BA-88A Semi-Auto Chemistry Analyzer

Host Interface Manual

© 2009 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2009-06.

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
called Mindray) owns the intellectual property rights to this Mindray product and this
manual. This manual may refer to information protected by copyright or patents and
does not convey any license under the patent rights or copyright of Mindray, or of
others.

Mindray intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or

any other derivative work of this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden.

, , , , BeneView, WATO,
BeneHeart, are the trademarks, registered or otherwise, of Mindray in China
and other countries. All other trademarks that appear in this manual are used only
for informational or editorial purposes. They are the property of their respective
owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not
be liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this
product, only if:

• all installation operations, expansions, changes, modifications and repairs of this

product are conducted by Mindray authorized personnel;

• the electrical installation of the relevant room complies with the applicable
national and local requirements; and

• the product is used in accordance with the instructions for use.

i
 WARNING:
It is important for the hospital or organization that employs this
equipment to carry out a reasonable service/maintenance plan.
Neglect of this may result in machine breakdown or personal injury.

NOTE:
This equipment must be operated by skilled/trained clinical
professionals.

Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Define：
• Main unit: Integrated facilities which implements the specified function
separately. General speaking, it should include power supply, control system and
some functional modules.

• Accessories: Materials connected to Main Unit to extend or implement

specified function.

• Consumables: Disposable or short-life parts which should be replaced each

time after use or periodically

Exemptions

Mindray's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product
or the use of parts or accessories not approved by Mindray or repairs by
people other than Mindray authorized personnel.

This warranty shall not extend to:

¾ Malfunction or damage caused by improper use or man-made failure.

¾ Malfunction or damage caused by unstable or out-of-range power input.

¾ Malfunction or damage caused by force majeure such as fire and

earthquake.

¾ Malfunction or damage caused by improper operation or repair by

unqualified and unauthorized service people.

¾ Malfunction of the instrument or part whose serial number is not legible

ii
 enough.

¾ Others not caused by instrument or part itself.

The standard warranty period is as below:

¾ Main unit: 18 months from shipment

¾ Accessories: 15 months from shipment

¾ Consumables: N/A

Return Policy
Return Procedure

In the event that it becomes necessary to return this product or part of this product
to Mindray, the following procedure should be followed:

1 Return authorization: Contact the international Customer Service Department

and obtain a Return Materials Authorization number. This number must appear
on the outside of the shipping container. Returned shipments will not be
accepted if the number is not clearly visible. Please provide the model number,
serial number, and a brief description of the reason for return.

2 Freight policy: The customer is responsible for freight charges when this
product is shipped to Mindray for service (this includes customs charges).

3 Return address: Please send the part(s) or equipment to the address offered
by the international Customer Service Department

Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
E-mail Address: [email protected]

Tel: +86 755 26582479 26582888

Fax: +86 755 26582934 26582500

EC Representative
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestraβe 80, Hamburg 20537, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

iii
Preface

Who Should Read This Manual

This manual is written for LIS (Laboratory Information Management System)
developers and those who need to learn the HL7 interface used by Mindray.
Instructions are provided in this manual for LIS developers to guide them to
develop LIS interface that enables their LIS to communicate with the BA-88A
semi-auto chemistry analyzer of Mindray. The developers are expected to have
knowledge of LIS and HL7 standards, and capacity of network programming. The
communication protocol is TCP/IP for network layer and HL7 version 2.3.1 for
application layer. LIS developers are recommended to develop the LIS interface
using Visual C++, Visual Basic, etc. in the Windows operating system.

What Can You Find in This Manual

This operation manual introduces the HL7 interface used by Mindray on the
BA-88A semi-auto chemistry analyzer. Chapter 1 describes the HL7 interface
generally. The system supports bidirectional communication with LIS, that is, it can
not only send test results to LIS but also download sample information from LIS.
Chapter 2 explains the imbalanced communication in detail. Chapter 3 explains the
communication process with examples.

Conventions Used in This Manual

This chart explains the symbols used in this manual.

When you see… Description

Read the statement following the symbol. The
NOTE statement is alerting you to information that
requires your attention.

1
 Contents
Preface............................................................................................................................ 1
Who Should Read This Manual ...................................................................................... 1
What Can You Find in This Manual ................................................................................ 1
Conventions Used in This Manual .................................................................................. 1

Contents ..........................................................................................................i
1 Mindray HL7 Interface........................................................................1-1
1.1 Messages Compatible with HL7 Interface ........................................................ 1-1
1.2 HL7 Lower Layer Protocol ................................................................................ 1-1
1.3 Minimal Lower Layer Protocol（MLLP）.......................................................... 1-2
1.4 Message Coding Mode ..................................................................................... 1-2
1.5 Channel No. Setup............................................................................................ 1-2
1.6 Parameter Setup for Serial Port Communication ............................................. 1-3

2 Communication Custom and HL7 Protocol .....................................2-1

2.1 Introduction ....................................................................................................... 2-1
2.2 Message Grammar ........................................................................................... 2-1
2.3 Compatible HL7 Messages............................................................................... 2-2
2.3.1 MSH Message Header......................................................................... 2-4
2.3.2 MSA - message acknowledgment segment......................................... 2-5
2.3.3 PID Patient Identification...................................................................... 2-6
2.3.4 OBR Observation Request .................................................................. 2-8
2.3.5 OBX Observation ............................................................................... 2-11

3 Communication Process and Message Example............................3-1

3.1 Sample Test Result ........................................................................................... 3-2
3.2 QC Test Result .................................................................................................. 3-4
3.3 Return confirmation message........................................................................... 3-5

i
 1 Mindray HL7 Interface

HL7 interface is a newly developed function of BA-88A. It can be connected to the

LIS (Laboratory Information Management System) and provide a channel for
BA-88A and other network on the basis of serial port communication.

The LIS server can receive test data from BA-88A through serial port. The data
include: sample test result and QC test result. In the meantime BA-88A receives
the confirming information from LIS. The following will explain the connection in
details. All data are transmitted in format of HL7 v2.3.1.The interface only supports
the imbalanced transfer between BA-88A and LIS server.

1.1 Messages Compatible with HL7 Interface

HL7 is electronic data exchange standard for inpatient care. It was first defined by
US and now adopted by many other countries. Mindray HL7 interface is defined
based upon HL7 v2.3.1. Refer to HL7 Interface Standards Version 2.3.1 for details.

Only portion of the messages, segments and other data defined are used for
Mindray HL7 interface that needs only part of these data.

1.2 HL7 Lower Layer Protocol

HL7 is a higher layer protocol that is based upon messages but provides no
message termination mechanism. To determine the message border, we have
employed the minimal lower layer protocol. Refer to HL7 Interface Standards
Version 2.3.1 for details.

Communication Layer

The messages are transmitted in format of:

1-1
 <SB> ddddd <EB><CR>

Where,

<SB> = Start Block character (1 byte)

ASCII <VT>, namely <0x0B>, must not be confused with the SOH or STX in ASCII.

ddddd = Data (variable number of bytes)

ddddd is an HL7 message, which only includes ISO 8859-1 characters

(hexadecimal 20-FF) and <CR>, exclusive of other control characters and those
that cannot be printed out.

<EB> = End Block character (1 byte)

ASCII <FS>, namely <0x1C >, must not be confused with the ETX or EOT in ASCII.

<CR> = Carriage Return (1 byte)

Enter character in ASCII is <0x0D>.

1.3 Minimal Lower Layer Protocol（MLLP）

MLLP, an encapsulation of HL7 messages, is defined in the HL7 standard. HL7
messages are encapsulated with a single character at the beginning and a dual
character at the end. The characters used by the HL7 interface are default in the
HL7 standard.

Start character: Hexadecimal <0B>

End character: Hexadecimal <1C><0D>

1.4 Message Coding Mode

The default message for HL7 protocol is GBK under the coding mode of
Chinese software, but the user can switch to UTF-8. The default for other language
software is UTF-8 and the user can not switch to others.

1.5 Channel No. Setup

Channel No.: The channel No. is a set of codes used in the transfer between
BA-88A and the LIS server. Simple characters or integral numbers correspond to
complicated information of the result, which can reduce the transferred information.

1-2
 Channel No. Setup: At the LIS server end, the user should set corresponding
channel No. in data dictionary on the basis of the information on BA-88A.

If the channel No. is not set, the software can not recognize the uploaded
information about test and control, displaying them as void or unknown.

The software can recognize the Test information, Qualitative description, and
Sample Type, etc, only when you set them in accordance with those set in the
system in Dictionary.

The channel No. of test information, qualitative description, and sample type should
be consistent with the index No. set on BA-88A in System-LIS setup.

1.6 Parameter Setup for Serial Port

Communication

Communic Flow Check Stop

Baud Rate Bit Delay
ation Port Control Digit Digit

Serial port 19200 8 None None 1 15s

1-3
 2 Communication Custom
and HL7 Protocol

The manual covers two areas on the communication between BA-88A and the LIS:
test result transfer and the confirmation information return. The test results include:
sample test result and QC test result. When LIS server receives the data, it should
return confirmation information indicating when the sending is successful.

2.1 Introduction
This chapter introduces the message types (Ver. 2.3.1) used by Mindray HL7
interface.

NOTE

HL7 supports many types of messages, but only 2 of them are employed on the
Mindray HL7 interface. To upload test result, ORU^R01 message is used. To
confirm, ACK^R01 message is used. The following text will explain it in detail.

The following sections introduce the common grammars in detail.

2.2 Message Grammar

This section introduces the general grammar of Mindray HL7 interface.

NOTE

For complete and detailed descriptions of HL7 message grammar, refer to the HL7
standard written by the HL7 standard committee.

2-1
 Each HL7 message is composed of segments that end with <CR>.

Each segment consists of a name (three characters) and variable fields that are
composed of components and subcomponents. The separators of each element
are defined in the MSH segment in every message.

For instance,

MSH|^~\&|Mindray|BS-200|||20060427194802||ORU^R01|1|P|2.3.1||||0||ASCII|||
Where,

The five characters following MSH are defined as delimiters to separate the fields,
components and subcomponents. Although the characters can be any non-text
ones, the HL7 standard recommends you to use the following:

Character Description
| Field separator
^ Component separator
& Subcomponent separator
~ Repetition separator
\ Escape character

Table 2.1 HL7 separator

MSH has the first field include all separators with most of the other fields empty that
are optional and not used by Mindray HL7 interface.

The order of the segments following MSH in every message is specially specified.
A segment is defined as optional or to be repeated by using the following grammar:

[ ] indicates the segment in it is optional.

{ } indicates the segment in it can be repeated for 0 or 1 time or more.

2.3 Compatible HL7 Messages

The HL7 message used by the interface includes: ORU^R01 and ACK^R01.

The uploading and confirming of the test result is indicated in the following figure.

Figure 2.1 The communication between BA-88A and LIS server

2-2
 Details are explained in the following.

ORU/ACK: Observe result (unsolicited)/Acknowledgment

ORU^R01 is used to transmit test results (sample test and QC test) to the LIS host.

An ORU^R01 message for sample test result includes:

-Patient information (patient name, gender, birth date, MRN, comment, reviewer
and etc.)

-Sample information (sample No., sample type, sender, Send D/T, Test D/T).

-Test result information (test No. test name, test result type, quantitative test result
–concentration, qualitative test result-Negative/Positive, unit, reference range,
abnormal symbol, test time and etc).

LIS can choose these items based on necessity. The details are in the following.

The structure is defined as follows:

ORU Observational Results (Unsolicited) Description

MSH Message Header

PID Patient Identifier
OBR Observation Report
{ OBX } Test Result

An ORU^R01 message for QC test result includes:

- Test information (test No., test name)

-QC information (QC time, QC rule, QC type)

-Control information (number, No. name, lot No., mean, concentration, SD)

-Test result information (concentration, unit)

The LIS host is able to choose any of the information in the message as needed.
Details are explained in the following.

The structure is defined as follows:

ORU Observational Results (Unsolicited) Description

MSH Message Header

OBR QC Observation Report

ACK^R01 message is used to respond to the ORU^R01 message. The structure is

as follows:

2-3
 ACK Acknowledgment Description

MSH Message Header

MSA Information Confirm

This section describes the components of each segment:

- Field name

- Field length

- Description

All fields used in message segment are listed in following tables. Mindray HL7
interface protocol uses the following fields. Void represents the one which has no
meaning and not used.

2.3.1 MSH Message Header

All HL7 messages begin with MSH, which is the first segment of an HL7 message
and always located at the beginning of the message. The MSH segment defines
the intention, source, purpose and grammar of the message.

The MSH segment of Mindray HL7 interface uses the following fields:

No. Segment Name Length Description

1# Field Separator 1 Includes the separator between segment ID and the
first real field, and defines the field separators (|) of
the remaining part of the message.
2# Encoding Characters 4 Includes component, repetition, escape and
subcomponent separators (^~\&).
3 Sending Application 180 Void and reserved.
4 Sending Facility 180 Void and reserved.
5 Receiving 180 Void and reserved.
Application
6 Receiving Facility 180 Void and reserved.
7 Date/Time Of 26 Time of the current message. Calling the system
Message time.
8 Security 40 Void and reserved.
9# Message Type 7 Type of the message, such as ORU^R01.
10# Message Control ID 20 Message control ID. Indicates one message each
and increases from 1 with message increasing.
11# Processing ID 3 Processing ID. Always set to P (product).
12# Version ID 60 Version ID. Version of HL7 protocol: 2.3.1.

2-4
13 Sequence Number 15 Void and reserved.
14 Continuation Pointer 180 Void and reserved.
15 Accept 2 Void and reserved.
Acknowledgment
Type
16 Application 2 Type of application response, used as result
Acknowledgment type.0-patient test result; 1-calibration test result;
Type 2-QC test result; 3-whole plate test result. The field
will return unchanged in response message. It will be
void in other messages.
17 Country Code 2 Void and reserved.
18 Character Set 10 Character set. ASCII is used.
19 Principal Language 60 Void and reserved.
Of Message
20 Alternate Character 20 Void and reserved.
Set Handling
Scheme
Table 2.2 field in MSH segment

Comments: MSH segment applies to all messages. Fields 10 and 16 are integers,
while others are strings.

2.3.2 MSA - message acknowledgment segment

The MSA segment of Mindray HL7 interface uses the following fields as indicated in
Table 2.3

No. Field Length Description

1# Acknowledgment Code 2 Confirmation code, AA means “accept”; AE
means “error”; AR means “refuse”.

2# Message Control ID 20 Message control ID, corresponding to MSH-10.

3 Text Message 80 Text message, a description of error or reject
event, corresponding to field 6.
It can be written into error logs.
4 Expected Sequence 15 Void and reserved.
Number
5 Delayed 1 Void and reserved.
Acknowledgment Type
6 Error Condition 100 Error condition (status code).
Table 2.3 field in MSA segment

Comments: The segment only applies to the ACK^R01 messages. Fields 6 are
integers, while others are strings.

2-5
 Note: Fields of MSA-6 are introduced as follows.

Status Code Status Description/Comment

(MSA-6) Text(MSA-3)
Succeeded: AA
0 Message accepted Succeeded
Error code: AE
100 Segment Segment sequence is incorrect or required segment
sequence error is missed.
101 Required field Required field in a segment is missed.
missing
102 Data type error Data type of a field is incorrect.
103 Table value not Table value is not found, therefore not used
found temporarily.
Reject code: AR
200 Unsupported Message type is not supported.
message type
201 Unsupported event Event code is not supported.
code
202 Unsupported Processing ID is not supported.
processing id
203 Unsupported Version ID is not supported.
version id
204 Unknown key Key identifier is unknown, such as inexistent patient
identifier information.
205 Duplicate key The key identifier already exists.
identifier
206 Application record The transaction could not be performed at the
locked application storage level, such as locked database.
207 Application internal Unknown application internal error.
error
Table 2.4 Message Status Code Table

2.3.3 PID Patient Identification

PID segment is mainly used to construct the patient information. Mindray HL7
interface uses the following fields as indicated in Table 2.5

No. Field Length Description

1 Set ID – PID 10 Identifies different patient fields

2-6
2 Patient ID 20 Void and reserved.
3# Patient Identifier List 20 MRN
4 Alternate Patient ID – PID 20 Void and reserved.
5# Patient Name 48 Name of patient
6 Mother’s Maiden Name 48 Void and reserved.

7 Date/Time of Birth 26 Birth date of the patient (Format: Year Month

and day, such as 19830512000000).
8 Sex 1 Gender Male, send M; Female, send F;
Others, send O
9 Patient Alias 48 Void and reserved.
10 Race 80 Void and reserved.
11 Patient Address 106 Void and reserved.
12 County Code 4 Void and reserved.
13 Phone Number - Home 40 Void and reserved.
14 Phone Number - Business 40 Void and reserved.
15 Primary Language 60 Void and reserved.
16 Marital Status 80 Void and reserved.
17 Religion 80 Void and reserved.
18 Patient Account Number 20 Void and reserved.
19 SSN Number -Patient 16 Void and reserved.
20 Driver's License Number – 25 Void and reserved.
Patient
21 Mother's Identifier 20 Void and reserved.
22 Ethnic Group 80 Void and reserved.
23 Birth Place 60 Void and reserved.
24 Multiple Birth Indicator 1 Void and reserved.
25 Birth Order 2 Void and reserved.
26 Citizenship 80 Common remark
27 Veterans Military Status 60 Void and reserved.
28 Nationality 80 Void and reserved.
29 Patient Death Date and 26 Void and reserved.
Time
30 Patient Death Indicator 1 Void and reserved.
Table 2.5 Fields in PID segment

Comments: The PID segment only applies to the ORU^R01 messages. Field 1 is
an integer, while others are strings.

2-7
2.3.4 OBR Observation Request
OBR segment is used to transfer the order information of test report. When the
sample test result is transferred (MSH-16 is 0), the field used in Mindray HL7
interface is shown in the following table.

No. Field Length Description

1 Set ID – OBR 10 Identifies different OBR fields
2 Placer Order Number 22 Void and reserved.
3 Filler Order Number 22 Sample ID
4 Universal Service ID 200 Universal service ID, set to ^
5 Priority 2 STAT. Y for yes and N for no.
6 Requested Date/time 26 Void and reserved.
7 Observation Date/Time 26 Sample testing date/time
8 Observation End Date/Time 26 Void and reserved.
9 Collection Volume 20 Void and reserved.
10 Collector Identifier 60 Void and reserved.
11 Specimen Action Code 1 Void and reserved.
12 Danger Code 60 Void and reserved.
13 Relevant Clinical Info. 300 Void and reserved.
14 Specimen Received Date/Time 26 Send D/T
15 Specimen Source 300 Sample Type. Serum-0, plasma-1, urine-2.
Others are define on the basis of
customer’s definition (it should be integral
larger than 2).
16 Ordering Provider 120 Sender
17 Order Callback Phone Number 40 Void and reserved.
18 Placer Field 1 60 Void and reserved.
19 Placer Field 2 60 Void and reserved.
20 Filler Field 1 60 Void and reserved.
21 Filler Field 2 60 Void and reserved.
22 Result Rpt/Status Change – 26 Void and reserved.
Date/Time
23 Charge to Practice 40 Void and reserved.
24 Diagnostic Serv Sect ID 10 Void and reserved.
25 Result Status 1 Void and reserved.
26 Parent Result 200 Void and reserved.
27 Quantity/Timing 200 Void and reserved.
28 Result Copies To 150 Void and reserved.

2-8
 29 Parent 150 Void and reserved.
30 Transportation Mode 20 Void and reserved.
31 Reason for Study 300 Void and reserved.
32 Principal Result Interpreter 200 Void and reserved.
33 Assistant Result Interpreter 200 Void and reserved.
34 Technician 200 Void and reserved.
35 Transcriptionist 200 Void and reserved.
36 Scheduled Date/Time 26 Void and reserved.
37 Number of Sample Containers 4 Void and reserved.
38 Transport Logistics of 60 Void and reserved.
Collected Sample
39 Collector’s Comment 200 Void and reserved.
40 Transport Arrangement 60 Void and reserved.
Responsibility
41 Transport Arranged 30 Void and reserved.
42 Escort Required 1 Void and reserved.
43 Planned Patient Transport 200 Void and reserved.
Comment
44 Ordering Facility Name 60 Void and reserved.
45 Ordering Facility Address 106 Void and reserved.
46 Ordering Facility Phone 48 Void and reserved.
Number
47 Ordering Provider Address 106 Void and reserved.
Table 2.6 Field of sample test result used in ORU segment

Comments: The PID segment only applies to the ORU^R01 messages. Field 1 is an
integer, while others are strings.

When QC test results are transferred (MSH-16 is 2), the applied fields include:

No. Field Length Description

1 Set ID – OBR 10 Identifies different OBR fields
2 Placer Order Number 22 Test channel No.
3 Filler Order Number 22 Test
4 Universal Service ID 200 Universal service ID, set to ^
5 Priority 2 Void and reserved.
6 Requested Date/time 26 Void and reserved.
7 Observation Date/Time 26 QC test time

2-9
8 Observation End Date/Time 26 Void and reserved.
9 Collection Volume 20 Rule

0：Westgard Multi-rule

1：Cumulative Sum Check

2：TWIN-PLOT rule

10 Collector Identifier 60 QC type

0: real-time; 1: daily; 2: day-to-day
11 Specimen Action Code 1 Number of controls
12 Danger Code 60 Control channel No. (Name_lot No.).
For example: The control name is C1
and the lot No. is 001, so the channel
No. is C1_001).
13 Relevant Clinical Info. 300 Control name
14 Specimen Received Date/Time 26 Lot No. of control
15 Specimen Source 300 Void and reserved.
16 Ordering Provider 120 Void and reserved.
17 Order Callback Phone Number 40 Concentration level of control. H for
high; M for medium, L for low.
18 Placer Field 1 60 Mean value (mean concentration)
19 Placer Field 2 60 Standard deviation of control
20 Filler Field 1 60 Test result (concentration)
21 Filler Field 2 60 Result unit channel No.
22 Result Rpt/Status Change – 26 Void and reserved.
Date/Time
23 Charge to Practice 40 Void and reserved.
24 Diagnostic Serv Sect ID 10 Void and reserved.
25 Result Status 1 Void and reserved.
26 Parent Result 200 Void and reserved.
27 Quantity/Timing 200 Void and reserved.
28 Result Copies To 150 Void and reserved.
29 Parent 150 Void and reserved.
30 Transportation Mode 20 Void and reserved.
31 Reason for Study 300 Void and reserved.
32 Principal Result Interpreter 200 Void and reserved.
33 Assistant Result Interpreter 200 Void and reserved.
34 Technician 200 Void and reserved.
35 Transcriptionist 200 Void and reserved.

2-10
 36 Scheduled Date/Time 26 Void and reserved.
37 Number of Sample Containers 4 Void and reserved.
38 Transport Logistics of Collected 60 Void and reserved.
Sample
39 Collector’s Comment 200 Void and reserved.
40 Transport Arrangement 60 Void and reserved.
Responsibility
41 Transport Arranged 30 Void and reserved.
42 Escort Required 1 Void and reserved.
43 Planned Patient Transport Comment 200 Void and reserved.
44 Ordering Facility Name 60 Void and reserved.
45 Ordering Facility Address 106 Void and reserved.
46 Ordering Facility Phone Number 48 Void and reserved.
47 Ordering Provider Address 106 Void and reserved.
Table 2.7 Field of QC test result used in ORU segment

Comments: The segment only applies to the ORU^R01 messages. Fields 1, 9, 10 and 11
are integers; fields 18, 19 and 20 are double numbers; others are strings. The tests of each
control are sent as one message.

2.3.5 OBX Observation

The OBX segment transmits the observations. If sample results are to be
transmitted (MSH-16 is 0)—Each patient may have multiple test results, then more
than one OBX segment will be used to transmit the results. On the analyzer, all test
results of a patient are transmitted separately. The HL7 interface does not check
the repeatability of the test results, which should be performed by the user system.

The OBX segment of Mindray HL7 interface uses the following fields as
indicated in Table 2.8

No. Field Length Description

1 Set ID – OBX 10 Identifies different OBX segments.
2 Value Type 3 Value type, identifies the test result.
NM (numeric), numeric value, for
quantitative tests
ST (string), for qualitative tests

BOTH ， for both quantitative tests and

qualitative tests.
3# Observation Identifier 590 Test channel No.
4 Observation Sub-ID 20 Test
5 Observation Value 65536 Quantitative test result (void for qualitative)

2-11
6 Units 90 Result unit channel No.
7 References Range 90 Reference range for test result.
(void for quantitative)
8 Abnormal Flags 5 Abnormity flag to indicate whether the test
result is normal or not.
H-high, L-low, N-normal (void for
quantitative)
9 Probability 5 Qualitative test result (void for quantitative )
Negative-0, weak positive-1, positive-2.
Others are define on the basis of customer’s
definition (it should be integral larger than
2).
10 Nature of Abnormal Test 2 Void and reserved.
11# Observe Result Status 1 Status of observation result, set to F-final
results.
12 Date Last Observe Normal Values 26 Void and reserved.
13 User Defined Access Checks 20 Original test result (void for qualitative)
14 Date/Time of the Observation 28 Inspection Date:
15 Producer's ID 60 Void and reserved.
16 Responsible Observer 80 Tester
17 Observation Method 60 Void and reserved.
Table 2.8 Field of sample test result used in OBX segment

Comments: The OBX segment only applies to the ORU^R01 messages. Fields 1
is integer; fields 5, 7 and 13 are double numbers; others are strings.

2-12
3 Communication Process
and Message Example

A message of HL7 protocol is the format of:

<SB> ddddd <EB><CR>

Where, <SB> means the start of the message and is <VT> in ASCII, that is 0x0B.

<EB> means the end of the message and is <FS> in ASCII, that is 0x1C.

<CR> acts as acknowledgement of message end and is used to separate different

messages, that is, 0x0D.

ddddd means what to be transferred and includes multiple segments, each of

which ends with <CR>, that is, 0x0D.

The microplate reader sends test result to the LIS server. On BA-88A, the test
result include three categories: sample test, QC test, whole plate test. The
uploading and confirming of the test result is indicated in the following figure.

Figure 3.1 The communication between BA-88A and the LIS server

The following lines list multiple message examples of the HL7 protocol.

3-1
3.1 Sample Test Result
The tests of one sample can be sent as one message. The LIS host responses
accordingly when receiving the message.

ORU Observational Results (Unsolicited) Description

MSH Message Header

PID Patient ID
OBR Observation Report
{ OBX } Test Result
For example, the information of one sample test result is shown in the following
figure.

Field Project 1 Project 2

Name of patient Caidapeng
Patient gender M
1980101000000 (it is calculated by the system on the basis of
Birth date
age. In the format of year and month).
MRN 50210160
Common remark Common remark
Sample ID 222
Sample Type 1 means plasma according to data dictionary
Sender Sender 2
Send D/T 20090513000000
Tester Tester 3 Tester 3
Inspection Date: 20090519085544 20090519085544
Test No. 111 111
Test ALT ALT
Test result type ST NM
Quantitative test result
-13396.000000
(concentration)
Qualitative test result
1
(Neg/Pos)
16 16
Unit 16 means u/L, according to 16 means u/L, according to
data dictionary data dictionary
Qualitative reference range
1.500000
upper limit

Qualitative reference range 0.100000

3-2
 lower limit
Quantitative reference
value
Abnormal symbol L-low
Original test result -13396.000000
Date 20090514162938 20090514142850
The sample test result report is shown as follows:

(1) The field of the message header-MSH appears on every report. The format is
the same. The meaning is shown as follows:

<SB>MSH|^~\&||||| 20090519094758 || ORU^R01 | 8 | P | 2.3.1 |||| 0 || ASCII |||<CR>

String set

System time Message type

Send result type

Message control ID P means product HL7 protocol version

(2) PID means patient information. The meaning of the field is as follows:

PID| 4 || 50210160 || Caidapeng|| 19840101000000 | M |||||||||||||||||| Comment |||||<CR>

MRN Patient Name Birth Date Gender Comment

(3) The following explains the meaning of the fields –OBR and OBX:

OBR| 4 || 222 | ^ | N || 20090519085544 ||||||| 20090513000000 | 1 | Sender 2 |

Sample ID STAT or not Test time Send time Sample type Sender

|||||||||||||||||||||||||||||||<CR>

OBX|1| ST | 111 | ALT || 16 ||| 1 || F ||| 20090519085544 || Tester 3 ||<CR>

T e s t t y p e
Test time
(qualitative) Qualitative result
Tester

Test No. Test name Result unit Result observation stauts

3-3
 OBX|1| NM | 111 | ALT | -13396.000000 | 16 | 0.100000-1.500000 | L ||| F |
Result type
(quantitative)
R e s u l t
Quantitative test Quantitative Abnormal observation
Result unit result range
symbol status
Test No. Test name result

| -13396.000000 | 20090519085544 || Tester 3 ||<CR>

Original test result

Test time Tester

<EB><CR>

3.2 QC Test Result

BA-88A sends the QC test result to LIS server. Daily QC is fixed. One QC test is
sent as a message.

ORU Observational Results (Unsolicited) Description

MSH Message Header

OBR QC observation report
A QC test result report is shown in the following figure:

Control test Value

Test No. 111
Test ALT
QC time 20090519093530
Rule 0-Westguard multi-rule
QC type 2-day-to-day
Number of controls 1
Control No. C1_control 1
Control name C1
Lot No. of control Control 1
Concentration level of control L-low
Mean value (mean concentration) 30.000000
Standard deviation of control 5.000000
Control test result (concentration) -13489.000000

3-4
 Unit 16 corresponding to the unit u/L

The sample test result report is shown as follows:

<SB>MSH|^~\&|||||20090519093550||ORU^R01|7|P|2.3.1|||| 2 ||ASCII|||<CR>

Type of the data

sent;2-QC

OBR|4| 111 | ALT | ^ ||| 20090519090530 || 0 | 2 | 1 | C1_CO1 | C1 | CO1 |

Test No. QC time Number of controls Control name

Test name Wildcard QC rule QC type Control number Control lot No.

|| L | 30.000000 | 5.000000 | -13489.000000 | 16 |||||||||||||||||||||||||||<CR>

Control
Control mean Control SD Test result Unit
level

<EB><CR>

3.3 Return confirmation message

After LIS server received information from the microplate reader, the
confirmation information is returned ACK^R01. The message format is as follows:

ACK Acknowledgment Description

MSH Message Header

MSA Confirmation
The ORU sending test result is use as an example here. The LIS server returns the
ACK report as follows:

3-5
<SB>MSH|^~\&||||| 20090514163006 || ACK^R01 | 7 | P | 2.3.1 |||| 0 || ASCII |||<CR>

In consistent with
Current message Fixed as P which means
Message type the message type of
time product
ORU

MSA| AA | 7 | Message accepted ||| 0 |<CR>

AA means accept; Text description of the

event, corresponding to 6th
AE means error; Error condition (status code)
segment and is used to
AR means refuse. write in error log

<EB><CR>

3-6
P/N: 046-000381-00(1.0)