BioCLIA 500 Maintenance Introduction

Watson ZHENG

International Business Dept.

Contents

Maintenance Procedure for User

Maintenance Procedure for Engineer

Downtime Maintenance
Maintenance Procedure for User
 Maintenance Procedure for User

I. Overview
Maintenance Procedure for User

II. Daily Maintenance

 Maintenance solution: 1:40 diluted 84 disinfectant.
 Ensure there is remain in Supply interface, and then go to
the Utility-Maintenance Instruction and click Daily
Maintenance once.
 It takes about 15 minutes, after finish turn off the software.
Maintenance Procedure for User

II. Daily Maintenance

Check & clean

the waste liquid
drum

Check & clean

the trash tray
Check the pipe
connections
Maintenance Procedure for User

III. Weekly Maintenance

 Refer to daily maintenance steps and execute daily maintenance. But do not turn off the instrument at the end of the
process.
 Proceed “Tubing Wash”, turn off the software after finish.
Maintenance Procedure for User

IV. Monthly Maintenance

 Refer to weekly maintenance steps and execute weekly maintenance. But do not turn off the instrument at the end of
the process.
 Proceed “Complete Wash”, turn off the software after finish.
Maintenance Procedure for User

IV. Maintenance Record – For Operator

Maintenance Procedure for Engineer
 Maintenance Procedure for Engineer

I. Maintenance Overview

Normally monthly. If the average

number of tests is less than 50T/Day, it
can be performed quarterly.
 Maintenance Procedure for Engineer

I. Monthly Maintenance - Preparation

No. Name Specification Source

1 75% medical alcohol 1 bottle Customer site
2 84 disinfectant/Sodium hypochlorite 1 bottle Customer site
3 Cotton swab Several Customer site
4 Absorbent paper Several Customer site
5 500ml measuring cylinder 1 Customer site
6 Medical rubber gloves 1 set Customer site
7 M3 Hexagon Screwdriver (Accessories) 1 set Engineer
8 M2.5 Hexagon Screwdriver (Accessories) 1 set Engineer
9 Cuvette Several Customer site

Remark: The power must be disconnected before cleaning.

Maintenance Procedure for Engineer

II. Monthly Maintenance - Cleaning

Sample chamber Reagent chamber

Maintenance Procedure for Engineer

II. Monthly Maintenance - Cleaning

Cuvette chamber Bottle chamber

Maintenance Procedure for Engineer

II. Monthly Maintenance - Probes Cleaning

System maintenance
Sample probe Sample diluent probe solution dispensing head

Reagent probe Diluent waste liquid probe

Maintenance Procedure for Engineer

II. Monthly Maintenance - Cleaning

Cuvette delivery trolley

Probe washing tank

Maintenance Procedure for Engineer

II. Monthly Maintenance - Cleaning

Washing waste liquid

suction probe and
washing probe swab

Substrate
Wash buffer dispensing probe
dispensing probe
Maintenance Procedure for Engineer

II. Monthly Maintenance - Cleaning

Detection chamber Mixing 1 & 2 Incubation chamber Cuvette throw slide

Maintenance Procedure for Engineer

III. Monthly Maintenance - Inspection

 Pass: No twist and turn on the

pipelines

Vacuum pump and

the pipelines

Gripper wiping sponge

Gripper 1 & 2
 Pass: No crystallization
 Pass: No crystallization.
Maintenance Procedure for Engineer

III. Monthly Maintenance - Inspection

Cuvette delivery trolley guide rail Wash buffer waste liquid suction
probe and wash buffer dispensing
 Pass: No crystallization and rust. probe
 Pass: Connections are good. No
crystal and floc inside pipeline.
Maintenance Procedure for Engineer

III. Monthly Maintenance - Inspection

Substrate Dispensing Pump Diluent piston pump

Connection of Sample(left) and

Reagent(right) Dispensing Piston Pump

 Pass: No crystallization and flocs in the pumps. The connections are tight.
Maintenance Procedure for Engineer

IV. Semiannual Maintenance - Preparation

No. Name Specification Source

1 75% medical alcohol 1 bottle Customer site
2 84 disinfectant 1 bottle Customer site
3 Cotton swab Several Customer site
4 Absorbent paper Several Customer site
5 500ml measuring cylinder 1 Customer site
6 Medical rubber gloves 1 set Customer site
7 M3, M2.5 internal hexagon screwdriver 1 Engineer
8 Nipper pliers 1 set Engineer
9 Probe-passing tool 1 set Accessory box
10 Sample rack bar code 1 set Accessory box
11 Syringe 1 Customer site
12 Cuvette Several Customer site
13 Semiannual maintenance package 1 pack Engineer
Maintenance Procedure for Engineer

IV. Semiannual Maintenance – Replacement of suction heads of gripper 1 and gripper 2

 Make sure no reagent left inside the reagent chamber.

 Remove the upper and lower left side plates, the top cover and the right side plate of the instrument using M3 internal
hexagon screwdriver.

After replacement:
1) Check whether the air pressure pipeline is deformed and tortuous, and
whether the joint is aging.
2) Check the pipe connection of three-way solenoid valve.
3) Check whether the spring can rebound normally.
4) At the end of the maintenance, run water test to check whether the
function is normal after replacement, and whether there is non-cuvette-
suction phenomenon.
Maintenance Procedure for Engineer

IV. Semiannual Maintenance – Replacement of suction heads of gripper 1 and gripper 2

 Remove the right lower shell.

 Replace the filter for forced discharge of waste liquid in the probe washing tank with a new one. Ensure there is no
twist and turn at the pipelines.
Maintenance Procedure for Engineer

IV. Semiannual Maintenance – Monthly maintenance cleaning and fans cleaning

 Proceed monthly maintenance cleaning steps.

 Remove the back shell.
 Use cotton swab or hand-held vacuum cleaner to clean reagent cooling fan, ambient heating fan and ambient cooling
fan.
 Use DI water or 1:40 84 disinfectant to clean buffer bottle and external drums.
Maintenance Procedure for Engineer

IV. Semiannual Maintenance – Monthly inspections and other inspections

 Proceed monthly maintenance inspection steps.

 Sample rack inspection.
 Function test of code scanner.
Maintenance Procedure for Engineer

IV. Semiannual Maintenance – Parameter calibration preparation

 Open Debug software, log in and backup the data.

Maintenance Procedure for Engineer

IV. Semiannual Maintenance – Parameter calibration preparation

 Calibrate the scan code position of the sample rack.

 Calibrate the code scanning position of sample tube.
 Calibration of Sample Probe Aspiration Position.
 Calibrate reagent installation and code scanning position.
 Calibrate the Aspiration position of reagent probe. Remark:
Please refer to the maintenance manual
 Calibration of washing parameters. for the procedures.
 Calibration of Sample Probe Parameters.
 Calibration of diluent dispensing position parameters.
 Calibration of reagent probe parameters.
 Calibration of cuvette delivery trolley parameters.
 Calibration of Gripper 1 & 2 Parameters.
 Calibration of weighing sensor.
Maintenance Procedure for Engineer

IV. Semiannual Maintenance – Status confirmation

To make sure the instrument is in good condition after maintenance, some basic performance tests need to be done:

No. Check items Standard Trigger condition

1 Running water test of two-step and two-cleaning project No abnormality in 50 + test Choose one from the other

2 Field test tracking There is no abnormality in the Choose one from the other
process result
3 Test dark value(PMT) ≤ 200 RLU Mandatory inspection

4 Test background value(SUB) Requirements meet the requirements Mandatory inspection

of reagent manufacturers

5 Test SUB WASH Requirements meet the requirements Mandatory inspection

of reagent manufacturers
Maintenance Procedure for Engineer

IV. Annual Maintenance – Preparation

No. Name Specification Source

1 75% medical alcohol 1 bottle Customer site
2 84 disinfectant 1 bottle Customer site
3 Cotton swab Several Customer site
4 Absorbent paper Several Customer site
5 500ml measuring cylinder 1 Customer site
6 Medical rubber gloves 1 set Customer site
7 M3, M2.5 internal hexagon screwdriver 1 Engineer

8 Probe-passing tool 1 set Accessory box

9 Sample rack bar code 1 set Accessory box
10 Syringe 1 Customer site
11 Cuvette Several Customer site
12 Annual maintenance package 1 pack Engineer
Maintenance Procedure for Engineer

IV. Annual Maintenance – Replacement

 Proceed semiannual maintenance replacement.

 Replace the forced discharge pipeline of waste liquid in probe washing tank.
 Replacement of washing 6-channel peristaltic pump pipe.
 Replace peristaltic pump pipes for diluent waste liquid suction and system maintenance liquid.
 Replace the gripper wiping sponge.
 Replace sample & reagent probe Z-axis synchronous belt. Remark:
 Replace filters of external drums and wash buffer bottle. Please refer to the maintenance manual
for the procedures.
 Replacement of air pump filter.
Maintenance Procedure for Engineer

IV. Annual Maintenance – Cleaning, inspection and parameter calibration

Same as semiannual maintenance.

Maintenance Procedure for Engineer

IV. Annual Maintenance – Pipelines clean

Pipeline Cleaner Operation

Substrate pipeline 1:40 diluted sodium hypochlorite Install cleaner to substrate position, proceed “Substrate
Wash” twice.
Diluent pipeline 75% medical alcohol Install cleaner to diluent position, proceed “Sample
Diluent Wash” twice.
Instrument internal DI water a) Empty wash buffer bottle and clean it;
lines 1:40 diluted sodium hypochlorite b) Put enough 1:40 diluted sodium hypochlorite to DI
water drum and a wash buffer bottle;
c) Put the three external tubes into the DI water drum.
After initialization, proceed “Tubing Wash”.
d) Clean the bottle and the drum with DI water, and
fill them with enough DI water;
e) Load them to the instrument and proceed 5 times
“Tubing Wash”.
f) Unplug the C4 and empty the bottle, restore the
drums and bottle connections.
Maintenance Procedure for Engineer

IV. Annual Maintenance – Status Confirmation

No. Check items Standard Trigger condition

1 Running water test of two-step and two-cleaning No abnormality in 50 + test Choose one from the other
project
2 Field test tracking There is no abnormality in the process Choose one from the other
result
3 Test dark value(PMT) ≤ 200 RLU Mandatory inspection

4 Test background value(SUB) Requirements meet the requirements Mandatory inspection

of reagent manufacturers

5 Test SUB WASH Requirements meet the requirements Mandatory inspection

of reagent manufacturers

6 Test the liquid dispensing accuracy of sample probe Required CV value ≤ 3% Mandatory inspection

7 Test the liquid dispensing accuracy of reagent probe Required CV value ≤ 3% Mandatory inspection
Maintenance Procedure for Engineer

IV. Maintenance Record – For Engineer

Downtime Maintenance
 Downtime Maintenance

I. Maintenance Timing and Purpose

1. Before the instrument is going to be downtime for more than 7 at the customer site.
2. Before the instrument needs to be returned back to warehouse.

Purpose: To avoid crystallization and contamination caused by the instrument liquid lingering in the pipeline for a long
time, which will affect the test results after re-enable the instrument.
 Downtime Maintenance

I. Maintenance Preparation

No. Material name Note

1 Recycle maintenance bottles Use two used substrate bottles and two sample diluent bottles, and mark them.

2 84 disinfectant (Sodium Hypochlorite) 1:40 Need to be diluted in advance and placed in dedicated maintenance substrate bottles, 40mL per bottle.

3 Medical alcohol Add into dedicated maintenance diluent bottles, 40mL per bottle.

4 Gloves Some

5 Absorbent paper Some

6 Cotton swabs Some

 Downtime Maintenance

I. Maintenance Procedures

Clean the substrate, After downtime

sample diluent and Empty the pipelines restore the
wash buffer pipeline. consumables
Thank you.