Service Manual - Diagnostics read the service manual before opening the ... The CYANSmart is a semi-automated biochemistry analyzer. ... CY009 CYANSmart Analyzer 1 - User manual …

www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: [email protected]

ISO 9001:2008ISO 13485:2003

CYANSmartService Manual

For a clear and precise diagnose

CY009

Engl

ish

Headquarters - Siège social: Langdorpsesteenweg 160 • 3201 Langdorp • Belgium • www.diagnostics.be

Factory - Fabrique: Industriepark 36 • Zone B5 • 2235 Hulshout • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: [email protected]

CYANSmart service manual, Version 20160905 Page 1

INDEX 1 INTRODUCTION ...................................................................................................................................................... 3

1.1 SYSTEM DESCRIPTION ....................................................................................................................................... 3 1.2 PRINCIPLE OF MEASUREMENT .......................................................................................................................... 3 1.3 TECHNICAL AND OPERATIVE SPECIFICATIONS ................................................................................................. 4

2 INSTALLATION ........................................................................................................................................................ 5 3 MAINTENANCE ....................................................................................................................................................... 6

3.1 PUNCTUAL MAINTENANCE .............................................................................................................................. 6 3.2 ROUTINE MAINTENANCE .................................................................................................................................. 6

3.2.1 Washing 6

3.2.2 Cleaning 7

3.2.3 Verification 7

3.3 REPLACEMENT OF SPECIFIC PARTS ................................................................................................................... 8 3.3.1 External cleaning 8

3.3.2 Internal washing 8

3.3.3 Replacement schedule 8

4 TECHNICAL CONTROL .......................................................................................................................................... 9 4.1 GENERAL DESCRIPTION AND BLOCK DIAGRAM ................................................................................................ 9 4.2 MAIN CONTROL BOARD ................................................................................................................................. 10

4.2.1 Connections on the mainboard 10

4.2.2 Voltage check points on the mainboard 11

4.2.3 Verification of the voltage to the mainboard 11

4.2.4 Replacement of the mainboard 12

4.3 OPTICAL SYSTEM ............................................................................................................................................ 12 4.3.1 Lamp 13

4.3.2 Filter wheel 13

4.3.3 Flowcell 13

4.3.4 Pre‐amplifier board 14

4.3.5 Verification of the optical system 14

4.3.6 Cleaning and/or replacement of the flowcell 16

4.3.7 Verification of the filter wheel home sensor 17

4.3.8 Cleaning and/or replacement of the filter wheel home sensor 18

4.3.9 Verification of the filter wheel motor 19

4.3.10 Replacement of the filter wheel motor 19

4.3.11 Cleaning and/or replacement of filters 21

4.3.12 Verification of the voltage to the lamp 22

4.3.13 Replacement of the lamp 23

4.3.14 Replacement of the pre‐amplifier board 26

4.3.15 Replacement of the optical system 26

4.4 HYDRAULIC AND ASPIRATION SYSTEM .......................................................................................................... 28 4.4.1 Verification of the aspiration and hydraulic system by pump calibration 28

4.4.2 Replacement of tubes in the hydraulic circuit 30

4.4.3 Replacement of peristaltic pump tube 31

4.4.4 Replacement of peristaltic pump rubbers 32

4.4.5 Cleaning and lubrication of the pump motor with rotor 32

4.4.6 Verification of the pump motor 33

4.4.7 Replacement of the pump motor with rotor 34

4.4.8 Verification of the aspiration switch 34

4.4.9 Replacement of the aspiration switch 35




4.4.10 Aspirate format 35

4.5 INCUBATOR BLOCK ......................................................................................................................................... 36 4.6 TEMPERATURE ................................................................................................................................................ 36

4.6.1 Temp display 36

4.6.2 Temperature calibration 37

4.6.3 Verification of the Peltier element 39

4.6.4 Replacement of the Peltier element 39

4.6.5 Verification of the heater element of the incubator 40

4.6.6 Replacement of the heater element of the incubator 41

4.6.7 Verification of the voltage to the heater elements on the mainboard 41

4.6.8 Replacement of the temperature sensor 42

4.6.9 Cleaning and/or replacement of the fan of the optical system 42

4.7 THERMAL CARBON PRINTER ........................................................................................................................... 43 4.7.1 Install or change the print paper 43

4.7.2 Verification of the voltage to the printer on the mainboard 44

4.7.3 Replacement of the printer 44

4.8 TOUCH SCREEN ............................................................................................................................................... 45 4.8.1 Touch screen calibration methods 45

4.8.2 Adjustment of the screen brightness 46

4.8.3 Verification of the voltage to the touch screen on the mainboard 46

4.8.4 Replacement of the touch screen cable 46

4.8.5 Functional verification of the parts of the touch screen 47

4.8.6 Replacement of the touch screen 47

4.9 POWER SUPPLY .............................................................................................................................................. 48 4.9.1 General electricity and installation requirements 48

4.9.2 Replacements of fuses 50

4.9.3 Locating power problem 51

4.9.4 Verification of the fuses 52

4.9.5 Verification of the power plug connector and power switch 52

4.9.6 Verification of the power supply 53

4.9.7 Cleaning and/or replacement of the fan for power assembly 54

5 VALIDATION .......................................................................................................................................................... 55 5.1 PREPARATION OF A DILUTION SERIES ............................................................................................................ 55

5.1.1 Ammonium colbalt (II) sulfate hexahydrate (powder) 55

5.1.2 Potassium dichromate (powder) 56

5.1.3 Magnesium Xylidyl Blue (liquid) 56

5.2 VERIFICATION OF PRECISION .......................................................................................................................... 56 5.3 VERIFICATION OF LINEARITY ........................................................................................................................... 57 5.4 VALUE 57

6 TROUBLESHOOTING ........................................................................................................................................... 58 6.1 OPERATIONAL ................................................................................................................................................. 58 6.2 TECHNICAL ...................................................................................................................................................... 60

7 SAFETY INFORMATION ...................................................................................................................................... 62 MAINTENANCE FORM MAINTENANCE INSTRUCTIONS REPAIR FORM INSTALLATION FORM SPARE PARTS




1 INTRODUCTION

1.1 SYSTEM DESCRIPTION

The CYANSmart is an easy to operate semi-automatic biochemical analyzer. It is a microcomputer-based independent unit, controlling several systems: built-in thermal printer, touch screen, optical detection system with flowcell, incubator and aspiration system.

1. Thermal printer 2. Touch screen 3. Optical system 4. Incubator block 5. Peristaltic pump 6. Aspiration “Push” button 7. Inlet tube 8. Rear panel

WARNING! Please read the service manual before opening the CYANSmart and performing problem diagnosis or replacements.

BIOHAZARD: Wear personal protective equipment. Use universal precautions. See chapter 8. Safety information for recommended precautions when working with biohazard materials.

1.2 PRINCIPLE OF MEASUREMENT

The CYANSmart is a semi-automated biochemistry analyzer. Samples are prepared manually outside the instrument and after an incubation period (in- or outside the instrument) the samples are measured in the flowcell and the analyzer calculates the result.

A halogen lamp emits light which passes through a filter selecting the required wavelength. The light then passes through the sample in the flowcell. The sample will transmit or reflect fractions of the light. The detector will measure how much light was reflected from/transmitted through the sample. This measurement is then amplified and converted to a digital number for further calculations. These calculations can be performed because there is a relationship between how much light is reflected/transmitted and the concentration of the substances in a sample.

Lamp Filter Flowcell Photodiode detector

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1.3 TECHNICAL AND OPERATIVE SPECIFICATIONS

Optical system Flowcell 32 μl, 10 mm light path Min. reaction volume 500 μl per test Light source Halogen lamp 6V / 10W Photo detector Silicon based (range 300 – 900 nm) Measurement range 0,000 – 3,500 Abs Wavelength 340 – 620 nm Wavelength selection Automatic via 7 interference filters: 340nm, 405nm, 492nm, 510 nm,

546nm, 578nm, 620nm Flowcell

25°C, 30°C, 37°C, ambient temperature (R.T.) Peltier element Thermostatic control: PID controlled, ± 0.5°C

Incubator 20 places with 14 mm diameter 37°C Thermostatic control: PID controlled, ± 1°C

Display Back-illuminated LCD Touch screen calibration possible 800 x 480 pixels (screen size: 7.0 Inch, 155.3 x 88 mm)

Printer Automatic or on-demand printing Built-in thermal printer 24 characters per line, prints graphs

Software Data storage 180 test methods and 6000 sample test results Methods Cypress methods pre-programmed at delivery Languages English, French, Spanish Quality control feature 2 controls programmable Separate QC result menu with (printable) graphs Calculation methods Absorbance, end point, two-point, kinetic, bichromatic Calibration methods Factor, calibrator and multi-point calibration Blank options Sample blank, reagent blank and distilled water Incubation time 0 – 999 seconds Reading time 3 – 999 seconds

Power supply AC 220 V ± 10 %, 50 Hz ± 2 % or AC 110 V ± 10 %, 60 Hz ± 2 % Automatic voltage and hertz switch Grounding required 2 fuses T2AL250V Power: 200VA, reduced to 140 VA in standby mode Power save / Standby mode

Weight and dimensions Instrument: 9 kg, 435 x 415 x 200 mm (LxWxH) Packed in box: 11.5 kg, 520 x 430 x 260 mm (LxWxH)

Environmental requirements Ambient temperature: 15°C – 30°C Storage temperature: 5-50°C Relative humidity: 30 % - 70% Air pressure: 860 hPa – 1060 hPa




2 INSTALLATION The CYANSmart is an easy to operate instrument with integrated user-friendly software. No additional computers or instruments are needed for good operations. In order to fully guarantee the performance of the CYANSmart, it is extremely important that it is correctly installed.

If the installation, usage and maintenance directions are not followed correctly and/or safety indications are not respected, Cypress Diagnostics cannot guarantee correct functioning of the instrument. Misuse can compromise the safety of the operator and his surroundings and will void the warranty. Consumables are not included in the warranty.

WARNING! Do NOT discard the carton box or protection material! If you need to ship the instrument (for example for service), be sure to use the original packing materials. Other forms of commercially available packing are not recommended and can void the warranty.

At installation, it is strongly recommend to fill in the installation form. It contains essential information and also provides a short checklist of all installation requirements.

The serial number can be found on the back label. This is essential information in every communication regarding the analyzer. The software version can be found in the System Settings – System Info.

Packing list:

Code Description Quantity

CY009 CYANSmart Analyzer 1

- User manual including application sheets 1

- CD with PC software (from P/D 2016/09 on) 1

CY004/9-S28 Waste tube 1

CY004/9-S44 Waste bottle 1

CY004/9-S22 Aspiration button 1

CY004/9-S49 Power cord 1

CY004/9-S48 Fuse T2AL250V 2

CY009-S11 Lamp with frame, cable and connector 1

CY009-S25 Pump tube 1

CY001-S01 Thermal print paper 5

CY004/9-S43 Dust cover 1

CY009-S56 USB cable (from P/D 2016/04 on) 1

For the detailed description of the installation, please check the user manual Chapter 2. After turning off the analyzer, you need to wait at least 60 seconds before turning it on again! Otherwise, the fuses will blow because of the residual current. ②




3 MAINTENANCE This chapter contains all routine operations concerning instrument maintenance. The procedures, listed and described below, should be carefully followed in order to guarantee the manufacturers quality specifications and the perfect working conditions of the instrument over time. The CYANSmart requires three levels of maintenance: Punctual maintenance: at special moments such as at installation Routine maintenance: to maintain the level of precision day in day out Special maintenance: replacement of specific parts

Please consult the maintenance form for an overview of the different maintenance actions. In case of repair, please register all undertaken actions in the repair form and sign it in order to keep track of the interventions.

3.1 PUNCTUAL MAINTENANCE

The punctual maintenance should be effectuated at installation and before or after a long period of inactivity. The following points of attention should be considered:

Check the installation instructions. Check all tubes visually for leaking or squashing. Pay special attention to the peristaltic pump

tube. Replace if necessary. Removing dust from the instrument. Wash the flowcell with a detergent (CYAN Wash Solution CY001-WS or 5% Tween 20) and rinse

the flowcell with distilled water. Disinfect the flowcell with a 5% Hypochlorite solution and rinse with distilled water. Check the pump calibration. Check the AD auto zero and replace the lamp/filters if necessary. In case the instrument will not be used for a long period:

o Remove all liquid inside the instrument by aspirating air. o Disconnect the pump tube.

3.2 ROUTINE MAINTENANCE

Frequency What Cleaning solution

Between methods Rinsing Distilled water End of the day

Washing Detergent + rinse with distilled water + rinse with air

Every week Detergent + sodium hypochlorite (diluted 5 %) + rinse

with distilled water + rinse with air End of the day (outside)

Cleaning CYDIS surface/detergent + dust cover

Every 6 months (inside) Pressurized air (by service engineer)!

Every morning Verification

AD auto zero

Every week Pump calibration

3.2.1 Washing

i. Between tests Between methods, always rinse the flowcell with distilled water. It is not necessary to wash the instrument between different samples for the same method. However: In case of high risk of cross-over, you could pre-rinse the flowcell by aspirating distilled water, followed

by air (to avoid dilution) between the samples. In case of a strongly colored reagent, it might be necessary to pre-rinse the flowcell with (working)

reagent before aspirating the first measurement. Otherwise the first measurement could be influenced by the distilled water used to zero the instrument.




ii. Daily washing At the end of each working day, wash the instrument with a neutral detergent (CYAN Washing Solution CY001-WS or 5% Tween 20):

a. Position the detergent solution under the inlet pipe. b. Press the “Tube Wash” button at least 10 times (=15 mL). c. Repeat this operation using air at least once to make an air gap between the detergent and the

distilled water. d. Repeat this operation using distilled water at least 10 times (=15 mL) to rinse the system. e. Repeat this operation using air at least 10 times (=15 mL) to dry the hydraulic system and avoid

microbiological contamination. iii. Weekly washing After a week of work, wash first with 15 ml detergent (end of day procedure); and then disinfect the hydraulic system (tubes and flowcell) with 5% sodium hypochlorite (bleach). a. Position the hypochlorite solution under the inlet pipe. b. Press the “Tube Wash” button at least 10 times (=15 mL). c. Incubate the hypochlorite in the flowcell for about 10 minutes (no longer!). d. Aspirate air (1x) and then rinse the instrument with distilled water (10x) and air (10x). NOTES: a. In case of air bubbles (visible during AD auto zero or perform test) rinse with diluted sodium

hypochlorite (5 %) then rinse with distilled water (10x), and with air (10x). b. This diluted sodium hypochlorite is normally market available. Please use only good trademarks. Cheap

ones contain contaminating solutions. c. Always dilute the sodium hypochlorite for 5%, never use it undiluted! This will damage the

instrument. d. Do not use corrosive detergents to wash the instrument.

3.2.2 Cleaning

i. Daily cleaning Please notice that the instrument, especially the optical system and the electrical circuit, are sensitive to dust. Avoid using the instrument in dusty spaces. Cover the instrument when not in use and keep the printer, pump and flowcell cover closed during use. At the end of each working session, dampen a tissue with a non-abrasive detergent like CYDIS Surface (Cod. CYDIS-S) or a 6% ESOFENOL solution and wipe the outside of the instrument. ii. Every 6 months It is recommended to clean the dust from inside the instrument at least every 6 months. To do so, remove the cover and blow the dust off the instrument using pressurized air. Make sure the air is completely dry! Open the filter cover and blow the dust off. NOTES: The instrument cover should only be removed when the CYANSmart is unplugged. We strongly advise to leave this procedure to the technical assistance of the service engineer of your

distributor.

3.2.3 Verification

i. Daily Perform an AD auto zero

ii. Weekly Perform a pump calibration




3.3 REPLACEMENT OF SPECIFIC PARTS

Before replacing any instrument part, repairing any defective item or performing any instrument maintenance procedure(s), the operator or maintenance technician must carry out the below-described decontamination procedure of the instrument part(s) involved in the operation(s).

3.3.1 External cleaning

Use CYDIS Surface Cod. CYDIS-S or a 6% ESOFENOL solution (60 cc in one liter of distilled water). These are antibacterial and antiviral substances.

Spray the solution all over the instrument. Allow the solution to stand for approximately 30 minutes. Wipe the solution off the instrument using a sponge dampened with distilled water.

3.3.2 Internal washing

Wash first with 15 ml detergent (end of day procedure); and then disinfect the hydraulic system (tubes and flowcell) with 5% Hypochlorite (bleach). Make sure to incubate for 10 minutes (no longer) and then rinse sufficiently with distilled water (procedure weekly washing).

3.3.3 Replacement schedule

Some spare parts should be replaced after a fixed period of time to ensure the good performance of the analyzer. Please check the table below:

Spare part Replacement, when? Who?

Peristaltic pump tube Every six months User / Service engineer

All tubes of hydraulic circuit

Every year or in case of leakage, obstruction or strong coloration

Service engineer

Lamp Every year Service engineer

Amplifier board Every 2/3 years (together with lamp replacement) Service engineer

Peristaltic pump rubbers

Every 2/3 years (together with pump tube replacement)

Service engineer

Connectors Every 2/3 years (together with the replacements of the tubes)

Service engineer

Flowcell In case of leakage, obstruction or strong coloration Service engineer




4 TECHNICAL CONTROL

4.1 GENERAL DESCRIPTION AND BLOCK DIAGRAM

The main control board controls the overall operation of the instrument, including motor control, temperature control and data management etc. It receives power from the power supply.

① Main control board ②Optical system ③ Peristaltic pump ④Push button ⑤Incubator ⑥ Fans ⑦ Power supply

The touch screen and the printer with separate board are connected to the mainboard but integrated in the instrument cover.

Main Control Board

Printer

Optical system: Filter motor & sensor

Lamp Flowcell temp control

Photodetector

Touch screen

Pump Fans

USB

Incubator

Power supply

Push button

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4.2 MAIN CONTROL BOARD

4.2.1 Connections on the mainboard The figure below shows the different connections. In case of problems, verify that the connection is correct and firm. Try to disconnect and then reconnect.

1 Printer power (5V) 10 RS232 interface

2 Lamp power (3 or 6V) 11 Aspiration switch

3 Flowcell temperature sensor 12 Motor of filter wheel

4 Incubator temperature sensor 13 Motor of peristaltic pump

5 Pre-amplifier board 14 Heater of incubator

6 Printer data cable 15 Fan for power assembly

7 Home sensor of filter wheel 16 Fan for optic system

8 Touch screen 17 Heater (Peltier) of flowcell

9 USB interface 18 Power input 24V

The following sections provide more explanation on the individual functions.

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12 13 14 15 16 17 18




4.2.2 Voltage check points on the mainboard The mainboard receives 24V from the power supply and will then regulate and provide the voltage necessary for every other part. The figure below shows the different voltage check points. More explanation about the test points can be found in the relevant chapter (verification of the voltage to...).

1 Input power +24V 7 Artificial circuit -5V

2 Digit circuit +9V 8 Lamp +3/6V

3 LCD/USB 5V 9 Printer +5V

4 Peltier flowcell +15V 10 Power supply changeover -12V

5 Grounding 11 Digital system +3.3V

6 Digital system +5V

4.2.3 Verification of the voltage to the mainboard Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. Remove

gently because the connections to the touch screen remain attached! 3. Turn ON the CYANSmart analyzer. 4. Measure the voltage on the mainboard:

a. Test point 1 on picture above compared to the grounding of test point 5 or a screw. The measured voltage should be 24V DC.

b. Or measure the voltage directly on the connector of the power input on the mainboard (see photo above). Also here the measured voltage should be 24V DC.

If the voltage is not correct, please proceed to the verification of the power supply (see 2).




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4.2.4 Replacement of the mainboard If the input power is correct (24V), but any other test point is not correct, the main control board (CY009-S13) needs to be replaced!

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect all the connections of the mainboard (see 4.2.1). 4. Unscrew the 4 screws attaching the mainboard. Remove the main control board. 5. To install the new part, repeat the steps above in reverse order. Verify that all connections are correct

and firm. 6. After the installation perform a temperature calibration (see 4.6.2) and pump calibration (see 4.4.1) NOTES: In case of an electric shock, the settings saved on the mainboard might have been altered or deleted. Please check and reset if necessary: a) Temperature calibration (see 4.5.2) b) Pump calibration (see 4.4.1) c) Method programming in the menu “Methods” (see application sheet) d) Settings: date and time, filter & cuvette …

4.3 OPTICAL SYSTEM

The optical system is the functional key compound of the instrument. It contains the light source, filters for wavelength selection, flowcell with heating mechanism and a PC board that contains the photodiode detector (pre-amplifier board). This pre-amplifier board also converts the light detection from an analog to a digital signal for further processing on the mainboard.

1. Lamp 2. Filter wheel with filters 3. Motor for filter wheel 4. Home sensor of filter wheel 5. Flowcell 6. Pre-amplifier board with

photodetector 7. Peltier element 8. Temperature sensor 9. Fan of optical system

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4.3.1 Lamp

The 6V, 10W halogen lamp (1) is installed in a lamp holder (2), which is installed on the optical system by a tightening screw (3).

The normal life span of the lamp is 2000 hours (= 1 year). The CYANSmart has a power saving standby mode. After a specified time of inactivity, the instrument will enter this standby mode which will diminish the voltage to the lamp from 6V to 3V, thereby increasing the life time of the lamp.

Upon replacement of the lamp, the height of the lamp in the holder needs to be optimized (4.3.13). If the analyzer is turned on, but the lamp does not emit light, please proceed with the lamp replacement (see 4.3.13). Make sure to verify the voltage on the mainboard before replacing the lamp (see 4.3.12).

4.3.2 Filter wheel

The filter wheel (1) has 10 positions: one dark filter, 7 interferential filters (340 nm, 405 nm, 492 nm, 510 nm, 546 nm, 576 nm and 620 nm) and 2 free positions. The correct filter is aligned in the light path through a cooperation between the filter wheel motor, the filter wheel home sensor (2) and the main control board.

All filters of the CYANSmart except the 340 nm, have a pre-filter installed before the filter. This is a non-selective absorbent circle with a central hole with dimensions from 0.2 mm to 2.5 mm. The pre-filter will decrease the light intensity of the light source before it passes the filter. By choosing a different diaphragm for each filter, the difference in light intensity is equalized for all the filters. Because of its low light intensity, the 340 nm filter has no pre-filter, and is thus regarded as the reference. The filters are kept in place by a locking ring.

Keep in mind: the numbering on the filter wheel ( ) does not increase with the wavelength. N° in software 1 2 3 4 5 6 7 8 9 0

Actual filter (nm) 340 405 492 510 546 578 620 Spare Spare Dark

N° on filter wheel 6 8 9 0 1 2 3 4 7 5

Pre-filter - 2.3 1.0 1.0 0.8 0.6 0.5

4.3.3 Flowcell

After the filter, the light passes through the flowcell that contains the sample to be measured. The light path of the flowcell is 10 mm. The flowcell is heated with a peltier element to 25°C, 30°C or 37°C and the heating is regulated by a temperature sensor. To prevent overheating, the abundant heat is guided with a heat sink towards the fan for the optical system. For more information on the heating mechanism, calibration and replacement see 4.6 Temperature.

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4.3.4 Pre-amplifier board

At the end of the light path the light is captured by the pre-amplifier board (1), more precise the silicon photodiode (2) on this board. The pre-amplifier board is thus responsible for receiving the light particles and converting the light detection from an analog to a digital signal for further processing on the mainboard.

To better understand the processing of the light signal, it is crucial to understand the difference between 3 values that are obtained during an AD auto zero measurement.

Gain The signal-amplification coefficient. This gain is automatically adjusted by the instrument to obtain AD values between 50.000 and 60.000 up to a maximal gain of 29 is reached. The instrument can measure a gain value in the range 1~30. The optimal value for measurement is between 8 to16.

AD value The amplified and converted (from analog to digital) signal. The AD value is expressed in mV. It refers to the light intensity captured by the photodiode. The instrument is capable of measuring AD values in a range of 0 – 65535. The optimal value for measurement is 80-90% of the maximum value thus between 50000 to 60000.

Offset The dark voltage, used to compensate for (background) interference. The light beam is sent through a black filter, so the pre-amplifier board does not receive any light signal from the lamp or sample. The voltage measured is thus the (background) voltage of the circuit board itself. The optimal value for measurement is between -150 to +150.

4.3.5 Verification of the optical system

The AD zero menu permits to verify the performance of the whole optical system (lamp, filters, flowcell and pre-amplifier board) and automatically adjust to compensate for aging of the lamp. Furthermore the values of gain and offset are used in the calculation of the test results. Consequently, to ensure precise and accurate measurements, it is strongly recommended to perform an AD zero:

Every day/morning. If the AD auto zero is outside the range in the perform test menu. At instrument installation. After installation of a new lamp.

Before performing an AD Zero it is essential to check that: a) The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water. b) The flowcell is filled with distilled water and without any air bubbles. c) The instrument is ON for at least 30 min, because the lamp needs this time to stabilize. d) The optical cover is closed.

Procedure: 1. Select the “AD Zero” menu. The result of the last performed AD zero is shown. It is recommended to

make a print-out of these results (by pressing the “Print” button) to be able to compare with the new reading.

2. Position a tube with distilled water under the aspiration inlet tube and press the PUSH button to aspirate the distilled water.

3. Pressing the “Read” button, the instrument will perform a new reading and display the results.

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Verify if the gain, AD and offset are within the acceptable range and the state is thus “OK” for all filters.

Gain: between 8 and 16 AD: between 50.000 and 60.000 Offset: between -150 and +150

Since the AD Zero should be performed every day, the variation between the new measurement and the previous (displayed when opening the menu) should be small. If you compare the results (always compare the same filter!):

The difference in gain should be ≤ 2 The difference in offset should be ≤ ±50.

If the difference is bigger or the obtained values are outside the range, check first if:

1. The instrument is ON for at least 30 min, because the lamp needs this time to stabilize. 2. The hydraulic system (flowcell + tubes) is clean and rinsed abundantly with distilled water.

Perform washing and rinsing (see 3.2.1). This washes both the flowcell and the tubes. 3. The windows of the flowcell are clean (no dirt/fingerprints on the outside).

Clean with special wipes for glasses. 4. There is no crack or leakage in the flowcell:

This can cause fluctuations in gain and AD value, the flowcell needs to be replaced (see4.3.6). 5. The flowcell is filled with distilled water. To ensure a correct measurement, the flowcell should be filled

with distilled water and free of air bubbles. This filling can be easily checked by opening the optical cover. Check the tubes going to and from the flowcell: If the filling is not correct, verify the pump calibration (see 4.4.1) and the absence of leakages.

- The aspiration tube has to be completely

filled with liquid and free of air bubbles from the fastening screw to the flowcell.

- The tube from the flowcell to the pump should be filled with liquid and free of air bubbles for at least 4 cm from the flowcell.

This photo is made with a colored sample to aid the visualization (instruction purposes). The AD auto zero should always be performed with distilled water!

If after these verifications, the values remain outside the ranges and

A. AD Zero out of range for one or few filters: 1. Verify the above points (1-5) even more thorough if (only) the 340 nm filter is out of range, because

this filter is the most sensitive to dirt or insufficient rinsing, proceed to 4.3.6 and only after this continue to the next step.

2. Verification of the movement of the filter wheel (Proceed to 4.3.7 and 4.3.8 and 4.3.9 and 4.3.10).

Aspiration tube completely filled with liquid, no air bubbles

Tube from flowcell to pump, air bubbles only visible after the 4 cm limit.




3. Cleaning and/or replacement of the filter (Proceed to 4.3.11).

B. AD Zero out of range for all filters, check: 1. If the instrument is ON, but the lamp does not give light, it needs to be replaced. Make sure to test

the voltage on the mainboard before replacing it (Proceed to 4.3.12 & 4.3.13). 2. The flowcell is in the correct direction (windows to front and back) and completely inserted to the

bottom of the flowcell holder (see attention points 4.3.6). 3. The optical cover is closed during measurement. 4. Verification of the movement of the filter wheel (Proceed to 4.3.7, 4.3.8, 4.3.9 and 4.3.10) 5. The gain of all/most filters is 15, 16 or more. The lamp is aged and should be replaced (Proceed to 4.3.12).

4.3.6 Cleaning and/or replacement of the flowcell

A. Cleaning of the flowcell In some cases, the normal hydraulic washing is not sufficient to clean away dirt attached to the inside of the flowcell, and some ‘force’ is necessary to clean the flowcell.

Procedure: 1. Aspirate air to make sure all tubes are dry and will not leak upon disconnection. 2. Turn OFF the CYANSmart analyzer. 3. Carefully detach both tubes form the flowcell and take the flowcell out of the support. 4. Insert/attach a syringe filled with 5% Hypochlorite (bleach) in (small) inlet of the

flowcell. 5. Put force on the syringe to flush the flowcell. Particles that were adhered inside the

flowcell, will be flushed with the liquid through the (bigger) outlet tube. 6. Incubate the 5% Hypochlorite solution for 10 min (no longer) in the flow cell. 7. Rinse the flowcell abundantly with distilled water.

B. Replacement of the flowcell When even the above cleaning procedure is not sufficient or when there is a crack or leakage in the flowcell, the flowcell needs to be replaced.

Procedure: 1. Aspirate air to make sure all tubes are dry and will not leak upon disconnection. 2. Turn OFF the CYANSmart analyzer. 3. Carefully detach both tubes form the flowcell and take the flowcell out of the support. 4. To install the new part, repeat the steps above in reverse order.

ATTENTION POINTS! 1. Insert the flowcell in the correct direction! The light has to be able to pass through the windows of the

flowcell, thus the windows need to be facing to the front and to the back. 2. The inlet pipe (6) is thin, connected to the aspiration tube and should be facing forward. The outlet

tube (7) is thick, connected to the tube going to the peristaltic pump and should be facing to the back. 3. Insert the flowcell completely to the bottom of the support. Make sure nothing is blocking the

insertion! 4. Secure its position with the designated golden plate.




4.3.7 Verification of the filter wheel home sensor

With this procedure the movement of the filter wheel and the correct positioning of the filters can be checked. It must be followed when after the initial verification the filters remain out of range in the auto zero reading or if an error is present in the self-test when starting up the instrument. The requested filter is aligned in the light path through a cooperation between the filter wheel motor, the filter wheel home sensor and the main control board. When the slit (1) in the filter wheel is between the 2 arms of the filter wheel sensor (2), this is detected and this is the ‘Home position’ of the filter movement. From this position on, the mainboard will ‘instruct’ the number of necessary motor turns to position the requested filter in the light path.

Procedure: 1. Turn ON the CYANSmart analyzer. 2. Select the “Filter test” menu. 3. Carefully remove the flowcell from the reading well (3) and position it in the socket for flowcell

protection (4). 4. Place a white paper of 1x5 cm in the reading well. 5. Select each filter separately and check the color displayed on the paper. Check that the color

corresponding to the requested filter is presented in a straight, well-aligned line (not scattered) : 340 nm (ultra)Violet 405 nm Dark blue 492 nm Cyan 510 nm Dark green 546 nm Light green 578 nm Yellow 620 nm Red

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⑦

X

⑥

⑦

window

⑦

⑥

①

②

③

④




If the colors are correct and the light falling onto the paper is a straight, well-aligned line (not scattered), but the AD values for most of the filters obtained are still out of range, continue to 4.3.12 & 4.3.13. If the colors above are not correct or it takes long to find one or two filters (several times), please continue with the cleaning and/or replacement of the home sensor (See 4.3.8). If the filter wheel does not turn, continue with the verification and/or replacement of the filter wheel motor (See 4.3.9 & 4.3.10). If the colors are found correctly but the line of one or two filters is scattered, continue with the cleaning and or replacement of those (pre)-filters (See 4.3.11) and then recheck the light scattering.

4.3.8 Cleaning and/or replacement of the filter wheel home sensor

If the slit in the filter wheel or the home sensor itself are dirty, the home position cannot be detected. Therefore, it is necessary to follow this procedure if the colors are not correct, if it takes long to find one or two filters (several times), or if an error is present in the self-test when starting up the instrument.

A. Clean the slit in the filter wheel

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Carefully remove the flowcell from the reading well and position it in the socket for flowcell protection. 4. Remove the tray of the optical system by unscrewing the 4 screws around the reading well and carefully

position the tray next to the optical system. 5. Remove the cover (1) of the filter wheel by unscrewing the hex/allen screw (2). 6. Turn the filter wheel manually (instrument is OFF!) until the slit is visible. 7. Clean the slit with (dry!) pressured air or by inserting strong paper. Make sure to remove all dirt.

B. Clean the home sensor of the filter wheel

Procedure: Follow the steps 1-5 of the procedure for cleaning the slit of the filter wheel (A). 6. Disconnect the home sensor of the filter wheel from the mainboard (see 4.2.1). 7. Remove the 2 screws (3) attaching the home sensor and carefully take it out. 8. Clean the inside of the arms of the home sensor with (dry!) pressured air, with a soft brush or with special

wipes for cleaning glasses. Make sure to remove all (build-up) dust/dirt. 9. Reposition the sensor by repeating the above steps in reverse order.

Attention: Make sure the filter wheel does not touch the home sensor while turning! The wheel should be in the middle of the home sensor opening. Otherwise, readjust its position by adjusting the tightening screws of the home sensor. Check visually by making a full turn of the wheel! When there is a bend in the filter wheel, the optical system needs to be replaced (see 4.3.15).

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②




NOTE: After cleaning of the filter wheel slit and/or the filter wheel home sensor, you must verify the filter wheel movement again (see 4.3.7) and the optical system (see 4.3.5) again!

C. Replacement of the home sensor of the filter wheel

If the problem is not solved, the home sensor of the filter wheel needs to be replaced.

Procedure:

Follow the steps 1-8 of the procedure for cleaning the home sensor (B).

9. To install the new part, repeat the above steps in reverse order. Verify that the filter wheel does not touch the home sensor when turning! Otherwise, readjust its position by adjusting the tightening screws of the home sensor. Check visually by making a full turn of the wheel!

4.3.9 Verification of the filter wheel motor

If the filter wheel does not turn anymore, you need to verify the filter wheel motor.

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Check if the connection of the motor is tightly set on

the mainboard (see 4.2.1). Detach and reattach it. 4. Check if the problem is solved. 5. If not, detach the connection and measure the

resistance of the motor (instrument is OFF!). 6. Use a voltmeter set to ohm (Ω). Measure the resistance

of the motor (see photo: black wire as reference versus second wire). The resistance should be between 4.5 - 5.5 Ω. Otherwise, the filter wheel motor needs to be replaced.

4.3.10 Replacement of the filter wheel motor

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect all the connections of the optical system from the mainboard (see 4.2.1): lamp, flowcell

temperature sensor, Peltier element, home sensor of filter wheel, motor of filter wheel, fan for optical system and pre-amplifier board.

4. Carefully remove the flowcell from the reading well and position it in the socket for flowcell protection. 5. Remove the tray of the optical system by unscrewing the 4 screws around the reading well and carefully

position the tray next to the optical system. 6. Unscrew the 4 screws attaching the optical system on the bottom plate. Remove the whole assembly. 7. Remove the cover of the filter wheel by unscrewing the hex/allen screw. 8. Remove the 2 screws attaching the home sensor and carefully take it out.

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CY004/9-S35




9. Unscrew the 4 screws (0) to detach the part with the lamp from the part with the filters. If necessary, first turn the optical system upside down and unscrew the 3 screws ( ) attaching the foot (for attachment to the bottom plate) to the optical system. The filter wheel is now completely visible.

10. Use 2 flat screwdrivers to loosen the fixing screw of the filter wheel. Remove the fixing screw and ring

and then pull up the filter wheel.

11. Remove the metal ring with pincers and then remove the rubber fixing ring with tweezers.

12. Unscrew the 4 hex/allen screws that attach the filter wheel motor to the optical system, and take it out.

Back view Side/below view

Back view




13. To install the new part, repeat the above steps in reverse order. Make sure the 4 screws joining the part with the lamp to the part with the flowcell and the 4 screws of the filter wheel motor are very tightly screwed. Because it is essential that the light travels in a perfectly straight line from the lamp, through the filters, through the flowcell to the photodiode.

NOTE: After replacement of the filter wheel motor, you must verify the filter wheel movement (see 4.3.7) and the optical system (see 4.3.5)!

4.3.11 Cleaning and/or replacement of filters

When one or two filters are out of range during AD auto zero, the problem is probably caused by dust/dirt on the (pre-) filter or by aging or breaking of the filter. Dust can cause fluctuation in the AD values because it increases light scattering. Over time and through normal use, the filters deteriorate. This aging of the filters, will increase their

gain. If the gain for a filter is >16, even with a clean system and a new lamp, the filter needs to be replaced.

A broken filter can result in gain < 8. If the filter is broken or scratched, the filter needs to be replaced.

A. Cleaning a filter(s)

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Carefully remove the flowcell from the reading well and position it in the socket for flowcell protection. 4. Remove the tray of the optical system by unscrewing the 4 screws around the reading well and carefully

position the tray next to the optical system. 5. Remove the cover of the filter wheel by unscrewing the hex/allen screw. 6. Turn the filter wheel manually (instrument is OFF!) until the filter is visible. To clean the filters, they have

to be removed from the filter wheel. 7. Remove the glue carefully with tweezers!

Do not scratch the filter glass. Check for residual glue in the filter wheel, this can affect the light alignment of the optical system

which can affect the obtained results of the AD auto zero. 8. Now the filter locking ring can be taken out with the tweezers. 9. Remove the filter and the pre-filter with a right angle wrench; make sure NOT to touch the filters with

your bare hands! 10. Clean the filters and pre-filters, using (dry!) pressurized air or special wipes for cleaning glasses or lint-

free tissue humidified with glass cleaning solution. Never use normal tissue because fibers will remain on the filter and will cause scattering.

11. Reposition the pre-filter, the filter and the locking ring in the correct order. Please note there is an arrow on the side of the filter, this arrow indicates the direction of the light path and the filter should be placed in the correct direction (arrow pointing away from the lamp and towards the flowcell/pre-amplifier board).

12.

CY009-S12




Keep in mind: the numbering on the filter wheel does not increase with the wavelength. Look at the table below for the correct numbering. Always position the pre-filter first. Only the 340 nm filter does not have a pre-filter. When repositioning the filter, make sure it is placed in the correct way (arrow = light direction!).

N° in software 1 2 3 4 5 6 7 8 9 0

Actual filter (nm) 340 405 492 510 546 578 620 Spare Spare Dark

N° on filter wheel 6 8 9 0 1 2 3 4 7 5

Pre-filter diaphragm - 2.3 1 1 0.8 0.6 0.5 - - -

B. Replacement of the filter(s)

If the problem is not solved by cleaning or the filter is scratched, the filter needs to be replaced.

Procedure: Follow the steps 1-10 of the procedure for cleaning the filter(s) (A). 11. To install the new part, repeat the above steps in reverse order. After the replacement of the filter, verify if the measured AD value is within range. If the cleaning or the replacement did not improve the results of the AD value, the lamp needs to be replaced.

4.3.12 Verification of the voltage to the lamp

If the instrument is ON, but the lamp does not give light, it needs to be replaced. Make sure to test the voltage on the mainboard before replacing it.

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Turn ON the CYANSmart analyzer. 4. Measure the voltage on the mainboard

a) Test point 8 compared to the grounding of test point 5 (see 4.2.2 or on picture below left) or a screw. The measured voltage should be 6V (DC) in normal mode. If the CYANSmart is in standby mode the measured voltage will be 3V (DC).

b) Or measure the voltage directly on the connector of the lamp on the mainboard (see 4.2.1 or picture above on right). The measured voltage should be 6V DC in normal mode or 3V DC in standby mode.

If the voltage is correct, proceed with the lamp replacement. If the voltage is not correct, the mainboard needs to be replaced (see 4.2.4). Do not proceed with

the lamp replacement until the problem is solved.

Pre-filter Filter Locking ring




4.3.13 Replacement of the lamp

Over time and through normal use, the lamp deteriorates and emits less light. The speed of lamp deterioration is variable and is dependent of the workload of the laboratory. To ensure the good performance of the analyzer, Cypress Diagnostics recommends to replace the lamp every 2000 working hours or at least once every year. To guarantee the long lifespan of the lamp, it is essential to optimize the height of the lamp after each replacement. With the aging of the lamp, the analyzer will automatically increase the gain to compensate for the reduced light intensity of the lamp and to keep the AD values in the optimal range. If the gain is 15, 16 or more for all the filters, the lamp needs to be replaced. Before the lamp replacement, it is essential to verify:

a) Only the lamps specific for the CYANSmart are used (CY009-S11). b) Never touch the lamp with your fingers! Use gloves.

c) Dust and dirt influence the gain/AD/offset values. So before changing the lamp or the pre-

amplifier board, make sure the CYANSmart is clean and dust free, both the hydraulic system and the filters (see 3.3.1 and 3.3.2).

4.3.13.1 Installing the lamp

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Carefully remove the flowcell from the reading well and position it in the socket for flowcell protection.

4. Remove the tray of the optical system by unscrewing the 4 screws around the reading well and carefully

position the tray next to the optical system. 5. Disconnect the lamp wire from the mainboard (see 4.2.1). 6. Unscrew the tightening screw of the lamp holder. Turn the screw anti-clockwise for loosening, take the

lamp and frame out from optical system.

√ X




7. Verify the old lamp. If the old lamp is not complete or if the bulb of the lamp is burned, please verify the voltage of the lamp (see 4.3.12).

8. If nothing abnormal is detected and the measured voltage is 6V (DC), place the new lamp and frame in optical system (reuse the tightening screw). Turn the screw clockwise to fix it. Connect the lamp wire to the mainboard (see 4.2.1).

Warning: After the lamp replacement, turn ON the CYANSmart and wait 30 minutes before adjusting the height of the lamp. It is necessary to stabilize the light emission.

4.3.13.2 Height adjustment of the lamp

After the replacement of the lamp, the height of the lamp in its holder needs to be aligned/optimized for the optical system (instrument specific).

Procedure: 1. Reinstall the tray of the optical system and position the flowcell

correctly in the reading well (see 4.3.6). 2. Turn ON the CYANSmart analyzer. 3. Wait at least for 30 minutes, because the lamp needs this time to

stabilize. 4. Select the “Filter test” menu to observe the AD value in real time. 5. Aspirate distilled water by pushing the PUSH button.

Check that the flowcell is completely filled. If there are any air bubbles present in the tubes around the flowcell, the AD values measured will not be correct.

6. Select all the filters one by one using the arrows and write down the AD values for all the different filters. Make sure to set the gain to 1 for all the filters.

7. Select the filter that gives the highest AD value (at gain 1!), to perform the height adjustment. See example below.

8. Hold the lamp base with one hand and in the other use a hex/allen key to loosen the screw on the side

of the lamp holder frame, in order to regulate vertical position of the lamp. Move the lamp manually up and down by holding it by its wire/base of the lamp.

340 nm 9450405 nm 8999492 nm 9580510 nm 10800546 nm 9600578 nm 9530620 nm 8500




Move the lamp little by little (mm by mm) to avoid damaging it. Be careful while handling the lamp, when heated the lamp is more fragile!

9. While adjusting the height of the lamp (point 8), follow the AD value on the screen (for the filter with

the highest AD value – point 7). Find the height position that gives you the highest AD value, then tighten the screw to fix the lamp position. With a clean system (hydraulic and filters) and a new lamp, this value should be above 10000 and as close to 15000 as possible.

10. Make sure that the lamp is tightly fixed to avoid movement of the lamp.

NOTES: 1. The height adjustment of the lamp requires a little bit of time and experience but it is essential to

obtain accurate and precise results. 2. During transport of the analyzer, it is possible that the height of the lamp has been slightly adjusted. If

during installation, the gain remains out of range during the AD auto zero measurement even after the verification of the different requirements (rinsing, washing, cleaning, no air bubbles, instrument on for at least 30 minutes,… (see 4.3.5)), then the height of the lamp needs to be adjusted.

3. Exceptionally, the correct height adjustment can result to gain values between 8 -10 (during the AD zero). a) Instruments with P/D before 2016 (software version < 1.1.3). There is an error with the AD auto

zero if the gain is below 10. If this is the case, it is necessary to make a less optimal adjustment of the height (value less high in point 9) in order to bring the AD auto zero within range (10 – 16).

b) Starting from software version 1.1.3 (instrument with the production date after March 2016), this is taken into account and will no longer give a warning.

Find the height position with the highest AD value for the filter selected in point 7 with gain 1.




4.3.13.3 Verification of the new lamp

Perform a new AD Zero to verify the optical system (See 4.3.5). All should be within range and the gain should be as low as possible (8-12). a) If with the new lamp and the correct height adjustment of the lamp, the gain remains high for all the

filters, check: i. The alignment of the optical system (see 4.3.15).

ii. The preamplifier board and replace if necessary. b) If with the new lamp and the correct height adjustment of the lamp, the gain remains high for one or

two filters, check: i. The alignment of the optical system (check if the filter is correctly placed).

ii. The filters: clean and/or replace if necessary. NOTES: If the height of lamp is not adjusted correctly (incorrect order, without height optimization, with an old lamp): 1. The preamplifier board can be damaged. 2. The gain, AD and offset values will not be in acceptable range and this will affect the accuracy of testing

results. 3. Instable results will be obtained for the AD value during the execution of the measurements.

4.3.14 Replacement of the pre-amplifier board

The pre-amplifier board contains a photodiode that captures the incoming light signal. Over time and through normal use, the photodiode ages and deteriorates. The capture efficacy will diminish. This will first influence the detection of low absorbance. Therefore, Cypress Diagnostics recommends to replace the pre-amplifier board every 2 or 3 years together with the replacement of the lamp.

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Remove the cover of the pre-amplifier board by unscrewing the 2 screws (figure below left). 4. Disconnect the wife connecting the pre-amplifier board to the mainboard (see 4.2.1) 5. Remove the pre-amplifier board by unscrewing the 2 screws (figure below right). 6. To install the new part, repeat the above steps in reverse order.

NOTE:

When replacing the pre-amplifier board, the lamp must be replaced as well. To perform this, the whole lamp replacement procedure should be followed, in the correct order.

4.3.15 Replacement of the optical system

It is essential that the light travels in a perfectly straight line from the lamp, through the filters, through the flowcell to the photodiode.




Make sure the 4 screws joining the part with the lamp to the part with the flowcell and the 4 screws of the filter wheel motor are very tightly screwed.

If anything compromises this straight line, like the presence of a bend or curve in the filter wheel, the optical system (CY009-S01) needs to be replaced! This spare part is delivered together with the filter wheel motor attached. The lamp, filters, sensors, flowcell, Peltier element, fan and pre-amplifier board are not included.



4. Remove all the additional parts: lamp, flowcell temperature sensor, Peltier element, home sensor of filter wheel, filters with pre-filter and locking ring, fan for optical system, and pre-amplifier board (for detailed description see above).

5. Unscrew the 4 screws attaching the optical system on the bottom plate. Remove the whole system. 6. To install the new part, repeat the above steps in reverse order.

Top view

Back view

CY009-S01




4.4 HYDRAULIC AND ASPIRATION SYSTEM

The peristaltic pump is situated on the left side of the instrument. It can be activated by: The ‘Tube wash’ button on the touch screen. The aspiration switch by pushing the aspiration button.

Upon activation of the peristaltic pump stepper motor, the pump rotor turns, moving a liquid column in the pump tube and thereby a quantitative volume is aspirated in the hydraulic system. This is a continuous line consisting of tubes, connectors, the flowcell, and ending in the waste bottle.

4.4.1 Verification of the aspiration and hydraulic system by pump calibration

To ensure precise and accurate sample aspiration, it is strongly recommended to calibrate the pump once a week, this is to determine how many motor steps are necessary to aspirate a certain volume.

Before performing a pump calibration it is essential to check that: a) There is no leakage or blockage in the hydraulic system (flowcell + tubes). b) The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water (See3.2.1). c) The pump tube is installed and connected correctly (see 4.4.3).

Procedure: 1. Select the “Pump Calibrate” menu. The number of steps registered during the last pump calibration is

shown.

2. Pressing the “volume” box, a numeric keyboard will appear, enter 3000 μl as the volume to aspirate and press OK to exit the keyboard view.

3. Pipette exactly 3000 μl of distilled water into a test tube. 4. Position the aspiration tip inside the test tube, be sure that aspiration tip is in the lower corner of the

test tube (see figure), so all liquid can be aspirated. 5. Press the PUSH button to start the aspiration. 6. Immediately and exactly when the tube is empty, press the PUSH key again to stop the aspiration. 7. The number of steps performed by the motor is displayed.

The value should be between 18.000 and 28.000.

It is strongly recommended to perform this procedure at least 3 times. All obtained values should be within this range and the difference between the obtained values should be smaller than 1000 steps.

8. By pressing the “Main Menu” button the software will exit this calibration menu. The software will ask “Sure to save?” Click “Yes” to save and use this calibration. This value is then stored and used as the reference to intake any quantity of sample. Click “No” to discard this calibration.




If the obtained values are outside the range or the difference between the replicates is > 1000 steps:

a) Verify the precision/accuracy of the pipette used (re)calibrate the pipette if necessary. NOTE: For a higher precision we advise to use CYANPipettes.

b) Verify that after aspiration of distilled water, there is no big drop formation at the tip of the aspiration tube. Drop formation indicates the presence of leakage or blockage in the hydraulic system (tubes or flowcell), which will increase the number of steps. If there is a leakage in one of the tubes or the flowcell.

i. Replacement is necessary (see 4.4.2, 4.3.6). Blockage in one of the tubes can be caused by:

i. Squashing of the tube, for example by the case, replace the tube if damaged (see 4.4.2).

ii. Sticking together of the pump tube. To prevent this, it is recommended to unhook the pump tube if the instrument is not used for more than one week.

iii. Accumulation of dirt in the tubes perform a cleaning with hypochlorite (see 3.2.1), if cleaning is not sufficient, replacement is necessary (see 4.4.2).

Blockage in the flowcell Accumulation of dirt in the flowcell perform a cleaning with hypochlorite (see 3.2.1), if cleaning is not sufficient, replacement is necessary (see 4.3.6).

c) Verify the correct installation of the pump tube. To verify the correct fastening of the peristaltic pump tube, the user can manually turn the rotor

of the peristaltic motor (correct direction!). If the rotor can be turned smoothly, the tubing is placed correctly, if not, check the attention points. ! This manual turning can only be performed when the instrument is turned OFF! When the instrument is turned ON, the motor movements are blocked and manually turning the rotor can damage the mechanism!

Make sure the pump tube is placed in the middle of the white rollers of the rotor. Verify that the tube is completely inserted into the holders. Make sure the pump tube connectors are completely inserted into the pump tube. Make sure the tubes are not squashed by the case.

d) Verify there is no lubricant on the pump tube or the rotor rollers. Too much lubricant can make the rollers slip and thereby increase the number of step clean and remove the lubricant.

e) Verify that the pump rotor is turning smoothly. Otherwise, the pump motor needs to be verified and/or replaced (see below).

If all the above is verified, but the pump calibration remains out of range, the pump tube or pump rubbers needs to be replaced (see below).

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X

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4.4.2 Replacement of tubes in the hydraulic circuit

Over time and through normal use, the tubes become worn. To ensure the good performance of the analyzer, all tubes of the hydraulic circuit should be replaced at least every year. In case of leaking, persistent obstruction or strong coloration, the tubes need to be replaced immediately. The connectors can be reused, but it is recommended to replace them at least every 3 years or in case of leaking, persistent obstruction or strong coloration.

Before replacing any part, make sure to perform an external and internal decontamination (See 3.3.1 and 3.3.2), to prevent contamination of the new spare parts.

Procedure: 1. Aspirate air to make sure all tubes are dry and will not leak upon disconnection. 2. Turn OFF the CYANSmart analyzer. 3. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 4. Replace the tubes and/or connectors (one by one). Please find the correct item code and description

using the diagram and table below. 5. Turn ON the analyzer and perform an internal decontamination (see 3.3.2). Make sure there is no

leakage. 6. Close the instrument cover, making sure NOT to squash or bend any of the tubes!

NOTE: After replacing any part of the hydraulic system, you must recalibrate the peristaltic pump (see 4.4.1)!

Tubes CY004/9-S26 Plastic aspiration tube

CY004/9-S27 Metal aspiration tube

CY004/9-S41 Tube from flowcell to pump

CY009-S25 Pump tube

CY004/9-S40 Tube from pump to waste connector

CY004/9-S28 Waste tube

Connectors

CY009-S30 Connector of pump tube (2 pcs)

CY009-S29 Connector of waste tube

Biological hazard: Carefully manipulate all the consumables and the waste produced during the routines analysis. Use appropriate protective garment. Disposal of wastes must be done in compliance with applicable regulation. It is recommended to periodically check the level in the waste container, in order to avoid overflow.

Rear panel Waste bottle Peristaltic pump Flowcell Aspiration switch

Aspiration button

Inlet fastening screw




4.4.3 Replacement of peristaltic pump tube

Because pressure is applied to the peristaltic pump tube, this tube wears out more quickly. To ensure the good performance of the analyzer, the peristaltic pump tube should be replaced at least every 6 months. This frequency may vary depending on the workload of the individual laboratory. The quality and reliability of this tube is fundamental to ensure precise and accurate aspiration. Procedure: 1. Aspirate air to make sure the tubes are dry and will not leak upon disconnection. 2. Turn OFF the CYANSmart analyzer. 3. Lift the handle to open the door on the side to the peristaltic pump. 4. To change the tube, remove it from peristaltic pump rotor (2) and disconnect the pump tube from its 2

connectors by gently pulling them out. Insert the connectors in the new tube and place the new tube (1) around the peristaltic pump rotor (2).

5. Make sure to insert the tubes in the correct direction. The tube coming from the flowcell (4) towards the front and the tube going to the waste connector (5) towards the back.

6. Then close the hinged guide lock (3). Make sure it is completely clicked on. 7. To verify the fastening of the pump tube, manually turn the peristaltic pump rotor (correct direction!).

If the rotor can be turned smoothly, the tube is placed correctly. This manual turning can only be performed when the instrument is turned OFF! When the instrument is turned ON, the motor movements are blocked and manually turning the rotor can damage the mechanism!

Note: After replacing the pump tube, you must recalibrate the peristaltic pump (see 4.4.1)!

! ATTENTION POINTS! 1. Make sure the new pump tube is placed in the middle of the white rollers of the rotor. 2. Verify that the new tube is completely inserted into the holders. 3. Make sure the pump tube connectors are completely inserted into the new pump tube. 4. Make sure the tube (4) and (5), are inserted in the wholes and not squashed by the case.

IMPORTANT NOTES: 1. Always use original replacement parts. 2. Never lubricate the peristaltic pump rotor roller. 3. After prolonged instrument inactivity: verify the functioning by performing a pump calibration. 4. If the instrument is not used for more than one week, unhook the hinged guide lock to prevent the

pump tube from sticking together.

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③

①

OUT To waste

IN From flowcell

④⑤

√

XX √




4.4.4 Replacement of peristaltic pump rubbers

The pressure that is applied to the peristaltic pump tube is regulated by rubbers. Over time and through normal use, these rubbers become worn. To ensure the good performance of the analyzer, the peristaltic pump rubbers should be replaced at least every 2 to 3 years. This frequency may vary depending on the workload of the individual laboratory.

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Lift the handle to open the door on the side to the peristaltic pump. 3. Unhook the hinged guide lock (1) and remove the pump tube from the pump rotor. 4. Unscrew the middle screw (4) and take off the lower guide for the tube (5). 5. Now the 4 corner screws become visible. Unscrew them, taking care not to lose the nuts and washer

located on the inside of the plate. Carefully take out the rotor with motor from the frame. 6. In the upper part, there is a pump tube guiding system (2). Remove this guiding system (pull it out). 7. Replace the 2 rubbers (3) inside the guiding system and then reposition it. 8. Reposition the lower tube guide and the pump tube and then close the hinged guide lock (1). Make

sure it is completely clicked on. 9. Verify the positioning of the rubbers and guiding system by manually turning the wheel of the

peristaltic motor (correct direction!). If the wheel can be turned smoothly, it is placed correctly. 10. If the position is correct, reattach the rotor with motor.

NOTES: After replacing the pump rubbers, you must recalibrate the peristaltic pump (see 4.4.1)! Make sure the rubbers are placed in the correct position. If the rubbers are not positioned correctly,

functionality of the pump will be impaired and aspiration is blocked.

4.4.5 Cleaning and lubrication of the pump motor with rotor

If the pump rotor is still turning but not smoothly, or makes excessive noise while turning, dirt might have been caught in the mechanism and cleaning and/or lubrication should be performed.

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Lift the handle to open the door to the peristaltic pump or remove the cover of the instrument

completely to have easier access. 3. Unhook the hinged guide lock and remove the pump tube from the pump rotor.

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4. To remove the pump rotor (1), loosen the grain (2) with a hex/allen key and pull it off the motor axis (3).

5. Use pressurized air (dry!) and clean the motor axis and all rollers (4) of the rotor (you can also use a damp

cloth for cleaning the rollers). 6. After cleaning and drying, you can put one drop of machine grease (WD40) on the motor axis (3) and

some silicon grease on the contact surface (5) between the rotor (1) and the rotor holder (6). 7. ! Make sure there is no lubricant on the rollers of the rotor or the places in contact with the pump tube!

8. To reposition the rotor, make sure the fastening grain is on the flattened side ( ) of the motor axis and that the rotor is coplanar (same level) with the rotor holder. Then tightly fasten the grain.

9. NOTE: After cleaning and/or lubrication of the pump rotor/motor, you must recalibrate the peristaltic

pump (see 4.4.1)!

4.4.6 Verification of the pump motor

If the rotor does not turn anymore, you need to verify the pump motor.

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6

hex/allen screws on the bottom plate. 3. Check if the connection of the motor is tightly set on the

mainboard (see 4.2.1). Detach and reattach the connection. 4. Check if the problem is solved. 5. If not, detach the connection and measure the resistance of the

motor (instrument is OFF!). 6. Use a voltmeter set to resistance (Ω).

Measure the resistance of the motor (see photo below: black wire as reference versus second wire). The resistance should be between 8-10 Ω. Otherwise, the pump motor needs to be replaced.

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4.4.7 Replacement of the pump motor with rotor

The pump motor is supplied with the rotor attached and already correctly aligned (CY009-S10).

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Unhook the hinged guide lock and remove the pump tube from the pump rotor. 4. Disconnect the pump motor wire from the mainboard (see 4.2.1). 5. Unscrew the middle screw (1) to take off the lower guide for the tube (2). 6. Now the 4 corner screws (3) become visible. Unscrew them, taking care not to lose the nuts and washer

located on the inside of the plate. 7. To install the new part, repeat the above steps in reverse order.

NOTE: After replacement of the pump rotor/motor, you must recalibrate the peristaltic pump (see 4.4.1)!

4.4.8 Verification of the aspiration switch

If the pump motor does not respond (no aspiration, no sound of turning) when pressing the aspiration switch (and you are in the correct menu) and it does turn when pressing the “tube wash” button in the software, you need to verify the aspiration switch. Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Check if the connection of the aspiration switch is tightly set on the mainboard (see 4.2.1). Detach and

reattach it again. 4. Check if the problem is solved. 5. If not, detach the connection and measure the resistance (instrument is OFF!). 6. Use a voltmeter set to ohm (Ω) and if the function is available to sound ( ). Connect the black pin to

one connection and the red pin to the other. a. When the button of the aspiration switch is not pushed in, the resistance infinite. b. Upon pushing in the aspiration switch, the circuit closes, and you should see a jump in the

resistance and hear the buzzer (if the sound is activated). 7. Otherwise, the aspiration switch with wire needs to be replaced.

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4.4.10 Replacement of the aspiration switch

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect the aspiration switch wire from the mainboard (see 4.2.1). 4. Unscrew the front locking ring (1) to take the aspiration switch from its support. 5. To install the new part, repeat the above steps in reverse order.

NOTE: After replacement of the aspiration switch, you must recalibrate the peristaltic pump (see 4.4.1)!

ATTENTION POINT! Make sure the wires are correctly attached on position 1 and 2 and NOT on 2 and 3!

4.4.11 Aspirate format

In the menu “Aspirate format”, in the folder “Reserved settings”, the aspiration format can be changed. This adjustment should only be done by a service engineer and after detailed explanation to the user about the consequences and possible risks involved with setting the format to express mode. This folder is password protected. The password is 123456 (do NOT give this password to the users!). The default format is normal. In the normal aspiration format, the programmed volume of sample is aspirated in the flowcell and measured. When the measurement is finished, an air gap of 500 μl is aspirated to prevent cross-contamination by the next sample. After that, the instrument will indicate that it is ready to aspirate the next sample. In the express mode, the programmed volume of sample is aspirated, which is almost immediately followed by aspiration of an air gap. Only after this the measurement is performed. After measurement, the instrument is ready for aspiration of the next sample. The volume of the air gap in the express mode can be set (20 μl – 800 μl). The recommended range is 50-150 μl. Attention: if the air gap is too big, air bubbles will flow into the flowcell during measurement, giving false results. If the air gap is too small, there is an increased risk for cross-contamination.

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4.5 INCUBATOR BLOCK

There are 20 spaces for reaction tubes up to 14 mm diameter. After start-up of the instrument, the instrument requires 15-30 minutes to reach the programmed temperature, the temperature will remain constant until the instrument is turned off. The incubator has a fixed set temperature of 37±1°C. The heating is performed by a heater element with a resistance wire and regulated by a temperature control switch and temperature sensor. For more information on the heating mechanism, calibration and replacement, see 4.6.

4.6 TEMPERATURE

4.6.1 Temp display

The flowcell and the incubator are under temperature control and maintained at a certain set temperature. In the “temp display” menu in the “System settings”, you can verify if the temperature of the flowcell (cuvette) and incubator measured by the instrument corresponds to the set temperature.

a) For the flowcell/cuvette, different set temperatures are possible: room temperature (R.T.), 25°C, 30°C, and 37°C. Allow 15 - 30 minutes for the instrument to obtain the requested temperature. The measured temperature should be the set temperature ± 1°C.

b) The incubator has a fixed set temperature of 37°C. The measured temperature, after 15 - 30 minutes, should be 37.5±1°C. The real temperature is set 0.5°C higher to ensure a more efficient heating of the (bigger) volumes that are placed in the incubator.

If the measured temperatures do not correspond to these specifications, a temperature calibration should be performed.

NOTES: 1. After start-up of the instrument, the instrument requires 15 - 30 minutes to reach the programmed

temperature. 2. If upon entering the perform test menu, the programmed temperature for the flowcell/cuvette is not

yet reached, the instrument will display a warning to inform the user of this discrepancy. 3. In case of an electric shock, the parameters saved on the mainboard might have been modified or

deleted. Please check and if necessary calibrate the temperature.




4.6.2 Temperature calibration

The temperature calibration should only be done by service engineers and after correctly following the entire procedure described below! Upon calibration, the instrument will adjust the automatic temperature control circuit.

Materials necessary: 1. Thermometer with an accuracy of 0.1°C 2. Cuvette filled with 1 mL of distilled water for the flowcell calibration 3. Test tube filled with 1 mL of distilled water for the incubator calibration

Procedure: 1. Turn ON the CYANSmart analyzer. 2. Wait for at least 15-30 min, for the instrument to reach the set temperatures. 3. Enter the “Reserved Setting” menu. 4. Input the password 123456 (do NOT give this password to the users!). 5. Select the “Temp Calibrate” menu. Upon entering this menu, the set temperature and the temperature

measured by the instrument for the flowcell/cuvette and the incubator is displayed.

4.6.2.1 Calibration of the flowcell temperature

6. Carefully remove the flowcell from the reading well (3) and position it in the socket for flowcell protection (4).

7. Fill a cuvette with 1 mL of distilled water, place it in the reading well and insert the thermometer in the distilled water. Wait for 15-30 min until the temperature becomes stable.

8. Compare the temperature measured by the thermometer with the temperature displayed by the

instrument “Temp” on the screen. For example the programmed temperature is 37.0°C for the flowcell. If the instrument is correctly calibrated, the temperature measured by the thermometer is 36.5±1°C and the temperature displayed by the instrument is 37±1°C. Otherwise proceed to step 9. NOTE: The limit for the temperature measured by the thermometer (36.5±1°C) is 0.5°C lower than the limit for the temperature of the flowcell (37±1°C). This is to compensate for:

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The bigger volume (1 ml in the cuvette instead of 32μl in the flowcell). Evaporation (open system in the cuvette instead of a close system in the flowcell).

9. Input the temperature shown by the thermometer in the “Actual Temp” and press “Calibrate”. 10. Wait for 15-30 min to allow the control circuit to adjust the temperature. 11. The temperature measured by the thermometer should be 36.5±1°C and the temperature displayed

by the instrument should be 37±1°C. Otherwise repeat steps 9 till 11. 12. If the calibration is successful, return to the “Reserved Setting” menu. Upon exiting this menu, by

pressing the “Main Menu” button, the instrument will ask if you want to save the changes made. Click “Yes” to save the changed settings, “No” to exit the menu without saving or “Cancel” to return to the “Reserved settings” menu.

If, after performing the calibration procedure twice, the temperatures remain outside the range set temperature ±1°C, continue with 13. Verification and/or replacement of the Peltier element (See 4.6.3, 4.6.4) 14. Verification and/or replacement of the mainboard (see 4.2). 15. Replacement of the temperature sensor (see 4.6.8).

4.6.2.2 Calibration of the incubator temperature

1. Fill a test tube with 1 mL of distilled water, place it in the incubator and insert the thermometer in the distilled water.

2. Wait for 15-30 min until the temperature becomes stable. Read the temperature displayed by the thermometer and the measured “Temp” on the display. If the instrument is correctly calibrated, the temperature on the thermometer should be 37.5±1°C and the temperature displayed in “Temp” should be 37.0±1°C. The real temperature is set 0.5°C higher to ensure a more efficient heating of the (bigger) volumes that are placed in the incubator for relatively short times (incubation time). Otherwise proceed to step 8.

3. Subtract 0.5 from the temperature displayed on the thermometer and insert this value in the “Actual Temp” and press “Calibrate”. E.g. Thermometer displays 32.8°C after 15-30 min Insert 32.8 – 0.5 = 32.3°C in the software.

4. Wait for 15-30 min to allow the control circuit to adjust the temperature. 5. The “Temp” on the display should be 37.0±1°C and the temperature on the thermometer should be

37.5±1°C. Otherwise repeat steps 7 until 10. 6. If the calibration is successful, return to the “Reserved Setting” menu. Upon exiting this menu, by

pressing the “Main Menu” button, the instrument will ask if you want to save the changes made. Click “Yes” to save the changed settings, “No” to exit the menu without saving or “Cancel” to return to the Reserved settings menu.




If after performing the calibration procedure twice, the temperatures remain outside the range 37.5±1°C, continue with 7. Verification and/or replacement of the heater element (see 4.6.5, 4.6.6) 8. Verification and/or replacement of the mainboard (see 4.2). 9. Replacement of the temperature sensor (see 4.6.8).

4.6.3 Verification of the Peltier element

If after the calibration procedure, the temperature measured with the thermometer does not reach 36.5±1°C, the Peltier element needs to be verified. Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on

the bottom plate. 3. Check if the connection of the Peltier element is tightly set on the mainboard

(see 4.2). Detach and reattach it again. 4. Check if the problem is solved. 5. If not, detach the connection and measure the resistance of the Peltier

element (instrument is OFF!). 6. Use a voltmeter set to resistance (Ω). Measure the resistance of the Peltier

element (see photo: black wire as reference versus second wire). The resistance should be between 9 and 12 Ω. Otherwise, the Peltier element needs to be replaced.

NOTE: The resistance of the Peltier element is dependent of the temperature. Always measure the resistance when the instrument is turned OFF and not heated/room temperature.

4.6.4 Replacement of the Peltier element

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect all the connections of the optical system from the mainboard (see 4.2): lamp, flowcell


4. Unscrew the 4 screws (1) attaching the optical system on the bottom plate. Remove the whole assembly and turn it upside down.

5. Remove the ventilator by unscrewing its 2 screws (2) and then remove the heat sink by its 2 screws (3)

6. The Peltier element is now visible.

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7. To install the new part, repeat the above steps in reverse order.

Attention: a) Put sufficient heat conduction silicone grease (=thermal grease) on both sides of the Peltier

element in order to assure heat conductivity between the Peltier element and flowcell and to efficiently drain the surplus of heat through the heat sink to the fan.

b) The Peltier element has a warm plate and a cold plate. The warm plate should be positioned on the side of the Peltier element, the cold plate should be positioned on the side of the heat sink. To assure the correct position of the Peltier element during installation, check the colors of the wires. The red wire is placed facing the back panel of the instrument (side of the filter wheel) and the black wire is placed facing the front side of the instrument (side of the pre-amplifier board).

c) Before turning ON the instrument, check if both the heat sink and the fan of the optical system

have been installed. Never turn ON the instrument when the heat sink and the fan are not installed, this can result to an overheating and will damage the Peltier element.

NOTE: After replacement of the Peltier element, a temperature calibration needs to be performed (see 4.5.2).

4.6.5 Verification of the heater element of the incubator

If after the calibration procedure, the temperature measured with the thermometer does not reach 37°C, the heater element needs to be verified. Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws

on the bottom plate. 3. Check if the connection of the incubator heater element is tightly set on the

mainboard (see 4.2.1). Detach and reattach it again. 4. Check if the problem is solved. 5. If not, detach the connection and measure the resistance of the heater

element (instrument is OFF!). 6. Use a voltmeter set to ohm (Ω). Measure the resistance of the heater element

(see photo: black wire as reference versus second wire). The resistance should be between 11 and 13 Ω. Otherwise, the heater element needs to be replaced.

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4.6.7 Replacement of the heater element of the incubator

The heater element of the incubator comes with the temperature control switch attached (CY009-S52).

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect all the connections of the incubator assembly from the mainboard (see 4.2.1): incubator

temperature sensor and heater of incubator. 4. Unscrew the 4 screws attaching the incubator on the bottom plate (1). Remove the whole assembly and

turn it upside down. 5. Remove the support on the side of heater wires by unscrewing its 2 screws (2) and then remove the

black plate by its 4 screws (3). 6. The heater element is now visible. Detach the temperature control switch by its 2 screws (4).

7. To install the new part, repeat the above steps in reverse order.

Attention: When replacing the heater element and the temperature control switch, put sufficient heat conduction silicone grease (=thermal grease) on the inside in order to assure efficient heat conductivity.

NOTE: After replacement of the heater element, you must verify and recalibrate the temperature of the incubator (see 4.6.2)

4.6.8 Verification of the voltage to the heater elements on the mainboard

If the resistance measured on the Peltier element or the heater element of the incubator is correct, but the temperature measured with the thermometer does not reach 37°C, the voltage supply to the respective part needs to be verified on the mainboard. Procedure: 1. Turn ON the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Measure the voltage on the mainboard by using a voltmeter set to V DC:

a. Peltier element of the flowcell: Test point 4 compared to the grounding of test point 5 or a screw (see 4.2.2): 15 V (DC) And measure the voltage directly on the connection of the Peltier element (see 4.2.1): The

measured voltage will vary between 0V – 15V (DC), depending on the current temperature of the Peltier element.

b. Heater element of the incubator:

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Test point 1 compared to the grounding of test point 5 or a screw (see 4.2.2): 24V (DC) And measure the voltage directly on the connection of the heater element of the incubator (see

4.2.1): 24V (DC) if the incubator is cold and if the incubator reaches its temperature the measured voltage varies between 0V - 15V (DC).

If the voltage is not correct, the mainboard needs to be replaced (see 4.2.4).

4.6.9 Replacement of the temperature sensor

If, after the calibration procedure, the temperature measured with the thermometer does not correspond to the temperature measured by the instrument but the heating element is functional (resistance is correct and you feel heating) and the voltage measured on the mainboard is correct, the temperature sensor needs to be replaced. Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect the temperature sensor wire from the mainboard (see 4.2.1). 4. Unscrew the temperature sensor from its seating. In the optical system, the temperature sensor is

positioned on the right side of the flowcell above the Peltier element (1). In the incubator assembly, the temperature sensor is located on the left side and above the heater element (2).

5. To install the new part, repeat the above steps in reverse order. Attention: When replacing the temperature sensor, put sufficient heat conduction silicone grease (=thermal grease) on the inside in order to assure efficient heat conductivity.

NOTE: After replacement of the temperature sensor, a temperature calibration needs to be performed (see 4.6.2)

4.6.10 Cleaning and/or replacement of the fan of the optical system

Accumulation of dust or dirt can block the fan. This can lead to overheating of the flowcell, which will influence the results. If the fan does not turn anymore, it needs to be cleaned and/or replaced.


temperature sensor, Peltier element, home sensor of filter wheel, motor of filter wheel and fan for optical system.

4. Unscrew the 4 screws (1) attaching the optical system on the bottom plate. Remove the whole assembly and turn it upside down and remove the ventilator by unscrewing its 2 screws (2).

5. Use pressurized air (dry!) or a damp cloth for cleaning the fan.

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If the problem is not solved by cleaning, the fan needs to be replaced.

6. To install the new part, repeat the steps (2-4) above but in reverse order.

NOTE: After replacement of the fan, a temperature calibration needs to be performed (see 4.6.2).

The fan of the optical system is not always activated. Only when the temperature reaches the programmed temperature (> 37±1°C), the fan will be activated for the cooling of the flowcell and to avoid overheating.

4.7 THERMAL CARBON PRINTER

The CYANSmart is equipped with a built-in thermal printer. The text or graph is printed on coated thermo-chromic paper. This paper is selectively heated when passing over the thermal printing head, and thereby the coating on these places turns black, producing an image.

4.7.1 Install or change the print paper

1. Switch ON the instrument. 2. Open printer cover of the instrument. 3. Remove any left-over of the old print paper roll. 4. Take a new paper roll and place it into the paper slot. Make sure to place the paper in the right direction

(check attention point) and that the end is straight. 5. Roll off the print-paper until the beginning of the paper touches the printing bar. 6. When the instrument is ON and the paper touches the printing bar, the instrument will feed the paper

automatically. If this is not sufficient, press the “Printer feed” button on the touch screen, while keeping the paper in contact with the printing bar.

7. Feed the paper until you can put it through the opening in the printer cover and close the printer cover.

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! ATTENTION POINT!

Make sure to place the paper in the right direction. Only the coated side can be used to print. If the paper is installed in the wrong direction (see below) the paper will move through the printer, but nothing will be printed. To verify the printable side of the paper, the operator can scratch the paper. Upon scratching the paper, only one side will become slightly greyish or shiny (see picture below), that is the side that can be used for printing and thus should contact the printing bar.

Warnings

Do not try to print without printing paper installed, this can cause a system crash! If the printing bar is (accidently) removed from the printer head, make sure to turn OFF the

instrument before repositioning it. Otherwise, the cogwheels can get damaged.

4.7.2 Verification of the voltage to the printer on the mainboard

If the paper is correctly installed, but the “Printer feed” button does not make the printing bar turn nor make the paper move forward, the voltage supply to the respective part needs to be verified on the mainboard.

Procedure: 1. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 2. Turn ON the CYANSmart analyzer. 3. Measure the voltage on the mainboard on test point 9 compared to the grounding of test point 5 (see

4.2.1). The measured voltage should be 5V (DC).

4.7.3 Replacement of the printer

If the voltage measured on the mainboard is correct and all connections (on both the mainboard and the printer board) are firm, but the printer still does not print, the printer needs to be replaced. The printer is supplied together with the printer board. Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove any left-over of the old print paper roll. 3. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 4. Disconnect the printer power cable (1) and the flat printer data cable (2) from the printer board (3). 5. Very carefully pull out the flat orange/golden cable (4) from its slot. 6. Unscrew the 2 screws attaching the printer board to the case (5). 7. The 2 screws attaching the printer head to the case are now visible (6). Unscrew them and remove the

printer head.

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8. To install the new part, repeat the steps (3-6) in reverse order.

! ATTENTION POINT! Insert the flat orange/golden cable straight, completely and in the correct direction (see below) in its slot on the printer board. The connections should be facing the inside of the board.

Warnings

Do not try to print without printing paper installed, this can cause a system crash! If the printer bar is (accidentally) removed from the printer head, make sure to turn OFF the

instrument before repositioning it! Otherwise the cogwheels can get damaged!

4.8 TOUCH SCREEN

The CYANSmart is equipped with a user friendly, touch-sensitive crystal display. A finger or smaller blunt object (stylus pen) should be used to operate the touch screen. If the operator gently touches the LCD, the analyzer will recognize the position where the screen was pressed; the software will activate the corresponding function/menu/button.

Upon touching a specific function/key/menu, this button will become darker blue (indicating its activation) and the CYANSmart will make a beeping sound. When data needs to be entered, a keyboard will appear. The keyboard will be adapted to the data that can be entered in that specific area: alphanumeric or numeric.

ATTENTION POINT! The screen can only react to one touch point at the same time. If something/someone else is touching or pressing the screen (on an empty position), it will not respond to the touch on a function key!

4.8.1 Touch screen calibration methods

If upon tapping a specific location, the required function is not activated, the touch screen needs to be recalibrated.

Procedure: 1. Turn ON the CYANSmart analyzer. 2. Choose an empty position on the touch screen (no button or fill in screen present). Tap this location

very quickly at least 20 times. 3. You will hear a buzzer and enter the calibration screen. Tap the reference points (+) one after another.

Make sure to tap exactly the sign. 4. When the calibration is completed, the software will exit the calibration interface automatically, and

return to the operating interface.

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4.8.2 Adjustment of the screen brightness

With aging and time, it can necessary to adjust the brightness of the touch screen. Go to the menu “System Setup” and select “Screen brightness”. Here you can adjust the brightness of the touch screen with a range going from 0 – 64, with zero the darkest state and 64 the brightest state.

4.8.3 Verification of the voltage to the touch screen on the mainboard

If even after the adjustment of the screen brightness, the screen remains dark, then the voltage supply to the touch screen needs to be verified on the mainboard.

Procedure: 1. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 2. Turn ON the CYANSmart analyzer. 3. Measure the voltage on the mainboard on test point 3 compared to the grounding of test point 5 (see

4.2.2). The measured voltage should be 5V (DC).

4.8.4 Replacement of the touch screen cable

The flat touch screen cable is a fragile part. It could get damaged for example if it is (accidentally) pulled too hard while removing the cover or if the cable gets squashed between the cover. If any damage is visible, the cable needs to be replaced. Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect the flat touch screen cable (1) from the touch screen board (2). To do this, lift the black

connection part up (3) and then the cable can be taken out without pulling! 4. Carefully pull out the flat touch screen cable (1) from its slot on the mainboard (4).


ATTENTION POINTS! 1. Insert the flat touch screen cable straight and in the correct direction in its slot on the touch screen

board. Then close/push down the black part of the connection to tighten it. The connections should be facing the board.

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2. Insert the flat touch screen cable straight and in the correct direction in its slot on the mainboard. The connections should be facing the outside of the board.

4.8.5 Functional verification of the parts of the touch screen

If the touch screen is black or there is no response upon touching the screen please check the different parts of the touch screen.

Number on the picture

Name Function

1 Battery The battery is only used for saving the date and time. When the battery is empty it has no influence on the results.

2 Touch connection If not correct or broken the display is lighted but there is no sound/response upon touching the screen.

3 Display connection If not correct or broken the display is black but there is still sound upon touching.

4 Connection between display and circuit board

If not correct or broken the display is black and there is no sound upon touching.

5 Connection to motherboard If not correct or broken the display will get no power.

4.8.6 Replacement of the touch screen

If the voltage measured on the mainboard is correct and all connections (on both the mainboard and the touch screen board) are firm, but the screen still does work, the touch screen needs to be replaced. The touch screen is supplied together with the touch screen board (CY009-S20).

Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 3. Disconnect the flat touch screen cable (1) from the touch screen board (2). 4. Remove the cover to get access to the touch screen board by unscrewing the 4 screws. 5. Unscrew the 4 screws attaching the touch screen to the case (3).

√ X

1

2 3

4

5





NOTE: After replacement of the touch screen, you must verify and/or adjust the screen brightness and perform a touch screen calibration (see 4.8.1, 4.8.2). ! ATTENTION POINTS ! 1. If there are dents or inequalities in the cover mold and the touch screen is attached firmly against the

cover, these inequalities will push in the touch screen, making it unresponsive to your touch! (See attention point 4.8).

2. Insert the flat touch screen cable in the correct direction in its slot on the touch screen board. The connections should be facing the board (see 4.8.4).

4.9 POWER SUPPLY

4.9.1 General electricity and installation requirements

The power voltages suited for the CYANSmart are indicated on the back label (1). It needs to be connected to a power supply consistent with this voltage and frequency. The instrument can work at 100 – 230V AC. The correct voltage setting is automatically detected and selected by the instrument. The instrument is connected with the AC wall outlet by the power cable (2); one side of the cable must be inserted into the electric socket, the other side in the power plug connector (seat) (3). To improve the device stability and to protect it from overcurrent, fuses are built in at the back of the CYANSmart analyzer. These two fuses (T2AL250V) are located below this power plug connector (4). When a fuse needs to be replaced, it is important to use the correct fuse to prevent damage to the CYANSmart.

When the power switch (5) is set to ON (I), the input power is going to the power supply (6), were it is transformed to 24V DC. This voltage is connected to the mainboard for further use/division/regulation.

①

②

③ ③

③ ③

①

②

③

④

⑤




ATTENTION POINTS! 1. Always use the original power cord supplied with the instrument. 2. Make sure the connection (wall outlet and instrument) is correct and firm. 3. Place on a stable, horizontal surface, free from vibrations. 4. Keep the instrument away from other appliances that generate electrical noise or magnetic fields (e.g.

radiological instruments, X-ray, radio…). 5. Connected to a suited and grounded AC wall outlet, preferably one that is not shared with other electric

appliances and with low fluctuation of line voltage: AC 220V ± 10%, 50Hz ± 2% or AC 110V ± 10%, 60Hz ± 2%.

6. If the AC wall outlet is not properly grounded, please connect a ground or earth wire to the bottom plate of the analyzer. A bad ground line connection may compromise analysis results and damage the instrument.

7. If the fluctuation is >10% use the following supplementary devices: Electronic stabilizer

This is used to stabilize the electric voltage in the laboratory. Any stabilizer, currently available on the market, with a power potential of at least 0.5 KW can be used.

No Break Module UPS (Uninterrupted Power Supply) This module has two important features:

o Stabilizes the main power. o Supplies power to the instrument in case of main power line failure.

After turning off the analyzer, you need to wait at least 60 seconds before turning it on again! Otherwise, the fuses will blow because of the residual current.

⑤ ③

⑥

INPUT 110-230VAC OUTPUT 24VDC




4.9.3 Replacements of fuses

When the power supply fuses are burned, it is necessary to replace them with the correct fuses: 2x T2AL250V Procedure: 1. Turn OFF the CYANSmart analyzer. 2. Disconnect the power cord from the power plug connector (seat). 3. Locate the fuses under the power plug connector. Use a screwdriver to pull out the fuses.

4. To install the new fuses, repeat the steps above (2-3) in reverse order.




4.9.4 Locating power problem

NO

Switch ON (I) the power switch

YES

NO

Check all the parts individually (see the relevant chapter). For example:

Lamp is burning? Light of the power supply is burning? Ventilator is turning? Display is working and turned ON? Lights on the mainboard are burning? Filter wheel is turning?

Fuses OK?

Verification of the fuses (4.9.4) 1. Switch OFF (O) 2. Disconnect power cord 3. Disconnect ACL and ACN on the

power supply 4. Replace the two fuses (4.9.2) 5. Reconnect power cord and switch

ON (I) 6. Check if the fuses remain ok 7. Measure the voltage on the end of

the disconnected ACL and ACN

YES

Verification of the power supply 1. Switch OFF (O) 2. Disconnect power cord 3. Disconnect +V0 and 2 grounding cables from

the power supply (leave ACL and ACN connected!)

4. Reconnect power cord and switch ON (I) 5. Check if:

a. Fuses remain ok? b. Light of the power supply is burning? c. Check the voltages on the power supply

ACL versus ACN: 110/230 V AC +V0 versus GND: 24V DC OK?

NO

Verification of the power plug connector and power switch (4.9.5) Measure the voltages between the

power connection and the power supply.

YES

Problem located after power supply

Power supply is broken: 1. Switch OFF (O) 2. Disconnect power 3. Replace the power supply 4. Reattach all wires to new power supply 5. Replace the two fuses (4.9.2) 6. Reconnect power cord and switch ON (I)

Verify general electricity and installation requirements (4.9.1)

OK?

YES

NO OK?

OK?




4.9.5 Verification of the fuses

If the fuses blow upon switching on the instrument, please follow the procedure below in order to identify the cause of this problem.


Procedure: 1. Verify the general electricity and installation requirements (4.9.1). Only proceed if these are OK. 2. Switch OFF (O) the analyzer and disconnect power cord. 3. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 4. Disconnect input ACL and ACN wires or L and N connector from the power supply.

5. Replace both fuses (see 4.9.2). 6. Reconnect the power cord and switch ON (I) the instrument. 7. Measure the voltage (AC) at the end of the disconnected wires (ACL and ACN or L and N). The value should

be 110V or 230V depending your location. If the fuses blow or the measured voltage is not correct, the problem is situated upstream between

the power plug connector and the power supply unit (see 4.9.5).

If the fuses don’t blow and the measured voltage is correct, the problem is caused by the power supply unit itself (see 4.9.6) or another unit located downstream (see relevant chapter).

4.9.6 Verification of the power plug connector and power switch

If the problem is situated between the power plug connector and the power supply unit, dismantle the connections one by one to identify the cause of the problem. Always verify that the fuses are NOT blown, then dismantle the connections step by step, in order to identify the defect.

Make sure both measuring pins do not touch each other while measuring. This will lead to an overcurrent, which will cause unrepairable damage to the instrument

CY009-S24A CY009-S24B

1 2




Make sure to unplug the instrument from the electrical current before dismantling the connections. Voltages are only measureable when the instrument is connected to a power supply. Be careful, electricity can kill.

Procedure: 1. Verify the general electricity requirements (see 4.9.1). Only continue if everything is OK. Proceed only if

the AC wall outlet meets the specifications of the value of voltage and frequency, the fluctuations and if it is correctly grounded.

2. Switch OFF (O) the instrument and disconnect power cord. 3. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate. 4. Verify unit 1 (power plug connector):

a. Disconnect the blue and red cable on unit 1, leave the grounding cable (yellow-green) connected. b. If necessary, replace the fuses (see 4.9.2). c. Reconnect the power cord and turn ON (I) the analyzer. d. Use a voltmeter (AC) to measure the voltage on the two pins of the power plug connector. The value

should be 110V or 230V (depending your location). If the measured voltage is not correct and the AC wall outlet meets the required specifications (see

4.9.1), the power plug connector needs to be replaced (CY009-S46). If the measured voltage is correct, proceed with step 5.

5. Switch OFF (O) the instrument and disconnect power cord. 6. Reconnect the cables of unit 1. 7. Verify the cables between unit 1 and 2:

a. Disconnect the two lower cables (blue and red) from unit 2. b. If necessary, replace the fuses (see 4.9.2). c. Reconnect the power cord and switch ON (I) the analyzer. d. Use a voltmeter (AC) to measure the voltage on the ends of the 2 disconnected cables. The value


4.9.1), verify the cables and replace them. If the measured voltage is correct, proceed with step 8.

8. Switch OFF (O) the instrument and disconnect power cord. 9. Reconnect the 2 upper cables of unit 2. 10. Verify unit 2 (power switch)

a. Disconnect the two upper cables (blue and red) from unit 2. b. If necessary, replace the fuses (see 4.9.2) c. Reconnect the power cord and switch ON (I) the analyzer. d. Use a voltmeter (AC) to measure the voltage on the two upper pins of the power switch. The value


4.9.1), the power switch needs to be replaced (CY004/9-S18). If the measured voltage is correct, proceed with step 4.9.6.

4.9.7 Verification of the power supply

Procedure for CY009-S24A or CYANSmart produced before 2017/01/31; until S/N BS6HSxxx 1. Turn OFF (O) the instrument and disconnect power cord. 2. Leave only the input connections (ACL, ACN and grounding) connected. Disconnect the output cables

from the power supply unit (GND and +V0). 3. Reconnect power cord and switch ON (I) the instrument.




4. Check if the fuses remain intact, the light of the power supply is burning, and use a voltmeter to check ifthe voltages are correct (measure on screws):- Input voltage: ACL versus ACN and ACN versus

grounding: 110 or 230V AC- Output voltage: +V0 versus GND: 24VDC. If this is not correct; the power supply needs to be

replaced (CY009-S24A). If this is correct, the problem is located downstream

from the power supply. Check all the parts individually(see relevant chapter for more information).

Procedure for CY009-S24B or CYANSmart produced after 2017/03/01; from S/N BS6IIxxx on 1. Turn OFF (O) the instrument and disconnect power cord.2. Leave only the input connector (L, N and grounding) connected. Disconnect the output connecter from

the power supply unit (- and +).3. Reconnect power cord and switch ON (I) the instrument.4. Check if the fuses remain intact, the light of the power supply is burning, and use a voltmeter to check if

the voltages are correct (measure on metal connections):- Input voltage: L versus N and N versus grounding: 110 or 230V AC- Output voltage: + versus – (grounding): 24VDC. If this is not correct; the power supply needs to be replaced (CY009-S24B). If this is correct, the problem is located downstream from the power supply. Check all the parts

individually (see relevant chapter for more information).

4.9.8 Cleaning and/or replacement of the fan for power assembly

Accumulation of dust or dirt can block the fan. This can lead to overheating of the power supply or mainboard. If the fan does not turn anymore, it needs to be cleaned and/or replaced.

Procedure: 1. Turn OFF the CYANSmart analyzer.2. Remove the cover of the instrument by unscrewing the 6 hex/allen screws on the bottom plate.3. Disconnect the wire of the fan for power assembly from the mainboard (see 4.2.1).4. Unscrew the 4 screws (1) attaching the gridding and fan to the rear panel.5. Use pressurized air (dry!) a damp cloth for cleaning the fan.

If the problem is not solved by cleaning, the fan needs to be replaced.



① ①

① CY009-S16 ①





5 VALIDATION Every year, the instrument should be validated to assure proper functioning. Validation is based on two principles: verification of linearity and verification of precision. This is done by measuring three reference solutions at different wavelengths potassium dichromate at 340 nm, Ammonium cobalt(II) sulfate hexahydrate at 510 nm. If they are not available Magnesium Xylidyl Blue at 510nm can be used.

5.1 PREPARATION OF A DILUTION SERIES

!ATTENTION POINTS!Always use freshly made solutions (not older than one day)

5.1.1 Ammonium colbalt (II) sulfate hexahydrate (powder)

1. Prepare a 100% solution by dissolving exactly 14g of ammonium cobalt (II) sulfate hexahydrate in100 mL distilled water.

2. Pipette 20 mL of this solution in the first tube (= 100% solution).3. Pipette 12 mL of the first tube into a second tube.4. Add 4 mL of distilled water to this second tube and mix well (= 75% solution).5. Pipette 8 mL of the second tube into a third tube.6. Add 4 mL of distilled water and mix well (= 50% solution).7. Pipette 4 mL of the third tube into a fourth tube.8. Add 4 mL of distilled water and mix well (= 25% solution).

Executed by Qualified personnel

Frequency Every year

Circumstances - 15-30°C for instruments and liquids

- Horizontal surface, away from direct sunlight

Equipment Balance (1 mg (0.001g) precision or better)

Reagent Ammonium cobalt(II) sulfate hexahydrate (powder, purity > 98%)

Potassium dichromate (purity > 99.5%)

Magnesium Xylidyl Blue (HB0320)

Registration Note and archive results

12 mL 6 mL 3 mL Mix well and use a different pipette point for every change of pipetting

20 mL

12 mL 8 mL 4 mL

4 4 4




5.1.2 Potassium dichromate (powder)

1. Prepare a 100% solution by dissolving exactly 180 mg of potassium dichromate in 1 L of distilledwater.

2. Continue like explained in the procedure above (see 6.1.1).

5.1.3 Magnesium Xylidyl Blue (liquid)

1. The 100% solution of Magnesium Xylidyl Blue is ready to use.2. Continue like explained in the procedure above (see 6.1.1).

5.2 VERIFICATION OF PRECISION

Measure the 100% solution of Potassium dichromate (340nm), Ammonium cobalt (II) sulfate hexahydrate (510 nm) and Magnesium Xylidyl Blue (510 nm) ten (10) times. Before proceeding with the measurement, it is essential to check that:

a) The hydraulic system is clean (flowcell + tubes) and rinsed with distilled water.b) The flowcell is completely filled with distilled water without any air bubbles.c) The instrument is ON for at least 30 minutes, this time is necessary for the lamp to stabilize and

for the flowcell and the incubator to reach the programmed temperature.d) The AD value has been executed and the results are within the acceptable ranges.

Procedure 1. Turn ON the CYANSmart analyzer and wait 30 min until the working temperature has been reached and

the lamp has stabilized.2. Go to the AD zero menu and perform an AD auto zero measurement with distilled water. The obtained

values need to be within acceptable ranges.3. Exit the Ad zero menu.4. Go to the “Filter Test” menu.5. Select the correct filter (340 or 510nm) by using the blue arrows.6. The gain (linked to the last AD zero performed) will automatically be displayed. DO NOT change this

gain!7. Position a tube filled with distilled water under the aspiration inlet and press PUSH to aspirate.8. Wait until the AD value of the blank for distilled water has stabilized.9. When the value is more or less stable, press “AD Test”. The value needs to be between 50.000 and 60.000.

Otherwise, rinse with distilled water and repeat the measurement.10. Press “OD test” to proceed with the sample measurement. In the new screen, the value for the blank of

distilled water will be displayed as soon as the button “AD test” is pressed.11. Position the tube filled with 100% solution under the aspiration inlet and press PUSH to aspirate the

sample.12. The instrument will measure the AD value of the sample and will calculate the optical density (OD). The

result will be displayed directly. Wait 3 seconds and then write the result.13. Repeat 10 times to aspirate 11 successive solutions (1 time to rinse and 10 times to measure).

NOTES: The first aspiration is done to rinse the tube and to avoid dilution by distilled water, do not write

down the result of this measurement. Start writing down the results starting from the secondmeasurement.

To accelerate the stabilization time, distilled water and the solutions can be preheated at 37°C.14. Calculate the precision:

a. Calculate the mean value of the three 100% solutions separatelyb. Calculate the standard deviation of the three 100% solution separatelyc. Calculate the %CV:




For example: the mean value is 1.884 and the standard deviation is 0.002:

5.3 VERIFICATION OF LINEARITY

Measure every sample of the dilution series (75%, 50%, 25%) ten times for the three reagents. Procedure Follow step 1 to 8 of the procedure in 6.2. 9. Position the tube filled with the solution (75%, 50% or 25%) under the aspiration inlet and press PUSH

to aspirate the sample. 10. The instrument will measure the AD value of the sample and will calculate the optical density (OD). The

result will be displayed directly. Wait 3 seconds and write the result. 11. Repeat 10 times to aspirate 11 successive solutions (1 time to rinse, 10 times to measure).

NOTES: Start with the measurement of the sample with the highest dilution: 25% 50% 75%. The first aspiration is done to rinse the tube and to avoid dilution by distilled water, do not write

down the result of this measurement. Start writing down the results starting from the second measurement.

To accelerate the stabilization time, distilled water and the solutions can be preheated at 37°C. 12. Calculate the linearity:

a. Calculate the mean value of every dilution (100%, 75%, 50% and 25%) for the 3 solutions separately. b. Calculate the standard deviation of every dilution (100%, 75%, 50% and 25%) for the 3 solutions

separately. c. Calculate the imperfection of linearity (%LE):

For example: the mean (100%) is 1.884 and the mean (75%) is 1.411:

5.4 VALUE

1. Precision: The maximal CV tolerated is 3% for the 3 solutions. 2. Linearity: The maximal linearity measurement (LEmax) tolerated is 4% for all the dilutions. If both conditions are fulfilled, the analyzer is approved. The instrument will then be labeled with the date and authentication sign. Please find the fill-in Excel sheet (with the correct formula) on our website in the distributor zone.




6 TROUBLESHOOTING

6.1 OPERATIONAL

Trouble Diagnosing and solution: AD Zero out of range for all filters

Check if (4.3.5): - The instrument is ON for at least 30 min. - The lamp is ON. If the lamp is OFF, check:

The voltage supplied to the lamp (see 4.3.12). There are no burns on the lamp wires. If the previous two points are OK, the lamp is broken and needs replacement (see

4.3.13). - The flow cell is in the correct direction (windows to front and back). - The flow cell is completely inserted to the bottom of the flow cell holder. - The optical cover is closed during measurement. - The hydraulic system (flow cell + tubes) is clean and rinsed with distilled water.

Perform washing and rinsing (see 3.2). - The windows of the flow cell are clean (no dirt/fingerprints).

Clean with wipes for glasses. - The flow cell is filled with distilled water and without any air bubbles.

Verify the pump calibration and the absence of leakages, cracks in tubes & flow cell. - The gain of all/most filters is 15,16 or more .

The lamp is aged and should be replaced (4.3.13). - The home sensor of the filter wheel is clean and working and replace if necessary (see

4.3.7, 4.3.8). AD Zero out of range for one or few filters

Check if (4.3.5): - The instrument is ON for at least 30 min. - The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water.

Perform washing and rinsing (see 3.2). - The windows of the flowcell are clean (no dirt/fingerprints).

Clean with wipes for glasses. - Verify the above 2 points even more thorough if only the 340 nm filter is out of range,

because this filter is the most sensitive to dirt are insufficient rinsing. - The flowcell is filled with distilled water and without any air bubbles.

Verify the pump calibration and the absence of leakages, cracks in tubes and flowcell.

- If after these verifications, the problems remain, check the individual filters (see 4.3.11, 4.3.7).

OD values are near zero

Check if - If the lamp is ON. If the lamp is off, check:

The voltage supplied to the lamp (see 4.3.12). There are no burn marks on the lamp wires. If the previous two points are OK, the lamp is broken and needs replacement.

- The flowcell is in the correct direction (windows to front and back). - The flowcell is completely inserted to the bottom of the flowcell holder. - The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water.

Perform washing and rinsing (see 3.2). - The windows of the flowcell are clean (no dirt/fingerprints).

Clean with wipes for glasses. - The flowcell is filled with distilled water and without any air bubbles.


- The reagents are deteriorated (reagent blank values out of range). - Preparation of the (working reagent) and the samples. - The method has been programmed correctly.




The concentrations are zero

Check if - The OD values are (near) zero.

See point above. - Restart the measurement and include a (new) calibration!

The first time you perform a method, it is essential that you perform a calibration, so the instrument can determine the factor for the calculation of the concentration.

Check the application sheets if a standard, calibrator or factor should be used. Some standard and all calibrators have a lot dependent concentration! Make sure

the correct concentration is programmed in the methods! Blank is out of range Check if:

- The instrument is ON for at least 30 min. - The method programming is consistent with the latest application sheets: distilled water

or reagent, the number of blank measurements and the blank limits. - The flowcell is filled with distilled water and without any air bubbles.


- Blank is distilled water. Perform washing and rinsing (see 3.2), then restart the test.

- Blank is reagent. Verify the preparation of the (working) reagent. Reagent is deteriorated, check storage conditions (expiration date and opening

date), open new kit or vial and restart the test. If after these verifications, the problems remain, please verify the optical system (see 4.3.5) and follow the correct procedure to diagnose and solve the issue.

QC is out of range or bad accuracy of results

Check if: - The instrument is ON for at least 30 min. - Reagent is deteriorated, check storage conditions (expiration date and opening date).

Open new kit or vial. - The preparation instructions of the (working reagent), blank, (standard) and the controls

have been followed strictly: stability, volumes, times (application sheets). - The method programming is consistent with latest application sheets.

Quality controls have a lot dependent concentration! Make sure the correct range is programmed in the methods!

- The flowcell is filled with distilled water and without any air bubbles. Verify the pump calibration and the absence of leakages, cracks in tubes and

flowcell. - Restart the measurement and include a new calibration!

o Check the application sheets if a standard, calibrator or factor should be used. o Some standard and all calibrators have a lot dependent concentration! Make sure

the correct concentration is programmed in the methods! o Some methods do not have a standard included in the kit. For these methods, a factor

is pre-programmed. You can use this factor if the QC measurements are within range. However, for the most accurate results, it is recommended to use a calibrator (see application sheets) to calculate the factor. This requires adjusting the settings of the method; program NUM of STD: 1 and CONC: as mentioned on the insert/vial.

o If even after recalibration with the standard included in the kit, the QC measurements are still outside the range, it is recommended to use a calibrator to perform a more accurate calibration (see application sheets). Adjust method programming!

If after these verifications, the problems remain, please verify the optical system (see 4.3.5) and follow the correct procedure to diagnose and solve the issue.




Bad repeatability of results

Check if: - The instrument is ON for at least 30 min. - The optical cover is closed during measurement. - The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water.

Perform washing and rinsing (see 3.2). - The flowcell is filled with distilled water and without any air bubbles.

Verify the pump calibration and the absence of leakages. - The reagents are not deteriorated. - The pipette for the manual handling has been correctly calibrated and the tips are

compatible.

6.2 TECHNICAL

Trouble Diagnosing and solution:

Power problem Check if: - The original power cord supplied with the instrument is used. - The connection of the power (wall outlet and instrument) is correct and firm. - The fuses are not burned.

Replace with the correct fuses: 2x T2AL250V. - Placed on a stable, horizontal surface, free from vibrations. - Placed away from other appliances that generate electrical noise or magnetic fields (e.g.

radiological instruments, X-ray, radio…). - Connected to a suited and grounded AC wall outlet, preferably one that is not shared

with other electric appliances and with low fluctuation of line voltage: AC 220V ± 10%, 50Hz ± 2% or AC 110V ± 10%, 60Hz ± 2%.

- If the AC wall outlet is not properly grounded, please connect a ground or earth wire to the bottom plate of the analyzer.

- If the fluctuation is >10% use the following supplementary devices: Electronic Stabilizer No Break module UPS – (Uninterrupted Power Supply).


If after these verifications, the problems remain, see 4.9 for more details. NOTE: In case of an electric shock, the settings saved in the mainboard can be modified or deleted. Please check and if necessary adjust the programming of the methods, the pump calibration, the temperature calibration and the other settings.

Temperature problem

Check if: - Not placed in direct sunlight, this could affect the operating temperature. - Not placed in a draught or under/up/ besides air conditioning or heat sources. - Leave 10 cm around and at the back of the instrument for air circulation and cooling. - Room temperature between 15 – 30 °C. - Instrument is on for at least 15-30 minutes. - In the temp display (system settings):

o The measured temperature for the flowcell is the set temperature ±1°C. o The measured temperature for the incubator is the set temperature 37.0 ±1°C.

If after these verifications, the problems remain, see 4.6 for more details.




Aspiration problem Check if: - The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water (see 3.2). - Verify that after aspiration of distilled water, there is no big drop formation at the tip of

the aspiration tube. Drop formation indicates the presence of leakage or blockage in the hydraulic system (tubes or flowcell):

- Leak in one of the tubes or the flowcell. Replacement is necessary.

- Blockage in one of the tubes can be caused by: Squashing of the tube, for example by the case, replace the tube if damaged. Sticking together of the pump tube. To prevent this, it is recommended to unhook

the pump tube if the instrument is not used for more than 1 week. Accumulation of dirt in the tubes perform a cleaning with hypochlorite (see 3.2),

replace if cleaning is not sufficient. - Blockage in the flowcell Accumulation of dirt in the flowcell perform a cleaning with hypochlorite (see

3.2), replace if cleaning is not sufficient. - The pump tube is installed and connected correctly (see 4.4.3). - The peristaltic pump is correctly calibrated. - The peristaltic pump motor is turning smoothly. If after these verifications, the problems remain, see 4.4 for more details.

Printing problem Check: - There is thermal paper inserted. - The paper is inserted in the correct direction (prints only on one side). - The result print is enabled in the print setup. If after these verifications, the problems remain, see 4.7 for more details.

Screen is not readable

Check: - Touch the screen to exit the standby mode. - Adjust the screen brightness in the system setup (see 4.8.2). - The voltage going to the touch screen (see 4.8.3). If after these verifications the problems remain, see 4.8 for more details.

System test failed If one of the tests fails, the System Test presents an error. Besides this general error, the instrument will indicate which part of the instrument causes the error. E.g. AD convert, Printer, Peltier element or sensor of filter wheel... Check the mentioned part, see the relevant chapter for more details.




7 SAFETY INFORMATION

This information summarizes the established guidelines for handling laboratory biohazard. Use this summary for general information only. It is not intended to replace or supplement your laboratory’s or hospital’s biohazard control procedures. By definition, a biohazard condition is a situation involving infectious agents biological in nature, such as the hepatitis B virus, the human immunodeficiency virus, and the tuberculosis bacterium. These infectious agents may be present in human blood, blood products and other body fluids.

The following are the major sources of contamination when handling potentially infectious agents: Needles Hand-to-mouth contact Hand-to-eye contact Direct contact with superficial cuts, open wounds and other skin conditions that may permit adsorption

into subcutaneous skin layers Splashes or aerosol contact with skin and eyes

To prevent accidental contamination in a clinical laboratory, strictly adhere to the following procedures: Wear gloves while servicing parts of the system that have been in contact with body fluids such as

serum, plasma, urine, or whole blood. Wash your hands before going from a contaminated area to a non-contaminated area, or when you

remove or change gloves. Perform procedures carefully to minimize aerosol formation. Wear facial protection when splatter or aerosol formation are possible. Wear personal protective equipment such as safety glasses, gloves, lab coats or aprons when working

with possible biohazard contaminants. Keep your hands away from your face. Cover all superficial cuts and wounds before starting any work. Dispose contaminated materials according to your laboratory’s biohazard control procedures. Keep your work area disinfected. Disinfect tools and other items that have been near any part of the system sample path or waste area

with 10% v/v bleach. Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the laboratory. Do not mouth pipet any liquid, including water. Do not place tools or any other items in your mouth. Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or washing hands. Do not recap, purposely bend, cut, break, remove from disposable syringes, or otherwise manipulate

needles by hand.



INSTALLATION FORM

Please FILL IN the INSTALLATION FORM and send a COPY BACK TO CYPRESS DIAGNOSTICS Make sure to register also the instrument on the website: www.diagnostics.be

Distributor (Company name)

Coordinates

(Country, city)

(E-mail)

(Website)

(Tel.)

Technician in charge

(Name)

(E-mail)

(Tel.)

Laboratory (Laboratory name)

Coordinates

(Country, city)

(E-mail)

(Website)

(Tel.)

Lab technician

(Name)

(E-mail)

(Tel.)

Instrument CYANSmart

Delivery date (date)

Installation date (date)

End warranty (date)

Serial number

Software version



Checklist for installation (for detailed explanation see manual)

□ Check content according to packing list

□ Check location requirements

□ Check electronical current requirements. If necessary, use:

□ Electronic stabilizer

□ UPS

Installation of all accessories on the CYANSmart analyser

□ Connect the power cord to a suited power supply

□ Install the peristaltic pump

□ Install the flowcell, aspiration button and aspiration tube

□ Install the waste tube and the waste bottle

□ Switch on the instrument

□ Install printing paper

Checking the CYANSmart analyser

□ Check system self-test at start-up

□ Perform washing and cleaning

□ Check the aspiration and hydraulic circuit by performing a pump calibration

□ Check the optical system by performing an AD autozero

Adaptation of the system to the customer

□ System setup: print setup, standby time, date and time, hospital name, language

□ Customize the methods, adjust the units if necessary

□ User manual and application sheets in laboratory

□ Give extensive information on daily use and maintenance to the user

Comments

Laboratory technician Name Signature

Maintenance engineer Name Signature Date



MAINTENANCE FORM

Distributor (Company name)

Coordinates

(Country, city)

(E-mail)

(Website)

(Tel.)

Technician in charge

(Name)

(E-mail)

(Tel.)

Laboratory (Laboratory name)

Coordinates

(Country, city)

(E-mail)

(Website)

(Tel.)

Lab technician

(Name)

(E-mail)

(Tel.)


Delivery date (date)

Installation date (date)

End warranty (date)

Serial number

Software version

Last visit: (date)

Next visit: (date)



Headquarters - Siège social: Langdorpsesteenweg 160 • 3201 Langdorp • Belgium • www.diagnostics.be • Factory - Fabrique: Industriepark 36 • Zone B5 • 2235 Hulshout • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: [email protected]

MAINTENANCE INSTRUCTIONS To be performed by Period Activity Date Date Date Date Date

Laboratory Technician

Daily

AD autozero

Rinse between methods

Wash the flowcell with detergent

Clean outside of the instrument

Use dust cover to protect the instrument after shutdown

Weekly Disinfect the flowcell with hypochlorite

Pump calibration

Maintenance Engineer

6 months Remove dust inside the instrument Replace the peristaltic pump tube (CY009-S25)

1 year/ 2000 hours Replace the lamp (CY009-S11)

1 year

Replace: Plastic aspiration tube (CY004/9-S26) Waste tube (CY004/9-S28) Tube from pump to waste connection

(CY004/9-S40) Tube from flowcell to pump (CY004/9-S41)

2/3 years

Replace: Pre-amplifier board with cable (CY009-S33)

together with lamp Rubbers of peristaltic pump (CY009-S54)

together with the pump tube Connector of waste tube (CY009-S29) Connector of pump tube (CY009-S30)

Problems Fill in repair form*



REPAIR FORM


Delivery date (Date)

Installation date (Date)

Serial number

Software version

Date of complaint (Date)

Description of problem (details)

Actions undertaken (details)

Spare parts used

Code Name

Problem solved YES NO



Comments



Please fill in the above document, in order to track the different interventions. We suggest to keep the original together with the instrument and to deliver copies to the maintenance

engineer and Cypress Diagnostics.

Actions for future (details)

When support from Cypress is requested, please also include in your communication:

Overview of previous maintenance Overview of previous problems regarding this instrument Is the instrument protected against power surges by a UPS and/or electronic stabilizer? AD autozero result (at least 2 repetitions) Pump calibration (results of at least 3 repetitions) Video or photo of the issue If there is only a problem with specific reagents, then include the following details of the reagents and standard/calibrator and quality controls:

Item code Lot number Date of opening Storage temperature and time Method programming Values of results (absorbance’s (OD), not only calculated

concentrations) o AD value o Reagent blank o Standard/Calibrator o Quality controls (normal and pathological)



Version: March 2017Valid till: next update

Page: 1

Item Code Item name Photo Comments Suggested stock:

for one year* 10 sold instruments

Consumable

Accessories & Consumables

CY001-S01 Thermal print paper (57mm width) Y user dependent user dependent

CY001-WS CYAN Washing solution Y 4 5

CY004/9-S43 Dust cover N 2

Hydraulic & aspiration assembly

CY009-S10 Peristaltic pump rotor with motor N 1

CY009-S54 Rubber of peristaltitic pump (2 pcs) Replace every 2-3 years (Y) 6

CY004/9-S21 Aspiration switch with cable N 1

CY004/9-S22 Aspiration button (black/blue) N 1

CY009-S25 Pump tubeReplace every 6 months See hydraulic diagram

Y 2 10

CY004/9-S26 Plastic aspiration tubeReplace every year See hydraulic diagram

Y 1 5

CY004/9-S27 Metal aspiration tube See hydraulic diagram N 3

CY004/9-S28 Waste tubeReplace every year See hydraulic diagram

Y 1 5

CY009-S29 Connector of waste tubeReplace every 2-3 yearsSee hydraulic diagram

(Y) 2

CY009-S30 Connector of pump tube (2 pcs)Replace every 2-3 yearsSee hydraulic diagram

(Y) 4

CY004/9-S40 Tube from pump to waste connectorReplace every yearSee hydraulic diagram

Y 1 5

CY004/9-S41 Tube from flow cell to pumpReplace every year See hydraulic diagram

Y 1 5

CY004/9-S44 Waste bottle (Y) 3

CYANSmart SPARE PARTS




Page: 2



Consumable

Incubator Assembly

CY009-S51 Incubating block/ heating block N 1

CY009-S34 Temperature sensor (optical & incubator) N 1

CY009-S52Heater element for incubator with temperature control switch

N 1

Main Assembly

CY009-S13 Main Control Board N 1

CY009-S19 Cable of touch screen N 1

CY009-S20A Touch screen (Type A)For SN BS6GHxxxsoftware version 1.0.11B & 1.0.11Includes CY009-S19

N 1

CY009-S20B Touch screen (Type B)For all other SNsoftware version 1.1.1B or higherIncludes CY009-S19

N 1

CY004/9-S23 Printer with board N 1

CY009-S42 Case N

CY004/9-S50 Rubber foot/support 4 per instrument N

CY009-S55 USB Socket with cable N 1

CY009-S56 USB cable for connection with PC and special software N

Optic Assembly

CY009-S01 Optical Assemblycorrect alignment with motor, without filters, lamp, flowcell, heater, sensors, fan or board

N

CY004/9-S02 Filter 340 nm N 1





Page: 3



Consumable






CY004/9-S09 Flowcell (Y) 2

CY009-S11 Lamp (with frame, cable and connector)Replace every 2000 hours/year Connection directly on main board (6V 10W)

Y 1 5

CY009-S12 Motor of filter wheel N 1

CY004/9-S14 Heater (Peltier) of flow cell N 2

CY009-S15 Fan of optical assembly (50x50) N 1

CY009-S33 Pre-amplifier board with cable Replace every 2/3 years (Y) 5

CY009-S34 Temperature sensor (optical & incubator) N 1

CY004/9-S35 Home sensor of filterwheel N 2

CY004/9-S45 Fixing screw for lamp N 1

Power Assembly

CY009-S24A Power supply (type A) Until SN BS6HSxxx; P/D 2017/01/31 N 1

CY009-S24B Power supply (type B) with cables From SN BS6IIxxx; P/D 2017/03/01 on N 1

CY009-S16 Fan for power assembly (80x80) N 1




Page: 4



Consumable

CF-T2.0AL250V Fuse T2AL250V (10 pcs) 2 per instrument (Y) 1

CY004/9-S49 Power cord N 1

CY004/9-S18 Power switch N 1

CY009-S46 Power plug connector (seat) N 1

Hydraulic diagram

Your Distributor

CYANSmart: Semi-Automatic Biochemistry Analyser

Up to 60 tests/hour

Optical system

• Flowcell: 32 μl, 10 mm light path• Min. reaction volume: 500 μl per test• Halogen lamp 6 V / 10 W• Photo detector: Silicon based (range 300 – 900 nm)• Measurement range: 0,000 – 3,500 Abs• Wavelength: 340 – 620 nm• Wavelength selection: Automatic via 7 interference

fi lters: 340, 405, 492, 510, 546, 578 & 620 nm

Flowcell

• 25°C, 30°C, 37°C, ambient temperature • Peltier element• Thermostatic control: PID controlled, ± 0,5°C

Incubator

• 20 places with 14 mm diameter• 37°C • Thermostatic control: PID controlled, ± 1°C

Display

• Back-illuminated LCD• Touchscreen calibration possible• 800 x 480 pixels (screen size: 7 Inch)

Printer

• Automatic or on-demand printing• Built-in thermal printer• 24 characters per line• Prints graphs

Software

• Memory: 180 test methods & 6000 sample test results• Cypress Diagnostics methods pre-programmed at

delivery• Languages: English, French, Spanish• QC: 2 controls programmable & separate QC result

menu with (printable) graphs• Calculation methods: Absorbance, End Point, Two-

Point, Kinetic, Bichromatic• Calibration methods: Factor, Calibrator and Multi-point

Calibration• Blank options: Sample blank, reagent blank and water• Incubation time: 0 – 999 seconds• Reading time: 3 – 999 seconds

Power supply

• AC 110/220 V 50/60 Hz • Automatic voltage and hertz switch• Grounding required• 2 fuses 2TAL250V• Power: 200 VA, reduced to 140 VA in standby mode• Power save / Standby mode

Weight and dimensions

• Instrument: 9 kg, 43,5 x 41,5 x 20 cm (H x W x L)• Packed in box: 11,5 kg, 52 x 43 x 26 cm (H x W x L)

Environmental requirements

• Ambient temperature: 15°C – 30°C• Storage temperature: 5 - 50°C• Relative humidity: 30 % - 70 %

Order code:

• CY009: CYANSmart

Contact: e-mail: [email protected]

tel: + 32 (0)15 67 67 68

Headquaters: Cypress Diagnostics

Langdorpsesteenweg 160

3201 Langdorp

Belgium

Factory: Industriepark 36

Zone B 5

2235 Hulshout

Belgium

URL: www.diagnostics.be

www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: [email protected]

ISO 9001:2008ISO 13485:2003

Documents

Service Manual - Diagnostics read the service manual before opening the ... The CYANSmart is a semi-automated biochemistry analyzer. ... CY009 CYANSmart Analyzer 1 - User manual …