i-Smart 30 electrolyte analyzer

Interface Protocols
(Operating Software Version 1.0.6.0)

i-Sens, Inc.
i-Smart 30 Interface Protocols S/W Ver. 1.0.6.0

1. Introduction
This protocol describes how data is transmitted from i-Smart30 to a Laboratory Information System
(LIS) via TCP/IP and /or the serial (RS-232) ports on the i-Smart 30.

The i-Smart 30 data transfer protocol is implemented according to LIS1-A and LIS2-A2 low and high
level data transfer protocols.

2. Physical Transfer Layer

2.1 RS-232
Connetor Pin:
D-SUB NO Signal
1 RING
2 RXD
3 TXD
4 RTS
5 SG
6 CTS
7 CD
8 DTR
9 DSR
Case Grounding FG

Serial Port Specificatons (default):

Baud rate: 9600
Parity:none
Start bits: 1
Data bits: 8
Stop bits: 1

2.2 TCP/IP
Ehternet port: standard RJ-45 network connector
Port: 3030 (Default)

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3. Low Level Protocol

3.1 Restricted Characters
<STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <LF>, <CR>, <NAK>, <ETB>

3.2 Transmission Phases

Establishment phase, Transfer phase, Termination phase
(Refer to i-Smart 30 state diagram in section 3.4)

Sender>
<STX> FN Message <ETB> or <ETX> Check Sum <CR><LF>

Receiver<
<ACK
>

Field Explanations
Field Name Description
<STX> Start of Transfer Message
FN Frame Number 0 through 7
Message Message
<ETB> or <ETX> End of Transmission, End of Text
Checksum Message checksum
<CR><LF> End of Message

3.3 Time-out
Waiting time: 3 seconds

3.4 State Diagram

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i-Smart 30 State Diagram

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4. High Level Protocol

The i-Smart 30 only sends messges to a receiving systme and does not receive requests from a
receiving system.

4.1 Message Structure

Message Message is a group of records.
Record Record is a group of fields
Field Field is a group of components
Component Components comprise field

4.2 Record Types

Header Record H
Patient Record P
Test Order Record O
Result Record R
Message Terminator Record L

4.3 Delimiter Definitions

Delimiter Type Name Character
Filed delimiter Vertical Bar |
Repeat delimiter Backslash \
Component delimiter Caret ^
Escape delimiter Ampersand &
Record delimiter Carriage return <CR>

4.4 Header Record

The Header record contains information that indicates the start of a message.

Field Descriptions:
1|2|3|4|5|6|7|8|9|10|11|12|13|14{RT/CR}

Field Name Descriptions

1 Record Type ID always the character H.
2 Delimiter Definitions Refer to the delimiter table in section 4.3
iSmart30^ Instrument Seiral Number^Instrument
5 Instrument Name
Name designated by operator^ Software version
Standard Protocol Version
13 1394-97
Number
14 Transmition Date&Time Format=YYYYMMDDHHMMSS
<CR> Carriage return Record Terminator.

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4.5 Patient Information Record

The Patient Information record contains patient identifying information for a patient sample.
For calibration result, other fields are null except for Record Type and Sequence Number fields.

Field Descriptions:
1|2|3|4|5|6|7|8|9|10|11|12|13|14|15|16|17|18|19|20|21|22|23|24|25|26|27|28|29|30|31|32|33|34|35{RT
/CR}

Field Name Comment

1 Record Type ID always the character P.
2 Sequence Number Always the number 1
Patient ID
4 Patient ID
*null in calibration and QC results
Patient Name
6 Patient Name
* null in calibration and QC results
<CR> Carriage return Record Terminator

4.6 Test Order Record

The Test Order record contains sample, QC, or calibration identifying information.

Field Descriptions:
1|2|3|4|5|6|7|8|9|10|11|12|13|14|15|16|17|18|19|20|21|22|23|24|25|26|27|28|29|30|31{RT/CR}

Field Name Comment

1 Record Type ID always the character O
2 Sequence Number Always the number 1
Cartridge Serial Number-Sxxx or Qxxxx
(S=Sample, Q=QC, xxx is the sequential number
assigned to each of samples tested with the
3 Assession Number cartridge)
Cartrdige Serial Number-Cxxx(xxx is the sequential
number assigned to each of the 2-point calibrations
performed on the cartridge)
4 Sample Number The sample number enterned by operator
Sample, QC, or Calibration
Ex) Sample, QC, or Cal2
16 Specimen Descriptor
For QC
Ex ) QC ^ Lot Number^ Lot Description
<CR> Carriage return Record Terminator.

4.7 Result Record

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The Result record contains information for a sample reulst or 2-point calibration result

Field Descriptions:
1|2|3|4|5|6|7|8|9|10|11|12|13|14{RT/CR}

Field Name Comment

1 Record Type ID always the character R.
2 Sequence Number Record sequence number
^^^Paramter^Type
Parameter:Na+, K+, Cl-, Hct
3 Parameter Name
Type: M (=Measured)
Ex) ^^^Hct^M
4 Parameter Value Result value
5 Parameter Units Measurement Unit
Patient Reference range: Low limit^High limit^Reference
Reportable range: Low limit^Upper limit^Reportable
QC range Low limit^Upper limit^QC
6 Reference Ranges Ex)
138^142^Reference
20^200^Reportable
112^122^QC
L: Reference Range Low(L) or QC Range Low(L)
H: Reference Range High(H) or QC Range High(L)
<: Reportable Range Low(L)(=Out of Range(L))
>: Reportable Range High(H)(=Out of Range(H))
7 Abnormal Result Flags
SE: Slope Error
IE: Insufficient Error
N: Normal Result
-: Reference range is not entered.
11 Operator Identification Operator ID
Date/Time Test The date and time the test is completed
13
Completed Format=YYYYMMDD HHMMSS
<CR> Carriage return Record Terminator

4.8 Termination Record

The Termination record contains information that indicates the end of a message.

Field Descriptions:
1|2|3|4|5{RT/CR}

Field Name Comment

1 Record Type ID always the character L.

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2 Sequence Number Always the number 1

3 Termination Code N: normal termination

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5. Message Examples
5.1 Example of a Patient Sample Data Message
H|₩^&|||iSmart30^iSmart367^30367^1.0.6.0||||||||1394-97|20110124213845
P|1||pID1234||pName1234|||||||||||||||||||||||||||||
O|1|000151-S388|000151-S388||||||||||||Sample|||||||||||||||
R|1|^^^Na+^M|100|mmol/L|20^250^Reportable|-||||oID1234||20100301100600|
R|2|^^^K+^M|19.0|mmol/L|0.8^18.0^Reference₩0.5^20.0^Reportable|H||||oID1234|||
R|3|^^^Cl-^M|22|mmol/L|30^220^Reference₩20^250^Reportable|L||||oID1234|||
R|4|^^^Hct^M|40|%|15^50^Reference₩10^60^Reportable|N||||oID1234|||
L|1|N

H|₩^&|||iSmart30^iSmart367^30367^1.0.6.0||||||||1394-97|20110124213358
P|1|||||||||||||||||||||||||||||||||
O|1|000151-S387|000151-S387||||||||||||Sample|||||||||||||||
R|1|^^^Na+^M|100|mmol/L|20^249^Reference₩20^250^Reportable|N||||||20100301100600|
R|2|^^^K+^M|19.0|mmol/L|0.8^18.0^Reference₩0.5^20.0^Reportable|H|||||||
R|3|^^^Cl-^M|22|mmol/L|30^220^Reference₩20^250^Reportable|L|||||||
R|4|^^^Hct^M|40|%|10^60^Reportable|-|||||||
L|1|N

H|₩^&|||iSmart30^iSmart367^30367^1.0.6.0||||||||1394-97|20110125161708
P|1|||||||||||||||||||||||||||||||||
O|1|000151-S386|000151-S386||||||||||||Sample|||||||||||||||
R|1|^^^Na+^M|Out of Range(L)|mmol/L|20^250^Reportable|<||||||20100301100600|
R|2|^^^K+^M|Out of Range(H)|mmol/L|0.5^20.0^Reportable|>|||||||
R|3|^^^Cl-^M|Slope Error|mmol/L|30^220^Reference₩20^250^Reportable|SE|||||||
R|4|^^^Hct^M|40|%|10^60^Reportable|-|||||||
L|1|N

H|₩^&|||iSmart30^iSmart367^30367^1.0.6.0||||||||1394-97|20110124211708
P|1|||||||||||||||||||||||||||||||||
O|1|000151-S385|000151-S385||||||||||||Sample|||||||||||||||
R|1|^^^Na+^M|Insufficient Error|mmol/L|20^250^Reportable|IE||||||20100301100600|
R|2|^^^K+^M|Insufficient Error|mmol/L|0.5^20.0^Reportable|IE|||||||
R|3|^^^Cl-^M|Insufficient Error|mmol/L|20^250^Reportable|IE|||||||
R|4|^^^Hct^M|Insufficient Error|%|10^60^Reportable|IE|||||||
L|1|N

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5.2 Example of a QC Sample Data Message

H|₩^&|||iSmart30^iSmart367^30367^1.0.6.0||||||||1394-97|20110530104542
P|1|||||||||||||||||||||||||||||||||
O|1||008847-Q2||||||||||||QC^Lot^Description|||||||||||||||
R|1|^^^Na+^M|143|mmol/L|30^240^QC|N||||oID||20110530104535|
R|2|^^^K+^M|3.9|mmol/L|0.6^19.0^QC|N||||oID|||
R|3|^^^Cl-^M|100|mmol/L|30^240^QC|N||||oID|||
R|4|^^^Hct^M|18|%|20^50^QC|L||||oID|||
L|1|N

H|₩^&|||iSmart30^iSmart367^30367^1.0.6.0||||||||1394-97|20110530105413
P|1|||||||||||||||||||||||||||||||||
O|1||008847-Q5||||||||||||QC^Lot-Level 1^Description-Level 1|||||||||||||||
R|1|^^^Na+^M|142|mmol/L|30^240^QC|N||||oID||20110530105404|
R|2|^^^K+^M|3.9|mmol/L|0.6^19.0^QC|N||||oID|||
R|3|^^^Cl-^M|100|mmol/L|30^240^QC|N||||oID|||
L|1|N

H|₩^&|||iSmart30^iSmart367^30367^1.0.6.0||||||||1394-97|20110530105524
P|1|||||||||||||||||||||||||||||||||
O|1||008847-Q6||||||||||||QC^Hct Level 1^Description-Hct Level 1|||||||||||||||
R|1|^^^Hct^M|25|%|20^50^QC|N||||oID||20110530105523|
L|1|N

5.3 Example of a Two Point Calibration Data Message

H|₩^&|||iSmart30^iSmart30367^30367^1.0.6.0||||||||1394-97|20100413112257
P|1|||||||||||||||||||||||||||||||||
O|1||005343-C37||||||||||||Cal2|||||||||||||||
R|1|^^^Na+^M|54|||N||||||20100413091031|
R|2|^^^K+^M|65|||N|||||||
R|3|^^^Cl-^M|54|||N|||||||
R|4|^^^Hct^M|13|||N|||||||
L|1|N

H|₩^&|||iSmart30^iSmart30367^30367^1.0.6.0||||||||1394-97|20100413113757
P|1|||||||||||||||||||||||||||||||||
O|1||005343-C37||||||||||||Cal2|||||||||||||||
R|1|^^^Na+^M|20|||SE||||||20100413094731|
R|2|^^^K+^M|65|||N|||||||
R|3|^^^Cl-^M|54|||N|||||||
R|4|^^^Hct^M|17|||SE|||||||
L|1|N