MALDI Biotyper-BD sirius one IVD System User Manual

MALDI Biotyper-BD sirius oneIVD SystemUser Manual

Copyright © 2022

Revision D (February 2022) Doc. no. 5039354

Language: en

1890213

Legal and regulatory notices Bruker

Legal and regulatory notices

Read this manual before using the MALDI Biotyper-BD sirius one IVD System. Followthese instructions when using the device.

Copyright © 2022

Bruker Daltonics GmbH & Co. KG

All other trademarks are the sole property of their respective owners.

All rights reserved

Reproduction, adaptation, or translation without prior written permission is prohibited,except as allowed under the copyright laws.

Warranty

Bruker Daltonics GmbH & Co. KG makes no warranty or guarantee of any kind withrespect to the performance of this instrument/material, when not used in accordancewith this User Manual, and/or if used for purposes outside the claimed Intended Use.

Bruker Daltonics GmbH & Co. KG assumes no responsibility for the use or reliability ofits software on instrument/material and other equipment that is not furnished by BrukerDaltonics GmbH & Co. KG.

Use of trademarks

BD and BD Logo are trademarks of Becton, Dickinson and Company. Bruker,IVD MALDI Biotyper and BigAnchor Target are trademarks of Bruker Daltonics GmbH &Co. KG.

Hyperlink disclaimer

Bruker Daltonics GmbH & Co. KG makes no express warranty, neither written nor oral,and is neither responsible nor liable for data or content from the linked Internetresources presented in this document.

Note If any serious incident has occurred in relation to the device this shall bereported to the manufacturer and to the competent authority of the user´slocalization. Contact Bruker under [email protected]

Page 2 of 39 MALDI Biotyper-BD sirius one IVD System User Manual Revision D

Bruker Legal and regulatory notices

Noise declaration

57 dB operator position normal operation under ISO 7779.

Instrument identification

Each instrument is identified by a serial number. This number is located on the rear ofthe instrument.

When corresponding with Bruker or BD about your instrument, be sure to include themodel name and the full serial number. Write the serial number of the instrument herefor reference:

Instrument serial

__________________

Part numbers

In this manual, Bruker Daltonics GmbH & Co. KG part numbers are generally listed inparentheses after the name of the part. A few tools and supplies listed have no partnumbers and are not available from Bruker Daltonics GmbH & Co. KG. Most of thesecan be obtained from laboratory supply companies.

MALDI Biotyper-BD sirius one IVD System User Manual Revision D Page 3 of 39

Manufacturer Bruker

Manufacturer

Bruker Daltonics GmbH & Co. KG

Fahrenheitstraße 4

28359 Bremen

Germany

If problems arise with your system, please contact your local BD representative (seewww.bd.com/support/contact/international.asp).

Support Sales informationEmail: [email protected] Email: [email protected]: +49 421 2205-1401 Phone: +49 421 2205-0Fax: +49 421 2205-106 Web: www.bruker.com/microbiology

ServiceEmail: [email protected]: +49 421 2205-350Fax: +49 421 2205-103Web: www.bruker.com

For Australian customers:Bruker Pty. Ltd.1/28a Albert Street Support (hardware and software) SalesPreston Email: [email protected] Email: [email protected] 3072 Phone: +61 (1800) 171-247 Phone: +61 (1800) 278-537Australia Fax: +61 (03) 9474-7070


http://www.bruker.com/

Bruker Manufacturer

Distributed by: Becton, Dickinson and Company

Email: Contact your local BD representativePhone: Contact your local BD representativeWeb: www.bd.com/ds


Document history Bruker

Document history

Title: MALDI Biotyper-BD sirius one IVD System User ManualRevision: Revision D (February 2022)First revision: April 2020

The following table describes important changes from the previous revision of thisdocument.

Section Changes- Chapters added to comply with IVDR requirements


Bruker Table of contents

Table of contents

Legal and regulatory notices 2Manufacturer 4Document history 6Table of contents 71 Intended purpose 92 Precautions and warnings 10

2.1 Safety symbols 102.2 General precautions and warnings 122.3 Meeting site requirements 132.4 Data safety and cybersecurity 142.5 Lifting and handling the instrument 142.6 Electrical and laser safety 152.7 Mechanical safety 172.8 Handling chemicals and clinical specimens 17

3 Product description 193.1 Limitations 193.2 Performance characteristics 203.3 Scope of supply 203.4 Materials required 203.5 Instrument specifications 22

3.5.1 Dimensions and weight 223.5.2 Environmental conditions 223.5.3 Technical specifications - laser units 23

4 System overview 244.1 Instrument interfaces 24

4.1.1 Status LED strip 254.1.2 MALDI target plate IN/OUT button 254.1.3 Load port 254.1.4 Rear panel 274.1.5 Data system connections 28

4.2 Data system 29


Table of contents Bruker

5 Operating the instrument 305.1 Turning the instrument on and off 305.2 Checking for instrument operational readiness 315.3 Loading MALDI target plates 315.4 Ejecting MALDI target plates 315.5 Controlling the instrument during acquisition 325.6 Taking the instrument out of operation 32

6 Maintaining and cleaning the instrument 336.1 Cleaning the instrument 336.2 Replacing the rear fan filter 33

7 Troubleshooting 347.1 Requesting a remote service session 35

8 Disposing of the instrument 369 Symbols 3710 Index 39


Bruker 1 Intended purpose

1 Intended purpose

The MALDI Biotyper-BD sirius one IVD System is a semi-automated IVD MALDI-TOFmass spectrometer that is used in conjunction with software, reference libraries, andreagents of the MALDI Biotyper workflow for qualitative identification and analysis ofmicroorganisms cultured from clinical samples from human specimens.

The device is intended for Professional Use only.


2 Precautions and warnings Bruker

2 Precautions and warnings

Warnings, cautions, and notes appear in this manual. These warnings and cautions willdetail the specific hazard, describe how to avoid it, and specify the possibleconsequences of not heeding the warning or caution. Read all warnings and cautionscarefully and observe them at all times. Their format is:

WARNING

A WARNING message appears in the manual when failure to observeinstructions or precautions could result in death or injury. Symbols depictingthe nature of the specific hazard are also placed alongside warnings (refer tosymbols on the next page).

CAUTION A CAUTION message is used when failure to observe instructions couldresult in damage to equipment.

Note A Note is used to give advice or additional information.

2.1 Safety symbols

Find the following symbols on or near various components of MALDI Biotyper-BD siriusone IVD System.

Symbol DescriptionIndicates that there is a risk of danger. This can be any type of hazard.Refer to the safety pages in the manual for further information.

Indicates the danger of electric shock due to the presence of highvoltage. Follow the precautions to avoid danger.


Bruker 2 Precautions and warnings

Symbol DescriptionIndicates that laser radiation may be present.

The instrument MALDI Biotyper-BD sirius one IVD System is classifiedas Class 1 Laser Product (IEC 60825-1). The classification label isshown on the product. With all covers in place the radiation of theinternal Class 4 laser component is not accessible.

Class 4 laser radiation, even scattered, is hazardous and might beinvisible; it can cause serious harm to skin and eye.

The load port of the ion source is equipped with a safety interlock toprotect from laser radiation.

Do not remove any other cover of the instrument and do not bypass ordisable safety features in any way.

Only Bruker Service Engineers are trained in procedures and allowedto operate the instrument with covers removed.

Bruker takes no responsibility for damage or injury caused due toinappropriate use of the instrument.

Indicates that a terminal either receives or delivers alternating currentor voltage.

Indicates that a protective grounding terminal must be connected toground before any other electrical connections are made to theinstrument.

Indicates the OFF position of the main power switch.

Indicates the ON position of the main power switch.

Indicates that potentially dangerous biological hazard may be present.



2.2 General precautions and warnings

Make sure that anyone involved with the operation of the instrument is knowledgeable inboth general safety practices for the laboratory and safety practices for the MALDIBiotyper-BD sirius one IVD System instrument. Seek advice from your safety engineer,industrial hygienist, environmental engineer, or safety manager before using theinstrument.

CAUTION Do not restrict ventilation of the air intake at the rear of the instrument or theexhaust at the top of the instrument.To ensure proper operation, check the ventilation air filter at the rear of theinstrument every three months and replace if necessary. The filter shouldbe replaced at least once a year, see section 6.2.

Before using the instrument, make sure that you have read and understood theinstructions and recommendations in the safety section of this manual.

Failure to comply with these instructions may compromise the performance andreliability of the instrument.

Note Authorized Bruker personnel must perform the installation of the MALDIBiotyper-BD sirius one IVD System.

Note The warranty does NOT cover damage resulting frommishandling by thecustomer. Do not open the shipping container unless a Bruker representativeis present. Opening of the container without authorized persons present willvoid the warranty of the instrument. A Bruker service engineer will set up theinstrument in the customer’s laboratory.Leave the instrument on the delivery pallet and wait for the Brukerrepresentative to move the instrument to its desired location.

CAUTION Protection provided by this equipment may be impaired if the equipment isused in a manner not consistent with the instructions in this manual.

IMPORTANT Do not use the MALDI Biotyper-BD sirius one IVD System if you suspectthat it is not functioning properly or in a way other than that described.Disconnect mains in any reasonable case if problems occurs. CallBruker Service for help.

Note No modification of this equipment is allowed.



Note Section 6 of this manual describes the allowed maintenance for users. OnlyBruker Service Engineers are allowed to carry out service procedures, theyare trained to operate the instrument with e.g. covers removed.

2.3 Meeting site requirements

The Site Preparation Specification defines the necessary on-site requirements. Thecustomer must ensure to meet these requirements; including space, power, andventilation requirements. Before a Bruker-certified engineer can perform the installation,the customer must have prepared the site and must have returned the signed fax replydocument to Bruker. Only a Bruker - certified engineer is qualified to carry out theinstallation or relocation of the instrument. Before moving the instrument, make sure thatsite requirements are met.

To obtain a copy of the relevant Site Preparation Specification, [email protected].



2.4 Data safety and cybersecurity

Cybersecurity

The MALDI Biotyper data system comes with an activated Windows Update feature inorder to automatically install (cyber) security related updates. Do not change this setting– especially if you connect the data system to the Internet.

The MALDI Biotyper data system comes with no antivirus software preinstalled. Beforeconnection of the MALDI Biotyper data system to the Internet we strongly recommendthat an appropriate antivirus software is installed and kept up-to-date. Contact your localIT specialists in this regard. It is the customer’s responsibility to ensure that their systemis effectively protected against cyber-attack.

Antivirus Software ConfigurationContact the MALDI Biotyper Hotline for a current list of ports to exclude from antivirussoftware.

2.5 Lifting and handling the instrument

For your safety, and in compliance with international regulations, the physical handlingof the Bruker instrument requires a team effort to lift and/or move the instrument. Theinstrument is too heavy and/or bulky for one person alone to handle safely. Contact yourlocal Bruker office for advice on occupational health and safety.

WARNING

Improper lifting can lead to back injuries.

Exercise caution when lifting the MALDI Biotyper- BD sirius oneinstrument, see Figure 2-1.

Wear appropriate clothing and support gear when carrying or movingthe instrument.

CAUTION When shipping or transporting the instrument it is critical that the MALDItarget plate is in the OUT position. Failure to eject the MALDI target platewill result in damage to the instrument.



Use the carrying handle when moving the instrument. The carrying handle is part of thedelivery. Keep the carrying handle in a safe place nearby.

1: Lashing strap

2: Edge protection

3: Carrying handle

Figure 2-1 Securing the instrument when moving

2.6 Electrical and laser safety

The following electrical and laser safety considerations must be addressed:

l General Safety: Before operating the MALDI Biotyper-BD sirius one instrument,read the following information concerning hazards and potential hazards.

l Position the MALDI Biotyper-BD sirius one instrument in a clean area that is freefrom dust, smoke, vibration, and corrosive fumes, out of direct sunlight, and awayfrom heating units, cooling units, and ducts.

l Verify that there is an adequate and stable power source for all systemcomponents.

l Verify that the power cord is the correct type for your laboratory and that it meetsthe national safety agency guidelines for the particular country of use.



WARNING — ELECTRICAL HAZARD

Connecting the instrument to a power source that is notequipped with a protective ground contact creates a shockhazard for the operator and can damage the instrument.

Any interruption of the protective ground conductor, inside oroutside the instrument, or disconnection of the protectiveground terminal creates a shock hazard for the operator and candamage the instrument.

WARNING — ELECTRICAL HAZARD

Disconnect mains in any reasonable case if problems occurs.

Do not operate the instrument with any covers or partsremoved.

Do not attempt to make adjustments, replacements or repairs to this instrument. OnlyBruker service engineers, that are trained to operate the instrument, for example, withcovers removed, are allowed to carry out service procedures.

If you suspect that the MALDI Biotyper-BD sirius one instrument has been impaired,proceed with these steps:

1. Turn off the MALDI Biotyper-BD sirius one instrument.2. Disconnect the power cord from the electrical outlet.3. Secure the instrument against any unauthorized operation.4. Contact Bruker Service.



WARNING — ELECTRICAL AND RADIATION HAZARDS

The MALDI Biotyper-BD sirius one instrument uses very highvoltages. Under normal operation, the instrument requires NOuser access to the inner components of the instrument. NEVERoperate the MALDI Biotyper-BD sirius one instrument with theprotective panels removed as this exposes the user to risk ofsevere electrical shock and harmful, invisible, ultraviolet orinfrared laser radiation.

Use of controls and adjustments or performance of proceduresother than those specified in this manual may result in hazardousradiation exposure.

2.7 Mechanical safety

The table or bench on which the device is placed must be stable and strong enough tosupport the weight of the device and any equipment next to it.

Note The surface which is foreseen for the instrument must be able to safelysupport up to 100 kg or 221 lbs, which is equivalent to the combined weight ofthe instrument and the computer, monitor, and printer.

2.8 Handling chemicals and clinical specimens

To protect the operator from harm and to prevent system malfunction, observe thefollowing guidelines.

o Wear appropriate protective clothing including safety glasses and gloveswhen preparing samples and solutions for use with the instrument.

o Follow the correct safety procedures and the manufacturer’srecommendations when using solvents and other chemicals.

o Clean the exterior surfaces of the instrument with a soft cloth dampened witha mild detergent and water solution. Do not use abrasive cleaners or solvents.

o Follow the correct safety procedure and the manufacturer's recommendationswhen using solvents.



o If contamination of the instrument is suspected, clean the exterior surfacesand the load port including the lid of the load port with a soft cloth that isdampened with 70% ethanol or a solution of mild detergent in water. Do notuse abrasive cleaners or solvents.


Bruker 3 Product description

3 Product description

The MALDI Biotyper-BD sirius one IVD System is a qualitative in vitro diagnostic matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometer forclinical use in conjunction with MALDI Biotyper software, reference libraries,consumables and workflows.

Key product characteristics:

l Benchtop system

l Gridless microSCOUTMALDI ion source

l Patented PAN technology for high mass resolution over a wide mass range

l Perpetual Ion Source with IR-laser self-cleaning functionality

l 200 Hz BRUKER smartbeam solid-state lifetime laser (500 Million laser shots orseven years after acceptance (whatever comes first))

3.1 Limitations

You may use the MALDI Biotyper-BD sirius one IVD System only in combination withdedicated software, and further consumables of the Bruker IVD MALDI Biotyper Systemportfolio, see section 3.4.

For specific limitations of the method, refer to the User Manual of the MBT Compass IVDor MBT Compass HT IVD software.

Use of the MALDI Biotyper-BD sirius one IVD System is limited to users that are trainedin the procedure. Bruker provides training during the commissioning of a MALDIBiotyper-BD sirius one IVD System.


3 Product description Bruker

3.2 Performance characteristics

As the MALDI Biotyper-BD sirius one IVD System is to be used in combination withfurther Bruker IVD devices, performance characteristics were obtained for the entireworkflow.

You can find details on the performance of the entire workflow in the User Manuals ofthe MBT Compass HT IVD or MBT Compass IVD Software.

3.3 Scope of supply

The MALDI Biotyper-BD sirius one IVD System is supplied with the following:

l Data system equipped with Microsoft Windows 10 operating system

l Power cables

l User manual

3.4 Materials required

The following hardware, consumables, reagents, and software are required in order touse the product as intended, and can be ordered separately:

Product Part numberIVD Matrix HCCA-portioned 8290200

IVD Bacterial Test Standard 8290190

Depending on your workflow, the following MALDI target plates and adapter arecompatible:

Product Part numberMBT Biotarget 96 IVD 1839298

MSP Biotarget Adapter 8267615



MSP 48 target polished steel BC 8281817

MSP 96 target polished steel BC 8280800

Depending on your configuration, your MALDI Biotyper-BD sirius one IVD System usesthe following MALDI Biotyper software:

Product Part numberMBT Compass IVD 1832771

MBT Compass HT IVD 1877017

The following air filter is exchanged during a Planned Maintenance:

Product Part numberAir filter 1862940

Further Bruker IVD consumables and kits may be used depending on the desiredapplication. Refer to the corresponding Instructions for Use. Contact your localrepresentative for availability in your country.

Note All consumables must be used within the use-by date indicated on the label.


3 Product description Bruker

3.5 Instrument specifications

3.5.1 Dimensions and weight

Weight:75 kg(165.4 lbs)

Figure 3-1 Dimensions of the MALDI Biotyper-BD sirius one instrument

3.5.2 Environmental conditions

The MALDI Biotyper-BD sirius one instrument is designed for indoor use and functionscorrectly under the following ambient conditions:

Operating conditions Storage conditionsTemperature 16 °C to 30 °C 10 °C to 40 °C

Relative humidity 20 % to 75 % non-condensing 15 % to 85 % non-condensing

During acquisition, the temperature gradient must be lower than 3 °C per hour.



3.5.3 Technical specifications - laser units

Specification of the internal laser units:

Laser unit 1 Primary radiation Secondaryradiation

Emitted wavelength range 315 – 360 nm 1064, 532 nmMax. output energy 500 µJ 1000 µJPulse duration > 500 ps > 500 psLaser unit 2Emitted wavelength range 900 -960 nm —

Max. output power 10 Watt —Pulse duration continuous —


4 System overview Bruker

4 System overview

The MALDI Biotyper-BD sirius one IVD System is the instrument, see section 4.1, andis supplied with a data system, see section 4.2.

4.1 Instrument interfaces

The MALDI Biotyper-BD sirius one instrument has three user interfaces:

1: LEDstatus strip

2: Load port

3: IN/OUTbutton

Figure 4-1 Location of the user interface elements


Bruker 4 System overview

4.1.1 Status LED strip

The Status LED strip gives an overview of the system status.

Color andstate

Instrumentstatus Description

Steady white NORMAL orSTARTUP

The system is ready for loading or unloading aMALDI target plate or for starting measurements. -The instrument is starting up.

Flashingwhite slow DOCKING MALDI target plate loading procedure is in

progress.Flashingwhite fast AUTOMODE Instrument is performing a measurement. The

IN/OUT button is not available.

Steady red ERROR Malfunction that requires an intervention of user orservice technician.

4.1.2 MALDI target plate IN/OUT button

The MALDI target plate IN/OUT button is used to start the procedure for loading andejecting MALDI target plates, see Figure 4-1.

4.1.3 Load port

The load port is an airlock that allows the user to load MALDI target plates into theinstrument at atmospheric pressure without compromising the high vacuum inside thevacuum chamber.

After the MALDI target plate is loaded into the load port and the lid is closed, thepressure is reequilibrated. An automatic mechanism transports the MALDI target plateto the measurement stage.

With the software, you can navigate from one sample position to any other sampleposition.



Figure 4-2 The load port containing a MALDI Biotarget 96 plate

Note To avoid contamination, close the lid of the load port and lock the MALDItarget plate. After insertion, the MALDI target plate needs to be flush.

Note Before you place the MALDI target plate on the target carrier, make sure thatthe sample positions have completely dried.



4.1.4 Rear panel

The following connections are at the rear of the instrument, see Figure 4-3.

1: Cable DET-LIN to socket DETECTOR

2: Cable VIDEO to socket VIDEO

3: EXHAUST

4: Disposable particle filter

5:Cable TOF to socket LAN

6: Cable TRIGGER to socket TRIGGER

7: Mains Power Connection

Figure 4-3 Overview of the rear panel

l EXHAUST: This outlet is fitted at the factory with a disposable particle filter (4).The gas load on the system is sufficiently low that ventilation of the pump exhaustis not required. Individual facilities may have safety guidelines which requireventilation. It is the responsibility of the user to adhere to the requirements of theirrespective facility.

l Mains Power Connection: The instrument is fitted with an IEC320-C14 mainsconnector.

l Rear Fan Filter: To ensure efficient instrument function, the rear fan filter needsto be replaced in certain intervals, see section 6.2.



4.1.5 Data system connections

The appearance of the sockets may differ slighty between PCs,see Figure 4-4.

1: PC

2: PC-VIDEO

3: PC-DETL

4: PC-TRG

Figure 4-4 Data system connections*

No. Port Used for Connectorlabel Comment

1 LAN Communication connection toinstrument

PC –

2 Video Camera signal input PC-VIDEO –

3 DigitizerInput

Signal input from detector PC-DETL Use AdapterSMA/BNC

4 DigitizerExternal

External trigger from instru-ment

PC-TRG Use AdapterSMA/BNC



4.2 Data system

The data system consists a PC that controls the instrument and acquires and storesdata. The data system delivered with the instrument contains the following components:

l LCD displayl Operating system: Microsoft Windows 10

l Software packages:o MBT Compass IVD or MBT Compass HT IVD for data acquisitiono Compass for flex for instrument control


5 Operating the instrument Bruker

5 Operating the instrument

Only personnel who have received familiarization training are permitted to operate theinstrument. During the installation of the instrument, the installation engineer willundertake familiarization training.

5.1 Turning the instrument on and off

Power to the instrument is controlled by the mains switch on the rear panel, see Figure5-1.

The two positions of the mains power switch are the following

l O = Off.l I = On.

The status LED strip is steady white when the instrument is switched on, see Figure 4-1.

To maintain the instrument vacuum, the instrument must be switched on.

Figure 5-1 Mains power switch on rear panel (here: off)

Note The instrument is instantly isolated by switching the mains power switch toO.


Bruker 5 Operating the instrument

5.2 Checking for instrument operational readiness

When the instrument is ready to operate, the LED status strip is a steady white.

For further details, refer to 4.1.1.

5.3 Loading MALDI target plates

1. Open the load port lid, see Figure 4-2, and place the MALDI target plate onto thetarget carrier.

Note If the lid does not open easily, the target carrier may be in the IN position.In this case, press the IN/OUT button once to bring the target carrier in theOUT position, see Figure 4-1.

CAUTION The presence of debris in or around the load port can adversely affectinstrument operation. Take care not to drop any debris into the load portor onto the black O-ring.

2. Check that there is no visible debris on the o-ring.3. If debris is visible, wipe the o-ring with a clean cloth.4. Shut the load port lid.5. Press the MALDI target plate IN/OUT button once, see Figure 4-1.

The MALDI target plate loading procedure starts. During the loading process, thestatus LED strip is flashing white with low frequency.

The MALDI target plate loading procedure typically takes 2 to 3 minutes and shouldnot take longer than 5 minutes. When the MALDI target plate loading procedure iscomplete, status LED strip is lit steady white.

5.4 Ejecting MALDI target plates

Note Only eject a MALDI target plate when a new plate is ready to replace it. If anew MALDI target plate is not ready, move the target carrier in, without aMALDI target plate in place. Move it out again when the new MALDI targetplate is available.


5 Operating the instrument Bruker

1. Press the MALDI target plate IN/OUT button once.

The MALDI target plate ejection procedure starts and the status LED strip is flashingwhite with low frequency.

2. When the MALDI target plate ejection process is finished, the status LED stripswitches to permanent white. Open the port load, remove the MALDI target plateand close the load port.

Note Do not leave the load port open for a prolonged time. It will prolong theMALDI target plate exchange time and might lead to debris entering anddamaging the system. To accelerate the loading of a new MALDI target plate,make sure that you close the lid of the load part immediately.

5.5 Controlling the instrument during acquisition

Data acquisition on the MALDI Biotyper-BD sirius one instrument is controlled by MBTCompass IVD MALDI software.

5.6 Taking the instrument out of operation

If the instrument is to be taken out of operation, contact Bruker Service for advice on thenecessary steps to be taken.

CAUTION When shipping or transporting the instrument, it is critical that the MALDItarget plate is in the OUT position. Failure to eject the MALDI target platewill result in damage to the instrument.


Bruker 6 Maintaining and cleaning the instrument

6 Maintaining and cleaning the instrument

Note Only personnel that have been trained and certified by Bruker are allowed toperform procedures that require removal of product covers.

Note Contact your local Bruker office for advice on preventive maintenance.

6.1 Cleaning the instrument

Do not use abrasive cleaners or solvents.

Clean the exterior surfaces of the instrument with a soft cloth dampened with a milddetergent and water solution.If you suspect that the instrument is contaminated, clean the exterior surfaces with a softcloth dampened with 70% ethanol or a solution of mild detergent in water.

CAUTION To prevent damage to painted surfaces, do not leave the dampened clothon the painted surfaces of the instrument.

6.2 Replacing the rear fan filter

To ensure efficient instrument function, inspect the rear fan filter at the rear of theinstrument every three months.Replace the filter by lifting the old filter up and out of the holder and sliding a new filterinto place, see Figure 6-1.

Figure 6-1 Rear fan filter

Find the ordering information for the air filter in section 3.4.


7 Troubleshooting Bruker

7 Troubleshooting

To maximize operating time, the MALDI Biotyper-BD sirius one IVD System has aremote service capability, see Figure 7-1. This feature allows troubleshooting over theinternet with the data system being fully controlled by the Bruker Service Hotline.Software and firmware updates can also be performed using this feature.

In case of instrument malfunction, the overall service process is accelerated by enablingthe service engineer to arrive on site with the appropriate spare parts after remotediagnosis.

Note The MALDI Biotyper sirius one IVD data system must have internet access touse the remote service capability.

Note Observe the notes on cybersecurity, see section 2.4.

Figure 7-1 Operating principle of remote service


Bruker 7 Troubleshooting

7.1 Requesting a remote service session

l Contact your local BD representative and provide them with the followinginformation:o Your name and locationo The serial number of your instrumento Version numbers of software used to run the instrument and process MALDIdata. The version number can be found by opening the software and selectingHelp > About

Bruker will contact you as soon as possible by email and provide instructions for the

remote service session.


8 Disposing of the instrument Bruker

8 Disposing of the instrument

Equipment Disposal

Under European Directive 2012/19/EU, this label applies to electricaland electronic equipment installed and sold in the European Union.

The consumer is committed by law to dispose of such equipment at theend of its lifetime. When disposing of the equipment or parts thereof, itmust not be disposed of in household waste. To do so can contaminateand pollute the environment.

To dispose of the equipment responsibly, contact your communitywaste disposal authority. The details are regulated in national law.


Bruker 9 Symbols

9 Symbols

The following symbols are used in the labeling:

Manufacturer

Date of manufacture

Catalog number

CE mark

Serial number

Waste electrical and electronic equipment (WEEE)

Temperature limit

In vitro diagnostic medical device

Laser radiation

Biohazard

High voltage hazard


9 Symbols Bruker

Warning


10 Index

DData system 29

EElectrical Safety 15

Environmental conditions 22

FFacility and electrical requirements 13

IInstrument layout 24

Intended purpose 9

IVD MALDI Biotyper software 32

LLED status strip 25

Legal and regulatory notices 2

Load port 25

MMaintenance 33

MALDI target plates

ejecting 31

loading 31

PPrecautions 12

SSafety symbols 10

Software

IVD MALDI Biotyper 32

TTurning the instrument on and off 30

WWeight and dimensions 22


Bruker 10 Index

MALDI Biotyper-BD sirius one IVD System User Manual

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