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IMMUNOHEMATOLOGY
IH-Com
Host Connection Manual
ASTM-1394
V1.7-01/2016
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
Identification
Version History
Version
Date
IH-Com Version
Comments
1.0
18.05.10
3.0
1.1
23.12.10
3.0
Updates
1.2
11.04.11
3.0 r58
1.3
09.11.11
3.0 r58
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
H009164 V1.7-01/2016
3/48
Identification
4/48
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
. . . . . . . . . . . . . . . . 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
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
H009164 V1.7-01/2016
5/48
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
Results record . . . . . . . . . . . . . . .
Result codes for interpretation records
Comment record after a Result record
Message Terminator Record . . . . . .
Example of result file . . . . . . . . . .
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.29
.29
.30
.30
.30
.31
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32
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36
38
39
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.1 Possible antigen result values
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
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
43
43
43
44
44
44
44
45
45
compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
European directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
7/126
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.
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.
H009164 V4.1-01/2016
9/126
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:
Procedure result
A procedure result is shown by the following symbol
Example:
Cross reference
This style helps the user to find complementary information linked to the current subject.
Example:
10/126
Generalities 1
List of items
This style is used in order to display a list of elements.
Example:
item 1
item 2
item 3
H009164 V4.1-01/2016
11/126
1 Generalities
1.4.1
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
2.1.3
H009164 V1.7-01/2016
13/48
2 Safety
14/48
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.
H009164 V1.7-01/2016
15/48
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
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
4.1
Value
Description
Header Record
Patient Record
Comment record
Results record
All other record types and fields with sign n/u will be ignored.
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
H009164 V1.7-01/2016
17/48
Format description
4.2.1
Header Record
18/48
Field title
Max. length
Record type ID
Delimiter definition
&
Field delimiter
Message control ID
n/u
Field delimiter
Access Password
n/u
Field delimiter
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
n/u
Field delimiter
14
20
14
Format CCYYMMDDHHNNSS
Patient record
#
Field title
Max. length
Record type ID
Field delimiter
Sequence number
Field delimiter
Field delimiter
Field delimiter
Patient ID No. 3
Field delimiter
6.1
Patient name
|
2
40
20
20
n/u
|
40
Component delimiter
6.2
Field delimiter
Maiden name
Field delimiter
Birth date
Field delimiter
Patient sex
Field delimiter
10
n/u
Field delimiter
11.1
Component delimiter
11.2
Field delimiter
12
Reserved field
n/u
Field delimiter
13
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
n/u
Field delimiter
21
Patient Diet
n/u
Field delimiter
22
n/u
Field delimiter
23
n/u
Field delimiter
24
Field delimiter
25
Admission status
n/u
Field delimiter
26
Location
n/u
Field delimiter
27
Field delimiter
28
|
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
40
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.
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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
30
40
comment
Field title
Max. length
11
Record Type ID
Field delimiter
Sequence Number
Field delimiter
Specimen ID
Field delimiter
4.11
Component delimiter
4.2
Component delimiter
4.31
Component delimiter
4.4
Repeat delimiter
4.1.1
Component delimiter
4.2.1
Component delimiter
H009164 V1.7-01/2016
|
2
20
20
15
203
15
20
15
23/48
Field title
Max. length
4.3.1
20
Component delimiter
4.4.1
Field delimiter
5.1
Universal Test ID
n/u
Component delimiter
5.2
n/u
Component delimiter
5.3
n/u
Component delimiter
5.41
Manufactures Test ID
Component delimiter
^
15
128
5.5
24/48
n/u
Component delimiter
5.6
Batch ID
Component delimiter
5.7
Test Code
Field delimiter
Priority
Field delimiter
71
Field delimiter
Field delimiter
n/u
Field delimiter
20
20
14
14
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
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
n/u
Field delimiter
19
Field delimiter
20
Field delimiter
21
n/u
Field delimiter
22
n/u
Field delimiter
23
Field delimiter
H009164 V1.7-01/2016
Max. length
14
25/48
Field title
Max. length
24
Instrument Charge
n/u
Field delimiter
25
Instrument Section ID
n/u
Field delimiter
26
Report Types
26/48
Test
Note
AB0
RhD
ABScr (antibody
screening)
Pheno type
16
Kell
32
64
X-match
128
Auto control
256
Other antigens
512
1024
n/u
2048
4096
8192
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
28/48
4.2.5.1
Test
AB0
RhD
512
Pheno
16
Kell
Order description
543
Default blood group test
1st 543
Resulting order
O|1||sample1^^^\^^^|^^^543|R|20080103152402|||||N|||||||1
4.2.5.2
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
O|3||sample2^^donation2^\^^^|^^^64|R|20080103152416|||||N|||||||1
O|4||sample2^^donation3^\^^^|^^^64|R|20080103152417|||||N|||||||1
O|5||sample2^^donation4^\^^^|^^^64|R|20080103152417|||||N|||||||1
H009164 V1.7-01/2016
29/48
AB0D/DAT
Test order
mask value
Test
AB0
RhD
32
35
1st 35
AB0D/DAT
Order description
Resulting order
O|1||sample4^^^\^^^|^^^35|R|20040103153205|||||N|||||||1
4.2.5.4
Test
AB0
RhD
1st 3
ABD control
2nd 4
3rd 64
4th 64
Note
Resulting orders
O|1||sample5^^^\^^^|^^^3|R||||||N|||||||1
O|2||sample5^^^\^^^|^^^4|R||||||N|||||||1
O|3||sample5^^donation1^\^^^|^^^64|R|20040103152414|||||N|||||||1
O|4||sample5^^donation2^\^^^|^^^64|R|20040103152414|||||N|||||||1
4.2.5.5
Test
Order description
1st 64
3 x-matches (64)
Resulting order
O|1||sample5^^^\^^^|^^^64|R|20040103152406|||||N|||||||1|3
30/48
H009164 V1.7-01/2016
31/48
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
n/u
Component delimiter
3.3
n/u
Component delimiter
3.4
|
2
20
Component delimiter
3.5
Component delimiter
3.6
Component delimiter
3.7
Test Code
^
64
^
64
20
Field delimiter
32/48
4.1
Data or Measurement
Value
Component delimiter
4.2
Component delimiter
4.3
Measurement Value of
Device
Field delimiter
Units of Measure
Field delimiter
Reference Ranges
n/u
Field delimiter
Field title
Max. length
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
Field delimiter
13
Field delimiter
14
Instrument ID
Field delimiter
15
Instrument Name
Field delimiter
16
Serial Number
Field delimiter
17
Operator ID (performed)
40
20
14
14
20
20
20
H009164 V1.7-01/2016
33/48
Content
Max. length
Possible values
4.1
Group
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
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
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
35/48
36/48
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
Component delimiter
3.4
Repeat delimiter
3.1
Description of Reagent2
Component delimiter
3.2
Barcode of Reagent2
Component delimiter
3.3
Component delimiter
3.4
Field delimiter
4.1
Component delimiter
4.2
Plate/id-card barcode
Component delimiter
4.3
Component delimiter
4.4
Component delimiter
4.5
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>
|
20
^
20
^
8
format <CCYYMMDD>
^
Field title
Comment
Field delimiter
H009164 V1.7-01/2016
Max. length
37/48
Field title
Max. length
Record Type ID
Field delimiter
2
Sequence Number
|
1
Field delimiter
3
38/48
Termination Code
1
|
H|\^&|||Bio-Rad|IH v5.0||||||||20150505151007
P|1|ID0815|ER-123456||Black^Elisabeth|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|^^^AntiC^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|^^^Anti_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|^^^AntiE^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|^^^Anti_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|^^^AntiK^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|^^^AbsI1^PR15B^Ab.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||
R|2|^^^AbsI2^PR15B^Ab.screening: I,II,III (IAT) (5053)^|0^^|C||||R||LabUser2^|20150505144920|20150505150931|9
C|1|ID-DiaCell II^^06090.00.0^20150506\^^^|CAS^5053000001505000003^50530.00.00^20150531^2||
R|3|^^^AbsI3^PR15B^Ab.screening: I,II,III (IAT) (5053)^|0^^|C||||R||LabUser2^|20150505144920|20150505150931|9
C|1|ID-DiaCell III^^06100.00.0^20150506\^^^|CAS^5053000001505000003^50530.00.00^20150531^3||
R|4|^^^Result^PR15B^Ab.screening: I,II,III (IAT) (5053)^|^^NEG^^^^^^|C||||R||LabUser2^Labor|20150505144920|20150505150931|9
C|1|^^^||This is a comment to the sample ER-123456.&XA&And this is a comment after a line break.
O|3||ER-123456^^^\^^^|^^^MP6040^^^|R|20150505132149|20150505131500|||||||||||10||||20150505150931|||F
R|1|^^^AntiA^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|^^^AntiB^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|^^^AntiD^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|^^^AntiD2^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
C|1|^^^||This is a comment to the sample ER-123456.&XA&And this is a comment after a line break.
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)^|^^^^^^INCMP^^|C||||R||LabUser2^Labor|20150505145214|20150505150927|9
C|1|^^^||This is a comment to the sample ER-123456.&XA&And this is a comment after a line break.
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
C|1|^^^||This is a comment to the sample ER-123456.&XA&And this is a comment after a line break.
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
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
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5 Appendix
5.2
42/48
Description
-30
-14
-15
-16
Deviation of pellet
-17
-18
Double populated
-19
Hemolysis or lipemia
-20
-21
Lack of erythrocytes
-22
-23
Fibrin
-24
Air bubbles
-25
-26
-27
-28
-40
No result
-45
External Result
-50
Empty well
Appendix 5
5.3
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
5.3.2
Rev. Group
Field Name
5.3.3
5.3.4
Description
cellA1
A1-cells
cellB
B-cells
cellA1c
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
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
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
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
EN ISO 13485:2012
EN ISO 14971:2012
EN 62304:2006
EN 62366:2008
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
DiaMed
Pra Rond 23, 1785 Cressier FR
Switzerland
www.bio-rad.com/immunohematology