TIM MIRUS Controller Instructions For Use Manual
Technology Innovated Medicine
www.tim-gmbh.de
Technologie Institut Medizin GmbH (TIM)
MIRUS
TM
Controller
Instruction for use • Software version 2.00.00
www.tim-products.de
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.
0 Table of contents
IFU, MIRUS Controller, en-GB, N.00 3
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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IFU, MIRUS Controller, en-GB, N.00 5
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
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.
1 Introduction
IFU, MIRUS Controller, en-GB, N.00 7
1.4.1 MIRUS Controller
1.4.2 Exchanger unit
Interface receptacle
Alarm lights
Fill port
Park Bay
Confirm button
Touch screen
MIRUS Reflector
(Multi patient device.
Use up to 7 days)
MIRUS Filter
(Single patient device.
Use up to 48 h)
Interface connector
1 Introduction
8 IFU, MIRUS Controller, en-GB, N.00
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
1 Introduction
IFU, MIRUS Controller, en-GB, N.00 9
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
1 Introduction
10 IFU, MIRUS Controller, en-GB, N.00
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.
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 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.
2 Safety
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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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IFU, MIRUS Controller, en-GB, N.00 13
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.
2 Safety
14 IFU, MIRUS Controller, en-GB, N.00
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.
2 Safety
IFU, MIRUS Controller, en-GB, N.00 15
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.
2 Safety
16 IFU, MIRUS Controller, en-GB, N.00
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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IFU, MIRUS Controller, en-GB, N.00 17
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).
3 Preparation
18 IFU, MIRUS Controller, en-GB, N.00
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.
3 Preparation
IFU, MIRUS Controller, en-GB, N.00 19
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.
3 Preparation
20 IFU, MIRUS Controller, en-GB, N.00
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.
3 Preparation
IFU, MIRUS Controller, en-GB, N.00 21
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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