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TIM MIRUS Controller Instructions For Use Manual Download Page 7

 

1 Introduction 

IFU, MIRUS Controller, en-GB, N.00 

 

7 

 

1.4.1 

MIRUS Controller 

 
 

 

 
 
 

1.4.2 

Exchanger unit 

 
 
 

 

 
 

 

 

Interface receptacle 

Alarm lights 

Fill port 

Park Bay 

Confirm button 

Touch screen 

MIRUS Reflector 

(Multi patient device. 

Use up to 7 days) 

MIRUS Filter 

(Single patient device.  

Use up to 48 h) 

Interface connector 

Summary of Contents for MIRUS Controller

Page 1: ...Technology Innovated Medicine www tim gmbh de Technologie Institut Medizin GmbH TIM MIRUSTM Controller Instruction for use Software version 2 00 00 www tim products de...

Page 2: ...M for repair This product or any of its parts should not be repaired other than in accordance with written instructions provided by TIM The product must not be altered without the prior written approv...

Page 3: ...manufacturer 12 2 1 6 Safety features 12 2 2 Warning symbols used in the IFU 13 2 3 Patient safety 13 2 3 1 Monitoring 13 2 3 2 Volatile anaesthetic agents VA 13 2 3 3 Control of patient relevant dosa...

Page 4: ...A 38 4 1 Starting application 38 4 2 Supervise patient respiratory data 39 4 3 Pausing application and reactivate 39 4 4 Stopping application 40 5 Turning off controller 41 6 Maintenance and Cleaning...

Page 5: ...ce parts 57 9 4 Documents 58 9 5 MIRUS Controller 58 10 Technical specifications 59 10 1 General specifications 59 10 2 Controls and Ranges 61 10 2 1 Agent dosage 61 10 2 2 Alarm settings 61 10 2 3 Pa...

Page 6: ...less than 200 mL tidal volume patients that have a contraindication for the application of volatile anaesthetic agents pure spontaneously breathing patients without a ventilator securing apnoea back...

Page 7: ...1 4 1 MIRUS Controller 1 4 2 Exchanger unit Interface receptacle Alarm lights Fill port Park Bay Confirm button Touch screen MIRUS Reflector Multi patient device Use up to 7 days MIRUS Filter Single p...

Page 8: ...e graphical 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 s...

Page 9: ...andard operation 6 Menu button Patient data gender weight size age 7 Menu button MAC Pilot setting wash in speed 8 Menu button Respiratory monitoring supervising respiratory patient data 9 Menu button...

Page 10: ...active VA is applied animated synchronously to lifeline NO VA VA application not active stop or pause 20 Status symbol Agent reservoir liquid level in anaesthetic agent colour 21 Graphic Target reache...

Page 11: ...in the parameters Changes in the parameters can be caused by changes in the status of the patient changes in the settings adjustment and or operation failures defects and or device malfunction changes...

Page 12: ...res The following safety features are built into the MIRUS Controller to warn the operator in case of hazard to the patient Device alarms Control of Control for Anaesthetic supply Internal reservoir e...

Page 13: ...tion safety mode For patient safety always perform a System test prior to operation In case of a non functioning touch screen always disable the delivery of anaesthetic by disconnecting the MIRUS Refl...

Page 14: ...tilators that are not according to ISO 80601 2 12 or ISO 80601 2 13 could endanger the patient Do not use the MIRUS System with jet or high frequency ventilators Do not use the MIRUS System with a hel...

Page 15: ...and moisture This may result in serious increase of airway resistance Always monitor for possible increase in airway resistance 2 4 User s and other patient s safety WARNING You will work with volati...

Page 16: ...ere with the device s cooling system Operate the system only according to the given specification for temperature and humidity In case the system s temperature is higher or lower than specified allow...

Page 17: ...parate safety system In case of a failure the safety system shifts the device to a fail safe mode which is safe for the patient During the fail safe mode there is no delivery of anaesthetic to the pat...

Page 18: ...aned completely by the user before it is used clinically for the first time Refer to chapter 6 2 Cleaning for more information 3 2 Connecting to mains supply Plug in power cable into the inlet on the...

Page 19: ...r Remove the MIRUS Reflector with interface plug from its packaging Note For further information refer to the manufacturer s instructions Remove plug from interface connector receptacle Lift Park Bay...

Page 20: ...yellow and green for visual control Test fail safe mode Confirm button and alarm lights flash in red for approx 3 seconds Panic alarm sound is heard Initial screen Power up test and system test If a...

Page 21: ...ndard mode refer to chapter 3 7 Patient data gender age size weight refer to chapter 3 8 MAC Pilot Change wash in speed refer to chapter 3 9 Respiratory monitoring refer to chapter 4 2 Alarm settings...

Page 22: ...ble adapter into the fill port CAUTION Double check bottle adapter colour fill port collar colour and agent bottle colour to match dedicated volatile anaesthetic agent prior to filling WARNING Do not...

Page 23: ...Press Confirm button Fill port flap opens automatically Request for filling Filling Insert bottle with attached adapter vertically in fill port Press bottle into fill port gently until a mechanical st...

Page 24: ...t flap Controller continues start up sequence 3 6 Anomaly in start up sequence In rare cases it can lead to an anomaly in start up sequence To restart MIRUS Controller disconnect AC supply wait for 5...

Page 25: ...alue e g SEVO MAC40 0 5 0 9 Vol Refer to chapter 8 1 Alarm settings and application defaults for more information about ISO and DES 3 8 Changing patient data Press menu button Patient data Note Changi...

Page 26: ...3 Preparation 26 IFU MIRUS Controller en GB N 00 3 8 1 Changing gender Press button for selected gender Button for selected gender is light grey Press Confirm button to verify change Change completed...

Page 27: ...en GB N 00 27 3 8 2 Changing age size weight Press button for parameter to be changed e g age Button for selected parameter is light grey Arrow keys are activated Use arrow keys to change parameter Pr...

Page 28: ...also possible during VA application MAC pilot pre set Wash in speed rabbit medium Further options turtle slow cheetah fast Refer to chapter 8 2 Specification of wash in speed parameters for further in...

Page 29: ...rm settings pre set alarm limits for SEVO et CO2 min 20 mmHg et CO2 max 50 mmHg et SEVO min 0 5 Vol et SEVO max 2 5 Vol Apnoe time 60 sec Alarm vol 100 Refer to chapter 10 2 2 Alarm settings for infor...

Page 30: ...completed 3 11 Filling and additional configurations Press menu button Configuration screens Note Configuration is also possible during VA application Options 1st tab filling screen 2nd tab setting l...

Page 31: ...process as long as internal pressure is sufficient WARNING Always control the et VA concentration of the patient during filling as it might decrease Note Observe the warnings in chapter 3 5 Filling du...

Page 32: ...tle with attached adapter vertically in fill port Press bottle into fill port gently until a mechanical stop is felt spring loaded valves open Note Device cannot be overfilled Maximum level reached Fo...

Page 33: ...and CO2 unit Select tab for Setting Setting Setting on screen language and CO2 unit pre set Language English CO2 unit mmHg Press button for parameter to be changed e g language Button for selected pa...

Page 34: ...nfirm button Change completed 3 11 3 Setting time Select tab for Time setting Time setting Setting Time zone date and time Pre set Time zone UTC 1h Note Check time zone setting and correct first if ne...

Page 35: ...3 Preparation IFU MIRUS Controller en GB N 00 35 Button for selected parameter is light grey Arrow keys are activated Use arrow keys to change parameter Press Confirm button Change completed...

Page 36: ...e screen Select tab for Service Service screen Information about SW and HW revision the web contact and a QR code 3 12 Setting MAC value Vol Operation mode Press button MAC Button for MAC is light gre...

Page 37: ...reflector already connected to the controller refer to chapter 1 4 2 Exchanger unit Note For information regarding the reflector and the filter and how to connect these accessories with the patient an...

Page 38: ...4 1 Starting application Press button Start Press Confirm button VA Application active Animated life line at the top of the screen see next picture MAC Pilot status symbol is active Pause and Stop but...

Page 39: ...2 Supervise patient respiratory data Press menu button Respiratory monitoring Respiratory monitoring screen 4 3 Pausing application and reactivate Press button Pause VA Application pauses Button Paus...

Page 40: ...pplication of VA 40 IFU MIRUS Controller en GB N 00 4 4 Stopping application Press button Stop Button Stop is light grey Press Confirm button VA Application is finished Pause and Stop buttons deactiva...

Page 41: ...41 5 Turning off Note Only if VA is not applied the menu button Turn off is activated Refer to chapter 4 4 Stopping application Press menu button Turn off Turn off screen Press button Turn off Button...

Page 42: ...5 Turning off 42 IFU MIRUS Controller en GB N 00 Button Turn off is coloured Controller switches off automatically Place Reflector in Park Bay Controller switched off off mode...

Page 43: ...n test Manufacturer or qualified personnel specially authorized by the manufacturer UPS Battery pack When not using the device leave device connected to mains supply or connect to mains supply at leas...

Page 44: ...pment s housing Do not autoclave any part of the MIRUS Controller No part of the MIRUS Controller is sterilisable WARNING To prevent patient contamination Follow general hygiene requirements of your h...

Page 45: ...otect In addition to the main ingredients cleaning agents and disinfectants often contain additives which can damage the materials If in doubt contact the supplier manufacturer of the disinfectant det...

Page 46: ...not be soaked rinsed washed sterilised or treated with liquid disinfectants 6 3 Draining the reservoir To drain the reservoir a draining kit from the manufacturer TIM is needed refer to chapter 9 Part...

Page 47: ...alate from 50 sound intensity up to the set volume max 100 until alarm is muted If there is another alarm after the first alarm the second alarm bar overlays the first alarm bar Exception if the furth...

Page 48: ...ble alarm Alarm is active Alarm message Start timer red flashing ON Confirming the alarm by pressing the alarm silence button Alarm message Start silence counter 2 min red continuous OFF Alarm is stil...

Page 49: ...Measured et VA max etVA for three consecutive breaths Measured et VA within the limit with the first breath Low et CO2 High Alarm Measured et CO2 min et CO2 for three consecutive breaths Measured et...

Page 50: ...A delivery Interface plug disconnected while in operation Reconnect interface plug Mains supply lost Low Alarm AC lost Connect mains supply Occlusion of Interface High Alarm and stop VA delivery A gas...

Page 51: ...ing the internal clock with a setpoint a deviation was detected e g after a long time without power supply Correct date and time UPS battery low High Alarm if UPS battery is down to of capacity 2 minu...

Page 52: ...ion of controller connection to power supply electronic components If a problem or an error is detected follow the instructions on the screen Depending on the instruction one or more of the following...

Page 53: ...ponents position of controller connection to power supply If a problem or an error is detected follow the instructions on the screen Depending on the instruction one or more of the following buttons a...

Page 54: ...tton 7 2 4 During On Call mode Follow request on screen 7 2 5 During operation mode During operation mode some user activity is required when filling the reservoir when turning off the controller Foll...

Page 55: ...alue Home MAC 0 5 Patient data Gender male Age 40 years Ideal body weight 80 kg Body height 180 cm Vol SEVO 0 9 Vol ISO 0 6 Vol DES 3 4 Vol MAC Pilot Wash in speed medium Alarm settings et CO2 min 20...

Page 56: ...Fast 2 set MAC value rabbit Medium 1 5 set MAC value turtle Slow 1 0 set MAC value max concentration 6 Vol Sevoflurane cheetah fast 2 set MAC rabbit medium 1 5 set MAC value turtle slow 1 0 set MAC v...

Page 57: ...01 014 1 MIRUS Mounting Bracket Rail 2pcs MC 01 014 2 9 2 Spare parts Description Order code Power supply cable DE ES MC 01 001 Power supply cable UK MC 01 002 Power supply cable FR MC 01 003 Power s...

Page 58: ...te http the mirus com mirus controller instructions for use html Description Order code MIRUS Controller Instruction for Use en GB de fr it es and Additional Information en GB CD MC MC IFU ALL 9 5 MIR...

Page 59: ...ve sea level Humidity range 20 to 50 C 500 to 1 060 hPa 5 500 to 0 m 18 050 to 0 ft 10 to 90 relative none condensing Environmental conditions Transport empty reservoir Temperature range Atm pressure...

Page 60: ...mL Electromagnetic compatibility according to EN 60601 1 2 Test parameters and limit values can be obtained from the manufacturer if required Display structure Screen Touchscreen 5 7 confirm button M...

Page 61: ...0 1 MAC single taps on button 0 5 MAC pressing button 1 sec 10 2 2 Alarm settings For Values et CO2 min et CO2 max Range 15 to 150 mmHg 2 0 to 19 7 2 0 to 20 0 kPa Increment 1 mmHg 0 5 0 5 kPa single...

Page 62: ...taps on button 5 kg pressing button 1 sec 10 3 Performance 10 3 1 Agent dosage accuracy For Values Isoflurane and Sevoflurane and Desflurane 15 of set MAC measured as average of MV all settings 15 of...

Page 63: ...stem Specification Device Safety monitoring Patient Breathing activity Alarms Apnoea Tidal volume Low Vt Agent dosage monitoring Dosage start start of inspiration Dosage end end of inspiration or end...

Page 64: ...entration of VA FiDes inspiratory Desflurane concentration FiIso inspiratory Isoflurane concentration FiSevo inspiratory Sevoflurane concentration FiVA set set target for the inspiratory volatile anae...

Page 65: ...MVi Minute Volume inspiratory Unit L min NIV Non Invasive Ventilation Ventilation with a mask or a helmet Ppeak highest airway pressure measured with last breath Paw Airway pressure the pressure with...

Page 66: ...ontinues working 1 Close Fill port flap Heating system failed Continues working 1 Turn off device into OFF mode Standby High et VA Continues working 1 Patient okay CO2 SpO2 2 Set MAC okay 3 Alarm sett...

Page 67: ...Notes IFU MIRUS Controller en GB N 00 67...

Page 68: ...reserved Rev N 00 of 03 18 Manufactured by Technologie Institut Medizin GmbH TIM Erfurter Stra e 9 D 56626 Andernach Germany T 49 0 2632 98 76 297 F 49 0 2632 98 76 299 info tim gmbh de http www tim...

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