MIRUSTM Controller · 2019-01-08 · 1 Introduction 6 IFU, MIRUS Controller, en-GB, N.00 1...
Transcript of MIRUSTM Controller · 2019-01-08 · 1 Introduction 6 IFU, MIRUS Controller, en-GB, N.00 1...
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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
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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.
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0 Table of contents
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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
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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 CO2 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
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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
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1 Introduction
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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.
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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
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1 Introduction
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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
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1.4.5 Elements in touch screen
e.g. Home screen – standard operation screen
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 CO2 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 CO2 min, et CO2 max, et VA min, et VA max, Apnoe time, Alarm vol.)
10 Menu button Configurations:
Tab Filling (during operation)
Tab Setting (on-screen language, CO2 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)
1 3 4
5
7
9
11
12
13 15
17
20
21
18
2
22
19
16 14
10
8
6
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1 Introduction
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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.
ST. System test was performed successfully.
No Test. System test is invalidated.
17 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.
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2 Safety
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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 VAC ± 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.
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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 Control for
Anaesthetic supply Internal reservoir empty, Dosage failure
Electrical energy Line supply fail, battery supply fail
Device’s control system Watchdog alarm, Device inclined
Interface control Occlusion or disconnection of Interface
MIRUS Reflector control 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
CO2 concentration Low and High et CO2
Apnoea Apnoea alarm
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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 CO2 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.
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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.
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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 CO2 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.
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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.
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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).
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3 Preparation
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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 VAC ± 10%, 50 to 60 Hz ± 5%.
Alarm lights turn on in green. (lights pulsate= battery charges)
Controller heats up.
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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.
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3 Preparation
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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.
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3 Preparation
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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, CO2 unit, Time zone, Date,
time. Filling during operation.
(refer to chapter 3.11)
Turn off
(refer to chapter 5)
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3 Preparation
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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.
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3 Preparation
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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.
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3 Preparation
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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).
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3 Preparation
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3.7 Change to operation mode
Press menu button Home.
Home screen
pre-set MAC value, 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: Changing patient data is also
possible during VA application.
Patient data pre-set:
gender: male
age: 40 years
size: 180 cm
weight: 80 kg
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3 Preparation
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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.
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3 Preparation
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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.
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3 Preparation
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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 wash-in 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.
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3 Preparation
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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 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 information about ISO and DES.
Press button for parameter to be changed, e.g. et CO2 max.
Button for selected parameter is light
grey.
Arrow keys are activated.
Use arrow keys to change parameter.
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3 Preparation
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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
1st tab: filling-screen
2nd tab: setting language, CO2 unit
3rd tab: setting time zone, date, time
4th tab: service screen
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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.
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3 Preparation
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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.
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3 Preparation
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3.11.2 Setting on-screen language 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 parameter is light
grey.
Arrow keys are activated.
Use arrow keys to change parameter.
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3 Preparation
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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.
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Button for selected parameter is light
grey.
Arrow keys are activated.
Use arrow keys to change parameter.
Press Confirm button.
Change completed.
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3 Preparation
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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.
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3 Preparation
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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 CO2 value.
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4 Application of VA
38 IFU, MIRUS Controller, en-GB, N.00
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.
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4 Application of VA
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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.
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4 Application of VA
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4.4 Stopping application
Press button Stop.
Button Stop is light grey.
Press Confirm button.
VA Application is finished. Pause and Stop buttons deactivated.
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5 Turning off
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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.
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5 Turning off
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Button Turn off is coloured. Controller switches off automatically. Place Reflector in Park Bay.
Controller switched off (off mode).
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6 Maintenance and Cleaning
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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
Every 12 months Safety Check
Visual Inspection
Electrical Safety Test
Checking gas monitor
Checking pump
Safety Function 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 least once a month for at least 24h. Replace every 2 years.
Manufacturer or qualified personnel specially authorized by the manufacturer
Fan filter Replace every 12 months.
Manufacturer or qualified personnel specially authorized by the manufacturer
VA reservoir Empty every 4 weeks. Do not re-use VA.
User / Operator
Software Manufacturer gives information as soon as software update is available.
Manufacturer or qualified personnel specially authorized by the manufacturer
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6 Maintenance and Cleaning
44 IFU, MIRUS Controller, en-GB, N.00
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.
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6 Maintenance and Cleaning
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For wipe disinfection use agents with the following ingredients:
Agent Specification
Alcohol based
Containing:
Isopropyl alcohol (70% solution)
Ethyl alcohol (70% solution)
Composition of Ethyl alcohol (70%) and Isopropyl alcohol (70%)
Non-alcohol based
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 Material
Housing Polystyrene (PS)
Alarm lights Polycarbonate (PC)
Touch Screen Polyester (PES)
Park Bay 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 Polyethylene (PE)
Housing feet Polyvinylchloride (PVC)
Fan filter Acrylonitrile butadiene styrene (ABS)
Power supply cord Acrylonitrile butadiene styrene (ABS), Polyvinylchloride (PVC)
IEC plug Polybutylene terephthalate (PBT)
Potential equalization Nickel-plated brass
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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: [email protected] Perform the packing as described in the manufacturer’s guide.
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7 Alarms and messages
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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: red or yellow alarm lights activated
On screen: red or yellow alarm bar with text, red or yellow highlighted icon
Audible alarm: 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
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
Alarm bar Silence button
No highlighted icon in this example.
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7 Alarms and messages
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7.1.3 High-priority alarms
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
Alarm bar Silence button
highlighted icon
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7 Alarms and messages
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7.1.4 Patient alarms
Alarm (in alphabetical order)
Priority Device action
Set condition Reset condition
Apnoea Low Alarm and stop VA delivery
No breathing activity. Breathing activity detected.
High et CO2
High Alarm
Measured et CO2 > max et CO2 for three consecutive breaths.
Measured et CO2 within the limit with the first breath.
High et VA VA = Sevo, Iso or Des
High Alarm 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 CO2 within the limit with the first breath.
Low et VA VA = Sevo, Iso or Des
High Alarm Measured et VA < min et VA for three consecutive breaths.
Measured et VA within the limit with the first breath.
Low Vt
High Alarm Measured Vti < 200 mL for five consecutive breaths.
Measured Vti ≥ 200 mL with the first breath.
High Alarm and stop VA delivery
Measured Vti < 50 mL for five consecutive breaths.
Measured Vti ≥ 50 mL with the first breath.
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7 Alarms and messages
50 IFU, MIRUS Controller, en-GB, N.00
7.1.5 Technical alarms
Alarm (in alphabetical order)
Priority Device action
Set condition Reset condition by user
Device inclined.
Low Alarm and stop VA delivery.
Tilt angle > 25° for t < 30 sec.
Reposition device on level surface.
High Alarm and stop VA delivery.
Tilt angle > 25° for t ≥ 30 sec.
Dosage failed! Start VA?
High Alarm and stop VA delivery.
Calculation problem was detected.
Restart VA delivery by pressing Play and confirm or turn off device.
Failure! Turn off.
High Alarm and stop VA delivery.
A technical failure was detected.
Turn off device.
Fill port flap still open.
Low Alarm Fill port flap open >5 min.
Close fill port flap. High Alarm
Fill port flap open >7 min.
Heating system failed.
High Alarm No activity of the heating system could be detected.
Turn off device.
Interface disconnected.
High Alarm and stop VA 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 sampling or measurement line is clocked.
Check interface for kinking. Check fresh gas flow of AWS to be min 1.5 * MV.
Overtem-
perature Low Alarm
Inner Controller
temperature > 55°C
Check fan input and
output.
Pause still active.
Low Alarm and pause VA delivery.
Delivery paused for > 2 min.
Neutralise interception by pressing Pause.
Please
replace
Reflector
promptly!
Low Alarm No valid values from
Reflector.
Replace reflector.
(System test should be
repeated as soon as
possible.)
Reflector expired.
Low Alarm Interface not released for >160 hours.
Prepare to replace or replace reflector.
Reflector soon expires.
Low Alarm MIRUS Interface not released for 144 –160 hours.
Prepare to replace or replace reflector.
Reservoir needs refill
Low Alarm Internal reservoir fill level < 60 mL
Refill reservoir.
Reservoir empty
High Alarm Internal reservoir fill level < 45 mL.
Refill reservoir.
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7 Alarms and messages
IFU, MIRUS Controller, en-GB, N.00 51
Alarm (in alphabetical order)
Priority Device action
Set condition Reset condition by user
Set date and time!
Low Alarm
When comparing 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 ≤ ¼ of capacity (2 minutes left).
Allow recharging of UPS battery.
VA
application
not active.
Low Alarm
Breathing activity
detected but VA
application is not
started by user via
Play.
Start VA application via
Play.
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7 Alarms and messages
52 IFU, MIRUS Controller, en-GB, N.00
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.
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7 Alarms and messages
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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.
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7 Alarms and messages
54 IFU, MIRUS Controller, en-GB, N.00
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.
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8 Standard values
IFU, MIRUS Controller, en-GB, N.00 55
8 Standard values
8.1 Alarm settings and application defaults
Screen Parameter Default value
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 mmHg
et CO2 max 50 mmHg
et VA min ISO 0.3 Vol % SEVO 0.5 Vol % DES 1.7 Vol%
et VA max MAC * 2.0 (VA specific)
Apnoea time 60 seconds
Alarm volume 100%
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8 Standard values
56 IFU, MIRUS Controller, en-GB, N.00
8.2 Specification of wash-in speed parameters
Volatile Anaesthetic agent Specification
Isoflurane
cheetah = 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-value
max. concentration: 8 Vol%
Desflurane
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%
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9 Parts list
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9 Parts list
9.1 Accessories
Description Order code
Bottle adapter Sevofluran QUIK-FIL BA-SEV-Q
Bottle adapter Sevofluran BA-SEV-K
Bottle adapter Isofluran BA-ISO-K
Bottle adapter Desfluran SAF-T-FIL BA-DES-S
MIRUS Mounting Bracket - Base MC-01-014
MIRUS Mounting Bracket - VESA arm MC-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 supply cable IT MC-01-004
Power supply cable CH MC-01-005
Power supply cable AU MC-01-006
UPS backup battery MC-01-011
9.3 Service parts
Description Order code
MIRUS Draining Kit MC-01-013
MIRUS Draining kit - Spare bottle MC-01-013-1
MIRUS Event Log µSD Card MC-01-016
MIRUS Replacement filter MC-09-905
MIRUS Data cable MC-SC-DC-01
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9 Parts list
58 IFU, MIRUS Controller, en-GB, N.00
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 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 MIRUS Controller
Description Order code
MIRUS Controller Isoflurane MC-MC-ISO
MIRUS Controller Sevoflurane MC-MC-SEV
MIRUS Controller Desflurane MC-MC-DES
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10 Technical specifications
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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 MC-MC-SEVO MC-MC-DES
For VA Isoflurane For VA Sevoflurane For VA Desflurane
Environmental conditions Operation (filled reservoir): Temperature range for MC ISO, SEVO Temperature range for MC DES Atm. pressure range Equivalent altitude (above sea level) Humidity range
+10 to +40°C +10 to +30°C 700 to 1,060 hPa 3,000 to 0 m (9,840 to 0 ft) 10 to 90% relative, none condensing
Environmental conditions Storage with filled or empty reservoir: Temperature range Atm. pressure range Equivalent altitude (above 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 range Equivalent altitude (above sea level) Humidity range
-20 to +70°C 500 to 1,060 hPa 5,500 to 0 m (18,050 to 0 ft) 10 to 90% relative, none condensing
Noise level Patient/device alarms at max. setting “Panic” alarms (fail safe, mains supply lost, microcontroller watchdog error)
≤ 49 dB (A) > 66 dB (A) (tone sequence) at max. setting > 63 dB(A) (permanent tone)
Classifications CE class according to 93/42/EEC Protection class acc. to EN 60601-1 Protection type acc. to EN 60601-1 IP Code
IIb I B IP20
GMDN codes MC-MC-ISO MC-MC-SEVO MC-MC-DES
36890 36980 36979
UMDNS code MIRUS Controller 10-144
Electrical supply Nominal voltage Frequency Power consumption Grounding Internal back-up
100 to 230 VAC ± 10% 50 to 60 Hz ± 5% < 75 VA Standard ground stud Built in backup battery, backup time: 15 min.
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10 Technical specifications
60 IFU, MIRUS Controller, en-GB, N.00
Specification Device
Agent supply
Internal reservoir
Maximum capacity = 270 mL Reserve capacity = 20 mL
Status information On screen
Filling system
Proprietary filling system, agent specific according to ISO 5360
Filling capacity Maximum = 190 mL Maximum overfill protection = 250 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
Menu language English, German, French, Italian, Spanish
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 CO2 Pressure (Paw, PEEP) VA concentration
mmHg, %, kPa mbar for German, cmH2O for all other languages Vol%
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10 Technical specifications
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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 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 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
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10 Technical specifications
62 IFU, MIRUS Controller, en-GB, N.00
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 Values
Isoflurane and Sevoflurane and Desflurane
+ 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 Values
Volumes ± 15% @ Vt 200 mL to 2000 mL (BTPS corrected, @rate < 40/min)
Pressures ± 4.0% or 2 cmH2O whichever is greater @ -10 to 100 cmH2O (@rate < 40/min)
Rate ± 1 breath per minute (@rate < 40/min)
I:E ± 25% (@rate > 40/min)
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10 Technical specifications
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10.3.3 Gas monitoring accuracy
Specification Values
CO2 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 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 of delivered anaesthetic agent volume
Control Monitoring of applied volume of anaesthetic agent. Comparison of calculated with measured volume
Alarms Dosage failed! No delivery
Gas monitoring
Agent Isoflurane, Sevoflurane, Desflurane
Numerical data et VA
Alarms Low et VA, High et VA
Metabolic gases CO2
Numerical data et CO2
Alarms Low et CO2, High et CO2
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11 Terms and abbreviations
64 IFU, MIRUS Controller, en-GB, N.00
11 Terms and abbreviations In alphabetical order:
AC alternating current
DC direct current
bpm breaths per minute
BTPS body temperature and pressure, saturated
DES Desflurane
DOGA Diffusion Optimized Gas Application Consumption optimising application of VA.
et CO2 end tidal CO2 concentration
et Des end tidal Desflurane concentration
et Iso end tidal Isoflurane concentration
et Sevo end tidal Sevoflurane concentration
et VA end tidal Volatile Anaesthetic concentration
Exp expiratory, expiration
Fe fraction expiratory VA, describes the expired concentration of VA
Fi fraction inspiratory VA, describes the inspired concentration of VA
FiDes inspiratory Desflurane concentration
FiIso inspiratory Isoflurane concentration
FiSevo inspiratory Sevoflurane concentration
FiVA set set target 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 water vapour and warmth and recycle it back to the patient with the next inspiration (artificial nose).
HMEF HME with bacterial/viral filter
HW x.n hardware revision number
I:E ratio between inspiratory and expiratory time
IBW Ideal Body Weight
IFU Instructions For Use
Insp inspiratory, inspiration
ISO Isoflurane
MAC
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.
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11 Terms and abbreviations
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MACset set target Minimum Alveolar Concentration
MAC Pilot
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.
MC MIRUS Controller
MDI Metered-Dose Inhaler
MF MIRUS Filter
MR MIRUS Reflector
MV Minute Volume Breathing volume of a patient per minute.
MVe Minute Volume, expiratory; Unit: L/min
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 within the patient’s breathing system
PEEP Positive End Expiratory Pressure within one breath, measured
PUT Power up test
Rate total number of breath per minute
Ref. stock number
SEVO Sevoflurane
SN Serial Number
ST System Test
SW x.nn.nn Software revision number
UPS Uninterruptible Power Supply
UTC Universal Time Coordinated, Primary time standard
VA volatile anaesthetic agent, to dose in gaseous state
Vt tidal volume in general
Vte expiratory tidal volume, per breath
Vti inspiratory tidal volume, per breath
Vt/kg tidal volume per kilogram body weight
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12 High priority alarms
66 IFU, MIRUS Controller, en-GB, N.00
12 High priority alarms
Alarm What MIRUS Controller does What to check or to do
Device inclined!
Device pauses the application and closes all valves until device is positioned on a level surface.
1. Reposition device on a level surface.
Dosage failed! Start VA?
Device stops the application. 1. Restart VA delivery by activating Play and Confirm or turn off device.
Failure! Turn off.
Device stops the application. Turn off tag becomes selectable. A major technical failure was recognised.
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.
Fill port flap still open!
Continues 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 settings okay?
High et CO2 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 CO2 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
Device pauses the application. 1. MIRUS Interface bent or pinched?
2. Fresh gas flow of Anaesthesia Work Station minimum 1.5 * MV?
Reservoir empty
Continues working. 1. Refill reservoir promptly.
UPS battery low
Continues working. 1. Allow recharging of battery.
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Notes
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12 High priority alarms
Technology Innovated Medicine
www.tim-gmbh.de Technologie Institut Medizin GmbH (TIM) www.tim-products.de
This document
MIRUSTM Controller Instruction for use English (GB) Printed in Germany © TIM GmbH All rights reserved Rev. N.00 of 03/18
Manufactured by
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