| Model |
Screen size (inch ) |
Puncture |
Storage |
Graphical Touch Screen |
Power |
| HP-HEMA6000A |
10.4 |
None |
20K |
NO |
50Hz±3Hz |
| Specifications |
| Test Items |
WBC, LY#, MO#, GR#, LY%, MO%, GR%, HGB, RBC, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, PCT, MPV, PDW, WBC Histogram, RBC Histogram, PLT Histogram |
| Background Count |
WBC: ≤0.3×109/L RBC: ≤0.03×1012/L HGB: ≤1g/L PLT: ≤10×109/L |
| Linearity |
Test Item |
Test Range |
Allow Difference of Linearity |
| WBC |
0~6.0×109/L |
±0.3×109/L |
| 6.0~99.9×109/L |
±5% |
| RBC |
0~0.99×1012/L |
±0.05×1012/ L |
| 1.0~9.99×1012/L |
±5% |
| HGB |
0~99 g/L |
±2g/L |
| 100~300 g/L |
±2% |
| PLT |
0~99×109/L |
±10×109/L |
| 100~999×109/L |
±10% |
| Repeatability |
Test Item |
CV(%) |
Teat Range |
| WBC |
≤2.0 |
7.0~15.0×109/L |
| RBC |
≤0.5 |
3.5~6.0×1012/L |
| HGB |
≤1.5 |
110~180g/L |
| PLT |
≤4.0 |
150~500×109/L |
| MCV |
≤0.5 |
80~110fL |
| Sample Volume |
Twig blood: 20μl |
| Dilution Ratio |
WBC/HGB: 1:500 RBC/PLT: 1:50000 |
| Interfaces |
RS232 joint, USB, PS2, Parallel port |
| Test Speed |
60 samples/hours |
| Continuous Work Time |
>8h |
Quality and Standard Production Process:
IName and the using range
The name of the machine is HP-HEMA6100 Automatic Hematology Analyzer,which mainly used to detect the parameters of the series of red blood cells and hemoglobin, platelet and leukocyte in the blood,It is a vitro diagnostic equipment which is applied to quantitative analysis of blood cells of clinical and laboratory.
The machine is mainly used for the quantitative measurement of the blood in the 19 parameters and 3 histograms:
| Haematology Analyzer |
| Fully automated to increase productivity |
| 3-part differential cell counter with 22 parameter and laser light source |
| Direct tube sampling from original collection vials for operator safety |
| Bar code capability to reduce manual input |
| Proven technology to provide accurate results |
| More than 60 samples per hour |
| Minimum maintenance required |
1 The total amount of WBC WBC
2 The amount of Lymphocyte Ly#
3 The amount of Monocyte MO#
4 The amount of Granulocyte GR#
5 Lymphocyte percentage Ly%
6 The percentage of mononuclear cells MO%
7 Granulocyte percentage GR%
8 The total amount of red blood cells RBC
9 Hemoglobin HGB
10 Hematocrit HCT
11 Mean volume of red blood cells MCV
12 Mean corpuscular hemoglobin MCH
13 Mean corpuscular hemoglobin concentration MCHC
14 Red blood cell volume distribution width Coefficient of variation RDW-cv
15 The standard deviation of red blood cell volume distribution width RDW-sd
16 The total amount of platelet PLT
17 Mean platelet volume MPV
18 Plateletcrit PCT
19 Platelet distribution width PDW
20 White blood cell distribution histogram WBC Histogram
21 Red blood cell distribution histogram RBC Histogram
22 Platelet distribution histogram PLT Histogram
II Product classification
Instrument classification standard description:
According to Chinese medical device management:
It belongs to the blood analysis systems of the clinical tests and analysis equipment (6840), Management Category is class II.Classified by electric shock protection: Transient overvoltage category II, the level of rated pollution is level 2.
Classified by working system: continuous operation equipment.
Equipment structural classification:
| Model |
Structure and Function |
| HP-HEMA6100 |
10.4-inch 640 × 480-TFT color LCD display, panel-type thermal printer, mask button, built-in common sampling and diluting (store 20000 data) |
| XFA6100 |
8-inch 800 × 600-TFT color LCD display, panel-type thermal printer, mask button, built-in common sampling and diluting (storage 10,000 data) |
III Parameters:
- 1.Use impedance method for RBC and platelet count
- 2. Cyanide free for Haemoglobin test
- 3. Flow cytometry +laser light scatter + chemical dye method for WBC differential analysis
- 4.Fully automated with an autoloader and sampler
- 5. Should use both closed tube sampling and open tube sampling
- 6. 2 counting mode, whole blood and pre-diluted mode
- 7. With histograms and scattergrams for differential results
-8. Throughput of at least 60 samples per hour
-9. Automatic flagging system for abnormal results and automatic sample re-run
-10. Automatic validation of results on a dedicated PC with at least a 10.4" colour monitor
- 11.Data storage capacity of at least 20,000 results
- 12.Optional integrated slide maker and on-board cytology atlas
- 13.Optional colour printer an on-board diagnostics
- 14.Flexible communication/connection (USB)
- 15.Operating temperature of 10 oc -35oc and humidity of up to 85%
-16. Floppy disc drive and DVD writer
-17. Power 98V-264V
-18. The equipment should be accompanied with all manufacturers' recommended spare parts
IV Principle of cell counts
The instrument measured blood can be diluted to the exact proportion by the diluent firstly, which is used to measure the parameters of WBC,RBC,PLT and HGB.WBC, RBC count pool diluted samples pass their own porous counting respectively under negative pressure, the amount of fluid that flowing through the small hole is the specimen volume of the instrument for analysis.
The instrument measured the size distribution and number of WBC, RBC and PLT by using impedance method. Electrodes inserted in the holes on both sides of the liquid, it sets up a field environment on both sides of the surrounding count microporous, according to the blood-cell non-conductive nature, when the cells passed the count microporous, it will cause impedance changes, the size of the impedance changes and proportional to the cell volume.
| Consumables usage of HP-HEMA6100 Auto Hematology Analyzer |
| Item |
Sequence |
Dilution(ml) |
Hemolysin(ml) |
Cleaning Solution (ml) |
Frequency of use |
| 1 |
Start up cleaning |
70 |
5 |
None |
More than one time per day |
| 2 |
Once Measuring |
30 |
1 |
None |
The amount of a specimen |
| 3 |
Auto Cleaning |
80 |
5 |
15 |
Cleaning one time per default 20 samples |
| 4 |
Power Off Cleaning |
80 |
5 |
15 |
More than one time per day |
| 5 |
Eliminate jam / Cleaning |
20 |
None |
None |
Generally do not use,only Eliminate jam use |
| 6 |
Replacement or Perfusion |
12 |
4 |
None |
Generally do not use,only use when replace the reagents |
| 7 |
Probe cleaning solution used once every 100 times, once consumed 1.1ml |
Regular use ,recommend 100 samples per time |
|
| Use Cost of HP-HEMA6100 Auto Hematology Analyzer |
| Consumes |
Specification |
Unit Price/EXW( USD) |
Number of users(20 per day) |
Number of users(100 per day) |
| Hemolysin |
500ml/box,2 bottles |
84.43 |
280 |
430
|
| Dilution |
20L/bucket |
12.66 |
480 |
620 |
| HB dense enzymatic cleaning solution |
1L/bucket |
15.48 |
660 |
1100 |
| Probe Cleaning Solution |
50ml/bottle |
7.04 |
1800 |
1800
|
| Printing Paper |
1roll |
1.41 |
60 |
60 |
| Takeblood Consumables |
1 set |
0.04 |
1 |
1 |
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| Free Reagent Supplied For HP-HEMA6100 |
| Number |
Name |
Specification |
Quantity |
| 01 |
Non-cyanogen Hemolysin |
500ml/bottle |
1 |
| 02 |
Diluent |
20L/barrel |
1 |
| 03 |
Washing Solution (contain Enzyme) |
1L/barrel |
1 |
| 04 |
Probe Cleaning Solution |
50ml/bottle |
1 |
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