ACUTRONIC MONSOON User manual
MONSOON
UNIVERSAL JET VENTILATOR
Instructions for Use
Version 5.6e
This manual only applies to:
monsoon with software Version: 1.15 or higher
Instructions for use MONSOON 5.6e
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Manufactured by:
ACUTRONIC Medical Systems AG
Fabrik im Schiffli
8816 Hirzel / Switzerland
Phone: +41 44 729 70 80
Fax: +41 44 729 70 81
e-mail:[email protected]
www.acutronic-medical.ch
0124
Instructions for use MONSOON 5.6e
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TABLE OF CONTENTS
TABLE OF CONTENTS .................................................................................................................................................3
FOR YOUR SAFETY AND THAT OF YOUR PATIENTS........................................................................................................5
Read Instructions for Use...................................................................................................................................................5
Safety Notices......................................................................................................................................................................5
Maintenance.........................................................................................................................................................................7
Accessories..........................................................................................................................................................................8
Safe Use ................................................................................................................................................................................8
Liability for Proper Function and Damage .......................................................................................................................8
Medical Purpose..................................................................................................................................................................9
Contraindications.................................................................................................................................................................9
Indications for Use.............................................................................................................................................................10
Ventilation Modes..............................................................................................................................................................11
Maintenance Intervals, Batteries ...................................................................................................................................12
Contents...............................................................................................................................................................................13
USER INTERFACE .....................................................................................................................................................14
Front View / Connectors ...................................................................................................................................................14
Control Panel Overview ....................................................................................................................................................15
Main Unit Overview...........................................................................................................................................................16
Display - Single Jet............................................................................................................................................................17
Display - Double Jet ..........................................................................................................................................................18
MONSOON ..............................................................................................................................................................19
PRESSURE LIMITS ...................................................................................................................................................20
PIP Limit (Respiratory Tract Pressure)...........................................................................................................................20
PP Limit (Pause Pressure)................................................................................................................................................20
Superimposed Pressure Limit (Superimposed Ventilation)........................................................................................20
START-UP ...............................................................................................................................................................21
Apparatus Preparation......................................................................................................................................................21
Check P-Pressure and PIP Safety Limits.......................................................................................................................22
Using the MONSOON with Single Lumen Catheter......................................................................................................23
OPERATION .............................................................................................................................................................24
Parameter Settings............................................................................................................................................................24
Menu ....................................................................................................................................................................................24
Superimposed Pressure Limit (SIPL)..............................................................................................................................25
Double Jet (Optional).........................................................................................................................................................25
Bypass .................................................................................................................................................................................26
Humidification.....................................................................................................................................................................26
Preparation ...................................................................................................................................................................27
Dehumidification ..........................................................................................................................................................28
Settings................................................................................................................................................................................29
Language.............................................................................................................................................................................29
Maintenance.......................................................................................................................................................................29
Disconnection.....................................................................................................................................................................30
Laser Application...............................................................................................................................................................30
etCO2– Measurement (Optional).....................................................................................................................................31
Video Camera (Optional)...................................................................................................................................................32
Remote Control (Optional) ................................................................................................................................................33
Automatic – Manual Operating Mode............................................................................................................................34
CLINICAL APPLICATIONS .........................................................................................................................................35
Patient Data ........................................................................................................................................................................35
CPAP Ventilation Set for MONSOON .............................................................................................................................36
Infraglottic Catheter Jet Ventilation ...............................................................................................................................38
Supraglottic (Catheterless) Jet Ventilation ...................................................................................................................39
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Rigid Bronchoscopy ..........................................................................................................................................................40
Infraglottic Jet Ventilation................................................................................................................................................40
Transtracheal Jet Ventilation ..........................................................................................................................................41
ALARMS AND ERROR CODES ...................................................................................................................................42
Patient Alarms....................................................................................................................................................................43
System Alarms....................................................................................................................................................................44
Notices.................................................................................................................................................................................47
ACCESSORIES..........................................................................................................................................................49
TREATMENT,DISINFECTING /CLEANING .................................................................................................................51
ABBREVIATIONS AND SYMBOLS..............................................................................................................................52
ABOUT ELECTROMAGNETIC COMPATIBILITY.............................................................................................................53
TECHNICAL SPECIFICATION .....................................................................................................................................57
Settings and Ranges..........................................................................................................................................................57
Dimensions..........................................................................................................................................................................57
Connections / Ports ...........................................................................................................................................................57
Environmental Conditions.................................................................................................................................................58
Disposal...............................................................................................................................................................................58
Rear View / Connections ..................................................................................................................................................59
Replacing Fuses .................................................................................................................................................................60
TABLE OF FIGURES...................................................................................................................................................61
Instructions for use MONSOON 5.6e
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FOR YOUR SAFETY AND THAT OF YOUR PATIENTS
Read Instructions for Use
Any use of this apparatus requires full understanding and strict observation of these instructions for
use.
This apparatus is only to be used for purposes specified here.
Safety Notices
Always observe
Any use of the ventilator requires full understanding and strict observation of these
instructions. The apparatus is only to be used for purposes specified here.
The ventilator is only to be operated by qualified technical staff or under their su-
pervision to immediately provide assistance in the event of malfunction.
If the new value is not confirmed by the operator by pressing the rotary pulse en-
coder or the touch monitor the value will automatically be reset after a few se-
conds.
Always have an alternate ventilation system (e.g. resuscitation bag) when using the
ventilator.
If the life support function can no longer be ensured due to an obvious ventilator
defect, immediately provide artificial ventilation to the patient via a self-contained
ventilator (e.g. resuscitation bag).
Never use the ventilator together with flammable gas or
Anaesthetics – acute fire and explosion hazard!
Do not use the ventilator in explosion-risk areas!
An audible sound indicates a system or patient alert and always requires action by
medical staff.
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An audible alarm will sound in the event of power failure. Resetting the alarm re-
quires the on/off switch to be pressed.
Never use the ventilator on patients when a fault is detected during equipment
check!
Do not connect to electrical devices not specified in this manual without consulting
the manufacturers or an expert professional.
Never cover the ventilator or position in a way which will negatively impact opera-
tion or function.
Always unplug before opening the housing!
Never use mobile phones within 10 metres of the ventilator. Mobile phones may
interfere with the performance of electromedical equipment.
Never use antistatic or electroconductive tubes.
Note: the absence of e.g. allergy stimulating or genetically harmful substances, e.g.
Phthalates, in our products ensures user safety and health.
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Maintenance1
MONSOON is a Universal Jet ventilator classified as device group IIb according to European di-
rective.
1.) The apparatus must be safety inspected and serviced at regular 6 months intervals in
compliance with the manufacturer instructions as well as §6 MPBetreibV Medical Devices Opera-
tor Ordinance dated 6/29/1998.
2.) Service must be performed by professionals trained by ACUTRONIC Medical Systems AG with the
suitable measuring and testing devices.
3.) ACUTRONIC Medical Systems AG recommends obtaining a service contract with an exclusive
representative of ACUTRONIC Medical Systems AG.
4.) Only use genuine ACUTRONIC Medical Systems AG replacement parts.
1Definition:
Inspection = Determine actual condition
Service = Measures to maintain desired condition
Repair = Measures to restore desired condition
Maintenance = Inspection, maintenance, repair
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Accessories
Use only accessories specified in the accessory list.
Safe Use
Do not use in explosion-risk areas.
This equipment is not approved for use in explosion-risk areas.
Safe connection with electrical devices
Do not connect to electrical devices not specified in this manual without consulting the manufacturers
or an expert professional.
Liability for Proper Function and Damage
Any and all liability for the proper function of the apparatus is irrevocably transferred to the owner or
operator if the apparatus has been serviced or repaired by personnel not associated with ACUTRONIC
Medical Systems AG Service or if the apparatus was used in a manner not conforming to its intended
use.
ACUTRONIC Medical Systems AG assumes no liability for damages caused by non-compliance with
preceding notices. The warranty and liability provisions of the terms of sale and delivery of
ACUTRONIC Medical Systems AG are likewise not modified by the recommendations mentioned above.
ACUTRONIC Medical Systems AG
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Medical Purpose
Universal Jet ventilator is designed for use in ICU (long term applications) and in the operating theatre
for laryngoscopy, rigid bronchoscopy, microsurgeries with or without laser. The apparatus is also suit-
able for use combined with imaging procedures to minimise organ motion due to artificial ventilation.
For ICU long-term applications we recommend performing routine blood gas analyses as the applied
minute volume cannot be accurately measured with Jet ventilation and could fluctuate greatly due to
modified pulmonary compliance.
Contraindications
With respect to contraindications please note Jet ventilation shall only be used by clinical specialists
with extensive knowledge of Jet ventilation.
There are no known contraindications in the area of laryngoscopy, bronchoscopy or laser surgery. In a
few cases CO2exhalation in heavy weight patients was associated with problems during Single Jet
ventilation. In these cases Jet ventilation was temporarily suspended and conventional ventilation
used until the CO2values returned to normal. With Double Jet CO2 exhalation is supported through the
low-frequency Jet, suspending Jet ventilation is therefore no longer required. Always monitor the CO2
values when using artificial ventilation. This may be done using a CO2 module for the MONSOON sold
separately, a capnograph or transcutaneous CO2measurement.
For detailed studies and experienced data please contact:
ACUTRONIC Medical Systems AG
Fabrik im Schiffli
8816 Hirzel / Switzerland
Tel: +41 44 72 9 70 80
Fax: +41 44 729 70 81
e-mail:[email protected]
www.acutronic-medical.ch
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Indications for Use
Always have a manual resuscitator ready when using a Jet ventilator in the event of insufficient CO2
elimination or insufficient oxygenation in the patient.
Oxygen saturation and CO2should be routinely monitored via capnograph and pulse oximeter or
blood gas analysis.
With long-term use of the Jet apparatus routinely check the function of the mucous membranes of the
trachea for sufficient humidification to prevent desiccation. Since the MONSOON features an efficient
heating and humidification system no problems have occurred in the field.
A large number of surgical procedures of the ventilation system are performed through the use of la-
ser. This poses a risk of flammable materials (e.g. catheter, swab, residual tissue) in the operating field
igniting, which could be further promoted by an increased concentration of oxygen.
Laser procedures may therefore only be performed together with the Jet catheter “Laserjet”.
The MONSOON features a function specifically for laser procedures allowing the user to set the oxy-
gen concentration to be administered during a laser procedure. This feature is activated with the
Laser
on/off
switch, the blender as quickly as possible regulates at the set default oxygen concentration of <
40 %Vol, the concentration cannot be increased with active laser function. Once the blender reaches
an oxygen concentration of < 40 %Vol the notification “
Laser OK
”
is displayed.
Once the laser procedure is completed or the function is deactivated the blender automatically returns
to the last O2value setting.
The notification “
Laser OK
” merely refers to having reached the default oxygen concentra-
tion in the blender. An increased oxygen concentration may still be present in the respirato-
ry tracts of the patient as the ventilation parameters or constricted respiratory tracts results
in a decreased depletion of the oxygen.
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Ventilation Modes
The Single Jet version features one port, the Double Jet features two ports for Jet ventilation. The fre-
quency, inspiration time and emission pressure are adjustable.
The apparatus further features an outlet for a so-called AUX-Flow, which may be used for patient pre-
oxygenation or emergency ventilation.
Only use this apparatus under the supervision of trained medical staff to provide immedi-
ate assistance in the event of a malfunction.
Never use the apparatus with flammable gasses or anaesthetics, fire hazard!
Never use mobile phones within 10 metres of the apparatus!
Mobile phones may interfere with the function of electromedical apparatuses.
Also Note:
Availability of manual ventilation
If the life support function can no longer be ensured due to an obvious ventilator defect, immediately
provide artificial ventilation to the patient via a self-contained ventilator (e.g. resuscitation bag).
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Maintenance Intervals, Batteries
Apparatus and/or parts must be cleaned and disinfected prior to any maintenance* - including return-
ing the apparatus for repair.
Every 6 months
-Maintenance and safety inspection according to
IEC 60601-1:1988+A1:1991+A2:1995+Cor.1995
Perform:
- Check alarm and limit functions
- Check pressure connections
- Check electrical connections
- Check safety shut-offs
Every 12 months
-Maintenance and safety inspection according to
IEC 60601-1:1988+A1:1991+A2:1995+Cor.1995
- Check alarm and limit functions
- Check pressure connections
- Check electrical connections
- Check safety shut-offs
- Calibration
- Replace the following components:
-O2sensor (P/N 7003)
-Qty. 2 gas supply input filter (P/N 1171)
-Water intake needle(s) (P/N 1265), qty. 2 on Double jet
-Water tube set:
-Double Jet (P/N 7918)
-Single Jet (P/N 7919)
Every 1000 operating hours
-Replace the following components:
-MATRIX Jet valve (P/N 7867), qty. 2 on Double jet
-Heating cartridge (P/N 7942)
Every 3 years replace all internal tubing
Every 10 years replace lithium battery for data backup (dispose of used battery)
Standard lithium battery CR 2032
Maintenance and safety inspection must be performed by professionals trained by ACUTRONIC
Medical Systems AG with the suitable measuring and testing devices.
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Contents
The MONSOON is available in the following configurations:
-MONSOON Basic
o1-channel Jet
oPause pressure monitor
oRespiratory tract pressure monitor
oAUX-Flow 15 lpm
oAir/oxygen blender
o9” touch screen colour display
oOptional:
Video camera
etCO2module
-MONSOON +
o1-channel Jet
oPause pressure monitor
oRespiratory tract pressure monitor
oFlow monitor
oBuilt-in heater and humidification
oAUX-Flow 0 -70 lpm
oAir/oxygen blender
o9” touch screen colour display
oOptional:
Video camera
2nd Jet channel
etCO2module
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USER INTERFACE
Front View / Connectors
Figure 1: MONSOON – front view
Legend:
Element 1: Control panel (MMI = ManMachineInterface) with rotary pulse encoder
Element 2: Main unit
Element 3: Control panel connection
Element 4: Controls for main unit
Element 5: Ports for patient tubes, water supply, etCO2measuring tube
Element 6: Connection cable control panel to main unit
4
5
1
6
3 2
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Control Panel Overview
Figure 2: Control panel overview
Legend:
Element 1: Patient alarm LED
Element 2: System alarm LED
Element 3: Display
Element 4: Jet on/off switch (with LED); hold key in manual mode
Element 5: Manual/automatic mode switch (with LEDs)
Element 6: Video channel activation for camera
Element 7: Laser function on/off switch (with LED)
Element 8: Reset alarms and notifications
Element 9: Mute alarm (with LED) (2 minutes)
Element 10: Rotary pulse encoder
4 5
3
7 8 9
10
1
2
6
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Main Unit Overview
In the event of an control panel defect ventilation will continue
with the previously set parameters, the defective piece can
meanwhile be replaced with a new control panel during opera-
tion.
For safety reasons the Jet may only be switched off from the
main unit.
Legend:
Element 1: Patient alarm LED
Element 2: System alarm LED
Element 3: Connected power LED
Element 4: Mute alarm (with LED) (2 minutes)
Element 5: Jet on/off switch (with LED)
Figure 3: Main unit overview
4
1
2
5
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Display - Single Jet
Figure 4: Single Jet display
Legend:
Element 1: Parameter Jet channel 1
Element 2: Graphics respiratory tract pressure and etCO2
Element 3: Alarm and notification field
Element 4: Measurements
Element 5: Help, menu and patient data keys
Element 6: Oxygen, Aux and humidification parameters
Element 7: Respiratory tract- and pause pressure limits
1
2
3
4 5
6
7
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Display - Double Jet
Figure 5: Double Jet display
Legend:
Element 1: Parameter Jet channel 1
Element 2: Graphics respiratory tract pressure and etCO2
Element 3: Alarm and notification field
Element 4: Measurements
Element 5: Help, menu and patient data keys
Element 6: Parameter Jet channel 2
Element 7: Oxygen parameter
Element 8: Respiratory tract- and pause pressure limits
8
1
2
3
4
5
6
7
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MONSOON
Depending on the model the MONSOON features a built-in O2-air supply blender, a separate mixed gas
outlet as well as a built-in heater coupled with ventilatory gas humidification.
Brief summary of built-in features:
Adjustable frequency
Adjustable inspiration time
Adjustable operating pressure
Adjustable oxygen concentration
Respiratory tract pressure measurement and monitoring including graphics
Pause pressure measurement
Continuous gas mixture volume via separate connection
Jet air flow heating and humidification (optional)
Pause pressure limit monitoring with automatic shut-off
Ventilatory volume measurement
etCO2measurement (optional)
Built-in clock with date
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PRESSURE LIMITS
PIP Limit (Respiratory Tract Pressure)
This limit can only be used with a separate measuring lead (proximal lead). The control panel displays
the current patient respiratory tract pressure in graphics and numbers. This allows ventilation patterns
to easily be recognised.
The display is automatically gauged based on the PIP alarm settings. If the pressure exceeds the de-
fined limit the main valve shuts off and an alarm notification appears on the display. The valve will only
be reactivated once the pressure has fallen to 40% of the limit. The audible alarm is automatically reset
once the main valve is cleared.
In graphics this PIP limit is displayed as a broken line!
PP Limit (Pause Pressure)
The PP alarm is activated as soon as the MONSOON is in automatic mode and the
“Start / stop”
key
has been pressed.
The pause pressure corresponds to the pressure inside the Jet lead and is measured a few millisec-
onds prior to engaging the main valve. The current patient respiratory tract pressure is indicated nu-
merically on the control panel. This method allows the residual pressure inside the lead to be meas-
ured. If the value exceeds the limit the valve can only be activated once the pressure inside the lead
falls to 20% of the limit. The audible alarm is automatically reset once the main valve is cleared.
Superimposed Pressure Limit (Superimposed Ventilation)
The SIPL limit works similar to the PIP limit, but will only disable the Jet valve 1 while the value exceeds
the limit, without triggering an alarm. This method allows the use of superimposed Jet ventilation.
Setting the SIPL limit below 10mbar will disable this limit.
The SIPL limit must be set to below the PP limit or ventilation will be interrupted due
to responding to the PP limit.
The SIPL is further automatically limited by the PIP.
The following formula applies: SIPLmax = PIP Ist - 5mbar
In graphics the PIP limit is displayed as a broken line!
Table of contents
