TIM Mirus MC ISO Installation manual

Additional Information
MIRUSTM Controller
Software version 2.03.02
Hardware version 2.n

Serial number
These products have a uniform serial number (XXXO12345), comprising the product group
(XXX), year of manufacture (N = 2020, O = 2021, etc.) and a consecutive number for exact
identification of the device itself (12345).
UDI label
A unique device identifier (UDI) for medical devices.
Example:
(01)4260665920013(21)221M00100(11)202005(91)MC-MC-ISO
Application identifier (AI)
Every UDI number can be divided into several parts, each
designated by its AI number.
(01)
Global Trade Item Number (GTIN)
(11)
Date of manufacture (YYMMDD)
(21)
Serial number (SN)
(91)
Reference number (REF)
GTIN
Example: 4260665920013
The GTIN consists of three parts:
a. GS-1 manufacturer number: 426066592
b. Number of articles: 001
c. Check digit: 3
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.

MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 0-1
0 Table of contents
1 Introduction
1.1 MIRUS System............................................................................................................. 1-2
1.1.1 Definitions .............................................................................................................. 1-2
1.1.2 General information ............................................................................................... 1-2
1.1.3 MIRUS Controller................................................................................................... 1-3
1.1.4 MIRUS Exchanger ................................................................................................. 1-4
1.1.5 Device user interface ............................................................................................. 1-4
1.2 Symbols on the device ................................................................................................. 1-5
1.3 Symbols used in this manual ........................................................................................ 1-5
1.4 Graphical user interface ............................................................................................... 1-6
1.4.1 Symbols on menu buttons...................................................................................... 1-6
1.4.2 Status icons ........................................................................................................... 1-7
1.4.3 Buttons .................................................................................................................. 1-8
1.4.4 Button states and behaviour................................................................................. 1-10
1.4.5 Colour code used in graphical user interface ....................................................... 1-11
1.4 MIRUS Controller screens .......................................................................................... 1-12
1.4.1 MIRUS Start up screens ...................................................................................... 1-12
1.4.2 MIRUS Operating and Configuration screens ...................................................... 1-13
1.4.3 MIRUS Software update screen........................................................................... 1-18
1.5 MIRUS Controller modes............................................................................................ 1-19
1.6 Abbreviations and terms used in this manual or on the equipment ............................. 1-20
2 Safety
2.1 General safety information............................................................................................ 2-2
2.1.1 Safe operation ....................................................................................................... 2-2
2.1.2 Symbols and product labels ................................................................................... 2-2
2.1.3 Electrical supply ..................................................................................................... 2-2
2.1.4 Built-in emergency power supply (UPS battery) ..................................................... 2-3
2.1.5 Positioning ............................................................................................................. 2-3
2.1.6 Use of volatile anaesthetics ................................................................................... 2-3
2.1.7 Devices required for use of the MIRUS System ..................................................... 2-4
2.1.8 Before every use.................................................................................................... 2-6
2.1.9 Equipment damage during use .............................................................................. 2-6
2.1.10 Monitoring the patient........................................................................................... 2-6
2.1.11 Alarms ................................................................................................................. 2-7
2.1.12 Transportation within the hospital......................................................................... 2-7
2.1.13 Modifications........................................................................................................ 2-8
2.1.14 Accessories ......................................................................................................... 2-8
2.1.15 Electromagnetic compatibility (EMC) ................................................................... 2-8
2.1.16 Infection risk......................................................................................................... 2-9

0 Table of contents
0-2 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
2.1.17 Maintenance ........................................................................................................ 2-9
2.1.18 Repairs ................................................................................................................ 2-9
2.2 Fail safe mode............................................................................................................ 2-10
2.3 Notification of serious incidents .................................................................................. 2-10
2.4 Safety features ........................................................................................................... 2-11
2.5 Warnings in these Instructions for use........................................................................ 2-12
3 General description
3.1 Intended use................................................................................................................. 3-2
3.2 Operator and user qualification..................................................................................... 3-2
3.2.1 Qualified medical personnel................................................................................... 3-2
3.2.2 Preparation personnel............................................................................................ 3-2
3.2.3 Maintenance personnel.......................................................................................... 3-2
3.3 Contraindications.......................................................................................................... 3-3
3.4 Facility requierements .................................................................................................. 3-3
3.5 Gas supply ................................................................................................................... 3-4
3.6 Agent supply................................................................................................................. 3-4
3.7 Functional description................................................................................................... 3-5
3.8 System controls............................................................................................................ 3-6
3.9 Handling before first use of MIRUS Controller .............................................................. 3-7
3.9.1 Cleaning before first use ........................................................................................ 3-7
3.9.2 Initial Filling before first use.................................................................................... 3-7
4 Preparation
4.1 Mains supply ................................................................................................................ 4-2
4.2 System warming up phase ........................................................................................... 4-3
4.3 Connection to the MIRUS Reflector.............................................................................. 4-3
4.4 Starting MIRUS Controller ............................................................................................ 4-5
4.5 Filling of the reservoir during start up............................................................................ 4-8
4.6 Self test ...................................................................................................................... 4-12
4.7 Anomaly in start up sequence .................................................................................... 4-13
5 Operation
5.1 Working with MIRUS Controller .................................................................................... 5-2
5.1.1 Setting MAC (Vol%) ............................................................................................... 5-2
5.1.2 Starting application of anaesthetic (VA) ................................................................. 5-3
5.1.3 Pausing application of anaesthetic (VA)................................................................. 5-4

0 Table of contents
MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 0-3
5.1.4 Stopping application of anaesthetic (VA)................................................................ 5-5
5.1.5 Filling during operation........................................................................................... 5-6
5.1.6 Turning off MIRUS Controller ................................................................................. 5-8
5.2 Additional settings ........................................................................................................ 5-9
5.2.1 Alarm settings ........................................................................................................ 5-9
5.2.2 Setting on-screen language ................................................................................. 5-10
5.2.3 Setting CO2unit ................................................................................................... 5-11
5.2.4 Setting Time zone, date or time ........................................................................... 5-12
5.2.5 Setting Patient data - Gender............................................................................... 5-13
5.2.6 Setting Patient data - Age .................................................................................... 5-14
5.2.7 Setting MAC Pilot Wash-in speed ........................................................................ 5-16
6 Cleaning and maintenance
6.1 Cleaning ....................................................................................................................... 6-2
6.5.1 General advice....................................................................................................... 6-2
6.5.2 Cleaning the individual components....................................................................... 6-3
6.2 Maintenance................................................................................................................. 6-4
6.2.1 General information ............................................................................................... 6-4
6.2.2 Schedule................................................................................................................ 6-4
6.2.3 Visual inspection .................................................................................................... 6-5
6.2.4 Electrical safety test ............................................................................................... 6-5
6.2.5 Checking gas monitor ............................................................................................ 6-6
6.2.6 Checking pump ...................................................................................................... 6-7
6.2.7 Safety function test ................................................................................................ 6-8
6.2.8 Exchange UPS battery........................................................................................... 6-9
6.2.9 Exchange fa filter ................................................................................................. 6-10
6.2.10 Perform software update.................................................................................... 6-11
6.2.11 Exporting event log data .................................................................................... 6-11
6.2.12 Five (5)-year service cycle ................................................................................ 6-11
6.2.13 End of MIRUS Controller service life ...................................................................6.11
6.3 Draining the reservoir ................................................................................................. 6-12
6.4 Shipping MIRUS Controller......................................................................................... 6-12
6.5 Service Information..................................................................................................... 6-12
6.11 Equipment for safety check and maintenance .......................................................... 6-13
7 Alarms and messages
7.1 Alarm modality.............................................................................................................. 7-2
7.2 Alarm handling ............................................................................................................. 7-3
7.2.1 Mute audible alarms............................................................................................... 7-3
7.2.2 Audible alarm escalation ........................................................................................ 7-5
7.2.3 1st High priority alarm handling............................................................................... 7-7
7.2.4 2nd High priority alarm handling .............................................................................. 7-8

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0-4 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
7.2.5 3rd High priority alarm handling............................................................................... 7-9
7.2.6 Low priority alarm handling .................................................................................. 7-10
7.3 Alarm messages......................................................................................................... 7-11
7.3.1 Patient alarms ...................................................................................................... 7-11
7.3.2 Technical alarms.................................................................................................. 7-12
7.4 Other messages ......................................................................................................... 7-14
7.4.1 Messages during Power up test ........................................................................... 7-14
7.4.2 Messages during System test .............................................................................. 7-17
7.4.3 Safety note in screen ........................................................................................... 7-20
7.4.4 Messages during On-Call mode........................................................................... 7-21
7.4.5 Messages during Operation mode ....................................................................... 7-22
7.4.6 Messages during SW update ............................................................................... 7-24
8 Specifications
8.1 General ........................................................................................................................ 8-2
8.2 Supply .......................................................................................................................... 8-4
8.3 MIRUS Controller Connection Interface........................................................................ 8-4
8.4 MIRUS Controller User Interface .................................................................................. 8-5
8.5 MIRUS Controller Controls and Ranges ....................................................................... 8-6
8.6 MIRUS Controller Performance .................................................................................... 8-8
8.7 MIRUS Controller Monitoring System ........................................................................... 8-9
8.8 Default values............................................................................................................. 8-10
8.8.1 Alarm settings and application defaults ................................................................ 8-10
8.8.2 Specification of Wash-in speed parameters ......................................................... 8-11
8.9 Connection to an IT-network....................................................................................... 8-12
8.9.1 General safety information ................................................................................... 8-12
8.9.2 Serial interface..................................................................................................... 8-12
8.9.3 RJ22/RJ10 interface ............................................................................................ 8-13
8.9.4 LAN interface (RJ45) ........................................................................................... 8-13
8.9.5 SD card interface ................................................................................................. 8-13
8.10 Materials of the external components of the MIRUS Controller................................. 8-14
9 Parts list
9.1 MIRUS Controller ......................................................................................................... 9-2
9.2 Bottel Adapter............................................................................................................... 9-2
9.3 ARKON data Bridge ..................................................................................................... 9-2
9.4 Accessories.................................................................................................................. 9-3
9.5 Service parts ................................................................................................................ 9-4
9.6 Documents ................................................................................................................... 9-4

MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 1-1
1 Introduction
1.1 MIRUS System ........................................................................................................... 2
1.1.1 Definitions............................................................................................................ 2
1.1.2 General information ............................................................................................. 2
1.1.3 MIRUS Controller................................................................................................. 3
1.1.4 MIRUS Exchanger ............................................................................................... 4
1.1.5 Device user interface ........................................................................................... 4
1.2 Symbols on the device................................................................................................ 5
1.3 Symbols used in this manual ...................................................................................... 5
1.4 Graphical user interface.............................................................................................. 6
1.4.1 Symbols on menu buttons ................................................................................... 6
1.4.2 Status icons ......................................................................................................... 7
1.4.3 Buttons ................................................................................................................ 8
1.4.4 Button states and behaviour ...............................................................................10
1.4.5 Colour code used in graphical user interface ......................................................11
1.5 MIRUS Controller screens .........................................................................................12
1.5.1 MIRUS Start up screens .....................................................................................12
1.5.2 MIRUS Operating and Configuration screens .....................................................13
1.5.3 MIRUS Software update screen..........................................................................18
1.6 MIRUS Controller modes ...........................................................................................19
1.7 Abbreviations and terms used in this manual or on the equipment.............................20

1 Introduction
1-2 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
1.1 MIRUS System
1.1.1 Definitions
"MIRUS System" in this instruction for use means "system" in terms of article 12 MDD and
describes a functioning composition of three separate registered medical products:
•MIRUS Controller, legal manufacturer "Technologie Institut Medizin GmbH (TIM)"
•MIRUS Reflector, legal manufacturer "PALL Medical, a division of PALL
International Sàrl".
•MIRUS Filter, legal manufacturer "PALL Medical, a division of PALL International
Sàrl".
For information to MIRUS Reflector and MIRUS Filter please refer to the manufacturer's
instruction for use.
1.1.2 General information
This manual describes the operation of the MIRUS Controller.
The MIRUS Controller is a part of the 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.
For further information regarding the MR please refer to the manufacturer’s
instructions for use (IFU).
•MIRUS Filter (MF):
The single patient device connected to the MIRUS Reflector, protecting the patient
and breathing system.
For further information regarding the MF please refer to the manufacturer’s
instructions for use (IFU).
The MIRUS Controller is available in three gas specific models:
•MC ISO for volatile anaesthetic agent (VA) Isoflurane.
•MC SEVO for volatile anaesthetic agent (VA) Sevoflurane.
•MC DES for volatile anaesthetic agent (VA) Desflurane.
MIRUS Controller functions:
•With built-in side stream gas monitoring.
•With consumption optimising DOGA function.
•With MAC Pilot function.

1 Introduction
MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 1-3
1.1.3 MIRUS Controller
1 Alarm lights
2 Fill port
3 Park Bay
4 Power connection
5 Terminal for connecting an equipotential bonding conductor
6 Interface receptacle
7 Confirm button
8 Slot for SD cards (downloading of event log data or for SW updates)
9 Touch screen
10 Fire wire port. Serial data output for PDMS etc.
11 Nurse call port to forward high priority alarms
12
LAN port, used for production and service purposes and is switched off during
application for safety reasons
6
4
1
2
3
7
9
10
12
11
5
8

1 Introduction
1-4 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
1.1.4 MIRUS Exchanger
1.1.5 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.
To start MIRUS Controller simply press button, when in OFF
mode (Standby).
MIRUS Reflector
(Multi patient device.
Use up to 7 days)
MIRUS Filter
(Single patient device.
Use up to 48 h)
Interface connector

1 Introduction
MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 1-5
1.2 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
1.3 Symbols used in this manual
Operate by touching an icon or symbol.
During operation the MC has diverse screens with different
functionalities. To select a screen push the icon (Tag) on the
right side of the display.
Pointing at a certain part of MIRUS Controller.
Take note of a change on the MIRUS Controller or the graphical
user interface.

1 Introduction
1-6 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
1.4 Graphical user interface
1.4.1 Symbols on menu buttons
Home (Standard operation screen)
Patient data settings
MAC Pilot settings. Set wash-in speed
Respiratory monitoring
Alarm settings
MULTI settings:
see the following 4 tags
Filling
MIRUS settings
Time settings
Service
Turn off

1 Introduction
MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 1-7
1.4.2 Status icons
“Life line”. Animated when delivery is in progress, stationary
when delivery is paused. Not visible when delivery is stopped.
Lung Symbol “breathes”; is animated in operation mode.
Reflector symbol; shows remaining allowed operation time of
MR in anaesthetic colour.
Agent reservoir symbol; shows remaining liquid level in
anaesthetic colour.
Device is powered by AC power supply.
Device is powered by battery; shows capacity.
Or battery is in charging mode (symbol is animated).
Status symbol for “MAC Pilot is active”.
Icon is animated synchronously to lifeline.
VA application not active (stop or pause).
Icon is animated.
System test was performed successfully.
System test invalidated.
“Target-reached level” shown by Fi/Fe ratio.

1 Introduction
1-8 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
High priority alarm sound active.
High priority alarm sound muted.
Low priority alarm sound active.
Low priority alarm sound permanently muted.
1.4.3 Buttons
In order of appearance
Repeat (e.g. a failed self-test in starting procedure).
OK.
Turn off device.
Start delivery of anaesthetic.
Pause delivery of anaesthetic.
Stop delivery of anaesthetic.

1 Introduction
MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 1-9
MAC button showing unit and current value.
Press to be able to set new value.
Setting button showing unit and current value.
Press to set value with arrow buttons aside, e.g. Alarm volume.
Instructive animation to open Fill port.
Activate mode.
Disable mode or Cancel (SW update).
“Female” setting in Patient data tag.
“Male” setting in Patient data tag.
Turtle = Slow wash-in speed.
Rabbit = Medium wash-in speed.
Cheetah = Fast wash-in speed.
Apnoea time
sec
60

1 Introduction
1-10 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
1.4.4 Button states and behaviour
Buttons to select and confirm
Normal state; not pressed.
Button is pressed; confirmation with Confirm button is needed.
Button is confirmed and now highlighted in anaesthetic colour.
Buttons to set a value
Inactive button.
Normal state; active but not yet pressed.
Button is pressed and highlighted in anaesthetic colour.
For final acceptance confirmation with Confirm button is
needed.
Buttons to select, set a value and confirm
Button with a value, not pressed.
Arrow buttons are inactive.
Button with a value, pressed.
Arrow buttons are active now.
While setting value, value is highlighted in anaesthetic colour.
Arrow button is highlighted in anaesthetic colour.
Apnoea time
sec
60
Apnoea time
sec
55
Apnoea time
sec
60

1 Introduction
MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 1-11
1.4.5 Colour code used in graphical user interface
Colour in graphical user interface for Sevoflurane.
For demonstration purposes, Sevoflurane / yellow highlighting
colour is used in this IFU.
Colour in graphical user interface for Isoflurane.
Colour in graphical user interface for Desflurane.

1 Introduction
1-12 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
1.5 MIRUS Controller screens
1.5.1 MIRUS Start up screens
Initial screen
Power up test
System is starting and performing safety tests
with its components.
System test
System is performing safety tests with its
components.
HW 2.n SW 2.03.02
One moment please…
HW 2.n SW 2.03.02
System test active. Please wait…

1 Introduction
MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB) 1-13
Safety note
Safety note needs to be confirmed by user. It
is also possible to turn off device.
1.5.2 MIRUS Operating and Configuration screens
On-Call screen
System is up and waiting for user action.
Home screen
no delivery
Set MAC value and start the delivery.
Refer to Chapter 8.8 for default values.
Power up test and System test
successfully completed on
11.01.2013 at 10:25:00.
To continue please choose a
menu button on the right.
HW 2.n SW 2.03.02
etSevo:
0.0 Vol%
etCO2:
31 mmHg
HW 2.n SW 2.03.02

1 Introduction
1-14 MIRUS Controller, SW 2.03.02, Additional Information (Master - en-GB)
Home screen
delivery active
Set MAC value and pause or stop the
delivery.
Snooze Screen
Appears only during active delivery and no
activity on the touch screen for 10 minutes.
Patient data screen
Adjust:
•gender
•age
•size
•weight
Refer to Chapter 8.5 for available settings.
etSevo:
1.9
Vol%
etCO2:
31 mmHg
Age
Size
Weight
kg (IBW)
years