Cyansmart: User Manual
Cyansmart: User Manual
English
CYANSmart
User Manual
ISO 13485-2016
www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: [email protected]
Layout 20181024
INDEX
1 INTRODUCTION .................................................................................................................................. 4
1.1 PRINCIPLE OF MEASUREMENT ...........................................................................................................................4
1.2 INTENDED USE ...................................................................................................................................................5
1.3 SYSTEM DESCRIPTION........................................................................................................................................5
1.3.1 Thermal carbon printer 6
1.3.2 Touch screen 6
1.3.3 Optical assembly 7
1.3.4 Incubator block 8
1.3.5 Hydraulic and aspiration system 8
1.3.6 Rear panel 8
1.4 TECHNICAL & OPERATIVE SPECIFICATIONS .......................................................................................................9
1.5 LIMITATIONS OF USE....................................................................................................................................... 10
1.6 REGULATORY COMPLIANCES ......................................................................................................................... 10
2 INSTALLATION ................................................................................................................................. 11
2.1 TRANSPORT AND STORAGE ............................................................................................................................ 11
2.2 UNPACKING .................................................................................................................................................... 11
2.3 INSTALLATION................................................................................................................................................. 13
2.3.1 Locations specifications 13
2.3.2 Power supply connection 13
2.3.3 Install the peristaltic pump tube 14
2.3.4 Install the flowcell, aspiration tube and aspiration button 15
2.3.5 Install the waste tube and waste bottle 17
2.3.6 Switch on the analyzer 17
2.3.7 Install or change the print paper 17
2.3.8 Verify the instrument 18
2.3.9 Adaptation of the system to the end customer 18
3 SOFTWARE DESCRIPTION ............................................................................................................. 21
3.1 SYSTEM START – “SELF-TEST” ....................................................................................................................... 21
3.2 MAIN MENU .................................................................................................................................................... 21
3.3 PERFORM TEST MENU ..................................................................................................................................... 22
3.3.1 AD auto zero (AD Value) 24
3.3.2 Test Blank 24
3.3.3 Test standard/calibrator 25
3.3.4 Test quality control N/P 26
3.3.5 Sample measurement 27
3.3.6 End of test 28
3.3.7 Specific method instructions and formulas 28
3.4 METHODS ....................................................................................................................................................... 33
3.4.1 Program Add 33
3.4.2 Program Modify 36
3.4.3 Program Delete 37
3.4.4 Program List 37
3.5 ARCHIVES ........................................................................................................................................................ 38
3.5.1 Result List 38
3.5.2 Delete all 40
3.5.3 Data Synchronization 40
3.5.4 Print report 40
3.5.5 Control manage 40
3.6 TUBE WASH ..................................................................................................................................................... 42
3.7 PRINTER FEED ................................................................................................................................................. 42
Cost savings
Minimum reaction volume of 500 μl results in a decreased cost per test
Limited consumables required
Extra consumables included at delivery (two fuses, five paper rolls a spare lamp and pump tube)
Integrated incubator, printer, pump, flowcell
Long life lamp, even further extended by power saving / standby mode
Robustness of the analyzer with minimal daily maintenance
Analyzer guides the user and thereby 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, bichromatic) 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 water) provide background correction of the
reagent and sample coloration
Convenience
All Cypress Diagnostics biochemistry reagents are pre-programmed at delivery
180 open channels are programmable to allow for unrestricted testing
Memory for up to 6000 sample results
Large font size, pleases the eye and reduced the effort
LCD touch screen with virtual alphanumeric keyboard
Multilingual capability
Minimal daily maintenance
1. Thermal printer
2. Touch screen
① 3. Optical system
4. Incubator block
5. Peristaltic pump
8 6. Aspiration “Push” button
④
③ 7. Aspiration inlet
⑤ 8. Rear panel
After a certain time of inactivity (programmable in the system setup), the instrument will go into a power-
saving “Standby” mode:
The touch screen is black.
CYANSmart user manual, Version 20160902_(5.1) Page 5
The lamp is supplied with low voltage power (3.0 V).
All other parts are kept ready for urgency samples: incubator and flowcell are maintained at 37°C.
Upon touching the screen:
The touch screen is lit up.
The lamp is supplied with regular voltage power (6.0 V).
When data needs to be entered, a keyboard will appear. The keyboard will be adapted to the data that can
be entered in that specific area:
1. A complete alphanumerical keyboard. Press the CAP button until it becomes orange to enter capital
letters (right panel). To confirm an insertion and return to the previous menu, press “OK”
① Lamp
② Filter wheel with filters
④ ③ Motor for filter wheel
⑦ ④ Flowcell
①
② ⑤ Temperature sensor
⑥ Peltier element
③ ⑦ Photodetector board
⑤
⑥
The optical system is the functional key compound of the instrument. It contains the light source, filters for
wavelength selection, flowcell with heating mechanism and a PC board that contains the photodiode
detector. This pre-amplifier board also converts the light detection from an analog to a digital signal for
further processing on the main board.
The 6V, 10W halogen lamp is installed on a lamp holder. The normal life span of the lamp is 2000 hours (= 1
year). The CYANSmart has a power saving standby mode. After a specified time of inactivity, the instrument
will enter this standby mode and this will diminish the voltage to the lamp from 6V to 3V, thereby increasing
the life time of the lamp.
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 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.
Absorbance measuring range:
0.0~3.500 OD
Absorbance linearity:
a) absorbance is 0.200 ~ ≤0.500, the bias is within ±5%
CYANSmart user manual, Version 20160902_(5.1) Page 7
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%
Inlet fastening
screw
③ ④
⑦
⑤ ⑥
① Fan for internal cooling (80 x 80)
② Back label with serial number
③Power plug connector with fuses 2 x T2AL250V
④ Power switch
⑤ RS232 connection
⑥ USB port connection
⑦ 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.
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
CY009 CYANSmart Analyzer 1
- User manual including application sheets 1
- CD with PC software (from P/D 2016/09 on) 1
CY004/9-S28 Waste tube 1
CY004/9-S44 Waste bottle 1
CY004/9-S22 Aspiration button 1
CY004/9-S49 Power cord 1
CY004/9-S48 Fuse T2AL250V 2
CY009-S11 Lamp with frame, cable and connector 1
CY009-S25 Pump tube 1
CY001-S01 Thermal print paper 5
CY004/9-S43 Dust cover 1
CY009-S56 USB cable (from P/D 2016/04 on) 1
If the instrument is damaged or items are missing, contact your local distributor/importer immediately for
assistance. Make sure to document with photos.
①
②
⑤ ④
OUT IN
To waste connector From flowcell
! ATTENTION POINTS!
1. Make sure the pump tube is placed in the middle of the white rollers of the rotor.
2. Verify that the tube is completely inserted into the holders.
3. Make sure the pump tube connectors are completely inserted into the pump tube.
4. Make sure the tube (4) and (5), are inserted in the wholes and not squashed or bent by the case.
⑦
③
① ⑥
②
②
③ ④ ⑤
! 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.
End of tube
Waste level
! ATTENTION POINT!
Make sure to place the paper in the right direction. Only the coated side can be used to print. If the paper
is installed in the wrong direction (see below) the paper will move through the printer, but nothing will be
printed. To verify the printable side of the paper, the operator can scratch the paper. Upon scratching the
paper, only one side will become slightly greyish or shiny (see picture below), that is the side that can be
used for printing and thus should contact the printing bar.
√ X
Warnings
Do not try to print without printing paper installed, this will cause a system crash!
If the printer bar is (accidentally) removed from the printer head. Make sure to turn OFF the
instrument before repositioning it! Otherwise the cogwheels can get damaged!
Examples:
A. 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 low 1.18 1.18 x 0.0555 0.0655
Linearity High 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 N min Lot dependent - see insert 4.46
e.g. lot 3577
Control N max Lot dependent - see insert 6.04
e.g. lot 3577
Control P min Lot dependent - see insert 11.8
e.g. lot 5567
Control P max Lot dependent - see insert 16.0
e.g. lot 5567
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).
NOTE:
If the programmed temperature is not reached yet, the following screen will appear when opening the
method. After start-up, the instrument needs 15 - 30 minutes to obtain the correct working temperature.
This time is also essential to stabilize the lamp. It is thus strongly recommended to NOT proceed if the
temperature has not yet reached 37°C. Proceeding can affect the measurement accuracy and precision!
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.
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.
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 3.8.
! ATTENTION!
- In the normal aspiration mode, the tubes have to be checked before the aspiration of the air gap!
- Close the optical cover for further measurements. Background light can interfere with the
measurements!
1. The first screen will show the OD value obtained during the last blank measurement of that method.
2. Press “YES” to perform new blank measurement. It is strongly recommended to measure a new blank
every time you perform a test.
If “NO” is selected, the instrument will use (and print) the last blank value to calculate the result of the
measurements and proceed to the standard measurement.
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 perform the measurement.
CYANSmart user manual, Version 20160902_(5.1) Page 24
5. When the measurement is finished, the OD measurement (= absorbance of the blank) will be displayed.
NOTE: For some methods, it is recommended to perform multiple blank measurements. Then the
request to aspirate will re-appear after aspiration of the blank until the programmed number of blanks
have been aspirated. Then all (up to 3) measurement results will be displayed (and printed).
6. This OD value should be between the range mentioned for “Blank Low” and “Blank High”.
a. If the OD Value is within range, press “Continue” to proceed to the next screen.
b. If NOT (The error “L” or “H” will be displayed behind the value), press “Rerun” to repeat the
measurement. Do NOT continue measuring if the OD value is outside the acceptable range!
! 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.
1. The first screen will show the factor obtained during the last calibration of that method.
2. Press “YES” to perform a new standard measurement. A new calibration should be performed:
a. First time you perform the test method.
b. When using a new lot number of reagent or new working solution.
c. When the QC measurement is out of range.
Press “NO” to keep (and print) this factor and immediately proceed to the QC measurements.
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 “Continue” to proceed to the next screen.
b. Press “Rerun” to repeat the measurement.
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 “Methods” “Program modify”
Select method STD Conc (Units!) (See 3.4.2).
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 quality control (QC) measurements are within range.
However, for the most accurate results, it is recommended to use a calibrator (see application sheets) to
1. Press “YES” to perform a new normal control measurement. Ideally, both controls are measured every
time you perform a test. QC measurements should at least be performed:
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.
If “NO” is selected, the instrument will proceed to the control P / sample measurement.
2. Position the test tube containing the QC preparation under the inlet pipe and press the aspiration
button.
3. It will be aspirated in the flowcell and the instrument will perform the measurement.
4. When the measurement is finished, the OD measurement and calculated concentration will be
displayed (and printed).
5. Check if the concentration is within target control range.
a. If the concentration is within range, press “Continue” to proceed to the next screen.
b. If NOT (The error “L” or “H” will be displayed behind the value), press “Rerun” to repeat the
measurement. Do NOT continue measuring if the concentration is outside the acceptable
range!
6. Repeat these steps for the pathological control.
! 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 15 mL (10x) distilled water (see 5.2.1).
Cleaning with detergent and/or hypochlorite (see 5.2.1).
Pump calibration and verify that the flowcell is completely filled with distilled water and free of air
bubbles (see 3.8).
AD auto zero to verify the performance of the complete optical system (see 3.9).
Restart the measurement and include a new calibration!
CYANSmart user manual, Version 20160902_(5.1) Page 26
NOTES:
1. Quality controls have a lot dependent concentration! Make sure the correct range is programmed in
the methods! Check or modify in “Methods” “Program modify” Select method Control min/max
(Units!) (See 3.4.2).
2. If after recalibration with the standard included in the kit, the QC measurements remain out off range,
it is recommended to use a calibrator to perform a more accurate calibration (see application sheets).
NOTE:
When the memory is full, a warning message will be displayed “Memory full! Original data will be
overwritten!”. It is recommended to print all the needed results and to delete them to make space in the
memory.
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 for performing the test
1. Incubation time is IN the instrument.
2. You need to prepare, mix and measure one sample at a time. Aspirate the mixture in the CYANSmart,
immediately after addition of the (working) reagent to the sample/calibrator/control.
3. It is thus essential that the CYANSmart is ready for the aspiration. This is when the CYANSmart displays:
“Press PUSH to aspirate sample/standard/control”.
4. Wait with the preparation of the next sample until the CYANSmart is finished with 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 influences the rate of a reaction and the
activity (factor).
Press the aspiration button to aspirate the sample. The CYANSmart 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.
Program Name Use the keyboard that will appear if you tap this area, to insert the desired name.
Program Method Press the arrow and select the required test method in the pull-down menu: End
point, Two point, Kinetic or Bichromatic.
Main Filter Use the up or down arrow to select the required filter: 340, 405, 492, 510, 546, 578
or 620 nm.
Sub Filter This option is only available when the bichromatic method is selected. Otherwise
“None” is indicated. Use the up or down arrow to select the required reference filter:
340, 405, 492, 510, 546, 578 or 620 nm.
Program Unit Press the arrow and select the required program unit in the pull-down menu: 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, or μg%, %.
Linearity Min The lower limit for linearity, expressed in concentration. If the patient result is below
this range, the result will be flagged (“*”).The measurement should be repeated
with new or more concentrated sample. The Insert the value using the numeric
keyboard that will appear.
Attention: Insert the value corresponding to the units of this method
programming!
Linearity Max The upper limit for linearity, expressed in concentration. If the patient result is
above this range, the result will be flagged (“*”). The measurement should be
repeated with diluted sample. Insert the value using the numeric keyboard that will
appear.
Attention: Insert the value corresponding to the units of this method
programming!
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 keyboard that will
appear. 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 that will appear.
Insert the numbers of standards using the numeric keyboard that will appear. In
Num of STD case of a calibration by means of 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.
STD The number displayed (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,
use the arrow keys present in the STD area, to switch between the different STD’s
and insert their respective concentration.
CONC The concentration of the standard corresponding to the number displayed in STD.
Insert the factor using the numeric keyboard that will appear.
In case of a multi-calibration, the standard concentrations have to be entered from
the lowest to the highest value.
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.
CYANSmart user manual, Version 20160902_(5.1) Page 35
Factor Value essential for the calculation of the concentration from the absorbance
measurement. In case of standard 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 that will appear.
Control N min The minimum value of the range of the normal control, expressed in concentration.
If the control measurement is below this range, the result will be flagged (“L”). Insert
the value using the numeric keyboard that will appear.
Attention: 3The 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!
Control N max The maximum value of the range of the normal control, expressed in concentration.
If the control measurement is above this range, the result will be flagged (“H”).
Insert the value using the numeric keyboard that will appear.
Attention: 3The 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!
Control P min The minimum value of the range of the pathological control, expressed in
concentration. If the control measurement is below this range, the result will be
flagged (“L”). Insert the value using the numeric keyboard that will appear.
Attention: 3The 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!
Control P max The maximum value of the range of the pathological control, expressed in
concentration. If the control measurement is above this range, the result will be
flagged (“H”). Insert the value using the numeric keyboard that will appear.
Attention: 3The 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 arrow and select the required flowcell temperature: room temperature
(R.T.), 25 °C, 30 °C or 37 °C. For all Cypress Diagnostics methods, 37 °C must be
selected.
Press “Back” at any time to return to the previous page or after finalization press “Done” to continue to the
final screen. 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 or “Cancel” to return to the previous screen.
If one of the parameters is not entered correctly or not entered at all; e.g. no program name, an error
screen will appear and will then automatically return to the method parameters.
Print List The CYANSmart will print out an overview of all programmed methods. No detailed
information of the methods is visible or printed.
Item print Scroll through the different methods by using the next page and previous page
buttons. Select the desired method by tapping it. The CYANSmart will print out the
different parameters of the selected method. Below you can find an example of an
“item print” printout.
3.5 ARCHIVES
After selecting the archives folder, the user can review the sample results, make a patient print report or
delete sample results. There is also a menu with all quality control results and it is also possible to back-up
the patient data through the USB port.
By clicking a test result in the result list or search list, the details of that test become visible.
Edit Clicking edit, you can adjust the reference of the sample. If for example you did
not have time to fill in this information during the perform test. Click back to
store the new reference name in the memory.
Print To print out the information for that test result.
Delete To delete the test result from the memory. Afterwards, the list will display N/A
for that sequence number.
Data synchronization For more information check 6.4.
Result List To return to the list view.
CYANSmart
CYAN Hospital
18-09-2014 10:28:28
Ref: Cypress
Nr: 620
Program Name: GLUCL
OD.: 0.7710
CONC: 154.200 mg/dL H
The statistics include: the program name, normal range for the control (as programmed in the method),
number of measurements performed, the average (AVG) of the measurements, the standard deviation (SD)
and the coefficient of variation (CV%).
Feed
This function is not only present in the main menu. In the perform test menu, there is also a
button to enable advancing the paper and review the (printed) results in between the
samples.
2. Pressing the volume box, a numeric keyboard will appear, enter 3000 μl as the volume to aspirate and
press OK to exit the keyboard view.
3. Pipette exactly 3000 μl of distilled water into a test tube.
4. Position the aspiration tip inside test tube, be sure that aspiration tip is in the lower corner of the test
tube (see figure), so all liquid can be aspirated.
5. Press the aspiration button to start the aspiration.
6. Immediately and exactly when the tube is empty, press the PUSH key again to stop the aspiration.
7. The number of steps performed by the motor is displayed. The value should be between 18.000 and
28.000.
It is strongly recommended to perform this procedure at least 3 times. All obtained values should be
within this range and the difference between the obtained values should be smaller than 1000 steps.
8. By pressing the “Main Menu” button the software will exit this submenu. The software will ask “Sure to
save?” Click “Yes” to save and use this calibration as reference to intake any quantity of sample. Click
“No” to discard this calibration.
If the obtained values are outside the range or the difference between the replicates is more than 1000
steps:
a) Verify the pipette used and its precision/accuracy calibration
NOTE: For a higher precision we advise to use CYANPipettes. Ask your distributor for more information
about the CYAN product range.
3.9 AD 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 measuring for aging of the lamp.
Furthermore the values of gain and offset are used in the calculation of the test results. Consequently, to
ensure precise and accurate measurements, it is strongly recommended to perform an AD zero:
Every day/morning.
If the AD auto zero is outside the range in the perform test menu.
At instrument installation.
After installation of a new lamp.
Before performing an AD Zero it is essential to check that:
a) The hydraulic system (flowcell + tubes) is clean and rinsed with distilled water.
b) The flowcell is filled with distilled water and without any air bubbles.
c) The instrument is ON for 30 min, because the lamp needs this time to stabilize.
d) The optical cover is closed.
1. Select the “AD Zero” menu. The result of the last performed AD zero is shown. It is recommended to
make a print-out (by pressing the “Print” button) to be able to compare with the new reading.
2. Position a tube with distilled water under the aspiration inlet tube and press the aspiration button to
aspirate the distilled water.
Filter 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 50.000 and 60.000 up to a maximal
gain of 29 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.
State Indicates “OK” if the values for that filter are within the acceptable ranges, or
“Error if one of the values is outside the acceptable range.
Optimal ranges Gain: between 8 and 16
AD: between 50.000 and 60.000
Offset: between -150 and +150
Read To start a new reading.
Print To print out the displayed results.
Main Menu To return to the main menu. This measurement that is last performed will be
saved and the gain and offset from this measurement will be used in the
calculations when performing tests.
Since the AD Zero should be performed every day, the variation between the new measurement and the
previous (displayed when opening the menu) should be small. If you compare the results (compare always
the same filter!),
The difference in gain should be ≤ 2
The difference in offset should be ≤ ±50).
If the difference is bigger or the obtained values are outside the range, check if:
- The instrument is ON for at least 30 min, because the lamp needs this time to stabilize.
- 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/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 absent of leakages.
- If the gain of all/most filters is 15, 16 are more.
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!
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.
NOTES:
1. After start-up of the instrument, the instrument requires 15 - 30 minutes to reach the programmed
temperature.
2. If upon entering the perform test menu, the programmed temperature for the flowcell/cuvette is not
yet reached, the instrument will display a warning to inform the user of this discrepancy.
CYANSmart Control N
CYAN Hospital Target Control N Range:
30-09-2014 08:32:11 80.3000 – 109.0000 mg/dL
Program name: GLUCL OD.: 0.4881
Program Method: End Point Control: 92.5848 mg/dL
Main filter: 510 nm
Range: Ref.: Cyan1
60.0000 – 110.0000 mg/dL Nr.: 625
Linearity Range: OD.: 0.3658
1.1800 – 600.0000 mg/dL 68.3694 mg/dL
AD: 55504
Blank: 0.0205 Ref.: Cyan2
CONC: 100.0000 mg/dL Nr.: 626
OD.: 0.5250 OD.: 1.0564
Factor: 198.0000 205.1082 mg/dL H
Normal mode
CYANSmart CYANSmart
CYAN Hospital CYAN Hospital
30-09-2014 08:32:11 30-09-2014 08:33:51
Program name: GLUCL Program name: GLUCL
Program Method: End Point Control N
Main filter: 510 nm Target Control N Range:
Range: 80.3000 – 109.0000 mg/dL
60.0000 – 110.0000 mg/dL OD.: 0.4881
Control: 92.5848 mg/dL
Linearity Range:
1.1800 – 600.0000 mg/dL
CYANSmart
AD Auto Zero
CYAN Hospital
AD: 55504
30-09-2014 08:34:43
AD Low: 50000
Ref.: Cyan1
AD High: 60000
Nr.: 625
CYANSmart Program Name: GLUCL
CYAN Hospital OD.: 0.3658
30-09-2014 08:32:43 CONC: 68.3694 mg/dL
Blank Normal Low: 60.0000
Program name: GLUCL Normal High: 110.0000
Blank: 0.0205
Blank Low: 0.0000 CYANSmart
Blank High: 0.3200 CYAN Hospital
30-09-2014 08:35:23
CYANSmart Ref.: Cyan2
CYAN Hospital Nr.: 626
30-09-2014 08:33:11 Program Name: GLUCL
STD OD.: 1.0564
Program Name: GLUCL CONC.: 205.1082 mg/dL H
CONC.: 100.0000 mg/dL Normal Low: 60.0000
OD.: 0.5250 Normal High: 110.0000
Factor: 198.0000
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.
4.2.1 AD Value
1. Press “Continue” to start the AD Auto zero measurement.
2. Position distilled water under the inlet pipe and press the aspiration button.
3. The AD value should be within range AD Low (50000) and AD High (60000).
a. If the AD Value is within range, press “Continue” to proceed to the next screen.
b. If NOT (The error “L” or “H” will be displayed behind the value), press “Rerun” to repeat the
measurement. Do NOT continue measuring if the AD value is outside the acceptable range!
4.6 WEEKLY
1. Perform a pump calibration and make sure to:
Pipet exactly 3000 μl of distilled water.
Press the aspiration button immediately after all the liquid has been aspirated.
Perform in triplicate (3 repetitions).
Obtain values between 18.000 and 28.000 and the difference between repetitions <1000.
2. Wash the instrument with a detergent (see end of day).
3. Disinfect the hydraulic system (tubes and flowcell) with 5% Hypochlorite (bleach).
a. Position the hypochlorite solution under the inlet pipe
b. Press the “Tube Wash” button at least 10 times to aspirate 15mL of hypochlorite solution.
c. Incubate the hypochlorite in the flowcell for about 10 minutes (no longer!).
d. Aspirate air (1x) and then rinse the instrument with 15mL distilled water and air (10x).
AD VALUE
1e CLEANING NO
e
OK?
2 AD AUTO ZERO
3e PUMP CALIBRATION YES NEW KIT & CHECK
BLANK MEASUREMENT STORAGE CONDITION
NO REAGENT DETERIORATION
OK?
YES
INCLUDE
(STD/CAL MEASUREMENT)
CONTROL MEASUREMENTS
NO
CHECK PREPARATION
OK? YES
SAMPLE MEASUREMENTS
5.2.1 Washing
1. Between tests
It is not necessary to rinse the instrument between different samples for the same method. However:
In case of high risk of cross-over, you could pre-rinse the flowcell by aspirating distilled water, followed
by air (to avoid dilution) between the samples.
In case of a strongly colored reagent, it might be necessary to pre-rinse the flowcell with (working)
reagent before aspirating the first measurement. Otherwise the first measurement could be influenced
by the distilled water used to zero the instrument.
Between methods, always rinse the flowcell with distilled water, to avoid contamination problems.
3. Weekly washing
After a week of work, wash first with 15 mL detergent (end of day procedure); and then disinfect the
hydraulic system (tubes and flowcell) with 5% Hypochlorite (bleach).
a. Position the hypochlorite solution under the inlet pipe
b. Press the “Tube Wash” button at least 10 times to aspirate 15mL of hypochlorite solution.
c. Incubate the hypochlorite in the flow cell for about 10 minutes (no longer!).
d. Aspirate air (1x) and then rinse the instrument with 15mL distilled water and air (10x).
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 is normally market available. Please use only good trademarks. Cheap
ones 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
It is recommended to clean the dust from inside the instrument at least every 6 months. To do so, remove
the cover and blow the dust off the instrument using pressurized air. Make sure the air is completely dry!
Open the filter cover and blow the dust off.
NOTES:
1. The instrument cover should only be removed when the CYANSmart 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.
①
②
⑤ ④
③
OUT IN
To waste connector From flowcell
! ATTENTION POINTS!
1. Make sure the new pump tube is placed in the middle of the white rollers of the rotor.
2. Verify that the new tube is completely inserted into the holders.
3. Make sure the pump tube connectors are completely inserted into the new pump tube.
4. Make sure the tube (4) and (5), are inserted in the wholes and not squashed by the case.
√
X √
X
NOTE:
After replacing any part of the hydraulic circuit, you must recalibrate the peristaltic pump aspiration
volume! See 3.8.
1. Click the Windows start button and choose Control Panel . In the window that
6.2.1.2 Windows XP
.
If your view is set to “by Category” (upper right corner), go to “Clock, Language, and Region” and then
click “Change the date, time, or number format”.
3. In the window that opens, select the Formats tab and click on Additional settings.
4. Adapt the decimal symbol from “,” (=comma) to “.” (=point), click apply and ok.
4. Open the CYANSmart software by double clicking the icon or Start All Programs
CYANSmart CYANSmart.exe.
Selection criteria This area can be used to visualize particular data/records. Data search can be done
using different criteria:
o Date of analysis (day of today as default)
o Age of the patient
o Sex of the patient
o Patient ID
o Name of the patient
o Reference of the patient (as inserted in the instrument)
After inserting all the information for the search of required data, click “Search” to
visualize all the results that corresponds to your search in the selected data area.
Note: There is an “AND” relation between the different fields. If more than 1 field
is filled in, the search can be narrowed down.
Selected data This area shows the data corresponding to your search. Upon selection of a result
in this area, the “Delete” and “Print” buttons and the “Patient information area”
become activated.
Patient information To edit or complete the patient information after selecting a record in the selected
data area. The ID field is read-only, all others can be modified. After changing
anything to a record: click ”Save”’ to confirm the change.
Print report title To adjust the heading of the patient report, write the correct title in the left bar.
Print (Ref) To print all results associated with a certain REF. See 6.4.4. for more details.
Delete To delete the result selected in the selected data area
Print To print the result selected in the selected data area on the printer set as default
for that computer.
Export to excel To export all the result to an excel file.
5. A window will pop-up were you can fill in the recommended patient information (if this was not yet
completed): Name, sex and age.
6.4.5 Methods
This folder is protected by password. It contains settings intended solely to be examined or changed at the
factory or by a qualified technician, for example when a method programming update is available.
For accessing the method programming go to CYANSmart Method setup. In this window you can easily
modify or update the methods settings on the CYANSmart itself.
ATTENTION: This menu should only be accessed by trained personnel. Changing methods can
influence the outcome of your results. Only change parameters of the methods when Cypress
Diagnostics instruct you to do so or launches an update of the application sheets.
Password: 999 and confirm by clicking ‘OK’.
Method overview An overview and list of all programmed methods. Click the method to see the
details of the programmed parameters in the method settings area. To change
the order and thus the ID number, use the green buttons at the bottom.
5. Select the correct Excel file with the latest settings supplied by Cypress Diagnostics or downloaded from
our website and click <Open>.
7. Click <Upload all methods> to transfer the method settings from the software to the CYANSmart
analyzer. A status bar will appear:
8. When the upload to the CYANSmart is successfully completed the following pop-up appears. Press
<OK>.
Verify that the update was successful by going to Methods Program List on the CYANSmart and verify
the method programming with the latest application sheets.
7.1 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 the lamp is off: 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/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 & flowcell.
- The gain of all/most filters is 15, 16, are more.
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/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 absence of leakages, cracks in tubes & 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 if:
zero - If the lamp is ON for at least 30 min.
If the lamp is off: 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/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 & 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.
7.2 TECHNICAL
Trouble Diagnosing and solution:
Power problem Check if:
- The original power cord supplied with the instrument is used.
- The connection of the power is correct and firm.
- The fuses are not burned.
Replace with the correct fuses: 2x T2AL250V.
- Placed on a stable, horizontal surface, free from vibrations.
- Placed away from other appliances that generate electrical noise or magnetic fields (e.g.
radiological instruments, X-ray, radio…).
- Connected to a suited and grounded AC wall outlet, preferably one that is not shared
with other electric appliances and with low fluctuation of line voltage:
AC 220V ± 10%, 50Hz ± 2% or AC 110V ± 10%, 60Hz ± 2%.
- If the AC wall outlet is not properly grounded, please connect a ground or earth wire to
the bottom plate of the analyzer.
- If the fluctuation is >10% use 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 mainboard 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/ beside 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):
- The measured temperature for the flowcell is the set temperature ±1°C.
- The measured temperature for the incubator is the set temperature 37.0 ±1°C.
If after these verifications, the measured temperatures do not correspond to these
specifications, contact a service engineer.
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.
□ System setup: print setup, standby time, date and time, hospital name, language
Laboratory technician
Name
Signature
Maintenance engineer
Name
Signature
Date
Laboratory technician
Name
Signature
Maintenance engineer
Name
Signature
Date
Replace:
Pre-amplifier board with cable (CY009-S33)
together with lamp
2/3 years Rubbers of peristaltic pump (CY009-S54)
together with the pump tube
Connector of waste tube (CY009-S29)
Connector of pump tube (CY009-S30)
Cypress Diagnostics: Nijverheidsstraat 8 • 2235 Hulshout • Belgium • www.diagnostics.be • Tel: ++ 32 15 67 67 68 • e-mail: [email protected]
Version: December 2016
Valid till: next update
Page: 1
CYANSmart CONSUMABLES
Item Code Item name Photo Comments Consumable Suggested stock:
for one year* 10 sold instruments
CY001-S01 Thermal print paper (57mm width) Y user dependent user dependent
CY009-S54 Rubber of peristaltitic pump (2 pcs) Replace every 2-3 years (Y) 6
Optic Assembly
CY009-S33 Pre-amplifier board with cable Replace every 2-3 years (Y) 5
Power Assembly
Hydraulic diagram
English
To all Healthcare Professionals,
CYANSmart
Cypress Diagnostics provides the tools and solutions that
let clinical laboratories worldwide deliver clear and precise
diagnostic results.
We manufacture the equipment needed for handling the
Semi-Automatic Biochemistry
samples, analyzers to perform the tests, reagents to carry out
the tests and - increasingly often - the software platforms to
report the results.
Kind regards,
ISO 13485-2016
www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: [email protected]
CYANSmart Technical Specifications