MIRUS TM Controller Instruction for use Software version

Technology Innovated Medicine MIRUS TM Controller Instruction for use Software version 2.00.00 www.tim-gmbh.de Technologie Institut Medizin GmbH (TIM) www.tim-products.de

User Responsibility 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. 2 IFU, MIRUS Controller, en-gb, N.00

0 Table of contents 0 Table of contents 1 Introduction... 6 1.1 Intended use... 6 1.2 Intended purpose... 6 1.3 Contraindications... 6 1.4 MIRUS System... 6 1.4.1 MIRUS Controller... 7 1.4.2 Exchanger unit... 7 1.4.3 Device user interface... 8 1.4.4 Colour code for the different volatile anaesthetic agents (VA)... 8 1.4.5 Elements in touch screen... 9 1.5 Symbols on the device...10 2 Safety... 11 2.1 General safety instructions...11 2.1.1 Safe operation...11 2.1.2 User qualification...11 2.1.3 Monitoring...11 2.1.4 Electrical supply...11 2.1.5 Responsibility of the 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 dosage...14 2.3.4 Combination of ventilators and MIRUS System...14 2.3.5 Triggering of ventilators...14 2.3.6 Minimum tidal volume...14 2.3.7 MDI Applications...15 2.3.8 Resistance of airway components...15 2.4 User s and other patient s safety...15 2.5 Device...15 2.5.1 Accessories...15 2.5.2 Positioning...16 2.5.3 Risk of electrical hazard...16 2.5.4 Risk of fire...16 2.5.5 Electromagnetic compatibility...17 2.6 Residual risk Fail-safe mode...17 3 Preparation... 18 3.1 Cleaning before first use...18 3.2 Connecting to mains supply...18 3.3 Connecting to MIRUS Reflector...19 3.4 Turning on...20 IFU, MIRUS Controller, en-gb, N.00 3

0 Table of contents 3.5 Filling during start-up sequence...22 3.6 Anomaly in start-up sequence...24 3.7 Change to operation mode...25 3.8 Changing patient data...25 3.8.1 Changing gender...26 3.8.2 Changing age, size, weight...27 3.9 Changing wash-in speed...28 3.10 Changing alarm settings...29 3.11 Filling and additional configurations...30 3.11.1 Filling during operation...31 3.11.2 Setting on-screen language and CO 2 unit...33 3.11.3 Setting time...34 3.11.4 Service screen...36 3.12 Setting MAC value (Vol%)...36 3.13 Connecting patient...37 4 Application of VA... 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... 43 6.1 Maintenance...43 6.1.1 General Information...43 6.1.2 Schedule...43 6.2 Cleaning...44 6.2.1 General advice...44 6.2.2 Cleaning the individual components...44 6.3 Draining the reservoir...46 6.4 Shipping MIRUS Controller...46 7 Alarms and messages... 47 7.1 Alarms...47 7.1.1 Alarm modality...47 7.1.2 Low-priority alarms...47 7.1.3 High-priority alarms...48 7.1.4 Patient alarms...49 7.1.5 Technical alarms...50 7.2 Messages and error messages...52 7.2.1 During power up test...52 7.2.2 During system test...53 7.2.3 Reminder screen...54 7.2.4 During On-Call mode...54 7.2.5 During operation mode...54 4 IFU, MIRUS Controller, en-gb, N.00

0 Table of contents 8 Standard values... 55 8.1 Alarm settings and application defaults...55 8.2 Specification of wash-in speed parameters...56 9 Parts list... 57 9.1 Accessories...57 9.2 Spare parts...57 9.3 Service 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 Patient data settings...62 10.3 Performance...62 10.3.1 Agent dosage accuracy...62 10.3.2 Respiratory monitoring accuracy...62 10.3.3 Gas monitoring accuracy...63 10.4 Monitoring system...63 11 Terms and abbreviations... 64 12 High priority alarms... 66 IFU, MIRUS Controller, en-gb, N.00 5

1 Introduction 1 Introduction 1.1 Intended use The MIRUS Controller is part of the MIRUS System. It is intended to be used for the application of volatile anaesthetic agents to humans with a tidal volume of 200 ml. 1.2 Intended purpose The MIRUS Controller is designed to work only in combination with the MIRUS Reflector. For hygiene safety reasons connection of the MIRUS System to a patient is only possible via the MIRUS Filter. Note: For more information about the MIRUS Reflector and the MIRUS Filter please refer to the manufacturer s IFU. 1.3 Contraindications Do not use the MIRUS System with patients requiring 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 up ventilation mode. jet or high frequency ventilation. leaking patient airway systems, such as face mask or helmet systems. additional filters (HME/F) or tubes that significantly increase dead space. active humidification. low flow anaesthesia. 1.4 MIRUS 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 device connected to the MIRUS Controller, inserted into the patient s breathing system. MIRUS Filter (MF) The single patient device connected to the MIRUS Reflector, protecting the patient and breathing system. 6 IFU, MIRUS Controller, en-gb, N.00

1 Introduction 1.4.1 MIRUS Controller Alarm lights Fill port Park Bay Touch screen Confirm button Interface receptacle 1.4.2 Exchanger unit MIRUS Filter (Single patient device. Use up to 48 h) MIRUS Reflector (Multi patient device. Use up to 7 days) Interface connector IFU, MIRUS Controller, en-gb, N.00 7

1 Introduction 1.4.3 Device user interface Touch screen. Operate MIRUS Controller by pressing buttons on the 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 seconds. 1.4.4 Colour code for the different volatile anaesthetic agents (VA) Colour for Sevoflurane Colour for Isoflurane Colour for Desflurane 8 IFU, MIRUS Controller, en-gb, N.00

1 Introduction 1.4.5 Elements in touch screen e.g. Home screen standard operation screen 1 2 3 4 22 5 6 21 19 20 18 7 9 11 8 10 17 16 14 12 15 13 1 Status symbol Lung. Animated when patient breathing is detected. 2 Status symbol Life line. Animated when delivery is in progress, stationary when delivery is paused. Not visible when delivery is stopped. 3 Display for et VA value 4 Display for et CO 2 value 5 Menu button Home (Home screen for standard 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 Alarm settings: change setting alarm limits (et CO 2 min, et CO 2 max, et VA min, et VA max, Apnoe time, Alarm vol.) 10 Menu button Configurations: Tab Filling (during operation) Tab Setting (on-screen language, CO 2 unit) Tab Time setting (local time zone, time and date) Tab Service (information about HW and SW version of MIRUS Controller, contact details of the manufacturer) IFU, MIRUS Controller, en-gb, N.00 9

1 Introduction 11 Menu button Turn off (turn off device) 12 Button Stop: stops application of VA 13 Button MAC: displays unit and currently set value, setting MAC value. 14 Button Pause: pauses application of VA 15 Button Play: starts application of VA 16 Status symbol System test. 17 ST. System test was performed successfully. No Test. System test is invalidated. Status symbol battery: Power supply via battery (with capacity indicator) or battery is in charging mode (symbol is animated). 18 Status symbol mains supply: device is powered by mains supply. 19 Status symbol application of VA. MAC pilot: MAC pilot 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 reached level: current Fi/Fe ratio. 22 Status symbol Reflector: remaining allowed operation time (in anaesthetic agent colour). Note: For more information about further symbols used on screens please refer to this IFU and to the Additional Information (AI) of MIRUS Controller chapter 1.3. 1.5 Symbols on the device STK label (in Germany): Indicates when the next safety check in accordance with 6 Medical Device Operator Ordinance (MPBetreibV) is required. Warranty seal: Warranty void if seal is broken. Note: For more information about further symbols used on the equipment please refer to the Additional Information (AI) of MIRUS Controller chapter 1.3. 10 IFU, MIRUS Controller, en-gb, N.00

2 Safety 2 Safety 2.1 General safety instructions 2.1.1 Safe operation To ensure safe operation of the MIRUS Controller, use the system only as intended. Operators need to be familiar with these Instructions for use (IFU) prior to operating the system. Only trained operators should use this system. Always ensure compliance with the requirements of this IFU and with the local governmental or other authority s requirements. 2.1.2 User qualification The MIRUS Controller should be operated by or on the order of a physician. The MIRUS Controller should only be operated by qualified medical personnel, to ensure adequate intervention in case of a device malfunction. 2.1.3 Monitoring The MIRUS Controller is equipped with monitoring functions that will help to observe the device situation and thereby serve to indicate changes 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 in the power supply changes in the anaesthetic supply An alternative for patient sedation should be present to maintain sedation in case of a device malfunction. 2.1.4 Electrical supply The MIRUS Controller is built for AC supply with electrical power from a line supply voltage of 100 to 230 V AC ± 10%, 50 to 60 Hz ± 5%. Verify your local AC line supply voltage matches the rated device s voltage on the serial plate. The MIRUS Controller is equipped with an internal backup battery (UPS battery) that provides a defined time of operation with reduced functionality upon loss of electrical mains supply during application (refer to chapter 10.1 General specifications). This backup battery will automatically switch on, whenever mains supply is lost. A symbol on the display appears to inform the user. Note: The device should only be stored with a fully charged battery. IFU, MIRUS Controller, en-gb, N.00 11

2 Safety 2.1.5 Responsibility of the manufacturer The manufacturer is not responsible for any functional change of the device, damage or injury to patient or operator that is caused by misuse or by disregard of the safety advice given in this instruction for use. The user or owner is responsible for the proper operation of the system, if the device is serviced, maintained or repaired by unauthorised personnel. The user or owner is responsible for the proper operation of the system if the device is misused or not used according to the instructions given in these instructions for use. 2.1.6 Safety features 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 Anaesthetic supply Electrical energy Device s control system Interface control MIRUS Reflector control Control for Internal reservoir empty, Dosage failure Line supply fail, battery supply fail Watchdog alarm, Device inclined Occlusion or disconnection of Interface MIRUS Reflector expiration time CAUTION The MIRUS Reflector control is only valid for a continuous connection between MIRUS Interface plug and a powered MIRUS Controller (AC connected). A disconnection of the plug or power off of the MIRUS Controller will reset the timer. Patient alarms Control of Control for Anaesthetic concentration Low and High et Sevo / et Iso / et Des CO 2 concentration Low and High et CO 2 Apnoea Apnoea alarm 12 IFU, MIRUS Controller, en-gb, N.00

2 Safety 2.2 Warning symbols used in the IFU Caution Not following this point will lead to damages to the device or the system. Warning Not following this point will lead to patient and/or user harm. 2.3 Patient safety 2.3.1 Monitoring WARNING For patient safety always use patient cardiovascular monitoring during operation of the MIRUS System. Do not use the MIRUS System for spontaneous breathing patients without an apnoea backup ventilation 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 Reflector Interface plug. Always set alarm levels for et VA and et CO 2 according to application and patient. 2.3.2 Volatile anaesthetic agents (VA) WARNING Using any other volatile anaesthetic agent than the one your MIRUS Controller is designed for can result in overdosing and serious patient injury. Never use any bypass to the keyed filler system. This can result in overdosing and serious patient injury. Do not switch type of volatile anaesthetic agent while treating a patient. IFU, MIRUS Controller, en-gb, N.00 13

2 Safety 2.3.3 Control of patient relevant dosage WARNING Always control the dosing of the volatile anaesthetic agent by measuring the dose relevant end-expiratory agent concentration (et VA). Do not deliver any additional volatile anaesthetic agent to a breathing system that is connected to the MIRUS System. 2.3.4 Combination of ventilators and MIRUS System WARNING Use the MIRUS System only in combination with TIM tested ventilators (see list of compatible ventilators). Using the MIRUS System with ventilators 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 helmet or face mask ventilation (NIV). 2.3.5 Triggering of ventilators WARNING When having placed the MIRUS System into the patient s breathing system ensure adequate triggering of the ventilator and readjust triggering parameter, if necessary. 2.3.6 Minimum tidal volume WARNING Do not use the MIRUS System at ventilation settings requiring inspiratory tidal volumes < 300 ml. Do not use the MIRUS System with additional breathing filters (HME/F) at the y-piece or at the tube connection. Do not use tubes etc. that significantly increase dead space. 14 IFU, MIRUS Controller, en-gb, N.00

2 Safety 2.3.7 MDI Applications WARNING Using MDI applications with the MIRUS System can result in an underdosage of the patient for a short period of time. 2.3.8 Resistance of airway components WARNING Never use an active humidification system when operating the MIRUS System. This may result in serious increase of airway resistance. When using the MIRUS System with an anaesthesia workstation, never adjust the fresh gas setting to low-flow values (< 1.5 x MV). The CO 2 absorption process in the rebreathing circuit may generate heat 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 volatile anaesthetic agents. To protect yourself and others, observe the volatile anaesthetic agent manufacturer s safety instructions for handling with volatile anaesthetic agents. Turn off volatile anaesthetic agent delivery when disconnecting the patient s breathing system to avoid ambient pollution. Do not use the MIRUS System in parallel to extracorporeal membrane oxygenation (ECMO) or extracorporeal membrane decarboxylation (ECOR). 2.5 Device 2.5.1 Accessories WARNING Use only accessories approved by the manufacturer of either the MIRUS Controller or the accessory. IFU, MIRUS Controller, en-gb, N.00 15

2 Safety 2.5.2 Positioning WARNING Never use the MIRUS Controller when not in a horizontal position to avoid the liquid agent entering the gas pathway. If the MIRUS Controller has tipped over, wait for a minimum of 10 seconds to ensure no liquid is in gas pathways before applying anaesthetic agent. Ensure the MIRUS Controller is always in a stable position. 2.5.3 Risk of electrical hazard CAUTION Use the enclosed original line supply cable only. Make sure, that the device is not covered by any material (e.g. a curtain) during the operation. This may interfere 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 the system to stabilise in the specified operation temperature for one hour before operation. Do not use the MIRUS System for intra or inner clinical transport. Do not use the MIRUS System in an emergency / ambulance car. Do not use the MIRUS System in a helicopter or airplane. 2.5.4 Risk of fire CAUTION Do not use materials such as Ammonium, Phenol, or Acetone to clean the device. Do not use the MIRUS Controller when there is doubt in the proper function of the electrical earth ground in the installation environment. Do not use the MIRUS Controller in the presence of flammable anaesthetics. 16 IFU, MIRUS Controller, en-gb, N.00

2 Safety 2.5.5 Electromagnetic compatibility CAUTION Do not use the MIRUS System in the presence of an MRI System. WARNING The use of other electrical equipment, e.g. the line supply cable, may cause a higher EM-emission or may weaken the immunity of the device. This may cause a risk to the patient. The use of other electrical equipment on or near this system may cause interference. Verify normal operation of equipment in your configuration before connecting a patient. 2.6 Residual risk Fail-safe mode During its operation, the MIRUS Controller is monitored by a separate 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 patient. Safe mode means: screen is blank no volatile anaesthetic agent is delivered alarm lights are flashing in red confirm button is flashing in red audible alarm sound To silence the audible alarm, press the Confirm button for at least 4 seconds. MIRUS Controller now turns off flashing red LEDs and stops alarm 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 for 5 seconds, reconnect AC supply, re-start by pressing the Confirm button (usual start). IFU, MIRUS Controller, en-gb, N.00 17

3 Preparation 3 Preparation 3.1 Cleaning before first use The MIRUS Controller does not come sterilised; the device has to be cleaned 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 right side of the Controller. Connect to AC supply. 100 to 230 V AC ± 10%, 50 to 60 Hz ± 5%. Alarm lights turn on in green. (lights pulsate= battery charges) Controller heats up. 18 IFU, MIRUS Controller, en-gb, N.00

3 Preparation 3.3 Connecting to MIRUS Reflector 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 clip Place Reflector. Insert interface plug into plug receptacle. Ready to turn on. IFU, MIRUS Controller, en-gb, N.00 19

3 Preparation 3.4 Turning on Press Confirm button. Start-up sound Alarm lights flash in sequence red, 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 problem or an error occurs, follow the instructions on the screen Refer to chapter 7.2 Messages and error messages for more information. 20 IFU, MIRUS Controller, en-gb, N.00

3 Preparation Reminder screen Press OK to confirm. Press Confirm button. On-Call mode Controller is ready for use. To continue press one of the menu buttons on the right: Home (standard 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: Change values of alarm limits (refer to chapter 3.10) Configurations and filling: setting on-screen language, CO 2 unit, Time zone, Date, time. Filling during operation. (refer to chapter 3.11) Turn off (refer to chapter 5) IFU, MIRUS Controller, en-gb, N.00 21

3 Preparation 3.5 Filling during start-up sequence If liquid volume level in reservoir is less than 75 ml, MIRUS Controller will require filling prior to the system test. Wait for a request to fill (message on screen) and follow the instructions. Note: For further information about the bottle adapter refer to the manufacturer's instructions. CAUTION Only the suitable bottle adapter will match with MIRUS Controller. CAUTION Don t force an unsuitable 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 press the fill port valve manually down at any time. This will result in pressure and vapour release. WARNING Slowly remove bottle from fill port to reduce vapour pressure to avoid ambient pollution. WARNING Avoid spilling volatile anaesthetic agent during filling process to avoid ambient pollution. Perform CAUTION Do not try to open the flap manually, it could be seriously damaged. Press Fill port flap button to open fill port flap or press Turn off button to shut down device. 22 IFU, MIRUS Controller, en-gb, N.00

3 Preparation Button for fill port flap is light grey. 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 stop is felt (spring loaded valves open). Reservoir is filled. Note: Device cannot be overfilled. IFU, MIRUS Controller, en-gb, N.00 23

3 Preparation Max. level reached Remove bottle. Close fill port 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 seconds (green lights off), reconnect AC supply, restart by pressing the Confirm button (usual start). 24 IFU, MIRUS Controller, en-gb, N.00

3 Preparation 3.7 Change to operation mode Press menu button Home. Home screen pre-set MAC value, e.g. SEVO MAC 40 = 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: Changing patient data is also possible during VA application. Patient data pre-set: gender: male age: 40 years size: 180 cm weight: 80 kg IFU, MIRUS Controller, en-gb, N.00 25

3 Preparation 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. 26 IFU, MIRUS Controller, en-gb, N.00

3 Preparation 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. Press Confirm button. Change completed. IFU, MIRUS Controller, en-gb, N.00 27

3 Preparation 3.9 Changing wash-in speed Press menu button MAC pilot. Note: Changing wash-in speed is 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 washin speed parameters for further information. Press button for selected wash-in speed. Button for selected wash-in speed is light grey. Press Confirm button. Change completed. 28 IFU, MIRUS Controller, en-gb, N.00

3 Preparation 3.10 Changing alarm settings Press menu button Alarm settings. Note: Changing alarm settings is also possible during application of VA. Alarm settings pre-set alarm limits for SEVO: et CO 2 min = 20 mmhg et CO 2 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 information about ISO and DES. Press button for parameter to be changed, e.g. et CO 2 max. Button for selected parameter is light grey. Arrow keys are activated. Use arrow keys to change parameter. IFU, MIRUS Controller, en-gb, N.00 29

3 Preparation Press Confirm button. Change completed. 3.11 Filling and additional configurations Press menu button Configuration screens. Note: Configuration is also possible during VA application. Options 1 st tab: filling-screen 2 nd tab: setting language, CO 2 unit 3 rd tab: setting time zone, date, time 4 th tab: service screen 30 IFU, MIRUS Controller, en-gb, N.00

3 Preparation 3.11.1 Filling during operation Filling-tab Filling VA reservoir. Note: Filling is also possible during VA application. Note: During application of VA, VA delivery is maintained during filling 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 during start-up. CAUTION Do not try to open the flap manually, it could be seriously damaged. Press Fill port flap button. Button Fill port flap is light grey. Follow instruction on screen. Press Confirm button. Fill port flap opens automatically. IFU, MIRUS Controller, en-gb, N.00 31

3 Preparation Fill port flap open. Filling: Insert bottle 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. Follow instruction on screen. Close fill port flap. Fill port flap closed. Reservoir filled. 32 IFU, MIRUS Controller, en-gb, N.00

3 Preparation 3.11.2 Setting on-screen language and CO 2 unit Select tab for Setting Setting Setting on-screen language and CO 2 unit pre-set: Language = English CO 2 unit = mmhg Press button for parameter to be changed, e.g. language. Button for selected parameter is light grey. Arrow keys are activated. Use arrow keys to change parameter. IFU, MIRUS Controller, en-gb, N.00 33

3 Preparation Press Confirm 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 necessary. Press button for parameter to be changed, e.g. hour. 34 IFU, MIRUS Controller, en-gb, N.00

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

3 Preparation 3.11.4 Service 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 grey. Arrow keys are activated. Use arrow keys to change MAC value. 36 IFU, MIRUS Controller, en-gb, N.00

3 Preparation Press Confirm button. Change completed. 3.13 Connecting patient In order to connect the patient to the device you need a filter in addition to the 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 and the controller please refer to the manufacturer s instructions for use (IFU). When the patient is connected to the controller, the lung icon is animated and the controller measures an et CO 2 value. IFU, MIRUS Controller, en-gb, N.00 37

4 Application of VA 4 Application of VA The following activities are all done on the Home screen (operation mode). Home screen (Operation mode) 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 buttons activated. After 10 minutes of no activity on the touch screen, the controller switches to snooze screen. Note: After touching screen, controller switches back to Home screen. 38 IFU, MIRUS Controller, en-gb, N.00

4 Application of VA 4.2 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 Pause flashes. Press button Pause. VA Application active again. IFU, MIRUS Controller, en-gb, N.00 39

4 Application of VA 4.4 Stopping application Press button Stop. Button Stop is light grey. Press Confirm button. VA Application is finished. Pause and Stop buttons deactivated. 40 IFU, MIRUS Controller, en-gb, N.00

5 Turning off 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 Turn off is light grey. Press Confirm button. IFU, MIRUS Controller, en-gb, N.00 41

5 Turning off Button Turn off is coloured. Controller switches off automatically. Place Reflector in Park Bay. Controller switched off (off mode). 42 IFU, MIRUS Controller, en-gb, N.00

6 Maintenance and Cleaning 6 Maintenance and Cleaning 6.1 Maintenance 6.1.1 General Information Maintenance, safety checks and maintenance measures must be performed only by the manufacturer or by qualified personnel authorized by the manufacturer. 6.1.2 Schedule Affected part Period Performer MIRUS Controller UPS Battery pack Fan filter VA reservoir Software Every 12 months Safety Check Visual Inspection Electrical Safety Test Checking gas monitor Checking pump Safety Function test When not using the device, leave device connected to mains supply or connect to mains supply at least once a month for at least 24h. Replace every 2 years. Replace every 12 months. Empty every 4 weeks. Do not re-use VA. Manufacturer gives information as soon as software update is available. Manufacturer or qualified personnel specially authorized by the manufacturer Manufacturer or qualified personnel specially authorized by the manufacturer Manufacturer or qualified personnel specially authorized by the manufacturer User / Operator Manufacturer or qualified personnel specially authorized by the manufacturer IFU, MIRUS Controller, en-gb, N.00 43

6 Maintenance and Cleaning 6.2 Cleaning 6.2.1 General advice WARNING Observe the following safety precautions: Read the material data sheet for each cleaning agent. Wear gloves and safety glasses. Do not breathe the fumes. CAUTION To prevent damage: Refer to the manufacturer s data if you have questions about a cleaning agent. Do not use organic, halogenated or petroleum based solvents, anaesthetic agents, glass cleaner, acetone or harsh cleaning agents. Do not use abrasive cleaning agents, such as steel wool, silver polish or silver cleaner. Keep all liquids away from electrical parts. Do not permit liquids to go into the equipment 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 hospital. Do not re-use single use components. 6.2.2 Cleaning the individual components MIRUS Controller surface a. Turn off the MIRUS Controller and ensure that the mains power cord is disconnected. b. Make sure the fill port is closed. c. Remove MIRUS Reflector and interface plug. d. Make sure the receptacle token is placed in the MIRUS Reflector receptacle and the receptacle is sealed. e. Make sure the three connector tokens are placed in the communication ports and the ports are sealed. f. Use a soft towel to clean the housing, the display and the user interface. When using fluid cleaner, use a mild detergent and do not permit liquids to penetrate the housing. 44 IFU, MIRUS Controller, en-gb, N.00

6 Maintenance and Cleaning For wipe disinfection use agents with the following ingredients: Agent Alcohol based Non-alcohol based Specification Containing: Isopropyl alcohol (70% solution) Ethyl alcohol (70% solution) Composition of Ethyl alcohol (70%) and Isopropyl alcohol (70%) Containing quaternary ammonium compounds: Didecyldimethylammoniumchloride max. 0,25 g / 100 g ready-for-use solution Alkyl(C12-16)dimethylbenzylammoniumchloride max. 0,5 g / 100 g ready-for-use solution For wipe disinfection TIM recommends: Bacillol Wipes Dr. Schumacher Cleanisept Wipes Terralin protect 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/detergent. List of materials used: Component Housing Alarm lights Touch Screen Park Bay Fill port Flap Seals / Covers Battery flap Screws Labels Housing feet Fan filter Power supply cord IEC plug Potential equalization Material Polystyrene (PS) Polycarbonate (PC) Polyester (PES) AlMgSi alloy, anodised, AlCuMg, anodised AlMgSi alloy, anodised Silicone, Polyethylene (PE), Synthetic rubber (EPDM) Aluminium, anodised Stainless steel Polyethylene (PE) Polyvinylchloride (PVC) Acrylonitrile butadiene styrene (ABS) Acrylonitrile butadiene styrene (ABS), Polyvinylchloride (PVC) Polybutylene terephthalate (PBT) Nickel-plated brass IFU, MIRUS Controller, en-gb, N.00 45

6 Maintenance and Cleaning WARNING Ensure that the housing and the touch screen have dried completely before reconnecting the MIRUS Controller to an electrical supply. MIRUS Controller Fill port Always keep the fill port flap closed to avoid the entry of dust or other substances. In case the fill port needs to be cleaned use a clean and lint free cloth. Avoid using cotton swabs as they too will leave small particles and lint in the fill port. MIRUS Reflector To clean the external surfaces of the MIRUS Reflector follow the instructions for use supplied with the product. MIRUS Filter The MIRUS Filter is a single use device and should 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 Parts list for ordering information). Perform the draining according to the manufacturer s guide that comes with the draining kit. 6.4 Shipping MIRUS Controller If the MIRUS Controller is to be sent, it must be cleaned and disinfected (refer to chapter 6.2 Cleaning), as well as completely emptied (refer to chapter 6.3 Draining the reservoir). Only use the original packing material to pack the MIRUS Controller: Safety bag Transport jacket (top and bottom frame) MIRUS Controller box white MIRUS Controller shipping box, 2-piece If the original packing material is not available, it can be ordered via: service@tim-products.de Perform the packing as described in the manufacturer s guide. 46 IFU, MIRUS Controller, en-gb, N.00

7 Alarms and messages 7 Alarms and messages 7.1 Alarms 7.1.1 Alarm modality The MIRUS Controller distinguishes between high- and low-priority alarms. Alarms only occur during operation and are shown in the following way: Alarm lights: On screen: Audible alarm: red or yellow alarm lights activated red or yellow alarm bar with text, red or yellow highlighted icon alarm sound Note: The alarm volume will escalate 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 further alarm is a low-priority alarm, the alarm bar of the high-priority alarm remains visible. The highlighted icons (if present by the alarms) are both recognizable. 7.1.2 Low-priority alarms Alarm bar Silence button No highlighted icon in this example. Activity Screen Alarm light Audible alarm Alarm is active. Alarm message yellow continuous ON Confirming the alarm by activating the alarm silence button. Alarm message yellow, continuous OFF IFU, MIRUS Controller, en-gb, N.00 47

7 Alarms and messages 7.1.3 High-priority alarms Alarm bar Silence button highlighted icon Activity Screen Alarm light Audible 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 still active after the 2 min silence time Alarm message Timer red, flashing ON 48 IFU, MIRUS Controller, en-gb, N.00

7 Alarms and messages 7.1.4 Patient alarms Alarm (in alphabetical order) Apnoea Priority Low Device action Alarm and stop VA delivery High et CO 2 High Alarm High et VA VA = Sevo, Iso or Des High Alarm Low et CO 2 High Alarm Low et VA VA = Sevo, Iso or Des Low Vt High High High Alarm Alarm Alarm and stop VA delivery Set condition No breathing activity. Measured et CO 2 > max et CO 2 for three consecutive breaths. Measured et VA > max etva for three consecutive breaths. Measured et CO 2 < min et CO 2 for three consecutive breaths. Measured et VA < min et VA for three consecutive breaths. Measured Vt i < 200 ml for five consecutive breaths. Measured Vt i < 50 ml for five consecutive breaths. Reset condition Breathing activity detected. Measured et CO 2 within the limit with the first breath. Measured et VA within the limit with the first breath. Measured et CO 2 within the limit with the first breath. Measured et VA within the limit with the first breath. Measured Vt i 200 ml with the first breath. Measured Vt i 50 ml with the first breath. IFU, MIRUS Controller, en-gb, N.00 49

7 Alarms and messages 7.1.5 Technical alarms Alarm (in alphabetical order) Device inclined. Dosage failed! Start VA? Failure! Turn off. Fill port flap still open. Heating system failed. Interface disconnected. Mains supply lost. Occlusion of Interface Overtemperature Pause still active. Please replace Reflector promptly! Priority Low High High High Low High High High Device action Alarm and stop VA delivery. Alarm and stop VA delivery. Alarm and stop VA delivery. Alarm and stop VA delivery. Alarm Alarm Alarm Alarm and stop VA delivery. Set condition Tilt angle > 25 for t < 30 sec. Tilt angle > 25 for t 30 sec. Calculation problem was detected. A technical failure was detected. Fill port flap open >5 min. Fill port flap open >7 min. No activity of the heating system could be detected. Interface plug disconnected while in operation. Reset condition by user Reposition device on level surface. Restart VA delivery by pressing Play and confirm or turn off device. Turn off device. Close fill port flap. Turn off device. Reconnect interface plug. Low Alarm AC lost. Connect mains supply. High Low Low Low Alarm and stop VA delivery. Alarm Alarm and pause VA delivery. Alarm A gas sampling or measurement line is clocked. Inner Controller temperature > 55 C Delivery paused for > 2 min. No valid values from Reflector. Check interface for kinking. Check fresh gas flow of AWS to be min 1.5 * MV. Check fan input and output. Neutralise interception by pressing Pause. Replace reflector. (System test should be repeated as soon as possible.) Reflector expired. Reflector soon expires. Reservoir needs refill Reservoir empty Low Low Low High Alarm Alarm Alarm Alarm Interface not released for >160 hours. MIRUS Interface not released for 144 160 hours. Internal reservoir fill level < 60 ml Internal reservoir fill level < 45 ml. Prepare to replace or replace reflector. Prepare to replace or replace reflector. Refill reservoir. Refill reservoir. 50 IFU, MIRUS Controller, en-gb, N.00

7 Alarms and messages Alarm (in alphabetical order) Set date and time! UPS battery low VA application not active. Priority Low High Low Device action Alarm Alarm Alarm Set condition When comparing the internal clock with a setpoint, a deviation was detected (e.g. after a long time without power supply) if UPS battery is down to ¼ of capacity (2 minutes left). Breathing activity detected but VA application is not started by user via Play. Reset condition by user Correct date and time. Allow recharging of UPS battery. Start VA application via Play. IFU, MIRUS Controller, en-gb, N.00 51

7 Alarms and messages 7.2 Messages and error messages 7.2.1 During power up test The following will be checked during power up test: level reservoir state of charge UPS battery position 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 buttons are available on the screen (after selecting press Confirm button): Fill Port Flap OK Turn off Press Confirm button. Note: For more information, refer to Additional Information (AI) of MIRUS Controller chapter 7.4.1. 52 IFU, MIRUS Controller, en-gb, N.00

7 Alarms and messages 7.2.2 During system test The following will be checked during system test: position of reflector connection of interface plug pneumatic components 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 are available on the screen (after selecting press Confirm button): Repeat OK Turn off Press Confirm button. Note: For more information, refer Additional Information (AI) of MIRUS Controller chapter 7.4.2. IFU, MIRUS Controller, en-gb, N.00 53

7 Alarms and messages 7.2.3 Reminder screen Verify that an alternative for patient sedation is present. Confirm by pressing OK or turn off device via Turn off button. Press Confirm button. 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. Follow instructions on screen. Refer to chapter 3.11.1 Filling during operation and chapter 5 Turning off for more information. Note: For more information, refer to Additional Information (AI) of MIRUS Controller chapter 7.4.5. 54 IFU, MIRUS Controller, en-gb, N.00

8 Standard values 8 Standard values 8.1 Alarm settings and application defaults Screen Parameter Default value Home MAC 0.5 Patient data Gender Age Ideal body weight Body height Vol. male 40 years 80 kg 180 cm SEVO 0.9 Vol% ISO 0.6 Vol% DES 3.4 Vol% MAC Pilot Wash-in speed medium Alarm settings et CO 2 min et CO 2 max et VA min et VA max Apnoea time 20 mmhg 50 mmhg ISO 0.3 Vol % SEVO 0.5 Vol % DES 1.7 Vol% MAC * 2.0 (VA specific) 60 seconds Alarm volume 100% IFU, MIRUS Controller, en-gb, N.00 55

8 Standard values 8.2 Specification of wash-in speed parameters Volatile Anaesthetic agent Isoflurane Sevoflurane Desflurane Specification cheetah = Fast 2* set MAC-value rabbit = Medium 1.5* set MAC-value turtle = Slow 1.0* set MAC-value max. concentration: 6 Vol% cheetah = fast 2* set MAC rabbit = medium 1.5* set MAC-value turtle = slow 1.0* set MAC-value max. concentration: 8 Vol% cheetah = fast 1.5* set MAC-value rabbit = medium 1.25* set MAC-value turtle = slow 1.0* set MAC-value max. concentration: 18 Vol% 56 IFU, MIRUS Controller, en-gb, N.00

9 Parts list 9 Parts list 9.1 Accessories Description Bottle adapter Sevofluran QUIK-FIL Bottle adapter Sevofluran Bottle adapter Isofluran Bottle adapter Desfluran SAF-T-FIL Order code BA-SEV-Q BA-SEV-K BA-ISO-K BA-DES-S MIRUS Mounting Bracket - Base MIRUS Mounting Bracket - VESA arm MIRUS Mounting Bracket - Rail (2pcs.) MC-01-014 MC-01-014-1 MC-01-014-2 9.2 Spare parts Description Power supply cable DE, ES Power supply cable UK Power supply cable FR Power supply cable IT Power supply cable CH Power supply cable AU Order code MC-01-001 MC-01-002 MC-01-003 MC-01-004 MC-01-005 MC-01-006 UPS backup battery MC-01-011 9.3 Service parts Description MIRUS Draining Kit MIRUS Draining kit - Spare bottle MIRUS Event Log µsd Card MIRUS Replacement filter MIRUS Data cable Order code MC-01-013 MC-01-013-1 MC-01-016 MC-09-905 MC-SC-DC-01 IFU, MIRUS Controller, en-gb, N.00 57

9 Parts list 9.4 Documents Documents can be ordered as printed version or accessed online on the manufacturer s website: http://the-mirus.com/mirus-controller-instructions-for-use.html Description MIRUS Controller Instruction for Use (en-gb, de, fr, it, es) and Additional Information (en-gb) CD Order code MC-MC-IFU-ALL 9.5 MIRUS Controller Description MIRUS Controller Isoflurane MIRUS Controller Sevoflurane MIRUS Controller Desflurane Order code MC-MC-ISO MC-MC-SEV MC-MC-DES 58 IFU, MIRUS Controller, en-gb, N.00

10 Technical specifications 10 Technical specifications 10.1 General specifications Specification Device Physical dimensions (L x H x D) 325 x 195 x 210 mm (12.8 x 7.6 x 8.2 in.) Weight with filled reservoir 9.0 kg (15.4 lb) HW Options MC-MC-ISO For VA Isoflurane MC-MC-SEVO For VA Sevoflurane MC-MC-DES For VA Desflurane Environmental conditions Operation (filled reservoir): Temperature range for MC ISO, SEVO +10 to +40 C Temperature range for MC DES +10 to +30 C Atm. pressure range 700 to 1,060 hpa Equivalent altitude (above sea level) 3,000 to 0 m (9,840 to 0 ft) Humidity range 10 to 90% relative, none condensing Environmental conditions Storage with filled or empty reservoir: Temperature range -20 to +50 C Atm. pressure range 500 to 1,060 hpa Equivalent altitude (above sea level) 5,500 to 0 m (18,050 to 0 ft) Humidity range 10 to 90% relative, none condensing Environmental conditions Transport (empty reservoir): Temperature range -20 to +70 C Atm. pressure range 500 to 1,060 hpa Equivalent altitude (above sea level) 5,500 to 0 m (18,050 to 0 ft) Humidity range 10 to 90% relative, none condensing Noise level 49 db (A) Patient/device alarms at max. setting > 66 db (A) (tone sequence) at max. setting Panic alarms (fail safe, mains supply > 63 db(a) (permanent tone) lost, microcontroller watchdog error) Classifications CE class according to 93/42/EEC IIb Protection class acc. to EN 60601-1 I Protection type acc. to EN 60601-1 B IP Code IP20 GMDN codes MC-MC-ISO 36890 MC-MC-SEVO 36980 MC-MC-DES 36979 UMDNS code MIRUS Controller 10-144 Electrical supply Nominal voltage 100 to 230 V AC ± 10% Frequency 50 to 60 Hz ± 5% Power consumption < 75 VA Grounding Standard ground stud Internal back-up Built in backup battery, backup time: 15 min. IFU, MIRUS Controller, en-gb, N.00 59

10 Technical specifications Specification Agent supply Internal reservoir Status information Filling system Filling capacity Electromagnetic compatibility (according to EN 60601-1-2) Display structure Screen Menu language Device Maximum capacity = 270 ml Reserve capacity = 20 ml On screen Proprietary filling system, agent specific according to ISO 5360 Maximum = 190 ml Maximum overfill protection = 250 ml Test parameters and limit values can be obtained from the manufacturer if required. Touchscreen, 5.7", confirm button Applied Standards EN 1041 EN 60601-1 EN 60601-1-2 EN 60601-1-8 EN ISO 5360 EN ISO 8835-4 EN ISO 14971 EN ISO 15223-1 EN ISO 21647 EN ISO 80601-2-12 IEC 60529 IEC 62304 IEC 62366-1 Units CO 2 Pressure (Paw, PEEP) VA concentration English, German, French, Italian, Spanish mmhg, %, kpa mbar for German, cmh 2O for all other languages Vol% 60 IFU, MIRUS Controller, en-gb, N.00

10 Technical specifications 10.2 Controls and Ranges 10.2.1 Agent dosage For Values Isoflurane Range: MAC 0.1 to 2.0 @ MVi 3.0 to 15.0 L/min where MAC 1 = 1.15 Vol% @ age = 40 Increment: 0.1 MAC @ single taps on button 0.5 MAC @ pressing button > 1 sec Sevoflurane Range: MAC 0.1 to 2.0 @ MVi 3.0 to 15.0 L/min where MAC 1 = 1.9 Vol% @ age = 40 Increment: 0.1 MAC @ single taps on button 0.5 MAC @ pressing button > 1 sec Desflurane Range: MAC 0.1 to 2.0 @ MVi 3.0 to 15.0 L/min where MAC 1 = 6.7 Vol% @ age = 40 Increment: 0.1 MAC @ single taps on button 0.5 MAC @ pressing button > 1 sec 10.2.2 Alarm settings For Values et CO 2 min. / et CO 2 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 taps on button 5 mmhg / 1.0% / 1.0 kpa @ pressing button > 1 sec et ISO min. / et ISO max. Range: 0.0 to 6.0 Vol% Increment: 0.1 Vol% @ single taps on button 0.5 Vol% @ pressing button > 1 sec et SEVO min. / et SEVO max. Range: 0.0 to 8.0 Vol%. Increment: 0.1 Vol% @ single taps on button 0.5 Vol% @ pressing button > 1 sec et DES min. / et DES max. Range: 0.0 to 18.0 Vol% Increment: 0.1 Vol% @ single taps on button 0.5 Vol% @ pressing button > 1 sec Apnoea time Range: 15 to 60 sec Increment: 5 seconds Alarm volume Range: 50 to 100% Increment: 10% @ single taps on button IFU, MIRUS Controller, en-gb, N.00 61

10 Technical specifications 10.2.3 Patient data settings Specification Values Age Range: 10 to 115 years Increment: 1 year @ single taps on button 5 years @ pressing button > 1 sec Size Range: 100 to 250 cm Increment: 5 cm @ single taps on button 10 cm @ pressing button > 1 sec Weight Range: 15 to 125 kg (ideal body weight) Increment: 1 kg @ single taps on button 5 kg @ pressing button > 1 sec 10.3 Performance 10.3.1 Agent dosage accuracy For Isoflurane and Sevoflurane and Desflurane Values + 15% of set MAC (measured as average of MV) @ all settings - 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 10.3.2 Respiratory monitoring accuracy Specification Volumes Pressures Rate I:E Values ± 15% @ Vt 200 ml to 2000 ml (BTPS corrected, @rate < 40/min) ± 4.0% or 2 cmh 2O whichever is greater @ -10 to 100 cmh 2O (@rate < 40/min) ± 1 breath per minute (@rate < 40/min) ± 25% (@rate > 40/min) 62 IFU, MIRUS Controller, en-gb, N.00

10 Technical specifications 10.3.3 Gas monitoring accuracy Specification Values CO 2 0 1 % ± 0.1% 1 5 % ± 0.2% 5 7 % ± 0.3% 7 10 % ± 0.5% > 10 % unspecified Isoflurane 0 1 % ± 0.15% 1 5 % ± 0.2% > 5 % unspecified Sevoflurane 0 1 % ± 0.15% 1 5 % ± 0.2% 5 8 % ± 0.4% > 8 % unspecified Desflurane 0 1 % ± 0.15% 1 5 % ± 0.2% 5 10 % ± 0.4% 10 15 % ± 0.6% 15 18 % ± 1.0% > 18 % unspecified 10.4 Monitoring system Specification Safety monitoring Patient Alarms Tidal volume Agent dosage monitoring Dosage start Dosage end Control Device Breathing activity Apnoea Low Vt start of inspiration end of inspiration or end of delivered anaesthetic agent volume Monitoring of applied volume of anaesthetic agent. Comparison of calculated with measured volume Dosage failed! No delivery Alarms Gas monitoring Agent Numerical data Alarms Metabolic gases CO 2 Numerical data et CO 2 Alarms Low et CO 2, High et CO 2 Isoflurane, Sevoflurane, Desflurane et VA Low et VA, High et VA IFU, MIRUS Controller, en-gb, N.00 63

11 Terms and abbreviations 11 Terms and abbreviations In alphabetical order: AC DC alternating current direct current bpm BTPS DES DOGA et CO 2 et Des et Iso et Sevo et VA Exp Fe Fi Fi Des Fi Iso Fi Sevo Fi VA set Flow HME HMEF HW x.n I:E IBW IFU Insp ISO MAC breaths per minute body temperature and pressure, saturated Desflurane Diffusion Optimized Gas Application Consumption optimising application of VA. end tidal CO 2 concentration end tidal Desflurane concentration end tidal Isoflurane concentration end tidal Sevoflurane concentration end tidal Volatile Anaesthetic concentration expiratory, expiration fraction expiratory VA, describes the expired concentration of VA fraction inspiratory VA, describes the inspired concentration of VA inspiratory Desflurane concentration inspiratory Isoflurane concentration inspiratory Sevoflurane concentration set target for the inspiratory volatile anaesthetic concentration airway flow, the flow within the patient s breathing system Heat and Moisture Exchanger Disposable device to store exhaled humid water vapour and warmth and recycle it back to the patient with the next inspiration (artificial nose). HME with bacterial/viral filter hardware revision number ratio between inspiratory and expiratory time Ideal Body Weight Instructions For Use inspiratory, inspiration Isoflurane Minimum Alveolar Concentration The concentration of the vapour in the blood/expiratory lung volume that is needed to prevent movement (motor response) in 50% of subjects in response to surgical (pain) stimulus. 64 IFU, MIRUS Controller, en-gb, N.00

11 Terms and abbreviations MAC set MAC Pilot MC MDI MF MR MV MVe MVi NIV P peak Paw PEEP PUT Rate Ref. SEVO SN ST SW x.nn.nn UPS UTC VA Vt Vt e Vt i Vt/kg set target Minimum Alveolar Concentration Function to calculate the necessary amount of volatile anaesthetic gas to be added to the breathing gas of the patient, based on the measured respiratory volumes, end tidal VA concentration and the desired concentration of the volatile anaesthetic gas. MIRUS Controller Metered-Dose Inhaler MIRUS Filter MIRUS Reflector Minute Volume Breathing volume of a patient per minute. Minute Volume, expiratory; Unit: L/min Minute Volume, inspiratory; Unit: L/min Non Invasive Ventilation Ventilation with a mask or a helmet. highest airway pressure, measured with last breath Airway pressure, the pressure within the patient s breathing system Positive End Expiratory Pressure within one breath, measured Power up test total number of breath per minute stock number Sevoflurane Serial Number System Test Software revision number Uninterruptible Power Supply Universal Time Coordinated, Primary time standard volatile anaesthetic agent, to dose in gaseous state tidal volume in general expiratory tidal volume, per breath inspiratory tidal volume, per breath tidal volume per kilogram body weight IFU, MIRUS Controller, en-gb, N.00 65

12 High priority alarms 12 High priority alarms Alarm What MIRUS Controller does What to check or to do Device Device pauses the application and 1. Reposition device on a level inclined! closes all valves until device is surface. Dosage failed! Start VA? Failure! Turn off. positioned on a level surface. Device stops the application. Device stops the application. Turn off tag becomes selectable. A major technical failure was recognised. 1. Restart VA delivery by activating Play and Confirm or turn off device. 1. Turn off device into OFF mode (Standby). 2. Wait 5 seconds and try to start device again. 3. If during self test "Sorry " message appears the device is seriously damaged. Call your service organisation. 1. Close Fill port flap. Fill port flap Continues working. still open! Heating Continues working. 1. Turn off device into OFF mode system failed. (Standby). High et VA Continues working. 1. Patient okay (CO 2, SpO 2)? 2. Set MAC okay? 3. Alarm settings okay? High et CO 2 Continues working. 1. Ventilator settings okay? 2. Alarm settings okay? 3. Patient okay? Interface disconnected Device pauses the application. 1. Reconnect MIRUS Interface plug. Low et CO 2 Continues working. 1. MIRUS Interface okay? 2. Ventilator settings okay? 3. Alarm settings okay? Low et VA Continues working. 1. Delivery active (Start button!)? 2. Alarm settings correct? 3. MRUS Interface okay? Low Vt Continues working. 1. Patient okay? 2. Ventilator settings okay? Vt has to be 200mL! Occlusion of Interface Reservoir empty UPS battery low Device pauses the application. Continues working. Continues working. 1. MIRUS Interface bent or pinched? 2. Fresh gas flow of Anaesthesia Work Station minimum 1.5 * MV? 1. Refill reservoir promptly. 1. Allow recharging of battery. 66 IFU, MIRUS Controller, en-gb, N.00

Notes IFU, MIRUS Controller, en-gb, N.00 67

12 High priority alarms Technology Innovated Medicine Manufactured by Instructions for use Service calls Support & Help service@tim-products.de Technologie Institut Medizin GmbH (TIM) Erfurter Straße 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-gmbh.de 0044 Distributed by MEDCAPTAIN Europe B.V. Kerkenbos 1077 T, 6546 BB Nijmegen, The Netherlands Phone: +31 (0)24-206 3000 Email: jurgen.reimer@medcapatain.eu This document MIRUS TM Controller Instruction for use English (GB) Printed in Germany TIM GmbH All rights reserved Rev. N.00 of 03/18 www.tim-gmbh.de Technologie Institut Medizin GmbH (TIM) www.tim-products.de