Technical Document - DAGATRON

Dagatronics Corp.

Technical Document NO. DGM-DM-001

Revision date 2013. 9.11

Ziehl-Neelsen AFB Auto Stainer

Model : AT-2000Z

Revision ver. 3

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Dagatronics Corporation

Table of Contents

1. The Purpose of documentation

2. The coverage of application

3. Technical description of product

4. Used materials

5. Performance and Technical specification of product

6. Standards and Methods of Incoming Quality Check

7. Standards and Methods of Intermediate Quality Check

for Semi assembled product

8. Standards and methods of Final Quality Check for finished product

9. Marking and Labeling

History of

Revision

Rev. NO. Revision date

Effective date Contents of Revision Write Review Approval

0 2007.04.01 2007.04.01.

Establish to start Quality management system for manufacturing IVD device in company.

1 2007.07.02. 2007.07.02.

Revise for amending and adding standards and methods of tests for Materials, and Finished product.

2 2009.10.06 2009.10.06 CE Marking(EMC, LVD)

3 2013. 9. 17 2013. 9. 11 Revise for changing components(Pumps and Valves)

Managed

Unmanaged /

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1. The Purpose of documentation

This technical document, for the purpose, prescribes the general information-standards and

characteristics of product, process of manufacturing, test, inspection, labeling and etc. in

Ziehl-Neelsen AFB Auto Stainer(In Vitro Diagnostic Medical Device for the acid-fast automatic

staining of smear slides in mycobacteriology by using Ziehl-Neelsen (ZN) staining method,

Model: AT-2000Z), manufactured in Dagatronics Corporation. It is the purpose for this

document that the product satisfies the general requirements.

2. The coverage of Application

This technical document shall apply to the following product manufactured in Dagatronics

Corporation.

Group of item In vitro diagnostic Medical Device(IVD)

Product name Item name Model name

Ziehl Neelsen AFB Auto Stainer AT-2000Z

Classification NO. A24020 Grade General

Company Dagatronics Corporation

Country Republic of Korea

3. Technical description of Device

1) Summary of product

AT-200Z is a laboratory instrument for the acid-fast automatic staining of smear slides in

mycobacteriology. The instrument enables the automatic staining of one to 10 slides in one

run using the Ziehl-Neelsen (ZN) staining method and it provides that users can classify

infected mycobacteria in color.

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2) Appearance and structure

(1) Appearance(Photos)

(2) The details of each part

① Main body: Maintain the appearance, protect the product.

② Lid Cover: Protect chamber and slide tray from dust, moisture, temperature of outside. The

product is not operating if this lid cover is opened.

③ Grip: To open or close Lid cover.

④ Display: Show the progress of operation of product on LCD monitor.

⑤ Holder for reagents: Holder to fix reagents bottles and can be disconnected from main

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body.

⑥ Foot: Support for not sliding and the height can be adjustable.

⑦ Power switch: Turn on or off the power.

⑧ Function select switches: Select the functions and control the operation of product.

⑨ FAN: Ventilate and radiate inside the product.

⑩ Fuse: Protect the product by breaking itself when over-current is flowing.

⑪ Power inlet: Connect power cord to supply AC power.

⑫ Drain output: Connect drain hose to drain the wastewater inside of chamber.

⑬ Rating Label: Marking and labeling for the information of product.

⑭ Tube for injecting reagent: Connect between stainer and reagent bottles and it can be

disconnected.

⑮ Terminal for grounding: Connection between internal ground and external ground.

⑯ Hinge: Connecting between Lid cover and main body for fixing.

⑰ Reagent connector: Connection for reagent injection tube to pumping system of product.

⑱ Reagent bottle holder connection cable(8P): Connection between reagent bottle holder

and main body of product for detecting the amount of rest reagents.

a) Panel controls

① LCD Display: Showing default settings of function and displaying the status of operating of

product.

② Function select switch: Select function and set the value of operation.

③ Mode select switch: Select the quantity of staining slides and Mode of operation.

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b) During staining (Inside of Chamber)

① Slide Tray: To insert smeared slides for staining. The maximum 10 slides can be stained.

The slide should be inserted from 1 to 10 according to the number which is marked on tray.

It spins in a counterclockwise direction.

② Nozzles: For injecting reagents. Each reagent has own injecting nozzle.

③ “0”(start) position sensor: As position control apparatus, it always meet number 1 at slide

tray when starting.

④ Micro switch: Control for opening or closing of Lid cover.

⑤ Horizontal gauge: To show the status of positioning of product. The position of indicator

should be in center of gauge.

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3) Dimensions and weight

(1) Main body

- Dimensions 446(W)x486(D)x282(H)mm

- Weight: Approx. 24

(2) Reagent Holder

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- Dimension: 100(W) x 370(D) x 121(H)mm

- Weight: 1.5

① Holder for reagents: Holder to fix reagents bottles and can be disconnected from main

Body.

② Micro switch : Sensing the amount of each Reagent.

③ Reagent bottle holder connection cable(8P): Connection between reagent bottle holder

and main body of product for detecting the amount of rest reagents.

4) Configuration and characteristic of product

(1) Configuration of product

This product consists of main body, Lid cover, slide tray, chamber and etc.

① Functions of each part

1) Main body: Maintain the appearance, protect the product and control the functions.

- Power supply: Supply DC Power to the product.

- Part of heating: It has ceramic heaters that heats smeared slides at right temperature for

staining according to Ziehl-Neelsen staining method.

- Part of spinning: It has stepping motor that rotates at high speed and controls injection

position. This part consists of stepping motor, motor drive, slide tray, shaft and etc.

- Part of injecting reagents: Inject reagents, water or distilled water to slides. This part

consists of nozzles, solenoid valve, reagent pump and etc.

- Part of controlling functions: It controls spinning of motor, position, various injections and all

the instruments operations. It consists of main board, selection switch, LCD.

2) Lid Cover: Protect chamber and slide tray from dust, moisture, temperature of outside. The

product is not operating during opened this lid cover.

3) Slide tray: It is the place that fixes smeared slide glass and connects with shaft of stepping

motor to the belt horizontally. When reagents, water, distilled water injected, slide tray and

motor spin together.

4) Chamber: Slide tray exists and spins in chamber.

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(2) Characteristics of equipment

① Principle of operation

Slide tray that emplace horizontally with shaft of stepping motor spins at high speed for

controlling injecting location of reagents and washing by Micom with main pcb. When it stops

at right location, equipment uses reagent pump for staining and washing with reagents or

water(distilled water). And for stained well, slide tray attaches part of heating. It works only

during reagent Carbol Fuchsin(CF) process in progress.

② Electricity characteristics: 100 - 240V, 50/60Hz

③ Lightening protection type and degree: Grade 1, BF type mounting

④ Device for protection

1) Device that does not open cover installed when it starts to work.(lock control)

2) Lock control that does not open lid cover installed when motor spins.

3) When lid cover does not close completely, it does not work with warning beep and

messages. (during staining and drying in dry mode)

4) Fuse : When over-current flowing, the fuse is breaking if self.(Rating of fuse: AC 250V,

8A(T))

5) When amount of rest reagents is not enough, LCD monitor of panel lights and sounds

warning beep, display warning message by sensing the amount of reagents in reagent

holder.

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⑤ The schematic of Operation

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4. Used Materials

No Part name Part number Specification Q’ty Remarks

1 Power switch RL2 250V,10A 1 RLEIL etc,

Or same grade

2 Stepping motor PK264A2-SG3.6

Current consumption:2A, Gear ratio:3.6 1step:0.5°, Permissible speed:0~500rpm

1 Vexta etc,

Or same grade

3 Reagent pump PML8537-KNF25 DC 12V FLOW:1.0 GPM ~ 3.8LPM

5 KNF

Or same grade

4 Heater Ceramic heater 48V,8.1Ω 8 Duil etc,

Or same grade

5 LCD ALCD204BLUE DC +5V,20 By 4 1 Commfile-

Technology etc, Or same grade

6 Panel Front, Right, Left ABS, 3t 1 / 2 Samjung etc,

Or same grade

7 Body

Cover AL 1.2t 1 Uri etc,

Or same grade Bottom SCP304 (Cold rolled steel)

1.5t 1

8 Holder of reagent bottles

SCP304 (Cold rolled steel)

1t 1 Uri etc,

Or same grade

9 Pressure Control Valve

PML9709 FDV31 5 KNF

Or same grade

10 Fuse General electric parts 250V,8A(T) 2 Oricell etc,

Or same grade

11 SMPS HA-1 DC +48V 12A,DC+24V 2.5A,DC +12V 2.5A DC +5V 2A

1 Hando etc,

Or same grade

12 Slide Tray AL6061 Tray wings:10, teflon coating

1 Seokwang etc, Or Same grade

13 MAIN control PCB PCB double-sided board 262mmX160mm,1.8t 1 Cowon etc,

Or same grade

14 KEY switch control PCB

PCB double-sided board 104mmX52mm,1.8t 2 Cowon etc,

Or same grade

15 Stepping motor drive

CSD2120-P Input power:DC+5V,+24V 1 Vexta etc,

Or sme grade

16 Nozzle PTFE(teflon) Outside:ø15, hole :ø2.5, L=40mm

5 Uri etc,

Or same grade

17 Chamber AC2 A-F.T(AL Cu Ai group, AL alloy casting)

ø324,H=102mm, Teflon coating

1 Uri etc,

Or same grade

18 Reagent tube PTFE(teflon) 1t,ø4,1m / 1t,ø4,80cm 1/4 Hanmi etc,

Or sSame grade

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19 Drain tube SRT-KS D 2341 colorless (translucent-silicone tube)

1.5m , 2.5t 1 Hanmi etc,

Or same grade

5. Performance and Technical specification of product

1) Performances (specification)

① Rated voltage: 100 - 240VAC

② Rated frequency: 50/60Hz

③ Power consumption during maximum rated output: 800W

④ Fuse : AC 250V , 8A(T)

⑤ Motor RPM (in dry): 200RPM± 10%

⑥ Amount of reagent injecting: full name (abbreviation)

(1) Carbol Fuchsin(CF) : 250/min± 10%

(2) Acid-Alcohol(AA) : 250/min± 10%

(3) Methylene Blue(MB) : 250/min± 10%

(4) Ethyl Alcohol(Et) : 250/min± 10%

(5) Distilled Water(DW) : 250/min± 10%

⑦ Operating time( for 1 cycle) : 18 Min ± 10%

⑧ Staining possible number of slide: Maximum 10

2) Purpose of Use

This product is used for staining the acid-fast bacteria of smear slides in mycobacteriology.

The instrument enables the automatic staining of one to 10 slides in one run using the

Ziehl-Neelsen (ZN) staining method and it provides that users can classify infected

mycobacteria in color

6. Standards and Methods of Incoming Quality Check

- Method of test: Sampling test

- Standard of test: KS A ISO 2859-1, size of rot is based on 1 day quantities of

stock.

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- Approved products by international standards(same grade as KS) are not

inspected.

Material Object Standard Method Remarks

Main body,

Cover,

Holder for

reagent bottles

Dimension See the drawing.

Measure with

tapeline,

Vernier calipers.

Check inspection

n=5,c=0

State of

plating

Not allowed:

exfoliation, instability of

plating,

debris penetration.

Visual inspection

(Macrograph)

Sample test

1)Standards: KS A 2859-

1

2)Test level: Special test

S-2

3)Sample format and test

of strict: Straight-forward

test once sampling

4)Approved quality

level:1.0

Color Same as colors of the

drawing.

Looks

Not allowed:

Breakage, torsion,

warp.

Chamber,

Slide Tray

Dimension See the drawing.

Measure with

tapeline,

Vernier calipers.

Check inspection

n=3,c=0

State of

plating

Not allowed:


plating,

debris penetration

Visual inspection

(Macrograph)

Sample test


1


S-2



test once sampling

4)Approved quality

level:1.0


drawing.

Looks

Not allowed:

Breakage, torsion,

warp.

Teflon nozzle

(group of

artifacts)

Dimension See the drawing. Measure with vernier calipers. Check inspection

n=3,c=0

State of

plating

Not allowed:


plating,

debris penetration

Visual inspection

(Macrograph)

Sample test


1


S-2



test once sampling

4)Approved quality

level:1.0


drawing.

Looks

Not allowed:

Breakage, torsion,

warp.

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PCB

assembly board

Assembling

parts

Same as reference

number of P/L.

Visual inspection

(Macrograph) Lot test Soldering

Allowed: soldering

surface flat,

Not allowed: not

soldering parts

Looks Allowed: right height,

shape

Material Object Standards Method Remarks

SMPS Output

voltage test

Input voltage :

AC 90V ~ 130V

AC 180V ~ 260V

Output voltage :

DC 48V± 1%

DC 24V± 1%

DC 12V± 1%

DC 5V± 1%

When equipment working,

changing input voltage with

dax slide, check output

voltage with digital tester.

Sample test


1


S-2



test once sampling

4)Approved quality

level:1.0

Power switch Operation

test

I(ON): red light on

O(OFF): red light off

Connecting AC220V to

equipment, check power

switch working.

Reagent pump Operation

test Observing water pumped

Connecting DC 12V,

attaching hose to input/output

part, observe water pumped

actually. At this, consider

current value(0.8A±0.2A)

, ±0.05 drift).

LCD Operation

test

==== Z/N STAIN ====

1.Prime 2.A-Prime

3.Time Setting

Set Slide No. 10 pcs

Making ZIG and connect it to

Main board, identify the initial

state of showing on LCD.

Heater

Measure

resister

value

8.0Ω±5% Check with digital tester.

Stepping motor Operation

test

Measuring RPM

200rpm±10%

Making ZIG and connecting

main board, check RPM with

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Stepping motor

drive

digital tachometer by

combining stepping motor

and drive.

Drain tube Dimension 1.5m± 10% , 2.5t± 10% Measure with

tapeline, vernier calipers.

Reagent tube Dimension 1t,ø4,60cm ±5%

/ 1t,ø4,40 ±5%

Measure with

tapeline, vernier calipers.

7. Standards and Methods of Intermediate Quality Check for Semi assembled product

- Method of test : Lot test

Operation Object Standards Method Remarks

Test of semi

manufactures

(Operation test)

Looks Not allowed:

Breakage, torsion, warp.

Visual inspection

(Macrograph)

Lot test State of fixing Allowed: state of screws tightened

Visual inspection

(Macrograph) and shaking

screw part

State of

wiring

Allowed: Every link has shrink

tubes, rubber caps. Right wirings.

Visual inspection

(Macrograph) and test circuit

presence test

Performance

test

SMPS

operating

Check voltage

: DC +24V,+12V,+5V, DC +48V

within ± 5%.(each voltage)

Check voltage of Fan SMPS,

J29 of main board with multi

tester.

Lot test Motor/hall

sensor

operation

1) Slide tray stops in front of hall

sensor.

Visual inspection (Macrograph)

※Control of hall sensor

intensity

- Spin point R11 with

adjustment rod.

- Clockwise: strong magnetism

-Counterclockwise:weak

magnetism

2)If it’s not there, it spins until it

locates in front of hall sensor.

3)When it stops, Red LED(D13)

of main PCB lights.

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Pump

operation

1) Pump selected works with

stable pumping sound.

Visual inspection

(Macrograph) (At prime mode,

choosing control switch 2,3,4,5

with reagents or water)

※When spraying at slide tray,

water or reagent do not splash.

Lot test

2) LED(D33,34,35,36,51) of main

PCB lights when pump works.

- PUMP0_AA --> D33 ON

- PUMP1_MB --> D34 ON

- PUMP2_CF --> D35 ON

- PUMP3_W --> D36 ON

- PUMP4_Et --> D51 ON

3) Voltage control of pump

working(operation voltage)

-PUMP0_AA(J19)->2.3~2.4± 1%

- PUMP1_MB(J20)-> 9V± 1%

- PUMP2_CF(J21)-> 7.3V± 1%

- PUMP3_W (J23)-> 5.3V± 1%

- PUMP4_Et(J31)-> 5.4V± 1%

※ Output voltage: DC

Connecting multi tester to

pump connecter, control

variable resister(VR

14,15,16,17,38)

-Clockwise: Voltage DOWN

-Counterclockwise: Voltage UP

Operation Object Standard Method Remarks

Performance test

PUMP operation

4) Control pump voltage (PRIME voltage) - PUMP0_AA(J19) --> 3V± 1V - PUMP1_MB(J20) --> 8V± 1V - PUMP2_CF(J21) --> 8V± 1V - PUMP3_W (J23) --> 8V± 1V - PUMP4_ET(J31) --> 8V± 1V ※ Output voltage: DC

Connecting multi tester to pump connecter, adjust jet-press control valve to required voltage. -Clockwise: CLOSE -Counterclockwise: OPEN

Lot test

Leak test

Do not enter the air in pump, hose, seams between pump and valve. Reagents do not leak. Especially, inspect seams carefully. If bubble is in hose, reassemble seams or instrument around seams.

Visual inspection

(Macrograph) Operation test

Lot test

Test of LCD operation

Identify showing of state at LCD monitor.

Visual inspection

(Macrograph) (identify marks with user’s manual)

Lot test

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Test of motor operation

CHECK operation current of motor ADC OFF : 1.6A ~1.8A

Choosing to measure DC voltage rang, red rod mounted on motor drive PCB CC+, black rod mounted on CC-, choosing off at ADC in deep switch, identify current when motor works. In controlling, spin RUN VR on motor drive PCB exactly.

Lot test

Test of sensor operation

Not enough reagent 1)on working: warning sound, red light on panel 2)after end of working : Warning sound, warning message on LCD, red light on panel

Check operation in attaching bottles to holder after holder connects equipment. If reagent lacks, identify amount of reagent in bottles.

Lot test

8. Standards and methods of Final Quality Check for finished product

1) Safety test for electricity and machinery

- Method of test: Lot test

No. Object Standard Method

1 Leakage current test

1. Leakage current(grounding) (1) Standard: below 0.5mA (2) Single-fault: below 1mA 2. Leakage current(external) (1) Standard: below 0.1mA (2) Single-fault: below 0.5mA

By KFDA notice. * By test of continual leakage current and measuring patients, current.

2 Grounding resistance test

1. Impedance between metal parts and protective earth terminal: below 0.1Ω (0.2Ω).

By KFDA notice * By test of protective grounding, functional grounding, light electricity

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3 Power input test 1. 800W ± 10% By KFDA notice * By test of power input

4 Looks and structure 1.Allowed: proper to appearance(photos) and parts specification.

By standard document of operation

5 Labeling and packing 1. Allowed: Same front, left, right, top, bottom labeling as equipment 2. Not allowed: having packing problems

By standard document of operation

2) Test of performance

No Object Standard Method Remarks

1 Test of safety device

1.Except forced open, cover doesn’t open at all.

Actual driving test Lot test (Operation test) 2. Not close, not operate with

warning sound and message.(stain operation, dry at dry mode: spinning inside)

2

Test of searching Starting location

1. Slide tray stops at hall sensor housing for starting location in a counterclockwise direction.

1.Actual driving test 2.With cover open and power on, find slide 1.(Slide 1 has magnet attaching front) 3. Hall sensor housing is inside chamber.

Lot test (Operation test) 2. Slide 1 is located in front of

hall sensor housing when tray stops.(Magnet in slide tray 1 finds starting point)

No. Object Standard Method

3

Test of temperature of Carbol Fuchsin operation

1.Temperature : 50± 15%

1.Measure temperature of slide tray(center position) 2.After spraying water or reagent to slide tray 1~10, wait. After 45 sec ~1 min, measure sprayed water or reagent’s temperature. 3.To success, supply exactly water or reagent 4.Use noncontact thermometer.

Lot test (Operation test)

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4

Test of temperature before decolorizing

1.Measure surface temperature of slide tray 1~10. (standard surface temperature: below 34)

1. After dry operation in washing(3) operation, immediately measure temperature. 2. Measure temperature of slide tray(center position). 3. To success, supply exactly water or reagent 4.Use noncontact thermometer.


5 Test of spraying location

1. Identify spraying fluid into slide tray. ※ slide Tray inner dimension: - width(77mm) x length(27mm)

1. Visual inspection

(Macrograph) 2. To success, supply exactly water or reagent.


6 Operation time 18Min±10% 1.Measure with clock. 2. To success, supply exactly water or reagent.


7 Motor RPM 200rpm± 10% Measure digital tachometer when dry mode operation.


8 LCD DISPLAY

Refer to users manual

1. Actual driving test 2. Visual inspection

(Macrograph)


9 Test of sensor for reagent holder

Not enough reagent 1)on working: warning sound, red light on panel 2)after end of working : Warning sound, warning message on LCD, red light on panel

1. Check operation(on/off) in attaching bottles (half filled with water or reagent) to holder after holder connects equipment. 2.If reagent lacks, identify amount of reagent in bottles.


10

Test of reagents spraying amount

1) CF : 250/min± 10%

2) MB : 250/min± 10%

3) AA : 250/min± 10%

4) Et : 250/min± 10%

5) D.W : 250/min± 10%

1.Dip reagent hose into beaker having graduation filed with reagent after measuring amount of reagent. 2.Spray for 1 min using operation voltage. 3.Measure amount of rest reagent with cylinder. 4.Amount spraying=before using-rest


9. Marking and Labeling

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