LRE Medical Esterline 8066000 Laboratory Equipment with RFID User Manual

LRE Medical GmbH Esterline Corporation Laboratory Equipment with RFID

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8066000 User Manual

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Philips minicare analyzerINSTRUCTIONS FOR USERelease 1.0EnglishPhilips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Published by Philips Electronics Nederland B.V.Philips Electronics Nederland B.V. reserves the right to makechanges to both this document and to the product it describes.Product specifications are subject to change without notice.Nothing contained within this document is intended as anyoffer, warranty, promise or contractual condition, and must notbe taken as such.© Koninklijke Philips Electronics N.V. 2011All Rights are reserved. Reproduction in whole or in part in anyform or by any means, electrical, mechanical or otherwise isprohibited without the written consent of the copyright holder.Issue Number [12nc xxxx xxx xxxx] [Draft version 0.2 Thislabel will be removed]Philips Electronics Nederland B.V.acting through Healtcare IncubatorHigh Tech Campus 55656 AE EindhovenThe NetherlandsUnauthorized copying of this publication may not only infringecopyright but also reduce the ability of Philips ElectronicsNederland B.V. to provide accurate and up-to-date informationto users.Non-Philips product names may be trademarks of theirrespective owners.Published in The Netherlands.0-2 Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 ContentsIntroduction..............................................................................................1 1-11.1 About the Philips minicare system............................................. 1-11.2 About these Instructions for Use................................................ 1-21.3 Intended use.............................................................................. 1-31.4 Compatibility............................................................................ 1-31.5 Compliance............................................................................... 1-41.6 European authorized representative........................................... 1-41.7 Training.................................................................................... 1-5Safety.........................................................................................................2 2-12.1 Important safety directions........................................................ 2-12.2 Emergency procedures............................................................... 2-22.3 Explosion safety......................................................................... 2-22.4 Electromagnetic Compatibility (EMC)...................................... 2-32.5 Labels and symbols.................................................................... 2-42.5.1 minicare analyzer label................................................. 2-42.5.2 minicare docking station label...................................... 2-52.5.3 Symbols....................................................................... 2-6Installation................................................................................................3 3-13.1 Equipment overview.................................................................. 3-13.1.1 Equipment connections............................................... 3-23.2 Action upon delivery.................................................................. 3-43.3 Site preparation......................................................................... 3-4Philips minicare analyzer Release 1.0 Contents 0-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 3.4 Storage and handling................................................................. 3-53.4.1 Environmental conditions............................................ 3-53.4.2 Battery care.................................................................. 3-63.4.3 Dust............................................................................. 3-6System overview......................................................................................4 4-14.1 Theory of operation................................................................... 4-14.2 Performance and limitations...................................................... 4-34.2.1 Performance characteristics.......................................... 4-34.2.2 Limitations of use........................................................ 4-44.3 Preparation prior to use............................................................. 4-44.4 Installing the data manager software.......................................... 4-44.5 Docking and undocking the minicare analyzer.......................... 4-54.5.1 Docking the minicare analyzer..................................... 4-54.5.2 Undocking the minicare analyzer................................. 4-64.6 Configuring analyzer connectivity.............................................. 4-74.6.1 Configuring the minicare analyzer with a static IPaddress......................................................................... 4-74.6.2 Configuring the minicare analyzer with a DHCP server.................................................................................... 4-84.6.3 Configuring the minicare analyzer on the datamanager software......................................................... 4-94.7 Configuring LIS connectivity..................................................... 4-94.8 Configuring analyzer settings..................................................... 4-12Operation - minicare analyzer................................................................5 5-15.1 minicare analyzer overview......................................................... 5-15.1.1 Main screen................................................................. 5-15.1.2 Blood analysis workflow............................................... 5-25.2 Starting up and shutting down................................................... 5-35.2.1 Starting the minicare analyzer...................................... 5-3Contents0-4 Contents Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 5.2.2 Shutting down the minicare analyzer........................... 5-65.3 Identifying the user.................................................................... 5-65.3.1 Logging on................................................................... 5-65.3.2 Logging out................................................................. 5-95.4 Starting analysis......................................................................... 5-95.5 Identifying the patient............................................................... 5-105.5.1 Identifying the patient by barcode scanning................. 5-105.5.2 Identifying the patient from a list................................. 5-115.5.3 Performing an anonymous test..................................... 5-125.6 Inserting a cartridge................................................................... 5-135.7 Adding a blood sample and performing a test............................ 5-145.8 Removing a cartridge................................................................. 5-165.9 Performing multiple tests........................................................... 5-165.10 Finishing a test or analysis.......................................................... 5-16Operation - minicare data manager......................................................6 6-16.1 Starting and stopping the data manager software....................... 6-16.1.1 Starting the data manager software............................... 6-16.1.2 Logging on................................................................... 6-16.1.3 Logging off.................................................................. 6-26.1.4 Exiting the data manager software................................ 6-36.2 System overview......................................................................... 6-36.2.1 Common elements....................................................... 6-76.3 Analysis orders........................................................................... 6-116.3.1 Patient List................................................................... 6-116.3.2 Details area.................................................................. 6-136.3.3 Creating a new analysis order....................................... 6-146.3.4 Transferring an analysis order to the minicare analyzer.................................................................................... 6-156.3.5 Deleting an analysis order............................................ 6-15ContentsPhilips minicare analyzer Release 1.0 Contents 0-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 6.4 Analysis results........................................................................... 6-166.4.1 Patient List................................................................... 6-166.4.2 Details area.................................................................. 6-186.4.3 Transferring analysis results from the minicare analyzer.................................................................................... 6-196.4.4 Editing analysis results................................................. 6-206.4.5 Printing analysis results................................................ 6-216.4.6 Transferring analysis results to the LIS......................... 6-226.5 QC results................................................................................. 6-236.5.1 QC results list.............................................................. 6-236.5.2 Additional QC results options...................................... 6-24System messages and troubleshooting..................................................7 7-17.1 System and error messages......................................................... 7-17.1.1 Philips minicare analyzer.............................................. 7-17.1.2 Data manager software................................................. 7-37.2 Contacting Service..................................................................... 7-10Maintenance..............................................................................................8 8-18.1 Cleaning and disinfection.......................................................... 8-18.1.1 Cleaning the minicare analyzer..................................... 8-28.1.2 Disinfecting the minicare analyzer............................... 8-38.1.3 Cleaning the battery in the battery compartment......... 8-48.2 Planned maintenance and user routine checks........................... 8-48.2.1 Planned maintenance program..................................... 8-48.2.2 User routine checks program........................................ 8-58.3 Quality control.......................................................................... 8-58.3.1 QC test workflow........................................................ 8-68.3.2 Performing a QC test................................................... 8-88.4 Antivirus protection................................................................... 8-98.5 After-sales support..................................................................... 8-10Contents0-6 Contents Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Product disposal.......................................................................................9 9-19.1 Passing this product on to another user...................................... 9-19.2 Final disposal of this product..................................................... 9-29.3 Fitting, removing and disposing of batteries............................... 9-29.3.1 Replacing the minicare analyzer battery....................... 9-3Technical data..........................................................................................10 10-110.1 Specifications............................................................................. 10-110.2 System requirements.................................................................. 10-1Glossary.....................................................................................................11 11-111.1 Definitions................................................................................ 11-111.2 Abbreviations............................................................................. 11-1Appendices................................................................................................12 12-112.1 Special functions........................................................................ 12-112.1.1 Additional host software options for Administrators.... 12-112.1.2 Analyzer menu and options.......................................... 12-912.2 Security and privacy requirements..............................................12-1012.3 References..................................................................................12-10Index.......................................................................................................... I-1ContentsPhilips minicare analyzer Release 1.0 Contents 0-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Contents0-8 Contents Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 IntroductionAbout the Philips minicare systemThe Philips minicare system comprises a handheld analyzer, its dockingstation, and data manager software for the quantitative determination of theconcentration of biomarkers in blood.Figure 1.1 Philips minicare analyzer, with docking station (right)Figure 1.2 Philips minicare analyzer, with cartridge loaded (right)Philips minicare analyzerThe minicare analyzer receives blood cartridges and performs tests on theblood sample. It is intended for use in medical care settings, for example,operating theaters.To perform a test with the minicare analyzer, a cartridge sample for aspecific application is also required. These cartridges can be used only once.11.1Philips minicare analyzer Release 1.0 Introduction 1-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Philips minicare data managerThe minicare data manager software allows you to configure the minicareanalyzer, and to exchange data from the minicare analyzer with an externalinformation system, for example, LIS.About these Instructions for UseThese Instructions for Use are intended to assist users in the safe andeffective operation of the product described.Before attempting to operate the product, you must read these Instructionsfor Use, noting and strictly observing all WARNINGS and CAUTIONnotices.Pay special attention to all the information given and procedures describedin the SAFETY section.A WARNING alerts you to a potential serious outcome, adverse event orsafety hazard. Failure to observe a warning may result in death or seriousinjury to the user or patient.A CAUTION alerts you to where special care is necessary for the safe andeffective use of the product. Failure to observe a caution may result in minoror moderate personal injury or damage to the product or other property,and possibly in a remote risk of more serious injury, and/or causeenvironmental pollution.Notes highlight unusual points as an aid to a user.[NOTE TO REVIEWERS: If there are no options on the system, thefollowing paragraph is can be removed. Please confirm.] These Instructionsfor Use describe the most extensive configuration of the product, with themaximum number of options and accessories. Not every function describedmay be available on your product.1.21.2 About these Instructions for Use1-2 Introduction Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Intended useThis Philips product is intended to be installed, used and operated only inaccordance with the safety procedures and operating instructions given inthis Instructions for Use for the purposes for which it is designed. Thepurposes for which this product is intended are given below. However,nothing stated in this Instructions for Use reduces user’s responsibilities forsound clinical judgment and best clinical procedure.The intended use of the Philips minicare system is as a point of care deviceto measure the concentration of biomarkers in blood using Magnotechblood cartridges.Installation, use, and operation of this product is subject to the law in thejurisdictions in which this product is being used. Operators must onlyinstall, use, and operate this product in such ways as do not conflict withapplicable laws, or regulations, which have the force of law.Uses of this product for purposes other than those intended and expresslystated by the manufacturer, as well as incorrect use or operation, may relievethe manufacturer (or his agent) from all or some responsibility for resultantnon-compliance, damage, or injury.Intended usersThe intended users of the Philips minicare system are laboratory and non-laboratory medical professionals (for example, nurses).Intended use environmentThe Philips minicare system is used to perform tests in different caresettings, for example, an emergency room or an operating theater.CompatibilityThe product described in this manual should not be used in combinationwith other products or components unless such other products orcomponents are expressly recognized as compatible by Philips ElectronicsNederland B.V. A list of such products and components is available fromthe manufacturer.1.31.4Intended use 1.3Philips minicare analyzer Release 1.0 Introduction 1-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Philips minicare analyzer identification Module no. [To be defined]Software version [To be defined]Changes and/or additions to the product should only be carried out byPhilips Electronics Nederland B.V. or by third parties expressly authorizedby Philips Electronics Nederland B.V. to do so. Such changes and/oradditions must comply with all applicable laws and regulations that have theforce of law within the jurisdiction(s) concerned, and with best engineeringpractice.Changes and/or additions to the product that are carried out by persons without theappropriate training and/or using unapproved spare parts may lead to the PhilipsElectronics Nederland B.V. warranty being voided. As with all complex technicalproducts, maintenance by persons not appropriately qualified and/or usingunapproved spare parts carries serious risks of damage to the product and of personalinjury.ComplianceThe Philips minicare analyzer complies with relevant international andnational standards and laws. Information on compliance will be supplied onrequest by your local Philips Electronics Nederland B.V. representative, orby the manufacturer.European authorized representativeThe European authorized representative is located at the following address:Philips Electronics Nederland B.V, acting through Healthcare IncubatorHigh Tech Campus 55656AE, EindhovenThe Netherlands.WARNING1.51.61.5 Compliance1-4 Introduction Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 TrainingUsers of this product must have received adequate training on its safe andeffective use before attempting to operate the product described in theseInstructions for Use. Training requirements for this type of device will varyfrom country to country. Users must make sure they receive adequatetraining in accordance with local laws or regulations.If you require further information about training in the use of this product,please contact your local Philips Electronics Nederland B.V. representative.Alternatively, contact the manufacturer.1.7Training 1.7Philips minicare analyzer Release 1.0 Introduction 1-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 1.7 Training1-6 Introduction Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 SafetyImportant safety directionsMaintenance and faults•Do not use the product for any application until you are sure that the user routine-checks have been satisfactorily completed, and that the periodic maintenance ofthe product is up to date. If any part of the product is known (or suspected) to bedefective or wrongly adjusted, DO NOT USE the product until a repair has beenmade. Operation of the product with defective or wrongly adjusted componentscould expose the user or the patient to safety hazards. This could lead to fatal orother serious personal injury, or to clinical misdiagnosis.Safety awareness•Do not use the product for any application until you have read, understood andknow all the safety information, safety procedures and emergency procedurescontained in this SAFETY section. Operation of the product without a properawareness of how to use it safely could lead to fatal or other serious personalinjury. It could also lead to clinical misdiagnosis.Adequate training•Do not use the product for any application until you have received adequate andproper training in its safe and effective operation. If you are unsure of your abilityto operate this product safely and effectively DO NOT USE IT. Operation of thisproduct without proper and adequate training could lead to fatal or other seriouspersonal injury. It could also lead to clinical misdiagnosis.•Do not operate the product with patients unless you have an adequateunderstanding of its capabilities and functions. Using this product without such anunderstanding may compromise its effectiveness and/or reduce the safety of thepatient, you and others.22.1WARNINGWARNINGWARNINGPhilips minicare analyzer Release 1.0 Safety 2-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Safety devices•Never attempt to remove, modify, or over-ride or frustrate any safety device onthe product. Interfering with safety devices could lead to fatal or other seriouspersonal injury.•[NOTE TO REVIEWERS — during review 1, a defect was raised indicating thiswarning (above) is too vague. In your review, please indicate one of the following:(A) that there are no safety devices on the analyzer (not required through gooddesign), in which case we can remove this warning altogether, or (B) there arespecific safety devices on the analyzer that require more in-depth explanation, inwhich case we need to expand this warning with more detail. Thank you.]Intended use and compatibility•Do not use the product for any purpose other than those for which it is intended.Do not use the product with any product other than that which Philips MedicalSystems recognizes as compatible. Operation of the product for unintendedpurposes, or with incompatible product, could lead to fatal or other serious injury.It could also lead to clinical misdiagnosis.Emergency proceduresThere are no emergency procedures for the minicare analyzer.Explosion safety[NOTE TO REVIEWERS - During review 1, the following defect was raised: “Do weneed a 'battery exploding warning' ? These types of batteries (used in remotecontroled cars e.g., sometimes self combust. Are our batteries safeguarded againatthat?” In your review, please could you indicate whether or not there is a risk of thebattery exploding that requires mitigation in the IfU. Normally, this will be driven bythe Risk Management Report (not available at the time of writing).WARNINGWARNING2.22.3WARNING2.2 Emergency procedures2-2 Safety Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Electromagnetic Compatibility (EMC)This Philips product complies with relevant international and national lawand standards on EMC (electro-magnetic compatibility) for this type ofproduct when used as intended. Such laws and standards define both thepermissible electromagnetic emission levels from product and its requiredimmunity to electromagnetic interference from external sources.Other electronic products exceeding the limits defined in such EMCstandards could, under unusual circumstances, affect the operation of theproduct.Medical electrical products needs special precautions regarding EMC, andneeds to be installed and put into service according to EMC informationprovided in the accompanying documents.The use of accessories and cables other than those specified, may result inincreased emission or decreased immunity levels.The product should not be used adjacent to or stacked with other productsand that if adjacent or stacked use is necessary, it should be observed toverify normal operation.Portable and Mobile PhonesPortable and mobile RF communications can affect medical electrical equipment. Usecaution when using such communication devices within the specified range of medicalelectrical devices.2.4CAUTIONElectromagnetic Compatibility (EMC) 2.4Philips minicare analyzer Release 1.0 Safety 2-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Labels and symbolsminicare analyzer labelThe following label is located on the rear side of the minicare analyzer.Figure 2.1 minicare analyzer label2.52.5.12.5 Labels and symbols2-4 Safety Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 minicare docking station labelThe following label is located on the rear side of the minicare docking station.Figure 2.2 minicare docking station2.5.2Labels and symbols 2.5Philips minicare analyzer Release 1.0 Safety 2-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 SymbolsThe following symbols are used on the equipment and on equipment labels.Authorized Representative in the European CommunityBatch codeCatalogue numberCaution, consult accompanying documentsCE markConsult Instructions for UseContains sufficient for (specified number of) testsContents•The contents of the package are listed below this symbolDo not use if package damagedDocking status•Illuminated: docked•Not illuminated: undockedIn Vitro Diagnostic Medical DeviceMains connection status•White: connected•Red: not connectedManufacturerNetwork connection port2.5.32.5 Labels and symbols2-6 Safety Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 On / Off buttonPolarityPower supply adapter connection portPrinter connection portProduct disposalThis symbol indicates that the equipment contains materials that areharmful to the environment if disposed of incorrectly. See section“Product disposal” on page 9-1 for details.Serial numberTemperature limitationThis symbol indicates the lower and upper limit of the acceptabletemperature range for storage or transportation.Use ByLabels and symbols 2.5Philips minicare analyzer Release 1.0 Safety 2-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2.5 Labels and symbols2-8 Safety Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 InstallationEquipment overviewFigure 3.1 Equipment inventoryLegend1 minicare analyzer 2 Docking station3 Docking station AC adapter 4 AC adapter power cord5 Ethernet cable 6 Data manager installation CD7 [Other items as appropriate] 33.1Philips minicare analyzer Release 1.0 Installation 3-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Equipment connectionsminicare analyzerFigure 3.2 Network connection port• Specification: Ethernet• An Ethernet cable is supplied with the minicare analyzerFigure 3.3 Docking station connector3.1.13.1 Equipment overview3-2 Installation Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Docking stationFigure 3.4 Docking station connection portsSymbol Description Specification1 Printer connection port•Specification: Mini USB•[To be confirmed — Cablesupplied?]2 Network connection port•Specification: Ethernet•An Ethernet cable is supplied withthe minicare analyzer3Power supply adapterconnection port•Input: 100–240 V AC, 47–63 Hz,700 mA•Output: 24 V DC, 1250 mA•A power supply adapter and powercord are supplied with theminicare analyzerEquipment overview 3.1Philips minicare analyzer Release 1.0 Installation 3-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Figure 3.5 Docking station connector for the minicare analyzerAction upon deliveryThe minicare analyzer is installed and configured by a Philips Serviceengineer as part of delivery. If you require information about suitablelocation, preparation, and connection of the system, contact your localPhilips Service organization.Site preparationConditions• A PC is required for installation of the data manager software.• The docking station requires a power connection.• To transfer data to the data manager PC, the docking station requires aconnection to the local network or directly to the PC.3.23.33.2 Action upon delivery3-4 Installation Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 1Unpack the minicare start pack.2Connect one end of the Ethernet cable to the docking station, and the otherend either to a port on the local network or directly to the PC.[NOTE TO REVIEWERS: Does direct connection to the PC require anEthernet crossover cable? If so, is this also provided?]3Connect the AC power adapter to the docking station and connect the ACpower adapter to the power source using the power cord.4Place the battery in the minicare analyzer.For details, see section “Fitting, removing and disposing of batteries” onpage 9-2.5Put the analyzer in docking station to charge the battery.For details, see section “Docking the minicare analyzer” on page 4-5.Storage and handlingEnvironmental conditionsStorageThe minicare analyzer can be stored and transported in the followingconditions. These conditions are valid while the minicare analyzer is still inits original packaging.Condition RangeAmbient temperature -25°C–70°CRelative humidity (non-condensing) 5%–95%Air pressure 70–110 kPaHandlingThe minicare analyzer can be used in the following conditions.Condition RangeAmbient temperature 2°C–27°CRelative humidity 20%–80%3.43.4.1Storage and handling 3.4Philips minicare analyzer Release 1.0 Installation 3-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Battery careDuring long periods of storage, you should remove the battery from theminicare analyzer. If the battery is left in the analyzer during storage, it willdischarge slowly over time. Damage to the battery may result if it is allowedto completely discharge while in storage.DustThe minicare analyzer cap should be closed while not in use to avoid dustentering the device at the cartridge entrance.3.4.23.4.33.4 Storage and handling3-6 Installation Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 System overviewThis product allows you to quickly and easily analyze the levels of certainbio markers in small blood samples taken from a patient. The system isdesigned for medical applications in various point of care settings, such asoperation theatres and hospital emergency rooms. The system allows you tosee and upload results to your information system for further analysis.The system consists of the following main parts.CartridgesBlood samples are dispensed into cartridges for analysis.The minicare analyzerA handheld device in which you insert the cartridge containing the bloodsample. The minicare analyzer executes the test and displays test results.Docking stationThe minicare analyzer can be docked in the docking station to charge thebattery and to transfer test result data to the data manager software.Data manager softwareThe data manager software allows you to configure the system and toexchange information with a hospital information system, for example, an LIS.This section provides an overview of the system functions. The followingsections provide details of the specific functions you use and the tasks youperform when operating the minicare analyzer and data manager software.Theory of operationThe minicare analyzer uses Philips Magnotech technology. Magnotech is atype of biosensor technology that uses magnetic nanoparticles to measurepicomolar concentrations of target substances in blood or saliva in a matterof minutes.44.1Philips minicare analyzer Release 1.0 System overview 4-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Integrated into a disposable biosensor cartridge that inserts into a handheldanalyzer, it automatically fills itself from a single drop of blood or saliva.Once filled, no other fluid movement is required. The entire assay processwithin the cartridge is executed by controlled movement of the magneticnanoparticles within the cartridge using external magnetic fields.The cartridge, constructed entirely from plastic components, has no movingparts or embedded electronics, and is disposable. The analyzer unit containsthe electromagnets, optical detection system, control electronics, softwareand the read-out display.Magnotech processFigure 4.1 Magnotech processCoated with appropriate ligand molecules, the magnetic nanoparticles bindto the target protein molecules in the sample blood or saliva.The target molecules end up locked between the active surface (bindingmagnet [1]) and attached nanoparticles.A second magnetic field is then generated (washing magnet [2]) to pullunbound magnetic nanoparticles away from the active surface. A very fastand accurately controlled separation between bound and unbound magneticnanoparticles is thereby achieved.4.1 Theory of operation4-2 System overview Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Figure 4.2 Magnotech process - final phaseIn the final phase, the number of bound nanoparticles is measured using anoptical technique based on frustrated total internal reflection.Performance and limitationsPerformance characteristicsPhilips minicare analyzerThe analyzer can perform 10 typical tests on a partial battery charge.The analyzer goes into sleep mode after 20 minutes of inactivity if it is not in the minicaredocking station.The analyzer takes 10 seconds to resume from sleep mode and be ready for testing.The analyzer goes into deep sleep mode when it has been in sleep mode for 5 hours and isnot in the minicare docking station.The analyzer takes 40 seconds to resume from deep sleep mode and be ready for testing.The analyzer is designed to perform correctly at an ambient temperature between 2° Cand 27° C, at a relative humidity between 20% and 80%.The analyzer measurement stability is ≤ 0.03% over a period of 8 minutes, starting afterthe sample has filled the chambers.The analyzer is ready to perform a test 30 seconds after the previous test.4.24.2.1Performance and limitations 4.2Philips minicare analyzer Release 1.0 System overview 4-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Limitations of useDepending on the application (duration and strength of measurement) andthe conditions (ambient temperature), the number of measurements in arow is limited.In case a limitation is needed, the system will detect this and will give a warning.Refer to the Instructions for Use of the specific application cartridges forfurther limitations.[NOTE TO REVIEWERS — the information above taken from defectsheet responses after review 1. No further information at this time. Moreinformation about limitations of use to be provided during the verificationphase and further reviews.]Preparation prior to useFirst, ensure that the minicare analyzer docking station is properlyconnected to the mains supply.Prior to use, you must charge the minicare analyzer battery to ensure thatthe minicare analyzer can function correctly when it is not docked in theminicare docking station. A partial battery charge takes one hour; a fullbattery charge takes 12 hours. For instructions on docking the minicareanalyzer to charge the battery, see section “Docking the minicare analyzer”on page 4-5.The system is capable of performing at least one test after one hour ofbattery charging, but it is preferable to fully charge the battery before use.Installing the data manager softwareThe system requires an available PC for data manager software installation.Installation from CDInsert the installation CD in the drive on the host PC. Follow the on-screeninstructions as the CD guides you through the installation process.4.2.24.34.44.3 Preparation prior to use4-4 System overview Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Installation from fileDouble-click the “setup.exe” installation file on the host PC. Follow the on-screen instructions as the program guides you through the installation process.Docking and undocking the minicare analyzerDocking the minicare analyzerTo establish data transfer between the minicare analyzer and data managersoftware, as well as to charge the analyzer battery, the minicare analyzermust be docked in the minicare docking station. Follow the procedurebelow to dock the minicare analyzer.•To dock the minicare analyzer, put the analyzer in the minicare dockingstation so that the docking station connectors are engaged.Figure 4.3 Docked minicare analyzerSee section “Equipment connections” on page 3-2 for details of the connectors.The minicare analyzer screen displays the confirmation messages “AnalyzerDocked” and “Connected”.4.54.5.1Docking and undocking the minicare analyzer 4.5Philips minicare analyzer Release 1.0 System overview 4-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Data automatically transfers between the minicare analyzer and the datamanager software as indicated on the minicare analyzer screen. Do notdisconnect the minicare analyzer from the minicare docking station duringdata transfer.The docking station has the following status indicators.Status light StatusDocked/UndockedstatusWhite•The minicare analyzer is correctly docked.Red•The minicare analyzer is not correctly docked.•Please try docking the analyzer again.Mains connection status White•The docking station is connected to the mainsupply.•The docking station automatically charges theminicare analyzer battery when the analyzer isdocked.Data automatically transfers between the minicare analyzer and the datamanager software as indicated on the minicare analyzer screen. Do notdisconnect the minicare analyzer from the minicare docking station duringdata transfer.Undocking the minicare analyzer•Lift the minicare analyzer out of the minicare docking station.When the minicare analyzer is undocked, it:•does not receive data from the data manager software.•does not transfer data to the data manager software.•performs a self test.4.5.2NOTE4.5 Docking and undocking the minicare analyzer4-6 System overview Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Configuring analyzer connectivityConditions:•You must have information from your network administrator aboutwhether the IP address used for the analyzer is a static address or assigneddynamically by a DHCP server.• You must have Administrator rights for the minicare analyzer and datamanager software.• The minicare analyzer displays “Analyzer docked”.You must configure analyzer connectivity before you can transfer data toand from the data manager software. You must perform configuration taskson both the minicare analyzer and the data manager software.Configuring the minicare analyzer with a static IP addressThis is the proceudre to follow on the minicare analyzer if you are assigninga static IP address.1On the minicare analyzer screen, press Menu.2If required, log on to the system.3Press Network settings.4Press Change.5To clear the warning screen, press OK.6To enter the static IP address details,• Select Static.• Press Next.• Enter the IP address, using the displayed numeric pad, and thenpress Next.• Enter the Subnet mask, using the displayed numeric pad, and thenpress Next.• Enter the default gateway, using the displayed numeric pad, and thenpress Next.4.64.6.1Configuring analyzer connectivity 4.6Philips minicare analyzer Release 1.0 System overview 4-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 7On the restart screen, press Yes.The minicare analyzer restarts.You can now proceed to the configuration procedure for the data managersoftware, to complete the configuration.Configuring the minicare analyzer with a DHCP serverThis is the procedure to follow on the minicare analyzer if your networkuses a DHCP server.1On the minicare analyzer screen, press Menu.2If required, log on to the system.3Press Network settings.4Press Change.5To clear the warning screen, press OK.6Select DHCP.7Press Next.8On the restart screen, press Yes.The minicare analyzer restarts.9Press Menu.10 Press Network settings.11 Write down the IP address.You can now proceed to the configuration procedure for the data managersoftware, to complete the configuration.4.6.24.6 Configuring analyzer connectivity4-8 System overview Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Configuring the minicare analyzer on the data manager softwareAfter you have changed the configuration settings on the minicare analyzer,you must ensure that the data manager software has the correct IP addressfor the minicare analyzer.1Start the data manager software, and log on as an administrator.2From the System menu, select Host configuration.3Enter the minicare analyzer IP address in the Analyzer address text box.4Press OK.The minicare analyzer is now configured to exchange data with the datamanager software.Configuring LIS connectivityLIS connectivity is a complex task. Contact your local sales organization if yourequire further information.4.6.34.7NOTEConfiguring LIS connectivity 4.7Philips minicare analyzer Release 1.0 System overview 4-9Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 The data manager software contains an LIS Configuration screen that canbe used to specify a limited number of options. You can access the LISConfiguration screen from the data manager software, byselecting LIS configuration from the System menu.Figure 4.4 LIS Configuration screenLIS enabledSelect this check box to enable communication between the data managersoftware and the LIS.Server addressThe host name, IPv4 or IPv6 address of the LIS server.Port numberThe TCP port to which the LIS server should connect.IHE/HL7 MSH parametersThese values correspond to parameters of the same name (message header)in the IHE/HL7 MSH segment.•Sending application•Sending facility[1] [2] [3] [4] 4.7 Configuring LIS connectivity4-10 System overview Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 •Receiving application•Receiving facilityAssigning authorityUsed in the Patient ID field of the IHE/HL7 PID (patient identification)segment.SecureSelect this check box to enable node authentication, which means that thedata manager software and the LIS verify that they are communicating tothe correct machine.When this box is not selected, no node authentication takes place and datais transferred unencrypted, making it possible to intercept all sent data.CertificateNode authentication uses certificates to verify the identity of computers.These certificates need to be installed on the PC, but the data managersoftware needs to be told which certificate to send to the LIS when asked forit.Encrypt data transferBesides node authentication, data transfer can be made more secure byencrypting, which happens when this box is checked. When it is notchecked, communication will happen unencrypted.Data mapperThe data manager software uses the Symphonia library in itsimplementation and as such leaves the possibility to map messages to andfrom the LIS to any desired format, using a message mapping configuration.LocationThe path to the Symphonia message mapping configuration. Theconfiguration file must be created with Orion Health’s Map Designer tool.Automatic transfer to LISWhen this check box is selected, any incoming analysis result that is receivedfrom an analyzer, is automatically transferred to the LIS on the conditionthat the result is complete, in other words, that there is no missing data thatmust be filled in by an operator of the data manager software[5] [6] [7] [8] [9] [10] [11] Configuring LIS connectivity 4.7Philips minicare analyzer Release 1.0 System overview 4-11Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 LIS identifier mappingThis button opens a dialog box that enables editing of the cartridge andtarget IDs of any installed cartridge file. These parameters manipulate theUniversal Service Identifier field in the IHE/HL7 OBR (ObservationOrder) segment and the Observation Identifier in the IHE/HL7 OBX(Observation Result) segment for cartridge and target results.Configuring analyzer settingsConditions:•The minicare analyzer must be connected to the data manager software.• You must have administrator privileges for the data manager software.The minicare analyzer configuration settings show the analyzer currentlyconnected, control the language used, how the user and patientidentification process is handled, and treatment of results. The screen alsoshows hardware and software information about the analyzer. For furtherdetails, see section “Configuring the minicare analyzer” on page 12-4Figure 4.5 Analyzer Configuration screen[12] 4.84.8 Configuring analyzer settings4-12 System overview Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Operation - minicare analyzerminicare analyzer overviewMain screenThe main screen of the minicare analyzer displays the following items.Figure 5.1 Main screen of the minicare analyzerLegend1 Date and time 3 Battery charge level2 Current user 4 Main display area55.15.1.1Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Blood analysis workflowDepending on your needs and available resources, you can perform testsusing the minicare analyzer in several different ways. The information belowdescribes the most common workflow.Workflow step Analyzer user interface1 Identify the patient by scanning a barcode.See section “Identifying the patient bybarcode scanning” on page 5-10 fordetails.You can also choose a patient from a listof analysis orders that have beentransferred from the data managersoftware. See section “Identifying thepatient from a list” on page 5-11 for details2 Insert the cartridge.3 The analyzer validates the cartridge.5.1.25.1 minicare analyzer overview5-2 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Workflow step Analyzer user interface4Add the sample and close the analyzer cap.5 Wait for analysis.6 View the result.Starting up and shutting downStarting the minicare analyzerSafety awareness: do not start up the product unless you and all other users presenthave read, fully understood and know all the safety information and emergencyprocedures given in the SAFETY section of this Instructions for Use. Operation of the5.25.2.1WARNINGStarting up and shutting down 5.2Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 product without having read, understood and knowing ALL the safety information andprocedures in the SAFETY section could lead to fatal or other serious personal injury.It could also lead to clinical misdiagnosis.1Press the Power button located on the side of the minicare analyzer shownin the figure below.Figure 5.2 Power button2The minicare analyzer starts and performs a self-test to ensure correctoperation.Details of the self-test are displayed on the minicare analyzer screen. Duringthe test, the system performs a sound check. You should hear an audible tone.Watch the minicare analyzer screen carefully during startup to ensure that allelements on the screen display properly.NOTE5.2 Starting up and shutting down5-4 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Figure 5.3 minicare analyzer self-test screen3Wait for the minicare analyzer to finish the self-test before continuing tooperate it.The analyzer screen indicates when the self-test is finished.The minicare analyzer performs a self-test each time that you:•Start up the analyzer after it has been shut down (turned off).•Undock the analyzer.•Restart the analyzer after it has entered “sleep” or “deep sleep” mode to conservebattery power during periods of inactivity.NOTEStarting up and shutting down 5.2Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Shutting down the minicare analyzerThe minicare analyzer can be shut down (powered off) or put into standbymode using the Power button.The minicare analyzer cannot be shut down during certain workflow steps. [Projectteam to provide details after Review 2 - not available at time of writing]1To shut down the minicare analyzer, press the Power button for a longduration (several seconds).2To put the minicare analyzer into standby mode, press the Power buttonfor a short duration.Identifying the userLogging onIf your minicare analyzer is configured to require user logon, the Log onscreen appears after starting the system.1There are two different ways you log on and begin using the analyzer:•To identify yourself by scanning your personal identification barcode,press Scan.• To identify yourself by entering your user PIN, press Manual.5.2.2NOTE5.35.3.15.3 Identifying the user5-6 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Figure 5.4 User log on screenIf you select Scan, the minicare analyzer displays “Scan Barcode.”If you select Manual, the analyzer displays “User log on” with a numerickeypad.2Log in with your personal identification barcode or your user PIN,depending on your selection in step 1.• Scan your personal identification barcode with the barcode reader locatedon the front of the minicare analyzer, OR• Enter your user PIN using the numeric keypad on the minicare analyzerscreen and press OK.Identifying the user 5.3Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Figure 5.5 Log on with your user PINThe system displays your user information on the screen after you havesuccessfully logged on.Figure 5.6 User identification on analyzer5.3 Identifying the user5-8 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Logging outWhen you are logged on and finish using the minicare analyzer, follow theinstructions below to logout:1From the minicare analyzer home screen, press Menu.2Press LogoutThe analyzer screen displays “Are you sure you want to Logout?”3Press Yes.The “User log on” screen appears.Starting analysisConditions•The minicare analyzer is docked. The analyzer screen displays “Analyzerdocked”.The minicare analyzer may remain in docked position on the dockingstation during an analysis, but it must be disconnected from the datamanager software to perform a test. Follow the steps below to terminate theconnection between the minicare analyzer and data manager software for adocked analysis.1Press Start to terminate the connection between the docked minicareanalyzer and the data manager software.2Press Yes to disconnect from the data manager software.The “Identify patient” screen is displayed. See section “Identifying thepatient” on page 5-10.5.3.25.4Starting analysis 5.4Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-9Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Identifying the patientYou can identify the patient before testing by either barcode scanning or bylocating patient data in a list that has been loaded by the data managersoftware. If necessary, you can also perform an anonymous test and enterpatient data later using the data manager software or using the HIS/LIS.You can cancel a test at any time by pressing Abort on the minicare analyzer screen.By confirming cancellation, the minicare analyzer settings will be reset to Identifyingthe patient. If Abort is not on the minicare analyzer screen, you can cancel the test byremoving the cartridge.Identifying the patient by barcode scanningConditions•The analyzer screen displays “Identify Patient” and the patient has apatient identification barcode available for scanning.Figure 5.7 Identify Patient screen5.5NOTE5.5.15.5 Identifying the patient5-10 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 1Press Scan.The minicare analyzer displays “Scan Barcode”.2Scan the patient barcode using the scanner on the front of the minicareanalyzer.The minicare analyzer displays the patient ID at the top of the “Ready foruse” screen.Identifying the patient from a listConditions•The minicare analyzer screen displays the “Identify Patient” and relevantpatient data has been transferred to the minicare analyzer from the datamanager software. See section “Transferring an analysis order to theminicare analyzer” on page 6-15.1Press Manual on the “Identify Patient” screen.The “Select Patient” screen appears.Figure 5.8 Select Patient screen5.5.2Identifying the patient 5.5Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-11Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2Touch the correct patient name on the list.The selected patient name is highlighted.3Press OK.The minicare analyzer displays the patient ID and name at the top of the“Ready for use” screen.If you selected the incorrect patient, press Abort and confirm your decisionby pressing Yes on the “Abort Analysis” screen to return to the “IdentifyPatient” screen.Performing an anonymous testConditions•The minicare analyzer screen displays “Identify Patient”.• No patient barcode is available for scanning, and the patient data has notbeen transferred to the minicare analyzer from the data manager software.1Press Manual.The “Select Patient” screen appears.2Touch <New patient>.3Press OK.The minicare analyzer displays “Anonymous” as the patient name on the“Ready for use” screen. The Patient ID field is left blank.5.5.35.5 Identifying the patient5-12 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Inserting a cartridgeConditions•The minicare analyzer displays the message “Ready for Use” and “InsertCartridge.”Read the assay Instructions for Use supplied with the cartridge for adding a bloodsample to the cartridge. Each assay type has specific procedures that you must followwhen collecting and handling blood samples.1Open the cartridge chamber cap on the minicare analyzer.Figure 5.9 Opening the minicare analyzer cap5.6NOTEInserting a cartridge 5.6Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-13Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2Insert the cartridge in the cartridge chamber as shown in the figure below.Always be sure to insert the correct cartridge for the intended test.Figure 5.10 Inserting a cartridgeThe minicare analyzer automatically validates the cartridge, using theinformation stored in the RFID tag.If the cartridge is validated, the minicare analyzer displays “Cartridge ready”and “Add blood sample”.Adding a blood sample and performing a testConditions• The cartridge has been inserted in and validated by the minicare analyzer.The minicare analyzer displays “Cartridge ready” and “Add blood sample.”Read the assay Instructions for Use supplied with the cartridge for adding a bloodsample to the cartridge. Each assay type has specific procedures that you must followwhen collecting and handling blood samples.NOTE5.7NOTE5.7 Adding a blood sample and performing a test5-14 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 The minicare analyzer can be either docked or undocked for this procedure.1Add the blood sample to the cartridge as specified in the assay instructions.Figure 5.11 Cartridge underfilled (left), overfilled (middle), and correctly filled (right)The blood sample must be added to the cartridge and read by the minicareanalyzer within the time limit for the assay, otherwise the system times outand the cartridge is no longer valid.2Close the cartridge chamber cap as soon as the blood sample is added.The analyzer will show instructions for closing the analyzer cap andcartridge lidIf the minicare analyzer cannot read the blood sample after a short period,the system times out and the cartridge is no longer valid.The cartridge registers the blood sample. There is a short waiting periodduring analysis.3When the cartridge registers the blood sample, the minicare analyzerautomatically begins blood analysis.The minicare analyzer displays “Analyzing” and the remaining time neededfor analysis.4The minicare analyzer completes the test and displays the analysis results.5Press Continue if you want to perform additional tests for the same analysis,or press Finish if you do not want to perform additional tests.Adding a blood sample and performing a test 5.7Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-15Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Removing a cartridgeConditions•The minicare analyzer displays “Remove cartridge” .1Open the cartridge chamber cap on the minicare analyzer.2Pull the cartridge out of the minicare analyzer.3Dispose of the cartridge immediately as described in the assay Instructionsfor Use supplied with the cartridge.4Close the minicare analyzer cap.Close the cap after each use to prevent dust and other foreign particles andsubstances from entering the cartridge chamber on the minicare analyzer.Performing multiple testsConditions• The Continue button has been pressed after a previous test.• Certain assays require multiple tests before completing the entire analysis.1Follow the procedures described in the previous sections for inserting acartridge (section “Inserting a cartridge” on page 5-13), performing analysis(section “Adding a blood sample and performing a test” on page 5-14), andremoving a cartridge (section “Removing a cartridge” on page 5-16).2Press Continue to perform additional tests.3Press Finish to complete all tests in the analysis.Finishing a test or analysisConditions• You have finished a test or multiple tests in an analysis.• The minicare analyzer displays test results.5.8CAUTION5.95.105.8 Removing a cartridge5-16 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 1Press Finish.The minicare analyzer displays a confirmation message.2Press Accept to accept the results and finish the analysis. The minicareanalyzer automatically transfers the results to the data manager software.Press Reject to reject the entire analysis.Press Cancel to return to the previous screen and continue with the currentanalysis (run additional tests).The minicare analyzer displays “Remove cartridge.”3Remove the cartridge. See section “Removing a cartridge” on page 5-16.If the minicare analyzer is currently docked and connected, it automaticallytransfers the results to the data manager software. If the minicare analyzer isnot currently docked and connected, the results will transfer automaticallythe next time it is docked and connected.Finishing a test or analysis 5.10Philips minicare analyzer Release 1.0 Operation - minicare analyzer 5-17Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 5.10 Finishing a test or analysis5-18 Operation - minicare analyzer Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Operation - minicare data managerThe data manager software connects to your minicare analyzer through theminicare docking station. It enables you to load patient data, transfer thepatient data to the minicare analyzer, transfer test results from the minicareanalyzer to the software, and then transfer analysis results to the hospitalLIS. The data manager software also provides areas for you to configureyour minicare analyzer and manage user accounts.SecurityThe data manager software provides the facility for user names andpasswords to protect patient data from unauthorized access. The system alsoautomatically logs the user off after a period of inactivity.For further details contact your Hospital Administrator.Starting and stopping the data manager softwareStarting the data manager software1Click the Windows Start menu.2Select Programs.3Select Philips Magnotech Host Software.4Click Philips Magnotech Host Software.The Philips Magnotech Host Software logon screen appears.Logging onIt is recommended that each user of the system is identifiable via a uniqueuser name, and that each user name is protected with a password knownonly to the user. User names and passwords are usually created by yourPoint of Care Coordinator or Hospital Administrator whenever a new username is required.66.16.1.16.1.2Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Figure 6.1 The Data Manager Software Logon panel1Type your user name in the User Name field.2Type your password in the Password field.3Click OK.The system opens to the Analysis orders tab.Logging offFigure 6.2 Log off button•Click Log off.Your work is saved and the Logon screen is displayed for the next user.An automatic logoff feature terminates the current user session after 15 minutes ofinactivity.6.1.3NOTE6.1 Starting and stopping the data manager software6-2 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Exiting the data manager softwareFollow the steps below to close the data manager software applicationcompletely.Figure 6.3 Exiting the data manager software1Click System2Click Exit.The entire data manager software application closes.System overviewThe data manager software provides an environment for creating analysisorders, transferring analyses, and managing patient analyses. There are twomain areas for managing patient data. In addition, there is an area tomanage Quality Control (QC) test results from the analyzer.For details on configuring data manager software settings, see section“Configuring the data manager software” on page 12-2.6.1.46.2System overview 6.2Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Analysis ordersThe Analysis orders tab displays the list of active patient orders for analysis.Figure 6.4 Analysis orders tabUse this area to:• Enter and edit patient data.• Create new orders for analysis.• Transfer orders to the minicare analyzer.6.2 System overview6-4 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Analysis resultsThe Analysis results tab displays the results of patient analyses.Figure 6.5 Analysis results tabUse this area to:• View analysis results.• Transfer analyses to the LIS.• Edit, delete, and print analysis results.System overview 6.2Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 QC results tabThe QC results tab displays the results of Quality Control (QC) tests.Figure 6.6 QC results tabUse this area to:• View QC test results.• Edit, delete and export QC test results.6.2 System overview6-6 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Common elementsThe following controls are available in all activities.Figure 6.7 Data manager software common elementsLegend1 Navigation tabs 2 System menu3 Help menu 4 Patient List5 Details area 6 Analyzer information7 Analyzer connection 8 User Identification9Log off button Navigation tabsThe navigation tabs allow you to switch between the two main screens. Thenavigation tabs are described in more detail later in this Instructions for Use.See section “Analysis orders” on page 6-11 and section “Analysis results”on page 6-16 and .6.2.1System overview 6.2Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 System menuYou can use the system menu to change your password or exit the system.For additional system menu options for Hospital Administrators, see section“Additional host software options for Administrators” on page 12-1.Changing your passwordYour first password will be configured by your Hospital Administrator. It isadvised that you change your password initially and at regular intervals asrecommended by your institution’s security guidelines.1Click System.2Select and click Change password.The Change Password dialog appears.3Type your old password in the Old password field.4Enter your new password in the New password field.5Reenter your new password in the Reenter password field.6Click OK to confirm your password change. If you do not want to changeyour password, click Cancel and your changes will not be saved.If you forget your user name or password, contact your Hospital Administrator. If theHospital Administrator cannot reset the user name or password, contact Service.NOTE6.2 System overview6-8 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Help menuThe help menu provides options for online assistance as well as systeminformation.HelpClicking Help opens this Instructions for Use, where you can search forguidance on functions and features.Online helpClicking Online Help opens the Philips web site, where you can search forinformation within the larger context of Philips.About Magnotech Host softwareClicking About Magnotech Host software displays a window containingthe following system information:•Version number• Build ID• Philips Electronics name and address• Copyright information and dateClick Close to exit the window and return to the main screen.Patient ListDepending on the selected tab, the Patient List displays either current ordersor analysis results. The Patient Lists are described in more detail later in thisInstructions for Use. See section “Patient List” on page 6-11 and section“Patient List” on page 6-16.Details areaThe Details area displays more information on the patient order selectedfrom the Patient List. The Details areas are described in more detail later inthis Instructions for Use. Seesection “Details area” on page 6-13 and section “Details area” on page6-18.System overview 6.2Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-9Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Analyzer areaThe Analyzer area provides information about the minicare analyzerconnected to the data manager software. It also displays a status bar duringdata transfer between the minicare analyzer and data manager software.The message “No analyzer connected” is displayed when there is nominicare analyzer connected to the data manager software via the minicaredocking station. When an analyzer is not connected, all options to transferorders to an analyzer are disabled until the connection is established.LIS connectionThe LIS connection area displays whether the data manager software isconnected to the LIS.The message “Not available” is displayed when there is no active LISconnection. When the LIS is not connected, all options to transfer results tothe LIS are disabled until the connection is established.6.2 System overview6-10 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 User informationThe User area displays the user name currently logged on. The User areaalso contains the Log off button.Analysis ordersThe Analysis orders screen provides an overview of patient orders awaitingor undergoing analysis.You use the Analysis orders screen to create a new order, transfer an orderto the minicare analyzer, view and edit order details, and delete orders.Patient ListThe Patient List shows patient orders waiting for analysis.Figure 6.8 Patient List entry attributes on the Analysis orders tabPatient IDThe unique number assigned to the patient upon admission.Patient nameThe patient’s name, in (lastname, firstname) format.CartridgeThe type of cartridge assigned to the particular test the patient requires.6.36.3.1[1] [2] [3] Analysis orders 6.3Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-11Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Order IDThe unique ID generated by the data manager software when the order wascreated.Order dateThe date the order was created.Transferred toThe minicare analyzer the order was transferred to. If the order has not beentransferred to an analyzer, the field remains blank.Patient List basic actionsTo Do thisSort the Patient List on an attribute inascending orderClick a Patient entry attributeSort the Patient List on an attribute indescending orderClick a Patient entry attributeChange the width of an attribute column Move the pointer over the split bar. Whenthe pointer becomes a doubleheadedarrow, drag the pointer to move the split bar.Reorder Patient List attributes Drag the attribute to a new position.Delete patient entry Select the patient entry and click Delete.You must confirm your action before it iscompleted. All series and associated objectscontained in the patient entry are deleted.[4] [5] [6] 6.3 Analysis orders6-12 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Details areaAnalysis orders Details areaThe Details area displays additional information on a specific order selectedfrom the Patient List.Figure 6.9 Analysis orders Details areaCartridgeThe type of cartridge assigned to the particular test the patient requires.Order IDThe unique ID generated by the data manager software when the order wascreated.Order dateThe date the order was created.RequesterThe user who created the order.Transferred toThe name of the minicare analyzer to which the order was transferred.Patient IDThe unique number assigned to the patient upon admission.Last nameThe patient’s last name.First nameThe patient’s first name.6.3.2[1] [2] [3] [4] [5] [6] [7] [8] Analysis orders 6.3Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-13Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Date of birthThe patient’s birth date.GenderThe patient’s sex (male or female).Creating a new analysis order1Click the Analysis orders tab.2Click the New order button.The New Order dialog box appears.3Enter the patient information for each field in the New Order dialog box.Fields marked with an asterisk (*) are mandatory.Figure 6.10 New Order dialog box4When all fields are complete, do one of the following:• Click Save to save the new order in the data manager software withouttransferring it to the minicare analyzer immediately.• Click Save and transfer to transfer the order to the minicare analyzerimmediately. This option is only available when an analyzer is connected.• Click Cancel to cancel the order. The information is deleted.[9] [10] 6.3.36.3 Analysis orders6-14 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 The new order appears in the Analysis orders Patient List.Transferring an analysis order to the minicare analyzerConditions•An analyzer is connected.• The analysis order saved in the Analysis orders Patient List has notalready been transferred.If the order has not yet been created, see section “Creating a new analysisorder” on page 6-14.• Click the Transfer button next to the patient order in the Analysis ordersPatient List.The order transfers to the minicare analyzer and the status changes to theminicare analyzer name. You can now select the patient for analysis from thePatient List on the minicare analyzer.Deleting an analysis orderConditions• An analysis order is saved in the Analysis orders Patient List.1Click the Delete button.2A confirmation dialog appears. Click OK to complete the deletionor Cancel to keep the order in the Analysis orders Patient List.If the analysis order has already been transferred to the minicare analyzer, adialog appears advising that deleting the order from the data managersoftware will not delete the order from the minicare analyzer, even if theminicare analyzer is connected.6.3.46.3.5Analysis orders 6.3Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-15Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Analysis resultsThe Analysis results screen provides an overview of patient analyses thathave been transferred from the minicare analyzer.You use the Analysis results screen to view analysis results, transfer analysisresults to the LIS, as well as edit, print, and delete results.Patient ListThe Patient List shows results of patient analysis before being transferred tothe LIS.Figure 6.11 Patient List entry attributes on the Analysis results tabPatient IDThe unique number assigned to the patient upon admission.Patient nameThe patient’s name, in (lastname, firstname) format.CartridgeThe type of cartridge assigned to the particular test the patient requires.Order IDThe unique ID generated by the data manager software when the order wascreated.6.46.4.1[1] [2] [3] [4] 6.4 Analysis results6-16 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Analysis dateThe date the analysis was completed on the minicare analyzer.StatusInformation whether the analysis is complete, incomplete, or rejected.AnalyzerThe name of the minicare analyzer on which the test was performed andregistered.Patient List basic actionsTo Do thisSort the Patient List on an attribute inascending orderClick a Patient entry attributeSort the Patient List on an attribute indescending orderClick a Patient entry attributeChange the width of an attribute column Move the pointer over the split bar. Whenthe pointer becomes a doubleheadedarrow, drag the pointer to move the split bar.Reorder Patient List attributes Drag the attribute to a new position.Delete patient entry Select the patient entry and click Delete.You must confirm your action before it iscompleted. All series and associated objectscontained in the patient entry are deleted.Filter the results list Click the Show field and choose the filtermethod that you want to use.[5] [6] [7] Analysis results 6.4Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-17Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Details areaAnalysis results Details areaThe Details area displays additional information on a specific patient resultselected from the Patient List.Figure 6.12 Analysis results Details areaCartridgeThe type of cartridge assigned to the particular test the patient requires.Order IDThe unique ID generated by the data manager software when the order wascreated.Order dateThe date the order was created.RequesterThe user who created the order.Analysis dateThe date the analysis was completed on the minicare analyzer.OperatorThe name of the current operator.Patient IDThe unique number assigned to the patient upon admission.Last nameThe patient’s last name.First nameThe patient’s first name.6.4.2[1] [2] [3] [4] [5] [6] [7] [8] [9] 6.4 Analysis results6-18 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Date of birthThe patient’s birth date.GenderThe patient’s sex (male/female).RemarksShows any remarks entered for the patient using the Edit function.ResultsClick the Details button for analysis results, including the time of each testin the analysis as well as the result of each test.Transferring analysis results from the minicare analyzer•Dock the minicare analyzer on the minicare docking station.Any completed test results that have not already transferred to the minicareanalyzer transfer automatically. The transfer progress appears in the Analyzerarea on the data manager software.When the transfer is complete, all new results appear in the Analysis resultsPatient List. The patient data is automatically deleted from the minicareanalyzer after it is transferred to the data manager software.[10] [11] [12] [13] 6.4.3Analysis results 6.4Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-19Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Editing analysis results1Click on a patient row in the Analysis results Patient List.The selected result is highlighted.2Click the Edit buttonThe Edit Result dialog appears.Figure 6.13 Edit Result dialog3Edit any of the patient information or add comments in the Remarks area.4Click Save to save your changes.If you click Cancel, your changes will not be saved.6.4.46.4 Analysis results6-20 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Printing analysis resultsCondition: a printer is configured for your workstation.1Click on a patient row in the Analysis results Patient List.The selected result is highlighted.2Click the Print buttonThe Windows Print dialog appears.3Select the printer from the list and click Print.6.4.5Analysis results 6.4Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-21Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Transferring analysis results to the LISYou can transfer results to a LIS using the Transfer button.Condition: LIS connectivity must be enabled.Figure 6.14 Transfer button on the Analysis results tab• On the Analysis results tab, press the Transfer button next to the result thatyou want to transfer.6.4.66.4 Analysis results6-22 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 QC resultsThe QC results screen provides an overview of QC tests that have beentransferred from the minicare analyzer.You use the QC results screen to view QC test analysis results, exportanalysis results, as well as edit remarks and delete results.QC results listThe QC results list shows results of QC tests before being exported or deleted.Figure 6.15 QC results entry attributes on the QC results tabReagent IDThe number assigned to the reagent.CartridgeThe type of cartridge assigned to the particular test.Order IDThe unique ID generated by the data manager software when the order wascreated.Analysis dateThe date the QC test analysis was completed on the minicare analyzer.6.56.5.1[1] [2] [3] [4] QC results 6.5Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-23Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 AnalyzerThe name of the minicare analyzer on which the test was performed andregistered.QC results list basic actionsTo Do thisSort the QC results list on an attribute inascending orderClick QC entry attributeSort the QC results list on an attribute indescending orderClick a QC entry attributeChange the width of an attribute column Move the pointer over the split bar. Whenthe pointer becomes a doubleheadedarrow, drag the pointer to move the split bar.Reorder QC results list attributes Drag the attribute to a new position.Delete QC test entry Select the QC result entry and click Delete.You must confirm your action before it iscompleted. All series and associated objectscontained in the entry are deleted.Filter the results list Click the Show field and choose the filtermethod that you want to use.Additional QC results optionsDetails areaThe Details area shows any remarks that have been written when youhighlight a specific QC result selected from the list.Transferring results from the minicare analyzerDock the minicare analyzer on the minicare docking station as you wouldwhen transferring analysis results. See section “Transferring analysis resultsfrom the minicare analyzer” on page 6-19.Any completed QC test results that have not already transferred to theminicare analyzer transfer automatically. The transfer progress appears inthe Analyzer area on the data manager software.When the transfer is complete, all new results appear in the QC test resultslist.[5] 6.5.26.5 QC results6-24 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Editing QC results remarksClick the Edit Remarks button below the results list. Click Save to saveyour changes and return to the patient list.Exporting QC resultsClick the Export button. You can then select where you would like to saveyour results in Microsoft Excel format.QC results 6.5Philips minicare analyzer Release 1.0 Operation - minicare data manager 6-25Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 6.5 QC results6-26 Operation - minicare data manager Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 System messages and troubleshootingSystem and error messagesPhilips minicare analyzerMessage number Category Description Action1000 Analyzer Failure Measuring unit power off failed. Please try again. If the problem persistscontact your local representative.1001 Analyzer Failure Measuring unit power on failed with code'{0}'.Please try again. If the problem persistscontact your local representative.1100 Analyzer Failure Failure during cartridge detection. Please try again. If the problem persistscontact your local representative.1101 Cartridge Failure Cartridge expired on '{0}'. Please use another cartridge1102 Workflow Failure Cartridge has been used before. Please use another cartridge.1103 Workflow Failure Cartridge '{0}' is not supported by analyzer. Install the cartridge using host software oruse a supported cartridge type.1104 Workflow Failure The selected patient requires cartridge '{0}'.Inserted cartridge is '{1}'.Use cartridge '{0}'.1105 Workflow Failure Cartridge was removed during analysis. Theanalysis has been aborted.Please try again.1106 Cartridge Failure Cartridge is invalid. Use another cartridge.1107 Analyzer Failure Access to protocol for cartridge '{0}' failed. Please try again. If the problem persistscontact your local representative.1108 Cartridge Failure Cartridge is invalid. Use another cartridge.1109 Analyzer Failure Cartridge configuration is invalid. Please contact your local representative.1110 Power Failure Battery level too low for cartridgemeasurement. The analyzer has stoppedoperation.Please charge the analyzer and then retrythe cartridge measurement.1200 Analyzer Failure RFID hardware failed. Please try again. If the problem persistscontact your local representative.1201 Cartridge Failure Invalid RFID format. Use another cartridge.1202 Cartridge Failure RFID version '{0}' is not supported. Use another cartridge.1203 Cartridge Failure Cartridge RFID could not be read. Remove cartridge and try again.77.17.1.1Philips minicare analyzer Release 1.0 System messages and troubleshooting 7-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Message number Category Description Action1300 Analyzer Failure Temperature hardware failed. Please try again. If the problem persistscontact your local representative.1302 Analyzer Failure Sample detection hardware failed. Please try again. If the problem persistscontact your local representative.1303 Workflow Failure Sample timeout. Please apply sample within '{0}' seconds andapply sufficient volume of sample.1304 Workflow Failure A sample was added before targettemperature was reached.Please add sample after analyzer reachestarget temperature.1305 Cartridge Failure Target temperature '{0}' out of analyzerrange.Cartridge '{1}' cannot be measured on thisanalyzer. Contact your local representative.1350 Analyzer Failure Frame capturing hardware failed. Please try again. If the problem persistscontact your local representative.1400 Update Failure Update of firmware failed. The analyzer hasstopped operation.Please reset the analyzer to retry thefirmware update.1401 Update Failure Update of firmware failed. The previousversion is running and the upgrade is aborted.Please retry the firmware update using thehost software.1402 Update Failure Battery level too low for firmware upgrade.The analyzer has stopped operation.Please charge the analyzer and then retrythe firmware update.1410 Analyzer Failure Self test failed with code '{0}'. The analyzerwill not allow to perform an analysis.Try to reset the analyzer. If the problempersists contact your local representative.1500 Analyzer Failure Result calculation failed. Contact your local representative.1600 Analyzer Failure Image of the cartridge is invalid. Please try another cartridge.1601 Cartridge Failure Sample did not reach the measurementchamber within the maximum '{0}' seconds.Please try another cartridge. Make suresufficient blood is applied.1602 Analyzer Failure Measurement hardware failed. Please try again. If the problem persistscontact your local representative.1603 Analyzer Failure Temperature was too low duringmeasurement.Please try another cartridge.1604 Analyzer Failure Temperature was too high duringmeasurement.Please try another cartridge.1605 Analyzer Failure Data processing has failed. Please try another cartridge.1606 Analyzer Failure Measurement failed. Please try again. If the problem persistscontact your local representative.1700 Workflow Failure Storage of new measurement results is full. Synchronize the analyzer with the Hostsoftware to free storage.7.1 System and error messages7-2 System messages and troubleshooting Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Message number Category Description Action1800 Analyzer Failure Cap hardware failed. Please try again. If the problem persistscontact your local representative.1801 Workflow Failure Cap not closed on time. Please try again. Make sure to close the capwhen prompted.1900 Analyzer Failure Power button hardware failed. Please try again. If the problem persistscontact your local representative.2000 Barcode Failure Unable to scan barcode. Please try again. If the problem persistscontact your local representative.2100 Analyzer Failure Battery hardware failed. Please try again. If the problem persistscontact your local representative.2200 Hardware failure Unable to detect docking station. Try to reset the analyzer. If the problempersists contact your local representative.9000 Critical Error Critical error '{0}' occurred. The analyzerhas stopped.Try to reset the analyzer. If the problempersists contact your local representative.9001 Critical Error Data access failed. The analyzer has stopped. Try to reset the analyzer. If the problempersists contact your local representative.Data manager softwareError messagesNumber Category Description ActionTBD Analyzer CartridgeNot CompatibleCartridge file '{0}' is not compatible withthe current analyzer.Contact the POC administrator to checkthe software version of the analyzer and toprovide compatible cartridge file.TBD AnalyzerCommunicationIncompatibilityAnalyzer and Magnotech Host Softwareincompatibility detected.Contact the POC Administrator to checkthe versions of the analyzer and MagnotechHost Software.TBD AnalyzerConnectionExceptionConnection with analyzer lost duringcommunication.Try docking the analyzer to reestablish theconnection.TBD Analyzer FirmwareFile Not FoundThe analyzer firmware update pack '{0}'could not be found.Contact the POC administrator to makesure the firmware update pack exists andsufficient permissions to access the file areavailable.7.1.2System and error messages 7.1Philips minicare analyzer Release 1.0 System messages and troubleshooting 7-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Number Category Description ActionTBD Analyzer General An unexpected problem with the analyzerhas occurred. The analyzer cannot performthe requested action.Try to reset the analyzer and/or theMagnotech Host Software. If the problempersists contact the POC administrator.TBD Analyzer LanguageFile Not FoundThe analyzer language pack '{0}' could notbe found.Contact the POC Administrator to makesure that the selected analyzer languagepack is installed in the Magnotech HostSoftware.TBD Analyzer Language InUseUnable to install this language on theanalyzer. This language is currently active.To update the active language, change theactive language to another language andback again.TBD Analyzer LanguageInvalid FileInvalid analyzer language pack '{0}'. Contact the POC Administrator to reinstallthe analyzer language pack.TBD Analyzer OrderAdding FailedFailed to transfer order '{0}' to the analyzer. Try to restart the analyzer and retransmitthe order. If the problem persists contactthe POC administrator.TBD Analyzer OrderCartridge NotSupportedOrder '{0}' cannot be transferred to theanalyzer due to missing cartridge '{1}' onthe analyzer.Contact the POC Administrator to addcartridge '{1}' to the analyzer. This can bedone in the Analyzer Configuration screen.TBD Analyzer ResultsReceiving FailedFailed to transfer result '{0}' from theanalyzer.Try to restart the analyzer. Docking theanalyzer automatically retries the resulttransmission. If the problem persistscontact the POC administrator.TBD Analyzer SettingsCannot Be SavedLoad settings failed because of the followingreason : {0}Save settings failed because of the followingreason : {0}TBD Analyzer Time DateSynchronizationFailedFailed to synchronize date and time withthe analyzer.Try to restart the analyzer. Docking theanalyzer automatically synchronizes the dateand time. If the problem persists contactthe POC administrator.TBD Analyzer Time ZoneSynchronizationFailedFailed to synchronize time zone with theanalyzer.Try to restart the analyzer. Docking theanalyzer automatically synchronizes thetime zone if needed. If the problem persistscontact the POC administrator.TBD Analyzer UsersSynchronizationFailedFailed to synchronize users list with theanalyzer.Try to restart the analyzer. Docking theanalyzer automatically synchronizes theusers list. If the problem persists contactthe POC administrator.TBD Cartridge AlreadyExists– No action is necessary.7.1 System and error messages7-4 System messages and troubleshooting Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Number Category Description ActionTBD Cartridge Already InUseCannot remove Cartridge '{0}'. Orders havebeen sent to an analyzer.First process the orders on the analyzer togenerate results or delete the orders fromthe analyzer, before removing the cartridge.TBD Cartridge Invalid The selected cartridge file '{0}' is not valid. Contact the POC Administrator to obtain avalid cartridge file.TBD Cartridge Not Found The analyzer cartridge '{0}' could not befound.Contact the POC administrator to makesure that the cartridge file still exists andsufficient permissions to access the file areavailable.TBD Cartridge NotInstalled In HSCartridge "{0}-{1}" is not installed on HS. TBD Cartridge XmlProblemCartridge '{0}' could not be transferred tothe analyzer, due to internal XML problem.Contact the POC administrator to inspectthe log files.TBD ConfigurationSetting Key DoesNot ExistFailed to read/write setting '{0}' from/to theconfiguration.Please contact the POC administrator. Thelog file contains further details. An uninstalland install of the Magnotech Host Softwarewill repair the configuration file.TBD ConfigurationSetting Save FailedSaving configuration setting '{0}' failed. Contact the POC administrator.TBD Database CartridgesProblemFailed to store or retrieve cartridgeinformation.Contact the POC administrator and inspectthe logs for further details.TBD Database OrdersProblemFailed to store or retrieve order information. Contact the POC administrator and inspectthe logs for further details.TBD Database ResultsProblemFailed to store or retrieve result information. Contact the POC administrator and inspectthe logs for further details.TBD Database SettingsProblemFailed to store or retrieve settinginformation.Contact the POC administrator and inspectthe logs for further details.TBD Database UsersProblemFailed to store or retrieve user information. Contact the POC administrator and inspectthe logs for further details.TBD General UnhandledAnalyzerUnexpected problem in backgroundcommunication with analyzer.Try restarting the computer. If the problempersists contact the POC Administrator.The log file contains further details.TBD General UnhandledApplicationAn unexpected problem occurred. TheMagnotech Host Software will now close.Try restarting the computer. Please contactthe POC administrator to inspect the logfiles for further analysis.System and error messages 7.1Philips minicare analyzer Release 1.0 System messages and troubleshooting 7-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Number Category Description ActionTBD General UnhandledLisUnexpected problem in backgroundcommunication with the LIS.Try restarting the computer. If the problempersists contact the POC Administrator.The log file contains further details.TBD Help File Not Found The help file cannot be opened. Contact the POC administrator to reinstallthe Magnotech Host Software installation.This will repair the help file.TBD Lis Ack Does NotMatchAn unexpected message from the LIS wasreceived. Message for order {0} receivedwhile waiting for a message for order {1}Contact the POC administrator to informsomething is wrong with the LIScommunication.TBD Lis Ack Time Out An acknowledge from the LIS was notreceived for analysis result '{0}'.Try to resend the result. If the problempersists, contact the POC administrator tocheck LIS availability.TBD Lis Certificate Invalid Invalid certificate '{0}' for secure LIScommunication.Contact the POC administrator to makesure the certificate is a valid X509 certificate.TBD LisConnectionAuthenticationA 'secure' connection with the LIS couldnot be established. The Magnotech HostSoftware will keep trying to connect.Contact the POC administrator to checkthe certificate in the LIS settings.TBD Lis Connection Connection with the LIS could not beestablished. The Magnotech Host Softwarewill keep trying to connect until the setamount of retries is reached.Contact the POC administrator to checkthe LIS settings.TBD Lis Could Not ParseLis MessageAn invalid message received from the LIS.The message is not a valid HL7 message.Contact the POC administrator to informsomething is wrong with the LIScommunication. The log file contain moredetails.TBD Lis Hl7 Conversion Result '{0}' could not be transferred to theLIS. An internal HL7 message parsing erroroccurred.Contact the POC administrator to inspectthe details in the log file.TBD Lis Hl7 MappingErrorFailed to tranfer result '{0}' to the LIS. Thedata mapper could not map the resultmessage.Contact the POC administrator to inspectthe logs for futher details.TBD Lis Invalid HL7Message ErrorInvalid HL7 message: {0} Contact the POC administrator.TBD Lis MapperConfiguration FileNot FoundThe data mapper configuration file '{0}'could not be found.Contact the POC administrator to makesure the data mapper configuration fileexists and sufficient permissions to accessthe file are available.7.1 System and error messages7-6 System messages and troubleshooting Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Number Category Description ActionTBD Lis MapperConfiguration InvalidInvalid data mapper configuration file '{0}'. Contact the POC administrator to makesure a valid OrionHealth Symphonia HL7mapper configuration file is selected.TBD Lis No SymphoniaLicenseNo valid Symphonia runtime license isavailableContact the POC administrator to install avalid Symphonia runtime license.TBD Lis No SymphoniaMapper LicenseNo valid Symphonia Mapper runtime licenseis availableContact the POC administrator to install avalid Symphonia Mapper runtime license.TBD Login Incorrect User name or password invalid. Please enter a valid combination of username and password.TBD Login User Blocked User '{0}' is blocked. Please contact an administrator to unblockyour account.TBD Order Xml Problem Order '{0}' could not be transferred to theanalyzer, due to internal XML problem.Contact the POC administrator to inspectthe log files.TBD Result Xml Problem Result '{0}' could not be transferred fromthe analyzer, due to internal XML problem.Contact the POC administrator to inspectthe log files.TBD Service Data TooLargeThe service data could not be retrieved,because it is too large.Retrieve the service data via the file systemof the analyzer (only possible when access isgranted).TBD Start UpConfiguration NotFoundThe Magnotech Host Softwareconfiguration is missing or broken. Theapplication will now close.Contact the POC administrator to reinstallthe software. The configuration will berepaired.TBD Start UpConfigurationSetting WrongVersionThe Magnotech Host Softwareconfiguration has an incompatible version.The application will now close. Currentversion = {0} Expected version = {1}Contact the POC administrator to reinstallthe software. The configuration will berepaired.TBD Start Up Error AppAlready RunningThe user interface is already running. Please use the user interface that is alreadyrunning.TBD Start Up Error BackEnd ConnectConnection to the Magnotech HostSoftware Service could not be made. Theuser interface will now close.Try restarting the computer. If the problempersists, please contact the POCadministrator.TBD Start Up Error NoDatabase AccessThe Magnotech Host Software Servicecould not initialize the database. The servicewill now close.Contact the POC administrator to makesure that the Windows service 'SQL Server(HIP)' is running or try restarting thecomputer. The log file may contain moredetailed information.TBD Start Up Error NoDatabase SpaceInsufficient database space. The MagnotechHost Software will now close.Contact the POC administrator to freedatabase space.System and error messages 7.1Philips minicare analyzer Release 1.0 System messages and troubleshooting 7-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Number Category Description ActionTBD Start Up Error NoDisk SpaceInsufficient disk space on drive '{0}'. Theminimum disk space level is '{1}' bytes. TheMagnotech Host Software will now close.Contact the POC administrator to free diskspace.TBD Start Up Error NoHost Languages Contact the POC administrator to reinstallthe Magnotech Host Software installation.TBD Start Up ErrorSecurity Keys MissingCould not retrieve security keys required tocommunicate with the analyzer. Thesoftware will now close.Contact the POC administrator.TBD Start Up ErrorWrong DatabaseSchemeIncompatible database version detected.Current version = {0} Expected version ={1} The Magnotech Host Software will nowclose.Contact the POC administrator.TBD Unhandled Exception The Magnotech Host Software userinterface caught an unexpected exceptionand will now shutdown.Contact the POC administrator to checkthe logs for details. Restart the computerand restart Magnotech Host Software.TBD User Xml Problem User '{0}' could not be transferred to orfrom the analyzer, due to internal XMLproblem.Contact the POC administrator to inspectthe log files.TBD Write To SelectedDirectory NotSuccessfulFailed to write to selected directory '{0}'.The directory does not exist or writing isnot permitted.Please select an existing directory withwrite access.TBD Xml Parse Exception Failed to load the views of the user interface. Contact the POC administrator. Acustomized 'Decimal symbol' and 'Digitgrouping symbol' for US English in theRegional Settings of the Control Panel is notsupported. Use a dot for the 'Decimalsymbol' and a comma for 'Digit groupingsymbol'. The user interface should now start.Warning messagesNumber Category Description ActionTBD Analyzer ExpectedRebootThe analyzer performed a reboot toeffectuate analyzer setting changes. Changesthat require a reboot are installation ofanalyzer languages, firmware updates andtime zone synchronization.It may take a few minutes for the analyzerto become available again. The analyzer willreconnect automatically.TBD Analyzer FirmwareInvalidThe firmware update pack '{0}' is invalid andcannot be used.Contact the POC administrator to obtain avalid firmware update pack.7.1 System and error messages7-8 System messages and troubleshooting Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Number Category Description ActionTBD Analyzer FirmwareUpgrade NotCompatibleThe firmware update pack '{0}' is notcompatible with the connected analyzer.Contact the POC administrator to checkthe compatibility of the firmware updatepack.TBD Analyzer FirmwareUpgrade NotPossibleIt is not safe to perform an analyzerfirmware update at this moment.Retry the firmware update when thebattery is not empty and the analyzer is notexecuting a measurement, booting orperforming a self test.TBD Analyzer LanguageInvalid LanguageThe selected language '{0}' is not a validlanguage code supported by the analyzer.Contact the POC administrator.TBD Analyzer LanguageNot CompatibleLanguage Pack '{0}' is not compatible withcurrent analyzer.Contact the POC administrator to providecompatible language packs for the analyzer.TBD Analyzer No ServiceDataNo service data is available on the analyzer. This is normal behavior when nomeasurements are performed.TBD Analyzer OrderAlready ExistsOrder '{0}' already exists on analyzer '{1}'. The order was already transferred to thisanalyzer.TBD Analyzer ResultAlready ExistsResult for order '{0}' already available. A result cannot be overwritten.TBD Analyzer Start Failed to communicate with the analyzer onaddress '{0}'.Contact the POC Administrator toconfigure the IP address in the HostConfiguration menu.TBD Language ChangedRestart NeededRestart the User Interface to make thelanguage change visible.Please restart the user interface.TBD Number Of UsersWith Access CodeZeroThe last user with an access code has beenremoved. If User Logon is enabled for youranalyzers, it will not be possible anymore tologon the analyzer.Add access codes to the users who need tooperate the analyzer or disable 'User logon'for the analyzer.TBD StartUp Warning NoCartridgesNo cartridges found. Creating orders is notpossible.Contact the POC administrator to installone or more cartridges in the MagnotechHost Software.TBD Start Up WarningNo Database SpaceDatabase space is low. Contact the POC administrator to freedatabase space.TBD Start Up WarningNo Disk SpaceLow disk space on drive '{0}'. Warning diskspace level is '{1}' bytes. The MagnotechHost Software will continue.Contact the POC administrator to free diskspace.TBD Warning Max IdleTime Incorrect ValueThe configuration contains an incorrectvalue for the automatic logoff function.Key='{0}'Contact the POC administrator. Use value0 to disable automatic logout or specify thenumber of seconds.System and error messages 7.1Philips minicare analyzer Release 1.0 System messages and troubleshooting 7-9Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Contacting ServiceWhen assistance is needed with your minicare analyzer, contact your localPhilips Electronics representative.7.27.2 Contacting Service7-10 System messages and troubleshooting Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 MaintenanceCleaning and disinfectionUse only the Philips-approved substances and methods listed in this chapterto clean or disinfect your equipment. Warranty does not cover damagecaused by using unapproved substances or methods. Philips makes no claimsregarding the efficacy of the listed chemicals or methods as a means forcontrolling infection. Consult your hospital’s Infection Control Officer orEpidemiologist.For comprehensive details on cleaning agents and their efficacy refer to“Guidelines for Prevention of Transmission of Human ImmunodeficiencyVirus and Hepatitis B Virus to Health Care and Public-Safety Workers”issued by the U.S. Department of Health and Human Services, PublicHealth Service, Centers for Disease Control, Atlanta, Georgia, February1989. See also any local policies that apply within your hospital, and country.General pointsKeep your minicare analyzer, docking station, associated cables, and anyaccessories free of dust and dirt. After cleaning and disinfection, check theequipment carefully. Do not use if you see signs of deterioration or damage.If you need to return any equipment to Philips, decontaminate it first.Observe the following general precautions:•Always dilute according to the manufacturer’s instructions or use lowestpossible concentration.•Do not allow liquid to enter the minicare analyzer or docking station case.• Do not immerse any part of the equipment or any accessories in liquid.• Do not pour liquid onto the system.• Never use abrasive material (such as steel wool or silver polish).• Never use bleach.88.1Philips minicare analyzer Release 1.0 Maintenance 8-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 SterilizationSterilization is not recommended for this analyzer, docking station, relatedproducts, accessories, or supplies unless otherwise indicated in theInstructions for Use that accompany the accessories and supplies.•If you spill liquid on the equipment, battery, or accessories, or they areaccidentally immersed in liquid, contact your service personnel or Philips serviceengineer. Do not operate the equipment before it has been tested and approvedfor further use.•Always isolate the product from the mains electrical supply before cleaning,disinfecting, or sterilizing to prevent electric shocks.•Strictly follow cleaning and disinfection guidelines to ensure that patient is notexposed to infections.•Cleaning and disinfection techniques for the product must comply with allapplicable local laws and regulations.Never allow water or other liquids to enter the product, since these may causeelectrical short-circuits or metal corrosion.Cleaning the minicare analyzerClean with a lint-free cloth, moistened with warm water (40°C/104°Fmaximum) and soap, a diluted non-caustic detergent, tenside, ammonia- oralcohol-based cleaning agent. Do not use strong solvents such as acetone ortrichloroethylene.Take extra care when cleaning the minicare analyzer screen because it ismore sensitive to rough cleaning methods than the housing.Do not permit any liquid to enter the analyzer housing case and avoidpouring it on the minicare analyzer while cleaning. Do not allow water orcleaning solution to enter the measurement connectors. Wipe around, notover, connector sockets.WARNINGSCAUTION8.1.18.1 Cleaning and disinfection8-2 Maintenance Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 The minicare analyzer/cartridge interface should only be cleaned by anapproved tool.To clean the touch-enabled display, disable the touch operation by switching off theanalyzer.Recommended cleaning agents•Tensides (dishwasher detergents) Edisonite Schnellreiniger®, Alconox®• Ammonias Dilution of Ammonia <3%, Window cleaner• Alcohol Ethanol 70%, Isopropanol 70%, Window cleanerDisinfecting the minicare analyzerThose parts of the minicare analyzer that are suitable for such treatment,including accessories and connecting cables, can be disinfected by wipingwith a cloth dampened with a suitable agent. Never use corrosive or solventdisinfectants or sterilizing agents. If you are not sure about the properties ofa disinfectant or sterilizing agent, do not use it.Hospital policyDisinfect the product as determined by your hospital’s policy, to avoid longterm damage to the product.Base approved agentsClean equipment before disinfecting. Recommended types of disinfectingagents are:• Alcohol Ethanol up to 70%• 1- and 2- Propanol up to 70%• Aldehyde Glutaraldehyde up to 3.6%CAUTION8.1.2Cleaning and disinfection 8.1Philips minicare analyzer Release 1.0 Maintenance 8-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Do not use flammable or potentially explosive disinfecting sprays. Such sprays createvapors, which can ignite, causing fatal or other serious personal injury.•Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gasesmay result.•Disinfecting a medical equipment room by means of sprays is not recommendedsince the vapor can penetrate the equipment causing electrical short-circuits orcorrosion.Cleaning the battery in the battery compartmentWipe with a lint-free cloth, moistened with warm water (40°C/104°Fmaximum) and soap. Do not use strong solvents.Do not soak the battery.Planned maintenance and user routine checksThis product requires proper operation, planned maintenance, and checksthe user must perform routinely, which are essential to keep the productoperating safely, effectively and reliably.Planned maintenance programPlanned maintenance may only be carried out by qualified and authorizedpersonnel, and is comprehensively described in the service documentation.Philips provides a full planned maintenance and repair service on both a callbasis and a contract basis. Full details are available from your Philips ServiceOrganization.A summary of the preventive maintenance program appears in the table below.Where the user carries out planned maintenance, he or she should alwaystake all practical steps to make sure that the Planned Maintenance Programis fully up to date before using the product with a patient.WARNINGCAUTIONS8.1.38.28.2.18.2 Planned maintenance and user routine checks8-4 Maintenance Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Preventive maintenance is to be performed on a regular basis.Check Actions Frequency[NOTE TO REVIEWERS: Project team to provide details after Review 2]User routine checks programThe user of the product must institute a User Routine Checks Program asdetailed in the table below. The user of the product shall make sure that allchecks and actions have been satisfactorily completed before using theproduct for its intended purposeCheck Actions Frequency[NOTE TO REVIEWERS: Project team to provide details after Review 2]Perform visual and/or audible checks during routine use.Quality controlYou can perform a Quality control (QC) test to ensure that the minicareanalyzer results are as accurate as possible. The test procedure is describedbelow.QC test results are transferred to the data manager when the minicareanalyzer is docked. For details of viewing and exporting stored QC testresults, see section “QC results” on page 6-23.8.2.2NOTE8.3Quality control 8.3Philips minicare analyzer Release 1.0 Maintenance 8-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 QC test workflowThe information below describes the QC test workflow.Workflow step Analyzer user interface1 Identify the reagent by either scanning or entering thereagent identification manually.2 Scan the barcode on the reagent sample label (orenter identification number manually).3 Insert the cartridge.4 The analyzer validates the cartridge.8.3.18.3 Quality control8-6 Maintenance Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Workflow step Analyzer user interface5 Insert test reagent sample.6 Close the analyzer cap.7 Wait for analysis.8 View result.Quality control 8.3Philips minicare analyzer Release 1.0 Maintenance 8-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Performing a QC testThe QC test is performed in a similar manner to the blood analysis test.1Log on to the analyzer by scanning your user ID barcode or entering your PIN.See section “Logging on” on page 5-6.2Press Menu from the “Identify Patient” screen.3Press Perform QC Test.4Select the method for identifying the test reagent.•Press Scan if you want to scan the test reagent barcode.• Press Manual if you want to enter the test reagent identification numbermanually.5Identify the test reagent.• Scan the test reagent identification barcode on the test reagent packagingor label.• Enter the test reagent identification number using the numeric keypad.The analyzer will confirm the test reagent identification number.6When the “Ready for use” screen appears, insert a new cartridge.See section “Inserting a cartridge” on page 5-13.The “Cartridge ready” screen appears.7Add the test reagent sample to the cartridge, close the cartridge cap, andpress Proceed to start the analysis.The analyzer begins the analysis. The screen displays “Analyzing” andestimated analysis time remaining.8The analyzer displays test results. Press Finish.8.3.28.3 Quality control8-8 Maintenance Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 9The analyzer asks if you want to finish the current measurement. Select oneof the following options:•Press Cancel to go back to the “Test result” screen.• Press Reject to delete the QC test you just performed. Your results arenot saved.• Press Accept to save the QC test results. When the analyzer is docked theresults will transfer to the QC results area of data manager software.10 Remove the cartridge and close the analyzer cap.Antivirus protectionWe recommend that the data manager software system is equipped withantivirus software, which is designed to detect viruses on your system, andto deny access to infected files before they can do any damage.Antivirus definitions should be updated on a regular basis. The majority ofantivirus software automatically checks for updated virus definition files atsystem startup and implements them, if available.For optimal protection, it is advisable to restart the system as soon as new virusdefinitions are loaded onto the system.MalwareAlthough the system incorporates protection mechanisms to protect itagainst the intrusion of malware, a remote possibility remains that a systemcould become infected. If you notice that unfamiliar system behavior orperformance occurs repeatedly, including after the system has been switchedoff and on again, you are advised to call Service to have the system checkedand, if needed, cleaned of malware.8.4NOTEAntivirus protection 8.4Philips minicare analyzer Release 1.0 Maintenance 8-9Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 After-sales supportFor the following services, please contact your local Philips Electronicsrepresentative.•List of uses and applications• Possibility of extension• Service and assistance• Warranty• Replacement batteryThe minicare analyzer and docking station have no replaceable parts apart from theminicare analyzer battery.8.5NOTE8.5 After-sales support8-10 Maintenance Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Product disposalPhilips Electronics is concerned to help protect the natural environment andto help ensure continued safe and effective use of the this product throughproper support, maintenance and training. Therefore Philips products aredesigned and manufactured to comply with relevant guidelines forenvironmental protection. As long as the product is properly operated andmaintained it presents no environmental risks. However, the product maycontain material[s] which could be harmful to the environment if disposedof incorrectly. Use of such material[s] is essential to performing thefunctions of the product, and for meeting statutory and other requirements.This section of this Instructions for Use is directed mainly at the user of theequipment or system, the body with legal authority over the equipment.Operators are not usually involved in disposal, except in the case of certainbatteries (see section section “Fitting, removing and disposing of batteries”on page 9-2).Passing this product on to another userIf this product passes to another user, it must be in its complete state,including all product support documentation.Make the new user aware of the support services that Philips MedicalSystems provides for installing, commissioning and maintaining the product.Before passing on the product or taking it out of service, all patient datamust be backed up elsewhere if necessary, and then be deleted on the product.It must be remembered by all existing users that passing on medicalelectrical products to new users may create serious technical, medical andlegal (for example, privacy) risks. Such risks can arise even if the product isgiven away. Existing users are strongly advised to seek advice from their localPhilips Medical Systems representative before committing themselves topassing on any product. Alternatively, contact the manufacturer.99.1Philips minicare analyzer Release 1.0 Product disposal 9-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Once the product has been passed on to a new user, a previous user may stillreceive important safety-related information, such as bulletins and fieldchange orders. In many jurisdictions there is a clear duty on the previoususer to communicate such safety-related information to new users. Previoususers who are not able or prepared to do this should inform Philips MedicalSystems about the new user, so that Philips Medical Systems can provide thenew user with safety-related information.Final disposal of this productFinal disposal is when the user disposes of the equipment or system in sucha way that it can no longer be used for its intended purposes.The minicare analyzer and minicare docking station comply with the EUdirective 2002/96/EC, Waste electrical and electronic equipment.Do not dispose any parts of this product with industrial or domestic waste. Theproduct contains hazardous substances, such as lithium, which require specialdisposal. Incorrect disposal of any hazardous materials may lead to seriousenvironmental pollution.Philips supports users in:•Recovering reusable parts• Recycling of useful materials by competent disposal companies• Safe and effective disposal of the product.For advice and information, contact your Philips Service Organization.Fitting, removing and disposing of batteriesFor continued optimal operation, the batteries must be replaced when theircapacity is reduced. To replace the batteries, refer to the instructions insection “Replacing the minicare analyzer battery” on page 9-3.9.2WARNING9.39.2 Final disposal of this product9-2 Product disposal Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Battery type: Philips XXX (BATTERY TYPE/NAME NEEDED)REACH requires Philips Medical Systems to provide chemical content information forsubstances of very high concern (SVHC) if they are present above 0.1% of the productweight. Components within electric and electronic equipment may contain phthalatesabove the threshold (for example, bis(2–ethyl(hexyl)phthalate), CAS nr.: 117–81–7).The SVHC list is updated on a regular basis. Therefore, refer to the following PhilipsREACH web site for the most up-to-date list of products containing SVHC above thethreshold:•http://www.philips.com/about/sustainability/reach.pageAlways remove the batteries if the product will not be used for some time.Replacing the minicare analyzer batteryConditions•A small flathead screwdriver is required to perform this procedure.1On the back of the minicare analyzer, locate the small screw holding thebattery cover in place. Using the screwdriver, remove the screw completelyand set it aside.2Slide the cover upward to remove it from the minicare analyzer as shownbelow.Figure 9.1 Removing the battery cover3Gently pull the battery from the battery compartment. Wires still connectthe battery and the minicare analyzer.NOTECAUTION9.3.1Fitting, removing and disposing of batteries 9.3Philips minicare analyzer Release 1.0 Product disposal 9-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 4Using the screwdriver, gently press the wire connector as shown below torelease it from the minicare analyzer.Figure 9.2 Disconnecting the battery wires from the minicare analyzer5Remove the new battery from any packaging and insert the plastic wireconnector into the minicare analyzer. You should hear or feel it snap into place.6Fit the new battery into the battery compartment. Ensure that the wires arenot crimped and will not interfere with reattaching the battery cover.7Slide the battery cover back in place on the minicare analyzer.8Screw the small screw back in to secure the battery cover.9.3 Fitting, removing and disposing of batteries9-4 Product disposal Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Technical dataSpecificationsProperty ValueDimensions 25 x 8 x 5 cm (approx)Weight 750 g including battery pack (approx)Power supply adapter Input: 100–240 V AC, 47–63 Hz, 700 mAOutput: 24 V DC, 1250 mATests per battery cycle 15 tests on a fully charged battery (approx)System requirementsThe minicare analyzer has no special requirements.The computer system requirements for the Data Manager software areshown in the following table.Item RequirementOperating system Windows Vista, Windows XPRAM 2 GBDisk space 15 GB1010.110.2Philips minicare analyzer Release 1.0 Technical data 10-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 10.2 System requirements10-2 Technical data Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 GlossaryDefinitionsTerm Explanationanalyzer The minicare analyzer receives blood cartridges and performs testson the blood sample. It is intended for use in medical care settings,for example, operating theaters.application assay blood cartridge data manager The minicare data manager software allows you to configure theminicare analyzer, and to exchange data from the minicare analyzerwith an external information system, for example, LIS.docking station Magnotech minicare operator self test system whole blood user The intended users of the Philips minicare system are laboratoryand non-laboratory medical professionals (for example, nurses).AbbreviationsAbbreviation ExplanationEMC Electromagnetic compatibilityEMF Electromagnetic fieldsESD Electromagnetic dischargeHIS Hospital information system1111.111.2Philips minicare analyzer Release 1.0 Glossary 11-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Abbreviation ExplanationIfU Instructions for UseIP Internet protocolIVD In vitro diagnosticLIS Laboratory information systemOS Operating systemPC Personal computerPIN Personal identification numberPOC Point of careQRC Quick reference cardRF Radio frequency11.2 Abbreviations11-2 Glossary Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 AppendicesSpecial functionsAdditional host software options for AdministratorsThere are certain functions for the data manager software that can only beperformed by a Point of Care Coordinator, including:•minicare analyzer configuration, see section “Configuring the minicareanalyzer” on page 12-4.• Data manager software configuration, see section “Configuring the datamanager software” on page 12-2.• User accounts, see section “Managing user accounts” on page 12-6.1212.112.1.1Philips minicare analyzer Release 1.0 Appendices 12-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Configuring the data manager softwareAs a Hospital Administrator, you can configure the data manager softwareID and language, which minicare analyzer is connected to the data managersoftware, and which cartridges are supported.1Click the System menu.2Roll the mouse pointer to Host Configuration, and click.The Host Configuration dialog box appears.Figure 12.1 Host Configuration dialog box12.1 Special functions12-2 Appendices Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 3Change your host configuration as desired.To Do thisChange the data manager software ID Enter the new ID in the Host software ID field.The data manager software ID is used to ensurethat generated orders have a unique ID. If you havemultiple installations of the data manager software,you must give each data manager softwareinstallation a unique ID to avoid duplicate order IDs.Change the data manager softwarelanguageSelect the desired language from the Language drop-down menu.Change the minicare analyzercurrently connectedEnter the IP address for the new minicare analyzer.See section “Configuring analyzer connectivity” onpage 4-7.Add a new supported cartridge type Click the Add button next tothe Supported Cartridges field and select the newcartridge type (with extension ‘.crt’) from theappropriate local or network location.After importing a new cartridge type, you canenable and disable the supported cartridges byselecting and clearing the check boxes.Note that the selected cartridge must also beactivated on the minicare analyzer being used. Seesection “Configuring the minicare analyzer” on page12-4Delete a currently supportedcartridge typeClick the Delete button next tothe Supported Cartridges field.Ensure that only results with username specified can be transferred toLISClick the check box so the checkmark appears.When the check box is cleared, all results (with orwithout username specified), can be transferred tothe LIS.4Click OK to save your changes and close the dialog box.If you click Cancel, the dialog box closes and your changes are not saved.Special functions 12.1Philips minicare analyzer Release 1.0 Appendices 12-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Configuring the minicare analyzerConditions•An analyzer must be connected to view this menu.As the Hospital Administrator, you can use the Analyzer Configurationmenu to view and change minicare analyzer settings including the minicareanalyzer name, software, language, user logon, print settings, and resultsoverwriting.1Click the System menu.2Roll the mouse pointer to Analyzer Configuration, and click.The Analyzer Configuration dialog box appears.Figure 12.2 Analyzer Configuration dialog box12.1 Special functions12-4 Appendices Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 3Change the configuration for the connected minicare analyzer as desired.To Do thisChange the name of the minicareanalyzer currently connected.Enter the new minicare analyzer name inthe Analyzer name field section “Analyzer menuand options” on page 12-9.View the Serial ID of the minicareanalyzer currently connected.The Serial ID is displayed in the Serial ID field.View the current minicare analyzersoftware.The current software version number is displayedin the Software field.Update the current minicareanalyzer software.Click the Update button and select the newsoftware update from the appropriate local ornetwork location.Note that this is not an automatic search function.Updates are communicated and provided throughthe Service organization.View the current Firmware. The current firmware number is displayed inthe Firmware fieldChange the minicare analyzerlanguage.Select the desired language from the Language drop-down menuChange the identification options forthe user logon screen or eliminatethe requirement for a user to log onbefore performing a test.Selecting Barcode requires users to scan anidentification barcode before using the minicareanalyzer.Selecting Manual requires users to enter a numericPIN before using the minicare analyzer.Selecting None disables user identification. Usersthen do not have to enter any identification to usethe minicare analyzer.Change the identification options forthe patient identification screen oreliminate the requirement for apatient identification beforeperforming a test.Selecting Barcode requires users to scan a patientidentification barcode before performing a test.Selecting Manual requires users to enter a numericPIN to identify the patient before performing a test.Selecting None disables user identification. Usersthen do not have to enter any patient identificationbefore performing a test.Special functions 12.1Philips minicare analyzer Release 1.0 Appendices 12-5Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 To Do thisOverwrite the oldest results on theanalyzer if memory is full.There is a limited amount of memory on theminicare analyzer for storing results.Select Automatic from the Overwrite oldest resultsdrop-down menu if the oldest results on theminicare analyzer should automatically beoverwritten by the newest results.Select Ask user from the Overwrite oldest resultsdrop-down menu if results should only beoverwritten after confirmation from the user.Select Never from the Overwrite oldest resultsdrop-down menu if results should never beoverwritten.Note that once results are transferred to the datamanager software they are automatically markedfor deletion on the minicare analyzer.Turn the analyzer sound on or off. Check the box next to Enable Sound to turn onthe sound. Uncheck the box to turn the sound off.Use the Windows date/time format. Check the box next to Use Windows date/time format to automatically synchronize the dateand time with the host PC. The date/time format issynchronized between the data manager softwareand the minicare analyzer.Specify the timeout period Enter a value in Autologout timeout.Select the supported cartridge type You can enable and disable the supportedcartridges for the minicare analyzer by selecting orclearing the check boxes next to the cartridgename in the Supported Cartridges area.4Click OK to save your changes and close the dialog box.If you click Cancel, the dialog box closes and your changes are not saved.Managing user accountsAs the Hospital Administrator, you can allow additional users to access thedata manager software. You can also disable user accounts.12.1 Special functions12-6 Appendices Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 1Click the System menu.2Roll the mouse pointer to User Accounts, and click.The User Accounts dialog box appears.Figure 12.3 User Accounts dialog box3Configure the user accounts as desired.To Do thisView existing user name, role, andanalyzer access codeClick the User name from the list.The user information appears in the User detailsarea to the right.Add a new user Click the Add user button and add the new useraccount details in the Add User Account dialog box.Select the new user name, role, analyzer accesscode, and password.Activate the user account by clicking the check box.Click Save to save changes and return to the UserAccounts dialog box.Special functions 12.1Philips minicare analyzer Release 1.0 Appendices 12-7Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 To Do thisActivate or deactivate a user account. Click the user name from the list and click the Editbutton.Click the check box until the check mark appearsto activate the user account.When the check box is cleared, the user account isinactive.Click Save to save changes and return to the UserAccounts dialog box.Edit an existing user name, roleassignment, analyzer access code, orpassword.Click the user name from the list and click the Editbutton.Change the user information in the correspondingfields as desired.Click Save to save changes and return to the UserAccounts dialog box.Delete an existing user Click the user name from the list and clickthe Delete button.A confirmation dialog box appears, click Yes toconfirm deletion.If you click No, the user account will not be deleted.Click Save to save changes and return to the UserAccounts dialog box.4Click Close to save any changes and close the dialog box.12.1 Special functions12-8 Appendices Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Analyzer menu and optionsWhen you press Menu on the minicare analyzer main screen, you can viewanalyzer information, view results, change IP address, and logout.Figure 12.4 Analyzer menuTo Do thisFind analyzer name, Serial ID,Software, Firmware, and OSPress Analyzer informationView results Press View resultsChange the analyzer IP address Press Network settings and changeYou can then enter the IP address. See section“Configuring analyzer settings” on page 4-12Logout as the current user Press LogoutPerform a Quality Control (QC) test Press Perform QC Test. See section “Performing aQC test” on page 8-8.12.1.2Special functions 12.1Philips minicare analyzer Release 1.0 Appendices 12-9Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Security and privacy requirementsAntivirusThe PC on which the data manager is installed should be protected fromattack or damage by computer viruses or malware. See section “Antivirusprotection” on page 8-9 for details.[NOTE TO REVIEWERS: Details about the following items will beprovided by the Project team after Review 2]Network portsEncryptionReferencesMagnotechInformation about the Magnotech process can be found at the followingweb site.www.philips.com/magnotech12.212.312.2 Security and privacy requirements12-10 Appendices Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 IndexAAbbreviations 11-1After-sales support 8-10AnalyzerAdding blood sample 5-14Anonymous test 5-12Cartridge insertion 5-13Cartridge removal 5-16Configuring 12-4Configuring connectivity 4-7Configuring settings 4-12Docking 4-5Finishing a test 5-16Identifying the patient 5-10Logging on 5-6Logging out 5-9Performance characteristics 4-3Performing multiple tests 5-16Quality Control (QC) test 8-8Self test 5-4Shutting down 5-6Starting 5-3Starting analysis when docked 5-9Undocking 4-6– – – – – – – – – – – – – – – – – – – – Antivirus protection 8-9BBatteries 9-2, 9-3Replacing 9-3– CCleaning and disinfection 8-1–8-3Cleaning 8-2Disinfection 8-3– – Compatibility 1-3Compliance 1-4Contacting Service 7-10DData manager softwareConfiguring 12-2Installing 4-4– – Definitions 11-1Disinfection 8-3DisposalFinal 9-2– EEnvironmental conditionsHandling 3-5Storage 3-5– – Equipment connections 3-2, 3-3Error messagesData manager 7-3Philips minicare analyzer 7-1– – European authorized representative 1-4HHandling requirements 3-5Host softwareAnalysis orders tab 6-11Analysis results tab 6-16Changing password 6-8Creating a new order 6-14– – – – Philips minicare analyzer Release 1.0 Index I-1Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Deleting an order 6-15Deleting a patient entry 6-12, 6-17Deleting a QC test entry 6-24Deleting a user 12-8Editing analysis results 6-20Exiting 6-3Filtering the patient list 6-17Filtering the QC result list 6-24Help menu 6-9Logging off 6-2Logging on 6-1Log off button 6-11Managing user accounts 12-6Printing analysis results 6-21Starting 6-1Transferring orders to the analyzer 6-15Transferring results to the LIS 6-22– – – – – – – – – – – – – – – – – IIntended use 1-3LLimitations of use 4-4LISConfiguring connectivity 4-9– MMagnotech technology 4-1, 4-2Maintenance 8-4PPassing this product to another user 9-1Performance characteristics 4-3Performing a blood test 5-14Preparation prior to use 4-4QQuality control 8-5, 8-8QC test 8-8– RReferences 12-10Routine checks 8-5SSafetyExplosion safety 2-2Important safety directions 2-1Safety awareness 5-3– – – Safety directions 2-1Security and privacy requirementsComputer viruses and malware 12-10Encryption 12-10Network ports 12-10– – – Service 7-10Spare parts 8-10Specifications 10-1Sterilization 8-2Storage requirements 3-5Symbols 2-6System and error messagesData manager 7-3Philips minicare analyzer 7-1– – System components 4-1System identification 1-3System requirements 10-1IndexI-2 Index Philips minicare analyzer Release 1.0Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 TTechnical specifications 10-1Terminology 11-1Theory, operation 4-1Training 1-5Transferring results from analyzer to data managersoftware 6-19UUser routine checks 8-5WWarnings and cautions (general) 2-1Warranty 8-10Workflow 5-2, 8-6Blood analysis workflow 5-2Quality control (QC) test workflow 8-6– – IndexPhilips minicare analyzer Release 1.0 Index I-3Philips Electronics Nederland B.V. [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]

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