Operation Manual

DTprime
Real-Time PCR instrument
PART I

Operating Procedure
TS 9443-004-96301278-2010

DNA-Technology, Research & Production LLC

Protvino
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 Safety Information
IMPORTANT: READ THIS MANUAL CAREFULLY BEFORE USING THE INSTRUMENT

General Safety

Whenever see the sign Caution! Danger! refer to the manual.

Before using the “DTprime” Real-Time PCR instrument (hereafter – the “instrument” or
“device”), please read this section carefully and pay particular attention to the safety
information. To avoid accidents, as well as breakdown of the instrument and equipment used
therewith, observe the safety rules given below.
If safety rules are violated during exploitation or in case of unintended use of the instrument,
the protection provided by the instrument may worsen and a health hazard may arise.
Do not operate the instrument if humidity exceeds 80% in the room. Condensate formation
may result of a short circuit in the instrument electronics.
The instrument should be saved from shocks and falling.

The instrument must be stored and transported only in a vertical position.

After transport or storage in humid and /or cold conditions, dry out the instrument not less
than 3 hours before connecting it to the supply voltage.
Avoid any liquids or objects getting inside the instrument's cabinet. This may result in
breakdown of the instrument.
“DNA-Technology, Research & Production”, LLC bears no responsibility for any injuries or
damage to health caused by unintended use or unauthorized modifications of the instrument.

Electrical Safety
Prior to connecting the instrument to an electric grid, check the presence of protective
grounding in the socket to which the instrument will be connected as well as integrity of the
power cable. Connection to the socket without grounding is prohibited. Please use the
power cable provided in the set of delivery. If liquid is spilt inside the instrument, disconnect
it from the power supply immediately and contact local service center or distributor.
Please connect the instrument to an electric grid with the corresponding voltage, which is
mentioned on the identification plate of it.

Caution! Danger of electrical shock! Replacement of fuses of the instrument has

to be carried out in compliance with the rules and guidelines of electrical safety
regulations. Fuses have to be replaced only when the instrument is switched off. The
instrument is considered to be unplugged if it is unplugged of the electricity socket and the
USB cable is disconnected from the USB 2.0 port of a PC.

During Operation
Do not expose the instrument to heat and sunlight or bright light from other intensive light
sources.

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Maintenance
Do not open the cabinet of the instrument! It does not contain user serviceable
components.
Note! Settings of motor controllers, calibration parameters of optical and temperature
modules of the instrument cannot be changed by the end user. Calibration of the instrument
has to be performed by the manufacturer in accordance with the internal regulations of quality
control. Calibration data, if necessary, can be provided by the service department of DNA-
Technology Research& production

Operational Safety

The instrument is designed to be used under the following environmental conditions:

 indoors;

 altitude up to 2 000 m;

 temperature from 5 °C up to 35 °C;

 maximum relative humidity of 80% for the temperature up to 25 °C;

 main voltage from 100 up to 220 V, frequency 50/60 Hz.

The istrument is IVD medical equipment and it is intended for studing of DNA samples using
the polymerase chain reaction (PCR) method and the detection of the accumulated product in
real time (real-time PCR). The instrument does not carry a direct biological hazard. Servicing
and maintainance of the instrument should be performed by specially trained, qualified staff.
While operation with the instrument:

 wear suitable protective clothing, gloves and secure eyes and face;
 do not pipette solutions by mouth;
 do not eat, drink, smoke or use cosmetic products in the operational area;
 after handling samples and chemical reagents wash your hands carefully;
 dispose of leftover / used reagents and waste in compliance with the regulations in
force;
 read the instruction for use provided with the PCR kit before running the assay;
 while running the assay, follow the instructions for use;
 do not use a PCR kit after its expiration date;
 use only the chemical reagents provided along with the kit and those, which are
recommended by the manufacturer;
 do not mix chemical reagents from different PCR kits or lots.

Environmental Effect
Deinstallation of the instrument for maintenance or recycling purposes: if properly operated,
the device doesn’t bear biologically hazardous.
Recycling of the instrument should be carried out in accordance with the regulations in force
at the area. The device does not contain any substances, which may represent a direct threat to
the environment.

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Notice
This instruction for use contains information protected by copyright. No part of it may be
reproduced without preliminary written consent of “DNA-Technology, Research &
Production”, LLC. Any software products, equipment and designations mentioned in the text
may represent trademarks of their holders.

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Table of Contents
1. General Information ............................................................................................................................ 8
1.1. Intended Use and modifications of the instrument ....................................................................... 8
1.2. Delivery Set .................................................................................................................................. 9
1.3 Technical specification .................................................................................................................. 9
1.4. Operating Conditions.................................................................................................................. 11
1.5. PC Requirements ........................................................................................................................ 11
2. Instrument description and principle of operation ............................................................................. 12
2.1. Fast Thermal Control System ..................................................................................................... 14
2.2. Optical system ............................................................................................................................ 14
2.3. Control and Display System ....................................................................................................... 15
2.4. Marking. Symbols used for marking. ......................................................................................... 16
3. Setting up the instrument ................................................................................................................... 18
3.1. Instrument Unpack ..................................................................................................................... 18
3.1.1. Instrument Carrying............................................................................................................. 18
3.2. Instrument installation ................................................................................................................ 18
3.3. Software Installation ................................................................................................................... 19
3.3.1. Instrument Driver Installation.............................................................................................. 19
3.3.2. Installation of RealTime_PCR software .............................................................................. 25
4. Operating Procedure .......................................................................................................................... 29
4.1. Instrument Switching-on and RealTime_PCR Launch ......................................................... 29
4.2. Preparing the Instrument for PCR .............................................................................................. 30
4.2.1. Checkup of Geometrical Settings ........................................................................................ 30
4.2.2. Optical Measurement Exposure Setting .............................................................................. 31
4.2.3. Checking the Cleanness of Thermal Plate Wells ................................................................. 32
4.2.4. Tubes Height Measurement ................................................................................................. 32
4.3 Creation of Plate protocol and Amplification Program ............................................................... 33
4.3.1. Filling in of Plate protocol ................................................................................................... 33
4.3.2. Creation/editing of Amplification Program ......................................................................... 34
4.4. Placement of Tubes with Samples ............................................................................................. 35
4.5. Startup of the amplification program.......................................................................................... 37
4.6 Amplification program running ................................................................................................... 38
5. Maintenance ...................................................................................................................................... 40
5.1 General Guidelines ...................................................................................................................... 40
5.2 Maintenance Procedure ............................................................................................................... 41
5.3 Disinfection requirements of the instrument prior to maintenance and repair procedures. ......... 41
5.4 Troubleshooting........................................................................................................................... 42
6. Storage and shipment ........................................................................................................................ 42
7. Recycling ........................................................................................................................................... 43
8. EMS declaration ................................................................................................................................ 43
9. Warranties.......................................................................................................................................... 44
10. Packing Certificate .......................................................................................................................... 45
11. Acceptance certificate...................................................................................................................... 45
12. Cards of warranty repair .................................................................................................................. 47
13. List of claims and instrument disinfection procedure...................................................................... 49

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Introduction
The “DTprime” Detecting Thermocycler (hereafter – the “instrument” or “device”) is
intended to conduct qualitative and quantitative PCR analysis dropping out electrophoresis
stage of PCR products in agarose gel when using PCR kits based on the fluorescent detection
principle. Measurement of the quantity of accumulated product of PCR amplification takes
place right in the course of reaction temperature cycles (real-time PCR). The qualitative
analysis is based on evaluation of kinetics of PCR visible part, carried out using relevant
mathematical tool.
The use of fluorescent detection of PCR products has a list of substantial advantages:

 high detection specificity (if oligonucleotide probes are applied, which allow detecting
only of certain amplicons);
 high efficiency;
 reduced assay time;
 carrying out detection in a closed tube, which practically eliminates contamination of
further experiments;
 availability of quantitative assessment of initial DNA-matrix;
 registering and accounting of the data in electronic format.

Fig.1. Instrument General View

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1. General Information
1.1. Intended Use and modifications of the instrument
The “DTprime” real time PCR instrument is intended for carrying out an assay using
polymerase chain reaction (PCR) method and accumulated product detection in a real time
(real-time PCR). Detection of the accumulated PCR amplification product occurs directly
during the execution of the amplification program, which increases the informative value of
the study.
The field of application - clinical laboratory diagnostics in vitro;
Purpose of use – diagnostics;
Sample type - samples of human DNA and microorganisms extracted from samples of
biomaterial;
The instrument is manufacturing in the following modifications: 2М1, 2М3, 2М6, 4M1, 4М6,
5M1, 5M3, 5M6, 6М6, 2Х1 4X1, 5X1, 6Х1.
Modification of the instrument is defined by the following structure – XXX, where:
1) 1st X is figure from 4 to 5 and it indicates the number of optical detection channels;
2) 2nd X is the symbol M or X and it determines the thermal block format: M - 96 wells of
200 l, X - 384 wells of 45 l.
3) 3rd X is figure 1, 3 or 6 and it means a thermal block version such as 1 – monoblock; 3 or
6 - the number of thermal block sections.
The instrument is designed for simultaneous analysis of up to 96 or up to 384 samples
depending on the modification (M or X).
Preparation and initialization of experiments on the instrument is realized with an IBM-
compatible personal computer, and further implementation of a preset program may be
executed autonomously. On completing the amplification program, the instrument goes to the
storage mode, and if the option “Turn off device after the run” is activated on the window
“Running”, the instrument goes to the power standby mode.
The optical measurements results may preliminarily be evaluated during the execution of the
amplification program, whereas the final evaluation – at any time after completing the
program. All data of the last amplification are saved in the internal memory of the instrument
and may be read out even in the case of power failure during amplification. As soon as the
mains supply is restored, the instrument continues to function with full recovery of the
amplification program status. Neither failure of the operating system, nor disconnection of the
external computer will halt the experiment. Thus, the instrument is highly protected against
major factors effect, which may result in a failure during PCR implementation.
One computer may control operation of several instruments, including ones of different types
(DTlite, DTprime) connected to it via USB ports.
To operate the instrument, the RealTime_PCR software is used, which allows performing the
following operations:

 Test creation and editing;

 Plate protocol creation;
 Checking geometrical and optical settings of the device;
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  Creation, launching, and monitoring of the amplification program;
 Monitoring the execution of the amplification program
 Analysis of optical measurements data.
 Data analysis report.
 Settings and diagnostics of the instrument.

Loading and unloading of analyzed samples may be automatic in case if the instrument is
built in a robotic system.

Instrument is open system and it is not depended of concrete PCR kits.

1.2. Delivery Set

Quantity
No. Description Reference Producer
pcs.

DNA-
1 DTPrime real time PCR instrument Technology 1
RT96-01IN
R&P

DNA-
2 Instruction for use (Part I and Part II) RT96-04IFU Technology 1
R&P

3
Computer communication cable USB 2.0 — China
1
High Speed А-В

4 Power cable (10А, 250V, 3х0,75mm2) 1

— Taiwan

5 Fuses. (10А, 5х20, 250 V) 179200.10 Germany 1

RealTime_PCR
DNA-
version 1.0.0.198
6 Distribution package of software Technology 2
and higher R&P

DNA-
7 Packing unit RT96-03PG Technology 1
R&P

The instrument may be delivered along with portable PC with the pre installed software in
accordance with customer’s request. Note: PC should be purchased along with the order of
the instrument.

1.3 Technical specification

Specification Value

Thermal block format (modification M) 96 test tubes of 0.2 ml (12 x 8)

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 Thermal block format (modification X) 384-well microplate

0.2-ml test tubes for PCR (individual, in strips, 8

Tube type (modification M)
pieces each, or in plates 12 x 8)

384-well microplate, 24x16 wells of 45 mcl

Tube type (modification X)
volume

Reaction volume (modification M) 10-100 mcl (10-50 mcl recommended)

Reaction volume (modification X) 5-30 mcl

Temperature range 0 C-100°C

Temperature step 0.1°С

Temperature accuracy ±0.2°С

Temperature uniformity ±0.15°С

Average heating ramp rate within temperature 3.3°C/s

range of 0…100°С (modification M)
Maximum heating ramp rate within temperature
range of 0…100°С (modification M) 3.5°C/s

Average cooling rate within temperature range of 2.1°C/s

100...55°С (modification M)
Maximum cooling rate within temperature range of
100...55°С (modification M) 2.5°C/s

Average heating ramp rate within temperature 2.1°C/s

range of 0…100°С (modification X)
Maximum heating ramp rate within temperature
range of 0…100°С (modification X) 2.5°C/s

Average cooling rate within temperature range of 1.0 °С /s

100...55°С (modification X)
Maximum cooling rate within temperature range of
100...55°С (modification X) 1.5 °С /s

“Hot lid” temperature 105°С ±1°С

Heating and cooling method Peltier elements

Excitation source LED

Detector CCD camera

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 Number of optical channels 4 (versions 2M1, 2M3,2M6,2Х1) 4 (versions
4M1, 4M3,4M6) 5 (versions 5M1, 5M3,5M6,
4X1,5X1) 4 (versions 6M1, 6M3,6M6,6Х1) *
Excitation/Detection wavelengths for each channel, 470/515, 530/560, 580/620, 630/660,687/731(*)
nm

Threshold sensitivity of each channel for standard

0,05хЕ-12 gram-mol
fluorophors solutions

Data connection USB 2.0 High-speed

Power consumption 550 W (max.)

Mains voltage 220 V

Line frequency 50/60 Hz

Dimensions, WxDxH 210х540х540 mm

Starting operation after switching on no more than 5 minutes

Weight 27 kg

* spectral characteristics of optical channels can be changed within the specified limits 450 ÷
750 nm in accordance to customer request.

1.4. Operating Conditions

The instrument is intended for the use indoors under the following climatic conditions:

 indoor temperature should be from 5°С to 35°С;

 relative humidity for temperatures up to 25 °С should not exceed 80%;

 at an altitude of not more than 2000 meters.

1.5. PC Requirements
The instrument operates under the control of IBM-compatible personal computer with the
following minimum requirements:

 1 GHz Pentium IV;

 512 Mb RAM;

 Free hard drive space 100 Mb;

 Screen resolution 1024x768 pixels;

 USB 2.0 High-Speed port.

To control the instrument the following parts of software pack must be installed:

 the instrument driver;

 Realtime PCR software to control the instrument and perform data analysis.

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The software may be downloaded for free from the company’s official website at
http://www.dna-technology.ru/eng/support/
The software is compatible with the following operating systems: Windows 98, Windows
ME, Windows 2k/XP, Windows Vista, Windows 7, Windows 8, Windows 10.

2. Instrument description and principle of operation

DTprime is a specialized instrument combining a precise programmable thermal cycler and an
optical system to collect fluorescent data at each stage of polymerase chain reaction.
Design of the instrument:
The design of the instrument is a supporting frame which bears the following installed
modules:

 thermo block including positioning module of actuated parts of the instrument

designed for automatic moving of it;
 the optical system module which consists of sources of excitation based on LEDs and
detection based on CCD camera;
 optical path module for transporting light beams;
 slide for the thermal block placement;
 hot lid module, which presses the tubes from the top and heat them for preventing
condensation and also eliminates self-opening of the tubes in order to avoid a possible
contamination of the instrument by amplicones;
 horizontal drive, which provides movement of the thermal block in horizontal plane
for loading and unloading tubes into it;
 vertical drive, which provides movement of the thermal block in vertical plane to
ensure that the tubes are pressured to the thermal lid;
 electronics modules including power supplies;
 cabinet of the instrument, which has several ventilation holes.

The instrument face panel accommodates the following (fig 2):

 LCD panel;

 push-button control panel;

 “hot lid” front panel;

 thermal block front panel.

Side walls of the instrument have ventilation slots.

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 Fig.2. Front view of DTprime instrument
The instrument rear panel accommodates the following (fig 3):

 power switch;
 two fuses;
 power input;
 USB connection (type B).

Fig.3. Rear view of DTprime instrument

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Functionally there are three main systems of the instrument:
 high-rate temperature control system;
 optical system;
 control and display system.

2.1. Fast Thermal Control System

The system of high-rate temperature control includes a thermal unit, its movement and
positioning module, and the hot lid module.
The thermal block ensures thermal cycling of the tubes according to the amplification
program. Six Peltier elements are used for thermal plate cooling and heating providing high
accuracy of temperature regulation, noiselessness, good characteristics of mass-and-
dimension ratio and high reliability. Each of these Peltier elements has its own temperature
sensor and regulator that allows the preset of necessary temperature gradients across the plate.
The instrument thermal plate is made of aluminum alloy, which possesses an optimal ratio
between good thermal conductivity, weight, and processing characteristics. The plate design
is a cellular structure with reinforcing ribs and corresponding number of wells:

 in M modification – 96 wells for standard 200 mcl PCR tubes with distance between
the rows as in standard 96-well plates. The well shape provides optimal heat transfer to the
samples with volume up to 50 mcl.

 in X modification – 384 wells for standard 384-well PCR microplates.

Note! For stable results, tubes with the angle of tapered part of 17º20' must be used.
Movement and positioning module is intended for precise positioning of the thermal unit
within 180 mm and 50 mm in horizontal and vertical planes correspondently and provides
easy access to the tubes.
The hot lid module provides a reliable heat contact between tubes and the thermal plate and
allows maintaining temperature of the tube caps at the level of 105±1°С in order to prevent
condensate formation on the tube caps, since it may cause substantial distortions in the
luminous flux measurements. The hot lid design provides an adjustable force of tube-to-plate
hold-down that depends on the number of the tubes installed. During running PCR the
thermal block moves vertically from bottom to top. The moment of contact of the tubes with
the hot lid is monitored by a special sensor, which passes information to electronic module of
the instrument to calculate the necessary pressing force. The positioning module moves the
thermal block vertically by an amount that provides the necessary pressure to hold the tubes
against the surface of the hot lid.

2.2. Optical system

The optical system consists of an optical module and a light beam transmission module.
The optical module is a system of lenses, mirrors and light filters that provides folding of the
luminous flux from several light sources on one optical axis and its separation from the
luminous flux entering the CCD camera. The light sources are powerful LEDs. The light
source design provides efficient heat removing from emitting crystals of the light-emitting
diodes for stable luminous flux.

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Optical path (light beams transmission module) ensures the transmission of the luminous
flux from light sources of the optical module to the tubes, and back transmission of the
fluorescent luminous flux from the tubes to CCD camera.
The module for light beams transmission is a rectangular duct. Rectangular mirrors located in
the duct corners provide the optical pathway in a required direction.
The system of light locks provides an absolute isolation of the optical channel from external
light.

2.3. Control and Display System

The control and display system comprises a push-button panel for manual control of the
thermal block movement and the LCD screen indicating the process of amplification program
running (Fig. 4).
Push-button of on-screen menu displays functions of other panel push-buttons within the
given operation mode. The push-button of thermal block control (the second one from the
left) is intended for launching the following operations:

 opening and closing of the thermal block for placing the tubes into the thermal plate
before PCR running;
 precise positioning of the thermal block under optical elements in their operating
position.
When the instrument operates under computer control, one can open or close the thermal

block using and buttons located under the button

in the Running window of RealTime_PCR

software.
LCD screen displays information about an amplification program and the running process.
It shows the following information:

 operator’s name;

 date of the amplification program start;

 Plate protocol number;

 name of the amplification program;

 instrument serial number;

 quantity of conducted measurements;

 amplification program timer;

 instrument status on completion of an amplification program;

 current temperature of the reaction mix;

 description of the amplification program;

 fluorescence measurement channels enabled;

 optical measurement indicator;

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 indicator of the amplification program run status.

Fig.4. LCD panel

2.4. Marking. Symbols used for marking.

labeling of the instrument meets the requirements of the following standards: EN ISO 18113-
1:2011, EN ISO 18113-3:2011, EN 61010-1:2010, EN 61010-2-101:2018.
Below provided example of the label on the rear panel of the instrument:

Real-time PCR

Detecting thermocycler DTprime 4M1

IVD Medical Equipment

TS9443-004-96301278-2010
2020 A5НD06

The following warning signs “Fragile”, “Top”, “Keep dry”, “Stacking is forbidden” are
placed on the shipping box as well as:

 trade mark or information about manufacturer;

 brand name;
 date of production;
 net weight;
 gross weight;
 requirements for transportation and storage.

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Symbols used for marking:

For in vitro diagnosis only

Storage requirements (temterature)

« Fragile »

«Top»

« Keep dry »

« Stacking is forbidden »

Date of production

Manufacturer details

High voltage

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3. Setting up the instrument
3.1. Instrument Unpack
DTprime real time PCR instrument is delivered packaged in a cardboard or wooden box with
inserts of polyethylene foam; the package is intended to protect the instrument from
mechanical damage when shipped or stored.
Before being packaged in the box, the instrument is placed to a special bag of durable and
waterproof material with zip fastener and transportation straps.
Caution! Heavy! The instrument has to be carried to the installation’s place in the
manufacturer’s package box by two persons.
Before taking the instrument out of the package box, perform the following procedures:

 provide a vacant space on a work table for the instrument;

 place the box with the instrument beside the table and open it;
 take the components out of the box, and remove the polyethylene foam inserts;
 compare the components with the delivery set (refer to item 1.2);
 observing all the precautions, lift the instrument by two persons using transportation
straps and place it on a table;
 remove the bag and inspect the instrument visually for external damages.
If any items are missing or damaged, contact your local “DNA-Technology” distributor or
“DNA-Technology” directly.
3.1.1. Instrument Carrying

During operation, the instrument may be carried over a short distance within the facility in
unpacked condition by two persons or using movable table (trolley) to other preliminary
prepared working place in accordance with corresponding precautions.

Note! In case the instrument is transported over long distances or shipped by a carrier, it has
to be placed into the original manufacturer’s package.
Caution! When instrument is moved the thermal block has to be in closed position.
Otherwise, in case of some problem with instrument please contact service department of
local distributor or “DNA-Technology” directly.

3.2. Instrument installation

Caution! The instrument has precision mechanical elements. To avoid displacement of them
any shocks during operation and movement of the instrument should be eliminated.
When selecting a place for the instrument’s installation, leave about 18 cm of space in the
front and 12 cm in the all others sides of the instrument for sufficient ventilation and free
access to the thermal block and power switch.
Plug the power cord into the back of the instrument and into an appropriate electrical outlet.
Plug the USB 2.0 cable into the back of the instrument and into an appropriate PC USB port.
Press the power switch on the back panel of the thermal cycler to start the system.
For a complete power off the instrument must be disconnected from the power outlet and PC.
The instrument does not require any additional devices to stabilize circuit voltage. When
plugging up the instrument to the devices of uninterruptable power supply, please note that
provided power must be not lower than 550W.

18
Prior to connecting the instrument to the supply voltage, check the presence of protective
grounding in the socket to which the instrument will be hooked up as well as integrity of the
connecting cable.
Caution! Hooking up to the socket without grounding is prohibited.
It is important that the instrument be correctly grounded. The instrument is supplied with
power cord that provides the instrument grounding, when connected to an appropriate power
outlet.
Also it is important that the instrument and PC must be connected to the same grounded
power outlet. Otherwise, there is a risk of the instrument damage.
Caution! After transport or storage under humid and cold conditions, dry out the instrument
(2-3 hrs) at indoor temperature (+18-25°С) before connecting it to the supply voltage. During
drying out the intrinsic protection may be impaired.

3.3. Software Installation

To control the instrument, software from the instrument’s delivery set should be installed on
PC. The software operates in Windows 98, Windows ME, Windows 2k/XP, Windows Vista,
Windows 7, Windows 8, Windows 10.
Software installation is required only if the instrument and PC are purchased separately. If the
computer is supplied as a part of the instrument set, the software has been already installed.
Caution! In case of purchasing the instrument without PC, any Windows operating system is
not provided.
Software installation procedure consists of two stages:
1. Instrument driver installation.
2. Installation of the software.
3.3.1. Instrument Driver Installation

Driver installation for the instrument is identical with one for any standard device and should
be performed as follows:

 Switch on PC and wait until the operating system is launched.

 Insert the USB flash drive with the drivers into the USB port of PC or download
drivers from DNA-technology official website at http://www.dna-technology.ru/eng/support/

 Turn on the instrument using the power switch on the back panel.

 The operating system indentifies a new device in 1-2 minutes (wait for message

on the computer screen) and start driver installation process using

the Found New Hardware Wizard (Fig. 5)

Caution! When installing the driver on the PC with Windows 7, Windows 8 or

Windows 10 operating system, the Found New Hardware Wizard window does
not appear automatically. Do the following to install the driver:
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  After connecting the instrument to the computer, open Device Manager window, then
right-click DT-964 and select Update driver in the list

 In the next window Driver Updating select Manual driver search and installation,
click Browse, select Drivers_DT96x_W32_2014 folder (for 32-bit version) or
Drivers_DT96x_W64_2014 folder (for 64-bit version).

 Click Next and complete the driver installation as described below.

Fig.5. Launching the Wizard for driver installation

 Select point No, not this time and click

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 Fig.6. Selecting a type of installation

 Select Install from a list of specific location and click (Fig. 6)

Fig. 7. Searching Drivers_DT96x folder on the USB flash drive

 Select a path to the driver folder by ticking Add this location to the search and click
(Fig.7).
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 Fig. 8. Selecting the Drivers_DT96x folder on the USB flash drive

 In the pop-up window Browse For Folder select Drivers_DT96x folder on the USB
flash drive and click (Fig.8).
 Making sure the driver folder path is correct click (Fig.9),

Fig. 9. Selecting inf-file on the USB flash drive

Select the latest version of the driver and ignoring message The driver has no digital
signature confirm the driver selection by clicking (Fig.9)

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 Fig.10. Further Driver_DT96x installation

 confirm the driver selection by clicking (Fig. 10).

 Select the path to Dt964.sys file on the CD by clicking (Fig. 11).

Fig.11. Selecting the path to Dt964R.sys file on the CD

 In the next window Locate file find this file in the Drivers DT96x folder on the CD,
select it and click (Fig.12)

23
 Fig.12. Confirmation of Dt964R.sys file selection on the USB flash drive

 Making sure that the path to the file in the window (Fig.11) is correct, click
.

 After message that the installation of the driver has been completed (Fig.13), click
.

Fig.13. Driver installation completion

If driver installation is successfully completed, the system will display a message

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Note! Installation of the instrument’s driver is required upon the first connection only.

3.3.2. Installation of RealTime_PCR software

Note! The software must be installed on the computer by a user with administrative
privileges.
Make sure you are logged in with administrative privileges.
Installation of RealTime_PCR software should be performed as follows:

 Launch Setup manager from the USB flash drive included in the delivery set (it can be
also downloaded official website http://www.dna-technology.ru/eng/support/).

 Select Russian/English language to use during the installation (Fig. 14) and click

Fig.14. Selecting a language

 Setup Wizard appears with the version of software (Fig.15).

Fig. 15. RealTime_PCR installation Wizard

25
  Select a folder for software installation (Fig. 16). RealTime_PCR software can be
installed into a default folder or any folder on the hard disk by clicking
(installation into a default folder is preferable).

Fig. 16. Folder selection to install software

 Having selected the installation folder, click .

- Select the name of the folder, where RealTime_PCR shortcuts will be created, and click

. (Fig. 17).

26
 Fig. 17. Selecting of folder to create shortcuts

 Confirmation window will appear, informing that software is ready for setup (Fig. 18).
Check the chosen options and click .

Fig.18. Confirmation window

 After the installation is completed you will see following window (Fig. 19). Click
to quit the Setup Wizard.
.

27
 Fig.19. Completed operation of the RealTime_PCR installation wizard

Caution! To ensure multi-instrument operational conditions, the corresponding

Server_RTDevice service is included in the RealTime_PCR software. This service is started
at the first start of the software in the mode with sign
displayed in the tray and stays active until the computer shutdown.
By right-clicking on this sign, the following box can be opened:

Choosing the Show List_Device shows the list of instruments connected to the PC.

Clicking the Close Server_RT stops this service at the PC.

28
4. Operating Procedure
4.1. Instrument Switching-on and RealTime_PCR Launch
Check whether the instrument is connected to the PC via USB cable, and then switch the
instrument and the PC on.

Start the RealTime_PCR software using icon on the Desktop or via the Start menu of
the Windows. In the window of selecting operation modes (Fig. 20) Guest operator is a
default (not recommended to use). Select another operator by using drop-down menu or add a
new one (drop-down menu last line). Please type in the name of Operator and select the
Directory where run protocol files and assay results be stored. Click Ok and select Device
operation.

Fig. 20. RealTime_PCR start window

Once RealTime_PCR is launched in the Device operation mode a window of running
program with an indication of the instrument status is displayed. In the status line
, and the dialog window List of devices available instruments are listed
(Fig. 21).

Fig.21. Window of connected devices

Select the instrument to start and click .

29
The instrument will be connected to the PC and the indication in the status line of the
operation procedure window will be changed to .
After instrument self testing, indication of its status in the status line will be changed to
and the instrument will be ready for running the amplification program.
A detailed procedure of starting and operating RealTime_PCR software is described in the
second part of the operation manual named Software guidance.
Indication of instrument status in the status line means:

– the instrument is on and ready for operation (green background).

– the instrument is on, however, is not ready for operation (yellow

background) – the warm-up is in progress. After warming-up (which is normally not longer
than 10 minutes since switch-on), the background color will change from yellow to green.

– the instrument is either switched off at the moment of launching

software, or is not connected to the PC via USB2.0 A-B cable or is not selected in the window
List of devices.
Note! Several instruments can be controlled by one computer. In this case the instruments
have to be connected to the computer via USB ports.
When working in a single-device mode, the operator connects and disconnects a selected
instrument by clicking and in the List of devices window,
which is displayed automatically at the launch of RealTime_PCR, and while operating this
window can be opened by clicking Preferences/ List of devices at the menu bar.
When working in a multi-device mode, each instrument requires launching of its
RealTime_PCR software in an individual window. In this case operation of several
instruments may be controlled simultaneously.

The status line represents current date and time , instrument serial
number and a version of optical controller firmware .

4.2. Preparing the Instrument for PCR

The instrument readiness to run the PCR assay is checked automatically every time it is
switched on. While this radiator temperature, thermal plate temperature, and the hot lid
temperature are checked against permissible values.

4.2.1. Checkup of Geometrical Settings

Attention! At the first switch on of the instrument after its transportation or any other change
of its position, checking the optic module’s geometrical settings is strongly recommended.

A detailed procedure of the geometrical settings checkup is described in the second part of the
operation manual named Software guidance.
The image of thermal plate wells outlining the boundaries of a measuring region (red circles)
has to completely encompass the light spots. If the circles are displaced relative to the light
spots, correction of the geometry of an optical image must be carried out (Fig. 22).

30
 a)

b)

Fig.22. Check of geometrical settings (a – M modification, b – X modification)

4.2.2. Optical Measurement Exposure Setting

Preset working exposure values for each channel are the following:

Fam – 1000; Hex – 1000; Rox – 1000; Cy5 – 1000; Cy5.5 – 1000

Note! Preset parameters of optical measurements for each channel are optimal to operate with
DNA-Technology PCR kits and could be suitable for the most of third party kits.

Exposure change is required only when levels of different channels’ optical signals
substantially differ, as it may result in incorrect color compensation in the process of analysis
of optical measurements. For exposure setting window see Fig. 23.

Caution! In case of using third party kits the optimal exposition values for channels must be
provided by manufacturer.

31
 Fig.23. Exposure setting window
A detailed procedure of exposure value selecting is described in the second part of the
operation manual named Software guidance.

4.2.3. Checking the Cleanness of Thermal Plate Wells

While checking the optical unit geometrical settings, one has to increase the value of
exposure in 2 times in comparison with the operational values. There must be no bright spots
on the image of empty thermal plate wells.
It is recommended to check the purity of the wells before placing tubes, strips or plates with
PCR mixes, if there was a risk of contamination before.
Note! Routine check of well cleanness must be carried out by the operator in compliance with
the instrument maintenance procedure (see item 5).

4.2.4. Tubes Height Measurement

Attention! The height of the test tubes must be measured every time new type or brand of
plastic consumables is used, to ensure proper pressure of the hot lid.

To perform the tubes height measurement procedure:

 Click and then place tubes or stripes uniformly along the

thermal plate;
 Select Preference/Device diagnostics/Measure height of the tubes in the menu bar and
wait for the message:

32
  Save measured value by clicking .

Caution! To measure tubes height, use at least 32 tubes or 4 strips putting them evenly
throughout thermal plate.

4.3 Creation of Plate protocol and Amplification Program

After switching on the instrument create or edit of a plate protocol and amplification program
using RealTime_PCR software.

4.3.1. Filling in of Plate protocol

The window for plate protocol filling in (Fig. 24) is displayed immediately after starting
RealTime_PCR and comprises: data input table, control buttons for plate protocol filling in
and a field of graphic representation of tubes arrangement in the thermal block.

Fill-in plate protocol in one of the following ways:

 by using Test procedure with saved standard assay parameters (recommended for
standard assays in clinical laboratories);

 by using plate protocol templates saved before.

Note! Do not fill in the plate protocol without using Test procedure, as window Analysis
Parameters won’t be active, and the optical calibration coefficients of the instrument
will not be used.
In the course of the filling in the plate protocol, enter the following data:

 identification code (description) of each tube;

 type of each tube (sample, standard or control +/- );;

 the number of replicas of each sample;

 concentration of calibration samples (in a quantitative assay);

 fluorophore is used (fluorescent label) and its purpose (specific target, IC or not
detected);

 arrangement of tubes in the thermocycler block;

 Plate protocol No.;

 operator’s name.
The procedure of creating (editing) the plate protocol is described in details in the second part
of the operation manual Software guidance.

33
 Fig.24. Window of plate protocol filling-in

4.3.2. Creation/editing of Amplification Program

After filling in the plate protocol proceed to the Start run tab. The amplification program,
specified in the Test procedure used for plate protocol filling in, will be displayed as the
default. If the plate protocol was filled in without using the Test procedure, the amplification
program of the last run will be displayed.

If required, the following steps may be carried out:

1. Open the amplification program by clicking .

2. Create a new amplification program (click ) by using the

Amplification program editor or choosing amplification program template (Fig. 25).

3. Edit the existing amplification program by clicking (Fig. 26).

34
 Fig.25. Creation of amplification program using template

Fig.26. Edit of existing amplification program

Creating and editing the amplification program are described in details in the second part of
operation manual Software guidance.

4.4. Placement of Tubes with Samples

35
To place or remove the test tubes with samples, do the following:

a)

b)
Fig.27. Exterior appearance of the thermal block in open position (a – M modification, b – X
modification)

1. Click in the Start run tab or push the button of thermal block manual
control and wait until the thermal block is opened (Fig.27).
2. If it is the first start of the instrument, rub the wells of the thermal block with a cloth
moistened in alcohol (96-% ethanol or 100-% isopropyl alcohol may be used) as described in
section 8 of instrument maintenance. In the course of operation, wipe the wells as set forth in
the Maintenance section.
3. Place the tubes with samples into the thermal block wells in compliance with filled in plate
protocol.

4. Click in Start run window or press the button of instrument manual

control and wait until the thermal block is closed.
36
Caution! Be sure to place at least 16 tubes in order to prevent their damage because of
hot lid pressure. If there are less of 16 tubes please add empty tubes of the same height
to make them as it is required.

Caution, dangerous! The instrument provides automatic loading and unloading of

tubes from the thermal block in the operational position. The command to move (open or
close) of the thermal block comes from the operator. It is forbidden to carry out any
manipulations during the movement of the thermal block because it can lead to damage of the
movement mechanisms of it. If an obstacle appears in the process of the thermal block
closing, it automatically switches to the opening mode. To prevent the failure of the
movement mechanism in case of a mechanical obstacle occurs during the movement of the
thermal block, the front panel of it is made flexible.
Caution, hot surface! During the instrument operation, the matrix of thermal block and hot
lid may get hot up to 100 and 105 ºC respectively. When execution of the PCR RUN
(operating mode) the thermal block matrix and the hot lid are not available for operator. Upon
completion of the PCR RUN operator is not allowed to remove the tubes from the thermo
block until the instrument enters in storage mode (low temperature mode) with the following
message:

4.5. Startup of the amplification program

Enter necessary notes such as the particularities and characteristics of the upcoming run and
the PCR mix volume in tubes;
Be sure that the instrument is on and properly connected to the computer, which is confirmed
by yellow or green indicator in the software status line.

Start the amplification program by clicking .

When running the amplification program, select a file name, data format and folder to save
future results of the upcoming RUN.
Note! If Run is started while the instrument is in the process of warming up (yellow indicator
in the software status line), blinking message Warming will be appeared
in Temperature Profile window:

The same message will appear at the instrument’s display as well. When warming up is
completed, the instrument will automatically proceed to the RUN execution mode.
37
In case of necessity of instrument’s autonomous functioning after the RUN completion and its
automatic turning to sleep mode perform the following:
1. In Running window activate the option - turn off device after the RUN

2. Close the Real Time PCR software by clicking in the upper right corner of its
window.
3. When RUN is completed the instrument will switch to the sleep mode, what is confirmed
by blinking diode on the front panel of the instrument.
Note! The instrument will proceed to the sleep mode only if “Turn off device after the run”
option is activated and the executed amplification program finishes as Holding mode.

4.6 Amplification program running

Running of the amplification program is controlled via RealTime_PCR software.
The following options could be done during its execution:

 pause running;

 stop running;

 add any number of cycles in a current block or skip execution of the remaining cycles
and proceed to the execution of the next temperature block;

 edit the log of optical measurement;

 to check optical measurement data of the selected tubes in the form of 3D histogram in
the Distribution of optical measurements over the plate window by clicking
(Fig. 28).

38
 Fig.28. Distribution of optical measurements over the plate window
If option “Turn off device after the run” was not activated, the instrument passes to the
Holding mode after completion of the RUN (Fig. 29).
In this case, a blinking message Holding… and a information about storage temperature will
appear on the chart.

Fig.29. Message about the RUN completion

The same message will appear on the instrument display as well.

When the temperature reaches the value close to holding temperature information message
appears on the screen notifying that the RUN has completed and instrument passes to the
holding mode (Fig. 30).

39
 Fig.30. Storage mode indication

By pressing button ОК RealTime_PCR software is switched to Archive viewer mode

(Data analysis tab).
If option “Turn off device after the run” was activated, then upon completion of the RUN
the instrument switched to the sleep mode. To exit this mode, launch RealTime_PCR
software and again connect to the instrument in the appeared window List of devices.
Note! To read results of the executed RUN after exit sleep mode proceed to menu
Preferences/Last run in device option.
The analysis of optical measurements results are described in details in the second part of
operation manual Software guidance.

5. Maintenance
5.1 General Guidelines
The maintenance of the instrument is necessary to keep it at optimum working condition,
which minimises the risk of having unscheduled downtime and providing for its maximum
operational life.
The instrument belongs to IVD medical equipment. Maintenance should be carried out only
by competent personnel, who have studied the present operation manual.
The instrument is required for minimal routine maintenance during normal laboratory
operation.

Caution, risk of electrical shock! Replacement of fuses should be done on de-

energized instrument only. Fuses type is T10AH250V with the following parameters - 10A,
250V (slow with high breaking capacity) and 5x20 mm size should be used in the case of

40
their replacement. De-energizing of the instrument is achieved by removing the power cord
connector from it or from the power outlet and disconnection of USB cable as well.
The instrument should be protected from mechanical shocks and any liquids getting on its
case.
To keep thermal block matrix and elements of the optical system clean, the instrument
thermal block has to be always closed (except operations for placement / removal of PCR
tubes with samples).
Caution! To avoid failure of the instrument’s optical system it is strictly forbidden to use any
substances (heat-resistant pastes, oils, etc.) to improve contact between PCR tubes and
thermal block wells.

5.2 Maintenance Procedure

The following procedures should be carried out by qualified personnel with a periodicity
specified below:
1) Visual inspection of the instrument to assure the absence of damages on its surface. The
condition (integrity) of the power cord and its reliable connection to the instrument.
Frequency of visual inspection: before each switch-on.
2) Timely removal of some dust / dirt from the instrument’s surface by using disinfectant
solutions in accordance with regulations settled in an institution. Frequency: as and when the
instrument gets dirty.
3) The exterior and functional surfaces of the instrument should be periodicity treated with
disinfectant solutions to eliminate possible contamination of it by amplification products of
nucleic acids in accordance to local regulations and rules. Cleaning of thermal block wells
has to be done by a cotton swab wrapped on a wooden rod and moistened with no less than
70-% ethanol.

Caution! Never use any metal objects (paper-clips, wire, etc.) for wells cleaning!
Attention ! When cleaning the wells and thermo block matrix do not allow a liquid
flowing inside of the thermal block and the instrument!
Cleaning frequency: after 20 executed RUNs image of thermal block matrix should be
checked for all channels (as it is described in point 4.2 of the present manual). In case of some
bright spots will be detected for any ranges of fluorescence registration, cleaning of the wells
have to done.

5.3 Disinfection requirements of the instrument prior to maintenance and

repair procedures.
The user is responsible for the proper usage of the instrument as well as for its disinfection
procedures before carrying out maintenance or repair operations.

Prior sending the instrument for repair or maintenance to local servise office or manufacturer
it is necessary to perform the disinfection operations with accordance to local rules and
regulations and fill out the disinfection certificate (see Appendix 1).

41
5.4 Troubleshooting
Trouble description Probable cause Corrective measures

Check if voltage available, socket works

No voltage in the mains
properly

After instrument switch-on Check the contact of power cord. If

there is no information shown necessary replace the cable with a similar
on the LCD display Poor contact or break- one (10A, 250V, 3x0.75mm2), change
age in the power cord Т10AH250V fuses (10A, 250V), which are
included in the set of delivery. It is allowed
changing the failed fuses only once!

Poor contact or break- Check the USB cable between instrument

age in the communica- and PC
Status line of RealTime_PCR tion cable with the PC
software shows message
“Device is OFF” while the Instrument driver is not Install the instrument driver (see item
instrument is switched on. installed 3.3.1)

Failure in the Windows

system Reset the PC

After 10 to 15-minute warm-up

process of the instrument, the
yellow background of “Device The instrument is Please contact local service office or
is ON” message in the status malfunctioned service department of the manufacturer
line of the software doesn't turn
into green

Restore the connection between the PC and

During the amplification pro- the instrument. Replace USB cable with a
gram execution the following Connection between similar one. RealTime_PCR software will
error message is displayed: the PC and the in- connect to the instrument and read out all
“Error! “ Program is running, strument is failed the data missed without amplification
but device does not reply! program interruption. If this message keeps
showing, please, restart the application

6. Storage and shipment

Caution! In case of storage in the cold conditions the instrument has be kept indoor at
temperature +18 +25 °С during at least 4 hours prior to switching it on.
The instrument should be stored indoor with natural ventilation at the temperature range from
+ 5°C to + 40°С and relative air humidity to 80% at 25°С. In case of long-term storage, when
it is not used, the instrument should be kept in the manufacturer’s package.
A room, where the instrument is stored or operated, should be free of dust, acid and alkali
vapors, corrosive gases and other harmful substances that may cause corrosion of the metal
parts and electric insulation breakdown.

42
During transportation, the instrument should be protected from dust and precipitation. It is
forbidden to tilt and turn over the instrument! Prior to the shipment, the instrument should
be secured to ensure its stable position and exclude any displacement and shocks.
Instrument can be shipped by any kinds of transport and it has to be carried in the
manufacturer’s transport package and treated with accordance to manipulation signs applied
on the outer surface of transport package. Acceptable environmental conditions for
transportation are the following: temperature from - 50°C to + 50°C and relative air humidity
up to 80 % at + 6°C.
Note! The instrument contains precision mechanical parts. To avoid their damage during
handling and shipping, the requirements of manipulation signs applied on package should be
strictly followed.

Attention! The instrument has to be shipped with the closed thermal block only.

7. Recycling
7.1 Recycling of medical devices has to be carried out in accordance with the classification,
rules for the collection, use, disinfection, storage, transportation, accounting and disposal of
medical waste established by the authorized federal executive authority.
7.2 Recycling of the instrument has to be carried out by special companies, which have the
appropriate license, using specially equipped places in accordance with the requirements
stipulated by existing Federal laws and in compliance with the mandatory requirements for
environmental protection in accordance with the local regulations.

8. EMS declaration
The instrument complies with the immunity and electromagnetic emission requirements of
EN 61326-2-6: 2013.
The instrument is intended for use in the electromagnetic environment described below:
- The device was designed and tested in accordance with the requirements of
CISPR 11 and it is suitable for use in all rooms, including ones, which are
directly connected to the public low-voltage mains network.
- The quality of the electricity supply has to comply with typical conditions of
use in commercial institutions or hospitals.
- Power frequency of magnetic fields has to be at a level corresponded with
typical conditions of use in commercial institutions or hospitals.
- The instrument uses radiofrequency energy exclusively for its internal
function. The level of radiofrequency emission is very low and does not lead to
disturbances in the operation of electronic equipment located close to it.
- It is forbidden to use the instrument near sources of strong electromagnetic
radiation that could interfere its normal functioning.
Notes:
1. The manufacturer is responsible for providing the consumer information about the
electromagnetic compatibility of the instrument.
2. The customer is responsible for maintaining electromagnetic environment, which
ensures instrument normal operation in accordance with its intended purpose.

43
9. Warranties
The manufacturer guarantees proper operation of the instrument and its conformity to TS
9443-004-96301278-2010 while meeting the requirements of this Operations Manual.
The warranty period for the instrument is 24 months from the date of its sale. Warranty repair
is acceptable upon providing of warranty repair card along with the filled deficiency report.
Average life of the instrument is not less than 5 years from the start of its operation.
Guaranteed storage life while meeting storage conditions (indoor under temperature 5 ° C - 40
° C) of the instrument is 12 months from the date of manufacture.
During the warranty period, the manufacturer bears responsibility to eliminate the
instrument's defects free of charge by repairing or replacing it on a similar one, provided that
the occurred defects are fault of the manufacturer.
Execution the warranty repair of the failed instrument by the manufacturer entails
prolongation of the warranty period for the time of such repair.
The manufacturer is not responsible for compatibility of the provided software with any
hardware or software supplied by other manufacturers, unless otherwise stipulated.
In no event shall the manufacturer and seller be liable for any losses, including loss of data,
loss of profits and other incidental, consequential or indirect losses arising from improper
installation, maintenance and operation or related to failure / temporary no operability of the
instrument.
The manufacturer is not responsible for defects and malfunctions of the instrument that
arising from the following:
- disregard of rules transportation, storage conditions, operation or improper
installation;
- improper actions connected to improper usage of the instrument as well as
disregard of the requirements set out in the operational manual;
- non authorized repair or changes in the design of instrument as well as cases of
violation of warranty seals on the body of the instrument;
- force majeure (fire, flood, earthquake, etc.) or influence of some random
external factors (power surges, etc.);
- Entering foreign objects (substances, liquids, insects, etc.) inside the
instrument.
The warranty does not cover instruments that have external defects (obvious mechanical
damage, cracks, cleavage on the body and inside, broken contacts of connectors and so on).

44
10. Packing Certificate

“DTprime” Real-Time PCR instrument,

Serial number _____________________ manufactured by
DNA-Technology, Research & Production, LLC has been packed in accordance with the TS
9443-004-96301278-2010 requirements.
Packaging date “……….”………………………., 20.….
The packaging is done by ____________________ (signature)
The packed product is accepted by ____________________ (signature)

L.S.

Note. The form is to be filled in at the factory that packed the product.

11. Acceptance certificate

“DTprime” Real-Time PCR instrument,
Serial number _____________________ manufactured by
DNA-Technology, Research & Production, LLC has passed the acceptance test, complies
with TS 9443-004-96301278-2010 and has been qualified for operations.
Date of issue “……….”………………………., 20.….

L.S.

Signatures of officers responsible for the acceptance ____________________________

45
46
12. Cards of warranty repair

CARD No. 1 to be filled in by the manufacturer

For warranty repair (maintenance) of DTprime Real-Time PCR instrument

………………………………. manufactured by ………………………………………
(factory No. of the product) (date)
Representative of the manufacturer’s quality control department ……………………….

(QCD stamp)

Note of sale______________________________
(manufacturer’s name)
“……….”………………………., 20.…. manufacturer’s stamp
(date) (personal signature)
Owner and his address …………………………………………………………………
…………………………………………………………………………………….……
(personal signature)
…………………………………………………………………………………………

CARD No. 2 to be filled in by the manufacturer

For warranty repair (maintenance) of DTprime Real-Time PCR instrument

………………………………. manufactured by ………………………………………
(factory No. of the product) (date)
Representative of the manufacturer’s quality control department ……………………….

(QCD stamp)

Note of sale______________________________
(manufacturer’s name)
“……….”………………………., 20.…. manufacturer’s stamp
(date) (personal signature)
Owner and his address …………………………………………………………………
…………………………………………………………………………………….……
(personal signature)
…………………………………………………………………………………………

47
Reverse of CARD No. 1 to be filled in by a service center

Product factory No. ………………….

Repair content ….…………….……………………………………………………………….

…………………………………………………………………………………………………
…………………………………………………………………………………………………
…………………………………………………………………………………………………
…………………………………………………………………………………………………
Date of repair………………………………….

(day, month, year)

Serviceman…………………….. Owner………………………….
(signature, stamp) (signature)
…………………………………………………………………………………………………

Reverse of CARD No. 2 to be filled in by a service center

Product factory No. ………………….

Repair content ….…………….……………………………………………………………….

…………………………………………………………………………………………………
…………………………………………………………………………………………………
…………………………………………………………………………………………………
…………………………………………………………………………………………………
Date of repair………………………………….

(day, month, year)

Serviceman…………………….. Owner………………………….
(signature, stamp) (signature)
…………………………………………………………………………………………………

48
13. List of claims and instrument disinfection procedure

Serial number of instrument: __________________

Detailed description of the defect: ___________________________________________

___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

Means used for disinfection: _________________________

___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

Procedure of instrument disinfection: __________________________________________

___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

Full name: _________________________________________

Position: ________________________________________
Company: ______________________________________
Signature: _____________________
Date: ________________________

49
Manufacturer: DNA-Technology, Research & Production, LLC
20 Zheleznodorozhnaya Street, Protvino,
Moscow Region, Russia, 142281
Phone/fax: +7(4967) 31-06-70
E-mail: [email protected]
http://www.dna-technology.ru

Seller: «DNA-Technology», LLC

117587, Russia, Moscow, int. ter. Municipal District
Chertanovo Severnoye, Varshavskoe shosse, 125Zh,
building 5, floor 1, office 12
Phone/fax: +7(495) 640-17-71
E-mail: [email protected]

Customer support:
Tel.: 8 800 200-75-15 (free for Russia)
E-mail: [email protected]
Feedback form see on DNA-Technology’s website
http://www.dna-technology.ru/customer_support/

Service department:
Tel.: +7(4967) 31-14-67, +7(4967) 31-06-71 (ex. 3126)
E-mail: [email protected]

Authorized representative in the EU:

OBELIS S.A
Registered address:
General Wahis Boulevard, 53
1030 Brussels,
Belgium
Tel: +32.2,732.59.54
Fax: +32.2,732.60.03
E-mail: [email protected]
http://www.obelis.net

Version 14-2021