1. 2017/10/26
NEPHSTAR®
Service Manual
Goldsite Diagnostics Inc.

2. Outline Brief Introduction of Nephstar Cautions of Nephstar
Trouble Shooting

3. Brief Introduction of Nephstar
Description
Test Principle
Features
Assays available

4. Description
Nephstar is a bench top nephelometric analyzer for rapid quantitative measurement of specific proteins in body fluids. It’s an ideal instrument in medium or small laboratories and it can also be used as a STAT or backup analyzer

5. Test Principle Fixed time nephelometry is used.
Nephstar uses a diode laser that emits at 670nm as the light source. When light passes through the mixture in cuvette, a portion of the light is scattered by the antibody-antigen complexes formed and is detected by a photodiode. The amount of light scattered is directly proportional to the analyte( a certain specific protein acting as an antigen or antibody) concentration in the test sample.

6. Features 30 assays covering many clinical fields
New assays in development such as D-dimer
Correlate well to Dade Behring
Latex enhanced immunoassay increases sensitivity
Optimized reaction conditions make antigen excess almost impossible

7. Features (cont’d) Uniform procedure Easy dilution schemes (1/11, 1/40)
Point of Care Testing (POCT)
Results available within 15 to 120 seconds
Broad linear ranges
Rapid, accurate, easy

8. Available Assays
IgA, IgG, IgM, ASO, RF, C1 Inactivator, k Light Chain ,λ Light Chain C3 C4
Albumin, Prealbumin, Apo A1, Apo B, Antithrombin III
CRP Ultra Sensitive CRP,Transferrin, Haptoglobin, Ceruloplasmin,α1 Antitrypsin, A1 Acid Glycoprotein
Urine Microalbumin, Cystatin C,α2 Macroglobulin β2 microglobulin
HbA1C

9. 2017/10/26
Caution of Nephstar

10. Caution of Nephstar Instrument Buffer, reagent, control, sample etc.
Sample/reagent addition

11. Cautions of instrument
The Nephstar has been designed for use in a laboratory temperature range of 15-30℃. Accuracy of results cannot be guaranteed when used out of this range.
The electrical circuitry of this equipment is designed to be safe under the following environmental conditions:
Indoor use
Altitude up to 4000m
Temperature range: 5-40℃
Max. Relative humidity 80%(at 31℃) or 50% (at 31-40℃)

12. Cautions of instrument (cont’d)
Avoid spilling liquids over the case or into Nephstar through the reaction chamber or other inlets.
Power supply voltage range is 220+/-10%
Only Nephstar cuvettes can be used when conducting assays and the cuvettes are for single use only. Reuse may lead to false results.

13. Cautions of instrument (cont’d)
Place the Nephstar on a solid, clean, dry surface avoiding direct sunlight, fluid spillage, dust contamination and heat sources.
Do not start to test until Nephstar is turned on and preheated for at least 20 minutes
Cover the chamber lid well when Nephstar is not in use.

14. Cautions of instrument (cont’d)
Make sure the card completely touching the bottom of the slot with constant speed when swiping the magntic card.
Maintenance of instrument: clean the cuvette chamber with alcohol swab once a month to keep it clean.

15. Cautions of buffer and sample diluent
Buffer and sample diluent are required to be equilibrated to room temperature before use, which would need more than 30 minutes if taking out from the refrigerator. Therefore, the buffer and diluent are recommended to be stored in room temperature at ℃.
Once opened, screw the cap tightly. The buffer and diluent are stable for 3 months.

16. Cautions of control and reagent
Control and reagents are required to be stored in 2-8 ℃, which can be used directly after taking out from the refrigerator, NO need to be equilibrated to room temperature. ( ***do not freeze***)
Once opened, store the antiserum and control at 2-8℃ and be sure to screw the cap tightly. Under these conditions, antisereum and control are stable for 1 month.

17. Cautions of sample Do not test the diluted sample overnight.
Make sure what kind of sample is used ( serum, whole blood or urine), choose the correct test mode.

18. Cautions of Sample (cont’d)
Highly lipemic, turbid and haemolysed samples are not suitable for nephelometric assays and should not be used unless centrifuged or prepared using other methods. If the background is too turbid and can not be removed, please think of other measuring method

19. Cautions of Sample (cont’d)
The pipette used for sample dilution must be standard and calibrated, otherwise, it will affect the accuracy of the result

20. Caution of Sample (cont’d)
Testing of samples containing rheumatoid factors, paraproteins or circulating immunocomplexes can result in misleading values due to non-specific scattering light possibly generated by these articles

21. Cautions for Sample Addition
2017/10/26
Cautions for Sample Addition

22. Sample addition Cuvette can not be recycling used
Do not hold or contaminate the clear sides of the cuvette
Sample addition requirement：Sample must be added to the bottom of the cuvette, be cautious not to add reagent to the sides of the cuvette; lots of air bubble can not be caused during the addition; otherwise the instrument will be in measuring procedure in advance.

23. Sample addition (Cont’d)
Every item has a default sample dilution scheme. Press number keys to enter the dilution number if not using the default value.)

24. Cautions for Reagent Addition

25. Reagent addition Electronic pipette tip can not be used recycling.
The tip should be attached firmly to the electronic pipette, otherwise it would cause reagent leakage and even contamination.

26. Reagent addition(cont’d)
The stirring bar fails to mix when reagent added, there are three possibilities:
- The speed set-up of electronic pipette is not correct.
- The power is not enough when dispensing the reagent into the cuvette
- Instrument problem.
The electronic tip can be immersed under the reagent level of the cuvette, but can not touch clear sides of the cuvette

27. Trouble Shooting

28. Trouble Shooting： Display “invalid card”:
①swipe the card incorrectly (swipe card again)
check the direction- the magnetic side facing the user,speed can not be too fast or too slow;
②Calibration card is for a different assay to that selected Check chemistry number labeled on the card and swipe the card that matches the selected assay

29. Trouble Shooting：
Display “wrong card”:
①the card is wrong or damaged (change the card)
②there is dust or water on card surface;
③the speed of swiping card is too fast or too slow;
④swipe the card on the wrong side, the magnetic side facing the user.

30. Trouble Shooting：
Display “reagent expired’：
① Check the date set-up is correct or not;
② use reagent before expiry date

31. The control result is out of the range
Does the reagent lot number is correct ？
Are the cuvette and the tip used recycling？
Does the temperature meets the requirement？（working condition and storage condition）
Does the dilution and sample addition method is correct？
Does the operation method is correct？（dilution scheme, sample amount and so on）
Is the reagent contaminated（ Try another new kit control）
Does the instrument has trouble（It can be known through testing controls of other reagent kits.)

32. Blank Display
Check the power, make sure the instrument is connected to the power and switch ON.
Fuse blown, change a new one.( pls note NO fuse anymore for instruments manufacturered since 2010)
Other malfunction, send back to the manufacturer for repair.

33. ‘Please add the reagent’ does not display after placing the cuvette into chamber
The cuvette is not completely placed into the chamber
Check whether there is some foreign particles in the microswitch, clean it with soft cloth with water or alcohol
Other malfunctions, pls send back to the manufacturer for repair

34. ‘Start to read blank before reagent added
Some liquid on the side wall of cuvette (take out the cuvette and replace it)
Too much bubbles produced when adding reagents
Check if any foreign particles blocked the micro-switch

35. Can’t swipe card Check if any foreign particles blocked in the slot
Check if any dust in the slot, clean the slot with the card wrapped with dust cloth
Switch off Nephstar and swipe the card again
Possibly caused by other problems, send back to the manufacturer for repair.

36. Display < xxx
Test result is lower than test range. If exact result required, please repeat the assay using less dilution, make sure the dilution set in the instrument has been changed as well.
If the result is from a patient in bad condition, it maybe antigen excess. Repeat the assay using higher dilution
If it happens to all samples and controls, it may be lead by laser fading or blocked by something else. Pls send back to manufacturer for repair.

37. Display > xxx
Test result is higher than test range. If exact result required, please repeat the assay using higher dilution, make sure the dilution set in the instrument has been changed as well.
Software problem

38. Fail to print Change a new roll of paper. Restart Nephstar
Thermal paper are wrong sided.
No paper
Paper jammed
Printer lid is not closed properly.
Restart Nephstar and test the printing again
Printer is damaged, send back to manufacturer for repair

39. No response after adding the reagent (stirring bar doesn’t work)
Cuvette is not completely placed into the chamber and ’ add the reagent’ is not displayed
Place a cuvette with highly turbid solution, to check whether laser can be seen or not. If not, the laser device may be damaged.
Change the mode to UPC mode. Test several clean empty cuvettes under UPC mode. If the scattered value is ZERO or lower than 15, it probably means laser fading or laser damaged. Pls send back to manufacturer for repair.

40. Display ‘Blank too high’ - 1
Sample is too turbid, check if any hyperlipemia, chyle, icterus, hemolysis and RF in the samples, which may need further centrifugation.
The reagent is contaminated, change a new kit and repeat the assay
Wrongly use sample diluent as sample treatment solution when doing whole blood CRP.

41. Display ‘Blank too high’ - 2
If blank too high happens to all samples and controls, possibly it’s caused by instruments.
- check whether the chamber is clean or not. If not, will lead to blank too high
- Under UPC mode, repeat testing several clean, empty cuvettes. If the scattered value is higher than 100 each time, it’s possibly caused by laser loosening.

42. Thank You If you have any question please write emails to export@goldsite.com