MONIVENT Neo100 User manual

Monivent Neo100
User Manual
N100-SY
EN


Monivent AB
Regnbågsgatan 8B
417 55 Göteborg, Sweden
[phone]
[email protected]
www.monivent.se
Monivent Neo100 conforms to European Medical Directive
93/42/EEC and meets applicable health, safety and
environmental requirements. The number in conjunction with

involved in the conformity assessment procedure.
Manufacturer
Declaration of Conformity
Trademark
Monivent® is a registered trademark of Monivent AB, Sweden.
© Copyright Monivent AB 2022. All rights reserved.
Document number: REG-0232
Document version: 8.0
Date of issue: 2022-05-10
0402

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
 ........................................................................
................................................................................................... 
 ............................................................................. 
..................................................................... 
 ........................................................................................ 
............................................................................................. 
............................................................................... 
.....................................................................................
 ................................................................................................ 
...................................................................................................... 
...................................................................
 ................................................................................ 
....................................................................................
 .................................................................................. 
...............................................................................................
...........................................
 .......................................................................
 ...............................................................................................
.............................................................
................................................................................
.................................................................................
......................................................................... 
 ......................................................
 ............................. 
 ........................................ 
 .............................................................................. 
 ......................................................................................... 
 ...................................................................... 
 ......................................................................... 
 ....................................................................................................... 
 ..................................................................................................... 
 ........................................................................................................
.................................................................................
................................................................................... 

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 .......................................................... 
 ...................................................................................................... 
 .................................................................................................. 
.......................................................................................................... 
........................................................................................ 
 ..................................................................... 
..................................................................... 
 ....................................................... 
 ....................................................... 
 ......................................................... 
............................................................................................. 
......................................................................................



The Monivent Neo100 is a monitoring device designed to provide continuous, real-time

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.

The Monivent Neo100 is intended to provide guidance on expiratory tidal volume
and monitoring of peak inspiratory pressure, positive end-expiratory pressure, mask
leakage and ventilation rate, during treatment of newborns in need of ventilation using
a bag resuscitator or T-piece resuscitator. The system is intended for use by medically


Throughout the manual, important information for a safe use of the product is

WARNING
avoided, could result in death or serious injury.
CAUTION
avoided, could result in minor or moderate injury.

NOTE




• 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.

The Monivent Neo100 system comprises of a Monitor (display and charger) and
Sensor Modules integrated into a single-use Sensor Mask or Mask Adapter. The system
enables wireless measurement of ventilation parameters through the Sensor Mask and
integrated Sensor Module.
The Monivent Neo100 system is an add-on to existing equipment used for manual


Mask Adapter
Monitor
(display and charger)


The Monitor displays Expiratory Tidal Volume (VTe) graphically and numerically,


also incorporates the charger for the three Sensor Modules which are connected
magnetically. The touch screen is operable with disposable gloves.



 face masks
other than Monivent's Sensor Masks, a Mask Adapter must be
inserted between the endotracheal tube/face mask and the
bag or T-piece resuscitator. The Mask Adapter is compatible


diameter of 7 mm.
The Sensor Mask and Mask Adapter form part of the
measuring unit together with the Sensor Module. The Sensor
Mask and Mask Adapter are single use to ensure measurement accuracy and to avoid

Sensor Module from potential contaminants.
WARNING

WARNING
conditions should be met:
• 
• 
Adapter prior to commencing ventilation
• 
• 
• 
instructions for use to reduce condensation forming in the breathing
circuit

accuracy.






from which the tidal volume is calculated. An algorithm detects the beginning and
end of each ventilation cycle and calculates the ventilation parameter values. The






The Monivent Neo100 system is supplied in a box containing the following items:
• 
• Monitor
• 
• Sensor Modules (3 pcs)
• 
• Screws for mounting the Monitor
• Stickers with the Sensor Modules' serial numbers
(can be placed on charger if needed)

and 
• 2 × Sensor Mask 40
• 2 × Sensor Mask 52
• 2 × Sensor Mask 66
• 3 × Mask Adapter
The Sensor Masks are made of silicone and polypropylene and are latex free. The Mask
Adapter is made of polypropylene.