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User Responsibility 

 

 

2 

 

IFU, MIRUS Controller, en-GB, N.00 

 

This  product  will  perform  in  conformity  with  the  description  thereof  contained  in  these 
instructions  for  use  and  accompanying  labels  and/or  inserts,  when  assembled,  operated, 
maintained and repaired in accordance with the instructions provided.  
 
This product must be checked periodically. A defective product should not be used. Parts that 
are broken, missing, clearly worn, distorted or contaminated should be replaced immediately.  
 
Should repair or replacement become necessary contact your service organisation and return 
the defective device to TIM 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 approval of TIM. 
 
The  user of  this  product  shall  have the  sole  responsibility for  any malfunction  which  results 
from improper use, faulty maintenance, improper repair, damage or alteration by anyone other 
than TIM. 
 
The product has a unit serial number (XXXD12345) with coded logic which indicates a product 
group  code (XXX),  the  year  of  manufacture (K = 2017,  L = 2018  etc.)  and  a  sequential  unit 
number for identification (12345).  
 
 
MIRUS™ and   

are trademarks of Technologie Institut Medizin GmbH (TIM). 

 
 
Other  brand  names  or  product  names  used  in  this  manual  are  trademarks  or  registered 
trademarks of their respective holders. 

 
 

Содержание MIRUS Controller

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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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