Page 1 Anaesthesia Unit Morpheus E User's Manual...
Page 3 The contents of this manual do not in any way limit the right of SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. to revise, change or modify without prior notice the equipment (including the relative software) described herein.
Page 4: Observations
We would be grateful if you would send us your comments (see address at page IX). The SIARE trademark is used throughout this manual as an abbreviation for the manufacturer: SIARE Engineering International Group s.r.l. Directive 93/42 EEC Definitions Three symbols are used in this User’s Manual to indicate particularly important...
Page 5: Warnings, Cautions And Notes
The user of this product is solely responsible for any operating defect caused by improper use or interventions carried out by third parties other than specialised SIARE personnel. •...
Page 6 • SIARE is aware that cleaning, sterilisation and disinfection procedures vary considerably from one health structure to another. SIARE cannot be held responsible for the efficacy of the cleaning and sterilisation procedures, nor for the other procedures carried out while the patient is being treated. As...
Page 7 • SIARE assumes all foreseen legal liability if the anaesthesia unit is used and periodically maintained according to the instructions contained in this manual: the Technical Assistance Report, drawn up and signed by the authorised SIARE technician, is proof of the completion of the scheduled maintenance.
Page 8 WARNING !! Before connecting the MORPHEUS to other electrical equipment not described in this manual, a request for authorisation should be sent to Siare. WARNING !! An auxiliary ventilation system is suggested for the patients for which the anaesthesia unit represents a life support.
Page 9: Year Of Manufacture
The Directive 93/42EEC on medical devices foresees that the manufacturer defines the shelf life of the device according to the intended purpose. The shelf life foreseen by SIARE for the MORPHEUS anaesthesia unit is 10 years. Manufacturer SIARE Engineering International Group s.r.l.
Page 10: Electromagnetic Compatibility
Electromagnetic Compatibility The MORPHEUS anaesthesia unit is designed to operate in the specified electromagnetic environment (see warning below). The customer or the user of MORPHEUS anaesthesia unit should ensure that it is used in such an electromagnetic environment. The MORPHEUS anaesthesia unit complies with the EN 60601- 1-2 regulations on Electromagnetic Compatibility of electro- medical equipment.
Page 11: Table Of Contents
Introduction .......................... 2-2 Versions ..........................2-3 2.2.1 MORPHEUS LT ........................2-3 2.2.2 MORPHEUS M ........................2-4 2.2.3 MORPHEUS E ........................2-5 Trolley ..........................2-6 2.3.1 Support for vaporizers ......................2-6 2.3.2 Control panel for manual ventilation ( 9 ) ................2-7 Side view ..........................2-9 2.4.1...
Page 12 VALVES GROUP MODULE ..................3-1 Introduction .......................... 3-2 Valves group ........................3-3 3.2.1 Main features ..........................3-3 Description ........................... 3-4 3.3.1 Patient circuit view ........................3-4 3.3.2 Electric connexion view ......................3-5 3.3.3 Upper view ..........................3-6 Use ............................3-7 3.4.1 CO2 soda lime absorber canister ...................3-7 3.4.2 Connections to valves group ....................3-10 DESCRIPTION ......................
Page 13 5.12 Ventilation parameters monitoring area ................5-42 5.12.1 Respiratory parameters monitoring ..................5-42 5.12.2 GAS parameters monitoring ....................5-43 5.12.3 ADDITIONAL parameters monitoring ...................5-44 5.13 Calibration programs (service area) .................. 5-47 5.13.1 Introduction ...........................5-48 5.13.2 Encoder knob ........................5-48 5.13.3 Disable/ Enable turbine (not available) .................5-49 5.13.4 Turbine characterization (not available) ................5-49 5.13.5 Expired flow sensor calibration .....................5-50 5.13.6 VTEc OFF ..........................5-50...
Page 14 VENTILATOR USE ....................7-1 Introduction .......................... 7-2 Flowmeter box ........................7-3 7.2.1 Dosing and administration of fresh gas ..................7-3 7.2.2 Administration of fresh gas in the "TO and FRO" system ............7-5 7.2.3 Electronic flowmeter box pre-setting ..................7-6 Lung ventilator ........................7-8 7.3.1 Operative mode selection .......................7-8 7.3.2...
Page 15 10.7 Disposal ............................10-13 11 APPENDIX ......................11-1 11.1 Technical sheet ......................... 11-2 11.1.1 MORPHEUS E - cod. OM3.SE .....................11-2 11.1.2 Table for Identification of medical gas hose colours .............11-9 11.2 Glossary ........................... 11-10 11.3 Electromagnetic compatibility tables ................11-15 11.3.1 Annex A: Table 1 ........................11-15 11.3.2 ANNEX B: Table 2 ......................11-16...
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Page 17: Foreseen Use
Even the maintenance procedures have been simplified and the parts subject to wear or deterioration have substantially decreased. Siare invested much on this project because we firmly believe that it will be a winning product. The new anaesthesia unit is considerably different from all previously manufactured versions: in fact, it can be configurable in different models to respond to the numerous market demands and requirements.
Page 18: Versions
Versions MORPHEUS anaesthesia unit is equipped with a unique trolley configurable in three different models to respond to the numerous market demands and requirements. The trolley is composed of the following parts: • mechanic structure of the trolley • work-shelf and chest •...
Page 19: Valves Group
The work-shelf is mono-bloc, made of a unit PUR mould. The shelf also includes the housing for the valves group and the manual ventilation controls. The shelf is very wide and the large handle below the perimeter allows to hold and easily move the unit.
Page 20: Flowmeter Box
1.3.3 Flowmeter box The FLOWMETER BOX, is available 3 versions, 2 mechanical (at three or five flowmeters) and 1 electronic version which foresees the Xenon option. The mechanical versions are characterized by the complete absence of mechanical controls; replaced by a small control panel located on the left side of the work-shelf to manage all manual ventilation operations.
Page 21: Various On Lung Ventilator
1.3.6 Various on lung ventilator For the controlled ventilation of newborn patients, make reference to the chapter 7.4, about use with premature patients. For a correct comprehension of MORPHEUS anaesthesia unit operation and for a correct and safe use both for the patient and user, the knowledge of recommendations and instructions indicated in the present User’s Manual is required.
Page 22: Correct Operation
To ensure the best performance of the MORPHEUS anaesthesia unit periodic maintenance of the lung ventilator by qualified technical personnel is recommended. For further information, contact SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. SIARE...
Page 23: Applicable Norms
Applicable norms The MORPHEUS anaesthesia unit is made in accordance with the following norms and it is manufactured according to UNI EN ISO 13485:2016 standards. EN 60601-1 :2006/A1 :2011/A1 :2013 Medical electrical equipment. General requirements for basic safety and essential performance. EN 60601-1-2:2015 Medical electrical equipment.
Page 24 IEC 62353:2014 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part1: General requirements User’s Manual, version DU3300105...
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Page 26: Description
In this chapter are illustrated and mostly considered the main parts and modules which compose the MORPHEUS anaesthesia unit. Introduction Type 2.2.1 MORPHEUS LT 2.2.2 MORPHEUS M 2.2.3 MORPHEUS E Trolley 2.3.1 Support for vaporizers 2.3.2 Control panel for manual ventilation ( 9 ) Side view 2.4.1 Valves group ( 10 ) 2.4.2...
Page 27 • MORPHEUS LT • MORPHEUS M • MORPHEUS E This three different models are different for type and ventilator section: • Ventilator with basic DISPLAY (LT) • Ventilator with 12” TFT advanced display (VM.S) and per flowmeter box type: •...
Page 28 Versions 2.2.1 MORPHEUS LT Accessories chest Patient circuit supporting arm (on demand). Work-shelf absorber canister releasable with Vaporizers for anaesthetic gas unlock lever. (rapid Siaretex connection type, compatible with vaporizers Control panel for the management of equipped with Interlock system). manual ventilation procedures.
Page 29 2.2.2 MORPHEUS E Storage drawers. Patient circuit supporting arm (on demand). Work-shelf. CO2 absorber canister releasable with Vaporizers for anaesthetic gas unlock lever. (rapid Siaretex connection type, compatible with vaporizers Control panel for the management of equipped with Interlock system).
Page 30 2.2.3 MORPHEUS E Storage drawers Patient circuit supporting arm (on demand). Work-shelf. CO2 absorber canister releasable with Vaporizers for anaesthetic gas unlock lever. (rapid Siaretex connection type, compatible with vaporizers Control panel for the management of equipped with Interlock system).
Page 31 Trolley The Morpheus trolley is composted by a mechanical structure with light aluminium alloy uprights and a steel base; it is foreseen also a steel vertical rod for fixing all patient monitoring and other accessories useful for anaesthesia unit operation. •...
Page 32 2.3.2 Control panel for manual ventilation ( 9 ) CO 2 absorber canister releasable by unlock lever. Control panel for management of manual ventilation procedures. APL valve for adjustment of airways maximum pressure during manual ventilation. The pressure increases by turning clockwise the valve knob and it decreases by turning it counter-clockwise.
Page 33 Fresh gas selection control: enabling output connector at fresh gas exit (AUX). Fresh gas exit selection control: enabling valves group (APL). In manual operative mode it is possible to select the correct mode to ventilate the patient: • by external auxiliary system, for example a manual ventilation system like MAPLESON C type or similar (AUX);...
Page 34: Side View
Side view Accessories chest Valves group Steel vertical rod for accessories Ventilator module support Patient circuit supporting arm (on demand) and Connections for scavenger support. Control panel for management of manual Electric power supply group ventilation procedures. MORPHEUS...
Page 35: Valves Group ( 10 )
2.4.1 Valves group ( 10 ) CO 2 absorber canister with lock lever. Control panel for management of manual ventilation procedures. Connector for fresh gas exit. Not used. Valves group (cfr. 3). (In the picture, version without cover). 10.1 Connector for supplied manual ventilation kit. 10.2 Connector for gas scavenging circuit 10.3...
Page 36 Valves group – external and inside view CO 2 absorber canister with lock lever. 10.1 Connector for supplied manual ventilation kit. 10.3 Connector for expiratory line flow sensor. 10.4 Connector for inspiratory line. 10.5 Unlock lever for CO 2 absorber canister release. 10.6 Valves group cover to gain access for accessories 10.a...
Page 37: Connections For Scavenger ( 21 )
2.4.2 Connections for scavenger ( 21 ) Valves group. 21.1 Gas supply connection for active gas scavenger 21.2 Gas scavenging connector. 2.4.3 Electric power supply group ( 22 ) 22.1 Switch for front panel light 22.2 Future uses 22.3 Socket for auxiliary devices (220Vac 6A) 22.4 Power supply group: main switch, protection fuses (5x20 250V 2x10...
Page 38: Back View
Back view Patient circuit supporting arm Fixing stirrup for cylinders (on demand) and support. Steel vertical rod for Electric power supply group accessories support. Identification label Gas supply group Grey round rubber pads for cylinder support (max. two Connectors for services cylinders of 10 lt.
Page 39: Gas Supply Group ( 23 )
2.5.1 Gas supply group ( 23 ) 23.1 Connections for O 2 exit 23.2 Connections for O 2 entry 23.3 Connections for O 2 entry 23.4 Connections for AIR entry 23.5 Connections for N 2 O entry 23.6 Connections for N 2 O entry Warning.
Page 40: Connectors For Services ( 24 )
Morpheus E - Morpheus M 24.1 RS232 : connection for data download or for gas analyser 24.2 LAN : network connection 24.3 PROG : connector for CPU board programming WARNING! Risk of equipment failure. Use and connect devices authorized by Siare, only. 2-15 MORPHEUS...
Page 41: Product Identification Label
Product identification label The equipment identification label contains some very important data like the model and the serial number, which should be always signalled to the technical service and in every spare parts request. The serial number allows to identify unequivocally the equipment and the composition of the same at the moment of supply.
Page 42 The mark identifies the protection level against electric shock (category of protection type B). CE mark, complying with European Regulation 93/42/CEE pertaining to medical devices. 0476 RAEE marc, indicates the waste of electronic or electric equipments. 2018 The number indicates the year of production of the equipment. The symbol indicates ‘refer to the instructions for use’...
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Page 44: Valves Group Module
3.3.1 Patient circuit view 3.3.2 Electric connexion view 3.3.3 Upper view 3.4.1 CO 2 soda lime absorber canister 3.4.2 Connections to valves group As regards assembling, interfacing and maintenance, refer to this manual or contact Siare’s technical assistance service. MORPHEUS...
Page 45: Introduction
All the pictures and the examples shown in the present chapter have the mere purpose of being an example and they do not make any reference to real clinical cases. Valves group (inside view) Morpheus E User’s Manual, version DU3300105...
Page 46: Valves Group
Valves group The valves group (or also the breathing system) is the device that conveys the fresh gases (coming from anaesthesia module) to the patient; collects the exhaust gases and conveys them to the CO 2 absorber canister, and then toward the bellow of valves group to be delivered to the patient When the CO 2 absorber canister is inserted, the system is automatically configured in rebreathing modality.
Page 47: Description
Description 3.3.1 Patient circuit view CO 2 absorber canister with lock lever 10.1 Connector for supplied manual ventilation kit 10.2 Connector for gas scavenging circuit 10.3 Connector for inspiratory line 10.4 Connector for expiratory line flow sensor 10.6 Valves group cover to gain access to the accessories; opening side 10.7 Bellows with weight 10.8 Bellows jar 10.9 Automatic gas connections to anaesthesia units...
Page 48: Electric Connexion View
3.3.2 Electric connection view CO 2 absorber canister with lock lever 10.1 Connector for supplied manual ventilation kit 10.2 Connector for gas scavenging circuit 10.6 Valves group cover to gain access to the accessories; opening side 10.9 Automatic gas connections Support for connection: •...
Page 49: Upper View
3.3.3 Upper view 10.1 Connector for supplied manual ventilation kit 10.5 Unlock lever for CO 2 absorber canister release 10.6 Valves group cover to gain access for accessories Support for connection: • 10.a flow sensor RJ connector • oxygen sensor RJ connector 10.b Oxygen sensor and connection cable 10.c Expiratory valve (EXP) 10.d Flow sensor and connection cable...
Page 50: Use
When the CO 2 absorber canister is inserted, the system is automatically configured in rebreathing modality. When the CO absorber canister is removed, the system is automatically configured in non-rebreathing modality. 3.4.1 CO 2 soda lime absorber canister • The CO 2 absorber canister is positioned in the upper side of valves group; it can be easily disconnected by apposite lock lever, this functionality make it replaceable also during surgical interventions.
Page 51 Assembling and disassembling of absorber canister (e.g. disposable model) 1. To unpack carefully the CO 2 absorber canister. 2. Shake the absorber canister (disposable model) in order to separate the soda lime granules. 3. Remove the seal from absorber canister (disposable model). 4.
Page 52 WARNING. Risk of injury for the user/patient All the interventions must be effected exclusively by personnel highly qualified and specifically trained and formally authorized by SIARE. WARNING. Risk of malfunctioning To be effected only in case of maintenance on valves group. Pay much ATTENTION during this operation.
Page 53: Connections To Valves Group
3.4.2 Connections to valves group O 2 cell WARNING. Risk of injury for the user To avoid risks of electric shocks and/or break of components, during interventions, verify that the anaesthesia unit has been disconnected from power supply. 1. Unpack carefully the O 2 cell 2.
Page 54 Double hose patient circuit • Connect the supplied patient circuit to the apposite INS and EXP connectors on the valves group. • Position the patient circuit on the patient circuit supporting arm. Tidal Volume Set of hoses < 50 mL Neonatal Use a patient circuit suitable for the patient to...
Page 55 Kit for manual ventilation • Connect the hose of supplied manual ventilation to the “Bag” connector on the valves group. • Position the bag of the kit on the patient circuit supporting arm. MAN (MANUAL) operative mode: • select the MAN operative mode on the ventilator membrane key board;...
Page 56 MAPLESON C adult patient circuit • Connect the hose of supplied patient circuit to the “AUX” connector on front panel. • Position the patient circuit on patient circuit supporting arm. MAN (MANUAL) operative mode: • select the MAN operative mode on the ventilator membrane key board;...
Page 57 Control panel for manual ventilation On the left side of work-shelf it is positioned a small control panel to manage all the operations of manual ventilation with the valves group. This panel includes the following functions. • The APL valve for the adjustment of airways maximum pressure during manual ventilation.
Page 58: Description
Anaesthesia module with electronic flowmeters box 4.2.1 Main features Description of SE version 4.3.1 MENU 4.3.2 Electronic flowmeter box alarm 4.3.3 Various notes As regards assembly, interfacing and maintenance, refer to this manual or contact Siare’s technical assistance service. MORPHEUS...
Page 59: Introduction
All the pictures and the examples shown in the present chapter have the mere purpose of being an example and they do not make any reference to real clinical cases. Morpheus E SE Anaesthesia module (electronic flowmeter). User’s Manual, version DU3300105...
Page 60: Anaesthesia Module With Electronic Flowmeters Box
Anaesthesia module with electronic flowmeters box The anaesthesia module with electronic flowmeters box, has the function to regulate quantity and concentration in gas mixture (Air, O 2 , N 2 O) showing it on flowmeter box TFT display, as well as to delivery it to the anaesthetic gas vaporizer. It allows selecting the mixture to be delivered (Air-O 2 , or N 2 O-O 2 ) and the O 2 enrichment to the delivered mixture in emergency situations.
Page 61 Medical gas supply OXYGEN • Pressure included between 280 kPa and 600 kPa (2,8 - 6 bar) • Max. required flow 90 l/min. NITROUS OXIDE • Pressure included between 280 kPa and 600 kPa (2,8 - 6 bar) • Max. required flow 15 l/min. MEDICAL COMPRESSED AIR •...
Page 62 Control for activation Setting of manual modality (MAN) on ventilator keyboard with automatic deviation of fresh gas or deviation to the manual system of exit of fresh gas for of anaesthesia unit valves group, or to a to-and-fro circuit with manual ventilations.
Page 63: Description
Description Anaesthesia module: electronic flowmeter box ( 4 ) Membrane key for silencing the audible alarm of electronic flowmeter box. 5,7” colour TFT Monitor The symbol indicates if there is the activation of: • exhaust fresh gas selecting control: enabling of valves group (APL).
Page 64 Graphic area for indications electronic flowmeter box alarms • Lack or low O2 pressure with consequent cut-off of nitrous oxide delivery • Lack or low nitrous oxide pressure • Lack or low xenon pressure • Lack or low air pressure •...
Page 65 Flowmeter with mechanical indication of total flow of fresh gas delivered to the valves group. Membrane key to select the anaesthetic gas to be combined with the oxygen. WARNING! Risk of injury for the patient. This operating and selecting system is prevents the administration at the same time of air and nitrous oxide / xenon.
Page 66 Manometer for air supplies pressure control. Manometer for nitrous oxide supply pressure control. 4.10 Manometer for oxygen supplies pressure control. The opening of this regulator automatically supplies a flow of oxygen of about 25% of the total mixture. The flow of oxygen is visible on flowmeter, through the red indicator turning.
Page 67: Menu
4.3.1 MENU The electronic flowmeter box of the MORPHEUS anaesthesia unit is equipped on the display of an area for menu displaying (4.7) and a membrane keypad for the selection and eventual variation of parameter’ values shown (4.6). Use of the membrane keypad Press MENU to pass from standard operation displaying (flowmeters) to electronic flowmeter box MAIN MENU...
Page 68 Pressing the membrane key increase (decrease) to move vertically and select the parameter to be modified. Press the MENU membrane key to enable the parameter modification. Press the membrane key increase (decrease) to vary the parameter value. Press the MENU membrane key to confirm and store the modification of parameter value.
Page 69 Press the increase (decrease) membrane key to vertically move and: • select the parameter to be modified; • select CLOSE to escape from MAIN MENU. Press the MENU membrane key to escape and return to standard displaying. 4-12 User’s Manual, version DU3300105...
Page 70 Available parameters • Possibility to select between: N 2 O - USED GAS Xenon • Setting of gas supply low pressure LOW O2 PRESSURE alarm limit. • Language setting: italian, english, LANGUAGE french, spanish, german • Alarm volume setting VOLUME •...
Page 71 Available parameters – default values • N 2 O or Xe USED GAS • LOW O2 PRESSURE (BAR) • - - - - - - LANGUAGE • VOLUME • ENERGY SAVING • BRIGHTNESS • - - - - - - DATE / TIME •...
Page 72: Electronic Flowmeter Box Alarm
4.3.2 Electronic flowmeter box alarm The electronic flowmeter box of MORPHEUS anaesthesia unit is provided with a display area for alarms view (4.3) and a membrane key for their silencing (4.2). The alarms operating logic - set values from flowmeter box menu. •...
Page 73: Various Notes
4.3.3 Various notes WARNING! Risk of break of anaesthesia module. To not compromise the duration and the correct operation of regulators avoid to close them too energically. The flow value must be read in correspondence of the upper edge of flowmeter while it is rotating.
Page 74: Lung Ventilator Module
LUNG VENTILATOR MODULE This charter illustrates the lung ventilator module, and the graphics of display are mainly taken into consideration. All information to use and display parameters and functions of ventilator module are reported in a simple way. Ventilator switching on Ventilator switching off Monitoring areas and parameters configuration Operative mode area ( A )
Page 75: Ventilator Switching On
Ventilator switching on • Place the main power switch in position I (ON) ; anaesthesia unit power on. • On the ventilator front panel, verify the electric power supply led; green led on. • Keep STAND BY / ON-OFF Soft key pressed for a few seconds to turn the ventilator module on.
Page 76 Follow the instructions for the checking of pressure and flow sensor • In order to carry out the “ SELF TEST “ correctly, close or plug the Y-shaped coupling of the patient circuit, as requested on the display screen. The ‘SELF TEST’ phase continues MORPHEUS...
Page 77 Displaying at the end of the first phase of ‘SELF TEST’ Checking of the acoustic alarm operation • IN PRESENCE of the acoustic alarm, press Alarm Reset (see picture here below). • IN ABSENCE of acoustic alarm, do not press Alarm Reset (on the display an error message ‘Press AUT to start’...
Page 78: Self Test" Not Passed
Press the AUT soft key to enter the ventilator module display in STAND-BY. Consult the chapters 8 and 9 to solve the problem. If the malfunctioning is not solved, contact the nearest Siare Service Centre or authorized by Siare. MORPHEUS...
Page 79: Stand-By Displaying At The End Of " Self Test " Phase
5.1.2 STAND-BY displaying at the end of “ SELF TEST “ phase STAND-BY : Mode in which the ventilator is placed before the start-up or the switching off STAND-BY : The operative mode can be selected, the ventilation parameter related to the operative mode of interest can be configured or modified.
Page 80: Ventilator Switching Off
Ventilator switching off • Anaesthesia unit and working of lung ventilator • Press the STAND BY / ON-OFF soft key to stop the ventilator • Anaesthesia unit and lung ventilator in STAND-BY • Keep pressed the STAND BY / ON-OFF soft key for a few seconds to turn the ventilator module OFF Press the STAND BY / ON-OFF soft key : the ventilator return in the state of STAND-BY operative mode...
Page 81: Monitoring Areas And Parameters Configuration
Monitoring areas and parameters configuration A. Operative mode F. Mai menu B. Alarms G. Ventilation parameters setting area C. User’s controls area H. Graphics displaying and gas monitoring D. General information Ventilation parameters monitoring area E. Graphics setting area Use of encoder knob •...
Page 82: Operative Mode Area ( A )
Operative mode area ( A ) Automatic Ventilation • Turn the encoder knob to select the required operative mode ; press AUT button to activate the ventilation. • Press the STAND BY soft key to interrupt the ventilation. Assisted pressure controlled ventilation, synchronised with patient's breathing.
Page 83: Alarms Area ( B )
Alarms area ( B ) The alarm area provides two indications: • an information list relevant to the activated alarm type; • the displaying of the “alarm bell” symbol. Typology of alarm present on ventilator. • Configurable alarms • System alarms For further information on the operating logic and how setting the Alarms operating parameters, make reference to the relevant chapter, cfr.
Page 84: User's Controls Area ( C )
User’s controls area ( C ) On the right side of front panel a control board and an encoder knob are provided. These components allow a rapid interaction between the user and the ventilator. Soft key for audible alarm silencing. ALARM RESET Soft key for activation of automatic ventilation.
Page 85 The multifunction encoder knob is used to select, modify and confirm all the functions shown on display. The encoder knob is used to access the MENU function and then to function modes, parameters, alarms, parameters’ values and all is concerned to the normal operation of ventilator Use of encoder knob.
Page 86: General Information Area ( D )
General information area ( D ) Indication of set hour and date. Indication of operation time of anaesthesia unit. Green “BATTERY” symbol, indication of battery charge level: • with fix symbol the battery is completely charged; • with flashing symbol the battery is under charging. Green “PLUG”...
Page 87: Graphics Setting Area ( E )
Red colour indication, flashing: power failure indication. Red colour indication, crossed, flashing: indication of power failure alarm “inhibition”. The power failure alarm is reported both by the visual signals of the corresponding message in the alarm area and the high priority red bell, as well as by the flashing electrical power symbol.
Page 88 GRAPHICS displayed • No displaying enabled • • • • FLOW • • • • • • • Vt / PAW (*) • • F / Vt (*) • RP1 (*) At the paragraph “Graphics displaying area” (cfr. 5.11) are shown the functions to enable the characteristics of graphics displayed.
Page 89: Main Menu Area ( F )
Main Menu area ( F ) • Press the encoder knob to select the MENU area. • Press the encoder knob to display the “MAIN MENU” page. • Rotate the encoder to select the desired item of MAIN MENU area [ e.g. SETUP ]. •...
Page 90: Main Menu - Setup
5.9.1 Main Menu – SETUP Use the MENU - SETUP function to set the items necessary for the correct operation of the unit. Area Main Menu items - SETUP LANGUAGE It is possible to set the language among the following: •...
Page 91 ENERGY SAVING It is possible to set the percentage value of the energy consumption of the machine. The energy saving condition is active after 30 minutes calculated from the moment the keys are not pressed, either the soft keys or the encoder. If the value 0% is set the screen, when the energy saving function is activated, will be black.
Page 92 Compensation parameter for O measurement CONCENTRATION The 3 values are referred to the concentration of O • • 50 % • 85 % Compensation parameter for NO measurement CONCENTRATION The 2 values are referred to the concentration of N • •...
Page 93 TECHNICAL Selecting the “Technical Contact ” it is possible to access to CONTACT a screen where setting the data relevant to the service contact developed in 6 lines of text. Pressing the encoder it is possible to select the single fields and, the values could be set and /or modified by turning the knob.
Page 94 Besides, the information relevant to this parameter are dedicated to highly qualified personnel, specifically trained and formally authorized by SIARE. For further information on the GAS SENSOR operation, please refer to the relevant chapter. PREVIOUS PAGE Return to the first SETUP view.
Page 95: Main Menu - Alarms
5.9.2 Main Menu – ALARMS • Rotate the encoder to select the desired item of MAIN MENU area [ e.g. ALARMS ]. • Press the encoder to display the page of desired item of MAIN MENU [ e.g. ALARMS ]. •...
Page 96: Main Menu - Trends
5.9.3 Main Menu – TRENDS • Rotate the encoder to select the desired item of MAIN MENU area [ e.g. TRENDS ]. • Press the encoder to display the page of desired item of MAIN MENU [ e.g. TRENDS ]. The system through the TRENDS modality, enable the user to monitor the most significant breathing parameters on medium –...
Page 97 TRENDS displaying includes: • indication by trait or vertical bar which indicates on displayed graph the time shift • the graphs, displayed in pairs • the parameters, selectable in pairs by the encoder • the temporal references on 72 hours with sampling/displaying every 4 minutes To display the TRENDS parameters Rotate the encoder knob clockwise (counter clockwise);...
Page 98 Rotate the encoder clockwise (counter-clockwise) to move the trait/vertical bar indication on the two displayed trend graphs and consequently, the following data change: • the numerical value of the two enabled parameters • the time and the date of detection How to display further TRENDS parameters Press the encoder, this way further available parameters can be displayed.
Page 99: Main Menu - Events
5.9.4 Main Menu – EVENTS • Rotate the encoder to select the desired item of MAIN MENU area [ e.g. EVENTS ]. • Press the encoder to display the page of desired item of MAIN MENU [ e.g. EVENTS ]. The system through the EVENTS modality allows to the user to monitor the history on the operation of ventilator also including the alarm conditions activated during the patient ventilation.
Page 100 The EVENTS displaying includes: The main parts featuring the events overview are: • an arrow indicates the time movement • a column indicating event date and hour • a column indicating the event description (white - red) Displaying the EVENTS Turn the encoder clockwise (counter-clockwise): the temporary displaying of the EVENTS can be modified The possibility to display the other available parameters is...
Page 101: Main Menu - Patient Data
5.9.5 Main Menu – PATIENT DATA • Rotate the encoder to select the desired item of MAIN MENU area [ e.g. PATIENT DATA ]. • Press the encoder to display the page of desired item of MAIN MENU [ e.g. PATIENT DATA ]. For NOT loading patient data and go back to the first page: •...
Page 102 How to load the PATIENT DATA (e.g. Name) Rotate the encoder to activate Name box to fill in. Press the encoder to activate the Name script in the box to fill in. Rotate to select the first letter of the name to be written. Press to confirm and continue to complete the name insertion.
Page 103: Main Menu - Patient Data Erase
5.9.6 Main Menu – PATIENT DATA ERASE • Rotate the encoder to select the desired item of MAIN MENU area [ e.g. PATIENT DATA ERASE ]. • Press the encoder to display the page of desired item of MAIN MENU [ e.g. PATIENT DATA ERASE ]. Follow the instructions on the display of the lung ventilator Press the encoder to confirm the ERASE PATIENT DATA, the MAIN MENU is displayed...
Page 104: Main Menu - Default Parameters
5.9.7 Main Menu – DEFAULT PARAMETERS • Rotate the encoder to select the desired item of MAIN MENU area [ e.g. DEFAULT PARAMETERS ]. • Press the encoder to display the page of desired item of MAIN MENU [ e.g. DEFAULT PARAMETERS ]. Follow the instructions on the display of the lung ventilator Press the encoder to LOAD DEFAULT PARAMETERS, the MAIN MENU is displayed...
Page 105: Ventilation Parameters Setting Area ( G )
5.10 Ventilation parameters setting area ( G ) WARNING! Risk of injury for the patient.  According to the preferred mode of ventilation, the same respiratory physiological parameter ( PRF ) can be a dependent variable (i.e. variable as a result of changing other parameters) or independent (i.e.
Page 106  Press the encoder to modify the parameter [ Vte ].  Rotate clockwise (counter-clockwise) to increase (decrease) the parameter value [ Vte ].  Press the encoder to confirm the value.  Press and rotate the encoder to select the parameter to be modified.
Page 107: Operative Modes And Relevant Ventilation Parameters
5.10.1 Operative modes and relevant ventilation parameters Set the max limit value of airways pressure. The parameter it is used in the pressure control modalities and it is to fix an operative limit on airways pressure which should not be overcome. Set the airways positive pressure value in expiratory phase.
Page 108 Set the flow level (pressure) to recognize the patient spontaneous activity. (L/min) - (cmH2O). Set the airways positive pressures support value in inspiratory phase. Set the airways positive pressure value in expiratory phase. Set the time establishing the minimum duration of inspiratory period.
Page 109 Set the ventilator respiratory rate. Set the relation between inspiratory and expiratory phases. Set the flow level (pressure) to recognize the patient spontaneous activity. (L/min) - (cmH2O). Set the airways positive pressure value in expiratory phase. Set the duration of the inspiratory pause. The duration is shown on display in % (% of inspiratory time).
Page 110 Set the value of guaranteed tidal volume at each breathing act. Set the value of forced respiratory rate in SIMV mode. Set the time establishing the duration of the inspiratory period of ventilator. Set the flow level (pressure) to recognize the patient spontaneous activity.
Page 111: Graphics Displaying Area ( H - E )
5.11 Graphics displaying area ( H - E ) The system allows displaying and selecting: • the type and the number (max. 2) of graphics available (Graphics setting area) • the type of graphic (SETUP - GRAPHIC: Line / Square) •...
Page 112 GRAPHIC displaying: Line / Square ( H ) The MENU - SETUP - GRAPHIC function allows to the user to select the type of graphic. Line: the line of graphics is traced without filling Square: the line of graphics is solid Press the encoder “twice”...
Page 113 GRAPHICS VISUALIZATION : Single / Double The MENU - SETUP - GRAPHIC VISUALIZ. function allows the operator displaying, two graphics in spite of one, a larger type of graphic: Single or Double graphics. Single Charts: it is displayed a unique graphic, larger dimensions. Double Charts: two graphics are displayed.
Page 114 Single charts visualization “Graphics displaying area” E allows the operator to select and displaying one graphic only. Double charts visualization “Graphics displaying area” E allows the operator to select and displaying two graphics. At the paragraph ‘Graphics setting area’ (5.8) the graphics than can be displayed are shown.
Page 115: Ventilation Parameters Monitoring Area
5.12 Ventilation parameters monitoring area 5.12.1 Respiratory parameters monitoring The led bar indicator (with scale from - 20 to + 80 cmH 2 O) displayed in real- Airways pressure time the airways pressure. Indicates the end expiration positive Positive expiratory airways pressure pressure value.
Page 116: Gas Parameters Monitoring
It indicates the value of O 2 concentration inspired by the patient. It indicates the value of tidal volume Tidal expired volume during the patient inspiratory phase. It indicates the value of minute volume Minute volume expired by the patient. 5.12.2 GAS parameters monitoring The values monitored are measured through a Sidestream or Mainstream GAS analyzer connected to the Anaesthesia unit.
Page 117: Additional Parameters Monitoring
5.12.3 ADDITIONAL parameters monitoring This graphic configuration is active in H area and it is used to monitor additional respiratory parameters (concerning the displaying procedure please refer to the previous paragraph). Mean airways pressure It indicates the mean airways pressure: the measurement unit is cmH Pause pressure It indicates the pause pressure: the...
Page 118 Inspiratory pause It indicates the duration of the patient’s inspiratory pause: the measurement unit is seconds. This measurement represents the inspiratory time during which the ventilator maintains a constant airways pressure. Example: setting RATE=15, I:E=1:1, Ppause=50% gives an inspiratory pause time of 1 second.
Page 119 Inspiratory resistance This is the parameter of lung mechanics that describes the resistance to the flow opposed by the airways: it is measured in O/(l/s). The higher the patient’s resistance, the higher the pressure that must be applied to the airways to achieve the same volume. The algorithm used by the ventilator to calculate inspiratory resistance is as follows:...
Page 120: Calibration Programs (Service Area)
The specialist SIARE personnel or qualified technical personnel, formally authorised by SIARE, must be aware of the full contents of this manual before carrying out the operations described below. Authorised SIARE technicians have the appropriate tools and spare parts and are trained to operate while ensuring product safety.
Page 121: Introduction
5.13.1 Introduction The lung ventilator (from SW version 1.16.4) foresees an area where some programs useful for the calibration of the equipment are available. WARNING! Risk of injury for the patient / operator The different colour of the string identifying the program indicates if the same is ENABLED or NOT (e.g.
Page 122: Disable/ Enable Turbine (Not Available)
5.13.4 Turbine characterization (not available) For the activation of the Turbine Characterization programs, it’s recommended this operation to be performed by qualified personnel formally authorized by SIARE to intervene on the MORPHEUS line equipments. 5-49...
Page 123: Expired Flow Sensor Calibration
5.13.5 Expired flow sensor calibration The activation of the Expiratory Flow Sensor Calibration is needed when differences higher than 15% (over 100 ml) between the configured Volume (VTi – Vte) and expired Tidal volume (Vte) are detected. In case it’s the first calibration of the ventilator, it’s recommended to effect this calibration after having checked both the calibration of the PEEP and of the APL and the verification of possible leaks (TEST ON DEMAND).
Page 124: High Altitude
5.13.7 High Altitude The activation of the function High Altitude (High Altitude ON) is useful to optimize the calculation of oxygen concentration (FiO 2 ) at heights higher than 2000 mt on the sea level. 5.13.8 Exit The selection of the string ‘Exit’ allows the operator to quit the CALIBRATION PROGRAMS.
Page 125: Calibration Programs Activation
5.13.9 CALIBRATION PROGRAMS activation To enable the CALIBRATION PROGRAM displaying the anaesthesia unit Morpheus must be correctly connected and work. • Prepared for the use (cfr.: Maintenance, Cleaning and Disinfection and Sterilization). • Correctly positioned. • All the accessories and devices for the functioning to be prepared. •...
Page 126: Preparation To Use
PREPARATION TO USE In the first part of this chapter it is illustrated how to install the MORPHEUS anaesthesia unit. In the second part it is illustrated how to perform the preliminary tests before using the MORPHEUS anaesthesia unit. General warnings Before the use Preparation to use Preliminary tests –...
Page 127: General Warnings
General warnings UNPACK THE EQUIPMENT • Unpack carefully. • It is suggested to keep the original package, to avoid damages to the equipment in case it should be returned to the factory. TRANSPORT – equipment moving • Move the anaesthesia unit by the wide handle under the work- shelf perimeter which allows to grab and easily move the unit.
Page 128 • The assembly and connection of all the accessories must be carried out by highly qualified technical personnel, trained and formally authorised by SIARE. • This type of anaesthesia unit is not suitable for and therefore cannot be used in a hyperbaric chamber.
Page 129: Before The Use
It is recommended to use only original SIARE spare parts or spare parts checked and approved by SIARE. The absorber canister is positioned in the upper side of valves group. The specific lock (unlock) lever makes very easy to hook (unhook) the canister.
Page 130 • Press the specific lock “PUSH” lever (unlock). • Press down and release the specific lock lever (unlock). • Ensure the correct assembly When the CO2 absorber canister is inserted, the system is automatically configured in rebreathing modality. When the canister is removed, the system is automatically configured in non rebreathing modality (real open circuit).
Page 131: Battery Charger
6.2.3 Battery charger • The anaesthesia unit is equipped with an internal battery that guarantees (if perfectly efficient) at least 120 minutes operation (90 minutes, according to ventilation parameters), in case of power failure. • The switching to battery operation is made automatically: on the ventilator screen appears the relevant message “Power failure”.
Page 132 • Verify on the front module of ventilator (user’s control area) if the green led is light on (it indicates the main power supply). To ensure maximum autonomy of operation, it is necessary to guarantee sufficient recharging time. To bring the charge level from 0 to 90% takes approximately 10 hours recharging through the mains power supply.
Page 133: Preparation To Use
Preparation to use 6.3.1 Medical gas connection  The compressed air must be of medical type, therefore oil free and filtered.  The equipment can also work with oxygen supply only, but in this case the FiO will be adjustable at 99% only. An alarm on flowmeter, indicats low air condition will occur at start-up of the equipment.
Page 134: Connection Of Medical Gas Supply From Cylinders
WARNING! Risk of power failure. If all the gas supply hoses (from main system and cylinder)are not correctly connected, the system will not be available in case of gas supply failure. Ensure that all supply hoses are connected according with the indication engraved on the gas inlet bloc and the illustrations in the back side of the equipment.
Page 135: Medical Gas Connection Checks
WARNING! Risk of explosion. If the pressure reducers for O 2 are touched with fingers/hands soiled with oil or grease, there is the risk of explosion. Do not apply oil or grease on the O 2 cylinders pressure reducers and never touch with fingers soiled with oil or grease.
Page 136: Connection Of Anaesthetic Gases Scavenging System
6.3.4 Connection of anesthetic gases scavenging system Refer on the manual, relative to the scavenger manufactured by SIARE. WARNING! Risk of injury for the patient. If the scavenging collector of the anaesthesia unit is blocked, in the breathing system and in patient lungs could create a negative pressure.
Page 137: Patient Circuit Connections
6.3.5 Patient circuit connections Insert the patient circuit supporting arm in the specific bracket, fixed to the full-height steel rod used for accessories mounting. Tidal Volume Set of hoses Use a patient circuit < 50 mL Neonatal suitable for the patient to ventilate.
Page 138: Fresh Gases Exit - To And Fro Patient Circuit
6.3.6 Fresh gases exit – TO and FRO patient circuit WARNING! Risk of injury for the patient. Do not connect the patient directly to the fresh gases exit without an adequate ventilation circuit with pressure relief system. If the patient is connected to the fresh gases exit without an adequate ventilation circuit with pressure relief system, there will be an high pressure dangerous for the patient.
Page 139: Connection Of Circuit For Manual Ventilation
6.3.7 Connection of circuit for manual ventilation Apply to the anaesthesia unit the circuit for manual ventilation as shown in the picture. MAN operative mode To activate the manual ventilation circuit act on the fresh gases exit selection control: enabling of valves group (APL). 6-14 User’s Manual, version DU3300105...
Page 140: Use Of Antibacterial Filter
6.3.8 Use of antibacterial filter Apply the antibacterial filters to the patient circuit. WARNING! Risk of injury for the patient. Replace the antibacterial filters as per maintenance instructions (cfr. 10). WARNING! Risk of injury for the patient. To protect the patient from particles and dust, generated for example by the soda lime, it is necessary to use a filter between the inpiratory hose and the patient, i.e., the filter on the Y connector or the filter on inspiratory hose.
Page 141: Mains Power Supply
6.3.10 Mains power supply The electrical connections are a very important part in the installation of the anaesthesia unit. Incorrect connections or connections to unsuitable electrical systems can compromise the safety of the patient and the operator. The mains power supply must comply with the CEI 64-8/7 regulations concerning type A premises for medical use.
Page 142 The MORPHEUS anaesthesia unit complies with the requirements on electromedical equipment stated in the IEC/EN 60601-1-1 and IEC/EN 60601-1-2 directive. To ensure correct functioning of the MORPHEUS anaesthesia unit, it is advisable that any equipment to which it is connected also complies with the regulations mentioned above.
Page 143 Battery charger (cfr. 6.2.3) The anaesthesia unit battery can be recharged by leaving the anaesthesia unit connected to the main power supply (using power cable supplied with the unit) it is not necessary that the unit is on. For battery recharging follow what specified at par. 6.2.3. WARNING! Risk of failure.
Page 144: Protection Fuses
12Vdc battery WARNING! Risk of injury for the user / patient The operations described here below must be carried out by highly qualified technical personnel, trained and formally authorised by SIARE only. In case of break of protection fuse: •...
Page 145: Connection To Other Equipments
6.3.12 Connection to other equipments Connection to Siare equipment If the equipment to be connected is a SIARE unit, all the instructions necessary for the connection to anaesthesia unit can be found in the documentation supplied with the unit. WARNING! Risk of injury for the user / patient Do not connect external devices NOT manufactured or NOT authorized by SIARE to the anaesthesia unit (e.g., scavenging systems, patient...
Page 146: Table Of Predisposition Sequence For Use
6.3.13 Table of predisposition sequence for use Before the use 6.2.1 Assembling of O2 cell 6.2.2 Assembling of absorber canister 6.2.3 Battery charger Preparation to use 6.3.1 Medical gas connection 6.3.2 Connection of medical gas supply from cylinders 6.3.3 Medical gas connection checks 6-10 6.3.4 Connection of anesthetic gases scavenging system...
Page 147: Preliminary Tests - Introduction
WARNING! Risk of explosion and/or fire In case of suspected oxygen loss from anaesthesia unit or from other neareby, do not start using the unit. Close all the oxygen supplies and contact the nearest Siare Service Center. 6-22 User’s Manual, version DU3300105...
Page 148 Other setting functionalities are activated through user’s controls, but only for default parameters in service procedures. All maintenance and/or repair operations require perfect knowledge of the equipment and must therefore be carried out by highly qualified personnel, specifically trained and formally authorised by SIARE only. 6-23 MORPHEUS...
Page 149: Verification Activity - " Self Test
6.4.1 Verification activity - “ SELF TEST “ • Place the main power switch in position I (ON) ; anaesthesia unit power on. • On the ventilator front panel, verify the electric power supply led; green led on. • Keep STAND BY / ON-OFF Soft key pressed for a few seconds to turn the ventilator module on.
Page 150 Follow the instructions for the checking of flow sensors and pressure • In order to carry out the “ SELF TEST “ correctly, close or plug the Y-shaped coupling of the patient circuit, as requested on the display screen. The ‘SELF TEST’ phase continues 6-25 MORPHEUS...
Page 151 Displaying at the end of the first ‘SELF TEST’ phase. Checking of the Acoustic alarm functioning • In PRESENCE of acoustic alarm, press Alarm Reset (see the picture below) • In ABSENCE of acoustic alarm, do not press Alarm Reset (on the display an error message appears ‘Press AUT for starting’...
Page 152 Press the MAN key to enter in TEST ON DEMAND Pressing the button MAN, allows the access to a screen where it’s possible to enable some supplementary tests. See paragraph Preliminary tests - TEST ON DEMAND” (cfr. 6.5) for the instructions on the test procedure. Press the AUT key to enter the ventilator display in STAND-BY mode STAND-BY is the state condition of the lung ventilator at start-up of patient ventilation, or before turning off.
Page 153: Self Test " Not Overcome
Press the AUT soft key to enter the ventilator module display in STAND-BY mode. Consult the chapters 8 and 9 to solve the problem. If the malfunctioning is not solved, contact the nearest Siare Service Centre or authorized by Siare. 6-28...
Page 154: Self Test " Verifications
“SELF TEST “ phase, consult the service manual. If the “ SELF TEST “ phase is not overcome consult the chapters 8 (Alarms) and 9 (Troubleshooting) or contact the nearest Siare Service Centre or a center authorized by Siare. 6-29...
Page 155: Stand-By Displaying
6.4.4 STAND-BY displaying STAND-BY : is the state condition of the lung ventilator at start-up of patient ventilation, or before turning off. STAND-BY : Is possible to select the operative mode and/or modify all the ventilatory parameters relevant to the interested operative modality. Rotate and /or press the encoder knob to select the operative mode box or ventilation parameter to be set and or/modify Press the button AUT to start to ventilate a patient with an...
Page 156: Preliminary Tests - Operating Phase
Preliminary tests – Operating phase The anaesthesia unit must be ON, in STAND-BY operative mode, once overcome the preliminary tests. The preliminary tests aer divided in four categories: 1. TEST ON DEMAND • O 2 Sensor Calibration • Leak Test •...
Page 157: Preliminary Checks - Test On Demand
6.5.1 Preliminary checks - TEST ON DEMAND The choice of the entries necessari for TESTS ON DEMAND activation is made, or at the end of “SELF TEST” or through the selection of MENU – MAIN MENU box. Press (turn) the encoder until activating the MENU box.
Page 158 Turn (press) the encoder to select the NEXT PAGE entry: the second view appears. Turn (press) the encoder to select the entry: TEST ON DEMAND. Selecting the “TEST ON DEMAND” box, you enter a view where it i possible to activate the functional tests. 6-33 MORPHEUS...
Page 159 O 2 SENSOR CALIBRATION WARNING! - Risk of anaesthesia unit failure and/or injuries for the patient. This test verifies the correct O 2 sensor operation. WARNING! - Risk of injury to the patient. Perform the O 2 sensor calibration test weekly. •...
Page 160 At the end of O 2 sensor calibration the display shows the message: Test Completed (about 60mV) Test completed (60mV) indicates the correct value in tension of the O 2 sensor at 99% of oxygen. For a correct calibration it is necessary that the O 2 sensor is: •...
Page 161 LEAK TEST WARNING! - Risk of anaesthesia unit failure and/or injuries for the patient. This test verifies that there are no leaks higher than 100 ml in the anaesthesia unit pneumatic circuits. WARNING! - Risk of injury for the patient. Perform the Leak Test weekly.
Page 162 Verified what listed in the previous note: • close the patient circuit; • press the AUT key located on the keypad of ventilator, as required on the display. Basing on known and calculated data (flow, pressure and time), it is possible to find out the parameters shown on the display.
Page 163 30 cmH 2 O. If the “ TEST ON DEMAND “ phase is not overcome, consult the chapters 8 (Alarms) and 9 (Troubleshooting) or contact the nearest Siare Service Centre or authorized by Siare. 6-38 User’s Manual, version DU3300105...
Page 164 GAS SENSOR - ZERO CALIBRATION WARNING – Risk of failure of anaesthesia unit and/or injury to the patient. This PROCEDURE, to be used to perfom the zeroing of gas analyzer, is ENABLED only when a GAS PROBE is connected to the relevant connector positioned on the back side of the unit for anaesthesia.
Page 165 The probe calibration procedure starts and takes a few seconds. State indicator on the probe: the green flashing indicator signals that the probe zeroing is in progress. If the calibration procedure cannot be activated (see picture here below) ensure that: •...
Page 166 WARNING – Risk of failure to the anaesthesia unit and/or of patient injuries. If the calibration procedure of gas probe is not overcome (Test Aborted): (Sidestream ISA gas probe) and cfr. 9 (Mainstream IRMA gas probe). Exit to TEST ON DEMAND Turn the encoder to select the entry: EXIT.
Page 167: Preliminary Checks - Flowmeter Box
6.5.2 Preliminary checks – Flowmeter box The preliminary tests have the aim to verify the correct connection and functionality of anaesthesia unit and of all its modules. • Before using the anaesthesia unit on a patient it is necessary to perform a series of preliminary tests to verify the correct unit operation.
Page 168 Electronic flowmeter box Manometers Verify that the pressures of medical gases displayed in the manometers are from 280 kPa to 600 kPa (2,8 - 6 bar). MIX-LIFE (device used to avoid the administration of hypoxic mixtures). • Activate the enabling control (9.4) of valves group.
Page 169 CUT-OFF (alarm activated in case of leak of O2 pressure or low O2 pressure. • Enable and open the N 2 O regulator (4.7) at around 2 l/min on flowmeter (4.d). • Close the O 2 supply from distribution system. •...
Page 170 Apply the patient circuit to valves group; INSP.and EXP. connectors. • Apply the patient simulator (SIARE type) to the patient circuit connector. The suggested patient simulator for tests and checks is the SIARE code LS.AB.001 which is equipped with variable compliance and resistance. 6-45 MORPHEUS...
Page 171 • Open the O 2 (4.11) regulator or AIR (4.6) at 2 l/min. • Press the AUT key to activate the VC/VAC ventilation (cfr. 6.5.3) • The anaesthesia unit begins the inspiratory (expiratory) phase determining a variation of parametes measured in the monitoring area of ventilator.
Page 172: Preliminary Tests - Lung Ventilator
(Trig. I). Set the following respiratory physiological parameters. 500 ml 12 bpm Trig. I PEEP Pausa For tests and checks the suggested patient simulator is SIARE code LS.AB.001 which is equipped with variable compliance and resistance. 6-47 MORPHEUS...
Page 173 Parameters monitoring Press the AUT key: the anaesthesia unit begins ventilating. • Basing on set respiratory physiological parameters and on patient characteristics [patient simulator], the ventilator module can measure and monitor a series of significative magnitude for clinical evaluation. • Check the correspondence of measured parameters in function of set ones.
Page 174: Preliminary Tests - Alarms
In the upper side are displayed the measured parameters: accepted tolerance +/- 10% of set value. In the lower side are displayed the set parameters. Before checking the parameters, leave the anaesthesia unit in operation for at least 10 minutes. This time allows to the anaesthesia unit to operate at full.
Page 175 • Set thelow pressure alarm limit at 5 cmH 2 O. • During anaesthesia unit operation discounnect the patient simulator from patient circuit (SIARE type). Low pressure • After around 15 seconds the low airways pressure alarm occurs: silence the alarm.
Page 176: Conclusions
• see cfr. 8 (Alarms) and cfr. 9 (Troubleshooting); • contact the nearest Siare Service Center or authorize by Siare. WARNING! ! Risk of injuries for the patient Before connecting a patient to the anaesthesia unit check the alarms set vlaues (cfr. 8).
Page 177: Preliminary Tests Sequence Table
Preliminary tests sequence table Preliminary tests - Introduction 6-22 6.4.1 Verification activity - “ SELF TEST “ 6-24 6.4.2 “ SELF TEST “ not overcome 6-28 6.4.3 Verifiche in “ SELF TEST “ 6-29 6.4.4 STAND-BY displaying 6-30 Preliminary checks - Operating phase 6-31 6.5.1 Preliminary checks - TEST ON DEMAND...
Page 178: Ventilator Use
VENTILATOR USE In this chapter the use of ventilator module is illustrated, and some operation modes and physiological patient parameters are taken into consideration. Introduction Flowmeter box Lung ventilator Operative Modes Respiratory physiological parameters [ PRF ] Monitoring MAIN MENU WARNING! Risk of injury to the patient All the pictures and the examples shown in the present chapter have the mere purpose of being an example and they do not make...
Page 179: Introduction
Introduction The correct setting of respiratory parameters and alarms limits, as well as the selection of most suitable ventilation modality are not described in the present manual. The choice of the operation modalities and alarm limits most suitable for the physiological conditions and pathologies of the patient under anaesthesia, it will be up to the User.
Page 180: Flowmeter Box
Flowmeter box 7.2.1 Dosing and administration of fresh gas The term “ fresh gas ” means the gas mixture that is dosed in the anaesthesia module and in the anaesthetic vaporizer The fresh gas is continuously delivered to the valves group to be administered to the patient.
Page 181 High flows open circuit ( NON REBREATHING ) To perform this type of ventilation it is necessary to take off the soda lime canister from valves group. • The breathing gas concentration is similar to the fresh gas ones. • There is a high consumption of fresh gas •...
Page 182: Administration Of Fresh Gas In The "To And Fro" System
Administration of fresh gas in the "TO and FRO" system 7.2.2 In order to deliver the fresh gas flow to the TO and FRO system it is necessary that: • the lung ventilator is in MANUAL operative mode; • the TO and FRO patient circuit is connected to the AUX connector;...
Page 183: Electronic Flowmeter Box Pre-Setting
7.2.3 Electronic flowmeter box pre-setting After calculation of Minute Volume needed by the patient basing physiologic and pathologic conditions: • obtained from the product of Tidal Volume x Respiratory Rate (Vti x RR) Determinate the total flow of fresh gas to be introduced in the patient circuit basing on chosen dosage.
Page 184 • Adjust the O 2 flow. • Verify that the sum of flows set on the display of flowmeter box corresponds to the foreseen value. • Adjust the concentration of anaesthetic agent onto the vaporiser. On the control panel for manual ventilation, select the type of desired breathing circuit: •...
Page 185: Lung Ventilator
Lung ventilator 7.3.1 Operative mode selection At start-up the system restores the previous display state (mode and ventilation parameters) before shut-down. Description of the start-up phase of Morpheus anaesthesia unit: see on cfr. 5. Press the encoder to activate the MENU box.
Page 186: Respiratory Physiological Parameters [Hereinafter Prf] Setting
7.3.2 Respiratory physiological parameters [hereinafter PRF] setting Press the encoder to activate the MENU box. TURN the encoder until selecting the box of PRF parameter to be set. Press the encoder to activate the PRF parameter to be set. • TURN the encoder clockwise •...
Page 187: Default Prf Parameters Setting
7.3.3 DEFAULT PRF parameters setting Press the encoder to activate the MENU box. Press the encoder to activate the MAIN MENU selection. TURN the encoder until selecting the DEFAULT PARAMETERS box. Press the encoder to enable the DEFAULT PARAMETERS. 7-10 User’s Manual, version DU3300105...
Page 188 To NOT load the DEFAULT PARAMETERS, press the STAND BY / ON-OFF membrane key: returns to MAIN MENU view. Press the encoder to confirm the ENTERING OF DEFAULT PARAMETERS. The MAIN MENU window appears. To return to STAND-BY view • press the STAND BY / ON-OFF •...
Page 189: Patient Data Setting
7.3.4 PATIENT DATA setting For further details or information on PATIENT DATA SETTING see cfr. 5.9.5. 7.3.5 PATIENT DATA erase For further details and information on PATIENT DATA ERASING, see cfr. 5.9.6. 7-12 User’s Manual, version DU3300105...
Page 190: Operative Modes
Operative Modes Automatic Ventilation • Rotate the encoder knob to select the required operative mode ; press the button AUT to enable the ventilation. • Press the STAND BY soft key to interrupt the ventilation. Assisted pressure controlled ventilation, synchronised with patient's breathing.
Page 191: Stand-By
7.4.1 STAND-BY STAND-BY is the state condition in which the equipment is positioned at start-up (or for switch-off), on hold for start of ventilation in selected ventilation modality. In STAND-BY select the operative mode, set and/or modify all the ventilation parameters (PRF) relevant to the concerned operative mode.
Page 192: Apcv
7.4.2 APCV APCV is a pressure controlled ventilation, synchronised with the patient's breathing. With this parameters configuration, APCV is a pressure controlled ventilation, synchronised with the patient's breathing, during which the system generates a ventilates the patient at a pre-set inspiratory pressure (PLIM), a pre-set flow (Flow), a calculated I:E ratio and a settable respiratory rate (RR).
Page 193 7-16 User’s Manual, version DU3300105...
Page 194: Apcv-Tv
7.4.3 APCV-TV APCV-TV is a pressure controlled ventilation, synchronised with the patient's breathing (automatic PLIM) with assured current volume (Vte). The system generates a ventilation at automatic inspiration pressure (automatic PLIM), in order for the expired volume to equal the volume set (Vte). During the inspiratory phase, the ventilator generates an automatic flow.
Page 195 7-18 User’s Manual, version DU3300105...
Page 196: Psv
7.4.4 PSV PSV is an assisted type of ventilation with pre-set pressure support (PS) with assured safety respiratory rate set by the clinician in case of patient apnoea (RR bk). PSV can be used to sustain spontaneous ventilation for patients with stabilised ventilation needs or who are in weaning phase.
Page 197 With optimal PSV, the breathing pattern can be standardised (by increasing the Vte and reducing the respiratory rate) and the work of breathing can be reduced, improving the respiratory exchange ratios. In this mode the patient's work of breathing is assumed by the ventilator. Each breath initiated by the patient (Trig I activated) is supported by the ventilator, that sends a gas flow inside the airway, at a certain pre-set pressure, called support pressure (PS).
Page 198: Vc/Vac
7.4.5 VC/VAC The VC/VAC is a volume controlled ventilation (Vti), synchronized with the patient breaths if the inspiratory trigger is active (Trig. I). This type of ventilation, being completely made by the device, is used when the patient is not able to breathe autonomously, or, to assure an effective pre-set tidal volume, it is necessary to ventilate the patient in a fully mechanical way.
Page 199 7-22 User’s Manual, version DU3300105...
Page 200: Vc/Vac Baby
7.4.6 VC/VAC BABY The VC/VAC BABY is a volume controlled ventilation (Vte), synchronized with the patient breathing acts if the inspiratory trigger is activated (Trig. I). In this operative mode specifically for neonatal patient, respect to the previous VAC, it has been introduced a parameter identifying the max pressure limit which can be reached during ventilation.
Page 201 7-24 User’s Manual, version DU3300105...
Page 202: Simv (+Ps / Spont)
7.4.7 SIMV (+PS / SPONT) The SIMV is a Synchronized Intermitted Mandatory Ventilation, where the equipment delivers a certain number of breaths per minute (RRsimv) at a set volume (Vti). Furthermore, the SIMV allows to the patient to breathe spontaneously between the mandatory breaths with positive pressure support set (PS) if the patient inspiratory act is enough to activate the flow trigger (Trig.
Page 203 At this point the weaning is finished, the patient is weaned and autonomous in breathing functionality. Pay particular attention in setting the trigger: in fact, it it should be too high, or completely excluded, the patient should have full respiratory efficiency to survive.
Page 204: Man
7.4.8 MAN To activate the MAN operative mode it is necessary to press the MAN key on the membrane keyboard. The ventilator is ready for manual ventilation ( MAN ). During the manual ventilation (MAN) the ventilator displays the graphic of both the pressure and the Vte value of the Minute Volume.
Page 205 The manual ventilation can be effected by the bag connected to the “BAG” connector positioned on the breathing system through the supplied manual circuit. On the work-shelf keyboard must be selected the APL key (green led on). During manual ventilation, with MAN operative mode activated, it is possible to detect on the display the pressure curve and the various...
Page 206 A manual ventilation can be effected also with an auxiliary ventilation system, Mapleson C type (to and fro), connected to the “AUX” connector placed on the valves group. On the work-shelf keyboard must be selected the AUX key. Set on flowmeter box enough fresh gases for the correct ventilation of the patient.
Page 207: Apnoea Back-Up
7.4.9 APNOEA BACK-UP The apnoea BACK-UP is a safety feature for the patient which can be activated in the operative modes: PSV e SIMV+PS / SPONT (RR=0). The apnoea BACK-UP function is activated in case the patient, ventilated in one of the above mentioned operative modes, stops generating breaths.
Page 208: Respiratory Physiological Parameters [ Prf ]
Respiratory physiological parameters [ PRF ] In the picture the displayed parameters are referred to the APCV-TV operative modality and have the mere purpose of being an example and they do not make any reference to real clinical cases. • According to the preferred mode of ventilation, the same respiratory physiological parameter can be a dependent variable (i.e.
Page 209 Pause INSPIRATORY PAUSE Through this parameter it is possible to adjust the inspiratory pause timing, which is measured on display by the % of inspiratory time.; furthermore it is used for calculation of the respiratory mechanics parameters (compliance and resistance). Its duration can be extended from 0% to 60% of inspiratory time with steps of 1%.
Page 210 PRESSURE SUPPORT With this parameter it is possible to set the value of the positive pressure of airways in inspiratory phase. It is possible to adjust this parameter on values from 6 to 60 cmH O with steps of 1 cmH This parameter is used in the following operative modalities: PSV, SIMV.
Page 211 RR simv RESPIRATORY RATE OF SIMV With this parameter it is possible to set the respiratory rate in SIMV operative modality. Between a set breaths and the other it is possible to breathe in spontaneous way. The values can be set from NO, 1 a 119 bpm with steps of 1 according with Ti set.
Page 212 INSPIRATION TIME With this parameter it is possible to set the time establishing the duration of the ventilator inspiration period. It is possible to select values from 0.2 a 5.0 sec. sec. with steps of 0.1 seconds according with RR parameter set. This parameter is combined with APCV, VC/VAC BABY, and SIMV operative modes.
Page 213: Monitoring
Monitoring 7.6.1 Parameters monitoring The picture shows parameters referred to APCV-TV operative modality and they have the mere purpose of being an example and they do not make any reference to real clinical cases. The measurement of airways pressure in cmH O is displayed in two PAW (cmH different ways.
Page 214 It indicates the real respiratory rate value (breaths per time unit), RR (bpm) considering in the calculation, also the eventual spontaneous Respiratory rate activity. This measure allows to control that the ventilator respects the set rate and, in assisted modality, allows to evaluate the patient spontaneous activity.
Page 215: Monitoring Of Curves And Loops
7.6.2 Monitoring of curves and loops For further details and information on the Monitoring – Graphics, see cfr. 5.11 7.6.3 TRENDS For further details and information on the Monitoring – TRENDS, see cfr. 5.9.3. 7-38 User’s Manual, version DU3300105...
Page 216: Events
7.6.4 EVENTS For further details and information on the Monitoring – EVENTS, see CFR. 5.9.4. 7-39 MORPHEUS...
Page 217: Main Menu
MAIN MENU 7.7.1 MENU (first level) The user at MENU first level can choose among the following entries. • SETUP See next paragraph • ALLARMI See chapter 8 • See paragraph in the present chapter TRENDS • EVENTS See paragraph in the present chapter •...
Page 218: Menu (Second Level)
7.7.2 MENU (second level) Turn the encoder until activating the box of the desired entry (e.g., SETUP). Press the encoder: the view of selected entry (e.g., SETUP – see next page) appears. How select and modify an entry from menu Turn the encoder until activating the desired entry box (e.g., LANGUAGE).
Page 219 To return to initial view, press: • the STAND BY / ON-OFF key • or select the CLOSE box The User at second level of SETUP MENU can choose among the following entries: LANGUAGE It is possible to set the language GRAPHIC It is possible to select the type of graph VOLUME...
Page 220 PASSWORD Function NOT enabled: future uses TCP SETTING Optional function: it is not available in the present HW version TECHNICAL CONTACT It is possible to access to a screen where setting the data relevant to the service contact developed in 6 lines of text.
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Page 222: Alarms
ALARMS In this chapter the part of the system relevant to the alarms of ventilator module is illustrated; also the operating logic and issues for alarms action are taken into consideration Definitions General Displaying and used symbols List of alarms and priorities Alarms adjustment Regulations and default values table Description...
Page 223: Definitions
Definitions Disable an alarm Inactivate an alarm function. Alarm inhibition Abolition of alarm signals which persists unless intentionally revocated. Alarm restore Make that the alarm function is restored to its default initial state. Alarm stop and Causing the cessation and restore of an acoustic alarm by a silencing deliberate action.
Page 224: General
General The ventilator module is equipped with automatic means for detection and identification of serious and sudden events through alarm or information signals. The aim of the alarm signal is to draw the attention of the user on the event, as well as to indicate the required response speed;...
Page 225 • Some alarms can be suspended by means of the relative key (the suspension interval of the acoustic signal depends on the type of alarm). • Only the power supply failure alarm can be inhibited by the operator through a specific selection window in MENU.
Page 226: Displaying And Used Symbols
Displaying and used symbols Alarms display area Alarm area: this area of the monitor provides the following indications: • a string of text relevant to the type of active alarm; • an “alarm bell” symbol which indicates the priority and the alarm state. ALARMS parameter, MAIN MENU Through the encoder it is possible to select the entry of the ALARMS area - MAIN MENU to access the Min and Max.
Page 227: Alarm Area
8.3.1 Alarm area This area of the monitor provides the following indications: • a text string relevant to the type of activated alarm • a symbol “alarm bell” which indicates the priority and the alarm state. Configurable alarms (displayed alarms - text string) •...
Page 228 System alarms • Apnoea • Power Supply Failure • Low Battery 50% Rem. • Low Battery 25% Rem. • Low Battery 10 Min. Rem. • Turbine Failure (available with turbine driven, only) • Turbine Overcurrent (available with turbine driven, only) •...
Page 229: Alarms Parameter, Main Menu
8.3.2 ALARMS parameter, MAIN MENU This monitor area, through the encoder, allows to display and set the Min and Max. alarms values. Alarms with limits that can be set by the operator • From 2 to 20 cmH Low Pressure •...
Page 230 Alarms with limits that can be set by the operator • From 18 to 100 % Gas Sensor Low FiO 2 From 18 to 100 % • Gas Sensor Low EtO 2 From 0.0 to 12.9 % • Gas Sensor Low FiCO 2 From 0.1 to 13.0 % •...
Page 231: General Information Area
8.3.3 General information area For further details and information on ‘General information Area’, see cfr.5.7 8.3.4 Acoustic alarm silencing The membrane key, during the normal operating phase of ventilator, allows the silencing of active acoustic alarm. • Pushing the ALARM RESET button will stop the acoustic alarm for a defined time.
Page 232: List Of Alarms And Priorities
List of alarms and priorities 8.4.1 Lung Ventilator – configurable alarms Alarm type Priority Delay time (s) Suspendable Delay (s) Inhibition High Pressure 3 patient HIGH breaths HIGH Low Pressure 3 patient High Frequency HIGH breaths Low Frequency HIGH Min. Exp. Volume HIGH Max.
Page 233: System Alarms
8.4.2 System alarms Alarm type Priority Delay time (s) Suspendable Delay (s) Inhibition APNOEA HIGH BATTERY LOW 50% MEDIUM REM. BATTERY LOW 25% HIGH REM. LOW BATTERY 10 HIGH MIN. REM. TURBINE FAILURE HIGH TURBINE HIGH OVERTEMPERATURE TURBINE HIGH OVERCURRENT LOW GAS SUPPLY HIGH (auto if...
Page 234: Gas Sensor (If Provided) - Configurable Alarms
8.4.3 Gas Sensor (if provided) – configurable alarms Alarm type Priority Delay time (s) Suspendable Delay (s) Note Low FiO 2 HIGH Low EtO 2 HIGH Low FiCO 2 HIGH High FiCO 2 HIGH Low EtCO 2 HIGH High EtCO 2 HIGH Low FiN 2 O HIGH...
Page 235: Gas Sensor (If Provided) - System Alarms
8.4.4 Gas Sensor (if provided) – system alarms Alarm type Priority Delay time (s) Suspendable Delay (s) Note Sampling Line HIGH Clogged No Sampling HIGH Line Replace Adapter HIGH No Adapter HIGH O 2 Port Failure HIGH O 2 Sensor Error HIGH Unspecified HIGH...
Page 236: Alarms Adjustment
Alarms adjustment 8.5.1 How setting the ALAMRS-MENU entries WARNING !! Risk of injury for the patient Using in the same area more than one medical device having different alarm limits setting, the User could have a potential false misinterpretation. • Before using the anaesthesia unit it is suggested to use the MENU function to adjust the items necessary for the correct operation of the equipment.
Page 237 Press the encoder to enable the ALARMS function. • Turn the encoder to select the box of the alarm to be modified. • Press the encoder to activate the box if the alarm to be modified. • Turn the encoder to modify the numerical value of the alarm. •...
Page 238: How To Adjust The Alarm Volume
8.5.2 How to adjust the alarm volume The SOUND VOLUME parameter allows the adjustment of the volume of acoustic alarms signals at any priority level. Acoustic intensity value at 1 mt distance • Minimum level Acoustic Volume setting at 1 = 54dBA •...
Page 239 Turn the encoder until activating the box of VOLUME entry. Press the encoder: the box for parameter modification is activated. Turn the encoder to modify the VOLUME parameter value. Turn the encoder to activate the modification of desired VOLUME value. WARNING !! Risk of injury for the patient When the alarm Sound Volume is set to the minimum value (Setting = 1), its intelligibility can be lost.
Page 240: Regulations And Default Values Table
Regulations and default values table 8.6.1 Lung Ventilator WARNING! Risk of injury for the user / patient The anaesthesia units used in the same health environments can have different preset configurations of alarm limits. • Verify that the preset alarm limits are appropriate for the new patient or adjust the alarm limits on values suitable to the new condition of use.
Page 241 Low pressure This entry is used to set the low pressure alarm limit • 02 – 20 cmH 2 O High pressure This entry is used to set the high pressure alarm limit • 20 – 80 cmH 2 O Low frequency This entry is used to set the low respiratory frequency alarm limit •...
Page 242: Gas Sensor (If Provided)
8.6.2 Gas Sensor (if provided) The available regulations and the default regulations which can be selected by the operator are listed here below. Low FiO 2 This entry is used to set the low FiO 2 alarm limit • From 18 to 100 % Low EtO 2 This entry is used to set the low EtO 2 alarm limit •...
Page 243 This entry is used to set the low FiN 2 O alarm limit Low FiN 2 O • From 0 to 79 % This entry is used to set the high FiN 2 O alarm limit High FiN 2 O •...
Page 244: Description
Description 8.7.1 Alarms with limits that can be set by the operator High Pressure This alarm detects when the airway pressure rises above the upper limit (set in automatic or manual operative mode). This is a high priority alarm activated when the alarm limit for the inspiratory pressure is reached in no more than 3 consecutive breaths: in this situation, the expiratory valve will be immediately opened.
Page 245 Min. Exp. Volume This alarm signals the overcoming of the low limit of the corresponding parameter. This is a high priority alarm, activated after a delay of 15 s. An acoustic indicator and a flashing string in the alarms zone, as visual signal, are provided.
Page 246: System Alarms And Those That Cannot Be Set By The Operator
Power Supply This is a high priority alarm activated after a delay time of 0 Fault sec. from the moment the mains power supply is disconnected. It is indicated by an acoustic and a visual signal. It can be silenced (suspended) for 120 s and inhibited. The internal part of the electrical power symbol changes from steady green to flashing red.
Page 247 Battery Low 50% This alarm is activated 0 sec. after the battery voltage falls rem. below 50% of the fully charged level. It is a medium priority alarm indicated by an acoustic and visual signal. It can be silenced. Inhibiting the acoustic signal of this alarm is the same as that for the power supply failure alarm (there is however a visual signal in the alarm area).
Page 248 Turbine Over- This is a high priority alarm which is activated after a 0 sec temperature delay starting from the max limit of the turbine temperature (105°C) and it is restored once the temperature goes under the 100°C. It is indicated by an acoustic and visual alarm and it can be silenced but not inhibited.
Page 249: Gas Sensor (If Provided)
8.7.3 Gas Sensor (if provided) Sampling Line Clogged This alarm occurs in case the sampling line is obstructed. No Sampling Line This alarm occurs in case the sampling line has not been correctly connected. Replace Adapter This alarm occurs in case the used adaptor for the gas sensor doesn’t properly work ;...
Page 250 O 2 Calibration Required This alarm occurs in case the oxygen sensor calibration has not been properly done; the oxygen calibration has to be repeated. The alarms are active and present in function of the type and model of the gas sensor which has been used. The high priority alarm are activated when the specifically alarm condition is started.
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Page 252: Troubleshooting
If the problem persists, carry out a complete check of the MORPHEUS anaesthesia unit to identify any irregularities. If the problem cannot be resolved, contact the Siare Service Centre or a Centre authorised by Siare. List of malfunctioning...
Page 253 I/E, Trigger). • Check that the patient circuit is connected correctly to the anaesthesia unit and to the patient. • If this is not the case, contact the Siare Service Centre or a Centre authorised by Siare. User’s Manual, version DU3300105...
Page 254 Adjust or repair the supply system (or replace the cylinders) if the pressure is insufficient. • Contact the Siare Service Centre or a Centre authorised by Siare. Battery charge level This alarm is activated when the charge level of the battery is at...
Page 255 Check the condition of the cable and the connector (if necessary, restore the connection and replace the cable if damaged). • If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare. FiO 2 high This alarm is activated when the measured concentration of oxygen exceeds the set limit.
Page 256 Check that the patient circuit is connected correctly to the anaesthesia unit and to the patient. • If this is not the case, contact the Siare Service Centre or a Centre authorised by Siare. Max expired volume This alarm condition occurs in case the expired volume is higher than set value •...
Page 257 • Check that nothing is limiting the patient's respiratory capacity. • If this is not the case, contact the Siare Service Centre or a Centre authorised by Siare. PAW low In this condition, the patient circuit + patient system presents a lower resistance than expected or a higher compliance.
Page 258 Check that the patient circuit is connected correctly to the anaesthesia unit and to the patient. • Contact the Siare Service Centre or a Centre authorised by Siare Apnoea In this condition, no spontaneous respiratory activities is detected (RR = 0).
Page 259 Check that the gas sensor is connected correctly to the anaesthesia unit and to the patient. • Contact the Siare Service Centre or a Centre authorised by Siare. For further information on operating logic and on gas sensor malfunctioning, make reference to Gas Sensor User’s Manuals.
Page 260: Maintenance
MAINTENANCE To ensure correct functioning of the MORPHEUS anaesthesia unit, carry out the following maintenance operations at the scheduled intervals. All the operations must be adapted to the regulations in force in the individual health structures. 10.1 Cleaning, disinfection and sterilisation 10.2 General instructions 10.2.1...
Page 261 All maintenance and/or repair operations require perfect knowledge of the equipment and must therefore only be carried out by highly qualified personnel, specifically trained and formally authorised by SIARE. Inappropriate intervention or unauthorised modifications can compromise safety and cause danger to the patient.
Page 262: Cleaning, Disinfection And Sterilisation
SIARE cannot be held responsible for the efficacy of the cleaning, disinfection and sterilisation procedures, nor for the other procedures carried out while the patient is being treated.
Page 263: General Instructions
Rinse the parts well with clean hot water (tap water can be used) and leave to dry. • Siare recommends that the components should be checked every time they are cleaned and any damaged parts should be replaced. • Whenever a part or component is changed, check the functioning of the equipment.
Page 264: Disinfection By Immersion (Chemical)
• In normal conditions, disinfect and sterilize according to how often the machine is used and in any case at least once a month. Siare recommends: • that the components should be checked every time they are sterilized and any damaged parts should be replaced.
Page 265: Cleaning, Disinfection And Sterilisation Table
10.2.4 Cleaning, disinfection and sterilisation table Component Procedure Notes Outer casing Use a moistened disposable cloth with Make sure that no sprays neutral detergent or a chemical substance or or liquids penetrate inside the like. Use water to remove any remaining the equipment and the traces of chemical.
Page 266  Do not clean or re-use disposable circuit tubes.  Do not clean or re-use if the filters are the disposable type. WARNING! Risk of injury for the patient It is necessary to have at least one spare patient circuit in stock for routine use and /or accidental breaks.
Page 267 Perform daily checking’s of cable condition; any On the aim to guarantee patient and damage, also a minimum Electrical operator safety it is necessary to keep the damage, must be connections power supply cable in perfect conditions. promptly eliminated, eventually replacing the whole cable.
Page 268: Periodic Maintenance
When you require service, please indicate the serial number of the unit and the problem to SIARE or to your authorised technicians. • SIARE assumes responsibility for all provisions foreseen by the law, if the equipment is used and maintained as per the instructions in this manual and the technical manual •...
Page 269 Frequency Component Procedure / Action Several times a day Patient circuit Check for any water collection, drain and clean the tubes when necessary. Every day / when Condensation trap necessary filter According to local Filters Check for wear. practice and standards Anaesthesia unit General cleaning and checks.
Page 270: Cleaning, Disinfection And Sterilization Before Use With Another Patient
Frequency Component Procedure / Action Every year Anaesthesia unit Check the performance. This includes an electrical safety test and inspection of the ventilator for mechanical damage and legibility of the labels. The anaesthesia unit must also be inspected and checked in general and worn parts must be replaced, using the appropriate preventive maintenance kit.
Page 271: Repairs And Spare Parts
3/6 months, depending on the storage temperature. See the technical sheet in the Appendix. 10.6 Repackaging and shipment If it is necessary to return the equipment to SIARE for any reason, we suggest using the original packaging to prevent damage to the equipment during shipment.
Page 272: Disposal
10.7 Disposal Batteries, accumulators, O2 cells and electronic parts in general: • do not put them in the fire, explosion risk • do not open them, corrosion danger • do not recharge batteries • do not throw them away with normal waste. The batteries and the accumulators are special waste materials and they must be disposed of in appropriate containers in accordance with local regulations for the disposal of such waste materials.
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Page 274 APPENDIX - MORPHEUS OM3.SE This chapter includes all the information and data necessary to provide full knowledge and interpretation of the Manual for the MORPHEUS E anaesthesia unit. 11.1 Technical sheet 11.2 Glossary 11.3 Electromagnetic compatibility tables 11.4 Preliminary tests...
Page 275: Technical Sheet
11.1 Technical sheet 11.1.1 MORPHEUS E - cod. OM3.SE INTENDED USE The MORPHEUS E is an anaesthesia unit and it can be used on adult, children and newborn patients. The MORPHEUS E is suitable for administration of Oxygen - Air - Nitrous Oxide - Halothane - Enflurane - Isoflurane - Sevoflurane - Desflurane mixtures.
Page 276 ELECTRONIC GAS MIXING SYSTEM It has the function to regulate the capacity and the concentration of gas mixture (Air, O 2 , N 2 O) by displaying them on the TFT (5.7”) colour monitor and deliver it to the anaesthetic gas vaporizer. It allows to select the mixture to be delivered (Air - O 2 , or N 2 O - O 2 ) and the O 2 enrichment for delivered mixture in case of emergency.
Page 277 Gauges No. 3 on front panel (O O - AIR), scale 0 - 6 bar Electric power supply 100 ÷ 240Vac / 45 ÷ 60Hz Back-up battery 12Vdc - 3,0 Ah Pb battery; it grants 120 minutes operation • Alarms Lack or low O pressure with consequent cut-off of N O delivery...
Page 278 • No. 1 sockets for O 2 OUT gas sockets on gas supply group • No. 1 sockets O 2 - AIR for active scavenger feeding • No. 1 fresh gas connector for external use for ex. TO AND FRO (selectable by apposite membrane key on the front shelf - AUX).
Page 279 Self-Test Primary test: at anaesthesia unit’s start-up, a control test of Turbine presence, Medical Gas Supply presence, INSP and EXP flow sensors operation, pressure sensor, patient circuit losses, back-up battery state, oxygen cell, integrity of audible alarm is automatically performed. This test takes around 15 seconds.
Page 280 Flow trigger From OFF, 1 ÷ 15 L/min (step 1 L/min) Pressure trigger From -1 to -9 cmH 2 O under the PEEP level Safety Electronic and mechanical limit of airways pressure Self-diagnosis system • Low / High airways Pressure, Low / High Breathing Rate, Low / High O 2 Alarms Concentration, Low / High Tidal Volume, Electric Power Supply •...
Page 281 ELECTRIC POWER SUPPLY Electric power supply 100 ÷ 240Vac / 45 ÷ 60Hz Maximum power 120 Watt Back-up battery 12Vdc - 3 Ah Pb battery which guarantees an autonomy of around 120 minutes Charging time Around 10 hours CONFORMITY TO DIRECTIVES Class and type according with IEC 601-1 Class I Type B Class according with 93/42/EEC...
Page 282 11.1.2 Table for Identification of medical gas hose colours SYMBOL ISO & UK GERMANY OXYGEN White Green Blue NITROUS OXIDE Blue Blue Grey CARBON Grey Grey DIOXIDE CYCLOPROPANE Orange Orange MEDICAL AIR White & Black Yellow Yellow ENTONOX 50/50 O + O Blue &...
Page 283: Glossary
11.2 Glossary Ampere (current intensity measurement unit) Alarm message A message which appears together with an alarm indication; this consists of a basic message indicating the type of alarm. Alarm silencing or Key that stops the acoustic alarm signal for a software value preset suspension key by the last pressing of the key.
Page 284 European norm referring to the European Economic Community Electric power supply unit: the battery powers the system with direct current if the alternate current supply is not available. On the basis of the ventilator settings, the battery can provide back-up power for at least 3 hours in rated and perfect working conditions.
Page 285 INSP. PAUSE Inspiratory pause, a manoeuvre started by the operator which closes the inspiratory and expiratory valves during the inspiratory phase of a breath. This manoeuvre can be used to determine the static compliance (C) and the resistance (R). IPPV Intermittent Positive Pressure Ventilation IPPV - AST Assisted Intermittent Positive Pressure Ventilation: a ventilation mode...
Page 286 Mode Ventilation mode; an algorithm which determines the type and sequence of ventilation: the system offers a series of possible choices, including assisted, spontaneous or synchronized ventilation. Millisecond (unit of time). NIST Non-interchangeable screw thread: standard for high pressure gas inlet connectors.
Page 287 System error Definition used by the safety system of the ventilator. System errors include faults of the hardware inside the ventilator and which affect its performance, software errors which occur momentarily inside the ventilator and interfere with its normal functioning, an inadequate supply of alternate current or gas and the problems of integrity of the patient circuit (block or disconnection).
Page 288: Electromagnetic Compatibility Tables
11.3 Electromagnetic compatibility tables 11.3.1 Annex A: Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions The MORPHEUS is intended for use in the electromagnetic environment specified below. The customer or the user of the MORPHEUS should assure that it is used in such an environment. Emissions test Compliance Virdict...
Page 289: Annex B: Table 2
11.3.2 ANNEX B: Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity The MORPHEUS is intended for use in the electromagnetic environment specified below. The customer or the user of the MORPHEUS should assure that it is used in such an environment. Electromagnetic IMMUNITY test environment –...
Page 290: Annex C: Table 3
11.3.3 ANNEX C: Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity The MORPHEUS is intended for use in the electromagnetic environment specified below. The customer or the user of the MORPHEUS should assure that it is used in such an environment. Electromagnetic environment –...
Page 291 Recommended separation distances between portable and mobile RF communications equipment and the MORPHEUS The MORPHEUS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MORPHEUS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MORPHEUS as recommended below, according to the maximum output power of the communications equipment.
Page 292: Preliminary Tests
11.4 Preliminary tests In the following table: List of preliminary tests - MORPHEUS ANAESTHESIA UNIT 11-19 MORPHEUS...
Page 293 The leak test has been overcome? SCHEDULED MAINTENANCE To be performed by the operator. Has the periodic maintenance (that should be performed by the operator) performed? SCHEDULED MAINTENANCE To be performed by SIARE’s Service Department Has the scheduled maintenance been performed? Date......Signature..........11-20...
Page 294 11-21 MORPHEUS...
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Page 297 Anaesthesia Unit Morpheus E User's Manual Version DU3300105 Revision 5 - 02.05.2019. SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. Via Giulio Pastore, 18 Località Crespellano, 40053 Valsamoggia (BO), ITALY Tel.: +39 051 969802 - Fax: +39 051 969809 E-mail: mail@siare.it Web: www.siare.it...

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Morpheus series Morpheus lt Morpheus m

Siare Morpheus E User Manual

1 Introduction

2 Description

3 Valves Group Module

4 Description

5 Lung Ventilator Module

6 Preparation to Use

7 Ventilator Use

8 Alarms

9 Troubleshooting

10 Maintenance

11 Appendix

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Summary of Contents for Siare Morpheus E