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User Manual RI Witness RESEARCH INSTRUMENTS LTD Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.com www.research-instruments.com Document 6-70-121UM, Issue 13, 26th January 2015, MRF 1636 CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO RI WITNESS Intended Use Medical Device Component Applicable Part Numbers Compatibility
Installation
SECTION 3 - SAFETY WARNINGS GuidanceandManufacturersDeclaration(Part15ofFCC)
ElectromagneticEmissions
GuidanceandManufacturersDeclaration(IEC60601-1-2)
ElectromagneticEmissions
GuidanceandManufacturersDeclaration
ElectromagneticImmunity
Safety/InformationSymbols
Safety and Reliability Temperature Safety Mains Power Supply RFID Reader Environment Startup / Shutdown Procedure SECTION 4 - PRODUCT OVERVIEW Data Capture Imaging Traceability Cryo RI Witness Work Area RI Witness Manager for Traceability, Data Capture and Imaging RFID Overview The Shared RI Witness Database Hardware Overview Work Area Reader Types Multiplexer
Control Units 1 2 2 2 2 3 3 4 5 5 6 8 9 9 10 10 10 11 12 12 13 13 13 14 15 15 16 16 17 17 CONTENTS Unheated Control Unit Heated Control Unit Auto Tuning Readers RFCalibration
RIWitnessWorkAreaSpecificationTable
SECTION 5 - RI WITNESS BASIC OPERATION Introduction
RI Witness RFID tags TaggingPlasticware
Dishes and Pots Tubes Handling RFID Tags How to Switch On SystemInformation
ToOpentheSystemInformation
How to Shut Down a Work Area Logging In Auto Logon Logging Out The WorkArea Interface Performing A Procedure in RI Witness Beginning a New Cycle in RI Witness WitnessPointConfirmation
Double Witness Points QuestionWitnessPoints
Record Witness Points Unassigned Tags Tag Mismatch Unassigned Tag Removal RecordLocationofTags
Training Mode ClearDemoTables(legacyworkareasforpresoftwareversion2.3only)
Admin Assign Discards Cycle Summary 17 18 18 19 20 21 21 22 22 22 22 23 24 24 25 25 25 25 26 27 28 28 30 30 31 32 32 33 33 34 35 35 36 36 37 CONTENTS Daily Lists Windowed Work Area Language and Keyboard Layout Foot Pedal Control To Rename the Work Area ToChangetheLocationofaWorkArea
ToViewWorkAreaLocationsorDisableaWorkArea
AlarmifTagsLeftinWorkArea
SECTION 6 - RI WITNESS MANAGER Logging In License Management License Request Form Database Management InitialScreen-MainMenuButtons
Home HowtoConfiguretheHomeScreen
Patients
EnteringNewPatientDetailsintoRIWitnessManager
EditingExistingPatientDetails
LookingUpPatientHistories
Assigning Donor Status Assigning Partners Cycle Types StartingaNewCycle
Assign a Cycle Type CollectionandTransferDates
Cycle Status Revert Status RIPatientIdentityLabels
PrintingPatientLabels
Label Styles Operator Management Operator Details Group Membership Enabled Operators Operator PIN 37 37 38 38 39 39 40 40 42 42 42 43 45 46 46 47 48 48 49 49 50 50 51 51 51 52 52 52 53 54 55 55 56 56 56 56 CONTENTS Clinic Details Mismatch Comments In RI Witness Manager The Witness Point Diagram Links Reassigned Tags Unassigned Tags Witness Point Inputs MultipleSourcesoftheSameTagType
MultipleTagTypes
Entry Witness Points Double Witness Points Donor Witness Points TaggedDonations
UntaggedDonations
WitnessPointQuestions
Witness Point Order The Witness Point Log Tag Types ExploretheWitnessPointLog
WitnessPointLogStatistics
SECTION 7 - CRYO WITNESSING AnIntroductiontoCryoWitnessing
PrintingBarcodes
Scanning Barcodes SECTION 8 - RI WITNESS MANAGER FOR TRACEABILITY Managing Materials Material Types Material Type Details Notes on GS1 Barcodes Cycle Types CreatingaNewBatch
DeletingaBatch
Batch Status ExpiredBatches
View All Batches 56 57 58 59 59 59 60 60 60 60 60 61 61 62 62 63 63 63 64 64 65 65 65 67 68 68 68 69 70 70 70 72 72 73 74 CONTENTS Patients-ManagingTreatmentCycles
ExcludingandIncludingBatchesforaCycle
SECTION 9 - DATA CAPTURE AnIntroductiontoDataCaptureforDataCollection
Collected Data Setup ParameterConfiguration
Numerical Parameters TextParameters
List Parameters Check Parameters Date, Time and Date Time Parameters CalculationParameters
Built In Parameters Sheet Contents Shared Between Sheets Treatment Cycle Sheets ViewingandEditingSheets
EditingSheetsattheWorkAreaTouchScreen
ViewingandEditingSheetswithRIWitnessManager
Egg Parameters The Number of Eggs Egg Count Parameter EggCountConflict
Sheets and Witness Points Cycle Summary Sheets ParameterAttributes
InitialValue
Editable Required SECTION 10 - IMAGING How to View Live Images MultipleScreenConfiguration
How to Take a Picture How to Record Video How to Zoom & Pan the Image 74 74 75 75 75 76 76 76 77 77 78 78 78 78 79 80 80 80 82 82 84 84 84 86 86 87 87 88 88 89 89 89 90 91 91 CONTENTS How to Perform Measurements How to Select Cameras Camera Flipping How to Set the Preset Zoom HowtoConfiguretheFootPedal/Keyboard
HowtoSelectObjectives
HowtoAddObjectives
HowtoRemoveObjectives
HowtoCheckObjectiveCalibration
PatientDisplay
Use of Saturn Laser Systems with RI Witness HowtoAccessSaturnLaserSystemInformationfromaWorkArea
SECTION 11 - TROUBLE SHOOTING SECTION 12 - TEMPERATURE CALIBRATION TemperatureProfile
TemperatureProfileChecklist
TemperatureCalibration
TemperatureCalibrationService
TouchScreenCalibrationChecklist
SECTION 13- CARE AND MAINTENANCE Cleaning SECTION 14 - REPAIRS AND RETURNS Reuse Statement RI Repairs System Product Disposal (European Union) RI Returns System Contact Details ObligationtoInform
Feedback 91 92 92 92 92 92 93 93 93 93 94 94 95 97 97 97 97 98 99 100 100 101 101 101 101 101 101 101 102 Research Instruments Ltd SECTION 1 - PREFACE Thank you for choosing RI Witness. The RI Witness family of products is made up of RI Witness, Data Capture, Traceability, Imaging and Cryo. ThismanualprovidesallnecessaryinformationtouseRIWitness.Thesystemshouldbeoperated
bytrainedpersonnelonly.Allsectionsofthismanualshouldbereadandunderstoodfullybeforeany
operationofthesystem.PleaseseetheIntendedUseformoreinformation. IftheoperatorisunsureofanyoftheinformationcontainedinthismanualtheyshouldcontactResearch
Instrumentsoranappointedrepresentativebeforeattemptingtousethisequipment. In no event does Research Instruments Ltd (RI) assume the liability for any technical or editorial errors ofcommission,oromission;norisRIliablefordirect,indirect,incidental,orconsequentialdamages
arising out of the use or inability to use this manual. The information in this manual is current at the time of publication. Our commitment to
product improvement requires that we reserve the right to change equipment, procedures and specifications at any time. The latest version of the User Manual can be downloaded from
software.research-instruments.com.TheRIWitnessmanualbelongswiththeRIWitnesssystem
and should be passed on with the system if relocated to another clinic. The use of in this manual indicates a trademark of Research Instruments Ltd. Any other brand names,referredtointhismanual,aretrademarksoftheirrespectiveowners. This manual is protected by copyright, all rights reserved, and no part here of may be photocopied orreproducedinanyformwithoutthepriorwrittenconsentofRI. This indicates cautionary text which should be followed to avoid injury to users or damage to samples. The system should be operated by qualified and trained personnel only. 1 Section 1RI Witness RFID Tags1 Research Instruments Ltd SECTION 2 - INTRODUCTION TO RI WITNESS Intended Use For RI Witness heated work areas only. Toidentifyandtrackhumansamplesthroughtheassistedreproduction(AR)cycleandwhererequired,
to maintain sample temperature. Contraindications: Therearenocontraindicationsassociatedwiththeuseofthisdevice. Medical Device Component Theheatedplate(andtemperaturecontrol)componentsofthissystemareclassifiedasaclass
IImedicaldeviceinaccordancewithArticle9,AnnexIX,rule9oftheDirectives93/42/EEC&
2007/47/EC,ieitadministersorexchangesenergytoorfromthehumanbody.Inrespect
oftheRIWitnesssystem,energyisemittedintheformofheat,toorfromtheARsample.
Thereisnodirectpatientcontact. Applicable indications for use are subject to the regulations of the country into which the device is sold. Availability of RI Witness for clinical use is dependent on the regulatory approval status of RI Witness within the country the device is intended to be sold into. Applicable Part Numbers Part Number 6-70-801 6-70-801/C 6-70-801/T 6-70-801/TC 6-70-802 6-70-802/C 6-70-802/T 6-70-802/TC 6-70-803 6-70-803/C 6-70-803/T 6-70-803/TC 6-70-804 6-70-804/C 6-70-804/T 6-70-804/TC Description Sit on Top Heated Work Area Assembly Sit on Top Heated Work Area Assembly with Card Reader Sit on Top Heated Work Area Assembly with Test Tube Reader Sit on Top Heated Work Area Assembly with Card and Test Tube Reader FlushFittedHeatedWorkArea1ChannelAssembly FlushFittedHeatedWorkArea1ChannelAssemblywithCardReader FlushFittedHeatedWorkArea1ChannelAssemblywithTestTubeReader FlushFittedHeatedWorkArea1ChannelAssemblywithCardandTestTubeReader Slim Heated Work Area Assembly Slim Heated Work Area Assembly with Card Reader Slim Heated Work Area Assembly with Test Tube Reader Slim Heated Work Area Assembly with Card and Test Tube Reader FlushFittedHeatedWorkArea2ChannelAssembly FlushFittedHeatedWorkArea2ChannelAssemblywithCardReader FlushFittedHeatedWorkArea2ChannelAssemblywithTestTubeReader FlushFittedHeatedWorkArea2ChannelAssemblywithCardandTestTubeReader 2 Section 2Introduction2 Research Instruments Ltd Part Number 6-70-805 6-70-805/C 6-70-805/T 6-70-805/TC 6-70-806 6-70-806/C 6-70-806/T 6-70-806/TC 6-70-852 6-70-852/C 6-70-853 6-70-853/C 6-70-853/T 6-70-853/TC Description ITO Reader ITO Reader with Card Reader ITO Reader with Test Tube Reader ITO Reader with Card Reader and Test Tube Reader Sit on Top Heated Work Area 2 Channel Assembly Sit on Top Heated Work Area 2 Channel Assembly with Card Reader Sit on Top Heated Work Area 2 Channel Assembly with Test Tube Reader Sit on Top Heated Work Area 2 Channel Assembly with Card and Test Tube Reader SpermPreparationWorkAreaAssembly SpermPreparationWorkAreaAssemblywithCardReader Unheated Work Area Assembly Unheated Work Area Assembly with Card Reader Unheated Work Area Assembly with Test Tube Reader Unheated Work Area Assembly with Card and Test Tube Reader Compatibility RIWitnessisusedinconjunctionwiththefollowing:
Essentialmedicaldevices-dishesandtubes,maybeARornot-ARspecific. Nonessentialmedicaldevices-safetycabinets,incubators,micromanipulators,lasers. Non medical devices (general laboratory equipment), eg work benches, microscopes, PCs. Installation InstallationsofRIWitnessshouldbecarriedoutbyaRItechnicianorotherRIauthorisedpersonnel.
Incorrectinstallationcouldresultinoverallpoorperformance. 3 Section 2Introduction2 Research Instruments Ltd SECTION 3 - SAFETY WARNINGS Thissymbolindicatescautionarytextwhichshouldbefollowedtoavoidinjurytousersor
damage to samples. Thesystemshouldbeoperatedbyqualifiedandtrainedpersonnelonly. DO NOT disassembleormodifyanypartoftheRIWitness,orsubstituteanycomponent
for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract. ONLY use the power cable and power supply adaptor supplied with the system. The cable to the power supply is the disconnect device for this equipment. To remove all electrical power from this product, disconnect the power cable from the electrical outlet. Equipmentshouldbepositionedsoastoalloweasyaccesstothepowercable.Theappliance
coupler or mains plug is used as the disconnect and must remain readily operable. WARNING To avoid the risk of electric shock, this equipment must only be connected to a supplymainswithprotectiveearth. WARNING Nottobeusedinapatientenvironment. 4 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration (Part 15 of FCC) Electromagnetic Emissions Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuanttopart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainst
harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance withtheinstructionmanual,maycauseharmfulinterferencetoradiocommunications.Operationof
thisequipmentinaresidentialareaislikelytocauseharmfulinterferenceinwhichcasetheuserwillbe
requiredtocorrecttheinterferenceathisownexpense. Note:ThisdevicecomplieswithIndustryCanadaslicence-exemptRSSs.Operationissubjecttothe
followingtwoconditions:
1. This device may not cause interference. 2. Thisdevicemustacceptanyinterference,includinginterferencethatmaycauseundesiredoperation
of the device. Guidance and Manufacturers Declaration (IEC 60601-1-2) Electromagnetic Emissions RIWitnessisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror
the user of RI Witness should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltagefluctuations/
flickeremissions IEC 61000-3-3 Group 2 Class B Not applicable Not applicable RIWitnessmustemitelectromagneticenergy
inordertoperformitsintendedfunction.Nearby
electronicequipmentmaybeaffected. RI Witness is suitable for use in all establishments otherthandomesticandthosedirectlyconnected
to the public low-voltage power supply network that supplies buildings used
for domestic
purposes. 5 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test Electrostaticdischarge
(ESD) IEC 61000-4-2 IEC 60601 Test level 6 kV contact 8 kV air Compliance level 6 kV contact 8 kV air Electrical fast transient/
burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/
output Lines Surge IEC 61000-4-5 1 kV line(s) to line(s) 2 kV line(s) to earth Voltage dips, short interruptionsandvoltage
variationsonpower
supply input lines IEC 61000-4-11
<5 % UT
(>95 % dip in UT ) for 0.5 cycle 40 % UT
(60 % dip in UT) for 5 cycles 70 % UT
(30 % dip in UT) for 25 cycles
<5 % UT
(>95 % dip in UT) for 5s
1kVdifferential Mode 2 kV common mode
<5 % UT
(>95 % dip in UT) for 0.5 cycle 40 % UT
(60 % dip in UT) for 5 cycles 70 % UT
(30 % dip in UT) for 25 cycles
<5 % UT
(>95 % dip in UT) for 5s 3A/m 3A/m Power frequency
(50/60 Hz) magneticfield IEC 61000-4-8 Note: UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel. Electro magnetic environment - guidance Floors should be wood, concreteorceramictile.
Iffloorsarecovered
withsyntheticmaterial,
therelativehumidity
should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of RI Witness requirescontinued
operationduringpower
mainsinterruptions,it
is recommended that RI Witness be powered fromanuninterruptible
power supply or a battery. Power frequency magneticfields
should be at levels characteristicofa
typicallocationina
typical commercial or hospital environment. 6 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test IEC 60601 Test level Compliance level Electro magnetic environment -
guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m the
recommended
PortableandmobileRFcommunications
equipment should be used no closer to any part of RI Witness, including cables, than
separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommendedseparationdistance d = [3.5/V 1]p d = [3.5/V1]p80MHz to 800MHz d = [3.5/V1p800MHz to 2.5GHz where p
the maximum output
power rating of the transmitter
in
watts (W) according to the transmitter
manufacturer and d is the recommended separationdistanceinmetres(m).Field
strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey, a should be less than the compliance in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
level is
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedby
absorptionandreflectionfromstructures,objectsandpeople. Note 3:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedby
absorptionandreflectionfromstructures,objectsandpeople. aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,
anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthinthelocationin
whichRIWitnessisusedexceedstheapplicableRFcompliancelevelabove,RIWitnessshouldbe
observedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmay
benecessary,suchasre-orientingorrelocatingRIWitness. bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan[V]V/m. 7 Section 3Safety Warnings3 Research Instruments Ltd Safety/Information Symbols Symbol Meaning Indicatesinstructionfordisposalofgoods. In accordance with Annex II of the European
MedicalDeviceDirective93/42/EEC,asamended
byDirective2007/47/ECunderthesupervisionof
notifiedbodyNo.0120,SGS,UKLtd. In accordance with the European Directive for
R&TTE,Directive1999/5/EC Indicates the medical device manufacturer. Indicates the need for the user to consult the instructions for use for important cautionary
informationsuchaswarningsandprecautionsthat
cannot, for a variety of reasons, be presented on the medical device itself. Followinstructionsforuse. Thefirstfourdigitsareauniqueidentifierassigned
to the product and the last 2 digits signify the year of manufacture, eg 5001/13 (this denotes a unique serial number of 5001 and a year of manufacture of 2013). Caution: US Federal law restricts this device for
sale to or on the order of a licensed healthcare practitioner. 8 SN Only Section 3Safety Warnings3 Research Instruments Ltd Safety and Reliability Pleasereadthismanualcarefullyandfollowtheinstructionstoensurethatthesystemwillworksafely
and reliably. Temperature Safety Safetyistheresponsibilityofthelaboratory.Riskassessmentandworkingpracticesshouldcomplywith
local regulatory policies. A warning triangle will be displayed on the work area touch screen and on the control unit display if the currently selected temperature cannot be maintained. A touch screen warning triangle will also be shown if temperature control has been disabled using the TurnOffbutton. Gently place your hand on the heated surface to verify that the temperature is appropriate for use. Aswithallheatingsystems,itisadvisabletoperformaperiodiccheckoftemperaturesusingacalibrated
thermocouple thermometer. 9 Section 3Safety Warnings3 Research Instruments Ltd Mains Power Supply Products from RI require a stable and noise free power supply ( 100V - 240V ). The supply must provide anearthconnection. The RI Witness control unit for heated readers contains a mains power supply. Do not remove the cover from any RI Witness product. RFID Reader Environment An RI Witness system uses readers to monitor a work area. Readers detect RFID tagged containers that are placed in the work area. Eachreaderisindividuallytunedtoitsenvironmentandmustnotberepositionedafterinstallation.The
performanceofRFIDtagdetectionmaybecompromisedbyrepositioningreadersandbytheproximity
ofmetalobjectsorelectricalequipmentthatwerenotpresentduringinstallation. Forcleaning,readersmaybeliftedandreturnedtothesameposition.SeeCleaningonpage100for
more cleaning details. Do not move readers. Do not place metal objects near readers. Do not place electrical equipment near readers. Do not disconnect readers. Do follow the startup/shutdown procedures. Startup / Shutdown Procedure RI Witness hardware may be damaged by incorrect startup and shutdown procedures. Section5-RIWitnessBasicoperationdescribestherecommendedstartupandshutdownprocedure
for the RI Witness work area. 10 Section 3Safety Warnings3 Research Instruments Ltd SECTION 4 - PRODUCT OVERVIEW Welcome to the User Manual for the Research Instruments (RI) RI Witness System. RI Witness, Data Capture, Traceability, Imaging and Cryo are members of the RI Witness family ofproducts.RIWitnessproductsshareacommondatabaseusuallyreferredtoastheWitness
database. RIWitnessisasystemwhichoperateswithinanassistedreproduction(AR)clinicsettingandprovides
amethodofidentifyinghumansamplesthroughoutanARcycle(fromeggandspermcollectionto
embryo transfer). The system is intended to minimise the risks associated with traditional/manual
double-checkingandprovidestheessentialcontrolsnecessarytoensureeggs,spermandembryosare
correctly matched and treated during the AR process. The RI Witness system comprises hardware, firmware and software components, which can be
configureddependingonthetreatmentactivities,numberofARcyclesconducted,sizeandlayoutof
the AR clinic. RFID (radio frequency identification) technology provides the means of identifying the containers
(dishes, tubes) in which eggs, sperm and embryos are transferred and stored. The containers are labelledbyaclinicianwithaspecialRFIDtagwhichhasbeenassignedauniqueidentifier.Theunique
identifierislinkedtoapatient/couple(specificparentage). As samples are processed as part of an AR cycle, RFID readers (both heated and non-heated) read the tagsonthecontainerandtheiridentityandstatus isconfirmedon-screen.Ifcontainerscontaining
samplesofincompatibleorigincomeintocontactatanystageofthisprocess,thesystemactivatesan
alarm and prompts the clinician to respond. Computer Control Unit RFID Test Tube Reader Multiplexer RI Witness Touch Screen RFID Tag Sit on Top Heated Work Area Reader Figure 4-1 RFID tag communicating with various antennas An antenna is incorporated into a work area reader. A control unit feeds an RF signal to the antenna. An RFIDtagispassiveuntilenergisedbythesignalfromtheantenna.Theenergisedtagthentransmitsan
identificationcodebacktothesameantenna.SeeFigure4-1. AnARprocedureisconductedwithinthemonitoredworkarea.Theprocedureisdefinedbyasequence
of Witness Points which are presented on the touchscreen. 11 Section 4Product Overview4 Research Instruments Ltd Data Capture Hand written notes are often taken whilst performing laboratory procedures. For example embryo
scoresandspermvolumesmightbewrittendownonadatasheetandlatermanuallytranscribedinto
aclinicfertilitydatabase. The features of Data Capture allow data sheets to be designed in RI Witness Manager and data entry to be performed in the laboratory using the work area touch screen. See Figure 4-2. Data entry may also be performed in RI Witness Manager. Figure 4-2 Lower: Data entry using a RI Witness WorkArea touchscreen Upper: Data sheet design using RI Witness Manager Imaging With the Imaging feature, you are able to capture images and videos from every microscope in the laboratory,ateverystageofthepatientcycle,inrealtime.Allthelatestinformationonacyclecanbe
accessed immediately from any networked PC. Images can also be sent to the embryo room to show thepatientpriortoembryotransfer. TheImagingfeatureiscompatiblewithRIIntegraandSaturnlasers. Figure 4-3 Example of patient view shown in embryo room 12 Section 4 Product Overview4 Research Instruments Ltd Traceability Traceabilityisasoftwareproductthatlinkspatienttreatmentcycleswiththebatchesofmaterialsthat
are in use. A barcode reader may be used to scan batches as they are delivered or made ready for use. Thelinksbetweentreatmentcyclesandmaterialbatchesmaybeexploredtogeneratevariousreports,
forexampleareportshowingallpatientsthathavebeenexposedtoaparticularmaterialbatch. Cryo TheCryofeatureextendstheRIWitnesssecuritysystem,allowingpatientsamplestobetrackedas
theyenterandleavecryostorage,creatingacompleterecordofthepatientcycle. A barcode reader is placed at the work area and used to scan a sample in or out of the cryo storage. RI Witness Work Area Figure 4-4 An RI Witness work area RFID tagged items are displayed on a touchscreen running RI Witness WorkArea software. A typical RI Witness work area includes a PC, touchscreen, one or more tag readers and an RF control unit.TheworkareaPCrunsRIWitnessWorkAreasoftwaretopresentanoperatorinterfaceonthe
touch screen. See Figure 4-4. The data presented on the touchscreen is generated from the shared Witness database, all work area events are logged to the shared Witness database. 13 Section 4Product Overview4 Research Instruments Ltd RI Witness Manager for Traceability, Data Capture and Imaging RI Witness Manager runs on any Windows PC and provides Witness, Data Capture, Cryo, Traceability andImagingfunctionality.
ThepatientsRIWitnessManagerpageisusedbyalloperators,thematerialsRIWitnessManager
pageisuniquetoTraceabilityoperatorsandthewitnesspointspageisuniquetoWitnessoperators.
See Figure 4-5. Figure 4-5 RI Witness Manager is used by RI Witness, Data Capture, Traceability, Imaging and Cryo 14 Section 4 Product Overview4 Research Instruments Ltd The Shared RI Witness Database AnexampleRIWitnessinstallationisshowninFigure4-6.FourworkareaswithRIWitnessWorkArea
software, two RI Witness Manager PCs and an admin reader PC share a common RI Witness
database.Traceability,RIWitnessandDataCapturemanagementfunctionsmaybeperformedat
each RI Witness Manager PC. Work Area Work Area Work Area Work Area Lab Manager Lab Manager Admin Reader Shared RI Witness Database Figure 4-6 The RI Witness database is shared by All RI Witness WorkArea and RI Witness Manager PCs RFID Overview Radio-frequency identification (RFID) is the technology used by RI Witness to identify tagged
plasticware. AcontrolunitfeedsanRFsignaltoamatchedantenna.AnRFIDtagispassiveuntilenergisedbythe
signalfromtheantenna.Theenergisedtagthentransmitsanidentificationcodebacktothesame
antenna. See Figure 4-1. AnRFIDsystemworksontheprincipleofinductivecoupling,whichrequiresthattheantennabetuned
tomatchthefrequencyinuseandoptimisedforthephysicalenvironment.Specificcablelengthsmust
beusedforallRFconnections. EachRIWitnessworkarearequiresacomputer,acontrolunitandatleastoneantenna.Multiple
antennaworkareasrequireamultiplexertoswitchtheRFsignalbetweenantennas. Antennas are built into RI Witness Readers. 15 Section 4Product Overview4 Research Instruments Ltd Hardware Overview Work Area Reader Types ReadersdetectRFID(RadioFrequencyIdentification)tagsusingtunedantennas.Thetesttubereader
(2axis)andthespermpreparationreader(3axis)useonetunedantennaforeachaxis.Allotherreaders
use a single tuned antenna. Aflushfittingvariantoftheheatedreaderisavailable,thisisintegratedintothesurfaceofthesafety
cabinetforeaseofuse.Legscanbefittedtoallowfurtherintegrationwithotherlightbases. Figure 4-7 ITO reader Figure 4-8 Card reader Figure 4-9 Admin reader Figure 4-10 Sit on top heated reader Figure 4-11 Sit on top unheated reader Figure 4-12 RFID Test tube reader Figure 4-13 Sperm preparation reader 16 Section 4 Product Overview4 Multiplexer AmultiplexerdistributesRFpowertomultipleantennas.Amultiplexercanfeeduptofourantennas.
Research Instruments Ltd Figure 4-14 An RI multiplexer Control Units Control units provide the RF power for readers. They may be used for heated or non-heated work areas depending on the procedures conducted there. Unheated Control Unit Theunheatedcontrolunitmaybeusedwithamultiplexertodriveuptofourantennas. 1 2 3 Figure 4-15 Back panel of unheated control unit Connections:
1. Mains socket 2. USB to PC 3. RFCoaxialOUTtomultiplexerorheatedreader 17 Section 4Product Overview4 Research Instruments Ltd Heated Control Unit Theheatedcontrolunitcontainsatemperaturecontrollerandmaybeusedwithamultiplexertodrive
up to four antennas. 1 2 3 4 Figure 4-16 Back panel of heated control unit Connections:
1. RFCoaxialOUTtomultiplexerorheatedreader 2. USB to PC 3. Heater cable to reader 4. Mains socket Auto Tuning Readers Figure 4-17 Sperm preparation reader Connections:
1. Place the reader in the desired area 2. Remove the cable clamp 3. Connect the power supply 4. Connect the Mini-USB connector 5. Replacetheretainingbracketandtightenscrew 6. Connect the USB-A connector to the PC, Tablet or USB ConnectionsaremadeupofaUSBA-Bcableandapowersupply.Thepowersupplyisa12Vpower
supplyandisexternaltothedevice.TheUSBisastandardUSB2.0cable.Thesearelocatedontherear
of the device and held in place by a retaining bracket and screw. 18 Section 4 Product Overview4 Research Instruments Ltd RF Calibration CalibrationoftheRIWitnessSpermPrepReaderismadealotsimplerbyhavinganautomatictuning
system. The procedure for this is as follows. 1. OpenRIWitnessWorkArea.MakesuretheRFIDreaderandMultiplexeraredetected. 2. Click the Change Settingsbuttononthebottomrightofthiswindow.
3. FromthisyouwillseetheWorkareaSettingswindow.ClickontheRFIDReadingtabtobringup
theRFIDConfigurationWindow.
Figure 4-18 4. FortheSpermPrep,settheAntennaConfigurationto3.Thenextthingtodoistoclickon
Autotune.Thiswilltunetheantennasfortheareatheyaresituatedin.Everytimethedeviceis
moved this will need to be done. This will take a few moments but when done the SWR for each channel should show a value of 1-50. If there are any RI tags in the work area, then they will be displayedinthegreybox.YouarenowreadytousetheRIWitnessSpermPrepReader. Figure 4-19 19 Section 4Product Overview4 Research Instruments Ltd RI Witness Work Area Specification Table Part Description HeatingSystems*
Heated metal and glass. TemperatureSensor*
Digital 14-bit SHT-15 or Analogue PT1000. Displays*
LCD Display. Accurate to 1 decimal place. Connectivity USBTypeBsocketforconnectiontoPC.ConnectedPCtobecompliant
with IEC 60950-1. Supply Voltage 100-240VAC,50-60Hz,Max.2.6A,ClassI. OperatingTemperature*
Temperature: 10C (50F) to 42C (107.6F). Humidity: 15% to 85% RH (Non Condensing). HeaterChannels*
2Channel122VDCat6AMax.Channel222VDCat1Amax. RFID 50Loadat13.56Mhz1.4WMax.I-4Antennas.
*Forheatedworkareasonly 20 Section 4 Product Overview4 Research Instruments Ltd SECTION 5 - RI WITNESS BASIC OPERATION Introduction RI Witness uses one or more readers to monitor RFID tagged containers in a work area. The work area interface is presented on a touch screen. See Figure 5-1. The operator touches screen buttonstologinandselectWitnessPoints. Figure 5-1 The RI Witness WorkArea interface is presented on a touch screen 21 Section 5RI Witness Basic Operation5 Research Instruments Ltd RI Witness RFID tags Tagging Plasticware Beforeuseintheworkarea,allplasticwaremustbeRFIDtaggedandlabelledwithpatientidentity. Rectangular,circularandsquaretagsareavailable.SeeFigure5-2.Thesampleidentitymaybeassigned
totheRFIDtagoncethetaggedplasticwareisplacedinaRIWitnessworkarea. Dishes and Pots RFIDtagsmustbepositionedonthebaseofdishesandpots.Thesquaretag,positioneddiagonally,is
recommended for a four well dish. Do not pre assign. Identity should be assigned as samples are transferred into the plasticware. If tagging plasticware in advance of procedures, it is recommended that you test the tag on a reader prior to transferring patient sample. Tubes Therectangulartagisrecommendedfortubes.Positionthelongedgeofthetagalongthelengthof
thetubeandholdinplaceusingtapeorapatientidentitylabel.Positiontagsnearthetopoftubesto
ensure they are not obscured by thermal blocks or tube warmers. Square Tag Square Tag Bridge Chip
+ UPM 18 mm Peel from here 18 mm Dia 43.8mm Circular Tag Circular Tag Bridge Rectangular Tag Rectangular Tag Bridge Chip
+
U P M 36 mm Peel from here 18 mm Time-lapse Tag Time-Lapse Tag Chip Bridge 375_1
+
12 mm Chip Peel from here 22 mm Peel from here Figure 5-2 RI Witness tags 22 Section 5RI Witness Basic Operation5 Research Instruments Ltd Handling RFID Tags When removing tags, bend the backing strip away from the tag, rather than the tag away from the backing strip. This will reduce the risk of damaging tags. 1. StartpeelingthebackingstripawayatthepeelfromherepointshowninFigure5-3toachieve
a peel line as shown. chip and bridge line Chip and bridge line peel line Peel line Figure 5-3 2. Whenstickingthetagtothedish,bringthetagintocontactwiththedishatonepoint.Thenuse
yourfingerorthumbtoworkthetagontothedishwithacircularmovement,movingawayfrom
theinitialcontactpointsoastoavoidanykinksinthetagasitstickstothedish.SeeFigure5-4. Storing Tags and Tagged Labware Unusedtagsandunusedtaggedplasticwareshouldnotbestoredonornearasurface(safetycabinet
or workbench) where a RI Witness reader is located. Figure 5-4 23 Section 5RI Witness Basic Operation5 Research Instruments Ltd How to Switch On RI suggests that you keep the RI Witness computers and work areas switched on. This means that the heatingandmonitoringisconstant. IfyouhaveswitchedoffaheatedRIWitnessworkarea,pleaseallow45minutesfortheworkareato
return to the required temperature. Please check there is power at the wall socket, the PC and touch screen (or tablet) and control tower. You may want to check the work area heating and touch screen calibration for accuracy before
commencingwork.SeeSection12-TemperatureCalibrationonpage97. System Information Thesysteminformationpanelwillshow:
1. Versionnumbersforsoftwareandfirmware 2. Workarealocation 3. Database version 4. Licensing status including Imaging dongle 5. RFIDreaderstatusandmultiplexer 6. Temperature control status 7. SaturnLaserSystemstatus,serialnumber,firmwaredetails 8. Camera status 9. Integra status 1 2 3 4 5 6 7 8 9 Figure 5-5 24 Section 5RI Witness Basic Operation5 Research Instruments Ltd To Open the System Information 1. Press the Information screen. icon in the work area or click the Settings icon from the Imaging 2. TheSystemInformationwindowshowsthecurrentstateoftheRIWitnesssystem. 3. 4. 5. Indicates there is no problem. Indicates a problem needs resolving. InsystemInformation,clickingontheclosedPadlock alltheexistingconfigurationsettingsandalsorevealthefollowingsettingsthatarehiddenwhen
theSystemInformationislocked:
Keyboard / foot pedal controls Auto logon Language Screenconfiguration atthebottomofthepagewillunlock
TheSystemInformationislockedbydefaultandclickingonthePadlockagainwillre-lockthesettings. How to Shut Down a Work Area DonotswitchoffanyRIhardwarewhilsttheWorkAreasoftwareisrunning.Tologout,selecttheuser
name, and then select Quit in the user name window. The system will then shut down. See Figure 5-8. Logging In ItisimportanttoensurethatallRIWitnesshardwareisswitchedonbeforetheworkareasoftware
isactivated. TheRIWitnesssoftwaremaybeactivatedautomaticallywhenthecomputerisstarted.Ifnot,double
click the RI Witness WorkArea desktop icon. Figure 5-6 RI Witness WorkArea icon To log in either touch Login, then your username or scan your operator ID tag and enter the appropriate 4 digit PIN if requested. Note: Operators can change the PIN assigned by the administrator and may assign an ID tag. See Figure 5-9. Auto Logon Afterunlockingthesysteminformation,screennavigatetotheautologonsection.Thereyoucansetup
the username and password (of the machine) for RI Witness to auto logon the PC. 1. Click System Information. 2. Unlocksettings. 3. Click AutoLogon. 4. Click Yes to the user Account Control message. 5. Enter the details required (contact IT department if unsure). 6. Click Save to Registry. 7. Tick AutoLogon. 8. Click the close window cross. Oninstallationoftheapplicationtheapplicationshortcutisplacedinthestart-up.Thiscausesthework
areatoautomaticallystartwithwindows. Figure 5-7 AutoLogon 25 Section 5RI Witness Basic Operation5 Research Instruments Ltd Figure 5-8 Logging into RI Witness Figure 5-9 RI Witness WorkArea logon and PIN entry windows Logging Out LogoutoftheworkareawhenyouhavefinishedyourproceduresbypressingyourUsername in the top right corner, then the Red Cross
.Anautomaticlogoutmaybeprogrammedafteraperiodof
inactivity.ThisissetusingtheRIWitnessManagerSettingspage. 26 Section 5RI Witness Basic Operation5 The WorkArea Interface The WorkArea interface screen is divided into 7 regions. See Figure 5-10 . 1 2 3 Research Instruments Ltd Emily 7 6 4 5 Figure 5-10 The WorkArea interface 1. Current patient Thisregionshowsthecurrentpatientname,dateofbirthandID.Whentagsfrombothpartners
arepresentthenameshownwillbethefemalepatient.Thepartnersnamewillappearin
brackets. 2. Recent history Therecenthistoryregionpresentsthefourmostrecentactionsthathavebeenrecordedagainst
thecurrentpatient,egwitnesspoints(action/protocolstep),operatormismatches,etc.A
timestampandoperatornamearealsoshown. 3. Work area The work area region displays an icon for each RFID tag detected by the work area. As tags progress through the witness points of a procedure they are assigned and reassigned appropriately.Aquestionmarkiconwillbeshownforanytagsthathaveyettobeassignedan
identitybytheRIWitnesssystem. 4. Status The status region summarises the work area contents. It is recommended that the number of tagsdisplayedinthestatusareaisvisuallyconfirmedateachstageofaproceduretoverifythat
each tag has been detected. Monitor the number of tags in the work area. 5. Temperature For heated systems this region displays the temperature of the work area. Click the temperature readout to show a Temperature Control window from where the temperature may be set. 27 Section 5RI Witness Basic Operation5 Research Instruments Ltd 6. Witness Points Thewitnesspointsregiondisplaysoptionsavailableforthenextstepasspecifiedbythelab
definedprotocol.Thetoponeistheprecedingactionandthecurrentcontentsoftheworkarea
determinewhatnextstepsarepossible.AnadministratorwillalsoseeanAdmin Assignoptionto
assign or reassign dishes outside of the prescribed protocol. 7. Current operator Thecurrentoperatorregionshowswhoisloggedon.Asuffix(Admin)isaddedforoperatorswho
belongtotheadministratorgroup.Allwitnesspointsperformedwillbeattributedtotheoperator
whoisloggedinatthattime. Performing A Procedure in RI Witness Bringthedishortubeyouwishtoworkonintotheworkarea.IfthetaghasbeenidentifiedbyRI
Witnessthepatientandthehistorywillbeshownonthescreen.Theoptionsforthenextactionswill
be shown in yellow on the witness point region. IntheexampleshownbelowaSpermWashTubeandanEggCultureDishhavebeenplacedinto
the work area and RI Witness has determined that the only appropriate procedure is represented by the IVF Insemination witness point. See Figure 5-11. Figure 5-11 The IVF insemination witness point is the only match for the contents of this work area Beginning a New Cycle in RI Witness ThefirststepintheRIWitnessprocedureiswhentheidentitycardforthepatientisassigned.This
isthemostimportantstepintheprotocolasiftheidentityofthepatientiscorrectlyassignedatthis
point, the security of the cycle is assured. 28 Section 5RI Witness Basic Operation5 Research Instruments Ltd Starting a New Procedure 1. To start a new procedure, log in then place one or more unassigned, tagged items into the work area(usuallyapatientIDcard,eggcollectiondishorspermpot).Ayellowquestionmarkwill
show that the tag has been detected and is unassigned. See Figure 5-12. Press the icon. In the All PatientstabtypethepatientnameorIDnumbertolocatethecorrectpatientinthe
database. See Figure 5-13. 2. 3. Alternatively,theDaily ListstabshowsallEggCollectionsandEmbryoTransfersscheduledfor
theday.ClickthepatientcycleforeitherEggCollectionorEmbryoTransfer,thiswilldisplaythe
chosenpatientsdetailsintheworkarea.
4. Choosewhichactionyouintendtoregister/performandthenclicktheConfirm 5. If a double check by another person has been set at this point, a 2nd Witness window will appear.ThisrequiresacolleaguetoverifytheactionbyinputtingtheirnameandPIN.See
DoubleWitnessPointsonpage30. icon again. Figure 5-12 Unassigned tag has been detected 29 Figure 5-13 Choose Patient/All Patients window to assign ID Section 5RI Witness Basic Operation5 Research Instruments Ltd Witness Point Confirmation Ateverystepintheprocedure,awitnesspoint(action)mustberegisteredinthesystem.Therefore
whenanactionisperformed,selecttherelevantwitnesspointandconfirmbycheckingthedetailsin
theconfirmationwindowandclickingtheConfirm icon
. Figure 5-14 Confirming a witness point Double Witness Points Criticalpoints,asdefinedbytheadministrator,mustbewitnessedbyasecondoperator.Thesecond
witness must enter their PIN. See Figure 5-15. Figure 5-15 A double witness point 30 Section 5RI Witness Basic Operation5 Research Instruments Ltd Question Witness Points Question Witness Points, as defined by the administrator, require a response from the operator.
ExamplesoftextandnumericquestionsareshowninFigure5-16andFigure5-17. The Witness Point question and the operator response is displayed during the final witness point
confirmationwindow.Thequestionandresponsealsoformpartofthehistoryloggedforthisevent. Figure 5-16 Add witness point question Figure 5-17 Edit witness point question 31 Section 5RI Witness Basic Operation5 Research Instruments Ltd Record Witness Points Gatherallthe(tagged)plasticwarethatarerequiredtoperformaprocedureandplacetheminthe
work area. Awindowrepresentingtheworkareawilldisplayallthetagsandshowtheidentityofanytagsalready
knowntothesystem.
An active patient is selected either manually or automatically; manually by clicking on the Patient Detailssectionoftheworkareaandchoosingapatientfromthelist,orbythesystemautomatically
selectingthepatientidentifiedbythetagsintheworkarea:
Ifthereisonepatientintheworkareathenthisisthecurrentpatient. Ifthereare2patientsintheworkareawhoaremale/femalepartnersthenthefemalepatientis
thecurrentpatient.
Ifthereare2ormorepatientsafteradonationwherethepatientsaredonor/recipient(s)then
thedonoristhecurrentpatient. Alistofpossiblewitnesspointsisshown,determinedbytheselectedpatientandvisibletags.Choose
the appropriate witness point. Ifthewitnesspointisataggeddonationtype,thentherecipientwillneedtobechosenfromalistat
this point. Ifthewitnesspointrequiresfurtherinformationenteredbytheoperator,thenthiswillbeaskedfor. If the witness point requires a 2nd witness, then another operator will now need to choose their name and enter their PIN. Aconfirmationwindowsummarisesallthedetailsrelatingtothewitnesspointthatwillberecorded.
Ifallthedetailsarecorrect,thenselectingthetickwillrecordthewitnesspoint. If any new tags are added to the work area during the processing of a witness point (or admin assign) then the witness point will be cancelled. Also, if during the processing of a witness point one of the tags in the work area drops out of range of the reader(s), then the witness point can be completed and the tag(s) will be reassigned successfully. Unassigned Tags Thetagsonunusedplasticwareareunassignedandareshownasaquestionmarkiconintheworkarea
display. SeeFigure5-18.Whenselectingawitnesspointunassignedtagsareautomaticallyassignedto
thepatientcurrentlydisplayedonthescreen.Theywillbeidentifiedasthesampletagdefinedbythe
witness point. Figure 5-18 The question mark icon represents an unassigned tag 32 Section 5RI Witness Basic Operation5 Research Instruments Ltd Unassigned Tag Removal A STOP warning is displayed when an unassigned tag is removed from the work area. See Figure 5-19. Thismessageinformstheoperatorthatanunassignedtagenteredandexitedtheworkareawithout
being registered in the current procedure. If that is correct select Closeandcontinue.Ifnot,replace
the sample/labware in the work area and perform a witness point. Figure 5-19 Unassigned tag removal Tag Mismatch TheRIWitnesssystemwillonlyallowonepatient(withdonor)oracouplessamplestobeplacedina
workareaatanytime.Ifanunlinkedsampleisplacedintheworkarea,acontinuousalarmwillsoundand
a mismatch window will appear immediately. The STOP message is displayed. 1. Remove the samples in order to stop the alarm and select Close to close the window. 2. Amismatchreasonwindowisdisplayed.Theoperatormustenteranexplanationforthemismatch
beforeworkcancontinue.Theexplanationwillappearinbothpatientscyclehistoriesandwillbe
visibleintheRIWitnessManagersoftware. Note:Ifthemismatchoccurredwhilenooperatorwasloggedin,anexplanationforthemismatchis
associatedwiththeoperatorexplainingbutnotthemismatchitself. Figure 5-20 Tag mismatch 33 Section 5RI Witness Basic Operation5 Research Instruments Ltd Record Location of Tags Ateachworkarea,alocationnamecanbesetthroughtheSystemInformationwindowthatuniquely
identifiesthatworkarea.InRIWitnessManageralistofalltheconfiguredlocationscanbeviewed.
Whenatagisplacedintoaworkarea,thelocationwillbestoredwiththetagdetails;thenwhenthe
tagsassociatedwithapatientaredisplayed,theirlastknownlocationwillalsobedisplayed.SeeFigure
5-21. Thenameofeachworkareacanbeconfiguredinitiallybyanyuser.Anadministratorcanmodifyany
locationname.AlistoflocationscanbeseeninRIWitnessManagerfromwheretheycanbedisabled
andenabled.DisablingalocationwillcausetherelatedworkareasnametoberesettoUnknownsoit
canthenberenamedbyauser.Anydisabledlocationcanbere-enabled.Thiswillsetitsnamebackto
the previous value. To name a work area:
1. Whentheworkareaisstartedinitiallyyouwillberequiredtogivetheworkarealocationa
name.Anyusercaninitiallysetthenameofaworkarea.Aredcrossiconwillappearaswellas
the System Information icon as a warning triangle. 2. Click the Warning Triangletoopensysteminformation. 3. Unlockthesettings. 4. Click WorkArea Location. 5. Enteralocationdescription/name. 6. Click the Confirm Icon Whenawitnesspointiscompleted,thelocationatwhichittookplacewillberecorded.
Note: PCs connected to the RI database must have unique computer names, if connected to a domain this will be set, otherwise please check. Figure 5-21 Tags tab 34 Section 5RI Witness Basic Operation5 Research Instruments Ltd Training Mode Fortrainingandtesting,anyRIWitnessworkareamaybesettoTrainingMode. 1. Log in as an admin operator. 2. Open System Information. 3. Select Screen Configuration / Training Mode. 4. ThenticktheTraining Modebox.
In Training Mode, the normal work area screen is replaced with an orange background. See Figure 5-22. OnloggingoutofTrainingMode,thetrainingworkareaeventswillautomaticallybedeleted. Clear Demo Tables (legacy work areas for pre software version 2.3 only) Training work area events are stored in a demonstration database which may be cleared using RI
Witness Manager. An admin operator may click Clear Demo Tables on the General Settings page of RI Witness Manager. Figure 5-23. Figure 5-22 Training mode 35 Figure 5-23 The RI Witness Manager general settings page Section 5RI Witness Basic Operation5 Research Instruments Ltd Admin Assign Designated operators may use the Admin Assignbutton,seeFigure5-24,toassignanytagtype(sperm
pot, inseminated dish, sperm wash tube, etc) to an unassigned tag at any point. Note:AdminAssignshouldonlybeusedunderexceptionalcircumstancesandbytrainedpersonnel
only. Note:WithAdminAssignyoucanalsochangethetypeofdishalreadyassignedtoapatient. Figure 5-24 Admin assign Discards When a single tag is placed in the work area the Discard buttonisenabled,seeFigure5-25.Pressingit
willdisplayaconfirmationscreenwithagreentickandredcross.Thered cross will cancel the will mark the tag as discarded -
discardandclosetheconfirmationwindow,whilstthegreentick
changinghowitisdisplayedintheworkareaandpreventinganywitnesspointstakingplacewhilstitis
in the work area. ThereisalsotheoptionfromwithinRIWitnessManagertoenableDiscardstorequireaWitness.
Onceenabled,awitnesswillbepromptedtologinonthescreenfollowingtheoperatorselectingthe
Discardbutton,afterasuccessfullogintheconfirmationwindowwillbedisplayedasusual. Figure 5-25 Discard 36 Section 5RI Witness Basic Operation5 Research Instruments Ltd Figure 5-26 Confirm discard Figure 5-27 Discard in the work area Cycle Summary Thecyclesummaryisdisplayedintheworkareaatalltimes;itisadatasheetthathasbeenselectedto
beshownfromtheRIWitnessManager.Ifapatientisnotselected,orthereisnocyclesummaryfor
aselectedpatient,thecyclesummarydisplaywillsay<No Details Available>.Iftheselectedpatient
contains a cycle summary sheet, this sheet will be displayed in the Cycle Summary area. Daily Lists Onthepatientselectwindow,youcanselectthedailylistwhichshowinglistofpatientsfortoday.The
dateisdisplayedinthetopleftofthewindow.Tochooseanotherdateandviewitsrelatedprocedures,
clickontheleftandrightarrowsatthetopofthewindow.(Theleftarrowmovesthedatebackoneday
andtherightarrowadvancesthedatebyoneday).Toselectapatient,clickonthepatientIDnumber. Windowed Work Area Foradminstationswithadminreaders,theWorkAreaapplicationcanbewindowedtoalloweasyaccess
tothetagreadingfunctionality. 1. OpentheRIWitnessWorkAreaapplication. 2. Click System Information. 3. Unlockthesettings. 4. Click Screen Configuration / Training mode. 5. Tick Windowed WorkArea. 6. Click Save and Quit. 7. Ifyouhavemultiplescreenssetup,theworkareawillnowreverttoonesingleworkarea
screen. 37 Section 5RI Witness Basic Operation5 Research Instruments Ltd Language and Keyboard Layout Afterunlockingthesysteminformationscreen,navigatetotheLanguageandKeyboardsettings.From
there the language on-screen and keyboard style can be changed using a drop-down menu. If the selected item in either drop down menu is changed, then clicking the red cross will save these changes and modify the language and keyboard. 1. Click System Information. 2. Unlockthesettings. 3. Select your required language from the drop down list. Figure 5-28 Language selection 4. Select your required keyboard style from the dropdown list. 5. Click the red cross to save and close the window. The language used can also be changed from RI Witness Manager 1. Click Settings 2. ChooseyourrequiredlanguagefromthedropdownlistintheLanguagesection Figure 5-29 RI Witness Manager Language Setting Foot Pedal Control IntheworkareatheSystemInformationPanelcontainsaKeyboard / Foot Pedal Shortcutsbutton
which launches the Keyboard Shortcut Configuration dialog. Withinthekeyboardshortcutconfigurationdialog,eachavailablecommandislistedfollowedbyan
inputboxandclearbutton(withacross). Toassignakeyboardshortcuttoacommand,clickinthecorrespondingtext/inputboxandthenhold
downthekeysyouwanttoassigntothiscommand.TheinputboxwillchangefromPleaseEnter
ShortcutKeytoalistofthecurrentlyhelddownkeyboardkeysseparatedby+s.Oncethekeyboard
keysarereleasedthosekeysaresavedtotheinputbox. Pressing the Clearbuttonwillremovethekeyboardshortcutforthatcommand. In order to save these changes you must press the Save and Quitbuttonatthebottomofthedialog. Intheworkarea,oncetheshortcutsaresetup,simplypresstheshortcutkeystoactivatethecommand. 38 Section 5RI Witness Basic Operation5 Research Instruments Ltd Enters laser control mode. Ifalreadyinlasercontrolmodethiscommandfiresthelaser. List of commands:
Fire / Enter Laser Mode. Preset Laser Down. Preset Laser Up. Start / Stop Recording. Take Picture. Zoom In / Zoom Out. Zooms out fully if already zoomed in. If zoomed out zooms into pre-set zoom value at centre. Zoom In. Zoom Out. Zooms into centre one step. Zooms out from centre one step. Freeze Frame. Please Note:Shortcutkeysshouldbelimitedtothefunctionkeystoavoidconflictswithtypingor
barcodes. To Rename the Work Area 1. Log in as an Admin user. 2. Click System Information. 3. Click WorkArea Location. 4. Type the name of the work area using the on screen keyboard. 5. Click the Confirm Icon. Figure 5-30 Figure 5-31 To Change the Location of a Work Area 1. Log in as an Admin user. 2. Click System Information. 3. Click WorkArea Location. 4. Click Change Location. 5. ChoosethelocationrequiredfromthelistorclickCreate New Locationtosetanotherlocationname. 6. Click the Confirm Icon to accept the change. 39 Section 5RI Witness Basic Operation5 Research Instruments Ltd To View Work Area Locations or Disable a Work Area 1. Open RI Witness Manager. 2. Click Settings. 3. Click WorkArea Locations,youwillnowseeallnamedworkarealocations. 4. Highlight the work area and click Disable. 5. DisabledaccountscanbeviewedbytickingShow Disabled Accounts. Alarm if Tags Left in Work Area TohelpavoidmismatchesbeingrecordedCardLeftinReader. 1. Open RI Witness manager. 2. Click Settings. 3. Click General Settings. 4. UnderworkareasettingstickWarn on logout if tags left in WorkArea. Figure 5-32 Figure 5-33 40 Section 5RI Witness Basic Operation5 Research Instruments Ltd Figure 5-34 41 Section 5RI Witness Basic Operation5 Research Instruments Ltd SECTION 6 - RI WITNESS MANAGER RI Witness Manager can be used on PCs or tablets outside of the RI Witness work areas, predominately foradministrationpurposes. Logging In 1. Double click the RI Witness Manager desktop icon. 2. Choose your assigned operator name from the list. 3. Enter your 4 digit PIN. 4. Click Login License Management Figure 6-1 Logging in RI Witness, Traceability, Data Capture, Cryo and Imaging must be licensed. LicensinginformationisstoredinthesharedRIWitnessdatabase.
On first use of RI Witness Manager a license warning window will be shown. On each subsequent use of RI Witness Manager, a license check is made and a similar license warning windowwillinformtheoperatorifanylicensesareclosetoexpiration. Atanytime,theRILicenseManagermayalsobeinvokedasaseparateapplicationbyclickingSettings and then RI License Manager. Figure 6-2 License warning 42 Section 6RI Witness Manager6 Research Instruments Ltd Figure 6-3 RI License Manager License Request Form Ifyourlicenseisclosetoexpiration,youcanquicklyrenewyourlicense. 1. Click License Manager in the RI Witness Manager license warning window. A license request form will open. See Figure 6-4. IfyouhaveaRegistrationCodeissuedbyRI,enteritatthebottomoftheform.
2. Complete the details on the form. 3. 4. Click Send Requestaftercompletingallthefields. 5. If internet access is available, a response will be returned by the RI Licensing Server. See Figure 6-5. 43 Figure 6-4 The license request form Section 6RI Witness Manager6 Research Instruments Ltd 6. Ifinternetaccessisnotavailable,pleasefollowthedisplayedinstructionstosavealicense
requestfile.ThefileshouldthenbeemailedtoRIatactivate@research-instruments.com. 7. OnceRIhasreceivedyourrequest,aLicenseDatafilewillbeemailedbyreturn. Figure 6-5 A response from the RI license server Figure 6-6 The license request email 8. TheLicenseDatafileshouldbemadeavailabletotheRIWitnessManagerPCwherelicensing
is performed. 9. EachtimeRIWitnessManagerisopenedfollowinglicenserequest,LicenseManagerwindow
will be displayed. See Figure 6-7. 10. OnreceiptoftheLicenseDatafile,clickImport New License File in the license manager dialoguebox.Browsetotheemailedlicensedatafileandselect.TheLicenseManagerwillnow
be updated with the new license details. 44 Section 6RI Witness Manager6 Research Instruments Ltd Figure 6-7 The License Manager window Database Management RI Witness Manager must connect to the shared RI Witness database. 1. AtRIWitnessManagerlogin,adatabaseconnectionswindowwillbeshownifaconnection
cannot be made. See Figure 6-8. Figure 6-8 The RI Witness database connection is unavailable 45 Section 6RI Witness Manager6 Research Instruments Ltd 2. Click the Database Settingspagebuttontoshowthedatabaseconnectionsettingswindowand
entertheappropriateservername,databasenameandauthenticationdetails.SeeFigure6-9. See the IT Requirements Manual for more details on database management. Initial Screen - Main Menu Buttons Afterlogin,aninitialscreenshowsanumberofmainmenubuttons.Themainmenubuttonspresented
will depend on operator group membership (administrator, normal) and the mixture of installed
products (RI Witness, Traceability, Data Capture, Imaging and Cryo). Figure 6-9 Database connection settings Home When first logging into RI Witness Manager the Cycles Overview Board is displayed. Clicking the
HomebuttononthelefthandtoolbarwillreturntheusertotheHomescreen.TheRefreshbuttonon
theHomescreencausesthedisplaytorefreshbyre-queryingthedatabasetofindtheactivetreatment
cycles. 1. Toseethecycledetailsofapatient,doubleclickontherowwiththepatientsdetails.A
Treatment Cycle page will open. Figure 6-10 Home screen 46 Section 6RI Witness Manager6 Research Instruments Ltd How to Configure the Home Screen Eachdayofacycleoraneventcanbegivenadifferentcolourcodetoaideasyandquickidentification
of the cycle status. This can also assist the ordering of procedures. ToconfigurethecolourcodingwithintheHomescreen,followthestepsbelow.ExactspellingsofCycle
Types and Events used in the Witness Point Diagram must be used. 1. Click Settings. 2. Click Home Screen Configuration. 3. FirstlyyouwillneedtosetupStates.Thesecanbedaysoreventsandarecolourcoded. Tip: YoucouldsimplydoDay1,2,3,4,5tostartwith. 4. Click +withintheStatesfield. 5. Type the name of the State, eg Embryo Freeze, Day 0, Day 1, etc. 6. Onclickingthebackgroundorforeground(TextColour)box,acolourpickerwillappear.Select
the desired colours. 7. Press Save. 8. Nextaddacycletype.Clickthe + buttonwithintheCycletypesfield.ACycleTypeboxwill
appear. Type in the cycle type carefully, ensuring there are no spelling mistakes. The cycle type willneedtomatchwhatyouhavealreadysetwithintheTreatmentCycleTypesfieldswithinthe
database(SeeCycleTypesonpage70.)AnexampleofacycletypecouldbeIVF,ICSI/IVF,
FET, ICSI, etc. Figure 6-11 Home screen 9. Click Save. 10. Select the Cycle Type drop down arrow you would like to colour code. 11. Click Add Day or Add Event. 12. Assign a day number, ie 3 for Day 3. 13. WithintheMessagefield,typetheDaydescription,ieDay3. 14. IntheStatedropdownfield,choseoneoftheStatesthathasbeensetup.
15. Save. 16. Repeat for each Cycle Type. 47 Section 6RI Witness Manager6 Research Instruments Ltd Patients Click the PatientsbuttontoshowtheChoose Patientwindowifnopatienthasbeenselectedortoview
detailsofaselectedpatient. Figure 6-12 Choose patient screen 1. TypethefirstfewcharactersofanameorpatientIDtobrowseaselectionofmatchingpatients.
2. HighlighttherequiredpatientandclickOKordoubleclicktherequiredpatienttoviewtheir
details. 3. Treatmentcycles,witnesspointsandtagsfortheselectedpatientcanalsobeviewedby
selectingthetabsinthisscreen. 4. ClinicswithCryoenabled,canprintbarcodesfortheselectedpatientbyclickingBarcode Printing. Barcodes printed from here will be recognised by the RI Witness system as belonging totheselectedpatient. 5. Click Label Printingtocreateadhesivesheetswiththeselectedpatientdetails.Thesecanbe
attachedtoplasticwareforthispatientssamples.Forfurtherdetailsregardinglabelprintingsee
PrintingPatientLabelsonpage54. Entering New Patient Details into RI Witness Manager 1. Click the Patients buttontoshowtheChoose Patient window. 2. Click on New Patientbutton. 3. Enterdetailsintoappropriatefieldsallfieldswhichhavebeeneditedarehighlightedinpink. 4. Save all changes. Note: FromthePatientspagethereisalsoanoptiontoaddorchooseanewpatient. Note: A patient cannot be assigned to a partner until the partner has also been entered into the
RIWitnessManagersoftwareseparatelySeeAssigningPartnersonpage50. Note: Label sheets and barcodes can be printed from this page. 48 Section 6RI Witness Manager6 Research Instruments Ltd Figure 6-13 New patient details Editing Existing Patient Details OpenPatientdetailsasoutlinedabove. 1. Click the Edit button
2. Click the Save buttontosavechanges. to change to the editable window. Looking Up Patient Histories 1. FromthePatientspage,selecttheTreatment Cycles tab to view all previous cycles undertaken forapatientorcouple. 2. Select the Witness Points tab to view all witness points registered in an open cycle. 3. Select the Tags tabtoseealllocationsthattagsassignedtothepatienthavebeenseenbyRI
Witness. RefertoFrequentlyAskedQuestionsifnecessary. 49 Figure 6-14 Looking up patient histories Section 6RI Witness Manager6 Research Instruments Ltd Assigning Donor Status InthePatientdetailswindowselectrelevantdonoroptions.
Can Receive Untagged Donations Can Receive Tagged Donations Can Donate Figure 6-15 Assign Donor Status Theavailabilityofthedonatecheckboxeswilldependonthegenderofthepatient,ieonlyfemale
patientscanreceivedonations. Assigning Partners 1. Createanewpatiententry,orchooseexistingpatient,leavingthepartnerfieldblank. 2. Createanewpatientforpartner.
3. Tolinkthe2patients,selecttheChoose Partner buttontoshowtheChoosePatientwindow. 4. LocatepartnerbytypingthefirstfewcharactersofanameorpatientIDinthesearchwindowto
browseaselectionofmatchingpatients.
5. ClickonthepatientnameandthenconfirmselectionbyclickingOK. See Figure 6-16. Figure 6-16 Assign Partners 50 Section 6RI Witness Manager6 Research Instruments Ltd Cycle Types Acyclerelatestoaspecificcourseoftreatment(IVF,ICSI,IUI,etc). Onlyadministratoroperatorsmaycreatecycletypes.
1. Click the SettingsmainmenubuttonandthenclickCycle Types to view all treatment cycle types. See Figure 6-17. 2. Click New to add each cycle type. 3. Use a right click to Rename a cycle type. Traceability operators may specify the range of materials that are used in a cycle type. Data Capture operators may specify the data sheets that are used in a cycle type. Starting a New Cycle 1. Click the PatientsmainmenubuttonandselectapatientbyenteringanameorpatientID.
2. Click the Treatment Cycle Typetabtoshowthelistoftreatmentcyclesforthispatient.Fora
Figure 6-17 The Treatment Cycle Types Window newpatientthislistwillbeempty.
3. On the Treatment Cycle TypestabofthepatientscreenclickAdd New Cycle to create a new cycle.ThenewcycleisshownwithastatusofInProgressandacycletypeofUnknown.See
Figure 6-18. 4. Traceability operators may click the Materials tab to view a list of material batches related to this cycle. 5. All operators may click the Witness Points tab to view a list of witness points performed during this cycle. Assign a Cycle Type Select a cycle type from the pulldown list. 51 Section 6RI Witness Manager6 Research Instruments Ltd Collection and Transfer Dates IfEggCollection/EmbryoTransferdatesareenteredontheDetails tab of a treatment cycle then these events will be available from the work area Show Daily Liststouchbutton. SeePerformingAProcedureinRIWitnessonpage28formoredetailsofpatientselectionusing
Daily Lists. Cycle Status AnewlycreatedcyclewillbeassignedthestatusInProgress.Whenthepatienttreatmenthasbeen
completed click End CycletochangethestatustoCompleted. Revert Status An administrator operator may click the Revert Status thestatustoInProgress.
buttonofaCompletedcycletoreturn
1. Click Add New CyclefromthePatientswindow.
2. Select a Cycle Type from the pulldown on the Treatment Cycle window. Figure 6-18 Starting a new cycle. 52 Section 6RI Witness Manager6 Research Instruments Ltd RI Patient Identity Labels LaserprintableadhesivepatientidentitylabelsareavailablefromRI. Thesheetprovidesarangeoflabelsizeswithaselectionofnormalandreverseprinting.SeeFigure
6-19. Figure 6-19 RI laser printable label sheet. Reverse printed labels are viewable through the base of containers. Label categories such as Petri Dish and Test Tube are for guidance only. Please select a label
appropriatetoyourplasticware. TesttubelabelsmaybeusedtoholdarectangularRFIDtaginpositionalongthelengthofatube. Thereverseprinted4welldishlabelandthesquareRFIDtagaretherecommendedchoicefora4
well dish. See Figure 6-20. RILabelsareanoptionalcomponentofRIWitness. 53 Figure 6-20 Positioning of patient identity labels Section 6RI Witness Manager6 Research Instruments Ltd Printing Patient Labels 1. FromthepatientdetailswindowclickLabel Printing See Figure 6-21. 2. Load a blank label sheet into a laser printer. For repeatability of alignment use a manual feed path and take care when placing each sheet. 3. SetallSheetAlignmentvaluestozeroandclick Print Labels. 4. Checktheprintedsheet.Measuretheoffsetsrequiredtocorrectlypositiontheprinteddetails
withinalabelboundary.Payparticularattentiontoverticalpositioningwithinthesmallestlabel.
See Figure 6-22. Figure 6-21 The label printing manager TheexampleshowninFigure6-22showsdetailsofanalignmentcorrectionwithintheboundaryofthe
smallest label. 5. Thefirstprintshowsincorrectalignment. 6. VerticalalignmentiscorrectedbyanegativeYoffset. 7. HorizontalalignmentiscorrectedbyapositiveXoffset. 54 Section 6RI Witness Manager6 Research Instruments Ltd Figure 6-22 Label text alignment Label Styles UsetheLabelLayoutbuttonstoselectanappropriatestyle. Style1isoptimisedforpopularplasticware,Style2maximisestheuseofavailablespaceandStyle3is
amixtureofStyles1and2. Note:Arotationalignmentcorrectionisrarelyrequired. Note: Check Print this row only and select a row number to print a single row of the smallest labels only. This may be useful if reusing a sheet during the alignment process. Operator Management Click Operators to display a list of all enabled operators. See Figure 6-23. 55 Figure 6-23 Operator management Section 6RI Witness Manager6 Research Instruments Ltd Operator Details 1. Click Add to specify details for a new operator. See Figure 6-24. 2. Select an operator and click Edit to change operator details. An operator must have a Username, Full Name and Anonymous ID. The Anonymous ID is used for printed reports. Group Membership Groupmembershipisspecifiedasnormaloradministrator. Some RI Witness features are only available to an administrator operator. Administrator only
features include the use of admin assign and making changes to the witness point diagram. Enabled Operators Only enabled operators may log in. Click Disable to remove an operator from the enabled list. Check ShowDisabledAccountstoviewalloperators. Figure 6-24 Operator Details Operator PIN The operator PIN must be a sequence of 4 numbers. Clinic Details Click the SettingsmainmenubuttonthenclickGeneral Settings to specify the Name of Clinic that will appear in all printed reports. SeeFigure 6-25. 56 Section 6RI Witness Manager6 Research Instruments Ltd Figure 6-25 The heading of a printed report will show My Clinic Name as specified by Name of Clinic on the general settings page. Mismatch Comments In RI Witness Manager Userscanaddextracommentstofurtherexplainanymismatchesinthehistory 1. Open RI Witness Manager. 2. Click the Cyclesbutton.
3. From Treatment Cycles double click the cycle required to view. This can be seen by clicking patientsalso. 4. Click the Witness Points tab. 5. Double click the Mismatch witness point. 6. Click the Edit 7. Enteradditionalcomments. 8. Click Done. icon. Figure 6-26 Report settings 57 Section 6RI Witness Manager6 Research Instruments Ltd The Witness Point Diagram ThewitnesspointsthatarepresentedtoallworkareaoperatorsaredefinedinRIWitnessManager
by a witness point diagram. To view the witness point diagram click the Settings mainmenubuttonandthenclickWitnessing. See Figure 6-27 and Figure 6-28. Figure 6-27 The settings screen Click Witnessing to view the witness point diagram To add a new witness point, click New Witness Point and then click anywhere in the diagram. Enter a nameforthewitnesspoint,egIVFInsemination UsetheWitnessPointInfopaneltospecifytheattributesofawitnesspoint.Witnesspointattributes,
egreassignaneggculturedishtagtobecomeaninseminateddishtag,aredescribedbelow. Tagnamessuchasinseminateddishmustbedefinedbeforetheymaybereferencedbyawitness
point.SeeTagTypesonpage63. Figure 6-28 The witness point diagram. 58 Section 6RI Witness Manager6 Research Instruments Ltd Links Thelinks(arrows)betweenwitnesspointboxesrepresenttags(dishes,testtubes,etc)thatarethe
requiredinputsandproducedoutputsoftheproceduredefinedbythatwitnesspoint. To create a link, click Add Link and then drag between two witness points. Reassigned Tags Awitnesspointmayrepresentthereassignment(transformation)ofonetagtypeintoanother,egan
EggCultureDishbecomesanInseminatedDishasthespermisintroduced. A reassignment is illustrated in Figure 6-29 where the Reassign this dishcheckboxischeckedtospecify
thattheselectedtagtypeEggCultureDishwillbereassignedasanInseminatedDishwhenthis
witnesspointisexercisedbytheworkareaoperator. Unassigned Tags Witness points may require that unassigned (empty, unused) tags be introduced into the work area. Note: TheIVFInseminationWitnessPointdoesnotrequireanunassignedtagastheUnassigned
tagswillbeassignedto:pulldowninFigure6-29showsnone. Whereawitnesspointrequirestheintroductionofanunassignedtag,usetheUnassignedtagswillbe
assignedto:pulldowntoselectthetargettagtype. Figure 6-29 Detailed information for the IVF Insemination witness point IVF Insemination Egg Culture Dish Patient ID (female) Inseminated Dish Figure 6-30 A reassigned tag is represented by a curved line between the two tag names Anunassignedtagisrepresentedbyastraightlinebetweenaquestionmarkandthetargettagname. A witness point may specify both a reassignment and the use of an unassigned tag. 59 Section 6RI Witness Manager6 Research Instruments Ltd Witness Point Inputs Incoming links to a witness point specify the tags that must be present before the procedure represented bythewitnesspointcanbeperformed.Ifanunassignedtagisspecifiedthenthatcontainermustalso
be present before the procedure can be performed. Multiple Sources of the Same Tag Type AwitnesspointwithmultipleinputlinksofthesametagtypeegdishX,representsanORoperation,
ie the required container may be sourced from the procedure represented by witness point A OR B. A B Dish X Dish X C Figure 6-31 Dish X must be available to witness point C Witness point A OR B may be the source Multiple Tag Types AwitnesspointwithmultipleinputlinksofdifferingtagtypesrepresentsanANDoperation,iethistag
type AND that tag type are required to perform the procedure represented by this witness point. See Figure 6-32. A B Sperm Wash Tube Egg Culture Dish IVF Insemination Inseminated Dish Figure 6-32 The IVF Insemination witness point represents a procedure that requires a Sperm Wash Tube AND a Egg Culture Dish Entry Witness Points Entry(initial,starting)witnesspointshavenoincominglinks.Anentrywitnesspointwillalwaysrequire
anunassignedtagwhichwillbecomeassignedoncompletion.SeeFigure6-33. Assign Patient ID (female)
? Patient ID (female) Patient ID (female) Assign Egg Wash Egg Wash Dish Figure 6-33 Assign Patient ID (female) is an entry witness point as it has no input links An unassigned tag (here an unassigned ID card ) is required Double Witness Points Checking the Double Witnessbox,seeFigure6-29,changesthecompletionsequenceforawitness
point. A second operator must log in to approve the procedure. Entry witness points are generally double witness points. 60 Section 6RI Witness Manager6 Research Instruments Ltd Donor Witness Points Amismatchalarmwillbegeneratediftagsassignedtopatientswhoarenotspecifiedaspartnersare
introduced to the work area. Theexceptiontothisruleisprovidedbydonorwitnesspoints.CheckingtheDonorboxwillcreatea
donor witness point which is given a diagonal colouring. See Figure 6-34. Assign Egg Wash Donate Eggs Egg Wash Dish Egg Prep Figure 6-34 A known donor witness point Tagged Donations Anincominglinktoadonorwitnesspointspecifiesataggeddonationandcoversproceduressuchas
egg/embryodonation/sharingaswellassurrogacy. Whenthewitnesspointisselectedtheoperatorchoosesthedonationrecipient.Therecipientidentity
isassignedtothetagcontainingthedonatedmaterial.Theworkareanowcontainstagswithamixture
ofdonorandrecipientidentities.Thisdoesnottriggeramismatchbecausethetagshavethedonor
witness point in common. TaggedDonationsrequirethatthedonorandrecipientbespecifiedassuchviatheCan Donate and Can Receive Tagged Donationcheckboxesavailableinthepatientdetails.SeeFigure6-35. First Name Wendy Last Name Rogers Date of Birth 27 October 1967 Can Receive Untagged Donations Can Receive Tagged Donations Can Donate Partner 36734M Mr John Rodgers Figure 6-35 The Can Donate checkbox specifies
theabilitytomakeataggeddonation. The Can Receive Tagged Donations checkbox must be checked for the
recipient. The donor witness point ensures that donated tagged material is only available to patients that have the
Can Receive Tagged Donations box
checkedintheirpatientdetails. 61 Section 6RI Witness Manager6 Research Instruments Ltd Untagged Donations Spermdonationsareusuallyuntagged. An donor point will be an entry witness point for a female recipient of donated sperm. The donated sperm will be transferred to an unassigned tag that is then assigned to the female recipient when the donor witness point is selected. ThedonorwitnesspointensuresthatuntaggedspermisonlyavailabletopatientsthathavetheCan Receive Untagged Donationsboxcheckedintheirpatientdetails. Witness Point Questions Aquestionmaybepresentedtoaworkareaoperator.Thequestionandresponsewillberecordedin
the history log. Tosetaquestionfortheselectedwitnesspoint:
1. Click the Add Questionbutton. 2. Chooseaquestiontypeandenterthequestiontext.SeeFigure6-36. 3. The diagram will show an Exclamationappendedtothewitnesspointnameifaquestion
!
has been added. 4. Click the Exclamationtoeditthequestiondetails.
!
IVF Insemination Egg Culture Dish Patient ID (female)
!
Inseminated Dish Figure 6-36 Adding a witness point question that requires a numerical answer Note the exclamation after the witness point name 62 Section 6RI Witness Manager6 Research Instruments Ltd Tag Types Click Tag Types to specify the name and icon for each RFID tagged item used in the witness point diagram. See Figure 6-37 Witness Point Order From the witness point diagram page click Witness Point Order to specify the order in which points will be displayed to the work area operator. Click Up or Down to change the order. See Figure 6-38. Figure 6-37 Tag types Figure 6-38 Setting the witness point order. The Witness Point Log Workareaevents,egwitnesspointselectionandtagmismatches,areloggedintheshareddatabase.
Thewitnesspointlogmaybeexploredindetailorviewedasasummary.Aprintedreportmaybe
generated from any view of the witness point log. Click the Witness PointsmainmenubuttonthenclickStatistics or Explore to view the witness point log. See Figure 6-39. 63 Section 6RI Witness Manager6 Research Instruments Ltd Figure 6-39 The witness points screen Click statistics or explore to view the witness point log Witness Point Log Statistics Thestatisticsviewsummarisesthewitnesspointlogbypresentingsignificanttotals,egTagsused,
Patientsseen,etc.Theviewmaybefilteredbydate.SeeFigure6-41. Figure 6-41 Statistics from the witness point log Explore the Witness Point Log TheWitnessPointExplorershowseventsfromthewitnesspointlog. Theviewmaybefilteredbydate,operator,patientandtagtype.Shortcutlinksareprovidedforcommon
filters,egMonday,Adminassignsthisweek.SeeFigure6-40. Figure 6-40 Exploring the witness point log 64 Section 6RI Witness Manager6 Research Instruments Ltd SECTION 7 - CRYO WITNESSING An Introduction to Cryo Witnessing Many embryology labs wish to extend witnessing and reporting to include samples stored in cryo
storage.TheCryofeatureisabarcodelabellingsolutionforcryostraws. Clinicshavetheoptionofscanningbarcodesthattheyhavealreadybeenassignedtosamples,andRI
barcodesthathavebeenprintedfromRIWitnessManagerandareassignedtoaparticularpatient. IfacliniconlywishestobeabletoscanabarcodeprintedfromtheRIWitnessManagerapplication 1. Open RI Witness Manager. 2. Click Settings. 3. Click General settings. 4. TickthecheckboxundertheBarcodesectionOnly use RI Barcodes. Figure 7-1 Only use RI barcodes Printing Barcodes 1. Open RI Witness Manager. 2. FromthepatientdetailswindowclickBarcode Printing. See Figure 7-2. Figure 7-2 RI Witness Manager 65 Section 7Cryo Witnessing7 Research Instruments Ltd 3. To print barcodes make sure that a correct label printer is plugged into the computer with the correct label stock loaded into it. Figure 7-3 Barcode printing window 4. Select The required number of barcodes Thestartingnumber
The freeze date of the barcodes. 5. A preview of the barcodes that will be printed is shown in the Label Preview. The last number onthesecondlineisthesamplenumberforthispatient.Thiscanbeeditedallowingreprinting
ofaparticularbarcode,forexampleiftheinitialprintingwasmisaligned. 6. Click Print Labels. 7. If you are using small style labels you may need to print a blank row to gain access to the printed labels. To print a blank row of labels, click Print Blank Row. 8. Tochecktheprintedlabels,measuretheYOffsetbetweenthetopofthebarcodeandthetopof
thenextlabelandsettheprintheadpositionontheprintertothisvalue. 1 2 Printheadpos.Y
+7.2 mm Figure 7-4 Aligning the label print stock 1. The first print shows incorrect alignment. 2. Alignment is corrected by setting the printhead Y position 66 Section 7Cryo Witnessing7 Research Instruments Ltd Scanning Barcodes Intheworkareaapatientcanbechosenbyscanninginasamplebarcodethathaspreviouslybeen
assignedtothispatient. Whencompletingawitnesspointthatincludesabarcodingstep,thebarcode,eitherabrandnew
barcodeorabarcodepreviouslyassignedtothecurrentpatient,mustbescannedpriortotheWitness
PointConfirmationscreen.SeeFigure7-5. Figure 7-5 Scanning a barcode Ifthebarcodehasnotbeenseenbythesystembeforeitwillbeassignedtothepatientafterthewitness
pointisconfirmed. Ifthebarcodehasalreadybeenscannedandassignedtoadifferentpatient,themismatchalarmis
activatedandthedifferingpatientisshownonthemismatchscreen.ClickingonthesmallRed cross nexttothedisplayedmismatchedpatientwillallowthemismatchscreentobeclosedandareason
attached.SeeFigure7-6. 67 Figure 7-6 Barcode mismatch Section 7Cryo Witnessing7 Research Instruments Ltd SECTION 8 - RI WITNESS MANAGER FOR TRACEABILITY Managing Materials Materialtypes,egdishes,pipettesandmediamustbedefinedforusewithinTraceability.Abarcode
readermaybeusedtoidentifybatchlotnumbers,expirydates,etcorthesedetailsmaybeentered
manually.Batchesareopenedorclosedtoreflecttheiravailabilitywithinthelab. Click the MaterialsmainmenubuttontoviewthematerialsrelatedfeaturesofTraceability.SeeFigure
8-1. Figure 8-1 Materials management Material Types Materialtypesmustbeconfiguredbeforethedetailsofadeliveredbatchmayberecorded. 1. Click the Materialsmainmenubutton.
2. Then click Actions to view a list of all material types. 3. Use Add New Type and Add New Group to specify the top level of your materials hierarchy. See Figure 8-2. 4. Right click a group and select Add Grouptoextendthehierarchy.
5. Right click a group and select Add Type to add a new material type to that group. See Figure 8-3. Figure 8-2 Viewing all material types 68 Section 8RI Witness Manager for Traceability8 Research Instruments Ltd Figure 8-3 Right click to add a sub group Material Type Details Double click a material type, or right click and select View Material Type to view the material type details. See Figure 8-4. Figure 8-4 Material type details SomematerialsaremarkedwithaGS1barcode.AGS1barcodemaycontainvariouscombinationsof
expirydate,lotnumberandauniqueproductidentifierknownasaGTIN.Hereweareonlyinterested
inaproductidentifier.
1. 2. Manually enter a unique product part number if no GTIN is available. If you have a barcode, click Scan GTIN and scan the barcode. 69 Section 8RI Witness Manager for Traceability8 Research Instruments Ltd Notes on GS1 Barcodes GS1isaglobalbarcodestandardthatmaycontainaUniqueProductIdentifier(GTIN)andmayalso
containlotnumberandexpirydateinformation.Someproductshaveabarcodethatdoesnotadhere
totheGS1standard.SomeGS1barcodesdonotcontainalltheinformationhighlightedabove,egabox
ofbottlesmayhaveabarcodethatcontainsGTIN,lotandexpiryinformationbutanindividualbottle
barcodemayonlyhaveLotandExpiryinformationbutnoGTIN. Traceability can interpret GS1 barcodes. ATraceabilitybuttonmustbeclickedtointerpretaGS1barcode,egclickScan It or Scan Batch or Scan GTIN. Cycle Types Treatmentcycletypesmustbeconfiguredandlinkedwithmaterialtypes.
1. Click Settings. 2. Then Treatment Cycle Types. 3. Then the Materials tab to view the materials linked to a cycle type. 4. Tick the materials within the list that are to be associated with the treatment cycle type. 5. Press Save. AspreviouslydescribedinSection6-RIWitnessManageronlyadministratoroperatorsmaycreate
cycletypes.Traceabilityadminoperatorsmayadditionallyconfiguretherangeofmaterialsthatare
used when performing a treatment cycle type. Anewlycreatedcycletypewillnotbeassociatedwithanymaterials.Usethematerialscheckboxesto
specify the range of materials that will be used for the selected cycle type. See Figure 8-5. Creating a New Batch A new batch of a GTIN barcoded material may be scanned directly into Traceability. 1. Click the MaterialsmainmenubuttonandthenclicktheScan Itbutton.
2. Youwillbepromptedtousethebarcodescannertoreadthebarcode.Scanthebarcode. 3. As the materials type is already logged in the system, it will recognise the GTIN barcode and add thenecessarydetailsofthatbatchofmaterialstothesystem,eglot,expirydate,etcwithinthe
Batch Details page. MaterialsthatarenotGTINbarcodedareselectedbynavigatingtotheappropriatematerialtype
detailsscreen.
1. Click the MaterialsmainmenubuttonthenclickActions to show a list of all materials. 2. Double click the material that is being processed to show the Batch Details page for that material. See Figure 8-7. 3. Alistofexistingbatchesofthismaterialisshown.ClickAdd New Batch to open the batch detailswindowforanewlycreatedbatchandfillinthebatchdetails.SeeFigure8-6. 4. Click Scan Batch to create a new batch if a GS1 barcode is available. 70 Section 8RI Witness Manager for Traceability8 Research Instruments Ltd Figure 8-5 Material type details checkboxes specify the range of materials associated with each cycle type 71 Figure 8-6 Creating a new batch by scanning a barcode Section 8RI Witness Manager for Traceability8 Research Instruments Ltd Figure 8-7 Listing all batches of a specific material type Click Add Batch to manually create a batch Deleting a Batch Normalbatchoperationsarestatuschanges,eg
Pending: The batch of materials will shortly be opened and used Open: The batch of materials has been opened and is in use within the lab Closed:Thebatchofmaterialshasbeenclosed,hasallbeenusedup,hasexpired,cannolonger
be used. Batchesarenotroutinelydeleted. Admin Operators Only If a batch is created in error then an admin operator may delete it. 1. Click the Materialsmainmenubutton. 2. Click Actions. 3. Double click the material type to be deleted. 4. The list of batches will be shown. Right click the appropriate batch and select Delete. Batch Status AnewlycreatedbatchwillbeassignedastatusofPending.ClickOpen Batch when the batch is made availableforuse.Thedetailsdisplayedforanopenbatchwillincludeallpatienttreatmentcyclesthat
are in progress. See Figure 8-8. When a batch is no longer in use, click Close BatchtochangethebatchstatusfromOpentoClosed. Admin Operators Only If a batch is opened in error, click the Revert Statusbutton
If a batch is closed in error, click the Revert Statusbutton
toreturnthebatchstatustoPending.
toreturnthebatchstatustoOpen. 72 Section 8RI Witness Manager for Traceability8 Research Instruments Ltd Figure 8-8 Patient treatment cycles related to a batch of materials Expired Batches Whenbatchesarecreatedanexpirydateisrecorded.IfanycurrentlyOpenorPendingbatchesare
expiredorwithin7daysofexpirythenanexpiryReportbuttonwillbeavailableonthemainMaterials
screen. See Figure 8-9. Doubleclickanexpiredbatchtoshowthebatchdetailsscreenfromwhichthebatchmaybeclosed.
Now remove the batch from use. Theexpiryperiodcanbesettoyourrequiredtimeperiod,ieextendedto10daysorshortenedto5
days. 1. Click Settings in the main menu. 2. Click General Settings. 3. WithintheMaterialssectionamendthebatchexpirywarningfield. 73 Figure 8-9 Expired and expiring batches Section 8RI Witness Manager for Traceability8 Research Instruments Ltd View All Batches From the main Materials screen click Reporttoviewallbatches.Afilteredlistofallbatchesisshown,
expiredbatchesarehighlightedinred.Thislistmaybefilteredbydateandbybatchstatus.SeeFigure
8-10. Patients - Managing Treatment Cycles SeeSection5-RIWitnessBasicoperationfordetailsofcreatingandmanagingatreatmentcycle. When viewing the details of a treatment cycle Traceability operators may click the Materials tab to show material batches related to this cycle. See Figure 8-11. Figure 8-10 A filtered view of all batches Excluding and Including Batches for a Cycle BatchescanbeexcludedfromcyclesbyrightclickingonthebatchandchoosingExclude Batch on the contextmenu. ExcludedbatchescanbeviewedorhiddenbyclickingtheHide Excluded Batchesbuttonabovethe
batcheslist.Excludedbatcheswillbehighlightedblue. Anexcludedbatchcanbeincludedagainbyrightclickingonanexcludedbatchandfromthecontext
menuleftclickingInclude Excluded Batches. The batch will now be visible in the list of batches for the cycle. Figure 8-11 Material batches related to this cycle 74 Section 8RI Witness Manager for Traceability8 Research Instruments Ltd SECTION 9 - DATA CAPTURE An Introduction to Data Capture for Data Collection Hand written notes are often taken whilst performing laboratory procedures. For example embryo
scoresandspermvolumesmightbewrittendownonadatasheetandlatermanuallytranscribedinto
aclinicfertilitydatabase. The features of Data Capture described in this chapter allow data sheets to be designed in RI Witness Manager and data entry to be performed in the laboratory using the work area touch screen. Data entry may also be performed in RI Witness Manager. Collected Data Setup 1. Click Settings. 2. Then click Data Collectiontoenterthesetupscreenfordatacollection.Sheetdesignis
performed using this screen. The Collected Data Setup screen, Figure 9-1, is divided into 4 regions. Note that region 4 shows the propertiesofanentryselectedfromregions1,2or3. 3 2 1 4 Figure 9-1 Collected data setup 1. Sheet Types Region 1 shows a list of all the sheet types that have been created. Click New to add a new sheet, setthenameofthenewsheetusingthepropertiesinregion4. 2. Parameters Parametersarefieldsthatmaybeplacedonadatasheet.Forexample,aparameternamed
SpermVolumethatrequiredanumericalvaluemightbeaddedtoanAndrologydatasheet. Region 2 lists the parameters that have been created and may be added to the contents of a sheet. Click the Add buttontoaddaparametertoasheetcontents.Theparameterwillmovefrom
region 2 to region 3. 75 Section 9Data Capture9 Research Instruments Ltd 3. Sheet Contents Region 3 shows the content layout of the selected sheet type. The contents of a sheet are parameters that have been added to the sheet from region 2. To change the layout order, highlight the parameter by clicking it. Then use the Up and Downbuttonstopositionitinthe
order required. Onceaparameterhasbeenaddedtoasheetcontents,additionalattributesmaybeset.For
example,andefaultvaluecanbesetoraparametercanbemarkedasrequiredsothatan
operator must provide a value. SeeParameterAttributesonpage87formoredetails. 4. Properties Thepropertiesshowninregion4reflectthemostrecentlyselectedentryfromregions1,2or3.
See Figure 9-2. Figure 9-2 Examples of parameter properties and sheet properties shown in region 4 Parameter Configuration The contents of a sheet are called parameters. 1. Click Newintheparametersregion(2)tocreateanewparameter.Thepropertiesregion(4)will
show details of the newly created parameter. See Figure 9-3. 2. Enteranameforthenewparameter,egSpermVolume. 3. Thefirstactiontoperformonanewlycreatedparameterwillbetoselectaparametertypefrom
thePropertiesTypedropdownmenu.Parameterpropertiesdependontheselectedparameter
type.Forexamplethetexttypehaspropertiesminandmaxlengthwhereasacalculationhas
twooperandsandanoperation. Figure9-3showsthepropertiesofeachparametertype.Figure9-4showstheParameterTypedrop
down menu. Numerical Parameters Thepropertiesofanumericalparameterincludeaminimumvalue,amaximumvalueandanoutput
format.Theformatspecifiesthenumberofdecimalplacestobeusedwhendisplayingnumbers. Format Nonemeansthatthevalueenteredbyanoperatorwillnotbeformatted.Figure9-5showsthe
Format pull down. Text Parameters Thepropertiesofatextparameterincludeaminimumlengthandamaximumlength.Leavethese
properties blank if length restrictions are not required when the operator enters a value for this
parameter. 76 Section 9Data Capture9 Research Instruments Ltd Figure 9-3 Parameter properties depend on the selected parameter type Select from: Number, Text, Check, List, Date, Time, Date Time, Built In and Calculation Figure 9-4 Selecting a parameter type Figure 9-5 Selecting a numerical format Figure 9-6 The properties of a list parameter List Parameters Listparametersallowtheoperatortochooseavaluefromapre-definedlist.Thepropertiesofalist
parameter are shown in Figure 9-6. Click the Edit ListsbuttontoshowtheManageListswindow.TheexampleshowninFigure9-7highlights
thePolarBodyPositionlistthatcontainsthe3valuesPB6, PB12 and No Injection.ThePolar
BodyPositionlistisassignedtotheInjlistparameter.SeeFigure9-6. Check Parameters CheckparameterstakeYes/Novalues.
SheetspresentedbyRIWitnessManagerwillshowcheckboxes.Aworkareatouchscreenwilloffer
aselectionofYes or No. 77 Section 9Data Capture9 Research Instruments Ltd Date, Time and Date Time Parameters DateandtimevaluesareviewedandeditedusingRIWitnessManager.Anoperatormaytypeavalue,
eg 12:30 or 14/08/2010 15:35. A date picker window is also available. Figure 9-8. Calculation Parameters Calculationsperformanoperationontwooperands,egaddtwonumbersorjointwopiecesoftext.
Theoperandsofacalculationmaybeparametersofanytypeincludingcalculationtypes.Aexample
calculationisshowninFigure9-9. Built In Parameters Builtinparameterswilldisplayvaluesderivedfromtheassociatedtreatmentcycle,egtheeggcollection
date. Figure 9-10 shows the available built in values. Figure 9-7 The manage lists window Figure 9-8 Setting a date time value Figure 9-9 Adding two numbers using a calculation parameter Figure 9-10 Selecting a built in value Sheet Contents Click the parameters Add buttontomoveparameterstoasheetcontents(region3).Intheexample
shown in Figure 9-11, four list parameters have been added to the contents of the Embryo Development sheet. Figure 9-12 shows another example of sheet contents where two list parameter and four number
parameters form the contents of the Sperm Pre Prep sheet. 78 Section 9Data Capture9 Research Instruments Ltd Figure 9-11 Adding parameters to the Embryo Development sheet Figure 9-12 Adding parameters to the Sperm Pre Prep sheet Shared Between Sheets A parameter may be part of the contents of many sheets. The same parameter may be editable on sheet A and sheet B and but not editable on sheet C. A parameter that appears on many sheets has asinglesharedvalue.IntheaboveexampleavaluechangeonsheetAwouldautomaticallyappear
changed on sheets B and C. Thecontentsofasummarysheetmighttakeparametersfrommanyothersheets.SeeCycleSummary
Sheets on page 86 for more details. See Parameter Attributes on page 87 for more details of
theeditable/noneditableparameterattribute. 79 Section 9Data Capture9 Research Instruments Ltd Treatment Cycle Sheets Treatmentcycletypes,egIVF,ICSIorIUI,willhavedifferentdatacollectionrequirements.Forexample,
a sheet designed for IUI would not be used during an ICSI treatment. 1. Click Settings then Treatment Cycle Types to associate sheet types with a treatment cycle type. 2. TheDataCollectiontablistsallavailablesheets.Checktheboxesofthosethatareassociated
with the selected cycle type. See Figure 9-13. 3. Click Save. Whenalistofsheetsispresentedtoanoperator,theywillbeorderedasspecifiedhere.UsetheUp and Downbuttonstochangethatorder. Viewing and Editing Sheets During a treatment cycle an operator may view and edit the values on a sheet. Each treatment cycle will start with blank copies of the sheet types that have been associated with the treatment type being performed. Figure 9-13 Use the checkboxes to associate sheets with the selected treatment cycle type Editing Sheets at the Work Area Touch Screen Sheets may be viewed and edited on a laboratory work area touch screen. If sheets have been associated with the treatment cycle type being performed, then a Data Sheet buttonwillbeshownonthetouchscreen.SeeFigure9-14. Touch the Data Sheetbuttontoseealistofavailablesheets.TouchaSheet Namebuttontovieworedit
the sheet values. See Figure 9-15 and Figure 9-16. Use the touch screen Up and Downarrowbuttonstohighlightthesheetvaluetobeedited.Noticethat
thetypeofthevaluerequiredisindicatedtotheleftofthevalueentrybox,eg123fornumericalinput,
ABCfortextinputandindicatinguseofthearrowkeysforlistandYes/Noinput. 80 Section 9Data Capture9 Research Instruments Ltd Figure 9-14 Touch the Data Sheets button to view or edit all sheets associated with this treatment Figure 9-15 Touch buttons for each available sheet are shown in the work area 81 Figure 9-16 Use the touch keyboard to edit sheet values Section 9Data Capture9 Research Instruments Ltd Viewing and Editing Sheets with RI Witness Manager Data values will most likely be entered at the work area touch screen but sheets may also be viewed and edited using RI Witness Manager. 1. Selectapatient. 2. Click the Treatment Cycles tab and then double click a cycle to show the Treatment Cycle screen. 3. Click the Sheets tab to view or edit any sheet associated with this treatment shown in Figure 9-17. Egg Parameters ThepropertiesofaparameterincludeaRelates TosettingthatdefaultstoCycle,ieatreatmentcycle
doesnothavemultiplevaluesforthisparameter.SeeFigure9-18. However many parameter values will relate to an individual egg. Change the Relates Tosettingfrom
CycletoEggforsuchparameters.Eggrelatedparametersaredisplayedtotheoperatorasatable
containing one row for each egg. See Figure 9-19 and Figure 9-20. On the work area touch screen, touch a row of the egg table to edit the values for that egg. See Figure 9-21. Note:Thecirculararrowbuttonsatthetopofthescreenmaybeusedtoselectanotheregg
without returning to the table view. Figure 9-17 Editing sheet values with RI Witness Manager Figure 9-18 The relates to setting defaults to cycle 82 Section 9Data Capture9 Research Instruments Ltd Figure 9-19 A RI Witness Manager view showing a table of egg related parameters. Figure 9-20 A RI Witness work area touch screen view showing a table of egg related parameters 83 Figure 9-21 Entering values for egg number 1 at the work area touch screen Section 9Data Capture9 Research Instruments Ltd The Number of Eggs 1. Click Settings. 2. Then Treatment Cycle Types to view a list of treatment types. TheDataCollectiontabisusedtoassociatesheettypeswithatreatmenttypeasdescribedearlierinthis
chapter.TheDataCollectiontabalsooffersanEggCountParametersetting.Thedropdownmenufor
the Egg Count Parameter is a list of all parameters. Select one parameter that will contain a numerical value. The selected parameter will control the number of rows in any table of egg related parameters. Egg Count Parameter The parameter selected to represent the egg count can be any parameter with a numerical value that relatestoacycle.InFigure9-22theparametercalledTotalNumberofEggshasbeenselectedfrom
a list of all parameters. Asanexample,TotalNumberofEggsmightbeacalculationparameterwhoseoperandsareother
parameters. See Figure 9-22. Figure 9-22 The number of eggs involved in a treatment is set using the egg count parameter Figure 9-23 This calculation parameter has been selected as the egg count parameter in the example shown in Figure 9-22 Egg Count Conflict Changes to the value of the parameter set as the Egg Count Parameter will change the number of rows in any table of egg related parameters. Ifthenumberofeggsisincreased,thenthenumberofrowsinalleggtableswillautomaticallyincrease.
Ifthenumberofeggsisdecreased,thenthenumberofrowsinalleggtableswillnotautomatically
decrease. A decrease in the number of eggs will be indicated in RI Witness Manager as an Egg /
Embryo Count Conflict. See Figure 9-24. 84 Section 9Data Capture9 Research Instruments Ltd AconflictresolutionwindowisshownwhentheEgg/Embryo Count Conflictbuttonisclicked.See
Figure9-25.Theconflictresolutionwindowallowstheoperatortomanuallyselecttheeggrecordsthat
willbedeletedtoachievetherequireddecreaseineggcount.Theconflictwillberesolvedwhenthe
number of egg records equals the value indicated by the Egg Count Parameter. Ifitisdecidedthatadecreasemustbeundone,thenclicktheCancelbuttontoexittheconflict
resolutionwindowandincreasethevalueoftheEggCountParametertomatchthenumberofegg
records. Figure 9-24 The Egg/Embryo Count Conflict button is shown if the value of the parameter selected as the egg count parameter is decreased Figure 9-25 The Egg/Embryo Count Conflict window 85 Section 9Data Capture9 Research Instruments Ltd Sheets and Witness Points The work area touch screen Data Sheetsbuttonoffersaccesstoallthedatasheetsthathavebeen
associated with a treatment type. Amoreselectiveapproachtodatacollectionispossiblebylinkingasheettypetoawitnesspoint.See
Figure 9-26. When a touch screen Witness Pointbuttonistouched,thelinkedsheetwillbeautomaticallypresented
so that the operator may enter data related to the procedure being performed. See Figure 9-27. Figure 9-26 The selected witness point IVF Insemination is linked to the data collection sheet 4 Insemination/ICSI, see above at bottom right Figure 9-27 A witness point will trigger the presentation of a linked data collection sheet Cycle Summary Sheets Any sheet type may be selected as the cycle summary sheet. 1. Click Settings in the main menu bar. 2. Then click Treatment Cycle Types. 3. Use the Cycle Summary drop down menu to select the sheet type that will become the summary sheet for this treatment type. See Figure 9-28. 86 Section 9Data Capture9 Atypicalsummarysheetwouldshowparametervaluesfrommanyothersheets.SeeSharedBetween
Sheetsonpage79formoredetails. Quick access to a read only view of the cycle summary sheet is visible in the work area via the touch screen Cycle Summary Button.SeeFigure9-29. Research Instruments Ltd Figure 9-28 Select one sheet to become the cycle summary sheet Figure 9-29 Touch the cycle summary button to see the cycle summary sheet Touch again to return to the original display Parameter Attributes Parameters that have been added to a sheet contents may be given sheet specific attributes. Click
Settings then Data Collection. See Figure 9-30. Initial Value Click in the Initial Value column and enter a value. Initialvaluesarelinkedwiththe Overwrite and Createcheckboxes. AninitialvaluesettingwillbeignoredunlessacombinationofOverwrite and or Create is also checked. See Figure 9-31. 87 Section 9Data Capture9 Research Instruments Ltd Figure 9-30 Setting parameter attributes. Initial Value, Editable, Overwrite, Create and Required Editable Thevalueofeditableparametersmaybechanged.Ifthischeckboxisnotcheckedthentheparameter
willbeshowngreyedoutandmaynotbechangedonthissheet. Required Anoperatormustenteravalueforarequiredparameter.Thesheetcannotbesaveduntilavalueis
entered. Required parameters are highlighted with an asterisk on the work area touch screen and in red when viewed in RI Witness Manager. d Description Whatdoesthiscombinationmean?
e t i r w r e v O l e b a t i d E e t a e r C e r i u q e R The value may not be edited n/a Editingallowedbutmaybeleftblank. Avaluemustbeenteredbutitmaynotbeleftblank. Ifavaluealreadyexistsitwillbeoverwrittenwiththeinitialvalue.Theusercannotchangethevalue.
n/a Ifavaluealreadyexistsitwillbeoverwrittenwiththeinitialvalue.Theusermaychangethevalue. Ifavaluealreadyexistsitwillbeoverwrittenwiththeinitialvalue.Theusermaychangethevaluebutitmaynotbe
leftblank Ifnovalueexiststhenshowtheinitialvalue. The user may not change this value. n/a Ifnovalueexiststhenshowtheinitialvalue. The user may change this value. Ifnovalueexiststhenshowtheinitialvalue. Theusermaychangethisvaluebutitmaynotbeleftblank. Theinitialvaluewillbeshown,overwritinganyexistingvalue. The user may not change this value. n/a Theinitialvaluewillbeshown,overwritinganyexistingvalue. The user may change this value. Theinitialvaluewillbeshown,overwritinganyexistingvalue. Theusermaychangethisvaluebutitmaynotbeleftblank. Figure 9-31 Combining parameter attributes 88 Section 9Data Capture9 Research Instruments Ltd SECTION 10 - IMAGING How to View Live Images A camera will need to be connected to the PC running RI Witness and the drivers installed correctly toviewliveimageswithinRIWitness.TheImagingsecuritydonglemustalsobefittedtoaUSBport
and a valid Imaging license issued. RIWitnesssoftwarewillautomaticallyrecognisebothanalogueandcompatibledigitalcameradevices
connected to the PC. If there is only one camera device detected, it will show the live image for that device.Ifmultiplecameradevicesareconnected,itwillusethecamerathatwaslastselectedfromthe
videosourcedropdownbox.
IftherearemultiplecamerasattachedtothePC,thedeviceyouwanttheliveimagetobeviewedfrom
may be selected. To do this, select the Camera from the dropdown list on the Settings panel. Multiple Screen Configuration MultipleImagingscreenscanbeconfiguredforusewithImaging. 1. Open System Information. 2. Unlocksettings. 3. Touch Screen Configuration / Training Mode. Figure 10-1 Combining parameter attributes 4. Setyourdesiredconfiguration Iftheworkareaiswindowed,thenmultipledisplayswillnotbeshown.Windowedworkarea
isrecommendedforAdminPCswithreadersconnected.ToenablesimplyticktheWindowed WorkAreabox. 5. ThecurrentoperatorandpatientwillbedisplayedonthesecondaryImagingscreen. Figure 10-2 Imaging screen showing operator and patient BothoperatorsandpatientsmaybechangedbyclickingtheappropriateareaontheImagingscreen. Imagesarecapturedforthepatientscyclecurrentlyactiveintheworkarea.Imagescapturedforthe
activecyclewillbedisplayedintheRIWitnessManagersortedbydateandtime. 89 Section 10Imaging10 Research Instruments Ltd Figure 10-3 Images captured shown in the RI Witness Manager screen Ensurethatthereisalocationsettostorecapturedimages.ThisissetinRIWitnessManager. 1. Click Settings in the Main Menu tool bar. 2. Click General Settings. 3. SetthedesiredfilepathwithintheImageStorageLocationfield. Figure 10-4 Image storage location How to Take a Picture This is available on both the work area screen and secondary Imaging screen. 1. Log in using your operator name and PIN. 2. Ensurethereisapatientwithanactive/opencycleintheworkarea. 3. Press the Camera icon
. 90 Section 10Imaging10 Research Instruments Ltd How to Record Video This is available on both the work area screen and secondary Imaging screen. 1. Login using your operator name and PIN. 2. Ensurethereisapatientwithanactive/opencycleintheworkarea. 3. Click the Film icon 4. Eachvideorecordingcanlastforamaximumofonehour.Thiseliminatestheproblemof
. accidentallyleavingthesoftwarerecordingandpossiblyrenderingthecomputerunusable.
5. When freeze frame is set as keyboard shortcut, the live image recording can be paused. A second press of the shortcut key will restart the live image recording. 6. Press or click Pause to stop recording. How to Zoom & Pan the Image Available on the Imaging screen There are three ways to zoom into an area on the screen. 1. Placethemouseatapointonthescreen.Clickandholdtherightmousebutton,thenrelease.
This will zoom to the preset zoom level into the spot where the mouse is placed. To zoom out, clickandholdtherightmousebutton.
2. Place the mouse at a point on the screen and use the scroll wheel on the mouse (if available). This will give the user control over how much digital zoom is given. 3. Usingthetoolbaratthebottomofthescreen,clickthe+ icon to zoom in incrementally. To zoom out by the same amount, click on the - icon on the tool bar. The magnifying glass icon will zoom in and out by the preset zoom. Whilstusingdigitalzoom,athumbnailimageofthescreenwillappearinthetopleftofthescreen.At
thetopofthispanelistheamountofmagnificationyouareusing.Whenzoomedoutfully,thispanel
will not appear on the screen. Zooming in and zooming out can also be achieved using the foot pedal. on the tool bar. How to Perform Measurements Available on the Imaging screen 1. Click Measure icon 2. Click on the screen to select a start point for the measurement. 3. Clickonthescreenasecondtimetoselectanendpointforthemeasurement.
The ends of the line can be dragged to change the measurement. Linescanberemovedbyclickingthecrossinthecontextwindow.
Duringlaseroperation,linesareshownbutcannotbedragged/createdandnomeasurementswillbe
displayed. Lines and measurements are shown on an image when images are taken in Line Mode. 91 Section 10Imaging10 Research Instruments Ltd How to Select Cameras Available on both the work area screen and secondary Imaging screen. 1. Open System Information. 2. Unlocksettings. 3. Press 4. Click on the drop down boxtoallowtheselectionofcameras.Clickingontherequiredcamera
in the list will change the live image to that of the selected camera. Camera Flipping Available on both the work area screen and secondary Imaging screen. 1. Open System Information. 2. Unlocksettings. 3. Press 4. Tick Flip Video Horizontal(forcameradevicesthatsupporttheseoptions).
5. Tick Flip Video Vertical(forcameradevicesthatsupporttheseoptions).
How to Set the Preset Zoom Available on the Imaging screen. 1. Click the Image Settings icon 2. Drag the Preset Zoom slider to the required zoom. from the Imaging screen. How to Configure the Foot Pedal/Keyboard Available on both the work area screen and secondary Imaging screen. 1. Open System Information. 2. Unlocksettings. 3. Press . 4. Clickthecorrespondingeditbuttontoassignashortcut.
5. Hold down the key or press the foot pedal to assign. 6. Click or press the green tick to save the shortcut. Oncetheshortcutsaresetup,presstheshortcutkeysorthecorrespondingfootpedaltoactivatethe
command. How to Select Objectives Available on the Imaging screen. 1. Click the Magnification on the tool bar. 2. Clicktherequiredobjectivemagnification.
92 Section 10Imaging10 Research Instruments Ltd How to Add Objectives Available on the Imaging screen. 1. Click on the tool bar. 2. Click the Objective Calibrationbutton.
3. Click New Objective.Themagnificationwillbethesameasthecurrentmagnification.
4. Clicktherequiredobjectivetoeditobjectivemagnificationandfineadjustmentvalues.
How to Remove Objectives Available on the Imaging screen. 1. Click on the tool bar. 2. Click the Objective Calibrationbutton.
3. Click Xnexttoanobjective. How to Check Objective Calibration Available on the Imaging screen 1. Click on the tool bar. 2. Click the Objective CalibrationbuttontoopentheObjectiveCalibrationpanel.
3. Place an object of known dimensions (a stage micrometer is supplied with each system for this purpose)inthefieldofview.
4. EnsurethattheobjectiveselectedinImagingmatchesthatbeingusedonthemicroscope.
5. Thestagemicrometersuppliedmeasures100mbetweenthelongerlines.Forbestaccuracy,
positioneachendpointofthelineatexactlythesamerelativepositiononthescale,for
exampleattherighthandedgeofeachverticalline.
6. Drag the rulers to the point where the stage micrometer is going to be measured from and use thefineadjustmentupanddownuntiltherulerscalematchesthestagemicrometer.
Patient Display 1. ToconfigureascreenasapatientdisplaysimplyselectthePatient Display Configuration for the desiredscreen.ThescreenwilldisplaytheRIlogountilthedisplayisturnedon. On O 2. Toturnthepatientdisplayon/offsothatitshowsthevideofromthecamera,clicktheOn or OffbuttoneitherontheworkareaoronthepatientdisplaypanelontheImagingdisplay.The
Imagingdisplayshowsapreviewofwhatthepatientdisplaywillshow.SeeFigure10-5. 3. Totakeasnapshotofthevideotouseonthepatientdisplay,pressthePausebuttononthe
workareaorpatientdisplaypanel.
4. To re-enable live streaming of the video, press Play. Figure 10-5 93 Section 10Imaging10 Research Instruments Ltd Figure 10-6 Information shown on patient display Note: Whenacurrentpatientisactivatedviatheworkarea,thepatientnameandIDwillappearonthe
PatientDisplay.Itwillonlybevisibleifthepatientdisplayisturnedon.SeeFigure10-6. 5. Closingthemainwindowwillalsoclosethepatientdisplay. Use of Saturn Laser Systems with RI Witness RIWitnesscanberunalongsideandinconjunctionwithSaturnLaserSystems.Pleaserefertothe
SaturnLaserSystemusermanualforfullinstructions.
How to Access Saturn Laser System Information from a Work Area Toaccesssettingsandinformationfromtheworkarea 1. Open System Information. 2. Unlocksettings. 3. DetailedinformationabouttheSaturnLaserSystemwillbedisplayed. 4. Press Setting icon
toenableBiopsyorMulti-PulseModes. Figure 10-7 Saturn Laser System information 94 Section 10Imaging10 Research Instruments Ltd SECTION 11 - TROUBLE SHOOTING Problem Possible Cause Solution Many devices in the lab can cause RF noise. ContactRIoraRIrepresentative. Metal objects may change antenna tuning. Positiontheantennawhereitwillbeused.If
the antenna that is not tuned is an auto tuning antennafollowtheinstructionsshowninRF
Calibrationonpage19,otherwisecontactRI
oraRIrepresentativetoretunetheantenna. Metal objects may change antenna tuning. Positiontheantennawhereitwillbeused.If
the antenna that is not tuned is an auto tuning antennafollowtheinstructionsshowninRF
Calibrationonpage19,otherwisecontactRI
oraRIrepresentativetoretunetheantenna. Checkforanycablesunpluggedornottightened
fully. ContactRIoraRIrepresentative. Checkthetagonadifferentantenna. Use the System Information. Non encrypted tags are shown in red. Many devices in the lab can cause RF noise. Contact RIoraRIrepresentative. Use the System Information to check that the number of antennas matches the number in the work area. Also check that the temperature controllerisspecifiedcorrectly. Metalobjectsmaychangeantennatuning.Position
the antenna where it will be used. If the antenna that is not tuned is an auto tuning antenna follow theinstructionsshowninRFCalibrationonpage
19, otherwise contact RI or a RI representative
to retune the antenna. Checkforanycablesunpluggedornottightened
fully.ContactRIoraRIrepresentative. ContactRIoraRIrepresentative. RF noise Antenna not tuned Tags Reading IntermittentlyorOnly
in Certain Areas Antenna not tuned Looseconnection Control unit / antenna /
multiplexerfaulty Broken tag Tag not encrypted RF noise WorkAreaconfiguration Antenna not tuned Looseconnection Control unit / antenna /
multiplexerfaulty Tags Not Reading 95 Section 11Troubleshooting11 Research Instruments Ltd Problem Possible Cause Solution Multiplexer / Control
Unit / Temp Controller Missing Database Missing RI Witness WorkArea configuration Use the System Information to check that the number of antennas matches the number in the work area. Also check that the temperature controllerisspecifiedcorrectly. Looseconnection Control unit / antenna /
multiplexerfaulty RI Witness WorkArea configuration Looseconnection Checkforanycablesunpluggedornottightened
fully. ContactRIoraRIrepresentative Use the System Information to check that database connectionisspecifiedcorrectly.ContactyourIT
department for assitstance. Check for any unplugged or loose network cables. Replace with a known good cable. 96 Section 11Troubleshooting11 Research Instruments Ltd SECTION 12 - TEMPERATURE CALIBRATION Temperature Profile Beforecheckingthetemperatureprofile,itisimportanttoestablishifthereaderisaoneortwochannel
reader.Thiscanbedonebyturningoffthecontrolboxandrestarting.Atthebeginningofthestart-up
procedurethecontrolboxscreenwillshowatickoracrossnexttothechannelnumber(seeheated
controlboxdisplaywarnings).Ifthereaderisasinglechannelitwilldisplayaticknexttochannelone
andacrossnexttochanneltwo,whilea2channelwilldisplayaticknexttoboth.
Thetemperaturegradientovertheheatedplateshouldnotexceed1.5C.Inasinglechannelreader
the temperature difference between the centre of the glass window and the highest temperature
measuredawayfromthewindowshouldnotexceed3.0C.Foradualchannelreaderthetemperature
differencebetweenthecentreoftheglasswindowandthehighesttemperaturemeasuredawayfrom
thewindowshouldnotexceed1.5C. Temperature Profile Checklist 1. Follow this guide to position small amounts of thermal paste at each point to be measured. Figure 12-1 Temperature profile template 2. Complete the form RI Witness Heated Antenna Service Record for each heated reader. The latest formsareavailablebycontactingRI. 3. Use a thermometer probe secured with masking tape to measure the temperature at each of the 14 points. Allow 3-5 minutes for the probe reading to stabilise at each measurement point. Temperature Calibration TheobjectiveoftemperaturecalibrationistoensurethatthetemperatureindicatedbytheRIWitness
softwareiswithin0.2Cofthetemperaturemeasuredonaheatedreadersurface.
Ensure that the work area setup is as it will be used, eg microscope light on, fan on, etc. Werecommendusingathermometercalibratedat37Cfittedwithasmallthermocoupleprobe,such
as the RI IVF Thermometer. 97 Section 12Temperature Calibration12 Research Instruments Ltd Temperature Calibration Service 1. Switch the control unit ON. 2. MakesurethecontrolunitRFpowerisswitchedofftoavoidinterferencewithathermometer
reading. 3. Placeasmallamountofthermalcompound5cmtotherightofthereaderwindow.Positiona
thermometer probe in the compound and secure the probe with masking tape. 4. Waituntilthethermometertemperaturestabilises.Thiscantakeupto45minutes.
5. Compare the temperature shown in the work area software with the thermometer reading.
Adifferencewithin+/-0.2Cisacceptable. If the readings are outside the above requirement then click temperature to open the temperature offset settings and make adjustments. Increase the offset to increase the displayed reading,
decreasetheoffsettodecreaseit. 6. 7. Allowasmalldelayfortheoffsetchangetoregister. Figure 12-2 98 Section 12Temperature Calibration12 Research Instruments Ltd Touch Screen Calibration Checklist Thetouchscreencursorshouldaccuratelytrackthepositionofanoperatorfinger.Ifaccuracyproblems
areexperiencedthenuseamousetoactivatethecalibrationutilityandperformthefollowingchecklist. 1. Double click the touchkit desktop icon, then click 4 Points Calibration on the Tools tab. 2. The touch screen shows a blinking Xinthelowerleftcorner.TouchandholdtheblinkingXuntilit
stopsblinkingandmovestothenextcornerposition.Repeatthetouchandholdforeachcorner
ofthescreen.Oncompletionacalibrationfinishedmessageisdisplayed. 3. Touchthescreeninafewrandomlocations.Repeatthecalibrationifthecursorisnotcorrectly
positioned. Figure 12-3 Touchkit : USB controller screen shot 99 Section 12Temperature Calibration12 Research Instruments Ltd SECTION 13- CARE AND MAINTENANCE Cleaning RIWitnessreadersmaybecleanedwithasoftclothandmilddetergent.Areadermaybeliftedand
returnedtoitsoriginallocation.Donotdisconnectthecablesattachedtoanyreader. Do not use solvents for cleaning. Do not disconnect readers. Donotchangethepositionofreaders. 100 Section 13Care and Maintenance13 Research Instruments Ltd SECTION 14 - REPAIRS AND RETURNS Reuse Statement AssumingRIWitnessisregularlymaintainedandroutinelyserviced,itshouldperformasrequiredfor
aminimumof7yearscontinualuse,afterwhichtimewerecommendyouconsideritsreplacement.
Shouldyounoticeimpairedperformanceand/oranyissueswheresafetyiscompromised,orhaveany
otherconcernsduringtheuseofRIWitness,seektheadviceofRIortheirauthorisedrepresentative
promptly. RI Repairs System In the event that you have a problem with a RI instrument, please follow the procedure below to ensure promptattention. 1. ReadtheTroubleshootingsection. 2. If you require any further help contact your distributor or RI directly. RI will try to resolve the problem as quickly as possible. Product Disposal (European Union) If the product is no longer serviceable it must be sent back to RI to be destroyed in an environmentally safe way. Do not dispose of RI Witness products with normal waste. RI Returns System 1. ContactRItoobtainaReturnedMaterialsAuthorisation(RMA)number.Note: Goods will not be replacedorrefundedwithoutprioragreementandclearlystatingtheRMAnumber. 2. Pack the item carefully in its original packaging. RI will not accept responsibility for damage due toincorrectpackaging.Replacementitemsoradditionalrepairswillbeinvoiced. 3. ClearlylabelthepackagewiththeRMAnumber,markthepackageUrgent-ReturnedItemsFor
Repair,andshiptotheaddressonthenextpage.Goodsshouldbeinsuredfortheirfullvalue
during shipping. Contact Details Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel:+44(0)1326372753Fax:+44(0)1326378783
E-mail: service@research-instruments.com Website: www.research-instruments.com Obligation to Inform IncompliancewiththeEuropeanMedicalDeviceDirective93/42/EECasamended,itisyourdutyto
informRIifyoubelievethisdevicehas,ormayhave,causedorcontributedtothedeathofapatientor
userortoaseriousdeteriorationintheirstateofhealth.
101 Section 14Repairs and Returns14 Research Instruments Ltd Feedback Thank you for purchasing a RI product. To help RI develop the best tools for ART, we rely on customer feedback.Ifyouhaveanysuggestionsforhowwecanimproveourproductsortheinformationwe
provide with them, please send them to feedback@research-instruments.com.Yourfeedbackwillhelp
usdeveloptheproductandsupportingmaterialstomeetyourfutureneeds. Thank you. 102 Section 14Repairs and Returns14
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2015-02-18 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2015-02-18
|
||||
1 | Applicant's complete, legal business name |
RESEARCH INSTRUMENTS LTD
|
||||
1 | FCC Registration Number (FRN) |
0023761844
|
||||
1 | Physical Address |
BICKLAND INDUSTRIAL PARK
|
||||
1 |
FALMOUTH, N/A TR11 4TA
|
|||||
1 |
United Kingdom
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
h******@acbcert.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ACOO
|
||||
1 | Equipment Product Code |
670854
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
W**** T******
|
||||
1 | Title |
Mr
|
||||
1 | Telephone Number |
+(44)********
|
||||
1 | Fax Number |
+(44)********
|
||||
1 |
w******@research-instruments.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | RI Witness Sperm Prep Reader | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Eurofins Hursley Ltd
|
||||
1 | Name |
A******** C******
|
||||
1 | Telephone Number |
00-44********
|
||||
1 | Fax Number |
00-44********
|
||||
1 |
a******@eurofins.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC