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

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

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



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.



The Monitor should be mounted
adjacent to a resuscitation table


mm) mount interface. Mounting screws
are provided for connector of choice.
Connect the Monitor to a power outlet
using the power supply provided.

charger and the display is properly
connected.


Switch the Monitor on by pressing the
power button at the top of the display











indicate charging status:
• 
• 

use is at least 1 hour.

Sensor Masks.
CAUTION





and tidal volume target.

Set the language from options in a droplist.


button until the language setup screen appears.

Set the region by selecting an option in the
drop-down list. The region represents where the
Monivent Neo100 system is located.
Set the regional format. The regional format will
control how dates and numbers are presented.
An example using the set format is presented
under the regional format drop-down.


located. Set the date and time to the current date
and time.
.....



Tidal volume target should be set according to
hospital guidelines. Measured volumes within
the target range will be indicated by a green

on the Sensor Module. The green color is used to
guide the operator in delivering appropriate tidal
volumes.

The upper and lower limits of the tidal volume target need to be set before proceeding


menu.

The Sensor Modules need to be paired to the Monitor, to enable connection and data
transmission. See further instructions on how to pair Sensor Modules in section "3.11



procedure for a new system.




The Monitor should be connected to a power outlet using the power supply provided

Modules should be placed in the charger when not used, otherwise batteries may
deplete and the device may be unavailable for use.



Mask Adapter then push the Sensor Module in and turn clockwise until it stops.
The system is designed to allow Sensor Modules and Sensor Masks or Mask Adapters to
be pre-assembled prior to use, when placed in the charger.
1 2 3 4
NOTE

cause a minor leakage in the system.



To initiate a new session, follow the steps below:
Remove a Sensor Module from the charger
and attach to a Sensor Mask of appropriate


with a Sensor Mask, remove the Sensor
Module and Sensor Mask assembly from the
charger.
The newborn's weight can be entered


Connect the Sensor Mask and Sensor
Module assembly to a bag or T-piece
resuscitator.
Apply the mask, covering the nose and
mouth of the newborn, without covering
the eyes or overlaping the chin, to make a

Begin ventilation in accordance to local,
clinical guidelines.

ventilation started, the clock starts counting







session.
GO
Enter estimated weight of the newborn in

Enter patient weight
123
456
789
0
_ _ _ 5 g
OK

automatically changes to the feedback
view.
%
16
cm
H
2
O
24
/min
61
cm
H
2
O
5
VTe
01:152500g
8
4
5mL/kg
ADA-053
LEAKPIP
RATEPEEP
WARNING 

measurements.
NOTE
for regular assessment of the patient's condition.






00:00
VTe
2500g Some specific warning text that can span sev-
eral lines if its really, really, really necessary,
or maybe we have many errors?
%
100
cm
H2O
100
/min
150
cm
H2O
1
8
4
5
mL/kg ADA-053ADA-050ADA-825
LEAKPIP
RATEPEEP
 Message Elapsed time
Quit session

not activated
Expiratory tidal volume
(VTe) in mL/kg
Active



tidal volume
target
Message/-s
Battery status



an icon is displayed with the corresponding serial number in the lower right corner. The
icon for the activated Sensor Module is highlighted with a white border. To make one of
the other available Sensor Modules active, touch the corresponding icon.

NOTE 



corner in feedback view.



The feedback view displays the following ventilation parameters in real time.
Displayed parameter Abbreviation Unit
Expiratory Tidal Volume VTe 
  cmH2
Mask leakage  
Ventilation rate RATE Ventilations/minute
  cmH2

ventilation cycle is registered.
Tidal volume guidance
The expiratory tidal volume (VTe) is presented both graphically and numerically, in





8
4
11 mL/kg
VTe
2500g
%
6
cm
H
2
O
31
/min
48
cm
H
2
O
4
00:00
ADA-053
LEAKPIP
RATEPEEP
00:00
8
4
2
mL/kg
VTe
2500g
%
94
cm
H2O
9
/min
74
cm
H2O
0
ADA-053
LEAKPIP
RATEPEEP
%
16
cm
H2O
24
/min
61
cm
H2O
5
VTe
01:152500g
8
4
5
mL/kg ADA-053
LEAKPIP
RATEPEEP
The graphical cylinder has a maximum displayed value at 2× the upper limit of the tidal

will be graphically displayed as a full cylinder.


Too high leakage

underestimation of the value. High leakage is indicated by:
• 
• tidal volume cylinder and value in gray
• 
red/green/orange
• message "Reduce leakage" appearing on
the display.

WARNING 


information can no longer be updated on the
display.


the tidal volume corresponds to the target,
keep ventilating and connection will be
re-established.


ventilation.
VTe
2500g
%
75
cm
H2O
41
/min
55
cm
H2O
3
00:00
ADA-053
8
4
5
mL/kg
LEAKPIP
RATEPEEP
Reduce leakage
8
4
--
mL/kg
VTe
2500g
%
--
cm
H2O
--
/min
--
cm
H2O
--
00:00
LEAKPIP
RATEPEEP
No Sensor Module available