MONSOON Instructions for Use sw ver 1.15 or higher Ver 5.7e Nov 2011

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MONSOON

UNIVERSAL JET VENTILATOR

Instructions for Use

Version 5.7e

This manual only applies to:

monsoon with software Version: 1.15 or higher

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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:info@acutronic-medical.ch

www.acutronic-medical.ch

0124

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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

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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 supervision to immediately provide assistance in the event of malfunction.

If the new value is not confirmed by the operator by pressing the rotary pulse encoder or the touch monitor the value will automatically be reset after a few seconds.

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 requires 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 operation 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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1

Maintenance

MONSOON is a Universal Jet ventilator classified as device group IIb according to European directive.

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 Operator 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.

1

Definition:

Inspection

Service

Repair

Maintenance

= Determine actual condition

= Measures to maintain desired condition

= Measures to restore desired condition

= 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 suitable 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 CO2 exhalation 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 CO2 values 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 CO2 measurement.

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:info@acutronic-medical.ch

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 CO 2 should 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 laser. 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 oxygen 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 O2 value setting.

The notification “Laser OK” merely refers to having reached the default oxygen concentration in the blender. An increased oxygen concentration may still be present in the respiratory 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 frequency, 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 preoxygenation or emergency ventilation.

Only use this apparatus under the supervision of trained medical staff to provide immediate 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 returning the apparatus for repair.

Every 6 months

-

Every 12 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

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:

- O2 sensor (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

o 1-channel Jet

o Pause pressure monitor

o Respiratory tract pressure monitor

o AUX-Flow 15 lpm

o Air/oxygen blender

o 9” touch screen colour display

o Optional:

 Video camera

 etCO2 module

-

MONSOON +

o 1-channel Jet

o Pause pressure monitor

o Respiratory tract pressure monitor

o Flow monitor

o Built-in heater and humidification

o AUX-Flow 0 -70 lpm

o Air/oxygen blender

o 9” touch screen colour display

o Optional:

 Video camera

 2nd Jet channel

 etCO2 module

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USER INTERFACE

Front View / Connectors

2

3

4

1

5

6

Figure 1: MONSOON – front view

Legend:

Element 1:

Element 2:

Element 3:

Element 4:

Element 5:

Element 6:

Control panel (MMI = ManMachineInterface) with rotary pulse encoder

Main unit

Control panel connection

Controls for main unit

2

Ports for patient tubes, water supply, etCO measuring tube

Connection cable control panel to main unit

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Control Panel Overview

1

2

3

4

5

6

7

8

9

10

Figure 2: Control panel overview

Legend:

Element 1:

Element 2:

Element 3:

Element 4:

Element 5:

Element 6:

Element 7:

Element 8:

Element 9:

Element 10:

Patient alarm LED

System alarm LED

Display

Jet on/off switch (with LED); hold key in manual mode

Manual/automatic mode switch (with LEDs)

Video channel activation for camera

Laser function on/off switch (with LED)

Reset alarms and notifications

Mute alarm (with LED) (2 minutes)

Rotary pulse encoder

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Main Unit Overview

1

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 operation.

For safety reasons the Jet may only be switched off from the

main unit.

2

4

Legend:

Element 1:

Element 2:

Element 3:

Element 4:

Element 5:

Patient alarm LED

System alarm LED

Connected power LED

Mute alarm (with LED) (2 minutes)

Jet on/off switch (with LED)

5

Figure 3: Main unit overview

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Display - Single Jet

3

5

4

2

1

6

7

Figure 4: Single Jet display

Legend:

Element 1:

Element 2:

Element 3:

Element 4:

Element 5:

Element 6:

Element 7:

Parameter Jet channel 1

Graphics respiratory tract pressure and etCO2

Alarm and notification field

Measurements

Help, menu and patient data keys

Oxygen, Aux and humidification parameters

Respiratory tract- and pause pressure limits

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Display - Double Jet

3

5

4

2

1

7

8

Figure 5: Double Jet display

Legend:

Element 1:

Element 2:

Element 3:

Element 4:

Element 5:

Element 6:

Element 7:

Element 8:

Parameter Jet channel 1

Graphics respiratory tract pressure and etCO2

Alarm and notification field

Measurements

Help, menu and patient data keys

Parameter Jet channel 2

Oxygen parameter

Respiratory tract- and pause pressure limits

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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



etCO2 measurement (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 defined 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 milliseconds prior to engaging the main valve. The current patient respiratory tract pressure is indicated numerically on the control panel. This method allows the residual pressure inside the lead to be measured. 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!

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START-UP

Apparatus Preparation

The following must be performed prior to initial use of the apparatus.

CAUTION:

Do not connect patients to this apparatus until these eight steps have been completed.

1. Connect apparatus to mains and switch on for 1 minute, then shut off. Unplug apparatus from mains and switch on again. An audible alarm must sound.

2. Connect air and oxygen supply tubes to the respective ports at the back of the apparatus and wall ports. The inputs are marked and coded to prevent reversing the two

gas connections.

The maximum available operating pressure is 3.5 Bar.

The following applies to supply pressures below 4 Bar:

Maximum operating pressure = lower supply pressure – 0.5 Bar.

3. Connect the apparatus to a suitable outlet using the power cable. The apparatus may

be operated at 100 VAC to 240 VAC and automatically adjusts to the respective voltage

without manual intervention. However, be sure the fuse used conforms to the value indicated on the label for the respective voltage. Fuses may only be exchanged by a

trained technician. When exchanging fuses always use the same value fuse.

4. Connect patient tube to the port at the front of the apparatus labelled JET.

5. Connect pressure sensing line to the port labelled accordingly. Acutronic recommends

using the separate pressure sensing line, if possible. This eliminates the risk of pneumothorax.

6. Finally, connect the AUX-Flow tube to the port labelled accordingly. The AUX-Flow is

primarily intended to pre-oxygenate the patient via mask, as well as for emergency patient ventilation via resuscitation bag. (e.g. AMBU or Laerdal)

7. Switch on apparatus. The power switch is located at the back of the apparatus to prevent accidental apparatus switch-off.

8. After being switched on the internal oxygen sensor will automatically be calibrated.

The apparatus is automatically calibrated every 24 hours. If calibration fails due to disconnected gas supply, calibration can be started manually from the “Settings” menu.

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Check P-Pressure and PIP Safety Limits

CAUTION:

the limits of the pressure switch-off must be tested using the included test lung

prior to using the Jet ventilator.

1. Connect Jet patient tube to one of the two LUER-LOCK connections on the test lung.

2. Connect pressure sensing line to the second LUER-LOCK connection on the test lung.

3. Set PIP pressure limit to 15 mbar

4. Set PP pressure limit to 20 mbar

5. Use the operating pressure control to set the operating pressure to 1.5 bar.

6. Switch apparatus to automatic mode. To do so press the key labelled auto/manual. The LED must

light on auto. LED = green

7. Set frequency to 150 CPM. Select inspiration time of 40%.

8. Start Jet ventilation by pressing the start/stop key.

9. Use your thumb to close the opening at the side of the test lung. Pressure will build and the apparatus will suspend ventilation once the set pressure limit is reached. The alarm notification "PIP too

high" will appear and an audible signal will sound; release test lunch. The apparatus will continue

ventilation and the audible alarm will mute.

10. Disconnect the pressure sensing line from the test lung and repeat test. The apparatus will suspend ventilation. The alarm notification "PP too high" will appear and an audible signal will sound.

Once the test lung is released ventilation will continue and the audible alarm will mute.

If using a Double Jet the second Jet must be tested by repeating steps 1 through 10.

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Using the MONSOON with Single Lumen Catheter

Caution:

Limited space may not always allow the use of a Jet catheter with second lumen

for continuous pressure monitoring or capnography. For this reason the MONSOON features a built-in pause pressure monitor.

It monitors the pressure still present in the respiratory tracts after applying the

Jet pulse. This determines whether the respiratory tract pressure has decreased

during expiration.

This safety feature provides reliable protection from patient barotrauma. To ensure this safety feature is effective the Jet frequency must be higher than 80

CPM. At a Jet frequency below 80 CPM the volume of a single Jet pulse may be

big enough to cause barotrauma.

The following graphic illustrates the PP (Pause Pressure) measurement:

Pause pressure measurement

Figure 6: Pause pressure measurement

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OPERATION

Parameter Settings

Select the ventilation parameter you would like to

adjust. The parameter window will open. Turn the

rotary pulse encoder to set the desired value and

confirm by pressing the rotary pulse encoder.

The following parameters may be set:

- Supply pressure Jet 1 (Jet 2)

- Frequency Jet 1 (Jet 2)

- Inspiration time Jet 1 (Jet 2)

- Pause pressure limit

- Proximal pressure limit

- Oxygen concentration

- Bypass flow (Aux.)

- Humidification

If no entry is made within 10 seconds of the parameter window opening it will automatically close.

Menu

The menu key allows access to additional settings:

-

SIPL

Double Jet

Aux-Flow

Humidification

Settings

Language

Service

Disconnect

These may be opened and activated/set by touching the tabs.

If no entry is made within 10 seconds of the parameter window opening it will automatically close and

return to the main screen.

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Superimposed Pressure Limit (SIPL)

The SIPL limit is works similar to the PIP limit but

will only block Jet valve 1 as long as the limit is

exceeded, without triggering an alarm. This method allows superimposed Jet ventilation to be implemented.

The SIPL is only available on the MONSOON+ in

IPS mode (see: Settings).

The SIPL limit must be set to below the PP limit or

ventilation will be interrupted in response to the PP

limit.

In addition the SIPL is automatically limited by the

PIP. The following formula applies:

SIPLmax = PIPIs- 5mbar

Setting the SIPL limit below 10mbar will disable this

limit; the maximum value is 40 mbar.

In graphics this SIPL limit is displayed as a broken

line!

Double Jet (Optional)

When activating the Double-Jet function the parameters for the second Jet are displayed at the

bottom right of the main screen, and can also be

adjusted from there.

In this case the parameters for bypass and humidification are no longer available. With Double-Jet

activated these settings can also be made through

the menu.

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