Maglumi X3 Standard Operating Procedure

ITSD
CONTENTS
01
PART ONE
System Overview
05
PART FIVE
Calibration

02
PART TWO
Switch On/Off 06
PART SIX
Control

03
PART THREE
Preparation 07
PART SEVEN
Sample Test

04
PART FOUR
System Test 08
PART EIGHT
Daily Maintenance

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01
PART ONE
System Overview

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01 System Overview
PART ONE

Alarm Light

Reagent Sample Area

RFID Reader

Consumable Indicator

Liquid Joints
Cuvette Storage

Cuvette Dustbin

Starter Area
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 01 System Overview
PART ONE

Comsumables
Code NAME STORAGE Usage Function
No sunlight or humidity.
1 Reaction module Disposable CLIA Reaction place
Shelf life:2 years.
15-30°C, Shelf life :1 year. 1bottle (714mL)+distill water= 10L Wash the magnetic micro-
2 Wash Concentrate
On board stability: 4 weeks. Wash liquid beads and needles.

Avoid bubbles; integral for needle Check the performance of

3 Light Check 2-8°C ,Shelf life: 1 year. Pipetting unit and
coordinate; the last reagent position measuring unit

Starter 1: Catalyst in 1.5%

NaOH 15-30 °C,Shelf life:1 year.
4 Avoid mistake Activate ABEI
Starter 2: 0.21% hydrogen Onboard stability: 4 weeks
peroxide solutions

Tubing Cleaning 5th, 6th and 7th vials with 13ml

5 15-30°C, Shelf life :1 year. Wash waste tubes
Solution respectively.

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01 System Overview
PART ONE

Measure
Wash

Incubation

Sampling

Add reagent

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02
PART TWO
Switch On and Off

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02 Switch On/Off
PART TWO

1. Turn on Main switch. 2. Switch on the computer.

Wait for 3 seconds then turn on Sub switch. Log in Maglumi X3 User Software.
The analyzer will initialize automatically with clean
cuvettes.

Username: snibe
Password: snibe

Main switch Sub switch

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02 Switch On/Off
PART TWO

3.When status of the machine marked by red rectangle show “Standby”，tests can be run.

4.Switch off the machine.

A. Software：Click “STOP”，
then click “EXIT”

B. Analyzer: Turn off the

sub-main switch at first
and then the main switch.
STOP EXIT

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03
PART THREE
Preparation

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03 Load Reagent Kits
PART THREE

Scan and load the reagents will be used to the reagent area. The analyzer will shake
the magnetic micro-beads Component for 30 minutes automatically.

Shaking remaining time

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03 Check Consumables
PART THREE

Check reaction modules

Check Starters
Check wash liquid

Empty waste bag

Empty waste liquid tanks

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03 Confirm Analyzer Status
PART THREE

Green : normal
Red : abnormal

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04
PART FOUR
System Test

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04 Load Light Check
PART FOUR

There is a integral for needle coordinate kit.

Press a LC bottle into the 4th vial of the kit.

The 4th vial

Put the kit at the 20th position in the reagent area.

The 20th position

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04 Run System Test
PART FOUR

Daily System Test：

1
10 times for Pipettor, Washer and
Chamber Prime

3 5 times for BGW:

RLU 100-1200, CV≤10%

5 times for LC：

RLU 450000-650000, CV≤3%
4
Note：
It’s recommended to run LC daily,
2 at least once a week.

5
If stop using the analyzer ≥5 days, 30 times for Pipettor, Washer and Chamber Prime.
If only replace the wash liquid, 30 times for Pipettor and Washer Prime, 10times for Chamber Prime.
If only replace the starters, 30 times for Chamber Prime, 10times for Pipettor and Washer Prime.
If replace both wash liquid and starters, 30 times for Pipettor, Washer and Chamber Prime
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05
PART FIVE
Calibration

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05 Run Calibration
PART FIVE

3
4
If you want to run batch calibration, select all reagents need to be calibrated at 2nd step.

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05 Check Calibration Result
PART FIVE

1
CV:＜15%

4 Dev:
-70%＜Dev＜70%
2 click once
5
6

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06
PART SIX
Quality Control

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06 Set QC Information
PART SIX

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06 Edit QC Information
PART SIX

2
②Set the QC information

④Select the QC assay

⑤ Fill in the QC information

Expected SD=(upper
bond – expected target
value)/3

① ③ ⑥

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06 Run QC
PART SIX

1 ① Load QC liquid in the sample rack.

② Scan the QC position and edit the

2 3 Select the QC sample position QC information in the work list interface.
Select the rack

4
5 Select the QC information
8 6 Select the QC assay

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06 Check QC Result
PART SIX

①Check the QC result and QC chart.

1
2 ②Check general QC level.

3
4

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07
PART SEVEN
Sample Test

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07 Prepare Sample
PART SEVEN

① Collect and deal with samples gently and avoid shaking violently; fibrin, hemolysis, lipemia, jaundice
and bubbles might affect the results.
② Avoid repeated freezing and thawing.(< 2 times)
③ Centrifugation for serum samples :10-15 min with over 4000r/min.
④ Use the required sample tube.

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 07 Run Sample
PART SEVEN

1 ①Load the sample in the sample

rack.
4 Select the assay
2 3
Select the rack Select the position

②Scan and edit the sample information

in the work list interface.

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 07 Edit STAT Sample
PART SEVEN

1
①Load the STAT sample in
the sample rack.
5 Select the assay
2
Select the rack
3
Select the position

②Edit the sample information

in the work list interface.
4

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07 Dilute Sample
PART SEVEN

1.Select the diluted ratio.

1
2
2.If you want to set the
diluted ratio by yourself,
Click “Add”.

3 6 Note:
Select the diluted assay 4 Select the preferred dilution ratio The sample volume is
at least 10μL.

And for each time the

total volume injected
5 should between 200
and 380μL.

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07 Dilute Sample
PART SEVEN

2
After finishing editing sample
4
information, click “Dilution” to
1
choose the diluted ratio you
5
have selected or set.
6
3
7

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07 Special Sample tubes
PART SEVEN

If these 3 tubes need to be used, following fixtures

need to be provided by Snibe additionally.

Standard tube is
recommended.

You can skip this part as if you use standard tube.

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 07 Special Sample tubes
PART SEVEN

Software and firmware requirement

MAGLUMI X3-1.2.3.0

Number Module Version

1 COP 1.01.03.0MC0
2 Multi-module 1.01.03.0MC0
3 Washer 1.01.03.0MC0
4 Chamber 1.00.03.0MC0
5 Claw 1.00.03.0MC0
6 Sample Arm 1.00.03.0MC0

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 07 Special Sample tubes
PART SEVEN

Fixtures
Sample rack installation
Precautions
The tube will be stuck as it rotates more than
Same sample tube for one rack, or it will 90°. Rotate in reverse until label faces rack
be an error. opening and unplug it out.

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 07 Special Sample tubes
PART SEVEN

① Service setting-need to be done by service engineer

[ Sample Arm ]→[ Sample tube type ]

Sample Tube Type: the name of the sample tube
Code: from B to Z
Z axis of Rack 1, Tube 1: need to be adjusted
Number: automatic generation; from 2-15

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 07 Special Sample tubes
PART SEVEN
② User software identification
In user, the sample tube is default (code-named A),
and you can add new type by two ways :
1) Scan identification 2) Manual setting
Priority for the type of Sample tube to identify:
Scan identification > Manual setting > Normal.
As the scanner identify the different type from the
Manual setting, the software will give priority to the
type identified by scanner.
1) Scan identification
When scanner identifies the code, it will upgrade the
second letter for the type of the tube in [ work list].
And it will restore back to the Manual setting code or
Normal code as the sample rack is unplugged.
Notice:
Load the rack with fixture and make sure
the type can be identified accurately each
time.
Adjust the fixture for a little inclined as if
it could not be identified every time.
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 07 Special Sample tubes
PART SEVEN

2) Manual setting
Click <General Setting> in <setting> , and select the type for each column then
Save. It will change immediately in [ working list ].

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 07 Special Sample tubes
PART SEVEN

2) Manual setting
The type of manual setting is fixed and effective that
it will not be changed as the rack is unplugged, and
the subsequent tube loaded in this column will be
defaulted to the type you set.
( It can only be temporarily covered by the type
identified by scanner, and it will restore back to the
default type when the rack is unplugged.)

Remember to modify the type when you want to

load sample rack for other type tubes.
Manual settings only allow modifying the sample
tube type for columns that are not inserted or in a
waiting state.

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08
PART EIGHT
Daily Maintenance

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08
PART EIGHT Daily Maintenance
Do the daily maintenance as the following steps.

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 Thanks
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