Subscribe to Our Youtube Channel
Summary of Contents for TIM MIRUS Controller
- Page 1 Technology Innovated Medicine MIRUS Controller Instruction for use • Software version 2.00.00 www.tim-gmbh.de Technologie Institut Medizin GmbH (TIM) www.tim-products.de...
- Page 2 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.
-
Page 3: Table Of Contents
Risk of fire ......................16 2.5.5 Electromagnetic compatibility .................17 Residual risk – Fail-safe mode ................17 Preparation ................18 Cleaning before first use ..................18 Connecting to mains supply ..................18 Connecting to MIRUS Reflector ................19 Turning on ......................20 IFU, MIRUS Controller, en-GB, N.00... - Page 4 Patient alarms ......................49 7.1.5 Technical alarms ....................50 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 IFU, MIRUS Controller, en-GB, N.00...
- Page 5 Patient data settings ....................62 10.3 Performance ......................62 10.3.1 Agent dosage accuracy ..................62 10.3.2 Respiratory monitoring accuracy ................62 10.3.3 Gas monitoring accuracy ..................63 10.4 Monitoring system ....................63 11 Terms and abbreviations ............64 12 High priority alarms ..............66 IFU, MIRUS Controller, en-GB, N.00...
-
Page 6: Introduction
1 Introduction Introduction 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. 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. -
Page 7: Mirus Controller
Fill port Park Bay Touch screen Confirm button Interface receptacle 1.4.2 Exchanger unit MIRUS Reflector Interface connector MIRUS Filter (Multi patient device. (Single patient device. Use up to 7 days) Use up to 48 h) IFU, MIRUS Controller, en-GB, N.00... -
Page 8: Device User Interface
1 Introduction 1.4.3 Device user interface Touch screen. Operate MIRUS Controller by pressing buttons on the graphical user interface via touch sensitive screen. Confirm button. Confirm actions performed on the touch screen display by pressing the Confirm button when flashing in anaesthetic colour within 5 seconds. -
Page 9: Elements In Touch Screen
Tab Filling (during operation) Tab Setting (on-screen language, CO unit) Tab Time setting (local time zone, time and date) Tab Service (information about HW and SW version of MIRUS Controller, contact details of the manufacturer) IFU, MIRUS Controller, en-GB, N.00... -
Page 10: Symbols On The Device
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. Symbols on the device STK label (in Germany): Indicates when the next safety check in accordance with §6... -
Page 11: Safety
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 ± 10%, 50 to 60 Hz ± 5%. Verify your local AC line supply voltage matches the rated device’s voltage on the serial plate. -
Page 12: Responsibility Of The Manufacturer
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... -
Page 13: Warning Symbols Used In The Ifu
Controller is designed for can result in overdosing and serious patient injury. Never use any bypass to the keyed filler system. This can result in overdosing and serious patient injury. Do not switch type of volatile anaesthetic agent while treating a patient. IFU, MIRUS Controller, en-GB, N.00... -
Page 14: Control Of Patient Relevant Dosage
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. -
Page 15: Mdi Applications
Do not use the MIRUS System in parallel to extracorporeal membrane oxygenation (ECMO) or extracorporeal membrane decarboxylation (ECOR). Device 2.5.1 Accessories WARNING Use only accessories approved by the manufacturer of either the MIRUS Controller or the accessory. IFU, MIRUS Controller, en-GB, N.00... -
Page 16: Positioning
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. -
Page 17: Electromagnetic Compatibility
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. -
Page 18: Preparation
3 Preparation Preparation 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. -
Page 19: Connecting To Mirus Reflector
Note: For further information refer to the manufacturer’s instructions. Remove plug from interface connector receptacle. Lift Park Bay clip Place Reflector. Insert interface plug into plug receptacle. Ready to turn on. IFU, MIRUS Controller, en-GB, N.00... -
Page 20: Turning On
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. IFU, MIRUS Controller, en-GB, N.00... - Page 21 Alarm settings: Change values of alarm limits (refer to chapter 3.10) Configurations and filling: setting on-screen language, CO unit, Time zone, Date, time. Filling during operation. (refer to chapter 3.11) Turn off (refer to chapter 5) IFU, MIRUS Controller, en-GB, N.00...
-
Page 22: Filling During Start-Up Sequence
3 Preparation 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. - Page 23 Insert bottle with attached adapter vertically in fill port. Press bottle into fill port gently until a mechanical stop is felt (spring loaded valves open). Reservoir is filled. Note: Device cannot be overfilled. IFU, MIRUS Controller, en-GB, N.00...
-
Page 24: 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). IFU, MIRUS Controller, en-GB, N.00... -
Page 25: Change To Operation Mode
Changing patient data Press menu button Patient data. Note: Changing patient data is also possible during VA application. Patient data pre-set: gender: male age: 40 years size: 180 cm weight: 80 kg IFU, MIRUS Controller, en-GB, N.00... -
Page 26: Changing Gender
3 Preparation 3.8.1 Changing gender Press button for selected gender. Button for selected gender is light grey. Press Confirm button to verify change. Change completed. IFU, MIRUS Controller, en-GB, N.00... -
Page 27: Changing Age, Size, Weight
Changing age, size, weight Press button for parameter to be changed, e.g. age. Button for selected parameter is light grey. Arrow keys are activated. Use arrow keys to change parameter. Press Confirm button. Change completed. IFU, MIRUS Controller, en-GB, N.00... -
Page 28: Changing Wash-In Speed
= 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. IFU, MIRUS Controller, en-GB, N.00... -
Page 29: Changing Alarm Settings
ISO and DES. Press button for parameter to be changed, e.g. et CO max. Button for selected parameter is light grey. Arrow keys are activated. Use arrow keys to change parameter. IFU, MIRUS Controller, en-GB, N.00... -
Page 30: Filling And Additional Configurations
Filling and additional configurations Press menu button Configuration screens. Note: Configuration is also possible during VA application. Options tab: filling-screen tab: setting language, CO unit tab: setting time zone, date, time tab: service screen IFU, MIRUS Controller, en-GB, N.00... -
Page 31: Filling During Operation
Do not try to open the flap manually, it could be seriously damaged. Press Fill port flap button. Button Fill port flap is light grey. Follow instruction on screen. Press Confirm button. Fill port flap opens automatically. IFU, MIRUS Controller, en-GB, N.00... - Page 32 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. IFU, MIRUS Controller, en-GB, N.00...
-
Page 33: Setting On-Screen Language And Co 2 Unit
Language = English unit = mmHg Press button for parameter to be changed, e.g. language. Button for selected parameter is light grey. Arrow keys are activated. Use arrow keys to change parameter. IFU, MIRUS Controller, en-GB, N.00... -
Page 34: Setting Time
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. IFU, MIRUS Controller, en-GB, N.00... - Page 35 3 Preparation Button for selected parameter is light grey. Arrow keys are activated. Use arrow keys to change parameter. Press Confirm button. Change completed. IFU, MIRUS Controller, en-GB, N.00...
-
Page 36: 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. IFU, MIRUS Controller, en-GB, N.00... -
Page 37: Connecting Patient
(IFU). When the patient is connected to the controller, the lung icon is animated and the controller measures an et CO value. IFU, MIRUS Controller, en-GB, N.00... -
Page 38: Application Of Va
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. IFU, MIRUS Controller, en-GB, N.00... -
Page 39: Supervise Patient Respiratory Data
Supervise patient respiratory data Press menu button Respiratory monitoring. Respiratory monitoring screen Pausing application and reactivate Press button Pause. VA Application pauses. Button Pause flashes. Press button Pause. VA Application active again. IFU, MIRUS Controller, en-GB, N.00... -
Page 40: Stopping Application
4 Application of VA Stopping application Press button Stop. Button Stop is light grey. Press Confirm button. VA Application is finished. Pause and Stop buttons deactivated. IFU, MIRUS Controller, en-GB, N.00... -
Page 41: Turning Off Controller
Note: Only if VA is not applied, the menu button Turn off is activated. Refer to chapter 4.4 Stopping application . Press menu button Turn off. Turn off screen Press button Turn off. Button Turn off is light grey. Press Confirm button. IFU, MIRUS Controller, en-GB, N.00... - Page 42 5 Turning off Button Turn off is coloured. Controller switches off automatically. Place Reflector in Park Bay. Controller switched off (off mode). IFU, MIRUS Controller, en-GB, N.00...
-
Page 43: Maintenance And Cleaning
Empty every 4 weeks. VA reservoir User / Operator Do not re-use VA. Manufacturer or qualified Manufacturer gives information as personnel specially Software soon as software update is available. authorized by the manufacturer IFU, MIRUS Controller, en-GB, N.00... -
Page 44: Cleaning
Do not re-use single use components. 6.2.2 Cleaning the individual components MIRUS Controller surface Turn off the MIRUS Controller and ensure that the mains power cord is disconnected. Make sure the fill port is closed. Remove MIRUS Reflector and interface plug. - Page 45 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 IFU, MIRUS Controller, en-GB, N.00...
-
Page 46: Draining The Reservoir
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). -
Page 47: Alarms And Messages
Alarms and messages 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 ... -
Page 48: High-Priority Alarms
Alarm message Confirming the alarm by Start silence counter pressing the alarm silence red, continuous button (2 min). Alarm message Alarm is still active after the red, flashing Timer “2 min” silence time IFU, MIRUS Controller, en-GB, N.00... -
Page 49: Patient Alarms
200 mL for five with the first breath. consecutive breaths. Low Vt Alarm and Measured Vt < 50 mL ≥ 50 mL Measured Vt High stop VA for five consecutive with the first breath. delivery breaths. IFU, MIRUS Controller, en-GB, N.00... -
Page 50: Technical Alarms
144 – Alarm soon expires. replace reflector. 160 hours. Reservoir Internal reservoir fill Alarm Refill reservoir. needs refill level < 60 mL Reservoir Internal reservoir fill High Alarm Refill reservoir. empty level < 45 mL. IFU, MIRUS Controller, en-GB, N.00... - Page 51 Allow recharging of to ≤ ¼ of capacity High Alarm UPS battery. (2 minutes left). Breathing activity detected but VA Start VA application via application Alarm application is not Play. not active. started by user via Play. IFU, MIRUS Controller, en-GB, N.00...
-
Page 52: Messages And Error Messages
(after selecting press Confirm button): Fill Port Flap Turn off Press Confirm button. Note: For more information, refer to Additional Information (AI) of MIRUS Controller chapter 7.4.1. IFU, MIRUS Controller, en-GB, N.00... -
Page 53: During System Test
(after selecting press Confirm button): Repeat Turn off Press Confirm button. Note: For more information, refer Additional Information (AI) of MIRUS Controller chapter 7.4.2. IFU, MIRUS Controller, en-GB, N.00... -
Page 54: Reminder Screen
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. IFU, MIRUS Controller, en-GB, N.00... -
Page 55: Standard Values
20 mmHg et CO 50 mmHg 0.3 Vol % et VA min SEVO 0.5 Vol % 1.7 Vol% Alarm settings MAC * 2.0 et VA max (VA specific) Apnoea time 60 seconds Alarm volume 100% IFU, MIRUS Controller, en-GB, N.00... -
Page 56: Specification Of Wash-In Speed Parameters
1.5* set MAC-value Sevoflurane turtle = slow 1.0* set MAC-value max. concentration: 8 Vol% cheetah = fast 1.5* set MAC-value rabbit = medium 1.25* set MAC-value Desflurane turtle = slow 1.0* set MAC-value max. concentration: 18 Vol% IFU, MIRUS Controller, en-GB, N.00... -
Page 57: Parts List
MC-01-006 UPS backup battery MC-01-011 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 IFU, MIRUS Controller, en-GB, N.00... -
Page 58: Documents
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 MIRUS Controller Description Order code... -
Page 59: Technical Specifications
Electrical supply Nominal voltage 100 to 230 V ± 10% Frequency 50 to 60 Hz ± 5% Power consumption < 75 VA Grounding Standard ground stud Internal back-up Built in backup battery, backup time: 15 min. IFU, MIRUS Controller, en-GB, N.00... - Page 60 EN ISO 14971 EN ISO 15223-1 EN ISO 21647 EN ISO 80601-2-12 IEC 60529 IEC 62304 IEC 62366-1 Units mmHg, %, kPa Pressure (Paw, PEEP) mbar for German, cmH O for all other languages VA concentration Vol% IFU, MIRUS Controller, en-GB, N.00...
-
Page 61: Controls And Ranges
Increment: 0.1 Vol% @ single taps on button 0.5 Vol% @ pressing button > 1 sec Apnoea time Range: 15 to 60 sec Increment: 5 seconds Alarm volume Range: 50 to 100% Increment: 10% @ single taps on button IFU, MIRUS Controller, en-GB, N.00... -
Page 62: Patient Data Settings
(BTPS corrected, @rate < 40/min) Pressures ± 4.0% or 2 cmH O whichever is greater @ -10 to 100 cmH O (@rate < 40/min) Rate ± 1 breath per minute (@rate < 40/min) ± 25% (@rate > 40/min) IFU, MIRUS Controller, en-GB, N.00... -
Page 63: Gas Monitoring Accuracy
Dosage failed! No delivery Gas monitoring Agent Isoflurane, Sevoflurane, Desflurane Numerical data et VA Alarms Low et VA, High et VA Metabolic gases Numerical data et CO Alarms Low et CO , High et CO IFU, MIRUS Controller, en-GB, N.00... -
Page 64: Terms And Abbreviations
Insp inspiratory, inspiration Isoflurane Minimum Alveolar Concentration The concentration of the vapour in the blood/expiratory lung volume that is needed to prevent movement (motor response) in 50% of subjects in response to surgical (pain) stimulus. IFU, MIRUS Controller, en-GB, N.00... - Page 65 Universal Time Coordinated, Primary time standard volatile anaesthetic agent, to dose in gaseous state tidal volume in general expiratory tidal volume, per breath inspiratory tidal volume, per breath Vt/kg tidal volume per kilogram body weight IFU, MIRUS Controller, en-GB, N.00...
-
Page 66: High Priority Alarms
1. MIRUS Interface bent or Interface pinched? 2. Fresh gas flow of Anaesthesia Work Station minimum 1.5 * MV? Reservoir Continues working. 1. Refill reservoir promptly. empty UPS battery Continues working. 1. Allow recharging of battery. IFU, MIRUS Controller, en-GB, N.00... - Page 67 Notes IFU, MIRUS Controller, en-GB, N.00...
- Page 68 6546 BB Nijmegen, The Netherlands Phone: +31 (0)24-206 3000 Email: jurgen.reimer@medcapatain.eu This document MIRUS Controller Instruction for use English (GB) Printed in Germany © TIM GmbH All rights reserved Rev. N.00 of 03/18 www.tim-gmbh.de Technologie Institut Medizin GmbH (TIM) www.tim-products.de...
Need help?
Do you have a question about the MIRUS Controller and is the answer not in the manual?
Questions and answers