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

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Document ID	1084499
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Document Description	Users Manual
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Document Type	User Manual
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Date Submitted	2009-03-24 00:00:00
Date Available	2009-03-24 00:00:00
Creation Date	2009-03-17 15:23:10
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Document Lastmod	2009-03-23 16:37:31
Document Title	Delivery Specification COBAS-Reader 8000
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Delivery specification
COBAS-Reader 8000
Revision: 1.1.1
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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. Rosenblatt
3 / 30
Delivery_Specification_COBAS_Reader_Roche_v1.1.1.odt
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Contents
1 General description......................................................................................................................................7
1.1 Supported RFID chips.........................................................................................................................................7
1.2 Functional description.........................................................................................................................................7
1.3 Model, Manufacturer..........................................................................................................................................8
1.4 Labelling..............................................................................................................................................................8
2 Applied standards and regulations............................................................................................................11
3 Specification...............................................................................................................................................12
3.1 Power supply.....................................................................................................................................................12
3.2 RFID data..........................................................................................................................................................13
3.3 Optical sensors..................................................................................................................................................15
3.4 Environmental conditions.................................................................................................................................16
3.5 Dimensions........................................................................................................................................................18
3.6 Dimensions of reader housing..........................................................................................................................18
3.7 Channel positions..............................................................................................................................................20
3.8 Connector..........................................................................................................................................................21
3.9 Serial interface parameters................................................................................................................................21
3.10 Host communication protocol.........................................................................................................................22
3.11 Life time..........................................................................................................................................................22
4 Packaging....................................................................................................................................................22
5 Embargoed countries.................................................................................................................................23
6 Installation notes........................................................................................................................................23
6.1 Recommended software algorithm for cassette position detection..................................................................24
7 Possible interactions between the COBAS-Reader 8000 and the host system......................................25
8 Product warranty.......................................................................................................................................26
9 List of appendixes.......................................................................................................................................27
10 Document revisions..................................................................................................................................28
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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:
●
1.2
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)
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°.
Power regulator
RS232
driver
µC
CH2
CH3
Optical
Sensors
CH0
CH1
RFID
Channel 0
RFID
Channel 1
Drawing 1: Block diagram of COBAS RFID reader
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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.
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:
Picture 1: Labelling of COBAS RFID reader
Position of labels on cassette:
The position of all labels on the cassette are shown on etifix drawing no. 7-50-1-1-2-1
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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
10.11.08
Achtung:
bei eingepaBter Zeichnung
auf eine DIN A... Seite
dürfen die MaBstabsangaben
nicht berücksichtigt werden
Maße ohne
Toleranzangabe
nach DIN 7168 f
verwendet in Zeichnung Nr.
Norm
Gepr.
Bearb.
Datum
Benennung
Typ
MaBstab
Werkstoff
Zeichnungs-Nr.
Teile ohne Form- und
Lagetoleranzenangaben
nach DIN 7184 T1
D. Wurster
Name
Mat.-Nr.:
7-50-1-1-2-1
alle Oberflächen ohne
Rauhtiefenangabe
gemittelte Rz min. 2,5
RFID - Gehäuse COBAS 8000
1:1 eingepasst
Änderungen nur bei gleichzeitiger Berichtigung im CAD-System zulässig.
Bl.
Blatt
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:
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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 7.2.2, RSS-210 Issue 7, Sections 2.2, 2.6, A2.6 (Category I Equipment)
●
Japan: ARIB standard T82 V1.1
The 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.
Warning: Any changes or modifications not expressly approved by the party responsible for compliance could
void the user's authority to operate the equipment.
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3
Specification
The following reader parameters refer to the below shown coordinate system:
Drawing 2: Coordinate system for measurement values
3.1
Power supply
Value
Symbol
Min
Max
Unit
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. ripple on supply voltage
Current consumption, standby
1)
4,60
Table 1: Power supply ratings
Measurement conditions: V = 5V, both RF channels switched off, all 4 LED's of the optical sensors are
switched off
Measurement conditions: V = 5V, both RF channels switched on, all 4 LED's of the optical sensors
switched on
1). .
2).
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.
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3.2
RFID data
Value
Symbol
RFID Frequency (typical)
Min
Max
13,56
Modulation degree according to ISO 15693
MHz
100%
Data transfer rate Tag <–> Reader according to
ISO 15693
Unit
Data coding 1 out of 4
26,48 kBit/sec
RFID Output power @ 50 Ω termination
PHF
70
90
mW
Read distance 1)
dPeak
20
mm
Minimum distance between two labels
(centre to centre of label) to avoid cross talking
dLL
40
mm
Table 2: RFID measurement values
1)
Measurement conditions: V = 5V, Transponder size = 20x10mm, Chip I-Code SLI
Transponder is converted to a label and placed on top of cassette
Read distance is measured from housing of reader to top surface of cassette
The transponder is readable over the whole operation distance between reader housing and the
specified maximum read distance
Y-displacement
[mm]
Operation ranges
15
20 mm
15 mm
10 mm
10
-20
-15
-10
-5
-5
10
15
20
X-displacement
[mm]
-10
-15
Diagram 1: Typical operation distance depending on label displacement from reader
antenna centre
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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
12
16
-20
-16
-12
-8
-4
X-Displacement
[mm]
12
20
16
24
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
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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
mm
max. displacement in Y-axis 3)
dY
mm
max. displacement in X-axis
Settling time of sensors (measurement delay
after LED is switched on)
ms
Table 3: Optical sensor values
1)
Measurement conditions: V = 5V, distance between sensor and white reference surface = 13 mm
Measurement conditions: V = 5V, distance between sensor and black reference surface = 13 mm
3)
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”
2)
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3.4
Environmental conditions
Value
Symbol
Min
Max
Unit
Operation temperature range
TOperation
+35
°C
Storage temperature range
TStorage
-20
+75
°C
95
Requested protection against mechanical
vibration in X/Y/Z direction at full
operation 1)
2,5
m/s2
Normal operation after single shock in X/Y/Z
direction 1,
294
m/s2
Housing protection class against intrusion of
rigid particles and liquids (DIN EN 60529)
IP 20
Requested Relative humidity for storage and
operation (not condensing)
Table 4: Environmental conditions
1)
Exact specification of mechanical vibration and shock tests see below
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 temperatures
2h exposure time for upper and lower temperature
5 cycles
<10 sec. transportation time from one chamber to the other
COBAS-Reader 8000 off during test
●
Cold storage according to EN 60068-2-1
+5°C exposure time
16h exposure time
1 K/min temperature changing speed from RT to test temperature
COBAS-Reader 8000 on during test
●
Dry heat according to EN 600068-2-2
+35°C exposure temperature
16h exposure time
1 K/min temperature changing speed from RT to test temperature
COBAS-Reader 8000 on during test
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●
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 lower frequency
200 Hz upper frequency
0,75 mm displacement amplitude
0,25 g acceleration
9,2 Hz cross-over frequency
1 octave/minute frequency sweep
10 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 60068-2-6
5 Hz lower frequency
200 Hz upper frequency
3,5 mm displacement amplitude
1,6 g acceleration
10,8 Hz cross-over frequency
1 octave/minute frequency sweep
10 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 60068-2-27
30 g acceleration
11 ms shock duration, half-sine pulse shape
3 shocks per direction, 6 directions tested (±X, ±Y, ±Z)
COBAS-Reader 8000 off during test
●
Free fall according to EN 60068-2-32
1 procedure
300 mm fall height
1 tests per defined orientation (5 fall tests)
COBAS-Reader 8000 without packaging
COBAS-Reader 8000 off during test
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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”) .
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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)
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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.pdf” (Appendix 10)
Pin assignment:
Pin
Name
Direction
Description
A1
+5V
PWR
Positive supply voltage
B1
GND
PWR
Reference voltage level for power
supply and serial communication
A2
RxD
In
Receive signal from host
B2
TxD
out
Transmit signal to Host
A3
Shorted with cable
B3
Table 5: Pin assignment cable connector
Maximum pull force at the cable:
3.9
40 N
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
19.200
No of Bits
Stop bit
Parity
Handshake
No hardware or software handshake
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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.
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.
Picture 2: Packaging of COBAS RFID reader
Picture 3: Carton box with labelling
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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.
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.
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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.:
Read RFID tag
Read
optical sensors
Tag readable
No
Empty position
No RFID
signal at all
cassettes?
No
Optical sensor
defect
No
-20
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