Hunan Lituo Biotechnology Co., Ltd.
Technical Specification
Product Name Feces Analysis & Processing System
Model LTS-E100
Hunan Lituo Biotechnology Co., Ltd.
Address: No.129, Weiluoke Road, Wangcheng Economic Development Zone,
Changsha, Hunan, China
Tel: 0086 0756 8639 521 Fax:0086 0756 8639 055
CMC Medical Devices & Drugs S.L
C/Horacio Lengo Nº 18, CP 29006, Málaga-Spain
Hunan Lituo Biotechnology Co., Ltd.
[Link] Information
1.1 Product Name：Feces Analysis & Processing System
1.2 Model：LTS-E100
LTS---Company Code
E100---Product Code
1.3 Composition
The instrument consists of an instrument, a sample tray, a sample holder, an aspiration device, an
experimental tray (30 wells), a sample filling device, a stirring device, a microscope device (1 x
10X low magnification and 1 x 40X high magnification), a cleaning device, a filming device, an
automatic pushing and unloading of the discarded cardboard device
[Link] Specification
2.1 Appearance
a) The appearance should be square, clean and evenly colored, without obvious scratches, cracks,
sharp edges or burrs.
b) Text and symbols should be clear, accurate and firm
c) Fasteners should be firmly connected, reliable and free from looseness.
d) The running parts should run smoothly, no jamming or jumping phenomenon should occur.
2.2 Function
a) Automatic check at power-on
After starting up, the analysis system should complete the self-test within 90s
b) Automatic sample transfer function
After the sample bottle is placed on the sample rack and starts to run, the analysis system should
automatically send the sample to the inspection position and be sensed.
c) Dilute and stir function
The amount of diluent added and stirring time can be manually set, and automatic dilution and
stirring can be completed to make the sample fully mixed.
d) sample filtration and enrichment function
During the stirring and mixing process of the sample bottle, the formed element can be filtered and
enriched to the sampling area through the filter device
e) Automatic sampling detection function
The system can automatically draw and filter the enriched sample, add it to a disposable glass slide
for smear operation, and load a chemical detection card for detection.
f) Auto Cleanup
After the analysis system completes the sample analysis and processing, it should be able to
automatically discard the chemical detection card and glass slides, and automatically clean the
pipeline.
g) Sample redo function
The same sample of the analysis system can be redone 5 times at most, and the test results should
be kept separately.
h) Emergency insert function
The system shall be capable of inserting up to 5 samples for emergency testing at any one time
Hunan Lituo Biotechnology Co., Ltd.
during the testing process.
i) Microscope autofocus screening function
The system should be able to automatically focus and take pictures of the slide pictures, and can
automatically filter out clear pictures with formed element.
j) Comprehensive Reporting Function
The system can combine the results of physical testing, microscopic testing, chemical index testing
and morphological pictures to form an inspection report with both pictures and texts.
k) Alarm prompt
The analysis system has a fault alarm prompt
l) Data storage function
The system can record the detection data in the memory for future reference
m) information transmission function
The analysis system can share and transmit the detection information
2.3 Main performance
2.3.1 Test item
a) Physical testing
The system can take pictures of the properties of feces samples for users to interpret, and can input
the sample color, soft and hard properties interpretation results on the software operation interface.
b) Microscopic inspection
The analysis and processing system should be able to automatically smear stool samples, and
automatically detect them under low-power mirrors (10X) and high-power mirrors (40X), and
provide at least one low-power mirror and one high-power mirror clear photo for users to effectively
formed element interpretation, and the results of formed element such as red blood cells and white
blood cells can be input on the software operation interface.
c) Diagnostic component immunoassay
According to different sample testing requirements, the system should be able to detect fecal occult
blood, rotavirus, adenovirus and Helicobacter pylori on feces samples, take pictures of the test
results and automatically analyze the results, upload and save them.
2.3.2 Maximum number of analyzed samples
According to the limitation of the sample rack placement area, the maximum number of samples
analyzed by the analysis and processing system at one time should be 40
2.3.3 Analysis speed
The sample analysis speed of the system should not be lower than 30 samples/hour
2.3.4 Accuracy of adding diluent
The automatic addition amount of the system is optional in the range of 3.5ml~8.0ml (0.5ml
adjustment range), and the error between the actual addition amount and the set value should be less
than 15%.
2.3.5 Accuracy of detection and interpretation of chemical indicators
The system should automatically detect the chemical indicators of the sample, and automatically
interpret the test results, and the consistency with the manual interpretation results should not be
less than 95%.
2.3.6 Cross Contamination Control
Sample carryover rate ≤2%
2.4 Safety
Hunan Lituo Biotechnology Co., Ltd.
Meet the requirement of IEC 61010-1:2010+A1:2016，IEC61010-2-101:2015
2.5 EMC
Meet the requirement of IEC 61326-1:2012，IEC61326-2-6:2012.
3. Test method
3.1 Working experiment
-- Temperature：15℃~30℃
-- Relative humidity：40%~85%
-- Free of conductive dust, explosive and corrosive gases, and vibration sources.
3.2 Appearance
Visual observation and hand feeling inspection are carried out, and the results should meet the
requirements specified in 2.1.
3.3 Function
According to the actual operation of the instruction manual, it should meet the requirements
specified in 2.2.
3.4 Main performance
3.4.1 Test items
a) Physical testing
Operate the system according to the instruction for use, test 10 stool samples, and the results should
meet the requirements of 2.3.1a)
b) Microscope inspection
Operate the system according to the instruction, select the slide item, and test 10 feces samples, and
the results should meet the requirements of 2.3.1 b).
c) Diagnostic component immunoassay
Operate the system according to the instruction, select the occult blood item, and test 10 feces
samples, and the results should meet the requirements of 2.3.1 c).
3.4.2 Maximum number of analyzed samples
Put four sample racks and 40 feces sample bottles into the position of the instrument sample to be
tested, and use software to send 40 sample test commands, and the results should meet the
requirements specified in 2.3.2
3.4.3 Analysis speed
Operate the analysis system according to the instruction manual, select slides and occult blood
indicators, select one low-power lens and one high-power lens for pictures, and run the test
continuously for 1 hour. The results should meet the requirements of 2.3.3.
3.4.4 Accuracy of adding diluent
Operate the system according to the instruction, set to add 3.5ml, 6.5ml, and 8.0ml purified water
20 times each, and measure the actual addition amount with the analytical balance. The actual
addition amount each time is equal to the mass divided by the pure water density at the current
temperature (Check the pure water density table, see Appendix C), and calculate the sampling error
at each setting value according to the following formula, and the result should meet the requirements
of 2.3.4.
V1−V2
Sampling error= V2
× 100%
Hunan Lituo Biotechnology Co., Ltd.
V1--- The average value of the actual amount added
V2--- The value of amount set
3.4.5 Accuracy of test card interpretation
Operate the analysis system according to the instruction, select the occult blood index, and actually
run 20 samples (including 10 positive samples and 10 negative samples), the instrument analyzes
and processes samples according to the software setting requirements with occult blood detection
reagents which has been approved by the Food and Drug Administration Registered, and at the same
time, manual interpretation of the picture results and calculation of the coincidence rate shall meet
the requirements of 2.3.5.
3.4.6 Cross Contamination
According to the instructions, 10 samples were actually cross-run (5 of which were occult blood
positive samples and 5 were occult blood negative samples), positive samples are run for odd times
and negative samples are run for even times, and the occult blood detection reagents that have been
approved and registered by the Food and Drug Administration are used for testing. Each result
should meet the requirements of 2.3.5
Note: The positive samples described in 3.4.5 and 3.4.6 are negative occult blood feces samples
with 2% concentration of human whole blood, that is, 0.16ml of human whole blood is added to
8.0ml of stool samples.
3.5 Safety
Test according to IEC 61010-1:2010+A1:2016，IEC61010-2-101:2015， and it should meet the
requirements of the corresponding clauses.
3.6 EMC
Test according to IEC 61326-1:2012，IEC61326-2-6:2012，and it should meet the requirements of
the corresponding clauses.
