Delivery specification COBAS-Reader 8000 Revision: 1.1.1 Delivery_Specification_COBAS_Reader_Roche_v1.1.1.
Delivery_Specification_COBAS_Reader_Roche_v1.1.1.
Document approval signatures Responsible for definition and writing of specification: Company Name Author TagStar Systems Michael Kober Reviewer maxsol Max Schneider Reviewer etifix Heinz-Jörg Schröder Reviewer Roche Helmut Jering Date Signature 17.02.2009 Approval and release of specification: Company Approval RD Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt Name Date Signature S.
Delivery_Specification_COBAS_Reader_Roche_v1.1.1.
Contents 1 General description......................................................................................................................................7 1.1 Supported RFID chips.........................................................................................................................................7 1.2 Functional description.........................................................................................................................................7 1.
Delivery_Specification_COBAS_Reader_Roche_v1.1.1.
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: ● 1.
1.3 Model, Manufacturer The COBAS-Reader 8000 can be ordered at etifix at the following order code: COBAS-Reader 8000 The 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.
78 9 ±3 maximium size for certification labels 51 183,27 76 ±3 Zust. Änderung Datum Name Diese Zeichnung ist unser Eigentum und darf ohne unsere Zustimmung weder vervielfÌltigt noch an Dritte herausgegeben werden. Wir behalten uns alle Rechte für den Fall der Schutzerteilung vor. etifix GmbH; D-72661 Grafenberg Riedericher StraBe 68 D-72661 Grafenberg CAD Zeichnung 51 to place certification symbols identification plate position of labels on the top side of the RFID reader 19 ±3 36 ±3 10.11.
Identification label Example of a label The factory number is defined by etifix. The serial number has the following syntax: JJMM-xxxx JJ: Year of production MM: Month of production xxxx: Serial number of the reader, continuously increased Security 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.
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 Specifications RSS-Gen Issue 2, Section 7.2.
3 Specification The following reader parameters refer to the below shown coordinate system: Y X Z Drawing 2: Coordinate system for measurement values 3.1 Power supply Value Symbol Min Max Unit V 4,75 5,25 VDC VSS 150 mVPP I standby 70 mA Max. current consumption 2) I max 350 mA Reader reset threshold voltage VThres 4,70 VDC Supply voltage (at external connector) Max.
3.
The typical field strength of the COBAS-Reader 8000 in a distance of 13 mm from the reader housing has the following characteristic: Field strength COBAS RFID reader 4500 4000 3500 3000 Field strength [mA/m] 2500 2000 1500 1000 500 -8 -12 -16 -4 0 4 8 12 16 -20 -16 -12 -8 -4 4 0 X-Displacement [mm] 8 12 20 16 24 0 Y-Displacement [mm] Diagram 2: Typical field strength in dependence of position under the reader measured at a distance of 13 mm measured from bottom of reader housing D
3.3 Optical sensors Value Current consumption per Sensor channel Wave length of sensor light Response value “white” 1) Response value “black” 2) Symbol Min Max Unit ISensor 25 35 mA λ 629 661 nm RVwhite 250 Digits RVblack 100 Digits 3) dX 3 mm max. displacement in Y-axis 3) dY 5 mm max.
3.
● Damp heat, steady state, according to EN 60068-2-78 30°C exposure temperature 5% relative humidity 16h exposure time 1 K/min temperature changing speed from RT to test temperature COBAS-Reader 8000 on during test ● Damp heat, steady state, according to EN 60068-2-78 30°C exposure temperature 95% relative humidity, non condensing 16h exposure time 1 K/min temperature changing speed from RT to test temperature COBAS-Reader 8000 on during test ● Vibration (sinusoidal) according to EN 60068-2-6 5 Hz lowe
3.5 Dimensions The PCB-Board of the COBAS-Reader 8000 has the following dimensions: Drawing 3: Final assembly of COBAS RFID reader electronic 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.
3.7 Channel positions For correct addressing of the RFID-channels and optical sensor channels please pay attention to the following drawing: Opt. Sensor 0 RFID channel 1 RFID channel 1 RFID channel 0 Opt. Opt. Sensor 2 RFID channel 0 Opt. Sensor 1 Opt. Sensor 3 Opt. Sensor 2 Opt. Sensor 1 Opt. Sensor 3 Drawing 4: Side view of COBAS RFID reader (red dots indicate position of LED) Delivery_Specification_COBAS_Reader_Roche_v1.1.1.
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 0044704 fire-retardant according to IEC 60332-1-2, UL VW1, CSA FT1 see Appendix 8, 9 Connector type: AMP D-2100, Product code 1318119 Drawing of cable: see attachment “Cable_v1.6.
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.
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.
6.1 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.
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 COBASReader 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.
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.
9 List of appendixes Appendix No. Description 1 I-Code SLI SL2 ICS20, Smart Label IC, Short Form Specification, April 2002 2 I-Code SLI SL2 ICS20, Smart Label IC, Functional Specification, January 2003 3 Country list for registration RFID readers 0-series and series for c701/702 4 RoHS compliance certificate 5 UL Compliance certificate 6 Data sheet 1.5SMC6.
10 Document revisions Datum Version Status 27.11.07 0.1 1st draft version 31.03.08 0.2 Extension with additional requested information 0.3 Internal working paper 0.4 Purpose: Draft as appendix to the “Einzelentwicklungsvertrag” 15.07.08 §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.
Datum 15.08.08 22.10.2008 Version Status 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 deleted Diagram with operation range in dependence of position added §3.
Datum 05.02.2009 Version 1.4 Status 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 diagram Wording 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.