Summary of Contents for ACUTRONIC MONSOON
- Page 1 MONSOON UNIVERSAL JET VENTILATOR Instructions for Use Version 5.6e This manual only applies to: monsoon with software Version: 1.15 or higher...
- Page 2 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 Instructions for use MONSOON 5.6e 20/09/2010 2 / 6 1...
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Page 3: Table Of Contents
Superimposed Pressure Limit (Superimposed Ventilation) ..................20 ................................21 TART Apparatus Preparation ..............................21 Check P-Pressure and PIP Safety Limits ........................22 Using the MONSOON with Single Lumen Catheter...................... 23 ................................24 PERATION Parameter Settings ................................24 Menu ....................................24 ... - Page 4 Connections / Ports ................................57 Environmental Conditions ..............................58 Disposal ....................................58 Rear View / Connections ..............................59 Replacing Fuses ................................. 60 ..............................61 ABLE OF IGURES Instructions for use MONSOON 5.6e 20/09/2010 4 / 6 1...
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Page 5: For Your Safety And That Of Your Patients
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 5.6e 5 / 6 1 20/09/2010... - Page 6 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 5.6e 20/09/2010 6 / 6 1...
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Page 7: Maintenance
Maintenance 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. -
Page 8: Accessories
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. -
Page 9: Medical Purpose
Jet, suspending Jet ventilation is therefore no longer required. Always monitor the CO values when using artificial ventilation. This may be done using a CO module for the MONSOON sold separately, a capnograph or transcutaneous CO measurement. -
Page 10: Indications For Use
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- Laser gen concentration to be administered during a laser procedure. -
Page 11: Ventilation Modes
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 5.6e 1 1 / 6 1... -
Page 12: Maintenance Intervals, Batteries
(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 5.6e... -
Page 13: Contents
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 ... -
Page 14: User Interface
NTERFACE 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:... -
Page 15: Control Panel Overview
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 Instructions for use MONSOON 5.6e 1 5 / 6 1 20/09/2010... -
Page 16: Main Unit Overview
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 Instructions for use MONSOON 5.6e 20/09/2010 1 6 / 6 1... -
Page 17: Display - Single Jet
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 Instructions for use MONSOON 5.6e 1 7 / 6 1 20/09/2010... -
Page 18: Display - Double Jet
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 Instructions for use MONSOON 5.6e 20/09/2010 1 8 / 6 1... -
Page 19: Monsoon
ONSOON Depending on the model the MONSOON features a built-in O -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 ... -
Page 20: Pressure Limits
PP Limit (Pause Pressure) “Start / stop” The PP alarm is activated as soon as the MONSOON is in automatic mode and the 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. -
Page 21: Start - Up
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 pneu- mothorax. -
Page 22: Check P-Pressure And Pip Safety Limits
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 5.6e 20/09/2010 2 2 / 6 1... -
Page 23: Using The Monsoon With Single Lumen Catheter
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 MON- SOON features a built-in pause pressure monitor. -
Page 24: Operation
These may be opened and activated/set by touch- ing the tabs. If no entry is made within 10 seconds of the param- eter window opening it will automatically close and return to the main screen. Instructions for use MONSOON 5.6e 20/09/2010 2 4 / 6 1... -
Page 25: Superimposed Pressure Limit (Sipl)
This meth- od allows superimposed Jet ventilation to be im- plemented. The SIPL is only available on the MONSOON+ in Settings IPS mode (see: The SIPL limit must be set to below the PP limit or ventilation will be interrupted in response to the PP limit. -
Page 26: Bypass
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. -
Page 27: Preparation
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”). -
Page 28: Dehumidification
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 5.6e 20/09/2010 2 8 / 6 1... -
Page 29: Settings
“ ” 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 ... -
Page 30: Disconnection
. Instructions for use MONSOON 5.6e 20/09/2010 3 0 / 6 1... -
Page 31: Etco - Measurement (Optional)
“ ” key is pressed to start the Jet. Connect Sample Line H (P/N 7715) to the front of the MONSOON. Please allow up to 20 seconds for calibration. IMPORTANT: Calibration must be performed against atmos- phere! etCO2”... -
Page 32: Video Camera (Optional)
Window function. This setting can be recognised by images now being displayed without bright- ness artefacts when using thin endoscopes. To deactivate this function press key again (min. 3 sec). Instructions for use MONSOON 5.6e 20/09/2010 3 2 / 6 1... -
Page 33: Remote Control (Optional)
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 5.6e 3 3 / 6 1 20/09/2010... -
Page 34: Automatic - Manual Operating Mode
Automatic – Manual Operating Mode The MONSOON features two operating modes: Automatic mode To select automatic mode press the „a to/manual “ key until the yellow LED next to the key lights. “start/stop” Pressing the key will start the MON- SOON. -
Page 35: Clinical Applications
LINICAL PPLICATIONS Patient Data The patient data menu allows information pertain- ing to treatment/application type and patient condi- tion to the entered. MONSOON will recommend parameter settings based on this information. „Patient Data” key to Press the access the menu. -
Page 36: Cpap Ventilation Set For Monsoon
CPAP Ventilation Set for MONSOON To apparatus port marked JET Figure 7: CPAP ventilation set Legend: 2 litre breathing bag Patient connecting tube (part number 1004) Swivel adapter with Jet cannula or Luer Lock adapter (part number 1010) Standard T-piece with 22 mm connections... -
Page 37: Figure 12: Cpap Ventilation
The following pressure-time diagram shows the pressure pattern with CPAP superimposed Jet ventila- tion. However, this curve will only be displayed on the Jet ventilator monitor with the proximal pressure sensing line connected. Figure 8: CPAP ventilation Instructions for use MONSOON 5.6e 3 7 / 6 1 20/09/2010... -
Page 38: Infraglottic Catheter Jet Ventilation
Infraglottic Catheter Jet Ventilation "Kleinsasser" technique: Applications: - Laryngotracheal diagnosis and microsurgery - Laser surgery - Removing foreign objects Figure 9: Principle of infraglottic Jet ventilation Instructions for use MONSOON 5.6e 20/09/2010 3 8 / 6 1... -
Page 39: Supraglottic (Catheterless) Jet Ventilation
Supraglottic (Catheterless) Jet Ventilation "Aloy" technique: Applications: - Laryngotracheal diagnosis and microsurgery - Laser surgery - Airway stenosis Figure 10: Principle of supraglottic Jet ventilation Instructions for use MONSOON 5.6e 3 9 / 6 1 20/09/2010... -
Page 40: Rigid Bronchoscopy
Rigid Bronchoscopy Infraglottic Jet Ventilation "Sanders" technique: Applications: - Laryngotracheal diagnosis and microsurgery - Laser surgery - Removing foreign objects Figure 11: Principle of rigid bronchoscopy Instructions for use MONSOON 5.6e 20/09/2010 4 0 / 6 1... -
Page 41: Transtracheal Jet Ventilation
Transtracheal Jet Ventilation "Ravussin" technique: Applications: - Laryngotracheal diagnosis and microsurgery - Laser surgery - Emergency oxygenation Figure 12: Principle of transtracheal Jet ventilation Instructions for use MONSOON 5.6e 4 1 / 6 1 20/09/2010... -
Page 42: Alarms And Error Codes
LARMS AND RROR ODES The MONSOON features a complex notification concept. There are 3 levels with different visual and audible indication: Figure 13: Alarm LEDs Legend LED1: Patient alarm LED2: System alarm Patient and System alarms can be muted for two minutes. If the error persists after this period the alarm will again sound. -
Page 43: Patient Alarms
15 seconds Proximal pressure sensing line connected? Check airways Jet tube blocked / kinked? PP high Excessive pause pressure Adjust ventilation parameter Catheter too small for driving pres- sure? Instructions for use MONSOON 5.6e 4 3 / 6 1 20/09/2010... -
Page 44: System Alarms
Check gas supply and start manual calibration O2 setting cannot be reached failure within 3 minutes Contact ACUTRONIC service Main-processor Discrepancy between main Contact ACUTRONIC service unit error and slave processor Instructions for use MONSOON 5.6e 20/09/2010 4 4 / 6 1... - Page 45 O2 calibration Gas supply disconnected Check gas supply and start manual calibration failed Replace O2 sensor or contact ACUTRONIC ser- O2 sensor weak O2 sensor worn, weak signal vice Measurement discrepancy PIP measuring...
- Page 46 PP sensor No pressure measurement by pneumatically Contact ACUTRONIC service sensor with Jet on disconnected Real Time Clock Undefined time measurement Contact ACUTRONIC service unit error Low oxygen O2 supply pressure too low < Check O2 gas supply supply pressure 2bar...
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Page 47: Notices
Humidifier is urement defective turned off Contact ACUTRONIC service Heater error Appears once the oxygen Laser ok saturation preset for laser Laser may be switched on applications is reached Instructions for use MONSOON 5.6e 4 7 / 6 1 20/09/2010... - Page 48 Message disappears once water is added to the water progress alarm humidification system Apparatus may continue to be used Annual safety control re- Service due quired Inspection and service by trained technician highly recommended Instructions for use MONSOON 5.6e 20/09/2010 4 8 / 6 1...
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Page 49: Accessories
CCESSORIES Description 7720 Jet tube MONSOON III, Jet 1, length 1.6m 7721 Jet tube MONSOON III, Jet 2, Length 1.6m 7722 Bypass flow tube MONSOON III, length 1.6m Proximal pressure tube MONSOON III 7723 length 1.6m 1011 Test lung for ACUTRONIC Jet ventilator... - Page 50 Metal laser needle for laser procedures of the upper respiratory 1059 tract, with laryngoscope Infant: 140 mm, ID: 1.4 mm, AD: 2.2 mm 1060 Needle holder for laryngoscopes for securing the laser needle misc. Laryngoscopy Set REMACLE Instructions for use MONSOON 5.6e 20/09/2010 5 0 / 6 1...
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Page 51: Treatment , Disinfecting / Cleaning
Teflon catheter for laser surgery Single use only 7715 etCO2 sample line Single use only 7716 Y-adapter etCO2 Single use only 7717 Drop sensor Surface disinfect 7920 Remote button Surface disinfect Instructions for use MONSOON 5.6e 5 1 / 6 1 20/09/2010... -
Page 52: Abbreviations And Symbols
Peak inspiratory pressure limit, which must be set. Jet pulsation is automati- cally interrupted if this limit is reached and a visual as well as audible alarm is triggered. Instructions for use MONSOON 5.6e 20/09/2010 5 2 / 6 1... -
Page 53: About Electromagnetic Compatibility
Guideline and manufacturer declaration – electromagnetic emission The device "MONSOON" is intended for operation in the environment described below. The customer or user of the "MONSOON" apparatus should ensure it is operated in this type of environment. EMI measurement... - Page 54 Guideline and manufacturer declaration – electromagnetic immunity The device "MONSOON" is intended for operation in the environment described below. The customer or user of the "MONSOON" apparatus should ensure it is operated in this type of environment. IEC60601 Immunity testing Compliance level Electromagnetic environment –...
- Page 55 Guideline and manufacturer declaration – electromagnetic immunity The device "MONSOON" is intended for operation in the environment described below. The customer or user of the "MONSOON" apparatus should ensure it is operated in this type of environment. IEC60601 Immunity testing Compliance level Electromagnetic environment –...
- Page 56 HF communication devices and the device "MONSOON" "MONSOON" is intended to be operated in an electromagnetic environment with controlled HF interferences. The operator of the "MONSOON" can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device "MONSOON"...
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Page 57: Technical Specification
Oxygen supply 4.0 to 6.5 bar Power supply 100 to 240 VAC 50/60 Hz Average power consumption: 100 W Ethernet port LAN connection / HL7 Instructions for use MONSOON 5.6e 5 7 / 6 1 20/09/2010... -
Page 58: Environmental Conditions
Do not force open Risk of chemical burn! Dispose of batteries and O sensors according to local waste management ordinances. Please contact your local environmental or regulatory authority and appropriate waste management companies. Instructions for use MONSOON 5.6e 20/09/2010 5 8 / 6 1... -
Page 59: Rear View / Connections
Rear View / Connections Figure 14: MONSOON - rear view Legend: Element 1: AIR input (NIST) Element 2: O input (NIST) Element 3: Fan Element 4: Nurse Call connection Element 5: Drop counter connection Element 6: Remote control connection Element 7: LAN / HL7 port Element 8: Mains switch Element 9: Mains connector (100 –... -
Page 60: Replacing Fuses
Always replace fuses with fuses of identical rating. We recommended having fuses replaced by train- ing service staff. The mains fuses are located inside the MONSOON’s mains input socket at the back of the device. Procedure: Unplug. Use a screwdriver to loosen the locking mechanism marked with arrows and open drawer. -
Page 61: Table Of Figures
ABLE OF IGURES Figure 1: MONSOON – front view ......................... 14 Figure 2: Control panel overview .......................... 15 Figure 3: Main unit overview ..........................16 Figure 4: Single Jet display ............................ 17 Figure 5: Double Jet display ........................... 18 Figure 6: Pause pressure measurement ......................23 ...
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