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1 Cell-Dyn Calculator Spreadsheet for MicroSoft Excel 1

±
Tab Calculators / Info. Opt Channel Target
Instructions Help on all procedures Lymph 0° 100 5
Calibration What-you-want over what-you-got calculator Lymph 7° 75 5
References Calculation references in service/support docs. WBC Neut 90°D 28 4
Optical Gains Neut 90° 125 15
WBC Gains Whole blood calculation for WBC gains Neut FL3 70 6
Retic Alignment Whole blood calculation for Retic IAS & FL1 RBCo 7° 182 2
Retic
PLT Optical Whole blood calculation for PLTo IAS & PSS RBC FL1 85 2
CD61 PLT Gain setting for ImmunoPlt (CD61) assay CD61 CD61 FL1 * 2
CD3/4/8 Whole blood calculation for CD3/4/8 *(Get FL-CAL target from ISA EDOC-024_ or the
Sapphire-CD4k Extras GSS website Hematology Assay page.)
Carryover Open & Closed carryover calculator FL1 * 190 15
Optical vs Impedence Checks RBC & PLT (PIC/POC & RIC/ROC) FL2 * 190 15
CD3/4/8
Open vs Closed Checks for acceptable open/closed variance FL1 * 195 15
Cell-Dyn 3200 / Ruby FL2 * 195 15
Cell-Dyn 3700 *(See ISA 98-051_ for details)
Calibration What-you-want over what-you-got calculator
Carryover Open & Closed carryover calculator PLT 90° 144 5
PLTo
WBC Gains Optimizing WBC gain settings PLT 7° 126 5
Cycle Counter Calculate cycles per day *(PLT values are for whole blood OR enter
Revision History History of changes to this spreadsheet target values for 1.4mm beads per ISA EDOC-024_
or the GSS website Hematology Assay page.)
Document Ver. 3.1; Create date 20 Jun 2007; Release Date: 11 July 2007; Unique
Identifier: DA-S01021.000VDD02V01

Notes:
1. Verify the use of values obtained using this spreadsheet by performing quality control testing according to approved operation
and/or service procedures.
2. This spreadsheet is for use by Abbott-trained service/support personnel to assist in calculating Hematology instrument gains. It
provides an automated method for calculations that would be done manually without it. Calculations have been verified per
Q09.14.005 to conform to approved instrument operation and service documentation (manuals and service advisories).
This spreadsheet has been assessed as Minor safety risk, per Q09.14.005.

Hematology Gain Calculator Spreadsheet - "Top" Tab Page 1 of 15 DA-S01021.000VDD02V01


Calibration Optical Gains CD61 Plt Gain Extras CD3200/3700/Ruby File Handling
"What you want over what Enable the moving Enable the moving Carryover Calibration
you got" calculator average program & average program & Run sample in open mode See Column A After all the data has been
clear current batch clear current batch Run 3 open backgrounds entered, the spreadsheet
Assay (what you want) Run sample closed mode Carryover can be printed.
A. Calibrator Run 10 normal bloods Target data may be Run 3 closed backgrounds Run sample in open mode (landscape orientation)
B. Open Mode Reference (or 5 in duplicate) obtained from Enter data in spreadsheet Run 3 open backgrounds
C. Reference instrument Print values, fill spreadsheet Hematology Assay Page Pass/Fail is calculated Run sample closed mode The file can also be saved
or contact Run 3 closed backgrounds to disk for archival use -
Mean (what you got) From SETPOINT screen Santa Clara GSS Optical vs Impedance Enter data in spreadsheet Click on File
A. Results from Calibrator enter current gain/PMT. Run 5 samples into a Pass/Fail is calculated Save As . .
B. Closed Mode Samples New gain will be calculated Enter target channel QC file for open and Select destination folder
C. Second instrument on TOP page Same 5 in closed mode WBC Gain Optize Create new name
Use either Gain or Voltage in field F12 Enter means for Opt. and Set Cell regions (ie - serial number)
Current Cal to adjust (NOT BOTH) Imp. into the spreadsheet Select BLOOD SAMPLE click Save
Enter Calibration now used Run FLCAL three times. Pass/Fail will be calculated Run up to 20 samples
Enter new Gain or Voltage Adjust PMT (coarse adjust) (Use fresh samples -
New Cal in Setpoint & Download Open vs Closed No Flags or Hi %N or L)
Will be calculated and (if gain >4095 or <1000 adj Run FLCAL three times Use means gathered from Record channels
ready for entering into PMT first. DSS - keep gain Adjust gain (fine tune) Opt. vs. Imp. check Enter Current Gains
system for use over 2000-see ISA 98-75) (RBC & PLT data will copy) Final Gains calculated
Run three more times Enter data into spreadsheet Enter Final Gains
Caution! Update spreadsheet to verifiy results D and k are calculated Run 7.0µm beads X3
Be sure to verify Current values,clear sample Pass/Fail is calculated Find new target - autogain
calibration with ANY data. Re-run bloods to FLCAL part number - Match Retic gains to WOC
change of factors ! ! verify channel recovery 8990072401 Save new settings to disk

Top
Ver. 3.1

Hematology Gain Calculator Spreadsheet - "Instructions" Tab Page 2 of 15 DA-S01021.000VDD01V02


References Top Ver. 3.1
Note: VP refers to (Service Manual) Verification Procedure. ISA refers to Instrument Service Advisory (ISA/TSB Database).

Calibration
Reference Systems Operations Manuals, Chapter 6

Optical Gains
WBC Platelet Retic CD61 CD3/4/8 FL3 (NRBC)
PMT Gain PMT Gain PMT Gain PMT Gain PMT Gain PMT Gain
CD-4000 *See Note VP-79 VP-78 ISA 98-051_ VP-82 VP-81 VP-97 VP-97 TSB 98-038A ISA 98-051_ VP-84 VP-83
CD-Sapphire *See Note VP-54 VP-60 VP-54 VP-64 VP-63 VP-76 VP-76 *See Note VP-55 VP-66 VP-65

*Note
CD4000 WBC PMT adjustment: Document 9157052H (Procedure, Standardization of the CELL-DYN 4000 System) - DSS/PSS: page 3, FL3: page 4
Sapphire WBC PMT adjustment: Document 9157075A (Test Procedure for CD Sapphire Optic Bench Assembly) - page 10 refers user to 9157052.
Sapphire CD3/4/8 PMT adjustment: Document 9180371M (Electrical Test Procedure - CD Sapphire) - page 38

Sapphire-4K Extras
Carryover Reference Systems Operations Manuals, Chapter 4
Optical vs. Impedance ISAs 98-125_ and 198-003_ Installation/Integration Checklists
Open vs. Closed ISAs 98-125_ and 198-003_ Installation/Integration Checklists

CD-3200 / Ruby
Calibration Reference Systems Operations Manuals, Chapter 6
Carryover Reference Systems Operations Manuals, Chapter 4
WBC Gain CD-3200 = VP-74; CD-Ruby = VP-54

CD-3700
Calibration Reference Systems Operations Manual, Chapter 6
Carryover Reference Systems Operations Manual, Chapter 4
WBC Gain ISAs 107-015_ and 108-019_

Cycle Counter
Reference Systems Operations Manuals, Chapter 5

Hematology Gain Calculator Spreadsheet "References" Tab Page 3 of 15 DA-S 01021.000 VDD-01 Ver-02
Calibration
Parameter Assay Value Mean Value Current Cal New Cal Factor % Diff
WBC 0.000 0.0%
RBCi 0.000 0.0%
RBCo 0.000 0.0%
HGB 0.000 0.0%
MCV 0.000 0.0%
PLTo 0.000 0.0%
PLTi 0.000 0.0%
MPV 0.000 0.0%

WBC 0.0%
Top
RBCi 0.0%
Ver. 3.1 RBCo 0.0%

HGB 0.0%

MCV 0.0%

PLTo 0.0%

PLTi 0.0%

Hematology Gain Calculator Spreadsheet - "Calibration" Tab Page 4 of 15 DA-S01021.000VDD01V02


Use this calculator for CD4000 and Sapphire optical gain settings
WBC Gains Neut 0° & 7° PLT Gains Retic Gains CD61 CD3/4/8 *
ALL IAS DSS PSS FL3 IAS PSS Retic IAS Retic FL1 CD61 FL1 CD3/4 FL1 CD3/4 FL2 CD3/8 FL1 CD3/8 FL2
New PMT N/A N/A #DIV/0! #DIV/0! #DIV/0! N/A #DIV/0! N/A #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
New gain #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! Used only to adjust #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
MAP targets &
Current PMT N/A N/A Signature ISA N/A N/A
98-056
Current gain
Lymph 0° Lymph 7° Neut 90°D Neut 90° Neut FL3 Neut 0° Neut 7° PLT 7° PLT 90° RBCo 7° RBCo FL1 CD61 PLT CD3/4 FL1 CD3/4 FL2 CD3/8 FL1 CD3/8 FL2
Target 100 75 28 125 70 140 143 144 126 182 85 0 190 190 195 195
± 5 5 4 15 6 10 7 5 5 2 2 2 15 15 15 15
sample 1
sample 2
sample 3
sample 4
sample 5
sample 6 #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
sample 7 #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
sample 8 ß *(See Hematology Assay Page for details)
sample 9 (Get FL-CAL target from
Hematology Assay
sample 10 Page.)
Average: #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!

DSS* - See instructions tab line 20 (PLT values for whole blood OR enter target values for 1.4mm beads from the Hematology Assay Page.)
Top
never set below 2000

Ver. 3.1 test Caution!!


Change gain OR pmt
Never both!

Hematology Gain Calculator Spreadsheet - "Optical Gains" Tab Page 5 of 15 DA-S01021.000VDD01V02


Carryover
Open WBC RBCi RBCo HGB PLTo PLTi Retic
Last Whole Blood
Background #1
Background #2
Background #3
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Spec < 1.0% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Closed WBC RBCi RBCo HGB PLTo PLTi Retic
Last Whole Blood
Background #1
Background #2
Background #3
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Spec < 1.0% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!

Optical vs Impedance
Open Mean 15% Max
RBCi
RBCo #DIV/0! #DIV/0!
PLTi
PLTo #DIV/0! #DIV/0!
Closed
RBCi
RBCo #DIV/0! #DIV/0!
PLTi
PLTo #DIV/0! #DIV/0!

Open vs Closed
WBC RBCi RBCo HGB MCV PLTo PLTi
Open 0.00 0.00 0.0 0.0
Closed 0.00 0.00 0.0 0.0
D 0 0 0 0 0 0 0
k 0 0 0 0 0 0 0
pass pass pass pass pass pass pass

Hematology Gain Calculator Spreadsheet - "Sapphire-4K Extras" Tab Page 6 of 15 DA-S01021.000VDD01V02


Top
Ver. 3.1

Hematology Gain Calculator Spreadsheet - "Sapphire-4K Extras" Tab Page 7 of 15 DA-S01021.000VDD01V02


Calibration
Parameter Assay Value Mean Value Current Cal New Cal Factor % Diff
WOC 0.000 0.0% ≤1.5% cal not required or >10% do not cal
NOC 0.000 0.0% ≤1.5% cal not required or >10% do not cal
RBC 0.000 0.0% ≤1.0% cal not required or >10% do not cal
HGB 0.000 0.0% ≤1.0% cal not required or >10% do not cal
MCV 0.000 0.0% ≤1.0% cal not required or >10% do not cal
PLT 0.000 0.0% ≤3.0% cal not required or >15% do not cal
MPV 0.000 0.0%
Mode to Mode Calibration Criteria
Parameter Clsd Mean Open Mean % Difference Cal Range Cal?
Top
WOC #DIV/0! ≥ 2.0% but <10% #DIV/0!
NOC #DIV/0! ≥ 2.0% but <10% #DIV/0! Ver. 3.1
RBC #DIV/0! ≥ 2.0% but <10% #DIV/0!
HGB #DIV/0! ≥ 2.0% but <10% #DIV/0!
MCV #DIV/0! ≥ 2.0% but <10% #DIV/0!
PLT #DIV/0! ≥ 3.0% but <15% #DIV/0!
MPV #DIV/0! ≥ 2.0% but <10% #DIV/0!
Mode to Mode Calibration Factors
Parameter Open Mean Clsd Mean Current Cal New Cal Factor % Diff
WOC 0.00 0.00 0.000 0.0%
NOC 0.00 0.00 0.000 0.0%
RBC 0.00 0.00 0.000 0.0%
HGB 0.00 0.00 0.000 0.0%
MCV 0.00 0.00 0.000 0.0%
PLT 0.00 0.00 0.000 0.0%
MPV 0.00 0.00 0.000 0.0%
Mode to Mode Post-Calibration Difference
Parameter New Clsd Open Mean % Difference Range OK?
WOC 0.00 #DIV/0! ≤ 2% #DIV/0!
NOC 0.00 #DIV/0! ≤ 2% #DIV/0!
RBC 0.00 #DIV/0! ≤ 2% #DIV/0!
HGB 0.00 #DIV/0! ≤ 2% #DIV/0!
MCV 0.00 #DIV/0! ≤ 2% #DIV/0!
PLT 0.00 #DIV/0! ≤ 3% #DIV/0!
MPV 0.00 #DIV/0! ≤ 2% #DIV/0!

Carryover
Open WOC NOC RBC HGB PLT MPV
Sample #3
Background #1
Background #2
Background #3
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Spec < 1.0% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Closed WOC NOC RBC HGB PLT MPV
Sample #3
Background #1
Background #2
Background #3
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!

Hematology Gain Calculator Spreadsheet - "CD3200 and Ruby" Tab Page 8 of 15 DA-S01021.000VDD01V02
Spec < 1.0% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!

Hematology Gain Calculator Spreadsheet - "CD3200 and Ruby" Tab Page 9 of 15 DA-S01021.000VDD01V02
WBC Gain Optimization - Service Manual (CD3200 = VP-74; Ruby = VP-54) for detail
Lym 0°D Gran 0°D Lym 10°D Gran 10°D Gran 90°D Gran 90°DP
Sample 1 Bead/Blood Settings
Sample 2 (DIAG - F12/F1 - LATEX/BLD COMPARE - CELL REGIONS)
Sample 3 Lower Upper
Sample 4 Channel Channel
Sample 5 Lym 0°D 29 89
Sample 6 Lym 10°D 29 89
Sample 7 Gran 0°D 110 210
Sample 8 Gran 10°D 99 199
Sample 9 Neu 90°DP 0 109
Sample 10
Sample 11 Select BLOOD SAMPLE
Sample 12 Run in OPEN mode (up to 20 samples)
Sample 13 Make sure to use fresh samples -
Sample 14 Avoid flags (BAND/IG; VAR LYMPH)
Sample 15 Avoid abnormal concentrations (90%+ LYMPH or NUET)
Sample 16 Record channels before next sample
Sample 17 Enter Current Gains
Sample 18 Final Gains will be calculated
Sample 19 Enter Final Gains in Set Point Entry
Sample 20 Run 7.0µm beads three times
Average #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! This will be the new target for autogains
Target 59 160 59 149 125 21 Verify WOC gains match RETIC gains (ISA 107-11)
±5 ±3 ±5 ±3 ±3 ±2 Save new settings to Set-Up floppy
Current Gains N/A N/A
Gran gains N/A #DIV/0! N/A #DIV/0! #DIV/0! #DIV/0!
Lym gains #DIV/0! N/A #DIV/0! N/A N/A N/A
Final gains N/A #DIV/0! N/A #DIV/0! #DIV/0! #DIV/0!

Set the FINAL GAINS and run 7.0µm beads three times
0°D 10°D 90°D 90°DEP
Run 1
Run 2
Top
Run 3
Autogain to - #DIV/0! #DIV/0! #DIV/0! #DIV/0! Ver. 3.1
Range 33-37 63-67 110-145 78-100

Hematology Gain Calculator Spreadsheet - "CD3200 and Ruby" Tab Page 10 of 15 DA-S01021.000VDD01V02
Calibration
Parameter Assay Value Mean Value Current Cal New Cal Factor % Diff
WOC 0.000 0.0% ≤1.5% cal not required or >10% do not cal
WIC 0.000 0.0% ≤1.5% cal not required or >10% do not cal
RBC 0.000 0.0% ≤1.0% cal not required or >10% do not cal
HGB 0.000 0.0% ≤1.0% cal not required or >10% do not cal
MCV 0.000 0.0% ≤1.0% cal not required or >10% do not cal
PLT 0.000 0.0% ≤3.0% cal not required or >15% do not cal
MPV 0.000 0.0%
Mode to Mode Calibration Criteria
Parameter Clsd Mean Open Mean % Difference Cal Range Cal?
Top
WOC #DIV/0! ≥ 1.75% but <10% #DIV/0!
WIC #DIV/0! ≥ 1.75% but <10% #DIV/0! Ver. 3.1
RBC #DIV/0! ≥ 1.25% but <10% #DIV/0!
HGB #DIV/0! ≥ 1.25% but <10% #DIV/0!
MCV #DIV/0! ≥ 1.25% but <10% #DIV/0!
PLT #DIV/0! ≥ 3.5% but <15% #DIV/0!
MPV #DIV/0! ≥ 2.0% but <10% #DIV/0!
Mode to Mode Calibration Factors
Parameter Open Mean Clsd Mean Current Cal New Cal Factor % Diff
WOC 0.00 0.00 0.000 0.0%
WIC 0.00 0.00 0.000 0.0%
RBC 0.00 0.00 0.000 0.0%
HGB 0.00 0.00 0.000 0.0%
MCV 0.00 0.00 0.000 0.0%
PLT 0.00 0.00 0.000 0.0%
MPV 0.00 0.00 0.000 0.0%
Mode to Mode Post-Calibration Difference
Parameter New Clsd Open Mean % Difference Range OK?
WOC 0.00 #DIV/0! ≤ 1.75% #DIV/0!
WIC 0.00 #DIV/0! ≤ 1.75% #DIV/0!
RBC 0.00 #DIV/0! ≤ 1.25% #DIV/0!
HGB 0.00 #DIV/0! ≤ 1.25% #DIV/0!
MCV 0.00 #DIV/0! ≤ 1.25% #DIV/0!
PLT 0.00 #DIV/0! ≤ 3.5% #DIV/0!
MPV 0.00 #DIV/0! ≤ 2% #DIV/0!

Carryover
Open WOC WIC RBC HGB PLT MPV
Sample #3
Background #1
Background #2
Background #3
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Spec < 1.0% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Closed WOC WIC RBC HGB PLT MPV
Sample #3
Background #1
Background #2
Background #3
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Spec < 1.0% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!

Hematology Gain Calculator Spreadsheet - "CD3700" Tab Page 11 of 15 DA-S01021.000VDD01V02


WBC Gain Optimization - See ISA 107-015/108-019 for detail
Lym 0°D Gran 0°D Lym 10°D Gran 10°D Gran 90°D Gran 90°DP
Sample 1 Bead/Blood Settings
Sample 2 (CD3700-> DIAG - F12 - F2 - CELL REGIONS)
Sample 3 Lower Upper
Sample 4 Channel Channel
Sample 5 Lym 0°D 29 89
Sample 6 Lym 10°D 29 89
Sample 7 Gran 0°D 110 210
Sample 8 Gran 10°D 99 199
Sample 9 Neu 90°DP 0 109
Sample 10
Sample 11 Select BLOOD SAMPLE
Sample 12 Run in OPEN mode (up to 20 samples)
Sample 13 Make sure to use fresh samples -
Sample 14 Avoid flags (BAND/IG; VAR LYMPH)
Sample 15 Avoid abnormal concentrations (90%+ LYMPH or NUET)
Sample 16 Record channels before next sample
Sample 17 Enter Current Gains
Sample 18 Final Gains will be calculated
Sample 19 Enter Final Gains in Set Point Entry
Sample 20 Run 7.0µm beads three times
Average #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! This will be the new target for autogains
Target 59 160 59 149 125 21 Verify WOC gains match RETIC gains (ISA 107-11)
±5 ±3 ±5 ±3 ±3 ±2 Save new settings to Set-Up floppy
Current Gains N/A N/A
Gran gains N/A #DIV/0! N/A #DIV/0! #DIV/0! #DIV/0!
Lym gains #DIV/0! N/A #DIV/0! N/A N/A N/A
Final gains N/A #DIV/0! N/A #DIV/0! #DIV/0! #DIV/0!

Set the FINAL GAINS and run 7.0µm beads three times
0°D 10°D 90°D 90°DEP
Run 1
Run 2
Top
Run 3
Autogain to - #DIV/0! #DIV/0! #DIV/0! #DIV/0! Ver. 3.1
Range 33-37 63-67 110-145 78-100

Hematology Gain Calculator Spreadsheet - "CD3700" Tab Page 12 of 15 DA-S01021.000VDD01V02


ss
4/
6/
01 CD1800 CD4000
System CD1400/1600 CD1700 Example
CD3k Series Sapphire
Oldest Cycle 00/00/00 00/00/00 00/00/00 00/00/00 2/24/06
Today's Date 12/29/20 12/29/20 12/29/20 12/29/20 4/11/06
Days to Roll-over #VALUE! #VALUE! #VALUE! #VALUE! 46
Datalog Size 320 5000 10000 10000 10000
Cycles per Day #VALUE! #VALUE! #VALUE! #VALUE! 217
(retic cycles not included)

Oldest Cycle - To look for oldest cycle:


Top
Search DATALOG for current sequence plus 1
Enter that cycle's run date on line 3 Ver. 3.1

Today's Date Calculator will insert today's date

Cycles per Day - Average daily cycles run by system


Includes backgrounds, QC, samples & SRPs

Hematology Gain Calculator Spreadsheet - "Cycle Counter" Tab Page 13 of 15 DA-S01021.000VDD01V02


Top
Version Date Editor Description Reason Justification
This release is starting at Ver. 3.0 to
3.0 19-Dec-06 R. Spielmann Initial Release Initial Release
distiguish from any earlier prototypes.

* Revised Notes in "Top" tab and File


Handling in "Instructions" tab
* Added References tab and added Ruby to CD3200 tab Clarification of information and Completeness and correctness of
3.1 3-Jul-07 M. Roubadeaux
* Removed Vet tab addition of reference information. information
* Removed Precision tab (see DA - S 01021.000 SPR-01)

Hematology Gain Calculator Spreadsheet - Revision History Page 14 of 15 DA-S01021.000VDD01V02


Affected Documents

Initial Release

None

Hematology Gain Calculator Spreadsheet - Revision History Page 15 of 15 DA-S01021.000VDD01V02

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