CAPILLARYS 3  OCTA  TERA Référence : ENR-SEB-12-2014-019

INSTALLATION SHEET Indice

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SERIAL NUMBER ___________ Phoresis/Instrument release: _____________ Date:___________

LABORATORY OR INSTITUTION:________________________________________________________

Address:__________________________________________________________________________

Country/Distributor:___________________________________________________________________

1. INSTALLATION

• Refer to the instructions for use to:

- Check the compliance with environmental requirements
- Ensure customized installation of the equipment

2. CHECKLIST

• Check CAPILLARYS, PC, monitor and printer’s connection

• After turning on the instrument:
- Check PC power-up
- Check PC date and time

3. CAPILLARYS POWER-UP

• Start the Phoresis software with the service password

• Select the working program
• Run the start cycle
• Run the capillaries activation
• Run CAPICLEAN cycle

4. VALIDATION

PROTEINE 6 □ □ □ Fill the form “Protéin(e) 6 validation“

YES NO N/A

IMMUNOTYPING 6 □ □ □ Fill the form “Immunotyping 6 validation“

YES NO N/A

HEMOGLOBINE □ □ □ Fill the form “Hemoglobine validation“

YES NO N/A

Hb A1c □ □ □ Fill the form “HbA1c validation”

YES NO N/A

URINE / IT URINE □ □ □ Fill the form “Urine / IT Urine validation“

YES NO N/A

CDT □ □ □ Fill the form “CDT validation“

YES NO N/A

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 CAPILLARYS 3  OCTA  TERA Référence : ENR-SEB-12-2014-019

INSTALLATION SHEET Indice

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5. SECURITY TEST AND EMERGENCY STOP

• Check the proper functioning of the micro-switch of the unloading / loading cover,
reactive hood and stopping the unit if the covers are open (no more hold rack and dilution)
• Check the off / on switch.

6. USER TRAINING

7. SYSTEM SETTINGS BACKUP

After each assays ran by the customer are validate:

• Backup the Phoresis folder.
Note date and software release on the backup unit

• Back up device settings using the script available on S.K.B online support
 http://support.sebia.com
• Back up the database using the Phoresis "Advanced Backup" menu

8. DOCUMENT

• Instruction manual

9. ACCEPTANCE

For purposes of this Agreement, the Capillarys3 system will be deemed accepted when Sebia has completed the setup, installation
and start-up testing of the system and confirms the system is performing according to manufacturer’s performance specifications,
and the Customer has evidenced acceptance by execution of Sebia’s Installation Sheet for the serial number of the Capillarys3 System
(the “Acceptance Date”)

SEBIA REPRESENTATIVE LABORATORY OR INSTITUTION REPRESENTATIVE

_______________________________ ________________________________
Name and signature
Name and signature

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 CAPILLARYS 3  OCTA  TERA Référence : ENR-SEB-12-2014-019

PROTEIN(E) 6 VALIDATION Indice

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SERIAL NUMBER ___________ Phoresis/Instrument release: _____________ Date:___________

LABORATORY OR INSTITUTION:________________________________________________________

Address:__________________________________________________________________________

Country/Distributor:___________________________________________________________________

Sheet to validate before routine use of the technique

1. REAGENT IDENTIFICATION

CAPI 3 reagent Lot number Expiration date

PROTEIN(E) 6 buffer

Wash solution

Normal Control Serum

Hypergamma Control Serum

2. CHECK CMOS CALIBRATION

• After startup check the CMOS calibration using the OPTICAL menu
- Integration time t ≤ 20 ms

3. CONTROL ANALYSIS
• Using the rack “0”, run both Normal and Hypergamma controls 2 times in positions 1 and 8
(with barcode)
• Verify absence of error messages
• Using the statistic tool in Phoresis, complete the tables below:

NORMAL CONTROL SERUM HYPERGAMMA CONTROL SERUM

Fraction values Fraction values
CVs (%) CVs (%)
(%) C/NC (*) (%) C/NC (*)
Albumin _______ ≤2% Albumin _______ ≤2%
Alpha1 _______ ≤10% Alpha1 _______ ≤10%
Alpha2 _______ ≤10% Alpha2 _______ ≤10%
(
Beta1 _______ ≤10% Beta1 _______ ≤10%
*
) Beta2 _______ ≤10% Beta2 _______ ≤10%
Gamma _______ ≤10% Gamma _______ ≤10%
:
(*): min/max values in the target values / see instructions for use of the PROTEIN(E) 6 technique
C/NC: Compliant/ Non Compliant

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 CAPILLARYS 3  OCTA  TERA Référence : ENR-SEB-12-2014-019

PROTEIN(E) 6 VALIDATION Indice

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• Report minimum OD obtained on all the measurements of the Normal Control: _____ > 0,35

And OD max: _______ ≤ 0.9

SEBIA REPRESENTATIVE LABORATORY OR INSTITUTION REPRESENTATIVE

_______________________________ ________________________________
Name and signature Name and signature

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 CAPILLARYS 3  OCTA  TERA Référence : ENR-SEB-12-2014-019

IMMUNOTYPING 6 VALIDATION Indice

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SERIAL NUMBER ___________ Phoresis/Instrument release: _____________ Date:___________

LABORATORY OR INSTITUTION:________________________________________________________

Address:__________________________________________________________________________

Country/Distributor:___________________________________________________________________

Sheet to validate before routine use of the technique

1. REAGENT IDENTIFICATION

CAPI 3 reagent Lot number Expiration date

PROTEIN(E) 6 buffer

Solution de lavage

IMMUNOTYPING KIT

Normal Control Serum

CAPI 3 IMMUNOTYPING
Sample diluent

2. CHECK CMOS CALIBRATION

• After startup check the CMOS calibration using the OPTICAL menu
- Integration time t ≤ 20 ms

3. CONTROL ANALYSIS

TERA : Analyze two normal control sera on 2 different "standard" racks in position 1 (standard dilution) (with
barcode)

OCTA : Analyze a normal control serum on a standard rack (standard dilution) (with barcode)

• Superposition quality : C/NC

• No noise visible on the curves

SEBIA REPRESENTATIVE LABORATORY OR INSTITUTION REPRESENTATIVE

_______________________________ ________________________________
Name and signature Name and signature

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HEMOGLOBIN(E) VALIDATION Page : 6/14

SERIAL NUMBER ___________ Phoresis/Instrument release: _____________ Date:___________

LABORATORY OR INSTITUTION:________________________________________________________

Address:__________________________________________________________________________

Country/Distributor:___________________________________________________________________

Sheet to validate before routine use of the technique

1. REAGENT IDENTIFICATION

CAPI 3 reagent Lot number Expiration date

HEMOGLOBIN(E) buffer
HEMOGLOBIN(E) Hemolysing
solution
Wash solution

Hb A2 Normal Control

2. PHORESIS SETTING

NA

3. CMOS CALIBRATION

• After startup check the CMOS calibration using the OPTICAL menu
- Integration time t ≤ 10 ms and current in the LED ≤ 900.

4. CONTROL ANALYSIS
• Using the rack “0”, run Normal control 3 times (with barcode)
• Verify proper dilutions and absence of error messages
• Using the statistic tool in Phoresis, complete the tables below:

Hb A2 NORMAL CONTROL
Fraction values (%)
CVs (%)
C/NC (*)
Hb A2 _______ ≤3%

(*) : min/max values in the target values / see instructions for use of the HEMOGLOBIN(E) technique

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HEMOGLOBIN(E) VALIDATION Page : 7/14

• Report minimum OD across all Normal Control measures obtained: ______ > 0,11
• On the same analyzes, check the absence of noise on the profiles.

In case of noise, follow the instructions provided by SEBIA service.

SEBIA REPRESENTATIVE LABORATORY OR INSTITUTION REPRESENTATIVE

_______________________________ ________________________________
Name and signature Name and signature

(Return this document to the Service Department)

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HbA1c VALIDATION Page : 8/14

SERIAL NUMBER ___________ Phoresis/Instrument release: _____________ Date:___________

LABORATORY OR INSTITUTION:________________________________________________________

Address:__________________________________________________________________________

Country/Distributor:___________________________________________________________________

Sheet to validate before routine use of the technique

1. REAGENT IDENTIFICATION

CAPI 3 reagent Lot number Expiration date

Hb A1c buffer

Hb A1c Hemolysing solution

Wash solution

Hb A1c Calibrator Level 1

Hb A1c Calibrator Level 2

Hb A1c Control Level 1

Hb A1c Control Level 2

2. PHORESIS SETTING

Activate the « Smart Centering » option in the Phoresis software

3. CMOS CALIBRATION

• After startup check the CMOS calibration using the OPTICAL menu
- Integration time t ≤ 10 ms and current in the LED ≤ 900.
3. CALIBRATION

• Analyze 1 rack "0" with calibrators level 1 and 2 in position 1 and 8 and with barcode
• Check Hb A0 peak positions on each profile and note the values in the table : values must be in the target
specifications 130-170 ; see the raw data on the profiles using “VIEW_RAW_DATA=1” in the Phoresys.ini file.

OCTA
TERA

C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 C12

Raw position of the Hb A0 peak

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HbA1c VALIDATION Page : 9/14

• On the same analyzes, check the absence of noise on the profiles.

In case of noise, follow the instructions provided by SEBIA service.

If at least one value is out of the specified target, launch an activation cycle.

Pursue the Hb A1c calibrations, in order to obtain 3 successful calibrations, with no alert (yellow, purple or red symbols, or
“atypical profile” on the profiles) and with Hb A0 positions in the specified target.

Notes :
Repetitive alerts demonstrate a problem of instrument or sample.
Pursue calibrations only after having resolved the problem.
- yellow alert when Hb A0 or Hb A1c peaks are out of range;
- red alert when raw values of %Hb A1c are out of the expected targets;
- purple alert when OD is below 0.06;
- “atypical profile” on the display window and on the calibration list when a normal peak is missing (Hb A0, Hb A1c,
Hb A2 or other HbA), or supplementary peak.
4. CONTROLS ANALYSIS

Analyze 1 rack "0" with level 1 and 2 controls in position 1 and 8 and with barcode

• Verify absence of error messages ((yellow, purple or red symbols, or “atypical profile”).
• Using the statistic tool in Phoresis, complete the tables below:

Level 1 Level 2
CVs (%) CVs (%)
Hb A1c _______ ≤2% Hb A1c _______ ≤2%
OR Difference (max-min)% A1c ≤ 0.3point : _____
OR Difference (max-min)% A1c ≤ 0.6point : _____

• Report minimum OD across the 12 level 1 Control obtained: _____ > 0.11
• Report minimum OD across the 12 level 2 Control obtained: _____ > 0.11

The average value of each control must be in the target range specified in the instructions for use.
Using Hb A1c technique, the target range must then be customized as described in the controls instructions for use.
Customized values :
Level 1 Level 2

_____ / _____ % _____ / _____ %

_____ / _____ mmol/mol _____ / _____ mmol/mol

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HbA1c VALIDATION Page : 10/14

IF CAPILLARY SAMPLES MUST BE TESTED, REFER TO THE 3 TERA / OCTA CAPILLARYS SERVICE MANUAL AVAILABLE ON
THE S.K.B ONLINE SUPPORT (HTTP://SUPPORT.SEBIA.COM).

SEBIA REPRESENTATIVE LABORATORY OR INSTITUTION REPRESENTATIVE

_______________________________ ________________________________
Name and signature Name and signature

(Return this document to the Service Department)

 CAPILLARYS 3  OCTA  TERA Référence : ENR-SEB-12-2014-019
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URINE / IT URINE VALIDATION Page : 11/14

SERIAL NUMBER ___________ Phoresis/Instrument release: _____________ Date:___________

LABORATORY OR INSTITUTION:________________________________________________________

Address:__________________________________________________________________________

Country/Distributor:___________________________________________________________________

Sheet to validate before routine use of the technique

1. REAGENT IDENTIFICATION

CAPI 3 reagent Lot number Expiration date

PROTEIN(E) 6 buffer

Dialysis buffer

Wash solution

IMMUNOTYPING KIT

Normal Control Serum

IMMUNOTYPING
Sample diluent

URINE Technique:

2. Perform the PROTEIN (E) 6 validation of the device if it has not already been performed.

3. CONTROL ANALYSIS

• Using the rack “0”, run Normal control diluted to 80th in dialysis buffer as for the normalization of
the capillaries.
• Verify absence of error messages
• On the same analyzes, check the absence of lifting of the profile.
Example :

In case of noise, follow the instructions provided by SEBIA service.

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URINE / IT URINE VALIDATION Page : 12/14

IT URINE Technique:

2. Perform the URINE validation of the device if it has not already been performed.

3. Perform IT validation of the device if it has not already been done.

SEBIA REPRESENTATIVE LABORATORY OR INSTITUTION REPRESENTATIVE

_______________________________ ________________________________
Name and signature Name and signature

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 CAPILLARYS 3  OCTA  TERA Référence : ENR-SEB-12-2014-019
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CDT VALIDATION Page : 13/14

SERIAL NUMBER ___________ Phoresis/Instrument release: _____________ Date:___________

LABORATORY OR INSTITUTION:________________________________________________________

Address:__________________________________________________________________________

Country/Distributor:___________________________________________________________________

Sheet to validate before routine use of the technique

1. REAGENT IDENTIFICATION
CAPI 3 reagent Lot number Expiration date
CDT buffer
CDT sample diluent
Wash solution
CDT Normal Control
CDT High Control
CDT Control diluent
Reagent Lot number Expiration date
CDT Calibrator Level 1
CDT Calibrator Level 2

2. CMOS CALIBRATION

• After startup check the CMOS calibration using the OPTICAL menu
Integration time t ≤ 20 ms

3. CALIBRATION

• If calibrated, analyze 1 rack "0" 3 times with calibrators level 1 and 2 in position 1 and 8 with barcodes.

4. CONTROLS ANALYSIS

on 1 rack "0" Analyze the 2 levels of controls in position 1 and 8 with barcode.
• Verify proper dilutions and absence of error messages.
(yellow, purple or red symbols, or “atypical profile” on the profiles).
• Using the stastistic tool in Phoresis, complete the tables below:

CDT NORMAL CONTROL CDT HIGH CONTROL

Fraction values (%) Fraction values (%)
CVs (%) CVs (%)
C/NC/NA (**) C/NC/NA (**)
CDT _______ ≤20% CDT _______ ≤10%
CDT-IFCC _______ ≤10% CDT-IFCC _______ ≤10%
(**) : min/max values in the target values / see instructions for use of the CDT technique
C/NC/NA: Compliant/ Non Compliant /Non Applicable

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CDT VALIDATION Page : 14/14

• Report minimum OD across all Normal Control obtained : _____ > 0.07

SEBIA REPRESENTATIVE LABORATORY OR INSTITUTION REPRESENTATIVE

_______________________________ ________________________________
Name and signature Name and signature

(Return this document to the Service Department)