Roche Diagnostics COBAS80 Inductive Tag Reader User Manual Delivery Specification COBAS Reader 8000

Roche Diagnostics GmbH Inductive Tag Reader Delivery Specification COBAS Reader 8000

Users Manual

Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 1 / 30Delivery specificationCOBAS-Reader 8000Revision: 1.1.1
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Document approval signaturesResponsible for definition and writing of specification:Company Name Date SignatureAuthor TagStar Systems Michael Kober 17.02.2009Reviewer maxsol Max SchneiderReviewer etifix Heinz-Jörg SchröderReviewer Roche Helmut JeringApproval and release of specification:Company Name Date SignatureApproval RD S. RosenblattDelivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 3 / 30
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Contents1 General description......................................................................................................................................71.1 Supported RFID chips.........................................................................................................................................71.2 Functional description.........................................................................................................................................71.3 Model, Manufacturer..........................................................................................................................................81.4 Labelling..............................................................................................................................................................82 Applied standards and regulations............................................................................................................113 Specification...............................................................................................................................................123.1 Power supply.....................................................................................................................................................123.2 RFID data..........................................................................................................................................................133.3 Optical sensors..................................................................................................................................................153.4 Environmental conditions.................................................................................................................................163.5 Dimensions........................................................................................................................................................183.6 Dimensions of reader housing..........................................................................................................................183.7 Channel positions..............................................................................................................................................203.8 Connector..........................................................................................................................................................213.9 Serial interface parameters................................................................................................................................213.10 Host communication protocol.........................................................................................................................223.11 Life time..........................................................................................................................................................224 Packaging....................................................................................................................................................225 Embargoed countries.................................................................................................................................236 Installation notes........................................................................................................................................236.1 Recommended software algorithm for cassette position detection..................................................................247 Possible interactions between the COBAS-Reader 8000 and the host system......................................258 Product warranty.......................................................................................................................................269 List of appendixes.......................................................................................................................................2710 Document revisions..................................................................................................................................28Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 5 / 30
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1 General description The COBAS-Reader 8000 is a customer specific adopted RFID reader based on TagStar's TS1415 reader technology. It is designed for the use in a Roche / Hitachi C701/702 system.1.1 Supported RFID chips Following ISO 15693-3 compatible chips are supported by the COBAS-Reader 8000 RFID reader. Due to the project definition the COBAS reader supports the following RFID chip:●NXP I-Code SLI, the following documents are attached: I-Code SLI SL2 ICS20, Smart Label IC, Short Form Specification, April 2002 (Appendix 1) I-Code SLI SL2 ICS20, Smart Label IC, Functional Specification, January 2003 (Appendix 2)1.2 Functional description The COBAS-Reader 8000 has a two channel detection system consisting of a RFID antenna and two optical sensors each. The optical sensors are used to detect the rotational orientation of a cassette placed below the reader unit. Therefore the cassettes are labelled with a black/white coloured RFID label. At the detection process the RFID reader reads the data of the transponder which is inserted into the RFID label. To control the cassette orientation both optical sensors measure the reflected light, which indicates the black and white label area. Depending on the reflection value the host system could decide if the cassette is inserted in the correct orientation or turned at 180°.Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 7 / 30Drawing 1: Block diagram of COBAS RFID readerOpticalSensorsCH0CH1CH2CH3RFIDChannel 0RFIDChannel 1µCPower regulatorRS232driver
1.3 Model, Manufacturer The COBAS-Reader 8000 can be ordered at etifix at the following order code:COBAS-Reader 8000The reader electronic unit consists of a two channel RFID reader main board, with two external detection units. These detection units carry an adopted RFID antenna and two optical sensors for the position detection of labelled cassettes. The electronic unit is assembled into a housing provided by etifix.The whole production of the COBAS-Reader 8000 unit will be done under the responsibility of etifix and a subcontractor which are ISO 9001:2000 certified. The subcontractor is qualified and trained to meet the special requirements of RFID reader production. (Appendix 12, 13)1.4 Labelling Each COBAS-Reader 8000 is labelled with different identification and security labels. The following picture shows the position of each label:Position of labels on cassette: The position of all labels on the cassette are shown on etifix drawing no. 7-50-1-1-2-1Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 8 / 30Picture 1: Labelling of COBAS RFID reader
position of labels on the top side of the RFID readeridentication platemaximium size forcertication labelsto place certication symbols78183,2736 ±3 19 ±376 ±39±35151alle Oberächen ohneRauhtiefenangabegemittelte Rz min. 2,5Teile ohne Form- undLagetoleranzenangabennach DIN 7184 T1Achtung:bei eingepaBter Zeichnungauf eine DIN A... Seitedürfen die MaBstabsangabennicht berücksichtigt werdenMaße ohneToleranzangabenach DIN 7168 fD-72661 GrafenbergRiedericher StraBe 6811WerkstoNameÄnderungen nur bei gleichzeitiger Berichtigung im CAD-System zulässig.CAD ZeichnungBenennungTypBl.BlattZeichnungs-Nr.verwendet in Zeichnung Nr.NormGepr.Bearb.Zust. Änderung Datum NameDatumMaBstabMat.-Nr.:7-50-1-1-2-1RFID - Gehäuse COBAS 800010.11.08 D. Wurster 1:1 eingepasst>Diese Zeichnung ist unser Eigentum und darf ohneunsere Zustimmung weder vervielfÌltigt noch anDritte herausgegeben werden.Wir behalten uns alle Rechte für den Fall derSchutzerteilung vor.etix GmbH; D-72661 Grafenberg
Identification label Example of a labelThe factory number is defined by etifix.The serial number has the following syntax: JJMM-xxxxJJ: Year of productionMM: Month of productionxxxx: Serial number of the reader, continuously increasedSecurity labels Certification labels Depending on national rules extra certification labels are applied on top of the reader housing.Sample of a label:Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 10 / 30
2 Applied standards and regulations The COBAS-Reader 8000 is conformal to the following radio regulations and standards:●Europe (CE): EN 300 330-1 V1.3.1 (2001-06), EN 300 330-2 V1.3.1 (2006-04), ETSI EN 301 489-1 V1.6.1 (2005-09), ETSI EN 301 489-3 V1.4.1 (2002-08), EN 60950-1:2006, EN 50364:2001●US: FCC Code of Federal Regulations, CFR 47, Part 15, Sections 15.205, 15.207, 15.215, 15.225●Canada: Industry Canada Radio Standards SpecificationsRSS-Gen Issue 2, Section 7.2.2, RSS-210 Issue 7, Sections 2.2, 2.6, A2.6 (Category I Equipment)●Japan: ARIB standard T82 V1.1The COBAS-Reader 8000 will be compliant to the upper mentioned standards.For the in appendix “Country list for registration RFID readers 0-series and series for c701/702” (see Appendix 3) listed countries a compliance certification will be applied for. Therefore additional standards will be applicable, but are not listed under this chapter. The compliance measurement and appliance will be done by CETEOM ordered by etifix. Additional applicable standards:●compliant to the RoHS regulations (Appendix 4)●relevant components of the COBAS-Reader 8000 are UL recognized (Appendix 5)Compliance certifications for national regulations are in progress of application and are not appended to the document.Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 11 / 30Warning: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
3 Specification The following reader parameters refer to the below shown coordinate system:3.1 Power supply Attention: Supply voltages higher than 5,5 V might permanently damage the circuitry of the COBAS-Reader 8000 and have to be avoided.The COBAS-Reader 8000 has no internal fuses or any inrush current limitation. It is recommended to integrate an appropriate protection circuit into the power supply line to protect the reader and surrounding hardware against damage in case of failure or over voltage. A suppressor diode is integrated into the power supply circuitry. Specific data of the suppressor diode see appendix “1.5SMC6.8AT3-D” (Appendix 6).The circuitry is operates with an internally stabilized voltage for optimum and stable operation. Behaviour of the COBAS-Reader 8000 at different supply voltages see at Appendix 7.Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 12 / 30Drawing 2: Coordinate system for measurement valuesValue Symbol Min Max UnitSupply voltage (at external connector) V 4,75 5,25 VDCMax. ripple on supply voltage VSS 150 mVPPCurrent consumption, standby 1) I standby 70 mAMax. current consumption 2) I max 350 mAReader reset threshold voltage VThres 4,60 4,70 VDCTable 1: Power supply ratings1). .Measurement conditions: V = 5V, both RF channels switched off, all 4 LED's of the optical sensors are switched off2). .Measurement conditions: V = 5V, both RF channels switched on, all 4 LED's of the optical sensors switched onXYZ
3.2 RFID data Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 13 / 30Value Symbol Min Max UnitRFID Frequency (typical) 13,56 MHzModulation degree according to ISO 15693 100% %Data transfer rate Tag <–> Reader according to ISO 15693Data coding 1 out of 426,48 kBit/secRFID Output power @ 50 Ω termination PHF 70 90 mWRead distance 1) dPeak 0 20 mmMinimum distance between two labels(centre to centre of label) to avoid cross talkingdLL 40 mmTable 2: RFID measurement values1) Measurement conditions: V = 5V, Transponder size = 20x10mm, Chip I-Code SLITransponder is converted to a label and placed on top of cassetteRead distance is measured from housing of reader to top surface of cassetteThe transponder is readable over the whole operation distance between reader housing and the specified maximum read distanceDiagram 1: Typical operation distance depending on label displacement from reader antenna centre 5 10 15 20-20 -15 -10 -5051015-5-10-150X-displacement[mm]20 mm15 mm10 mmOperation rangesY-displacement[mm]
The typical field strength of the COBAS-Reader 8000 in a distance of 13 mm from the reader housing has the following characteristic:Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 14 / 30Diagram 2: Typical field strength in dependence of position under the reader measured at a distance of 13 mm measured from bottom of reader housing24201612840-4-8-12-16-201612840-4-8-12-16050010001500200025003000350040004500Field strength[mA/m]X-Displacement[mm]Y-Displacement[mm]Field strength COBAS RFID reader
3.3 Optical sensors Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 15 / 30Value Symbol Min Max UnitCurrent consumption per Sensor channel ISensor 25 35 mAWave length of sensor light λ629 661 nmResponse value “white” 1) RVwhite 250 DigitsResponse value “black” 2) RVblack 100 Digitsmax. displacement in X-axis 3) dX3 mmmax. displacement in Y-axis 3) dY5 mmSettling time of sensors (measurement delay after LED is switched on)5 msTable 3: Optical sensor values1) Measurement conditions: V = 5V, distance between sensor and white reference surface = 13 mm2) Measurement conditions: V = 5V, distance between sensor and black reference surface = 13 mm3) Measurement conditions: V = 5V, distance between sensor and cassette = 13 mm;transponder label applied 2,5mm out of cassette centre (white area at cassette border)All values are measured with both channels at one detection position switched on simultaneously. The following commands are used: WriteOutput and ReadAnalogInput according to the document “COBAS interface protocol v1.5”
3.4 Environmental conditions Note: The COBAS-Reader 8000 housing is only sealed against condensing of water at the bottom of the reader housing at normal assembly orientation in the rotor housing. No special protection against water intrusion from all other sides is provided.Because Hitachi has confidential internal standards the environmental tests are specified as follows:●Rapid Change of Temperature according to EN 60068-2-14-20°C / +75°C test temperatures2h exposure time for upper and lower temperature5 cycles <10 sec. transportation time from one chamber to the otherCOBAS-Reader 8000 off during test●Cold storage according to EN 60068-2-1+5°C exposure time16h exposure time1 K/min temperature changing speed from RT to test temperatureCOBAS-Reader 8000 on during test●Dry heat according to EN 600068-2-2+35°C exposure temperature16h exposure time1 K/min temperature changing speed from RT to test temperatureCOBAS-Reader 8000 on during testDelivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 16 / 30Value Symbol Min Max UnitOperation temperature range TOperation 5 +35 °CStorage temperature range TStorage -20 +75 °CRequested Relative humidity for storage and operation (not condensing) 5 95 %Requested protection against mechanical vibration in X/Y/Z direction at fulloperation 1)2,5 m/s2Normal operation after single shock in X/Y/Z direction 1,294 m/s2Housing protection class against intrusion of rigid particles and liquids (DIN EN 60529)IP 20Table 4: Environmental conditions1) Exact specification of mechanical vibration and shock tests see below
●Damp heat, steady state, according to EN 60068-2-7830°C exposure temperature5% relative humidity16h exposure time1 K/min temperature changing speed from RT to test temperatureCOBAS-Reader 8000 on during test●Damp heat, steady state, according to EN 60068-2-7830°C exposure temperature95% relative humidity, non condensing16h exposure time1 K/min temperature changing speed from RT to test temperatureCOBAS-Reader 8000 on during test●Vibration (sinusoidal) according to EN 60068-2-65 Hz lower frequency200 Hz upper frequency0,75 mm displacement amplitude0,25 g acceleration9,2 Hz cross-over frequency1 octave/minute frequency sweep10 cycles per axis, 3 axis tested (X;Y,Z)COBAS-Reader 8000 on during test (normally off, on requested by HHT)●Vibration (sinusoidal) according to EN 60068-2-65 Hz lower frequency200 Hz upper frequency3,5 mm displacement amplitude1,6 g acceleration10,8 Hz cross-over frequency1 octave/minute frequency sweep10 cycles per axis, 3 axis tested (X;Y,Z)COBAS-Reader 8000 on during test (normally off, on requested by HHT)●Shock according to EN 60068-2-2730 g acceleration11 ms shock duration, half-sine pulse shape3 shocks per direction, 6 directions tested (±X, ±Y, ±Z)COBAS-Reader 8000 off during test●Free fall according to EN 60068-2-321 procedure300 mm fall height1 tests per defined orientation (5 fall tests)COBAS-Reader 8000 without packagingCOBAS-Reader 8000 off during testDelivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 17 / 30
3.5 Dimensions The PCB-Board of the COBAS-Reader 8000 has the following dimensions:3.6 Dimensions of reader housing The reader housing is specified in drawing no. 7-50-1-1-2 (Document “Reader housing”) .Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 18 / 30Drawing 3: Final assembly of COBAS RFID reader electronic
3.7 Channel positions For correct addressing of the RFID-channels and optical sensor channels please pay attention to the following drawing:Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 20 / 30Opt. Sensor 1Opt. Opt. Sensor 2Opt. Sensor 3RFID channel 1 RFID channel 0Drawing 4: Side view of COBAS RFID reader (red dots indicate position of LED)Opt. Sensor 0RFID channel 1Opt. Sensor 1Opt. Sensor 2RFID channel 0Opt. Sensor 3
3.8 Connector The COBAS-Reader 8000 comes with a 800 mm long cable for the connection to the external host.Cable type: UNITRONIC LiYCY UL/CSA 4x AWG22/7,Manufacturer LAPPKABEL, order code 0044704fire-retardant according to IEC 60332-1-2, UL VW1, CSA FT1see Appendix 8, 9Connector type: AMP D-2100, Product code 1318119Drawing of cable: see attachment “Cable_v1.6.pdf” (Appendix 10)Pin assignment:Maximum pull force at the cable: 40 N3.9 Serial interface parameters The data between the COBAS-Reader 8000 and a host system are transmitted via a serial interface. The voltage levels at the serial interface is fixed to V24-level standard, e.g. for communication with a PC.Interface parameters:Baud rate 19.200No of Bits 8Stop bit 1Parity NHandshake No hardware or software handshakeDelivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 21 / 30Pin Name Direction DescriptionA1 +5V PWR Positive supply voltageB1 GND PWR Reference voltage level for power supply and serial communicationA2 RxD In Receive signal from hostB2 TxD out Transmit signal to HostA3 Shorted with cableB3Table 5: Pin assignment cable connector
3.10 Host communication protocol The communication protocol between a host system and the COBAS-Reader 8000 is defined in the document “COBAS Interface Protocol v1.5” (Appendix 11)3.11 Life time The analysis of the critical components and the corresponding circuitry of the COBAS-Reader 8000 resulted in an expected life time of more than 16.000 hours of operation.4 Packaging Every COBAS-Reader 8000 is packed into an ESD proof carton box, protected with ESD save foam against mechanical shocks. Each carton box is labelled with a label showing the product name and the serial number.Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 22 / 30Picture 2: Packaging of COBAS RFID readerPicture 3: Carton box with labelling
5 Embargoed countries According to the information given from Mr. Martin, Head of division for Electronics, Optics and Sensors (phone: 06196 / 908 – 788) at the Federal Office of Economics and Export Control in Germany are the COBAS-Reader 8000 not restricted in any countries if they are used for medical applications as they are designed for. The end user has to ensure that the COBAS-Reader 8000 are only used for their intent application in the COBAS 8000 systems.6 Installation notes No special ESD prevention is required to assemble the COBAS-Reader 8000. It is recommend to use a ESD wristband when you unpack the reader and connect it to the host system. The system power has to be switched off prior to the assembly.Be aware of the following possible environmental effects when your are installing the COBAS-Reader 8000 into a device. Also the transponders might be effected by:•Nearby existing metal objects like housings, shielding and also PCB-boards with large ground plates.•EMC effects from cables•EMC effects from magnetic fields.Metal surface in direct vicinity of the active internal antenna will detune the antenna and thus have a direct influence to the operating distance. Increase the distance between the antenna and the metal layer to the possible maximum for least influence. Communication between the reader and a transponder can never pass through a metal layer.The optical sensors might be influenced (reduced) by condensed water on the housing of the LED / detector components. A transparent medium should be placed on the rotor jacket cover for preventing water condensing at the optical sensor area. The medium should be selected carefully and has to be transparent for red light emitted by the LEDs.Contamination by deposition of reactants on the optical sensors will reduce the reflection values for the white and black label surface until no distinction can be made. Please take care that the sensors are periodically cleaned.The COBAS-Reader 8000 housing is designed to protect the reader electronics against humidity and water condensation from the reagent rotor side. Please take care for a good sealing of the COBAS housing against the rotor cover to prevent moisture / condensed water getting into the housing through the cable outlet.Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 23 / 30
6.1 Recommended software algorithm for cassette position detection Based on several tests done at Roche Mannheim and Roche Penzberg the following procedure for cassette position detection is recommended. This algorithm is able to distinguish between different states.:Depending on further evaluation the decision criteria for valid sensor signals and valid differences might have to be adopted.Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 24 / 30Picture 4: Program flow for analysis of optical sensor outputRead RFID tagTag readable?Readoptical sensorsNo-20<C<20?NoEmpty positionDefect RFIDreader0<R<10?Optical sensordefectC<-20?-20<C<20?No20<C<50?NoWrong cassetteorientationNo optical detectioncleaning requiredCassette orientationcorrect,cleaning requiredCassette orientationcorrectC: Contrast value (CH1-CH0 or CH3-CH2)R: Return value of each optical sensorNo RFID signal at allcassettes?NoNoDefect RFID labelNo
7 Possible interactions between the COBAS-Reader 8000 and the host system Several different failure modes could have an impact on the functionality of the host system. The COBAS- Reader 8000 is designed according to best knowledge to avoid any negative interactions with an host system. All electrical interfaces to the host system are designed in conformance to existing standards. The following table lists possible failure modes and methods to prevent defects on the host system.Failure mode / possible influence Protective measuresShort circuit on reader board at the power supplyIntegration of an appropriate protection circuit into the power supply which limits the supply current to 350mA during operationFailure at the RS232 interface, like short or open wiresThe COBAS-Reader 8000 uses an RS-232 interface driver which is according to industrial specificationsData failure inside the COBAS machine due to EMC / EMVThe reader will be qualified according to international standards as listed in chapter 2 to minimize the risk of potential influences.Impact of the emitted RFID field to the measurementsThis effect can't be estimated and depends strongly on the measurement methods used. Switch off the RFID antennae of the reader before starting the measurementsMalfunction of the optical detection due to humidity condensationCondensed humidity reduces the responses values of the black and white label area. Therefore software could distinguish between both colours by measuring the relation/difference of both responses values.Threshold values for contrast and absolute sensor values for black and white label areas have to be defined.Malfunction of the optical detection due to contamination by reactantsPeriodical manual cleaning of the optical sensors by service personal or operatorsThreshold values for contrast and absolute sensor values for black and white label areas have to be defined.Malfunction of the optical detection due to HF fieldDue to the mechanical design of the detection channels a powered HF field has a direct influence to the response values. For save measurements it is strongly recommended to switch the appropriate HF channel off before the optical sensors are read out.Interference of optical sensors The interferences between the optical sensors CH0/CH1 or CH2/CH3 are at an absolute minimum and have no impact to the measurement.Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 25 / 30
8 Product warranty etifix provides customer assistance in various technical areas, but does not have full access to data concerning the use and applications of customer's products. Therefore, etifix assumes no liability and is not responsible for customer applications or product or software design or performance relating to systems or applications incorporating etifix products.etifix assumes no liability and is not responsible for infringement of patents and/or any other intellectual or industrial property rights of third parties, which may result from assistance provided by etifix. The electronic circuitry and reader firmware has been checked for critical solutions and routines. etifix is not liable for infringements of patents and/or any other intellectual or industrial property rights of third parties resulting out of the usage in the COBAS analysis system.etifix products are not designed, intended, authorized or warranted to be suitable for life support applications or any other life critical applications which could involve potential risk of death, personal injury or severe property or environmental damage. A critical component is a component used in a life-supporting device or system whose failure can reasonably be expected to cause the failure of that life-support device or system, or to affect its safety or effectiveness of that device or system. Life support devices or systems are intended (a) to be implanted in the human body, or (b) to support and/or maintain and sustain human life. If they fail, it is reasonable to assume that the health of the user may be endangered.The product warranty is defined by governmental law and in etifix's “General Conditions for the supply of products and services. Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 26 / 30
9 List of appendixes Appendix No. Description1 I-Code SLI SL2 ICS20, Smart Label IC, Short Form Specification, April 20022 I-Code SLI SL2 ICS20, Smart Label IC, Functional Specification, January 20033 Country list for registration RFID readers 0-series and series for c701/7024RoHS compliance certificate5UL Compliance certificate6Data sheet 1.5SMC6.8AT3-D7Behaviour of the COBAS-Reader 8000 at different supply voltages8Data sheet of cable9Ohmic resistance of cable10 Cable_v1.6 specification11 COBAS Interface Protocol v1.512 ISO 9001 certificate etifix13 ISO 9001 certificate ZollnerDelivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 27 / 30
10 Document revisions Datum Version Status27.11.07 0.1 1st draft version31.03.08 0.2 Extension with additional requested information0.3 Internal working paper15.07.08 0.4 Purpose: Draft as appendix to the “Einzelentwicklungsvertrag”§1: Changes in overall description of product, added block diagram and identification plate layout§2: Extension of applied standards§3: General changes at all sub chapters§4. Extensions§5: Extensions§6: Extensions§7: Extensions§8: Extension about raw material discontinuation0.5 §1.4: Change of label samples, extended explanation§3.1 Change of power supply data§3.2 Change of RFID data§3.3 Change of optical data§3.4 Description of environmental tests§3.5 Drawing of reader electronics assembly§3.7: Correction of optical sensor position, additional 3D drawing§3.8 Change of cable length to 800mm (future deliveries)08.08.08 1.0 Public document for first shipment of COBAS-Reader 8000 (pre- production)Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 28 / 30
Datum Version Status15.08.08 1.1 §1.4: Added picture of labelled reader§2: Sentence about risks of third country certification removed, Canada added§3: Drawing with coordinate system showing axis of measurement values added§3.1: Change of data, change of recommended fuse§3.2: Change of data, read area values at 80% of read range deletedDiagram with operation range in dependence of position added§3.3: Change of data, digram showing valid reflection values in dependence on position above label added§3.4: Standard for IP protection class added, editorial changes§3.6: editorial changes§3.8: Maximum pull strength of cable fixture added§3.10:Release info of COBAS interface protocol document added§4: Secondary packaging removed§6: ESD handling precautions added§7: Exchange TagStar with etifix1.2 Working paper, not released22.10.2008 1.3 Added Reviewer and Approval list§1.2: Correction on position of label on cassette§1.3: Correction of product name§1.4: Change of picture of labellingAdded drawing about position of labels§2.0: Intern. Compliance certifications are excluded to this document§3.1: Added behaviour at different supply voltagesAdded notice about over voltage§3.2: Change of RF output powerAdding diagram of HF field strength§3.3: Change of X/Y limits of acceptable label displacementAdoption of black/white limits to new label surfaceSensor values measured simultaneously§3.6: Implementation of housing drawing§3.7: Removed drawing form bottom side, added LED position at optical sensors§3.8: Interface cable drawing changed from v1.2 to v1.4 (length tolerance, mounting ring, additional pins A3, B3)§3.10: Changed document version of interface protocol to 1.5§3.11: Added topic Expected life time§4: Added pictures about packaging§5: Embargoed countries (none)§6: Editorial change at water condensation protection§7: Adopted value for recommended external fuse at power lineDefinition of threshold values recommended§8: Extension of intellectual property rights and exclusion of life supporting devices§9: Added topic Table of appendixesDelivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 29 / 30
Datum Version Status05.02.2009 1.4 General name change of the reader to COBAS-Reader 8000 (change from development project name to product name)§1.2: Remove over voltage protection from block diagramWording misleading, see chapter 3.1§1.4: Exchange of identification label to newer design(corrected max. current consumption 300 → 350mA)§2: Extension and correction of radio regulations and standards according to granted certificates§3.1: max. standby current consumption changed from 55mA to 70mA caused by review of first 150 readers.Change of wording for over voltage protection§3.4: Change of Damp heat testing standard from sub part 30 (dynamic humidity change during test) to sub part 78 (static humidity during test) as qualification test have been done and certified.§3.11:Change Expected life time → Life Time§6.1: Added chapter: Recommended software algorithm for cassette position detection§7: Change of wording for protective measures against short circuit and failures at communication interface 10.02.2009 1.4.1 §1.4: Correction of identification plate picture (same plate as shown in other pictures used in this document)§3.1: Removed annotation about Reader reset threshold voltageVoltage will be measured at production testes§3.2: Removed annotation “Not verified at mass production” at diagram 1 and diagram 2§3.8: Removed annotation “Not verified at mass production” at value for maximum pull force applied to the cable§ 8: Removed clause about discontinuation of raw material. Has to be defined in delivery contract.Removed misspelling in sentence about critical solutions and routines.17.02 1.5 Removal of HHT from the list of document approvals§3.1: Misleading wording about suppressor diode deletedDelivery_Specification_COBAS_Reader_Roche_v1.1.1.odt 30 / 30

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