Tridema Engineering S.r.L.

DIAMOND II

User Manual Rel. 1.0

Index

Symbol Description...................................................................................................................... 1
Ceck List........................................................................................................................................... 2
Chapter 1............. Principle......................................................................................................... 3
Chapter 2............. Importane Note........................................................................................... 4
Chapter 3............. technical Features..................................................................................... 5
Chapter 4............. Operative Function.................................................................................... 6
Start Screen.................................................................................................. 7
Analisys Pahse.............................................................................................. 8
Control Phase.............................................................................................. 9
Parameters Phase........................................................................................ 10
Calibration Phase....................................................................................... 11
Chapter 5............. How to run a Test....................................................................................... 12
Chapter 6............. How to - PT Test ......................................................................................... 13
How to - APTT Test.................................................................................... 14
How To - Thrombin Time or TT Test..................................................... 15
How To - Fibrinogen Test......................................................................... 16
Chapter 7............. Customer Service........................................................................................ 17
Contact............................................................................................................................................. 18

DIAMOND II - USER MANUAL REL. 1.0 3

Symbol Description

On the packaging and on the label on the instrument appear the symbols hown
below. The symbol have the following meaning:

Consult the User Manual

Caution (refer to attached documents) Observe the notes

Relevant News

Manufcturer

DIAMOND II - USER MANUAL REL. 1.0 1

Check List

• Diamond Instrument

• Power Supply 12v

• CD-ROM User Manual

• CE Certifcate

• Certifcate of analysis

DIAMOND II - USER MANUAL REL. 1.0 2

Chapter 1 Principle

The Diamond is a semi-automatic coagulation analyzer, the reading principle is

photometric,
it is based on a solid state source emitting at 3 wavelenghs:

• 450 nm
• 10 nm
• 630 nm
Each of thes wavelengths can be used each diferent test.
The Beam emitted by the solid state led is driven through a hole to a plastic cup
used to hold the plasma.
The light beam passed through the plasma-reagent solution is read by a solid
state photodiode, amplifed and converted to a digita signal.
The microcomputer analyzes the data and after some mathematical calculation
gives the result to user.
The system machine is managed by a Linux microcomputer the reading units are
equipped each with a single micro computer connected to the Linux PC optional
USB Keyboard and Mouse are avilable.

DIAMOND II - USER MANUAL REL. 1.0 3

Chapter 2 Important Note

Important
The Diamond II is a computer based system. This means that in the machine there
is a real Linux computer with the operative software running.
It is Very Important to use a correct procedure to switch it OFF.
Please DO NOT SWITCH OFF with the power directly when needed use the
“Shoutdown” key on the main screen, wait the Shoutdown procedure and after
this process only you can use the Power ON/OFF switch.
An unappropriate Shoutdown sequence can cause permanent damages to the
System

DIAMOND II - USER MANUAL REL. 1.0 4

Chapter 3 Technical Features

• Ready to use after 5 minuts warm up

• 3 wavelength 450nm, 510nm e 630nm

• Solid state photodiode-amplifer adc converter

• Display Touch Screen

• 16 position sample holder 37° C

• 4 position warmed reagents 37° C

• 2 position for reagents at room temperature

• 10 MIPS microprocessor x 2

• 300 bytes ram

• 64k fash eprom

• 1024 bytes eprom

• Keyboard and Mouse Optional

DIAMOND II - USER MANUAL REL. 1.0 5

Chapter 4 Operative Function

Connect the Power Supply to instrument and switch ON

Figura 1.

When switched on, the initial screen looks like in figure 1.

By pressing the UP and DOWN keys it is possible to select the type of analysis to
be performed.
The exams that can be taken are 20 as follows:

• PT
• APTT
• Fibrinogeno
• Thrombin Time
• Protein C
• Protein S
• D-Dimer
• Lupus
• Factor II/Factor XXII
• FDP

In the box between the UP and DOWN keys the selected exam is lightened

DIAMOND II - USER MANUAL REL. 1.0 6

Chapter 4 Start screen

1 4 5

2 6 7

8 9

Figura 2

1. Change analisys
2. Change analisys
3. Active test selected
4. Analisys Fase
5. Control Fase
6. Calibration Fase
7. Parameters Fase
8. Save data
9. Shutdown button

DIAMOND II - USER MANUAL REL. 1.0 7

Chapter 4 Analisys Phase

1 2

3 7

4 8

5 9

6 10

11 12
18

13 14 15 16 17

Figura 3

1. Test Name 15. Exit button

2. Reagent Lot 16. Channel 2 Start
3. Channel 1 Time 17. Channel 2 Reset
4. Chennel 1 Ratio 18. Doublets Calculation
5. Chennel 1 INR
6. Chennel 1 Activity
7. Channel 2 Time
8. Chennel 2 Ratio
9. Chennel 2 INR
10. Chennel 2 Activity
11. Chennel 1 Progress bar
12. Chennel 2 Prograss bar
13. Chennel 1 Reset
14. Chennel 2 Start

DIAMOND II - USER MANUAL REL. 1.0 8

Chapter 4 Control Phase

1 2

3 4

Figura 4

The Control screen differs from the Analysis screen only for the control keys.

1. Lot of the check

2. Switch between normal and pathological

The 3 and 4 “Store” keys are used to save the results of the check in the QC data-
base.
Usage is identical to the analysis screen

DIAMOND II - USER MANUAL REL. 1.0 9

Chapter 4 Parameters Phase

1 8 8 12

2 8 8 13

3 8 8

4 8 8 14

15
5 9
16

6 10 17

7 11
18

Figura 5

1. Wavelength 12. exit

2. Cutline A 13. Save data in memory
3. Cutline B 14. Recover data from the USB stick
4. Delay reading delay 15. Backup data on USB
5. Reading time 16. Update program from USB
6. Detecation sensitivity for auto- 17. Reset all data
matic start 18. Test in progress
7. Incubation time
8. calibration points
9. Reading method
0 = coagulative assay
1 = delta abs
10. Multiplication factor
11. Reagent bench

DIAMOND II - USER MANUAL REL. 1.0 10

Chapter 4 Calibration Phase

Figura 5

1. PT ISI Reagent 12. Display QC report norm

2. Reagent lot number 13. Create a new QC inspection lot
3. Info line Pressing this button clears
4. Normal control lot everything
5. Normal control minimum value 14. QC patologic display repor
6. normal control average value 15. Create a new pathological
7. normal control maximum value control
8. Pathological lot number Pressing this button clears
9. Minimum pathological control everything
value 16. Save the data
10. Average pathological control 17. Exits
value
11. Maximum value for pathological
control

DIAMOND II - USER MANUAL REL. 1.0 11

Chapter 5 How to run a Test

• Choose the test on the start screen

• Prepare the solution to be incubated and incubate

• insert the cuvette into the waste channel

• press the START key for the selected channel

• Pipette the reagent

• Check that the Progress Bar starts

• Wait for the results

DIAMOND II - USER MANUAL REL. 1.0 12

Chapter 6 How To - PT test

1. Put 50 ul of plasma in a reading cuvette

2. Put the cuvette in the reading channel (IE channel 1)

3. Wait for incubation

4. After incubation press the START key of the used channel (IE START1)

5. The START key becomes green

6. Pipette 100 ul of pt reagent in the cuvette, at this moment in the info line
you will

7. See the information “READING”

8. The progress bar of the channel 1 will start and the result will be displayed

9. At the end of programmed reading time

10. After the progress bar started you will be able to perform another pt in the
other

11. Channel, IE channel 2, at the same time.

12. If you performed two tests at the same time , pressing the key “DOUBLETS”

13. You will get, in the middle of the screen the AVERAGE RESULTS of the two

14. Channels readings.

15. After this , pressing the RESET key you will be ready to perform other tasks

16. Key EXIT will bring you back to the main screen

DIAMOND II - USER MANUAL REL. 1.0 13

Chapter 6 How To - APTT test

1. APPT or PTT or TTP test

2. Put 50 ul of plasma in a reading cuvette

3. Add 50 ul of Ellagic Acid and mix it well

4. Put the cuvette in the reading channel (IE channel 1)

5. Wait for incubation

6. After incubation press the START key of the used channel (IE START1)

7. The START key becomes green

8. Pipette 50 ul of CA2CL in the cuvette, at this moment in the info line you
will

9. See the information “READING”

10. The progress bar of the channel 1 will start and the result will be displayed

11. At the end of programmed reading time

12. After the progress bar started you will be able to perform another pt in the
other

13. Channel, IE channel 2, at the same time.

14. If you performed two tests at the same time , pressing the key “DOUBLETS”

15. You will get, in the middle of the screen the AVERAGE RESULTS of the two

16. Channels readings.

17. After this , pressing the RESET key you will be ready to perform other tasks

18. Key EXIT will bring you back to the main screen.

DIAMOND II - USER MANUAL REL. 1.0 14

Chapter 6 How To - Thrombin Time or TT test

1. Put 100 ul of plasma (calibrator or control or patient sample) in a reading

cuvette

2. Put the cuvette in the reading channel (IE channel 1)

3. Wait for incubation

4. After incubation press the START key of the used channel (IE START1)

5. The START key becomes green

6. Pipette 100 ul of Thrombin Time reagent in the cuvette, at this moment

7. In the info line you will see the information “READING”

8. The progress bar of the channel 1 will start and the result will be displayed

9. At the end of programmed reading time

10. After the progress bar started you will be able to perform another pt in the
other

11. Channel, IE channel 2, at the same time.

12. If you performed two tests at the same time , pressing the key “DOUBLETS”

13. you will get, in the middle of the screen the AVERAGE RESULTS of the two

14. channels readings.

15. After this , pressing the RESET key you will be ready to perform other tasks

16. Key EXIT will bring you back to the main screen.

DIAMOND II - USER MANUAL REL. 1.0 15

Chapter 6 How To - Fibrinogen Test

1. Put 180 ul of imidazole buffer in a reading cuvette

2. Add 20 ul of plasma (calibrator or control or patient sample) and mix it well

3. Put the cuvette in the reading channel (IE channel 1)

4. Wait for incubation

5. After incubation press the START key of the used channel (IE START1)

6. The START key becomes green

7. Pipette 100 ul of fibrinogen reagent in the cuvette, at this moment in the

info line you will

8. See the information “READING”

9. The progress bar of the channel 1 will start and the result will be displayed

10. At the end of programmed reading time

11. After the progress bar started you will be able to perform another pt in the
other

12. Channel, IE channel 2, at the same time.

13. If you performed two tests at the same time , pressing the key “DOUBLETS”

14. you will get, in the middle of the screen the AVERAGE RESULTS of the two

15. channels readings.

16. After this , pressing the RESET key you will be ready to perform other tasks

17. Key EXIT will bring you back to the main screen.

DIAMOND II - USER MANUAL REL. 1.0 16

Chapter 7 Customers Service

For all questions relating to the use of the diamond instruments, repeatability
of the results and

possible damage of the instrument, see TROUBLESHOOTING menu or contact

your local

distributor.

Not groped to repair or make modifcations to the instrument.

Our staf will help you solve any problem relating to the instrument.

DIAMOND II - USER MANUAL REL. 1.0 17

 Contact

Enquiries:
Antonio Scordari
[email protected]

Sales:
[email protected]

Customer Service:
Gennaro Murolo
[email protected]

TRIDEMA ENGINEERING srl

Via Circumvallazione Esterna, 91

80017 - Melito di Napoli

Tel. +39 081 7101661

Fax +39 081 7100658

Web: www.tridema.it
E-mail: [email protected]

DIAMOND II - USER MANUAL REL. 1.0 18