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

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 5.7e 11/2011

2/61

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 Instructions for use MONSOON 5.7e

3/61

11/2011

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 5.7e 11/2011

4/61

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.

Instructions for use MONSOON 5.7e

5/61

11/2011

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.

Instructions for use MONSOON 5.7e 11/2011

6/61

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 Instructions for use MONSOON 5.7e

7/61

11/2011

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

Instructions for use MONSOON 5.7e 11/2011

8/61

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:[email protected] www.acutronic-medical.ch

Instructions for use MONSOON 5.7e

9/61

11/2011

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.

Instructions for use MONSOON 5.7e 11/2011

10/61

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).

Instructions for use MONSOON 5.7e

11/61

11/2011

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.

Instructions for use MONSOON 5.7e 11/2011

12/61

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

Instructions for use MONSOON 5.7e

13/61

11/2011

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

Instructions for use MONSOON 5.7e 11/2011

14/61

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

Instructions for use MONSOON 5.7e

15/61

11/2011

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

Instructions for use MONSOON 5.7e 11/2011

16/61

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

Instructions for use MONSOON 5.7e

17/61

11/2011

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

Instructions for use MONSOON 5.7e 11/2011

18/61

6

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

Instructions for use MONSOON 5.7e

19/61

11/2011

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!

Instructions for use MONSOON 5.7e 11/2011

20/61

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.

Instructions for use MONSOON 5.7e

21/61

11/2011

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.

Instructions for use MONSOON 5.7e 11/2011

22/61

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

Instructions for use MONSOON 5.7e

23/61

11/2011

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.

Instructions for use MONSOON 5.7e 11/2011

24/61

-

+

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.

Instructions for use MONSOON 5.7e

25/61

11/2011

Bypass In Single-Jet mode the bypass can be adjusted directly on the main screen. MONSOON Basic features a constant flow of 15 lpm. MONSOON+ features a flow range of 0 - 70 lpm, which can be adjusted in 5lpm increments. In Double-Jet mode the bypass must be adjusted through the menu.

Humidification In Single-Jet mode humidification can be adjusted directly on the main screen.

In Double-Jet mode humidification must be adjusted through the menu.

Instructions for use MONSOON 5.7e 11/2011

26/61

There are 8 humidification settings (see table at the right). Caution: When using the MONSOON for long-term applications, e.g. the ICU or longer than 30 minutes in the operating theatre, humidification must be used to avoid damage to the respiratory tracts. During humidification the respiratory tracts must be routinely monitored for proper humidification. Only use sterile water. Never use NaCl for humidification to avoid damage to the vaporiser unit inside the apparatus.

Setting 0 1 2 3 4 5 6 7 8

RH[%] at 37° 0 30 40 50 60 70 80 90 100

Preparation Connect IV set to IV bottle and completely fill set with water. The drip chamber should be filled 1/3 of the way with water. Now connect the set to the Luer-Lock connection at the front of the MONSOON. Attach drop counter to the drip chamber (white ring inside sensor slot) and plug into the rear of the MONSOON (marked “Counter”).

Open seals on IV set, select the desired humidification level and start Jet. The notification: “No water” will appear which must be reset with the “alarm reset” key. The ventilation parameters will then be adjusted downward to quickly supply the internal humidification system with water. Once this is completed the apparatus will return to the previously set parameters. Humidification is monitored and controlled via the drop sensor.

Instructions for use MONSOON 5.7e

27/61

11/2011

Dehumidification

Once the apparatus is no longer being used it must be dehumidified to eliminate the risk of germs potential forming inside the humidification system. If the power switch is activated to shut the equipment off without first initiating the dehumidification cycle, an alarm will indicate dehumidification has not been performed. Press the power switch again to reset the alarm and initiate dehumidification. The dehumidification cycle is started through the humidification menu. The dehumidification key only appears with the Jet switched off.

Confirm key and follow these instructions: -

Remove Jet tubes from patient Disconnect water supply

Be sure to keep the Jet tubes away from people. Risk of scalding during dehumidification!

After confirming dehumidification will start and automatically stop once the residual water has been removed from the system. This process takes up to 1 minute.

Instructions for use MONSOON 5.7e 11/2011

28/61

Settings The „Settings“ menu allows the following to be adjusted: -

etCO2 module ON / OFF

-

etCO2 interval measurement: measurement automatically starts at the selected intervals during Jet operation

-

etCO2 measuring unit

-

Manual oxygen sensor calibration

-

Application selector (MONSOON+): OR mode -> SIPL not available ICU mode -> SIPL available

-

Display contrast

-

Laser O2 level: O2 value default for “Laser on/off” key

-

Alarm volume

Language Set the desired language.

Maintenance The “Maintenance” menu is password protected. Only ACUTRONIC Medical Systems AG trained staff will have the password to access:  Calibrations  Time / Date  Factory settings  Demo mode

Instructions for use MONSOON 5.7e

29/61

11/2011

Disconnection With the “Disconnection” function activated pressure changes in the respiratory tract are measured via the proximal tube.

If no change in the airway pressure is detected over a period of 15 seconds the Jet will stop and an alarm will sound. This alarm will mute and the Jet automatically continues once a pressure change is detected.

Laser Application The desired oxygen concentration for laser procedures can be adjusted under settings (21% to 40%).

Pressing the “Laser on/off” key to activate regulating the oxygen concentration at the default. Once the oxygen concentration is reached inside the blender a notification “Laser OK” will appear. Once the function is deactivated the blender will automatically return to the last O2 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.

Instructions for use MONSOON 5.7e 11/2011

30/61

etCO2 – Measurement (Optional) The etCO2 module is activated through the “Settings” menu. In addition, times for interval measurements and units can be set. With an interval measurement time set etCO2 measurement is automatically triggered in the set intervals. The interval measurement time proceeds once “start/stop” key is pressed to start the Jet. Connect Sample Line H (P/N 7715) to the front of the MONSOON.

Airway pressure Y-Piece #7716

Jet 1

Jet Catheter EtCO2 sample Line

Please allow up to 20 seconds for calibration. IMPORTANT: Calibration must be performed against atmosphere!

Pressing the “etCO2” key with the Jet on will trigger the measuring cycle. The MONSOON automatically switches to 5 long inhalations followed by the measurement over a period of 10 seconds with the Jet switched off. Following measurement the apparatus will continue with the previous parameter settings.

The right of the graph (1) displays the graphic and numerical real time measurement. The elapsed time (2) is displayed below the etCO2 key, the peak measurement from the last measurement at the left of the graph (3). The graph also indicates measurements as a trend (4).

(2)

(3) (4)

(1)

Instructions for use MONSOON 5.7e

31/61

11/2011

Video Camera (Optional) Press the “Video” key to activate the video camera.

Focusing the image To focus the image, turn the optical focusing ring (2) on the camera head. Adjust white balance Proceed as follows: Aim the endoscope at a white object, e.g. sterile gauze. Briefly press the white balance button (3) and keep the endoscope aimed at the white object for 5 sec. The image will now change to pure white. This process allows true colour rendering for all colours. Window function The „Window” button (3) will select a preset window. Only the part of the camera chip containing image information will be used to control sensitivity. This function allows black edges of e.g. thin optics with small working diameters to be removed, thus optimizing the images. The window function is deactivated in the factory settings. Hold button 3 (min. 3 sec) to activate the Window function. This setting can be recognised by images now being displayed without brightness artefacts when using thin endoscopes. To deactivate this function press key 3 again (min. 3 sec).

Instructions for use MONSOON 5.7e 11/2011

32/61

(1)1

2 (2)

3 (3)

4 (4)

1 Lock for endoscope ocular 2 Focus 3 White balance/window function 4 Remote function

Remote Control (Optional) The function of the remote control is identical to the Start/Stop key function on the control panel. The remote cable is 2 metres long.

Connect the remote to the jack at the back of the apparatus labelled “Start/Stop”. The jet may now be controlled via remote control or control panel.

Instructions for use MONSOON 5.7e

33/61

11/2011