MEDsan ULTRA SBMS 24 User manual

| ULTRA SBMS 24
Operation Manual
Nur für den professionellen Gebrauch
Real-time qPCR instrument
ultraSBMS24
Professional use only
©MEDsan®Biotech GmbH | Brandshofer Deich 10 | 20539 Hamburg | Germany

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Manual V3 EN 2021-12-16
The text contains the patent data protected by copyright, with all rights reserved. Any
part in the document shall never be copied, remade or translated into other languages
without the prior written approval of MEDsan® Biotech GmbH.
The analyser is a kind of analyser for special purpose. Please operate in strict accor-
dance with the Operating Instructions to avoid any damage or incorrect results to the
analyser.
The user should operate the instrument in strict accordance with the
Operation Manual. The protection provided by the instrument may be
damaged if not used as specified.
Thank to you for choosing our products. Please make sure to read the
operations manual carefully before you use the instrument for the first
time!.
Software: SBMSnodus
MEDsan GmbH | Brandshofer Deich 10 | 20539 Hamburg | Germany
After-sales Service: MEDsan®Biotech GmbH
E-mail: devices.ser[email protected]
Website: https://www.medsanbiotech.com
! Statement !
The users should use the instrument strictly in accordance with the method
specified in the “Operation Manual”.
If it is not used according to the regulations, the protection provided by the
instrument may be damaged.

Contents
CHAPTER 1. Safety Warning ................................................................................5
1.1 Use attention................................................................................................5
1.2 Safety Symbols ............................................................................................8
1.3 Safety precautions .......................................................................................8
1.4 Warning and safety tips................................................................................9
1.5 Notice .........................................................................................................10
CHAPTER 2. Introduction ..................................................................................11
2.1 Real-time qPCR instrument........................................................................11
2.2 Structural features and module description................................................11
2.3 Parameters and performance indicators................................................... 12
CHAPTER 3. Instrument installation .................................................................12
3.1 Unpack the instrument............................................................................... 12
3.2 Installation and use environment............................................................... 13
3.3 Power requirements................................................................................... 13
CHAPTER 4. Instrument use...............................................................................14
4.1 Boot............................................................................................................ 14
4.2 Shutdown.................................................................................................... 14
CHAPTER 5. Software installation....................................................................14
5.1 Windows desktop software installation...................................................... 14
CHAPTER 6. Software use.................................................................................14
6.1 Use of stand-alone operating software...................................................... 14
6.2 PC operating software use.........................................................................40
CHAPTER 7. Maintenance..................................................................................40
CHAPTER 8. Troubleshooting ...........................................................................40
8.1 Failure to boot.............................................................................................40
8.2 Software system failure..............................................................................40
8.3 Test process failure.....................................................................................41
8.4 Abnormal test results ..................................................................................41
8.5 Other faults..................................................................................................41
CHAPTER 9. After-sales service.......................................................................41

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CHAPTER 1.Safety Warning
1.1 Use attention
In order to use this detection system correctly and effectively, please read the following
precautions carefully.
SYSTEM PURPOSE
WARNING
Please refer to «Scope of Application» for the purpose of this detection system. If you
need to use this system beyond this scope of application, please consult MEDsan Biotech
GmbH. When making clinical judgments based on analysis results, please also consider
clinical symptoms or other test results.
OPERATOR
WARNING
This system is limited to inspection professionals or experimenters who have been trained
in ultraSBMS24 operation methods to operate and use.
INSTALLATION ENVIRONMENT
WARNING
Please install the system correctly in accordance with the installation environment speci-
fied in this manual. Installation and use of this system outside the specified conditions may
result in unreliable results and may cause damage to the system.
If you need to change the system status, please contact the customer service department
of MEDsan Biotech GmbH or the distributor in your area.
USE ENVIRONMENT
CAUTION:
(1) Please use the detection system in accordance with the relevant instructions in this
manual. Incorrect use may cause incorrect measurement results and may even cause
damage to the instrument or personal injury.
(2) Do not open the upper cover while the detection system is working

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ELECTROMAGNETIC COMPATIBILITY
NOTICE
(1) The real-time qPCR instrument (ultraSBMS24 IVD) meets the emission and immunity
requirements specified in this part of IEC61326-2-6, see the table below.
Table 1:
Electromagnetic emission
Launch test Compliance
CISPR 11 Conducted emission 1 group A
CISPR 11 Radiation emission
IEC61000-3-2 Harmonic emission Not applicable
IEC61000-3-3 Voltage fluctuation/flicker emission Not applicable

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Table 2:
Electromagnetic immunity
Immunity test item Basic standard Test value Meet
performance
Electrostatic discharge
(ESD) IEC61000-4-2 Contact discharge: ±2kV, ±4kV
Air discharge: ±2kV, ±4kV,
±8kV B
Radio frequency
electromagnetic
field IEC61000-4-3 3V/m, 80MHz ~ 2.0GHz,
80% AM A
Burst IEC61000-4-4 Power cord:
±1kV (5/50ns, 5kHz) B
surge IEC61000-4-5 Line to ground: ±2kV
Wire to wire: ±1kV B
RF conduction IEC61000-4-6 Power cord: 3V/m, 150kHz ~
80MHz, 80%AM A
Power
frequency magnetic field IEC61000-4-8 3A/m, 50Hz/60Hz A
Voltage dips, interruptions IEC61000-4-11
1 cycle 0%;
5/6 cycle 40%;
70% for 25/30 cycle;
250/300 cycle 5%
B
C
C
C
Performance judgment:
A. During the test, the performance is normal within the specification limits.
B. During the test, the function or performance is temporarily reduced or lost, but it can
recover by itself.
C. During the test, the function or performance is temporarily reduced or lost, but ope-
rator intervention or system reset is required
(2) The user is responsible for ensuring the electromagnetic compatibility environment of
the equipment so that the equipment can work normally.
(3) It is recommended to evaluate the electromagnetic environment before using the
equipment.
WARNING
(1) The ultraSBMS24 IVD real-time qPCR instrument is designed and tested according
to the Class A equipment in CISPR 11. In a home environment, this device may cause
radio interference, and protective measures are required.
(2) It is forbidden to use this equipment near strong radiation sources (such as unshiel-
ded radio frequency sources), otherwise it may interfere with the normal operation of
the equipment.

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1.2 Safety Symbols
CAUTION and WARNING
“Caution”, “Warning” and “Notice”
are all mentioned in this manual.
Types of safety signs: The following signs appear in this manual or instrument accesso-
ries:
CAUTION — If you do not follow the prescribed procedures or inst-
ructions, it may cause damage to the equipment.
WARNING—If you do not follow the prescribed procedures or insto-
ructions, it may cause physical injury.
1.3 Safety precautions
Prevent electric shock
To prevent electric shock, please observe the following precautions.
WARNING
When the main power of the detection system is turned on, unauthorized maintenance
personnel must not open the fixed casing of the instrument. Spilled reagents and samples
inside the instrument may cause the instrument to malfunction and cause electric shock.
Don›t place samples and reagents above the instrument. If spilling occurs, turn off the
power immediately and contact the service department of
MEDsan GmbH | Brandshofer Deich 10 | 20539 Hamburg | Germany.
Protection against biological hazards
In order to effectively protect against biochemical hazards, please observe the following precauti-
ons.
Biological infection risk:
If you use infectious samples, incorrect use of samples may result in infection. Do not touch
the sample mixtures and waste liquids directly with your hands. Please be sure to wear gloves
and overalls during operation to prevent infection and wear protective glasses if necessary.
If the sample accidentally touches the skin, please handle it immediately in accordance
with laboratory work standards and consult a doctor.

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Prevent injury from static electricity
To prevent injury caused by static-charged parts, please observe the following precautions.
Beware of static electricity:
There may be static electricity on the surface, please do not touch it during use.
Prevent injury caused by hot parts
To prevent burns, please observe the following precautions.
Warning:
Here show fever or high temperature, do not touch during use.
1.4 Warning and safety tips
Please read the following warnings carefully before use and must be
strictly
followed. Warning: Please read the following precautions
carefully before using this instrument
• Avoid blood, reagents, staples and other metal parts from entering the inside of the
instrument.
• If an abnormality occurs, cut off the power immediately and unplug the power plug
from the power socket. At this time, an inspection application should be submitted to
the distributor or our company›s agent immediately.
• The operator should not touch the electronic circuit in the instrument, especially
contact with wet hands is more likely to get an electric shock.
• When repairing and inspecting the instrument, you must wear rubber gloves and use
the specified tools and parts. After the operation, please wash your hands with dis-
infectant Otherwise, the part of the skin in contact with blood may be infected or get
an electric shock or be burned.
• Be very careful when handling specimens. Be sure to wear rubber gloves, otherwise
it may cause infection. If the specimen enters the eye or wound, rinse it immediately
with plenty of water and accept a doctor›s examination.
• If the equipment is not used in accordance with the method specified by this instru-
ment, the protection provided by the instrument may be destroyed.

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Use and disposal of reagents (If used)
• Avoid contact of reagents with skin and clothing during operation.
• If the reagent gets into the eyes accidentally, rinse it off with plenty of water immedia-
tely and accept a doctor›s examination.
• If you drink the reagent by mistake, you should immediately seek help from a doctor
and drink plenty of water to spit out the reagent.
• If the reagent gets on your hands or skin, immediately rinse it off with clean water.
• Waste products such as used reagent strips and other equipment consumables
should be treated as medical waste or infectious waste. If it is contaminated by blood,
it may be infected by pathogens.
Power supply voltage, connection and grounding
• Ensure that the network power supply and grounding environment of the instrument
is good and stable.
• Do not insert the power plug into a power outlet outside the allowable voltage range.
• When installing the instrument, be sure to use the three-core power cable that
comes with the machine and ensure that it is well grounded and placed in a position
where it is easy to operate and disconnect the power supply. Otherwise, it may
cause fire or electric shock.
• When connecting peripheral equipment, be sure to cut off the power first. Otherwise,
it may cause electric shock or malfunction.
1.5 Notice
Please pay attention to the following precautions during use:
(1) When a failure occurs, you can refer to the «Troubleshooting» section for exclusion. If
the emergence of the problem cannot be solved, please contact our service depart-
ment.
(2) It is forbidden to use this equipment near strong radiation sources (such as unshielded
RF sources), otherwise it may interfere with the normal operation of the equipment.
(3) When using this real-time qPCR instrument, in order to get the best PCR detection
results, it is recommended to use paraffin oil.

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CHAPTER 2. Introduction
2.1 Real-time qPCR instrument
Product name: Real-time qPCR instrument Model specification: ultraSBMS24 IVD
Scope of application: Medical institutions, testing institutions, food companies, breeding
companies, schools and other research and teaching markets.
Intended use: This product is based on fluorescent polymerase chain reaction, which can
analyze nucleic acid samples (RNA/DNA) derived from the human body in medical and
clinical applications.
Transportation conditions and methods: The product should be placed upwards during
transportation to prevent heavy pressure, rain and direct sunlight, and the maximum
number of stacked layers cannot exceed 2 layers. Transport according to the storage
temperature in 3.2.
The real-time qPCR instrument is a detection instrument completely independently developed
by our company, which can complete the gene amplification of 24 holes and 4 channels.
Support online update of control software functions, support USB and WIFI control modes.
2.2 Structural features and module description
The equipment frame is shown in Figure 2.2.1:
Screen Hot cover
Tempreature
sensor 1
Heating module
Optical acquistion
Refrigeration
Power
Serial port
USB/WiFi
Computer
Human-
computer
inteaction
module
Main
control
module
Tempreature
sensor 2
Figure 2.2.1
Moduledescription:
Hot lid: Make sure the temperature above the test tube is higher than the temperature
of the test tube itself.

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Heating module: Control its temperature to raise and lower temperature.
Temperature sensor: Collect the temperature of the thermal lid or heating module to
control the output.
Refrigeration module: For air cooling, cooling the heating module. Optical acqui-
sition module: Data acquisition during PCR reaction. Light source: Fluorescence
excitation.
Main control module: Control all peripherals for temperature rise and fall, optical
acquisition, temperature acquisition, etc.; At the same time, it communicates with the
human-computer interaction module.
Human-computer interaction module: Control screen, communicate with main
control module and computer.
Computer: Communicate with human-computer interaction module via USB/WIFI.
2.3 Parameters and performance indicators
Parameters Performance indicators
size 235 * 212 *255mm
Maximum heating rate ≥5.0 °C/s
Maximum cooling rate ≥3.0 °C/s
Module temperature control accuracy ≤0.2 °C/s
Module temperature uniformity ±0.25 °C/s
Temperature control range 35 - 99°C
Detection throughput 24
CHAPTER 3.Instrument installation
3.1 Unpack the instrument
3.1.1 Unpack step
Unpack the instrument and remove the pearl cotton and other materials used for transpor-
tation. Save the packing box and packing materials so that you can repack the instrument
in the future. The specific steps are as follows:
(1) Remove the equipment
(2) Take out the accessories and check whether the items are complete according to the
accessories list. If there are any missing, please notify the service apartment or the
dealer immediately.

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Note: The product packing accessories are subject to the packing list. If
any parts are missing or the accessories do not match the packing list,
please contact the seller.
3.1. 2 Transport method
When the machine is moved out of the packing box, pay attention to keeping the machine stable.
Note: Please save the packing box for packing and transportation before long-distance
transportation. The instrument must be placed on a horizontal operating table, not on an
inclined surface.
The installation process of the instrument is handled by professionals authorized by our
company. To ensure the normal operation of the instrument, please choose an indoor
workplace that meets the following requirements to place the instrument:
■ The ground or table top is flat;
■ No direct sunlight;
■ No large amount of dust;
■ No strong electromagnetic radiation;
■ Easy to operate the location of the disconnect device;
■ Well-ventilated location;
■ Avoid humidity and high temperature. Avoid violent vibration and shock.
3.2 Installation and use environment
■ Normal working environment of the instrument is 15 °C ~ 30 °C , relative humidity
20~70% , no condensation.
■ The storage environment of the instrument is: the packaged UltraSBMS24 IVD in-
strument should be stored at -20°C ~ 55°C, relative humidity≤85%, no corrosive gas
and a well-ventilated environment.
■ After the instrument is installed, try to avoid frequent movement, and avoid vibration
if it needs to be moved.
■ Must be installed and moved by authorized professionals.
■ When installing, make sure that the distance between the side of the instrument and
other objects for quality inspection is not less than 20cm to facilitate ventilation and
heat dissipation.
3.3 Power requirements
■ Power supply voltage: 100V ~ 240V
■ Frequency: 50Hz / 60Hz
■ Power: 500 W

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CHAPTER 4.Instrument use
4.1 Boot
In order to use the real-time qPCR instrument safely, correctly and stably, you must
complete the boot process in the prescribed order:
(1) Install the antenna to the fixed position of the antenna behind the instrument;
(2) Plug in the power cord;
(3) Turn on the power switch on the back of the device.
4.2 Shutdown
(1) Turn off the power switch on the back of the device.
CHAPTER 5. Software installation
5.1 Windows desktop software installation
(1) Go to www.medsanbiotech.com à support Download the software and example files.
(2) A 64 -bit system is required to install the software.
(3) If you have any questions about the installation, please contact customer service staff
to consult the installation process.
CHAPTER 6. Software use
6.1 Use of stand-alone operating software
6.1.1 Main interface Profile
After entering the operating software, the software enters the opening animation, and then
the main interface is displayed as shown in Figure 6.1.1.1. At this time, the top cover of
the device is in a locked state, click the lock icon in the lower right corner to unlock and
lock the top cover:

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Figure 6.1.1.1
The interface function is divided into six operation units: [New Detect], [Login], [Setup],
[Load Template], [Records], [Lock Lid].
Click the label 1 in Figure 6.1.1.1 to edit the serial number of the device, as shown in Fi-
gure 6.1.1.2: The serial number can be used to identify your devices in case you operate
more devices. This serial number is not equal the device technical serial number.
Figure 6.1.1.2

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After entering the device number, click [Save] to edit the device number. The device serial
number is used to identify the corresponding device that needs to be connected when the
PC is connected.
Click the Bluetooth icon marked 2 in Figure 6.1.1.1 to connect to the Bluetooth printer,
and a list of Bluetooth devices will pop up in this interface, as shown in Figure 6.1.1.3:
Figure 6.1.1.3
Click the Bluetooth printer to be connected for pairing connection, as shown in Figure
6.1.1.3.1:
Figure 6.1.1.3.1

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After clicking [Ensure], the pairing code will pop up (according to the pairing code in
the manual of the paired Bluetooth printer, generally 0000 or 1234), as shown in Figure
6.1.1.3.2:
Figure 6.1.1.3.2
After the pairing and connection are completed, the connected state of the printer will be
displayed. After the binding, the operation does not need to be repeated next time when
restarting, as shown in Figure 6.1.1.3.3:
Figure 6.1.1.3.3

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Click the network icon labeled 3 in Figure 6.1.1.1, the wireless network list pops up in
this interface, as shown in Figure 6.1.1.4:
Figure 6.1.1.4
Select the network you want to connect to connect. After the network connection is suc-
cessful, click the red cross button to exit the interface.
Click the mark 4 in Figure 6.1.1.1 to perform the system time setting function. After the
time is selected, click the [Ensure] button to complete the system time setting, as shown
in Figure 6.1.1.5:
Figure 6.1.1.5

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6.1. 2 New Detect
After opening the lid of the instrument and putting in the reagents, click the main interface
function [New Detect] to enter the function interface of [Create Detect] setting, as shown in
Figure 6.1.2.1:
Figure 6.1.2.1
The user name in this operation interface is not editable. After logging in, the user name of
the account will be displayed. Enter the detect name and select the detect type.
There are two types of detect: QPCR and Standard. Select [QPCR] or [Standard], and click
[Next]. Enter the function interface of operating condition setting as shown in Figure 6.1.2.2
and Figure 6.1.2.3. Figure 6.1.2.2 is for the setting of QPCR operating conditions, and Figu-
re 6.1.2.3 is for the setting of Standard operating conditions:
Figure 6.1.2.2

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QPCR condition setting:
As shown in figure 6.1.2.2, in the condition input box, you can slide left and right to view
or edit the conditions, click the icon marked 1[+] in the figure to set the temperature
conditions, click the mark 2[-] in the figure to delete the selection To set the temperature
conditions, click the mark 3in the figure to enter the number of cycles that need to be run,
click mark 4in the figure to enter the temperature, click mark 5in the figure to enter the
time, click mark 6in the figure to choose whether to collect, click mark 7in the figure to
enter the reagent volume, click mark 8in the figure [Save template]. click mark 9to add
1-3 PCR cycles, click mark 10 to delete 1 PCR cycle.
Standard setting: as shown in Figure 6.1.2.3, enter the temperature and time to complete
the input of the conditions, click [Next] to enter the sample setting function, as shown in
Figure 6.1.2.4:
Figure 6.1.2.3