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Operator’s Manual

For

Semi-Automated Clinical Chemistry


Analyzer

Z-Delite S
Z-Delite S Operator Manual

Foreword

This manual is created with the purpose of providing a reference for easy operation and
general maintenance of this analyzer. It contains detailed description of the analyzer
features, specifications and maintenance activities.
Use of the analyzer with proper knowledge will ensure proper test results and trouble
free analyzer operation with optimum performance.
This operation manual is prepared based on the assumption that the user has prior
knowledge of clinical chemistry.
Before operating the analyzer, user should:
1. Thoroughly read and understand this manual.

2. Be familiar with the operation of the analyzer.

3. Be trained by authorized person/s deputed by Zovec Healthcare Private Limited.

NOTE: Keep this manual in an easily accessible place.

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Contact Us

We welcome your feedback about the analyzer. You can reach us via the following
contact details,

Zovec Healthcare Private Limited


Address 303E, Sector 59, Faridabad-121004
Phone +91 129 4300777
Website www.zovechealthcare.com
Email sales@zovechealthcare.com

German Subsidiary
Zovec Diagnostics GmbH
Mühlenstraße 8a, 14167
Berlin, Germany

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Table of Contents
1. OVERVIEW OF ANALYZER........................................................................................................... 6
1.1. INTRODUCTION ....................................................................................................................... 6
1.2. ANALYZER VIEW .................................................................................................................... 7
1.3. KEYPAD ..................................................................................................................................... 8
1.4. ASPIRATION SWITCH ............................................................................................................ 9
2. SAFETY ............................................................................................................................................ 10
2.1. GENERAL SAFETY ............................................................................................................... 10
3. SYSTEM SPECIFICATIONS AND FEATURES ........................................................................ 11
3.1. SOFTWARE SPECIFICATIONS .......................................................................................... 12
4. INSTALLATION .............................................................................................................................. 14
4.1. INSPECTION ........................................................................................................................... 14
4.2. UNPACKING ........................................................................................................................... 14
4.3. INSTALLATION REQUIREMENTS ..................................................................................... 15
4.4. ELECTRICAL REQUIREMENTS ......................................................................................... 15
4.5. INSTALLATION PROCEDURE ............................................................................................ 16
4.6. PRINTER AND INSTRUMENT COMMUNICATION INSTALLATION ........................... 16
5. PRINCIPLES OF OPERATION .................................................................................................... 17
5.1. MODES OF OPERATION ..................................................................................................... 17
5.2. READING THE FLOWCELL/CUVETTE ............................................................................. 18
5.3. CARRYOVER AND ASPIRATION VOLUME .................................................................... 18
5.4. CALCULATION OF THE KINETIC TEST RESULTS ....................................................... 19
5.5. ADDITIONAL CUVETTE HOLDER ..................................................................................... 19
6. SCREEN NAVIGATION ................................................................................................................. 20
6.1. POWER ON MENU ................................................................................................................ 20
6.2. HOME SCREEN MENU ......................................................................................................... 21
6.3. SETUP ...................................................................................................................................... 23
6.4. ASSAY NAME GENERATION ............................................................................................. 26
6.5. SETTING OF PARAMETERS............................................................................................... 26
7. MODES OF OPERATION ............................................................................................................. 28
7.1. END POINT LINEAR MODE ................................................................................................. 28
7.2. FIXED TIME LINEAR MODE ................................................................................................ 32
7.3. KINETIC (RATE) LINEAR MODE ........................................................................................ 33
7.4. SAMPLE BLANK LINEAR MODE ....................................................................................... 33
7.5. END POINT NON LINEAR MODE ....................................................................................... 33
7.6. FIXED TIME NON LINEAR MODE ...................................................................................... 33
7.7. RATE NON LINEAR MODE.................................................................................................. 34
7.8. COAGULATION MODE ......................................................................................................... 34

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7.9. ABSORBANCE MODE .......................................................................................................... 34


8. QUALITY CONTROL ..................................................................................................................... 35
8.1. QUALITY CONTROL VIEW MENU ..................................................................................... 35
8.2. DAILY QUALITY CONTROL ................................................................................................ 36
8.3. MONTHLY QUALITY CONTROL ........................................................................................ 37
9. SEARCH REPORTS ...................................................................................................................... 38
9.1. SEARCH REPORTS BY I.D ................................................................................................. 38
9.2. SEARCH REPORTS BY DATE............................................................................................ 39
9.3. SEARCH REPORTS BY TEST CODE................................................................................ 40
9.4. SEARCH REPORTS BY ID and DATE .............................................................................. 41
9.5. SEARCH REPORTS BY TEST CODE and DATE............................................................ 42
10. MAINTENANCE .......................................................................................................................... 43
10.1. MAINTENANCE MENU ..................................................................................................... 43
10.2. DAILY MAINTENANCE ..................................................................................................... 46
10.3. QUARTERLY MAINTENANCE ........................................................................................ 46
11. TROUBLE SHOOTING GUIDE ................................................................................................ 55
12. LIST OF CONSUMABLES ........................................................................................................ 58
13. REVISION HISTORY.................................................................................................................. 59

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1. OVERVIEW OF ANALYZER
1.1. INTRODUCTION

The Z-DELITE S instrument hereafter referred as an analyzer is a Compact, High


performance, 32 bit processor based semiautomatic biochemistry analyzer for Routine
Chemistries, Electrolytes, Immunoassays, Hormones, Coagulation and Drug tests.

There are 10 modes of operation. Assay Programming, Results reading and reporting
operations are user friendly.

Operation is through a soft-touch keypad (or a USB mouse/keyboard) with quick shift
from one function to another without going through complex sequential operations.

The analyzer is provided with an user friendly and easy to operate GUI which is further
enhanced by the provision of a 800x480 dots colour TFT display with LED backlight;
with alphanumeric and graphic capabilities.

The analyzer has memory for storage of all Assay Parameters including Reagent Blank
Absorbance, Factor, Non-linear Calibration Data. A patient-wise collated report is
obtained upon request. Exhaustive quality control data at 4 levels, for any of the tests is
also stored in the memory of the analyzer.

The analyzer software provides device diagnostics with Maintenance function, which is
capable of providing timely flag / error messages related to test results or analyzer
malfunctioning.

This analyzer is intended to be used for In-vitro quantitative and qualitative


determination of wide range of analytes in body fluids by the trained person, in
controlled environment and continuously monitored operation.

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1.2. ANALYZER VIEW

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1.3. KEYPAD

KEY DESCRIPTION
There are 8 dynamic function keys,
which are TFT display screen specific
Numeric Keys from 0 to 9, they are
used to enter
TO
There are 30 multifunction keys, which
act as 60 direct chemistry access
function keys. The function of this key
depends on number of times the key is
pressed. If pressed once chemistry
written on the top of the key
gets activated and if pressed twice
chemistry mentioned at the lower part of
the key gets activated.
E.g. If pressed once GLU will activate
and if pressed twice A1C gets activated.
The same key is used to enter the
alphabets from ‘A’ to ‘Z’, special
characters ‘@’ , ‘%’, ‘(‘, ‘)’ and ‘a’ to ‘z’,
special characters ‘#’, ‘&’, ‘*’, ‘/’
indicated on the right side of the
direct chemistry access key. These
alphabets can be utilized to enter
laboratory information or sample ID.
E.g. If pressed once capital letter ‘A’ to
‘Z’ will be entered and when pressed
twice small letters ‘a’ to ‘z’
gets entered for the corresponding key.

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Arrow Keys, which are used to browse


through screens and options.
This key is used to enter decimal point
or negative sign when required. If
pressed once the decimal point ’.’ gets
entered. If pressed twice ‘-’ sign gets
entered.
This key is used to enter comma sign or
underscore sign when required. If
pressed once the comma sign ’,’ gets
entered. If pressed twice underscore
sign ‘_’ gets entered.

1.4. ASPIRATION SWITCH

The Aspiration Switch Actuator is located at centre of the instrument below the
aspiration tube which is provided for aspiration of liquid into the flow cell and for
washing flow cell.

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2. SAFETY
This section provides safety information about analyzer. Use this product properly
and safely to prevent injuries and or damage to instrument/property. User must read
these safety precautions before installation/use and follow the directions.

2.1. GENERAL SAFETY


a) Only qualified and trained personnel should use the analyzer.

b) While operating, maintaining, servicing or repairing the analyzer, follow all the
procedures described in this manual.

c) Always ensure that mains switch is OFF while,


 connecting or removing or servicing the analyzer.
 replacing the fuse, either in Power Supply PCB or SBC PCB.

d) Observe all WARNINGS and CAUTIONS posted on the system or described in


this manual.

e) Never use substitute parts on the analyzer or modify it in any waywithout the
written consent of the manufacturer.

f) DO NOT open the instrument under any circumstances.

g) Avoid using dangerous flammable material around the analyzer. Fire or


explosion may be caused by ignition.

h) Avoid installation of instrument at location which is adversely affected by


environmental hazards which in turn may affect the functioning and performance
of the analyzer.

i) Take necessary precautions against hazards associated with the use of clinical
laboratory chemicals and reagents. Wipe any reagent spillage on the analyzer
immediately.

j) In case of any malfunction detected in the instrument, immediately shutdown the


instrument and contact authorized service personnel for repair.

CAUTION: DO NOT OPERATE THE ANALYZER ON A WET OR DAMP SURFACE

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3. SYSTEM SPECIFICATIONS AND FEATURES


1 SYSTEM TYPE Open
2 MEASUREMENT Colorimetry (Rate/EndPoint), Turbidometry,
PRINCIPLE Immunoassay
3 APPLICABLE Photometric assays – Enzymes, lipid, protein, Sugar,
ANALYTES Inorganic substances & others
Turbidometric Assay – IgG, IgA, C3, C4, RF etc.
4 SETUP Benchtop
5 MEASURE METHOD Monochromatic and Bichromatic
6 LIGHTSOURCE 12V, 20W Quartz Halogen Lamp
7 ABSORBANCE 0 - 3 Absorbance
RANGE
8 RESOLUTION 0.0001
9 WAVELENGTHS 9 wavelength (filters): 340, 405, 450, 505, 546, 578,
(FILTERS) 620, 670, 700nm
10 DETECTORS 9 UV / VIS Silicon photodiodes
11 TYPE OF Unique triple cuvette system:
TESTWARE 18 μl Flow cell or 33 μl (optional)
10 mm square cuvette
6 mm round Glass Tube with adapter for Coagulation
and Elisa tests
12 TEMPERATURE Peltier temperature control for 25, 30 and 37°C
CONTROL Accuracy ±0.1°C
13 MEASUREMENT 18μl (33 μl optional)
VOLUME
14 ASPIRATION Programmable from 200 μl to 2000 μl
VOLUME
15 KEYPAD Rugged water proof keyboard.
48 fixed and 8 dynamic keys
16 SMPS EXTERNAL(18V; 8A, 144W)
17 PRINTER High resolution, 384 dots per line, thermal printer with
full graphics facility and option for connecting
external USB printer
18 DISPLAY 800x480 pixels, colour TFT, with LED backlight. View
area: 154.08(W) × 85.92(H) mm
19 INTERFACES USB B type port for host computer.
USB A type port for connecting to External USB
Printer, USB mouse and USB keyboard.
USB A type port for Pen drive for Backup and
software update.
Ethernet connector for LIS and remote software
update
20 AUDIO Voice Support for Help/Guidance
21 PROCESSOR Up to 1GHz, ARM Cortex-A8, 32-bit Processor
22 MEMORY 176KB of On-Chip Boot ROM, 64KB SRAM, Up
to16GB of External memory
23 REAL TIME CLOCK Built in
24 REPLACEABLE Lithium Battery CR1220 (3v)
BATTERY
ON PCB
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25 WASTE Waste collected in closed container


COLLECTION
26 INCUBATOR Optional external incubator
27 OPERATING 20 to 40 °C
TEMPERATURE
28 STORAGE -10 to 40 °C
TEMPERATURE
29 HUMIDITY <=80% RH, non-condensing.
30 MAINS SUPPLY 115/230V AC (±10%), 50/60 Hz (input for power
adapter)
31 DIMENSIONS 48 cm(L) x 39 cm(W) x 28 cm(H)
32 WEIGHT Approximately 7 kgs
DISCLAIMER: Specifications mentioned are subject to change by the manufacturer
without prior notice.

3.1. SOFTWARE SPECIFICATIONS


1) 10 analytical modes of operation:
a) End Point Linear.
b) Fixed Time Linear.
c) Kinetic(Rate) Linear.
d) Multi Point Non-Linear (Point to point / Exponential / Cubic Spline / Logit Log).
e) Fixed Time Non-Linear (Point to point / Exponential / Cubic Spline / Logit Log).
f) Rate Non-Linear (Point to point / Exponential / Cubic Spline / Logit Log).
g) Sample Blank Linear.
h) Sample Blank Non-linear (Point to point / Exponential / Cubic Spline / Logit Log).
i) Absorbance
j) Coagulation.

2) 250 totally “open” test programs selectable through keypad.

3) Parameters can be viewed, edited, and printed.

4) Facility to memorize reagent blank O.D., Standard O.D., Factor and Nonlinear curve
for 10 Standards including Standard 0.

5) Patient report up to 6 months can be stored in memory and can be obtained by,
a) I.D.
b) Date.
c) Test Code
d) By I.D. and Date
e) By Test Code and Date.

6) Levy Jennings Graph for Daily and Monthly QC (available for 4 levels of controls per
test).

7) Facility to view and edit,


a) Control values of 4 levels (L1/L2/L3/L4).
b) Normal ranges of 4 sample types (Male/Female/Infant/General).

8) Five fixed calculation formulas for calculation of certain parameters from the
previously run chemistry results.

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9) Rate calculation by linear regression method.

10) Online reaction graph for all Assay Run.

11) Automatic zeroing at the start of each Assay Run.

12) Up to 10 Standards (including Standard Zero) for Non-linear tests with calibration
and graphs by 4 methods,
a) Point to Point.
b) Exponential.
c) Cubic Spline.
d) Logit Log.

13) On-line reagent stability check.

14) Substrate depletion / Non-linearity check.

15) Calibration of peristaltic pump.

16) On-line display of temperature.

17) Audible Help/Informative and Error messages available.

18) On-line Help messages available.

19) Power ON Self-diagnostics.

20) Printout can be obtained on USB Printer or/and Thermal Printer by using PRINT
key.

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4. INSTALLATION
4.1. INSPECTION
The analyzer is tested before shipment and is packed carefully to prevent any
shipping damage. It is user’s responsibility to inspect all cartons upon arrival and
notify the carrier of any apparent damage. Follow the steps described in the
paragraphs below to install the analyzer.

4.2. UNPACKING
The main unit and accessories are packed in single carton; other additional
accessories such as power cord are packed in another carton. The authorized
representative is responsible for unpacking, installing and initial setting up of the
analyzer.

Installation check list:*** Please refer to dispatch note for detailed checklist.

Serial Item Code Description Quantity


Number
Standard Accessories
1 ZOE-00003 Power Adapter 18V/8A_S 1
2 ZOE-00012 Power Cord IEC320-C13, 6A/250V 1
3 ZOM-00068 Thermal Paper Roll-57MM X 30 mtrs 1
4 ZCM-00066 Waste Can_S 1
5 Panel Connector 1/4" 28 UNF TO 200 SR.
1
ZOM-00052 PMS230-1
6 Panel Mount Nut 1/4"-28 UNF PMSN-XO,
1
ZOM-00054 SS
7 ZCM-00064 Dust Cover_S 1
8 Holder for Glass Cuvette ID 6 mm & OD 8
1
ZCM-00234 mm
9 ZOM-00087 Round Glass Cuvette ID 6 mm & OD 8 mm 10
10 ZOM-00088 Rectangular cuvette Polystyrene 10
11 ZCM-00065 User Manual_S 1
PM Kit _Z_Delite
1 ZKM-00004 Lamp Assembly_S
2 ZCM-00032 Lamp Holder_S 1
3 ZCM-00033 Holder for G4 Connector_S 1
4 ZOE-00047 G4 LampHolder for low volt.halogen lamps 1
5 ZOE-00006 Halogen Lamp 12V 20W 1
6 ZOM-00089 5ml Syringe
7 ZOM-00040 FEP Tube I.D 0.8 x O.D 1.6 mm 0.4
8 ZOM-00039 FEP Tube I.D 1.0 x O.D 2.0 mm 0.05
9 Peroxide-Cured Silicone Tubing ID 0.8 x OD
0.015
ZOM-00037 2.4 mm
10 Peroxide-Cured Silicone Tubing ID 2.0 x OD
0.2
ZOM-00038 4.0 mm
11 Peroxide-Cured Silicone Tubing ID 2.0 x OD
0.24
ZOM-00038 4.0 mm
12 Peroxide-Cured Silicone Tubing ID 3.0 x OD
0.5
ZOM-00033 6.0 mm
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Optional Accessories
1 ZOM-00090 Adjustable Volume Pipette 5-50ml 1
2 ZOM-00091 Adjustable Volume Pipette 100-1000ml 1
3 ZOM-00092 Pipette Stand 1
4 ZOM-00093 Pipette Tips series 200ul Yellow 100
5 ZOM-00094 Pipette Tips series 1000ul Blue 100
6 ZOM-00095 Incubator Assembly 1
7 ZOM-00096 Test Tube Stand 1
8 ZOM-00097 Demo kit 1

4.3. INSTALLATION REQUIREMENTS


Please follow our environmental and electrical suggestions to ensure the accuracy and
precision of analyzer and to maintain high level of safety for your personnel. The proper
location is an important consideration as an improper location can lead to malfunction of
the analyzer.

Since the analyzer is comparatively smaller, it can be comfortably accommodated


on any standard sized table, and the waste bottle should be placed on the same level or
below the level of analyzer.

Remember that minimum 30 cm. space should be maintained between the rear panel
and the wall to allow for heat dissipation. Also the ventilation present at the rear and
bottom of the instrument should not be blocked as it is required for proper Air
circulation.

Please ensure while taking any electrical measurement, the multimeter used must
have been calibrated and should possess valid calibration identification traceable
to National/International standards.

PROBLEM/s resulting from the relocation of the analyzer done by unauthorized service
representative are not covered under warranty.
Note: Installation should be done by properly trained personnel only.

4.4. ELECTRICAL REQUIREMENTS


Voltage and Frequency: Stabilized Single phase AC mains supply of 110/230 V ± 10%,
50 / 60 Hz.
Plug Points: 3 Numbers of 5 Ampere sockets should be available near the installation
desks. (Normally only one socket is required per analyzer and 2 extra sockets are
recommended for using any measuring equipment and engineering tool if required
while servicing).
Grounding: Perfect earthing must be provided at power source with all applicable local
requirement (A grounded, power plug only should be used. The voltage between earth
and neutral should not exceed more than 5 VAC). Failure to properly ground the
analyzer bypasses important safety features and may result in an electrical hazard.

Always ensure that the ON/OFF switch is easily accessible to the user in case of
emergency switch OFF.
Heavy-duty electrical devices like Air conditioners, refrigerators, oven’s etc., should not
be operated on the same electrical lines as the analyzer.

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4.5. INSTALLATION PROCEDURE


1. Unpack the accessory box.

2. Remove the waste bottle and place it on the table.

3. Direct the peristaltic pump tubing coming out from the analyzer into the waste
bottle.

4. The analyzer comes equipped with an external power adapter and one three/two
pin power cord (with earth terminal) for Mains supply.

5. Connect the 3/2 pin cord (with earth terminal) of the external power adaptor to
the mains socket and check the output of the adaptor, it should be within ± 0.5 V
range.

6. Proper use of the appropriate power cord assures adequate grounding for the
system. Failure to properly ground the analyzer bypasses important safety
features and may result in an electrical hazard.

4.6. PRINTER AND INSTRUMENT COMMUNICATION INSTALLATION

4.6.1. INTERNAL PRINTER


There is a Thermal printer mounted inside the cabinet. It is extremely low noise
printer. The paper installation is explained later in Maintenance section.

4.6.2. EXTERNAL PRINTER


1. External USB Printer can be attached to the analyzer. For Printer List, kindly
contact service/support team.
2. Switch off the analyzer before connecting the printer.
3. USB A Type connector is provided at the rear of the analyzer. Connect the
printer cable to this port and then switch ON the analyzer.
NOTE: In case of error at external printer get the error corrected, restart the printer
and reissue PRINT command.

4.6.3. PC COMMUNICATION
USB B Type connector is provided for PC Communication and Debug Purpose.

4.6.4. LIS COMMUNICATION


Ethernet connector is provided for bi-directional LIS communication. For LIS
Communication setup kindly refer Annexure section.

4.7. EXTERNAL KEYBOARD and MOUSE INSTALLATION


Switch off the analyzer before connecting USB keyboard or USB mouse. Then connect
to any available USB port provided at the rear of the analyzer.

4.8. 1D BARCODE INSTALLATION


Switch off the analyzer before connecting USB 1D Barcode. Then connect to any
available USB port provided at the rear of the analyzer.

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5. PRINCIPLES OF OPERATION
The analyzer works on the Beer – Lambert’s Law which state’s that “In absorbance
spectrophotometer, when the light is incident on the colored solution the amount of light
absorbed is directly proportional to the concentration of the solution with the constant
path length”

A concentrated beam of light is passed through filter and is incident on flow cell.
Amount of light transmitted through the flow cell is measured by the photometer. This
signal is further amplified and converted into digital form for data processing and
analysis.

5.1. MODES OF OPERATION


The analyzer is capable of performing analysis using the following modes.

5.1.1. ABSORBANCE MODE


The optical density reading in the range of 0 – 3 O.D. can be measured directly on the
analyzer by selecting appropriate wavelength.

5.1.2. END POINT LINEAR MODE


Results are directly obtained after the analyzer has been calibrated using a standard
/calibrator of known concentration or using Factor. This mode is used for all routine
End-Point assays.

5.1.3. FIXED TIME LINEAR MODE


Two readings at any fixed interval are used for the calculation of results. It is also
referred to as Pseudo Kinetic assay. Results are directly obtained after the analyzer has
been calibrated using standard /calibrator of known concentration. A direct calibration
factor can also be used for calculation of results in this mode.

5.1.4. KINETIC (RATE) LINEAR MODE


The change in absorbance over a given time is monitored and recorded to calculate the
result of any enzyme reaction. The result obtained is followed by a graphical
representation of the reaction. This mode is used for kinetic assays.

5.1.5. SAMPLE BLANK LINEAR MODE


In this mode the concentration (End-Point) of the sample is obtained after sample
blanking. This mode is generally used for those test methods whose results are greatly
affected by Icteric, Lipemic or Haemolysed samples; the sample absorbance is
obtained after subtraction of sample blank absorbance.

5.1.6. CONCENTRATION (NON-LINEAR) MODE


The concentration is obtained from a non-linear graph, plotted by the analyzer
using a maximum of ten standards of increasing or decreasing concentrations
including zero standard (with concentration zero). This mode is useful for Hormone
assays.
The concentration (non-linear) mode is of the following types:
a) Multi Point Non-Linear
b) Fixed Time Non-Linear
c) Rate Non-Linear
d) Sample Blank Non-Linear

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Following curve types are available to obtain the non-linear graph,


a) Point to point
b) Exponential
c) Cubic Spline
d) Logit Log

5.1.7. COAGULATION MODE


This mode is used for performing common Coagulation tests like Prothrombin Time
(PT) or Partial Thromboplastin (PTT) etc. The final result is obtained in seconds.

5.2. READING THE FLOWCELL/CUVETTE


The internal volume of the flowcell is 18 μl. The flowcell holds the different reaction
Mixtures/samples whose absorbance, change in absorbance is to be measured. The
flowcell is inserted inside a block, which is heated in metallic thermostat by peltier
effect. The light beam from the halogen lamp enters the transparent wall of the flowcell
and reads the absorbances of the coloured solutions. This is also referred to as
reading area of the flowcell; the path length is 10 mm or 1 cm. Alternately, a 10 mm
cuvette can also be used in place of Flowcell. For proper reading, minimum volume of
solution inside the cuvette(whose absorbance is to be read), should be 400ul.
The diagram of the flowcell is as shown below:

5.3. CARRYOVER AND ASPIRATION VOLUME


Carryover is the influence of a solution, which has been flushed out from the flowcell, on
the absorbance readings of the solution that is aspirated next. The major contributing
factor to the carryover is the dead volume of the flow cell. Flow cell volume is only 18 μl
and hence the minimum recommended Volume for Aspiration is 400 μl.
In order to remove carry over effect completely, facility to aspirate air after each
aspiration is given. So after every aspiration, maximum 160μl air is aspirated by
peristaltic pump.
The aspiration volume is programmable from 200 – 2000 μl.
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For Rate A and Two Point mode, extra air(maximum upto 500 μl) is aspirated after
displaying the result. However, the Air Purge between samples is optional and the
same can be enabled/disabled from System Setup Menu.
NOTE: It is recommended to use an aspiration volume of at least 400 μl for better
accuracy and minimize carryover.

5.4. CALCULATION OF THE KINETIC TEST RESULTS


The Kinetic test results are derived from mathematical calculations, which
Is explained below.
The sample under examination is measured at the end of the aspiration into flowcell.
For result calculations, Absorbance at the first Read Time is considered as the initial
absorbance (after the end of incubation). All the subsequent readings are stored in the
memory at the rate of one reading every second during the whole period of the
analysis. All the acquired values describe a curve which will be divided into as many
segments as are delta absorbance values, which have been chosen by the number
entered in the parameters “READ TIME” and “READ NUMBER” (TOTAL READ.T =
READ T * READ NUMBER).
The result of the analysis is obtained by use of linear regression equation, performed on
the extremes of these segments.

5.5. ADDITIONAL CUVETTE HOLDER


The analyzer’s main cuvette holder can accommodate 3 types of cuvette namely,
a) 18 μl flowcell.
b) 10 mm Square Cuvette
c) Round, reusable, 6 mm glass tube with adapter for coagulation
The analyzer is also provided with one Additional Cuvette Holder to hold the
Flowcell when either Square Cuvette or round glass is used as reading device in
the main cuvette holder.

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6. SCREEN NAVIGATION
6.1. POWER ON MENU
Switch ‘ON’ the analyzer. After Power ON software Loading processes, it will display
the Zovec Healthcare Private Limited company’s LOGO for 5 seconds.

Then it will automatically check all the important devices and will show the status on
display.
NOTE: It is mandatory to place the flowcell in main flowcell/cuvette holder and the
flowcell needs to be filled with DI Water while switching ON the instrument or else all
the photometer filters will be shown NOT OK in Initialization Process Check screen.

After Printer Check, it is required to press <WASH> to Perform Wash.

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If any of the parameter is NOT OK then we have to press <HOME> to proceed.

If all the initialization checks are OK then automatically the Home Screen will be
displayed.

6.2. HOME SCREEN MENU

This screen is also referred to as the “Home screen” of the analyzer. This menu
is used for the selection of test, viewing/programming of test parameters, obtaining QC
data, searching of previous results/reports, running a Maintenance check, programming
System settings or shutting down the instrument.

Select any one of the options in Home screen by pressing corresponding number
‘< 1 to 8 >’ on the Keypad or by navigating through arrow Keys and then selecting by
pressing ‘< ENTER >’.
Each sub-menu is described below.

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6.2.1. RUN TEST


This menu is used to select a test/chemistry to run, from the Test List page by pressing
the direct access keys or by pressing ‘< ENTER >’ key on the highlighted Test code.
Browsing in Test List page can be done with the help of arrow keys or
‘< PGUP >’, ‘< PGDN >’ keys.

6.2.2. PROGRAM
This menu is used to view, print and edit, appropriate parameters of selected chemistry
including,
Control values (Mean and SD) for 4 levels of controls
Normal minimum and maximum ranges for multiple Patient types
(Male/Female/Infant/General)

6.2.3. QUALITY CONTROL


It checks the accuracy of sample analysis data from day to day. Specifically,
QC program consists of checking the accuracy and precision of analysis
(whether the same values are obtained when the analysis is repeated). Test
results can be memorized for all tests at 4 levels of controls for 31 days.
Daily and Monthly QC values can be viewed in the form of LJ graphs.

6.2.4. SEARCH
Patient-wise report of all chemistries runs for a particular sample identified by
the following parameters.
a) ID.
b) Date.
c) Test Code
d) I.D. and Date
e) Test Code and Date

6.2.5. MAINTENANCE
For self-diagnostics tests.

6.2.6. SETUP
To set the Printer settings, System settings, Lamp Control settings and Laboratory
information.

6.2.7. ABOUT US
This menu displays the contact information about Zovec Healthcare Private Limited.

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6.2.8. POWER OFF


The instrument prompts to Perform Wash and after Wash is performed, the instrument
displays the Shutdown screen.

6.2.9. WASH
When this key is pressed once, the peristaltic pump starts aspirating. If
pressed again the peristaltic pump stops aspiration. If the key is not pressed
again to stop washing it will stop automatically after aspirating approx. 5 ml
water.

6.3. SETUP
The setup menu allows the user to view, edit the Printer Settings, System Settings,
Lamp Control Settings and Lab Information. Select any one of the options in SETUP
screen by pressing corresponding number ‘< 1 to 4 >’ on the Keypad or by navigating
through arrow Keys and then selecting by pressing ‘< ENTER >’.
The “SETUP” screen is as follows:

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6.3.1. PRINTER SETTING


The analyzer supports interface to a Thermal printer and an external USB Printer. This
menu allows user to Enable or Disable a particular printer, select Auto Printout option,
and set the settings for the individual printers.

6.3.2. SYSTEM SETTING


This menu is used to set the Date(DD-MMM-YYYY) and Time(HH:MM:SS) of the
system, select QC Rules, select settings for LIS communication and set System
settings like Language, Air Aspiration, Air purge etc.
Changes in these settings are to be made by a trained personnel only.

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6.3.3. LAMP CONTROL SETTING


This menu informs the user, the duration of Lamp Life consumed in Hours and the Date
of Installation of the Lamp.

6.3.4. LAB INFORMATION


This menu allows the user to enter the Header to be printed on the Reports.

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6.4. ASSAY NAME GENERATION


The analyzer is pre-programmed with Test/ Assay codes. The assay code for any
chemistry can be created, changed or viewed by the operator. An assay code can have
a maximum of six characters which could be an abbreviation of the chemistry name as
per the convenience of the operator e.g. GLU, CHO, URE etc. or alphanumeric such as
NH3, C3, C4 etc.
After this screen appears press the key ‘< ENTER >’ to view or edit the Parameters
corresponding to the selected analysis code.

To create a new assay code, choose ‘< OTHER TESTS >’ in the Program Test List
page. To add a new assay code press key.

6.5. SETTING OF PARAMETERS


After the Assay code of the chemistry is set, the parameters for the chemistry will have
to be entered. To set the parameters press the ‘< ENTER >’ key.
The display will show all the parameter heads concerning the selected assays. Using
the ‘< >’ and ‘< >’ arrow keys, browse through the parameters of the chemistry.
Predefined values for selected parameters with dropdown will be displayed on pressing
‘< ENTER >’ key; then browse through the options using Up/Down arrow keys and
press ‘< ENTER >’ key to select one option. Parameters with Text boxes can be edited
by using alphanumeric keys to enter appropriate data.

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Following is an example of main parameters of GLU in the End Point mode.

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7. MODES OF OPERATION
7.1. END POINT LINEAR MODE
In this mode, the analyzer displays both, absorbance as well as concentration
readings on the screen. The concentration value is obtained by the analyzer after
multiplying the absorbance value with a factor, which was previously obtained
during calibration.

The operational steps are as follows:


1. The analyzer displays “ASPIRATE 1000uL DI WATER”: Aspirate DI water and
wait for a few seconds (The analyzer automatically zero’s the O.D.).

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2. After successful Baseline Test, the parameters necessary for operation in the mode
are as displayed on the screen.

3. Press dynamic key ‘< BLNK >’ to perform Reagent Blanking.

4. Aspirate the Reagent Blank when the analyzer displays “ASPIRATE REAGENT
BLANK” and wait for a few seconds. The O.D. of the Reagent Blank is calculated and a
pop up message appears, “Do You want to save Blank Value?”

5. Use arrow keys to toggle between Yes/No keys. When ‘Yes’ key is selected and user
presses the ‘< ENTER >’ key then O.D. of Reagent Blank is automatically stored in the
memory of the analyzer and for all subsequent readings; this O.D. is subtracted to
obtain a final O.D. of reaction mixture.

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6. Now if Standard is previously run and a factor is already obtained for the particular
Assay Test then the following pop up appears “Do you want to Run New
Calibration?”

7. Alternately press dynamic key ‘< CALIB >’ to aspirate standard. The analyzer then
displays “ASPIRATE STANDARD”, or as shown in the following screen.

8. Now Aspirate standard solution (RGT + STD). Wait for a few seconds, to allow the
solution to stabilize in the flowcell. The analyzer displays the absorbance of the
Standard Solution, then the factor is calculated and pop up appears “Do you want to
save new factor?”

9. Use arrow keys to toggle between Yes/No keys. When ‘Yes’ key is selected and user
presses the ‘< ENTER >’ key then the new factor is memorized. The factor obtained is
now displayed against the FACTOR on the Screen. Steps 4 and 5 can be skipped if
factor is entered or predefined in test parameters.

10. Now press dynamic key ‘< SAMPLE >’ to perform samples. The following screen is
displayed,

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11. Perform samples while the analyzer is prompting “ASPIRATE SAMPLE”. On


pressing the alphanumeric keys, the alphanumeric sample I.D. can be entered. Also
external USB Barcode reader can be used to scan alphanumeric sample I.D. in this
screen.

12. Perform the sample run, the analyzer will automatically start incubation countdown
(entered as Delay time in parameters). At the end of delay time the analyzer will give
the absorbance and the concentration is calculated.

13. User has to enter sample type (Male /Female / Infant / General) to give the flag as
per the normal ranges for each type. If Auto Print is turned ON then the result is directly
printed.

14. Aspirate other test solutions one after another.

15. The display will show the absorbance as well as the concentration of each sample,
its net absorbance. A printout of the result is obtained either automatically or by using
the dynamic <PRINT> key.

16. Re-reading of the currently aspirated sample is performed through the ‘< RETEST
>’ key. function

17. After aspiration of each sample, message will be displayed to withdraw tube after
which air will be aspirated. The amount of air aspirated is user defined.

16. After all readings are taken, press the ‘< PREV >’ or ‘< HOME >’ key to return to the
“Test List” or “Home Screen” or press direct access key of another test to be performed
next. Before the selected screen appears the following message will appear “Perform
WASH operation to rinse Flowcell thoroughly, Aspirate 4-5 ml DI water, Select WASH to
Start”. Perform Wash by pressing the dynamic Key ‘< WASH >’.

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7.2. FIXED TIME LINEAR MODE


1. Follow steps 1 to 9 from section 7.1 to perform Baseline, Reagent Blank and
Standard Tests.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Select the
<Sample I.D> by pressing UP/DOWN keys and then edit the Sample I.D. by using
Alphanumeric keys or scanning a Barcode with the interfaced Barcode Reader.

3. Perform samples while the analyzer is prompting “ASPIRATE SAMPLE”.

4. Perform the sample run, the analyzer will automatically start incubation countdown
(entered as Delay time in parameters). At the end of delay time the analyzer will
automatically start with Read time countdown; and also store the absorbance of the
sample at the start of Read Time countdown as Initial Absorbance. At the end of Read
Time countdown it will once again store the absorbance of the sample as Final
Absorbance. The analyzer will then subtract the two absorbance readings and give the
net Absorbance along with the concentration of the analyte in the sample.

5. Follow steps 13 to 16 from section 7.1 to perform repeated Samples or to exit from
the Test run.

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7.3. KINETIC (RATE) LINEAR MODE


1. Follow steps defined in section 7.1 to perform Baseline, Reagent Blank and Standard
Tests.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.

3. Follow steps defined in section 7.1 to perform repeated Samples or to exit from the
Test run.

7.4. SAMPLE BLANK LINEAR MODE


1. Follow steps defined in section 7.1 to perform Baseline, Reagent Blank and Standard
Tests.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.

7.5. END POINT NON LINEAR MODE


1. Follow steps defined in section 7.1 to perform Baseline, Reagent Blank and Standard
Tests.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.

7.6. FIXED TIME NON LINEAR MODE


1. Follow steps defined in section 7.1 to perform Baseline, Reagent Blank and Standard
Tests.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.

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7.7. RATE NON LINEAR MODE


1. Follow steps defined in section 7.1 to perform Baseline, Reagent Blank and Standard
Tests.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.

7.8. COAGULATION MODE


1. After section 7.1 to perform Baseline, Reagent Blank and Standard Tests.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.

7.9. ABSORBANCE MODE


1. After section 7.1 to perform Baseline.

2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.

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8. QUALITY CONTROL
Quality control of a calibrated biochemistry analyzer is the periodic monitoring of
the system performance by use of specimens both in the normal and abnormal
range for comparison. The obtained data is compared with previously obtained
data. A variety of QC materials are available for this use.
The analyzer can store data of 4 levels of controls for 31 days, for all the 200 tests.
The target/mean value and the range/SD (allowed variation from the target) are fed into
the analyzer. Data for each run (QC) is graphically plotted on LEVY – JENNINGS
control chart for the each chemistry for rapid or early identification of trends.

USE OF REFERENCE / QUALITY CONTROL MATERIALS


Any commonly available quality control material can be used for the purpose of
quality check. Assayed serum control for biochemistry, in the normal and abnormal
range is readily available. Calibration of the analyzer should be checked daily in
accordance with the requirement governing quality control in your laboratory.
Replicates run for the same analysis are regarded as another sample and is
retained. Total 5 values for each test per control per day can be stored in the
analyzer.
To ensure result accuracy following points should be followed while running
commercial control
1. Follow the manufacturer’s recommendations for reconstitution of each vial.
2. Never use an open vial longer than recommended. Do not subject any vial
to excessive heat or agitation.
3. Verify the lot number & expiry of each vial.

8.1. QUALITY CONTROL VIEW MENU


Results for each specimen run when a particular chemistry is selected are
automatically stored in that chemistry file. Results for the 200 tests are available at
all times. All QC file stored data are available for operator review on a printer
output. When the Quality Control option is selected by pressing numeric key
‘< 3 >’ the following screen is displayed;

Select the appropriate Test/Assay code by using Arrow keys and press ‘< ENTER >’.
The display changes to the following screen.
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8.2. DAILY QUALITY CONTROL


It is a plot of standard deviation (Y-axis) vs. the number of controls run (X- axis).
Data for each run (QC) is graphically plotted on LEVY – JENNINGS control chart
for the each chemistry for rapid or early identification of trends. It gives the plot and
the result calculation for the latest five results of the control level(L1/L2/L3/L4) run for
the day.

Daily Quality Control Data for L1/L2/L3/L4:


After the pressing dynamic key ‘< DATA >’, the last five results for the day of quality
control are displayed and the display obtained for Daily Quality Control Data for
L1/L2/L3/L4 respectively is as follows.

Printout of the daily quality control data for any level can be obtained using the dynamic
< PRINT > key.
Any of the points which are not in the control range can be selected by Arrow Keys and
deleted by the use of < DEL > key.

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8.3. MONTHLY QUALITY CONTROL


It is a plot of standard deviation (Y-axis) against the number of days in a month (X axis).

Data for each run (QC) is graphically plotted on LEVY –JENNINGS control
chart for the each chemistry for rapid or early identification of trends. It gives the
plot and the result calculation for the last 31 days of the control level(L1/L2/L3/L4) run.
After the pressing dynamic key ‘< DATA >’, the last 31 days results of quality control
are displayed and the display obtained for Monthly Quality Control Report for
L1/L2/L3/L4 respectively is as follows.

Printout of the monthly quality control Report can be obtained using the dynamic
<PRINT> key.
NOTE: Taking monthly QC report print is possible only if valid SD and Mean values are
defined.

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9. SEARCH REPORTS
Reports can be obtained by pressing the numeric key < 4 > in the “Home
Screen”. It allows the printing of the results obtained in the analysis for each patient.
The Patient Report can be obtained by:
a) I.D.
b) Date
c) Test Code
d) I.D and Date
e) Test Code and Date.

9.1. SEARCH REPORTS BY I.D


Enter Patient/Sample ID using Alphanumeric keys.

Press dynamic key ‘< SEARCH >’ to display results by entered I.D.,

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9.2. SEARCH REPORTS BY DATE


Enter the Start and End Dates by UP/DOWN Arrow Keys.

Press dynamic key ‘< SEARCH >’ to display results by entered Start and End Date,

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9.3. SEARCH REPORTS BY TEST CODE


Enter Test Analysis Code by using Alphanumeric keys.

Press dynamic key ‘< SEARCH >’ to display results by entered Test Code,

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9.4. SEARCH REPORTS BY ID and DATE


Enter Patient/Sample ID using Alphanumeric keys and Date by using numeric and
Arrow keys.

When dynamic key ‘< SEARCH >’ is pressed, the analyzer searches for the report by
selected parameters and the report is displayed.

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9.5. SEARCH REPORTS BY TEST CODE and DATE


Enter Test Analysis Code using Alphanumeric keys and Date by using numeric and
Arrow keys.

When dynamic key ‘< SEARCH >’ is pressed, the analyzer searches for the report by
selected parameters and the report is displayed.

When dynamic ‘< PRNT >’ key is pressed, selected report is printed on thermal printer
or USB printer or both as per the printer selection in SETUP > PRINTER SETTINGS
menu.
When dynamic ‘< PRNT ALL >’ key is pressed, all reports are printed (on selected
printer).

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10. MAINTENANCE
The analyzer is designed for trouble free operation and requires minimum
maintenance. For good functioning of the analyzer it is advisable to follow the
instructions given below
1. Handle the analyzer with care and keep it clean.

2. When not in use, cover the analyzer with the dust cover to avoid
accumulation of dust.

3. Though air conditioning is not a must, it is advisable to keep the analyzer in


a dust free, cool atmosphere, away from direct sunlight.

10.1. MAINTENANCE MENU

10.1.1. Keypad
Working of individual Keys of the Keypad can be checked.

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10.1.2. Thermal Printer


Working of Thermal Printer can be checked. In this menu a test printout is obtained on
the Thermal Printer.

10.1.3. External Printer


Working of External Printer can be checked. In this menu a test printout is obtained on
the connected external USB printer.

10.1.4. Photometer
Photometer counts of each filter can be checked.

10.1.5. Pump Calib


This function of the analyzer is used to calibrate the pump for aspirating specific
volumes from 200-2000 μl.
To perform pump calibration press the numeric key < 5 > in MAINTENANCE menu.

Take 1 ml of DI water in a test tube. Press <ASP> switch to start aspiration and

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when the last drop is left in the tube, press <ASP> switch again. Now the
peristaltic pump is calibrated to aspirate any volume from 200 μl up to 2000 μl.

10.1.6. Lamp Life


Lamp working hours can be checked.

10.1.7. Temperature Calibration


Temperature Calibration can be performed.

10.1.8. Backup
Backup can be obtained.

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10.2. DAILY MAINTENANCE


1. Wipe off any reagent spills on the analyzer immediately.

2. After every chemistry run, wash the flowcell thoroughly with good quality DI water
using the dynamic key <WASH>.

3. Always leave the flowcell filled with DI water. Never leave any reaction mixture in it.

4. At the end of each day, aspirate neutral cleaning solution into the flowcell and leave it
filled overnight. Every morning aspirate DI water 5 ml to thoroughly rinse the flowcell.

5. Empty the waste solution bottle every evening.


Caution: DO NOT USE STRONG ACIDIC OR ALKALINE SOLUTIONS WHICH CAN
CAUSE IRREPARABLE DAMAGE TO THE ANALYZER.
Caution: DO NOT LEAVE THE FLOWCELL DRY. ALWAYS LEAVE IT FILLED WITH
DEIONIZED WATER DURING THE DAY AND WITH CLEANING SOLUTION AT
NIGHT.
NOTE: It is advisable to carry out the peristaltic pump calibration every week in order to
compensate for the change in elasticity of the tubing.

10.3. QUARTERLY MAINTENANCE


Certain simple maintenance operations have to be performed as and when required.
These are:
a) Replacement of Tubing
b) Replacement of the paper roll
c) Replacement of Lamp

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10.3.1. REPLACEMENT OF TUBING


Replace the aspiration tubing and peristaltic pump tubing once every THREE months or
earlier if it shows signs of wear and tear. Failure to change the peristaltic pump tubing in
time can cause serious errors of aspiration volumes and can also damage the analyzer
due to the leakage of corrosive reagents through torn tubing.

Warning: THE REPLACEMENT OF ASPIRATION AND PERISTALTIC TUBINGS


SHOULD BE PERFORMED BY THE TRAINED PERSON ONLY.
The replacement has to be carried out once in THREE months, or whenever an
alteration in the aspiration volume occurs.

10.3.1.1. ASPIRATION TUBE REPLACEMENT

1. Open the Photometer Cover.

2. Gently remove the flow cell from cuvette housing.

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3. Unscrew the aspiration tubing from the flow cell.

4. Slide out the washer and ‘O’ ring of the old aspiration tubing.

5. Discard the old aspiration tubing onto an appropriate location, as it is


biohazardous.

6. Slide the washer and ‘O’ ring into the new aspiration tubing.

7. Lock it to the flow cell with the plastic screw available.

8. Place the flow cell back into its slot.

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9. Pass the end of the aspiration tube through the holder and pull it out so that
the length is adequate.

10. Aspirate the DI water.

11. Close the Photometer Cover.


NOTE: Take care to see the side of the flowcell with the arrow mark is in light
path and in front. Also, whenever the flowcell is not in use, fill flowcell with
DI water.

10.3.1.2. REPLACEMENT OF PERISTALTIC PUMP CASSETTE

1. Pull out both the tubings of the peristaltic pump.

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2. Press the lock gently and Pull out the cassette of the peristaltic pump.

3. Insert a new cassette with new tubings inside the spindle and gently push so that
the locks are fastened.

4. Reattach both the tubing to the respective tube connectors.

5. Aspirate DI water and check for proper flow rate and leakages.

6. Compulsorily perform pump calibration with 1 ml. DI Water.

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10.3.2. REPLACEMENT OF LAMP ASSEMBLY


Warning: THE REPLACEMENT OF LAMP ASSEMBLY SHOULD
BE PERFORMED BY THE TRAINED PERSON ONLY.
Warning: SWITCH OFF THE POWER SUPPLY BEFORE
REMOVING THE COVER.

1. Open the Photometer cover and unplug the Lamp connector.

2. Remove both the screws with a ‘+’/pan head screw driver.

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3. Pull out the Lamp gently.

4. Place a new lamp and connect the lamp connector and then fix the screws.

5. Close the photometer cover.

6. Check the Photometer counts for all wavelengths in Home Screen >
Maintenance > Photometer menu.

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10.3.3. REPLACEMENT OF PRINTER PAPER


Warning: THE REPLACEMENT OF PRINTER PAPER SHOULD
BE PERFORMED BY THE TRAINED PERSON ONLY.

Before starting the instrument, make sure that enough printer paper is on the roll.
The paper roll is located under the printer cover. To check and / or replace the
paper roll lift off the printer cover after unlocking the Lid lock. For inserting a new paper
roll do as follows.

1. Unlock the lid lock of Printer cover.

2. Lift off the printer cover and take the roll out of the paper roll housing.

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3. Then take a new paper roll and lay down into the paper roll housing.

4. Pull sufficient paper outside the printer cover.

5. Close the printer cover by pressing it down.

6. Press PAPER FEED key on top of printer to advance the paper.

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11. TROUBLE SHOOTING GUIDE


SERIAL OBSERVATIONS LIKELY CAUSE/CORRECTIVE ACTION
NUMBER
1 Liquid is not aspirated 1. Check if peristaltic pump tubing is
when the Dynamic key connected properly, if not reconnect
<WASH> is pressed correctly.
2. Check if keypad is working.
3. Check if waste can is full.
4. Call Service Engineer.
2 Liquid is not aspirated 1. Check if peristaltic pump tubing is
when the (ASPIRATE) connected properly, if not reconnect
“ASP” switch is pressed correctly.
2. Check if “ASP” switch is working.
3. Perform pump calibration again.
3. Check if waste can is full.
4. Call Service Engineer.
3 Peristaltic Pump operates 1. Check if peristaltic pump tubing is
but liquid is not aspirated. connected properly, if not reconnect
correctly.
2. Check tubing for blockage, crimps or
leaks in tubing.
3. Replace tubing’s.
4. Perform pump calibration again.
5. Call Service Engineer.
4 Thermal Printer does not 1. Make sure that the paper roll is
work. installed properly with the heat sensitive
surface up.
(The analyzer will not print if the paper is
fed reverse).
2. Check if paper is thermal paper as per
the specifications.
3. Ensure thermal printer option is
selected in system setup.
4. Check printer cover locking
arrangement. It should be in closed
position.
5. Check if Printer LED on printer top is
turned ON.
5 External printer does not 1. Ensure external printer option is
work. selected in Setup > Printer Settings.
2. Ensure that attached printer cable is
connected firmly using proper printer
cable.
3. Ensure proper printer driver is
installed.
6 The temperature attained 1. Ensure that the flow cell is completely
in the flow cell is not within inserted in the slot in its proper position.
± 0.1º C of the selected 2. Solution whose temperature is very
temperature. different from the selected temperature
should not be introduced directly into the
flowcell.
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3. Refrigerated reagents should be


allowed to attain Room Temperature
before use.
4. Call service engineer.
7 Poor reproducibility and 1. Check if the aspiration volume is
erratic readings. programmed and whether the amount of
liquid aspirated is as programmed.
2. If the aspiration is not proper then
perform pump calibration.
3. Check expiry date of the reagent,
standard and control material used.
4. Check if all the necessary precautions
have been taken. Always use clean
glassware and calibrated pipettes .
5. Check flowcell for possible air bubbles.
6. Call service engineer.
8 Control values not within 1. Ensure that the procedures specified
range by the reagent manufacturer are
followed.
2. Check for Assay parameters like
wavelength, temperature, sample and
reagent volumes, factor and standard
concentration are programmed correctly.
3. Ensure that the water for the
reconstitution of dry reagent is of reagent
grade quality i.e. DI water.
9 The result is accompanied 1. The value of the sample is greater
by a warning message than the value fed as “Linearity Limit”.
“LIN” 2. Dilute the sample and perform the test
again. Multiply the result by the dilution
factor.
10 Fluctuations observed in 1. Check for any heavy fluctuation in
TFT display. mains supply. Should not be more than
+/-10%.
2. Check loose connection of mains
cable or DC jack pin.
11 Halogen Lamp Blinking. 1. Check for any heavy fluctuation in
mains supply. Should not be more than
+/-10%.
2. Check loose connection of mains
cable or DC jack pin.
3. Check loose connection of lamp cable
connector.
12 The result printout is 1. The initial absorbance of reaction
accompanied by the mixture is greater than the ABS minimum
warning “RxABS_O” in all value in test parameters for increasing
chemistries chemistry.
2. Check if the “Reaction ABS Limit”
value has been correctly entered.
3. Prepare fresh reagent and repeat test.
13 The result printout is 1. The initial absorbance of reaction
mixture is less than the ABS minimum

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accompanied by the value in test parameters for decreasing


warning “RxABS_U” in all chemistry.
chemistries 2. Check if the “Reaction ABS Limit”
value has been correctly entered.
3. Prepare fresh reagent and repeat test.
14 All readings are zero or 1. Check if the lamp is ON.
very low 2. Check if the flowcell is placed correctly
in the light path of the cuvette.
3. Check if calibration/Factor value are
proper.
3. Call service engineer.
15 External USB keyboard or Check if the USB cable is connected to
mouse is not working the rear panel of the analyzer.
16 In Initialization check Filter 1. Check if flowcell is empty or free from
is NOT O.K. message air bubbles.
displayed on Display 2. Check if flowcell is properly inserted in
the flowcell housing.
17 Analyzer does not switch 1. Check mains cord properly inserted in
ON mains socket/ power adaptor plug.
2. Check if adapter DC power cable is
connected properly.
18 Paper key does not 1. Check if sufficient paper is present.
advance the paper. 2. Check if printer roller is properly
connected.

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12. LIST OF CONSUMABLES


For continuous and trouble free working of analyzer, it is a recommended to keep
certain spare consumables handy.
One set of the items mentioned below is also supplied along with the instrument as
standard accessories. It is recommended to store the consumables/spare in the
OEM packing until the actual use.

Serial
Item Code Description Unit / Quantity
Number
1 ZOM-00098 Peristaltic Pump Cassette 2

2 ZOM-00040 FEP Tube I.D 0.8 x O.D 1.6 mm 0.4m

3 ZKM-00004 Lamp Assembly_S 1

4 ZOM-00068 Thermal Paper Roll-57MM X 30 mtrs 3

5 ZOM-00088 Rectangular cuvette Polystyrene 10


Round Glass Cuvette ID 6 mm & OD 8
6 ZOM-00087 10
mm
7 ZOM-00097 Demo kit 1

Year: 2021 Page 58 of 59


Z-Delite S Operator Manual

13. REVISION HISTORY


REVISION DATE DESCRIPTION
V0.1 20-Feb-2021 Draft Version
V0.2 09-Mar-2021 Review from Service Team
V1.0 11-Mar-2021 Operator Manual Released

Year: 2021 Page 59 of 59

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