipes or a lightly damp cloth with cleaning agent. 2) Using disinfectant – wipe all outer surfaces of the Monitor and charger and let dry according to instructions from the manufacturer of the disinfectant. 3) To clean inside the cavities of the charger, remove the USB cable from the display and remove the Sensor Modules.

  • Page 29: Storage

    4.4 Storage To store the Monivent Neo100 system, turn the Monitor off and unplug the power supply. The Sensor Modules will turn off automatically. Charge the Monitor and Sensor Modules for at least one hour before use after storage. 4.5 Parts and accessories...

  • Page 30: Functionality Check

    4.6 Functionality check Monivent AB recommends annual testing of the Monitor and Sensor Modules for continued suitability using the following list in line with local guidelines for maintenance of equipment used in the same environment. Steps Expected Results Remove all Sensor Modules from...

  • Page 31: Service And Support

    Monivent warrants the supplied product and accessories against defects in materials and workmanship for one (1) years from the date of purchase, when used and handled according to user instructions. Monivent’s warranty does not cover normal wear and tear or damage caused by accident, misuse or negligence.

  • Page 32: Troubleshooting

    Sensor Modules. See section "3.11 Module does not show up in the Configuration menu – Pair Sensor Modules" for available list. more info. Sensor Module defective. If issue remains, contact Sensor Module flashing in red. your local distributor or Monivent AB.

  • Page 33: Symbols Used

    6. Symbols Used CE-mark and notified body identification number 0402 Consult instructions for use Number of pieces in package Manufacturer Do not re-use Use-by date Catalogue number Batch code Serial number Use with specified adapter Non-ionizing electromagnetic radiation Dispose of waste electrical and electronic equipment according to WEEE Directive Alternating current Direct current...

  • Page 34: Specifications

    Accuracy: ± 1 mL or 10 % of reading Monivent Neo100 is calibrated on breathing gas containing 20% oxygen. Using higher concentrations of oxygen will make the system over estimate volumes up to 10%. PIP – Peak Inspiratory Pressure (cmH...
  • Page 35 Sensor Module specifications Battery type LiPo Battery life > 1 hour Sensor Mask / Mask Adapter specifications Sensor Mask sizes 40 mm, 52 mm, 66 mm (outer diameter) Flow Resistance < 500 Pa at 250 mL/s Connection interface ISO 5356-1 15 mm male connection Added deadspace <...

  • Page 36: Safety And Compliance

    (e.g. unshielded intentional RF sources), as these can interfere with the proper operation. The only power supply and cable to be used with the Monivent Neo100 is the power supply manufactured by Adapter Tech (part number ATM036T-A150), supplied by Monivent AB as part of the Monivent Neo100 system.

  • Page 37: Technical Description

    Guidance and manufacturer’s declaration – electromagnetic emissions The Monivent Neo100 is intended for use in the electromagnetic environment specified below. The customer or the user of the Monivent Neo100 should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 38 Guidance and manufacturer’s declaration – electromagnetic immunity The Monivent Neo100 is intended for use in the electromagnetic environment specified below. The customer or the user of Monivent Neo100 should ensure that it is used in such an environment. Immunity test...
  • Page 39 Guidance and manufacturer’s declaration – electromagnetic immunity The Monivent Neo100 is intended for use in the electromagnetic environment specified below. The customer or the user of the Monivent Neo100 should ensure that it is used in such an environment. Immunity test...
  • Page 40 If the measured field strength in the location in which the Monivent Neo100 is used exceeds the applicable RF compliance level above, the Monivent Neo100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Monivent Neo100.

  • Page 41: Third Party Licences

    10. Third party licences Micro-ecc license Copyright (c) 2014, Kenneth MacKay. All rights reserved. This software is provided by the copyright holders and contributors “as is” and any express or implied warranties, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose are disclaimed.

  • Page 42: Notes

    Notes ................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
  • Page 43 ..........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
  • Page 44 ..........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
  • Page 45 Supporting Gentle Ventilation of Newborns.

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N100-sy

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