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8 Specifications

8-2

MIRUS Controller, SW 2.03.02, Additional Information Master (en-GB)

8.1 General

Application

Intended use:

Application, dosing and control of volatile anaesthetic

agents to humans with tidal volumes

≥ 200mL

Product type:

Active medical device, reusable, standalone

Restrictions:

Only to be used in combination with MIRUS Reflector and
MIRUS Filter

Area of application:

Anaesthesia applications in medical environment

(Intensive care, intermediate care, recovery room,

operating theatre)

Usage:

Stationary

Patients:

Patients under the need of sedation, with Vt

≥ 200mL.

Applicable agents:

Volatile anaesthetic agent (VA)

- Isoflurane

- Sevoflurane

- Desflurane

Appl. state of VA:

Gaseous

Working principle:

Diffusion optimised vaporiser without fresh gas

Physical dimensions

Length:

approx. 325 mm, 12.8 in.

Depth:

approx. 210 mm, 8.2 in.

Height:

approx. 195 mm, 7.6 in.

Weight:

approx. 9.0 kg, 15.4 lb, including filled agent reservoir

Set-up

MIRUS Controller:

Equipped with:

- integrated side stream gas monitoring

- MIRUS DOGA = diffusion optimised application

of anaesthetics

- MAC Pilot = automatic control and adjustment of

applied anaesthetic dose according to set target MAC

Options

HW options

MC-MC-ISO:

for VA Isoflurane

MC-MC-SEVO:

for VA Sevoflurane

MC-MC-DES:

for VA Desflurane

Operation

Structure:

Multi-layer screen arrangement

Principle:

Select

– Adjust – Confirm

Operation control:

Touch screen

Control button with guidance light

Menu language:

English, German, French, Italian, Spanish, Polish

Содержание Mirus MC DES

Страница 1: ...Additional Information MIRUSTM Controller Software version 2 03 02 Hardware version 2 n...

Страница 2: ...lication identifier AI Every UDI number can be divided into several parts each designated by its AI number 01 Global Trade Item Number GTIN 11 Date of manufacture YYMMDD 21 Serial number SN 91 Referen...

Страница 3: ...s 1 12 1 4 2 MIRUS Operating and Configuration screens 1 13 1 4 3 MIRUS Software update screen 1 18 1 5 MIRUS Controller modes 1 19 1 6 Abbreviations and terms used in this manual or on the equipment...

Страница 4: ...3 4 Facility requierements 3 3 3 5 Gas supply 3 4 3 6 Agent supply 3 4 3 7 Functional description 3 5 3 8 System controls 3 6 3 9 Handling before first use of MIRUS Controller 3 7 3 9 1 Cleaning befor...

Страница 5: ...6 2 Maintenance 6 4 6 2 1 General information 6 4 6 2 2 Schedule 6 4 6 2 3 Visual inspection 6 5 6 2 4 Electrical safety test 6 5 6 2 5 Checking gas monitor 6 6 6 2 6 Checking pump 6 7 6 2 7 Safety fu...

Страница 6: ...8 3 MIRUS Controller Connection Interface 8 4 8 4 MIRUS Controller User Interface 8 5 8 5 MIRUS Controller Controls and Ranges 8 6 8 6 MIRUS Controller Performance 8 8 8 7 MIRUS Controller Monitoring...

Страница 7: ...used in this manual 5 1 4 Graphical user interface 6 1 4 1 Symbols on menu buttons 6 1 4 2 Status icons 7 1 4 3 Buttons 8 1 4 4 Button states and behaviour 10 1 4 5 Colour code used in graphical user...

Страница 8: ...US System The MIRUS System consists of three devices MIRUS Controller MC The electrical device that contains the anaesthetic agent and controls the agent delivery MIRUS Reflector MR The multi patient...

Страница 9: ...quipotential bonding conductor 6 Interface receptacle 7 Confirm button 8 Slot for SD cards downloading of event log data or for SW updates 9 Touch screen 10 Fire wire port Serial data output for PDMS...

Страница 10: ...raphical user interface via touch sensitive screen Confirm button Confirm actions performed on the touch screen display by pressing the Confirm button when flashing in anaesthetic colour within 5 seco...

Страница 11: ...inance MPBetreibV is required Warranty seal Warranty void if seal is broken 1 3 Symbols used in this manual Operate by touching an icon or symbol During operation the MC has diverse screens with diffe...

Страница 12: ...1 4 Graphical user interface 1 4 1 Symbols on menu buttons Home Standard operation screen Patient data settings MAC Pilot settings Set wash in speed Respiratory monitoring Alarm settings MULTI settin...

Страница 13: ...ing allowed operation time of MR in anaesthetic colour Agent reservoir symbol shows remaining liquid level in anaesthetic colour Device is powered by AC power supply Device is powered by battery shows...

Страница 14: ...ctive High priority alarm sound muted Low priority alarm sound active Low priority alarm sound permanently muted 1 4 3 Buttons In order of appearance Repeat e g a failed self test in starting procedur...

Страница 15: ...etting button showing unit and current value Press to set value with arrow buttons aside e g Alarm volume Instructive animation to open Fill port Activate mode Disable mode or Cancel SW update Female...

Страница 16: ...a value Inactive button Normal state active but not yet pressed Button is pressed and highlighted in anaesthetic colour For final acceptance confirmation with Confirm button is needed Buttons to selec...

Страница 17: ...4 5 Colour code used in graphical user interface Colour in graphical user interface for Sevoflurane For demonstration purposes Sevoflurane yellow highlighting colour is used in this IFU Colour in grap...

Страница 18: ...Controller screens 1 5 1 MIRUS Start up screens Initial screen Power up test System is starting and performing safety tests with its components System test System is performing safety tests with its c...

Страница 19: ...Operating and Configuration screens On Call screen System is up and waiting for user action Home screen no delivery Set MAC value and start the delivery Refer to Chapter 8 8 for default values Power u...

Страница 20: ...active Set MAC value and pause or stop the delivery Snooze Screen Appears only during active delivery and no activity on the touch screen for 10 minutes Patient data screen Adjust gender age size weig...

Страница 21: ...lecting turtle slow rabbit medium or cheetah fast Comment Wash in speed default is rabbit MAC Pilot screen delivery active This screen is to set the wash in parameter Choose wash in speed by selecting...

Страница 22: ...b screens which are described below The last selected screen will appear when pushing the MULTI settings tag For user configuration the following can be selected initialisation of the filling process...

Страница 23: ...able settings Time setting screen First set your time zone UTC xh and then date and local time Comment Automatic change from daylight savings to standard time Service screen Information about SW and H...

Страница 24: ...g this screen Comment Delivery must be stopped to be able to turn off No patient should be attached to the MIRUS System 1 5 3 MIRUS Software update screen Software update Only appears when SW update S...

Страница 25: ...modes OFF state Device is turned off and not connected to mains supply OFF mode Standby Device is connected to mains supply but not turned on yet Fail safe Device has detected a major failure and has...

Страница 26: ...get for the inspiratory Volatile Anaesthetic concentration Flow Airway flow the flow within the patient s breathing system HME Heat and Moisture Exchanger Disposable device to store exhaled humid wate...

Страница 27: ...sure the pressure within the patient s breathing system PDMS Patient Data Management System PEEP Positive End Expiratory Pressure within one breath measured PUT Power up test Rate Total number of brea...

Страница 28: ...1 Introduction 1 22 MIRUS Controller SW 2 03 02 Additional Information Master en GB Notes...

Страница 29: ...etics 3 2 1 7 Devices required for use of the MIRUS System 4 2 1 8 Before every use 6 2 1 9 Equipment damage during use 6 2 1 10 Monitoring the patient 6 2 1 11 Alarms 7 2 1 12 Transportation within t...

Страница 30: ...labels If the symbols and product labels are not heeded this may endanger the patient and other persons or cause equipment damage Pay attention to all symbols and product labels Replace damaged produ...

Страница 31: ...ernal reservoir with liquid volatile anaesthetic If liquid anaesthetic were to enter the gas flow due to tilting of the MIRUS Controller this would put the patient at risk of overdosing To prevent suc...

Страница 32: ...or 5 1 5 Drain the reservoir as described in Chapter 6 3 2 1 7 Devices required for use of the MIRUS System If the Instructions for use of the connected devices or device combinations are not followed...

Страница 33: ...oller with a ventilator that is connected to an anaesthetic gas scavenging or disposal system Triggering of the ventilator The MIRUS Filter and the MIRUS Reflector are integrated in the patient s vent...

Страница 34: ...tions and components work flawlessly A MIRUS Controller that clearly does not work properly must be replaced with a functioning unit 2 1 9 Equipment damage during use If the touchscreen does not funct...

Страница 35: ...of the acoustic alarm signal Set the alarm volume to such a level that the alarm signals can be heard Always keep the display and alarm lights unobstructed If the alarm thresholds are not correctly a...

Страница 36: ...compatibility EMC Medical electrical devices are subject to special precautions regarding electromagnetic compatibility EMC and must be installed and operated in accordance with the EMC instructions c...

Страница 37: ...declaration 2 1 16 Infection risk To avoid putting patients and users at an increased risk of infection from a contaminated MIRUS Controller the MIRUS Controller must be cleaned Observe the hygiene re...

Страница 38: ...sound To turn off the fail safe mode disconnect mains supply and press the Confirm button again for at least 4 seconds The red LEDs now turn off To restart MIRUS Controller after a fail safe mode wait...

Страница 39: ...ly Internal reservoir empty Dosage failure Electrical supply Failure of mains power supply Failure of emergency battery Device Watchdog alarm Incorrect positioning of the MIRUS Controller inclination...

Страница 40: ...nformation about a possible hazard and instructions on how to avoid the hazard They are divided into different hazard levels depending on the degree of the danger WARNING Denotes a hazard with a mediu...

Страница 41: ...ualified medical personnel 2 3 2 2 Preparation personnel 2 3 2 3 Maintenance personnel 2 3 3 Contraindications 3 3 4 Facility requirements 3 3 5 Gas supply 4 3 6 Agent supply 4 3 7 Functional descript...

Страница 42: ...MIRUS Reflector and MIRUS Filter can be found in the manufacturer s Instructions for use 3 2 Operater and user qualification 3 2 1 Qualified medical personnel The MIRUS Controller may only be used by...

Страница 43: ...tion ECMO or VA permeable extracorporeal carbon dioxide removal ECCO2R 3 4 Facility requirements The MIRUS Controller is intended for stationary use in hospitals and rooms used for medical purposes WA...

Страница 44: ...ld on board and can be filled by using a proprietary filling system called Fill port refer to chapter 4 5 for more information During operation the MIRUS Controller uses this internal reservoir as a s...

Страница 45: ...umption of anaesthetic gas is not constant but varies depending on the application The MAC Pilot function of the MIRUS Controller evens out different reflection values and changes in the ventilation p...

Страница 46: ...d as long as the Confirm button was not activated An adjusted value will be reset to its previous normal status when no further activity on touch screen or Confirm button is registered within 5 second...

Страница 47: ...eaned completely by the user before it is used clinically for the first time 3 9 2 Initial filling before first use The MIRUS Controller always comes with an empty reservoir To fill the MIRUS Controll...

Страница 48: ...3 General description 3 8 MIRUS Controller SW 2 03 02 Additional Information Master en GB Notes...

Страница 49: ...Master en GB 4 1 4 Preparation 4 1 Mains supply 2 4 2 System warming up phase 3 4 3 Connection to the MIRUS Reflector 3 4 4 Starting MIRUS Controller 5 4 5 Filling of the reservoir during start up 8 4...

Страница 50: ...omment Use only the original power cable Plug the power cable into the line inlet on the right side of the device Make sure that the cable is safely locked Then plug the other end of the power cable i...

Страница 51: ...agents on room temperature Comment To avoid a long warm up time it is recommended to always leave the device connected to the mains supply This will reduce the warming up phase to 2 minutes 4 3 Connec...

Страница 52: ...or with large opening facing down under the clip fitting the nozzle Release clip gently 3 Now remove black connector protection and insert MIRUS Interface plug into the MIRUS Connector receptacle unti...

Страница 53: ...r more information MIRUS Reflector is placed in Park Bay refer to Chapter 4 3 for more information 1 Press Confirm button to start MIRUS Controller 2 MIRUS Controller is starting The start up sound is...

Страница 54: ...out messages during Power up test 6 MIRUS Controller starts System test automatically when Power up test has successfully finished MIRUS Reflector in Park Bay is inserted MIRUS Interface plug is inser...

Страница 55: ...ontinue confirm via OK button or turn off device by pressing turn off button 9 After confirming the Reminder screen by user this screen confirms a successfully performed Power up test and System test...

Страница 56: ...adapter in the manufacturer s Instructions for use CAUTION Hazard to persons if volatile anaesthetic accumulates in the environment around the patient Observe the Instructions for use of the bottle ad...

Страница 57: ...amaging the flap do not open it manually 3 Press Confirm button to open Fill port access 4 Fill port flap now opens automatically 5 Following screen shows changing of VA level during filling process 6...

Страница 58: ...locks in Comment Device cannot be overfilled If the content of the bottle is emptied before the maximum level is reached simply continue with a new bottle of anaesthetic agent until maximum level is...

Страница 59: ...rts as soon as the device is connected to a line supply and Confirm button has been pressed During Power up test all safety relevant components will be tested In case of a malfunction the MIRUS Contro...

Страница 60: ...lve pneumatic integrity 4 7 Anomaly in start up sequence In rare cases it can lead to an anomaly in start up sequence To restart MIRUS Controller disconnect mains supply wait for 5 seconds green light...

Страница 61: ...ation of anaesthetic VA 4 5 1 4 Stopping application of anaesthetic VA 5 5 1 5 Filling during operation 6 5 1 6 Turning off MIRUS Controller 9 5 2 Additional settings 10 5 2 1 Alarm settings 10 5 2 2...

Страница 62: ...5 6 Comment Default setting for age at MAC to Vol conversion is 40 years MAC40 Power up test and System test successfully completed on 11 01 2013 at 10 25 00 To continue please choose a menu button on...

Страница 63: ...Starting application of anaesthetic VA 1 2 3 4 5 Power up test and System test successfully completed on 11 01 2013 at 10 25 00 To continue please choose a menu button on the right HW 2 n SW 2 03 02 e...

Страница 64: ...er en GB 5 1 3 Pausing application of anaesthetic VA 1 2 3 4 5 Comment Pause button must not be confirmed to activate function etSevo 1 9 Vol etCO2 31 mmHg etSevo 1 9 Vol etCO2 31 mmHg etSevo 1 9 Vol...

Страница 65: ...dditional Information Master en GB 5 5 5 1 4 Stopping application of anaesthetic VA 1 2 3 4 5 6 etSevo 1 9 Vol etCO2 31 mmHg etSevo 1 9 Vol etCO2 31 mmHg etSevo 1 9 Vol etCO2 31 mmHg etSevo 1 9 Vol et...

Страница 66: ...ressure of the vaporiser unit of the MIRUS Controller drops too sharply during filling the anaesthetic gas is no longer supplied Monitor the patient s etVA concentration while the MIRUS Controller is...

Страница 67: ...tCO2 31 mmHg etSevo 1 9 Vol etCO2 31 mmHg Reservoir empty 24 since 20 sec 1 40 min Mute 1 45 min Mute 1 35 minMute 43 ml Filling level max 190 ml 1 30 minMute 43 ml Filling level max 190 ml 1 25 minMu...

Страница 68: ...the fill port flap immediately after filling 11 12 Comment By using an almost empty bottle for filling it may occur that the bottle will partly fill with liquid VA before releasing the content into t...

Страница 69: ...6 Turning off MIRUS Controller Comment Only if VA is not delivered Turn OFF tag becomes active Refer to Chapter 5 1 4 1 2 3 4 5 6 etSevo 0 0 Vol etCO2 31 mmHg Please confirm to turn off the MIRUS Cont...

Страница 70: ...will be automatically reset to default values during a system test 1 2 3 4 5 6 Also refer to Chapter 7 etSevo Min etSevo Max Apnoea time Alarm vol sec etCO2 Max etCO2 Min etCO2 etCO2 Max etSevo Min et...

Страница 71: ...l Information Master en GB 5 11 5 2 2 Setting on screen language 1 2 3 4 5 6 Refer to Chapter 8 1 for available languages English Language Language English CO2 CO2 mmHg mmHg Language English CO2 mmHg...

Страница 72: ...03 02 Additional Information Master en GB 5 2 3 Setting CO2 unit 1 2 3 4 5 6 Refer to Chapter 8 5 for available units Language English CO2 mmHg Language English CO2 mmHg Language English CO2 mmHg Lan...

Страница 73: ...5 Operation MIRUS Controller SW 2 03 02 Additional Information Master en GB 5 13 5 2 4 Setting Time zone date or time 1 2 3 4 5 6...

Страница 74: ...dditional Information Master en GB 5 2 5 Setting Patient data Gender 1 2 3 4 5 Age Size Weight cm 40 years 180 80 kg IBW Age Size Weight cm 40 years 180 80 kg IBW Age Size Weight cm 40 years 180 80 kg...

Страница 75: ...etting Patient data Age 1 2 3 4 5 6 Refer to Chapter 8 5 for available values Age Size Weight cm 40 years 180 80 kg IBW Age Size Weight cm 40 Years 180 80 kg IBW Age Size Weight cm 40 years 180 80 kg...

Страница 76: ...5 Operation 5 16 MIRUS Controller SW 2 03 02 Additional Information Master en GB 7 Before 8 After etSevo 1 9 Vol etCO2 31 mmHg etSevo 1 9 Vol etCO2 31 mmHg...

Страница 77: ...5 Operation MIRUS Controller SW 2 03 02 Additional Information Master en GB 5 17 5 2 7 Setting MAC Pilot Wash in speed 1 2 3 4 5 Wash in speed Wash in speed Wash in speed Wash in speed...

Страница 78: ...5 Operation 5 18 MIRUS Controller SW 2 03 02 Additional Information Master en GB Notes...

Страница 79: ...Visual inspection 5 Electrical safety test 5 Checking gas monitor 6 Checking pump 7 Safety function test 8 Exchange UPS battery 9 Exchange fan filter 10 Perform software update 11 Exporting event log...

Страница 80: ...y ammonium compounds Terralin Protect Sch lke Mayr GmbH The use of other surface disinfectants is at the responsibility of the user Many materials are damaged by certain organic solvents that are some...

Страница 81: ...tokens are placed in the MIRUS Controller communication ports and the ports are sealed f Carry out wipe disinfection g Allow the device surface to dry fully MIRUS Controller Fill port If the fill port...

Страница 82: ...t maintenance Maintenance measures may only be conducted by maintenance personnel in accordance with Chapter 3 2 Schedule Affected part Period Performer MIRUS Controller Every 12 months Safety Check V...

Страница 83: ...e MIRUS Controller for distortion deterioration and cracks Check safety relevant labelling SN SI Label on the device for availability and readability Check mechanical parts are not defective Check for...

Страница 84: ...stem test according to Chapter 4 b Insert the MIRUS Service Test plug into the connector receptacle until mechanically locked according to Chapter 4 c Change MIRUS Controller to Home screen d Connect...

Страница 85: ...sampling line to the air gas calibrator Perform pump check as follows a Mount the MIRUS Reference MR and perform a Power up Test and a System test according to Chapter 4 b Insert the MIRUS Service Tes...

Страница 86: ...lowing accessory is required refer to Chapter 6 6 MIRUS Reference MR Perform the safety function test as follows a Mount the MIRUS Reference MR and perform a Power up Test and a System test according...

Страница 87: ...out the exchange a Turn the MIRUS Controller OFF and disconnect it from AC b Open the battery housing c Remove the old battery from housing d Disconnect the old battery from the battery connector e C...

Страница 88: ...least every 12 months or earlier if necessary The following accessory is required refer to Chapter 6 6 Replacement filter Carry out the exchange a Turn the MIRUS Controller OFF and disconnect it from...

Страница 89: ...the event log data to the manufacturer TIM can be found in the Instructions for use of the SD card which can be ordered in a print version or found online in the manufacturer s website https tim gmbh...

Страница 90: ...sively on land the packaging is labelled VA Only use the original packaging materials for the MIRUS Controller Safety pouch Transportation securings Shipping carton white Shipping carton brown If you...

Страница 91: ...ibration gas kit Isoflurane from a manufacturer of your choice containing n a CO2 4 5 5 0 Vol ISO 1 0 2 0 Vol O2 30 50 Vol Adapter to connect the sampling line male male to the calibration gas kit n a...

Страница 92: ...6 Cleaning and maintenance 6 14 MIRUS Controller SW 2 03 02 Additional Information Master en GB Notes...

Страница 93: ...m handling 7 7 2 4 2nd High priority alarm handling 8 7 2 5 3rd High priority alarm handling 9 7 2 6 Low priority alarm handling 10 7 3 Alarm messages 11 7 3 1 Patient alarms 11 7 3 2 Technical alarms...

Страница 94: ...ve Display alarm message in black characters on red background Start timer ON flashing ON Confirming the alarm by activating the alarm silence button Display alarm message in black characters on red b...

Страница 95: ...RUS Controller SW 2 03 02 Additional Information Master en GB 7 3 7 2 Alarm handling 7 2 1 Mute audible alarms 1 2 3 since 2 sec Low etCO2 11 since 2 sec Low etCO2 11 etSevo 1 9 Vol etCO2 25 mmHg etSe...

Страница 96: ...7 Alarms and messages 7 4 MIRUS Controller SW 2 03 02 Additional Information Master en GB 4 since 5 sec Low etCO2 11 1 58 minMute etSevo 1 9 Vol etCO2 25 mmHg...

Страница 97: ...m volume will escalate from 50 sound intensity up to the set volume max 100 until alarm is muted Comment The set value for alarm volume represents the maximum sound level First time of alarm appears S...

Страница 98: ...RUS Controller SW 2 03 02 Additional Information Master en GB Third time of alarm appears Fourth time of alarm appears since 56 sec Low etCO2 11 since 38 sec Low etCO2 11 etSevo 1 9 Vol etCO2 25 mmHg...

Страница 99: ...n Master en GB 7 7 7 2 3 1st High priority alarm handling 1 2 3 4 since 2 sec Low etCO2 11 since 18 sec Low etCO2 11 since 36 sec Low etCO2 11 1 58 minMute etSevo 1 9 Vol etCO2 31 mmHg etSevo 1 9 Vol...

Страница 100: ...4 2nd High priority alarm handling 1 2 3 4 since 56 sec High etSevo 10 1 58 minMute since 28 sec High etSevo 10 since 38 sec Low etCO2 11 since 28 sec High etSevo 10 etSevo 4 8 Vol etCO2 25 mmHg etSev...

Страница 101: ...7 2 5 3rd High priority alarm handling 1 2 3 4 since 56 sec High etSevo 10 1 58 minMute since 5 sec Low Vti 04 since 16 sec Low Vti 04 1 53 minMute since 10 sec Low Vti 04 etSevo 4 8 Vol etCO2 25 mmH...

Страница 102: ...r SW 2 03 02 Additional Information Master en GB 7 2 6 Low priority alarm handling 1 2 3 4 Mains supply lost 33 et Sevo 1 9 Vol et CO2 31 mmHg etSevo 1 9 Vol etCO2 31 mmHg Mains supply lost 33 etSevo...

Страница 103: ...settings Check ventilator settings High etVA 10 High The upper alarm limit for the etVA concentration was exceeded while the VA application is active Start button in active status Check patient condit...

Страница 104: ...s tilted Reposition MIRUS Controller on level surface Dosage failed Start VA 16 17 18 19 50 High Stops VA delivery Calculation problem was detected Restart VA delivery by pressing Play and confirmatio...

Страница 105: ...sed for more than 6 days Replace MIRUS Reflector Reflector soon expires 35 Low MIRUS Reflector is used for 6 days Prepare to replace or replace MIRUS Reflector Replace Reflector 44 45 46 47 Low No val...

Страница 106: ...rocedure A02 The agent reservoir is empty To continue please refill the device To open Fill port please confirm Internal reservoir fill level 75 mL Refill the MIRUS Controller or turn off via turn off...

Страница 107: ...y capacity too low Operation is prohibited Wait for recharging to an appropriate level Internal UPS battery low Wait until battery charging level has reached status of A07 System then automatically sw...

Страница 108: ...disconnect from AC wait until Alarm lights are off then reconnect and re start the MIRUS Controller Contact your service in case the MIRUS Controller will continue to show this message Performs turn...

Страница 109: ...test sequence until Interface is connected or performs turn OFF sequence after user selection B03 Power up test successful Reflector expires within the next 24 hours MIRUS Interface connection not rel...

Страница 110: ...tected Check MIRUS Interface connection to MIRUS Controller or turn off MIRUS Controller via turn off button Stops System test sequence until user activity is done Then repeats test step Or performs t...

Страница 111: ...lease confirm A technical failure was recognized during System test Confirm to turn off MIRUS Controller Then disconnect from AC wait until Alarm lights are off then reconnect and re start the MIRUS C...

Страница 112: ...ice action R01 WARNING Never use an active humidification system when operating the MIRUS system This may result in serious increase of airway resistance Is shown after Power up test and System test a...

Страница 113: ...ght Power up test and System test successfully finished None Stays in On Call mode until user activates one of the tags C02 Mains supply lost Restore mains supply or the device will turn off automatic...

Страница 114: ...ected Fill port button on MULTI settings Filling tag Confirm Waits for user to confirm or reset after 5 seconds of no activity D02 Thank you Please start the filling process User confirmed to open Fil...

Страница 115: ...S Controller User selected Turn OFF button on Turn OFF tag Confirm Waits for user to confirm or resets after 5 seconds of no activity D05 Please place the MIRUS Reflector on the Reflector Park Bay Use...

Страница 116: ...Applying software update Please wait During SW update screen goes black SD card is checked and valid SW version on card is higher than on MIRUS Controller Internal battery is full and guarantees succ...

Страница 117: ...s SW update Will proceed with regular start up after user action E08 SW update cancelled Please remove SD card SW update cancelled by user Remove SD card Stops update process Will proceed with regular...

Страница 118: ...7 Alarms and messages 7 26 MIRUS Controller SW 2 03 02 Additional Information Master en GB Notes...

Страница 119: ...IRUS Controller Performance 8 8 7 MIRUS Controller Monitoring System 9 8 8 Default values 10 8 8 1 Alarm settings and application defaults 10 8 8 2 Specification of Wash in speed parameters 11 8 9 Con...

Страница 120: ...evoflurane Desflurane Appl state of VA Gaseous Working principle Diffusion optimised vaporiser without fresh gas Physical dimensions Length approx 325 mm 12 8 in Depth approx 210 mm 8 2 in Height appr...

Страница 121: ...050 to 0 ft above sea level Humidity range 10 to 90 relative none condensing During transport with drained reservoir Temperature range 20 to 70 C 4 to 158 F Atm pressure range 500 to 1 060 hPa 7 3 to...

Страница 122: ...pply at least once a month for at least 24h Agent supply Internal Reservoir Maximum internal reservoir capacity 270 mL Reserve internal reservoir capacity 20 mL Status information On screen Filling sy...

Страница 123: ...tate indices titles etc Selection fields Active touch field Information fields Inactive touch screen field Colour code for agent VA specific Audible indicators Standard alarms Applies for Patient alar...

Страница 124: ...o 1 0 MVi 10 0 to 15 0 L min where MAC 1 6 7 Vol age 40 Increment 0 1 MAC single tap on the touch button 0 5 MAC pressing the touch button for 1 sec Alarm settings End tidal CO2 etCO2 min Range 15 to...

Страница 125: ...ing the touch button for 1 sec etDES min Range 0 0 to 12 0 Vol Increment 0 1 Vol single tap on the touch button 0 5 Vol pressing the touch button for 1 sec etDES max Range 0 5 to 12 0 Vol Increment 0...

Страница 126: ...sflurane 15 of set MAC measured as average of MV Vt 500 mL Rate 15 min I E 1 2 MAC 1 0 Wash in speed Turtle Maximum rate 40 min Respiratory monitoring accuracy Volumes 20 Vti 200 mL to 2000 mL BTPS co...

Страница 127: ...nt dosage monitoring Dosage control Agent Dosage start Start of inspiration Dosage end End of inspiration or end of delivered anaesthetic agent volume Control Monitoring of applied volume of anaesthet...

Страница 128: ...alue Note Home MAC 0 5 Vol 0 6 Vol ISO Vol 0 9 Vol SEVO Vol 3 4 Vol DES Patient data Gender male Age 40 years Ideal body weight 80 kg Body height 180 cm MAC Pilot Wash in speed medium Alarm settings e...

Страница 129: ...n Wash in speed parameters Note Isoflurane Cheetah Fast 2 set MAC Rabbit Medium 1 5 set MAC Turtle Slow 1 0 set MAC max concentration 5 0 Vol Sevoflurane Cheetah Fast 2 set MAC Rabbit Medium 1 5 set M...

Страница 130: ...e IT network Add further devices to the IT network Updating devices in the IT network Perform upgrades on devices in the IT network To connect to an IT network the following documents must be observed...

Страница 131: ...J10 interface transfers a high priority alarm signal to a connected nurse call device The transfer takes place via a galvanic insulated changeover contact Data transfer to the MIRUS Controller is not...

Страница 132: ...ay AlMgSi alloy anodised AlCuMg anodised Fill port Flap AlMgSi alloy anodised Seals Covers Silicone Polyethylene PE Synthetic rubber EPDM Battery flap Aluminium anodised Screws Stainless steel Labels...

Страница 133: ...IRUS Controller SW 2 03 02 Additional Information Master en GB 9 1 9 Parts list 9 1 MIRUS Controller 2 9 2 Bottle Adapter 2 9 3 ARKON Data Bridge 2 9 4 Accessories 3 9 5 Service parts 3 9 6 Documents...

Страница 134: ...s to Baxter Suprane Isofluran K BA ISO K Fits to AbbVie Forane Piramal Critical Care Isoflurane Baxter Forane Aerrane Sevofluran K BA SEV K Fits to AbbVie Ultane Piramal Critical care Sevoflurane USP...

Страница 135: ...02 Power supply cable FR MC 01 003 Power supply cable IT MC 01 004 Power supply cable CH MC 01 005 Power supply cable AU MC 01 006 Power supply cable US MC 01 007 Shipping carton brown MC 09 902 Shipp...

Страница 136: ...107 R Instructions for use en GB 021 0108 R Manuel utilisateur fr 021 0109 R Istruzioni d uso it 021 0110 R Instrucciones de uso es 021 0111 R Instrukcje u ytkowania pl 021 0101 R Additional informati...

Страница 137: ...ganisation Fill port flap still open Continues working 1 Close Fill port flap Heating system failed Continues working 1 Turn off MIRUS Controller High etVA Continues working 1 Patient okay CO2 SpO2 2...

Страница 138: ...49 261 899 689 00 Fax 49 261 899 689 09 info tim gmbh de http www tim gmbh de 0044 Instructions for use Service calls Support Help service tim gmbh de This document MIRUSTM Controller SW 2 03 02 HW 2...

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