Professional Documents
Culture Documents
S ys te m
www.siemens.com/diagnostics
The information in this guide was correct at the time of printing. However, Siemens continues to
improve products and reserves the right to change specifications, equipment, and maintenance
procedures at any time without notice.
Implementing an LIS software interface to a RAPIDLab 348EX system is solely the responsibility of
the customer. Siemens recommends that a professional software programmer develop and
implement the LIS software interface. Siemens is not responsible for any communications
problems or for any damage to a RAPIDLab 348EX system or an LIS that might result from
implementing an LIS communication protocol.
Contents
Contents
1 Introduction
Communication Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
About the Communication Protocols . . . . . . . . . . . . . . . . . . .7
5 Message Formats
Identifier Record Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Sequence Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Data Record Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Sample Assay Data Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Exceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Exceptions for Gases and Electrolytes . . . . . . . . . . . . . . . . . . . . . . . . . .36
Exceptions for Hematocrit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Sample Assay Data Record (Dialysis Fluid) . . . . . . . . . . . . . . . . . . 36
Exceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
QC Assay Data Record – LIS 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Exceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Index
Communication Options
The system can communicate with a variety of systems through the RS232
ports at the rear of the instrument. Specific systems with which the system
can communicate are:
• External printers
• RAPIDLink® Data Management System
• RAPIDComm® Data Management System
• LIS/HIS systems
This guide provides information that helps you connect the
RAPIDLab 348EX system with any of these systems. For configuration
information, see the RAPIDLab 348EX Operator’s Guide.
• LIS 3 protocol transmits patient, QC, and calibration data from the
system to the LIS or HIS upon the request of the LIS.
Messages sent using the LIS 3 protocol are enclosed within control
characters so that the LIS can detect the start and end of transmissions.
Each message also includes a checksum to enable the detection of bad
transmissions. Messages are automatically retransmitted once if the LIS
does not acknowledge a transmission.
Hardware Requirements
The system has two data ports. (See Figure 1.)
• Port 1 supports 3 data communication protocols.
• Port 2 supports only the LIS 1 protocol. Use port 2 when connecting an
external printer.
For information about configuring the data ports, see the RAPIDLab 348EX
Operator’s Guide.
The interconnection cable required depends on the PC used as the platform
for the data management system. The output pin configuration of both
RS232 ports is as follows:
3. Reconnect the power and turn on both systems and the printer.
The systems are now connected.
4. Configure the protocol to use for each port.
For detailed configuration information, see the RAPIDLab 348EX
Operator’s Guide.
Protocol Specifications
Protocol Supports
LIS 1 Communication to an external printer or to a data
collection system that can accept an asynchronous,
unidirectional data transmission.
LIS 2 Unidirectional communications with an external LIS
system.
LIS 3 Bi-directional communications with an external data
management system such as a RAPIDLink, RAPIDComm,
HIS, or LIS system.
Data Format
The transmitted data reflects the internal printer format. The system does
not transmit any control codes. The blocks of data that are transmitted are
as follows:
• Sample data
• QC sample data
• Calibration data
• Set-up data
• Calibration history file
• QC analysis file
• Test sample data
Conventions
This guide uses the following conventions to represent string delimiters:
Symbol Description
< > (angle brackets) Delimit a control code
{ } (braces) Delimit data strings
2. To set the protocol to use for Port 1, select Port 1 Protocol, then select
the appropriate option:
• LIS 1 (default)
• LIS 2
• LIS 3
Note Selecting a different protocol for a port overwrites previous
selections.
3. To set the communication options for Port 1, select Port 1 Options,
then select the appropriate parameters:
LIS 1
Interfacing with an External Printer
Use the LIS 1 protocol when interfacing with an external printer or with
any device using a printer-compatible communications format.
LIS 2
For details about data records, see LIS 3 Communication Protocol Formats
on page 24
LIS 3
Using the LIS 3 protocol, the system transmits a data-available message
following the completion of a patient sample, quality control, or calibration
measurement. It is then up to the LIS to request that data. The system also
sends a data-available message if the operator initiates a print function for
the respective data.
In addition to patient and operator identification, the protocol also
supports instrument identification, sample assay order and some remote
control transactions.
LIS 3 also includes a mechanism for requesting a retransmission of data
upon detection of a transmission error. This mechanism uses a relatively
simple message acknowledgement protocol that allows one retry.
When using the LIS 3 protocol, the receiving system must respond to all
messages with the acknowledge message.
The protocol does not detect when the same, error-free message is
transmitted twice. This situation can occur when the receiving device
acknowledges an error-free message, but the acknowledgement is
corrupted, causing the transmitting device to resend the message.
• If the LIS application has a problem with receiving duplicated data,
then the receiver can check each data message to ensure it is not a
duplicate of the preceding message.
• If the environment in which the interface is used has a low risk of
message corruption, then the application can choose to ignore the
possibility of a duplicate message.
• If the environment is noisy, it may be useful, to use hardware, (for
example, short haul modems), to improve the environment and still
ignore the possibility of a duplicated message.
Note The system should send the sample canceled message only after it
has sent the sample start message.
Data Available
The following messages indicate to the LIS when patient sample data is
available:
Sample assay: LIS 3 {SMP_NEW_AV}{aMOD,iIID,rSEQ}
This message is initiated by the system when results are available following
a patient sample measurement process. It signals completion of the assay
for sample sequence # rSEQ.
The same message is initiated for updated data when the operator selects
Print Data in Data Recall.
If the requested data is available, the system sends one of the following
messages:
• Sample data original: {SMP_NEW_DATA}{sample assay data}
• Edited sample data: If the operator recalls and edits patient sample
data and then selects Print Data, the system sends the following
message:
LIS 3 {SMP_NEW_AV}{aMOD,iIID,rSEQ}
If the LIS responds with the SMP_REQ message, the system sends the
following message:
Refer to Sample Assay Data Record, page 33 and Sample Assay Data
Record (Dialysis Fluid), page 36 for descriptions of sample assay data
records.
QC Assay Transactions
The system does not support QC assay order and QC Set-up File
transactions.
Measurement Status
The system informs the LIS when it initiates a QC sample measurement
(sample detected) and when, if applicable, the operator cancels the
measurement sequence. The system sends the following message:
QC sample measurement initiated: LIS 3 {QC_START}{aMOD,iIID}
Data Available
The following message indicates to the LIS that QC data is available.
QC assay: LIS 3 {QC_NEW_AV}{aMOD,iIID,rSEQ}
The system initiates this message when results are available following a QC
measurement process. It signals completion of the assay for QC sequence
# rSEQ.
The system transmits the same message in Data Recall when the Print QC
Data option is selected.
Request QC Data
After being notified that data is available, the LIS may request the data by
sending the following message, which identifies the sequence number of
the required QC data:
Request QC data: LIS 3 {QC_REQ}{aMOD,illD,rSEQ}
QC Assay Data
If the requested data is no longer available, the system sends the following
message:
QC data not available: LIS 3 {QC_NOT_AV}{aMOD,iIID,rSEQ}
If the requested data is available, the system sends the following message:
QC data original: {QC_NEW_DATA}{QC assay data}
See QC Assay Data Record – LIS 3, page 37 for a description of QC assay
data records.
Delete QC Data
To allow the LIS to track QC sample file operations performed on the
system, the following delete message is made available.
QC delete data:
LIS 3 {QC_DEL}{aMOD,iIID,iQFILE,rSEQ,rDATE,rTIME}
The system transmits this delete message as a result of the following data
operation:
The user recalls a QC sample and moves it to another QC file at the system.
In this case, the system sends the delete message, followed by a
QC_NEW_AV message for the new file entry.
If user moves a QC sample to a full file, and the QC sample is older than any
other samples in the file, then it will be discarded.
Calibration Transactions
Calibration Initiated
The system sends the following messages to the LIS when a calibration
sequence is initiated and when the operator cancels the sequence:
Calibration initiated: LIS 3 {CAL_START}{aMOD,iIID}
Calibration canceled: LIS 3 {CAL ABORT}{aMOD,iIID}
Data Available
The following messages indicate to the external device when calibration
data is available:
Calibration: LIS 3 {CAL_NEW_AV}{aMOD,iIID,rSEQ}
The system initiates this message when results are available following the
measurement of a calibrant. It signals completion of the measurement for
calibration sequence # rSEQ.
Calibration Data
If the requested data is no longer available, the system sends the following
message:
Calibration data not available: LIS 3 {CAL_NOT_AV}{aMOD,iIID,rSEQ}
If the requested data is available, the system sends the following message:
Calibration data original: {CAL_NEW_DATA}{calibration data}
Note Only the last calibration is available. Previous calibrations are stored
in the history file in a different format.
Calibration Pending
The system sends the following message when the countdown to the next
calibration reaches the last 5 minutes:
{SYS_CAL_PEND}{aMOD,iIID}
The calibration data records sent by the system depend upon the particular
type of calibration performed. Each type of calibration sequence contains
either a cal data set, a slope data set, or both:
• Hematocrit (slope only)
• 1-point Total (cal only)
• 2-point Total (cal followed by slope)
• 1-point Gas (cal only)
• 2-point Gas (cal followed by slope)
• 1-point pH/electrolytes + Hct (cal only)
• 2-point pH/electrolytes (cal followed by slope)
Within each calibration and slope data set, each analyte, except measured
barometric pressure, is represented by 3 entries, as shown in the following
table:
In this table, the terms in the Function columns have the following
meanings:
• MEASURED is the measured calibrant value.
• ADJUSTED is the system's target calibrant value.
• DRIFT is the drift in cal or slope for that analyte, calculated by the
system as: DRIFT = MEASURED – ADJUSTED.
If applicable, one entry at the end of each data set corresponds to the
measured barometric (mBP), if applicable.
Refer to Calibration Data Record, page 40 for a description of calibration
data records.
Note If more than one attempt is made during a calibration, the measured
data sent is the data from the first attempt.
For a description of the sample assay order data record, refer to Sample
Assay Order Data Record, page 44
To cancel the sample assay order, you can perform one of the following
actions:
• Select Cancel from the sample assay order screen.
• Open the probe, select Cancel, then close the probe.
If you perform one of these actions, the system sends the following
message:
LIS 3 {SMP_ORD_ABORT}{aMOD,iIID,iPID}
If the system receives a patient sample assay order during the cal-pending
period, the cal pending 5-minute countdown restarts. After 5 minutes, if
the sample has not been measured, the system transmits the calibration-
initiated message, waits for acknowledgement, then transmits the sample
order canceled message.
The system ignores any fields sent that are not defined in the Calibration
Data Record, page 40. The patient ID field must always contain a valid
patient ID. All data sent with the sample assay order can be edited on the
system.
Wash Request
Initiate wash: LIS 3 {CTL_WASH}{aMOD,iIID}
Frame Format
The format of the frame is as follows:
<STX>{identifier}<RS>{data}<RS> <ETX>checksum<EOT> Message
where:
• <STX> is the ASCII control character Start of Text (02 decimal).
• <ETX> is the ASCII control character End of Text (03 decimal).
• checksum is the variable 2-digit hexadecimal number included to
support error checking by the receiver.
• <EOT> is the ASCII control character End of Transmission (04 decimal).
Acknowledgement Format
The format of an acknowledgement is as follows:
<STX><ACK><ETX>checksum<EOT>
where:
<ACK> is the ASCII control character Acknowledgement (06 decimal)
Message Acknowledgement
The LIS software performs the following functions to implement the
acknowledgement protocol:
• When the sender has a message to send, it transmits the message and
starts a timer. It then waits for the receipt of an acknowledgement
from the receiver and also sets a variable, RETRY = FALSE (Transaction
Started).
All messages are acknowledged, provided the aMOD and iIID fields match.
After a message is sent, no further messages are sent until either an
acknowledgement is received or the transaction is complete and an error
logged.
Flow Control
During data transfers, the LIS may monitor its input buffers to ensure that
sufficient space remains to allow it time to react to the receipt of additional
data. When insufficient sufficient space remains, the LIS may send an
<XOFF> to the system, which suspends the transmission until the LIS sends
an <XON>, to indicate that transmission may resume.
Checksum
The checksum consists of 2 ASCII characters that represent a 2-character
hexadecimal number in the range 00 through FF.
The hexadecimal number is generated by performing a modulo-25610
summation of all the previous characters in the frame (that is, over the
range <STX>..<ETX>, inclusive) and then expressing the resulting 8-bit
unsigned integer in hexadecimal format.
For example, consider the {ID_DATA} message:
<STX>ID_DATA<FS><RS>aMOD<GS>348<GS><GS><GS><FS>iIID
<GS>1234<GS><GS><GS><FS><RS><ETX>
The summation of the value of each character in the string and the
resulting hexadecimal numbers is as follows:
Decimal Hexadecimal
Summation 1899 76B
Modulo 25610 107 6B
2-Character Hexadecimal NA 6B
Number
Example Transaction
The example describes the messages transmitted during a typical patient
sample analysis. The content of the messages is explained in the message
key following the transaction table.
Transaction Table
Message key
Message #1:
<STX>SMP_START<FS><RS>aMOD<GS>348<GS><GS><GS>
<FS>iIID<GS>1234<GS><GS><GS><FS><RS><ETX>43<EOT>
Message #2:
<STX><ACK><ETX>0B<EOT>
Message #3:
<STX>SMP_NEW_AV<FS><RS>aMOD<GS>348<GS><GS><GS>
<FS>iIID<GS>1234<GS><GS><GS><FS>rSEQ<GS>6<GS><GS>
<GS><FS><RS><ETX>B6<EOT>
Message #4:
<STX>SMP_REQ<FS><RS>aMOD<GS>348<GS><GS><GS>
<FS>iIID<GS>1234<GS><GS><GS><FS>rSEQ<GS>6<GS><GS>
<GS><FS><RS><ETX>BE<EOT>
Message #5:
<STX> SMP_NEW_DATA<FS><RS>
aMOD <GS>
348 <GS>
<GS>
<GS><FS>
iIID <GS>
1234 <GS>
<GS>
<GS><FS>
rTYPE <GS>
SAMPLE <GS>
<GS>
<GS><FS>
rSEQ <GS>
6 <GS>
<GS>
<GS><FS>
rDATE 27Nov11
<GS>
<GS><FS>
rTIME <GS>
11:06 <GS>
<GS>
<GS><FS>
iPID <GS>
123-456-789 <GS>
<GS>
<GS><FS>
iOID <GS>
987-654-321 <GS>
<GS>
<GS><FS>
rDEVICE <GS>
SYRINGE <GS>
<GS>
<GS><FS>
mpH <GS>
7.329 <GS>
<GS>
<GS><FS>
mPC02 <GS>
13.5 <GS>
mmHg <GS>
<GS><FS>
mPO2 <GS>
107.2 <GS>
mmHg <GS>
<GS><FS>
mBP <GS>
761 <GS>
mmHg <GS>
<GS><FS>
cHC03std <GS>
27.9 <GS>
mmol/L <GS>
<GS><FS>
cBE(vt) <GS>
3.9 <GS>
mmol/L <GS>
<GS><FS>
ctC02 <GS>
30.1 <GS>
mmol/L <GS>
<GS><FS>
c02SAT <GS>
7.3 <GS>
% <GS>
<GS><FS>
mNa+ <GS>
135 <GS>
mmol/L <GS>
<GS><FS>
mCa++ <GS>
1.17 <GS>
mmol/L <GS>
<GS><FS>
cCa++ <GS>
1.19 <GS>
mmol/L <GS>
<GS><FS>
mK+ <GS>
4.15 <GS>
mmol/L <GS>
<GS><FS>
mHct <GS>
43.5 <GS>
% <GS>
<GS><FS>
ctHb <GS>
14.8 <GS>
g/dL <GS>
<GS><FS><RS>
<ETX>6D<EOT>
This section describes the rules for building messages (message structure)
and the rules for decoding the received messages.
Each message consists of at most 2 records:
• The first record identifies the message type (identifier record).
• The second record (if present) contains further information or data
(data record).
The {identifier} record and the {data} record are each terminated by the
ACSII control character Record Separator (decimal 30), <RS>. That is, the
message has the format:
{identifier}<RS>{data}<RS>
{name}<GS>{value}<GS>{units}<GS>{exception(s)}<ETB>
<GS><FS>
Date/Time
Day, year, hours, and minutes are sent with leading zeroes; for example, 2
minutes past 8 o'clock on 1 January 2012 is sent as
01Jan1208:02
Invalid dates/times are sent as ddMmmyy and HH:MM.
Sequence Numbers
Sequence numbers appear without leading zeroes in reports. They are
reset only by a restart, which sets the first sequence number to 1.
Canceled samples, calibrations and QC samples do not increment the
associated sequence number.
Notes
1. The model identification is normally the serial number.
2. Either Ca++ or Cl– is present, but not both.
3. cCa++ is reported only if pH is between 7.20 and 7.60.
4. Oxygen content is reported only if calculated tHb is selected, or an
actual tHb is input.
5. The gas indices are reported only if FIO2 is input.
6. Both Base Excesses can be negative as well as positive.
7. Calculated Hemoglobin is derived from Hematocrit and is overridden by
input Hemoglobin.
If any parameter is not selected, then its associated field is not transmitted.
Exceptions
The following tables show the exceptions to this list in priority order,
highest first, for gases and electrolytes and for Hematocrit.
Exception Mnemonic
No end point (unstable) NEP
Bubble in Sample BUB
Split sample SPLIT
Temperature Warning TEMP
Above reporting range >
Below reporting range <
Above reference range H
Below reference range L
Exception Mnemonic
No end point (unstable) NEP
Bubble in Sample BUB
Split sample SPLIT
Temperature Warning TEMP
Uncorrected UNCORR
Above reporting range >
Below reporting range <
Above reference range H
Below reference range L
Exceptions
Exception Mnemonic
No end point (unstable) NEP
Bubble in Sample BUB
Temperature Warning TEMP
Above reporting range >
Below reporting range <
Above reference range H
Below reference range L
Exceptions
The following table shows the exceptions for the QC Data Assay
Record in priority order, highest first:
Exception Mnemonic
No end point (unstable) NEP
Temperature Warning TEMP
Above reporting range >
Below reporting range <
Above reference range H
Below reference range L
QC File Structure
The system has a fixed QC file structure, defined as follows:
Note The DRIFT value can be either positive or negative. The system
reports either Ca++ or Cl–, but not both.
Except for the Calibration Type parameter, all of the parameters in the
following table appear between the end of the calibration data and the
barometric pressure.
These records are identical to the 1-Point record, with the following
exceptions and additions:
Note The DRIFT value can be either positive or negative. The system
reports either Ca++ or Cl–, but not both.
Exceptions
The following table shows the exceptions for the QC Data Assay Record in
priority order, highest first:
Exception Mnemonic
Slope out of range SLPO
Offset out of range OFFO
No end point (unstable) NEP
Excessive drift DRIFT
Note If the units for tHb that are sent with the assay order do not match
the RAPIDLab 348EX system selection, the system converts them to the
selected units.
Example of an Error
If the oxygen channel, for example, had no endpoint, the measured
oxygen field would be as follows:
mPO2<GS>107.2<GS>mmHg<GS>NEP<ETB<GS><FS>
QC Data Record
Record Comment/Field Description
<STX> Start of record
QC_NEW_DATA<FS><RS> QC data record
aMOD<GS>348<GS><GS><GS><FS> Model number (348)
iIID<GS>A123<GS><GS><GS><FS> Serial number
rTYPE<GS>QC<GS><GS><GS><FS> Record Type (QC)
rSEQ <GS>00007<GS><GS><GS><FS> Sample number (00007)
rDATE<GS>30Nov11<GS><GS><GS><FS> Date (30 November 2011)
rTIME<GS>11:06<GS><GS><GS><FS> Time 11:06
(A.M., 24-hour clock)
iQFILE<GS>1<GS><GS><GS><FS> File number
iQLEV<GS>1<GS><GS><GS><FS> QC Level (Level 1)
iQLOT<GS>331408<GS><GS><GS><FS> Lot number (331408)
mpH<GS>7.150<GS><GS><GS><FS> pH
sLQmpH<GS>7.126<GS><GS><GS><FS> Lower limit for Level 1 QC
(pH)
sHQmpH<GS>7.166<GS><GS><GS><FS> Upper limit for Level 1 QC
(pH)
mPO2<GS>65.0<GS>mmHg<GS><GS> pO2 (measured)
<FS>
sLQmPO2<GS>64.2<GS>mmHg<GS><GS> Lower limit for Level 1 QC
<FS> (pO2)
sHQmPO2<GS>74.2<GS>mmHg<GS><GS> Upper limit for Level 1 QC
<FS> (pO2)
mPCO2<GS>71.0<GS>mmHg<GS><GS> pCO2 (measured)
<FS>
sLQmPCO2<GS>65.2<GS>mmHg<GS> Lower limit for Level 1 QC
<GS><FS> (pCO2)
sHQmPCO2<GS>75.2<GS>mmHg<GS> Upper limit for Level 1 QC
<GS><FS> (pCO2)
mNa+<GS>117<GS>mmol/L<GS><GS> Na+ (measured)
<FS>
sLQmNa+<GS>112<GS>mmol/L<GS> Lower limit for Level 1 QC
<GS><FS> (Na+)
sHQmNa+<GS>122<GS>mmol/L<GS> Upper limit for Level 1 QC
<GS><FS> (Na+)
C drift, calculation 22
duplicate messages 14
calibration
remote request 23 E
transactions 20 edited sample data message 18
calibration canceled message 20 external printer
calibration data available message 20 interface 13
calibration data not available message 21 external printers 7
calibration data original message 21
F
calibration data, request 20
calibration initiated message 20 Flow Control 25
calibration pending message 21 flow control 13
checksum 13 format
communication data 11
protocols 9, 10 H
communication options 7
HIS 11
communication protocol 7
HIS (hospital information system) 7
conventions 11
hospital information system (HIS) 7
D L
data available message 18
laboratory information system (LIS) 7
data communication
LIS 11
protocol 9, 10
LIS (laboratory information system) 7
data format 11
LIS 1
data management system
description 9, 10
interface with a RAPIDLab 348EX system 11
LIS 1 protocol 13
data manager 7
overview 7
data messages
LIS 2 protocol 13
LIS 2 14
overview 7
data ports
LIS 3 protocol
configuring 11
calibration and slope data 21
QC assay transactions 19 X
QC data available message 19 XON/XOFF flow control 13
QC data not available message 19
QC data original message 19
QC data, request 19
QC delete data message 20
QC sample measurement status 19
R
RAPIDComm Data Management System 7,
11
RAPIDLink Data Management System 7, 11
remote control requests 23
request calibration data message 20
request device identity message 22
request QC data 19