Page 1 Anaesthesia Unit User's Manual – Morpheus LT / RMI...
Page 3 INTERNATIONAL GROUP s.r.l. as regards the anaesthesia unit and its use is limited to what is indicated in the guarantee supplied with the equipment. 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
SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. Tel.: +39 051 969802 - Fax: +39 051 969366 E mail: mail@siare.it Web: www.siare.it 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 MORPHEUS MRI...
Page 5: Definitions
Definitions Three symbols are used in this User’s Manual to indicate particularly important information. WARNING! This indicates a condition of danger for the patient or for the operator. CAUTION This indicates the possibility of danger to the equipment. N.B. This indicates information worthy of note, making the operation of the of MORPHEUS anaesthesia unit more efficient or practical.
Page 6: Warnings, Cautions And Notes
(model, serial number, ……) when requesting intervention. • SIARE recommends establishing a maintenance and service contract with SIARE or the local authorised service dealer in order to guarantee the scheduled maintenance required to operate the anaesthesia unit in a safe and correct manner.
Page 7 • 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.
Page 8 • The correct functioning of the anaesthesia unit can be impaired if original SIARE spare parts and accessories are not used; the use of other accessories is however allowed only if formally authorised by SIARE in accordance with current safety regulations.
Page 9 The equipment cannot be used in the presence of explosive gases. WARNING !! Before connecting the anaesthesia unit to other electrical equipment not described in this manual, a request for authorisation should be sent to Siare. WARNING !! Qualified staff must make the regulation of ventilation parameters. WARNING !! An auxiliary ventilation system is suggested for the patients for which the ventilator represents a life support.
Page 10 SIARE declines all civil and penal responsibility in the following cases: • If the anaesthesia unit is used in conditions and for purposes not stated or described in this manual. • If the anaesthesia unit is used by non-qualified personnel.
Page 11 Year of manufacture Check the identification data label of the equipment in the relative chapter. Manufacturer SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. Via Giulio Pastore , 18 - Località Crespellano, 40053 Valsamoggia (Bologna), ITALY Tel.: +39 051 969802 - Fax: +39 051 969366 E-mail: mail@siare.it - Web: www.siare.it...
Page 12 MORPHEUS MRI...
Page 13: Table Of Contents
Index Table of contents GENERAL INFORMATION ....................III Observations ........................... IV Definitions ............................V Warnings, cautions and notes ......................VI Table of contents ..........................III INTRODUCTION ..................... 1-1 1.1 Foreseen use ........................1-1 1.2 Versions ..........................1-1 1.3 Main technical characteristics ....................1-2 1.3.1 Trolley............................1-2 1.3.2 Valves group ..........................1-2 1.3.3 Flowmeter box ...........................1-3...
Page 14 Index VALVES GROUP MODULE ..................3-1 3.1 Introduction..........................3-2 3.2 Valves group ......................... 3-3 3.2.1 Main features ..........................3-3 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 3.4 Use ............................3-7 3.4.1 CO2 soda lime absorber canister ....................3-7 3.4.2 Connections to valves group ....................3-10 DESCRIPTION ......................
Page 15 Index 6.3 Preparation to use ....................... 6-11 6.3.1 Medical gas connection ......................6-11 6.3.2 Connection of anesthetic gases scavenging system ...............6-14 6.3.3 Patient circuit connections .......................6-15 6.3.4 Fresh gases exit - TO and FRO patient circuit ................6-17 6.3.5 Connection of circuit for manual ventilation ................6-18 6.3.6 Use of antibacterial filter ......................6-19 6.3.7 Mains power supply .........................6-20 6.3.8 Protection fuses ........................6-24...
Page 16 Index ALARMS ......................... 8-1 8.1 Definitions..........................8-2 8.2 General ..........................8-3 8.3 Alarms visualization ......................8-5 8.4 List of alarms and priorities ....................8-7 8.4.1 Regulations and default values table ..................8-8 8.5 Description ..........................8-9 8.6 Setting of alarm parameters ....................8-12 TROUBLESHOOTING ....................
Page 17: Introduction
40 years of experience and investment in technological innovation that we are implementing in recent years. Siare has focused heavily on innovation of materials, ergonomics and ease of use. All routine operations have been simplified and the operational procedures are “foolproof”, in this way there is no margin for the user to make incorrect or inadequate...
Page 18: Main Technical Characteristics
Introduction Main technical characteristics 1.3.1 Trolley The mechanic structure of the trolley is made of completely non-magnetic materials. The pedestal base is made of a shockproof ABS and polyester coated. This ensures an excellent impact resistance thanks to its flexibility and excellent abrasion resistance.
Page 19: Flowmeter Box
Introduction • The CO 2 absorber canister is located in the upper side and it easy to disconnect by apposite unlock lever. With canister inserted the system makes automatic configuration in rebreathing modality; with taken off canister, the system makes automatic configuration in non rebreathing modality (real open circuit).
Page 20 Introduction 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 LT/MRI 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 21: Correct Operation
To ensure the best performance of the MORPHEUS LT/MRI anaesthesia unit periodic maintenance of the ventilator by qualified technical personnel is recommended. For further information, contact SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. recommends careful reading of this manual and the relative labels before operating the ventilator or carrying out any maintenance.
Page 22: Applicable Norms
Introduction Applicable norms The MORPHEUS LT anaesthesia unit is made in accordance with the following norms: 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. General requirements for basic safety and essential performance.
Page 23 Introduction 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, DU3310103-MRI / rev.
Page 24: Description
Equipment identification Concerning the assembling, the interfacing and maintenance make reference to relevant chapters of the present manual or contact the SIARE Service Centre. WARNING! 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.
Page 25: Morpheus Lt/Mri
Description MORPHEUS LT/MRI Patient circuit supporting arm (on demand). CO2 absorber canister releasable with Work-shelf unlock lever. Vaporizers for anaesthetic gas Control panel for the management of (rapid Siaretex connection manual ventilation procedures. type, compatible with vaporizers equipped with 10. Valves group (breathing system). Interlock system).
Page 26: Trolley
Description 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 27: Control Panel For Manual Ventilation ( 9 )
Description 2.2.2 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 28 Description 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 29: Side View
Description Side view Steel vertical rod for accessories Ventilator module support Patient circuit supporting arm Connections for scavenger (on demand) and support. Control panel for management of manual ventilation Electric power supply group procedures. Valves group MORPHEUS MRI...
Page 30: Valves Group ( 10 )
Description 2.3.1 Valves group ( 10 ) CO 2 absorber canister with lock lever. Control panel for management of manual ventilation procedures. Connector for fresh gas exit. Valves group (cfr. 3). 10.1 Connector for supplied manual ventilation kit. 10.2 Connector for gas scavenging circuit. 10.3 Connector for inspiratory line.
Page 31 Description Valves group – user’s and inside view CO 2 absorber canister with lock lever. 10.1 Connector for supplied manual ventilation kit. 10.3 Connector for inspiratory line. 10.4 Connector for expiratory line. 10.5 Unlock lever for CO2 absorber canister release. 10.6 Valves group cover to gain access to the accessories;...
Page 32: Valves Group ( 10 )
Description 2.3.2 Connections for scavenger ( 21 ) ( 21 ) Valves group. 21.1 Gas supply connection for active gas scavenger. 21.2 Gas scavenging connector. 2.3.3 Electric power supply group ( 22 ) 22.1 Switch for front panel light. 22.2 Future uses.
Page 33: Back View
Description Back view Patient circuit supporting arm (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. capacity). 2-10 MORPHEUS MRI...
Page 34: Gas Supply Group ( 23 )
Description 2.4.1 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 35: Connectors For Services ( 24 )
PAW OUT : connector for measuring the PAW by external monitor. WARNING! Risk of equipment failure. 24.1 : white hose connected up, blue hose connected down WARNING! Risk of equipment failure. Use and connect devices authorized by Siare, only. 2-12 MORPHEUS MRI...
Page 36: Equipment Identification
Description 2.4.3 Equipment identification The identification label of MORPHEUS LT/MRI anaesthesia unit is applied in the back side of the same. 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.
Page 37 Description This page has been left blank intentionally to make front / back copying easier. 2-14 MORPHEUS MRI...
Page 38: Valves Group Module
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. User’s Manual, DU3310103-MRI / rev.3 - 02.05.2019...
Page 39: Introduction
Valves group MORPHEUS LT/MRI As far as assembly, interfacing and maintenance are concerned, make reference to the present manual or contact SIARE service. MORPHEUS MRI...
Page 40: Valves Group
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 41: Description
Valves group 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 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 unit...
Page 42: Electric Connexion View
Valves group 3.3.2 Electric connexion 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: 10.a •...
Page 43: Upper View
Valves group 3.3.3 Upper view 10.1 Connector for supplied manual ventilation kit 10.4 Connector for expiratory line 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 • oxygen sensor RJ connector 10.b Oxygen sensor and connection cable 10.c Expiratory valve (EXP)
Page 44: Use
Valves group 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 •...
Page 45 Valves group Assembling - 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).
Page 46 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 47: Connections To Valves Group
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.
Page 48 Valves group Flow sensor 1. Unpack carefully the flow sensor and the connecting hoses to detect the airways pressure. 2. Insert the flow sensor in the EXP adapter of valves group. 3. Fix correctly the hoses for the pressure detection from sensor to the adaptors on the anaesthesia unit.
Page 49 Valves group Double-hose patient circuit • Connect the supplied patient circuit to the apposite INS and EXP connectors (flow sensor) on the valves group. • Position the patient circuit on the patient circuit supporting arm. Tidal Volume Set of hoses <...
Page 50 Valves group 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 51 Valves group 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 52 Valves group 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 53 Valves group This page has been left blank intentionally to make front / back copying easier. 3-16 MORPHEUS MRI...
Page 54: Description
Introduction Anaesthesia module with mechanical flowmeters box 4.2.1 Main features Description of S5 version 4.3.1 Notes As regards assembly, interfacing and maintenance, refer to this manual or contact Siare’s technical assistance service. User’s Manual, DU3310103-MRI / rev.3 - 02.05.2019...
Page 55: Introduction
S5 Description 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 LT/MRI Example with anaesthesia module S5 (mechanical flowmeter 3 gas box with five rotameters).
Page 56: Anaesthesia Module With Mechanical Flowmeters Box
S5 Description Anaesthesia module with mechanical flowmeters box The anaesthesia module has the function to adjust the flow and concentration of gas mixture (Air, O 2 , and N 2 O) as well as to deliver 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 57 S5 Description Low flows oxygen Scale 0.1 - 1 l/min. rotameter Resolution: 0.05 l/min Accuracy: ± 10% of read value or: ± 1% of end scale whichever is the worst case. Low flow nitrous Scale: 0.1 - 1 l/min. oxide rotameter Resolution: 0.05 l/min Accuracy: ±...
Page 58 S5 Description AGAINST THE ADMINISTRATION OF HYPOXIC MIXTURES Safety devices MIX-LIFE: it always guarantees a minimum concentration of 25 % oxygen on mixtures which includes nitrous oxide. IN CASE OF LACK OR LOW OXYGEN PRESSURE CUT-OFF: audible alarm with immediate cut-off of Nitrous Oxide delivery. AGAINST FRESH GAS HIGH PRESSURE IN SUPPLY : safety valve calibrated at 0.8 bar for the protection of the glass rotameters.
Page 59 S5 Description Description Anaesthesia module (in the example shown above, the mechanical flowmeter box with five flowmeters). Oxygen flowmeter (max. flow 15 l/min). Oxygen flowmeter with 1 liter end-scale for low fows. Nitrous Oxide flowmeter (max. flow 12 l/min). Nitrous Oxide flowmeter with 1 liter end-scale for low fows AIR flowmeter (max.
Page 60 S5 Description WARNING! Risk of injury for the patient. This operation and selection system prevents the administration at the same time of air and nitrous oxide. Only the gas selected by key button (green led on) will be available on flowmeters. Air flow regulator for fresh gas (it opens in counter-clockwise).
Page 61: Notes
The indicated flow value must be read at the upper level of the rim of the flowmeter indicator when it rotates. If there is not rotation, call the Siare technical assistance. Reading point of flowmeter WARNING! Risk of injury for the patient.
Page 62 AD.A module VENTILATOR MODULE This chapter illustrates the ventilator module, and the graphics of display are mainly taken into consideration. All information to use and display parameters and functions of the ventilator module are reported in a simple way. Description Monitoring areas and functional areas 5.2.1 User’s controls area and operative mode selection...
Page 63: Description
AD.A module Description START-UP PROCEDURE OF THE VENTILATOR • 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 button pressed for a few seconds to turn the ventilator module on.
Page 64 • consult the chapters 8 and 9 to solve the problem; • consult the service manual; • if the malfunctioning is not solved, contact the nearest Siare Service Centre or authorized by Siare. User’s Manual, DU3310103-MRI / rev.3 - 02.05.2019...
Page 65 AD.A module STAND-BY DISPLAYING AT THE END OF “ SELF TEST “ PHASE. • Press one the PRESET key to set a default setting of respiratory parameters (newborn baby, child, adult). MORPHEUS MRI...
Page 66 AD.A module TURN-OFF PROCEDURE OF THE VENTILATOR • Keep pressed the STAND-BY / ON-OFF button for a few seconds to turn the ventilator module OFF. WARNING! All the figures and the examples reported in the present chapter are just indicative and they do not make any reference to real clinical cases.
Page 67: Monitoring Areas And Functional Areas
AD.A module Monitoring areas and functional areas A. Ventilation parameters monitoring D. Ventilation parameters setting area area E. Selection of default respiratory B. Controls for preliminary tests on parameters (newborn baby, child, device adult) C. User’s controls area and operative F.
Page 68: User's Controls Area And Operative Mode Selection
AD.A module 5.2.1 User’s controls area and operative mode selection To enter the ventilator module, keep pressed for a few seconds the STAND-BY / ON-OFF key. • Press the membrane key relevant to the operative mode to activate (the led relevant to the membrane key lights on).
Page 69: Controls For Preliminary Checks
AD.A module 5.2.2 Controls for Preliminary checks O 2 CELL CALIBRATION WARNING! - Risk of anaesthesia unit failure and/or injuries for the patient. This test verifies the correct O 2 cell operation WARNING! - Risk of injury to the patient. Perform the O 2 CELL CALIBRATION : consult the “Maintenance“...
Page 70 AD.A module • At the end of calibration procedure a FiO value equal to 99% is displayed. At the end of calibration procedure, if all has been performed properly, a percentage value equal to 99% should appear . For a correct calibration it is necessary that the cell is mounted in the apposite location and electrically connected by the apposite cable.
Page 71 AD.A module 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 : consult the “Maintenance“...
Page 72: Troubleshooting
AD.A module The losses value of anaesthesia unit is displayed in ml basing on known and calculated data (flow, pressure and time), The displayed value must be less than 100 ml. The values obtained during the LEAK TEST are displayed for the “compensation of dead space”...
Page 73: Preset Area
AD.A module 5.2.3 PRESET Area Default settings RATE (Bpm) Pmax (cmH2O) Trigger Vt (ml) 0050 0200 0500 FLOW (l/min) In STAND-BY modality. To activate the default settings keep pressed, for a few seconds, the membrane key relevant to PRESET settings of required respiratory parameters.
Page 74: Alarm Area
AD.A module 5.2.4 Alarm area Gas supply failure High airways pressure Low airways pressure Low O 2 concentration Apnoea Expired Tidal Volume Silencing of active acoustic alarm The battery symbol is combined with orange led indicating that: • Battery is charging (with main power supply connected) •...
Page 75: Ventilation Parameters Setting Area
AD.A module 5.2.5 Ventilation parameters setting area Trigger Set the flow level (pressure) to recognize the patient spontaneous activity. (l/min) (cmH 2 O). From OFF, 1 to 15 cmH 2 O / From OFF, -1 to -9 l/min Flow Upon selected operative mode, with this parameter it is possible to set the inspiratory flow value to be delivered by the ventilator.
Page 76 AD.A module Set the relation between inspiratory and expiratory phases. From 4:1 to 1:4. RATE Set the ventilator respiratory rate. From 5 to 90 Bpm (set value in function of max flow value of 80 liters). For further information on the logic and how setting the ventilation parameters, make reference to the relevant paragraph.
Page 77 AD.A module • Turn clockwise (counter-clockwise) to increase (decrease) the parameter value [ Vt ]. • 0400 The parameter value is flashing. • Press the knob to confirm the selected value. • The parameter value ( 0400 ) DOESN’T flash. Use of encoder •...
Page 78: Ventilation Parameters Monitoring Area
AD.A module 5.2.6 Ventilation parameters monitoring area Airways The led bar indicator (with scale from - 10 to + 80 cmH 2 O) displayed pressure in real-time the airways pressure. The value shown on the PAW indicates the maximum value of airways pressure (cmH VM, Vte, Ti, Ventilation parameters displaying are, selectable by soft key.
Page 79 AD.A module Ventilation parameters displaying • Press the key alongside the ventilation parameters monitoring to display in sequence other available values. VM (l) Minute volume It indicates the value of minute volume expired by the patient. The displayed value is in function of the parameters: Vt and RATE set.
Page 80 AD.A module Ti (sec) Inspiratory time It indicates the time value that states the duration of inspiration period. The displayed value is in function of parameters : I:E and RATE set. WARNING! 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.
Page 81: Flow Sensor Calibration
WARNING – Risk of failure to the anaesthesia unit and/or injuries to the patient. The flow sensor calibraition should be performed: • Exclusively by qualified and SIARE trained personnel. • When there are differences higher than 20% between set volume (Vt) and measured value of expired tidal volume (Vte).
Page 82 AD.A module 1. Press for around 5 seconds the soft key of ventilation parameters monitoring. 2. The flow sensor calibration procedure starts: The calibration phases are 5, and they corresponds to 5 flow values delivered by MORPHEUS: 0.0, 2.5, 5.0, 10.0, 20.0 l/min. During the calibration phase the valves group bellow rises and falls depending on the delivered flow.
Page 83 AD.A module 4. In the ventilation parameters setting area Flow “ ” is shown the sequence of flow values delivered by the MORPHEUS: 0.0, 2.5, 5.0, 10.0, 20.0 l/min. At the end of calibration the ventilator returns automatically in STAND- BY operative mode.
Page 84 AD.A module Setting of Vte alarm limit WARNING! After having performed the “Flow Sensor Calibration” it is necessary, each time, to set the value, in %, of Vte alarm limit. • LOFF, from L 10% to L 90% (step 10% ) •...
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Page 86: Preparation To Use
Preparation to use PREPARATION TO USE In the first part of this chapter is illustrated how to install the MORPHEUS LT/MRI anaesthesia unit. In the second part it is illustrated how to perform the preliminary tests before using the MORPHEUS LT/MRI anaesthesia unit. General warnings Before the use 6.2.1...
Page 87: General Warnings
Preparation to use General warnings UNPACK THE EQUIPMENT • Unpack carefully. • It is suggested to keep the original package, to avoid damages to the equipment in case of it should be returned to the factory. TRANSPORT – equipment moving •...
Page 88 • 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 89 Preparation to use If this is the first time you install anesthesia unit, it is suggested to consult thoroughly this manual. Before using the anaesthesia unit, clean the external surfaces and sterilize the components. Use the maintenance instructions provided in this manual and respecting the regulations in force in the country where the anaesthesia unit is sold.
Page 90: Before The Use
Preparation to use Before the use 6.2.1 Assembling of O 2 cell WARNING. Danger of injuries to the user To avoid the danger of electric shocks and/or break of component parts, during interventions, ensure that the electric power supply disconnected from anaesthesia unit. •...
Page 91: Flow Sensor Assembling
Preparation to use 6.2.2 Flow sensor assembling • Unpack carefully the flow sensor and the connecting hoses for airways pressure detection. • Insert the flow sensor in the EXP connector of the valves group. • Fix correctly the hoses for pressure detection from sensor to the connectors on the anaesthesia unit.
Page 92: Assembling Of Absorber Canister
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 apposite lock (unlock) lever makes very easy to hook (unhook) the canister.
Page 93 Preparation to use When the CO 2 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). It is possible to insert and remove the canister during interventions. The canister is available in reusable or pre-loaded disposable versions.
Page 94: Battery Charger
Preparation to use 6.2.4 Battery charger • The anaesthesia unit is equipped with an internal battery (Pb 12Vdc 3Ah) that guarantees (if perfectly efficient) at least 120 minutes operation (90 minutes, according to ventilation parameters), in case of power failure. •...
Page 95 Preparation to use Follow the instructions. • Connect the outlet of the power cable to the plug on the anaesthesia unit. • Insert the plug of the power cable in the mains supply wall socket. The electric main power supply must correspond to that indicated in the identification label in tbe back side of the machine.
Page 96: Preparation To Use
Preparation to use Preparation to use 6.3.1 Medical gas connection Screw the gas supply hoses (O 2 , AIR, N 2 O) to relevant connectors of the gas supply group. Screw the gas supply hoses (O 2 , AIR, N 2 O) to the relevant connectors of the hospital distribution system (O 2 , AIR, N 2 O).
Page 97 Preparation to use The equipment can also work with oxygen supply only, but in this case the FiO 2 will be adjustable at 99% only. WARNING! Risk of equipment failure. In order that the anesthesia machine operates as specified, the inlet pressures of medical gases must be between 280 kPa and 600 kPa (2.8 - 6 bar).
Page 98 Preparation to use Medical gas connection checks WARNING! Risk of gas power failure. This check is strictly necessary and has to be performed whenever a hose from hospital gas distribution system is mounted on the machine (first connection or first replacement of hoses or connectors for maintenance reasons).
Page 99: Connection Of Anesthetic Gases Scavenging System
Preparation to use 6.3.2 Connection of anesthetic gases scavenging system Consult the manual relevant 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 100: Patient Circuit Connections
Preparation to use 6.3.3 Patient circuit connections Patient circuit supporting arm Insert the patient circuit supporting arm in the apposite bracket, fixed to the full-height steel rod used for accessories mounting. Patient circuit connections Tidal Volume Set of hoses Use a patient circuit suitable for the patient to ventilate.
Page 101 Preparation to use WARNING! Risk of injury for the patient. Whenever the circuit is changed or replaced, it is necessary to perform the LEAK TEST to verify eventual leaks and the compliance of patient circuit (Preliminary tests cfr. 6.4). WARNING. Risk of strangling. Pay special warning when connecting the patient circuit to the anaesthesia unit.
Page 102: Fresh Gases Exit - To And Fro Patient Circuit
Preparation to use 6.3.4 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 103: Connection Of Circuit For Manual Ventilation
Preparation to use 6.3.5 Connection of circuit for manual ventilation Apply to the anaesthesia unit the circuit for manual ventilation as shown in the picture. Select on ventilator: MAN operative mode. To activate the manual ventilation circuit act on the fresh gases exit selection control: enabling of valves group (APL).
Page 104: Use Of Antibacterial Filter
Preparation to use 6.3.6 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...
Page 105: Mains Power Supply
Preparation to use 6.3.7 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 106 Preparation to use • Verify on ventilator module front side (user’s control area) if the green led is on (it indicates the presence of main power supply). WARNING! Risk of personal-physical injuries To prevent the risk of electric shock, connect the power cable of the lung ventilator to an earthed socket.
Page 107 Preparation to use Battery power supply • The battery, inside the MORPHEUS LT/MRI anaesthesia unit, must always be installed. • If the battery is not fitted, the anaesthesia unit is not protected against fluctuations or failures of the power supply. •...
Page 108 Preparation to use The operation time of the anaesthesia unit guaranteed by the battery can vary in the following cases: • old battery or not perfectly efficient; • not standard ventilatory parameters. Battery charger (cfr. 6.2.4) The anaesthesia unit battery can be recharged by connecting the anaesthesia unit to main power supply (using power cable supplied with the unit) it is not necessary that the unit is on.
Page 109: Protection Fuses
12Vdc battery power supply 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 110: Connection To Other Equipments
Preparation to use 6.3.9 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.
Page 111: Table Of Predisposition Sequence For Use
Preparation to use 6.3.10 Table of predisposition sequence for use Before the use 6.2.1 Assembling of O2 cell 6.2.2 Montaggio del sensore di flusso 6.2.3 Assembling of absorber canister 6.2.4 Battery charger Preparation to use 6-11 6.3.1 Medical gas connection 6-11 6.3.2 Connection of anesthetic gases scavenging system 6-14...
Page 112: Preliminary Tests - Introduction
• it is used a patient simulator fixed to the terminal of supplied patient circuit. The patient simulator suggested for tests and checking’s is SIARE code LS.AB.001 which is equipped with variable compliance and resistance.
Page 113 WARNING! Risk of explosion and/or fire In case of suspected oxygen loss from anaesthesia unit or from other nearby, do not start using the unit. Close all the oxygen supplies and contact the nearest Siare Service Center. Risk of accidental movement.
Page 114: Verification Activity - " Self Test "
Preparation to use 6.4.1 Verification activity - “ SELF TEST “ Position the main power supply main switch in position (ON) ; anaesthesia unit start-up On the ventilator front panel, verify the electric power supply led; green led on. Keep STAND-BY / ON-OFF button pressed for a few seconds to turn the anaesthesia unit on.
Page 115 Preparation to use After checks of displays and leds il ventilator proceeds with “ SELF TEST “ and displays: • tESt ( execution of electronic test phase) • ( release of installed software ) • 0006 (operation hours) During the “ SELF TEST “ phase the system verifies Gas supply Verification of the presence of Air and O 2 supply pressure...
Page 116 “ SELF TEST “phase, consult the service manual; • if the case of persisting of malfunctioning, contact the nearest Siare Service or Siare authorized center. At the end of “ SELF TEST “ the ventilator automatically pass to STAND-BY view.
Page 117 Preparation to use STAND-BY displaying at the end of “ SELF TEST “ phase STAND-BY is the state condition of the anaesthesia unit at start-up, or before turning off. In STAND-BY, select the operative mode and/or modify all the ventilatory parameters (RPP) relevant to the interested operative modality.
Page 118 Preparation to use MORPHEUS anaesthesia unit OFF • Operative mode: STAND-BY • Keep pressed the STAND-BY / ON-OFF button for a few seconds to turn the anaesthesia unit OFF. WARNING! Risk of injuries for 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 any reference to real clinical cases.
Page 119: Preliminary Checks - Operating Phase
Preparation to use Preliminary checks – Operating phase The anaestesia 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 CELL CALIBRATION •...
Page 120: Preliminary Checks
Preparation to use 6.5.1 Preliminary checks O 2 CELL CALIBRATION WARNING! - Risk of anaesthesia unit failure and/or injuries for the patient. This test verifies the correct O 2 cell operation WARNING! - Risk of injury to the patient. Perform the O 2 CELL CALIBRATION : consult the “Maintenance“ chapter.
Page 121 Preparation to use • A FiO 2 value equal to 99% is displayed at the end of calibration procedure. At the end of calibration procedure, if all has been correctly performed, a percentage value of FiO 2 equal to 99% shoould be displayed.
Page 122 Preparation to use 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. ATTENZIONE - Rischio di lesioni al paziente. Perform the LEAK TEST : consult the “Maintenance“...
Page 123 Preparation to use The losses value of anaesthesia unit is displayed in ml basing on known and calculated data (flow, pressure and time), The displayed value must be less than 100 ml. The values obtained during the LEAK TEST are displayed for the “compensation of dead space”...
Page 124: Preliminary Checks - Flowmeter Box
Preparation to use 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 125 Preparation to use Flowmeter box S5 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 126 Preparation to use 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 (4.2). • Close the O 2 supply from distribution system.
Page 127 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 LS.AB.001 which is equipped with variable compliance and resistance.
Page 128 Preparation to use • Apen the O 2 (4.11) regulator or AIR (4.6) at 2 l/min. • Press the AUT key to activate the 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 129: Preliminary Tests - Lung Ventilator
Proceed as described for setting of needed respiratory physiological parameters: for more details see chapter 5, Ventilation parameters . The patient simulator suggested for tests and checking’s is SIARE code LS.AB.001 which is equipped with variable compliance and resistance. 6-44...
Page 130 Preparation to use Trig. I 500 ml RATE 15 bpm PEEP Pmax Press the VAC key: the anaesthesia unit begins ventilating. Basing on set respiratory physiological parameters and to the characteristics of the patient [patient simulator], the ventilator module measures and displays the value to be verified.
Page 131 Preparation to use Parameters monitoring and spirometry • 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 132 Preparation to use 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 133: Preliminary Tests - Alarms
For additional information on alarm operation logic consult cfr. 8. • • Low pressure During anaesthesia unit operation discounnect the patient simulator from patient circuit (SIARE type). • After around 15 seconds the low airways pressure alarm occurs: silence the alarm. •...
Page 134 Preparation to use • • Power failure During the anaesthesia unit operation place on OFF ( 0 ) the main switch (cfr. 6.3.9). • The power failure alarm occurs: silence the alarm. • The indication “ Power failure“ is activated. •...
Page 135 • 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 136: Preliminary Tests Sequence Table
Preparation to use 6.5.5 Preliminary tests sequence table Preliminary tests - Introduction 6-27 6.4.1 Verification activity - “ SELF TEST “ 6-29 Preliminary checks – Operating phase 6-34 6.5.1 Preliminary checks 6-35 6.5.2 Preliminary checks – Flowmeter box 6-39 6.5.3 Preliminary tests –...
Page 137 Preparation to use This page has been left blank intentionally to make front / back copying easier. 6-52 MORPHEUS MRI...
Page 138 AD.A module USE OF VENTILATOR MODULE In this is illustrated the use of ventilator module, and some operation modes and physiological patient parameters are taken into consideration. Preliminary Flowmeter box 7.2.1 Dosing and administration of fresh gas 7.2.2 Administration of fresh gas in the "TO and FRO" system 7.2.3 Mechanical flowmeter box pre-setting Lung ventilator: AD.A...
Page 139 AD.A module Preliminary • 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 140: Flowmeter Box
AD.A module 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 141 AD.A module 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. •...
Page 142 AD.A module Low flows semi-closed circuit ( REBREATHING ) • The fresh gas flow in the patient circuit is a litter higher than the basal consumption of the patient; therefore, the used gas concentration can be very different than the ones of the fresh gas. •...
Page 143: Administration Of Fresh Gas In The "To And Fro" System
AD.A module 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; •...
Page 144: Mechanical Flowmeter Box Pre-Setting
AD.A module 7.2.3 Mechanical 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 145 AD.A module • Adjust the O 2 flow. • Verify that the sum of the flows read on all flowmeters corresponds 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 146: Lun G Ventilator
AD.A module Lung ventilator: AD.A How selecting the operative mode Description of the start-up phase of MORPHEUS LT/MRI anaesthesia unit: see on cfr. 5. At the end of “ SELF TEST “ the ventilator automatically switches to STAND-BY view. • Press the membrane key relevant to the operative mode to activate (the led relevant to the membrane key lights on).
Page 147 AD.A module How setting the default respiratory parameters RATE (Bpm) Pmax (cmH2O) Trigger Vt (ml) 0050 0200 0500 FLOW (l/min) In STAND-BY modality. To activate the default settings keep pressed, for a few seconds, the membrane key relevant to PRESET settings of required respiratory parameters.
Page 148 AD.A module How setting the physiological respiratory parameters [PRF] Example: Modification of Vt parameter • Press the key alongside the parameter to be modified. • 0500 The parameter value will start flashing. • Turn clockwise (counter-clockwise) to increase (decrease) the parameter value [ Vt ].
Page 149: Operat Ive Modes
AD.A module Operative modes STAND-BY State condition in the equipment is positioned awaiting the start of ventilation in selected ventilation modality. Pressure Control Ventilation. Volume Controlled / Volume Assisted Controlled. Manual ventilation. 7-12 MORPHEUS MRI...
Page 150: Stand-By
AD.A module 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 151 AD.A module 7.4.2 PCV Respiratory physiological parameters in PCV Trigger Flow 60 l/min RATE 15 bpm PEEP Pmax 30 cmH The PCV is a pressure controlled ventilation synchronized with patient breath, in which the system delivers a ventilation at a preset inspiratory pressure (Pmax), a preset flow (Flow), for an inspiratory time (Ti), an I:E ratio calculated and an adjustable rate (Rate).
Page 152 AD.A module The PCV supplies a tidal volume upon the pressure limit (Pmax) and the patient pulmonary conditions (compliance, pulmonary capacity) therefore the tidal volume varies to changing of mechanic pulmonary conditions. During the inspiratory phase the ventilator generates an adjustable flow (Flow). When the control pressure is reached in airways (Pmax), such pressure level is maintained constant by the ventilator, until the end of inspiratory act adjustable by (Rate) and inspiratory time (Ti).
Page 153 AD.A module 7.4.3 VAC Respiratory physiological parameters in VAC Trigger 500 ml RATE 15 bpm PEEP Pmax 30 cmH The VAC is a volume controlled ventilation (Vt), synchronized with the patient breaths if the inspiratory trigger is active (Trigger). 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 154 AD.A module The inspired volume (Vt) is pre-set and it is delivered in a preset time (Rate and I:E) and determines the characteristics and the width of the necessary pressure to reach the preset quantity of gas mixture to be delivered. A tented inspiratory act of the patient is detected by the system (Trigger) which automatically provides to send a gas flow to the airways at a preset volume (Vt).
Page 155 AD.A module 7.4.4 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. 7-18 MORPHEUS MRI...
Page 156 AD.A module 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). Set on flowmeter box enough fresh gases for the correct ventilation of the patient.
Page 157 AD.A module 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 158: Respiratory Physiological Parameters [ Prf ]
AD.A module Respiratory physiological parameters [ PRF ] 7.5.1 Ventilation parameters 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. The respiratory physiological parameters can be set manually in STAND-BY before activating any operative mode.
Page 159 AD.A module Trigger The threshold of flow level is set (or pressure) for recognition of patient spontaneous activity in l/min (cmH 2 O). The ventilator. once recognized such spontaneous activity provides to deliver a synchronized inspiratory act with patient tented breath The detection of spontaneous activity is displayed when the orange indicator lights on.
Page 160 AD.A module Pmax In pressure mode it is possible to set the airways pressure limit. In volumetric modality it is possible to set the limit level of airways high pressure alarm. • Set the pressure limit from: 10 to 80 cmH 2 O. For a better detection of abnormalities on the airways pressure, it is suggested to set the value of: PAW HIGH is 10 cmH 2 O over peak pressure reached by the patient.
Page 161 AD.A module By this parameter it is possible to set the relation between the inspiratory time and expiratory time. This relation can be set in different ways upon the respiration type and the mode. The variation of this parameter modifies the inspiratory flow but not the tidal volume.
Page 162: Monitoring
AD.A module Monitoring 7.6.1 Ventilation parameters monitoring area Airways The led bar indicator (with scale from - 10 to + 80 cmH 2 O) displayed in pressure real-time the airways pressure during respiratory phase. The value shown on the PAW indicates the maximum value of airways pressure (cmH VM, Vte, Area for ventilation parameters displaying, selectable by soft key.
Page 163 AD.A module FiO 2 The value shown on the FiO 2 display indicates the percentage value of O measured which is delivered to the patient. After the self-calibration phase (see the relevant procedure by the CAL button), the display shows the value of 99%. In case of malfunctioning of the cell and/or its connection interruption after around 30 seconds the alarm sounds and the relevant led red lights on.
Page 164: Power Supply
AD.A module Power supply Battery symbol combined with green led: • Full battery • Recharging battery (with main power supply The green led on indicates the connection) main power presence. Power failure fault (main power supply) Battery symbol combined with red-green flashing led: •...
Page 165 AD.A module Battery symbol combined with red led: • Battery charge level = 10% An acoustic signal is activated and cannot be silenced; residual operation lower than 10minutes. Flashing led in red colour (high priority alarm): such an high severity alarm condition indicates that the battery is almost completely exhausted.
Page 166: Alarms
Alarms: AD.A module ALARMS In this chapter is illustrated the part of the system relevant to the alarms of ventilator module; also the operating logic and issues for alarms action are taken into consideration. Definitions General Alarms visualization List of alarms and priorities 8.4.1 Regulations and default values table Description...
Page 167: Definitions
Alarms: AD.A module 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 168: General
Alarms: AD.A module General The ventilator module is equipped with automatic means for detection and identification of serious and sudden events through alarm signals 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 169 Alarms: AD.A module Logic on alarm management • The system checks the status of each alarm in every verification cycle identified in the software. • The signal of alarm active state after a time to trigger, during which the alarm condition should persist (the time to trigger is variable upon the type of alarm and operative mode in use).
Page 170: Alarms Visualization
Alarms: AD.A module Alarms visualization Not operating fan It is displayed during the Self Test phase at ventilator start-up. Gas Supply No gas supply It is activated when the gas pressure is under 2,4 bar High PAW High airways pressure VAC : it can be set through Pmax parameter PVC : when it overcomes the pressure...
Page 171 Alarms: AD.A module FiO2 Low oxygen Fixed value: it is activated when the concentration oxygen concentration is lower and/or equal to 19% Operating or not present It is activated when the cell is exhausted cell or disconnected: no signal is detected by the system.
Page 172 Alarms: AD.A module Power failure fault (main power supply) Battery symbol combined with green led: • Full battery • Recharging battery (with main power supply connection) Battery symbol combined with red-green flashing led: • Battery charge level = 100% Without main power supply connected the led starts flashing in red- green colour, with activation of an acoustic signal which could be silenced;...
Page 173: List Of Alarms And Priorities
Alarms: AD.A module List of alarms and priorities Alarm type Priority Delay time (s) Suspendable Delay (s) HIGH HIGH Gas Supply HIGH High PAW MEDIUM Low PAW HIGH FiO2 MEDIUM Apnoea MEDIUM Power failure Until 10% of HIGH (main power battery charge supply) MORPHEUS MRI...
Page 174: Regulations And Default Values Table
Alarms: AD.A module 8.4.1 Regulations and default values table The available regulations and the default regulations which can be selected by the operator are listed here below. Gas supply No setting High PAW This entry allows to set the high pressure alarm limit: •...
Page 175: Description
Alarms: AD.A module Description Gas Supply It is activated if the oxygen supply pressure is at a value lower than minimum required for equipment operation. It is signalled by an acoustic and visual alarm. High PAW This alarm indicates the violation of upper limit (set in the operative mode) of airways pressure.
Page 176 Alarms: AD.A module This alarm is activated when the value of expired tidal Volume is higher (lower) than the value in % of max. (minimum) limit set by the operator. It is signalled by an audible and visual alarm. It can be silenced (suspended) for 20 s.
Page 177: Setting Of Alarm Parameters
Alarms: AD.A module Setting of alarm parameters How setting and/or modifying the Pmax parameter • Press the key aside the Pmax parameter • The value of the parameter ) will start flashing • Turn clock-wise (counter-clockwise) to increase (decrease) the parameter value [Pmax ].
Page 178 Alarms: AD.A module How setting and/or modify the Vt parameter (Vte alarm) Keep pressed for at least 5 seconds the key aside the Vt parameter The display shows the DEFAULT parameter referred L 50 to the Vte alarm ( ) or a value previously set L 50 The DEFAULT parameter ( ) flashes...
Page 179 Alarms: AD.A module The display returns autonomously to Vt parameter displaying WARNING. Danger of injuries for the patient The Vte alarm signal is activated when the value of expired tidal Volume will be higher (lower) than the value in % of max (minimum) limit set by operator.
Page 180 If the problem persists, carry out a complete check of the MORPHEUS LT/MRI anaesthesia unit to identify any irregularities. If the problem cannot be resolved, contact the Siare Service Centre or a Centre authorised by Siare. No power The anaesthesia unit does not switch on •...
Page 181 “SELF TEST” phase. • Turn off and on the anaesthesia unit and repeat “SELF TEST” phase. • Contact the Siare Service Centre or a Centre authorised by Siare. Keys and The keys or the encoder knob do not work encoder knob •...
Page 182 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 % This alarm is activated when the measured concentration of oxygen is below the set limit.
Page 183 • 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 184 Check that the corresponding alarm limits are set correctly. • Check the expired flow sensor calibration • Contact the nearest Siare Service Centre or a Centre authorised by Siare. VTE low This alarm is activated when the expired tidal volume is lower than the set value.
Page 185 Check that the patient circuit is connected correctly to the ventilator and to the patient. • Contact the nearest Siare Service Centre or a Centre authorised by Siare. Apnoea In this condition, no automatic or spontaneous respiratory is detected (Rate = 0).
Page 186: Maintenance
Maintenance MAINTENANCE To ensure correct functioning of the MORPHEUS LT/MRI 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 187 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 188: 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 189: 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 190: Disinfection And Sterilisation
• 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 191: Disinfection By Immersion (Chemical)
If a steam disinfection chamber is not available, the dismantled parts can be chemically disinfected by means of immersion. Immerse the dismantled components in the solution with the disinfectant, following the manufacturer’s instructions. Siare recommends: • not using formaldehyde or phenol-based disinfectants as they can cause cracking and reticulation of plastic parts;...
Page 192: Cleaning, Disinfection And Sterilisation Table
Maintenance 10.2.4 Cleaning, disinfection and sterilisation table Component Procedure Notes Outer casing Use a moistened disposable cloth with Make sure that no neutral detergent or a chemical substance sprays or liquids or the like. Use water to remove any penetrate inside the remaining traces of chemical.
Page 193 Maintenance Patient Dismantle and clean, then sterilize in an Before using again, circuit autoclave, disinfect with steam or eliminate any humidity (silicone chemically. inside the tubes by hoses) means of compressed air. Check that there are no splits in the tubes and replace them if they are damaged.
Page 194 Maintenance Breathing Dismantle and clean, then sterilize in an Before using again, system autoclave, disinfect with steam or eliminate any humidity chemically. inside the components by means of compressed air. Flow sensor Single patient use type at differential It is possible to sterilize pressure with gamma rays or with ethylene oxide (ETO), at...
Page 195: 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 196 Maintenance Frequency Component Procedure / Action Several times Patient circuit Check for any water collection, drain and clean a day / the tubes when necessary. according to Filters Verify their wear. local practice and standards Condensation trap Check for any water collection, drain and clean filter when necessary.
Page 197 Maintenance Frequency Component Procedure / Action Every 6 Oxygen sensor Replace. months or The working life of the cell depends on the 1000 working working environment. If the temperature or the hours O2 % is high, the working life of the sensor will be lower.
Page 198: Repairs And Spare Parts
Spare parts kit for annual maintenance to be used with the MORPHEUS LT/MRI anaesthesia unit. 10.4 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 199: Disposal
If it is believed that the anaesthesia unit will be left unused for at least 6 months, Siare recommends disconnecting the battery or recharging it every 3/6 months, depending on the storage temperature.
Page 200: Appendix
Appendix APPENDIX This chapter includes all the information and data necessary to provide full knowledge and interpretation of the manual for the MORPHEUS LT/RMI anaesthesia unit. 11.1 Technical sheet 11.2 Table for Identification of medical gas hose colours 11.3 Glossary 11.4 Electromagnetic compatibility tables 11.4.1...
Page 201: Technical Sheet
Appendix 11.1 Technical sheet INTENDED USE The MORPHEUS LT/MRI is an anaesthesia unit that can be used on adult, children and newborn patients. The MORPHEUS LT/MRI is an anaesthesia machine compatible for Magnetic Resonance rooms from 1,5 T (15000 G) and from 3 T (30000 G) and positionable at a min.
Page 202 Appendix GAS MIXING SYSTEM It has the function to regulate the capacity and the concentration of gas mixture (Air, O 2 , N 2 O) as well as to 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 203 Appendix OXYGEN Medical gas supply • 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.
Page 204 Appendix • OUT gas sockets on gas No. 1 sockets for O 2 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 keyboard on the front shelf - AUX).
Page 205 Appendix Automatic compensation Present (max. 5000 mt) of atmospheric pressure on measured pressure Respiratory parameters Present (newborn, children, adult) default setting Flow generation Electronic system Gas feeding Medical compressed air or Oxygen with pressure included between 280 kPa and 600 kPa (2,8 – 6 bar) Autotest Primary test: at anaesthesia unit’s start-up, a control test of medical gas supply, sensors operation, back-up battery, oxygen cell, integrity of the alarm audible...
Page 206 Appendix ELECTRIC POWER SUPPLY Electric power supply 100 ÷ 240Vac / 45 ÷ 60Hz Maximum power 100 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 Dir.ve.
Page 207: Table For Identification Of Medical Gas Hose Colours
Appendix 11.2 Table for Identification of medical gas hose colours SYMBOL ISO & UK GERMANY OXYGEN White Green Blue NITROUS Blue Blue Grey OXIDE CARBON Grey Grey DIOXIDE CYCLOPROPAN Orange Orange MEDICAL AIR White & Black Yellow Yellow ENTONOX 50/50 O + O Blue &...
Page 208: Glossary
Appendix 11.3 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 209 Appendix Electromagnetic Compatibility 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 210 Appendix 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...
Page 211 Appendix 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 212 Appendix 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 213: Electromagnetic Compatibility Tables
Appendix 11.4 Electromagnetic compatibility tables 11.4.1 Annex A: Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions The Morpheus LT is intended for use in the electromagnetic environment specified below. The customer or the user of the Morpheus LT should assure that it is used in such an environment. Virdict Emissions test Compliance...
Page 214: Annex B: Table 2
Appendix 11.4.2 ANNEX B: Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity The Morpheus LT is intended for use in the electromagnetic environment specified below. The customer or the user of the Morpheus LT should assure that it is used in such an environment. Electromagnetic IMMUNITY test environment –...
Page 215: Annex C: Table 3
Appendix 11.4.3 ANNEX C: Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity The Morpheus LT is intended for use in the electromagnetic environment specified below. The customer or the user of the Morpheus LT should assure that it is used in such an environment. Electromagnetic environment –...
Page 216: Annex E: Table 5
Appendix 11.4.4 ANNEX E: Table 5 Recommended separation distances between portable and mobile RF communications equipment and the Morpheus LT The Morpheus LT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Morpheus LT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Morpheus LT as recommended below, according to the maximum output power of the communications equipment.
Page 217 Appendix 11-18 MORPHEUS MRI...
Page 218: Preliminary Tests
Appendix 11.5 Preliminary tests In the following table: List of preliminary tests - MORPHEUS LT ANAESTHESIA UNIT 11-19 User’s Manual, DU3310103-MRI / rev.3 - 02.05.2019...
Page 219 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 220 Appendix 11-21 User’s Manual, DU3310103-MRI / rev.3 - 02.05.2019...
Page 221 Appendix This page has been left blank intentionally to make front / back copying easier. 11-22 MORPHEUS MRI...

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Siare Morpheus Series User Manual

1 Introduction

2 Description

3 Valves Group Module

4 Description

5 Lung Ventilator Module

9 Troubleshooting

6 Preparation to Use

8 Alarms

10 Maintenance

11 Appendix

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