AU680/AU480

Offline Specifications

31. Oct, 2008

Olympus

1
 Contents

1. Function Outline ................................................................................................................................3

1.1 Outline........................................................................................................................................3
1.2 Explanation of terms ..................................................................................................................3
2. Basic Specifications...........................................................................................................................4
2.1 Device used ...............................................................................................................................4
2.2 Output code ...............................................................................................................................4
2.3 Basic File Format .......................................................................................................................4
3. Record format ...................................................................................................................................8
3.1 Common items ...........................................................................................................................8
3.2 Format by record........................................................................................................................9
3.3 Record format ..........................................................................................................................14
A.1 Reference: List of data flag ..........................................................................................................16
A.2 Reference: Data format ...............................................................................................................18

2
1. Function Outline
1.1 Outline
(1) Stored test data can be saved in external memory device by the menu.

(2) The following conditions can be set by the operation menu of AU680/AU480.

To format sample information

To format test data

1.2 Explanation of terms

(1) Field
Minimum unit for data
(2) Block
The mass of plural fields. The mass of information.
(3) Record
The mass of plural (or single) blocks. Data for single sample (or batch).
(4) File
The mass of plural (or single) records. Unit for writing one time.
(5) Folder
The mass of plural (or single) files. Destination to save test data.
(6) Volume
Single memory device

3
2. Basic Specifications

2.1 Device used

Item Contents
2HD(1.44MB), CD-R
Device
Devices connected by USB such as memory sticks, hard disks
Format style MS-DOS format, FAT, FAT32, NTFS, CDFS*
* Among those, use them as instructions for the devices explain

2.2 Output code

Item Contents Value range

7 bit code 20H to 7EH

8 bit code

1 byte code 20H to 7EH

(JIS code) A1H to DFH
Data code

81H to 9FH
(First byte)
E1H to EAH
2 byte code
(Shift JIS code)
40H to FCH
(Second byte)
(7FH is excluded)

2.3 Basic File Format

(1) Rules for a file
Item Contents
Volume label No rules (or AU680DATA/AU480DATA)
File structure in
Plural files are available for one volume
volume

OLY_AU_YYYYMMDD_hhmm_nnn.csv

"OLY_AU_": The common header for Olympus AU series

File name
"YYYYMMDD_hhmm": Time and date index for target output
(Not correspond with the display. Output followed by the above.)
"nnn": serial number (000 to 999)

Structured by the following order and record

The number of
Record name Remarks
record
Analysis data start record 1 *1
Normal sample record(Routine/Emergency/STAT) n1 *2
Repeat run sample(Routine/Emergency/STAT) n2 *2
Record structure in QC sample data record n3 *2
file
Reagent blank sample data record n4 *2
Calibration sample data record n5 *2
Analysis data end record 1 *1

The number of samples output(n) = n1 + n2 + n3 + n4 + n5

*1: Nonuse is possible depending on the output setting.

*2: May not be output depending on the choice by an operator.

4
 (2) Record structure

Field Contents
Block/field name Remarks
length Value range Description
D Analysis data-related identification
DB Output start identification record *3 In the output
Normal sample(Routine/Emergency/STAT)data menu,
D*1
record identification cord
Repeat run mentioned on the
1) Identification DH
2 sample(Routine/Emergency/STAT)data record left is output at
code field
DQ QC sample data record the first for
selected data
DR Reagent blank sample data record record of sample
DA Calibration sample data record types

DE Output end identification record *3

2) Data part
(exclude output
end
identification
record)
2)-1 *4 One exists at the first of data part for each
Sample block record.
(The mass of Field structure is common among all fields
field) Depen (Structure with fixed field/variable field.)
ding on
each For each record, only the number ruled followed
2)-2 *4 record sample basic information block.
Item block Field structure is common among all fields
*2
(The mass of (Structure with fixed field/variable field)
field) The number of block is common among all
records

2)-3 *3
Time and date Output time date information
field

0DH + 0AH
3) End code field 2 Indicates end record
(CR + LF)
*1: indicates space (20H)
*2: Output target item is followed by the Offline Format menu.
Order of information block by item is order of the parameter setting (Offline Format).
If an AU680 Offline Format parameter regards Hemoglobin A1(item name: HbA1c%) as target output, put out the
blocks of 3 items (HbA1c%,T-Hb, HbA1c). However, those blocks are used as follows according to target output
sample type.
Block of HbA1c% Block of T-Hb Block of HbA1c
Normal sample record Output Not output Not output
Repeat run sample Output Not output Not output
QC sample data record Output Not output Not output
Reagent blank sample data record Not output Output Output
Calibration sample data record Not output Output Output
Put out all the fields construct blocks of items without output as blanks (0x20).
*3: Can be omit depending on the parameter setting (Offline Format)
*4: Only in the case of identification record DB. It can be omit depending on the parameter setting (Offline Format)

For detail, refer to 3.3 Record Format.

5
For ex.1) In the case of test data start record (identification cord: DB), test data record (identification code :
D, DH, DQ, DR, DA)

1) 2) -1 2) -2 3)

D sample block item block item block item block End code field

For ex.2) In the case of test data end record (identification code: DE)

1) 2) -3 3)

DE Output end identification field End code field

6
(3) Rules of field
Item Contents
Insert a comma [,] (standard setting)
Field In the offline output menu, one type can be chosen from the following 1 byte
delimitation characters on outputting "Space(20H)", "Tab(09H)", ",(2cH)", ".(2eH)", ":(3aH)",
";(3bH)", "_(5fH)", "/(2fH)", "|(7cH)"

7
3. Record format
3.1 Common items
(1) In the description of record format, [] indicates the points of blocking.
(2) The unit of field length is byte.
(3) Limitation of the number of single sample.
In the case that the Offline Format menu and delimitation field are on
Check delimitation field.
If an error occurs on delimitation field, data is output with delimitation of 256 field.
If it exceeds 256, it will be deleted.Also, the 256 field is whitin the item block field, it is
delimited with blacoking position, and end field is added andoutput. Refer to the example
In the case that the offline menu and field limitation are off
Data is output even though it exceeds the 256 field.
Formula for calculating the number of field:
The number of field = Identification code field (1) + Sample block field (7 to 14)*1 + Item block
field (2 to 5 the number of selected items)*1 + End code field (1)
*1: The number of field changes (variable length) depending on parameter setting (Offline Format)

The contents of filed limitation check.

Make sure whether or not field limitation is on besides the number of field > 256.

Ex.) In the case that the 256 field is within item block field

8
3.2 Format by record

(1) Analysis data start record (Identification : DB)

Sample block and item block included in test data start record can be omit by the parameter
setting (Offline Format)
A) Identification code field

Field name Field length Contents Remarks

1) Identification code field 2 DB

B) Sample block

In English
Field name
Field length Contents
1) Sample No. 5 S.No.
2) Rack No. 8 Rack No.
3) Cup position 8 Cup Pos.
4) Sample types 4 Type
5) Sample ID(or Kind ID) 4 S.ID
6) Kind No.[-Step] 8 Kind No.
7) Original sample No. 9 Org.S.No.
8) Sex/year age/month age*1 10 Gender-Age
9) Patient information1*1 9 Pat.Inf-1
10) Patient information2*1 9 Pat.Inf-2
11) Patient information3*1 9 Pat.Inf-3
12) Patient information4*1 9 Pat.Inf-4
13) Patient information5*1 9 Pat.Inf-5
14) Patient information6*1 9 Pat.Inf-6
*1: Addition Yes/No setting can be made at the [Offline Format] screen.

9
 C) Item block

In English
Field name
Field length Contents
1) Analysis result (CONC)*1 10 XXX.XXXXXX
2) Data flag 9 Data Flag
3) Analysis result (OD)*2 2 OD
4) Reagent lot No./bottle No.*2 10 Lot/Bottle
5) Repeat run sample
2 6 Method
dispensing*
*1: XXX.XXXX indicates item No.. Item name[ex. 001.AST ].
*2: Addition Yes/No setting can be made at the [Offline Format] screen.

D) Identification code field

Field name Field length Contents Remarks

1) End code field 2 CR+LF(0DH+0AH)

(2) Analysis data record (identification : D,DH,DQ,DR,DA)

A) Identification code field

Field name Field length Contents Remarks

Routine/Emergency/STAT
sample : D
Repeat run sample : DH
QC sample data : DQ
1) Identification code field 2
Reagent blank sample
data : DR
Calibration sample data
: DA

10
B) Sample block

Field
Field name Contents Remarks
length
Routine sample : 0001 to 9999
Emergency sample : E001 to E999 For repeat run samples, "H"
STAT sample : P001 to P999 is not added to the sample
1) Sample No. 4 QC sample : Q001 to Q999 No. when differentiation is
Reagent blank sample possible with the record
: R001 to R999 identification field.
Calibration sample : A001 to A999
Rack No. The number of digits depend
4-digits: 0001 to 9999 on the setting Set [20H] all
2) Rack No. 4 or 5
5-digits: 00001 to 99999 digits mentioned on left for
STAT
Rack sample : 01 to 10 In case of RB result with the
3) Cup position 2 STAT sample : 01 to 22 STAT table of AU680, put
out with either 23 or 24.
Serum :S
Urine :U
Only AU680 can put out
4) Sample types 1 Other :X
whole blood samples.
Other-1 :Y
Whole blood :W
The number of digits can be
5) Sample ID (or Kind ID) 4 to 26 Sample ID(or kind ID) set with the sample
reception conditions.
KKK(-S)
With Advanced-Caribration,
KKK : kind No.
KKK-S
Calibration sample : 001 to 200
6) Kind No.[-Step] 3 or 5 Without
QC sample : 001 to 100
Advanced-Calibration
S : step (0 or 1 to 5)
Advanced-Calibration, KKK
0 indicates kind bottle is used
Routine sample : 0001 to 9999
Emergency sample : E001 to E999
All 4 digits are [20H] for QC
7) Original sample No. 4 or 2 STAT sample : P001 to P999
sample/Calibration sample
Reagent blank first data : -1
Reagent blank second data : -2
G-YYYMM
G : sex (M,F,[20H] or
1
8) Sex/year age/month age* 6 Null[00H])
YYY : year age (0 to 150)
MM : :month age (0 to 11)
1 The number of digits depend
9) Patient information1* (20) Patient information 1 data
on test requisition conditions
1 The number of digits depend
10) Patient information2* (20) Patient information 2 data
on test requisition conditions
1 The number of digits depend
11) Patient information3* (20) Patient information 3 data
on test requisition conditions
1 The number of digits depend
12) Patient information4* (20) Patient information 4 data
on test requisition conditions
1 The number of digits depend
13) Patient information5* (20) Patient information 5 data
on test requisition conditions
1 The number of digits depend
14) Patient information6* (20) Patient information 6 data
on test requisition conditions
*1: Can be omit depending on the parameter setting (Offline Format)

11
C) Item block

Field
Field name Contents Remarks
length
The number of digits can
1) Analysis result (CONC) 9 CONC value*2 be set at the [Online
Format] screen.
Set as the number of digits by
2) Data flag 8
pripority order
3) Analysis result (OD)*1 9 Reaction OD value
R1 (R1-1) lot No.
R1 (R1-1) bottle No.
R2 (R2-1) lot No.
R2 (R2-1) bottle No.
Reagetn lot No./bottle R1-2 lot No.
4) 1 39
No.* R1-2 bottle No.
R2-2 lot No.
R2-2 bottle No.
Fill out black area with (20H)
Each value is combined "-"
Normal : 0
Repeat run sample [20H] is for other than
5) 1 1 Diluent : 1
dispensing pattern* repeat run sample*3
Condense : 2
*1: Can be omit depending on the parameter setting (Offline Format) for after 3) [Analysis result(OD)]
*2: For the test results of reagent blank sample, calibrator sample, first data/second data, reaction OD value are put out
in this area. (For reagent blank sample, calibrator sample, value is the same as the value of analysis result (OD)
output.)
*3: In the system that normaly sample dispensing pattern can be selected, sample data is also set one of
[normal/diluent/condence].

D) Item block data of LIH

Data storage method for LIH is as follows

Field
Field name Contents Remarks
length
The number of digits can
1) Analysis result 6 or 9 Result of LIH judgment be set at the [Online
Format] screen.
The number of digits can
Set as the number of digits by
2) Data flag 8 be set at the [Online
pripority order
Format] screen.
3) Analysis result (OD)*1 9 All is (20H)
R1 (R1-1) lot No.
R1 (R1-1) bottle No.
R2 (R2-1) lot No.
R2 (R2-1) bottle No.
Reagetn lot No./bottle R1-2 lot No.
4) 1 39
No.* R1-2 bottle No.
R2-2 lot No.
R2-2 bottle No.
Fill out black area with (20H)
Each value is combined "-"
Repeat run sample
5) 1 1 Normal : Space
dispensing*
*1: Item "3) Analysis result (OD)" and the later items can be omit by certain parameter settings (Offline Format)

12
 E) Identification code field

Field
Field name Contents Remarks
length
1) End code field 2 CR+LF(0DH+0AH)

(3) Analysis data end record (identification code: DE)

A) Identification code field

Field
Field name Contents Remarks
length
1) Identification code field 2 DE

B) Output time and date field

Field
Field name Contents Remarks
length
YYYY/MM/DDhh:mm
Output time and date 16 or or Format of time and date
1)
field 19 YYYY/MM/DDhh:mm is followed by the display.
xx : 20H

xx: AM or PM

C) Identification code field

Field
Field name Contents Remarks
length
1) End code field 2 CR+LF(0DH+0AH)

13
3.3 Record format
In the description of record format, indicates the points of blocking.

(1) Test data start record. Analysis data start record (Identification code: DB)
A. Identification code, Sample block format

B. Sample block format

*1: Can be omit depending on the parameter setting (Offline Format).

C. Test block format

*1: Can be omit depending on the parameter setting (Offline Format).

(2) Test data record. Analysis data record (Identification code: D, DH, DQ, DR, DA)
A. Identification code, Sample block format

1) Set one of ,H,Q,R,A

2) Cup position
3) Sample types

14
 B. Sample block format

*1: Can be omit depending on the parameter setting (Offline Format)

C. Test block format

4) Repeat run dispensing pattern *1

*1: Can be omit depending on the parameter setting (Offline Format)

(3) Test data end record(identification code: DE)

A. Identification code, test data end format

*1: Can be omit depending on the parameter setting (Offline Format)

15
A.1 Reference: List of data flag
Priority Data flag Meaning
1 d_ Excluded from QC by user.
2 e_ Data edited by user.
3 (_ Shortage of detergent for contamination parameters.
4 Wa Result has been analyzed with an erroneous cuvette.
5 R_ Insufficient reagent.
6 #_ Insufficient sample.
7 %_ Clot detected.
8 ?_ Unable to calculate a result.
9 ?a Error in detection of reagent or sample.
10 n_ LIH test not performed.
11 l_ Result may be affected by lipemia.
12 i_ Result may be affected by icterus.
13 h_ Result may be affected by hemolysis.
14 Y_ Reagent blank OD at last photometric point high.
15 U_ Reagent blank OD at last photometric point low.
16 y_ Reagent blank/routine OD at first photometric point high.
17 u_ Reagent blank/routine OD at first photometric point low.
18 @_ OD is higher than 3.0.
19 $_ Not enough data to determine linearity of reaction.
20 D_ OD of reaction is higher than maximum OD range.
21 B_ OD of reaction is lower than minimum OD range.
22 *_ Linearity error in rate method.
23 &_ Prozone test data is abnormal.
24 Z_ Prozone error.
25 E_ Overreaction in a rate assay detected.
26 Fx Result (OD) is higher than the dynamic range.
27 Gx Result (OD) is lower than the dynamic range.
28 !_ Unable to calculate concenatration.
Reagent lot no. used at sample analysis is different from that used at calibration
29 )_
analysis.
30 a_ Reagent expired.
31 ba Calibration expired.
32 bh No valid calibration used.
33 bn Mastercurve used.
34 bz Calibration curve for Prozone data used.
35 F_ Result is higher than the dynamic range.
36 G_ Result is lower than the dynamic range.
37 Tx Result of T-Hb or/and HbA1c is higher than the dynamic range.
38 ph Result is higher than the upper panic value.
39 pl Result is lower than the low panic value.
40 T_ Abnormality found in inter-chemistry check.
41 P_ Positive.
42 N_ Negative.
43 H_ Result is higher than reference range.
44 L_ Result is lower than reference range.
45 J_ Result is higher than the repeat decision range.
46 K_ Result is lower than the repeat decision range.

16
Priority Data flag Meaning
47 fh Result is higher than the repeat run reflex range.
48 fl Result is lower than the repeat run reflex range.
49 Va The result of multiple measurement alienation check is NG.
50 8Q QC deviation error
51 xQ Failure of one control used in a multirule QC.
52 1Q QC data exceeds the range entered in the Single Check Level field.
53 2Q QC data exceeds 13S control range.
54 3Q QC data exceeds 22S control range.
55 4Q QC data exceeds R4S control range.
56 5Q QC data exceeds 41S control range.
57 6Q A preset number of consecutive QC results fall on one side of the mean.
58 7Q Consecutive QC results show steadily increasing or decreasing values.
59 S_ Sample repeated and original results replaced by repeat result.
60 /_ Test pending or not analyzed.
61 r_ Data transmitted to host.
62 c_ Data corrected by user.

17
A.2 Reference: Data format
indicates a space (20H).
_ indicates a NULL (00H).

(1) Analysis result (CONC)

A) When the number of output digits is 6 digits and there is no zero suppression

B) When the number of output digits is 9 digits and there is no zero suppression

C) When the number of output digits is 6 digits and there is no zero suppression

D) When the number of output digits is 9 digits and there is no zero suppression

(2) Expression when the analysis results (CONC) exceed the number of digits of the format
A) When the number of output digits is 6 digits

B) When the number of output digits is 9 digits

(3) Analysis result (OD)

A) When the number of output digits is 6 digits

Caution: If a value of OD is negative, it will be the digit over format. B) When the number of output digits is 9 digits

B) When the number of output digits is 9 digits

18
(4) LIH data
Description of nL, nI, nH
0: Normal
1: +
2: ++
3: +++
4: ++++
5: +++++
6: ABN

A) When the number of output digits is 6 digits and there is no zero suppression

B) When the number of output digits is 9 digits and there is no zero suppression

C) When the number of output digits is 6 digits and there is no zero suppression

D) When the number of output digits is 9 digits and there is no zero suppression

(5) Data flag

Output of max. four data flags of two digits.

(6) Reagent lot No./bottle No.

19
 (7) Sex/Year age/Month age
A) No zero suppression (no reply for sex)
1) Male/20 years/ 2) No reply/ 3) No reply/ 4) No reply/
5 months 20 years/5 months 20 years/no reply no reply/no reply

B) No zero suppression (space for sex)

1) Male/20 years/ 2) No reply/ 3) No reply/ 4) No reply/
5 months 20 years/5 months 20 years/no reply no reply/no reply

C) Zero suppression (no reply for sex)

1) Male/20 years/ 2) No reply/ 3) No reply/ 4) No reply/
5 months 20 years/5 months 20 years/no reply no reply/no reply

D) Zero suppression (space for sex)

1) Male/20 years/ 2) No reply/ 3) No reply/ 4) No reply/
5 months 20 years/5 months 20 years/no reply no reply/no reply

20
AU680/AU480 Offline Specifications Revision History Table

Version flag A: Analyzer, B: Parts, S: Program, V: Document version number

CHANGE
DATE DESCRIPTION PAGE VERSION CONFIRM
METHOD
21. Sep, 2007 New publication All page 1st Edition
31. Oct, 2008 Descriptions 1, 3 to 6, 8 to 11,14,15,19 Change V2
added Revision History Table

R-1