Ih Com Host Connection Manual Astm-1394 en h009164 v1 7

Bio-Rad Laboratories
IMMUNOHEMATOLOGY
IH-Com
Host Connection Manual
ASTM-1394
V1.7-01/2016
The Complete Solution for Safe Transfusion
Identification
Document
IH-Com Host Connection Manual ASTM-1394 Version: 1.7 - 01/2016
IH-Com Software Version: 5.0.9
REF :
H009164
IVD
Manufacturer
DiaMed GmbH
Pra Rond 23
1785 Cressier FR
Switzerland
Copyright and Disclaimer

Copyright 2014, DiaMed GmbH, Pra Rond 23, 1785 Cressier (FR), Switzerland
All rights reserved.
No part of this publication may be reproduced in any form or by any means without prior written
permission of the publisher. While every precaution has been taken during document preparation,
the publisher assumes no responsibility for errors or omissions. Neither is any liability assumed for
damages resulting from the use of the information contained herein.
Identification
Version History
Version
Date
IH-Com Version
Comments
1.0
18.05.10
3.0
First version for service engineers
1.1
23.12.10
3.0
Updates
1.2
11.04.11
3.0 r58
1.3
09.11.11
3.0 r58
One chapter removed
1.4
27.11.12
4.0 r27
Minor updates
1.5
29.04.13
4.2 r7
1.6
30.06.15
5.0.8
Updates in:
3.2 Communication modes on page 15
4.1 Data record formats on page 17
4.2 Format description on page 18
1.7
01.12.15
5.0.9
Update: 4.2.6 Results record on page 32
Technical Information Contacts

Tel. +41 (0)26 67 45 111
Fax +41 (0)26 67 45 145
H009164 V1.7-01/2016
3/48
Identification
PAGE INTENTIONALLY LEFT BLANK
4/48
IH-Com Host Connection Manual ASTM-1394 Bio-Rad
TABLE OF CONTENTS
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1
Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.1 Appropriate Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.2 Warranty limitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.3 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.3.1
1.3.2
Persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.4 Typographical conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

1.4.1
Labeling and Classification of Safety Instructions

1.4.1.1
1.4.1.2
. . . . . . . . . . . . . . . . 12
Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1.1
2.1.2
2.1.3
Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Importance of the safety instructions . . . . . . . . . . . . . . . . . . . . . . . 13
Disregarding the safety rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Description of communication protocols . . . . . . . . . . . . . . . . . . . . . . . . 15

3.1 Overview
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2 Communication modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.3 Shared folder (Windows shares) . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.4 FTP file transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
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Data frame format (ASTM 1394) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.1 Data record formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.2 Format description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.2.1
4.2.2
Header Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Patient record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.2.2.1
4.2.3
4.2.4
4.2.5
4.2.5.1
4.2.5.2
4.2.5.3
4.2.5.4
4.2.5.5
4.2.5.6
4.2.6
4.2.7
4.2.8
4.2.9
4.2.10
Comment record after a patient record . . . . . . . . . . . . . . . . . . . . . .22
Test Order record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

IH-Com test mask reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Samples for test order mask values . . . . . . . . . . . . . . . . . . . . . . . . 29
Blood group test: (usually a test profile in this example) .
ABD and 4 x-matches: . . . . . . . . . . . . . . . . . . . . .
AB0D/DAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABD, ABScr and 2 x-matches: . . . . . . . . . . . . . . . . .
3 x-matches where donation numbers are not known yet:
Example of a complete order file: . . . . . . . . . . . . . . .
Results record . . . . . . . . . . . . . . .
Result codes for interpretation records
Comment record after a Result record
Message Terminator Record . . . . . .
Example of result file . . . . . . . . . .
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32
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Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.1 Possible antigen result values
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.2 Possible error codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5.3 Possible field name values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
5.3.7
5.3.8
5.3.9
5.3.10
5.4
5.4.1
ABD . . . . . . . . .
Rev. Group . . . .
Rh. Phenotype/Kell
Direct Coombs . .
Auto Control . . . .
Crossmatch . . . .
AB Screening . . .
Panels . . . . . . .
Antigen . . . . . . .
Others field names
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43
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45
45
compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
European directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.5 Device disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6/48
Generalities 1
GENERALITIES
This chapter contains basic information on the software and the document structure.
1.1
Appropriate Use
IH-Com is software used exclusively for in vitro diagnostic testing.
IH-Com is a software solution used for patient data, QC, sample and instrument management.
IH-Com may only be operated by trained personnel and is not intended for use in a direct patient
environment.
The instructions contained in the Host Connection Manual ASTM-1394 must be followed with
particular attention to the safety instructions
1.2
Warranty limitation
Bio-Rad Laboratories recommends a backup of the computer before installation of IH-Com.
Bio-Rad denies any responsibility in case of:
wrong use of the software;
unauthorized modification (willingly or unwillingly);
not complying with the instructions contained in the provided manuals;
not complying with the safety instructions contained in the manuals;
damages, in particular any data loss or financial loss which could possibly be attached to the
use of the software.
When IH-Com is connected to an LIS, the user takes full responsibility for an error free
transmission of orders and/or results (hardware, software, firmware, etc)..
Any warranty will, be deemed void if fault is found to have been caused by maltreatment,
misuse, unauthorized maintenance of service or negligence of regular maintenance and service,
accidental damage, incorrect storage or use of the products for operations outside their
specified limitations, outside their specifications, contrary to the instructions given in this
manual or with other than the manufacturers original tips.
H009164 V4.1-01/2016
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1 Generalities
1.3
Glossary
The following terms, among others, are used in this manual.
1.3.1
Persons
Manufacturer
The manufacturer of IH-Com is:
DiaMed GmbH
Pra Rond 23
1785 Cressier FR
Switzerland.
Operator
The operator is the owner of IH-Com, when using it as the owner, or if transferring it to a
thirdparty.
Personnel
Any person who operates IH-Com. These individuals should be qualified in accordance with the
manufacturer's requirements.
Technical Personnel
Technical personnel are trained individuals who are allowed to perform specific tasks IH-Com.
Personnel qualifications
Certain personnel qualifications are required in order to perform the activities related to IH-Com.
The personnel qualifications define the minimum requirements which must be met by the
authorized personnel.
Minor Injury
A reversible injury that does not require a medical treatment.
Moderate Injury
A reversible injury that does require a medical treatment.
Major Injury
A damage that is irreversible, causes handicap or death.
8/126
Generalities 1
1.3.2
Product
Software
IH-Com distributed by the manufacturer.
Bio-Rad authorized gel card

Product based on column agglutination technique including a microtube system consumable where
the antigen-antibody binding is fixed in Gel-Matrix.
Only gel cards manufactured by Bio-Rad may be used.
Microplate
A microplate is a standard product with 96 wells, in which tests are performed. The reaction
substance is either coated in the well of the Microplate or pipetted into the well of the microplate
in order to get a antigen-antibody binding
Sample
Content of any sample tube.
Bio-Rad authorized reagent

A substance or compound that is added to a system in order to achieve a chemical reaction. Such
a reaction is used to confirm the presence of another substance.
Only reagents authorized by Bio-Rad may be used.
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1 Generalities
1.4
Typographical conventions
The following styles are used in this manual.
Description
This style, used in conjunction with illustration numbers, is preceded with the corresponding
numbers:
Example:
First element.
Second element.
Etc...
Command
Any software command, button, function key, window, icon, option, tab, checkbox, selection box,
article, menu, tool bar, field and section used in this document is represented by a bold italic font.
Example:
The Exit command allows to quit the software.Procedure
Each procedure step to be carried out step-by-step by the user is preceded by a letter.
Procedure
Example:
Start the IH-Com Communicator by double clicking on the desktop shortcut.
Select the Program/Login user menu.
Click New User (1).
Procedure result
A procedure result is shown by the following symbol
Example:
Click on the Parameters button.
The Parameter screen is displayed.
Cross reference
This style helps the user to find complementary information linked to the current subject.
Example:
10/126
See chapter " Cross reference" on page 10.
Generalities 1
List of items
This style is used in order to display a list of elements.
Example:
item 1
item 2
item 3
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1 Generalities
1.4.1
Labeling and Classification of Safety Instructions

Depending on the importance of the warning and the associated risks, two warning styles are
defined.
1.4.1.1
Warning
Indicates:
an imminently hazardous situation which, if not avoided, will result in death or serious injury
a potentially hazardous situation which, if not avoided, could result in death or serious injury
a potentially hazardous situation which, if not avoided, may result in minor or moderate injury
a risk of minor damage, but no possible injury
1.4.1.2
Note
designates:
a preferred procedure or a recommended usage
a general or purely informative remark
12/126
Safety 2
SAFETY
Chapter contents
This chapter sets out safety instructions to ensure safe and trouble-free operation of the IH-Com
and its associated instruments.
2.1
Introduction
2.1.1
Principles
Before carrying out any operation whatsoever on the IH-Com, it is imperative to read this
chapter and fully understand it.
In case of any doubt, consult your Bio-Rad representative.
Repair and service operations must only be performed by a qualified service engineer appointed
by the manufacturer.
Take into account all the warnings and follow all instructions provided with the IH-Com and in
the documentation.
The IH-Com may only be operated with the instruments and with the accessories approved by
the manufacturer (example: external barcode reader).
Only use virus free USB sticks on all of our IHD instruments and computers.
2.1.2
Importance of the safety instructions

All the safety instructions in this Host Connection Manual ASTM-1394 and in the software must
be complied with in order to prevent accidents to persons, damage to equipment or pollution of
the environment.
In a similar manner, the legal bylaws and the recognised technical rules which apply in the country
of use of the IH-Com must be adhered to.
2.1.3
Disregarding the safety rules

Disregarding the safety rules, as well as existing legal and technical regulations, may lead to accidents, property damages or environmental pollution.
Disregarding the instructions for use given by the manufacturer may reduce the level of
protection offered by the instrument.
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2 Safety
14/48
Description of communication protocols 3
DESCRIPTION OF COMMUNICATION PROTOCOLS
3.1
Overview
The IH-Com software can be connected to a LIS (Laboratory Information System) to download
request data to DiaMed systems and upload result data to the LIS. IH-Com makes plausibility
checks before transferring results back to LIS. Functions to search lots, ID-Cards, plate numbers
and tests are integrated in the IH-Com software. A lot of useful reports are possible: test
summaries, statistic reports and reports for billing information.
3.2
Communication modes
Generally the communication is based on Ethernet Networks using TCP/IP (Version 4).
Other types of networks may work with restrictions and have to be validated by the end user.
All information will be transferred in unique ASCII files (Appending is not supported!).
Processed files should be deleted immediately.
Following communication modes can be used:
Based on FTP file transfer over TCP/IP. IH-Com can act as a FTP client, in this case the hostname, FTP user name and FTP password has to be provided by the administrator of the FTP
server.
Based on a drive mapping to a shared folder at LIS server using windows shares. Hostname,
remote user name and password has to be provided by the administrator of the LIS server.
It is also possible to provide a local folder as a share for communication.
Serial port connection.
TCP/IP socket transfer. IH-Com can act as a TCP Server or Client and supports the ASTM
1381 protocol and a simple transfer protocol using start and stop signs.
Refer to IH-Com LIS Connection Manual for details.

The appropriate instruments should not be visible to internet. This has to be guaranteed by
customers network administrator.
IH-Com internally works with special machine protocols for all connected instruments types.
IH-Com workstations must have a fixed IP address.
All work list files should not be created in append mode.
File name format for work lists of LIS:
[Any expression (e.g. including date and time)].dnl
Sample: 010903140502.dnl
The result file has the same format with appendix .upl (upload file):
[Any expression (usually IH and a 6 digit number)].upl
Sample: H000105.upl
All *.upl and *.dnl files will be archived in special directories at IH-Com workstation. In the case
of socket connections only the contents of the files are transferred.
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3 Description of communication protocols

3.3
Shared folder (Windows shares)

A share folder has to be defined, where the communication files will be placed.
There should be two subdirectories "orders" and "results".
IH-Com will get work lists from "orders" and put results to "results".
This user has to get rights to read, write and delete files for the shared folder and all
directories.
IH-Com will map the shared folder actively if the connection is lost.
A fixed drive mapping in Windows Explorer or a drive mapping by a batch file is not
recommended.
3.4
FTP file transfer

For this mode an FTP server at the LIS server will be used.
Set up this FTP server as follows:
Create a user diamed with password diamed
User diamed should have a home directory with two subdirectories: orders and
results
This user has to get rights to read, write and delete files in its home and
subdirectories.
16/48
Data frame format (ASTM 1394) 4
DATA FRAME FORMAT (ASTM 1394)

This chapter describes the data records formats of IH-Com.
4.1
Data record formats

The following record types are used:
Record type
Value
Description
Header Record
System data, date and time
Patient Record
Sample data, demographics
Test Order record
Message Terminator Record
See chapter "4.2.3 Test Order record" on page 23.
Result data linked to specimen ID's
Comment record
See chapter "4.2.2 Patient record" on page 19.
Tests requests linked to specimen ID's
Results record
See chapter "4.2.1 Header Record" on page 18.
See chapter "4.2.6 Results record" on page 32.
Miscellaneous information (can be used after P, O or

R records)
See chapter "4.2.2.1 Comment record after a

patient record" on page 22.
See chapter "4.2.8 Comment record after a Result

record" on page 36.
Indicates the end of the transfer session
See chapter "4.2.9 Message Terminator Record"

on page 38.
All other record types and fields with sign n/u will be ignored.
Use ASCII (h0D) for signing End-Of-Line in ORDER-files.
Character set used for download and upload files is Windows ANSI (code page 1252 ).
Neither carriage return nor line feed (ASCII h0A or h0D) nor delimiter characters
See chapter "4.2.1 Header Record" on page 18.
are allowed inside of comments or other strings (e.g. names).

Results: Escape sequences are transferred if the IH-Com user entered in comment fields line
breaks or signs which are defined as delimiter.
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4 Data frame format (ASTM 1394)

4.2
Format description
4.2.1
Header Record
18/48
Field title
Max. length
Description and Valid Values
Record type ID
Delimiter definition
Following the order of emission:

|
field delimiter.................................... ASCII: 124
repeat delimiter ................................ ASCII: 92
component delimiter ........................ ASCII: 94
&
escape delimiter............................... ASCII: 38
Field delimiter
Message control ID
n/u
Field delimiter
Access Password
n/u
Field delimiter
Sender (name or ID)
Field delimiter
Sender address
Field delimiter
Reserved field
n/u
Field delimiter
Sender telephone
n/u
Field delimiter
Sender characteristics
n/u
Field delimiter
10
Receiver ID
n/u
Field delimiter
11
Comments/Special
n/u
Field delimiter
12
Session ID
n/u
Field delimiter
13
Current ASTM version
n/u
Field delimiter
14
Current date and time
Bio-Rad (only in results from IH-Com)

|
20
14
IH v4.0 (Only in results from IH-Com. Part "IH"

is static, part "v4.0" will be dynamically changed
with each update.)
Format CCYYMMDDHHNNSS

4.2.2
Patient record
#
Field title
Max. length
Record type ID
Field delimiter
Sequence number
Field delimiter
Practice Assign Patient ID
Field delimiter
Laboratory Assign Patient

ID
Field delimiter
Patient ID No. 3
Field delimiter
6.1
Patient name
|
2
(in the list of P)

|
40
External ID, which uniquely identifies a

patient. This number must not change, when
new orders for the patient are received at a
later time.
|
20
Patient file number (for requests and results).

If not available the specimen number is used
in results
|
20
n/u
|
40
Component delimiter
6.2
Patient first name
Field delimiter
Maiden name
Field delimiter
Birth date
Field delimiter
Patient sex
Field delimiter
10
Patient Race/Ethnic Origin
n/u
Field delimiter
11.1
Patient Address Part 1
Component delimiter
11.2
Patient Address Part 2
Field delimiter
12
Reserved field
n/u
Field delimiter
13
Patient Tel. Number
n/u
H009164 V1.7-01/2016
40
|
40
|
8
Format CCYYMMDD
|
30
M/F/U (unknown)
n/u
^
30
n/u
19/48
20/48
Field title
Max. length
Field delimiter
14.1
Attending Physician ID 1
Component delimiter
14.2
Attending Physician ID 1
Field delimiter
15
Special Field 1
n/u
Field delimiter
16
Special Field 2
n/u
Field delimiter
17
Patient height
n/u
Field delimiter
18
Patient weight
n/u
Field delimiter
19
Patient Illness
n/u
Field delimiter
20
Patient active medication
n/u
Field delimiter
21
Patient Diet
n/u
Field delimiter
22
Practice field No. 1
n/u
Field delimiter
23
Practice field No. 2
n/u
Field delimiter
24
Admission and Discharge

Date
Field delimiter
25
Admission status
n/u
Field delimiter
26
Location
n/u
Field delimiter
27
Nature of Alternative Diag.

Code
Field delimiter
28
Alternative Diagnostic Code
|
20
n/u
^
20
14
010
n/u
n/u
n/u
|
n/u
Field title
Max. length
Field delimiter
29
Patient Religion
n/u
Field delimiter
30
Marital Status
n/u
Field delimiter
31
Isolation Status
n/u
Field delimiter
32
Language
n/u
Field delimiter
33.1
Hospital Service 1
Component delimiter
33.2
Hospital Service 2
40
Requests only: Ward or service name

^ (optional)
40
Requests only: Division or service name

(optional)
Birth Place and comments are not accessible via patient fields.
For requests to IH-Com, all fields are optional. If no patient data is available IH-Com creates a
request which is not linked to a patient record and which is only identified by the specimen
number.
If patient data is available, patients first name, last name and birth date are required in order to
create the record in the patient database. If the patient already exists, first name, last name and
birth date must be identical in order to overwrite existing data (e.g. sex) with the value of the
new fields.
H009164 V1.7-01/2016
21/48

4.2.2.1
Comment record after a patient record

The following format is only valid for a Comment record that follows a Patient record in
IH-Com results.
Comment records for patients are ignored in requests.
22/48
Field title
Max. length
Record type ID
Field delimiter
Sequence Number
Field delimiter
3.1
Comment Text 1
Component delimiter
3.2
Comment Text 2
|
1
(in the list of C)

|
30
Birth Place (n/u)

^
40
comment

4.2.3
Test Order record

#
Field title
Max. length
11
Record Type ID
Field delimiter
Sequence Number
Field delimiter
Specimen ID
Field delimiter
4.11
Code of the specimen/

recipient sample 1
Component delimiter
4.2
Type of the specimen/

recipient sample 1
Component delimiter
4.31
Code of the donor sample 1
Component delimiter
4.4
Type of the donor sample 1
Repeat delimiter
4.1.1
Code of the specimen /

recipient sample 2
Component delimiter
4.2.1
Type of the specimen /

recipient sample 2
Component delimiter
H009164 V1.7-01/2016
|
2
(in the list of O)

|
20
Normally not used.

Optional: Sorter for manual work list
(upload only).
|
20
(First) patient specimen number (= barcode

at test tube)
^
15
Requests: The sample type2 (e.g.

CENTBLOOD) is not used with current
DiaMed devices. It may be used in future
versions. Leave empty.
Results: Additional test tube number (rarely
used, see 4.1.1)
^
203
First donation test tube number / donation

information referring Eurocode data
structure
^
15
Requests: The donation sample type (e.g.

CENTBLOOD) is not used with current
Results: Additional donation test tube
number (rarely used, see 4.4.1)
\
20
Requests: The second patient test tube

number is not used with current DiaMed
devices. It may be used in future versions.
Leave empty.
^
15
Requests: The second patient sample type

(e.g. CENTBLOOD) is not used with current
^
23/48
Field title
Max. length
4.3.1
Code of the donor sample 2
20
Requests: The second donation test tube

number is not used with current DiaMed
devices. It may be used in future versions.
Leave empty.
Component delimiter
4.4.1
Type of the donor sample 2
Field delimiter
5.1
Universal Test ID
n/u
Component delimiter
5.2
Universal Test ID Name
n/u
Component delimiter
5.3
Universal Test ID Type
n/u
Component delimiter
5.41
Manufactures Test ID
Component delimiter
^
15
128
Requests: Test order mask value (32 bit

integer) as defined in IH-Com test reference
[recommended] or test name4
Results: test name
^
5.5
24/48
Requests: The second donation sample

type (e.g. CENTBLOOD) is not used with
current DiaMed devices. It may be used in
future versions. Leave empty.
n/u
Component delimiter
5.6
Batch ID
Component delimiter
5.7
Test Code
Field delimiter
Priority
Field delimiter
71
Request Ordered Date/Time
Field delimiter
Specimen Collect Date/Time
Field delimiter
Collection End Time
n/u
Field delimiter
20
Batch ID (results only)

^
20
Test order mask value (results only)

(optional)
|
R (routine), S (stat) Default: R

|
14
Requests only: Format

CCYYMMDDHHNNSS
|
14
Requests only: Format

CCYYMMDDHHNNSS
Field title
10
Collection Volume/Units
n/u
Field delimiter
11
Collector ID
n/u
Field delimiter
125
Action Code
Field delimiter
13
Danger Code
n/u
Field delimiter
14
Relevant Clinical Info.
n/u
Field delimiter
15
Date/Time Specimen
Received
n/u
Field delimiter
16
Specimen Type/Source
n/u
Field delimiter
17
Ordering Physician
n/u
Field delimiter
18
Physician Tel. Number
n/u
Field delimiter
19
User Field No. 1
Field delimiter
20
User Field No. 2
Field delimiter
21
Lab. Field No. 1
n/u
Field delimiter
22
Lab. Field No. 2
n/u
Field delimiter
23
Date/Time Results Reported

Last or Modified
Field delimiter
H009164 V1.7-01/2016
Max. length
Requests only: C(anceled) or N(ew). Default:

N
Machine number as defined in IH-Com

(Request: empty or 0 means default device,
other values should only be used for very
special purposes in requests)
|
14
Requests only: requested quantity of XM

(Only to use if field 4.3 is empty!)
Results only: Date of last modification of

sample results.
Format:
CCYYMMDDHHNNSS
|
25/48
Field title
Max. length
24
Instrument Charge
n/u
Field delimiter
25
Instrument Section ID
n/u
Field delimiter
26
Report Types
Results only: F (final), X (cancelled) or P

(preliminary results). Default: F
1. fields required for ordering (orange)

2. empty means default type (CENTBLOOD: centrifuged blood), possible values: CENTBLOOD, PACKEDCELLS, PLASMA, 0.8CELLS, 3CELLS
3. Maximum length of 20 characters can be exceeded only by using donor information coded referring Eurocode
or ISBT data structure
4. The real name of test profile (as defined in DiaMed devices) can also be used to order a test. This is not recommended, because test names can change (e.g. when the user switches to a similar test with other reagents).
5. Field 7 (Request Ordered Date/Time) must be the same like in the order file with Action Code N for canceling an
order in IH-Com.
26/48

4.2.4
IH-Com test mask reference

Value
Test
Note
AB0
RhD
ABScr (antibody
screening)
Pheno type
16
Kell
32
DAT (direct Coombs)
64
X-match
128
Auto control
256
Other antigens
512
Reverse blood group
1024
n/u
2048
2nd level (shift)
Use another type of arbitrary test (dependent on customer

configuration)
4096
3rd level (shift)

configuration)
8192
4th level (shift)

configuration)
Ordering a combination of tests is possible by adding (logical OR) to the appropriate values.
The recommended way of ordering tests in IH-Com is using a test mask of an existing single test.
A list of tests can be printed in the IH-Com software.
If more than one test exists with the same test mask, the alternative test mask (IH-Com -> Test
definitions) can be defined to determine, which test will be requested.
E.g.: The user sets the alternative test mask 512 for test PR07D (Reverse A1, A2, B, 0). This alternative
test mask can easily be assigned to another test, if the user wants to switch the test in the future.
To request different tests with the same test mask from the LIS, use the bits 2048, 4096 and 8192
in addition to the test mask. In this case the user has to assign alternative test masks in IH-Com.
E.g.: PR15B Antibody Screening IAT = 4, PR15C Antibody Screening Enzyme = 2052, PR15S Antibody
Screening Saline = 4100
H009164 V1.7-01/2016
27/48

IH-Com can also split (complex) test masks in separate tests, if test profiles are defined by the
user. In this case results will contain more tests (Order records in ASTM) than the original request.
These test profiles need do be defined manually by the user. E.g.: 547 could be split into 35 (AB0D + DAT)
and 512 (Reverse)
If neither a test profile, test mask nor an alternative test mask is found, the order will be ignored.
Remarks:
If crossmatches are requested along with other tests (e.g. Crossmatch 64 + AutoControl 128 =
192) two separate results will be returned.
If autocontrol and crossmatch combinations are ordered at different times, the autocontrols may
be processed for each order
If test profiles are used, separate results will be returned for each contained test.
If neither a test profile, test mask nor an alternative test mask is found, the order will be
ignored.
28/48

4.2.5
Samples for test order mask values
4.2.5.1
Blood group test: (usually a test profile in this example)

Test order
mask value
Test
AB0
RhD
512
Reverse blood group
Pheno
16
Kell
ABScr (Antibody screening)
Order description
Calculation of order mask
543
Default blood group test
1st 543
Resulting order
O|1||sample1^^^\^^^|^^^543|R|20080103152402|||||N|||||||1
4.2.5.2
ABD and 4 x-matches:

Test order
mask value
Test
AB0
RhD
1st 3
ABD control
2nd 64
1st x-match
3rd 64
2nd x-match
4th 64
3rd x-match
5th 64
4th x-match
Note
Resulting orders
O|1||sample2^^^\^^^|^^^3|R||||||N|||||||1
O|2||sample2^^donation1^\^^^|^^^64|R|20080103152416|||||N|||||||1
H009164 V1.7-01/2016
29/48

4.2.5.3
AB0D/DAT
Test order
mask value
Test
AB0
RhD
32
DAT (Coombs direct)
35
1st 35
AB0D/DAT
Order description
Resulting order
O|1||sample4^^^\^^^|^^^35|R|20040103153205|||||N|||||||1
4.2.5.4
ABD, ABScr and 2 x-matches:

Test order
mask value
Test
AB0
RhD
1st 3
ABD control
2nd 4
Antibody screening (4)
3rd 64
1st x-match (64)
4th 64
2nd x-match (64)
Note
Resulting orders
O|1||sample5^^^\^^^|^^^3|R||||||N|||||||1
O|2||sample5^^^\^^^|^^^4|R||||||N|||||||1
4.2.5.5
3 x-matches where donation numbers are not known yet:

Test order
mask value
Test
Order description
1st 64
3 x-matches (64)
Resulting order
O|1||sample5^^^\^^^|^^^64|R|20040103152406|||||N|||||||1|3
30/48

4.2.5.6
Example of a complete order file:

H|\^&|||LIS||||||||1|20080123173700
P|1|445566|12345678||Mytestpatient^Myfirstname||19610921|F||||||||||||||||||||||||HN
O3|
O|1||987654^^^\^^^|^^^3|R|20080123171500|20080123170000||||N|||||||1
O|2||987654^^^\^^^|^^^4|R|20080123171500|20080123170000||||N|||||||1
O|3||987654^^2769990812345678^\^^^|^^^64|R|20080123171500|20080123170000||||N|||||||
1
O|4||987654^^2769990898765432^\^^^|^^^64|R|20080123171500|20080123170000||||N|||||||
1
L|1|N
H009164 V1.7-01/2016
31/48

4.2.6
Results record
#
Field title
Max. length
Record Type ID
Field delimiter
Sequence Number
Field delimiter
3.1
Universal Test ID
n/u
Component delimiter
3.2
Universal Test ID Name
n/u
Component delimiter
3.3
Universal Test ID Type
n/u
Component delimiter
3.4
Manufacturers Test Type
|
2
20
Reaction line: field name e.g.: AntiA, AntiB1;

Result line (interpretation): Result
Component delimiter
3.5
Manufacturers Test Name
Component delimiter
3.6
Manufacturers Test Code
Component delimiter
3.7
Test Code
^
64
^
64
e.g.: BG: AB0/D+DAT (DiaClon) (5049)

(Depending of device configuration and
language! Do not use for identification)
^
20
Field delimiter
32/48
e.g.: AB0, MO01B (see IH-Com test printout)
Test order mask value (results only) (optional)

|
4.1
Data or Measurement
Value
Component delimiter
4.2
Initial Measurement Value
Component delimiter
4.3
Measurement Value of
Device
Field delimiter
Units of Measure
Field delimiter
Reference Ranges
n/u
Field delimiter
Result code2 (End result)

^
Result code of first reading

^
Result code of the automate

|
Type of reaction support: C = id-card

M = micro plate
Field title
Max. length
Result Abnormal Flags
n/u
Field delimiter
Nature of Abnormality
n/u
Field delimiter
Result Status
Field delimiter
10
Date of Change in
Instrument Normative
Values or Units
n/u
Field delimiter
11.1
Operator ID (performed)
Component delimiter
11.2
Operator ID (verified)
Field delimiter
12
Date/Time Test Started
Field delimiter
13
Date/Time Test Completed
Field delimiter
14
Instrument ID
Field delimiter
15
Instrument Name
Field delimiter
16
Serial Number
Field delimiter
17
Operator ID (performed)
40
R: automated reading result, M: operator

modified result,
S: partial results, X: cancelled result
Name of the operator who has performed the

test or the instrument name with serial
numbers
^
20
Name of the operator who has last edited

(result record) respectively accepted
(interpretation record) the sample results
|
14
Date/Time of test finishing (aberrant to astm

field description!)
Syntax: CCYYMMDDHHMMSS
|
14
Date/Time of last modification (aberrant to

astm field description!) Syntax:
CCYYMMDDHHMMSS
|
Machine number (defined in IH-Com)

|
20
Instrument name(s) where the test was

performed
|
20
Serial number of the instrument

|
20
Name of the operator who has performed the

test
1. See chapter "5.3 Possible field name values" on page 43.

2. If this is an interpretation record, the assembly of field 4 is described in chapter 4.2.7 Result codes for interpretation records on page 34
H009164 V1.7-01/2016
33/48

4.2.7
Result codes for interpretation records

If this is an interpretation record, the field 4 contains the following components:
#
Content
Max. length
Possible values
4.1
Group
0, A, B, AB, DSCR, ?, A1, A2, A1B, A2B,

Awv, Bwv, AwvB, ABwv, AwvBwv, A1Bwv, A2Bwv1
Component delimiter
4.2
Type
Component delimiter
4.3
ABScr
Component delimiter
4.4
Pheno
Component delimiter
4.5
Kell
Component delimiter
4.6
DAT
Component delimiter
4.7
X-Match
Component delimiter
4.8
Auto control
Component delimiter
4.9
Other antigen
^
8
POS, NEG, WEAK, PART, DSCR, ?, wv1

^
POS, NEG, DSCR, ?

^
e.g.: ccEe, ccD.Ee, DSCR, ?, ccEewv1, ccD.Eewv, c+,

c-, c+wv (c antigen only)
Combinations of CC, Cc, cc, C., c., EE, Ee, ee, E., e.
and wv as a suffix for single phenotype antigens and
combinations of them.
^
K-, K+, DSCR, ?, Kwv1

^
POS, NEG, DSCR, ?

^
CMP, INCMP, DSCR, ?

^
POS, NEG, DSCR, ?

^
See chapter "5.1 Possible antigen result values"

on page 41.
1. wv equals weak verify. This is not an overall blood group result. It means that further investigation is necessary to verify the correct result. This may not be possible with the available tests.
All interpretation records contain the cumulated result of all results belonging together (same
patient /sample). If it is medically reasonable previous results may be considered too.
34/48

Otherwise it contains the following components:
#
Content
Max. length
Possible values
Result code
0 (0 or -)
5 (0.5 or +/-)
10 (1+ or +)
20 (2+ or ++)
30 (3+ or +++)
40 (4+ or ++++)
? (Suspect result)
-000 (neg. value=error code)
H009164 V1.7-01/2016
See chapter "5.2 Possible error codes" on page 42.
35/48

4.2.8
36/48
Comment record after a Result record

#
Field title
Max. length
Record Type ID
Field delimiter
Sequence Number
Field delimiter
3.1
Description of Reagent
Component delimiter
3.2
Barcode of Reagent
Component delimiter
3.3
Lot number of Reagent
Component delimiter
3.4
Expiration Date of Reagent
Repeat delimiter
3.1
Description of Reagent2
Component delimiter
3.2
Barcode of Reagent2
Component delimiter
3.3
Lot number of Reagent2
Component delimiter
3.4
Expiration Date of Reagent2
Field delimiter
4.1
Type of test media
Component delimiter
4.2
Plate/id-card barcode
Component delimiter
4.3
Lot number of cassette /Plate
Component delimiter
4.4
Exp. date for id-card/ plate
Component delimiter
4.5
Id-card/plate real well number
Field delimiter
|
2
|
30
e.g.: ID-DiaCell I
^
20
n/u
^
20
e.g.: 06084.30.1
^
format <CCYYMMDD>
\
30
e.g.: ID-Diluent 2
^
20
n/u
^
20
^
8
format <CCYYMMDD>
|
CAS: id-card; MIC: micro plate

^
20
^
20
^
8
format <CCYYMMDD>
^
Real well or column number

Possible values on ID-cards: 1 6
Possible values on microplates: 1 96
(A1, A2 H12)
|
Field title
Comment
Field delimiter
File name of reaction picture
Optional (not available if using socket

protocol or serial protocol)
H009164 V1.7-01/2016
Max. length
37/48

4.2.9
Message Terminator Record

#
Field title
Max. length
Record Type ID
Field delimiter
2
Sequence Number
|
1
Field delimiter
3
38/48
Termination Code
1
|

4.2.10
Example of result file
H|\^&|||Bio-Rad|IH v5.0||||||||20150505151007
P|1|ID0815|ER-123456||BlackÊlisabeth|Withe|19570227|F||||||||||||||||||||||||HNO3^
C|1|^This is a comment to the Patient "Black, Elisabeth".
O|1||ER-123456^^^\^^^|^^^PR09A^^^|R|20150505132319|20150505131500|||||||||||8||||20150505150931|||F
R|1|^^ÂntiC^PR09A^Phenotype: C,c,E,e,K,ctl (5010)^|40^^|C||||R||LabUser^|20150505144550|20150505150931|8
C|1|ID-Diluent 1^^05750.47.11^20150430\^^^|CAS^5010008151504000004^50100.08.15^20150430^1||
R|2|^^Ânti_C^PR09A^Phenotype: C,c,E,e,K,ctl (5010)^|0^^|C||||R||LabUser^|20150505144550|20150505150931|8
C|1|ID-Diluent 1^^05750.47.11^20150430\^^^|CAS^5010008151504000004^50100.08.15^20150430^2||
R|3|^^ÂntiE^PR09A^Phenotype: C,c,E,e,K,ctl (5010)^|40^^|C||||R||LabUser^|20150505144550|20150505150931|8
C|1|ID-Diluent 1^^05750.47.11^20150430\^^^|CAS^5010008151504000004^50100.08.15^20150430^3||
R|4|^^Ânti_E^PR09A^Phenotype: C,c,E,e,K,ctl (5010)^|40^^|C||||R||LabUser^|20150505144550|20150505150931|8
C|1|ID-Diluent 1^^05750.47.11^20150430\^^^|CAS^5010008151504000004^50100.08.15^20150430^4||
R|5|^^ÂntiK^PR09A^Phenotype: C,c,E,e,K,ctl (5010)^|0^^-30|C||||M||LabUser^Labor|20150505144550|20150505150931|8
C|1|ID-Diluent 1^^05750.47.11^20150430\^^^|CAS^5010008151504000004^50100.08.15^20150430^5|This is a comment to the well "Anti-K"|
R|6|^^^CtrlRH^PR09A^Phenotype: C,c,E,e,K,ctl (5010)^|0^^|C||||R||LabUser^|20150505144550|20150505150931|8
C|1|ID-Diluent 1^^05750.47.11^20150430\^^^|CAS^5010008151504000004^50100.08.15^20150430^6||
R|7|^^^Result^PR09A^Phenotype: C,c,E,e,K,ctl (5010)^|^^^CCEe^K-^^^^|C||||M||LabUser^Labor|20150505144550|20150505150931|8
C|1|^^^||This is a comment to the sample ER-123456.&XA&And this is a comment after a line break.
O|2||ER-123456^^^\^^^|^^^PR15B^^^|R|20150505132149|20150505131500|||||||||||9||||20150505150931|||F
R|1|^^ÂbsI1^PR15BÂb.screening: I,II,III (IAT) (5053)^|0^^|C||||R||LabUser2^|20150505144920|20150505150931|9
C|1|ID-DiaCell I^^06080.00.0^20150506\^^^|CAS^5053000001505000003^50530.00.00^20150531^1||
C|1|ID-DiaCell II^^06090.00.0^20150506\^^^|CAS^5053000001505000003^50530.00.00^20150531^2||
C|1|ID-DiaCell III^^06100.00.0^20150506\^^^|CAS^5053000001505000003^50530.00.00^20150531^3||
R|4|^^^Result^PR15BÂb.screening: I,II,III (IAT) (5053)^|^^NEG^^^^^^|C||||R||LabUser2^Labor|20150505144920|20150505150931|9
O|3||ER-123456^^^\^^^|^^^MP6040^^^|R|20150505132149|20150505131500|||||||||||10||||20150505150931|||F
R|1|^^ÂntiA^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|20^^|M||||R||LabUser^|20150505145353|20150505150931|10
C|1|ID-Diluent 1^^05750.00.00^20150531\^^^|MIC^604000000150500001^60400.00.00^20150531^85||
R|2|^^ÂntiB^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|0^^|M||||R||LabUser^|20150505145353|20150505150931|10
C|1|ID-Diluent 1^^05750.00.00^20150531\^^^|MIC^604000000150500001^60400.00.00^20150531^73||
R|3|^^ÂntiD^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|20^^|M||||R||LabUser^|20150505145353|20150505150931|10
C|1|ID-Diluent 1^^05750.00.00^20150531\^^^|MIC^604000000150500001^60400.00.00^20150531^61||
R|4|^^ÂntiD2^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|20^^10|M||||M||LabUser^Labor|20150505145353|20150505150931|10
C|1|ID-Diluent 1^^05750.00.00^20150531\^^^|MIC^604000000150500001^60400.00.00^20150531^49||
R|5|^^^CtrlAB^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|0^^20|M||||M||LabUser^Labor|20150505145353|20150505150931|10
C|1|ID-Diluent 1^^05750.00.00^20150531\^^^|MIC^604000000150500001^60400.00.00^20150531^37||
R|6|^^^cellA1^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|0^^|M||||R||LabUser^|20150505145353|20150505150931|10
C|1|DiaCell-MP A1^^16400.00.0^20150506\^^^|MIC^604000000150500001^60400.00.00^20150531^25||
R|7|^^^cellA2^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|0^^|M||||R||LabUser^|20150505145353|20150505150931|10
C|1|DiaCell-MP A2^^16410.00.0^20150506\^^^|MIC^604000000150500001^60400.00.00^20150531^13||
R|8|^^^cellB^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B (6040)^|20^^|M||||R||LabUser^|20150505145353|20150505150931|10
C|1|DiaCell-MP B^^16420.00.0^20150506\^^^|MIC^604000000150500001^60400.00.00^20150531^1||
R|9|^^^Result^MP6040^MP-Test: A-B-D(VI-)-D(VI+)-ctl/A1-A2-B
(6040)^|A^POS^^^^^^^|M||||M||LabUser^Labor|20150505145353|20150505150931|10
O|4||ER-123456^^!2769990511000016^\^^^|^^^PR80^^^|R|20150505132149|20150505131500|||||||||||9||||20150505150927|||F
R|1|^^^XM^PR80^Crossmatch: IAT(5053)^|10^^|C||||R||LabUser2^|20150505145214|20150505150927|9
C|1|ID-Diluent 2^^05760.00.00^20150531\^^^|CAS^5053000001505000004^50530.00.00^20150531^1||
R|2|^^^Result^PR80^Crossmatch: IAT(5053)^|^^^^^ÎNCMP^^|C||||R||LabUser2^Labor|20150505145214|20150505150927|9
O|5||ER-123456^^=A00400800000143^\^^^|^^^PR80^^^|R|20150505132149|20150505131500|||||||||||9||||20150505150927|||F
R|1|^^^XM^PR80^Crossmatch: IAT(5053)^|0^^|C||||R||LabUser2^|20150505145234|20150505150927|9
C|1|ID-Diluent 2^^05760.00.00^20150531\^^^|CAS^5053000001505000004^50530.00.00^20150531^1||
R|2|^^^Result^PR80^Crossmatch: IAT(5053)^|^^^^^^CMP^^|C||||R||LabUser2^Labor|20150505145234|20150505150927|9
L|1|N
H009164 V1.7-01/2016
39/48
40/48
Appendix 5
APPENDIX
This chapter contains additional and helpful information for the
Host Connection Manual ASTM-1394.
5.1
Possible antigen result values

Syntax: AntigenResult{+|-|?| DSCR} [\AntigenResult{+|-|?| DSCR}]
Antigen Result
Description
Antigen Result
Description
Antigen Result
Description
Cw
Cw
Tja
Tja
Lua
Lutheran a
_k
Cellano
Vel
Vel
Lub
Lutheran b
Wra
Wra
Dia
Diego a
Xga
Xga
Dib
Diego b
Fya
Duffy a
Jsa
Sutter
_s
Fyb
Duffy b
Jsb
Matthews
Jka
Kidd a
Kpa
Penny
_i
Jkb
Kidd b
Kpb
Rautenberg
Lea
Lewis a
Kp
Kp
P1
P1
Leb
Lewis b
H009164 V1.7-01/2016
41/48
5 Appendix
5.2
42/48
Possible error codes

Error code
Description
-30
Suspect result (general error code)
-14
Doubtful reaction or foreign bodies
-15
Nonhomogeneous reaction area
-16
Deviation of pellet
-17
Doubtful dispersion of cells
-18
Double populated
-19
Hemolysis or lipemia
-20
Too much erythrocytes
-21
Lack of erythrocytes
-22
Wrong liquid level
-23
Fibrin
-24
Air bubbles
-25
Image interpretation not possible
-26
Doubtful liquid distribution
-27
Well not detected
-28
Well not used for test
-40
No result
-45
External Result
-50
Empty well
Appendix 5
5.3
Possible field name values
5.3.1
ABD
Field Name
Description
Field Name
Description
Field Name
Description
AntiA
Anti-A
CtrlAB
AB Control
AntiD2
Anti-D'
AntiA1
Anti-A1
AntiAXM
Anti-A1
AntiD3
Anti-D''
AntiB
Anti-B
AntiBXM
Anti-B1
AntiD4
Anti-D'''
(for Dweak)
AntiAB
Anti-AB
AntiDXM
Anti-D1
AntiDu16
Anti-Du
AntiH
Anti-H
AntiD
Anti-D
Field Name
Description
1. Complete crossmatch only
5.3.2
Rev. Group
Field Name
5.3.3
5.3.4
Description
cellA1
A1-cells
cellB
B-cells
cellA1c
A1-cells (Coombs) cellO
0-cells
cellA2
A2-cells
Rh. Phenotype/Kell
Field Name
Description
Field Name
Description
AntiC
Anti-C
AntiCw
Anti-Cw
Anti_C
Anti-c
AntiCDE
Anti-CDE
AntiE
Anti-E
CtrlRH
Rh-Ctrl
Anti_E
Anti-e
AntiK
Anti-K
Field Name
Description
Field Name
Description
Field Name
Description
DirCmbs1
Dir. coombs1
AntiIgM
Anti-IgM
AntiG300
Anti-IgG
DirCmbs2
Dir. coombs2
AntiG10
Anti-IgG
1:10
AntiC3c
Anti-C3c
DirCmbs3
Dir. coombs3
AntiG100
Anti-IgG
1:100
AntiC3d
Anti-C3d
AntiIgA
Anti-IgA
AntiG1000
Anti-IgG
1:1000
CtrlDAT
DAT control
AntiIgG
Anti-IgG
AntiG30
Anti-IgG
1:30
Direct Coombs
H009164 V1.7-01/2016
1:300
43/48
5 Appendix
5.3.5
5.3.6
Auto Control
Field Name
Description
Field Name
Description
CtrlAuto1
Auto Control
CtrlAuto3
Auto Control 3
CtrlAuto2
Auto Control 2
CtrlAuto4
Auto Control 4
Field Name
Description
Field Name
Description
Field Name
Description
AntiAXM
Anti-A1
XMG
IgG
XMRevG
Reverse IgG
AntiBXM
Anti-B1
XME
Enzyme
XMRevB
Rev. Bromelaine
AntiDXM
Anti-D1
XMS
Saline
XMRevE
Rev. Enzyme
XM
IAT
XMRev
Reverse
XMRevS
Rev. Saline
Field Name
Description
AbsG26
Cell 2 to 6
AbsP26
Cell 2 to 6
Crossmatch
1. Complete crossmatch only
5.3.7
5.3.8
44/48
AB Screening
Field Name
Description
Field Name
Description
AbsI1
IAT cell 1
AbsL1
Low temp
AbsE1
Enzyme cell 1
AbsY1
Enzyme cell 1
AbsG1
IgG cell 1
Same for all other cells and

panels: e.g. AbsI2, AbsS5
AbsS26
Cell 2 to 6
AbsP1
Papaine cell 1
AbsI26
Cell 2 to 6
AbsL26
Cell 2 to 6
AbsS1
Saline cell 1
AbsE26
Cell 2 to 6
AbsY26
Cell 2 to 6
Field Name
Description
Field Name
Description
PanI118
IAT
PanS118
Saline
PanE118
Enzyme
PanL118
Low temp
PanG118
IgG
PanY118
Enzyme
PanEC11
8
Enzyme IAT
c. 1
Panels
Appendix 5
5.3.9
5.3.10
Antigen
Field Name
Description
Field Name
Description
Field Name
Description
AntiFya
Anti-Fya
AntiLua
Anti-Lua
AntiN
Anti-N
AntiFyb
Anti-Fyb
AntiLub
Anti-Lub
AntiP
Anti-P
AntiJka
Anti-Jka
AntiTja
Anti-Tja
AntiP1
Anti-P1
AntiJkb
Anti-Jkb
AntiVel
Anti-Vel
AntiS
Anti-S
AntiJsa
Anti-Jsa
AntiWra
Anti-Wra
Anti_S
Anti-s
AntiJsb
Anti-Jsb
AntiXga
Anti-Xga
Anti_P_P1_PK
Anti-p+p1+pk
AntiKpa
Anti-Kpa
Anti_K
Anti-k cellano
AntiU
Anti-U
AntiKpb
Anti-Kpb
AntiI
Anti-I
CtrlAG
AG Control
AntiLea
Anti-Lea
Anti_I
Anti-i
AntiLeb
Anti-Leb
AntiM
Anti-M
Others field names

HbS, EMPTY, B19, MIRL, DAF, Chagas, dsDNA, SYPH, LEISH, DIPH, HPF4, AntiIgAAB, IgaDEF.
H009164 V1.7-01/2016
45/48
5 Appendix
5.4
compliance
The IH-Com software has been designed to meet all current requirements for safety at work and
operating. It complies with all relevant European Community directives and associated harmonized
standards.
5.4.1
5.5
European directives
Reference
Designation
IVD 98/79/EC
In Vitro Diagnostic Medical Devices Directive
EN ISO 13485:2012
Medical devices - Quality management systems - requirements for

regulatory purposes
EN ISO 14971:2012
Medical devices - Application of risk management to medical devices
EN 62304:2006
Medical device software - Software life-cycle processes
EN 62366:2008
Medical devices - Application of usability engineering to medical

devices
Device disposal
In order to protect the persons and the environment, any instrument and its accessories must
be disposed of in an appropriate way. Its is mandatory to strictly apply laws and local bylaws
relative to an appropriate disposal procedure.
46/48
Index
INDEX
R
Result file (example) . . . . . . . . . . . . . . . . . . . . . . . . 39
A
Antigen result values . . . . . . . . . . . . . . . . . . . . . . . .41
C
Communication modes . . . . . . . . . . . . . . . . . . . . . .15
Complete order file (example) . . . . . . . . . . . . . . . . .31
D
Data record formats . . . . . . . . . . . . . . . . . . . . . . . . .17
Header Record . . . . . . . . . . . . . . . . . . . . . . . . . .18
IH-Com test mask reference . . . . . . . . . . . . . . . .27
Message Terminator Record . . . . . . . . . . . . . . .38
Patient Record . . . . . . . . . . . . . . . . . . . . . . . . . .19
Results record . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Test Order record . . . . . . . . . . . . . . . . . . . . . . . .23
E
Error codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
S
Safety
Disregarding the safety rules . . . . . . . . . . . . . . . 13
Importance of the instructions . . . . . . . . . . . . . . 13
Non-compliance with rules . . . . . . . . . . . . . . . . 13
Samples for test order mask values
AB0D/DAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
ABD, ABScr and 2 x-matches . . . . . . . . . . . . . . 30
Blood group test . . . . . . . . . . . . . . . . . . . . . . . . 29
Shared folder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
U
Use
Appropriate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
W
Warranty
Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
F
Field name values
AB Screening . . . . . . . . . . . . . . . . . . . . . . . . . . .44
-ABD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Auto Control . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Crossmatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Direct Coombs . . . . . . . . . . . . . . . . . . . . . . . . . .43
Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Rev. Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Rh. Phenotype/Kell . . . . . . . . . . . . . . . . . . . . . . .43
FTP (setup server) . . . . . . . . . . . . . . . . . . . . . . . . . .16
G
Glossary
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Product
Gel card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Microplate . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Serious injury . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
L
List of documents . . . . . . . . . . . . . . . . . . . . . . . . . .46
O
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
H009164 V1.7-01/2016
47/48
Bio-Rad
Laboratories
Clinical
Diagnostics Group
Bio-Rad Laboratories is a multinational manufacturer and distributor

of clinical diagnostics and life science research products.
DiaMed
Pra Rond 23, 1785 Cressier FR
Switzerland
www.bio-rad.com/immunohematology
Bio-Rad H009164 V1.7-01/2016

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Bio-Rad Laboratories

The Complete Solution for Safe Transfusion

Copyright and Disclaimer

First version for service engineers

One chapter removed

Update: 4.2.6 Results record on page 32

Technical Information Contacts

PAGE INTENTIONALLY LEFT BLANK

IH-Com Host Connection Manual ASTM-1394 Bio-Rad

1.4 Typographical conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Labeling and Classification of Safety Instructions

Description of communication protocols . . . . . . . . . . . . . . . . . . . . . . . . 15

3.2 Communication modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Data frame format (ASTM 1394) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Comment record after a patient record . . . . . . . . . . . . . . . . . . . . . .22

Test Order record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.2 Possible error codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5.5 Device disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

IH-Com Host Connection Manual ASTM-1394 Bio-Rad

IH-Com Host Connection Manual ASTM-1394 Bio-Rad

Bio-Rad authorized gel card

Only gel cards manufactured by Bio-Rad may be used.

Bio-Rad authorized reagent

Only reagents authorized by Bio-Rad may be used.

Start the IH-Com Communicator by double clicking on the desktop shortcut.

Select the Program/Login user menu.

Click New User (1).

Click on the Parameters button.

The Parameter screen is displayed.

See chapter " Cross reference" on page 10.

IH-Com Host Connection Manual ASTM-1394 Bio-Rad

Labeling and Classification of Safety Instructions

IH-Com Host Connection Manual ASTM-1394 Bio-Rad

Importance of the safety instructions

Disregarding the safety rules

PAGE INTENTIONALLY LEFT BLANK

IH-Com Host Connection Manual ASTM-1394 Bio-Rad

Description of communication protocols 3

DESCRIPTION OF COMMUNICATION PROTOCOLS

Refer to IH-Com LIS Connection Manual for details.

3 Description of communication protocols

Shared folder (Windows shares)

FTP file transfer

Create a user diamed with password diamed

IH-Com Host Connection Manual ASTM-1394 Bio-Rad

Data frame format (ASTM 1394) 4

DATA FRAME FORMAT (ASTM 1394)

Data record formats

System data, date and time

Sample data, demographics

Test Order record

Message Terminator Record

See chapter "4.2.3 Test Order record" on page 23.

Result data linked to specimen ID's

See chapter "4.2.2 Patient record" on page 19.

Tests requests linked to specimen ID's

See chapter "4.2.1 Header Record" on page 18.

See chapter "4.2.6 Results record" on page 32.

Miscellaneous information (can be used after P, O or

See chapter "4.2.2.1 Comment record after a

See chapter "4.2.8 Comment record after a Result

Indicates the end of the transfer session

See chapter "4.2.9 Message Terminator Record"

Use ASCII (h0D) for signing End-Of-Line in ORDER-files.