Host Communication LXL - TN - 107 - Rev - A

TECHNICAL NOTE
Subject: Allowed characters set for Liaison® XL host communication

Project: Liaison® XL
ID Number: 107
Revision: A
Date: 20/02/2014
Author: D. Belluto
Ref ECR / TB / DC / ECO / QH
/ FA / WS / Other:
 Service manual
 User manual
 Quick Guide
Impact on:
 Maintenance Book
 SW
 Other _________
Attachments:
-
Implementation: Affected Spare Parts / Kits: Estimated implementation time

n. a. n. a. n. a.
Timeline:
n. a. Note
Revision History
Revision Date Changed by Detail
A 20/02/2014 D. Belluto Initial version
DiaSorin Confidential
Potential Biohazard & Electrical Hazard.

Observe local and national provisions, legislation and laboratory regulations at all Times.
Page 1 of 11
validity extended until next revision
Subject:
Allowed characters set for Liaison® XL host
communication
ID Number: 107 Revision: A Date: 20/02/2014 Author: D. Belluto
Index
1. DISTRIBUTION ............................................................................................................................... 3
2. PURPOSE ......................................................................................................................................... 3
3. ADMINISTRATIVE NOTES ............................................................................................................... 3
4. SPARE PARTS .................................................................................................................................. 3
5. PROCEDURE .................................................................................................................................... 3
5.1. ALLOWED CHARACTERS SET FOR LIAISON® XL ............................................................................................. 3
5.2. DESCRIPTION OF THE OBSERVED ISSUE ...................................................................................................... 8
5.3. MODIFICATION OF "USER UNIT" .............................................................................................................. 9
6. REQUALIFICATION ....................................................................................................................... 11
7. PPE ................................................................................................................................................ 11
Page 2 of 11
Subject:
communication
1. Distribution
All DiaSorin Subsidiaries and Distributors.
2. Purpose
The aim of this TN is to inform about the official list of the allowed characters for Liaison® XL
host communication, according to the ASTM standard number E 1394-97 (par 6.1.1).
3. Administrative notes
During each service intervention, Field Service Engineer (FSE) and/or System
Specialist (SS) has to identify and check the root cause of the instrument failure (if
any), and evaluate the related effect. If the identified effect may lead to potential
risks for the sample result and/or the end user, FSE / SS is required to report the
event to the reference Service Manager and to Corporate Service department for
the proper assessment.
4. Spare Parts
n. a.
5. Procedure
Allowed characters for Liaison® XL host communication are listed in this chapter; in case of
assays using ASTM 1394 not compatible characters in the “Default Unit” field, "User Unit" field
can be customized by the user in order to avoid LIS communication problems.
Note: Not compatible characters (e.g. “µ”) are used as “Default Unit” in the Assay Protocol
because of assays Regulatory constraints.
5.1. Allowed characters set for Liaison® XL

The allowed characters set for Liaison® XL is described by the ASTM standard number E 1394-
97 (par 6.1.1). In addition, all those characters included as delimiter characters used in a
particular transmission should be ruled out: #38, #92, #94, #96 and #124.
As far as data transmission is concerned, the more stringent ASTM standard number E 1381-95
is applied.
Here below a table of the only allowed characters is given.
Page 3 of 11
Subject:
communication
Character/definition Decimal code Named entity Description
BEL 007 --- Bell
TAB 009 --- Horizontal tab
VT 011 --- Vertical tab
FF 012 --- NP form feed, new page
CR 013 --- Carriage return
032 --- Space
! 033 --- Exclamation mark
" 034 " Quotation mark
# 035 --- Number sign
$ 036 --- Dollar sign
% 037 --- Percent sign
' 039 --- Apostrophe
( 040 --- Left parenthesis
) 041 --- Right parenthesis
* 042 --- Asterisk
+ 043 --- Plus sign
, 044 --- Comma
- 045 --- Hyphen
. 046 --- Period (fullstop)
/ 047 --- Solidus (slash)
0 048 --- Digit 0
Page 4 of 11
Subject:
communication

1 049 --- Digit 1
2 050 --- Digit 2
3 051 --- Digit 3
4 052 --- Digit 4
5 053 --- Digit 5
6 054 --- Digit 6
7 055 --- Digit 7
8 056 --- Digit 8
9 057 --- Digit 9
: 058 --- Colon
; 059 --- Semicolon
< 060 < Less than
= 061 --- Equals sign
> 062 > Greater than
? 063 --- Question mark
@ 064 --- Commercial at
A 065 --- Capital A
B 066 --- Capital B
C 067 --- Capital C
D 068 --- Capital D
E 069 --- Capital E
Page 5 of 11
Subject:
communication

F 070 --- Capital F
G 071 --- Capital G
H 072 --- Capital H
I 073 --- Capital I
J 074 --- Capital J
K 075 --- Capital K
L 076 --- Capital L
M 077 --- Capital M
N 078 --- Capital N
O 079 --- Capital O
P 080 --- Capital P
Q 081 --- Capital Q
R 082 --- Capital R
S 083 --- Capital S
T 084 --- Capital T
U 085 --- Capital U
V 086 --- Capital V
W 087 --- Capital W
X 088 --- Capital X
Y 089 --- Capital Y
Z 090 --- Capital Z
Page 6 of 11
Subject:
communication

[ 091 --- Left square bracket
] 093 --- Right square bracket
_ 095 --- Horizontal bar (underscore)
a 097 --- Small a
b 098 --- Small b
c 099 --- Small c
d 100 --- Small d
e 101 --- Small e
f 102 --- Small f
g 103 --- Small g
h 104 --- Small h
i 105 --- Small i
j 106 --- Small j
k 107 --- Small k
l 108 --- Small l
m 109 --- Small m
n 110 --- Small n
o 111 --- Small o
p 112 --- Small p
q 113 --- Small q
r 114 --- Small r
Page 7 of 11
Subject:
communication

s 115 --- Small s
t 116 --- Small t
u 117 --- Small u
v 118 --- Small v
w 119 --- Small w
x 120 --- Small x
y 121 --- Small y
z 122 --- Small z
{ 123 --- Left curly brace
} 125 --- Right curly brace
~ 126 --- Tilde
5.2. Description of the Observed Issue

It has been experienced an issue on the LIS communication due to the fact that Host was not
able to display the received results whose tests had the “µ” character in the measuring units.
The µ character does not belong to the allowed character set as listed in the ASTM E 1381-95
standard, its usage may cause troubles in the communication between clinical laboratory
instruments and computer systems (Reference document: ASTM E 1394-97 and E 1381-95).
The micro (µ) type is used in measurement units (“Default Unit”) of different assays in
accordance with the International System but is not part of the approved characters list during
communication between host and Liaison® XL. This may lead to a failure in transmission of the
analytical result to Host for those specific assays.
After internal investigation about all Liaison® XL assay protocols currently on the market, the
following cases have been found where illegal characters are present in the “Default Unit”:
Page 8 of 11
Subject:
communication
Insulin, ArtN 310360, µIU/mL

DHEAS, ArtN 310430, µg/dL
Ren, ArtN 310470, µIU/mL
NSE, ArtN 314561, µg/L
S100, ArtN 314701, µg/L
BAP Ostase, ArtN 310970, ug/L: in BAP Ostase assay protocol revision B, the character
“u” replaces the character μ (the measure unit, discussed in the IFU of the kit, µg/L is
then displayed as ug/L): in order to make the assay protocol compliant with the IS units
the symbol µ will be restored in the unit definition.
N.B.: DiaSorin decided not to change the assay “Default Unit” in the assay protocol because
the result given to the customer should be consistent with the International System or any
other standardization method referred to in the assay Instruction For Use.
5.3. Modification of "User Unit"

In order to avoid the issue described in § 5.2, Liaison® XL User SW leaves the possibility to
manage the "User Unit": for the assays containing the µ character, or possibly other critical
characters, customer can change the content of "User Unit" field at their will directly on the
instrument by inserting a string with characters allowed by the host, opening the details page of
a specific Assay Protocol imported present in the page Definition  Assay; see the two pictures
below: in S100 assay, for example, it is possible to replace µg/L with ug/L; from that moment
on, the new unit (ug/L) will be used by the User SW to show the unit of all the S100 results in
the Results page and to send them to Host.
Field service engineer can support the user in doing that, thus avoiding communication errors.
The user must be informed and agree on the “User Unit” defined to correctly establish his
reference ranges.
N.B.: In case of an Assay Protocol new revision import, the field “User Unit” is kept unchanged;
e.g. if the customer types “uIU/mL” in the field “User Unit” for Insulin Assay Protocol revision A,
when customer imports revision B of the same Assay protocol the field “User Unit” is left
“uIU/mL” and customer doesn’t need to modify it again.
Page 9 of 11
Subject:
communication
Page 10 of 11
Subject:
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6. Requalification
n. a.
7. PPE
n. a.
Page 11 of 11

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TECHNICAL NOTE

Subject: Allowed characters set for Liaison® XL host communication

Implementation: Affected Spare Parts / Kits: Estimated implementation time

A 20/02/2014 D. Belluto Initial version

Potential Biohazard & Electrical Hazard.

5.1. Allowed characters set for Liaison® XL

Character/definition Decimal code Named entity Description

BEL 007 --- Bell

TAB 009 --- Horizontal tab

VT 011 --- Vertical tab

FF 012 --- NP form feed, new page

CR 013 --- Carriage return

032 --- Space

! 033 --- Exclamation mark

" 034 &quot; Quotation mark

# 035 --- Number sign

$ 036 --- Dollar sign

% 037 --- Percent sign

' 039 --- Apostrophe

( 040 --- Left parenthesis

) 041 --- Right parenthesis

* 042 --- Asterisk

+ 043 --- Plus sign

, 044 --- Comma

- 045 --- Hyphen

. 046 --- Period (fullstop)

/ 047 --- Solidus (slash)

0 048 --- Digit 0

Character/definition Decimal code Named entity Description

2 050 --- Digit 2

3 051 --- Digit 3

4 052 --- Digit 4

5 053 --- Digit 5

6 054 --- Digit 6

7 055 --- Digit 7

8 056 --- Digit 8

9 057 --- Digit 9

: 058 --- Colon

; 059 --- Semicolon

< 060 &lt; Less than

= 061 --- Equals sign

> 062 &gt; Greater than

? 063 --- Question mark

@ 064 --- Commercial at

A 065 --- Capital A

B 066 --- Capital B

C 067 --- Capital C

D 068 --- Capital D

E 069 --- Capital E

Character/definition Decimal code Named entity Description

G 071 --- Capital G

H 072 --- Capital H

I 073 --- Capital I

J 074 --- Capital J

K 075 --- Capital K

L 076 --- Capital L

M 077 --- Capital M

N 078 --- Capital N

O 079 --- Capital O

P 080 --- Capital P

Q 081 --- Capital Q

R 082 --- Capital R

" 034 " Quotation mark

< 060 < Less than

> 062 > Greater than