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CY004

English
CYANStart
User Manual

For a clear and precise diagnose

 ISO 13485:2003


ISO 9001:2008

www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be


INDEX
1 INTRODUCTION...................................................................................................................................................................... 4
1.1 PRINCIPLE OF MEASUREMENT ...........................................................................................................................4
1.2 INTENDED USE ...................................................................................................................................................5
1.3 DESCRIPTION OF THE ANALYZER ......................................................................................................................5
1.3.1 Thermal printer 5
1.3.2 Screen 6
1.3.3 Keyboard 6
1.3.4 Optical system 7
1.3.5 The hydraulic and aspiration system 8
1.3.6 Rear panel 9
1.4 TECHNICAL & OPERATIVE SPECIFICATIONS .......................................................................................................9
1.5 USE RESTRICTIONS .......................................................................................................................................... 10
1.6 REGULATORY COMPLIANCE ........................................................................................................................... 10
2 INSTALLATION ..................................................................................................................................................................... 11
2.1 TRANSPORT AND STORAGE ............................................................................................................................ 11
2.2 UNPACKING .................................................................................................................................................... 11
2.3 INSTALLATION................................................................................................................................................. 12
2.3.1 Locations specifications 12
2.3.2 Power supply connection 12
2.3.3 Install the peristaltic pump tube 13
2.3.4 Install the flowcell, aspiration tube and aspiration button 14
2.3.5 Install the waste tube and waste bottle 15
2.3.6 Switch on the analyzer 16
2.3.7 Install or change the print paper 16
2.3.8 Verify the instrument 17
2.3.9 Adaptation of the system to the end customer 17
3 SOFTWARE DESCRIPTION ................................................................................................................................................ 19
3.1 SYSTEM START – “SELF-TEST” ....................................................................................................................... 19
3.2 MAIN MENU .................................................................................................................................................... 19
3.3 PERFORM TEST ................................................................................................................................................ 20
3.3.1 AD Auto Zero (AD value) 22
3.3.2 Test Blank 22
3.3.3 Test standard 23
3.3.4 Quality Control Measurement 24
3.3.5 Sample Measurement 26
3.3.6 End of test 27
3.3.7 Specific method instructions and formulas 27
3.4 PROGRAM SETUP............................................................................................................................................ 30
3.4.1 Program add 31
3.4.2 Program modify 34
3.4.3 Program delete 34
3.4.4 Program print 34
3.4.5 Item list 35
3.5 RESULT PROCESS ............................................................................................................................................ 35
3.5.1 Result list 35
3.5.2 Delete all results 36
3.5.3 Control manage 36

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3.5.4 Print report 37
3.6 PUMP CALIBRATION ....................................................................................................................................... 37
3.7 AD AUTO ZERO ............................................................................................................................................. 39
3.8 AD VALUE ...................................................................................................................................................... 40
3.9 SYSTEM SETUP ................................................................................................................................................ 40
3.9.1 Temp display 40
3.9.2 Filter and Cuvette 41
3.9.3 Printer Setup 41
3.9.4 Language Setup 42
3.9.5 Aspiration Format 42
3.10 OTHER SETTINGS ............................................................................................................................................ 43
3.10.1 Heading Setup 43
3.10.2 Date Format Setup 43
3.10.3 Date & Time Setup 43
3.10.4 Hospital Setup 43
3.10.5 OD Test 43
4 DAILY ROUTINE ................................................................................................................................................................... 45
4.1 PREPARATIVE WORK ....................................................................................................................................... 45
4.1.1 Preparation of the analyzer 45
4.1.2 Perform an AD auto zero 45
4.1.3 Preparation of the reagent 45
4.1.4 Preparation of the samples 45
4.2 START SAMPLE ANALYSIS ............................................................................................................................... 45
4.2.1 AD Auto zero (AD Value) 45
4.2.2 Test Blank 46
4.2.3 Test Standard/Calibrator 46
4.2.4 Quality control measurement 46
4.2.5 Sample measurement 47
4.3 END OF TEST ................................................................................................................................................... 47
4.4 EVALUATE THE SAMPLE RESULTS ................................................................................................................... 47
4.5 SHUT DOWN ................................................................................................................................................... 47
4.5.1 At the end of the day 47
4.5.2 At the end of the week 47
5 MAINTENANCE .................................................................................................................................................................... 49
5.1 PUNCTUAL MAINTENANCE ............................................................................................................................ 49
5.2 ROUTINE MAINTENANCE ................................................................................................................................ 49
5.2.1 Washing 49
5.2.2 Cleaning 50
5.2.3 Verification 50
5.3 REPLACEMENT OF SPECIFIC PARTS ................................................................................................................. 51
5.3.1 External cleaning 51
5.3.2 Internal washing 51
5.3.3 Replacement schedule 51
5.3.4 Replacement of peristaltic pump tube 51
6 TROUBLESHOOTING.......................................................................................................................................................... 53
6.1 OPERATIONAL................................................................................................................................................. 53
6.2 TECHNICAL...................................................................................................................................................... 55
7 SAFETY INFORMATION ..................................................................................................................................................... 57
MAINTENANCE FORM

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MAINTENANCE INSTRUCTIONS
REPAIR FORM
INSTALLATION FORM
CONSUMABLES

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1 INTRODUCTION
The CYANStart is an easy to operate semi-automatic biochemistry analyzer. This in vitro diagnostic
instrument is designed to have powerful features in a compact, independent unit.

Cost savings
 Minimum reaction volume of 500 μl results in a decreased cost per test
 No consumables required
 Extra consumables included at delivery (two fuses, five paper rolls, one spare lamp and a pump
tube)
 Integrated pump, flowcell and printer
 Long life lamp
 Robustness of the analyzer, guides the user and reduces mistakes
Flexibility
 On board printer for automatic or on-request printing
 Seven wavelengths (340, 405, 492, 510, 546, 578 and 620 nm filters) cover all clinical diagnostic
applications
 Five calculation methods (absorbance, end point, two-point, kinetic, dichromatic) and three
calibration methods (factor, calibrator and multi-point calibration) provide plenty processing
options with one system
 Three blank options (sample blank, reagent blank and distilled water) provide background
correction of the reagent and sample coloration
Convenience
 All Cypress Diagnostics biochemistry reagents are pre-programmed at delivery
 200 open channels are programmable to allow for unrestricted testing
 Memory for up to 1000 results
 Large font size, pleases the eye and reduced the effort
 Large keyboard buttons, for unambiguous manipulation with gloves
 Multilingual possibility
 Minimal daily maintenance

1.1 PRINCIPLE OF MEASUREMENT


CYANStart is a semi-automated biochemical 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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1.2 INTENDED USE
(Semi-) automatic biochemistry analyzers are medical laboratory instruments, widely applied in hospitals
and research institutes. They are designed for the quantitative determination of different biochemical
substances and other characteristics in a number of biological samples. These measured properties of blood
and other fluids may be useful in the diagnosis of disease.
The type of in vitro diagnostic test that can be performed on this analyzer include enzyme levels (such as
many of the liver function tests), ion levels (e.g. sodium and potassium, and other tell-tale chemicals (such
as glucose, serum albumin, or creatinine). Enzymes may be measured by the rate they change one colored
substance to another; in these tests, the results for enzymes are given as an activity, not as a concentration
of the enzyme. Other tests use colorimetric changes to determine the concentration of the chemical in
question. Turbidity may also be measured.
The automation of laboratory testing does not remove the need for human expertise (results must still be
evaluated by medical technologists and other qualified clinical laboratory professionals), but it does
minimalize the potential human errors, resulting in higher precision and accuracy. Furthermore, it reduces
sample and reagent volumes and increases the speed of the testing compared to measurement with a
spectrophotometer.
NOTE:
CYANStart is a system that allows configuration with different reagents selected by the customer in order
to fit his needs. Upon delivery, the instrument is configured for the validated biochemistry kits of Cypress
Diagnostics. In order to assure the analytical performances of the system « instrument + reagents », it is
strongly recommended only to use reagents, controls and calibrators validated on CYANStart.
1.3 DESCRIPTION OF THE ANALYZER
The CYANStart is a microcomputer-based independent unit, controlling several systems: built-in thermal
printer, screen, keyboard, optical detection system with flowcell and the aspiration system.
5
1
2 1. Printer cover
2. Screen
4 3. Keyboard
3
4. Optical system
5. Peristaltic pump
8
6. Aspiration button
6 7. Inlet tube
7 8. Rear panel

1.3.1 Thermal printer


The CYANStart has an internal thermal printer. The texts or graphs are printed on the surface of
thermochromic paper, which is heated selectively by passing through a thermal print head. The heated
parts produces a black character or image on the paper. The use of thermal printers has a big advantage
because the use of ink, which are usually expensive, is unnecessary.
NOTE:
There are two types of thermal printers depending on the serial number of the analyzer.
A. Type A: CYANStart produced before 09/2014: S/N until BS1FL203
The old printer has a blue/white lever. This lever generates the necessary pressure needed for printing. The
lever needs to be pushed up to insert a new roll of paper and it needs to be pushed down to apply the
necessary pressure needed for printing (see 2.3.7).
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B. Type B: CYANStart produced from 09/2014: S/N BS1FSxxx et BS1GPxxx
In the new printer the correct pressure is generated by the rubber pressure bar, it is not necessary to
adjust it. The new printers are compatible with all CYANStart analyzers.
Old New

Lever

1.3.2 Screen
The screen of the CYANStart displays all the menus/functions available for the CYANStart. Upon selection
of a menu using the keyboard, the selected menu will be colored (see image below) and the instrument will
generate a beep sound as confirmation of the activation.

1.3.3 Keyboard
The keyboard is composed of the following keys:

To insert the number 1. To insert the number 0 or spaces. To


insert numbers or letters. For example to insert the letter b, this button
needs to be pushed twice.
To insert a point for the decimal numbers.

This button is used to move the print paper forward without printing and to
load a new roll of print paper (see 2.3.7).
Arrows in 4 directions (left-right, up-down). To select/activate different
menus/functions/pages on the screen (see specific menus for more details).
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To confirm a selection, data entered and to carry out the requested
instructions.
To suspend the performing operation and return to the previous menu.

This button is used to activate the peristaltic pump to rinse/wash/disinfect


the hydraulic system (tubes + flowcell). Insert the inlet pipe in the liquid you
want to aspirate and press the “Wash” button. The instrument will aspirate
the liquid as long as the “Wash” button is pressed. At least 15 mL of distilled
water is required to rinse the whole hydraulic system. This function is used
to:
 Aspirate distilled water to rinse the system.
 Aspirate detergent or hypochlorite solution to wash/disinfect the
system.
 Aspirate air to dry the system.
Furthermore, pushing the aspiration button (when this is NOT requested by
the software, thus in the absence of the notification “Press Push to
aspirate…”) has the same function.
! WARNING !
The keyboard can only respond to a single point of contact at a time. If something else is in contact or
presses on the keyboard, the keyboard will not respond to your touch!

1.3.4 Optical system


① Lamp
② Filter wheel
③ Filter wheel motor

⑦ ④ Flowcell

② ⑤ Temperature sensor
⑥ Peltier element
③ ⑦ Pre-amplification board

⑥ with photodiode detector

The optical system is the functional key component of the instrument. It contains the light source, filters for
wavelength selection, flowcell with heating mechanism and a pre-amplification board which has several
functions. It contains the photodiode detector and resistances responsible for the adjustment of the signal
amplification coefficient (gain) and offset. Furthermore, this pre-amplifier board also converts the light
detection from an analog to a digital signal for further processing.
The 6V, 10W halogen lamp is installed on a lamp holder. The normal life span of the lamp is 2000 hours (= 1
year).
The filter wheel 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 pad through a
cooperation between the filter motor and the filter home sensor. The wavelength accuracy is ± 2 nm.
The light then passes the flowcell, which has a light path of 10 mm. The flowcell is heated with a Peltier
element preset to 25°C, 30°C or 37°C and the heating is regulated by temperature sensor.
Ultimately, the light is detected by a silicon photodiode on the pre-amplifier board. This photodetector has
a range of 300-900 nm.

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Absorbance measuring range:
0.000 ~ 2.500 optical density (OD)
Absorbance linearity:
a) absorbance is 0.200 ~ ≤0.500, the bias is within ±5%
b) absorbance is >0.500 ~ ≤1.000, the bias is within ±4%
c) absorbance is >1.000 ~ ≤1.800, the bias is within ±2%
d) absorbance is >1.800, the bias is within ±5%
Stability:
At 340nm, in 20 min, the absorbance drift of distilled water is ≤0.005.
Repeatability:
The variable coefficient of repeatability measurement should be CV ≤1.0%
Carry-over:
If the total reaction fluid is 1.0 ml, the carry-over of neighboring samples is ≤1.0%

1.3.5 The hydraulic and aspiration system


The peristaltic pump is situated on the left side of the instrument. It can be activated by:
- The ‘Wash’ button on the keyboard
- The aspiration switch by pushing the aspiration button
Upon activation of the peristaltic pump, a quantitative volume is aspirated in the hydraulic system. This is a
continuous line consisting of various tubes, connectors, the flowcell, and ending in the waste bottle.

Inlet fastening
screw

Aspiration
button

Waste Rear panel Peristaltic pump Flowcell Aspiration


Bottle switch

Tubes
CY004/9-S26 Plastic aspiration tube
CY004/9-S27 Metal aspiration tube
CY004/9-S41 Tube from flowcell to pump
CY004/S25 Peristaltic pump tube
CY004/9-S40 Tube from pump to waste connector
CY004/9-S28 Waste tube
Connectors

CY004-S30 Connector pump tube (2 per instrument)

CY004-S29A Connector waste tube (old)

CY004-S29B Connector waste tube (new)

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1.3.6 Rear panel
Below you can find a picture of the rear panel of the CYANStart.

1. Back label with serial number


1 2. Fan for internal cooling
(80x80)
3. RS232 connection
3 5 6 4. Voltage switch
2
5. Power connection with the
7 first fuse
4 6. Power supply switch
8 7. Second Fuse
8. Connector of waste tube

Symbol Explanation
Attention:
Read the instructions in the user manual before use
Biological hazard:
Carefully manipulate all the consumables and the waste produced during the analysis
routines. Use appropriate protective garment. Disposal of waste 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.
1.4 TECHNICAL & OPERATIVE SPECIFICATIONS
Optical system
Flowcell 32 μl, 10 mm light path
Reaction volume 500 μl per test
Light source Halogen lamp 6V / 10W
Photo detector Silicon based (range 300 – 900 nm)
Measurement range 0,000 – 2,500 Abs
Wavelength 340 – 620 nm
Wavelength selection Automatic via 7 standard interference filters: 340nm, 405nm,
492nm, 510nm, 546nm, 578nm, 620nm
Flowcell
 25°C, 30°C, 37°C, ambient temperature (R.T.)
 Peltier element
 Controlled by adjustment of resistance VR203 on the main board
Screen
 240 x 128 pixels
 Brightness controlled by adjustment of resistance VR101 on the main board
Printer
 Automatic or on-demand printing
 Built-in thermal printer
 24 characters per line
 Prints graphs
Software
 Data storage 200 test methods & 1000 sample test results
 Methods Cypress methods pre-programmed at delivery
 Languages English, French, Spanish
 Quality control feature 1 control programmable
Separate QC result menu with printable graphs
 Calculation methods Absorbance, end point, two-point, kinetic, bichromatic
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• Calibration methods Factor, calibrator and multi-point calibration
• Blank options Sample blank, reagent blank and distilled water
• Incubation time 0 – 999 seconds
• Reading time 1 – 999 seconds
Power supply
 AC 230 V ± 10 %, 50 Hz ± 2 % or AC 110 V ± 10 %, 60 Hz ± 2 %
 Voltage and hertz switch are easily accessible
 Grounding required
 2 Fuses F2AL250V
Weight and dimensions
 Instrument: 8,5 kg, 350x 400 x 240 mm (LxWxH)
 Packed in box: 11 kg, 520 x 430 x 260 mm (LxWxH)
Recommended environment
 Ambient temperature: 15°C – 30°C
 Storage temperature: 5°C – 50°C
 Relative humidity: 30% - 70%
 Atmospheric pressure: 860hPa – 1060hPa
1.5 USE RESTRICTIONS
After turning on the instrument, be careful not to splatter the instrument and its’ surrounding surface. Keep
the instrument out of reach of children
1.6 REGULATORY COMPLIANCE
The CYANStart complies with European Directive 97/79/CE for In Vitro diagnostic.

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2 INSTALLATION

2.1 TRANSPORT AND STORAGE


The packing has been expressly studied and designed to insure maximum protection of the contents during
shipping and handling. It is therefore extremely important that the box is carefully examined upon delivery
in order to assure the integrity. All visible external damage (for example: holes, dents, rips or tears, water
marks, etc.) must be noted on the delivery note. Please make photos of the damage. This will simplify
matters in the event of any future claims for damages.
NOTE:
Once the carrier has taken possession of the system for transportation from the factory, the carrier takes
total responsibility until delivery. All claims for damage due to transportation must be filed against the
carrier as soon as these damages are noticed.
The CYANStart carton box should be stored in an environment with a temperature range of 5 – 50 °C, relative
humidity not more than 80 %, well ventilated and indoors. Storage should be away from toxic, harmful and
corrosive substances. Make sure the box is in the upright position (arrows on box).

2.2 UNPACKING
Open the box and carefully take out the analyzer and accessories.
1. Makes sure the SN (on the back label) is in accordance with the delivery note/packing list.

2. Check that all the items of the following list are undamaged and included in the carton box.

Code Description Quantity


CY004 CYANStart Analyzer 1
- User manual including application sheets 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 2AL250V 2
CY004-S11 Lamp with frame, cable and connector 1
CY004-S25 Pump tube 1
CY001-S01 Thermal print paper 5
CY004/9-S43 Dust cover 1

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If the instrument is damaged or items are missing, contact your local distributor/importer immediately for
assistance. Make sure to document with photos.

! 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.
2.3 INSTALLATION
CYANStart is an easy to operate instrument with integrated user-friendly software. No additional computers
or instruments are needed. In order to fully guarantee the performance of CYANStart, it is extremely
important that it is correctly installed.
If the installation, usage and maintenance directions, given in this manual, 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.
Procedure
1. Verify the locations requirements
2. Connect power cord to a suited power supply
3. Install the peristaltic pump
4. Install the waste tube and the waste bottle
5. Install the flowcell, aspiration button and aspiration tube
6. Switch on the instrument
7. Install printing paper
8. Verify the instrument
9. Adaptation of the system to the end customer

2.3.1 Locations specifications


Please take note of the following conditions required for the location of the installation:
 Clean, dust-free environment
 Not in direct sunlight, this could affect the operating temperature and the quantity of light
measured by the instrument.
 Avoid draughts, and do not place under/up/ besides air conditioning or heat sources
 Away from other appliances that generate electrical noise or magnetic fields (e.g. radiological
instruments, X-ray, radio…)
 Placed on a stable, horizontal surface, free from vibrations
 Leave 10 cm around and at the back of the instrument for air circulation and cooling.
 Room temperature between 15 – 30 °C
 Humidity between 30 – 70 %
 Atmospheric pressure between 860 hPa – 1060 hPa

2.3.2 Power supply connection


1. Connect the power cord 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
VOLTAGE
AC 110V ± 10 %, 60Hz ± 2%
2. If the AC wall outlet is not properly grounded, please connect a ground or earth wire to the bottom
plate of the analyzer.
NOTE: The instrument can work at 110V or 230V. The correct voltage setting can be adjusted manually in

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the rear panel of the instrument. There are 2 fuses (F2AL250V) present in the rear panel of the instrument,
one on the power connection and one separate. These fuses prevent damage to the instrument due to the
instrument overcurrent.
Before establishing the connection, please check the setting of the voltage switch according to your
country’s electrical network.
 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.
 ! Fire hazard. For continued protection replace only with the same type and rating of the fuses!
Always disconnect power cord before replacing the fuses!
 In order to ensure proper instrument functioning, the manufacturer strongly advises to use a
stable tension supply outlet (±10 %). If this cannot be guaranteed, use of the following
supplementary devices is recommended:
o 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.
o No Break module UPS - (Uninterrupted Power Supply) This module provides two important
functions:
 Stabilizes the main-line power
 Supplies current to the instrument in case of a main-line power failure.
NOTE:
In case of an electric shock, the parameters saved on the motherboard can be modified or deleted. Please
ask the technician of your distributor to check and if necessary readjust the programming methods, the
pump calibration, the temperature calibration and the settings of filters and flowcell.

2.3.3 Install the peristaltic pump tube


The peristaltic pump is situated on the left side of the instrument. During transport, the peristaltic tube is
disconnected (as indicated below) to avoid any damage.
1. Unscrew the 4 screws fixing the cover of the peristaltic pump on the left side of the instrument to have
access to the peristaltic pump.
2. Place the tube (1) around the middle of the peristaltic rotor (2). The easiest method is by removing one
connector from its support, then place the tube around the rotor and finally place back the connector
to its support.
3. Make sure that the tube is placed in the correct direction. The tube coming from the flowcell is placed
down and the tube going to the waste connector is placed up.
4. Turn the peristaltic rotor manually (in the correct direction, see direction red arrow) to verify if the pump
tube is correctly fixated. A rotor turning easily indicates a correct placement of the tube. If not, check
“Attention Points” below.
! The manual rotation of the rotor can only be performed while the instrument is turned off (O).
! If the instrument is turned (I), the movement of the rotor will be blocked and the manual rotation could
damage the mechanism.
5. Place back the cover of the peristatic pump.

OUT
To waste connector

IN
From flow-cell

! ATTENTION POINTS!
1. Verify is the tube is placed in the middle of the rollers of the rotor.
2. Make sure that the connectors are completely inserted in the tube.
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3. Verify if the white plastic connectors are placed correctly around/on the pump tube and in their support.
4. Make sure that the tubes are not squashed or bent by the mold of the instrument.

√ √ √ √ √

X X X X X

2.3.4 Install the flowcell, aspiration tube and aspiration button


1. Open the optical cover.
2. If the flowcell (1) is wrapped (protection during transport), unpack it, insert it in the reading well and
secure its position. Check the attention points.
3. Insert the metal part (2) of the aspiration inlet in the designated support and secure the position by
tightening the screw (3).
4. Under the aspiration tube, a switch/lever (4) is present. Place the aspiration button (5) over this lever.
5. Close the optical cover.

! 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. Make sure nothing is blocking the insertion!
4. Secure its position with the designated golden plate.

√ X
⑦ ⑥ ⑦⑦
⑥ ⑦ ⑥ ⑥

window

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2.3.5 Install the waste tube and waste bottle
There are two types of waste tube connectors.
A. Type A: CYANStart produced before 04/2014: S/N until BS1EP199
CY004-S29A Waste tube connector (old)
1. Insert the waste tube completely on the waste tube connector to avoid leakage and disconnection
of the tube.
2. Insert the other side of the waste tube in the waste bottle.
! Place the tube deep enough to avoid it slipping out during measurement, but avoid inserting it too
deep so it does not reach the waste liquid level. This latter could cause poor drainage and increases
the risk of tube contamination!

End of waste tube

Waste liquid level

NOTE:
If you replace the waste tube, carefully remove the tube to avoid damaging the waste tube
connector.
B. Type B: CYANStart produced from 04/2014: S/N BS1FLxxx and BS1GPxxx
CY004-S29B Waste tube connectors (new) – 2 parts

1. The waste tube is delivered with the connector (part 1) attached.


2. Screw part 1 on the waste connector (part 2) on the back panel.
3. Insert the other side of the waste tube in the waste bottle.
! Place the tube deep enough to avoid it slipping out during measurement, but avoid inserting it too
deep so it does not reach the waste liquid level. This latter could cause poor drainage and increases
the risk of tube contamination!

Part 1

Part 2

End of waste

Waste liquid

NOTES:
1. To replace the waste tube, unscrew anti-clockwise part 1 from part 2.
2. It is possible to replace the old connector type A with the new type B in order to take advantage of the
new waste tube. Type B is compatible with all CYANStart analyzers.

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2.3.6 Switch on the analyzer
At start-up, the instrument will perform a system self-test. After a start-up system test has been performed
successfully, the screen with the software version will be displayed. Press ENTER to let the user enter the
main menu of the CYANStart user software.

2.3.7 Install or change the print paper


The procedure is dependent of the printer version.
A. Type A: CYANStart: P/D before 09/2015: S/N BS1FL203
1. Switch OFF the instrument.
2. Open the printer cover, locate the blue/white lever on the right side of the instrument and raise it.

Lever

3. Take a new paper roll and place it in its designated place. Make sure that the paper is placed correctly
(see attention points below) and that the end of the paper is free.
4. Roll off the print-paper a little and pass the edge of the paper under the printer bar. Pull the paper
through the printer bar manually until the paper is 4 cm long.
5. Pull down the lever completely to generate enough pressure, otherwise the printing will not be
successful.
6. Pass the edge of the paper through the opening in the printer lid and place the printer cover in its proper
position. If the paper is not long enough, turn ON the analyzer (I) and press FEED until the paper is long
enough to pass through the printer lid.
! ATTENTION POINT! Type A & B
Make sure to place the paper in the right direction for both printer types. 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.

√ X

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B. Type II: CYANStart S/N BS1FSxxx et BS1GPxxx
1. Switch ON the instrument.
2. Open printer cover and remove any left-over of the old print paper roll.
3. 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.
4. Roll off the print-paper until the beginning of the paper touches the printing bar.
5. 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 « Feed » button, while keeping the paper in contact with
the printing bar.
6. Feed the paper until you can put it through the opening in the printer cover and close the printer cover.

! WARNING !
 Do not try to print without printing paper installed, this will cause a system crash!
 Type B: 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!

2.3.8 Verify the instrument


1. During start-up, the instrument will automatically perform a ‘Self-test’. Verify that this is ok (3.1).
2. Perform a washing and cleaning.
During packing and transport, dirt can get in the tubes and on the instrument. Before starting the
measurements, it is thus recommended to perform a washing of the tubes (5.2.1) and to clean the
outside of the instrument (5.3.1).
3. Verify the aspiration and hydraulic system by performing a pump calibration (3.6).
4. Verify the optical system by performing an AD auto zero (3.7).
NOTE:
During transport of the CYANStart analyzer, it is possible that the height of the lamp is slightly shifted.
This can result in out of range values for the gain during the AD auto zero. If after verification of all other
causes (see 3.7: clean, rinsed, no air bubble, instrument ON for at least 30 min,…), the problem persist,
please contact the technician of your distributor to adjust the height of the lamp.

2.3.9 Adaptation of the system to the end customer


1. System setup
 Adjust the print setup to the end customer’s needs
 Adjust the date format, and set the date and time
 Insert the name of the hospital or laboratory where the instrument is installed
 Adjust the language if necessary

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2. Customize the methods
If you wish to obtain results in a different unit than the one already preprogrammed, please follow this
procedure:
1. Turn on the instrument and enter the main menu.
2. Go to the « Program Setup » folder and select « Program Modify ».
3. Select the program you want to modify.
4. On page 2, select the desired Program units from the list.
5. On page 4, adjust the linearity limits (min and max) and the reference range (normal low and normal
high value)
6. On page 5 adjust the concentration of the standard/calibrator.
7. On page 6 adjust the concentration of the control (mean).

Do NOT change any other parameter! The other parameters are independent of the unit!
It is essential that you correctly recalculate the parameters that are expressed in units!

Examples:
1. Conversion mg/dl to mmol/L
The conversion factor needed can be found on the insert. This value is different for every method!

Glucose liquid: the method is originally programmed in mg/dl, the desired unit is mmol/l. The conversion
factor (mentioned in the insert): mg/dl x 0,0555 = mmol/l.
Parameter to change Original Calculation New
(x conversion factor)
Program unit mg/dl - mmol/L
Linearity max 600.0 600 x 0.0555 33.3
Normal low 60.0 60.0 x 0.0555 3.33
Normal high 110.0 110 x 0.0555 6.105
Conc of STD 100.0 100 x 0.0555 5.55
Of cal Lot dependent - see insert 10.8
e.g. lot 2478
Control Lot dependent - see insert 4.46
e.g. lot 3577
NOTE:
On the inserts of the calibrators and controls, different values are already mentioned (for different units).
Insert the value corresponding to the desired unit. If your unit is not mentioned on the insert, you need to
recalculate the value yourself (original x conversion factor).

2. Conversion mg/dl to g/L


1) First you need to calculate/ find the conversion factor
1 mg = 0.001 g and 1 dL = 0.1 L  1 mg/dL = 0.001/0.1 g/L = 0.01 g/L
Conversion factor: mg/dL * 0.01 = g/l
2) Recalculate the unit dependent parameters by multiplying them with this conversion factor.
For example 50 mg/dL * 0.01 = 0.5 g/L
NOTE:
For enzymatic reactions like GOT or GPT, concentrations will always be given in « U/l ». Therefore it is not
advised to change the units.

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3 SOFTWARE DESCRIPTION
! WARNING ! Please read the user manual before operating the CYANStart analyzer and make sure
that the installation is performed correctly.
BIOHAZARD: Wear personal protective equipment. Use universal precautions (See 7. Safety
information for recommended precautions when working with biohazard materials.).

3.1 SYSTEM START – “SELF-TEST”


Switch on the instrument from the main power switch located on the rear side of the instrument. During
the system start-up, the system will execute some self-tests. It will verify the correct functioning of the
crucial components present in the analyzer.
System Start
System Test…….….……………………Ok !
A/D Conversion……………..………….Ok !
Filter check……………………………..Ok !
Printer online.………………………….OUI !
System initialisation…………..….……Ok !

3.2 MAIN MENU


If the instrument functions correctly, the name and the software version will appear automatically on the
screen. Press ENTER to continue and proceed to the main menu of the CYANStart user software.

CYANStart
CYANStart
Perform Test AD Auto Zero
Version: 5.25
Program Setup AD Value Check
Result List Pump calibrate
Biochemistry Analyzer
System Setup Other Settings

1. Use the arrows in 4 directions (left-right, up-down) to select the submenu of your choice.
2. Press ENTER to confirm your choice.
The submenus will help you to do the following (short overview):
Perform test To measure samples for a certain method.
Program setup To setup parameters for each test method.
Result process Sample and quality control result database, to (re)view, print and delete, and
view QC statistical information.
System Setup To set the parameters for: the temperature, filter and flowcell, printer, aspiration
format and the language.
AD Auto zero To zero the instrument and to verify the functioning of the optical system.
AD value check To verify the filters separately.
Pump calibrate To calibrate the aspiration steps for the pump.
Other settings To set other parameters: heading setup, date format setup, date & time setup,
hospital setup and OD. Test.
Press ESC to return to the previous screen.

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3.3 PERFORM TEST
For the best results, we advise to use Cypress Diagnostics reagent. The CYANStart is delivered with all
Cypress Diagnostics biochemistry test methods pre-programmed. These methods have been extensively
verified and optimized for the CYANStart. In the application sheets you find detailed information on the
preparation of the samples and execution of the tests for all Cypress kits. Cypress Diagnostics guarantees
the accuracy and precision as stated in the kit’s insert by using the pre-programmed methods and by
following the preparation instruction correctly. It is always possible to include other methods of your choice.
NOTE:
For best use of our kits on a Cypress Diagnostics analyzer we kindly advise to follow the application sheets
of the respective analyzer (NOT the kit insert). Upon registering to our website (www.diagnostics.be) you
can find the latest application sheets under the analyzers.

By selecting « Perform Test » in the main menu, the list with the preprogrammed methods will appear.
Program List
001 AMY
002 ACPt
003 ACPnp
004 ALB
005 ALP
1. There are 2 ways to select the desired method.
a. Use the arrows in 4 directions. Up-down to change the method on the page and left-right to
select the correct page.
b. Insert the number of the method using the numeric keys. For example to select albumin, press
004.
2. Press ENTER to confirm the selection.
NOTE:
If the programmed temperature is not yet reached, the following screen will appear when opening the
method. After turning ON the analyzer, the instrument needs 15 - 30 minutes to reach the optimal
functioning temperature. Furthermore, this time is also required to let the lamp stabilize. It is strongly
recommended to NOT proceed with the measurements if the set temperature 37°C has not yet been
reached. This can affect the precision and the exactitude of the measures.
Temp Display

Setting Measured
Cuvette 37°C 31.2°C
Temp doesn’t match!
Ignore Wait Exit

Setting The required temperature for the cuvette/flowcell as programmed in the method
parameters.
Measured The temperature of the flowcell currently measured by the instrument.
Ignore To continue the test without taking the temperature into account.
Wait To wait until the required temperature is reached. When the measured temperature
is the same as the set temperature, the following screen will automatically be shown.
Exit To exit the test and to return to the main menu.
The following screen will guide the user through the test procedure. The software will inform the
operator what to perform: AD auto zero, blank, standard, control or sample measurement; and it will
indicate the acceptable range to facilitate the decisions the user has to make.

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The different menus will now be explained using the end point test glucose. If differences exist for the other
method types, these are explained in (3.3.7)

Operating tips: how to aspirate the liquids into the flowcell.


Under the aspiration inlet there is a lever (the aspiration button). Upon pressing the aspiration button (for
no more than half a second), the peristaltic pump is activated and the correct amount of liquid volume
(according to the method settings 500 - 1000μl) is aspirated in the flowcell, where it will be measured.
In order to reduce interference, carryover and the risk of contamination, an air gap will be automatically
aspirated between the samples.
Instruction for a correct aspiration:
1. Prepare disposable test tubes with correct amount of reagent and
sample volume according to the method.
2. Position the aspiration tip inside the test tube, be sure that the
aspiration tip is in the lower corner of the test tube (see figure) Test tube
3. Press the aspiration button, the sample will be aspired automatically.
4. After aspiration is completed (no more pump motor sound), remove
Aspiration tip
the aspiration tip from the liquid, so air can aspirated (=air gap).
To ensure a correct measurement, the flowcell should be filled with liquid 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.
- 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
If these tubes are filled with liquid until the limits indicated below and are free of air bubbles, the flowcell is
correctly filled. Otherwise check the pump calibration (3.6).
! ATTENTION!
1. In the normal aspiration mode, the tubes have to be checked before the aspiration of the air gap!
2. Close the optical cover for further measurements. Background light can interfere with the
measurements!
Tube from flowcell to pump, air bubbles
only visible after the 4 cm limit.

Aspiration tube completely filled


with liquid, no air bubbles

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3.3.1 AD Auto Zero (AD value)
The first step in the test procedure is always the zero/reference measurement (AD auto zero) for the filter
used in the method. This measurement is always performed with distilled water. The zero-setting enables
to check if the instrument is working well.
NOTE:
To have a correct reference measurement, it is essential that the hydraulic system (tubes and flowcell) is
clean. Therefore it is recommended to rinse the CYANStart with 15mL distilled water by pressing the “Wash”
button BEFORE performing a test.
024 GLUCL 024 GLUCL
AD Auto Zero AD Auto Zero
Filter 510 nm Filter 510 nm

AD 27930
AD 35533
Press PUSH aspirate Water

Procedure
1. The first screen will display the AD value measured during the last measurement for this method.
2. Position the distilled water under the inlet pipe and press the aspiration button.
3. Distilled water will be aspirated in the flowcell and the instrument will perform the zero measurement.
4. When the measurement is finished, the AD value will temporarily be displayed before proceeding to
the next screen. This value will not be printed.
5. The AD value should be between 26000 (AD Low) – 38000 (AD High).
a. If the AD value is within range, proceed with the measurement
b. If the AD value is out of range, DO NOT proceed with the measurement. Exit the test by pushing on
the button “ESC” and restart the test.
! ATTENTION! If after 2 reruns the value is still outside the acceptable range. Check:
 Rinsing with 15mL distilled water (see 5.2.1)
 Cleaning with detergent and/or 5% hypochlorite (see 5.2.1)
 Pump calibration and verify that the flowcell is completely filled with distilled water and free of air
bubbles (see 3.6)
 AD auto zero to verify the performance of the complete optical system (see 3.7)

3.3.2 Test Blank


The blank measurement is essential in the calculation of end point tests. In addition, it will also provide an
indication of the reagent deterioration or the cleanness of the instrument. Check the application sheets if
reagent or distilled water needs to be measured and for the number of blank measurements that are
recommended to be performed.
Procedure
1. The first screen will display the optical density value (OD) obtained during the last blank measurement
for this method.
2. Select « YES» to perform a new blank measurement. It is strongly recommended to measure a new blank
every time a test is performed.
If “No” is selected, the blank measurement will not be performed. The instrument will use the last blank
value to calculate the result of the measurements and proceed to the standard measurement. The blank
value used will not be printed.

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024 GLUCL 024 GLUCL
Test Blank? Test Blank
OD: 0.0195

No YES
Press PUSH aspirate Blank

3. Position the test tube containing the blank (reagent or distilled water) under the inlet pipe and press
the aspiration button.
4. The blank will be aspirated in the flowcell and the instrument will proceed with the measurement.
5. After the measurement, the blank OD Value (= absorbance of the blank) will be displayed on the screen
and printed.
NOTE: For some methods, it is recommended to perform multiple blank measurements. Then the
request to aspirate will re-appear after the aspiration of the blank until the programmed number of
blanks have been aspirated. Between the different blank measurements, the result of the previous blank
measurement will be displayed and (printed) while the next blank measurement is performed. After
each blank measurement performed, the OD value measured will be displayed and (printed).
024 GLUCL 024 GLUCL
Test Blank Test Blank
OD. 0.0205

Time: “countdown“ Sec Press ENTER to continue

6. Check if the OD Value is within range as mentioned in the application sheet (Blank low- Blank high).
a. If the OD value is within range, press “ENTER” to proceed to the next screen.
b. If not, the error message “L” and “H” will be displayed beside the value. DO NOT proceed with the
test if the obtained OD value is out of range. Exit the test by pressing on the “ESC” button and restart
the test.
NOTE:
The CYANStart give an error message “L” (low) or “H” (high) if the obtained values are out of range.
However, this message will not be printed by the CYANStart during the printout of the results.
! ATTENTION! If after 2 reruns the value is still outside the acceptable range:
- Water as blank
 Clean and then rinse instrument abundantly with distilled water and restart the test.
- Reagent as blank
 Check (working) reagent preparation
 Reagent is deteriorated, check storage conditions (expiration date and opening date), open new kit
or vial and restart the test.

3.3.3 Test standard


The standard or calibrator measurement is essential for the determination of the factor and thus the
calculation of all the sample tests results. Check the application sheets if a standard, a calibrator or a factor
should be used. If STD = 0 is programmed, the software will not ask to test a STD (see 3.4) and immediately
proceed to the QC (quality control) measurement.
Procedure
1. The first screen will display the factor obtained during the last calibration of that method.
2. Press « YES» to perform a new calibration. A new calibration should be performed:
a. First time a test method is performed.
b. When using a new lot number of reagent or new working solution.
c. When QC measurement is out of range.

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Press “No” to keep the current factor and to proceed to the quality control measurement. The value
used will not be printed.
024 GLUCL 024 GLUCL
Factor: 186.0
CONC 100 mg/dL
Test Standard?
No Yes
Press PUSH aspirate STD

3. Position the test tube containing the standard preparation under the inlet pipe and press the aspiration
button.
4. The standard preparation will be aspirated in the flowcell and the instrument will perform the
measurement.
5. When the measurement is finished, the OD value measured will be displayed (and printed).
6. Taking into account the programmed concentration of the standard, the instrument will calculate,
display (and print) the new calibration factor.
a. Press « ENTER» to proceed to the next screen
b. To rerun the measurement, exit the test by pushing on the “ESC” button and then restart the test.
024 GLUCL 024 GLUCL

CONC. 100 mg/dL CONC. 100 mg/dL


OD. 0.5256
Factor 198.0
Time: “countdown“ Sec Press ENTER to continue

NOTES:
1. Some standard and (almost) all calibrators have a lot dependent concentration! Make sure the correct
concentration is programmed in the methods! Check or modify in “Program Setup”  “Program
modify”  Select method STD Conc (Units).
2. Some methods do not have a standard included in the kit. For these methods, a factor is
preprogrammed. 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.
3. If even after recalibration with the standard included in the kit, the QC measurements are still out of
range, it is recommended to use a calibrator to perform a more accurate calibration (see application
sheets).
4. In case of a multi-standard, aspirate the standards from the lowest to the highest concentration. This
should also be programmed this way in the “Program Setup” menu. The result screen will show the
graph obtained from these measurements instead of a single factor.

3.3.4 Quality Control Measurement


Performing quality control measurements is the only way to ensure that the results you obtain are accurate.
If the QC measurements are within range, you can be sure the correct procedure is used (pipetting, storage,
contamination ...), that the analyzer is clean and correctly functioning, that the reagent is not deteriorated
and that the calibration is performed correctly. This will result in more accurate results, thereby less false
negative and positive results and thus exclusion of false diagnosis. All advantages for the patient, laboratory
and doctor.
It is strongly recommended to perform a Quality Control (QC) by measuring both normal control and
pathological control serum. Check the application sheets which control sera should be used. Ideally, both
controls are measured every time you perform a test. QC measurements should at least be performed:

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a. First time you perform the test method.
b. When using a new lot number of reagent or new working solution.
c. Once a week.
Procedure
1. The first screen gives you the choice to perform a quality control measurement yes or no.
2. Press “YES” to perform a new control measurement. If “NO” is selected, the instrument will proceed to
the sample measurement.
024 GLUCL 024 GLUCL
Control Value 94.6500 mg/dL

Test Control?
No Yes
Press PUSH aspirate control
3. The displayed value is the value programmed for the control (see 3.4). This is the mean value mentioned
on the insert of the control serum.
4. Position the test tube containing the QC preparation under the inlet pipe and press the aspiration
button.
5. It will be aspirated in the flowcell and the instrument will perform the measurement.
6. When the measurement is finished, the OD measurement and calculated concentration will be
displayed (and printed).
024 GLUCL 024 GLUCL
Control Value 94.6500 mg/dL NO. 001
OD. 0.4881

Control: 92.5848 mg/dL


Time: “countdown“ Sec Press PUSH aspirate Sample
7. Check manually if the obtained concentration value is in range as mentioned in the insert of the control
serum.
a. If the concentration is within range, press “PUSH” to proceed to sample measurement
b. If NOT, rerun the test by pushing the “ESC” button to exit the test and restart the test.
! ATTENTION! If after the rerun the value is still outside the acceptable range. Check:
 The preparation instructions (application sheets): stability, volumes, and times should be strictly
followed.
 Rinsing with 15mL distilled water.
 Cleaning with detergent and/or 5% hypochlorite.
 Pump calibration and verify that the flowcell is completely filled with distilled water and free of air
bubbles.
 AD auto zero to verify the performance of the complete optical system.
 Restart the measurement and include a new calibration!
NOTES:
1. Quality controls have a lot dependent concentration! Make sure the correct value is programmed in
the methods! Check or modify in “Program Setup” > “Program modify” > Select method > Control
(Units!) (see 3.4.2).
2. It is not possible to program two quality control measurements with the CYANStart. It is necessary to
choose between normal or pathological serum. As mentioned above, it is strongly recommended to
perform a quality control measurement using both the normal and pathological sera. This can be
accomplished by measuring one of the control sera as control and the other control sera as sample or
by simply measuring both control sera as sample. We suggest to measure both control sera as sample
so that it is not necessary to program the value in the method programming (lot dependent!).

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3. In the method programming, it is not possible to set a range (high and low values), only the mean.
Therefore, it is necessary to manually compare the obtained results with the range mentioned in the
insert of the control sera after the measurement.
4. If even after recalibration with the standard included in the kit, the QC measurements are still out of
range, it is recommended to use a calibrator to perform a more accurate calibration (see application
sheets).

3.3.5 Sample Measurement


If the AD Value, blank and QC are OK, you can proceed with the sample measurement.
The first screen will show the sequential (changeable) number for this sample measurement during the
execution of a certain method.
NOTES :
1. After finishing and leaving the test menu, the numbering of the test results will restart at 001 once a
new sample measurement is executed by selecting the same or another test method.
2. It is possible to change the reference number of a measurement (NO.) before performing a sample
measurement by using the arrows with 4 directions. Use the up arrow to increase the number (0  9),
the down arrow to decrease the number from (9  0) and the left and right arrows to insert the numbers
in the left and right position.
024 GLUCL
NO. 001

Press PUSH aspirate Sample

Procedure
1. Position the tube containing the 1st sample preparation under the inlet pipe and press the aspiration
button.
2. It will be aspirated in the flowcell and the instrument will perform the measurement.
3. When the measurement is finished, the OD measurement and calculated concentration will be
displayed (and printed).
4. Press the aspiration button to proceed with the next sample.
5. Proceed like this until all the samples are analyzed.
024 GLUCL 024 GLUCL
NO. 001 NO. 001
O.D. 0.9123

CONC. 176.5764 mg/dL


Time: “Countdown“ Sec Press PUSH aspirate Sample

NOTES :
1. It is possible to press “Wash” on the keyboard to rinse the hydraulic system (tubes + flowcell) before
aspirating the sample.
 In case of high risk of cross-over, the flowcell can be pre-rinsed 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.
2. It is possible to press “FEED” on the keyboard between sample measurements. By pressing « FEED », the
paper will move forward without printing. This option is only possible if « Result print » in the menu
“Printer Setup” is activated.

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3.3.6 End of test
1. Press « ESC » in the keyboard to exit the test method.
2. The instrument will ask for confirmation. Press “YES” to proceed and “NO” to return to the test
performance.
3. Rinse the instrument with 15mL distilled water by pressing the “WASH” button on the keyboard.
NOTE:
When the memory is full, a warning will be displayed “Memory full! Original data will be replaced!!” (For the
CYANStart with software version 5.2 or higher). For the CYANStart with software version < 5.2, there will be
no warning and the results will always be saved on position 1. It is recommended to print all the needed
results and to delete them to make space in the memory.

3.3.7 Specific method instructions and formulas


There are different methods: the end point method, the two-point method and the kinetic method. In the
application sheets you can find detailed information on the preparation of the samples and execution of
the tests for all Cypress Diagnostics kits.

3.3.7.1 END POINT METHOD


After a certain incubation time, this type of reaction reaches an absorbance that remains stable for a specific
period. Within this stable period (at time t1), the measurement is performed. Before the addition of the
sample (at time t0), the reagent has a certain absorbance. To correct for this absorbance, the reagent is
measured as blank and the difference in absorbance of the sample to the blank is calculated.

Calculation formula:
Conc. sample = F x (Abs sample-Abs blank) with factor F = Conc. standard / (Abs standard - Abs blank)
Implications for performing the test
1. Incubation time is performed outside the instrument.
2. You can prepare several samples simultaneously. Mix and incubate for the specified time at the
specified temperature. After the incubation time, aspirate and measure all the samples within the
specified stable period after preparation.
3. For some end point tests, the incubation needs to be exact. A special time scheme can be used to
prepare several samples ‘simultaneously’ as long as time mentioned is respected!
E.g. Bilirubin direct and total, LDL cholesterol, HbA1c, Haemoglobin, Phosphorus,…
4. Correct measurement of the (reagent) blank is very important!
NOTE:
For an endpoint test where the absorbance of the sample itself can affect the analytical result, it is necessary
to measure and correct for the sample blank. This correction can be done by choosing one of the following
methodologies according to the specific need:
1. Sample/serum blank: absolute correction
2. Bichromatic partial correction

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3.3.7.2 SERUM BLANK
The calculation of the serum/sample blank is dependent of the software version.
A. Software version from 5.25
Calculation formula
Conc. sample = F x (Abs sample-Abs sample/serum blank) with factor F = Conc. standard / (Abs standard - Abs standard blank)
Implication for performing the test
1. For every measurement you need to prepare 2 tubes: one for measuring the sample/serum blank
(background absorbance) and one for measuring the real sample absorbance. Both are measured on
the same wavelength.
2. The above is valid for samples, but also for the standard/calibrator and control preparations.
3. The blank method programmed is Serum. ! Pay attention! This determines the calculation of the result,
NOT the blank aspiration in the “perform test” menu!
1. Aspirate distilled water to adjust the instrument to zero (AD Value).
2. In the blank menu aspirate (working) reagent (see application sheets).
3. In the standard/sample menu:
a. First: “Press PUSH to aspirate Serum” = Standard/Sample blank  OD1.
b. Secondly: “Press PUSH to aspirate Sample” = complete Standard/Sample  OD2.
c. Press PUSH to aspirate Serum.
008 BILT 008 BILT 008 BILT
NO. 001 NO. 001 NO. 001
OD1 0.0457 OD1 0.0457
OD2 OD2 0.0741
CONC.: 0.540 mg/dL
Press PUSH aspirate serum Press PUSH aspirate sample Press PUSH aspirate serum

B. Software version before 5.25


The old software versions (before 5.25) contain a mistake in the calculation. To exclude the impact of this
error on the results, it is necessary to follow the instructions on the application sheets!
Calculation Formula
Conc.sample = F x (Abssample-Abssample/serum blank-Absblank)
Implication for performing the test
1 & 2: As mentioned in paragraph A.
3. The blank method programmed is Serum. ! Pay attention! This determines the calculation of the result,
NOT the blank aspiration in the “perform test” menu!
4. “Test Blank”  “Yes” and aspirate distilled water  the result needs to be as close as possible to zero
(to minimize the mistake in the calculation).
5. Afterwards (before the aspiration of serum or sample), rinse the flowcell with 1mL of working reagent
by pressing the “Wash” button” :
6. In the standard/sample menu: (ASPIRATION BUTTON)
a. First: “Press PUSH to aspirate Serum” = Standard/Sample blank  OD1.
b. Secondly: “Press PUSH to aspirate Sample” = complete Standard/Sample  OD2.
c. Press PUSH to aspirate Serum.

3.3.7.3 BICHROMATIC
This type of methodology is applicable to end point reactions that require a correction due to biological
liquid’s properties of the sample (turbidity, icteric and hemolysis). The correction on the matrix is not
absolute, but relative. The bichromatic calculation requires measurement at two wavelengths: the main
filter and sub filter.
Calculation formula:
Conc. sample = F x (Abs main nm sample-Abs sub nm sample) with factor F = Conc. standard / (Abs main nm standard - Abs sub nm standard)

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Implications for performing the test
For every measurement (AD value, blank, standard, QC and samples), the instrument will perform
measurements with both the main and the sub filter and display the results (OD1 = main and OD2 = sub).
058 Bichrom
058 Bichrom 058 Bichrom
NO. 001
AD Auto zero Test Blank
OD1 0.9123
Filter 340 nm AD: 58889 OD1 0.0080
OD2 0.3564
Filter 620 nm AD: 57536 OD2 0.0004
CONC.: 5.559 mg/dL
Press PUSH aspirate Sample

3.3.7.4 TWO-POINT METHOD


After a certain period of time, this type of reaction has a linear progress. For each measurement/aspiration,
the instrument will carry out two readings within the linear time period, respectively t1 and t2. The analytical
result can be calculated using Δ Abs (delta) = difference in absorbance at the times t2 and t1.
Calculation formula
Conc. sample = F x (Abs sample t2-Abs sample t1) with factor F = Conc. standard / (Abs standard t1- Abs standard t2)

Implications for performing the test


1. Incubation time is IN the instrument
2. The preparation, mixture and measurement of the samples is done one sample at a time. Aspirate the
mixture in the CYANStart analyzer, immediately after the addition of the (working) reagent to the
sample/standard/control.
3. It is thus essential that the CYANStart is ready for aspiration. This is when the CYANStart displays:
“Aspirate Sample/Standard/Control”.
4. Wait with the preparation of the next sample until the CYANStart is finished measuring the previous
one.
5. The above is valid for samples, but also for the standard/calibrator and QC preparations.
6. The correct temperature is very important since temperature can affect the rate of the reaction.
021 CRE
021 CRE 021 CRE
NO. 001
NO. 001 NO. 001
OD1 1.4510
OD1 1.4510
OD2 1.3230
CONC.: 102.4 mg/dL H*
Delay time: “countdown“ Sec Test time: “countdown“ Sec
Press PUSH to aspirate Sample

3.3.7.5 KINETIC METHODS


This methodology type is used to determine enzyme activity. For each measurement/aspiration, the system
carries out a number of readings. From all the reading points taken during the reading time, the slope of a
theoretical straight line is determined, using the criteria of minimum squares. The slope is used to calculate
the analytical result. Furthermore, for every measurement, the instrument will display the linear correlation

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coefficient (COR). This could be used as a control parameter for kinetic reactions. The closer to one, the more
perfect the fit resembles a straight line. The COR should be ≥ 0.95.

Calculation formula
Conc. sample = F x ΔAbssample /min or (ΔAbssample x 60) / Δt
With F = fixed factor or F = (Conc.calibrator x Δt) / (ΔAbscalibrator x 60)
ΔAbssample = the sum of the absorbance of each inter zone of the dynamic test time = (AS2- AS1) + (AS3-
AS2) + … + (ASn-1- ASn-2) + (ASn- ASn-1)
Δt =the dynamic test time = (t2- t1) + (t3- t2) + … + (tn-1- tn-2) + (tn- tn-1)
Implications to for performing the test
1. Incubation time is IN the instrument
2. The preparation, mixture and measurement of the samples is done one sample at a time. Aspirate the
mixture in the CYANStart analyzer, immediately after the addition of the (working) reagent to the
sample/calibrator/control.
3. It is thus essential that the CYANStart is ready for aspiration. This is when the CYANStart displays:
“Aspirate Sample/Standard/Control”.
4. Wait with the preparation of the next sample until the CYANStart is finished measuring the previous
one.
5. The above is valid for samples, but also for the calibrator and QC preparations.
6. The correct temperature is very important since temperature can affect the rate of the reaction.
Press the aspiration button to aspirate the sample. The CYANStart will display the measurement result and
reaction curve expressed as absorbency in real time during the testing. At the end of the measurement the
absorbance rate, correlation, and concentration will be displayed and the results will be printed.
030 GPTL 030 GPTL
NO. 001 NO. 001
OD.: 1.3955 RATE.:
Read: “countdown” Sec COR: 0.9938
CONC: 102.337 U/L H
Press PUSH aspirate Sample

3.4 PROGRAM SETUP


After selecting « Program setup », you can add, modify, delete a program or print the list of methods
programmed in the CYANStart.
Program Setup

Program Add Item Print


Program Modify
Program Delete
Program Print
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3.4.1 Program add
Move the cursor to « Program Add » and press Enter, the following screen will appear:

Program Setup
Program Name GLUCL
Program Method End Point
Main Filter 510 nm
Sub Filter No nm

Here the operator can add new items. Please ensure that the testing method of each item is correct to avoid
any problems later on. Press Enter to access the next field.

Program Name Insert the name of the method.


Program Method Select the type of method by pressing the right or left arrow keys on the keyboard.
Choices: End Point, Two Point, Kinetic, and Bichromatic
Main Filter Use the left and right arrow keys to select the required filter: 340, 405, 492, 510, 546,
578 or 620
Sub Filter This option is only available if the bichromatic method is selected. Use the right or
left arrow keys to select the required filter: 340, 405, 492, 510, 546, 578 or 620.
Otherwise “NO” is be indicated.
After filling in the first line, press ENTER to proceed to the next line and use the up arrow to go back to the
previous line. After finalizing the above, press ENTER to proceed to the next page. Press “ESC” at any time
to return to the “Program Setup” menu.

Progam Setup
Delay Time 001 sec
Test time 003 sec
Program Unit mg/dL
Aspirate Volume 0500 μl

Delay Time This is the incubation time in the flowcell. Insert the required time using the numeric
keyboard. The limits are: 0- 999 seconds.
NOTE: A minimum of 1 seconds is recommended to have a stabilization in the flowcell
after aspiration.
Test Time This is the measuring time. Insert the required time using the numeric keyboard. The
limits are: 0-999 seconds.
NOTE: If the selected Test Time is less than 3 seconds, the sample will not be
measured.
Program Unit Select one of the following units by pressing on the right or left arrow key to choose:
g/dl, g/l, mg/l, mg/dl, U/l, μmol/l, U/ml; mmol/l, μg/ml, ƞg/ml, μg/dl, ng/dl, ƞmol/l,
mEq/l, IU/l; mIU/l, μIU/ml, ou μg%, %.
After setting the program unit, this will automatically be registered for the other
parameters for which the values are unit dependent.
Aspirate Volume Insert the required volume using the numeric keyboard. The limits are 500-1000 μl.

After filling in the first line, press ENTER to proceed to the next line and use the up arrow to go back to the
previous line. After finalizing the above, press ENTER to proceed to the next page. Press “ESC” at any time
to return to the “Program Setup” menu.

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Program Setup
Blank Reagent
NUM of Blank 1
Blank Low 0.000000
Blank High 0.320000

Blank Press the arrow and select the required blank method: water (bi-distilled), reagent or
serum (= sample blank). The serum or sample blank measurement can only be
performed for an end point method.
NUM of Blank Insert the required number of replicates using the numeric keyboards. The limits are:
1-3.
Blank Low The lowest acceptable absorbance value for the blank measurement. Blank
measurements below this value will automatically be flagged (“L”). Insert the value
using the numeric keyboard.
If reagent is measured as blank, a value below this limit could give an indication of
reagent deterioration (especially for downward reactions).
Blank High The highest acceptable absorbance value for the blank measurement. Blank
measurements above this value will automatically be flagged (“H”). Insert the value
using the numeric keyboard.
If water is measured as blank, a value above this limit could give an indication of
contamination of the water or of the hydraulic system of the instrument.
If reagent is measured as blank, a value above this limit could give an indication of
reagent deterioration (especially for upward reactions).
After filling in the first line, press ENTER to proceed to the next line and use the up arrow to go back to the
previous line. After finalizing the above, press ENTER to proceed to the next page. Press “ESC” at any time
to return to the “Program Setup” menu.

Program Setup
Normal Low 60.00000
Normal High 110.0000
Liniarity 600.0000
Dilution factor 1.000000

Normal Low The normal value of reference range, expressed in concentration.


Attention: Insert the value corresponding to the units of this method programming!
The values on the insert or pre-programmed in the instrument are for orientation
purpose. Each laboratory should establish its own reference range.
Normal High The maximum value of the normal reference range, expressed in concentration. If
the patient result is above this range, a warning massage “H” will be displayed next
to the obtained value. Insert the value using the numeric keyboard.
Attention: Insert the value corresponding to the units of this method programming!
The values on the insert or pre-programmed in the instrument are for orientation
purpose. Each laboratory should establish its own reference range.
Linearity The upper limit for linearity, expressed in concentration.
Attention: Insert the value corresponding to the units of this method programming!
Dilution Factor If manually a dilution of the samples is made, the dilution ratio can be inserted here.
This factor will then be taken into account in the calculation of the result. The default
is 1 (no dilution).

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After filling in the first line, press ENTER to proceed to the next line and use the up arrow to go back to the
previous line. After finalizing the above, press ENTER to proceed to the next page. Press “ESC” at any time
to return to the “Program Setup” menu.

Program Setup
Num of STD 1
STD 1
CONC 100.0000 mg/dL²
Factor 1.000000

NUM of STD Insert the number of standards by using the numeric keyboard. In case of a
calibration by means a factor, insert 0 and proceed with inserting the factor. Insert a
value ranging from 1-6, in case of a single or multi-point calibration.
NOTE: NUM of STD = 2 is only possible for CYANStart analyzer with software version
5.22 and higher.
STD The given number (from 0-6) is the « name » (reference) of the standard, for which
the concentration needs to be inserted.
In case of a multi-point calibration, make sure to first set the correct values for the
first STD. Then press “ENTER” to proceed to the next STD (and insert its
concentration). It is not possible to return to the previous page.
Conc The concentration of the standard corresponding to the number displayed in STD.
Insert the factor using the numeric keyboard.
Attention: Insert the value corresponding the units of this method programming!
² For some standards and in case a calibrator is used, the value is lot dependent, thus
needs to be adjusted for a new lot number.
NOTE: In case of multi-point calibration, the standards have to be inserted from the
lowest to the highest value.
Factor Value essential for the calculation of the concentration from the absorbance
measurement. In case of standard or calibrator calibration, the factor will be
automatically filled in by the instrument after the calibration has been performed. In
case of factor calibration, insert the factor using the numeric keyboard.
After filling in the first line, press ENTER to proceed to the next line and use the up arrow to go back to the
previous line. After finalizing the above, press ENTER to proceed to the next page. Press “ESC” at any time
to return to the “Program Setup” menu.
Program Setup
Control Non
Control Value 0.000000 mg/dL
Cuvette Temp 37.0 °C

Control To perform a quality control measurement that is saved in the QC-menu, select
YES. If NO is chosen, the instrument will not display the screens for the equality
control measurement during the execution of a test.
Control value Insert the mean value of the range of the control by using the numeric keyboard.
Attention: The value is lot dependent, thus needs to be adjusted for a new lot
number. Insert the value corresponding to the units of this method
programming!
Cuvette temp Press the left and right arrows to select the required flowcell temperature: room
temperature (R.T.), 25°C, 30°C or 37°C. For all Cypress Diagnostics method, 37°C
must be selected.

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After finalizing the above, press “ENTER” to proceed to the last page. Press “Yes” to save the test with the
inserted parameters, the test will be added to the program list. Press “No” to delete the test.
Program Setup

Sure to Add?

Yes No

3.4.2 Program modify


This option will be used to check and/or to modify programmed items. This function is used to change lot
dependent values, adjust programmed units, etc….
Program List Program Setup
001 AMY
002 ACPt Sure to Save?
003 ACPnp
004 ALB Yes No
005 ALP
1. There are 2 ways to select the desired method:
a. Use the arrows in 4 directions: Up/down to change the method on the page and left/right to select
the correct page.
b. Insert the number of the method using the numeric keyboard. For example to select Albumin,
press 004.
2. Press “ENTER” to confirm the selection.
3. The screens above for the addition of a method will be displayed and the programmed parameters can
be viewed or adjusted.
4. Before proceeding to the next page, make sure that all the inserted values are correct because it is not
possible to return to the previous page.

3.4.3 Program delete


Choose the item you would like to delete and press Enter. The software will ask “Sure to delete?” Select “Yes”
or “No”
Program List Program Setup
001 AMY
002 ACPt Sure to delete?
003 ACPnp
004 ALB Yes No
005 ALP

3.4.4 Program print


It is possible to print the list of all programmed methods.
Program List
001 AMY
002 ACPt
003 ACPnp
004 ALB
005 ALP

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1. There are 2 ways to select the desired method:
a. Use the arrows in 4 directions: Up/down to change the method on the page and left/right to select
the correct page.
b. Insert the number of the method using the numeric keyboard. For example to select Albumin, press
004.
2. Press “ENTER” to confirm the selection.
3. The chosen method will be printed and the instrument will automatically return to the main menu.
Printout example for Urea:
CYANStart
042
Program Name: UREA
Program Method: End Point
Program Unit: mg/dl
Main Filter: 578
Sub Filter: No
Delay Time: 000
Test Time: 003
Blank: Reagent
NUM Of Blank: 1
Blank Low: 0.0
Blank High: 0.32
Normal Low: 15
Normal High: 45
Linearity: 200
Dilution Factor: 1
NUM Of STD: 1
CONC of STD: 50.000 mg/dL
Factor: 0
Control: Yes
Value: 40.7 mg/dL
Cuvette Temp: 37.0

3.4.5 Item list


The CYANStart will printout an overview of all programmed methods. No detailed information of the
methods is visible or printed.
3.5 RESULT PROCESS
After selecting the « Result process », the user can review the sample results, make a patient print report or
delete sample results. There is also a menu containing all the quality control results.
Result Process
Result List
Delete All Result
Control Manage
Print report

3.5.1 Result list


Pressing the “Result List” button will give access to the list of all stored sample results. The instrument can
store up to 1000 test results. All results receive a sequential number and are stored chronologically.
There are 2 ways to select the desired method:

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a. Use the arrows in 4 directions: Up/down to change the method on the page and left/right to select
the correct page.
b. Insert the sequential number of the result using the numeric keyboard.
Press ENTER to confirm the selection. The details of the test will be displayed:
Result List GLUCL NO. 001
0620 18-09-14 10:28:28 18-09-14 10 :28 :28
0621 18-09-14 10:28:45 CONC : 154.2 mg/dL H*
0622 18-09-14 10:29:01 Normal Low : 60
0623 20-09-14 08:15:02 Normal High : 100
0624 N/A Exit Print

Press Exit to return to the result list without printing. Press Print to print the result and to return to the result
list.
NOTES:
1. The number given to the results saved in the menu “Result List” does not correspond with the number
given to the test results of samples during the execution of a certain method. During the measurement
of the samples, the numbering of the obtained results goes back to 001 for every new method executed.
The sequential number given to the results in the menu “Result List” are date and time dependent.
2. When the memory is full, a warning will be displayed “Memory full! Original data will be replaced!”
(Software version 5.2 or higher). For CYANStart analyzers with software version < 5.2, there will be no
warning and the results will always be saved on position 1. It is recommended to print all the needed
results and to delete them to make space in the memory.

3.5.2 Delete all results


In this menu, it is possible to delete all the patient data stored in the memory. To avoid accidental deletion
of results, the CYANStart will ask for confirmation when this button is selected.

3.5.3 Control manage


In this menu you can review the statistics of the results from the quality control measurements. Only results
that are measured as controls will be stored in this menu.
Control Manage
Control Statistic
Control Result
Delete Control Result
Delete Control All Result

3.5.3.1 CONTROL STATISTIC


After selecting the Control Statistic submenu an overview of the stored method list will be given. Select the
test method of your choice to view the Control Statistics of that method. The individual data used for the
analysis can be found under Control Result.
1. There are 2 ways to select the desired method:
a. Use the arrows in 4 directions: Up/down to change the method on the page and left/right to select
the correct page.
b. Insert the number of the method using the numeric keyboard. For example to select Albumin, press
004.
2. Press “ENTER” to confirm the selection.
3. The statistics of this method will be displayed. The statistics include: the name of the method, the mean
of the measurement, the standard deviation (SD) and the coefficient of variation (CV%).
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4. The control statistics can be viewed by selecting “Curve”. Press “Print” to print all the results of the
control statistics.
Control Statistic GLUCL

AV = 93.30
SD = 3.62 AV
CV = 3.89%

Curve Print
NOTE:
1. This control menu doesn’t check the accuracy of the results. Check the accuracy manually by using the
table, included in the package of the control serum.
2. Only the results of the tests performed as control will be included in this list.

3.5.3.2 CONTROL RESULT


In this menu you can review the results of the quality control measurements for each test method. Only
results that are measured as controls will be stored in this menu. Select the method, then the list will be
displayed. Select the result for more details. The results will be used as data input for the “Control Statistic”.

3.5.3.3 DELETE CONTROL RESULT


This menu is used to delete all control results for a certain method. After selecting this menu, an overview
of the programmed methods is shown. Select the method for which you want to delete the control results.
A confirmation screen will request to confirm the deletion. The results of the performed controls will be
deleted. It is recommended to perform this when opening a new lot of the kit or using a new control lot.

3.5.3.4 DELETE CONTROL ALL RESULT


This menu is used to delete all the control results for all the methods. This should be done when opening a
new lot of the kit or using a new control. A confirmation screen will request to confirm the deletion.

3.5.4 Print report


This function enables to print a patient report, this includes all the test results of a certain reference
performed on a certain date.
Enter the reference number and the date followed by “ENTER”. The system will look up and print all the
results that corresponds with the inserted reference and date. The message “No data!” will be displayed if
there are no results that matches the inserted criteria. 26-09-2014 14:22:21
No .:624 Name :
Print Report
Sex : Age :
Item Results Range
No. : 624
CHOLL 210.00 120.00-200.00 H*
26-09-14
CRE 0.80 0.60-1.40
GLUCL 154.20 60.00-110.00 H*
NOTES: TP 6.200 6.60-8.30 L*
If you want to use this function to print patient reports, you need to change the reference number (No)
manually before performing the measurement. If not changed, the numbering will return to 001 (and
increase automatically) every time you enter a new method. When inserting 001 as reference, the software
will find and print all the data containing this reference number executed on a specified date.
3.6 PUMP CALIBRATION
The peristaltic pump tube is placed on the pump rotor that is turned by the pump stepper motor. This menu
enables the user to calibrate the peristaltic pump, this is to determine how many motor steps are necessary

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to aspirate a certain volume. To ensure precise and accurate sample aspiration, it is strongly recommended
to calibrate the pump once a week.
Before performing a pump calibration it is essential to check that:
1) There are no leakage or blockage in the hydraulic system (flowcell + tubes).
2) The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water.
3) The pump tube is installed and connected correctly.
Procedure
1. Select “Pump calibrate” in the main menu. The number of steps registered during the last pump
calibration will be displayed.

Pump Calibrate

5000 μl
08900 Press PUSH to Start

Press PUSH aspirate water Press PUSH to Stop

2. Enter 5000 μl as the desired volume to aspirate by using the keyboard. Press “ENTER” to register.
3. After pressing “Enter”, the next level (number of steps) will be selected.
4. Pipette exactly 5000μl distilled water in a test tube.
5. Position the aspiration tip inside test tube, be sure that the aspiration tip is in the lower corner of the
test tube (see figure), so all liquid can be aspirated.
6. Press the PUSH button to start the aspiration.
7. Immediately and exactly when the tube is empty, press the PUSH button again to stop the aspiration.
8. The number of steps performed by the motor will be displayed. The obtained value should be between
7500 and 14000. 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.
9. Press “ENTER” to exit the menu and to save and use this calibration as reference to intake any quantity
of sample. Press “ESC” to exit the pump calibration menu without saving the obtained results.

If the obtained results are not situated in the range mentioned above or if the difference between the
obtained values are more than 1000 steps:
a) Verify the precision/repeatability of the pipet used  pipet calibration
NOTE: For a higher precision we advise to use CYANPipettes. Ask your distributor for more information
about the CYAN product range.
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):
 Leak in one of the tubes or the flowcell:
 Replacement is necessary, contact your service engineer.
 Blockage in one of the tubes can be caused by:
 Squashing the tube, for example by the case, replace the tube
if damaged, contact your service engineer.
 Sticking together of the pump tube. To prevent this, it is recommended to unlock the pump
tube if the instrument is not used for more than one week.
 Accumulation of dirt in the tubes  perform cleaning with 5% hypochlorite (see 5.2.1). If the
cleaning is not sufficient then the tube needs to be replaced, contact your service engineer.
 Blockage of the flowcell
 Accumulation of dirt in the flowcell  perform cleaning with 5% hypochlorite (see 5.2.1). If the
cleaning is not sufficient then the tube needs to be replaced, contact your service engineer.
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c) Verify if there are no lubricant in the pump tube or the rotor roller. Too much lubricant can make the
rollers slip and increase the number of step  clean and remove the lubricant.
d) Verify if the rotor is turning smoothly, contact your service engineer otherwise.
e) If after these verifications, the values remain outside the ranges, please contact a service engineer. DO
NOT proceed with any measurements if the results of the pump calibration are out of range!
3.7 AD AUTO ZERO
The AD zero menu permits to verify the performance of the whole optical system (lamp, filters, flowcell and
pre-amplifier board) and automatically adjust the measurements 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 auto 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 Auto 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 30 min, because the lamp and temperature needs this time to
stabilize.
d) The optical cover is closed.
Procedure
1. Enter menu “AD auto zero”. The results of the former AD auto zero will be displayed. It is recommended
to note these results in order to make a comparison between the former and the new measurement.
2. Position the test tube with distilled water under the aspiration inlet tube and press the PUSH button to
aspirate the distilled water.
3. The instrument will automatically perform a new AD auto zero measurement and then the results will
be displayed as seen in the image below (the legend is not visible).
4. Press “ESC” to return to the main menu. The last measurement will be saved and the gain and offset of
this measurement will be used for the calculation of the test results.

Nm The filter wavelength expressed in nm. Every filter will be tested separately.
Gain The signal-amplification coefficient. This gain is automatically adjusted by the
instrument to obtain AD values between 26000 and 38000 up to a maximal
gain of 7 is reached.
AD The amplified and converted (from analog to digital) signal.
Offset To compensate for negative counts, the light beam is sent through a black filter
to determine the offset-value.
Acceptable ranges Gain: between 3 et 5
AD: between 26000 et 38000
Offset: between15 et 150

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Since the AD auto 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 with the same filter!),
 The difference in gain should be ≤ 1
 The difference in offset should be ≤ ±20.
If the difference is bigger or the obtained values are outside the range, check 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 with distilled water,
 Perform washing and rinsing (see 5.2).
3. The windows of the flowcell are clean (no dirt/fingerprints on the outside),
 Clean with wipes for glasses.
4. The flowcell is filled with distilled water and without any air bubbles,
 Verify the pump calibration and the absent of leakages.
5. If the gain of all/most filters is high (5, 6, 7),
 The lamp should be replaced: contact your service engineer.
If after these verifications, the values remain outside the ranges, please contact a service engineer. Do NOT
continue measuring with the instrument if the AD zero is out of range!
3.8 AD VALUE
This menu is used by the service engineer during lamp replacement and optimization and for checking the
individual filters and the optical sensor.
3.9 SYSTEM SETUP
The menu « System Setup » is used to adjust and display various function and parameters of the instrument
(temperature display, filter & flowcell, printer setup, aspiration setup and language). After selecting the
System Setup in the main menu, the following screen will appear:

System Setup
Temp Display Language Setup
Filter & Cuvette
Printer Setup
Aspirate Format

NOTE:
In case of an electric shock, the parameters saved on the mainboard can be modified or deleted. Please ask
the technician of your distributor to check and if necessary readjust the settings.

3.9.1 Temp display


This menu enables to verify if the temperature of the flowcell measured by the instrument corresponds to
the set temperature. The temperature is expressed in degrees Celsius. Press the “ESC” to exit the menu.
a) For the flowcell, it is possible to set different temperatures. Press the blue arrow to switch between
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.
If the measured temperatures to not correspond to these specifications, contact a service engineer.
b) Please ignore the displayed temperature for the incubator because the CYANStart does not have an
integrated incubator.

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This option will enable the user to read the temperature of the flowcell. This is the real measured
temperature by the instrument (not the selected temperature). The temperature is expressed in degrees
Celsius. Press “ESC” to exit the menu.
Temp Display
Setting Measured
Cuvette : 37.0 36.8°C
Incubator 37.0 -273.0°C
Temp Cal :

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 is not yet
reached, the instrument will display a warning to inform the user of this discrepancy.

3.9.2 Filter and Cuvette


This menu contains parameters that are established in the factory. They cannot be modified.

3.9.3 Printer Setup


This menu enables the user to switch on or off the automatic printing and to determine the print out format.
Press the “ENTER” to save the changes before exiting the menu. If “ESC” is chosen to exit the menu then the
changes will not be registered.

Printer Setup

Result Print Enable


Curve Print Disable
Print Mode Concision

3.9.3.1 RESULT PRINT


Use the arrows on the keyboard to view the available options: enable or disable. When this option is
enabled, the instrument will print all results automatically upon finishing a measurement. Furthermore, all
“on demand” printing in the menus “Perform test”, “Result process” and the method list and the methods
(in detail) in the menu “Program setup” will be possible as well. If “Disable” is chosen, the printer will be
deactivated.
Press “ENTER” to register the change and to proceed to the next level.

3.9.3.2 CURVE PRINT


Use the arrow on the keyboard to view the available options: enable or disable. When this option is enabled,
the curves obtained during the performance of a kinetic test will be printed.
NOTE:
Curves are only printed when the print mode “Normal” is selected. When the print mode is “Concision”, the
curves are never printed.

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3.9.3.3 PRINT MODE
Use the arrow on the keyboard to view the available options: normal or concision. The concision printing
mode is a more economic printing and uses less paper than the normal mode.
Mode “Concision”
CYANStart
23-01-16 10 :42 :40
Patient Name :
Name : GLUCL
Program method: End point
Main Filter: 510
Range: 60 - 100
Linearity: 500

No. Abs mg/dL

Blank: 0.0205
STD: 0.5250 100
Fact: 198.000
C: 0.4881 92.58
001: 1.0564 205.108 H*

Mode “Normal”

CYANStart CYANStart
23-01-16 10 :42 :40 23-01-16 10 :45 :40
Name : GLUCL Control
Blank: 0.0205 Name : GLUCL
Blank low: 0 OD. : 0.4881
Blank high: 3.2 Control : 92.585 mg/dL

CYANStart CYANStart
23-01-16 10 :43 :40 23-01-16 10 :46 :40
STD Patient Name :
Name : GLUCL No. : 001
CONC : 100 mg/dL Name : GLUCL
OD. : 0.5250 OD. : 1.0564
Factor : 198.00 CONC : 205.108 mg/dL H*
Normal Low : 60
Normal High : 100

3.9.4 Language Setup


The current version of the CYANStart software is available in English, French and Spanish. The menu is
currently protected by a password. Contact your service engineer to modify the language. Press “ESC” to
return to the main menu.

3.9.5 Aspiration Format


Use the arrow on the keyboard to view the available options: normal or express. 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 with/of the next
sample. Then the instrument will indicate it is ready to aspirate the next sample. In the express mode, the

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programmed volume of sample is aspirated and this is almost immediately followed by aspiration of an air
gap, and then 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, given
false results and if the air gap is too small, there is increased risk of cross-contamination.
Press “ENTER” to exit the menu while saving the modifications. If “ESC” is pressed to exit the menu, the
modifications will not be registered.
3.10 OTHER SETTINGS
The menu « Other settings » is used to adjust and display various function and parameters of the instrument
(the heading setup, the date format setup, the date and time setup, the hospital setup and the OD. test).
After selecting the « Other settings » in the main menu, the following screen will appear:

Other Settings
Heading Setup OD. test
Date Format Setup
Date & Time Setup
Hospital Setup

3.10.1 Heading Setup


This menu is established in the factory. It contains the name of the instrument. Do not change this setting.
Press the “ESC” button to exit the menu.

3.10.2 Date Format Setup


This menu enables the user to select the date format: DD/MM/YY or MM/DD/YY or YY/MM/DD. Use the left
and right arrows to select the right format, press ENTER to confirm and store your choice. Press “ESC” to exit
the menu.

3.10.3 Date & Time Setup


This menu enables you to input the correct time and date according to the format selected under the menu
Date Format Setup. Setting the correct date & time is essential to re-find results in the archives because the
data is stored chronologically.
Use the arrows and the numbers on the keyboard to adjust the date and the time. Press “ENTER” to exit the
menu and to save all the modifications. If “ESC” is pressed to exit the menu, the modifications will not be
registered.

3.10.4 Hospital Setup


This menu enables to personalize the heading on the print reports with the name of the hospital or the
laboratory. Use the alphanumeric keyboard to insert the heading. Press “ENTER” to exit the menu and to
save all the modifications. If “ESC” is pressed to exit the menu, the modifications will not be registered.

3.10.5 OD Test
This menu is used to measure the optical density (OD) or the absorbance for the different filters.
Before performing a filter test it is essential to check that:
1. The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water.
2. The flowcell is filled with distilled water and without any air bubbles.
3. The instrument is ON for at least 30 min, this time is necessary for the lamp to stabilize and for
the flowcell to obtain the correct temperature.

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4. The AD Zero is performed and is within the acceptable ranges.
Procedure
1. Select the required filter by using the right and left arrow on the keyboard or by entering the number
corresponding to the desired filter (see table below).
2. Press “ENTER” to register the selection. Afterwards, the selection marker needs to be positioned on the
AD value.
0 No
OD. Test
1 340
2 405
Filter 510 nm
3 492
AD value 30125 4 510
OD. 0.6354 5 546
6 578
7 620
3. Position a tube filled with distilled water under the inlet tube and press the PUSH button.
4. Wait until the AD value of the blank for water is stabilized.
5. When the value is more or less stable, press “ENTER”. The AD value should be between 26.000 and
38.000. If not, rinse with distilled water and repeat the measurement.
6. The selection marker should be positioned on OD.
7. Position a tube filled with the sample under the inlet tube and press the PUSH button to aspirate the
sample.
8. The instrument will measure the AD value of the sample and will calculate its optical density (OD). The
result will be displayed directly.
9. Position the next sample tube under the inlet tube and press the PUSH button to aspirate the sample.
10. Proceed like this until all the samples are analyzed.

NOTES:
1. It is possible to accelerate the stabilization time by preheating the distilled water and the samples at
37°C.
2. This menu will only give absorbency results as OD values, no concentrations!

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4 DAILY ROUTINE
NOTE:
For best use of our kits on a Cypress Diagnostics analyzer we kindly advise to follow the application sheets
of the respective analyzer (NOT the kit insert). Upon registering to our website (www.diagnostics.be) you
can find the latest application sheets under the analyzers.
4.1 PREPARATIVE WORK

4.1.1 Preparation of the analyzer


1. Switch ON the CYANStart analyzer. After a short system auto-check, the software version is shown.
2. Press « ENTER » to proceed to the main menu.
3. Wait around 30 minutes to allow the instrument to reach the optimal working temperature and for
the lamp to stabilize before proceeding to the test measurements. In the meantime, you can perform
the preparative work.
4. Check the liquid level of the waste container (empty if necessary).
5. Pre-rinse the CYANStart with 15mL distilled water by pressing the « WASH » button.

4.1.2 Perform an AD auto zero


! ATTENTION ! When performing AD Auto Zero, make sure that:
1. The flowcell is washed and sufficiently rinsed with distilled water
2. The flowcell is completely filled with distilled water and free of air bubbles (~pump calibration)
3. The obtained values are within the acceptable limits.

4.1.3 Preparation of the reagent


For certain methods it is necessary to prepare a working solution. Check the application sheets at the end
of the user manual for specific requirements for each reagent.

4.1.4 Preparation of the samples


1. Prepare the blank as described in the application sheets.
2. Prepare the standard/calibrator and sample(s) as described in the application sheets.
3. Prepare the quality controls in the same way as the samples
a. Take the same amount of control serum as indicated for the sample
b. Respect the incubation times and use the same measuring procedure
4.2 START SAMPLE ANALYSIS
Go to the « Perform Test » menu and select the test of your choice from the program list. Follow the work
flow as displayed on the screen and in the daily routine schematics:
If the programmed temperature is not reached yet, « Temp. doesn’t matched! » will appear when opening
the method. Click ‘Wait’. Do NOT proceed if the temperature has not reached 37 °C!

4.2.1 AD Auto zero (AD Value)


1. Position distilled water under the inlet pipe and press the PUSH button.
2. Make sure the value is between 26.000 and 38.000.
a. If the obtained values are within the acceptable limits, press “ENTER” to proceed to the next screen.
b. If NOT, exit the test, rinse abundantly with distilled water and then restart the test. DO NOT proceed
if the obtained AD values are not within the acceptable limits.
! ATTENTION ! If the values remain out of range, wash and rinse abundantly with distilled water. If
after several washing and cleaning procedure the values remain out of range, perform an AD auto
zero.

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4.2.2 Test Blank
1. Check the application sheet to verify if distilled water or reagent needs to be measured.
2. Select « YES ». It is strongly recommended to measure a new blank every time you perform a test.
3. Position the blank test tube under the inlet pipe and press the PUSH button.
4. Check if the OD value is within range as mentioned in the application sheets (Blank Low – Blank High).
a. If the OD value is within range, press “ENTER” to proceed to the next screen.
b. If NOT, the error message “L” or “H” will be displayed on the screen next to the measured value. Exit
and restart the test to repeat the measurement. DO NOT proceed with the measurement if the OD
value is not within the acceptable range.
! ATTENTION ! If after the new measurement, the value is not within range and the blank is:
a. Water  rinse instrument abundantly with water and restart the test.
b. Reagent  1) check the preparation of the working reagent and the reagent.
 2) Reagent is deteriorated, check storage conditions, open new kit and restart test.

4.2.3 Test Standard/Calibrator


1. Check the application sheets if a standard, calibrator or factor should be used. If STD = 0 is programed,
the software will not ask to test a STD.
2. Select « YES »
a. First time you perform the test method.
b. When using a new lot number of reagent or new working solution.
c. When QC measurement is out of range (see following point).
3. Place the standard test tube under the inlet pipe and press the PUSH button.
4. The factor will be automatically calculated and stored in the method programming.
NOTES:
1. Make sure the correct concentration is programmed (concentration is lot number dependent). Check
or modify in « Program Setup »  « Program modify »  Select method STD Conc (Units!).
2. 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 to calculate the factor. This requires adjusting the
settings of the method; Program ‘NUM of STD: 1’ and ‘CONC’: as mentioned on the insert or vial.

4.2.4 Quality control measurement


It is strongly recommended to perform a QC by measuring both normal control and pathological control
serum. Check in the application sheet which control sera should be used. Ideally, both controls should be
measured each time an analysis is performed. The QC measurement needs to be performed:
a. The first time you perform the test method.
b. When using a new lot number of reagent or new working solution.
c. Once a week
It is not possible to program two quality controls on the CYANStart. We suggest to measure the quality
controls as samples.
1. Position the test tube with the QC preparation under the inlet pipe and press the PUSH button.
2. Check manually if the concentration is within target control range (insert of the control serum).
NOTES:
1. Quality controls have a lot dependent concentration! Make sure to compare the obtained results with
the correct control values (see insert).
2. 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.

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4.2.5 Sample measurement
1. If the AD value, blank and QC are OK, proceed with the sample measurement.
2. Insert the reference number.
3. Position the test tube with the sample preparation N°1 under the inlet pipe and press the PUSH button.
Aspirate the sample.
4. Proceed like this until all the samples are analyzed.
4.3 END OF TEST
1. Press « ESC » to exit the test method and confirm.
2. Rinse with 15mL distilled water, by pressing the « WASH » button.
4.4 EVALUATE THE SAMPLE RESULTS
1. The results (OD and concentration value) can be printed with the built-in thermal printer.
2. In the menu “Result process”, the results of the sample measurement can be examined, printed or
deleted and a patient print report can be made.
4.5 SHUT DOWN

4.5.1 At the end of the day


1. Rinse the instrument with a15mL detergent (CYAN Washing Solution CY001-WS or 5% Tween 20).
a. Position the tube with the detergent solution under the inlet pipe.
b. Press the « Wash » button until the solution is completely aspirated.
c. Repeat this operation with air to make an airgap between the detergent and distilled water.
d. Repeat this operation using 15mL distilled water.
e. Repeat this operation using air to dry the hydraulic system.
2. Switch OFF the CYANStart.
3. Clean the external surface of the instrument, with a cloth and some detergent.

4.5.2 At the end of the week


1. Perform a pump calibration and make sure that:
a. Exactly 5000 μl of distilled water is aspirated.
b. Press the PUSH button immediately after all the liquid has been aspirated.
c. Perform in triplicate (3 repetitions).
d. Obtain a value between 7500 and 14000 and difference between repetitions is less than 1000.
2. Rinse the instrument with 15mL detergent (see above: At the end of the day).
3. Disinfect the hydraulic system with 15mL 5% Hypochlorite (bleach).
a. Position the tube with the hypochlorite solution under the inlet tube.
b. Press “WASH”.
c. Incubate the hypochlorite in the flowcell for about 10 minutes (no longer!).
d. Aspirate air and then rinse the instrument with 15mL distilled water and aspirate air abundantly.

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DAILY ROUTINE SCHEMATICS

PREPARATION OF THE ANALYZER


1. WAIT 30 MIN (lamp + temp)
2. CHECK WASTE LEVEL
3. PRERINSE WITH DISTILLED WATER
4. PERFORM AD AUTO ZERO

PREPARE (WORKING) REAGENT

PREPARE BLANK / STD/ QC / SAMPLES

PERFORM TEST –SELECt METHOD

AD VALUE

1e CLEANING NO
OK?
e
2 AD AUTO ZERO
YES NEW KIT & CHECK
3e PUMP CALIBRATION
BLANK MEASUREMENT
STORAGE CONDITION

NO
OK?
REAGENT DETERIORATION
YES

INCLUDE
(STD/CAL MEASUREMENT)

QC MEASUREMENT

NO
CHECK PREPARATION OK?

YES

SAMPLE MEASUREMENTS

END OF DAY END OF WEEK

CLEAN WITH DETERGENT


CLEAN WITH DETERGENT

CLEAN WITH 5% HYPOCHLORITE


RINSE WITH DISTILLED WATER
RINSE WITH DISTILLED WATER
RINSE WITH AIR
RINSE WITH AIR
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5 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 CYANStart 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 program maintenance form for an overview of the different maintenance actions. In case
of repair, please register all undertaken actions in the repair form in order to keep track of the interventions.
5.1 PUNCTUAL MAINTENANCE
The punctual maintenance should be effectuated at installation, before or after a long period of duty.
The following points of attention should be considered:
 Select the right voltage (110 or 230V).
 Check the instruction for installation.
 Connecting the waste bottle to the instrument.
 Check all tubes visually for leaking or squashing. Pay special attention to the pump tube. Replace if
necessary.
 Removing dust from the instrument.
 Washing the flowcell with 15mL of detergent (CYAN Washing Solution CY001-WS or 5% Tween 20)
and rinse with distilled water.
 Disinfect the flowcell with 5% Hypochlorite solution and rinse the flowcell 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.
5.2 ROUTINE MAINTENANCE
FREQUENCY WHAT CLEANING SOLUTION
Between methods Rinsing Distilled water
End of the day Detergent + rinse with distilled water + rinse with air
Washing Detergent + sodium hypochlorite (diluted 5 %) + rinse with
Every week
distilled water + rinse with air
End of the day (outside) CYDIS surface/detergent + dust cover
Cleaning
Every 6 months (inside) Pressurized air (by service engineer)!
Every morning AD auto zero
Verification
Every week Pump calibration

5.2.1 Washing
1. Between tests
It is not necessary to wash the instrument between different samples for the same method.
However:
a. 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.
b. 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.
Between methods, always rinse the flowcell with distilled water to avoid contamination problems.

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2. Daily washing
At the end of each working session, it is recommended to rinse the instrument with a neutral detergent
solution (CYAN Washing Solution (CY001-WS) or 5% Tween 20):
a. Position 15mL of detergent solution under the inlet pipe.
b. Press “WASH” until the complete solution is aspirated.
c. Repeat this operation with air to make an air gap between the detergent and distilled water.
d. Repeat this operation with distilled water to rinse the system.
e. Repeat this operation with air to dry the hydraulic system and avoid microbiological contamination.
3. Weekly washing
After a week of work, wash first with 15 ml detergent (see Daily washing); afterwards, disinfect the hydraulic
system (tubes and flowcell) with 5% hypochlorite (bleach).
a. Positon 15mL of hypochlorite solution under the inlet tube.
b. Press “WASH”.
c. Incubate the hypochlorite solution in the flowcell for 10 minutes (no longer!).
d. Aspirate air and then rinse the instrument abundantly with 15mL of distilled water and air.
NOTES:
1. In case of air bubbles (visible during AD auto zero or perform test) rinse with diluted sodium
hypochlorite (5 to 10%), then rinse with plenty of distilled water, followed by a few washing cycles with
air.
2. This diluted sodium hypochlorite 5% is normally market available. Please use only good trademarks.
Cheap ones can contain contaminating solutions.
3. Always dilute the sodium hypochlorite for 5 to 10%, never use it undiluted! This will damage the
instrument.
4. Do not use corrosive detergents to wash the instrument.

5.2.2 Cleaning
1. 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
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) and wipe the outside of the instrument.

2. Every 6 months
We advise 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.
NOTE:
1. The instrument cover should only be removed when the CYANStart is unplugged.
2. We strongly advise to leave this procedure to the technical assistance of the service engineer of your
distributor.

5.2.3 Verification
1. Daily
Perform an AD auto zero.
2. Weekly
Perform a pump calibration.

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5.3 REPLACEMENT OF SPECIFIC PARTS
Before replacing any instrument part, repairing any defective items 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).

5.3.1 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.
1. Spray the solution all over the instrument.
2. Allow the solution to stand for approximately 30 minutes.
3. Wipe the solution off the instrument using a sponge dampened with distilled water.

5.3.2 Internal washing


Wash first with 15 ml detergent (end of day procedure); and then disinfect the hydraulic system (tubes and
flowcell) with 15mL of 5% Hypochlorite (bleach). Make sure to incubate for 10 minutes and then rinse
sufficiently with distilled water.

5.3.3 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 Every year or in case of leaking/obstruction or Service engineer
circuit strong coloration
Lamp Every year Service engineer
Amplifier board Every 2/3 years (together with lamp replacement) Service engineer
Connectors Every 2/3 years (together with tube replacement) Service engineer
Flowcell In case of leaking/obstruction or strong Service engineer
coloration

5.3.4 Replacement of peristaltic pump tube


1. Aspirate water to be sure that the tubes are dry and will not leak upon disconnected.
2. Turn OFF the CYANStart analyzer.
3. Unscrew the 4 screws to remove the cover on the left side of the instrument to access the peristaltic
pump.
4. To replace the tube, remove it from the pump rotor then disconnect the tube from its connectors. Insert
the new tube on the connectors and place the tube around the pump. The easiest method is to place
the connector into its support, then place the tube around the rotor and finally place the second
connector into its support by gently pulling the tube.
5. Make sure to place the tube in the correct direction. The tube coming from the flowcell is placed down
and the tube going to the connector of the waste is placed up.
6. To verify if the peristaltic pump tube is properly placed, turn the rotor manually (in the correct direction,
see arrow). If the rotor turns easily, this indicates that the tube is placed correctly. If not, check the
“attention points” below.
! The manual rotation can only be performed when the instrument is turned OFF (O). If the instrument
is turned ON (I), the movement of the rotors will be blocked and the manual rotation could damage the
mechanism.

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7. Place back the cover.

EXIT
To the waste

ENTER
From flowcell

! ATTENTION POINTS!
1. Make sure the new pump tube is placed in the middle of the rollers of the pump rotor.
2. Verify that the new tube is completely inserted into the connectors.
3. Verify that the white plastic connectors are correctly placed around/on the pump tube and in their
support.
4. Make sure that the tubes are not squashed or bent by the mold of the instrument.

√ √ √ √ √

X X X X X
NOTE:
After the replacement of any part of the hydraulic system, it is necessary to recalibrate the peristaltic
pump aspiration volume (see 3.8)!

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6 TROUBLESHOOTING

6.1 OPERATIONAL
Trouble Diagnosing and solution:
AD Zero out of range Check if:
for all filters - The instrument is ON for at least 30 min.
- The lamp is ON. If not, contact a service engineer.
- 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 optical cover is closed during measurement.
- The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water.
 Perform washing and rinsing (5.2).
- The windows of the flowcell are clean (no dirt, no fingerprints on the outside).
 Clean with wipes for glasses.
- The flowcell is filled with distilled water and without any air bubbles.
 Verify the pump calibration and the absence of leakages, or cracks in tubes and
flowcell.
- The gain of all/most filters is 5, 6, 7
 The lamp is aged and should be replaced: contact a service engineer.
If after these verifications, the problems remain, please contact a service engineer.
Check (by service engineer):
- Lamp, and replace if necessary
- Sensor of filter wheel
AD Zero out of range Check if:
for one or few filters - 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 (5.2).
- The windows of the flowcell are clean (no dirt, no fingerprints on the outside).
 Clean with wipes for glasses.
- Verify the 2 points above 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 absent of leakages, cracks in tubes and flowcell.
If after these verifications, the problems remain, please contact a service engineer.
Check (by service engineer):
- Sensor of filter wheel
- Filter
OD values are near Check (by user):
zero - If the lamp is ON. If not, contact a service engineer.
- 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 (5.2).
- The windows of the flowcell are clean (no dirt, no fingerprints on the outside).
 Clean with wipes for glasses.
- 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.
- The reagents are deteriorated (reagent blank values out of range).
- Preparation of the (working reagent) and the samples.
- The method has been programmed correctly.
If after these verifications, the problems remain, please contact a service engineer.

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The concentrations Check if:
are zero - The OD values are close to zero
 See above
- Restart the measurement and register the (new) calibration!
 The first time a method is executed, a calibration needs to be performed so that the
instrument can define the factor for the calculation of the concentrations.
 Check the application sheet if a standard, calibrator or a factor needs to be used.
Some standards and all of the calibrators have a lot dependent concentration! Make sure
that the correct values have been registered.
Blank is out of range Check if:
- The instrument is ON for at least 30 min.
- The method has been programmed correctly, consistent with application sheets:
distilled water or reagent, the number of blank measurements and the limits of the
blank.
- 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.
- Blank is distilled water.
 Perform washing and rinsing (5.2), 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 contact a service engineer.
QC is out of range or Check if:
bad accuracy of - The instrument is ON for at least 30 min.
results - 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 has been programmed correctly (consistent with 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 & 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 contact a service engineer.

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Bad repeatability of Check if:
results - No power problem (see below)
- 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 (5.2).
- 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.
If after these verifications, the problems remain, please contact a service engineer.

6.2 TECHNICAL
Trouble Diagnosing and solution:
Power problem Check if:
- Verify if the voltage switch 110/220 in the rear panel of the instrument is correctly set.
This is dependent of the location.
- The original power cord supplied with the instrument is used.
- The connection of the power is correct and firm.
- The fuses are not burned.
 Replace the fuses: 2x F2AL250V
- 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 230V ± 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 of the following supplementary devices is strongly
recommended:
 Electronic Stabilizer
 No Break module UPS – (Uninterrupted Power Supply)
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.
If after these verifications, the problems remain, please contact a service engineer.
NOTE :
In case of an electric shock, the parameters saved on the motherboard can be modified or
deleted. Please ask the technician of your distributor to check and if necessary readjust the
programming methods, the pump calibration, the temperature calibration and the other
settings.
Temperature Check if:
problem - Not in direct sunlight, this could affect the operating temperature.
- Not 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.
If after these verifications, the measured temperatures do not correspond to these
specifications, contact a service engineer.

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Aspiration problem Check if:
- The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water (5.2).
- 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, contact a service engineer.
- Blockage in one of the tubes can be caused by:
 Squashing of the tube, for example by the case, replace the tube if damaged,
contact a service engineer.
 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 (5.2.1),
replace if cleaning is not sufficient.
- Blockage in the flowcell.
 Accumulation of dirt in the flowcell  perform a cleaning with hypochlorite (5.2.1),
replace if cleaning is not sufficient.
- The pump tube is installed and connected correctly (2.3.3)
- The peristaltic pump is correctly calibrated.
- The peristaltic pump motor is turning smoothly.
If after these verifications, the problems remain, please contact a service engineer.
Printing problem Check (user):
- 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, please contact a service engineer.
Screen is not Check (user):
readable - Contact your service engineer

System test failed If one of the tests fails, the System Test presents an error. Besides this general error, the
instrument will indicate what part of the instrument causes the error. Ex: AD conversion,
printer, filter wheel motor or sensor…
If this is the case, please contact a service engineer.
System Start
System Test …………………………Error!
A/D Convert…………………………Error!
Filter Test……………………………Error!
Printer online…………………………No!
System Initialization…………………Error!
NOTE:
If the system start-up is blocked and the analyzer does not respond, please check the
connection of the keyboard. When the instrument receives a signal from the keyboard
during start-up, this can interfere with the system start-up. In this case, please contact your
service engineer.
System Start
System Test ……………………………
A/D Convert……………………………
Filter Test………………………………OK!

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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.

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MAINTENANCE FORM
Distributor: (name)

(address)
Coordinates: (E-mail)
(website)

Technician in charge:
Tel: Mobile:

Laboratory: (name)

(address)
Coordinates: (E-mail)
(website)

Tel:

Installation date: (date)


End Warranty: (date)
Instrument: CYANStart
Serial number:
Software version:

Last visit: (date)


Next visit: (date)

Laboratory Technician:
Name
Signature

Maintenance Engineer:
Name Date
Distributor
Signature

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MAINTENANCE INSTRUCTIONS
To be performed by Period Activity

AD auto zero

Rinse between methods


Daily
Wash the flowcell with detergent
Laboratory
Technician
Clean the outside of the analyzer

Wash the flowcell with hypochlorite


Weekly
Pump calibration

Period Activity Date Date Date Date Date


Replace the peristaltic pump
tube
6 Months
Remove dust inside instrument

2000 Hours / 1 Year Replace the lamp

Maintenance 1 Year Replace all the tubes


Engineer Replace the pre-amplifier board
together with the lamp
2/3 years replacement
Replace the connectors
together with the tubes
replacement
Problems Fill in repair form*

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REPAIR FORM
Item code instrument: …………………

Serial number (SN): …………………

Software version: …………………

Date of installation: …/…/….

Date of complaint: …/…/….

Description of problem: (details)

Actions undertaken: (details)

Code Name

Spare parts used :

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Problem solved: YES / NO

Actions to be
(details)
undertaken:

AD auto zero result (at least 2 repetitions).


Pump calibration (results of 3 repetitions).
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?
When support from If there is only a problem with specific reagents?
Cypress is requested,  Item code of reagent?
please also include in  Lot number of reagents, standard/calibrator, quality controls?
your communication:  Date of opening?
 Storage temperature?
 Method programming?
 Values of results (absorbance (OD), not calculated concentrations)
o Blank
o Standard/Calibrator
o Quality controls

Comments:

Laboratory Technician:
Name
Signature

Maintenance Engineer:
Name Date
Distributor
Signature

Please file in the above documents, in order to track the different interventions.
We suggest to keep the original together with the instrument and to deliver a copy to the
maintenance engineer.

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INSTALLATION FORM
Please FILL In the INSTALLATION FORM and send a COPY BACK TO CYPRESS DIAGNOSTICS

Distributor: (name)

(address)
Coordinates: (E-mail)
(website)

Technician in
charge:
Tel: Mobile:

Laboratory: (name)

(address)
Coordinates: (E-mail)
(website)

Tel:

Delivered: (date)
End warranty: (date)
Instrument: CYANStart
Serial number:
Software version:

Checklist for Installation:

□ Check content according to packing list

□ Verify location requirements

□ Verify the electronic current requirements. If necessary:

□ UPS
□ Electronic stabilizer

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: cypress@diagnostics.be
Installation of all accessories on the CYANStart analyzer:

□ 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 CYANStart analyzer:

□ Check system self-test at start-up

□ Perform washing and cleaning

□ Verify the aspiration and hydraulic system by performing a pump calibration

□ Verify the optical system by performing an AD auto zero

Adaptation of the system to the customer:

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

□ Customize the methods, adjust the units if necessary

□ User manual with application sheets in laboratory

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

Laboratory Technician:
Name
Signature

Maintenance Engineer:
Name Date
Signature

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: cypress@diagnostics.be
Version: March 2016
Valid till: next update
Page: 1

Item Code Item name Photo Comments Consumable Suggested stock:


for one year* 10 sold instruments

CYANStart CONSUMABLES
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

Replace every 6 months


CY004-S25 Pump tube Y 2 10
See hydraulic diagram

Replace every year


CY004/9-S26 Plastic aspiration tube Y 1 5
See hydraulic diagram

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

Replace every year


CY004/9-S28 Waste tube Y 1 5
See hydraulic diagram

CYANStart till P/D 05/2015


CY004-S29A Connector of waste tube (old) Replace every 2-3 years (Y) 4
See hydraulic diagram

From CYANStart P/D 05/2015 on


CY004-S29B Connector of waste tube (new) Replace every 2-3 years (Y) 2
See hydraulic diagram

2 per instrument
CY004-S30 Connector of pump tube (1 unit) Replace every 2-3 years (Y) 4
See hydraulic diagram

Replace every year


CY004/9-S40 Tube from pump to waste connector Y 1 5
See hydraulic diagram

Replace every year


CY004/9-S41 Tube from flow cell to pump Y 1 5
See hydraulic diagram

CY004/9-S44 Waste bottle (Y) 3

Optic Assembly

CY004/9-S09 Flowcell (Y) 2

Connection on power supply


CY004-S11 Lamp (with frame, cable and connector) Y 1 5
Replace every 2000 hours/ year

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: cypress@diagnostics.be
Version: March 2016
Valid till: next update
Page: 2

Item Code Item name Photo Comments Consumable Suggested stock:


for one year* 10 sold instruments

CY004-S33 Pre-amplifier board with cable Replace every 2-3 years (Y) 2

Power Assembly

CF-F2.0AL250V Fuse F2.0 AL250V 5x20mm (10 pcs) 2 per instrument (Y) 1 1

Hydraulic diagram

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: cypress@diagnostics.be
CYANStart: Semi-Automatic Biochemistry Analyser
Up to 60 tests/hour

General:
• Data storage: 200 test parameters & 1000 test results
• Flow cell: 32 μl, 10 mm light path
• Halogen lamp: 6V/10W
• Measurement range: 0,000 – 2,500 ABS
• Quality control feature
• Required volume: 500 μl
• Screen size: 240 x 128 pixels
• Voltage: 110/230V - 50/60 Hz
• Languages: English, French, Spanish

Printer:
• Built-in printer
• Prints graphs
• 24 characters per line

Temperature control:
• Peltier element
• 25°C, 30°C, 37°C, Ambient temperature

Weight and dimensions:


• 8,5 kg
• 35 x 40 x 24 cm (L x W x H)

Order code:
• CY004: CYANStart

Contact: e-mail: cypress@diagnostics.be Your Distributor


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

 ISO 13485:2003


ISO 9001:2008

www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be

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