3.7 HDSD Neo Chem 40

Neo Chem 40
Automatic Chemistry Analyzer
Operating Manual
Operating Manual Neo Chem 40
Catalogue
COPYRIGHT AND DECLARATION .......................................................................................... 1
PREFACE ................................................................................................................................... 3
CHAPTER 1 SAFETY GUIDELINES......................................................................................... 4
1.1 Safety Cautions ................................................................................................................ 4
1.2 Using Precaution .............................................................................................................. 6
1.3 Installation ....................................................................................................................... 10
1.3.1 Instrument Inspection ............................................................................................... 10
1.3.2 Installation Requirement .......................................................................................... 10
1.3.3 Location Requirements ............................................................................................. 11
1.3.4 Power Requirements ................................................................................................ 11
1.3.5 Instrument Connection ............................................................................................. 12
CHAPTER 2 INSTRUMENT INTRODUCTION ....................................................................... 14
2.1 Brief Introduction............................................................................................................. 14
2.2 Intended Use .................................................................................................................. 15
2.3 Main Structure ................................................................................................................ 15
2.3.1 Performance and Composition ................................................................................ 15
2.3.2 Top View ................................................................................................................... 16
2.3.3 Rear View ................................................................................................................. 16
2.3.4 Function of Main Part ............................................................................................... 17
2.4 Function and Specification ............................................................................................. 17
2.5 Technical Parameter ....................................................................................................... 19
CHAPTER 3 MEASURING PRINCIPLE.................................................................................. 21
3.1 Principle .......................................................................................................................... 21
3.2 Test Methods................................................................................................................... 21
3.2.1 Endpoint method ...................................................................................................... 21
3.2.2 Two-point Method..................................................................................................... 22
3.2.3 Rate Method (Kinetic Method) ................................................................................. 23
CHAPTER 4 OPERATION ....................................................................................................... 24
4.1 Operating Step................................................................................................................ 24
I
4.1.1 Operating Step ......................................................................................................... 25
4.1.2 Start up ..................................................................................................................... 25
4.1.3 Create Standard Curve ............................................................................................ 26
4.1.4 QC Test .................................................................................................................... 26
4.1.5 Test Patient’s Sample............................................................................................... 26
4.1.6 Finish ........................................................................................................................ 27
4.2 Basic Operation .............................................................................................................. 27
4.2.1 Check Before Powering On ..................................................................................... 27
4.2.2 Power On ................................................................................................................. 27
4.2.3 Starting the Operating Software .............................................................................. 28
4.2.4 Preparation of Reagent ............................................................................................ 28
4.2.5 Preparation of Sample, Standard Solution and Detergent ...................................... 29
4.2.6 Registration of Standard and QC ............................................................................. 30
4.2.8 Analyses ................................................................................................................... 31
4.2.9 STAT Analyses ......................................................................................................... 31
4.2.10 End of Analyses ..................................................................................................... 31
4.3 Obtain Result .................................................................................................................. 32
4.3.1 Registration of Sample Information ......................................................................... 32
4.3.2 Modification of Test Result ....................................................................................... 32
4.4 Query of Analytical Result .............................................................................................. 32
4.5 Analytical Curve Display ................................................................................................. 33
4.6 Database Maintenance ................................................................................................... 33
4.6.1 Database Backup ..................................................................................................... 33
4.6.2 Database Reduction ................................................................................................ 33
4.6.3 Automatic Backup .................................................................................................... 33
CHAPTER 5 OPERATION ....................................................................................................... 34
5.1 System Menu .................................................................................................................. 34
5.2.1 Sample ..................................................................................................................... 34
5.2.2 Standard ................................................................................................................... 36
5.2.3 QC ............................................................................................................................ 37
5.3 STAT Analyses ................................................................................................................ 37
II
5.4 Data ................................................................................................................................ 37
5.4.1 Sample Registration ................................................................................................. 37
5.4.2 Result Review .......................................................................................................... 38
5.5 Reagent .......................................................................................................................... 39
5.5.1 Normal Item .............................................................................................................. 39
5.5.2 Manual Item ............................................................................................................. 43
5.5.3 Calculate Item .......................................................................................................... 43
5.5.4 Combinate Item ........................................................................................................ 44
5.6 Standard ......................................................................................................................... 45
5.7 QC ................................................................................................................................... 45
5.7.1 QC Setup.................................................................................................................. 46
5.7.2 QC Data ................................................................................................................... 46
5.8 Maintenance ................................................................................................................... 47
5.9 System Parameter .......................................................................................................... 47
5.9.1 System Parameter ................................................................................................... 48
5.9.2 User Setup ............................................................................................................... 48
5.9.3 Operator Setup......................................................................................................... 48
5.9.4 Dictionary ................................................................................................................. 48
5.9.5 Print Setup ............................................................................................................... 48
5.9.6 Bar Code Setup........................................................................................................ 48
5.9.7 ISE Setup ................................................................................................................. 48
5.9.8 LIS Setup.................................................................................................................. 48
CHAPTER 6 QUALITY CONTROL ANALYSES AND CALIBRATION .................................. 49
6.1 General Information ........................................................................................................ 49
6.2 Quality Control ................................................................................................................ 49
6.2.1 Type of Quality Control Materials ............................................................................. 49
6.2.2 Use and Storage ...................................................................................................... 49
6.2.3 Setup of Target Value, SD and Control Limit ........................................................... 50
6.2.4 QC Procedures ........................................................................................................ 50
6.3 Quality Control Method ................................................................................................... 50
6.3.1 Levey-Jennings Method ........................................................................................... 50
III
6.3.2 Westgard QC Rule ................................................................................................... 50
6.3.3 Reasons of Random Error ....................................................................................... 53
6.3.4 Reason of Systematic Error ..................................................................................... 54
6.4 How to Deal With Out-of-Control .................................................................................... 54
6.5 Calibration and Procedures ............................................................................................ 55
6.5.1 When to calibrate ..................................................................................................... 55
6.5.2 Calibrate Procedures ............................................................................................... 55
CHAPTER 7 MAINTENANCE ................................................................................................. 56
7.1 Reset ............................................................................................................................... 56
7.2 Probe and Stirrer Rinse .................................................................................................. 56
7.3 Cuvette Rinse ................................................................................................................. 57
7.4 Cuvette Signal ................................................................................................................ 58
7.5 Reading of A/D Value...................................................................................................... 59
7.6 ISE Maintenance ............................................................................................................ 59
7.6.1 ISE Calibration ......................................................................................................... 60
7.6.2 Wash ........................................................................................................................ 61
7.6.3 Pump Calibration...................................................................................................... 61
7.6.4 Bubble Calibration .................................................................................................... 61
7.6.5 Maintenance............................................................................................................. 61
7.7 Maintenance of Barcode Scanner .................................................................................. 62
7.8 Daily Maintenance .......................................................................................................... 62
7.9 Weekly Maintenance ...................................................................................................... 62
7.10 Monthly Maintenance ................................................................................................... 64
7.11 Longtime Disuse Maintenance ..................................................................................... 64
7.12 Preventive Maintenance ............................................................................................... 64
7.13 Replace Component ..................................................................................................... 64
7.13.1 Replace Lamp ........................................................................................................ 64
7.13.2 Replace Tube ......................................................................................................... 65
7.13.3 Replace Cuvette..................................................................................................... 65
7.13.4 Replace Vacuum Pump ......................................................................................... 65
7.13.5 Replace Solenoid Valve ......................................................................................... 65
IV
7.13.6 Replace Aspirating Probes..................................................................................... 65
CHAPTER 8 TROUBLESHOOTING ....................................................................................... 66
8.1 Troubleshooting Guide ................................................................................................... 66
8.2 Obtaining Technical Help ................................................................................................ 67
8.3 Troubleshooting Method ................................................................................................. 67
CHAPTER 9 STORAGE AND TRANSPORTATION ............................................................... 71
9.1 Storage ........................................................................................................................... 71
9.2 Transportation ................................................................................................................. 71
APPENDIX A REPLACEABLE COMPONENT ....................................................................... 72
V
Copyright and Declaration

Copyright: NeoMedica
Thank you very much for your purchase of the NeoMedica - Neo Chem 30 Automatic
Chemistry Analyzer.
All contents of this manual are complied with the related laws and regulations, as well as
the specific conditions of the NeoMedica-Neo Chem 30 Automatic Chemistry Analyzer. All
the updated information is included in this manual before printing. NeoMedica is fully
responsible for the revision and explanation of this manual, and reserves the right to
renovate the relevant contents without separate notice. Some of the schematic pictures in
this manual are for reference, if there is any difference, please according to the real object.
All the information of this manual is protected by the Copyright Law. No part of this manual
may be reproduced, stored or transmitted in any form, or by any means without the
express written permission of NeoMedica.
All instructions must be followed strictly during operation. In no event should NeoMedica
be responsible for failures, errors and other liabilities resulting from user's noncompliance
with the procedures and precautions described in this manual.
Guarantee of limited quality liability: The Operating Manual of NeoMedica - Neo Chem 30
Automatic Chemistry Analyzer has been clearly shown the guarantee of quality liability
between NeoMedica and users, rights and duties in the after sale service and starting and
ending of the agreement.
If a malfunction occurred under normal use because of the material and workmanship,
NeoMedica will provide one year’s warranty service from the date of installation to this
instrument which sold by NeoMedica and agents. The using period of this instrument is 10
years.
Once the following situations occurred, NeoMedica assumes no liability to the safety,
reliability and operation condition of the instrument, and all agreed right of free service is
deem to be waived permanently and unconditionally.
 Instrument under improper use or not by maintenance or has been damaged.
 Using the reagents and accessories not supplied or approval by NeoMedica.
 Instrument damage caused by false operation or negligence because of user or
others operates the instrument not comply with this manual.
 Replace accessories not specified by NeoMedica, maintaining, repairing by a
personnel who does not authorized by NeoMedica.
 Components are discounted, drawing and readjusted not approved by NeoMedica.
All of the information contained in this manual is subject to change without relevant notice.
Manufacturer’s responsibility:
NeoMedica is responsible for the safety and performances of this analyzer under following
conditions:
 Using of the device according to the manual
 Assembly, upgrade, resetting and service are possible and performed by the
authorized NeoMedica d.o.o. staff.
 Instrument storage and workplace conditions as well as electrical requirements
1
comply with the conditions stated in the manual.

 Serial numbers and signs on the product are used to verify the identity of the
product, manufactured by NeoMedica d.o.o.
 Defects not caused by improper use or due to accidental fall.
Free service applies to all products within the warranty period. For those without warranty,
NeoMedica will charge the service. The buyer will be charged with all of the transport and
customs’ costs for all products returned to NeoMedica for service.
Returning procedure
If the instrument needs to be returned to the manufacturer, follow these instructions:
1. In order to return the instrument a license from NeoMedica’s service department
needs to be granted. Inform NeoMedica of the serial number and mark this number
on the carton box. If the instrument’s serial number cannot be recognized, the
returning of the instrument will not be allowed. Briefly describe the cause for
returning the goods.
2. Transport costs: the buyer is responsible for transport costs in the process of
returning of the instrument (including the customs).
NOTE
NeoMedica makes no warranties, either express or implied, as to product

quality, performance, and value as a commodity or applicability for any
particular purpose.
NeoMedica
Tel : 00381 (0) 18 573 820
Fax: 00381 (0) 18 573 616
Web: www.NeoMedica.com
E-mail: info@neomedica.rs
Supplied by:
NeoMedica
Version: 06/2016
2
PREFACE
This document is the operating manual for NEOMEDICA Automatic Chemistry Analyzer. It
describes the structure, operation, maintenance and troubleshooting concerning the
instrument in details. Users should read carefully the manual and get special training
before operating to guarantee instrument precision, normal operation and personal safety.
Safety Symbol
Following are the safety symbols which used together with character in the manual.
Marking Meaning
Operator should operate under the manual otherwise serious injury
Warning maybe caused or even lost life. Serious injury involving go blind,
trauma, burn (excess temperature), electric shock, cataclasis,
toxication and other sequela.
System damage or incorrect result may cause if not comply with the
Caution
manual to operate.
Following the manual to avoid personal injury, physics damage and a
series of adverse impact on test results. Also point out source of
Note
infection. Personal injury involving mild burns, electric shock or drug
allergy. Physical damage involves damage to building, animal and pet.
Biohazard means the biological factor may be caused hazard to the
Biohazard
environment and organism.
Sign Illustration
Meaning of the signs used in Automatic Chemistry Analyzer is as following.
Caution. Refer to the
Caution. Electric shock
accompanying document
Caution. Hot surface Biohazard
Protective earthing Power on
In vitro diagnostic
Power off
medical device
Environmental protection Keep away from heat
lifetime and radioactive source
Serial number Manufacturer
May cause personal

Recovery
injury
Refer to the operating manual EC Representative
3
CHAPTER 1 SAFETY GUIDELINES
1.1 Safety Cautions
Please comply with the following rules for safety and effective use.
Prevent Breakage and Flammability

Please comply with the following precaution to prevent breakage.
CAUTION
1) Installation should be complied with installed instruction of the manual.
2) If relocation is necessary, contact your local distributor or NEOMEDICA
firstly.
Prevent Electric Shock

Please comply the following precaution for preventing electric shock.
CAUTION
1) Users other than the servicing personal authorized by our company must not
open the rear cover and left/right cover when turn on the power.
2) If a spill occurs or liquid gets into the instrument, please contact
NEOMEDICA. Neglecting the liquid may cause electric shock.
Prevent Personnel Injury

Please comply the following precautions for preventing injury.
CAUTION
1) While the instrument is in motion, DO NOT touches the moving parts, such
as aspirating probe and stirrer, etc.
2) DO NOT put your finger or hand into the open part of instrument.
Eyes Protection
Please comply with the following precaution for eyes protection.
CAUTION
1) DO NOT directly look at the light emitting from the lamp source when the
instrument is in motion.
2) Turn off the power and wait for at least 15 minutes until the light source is
cooling before replacing light source to prevent scald.
4
Precision and Accuracy of Data

Please attention the following matters for getting the accurate data.
CAUTION
1) DO NOT open the top cover, rear cover and reagent tray when the
instrument is under analyzing condition.
2) Please check the accuracy of instrument by quality-control before using.
3) Please comply with the manual to maintain, check and replace the assembly
unit.
4) Please comply with the corresponding explanation to handle the reagent,

quality-control materials and reference materials.
5) Please handle the sample according to the requirements in the manual.
Chemical and Biological Safety

Please comply with the following matters for chemical and biological prevention.
Biological Hazard
If chemical adheres to the human body, contagion may occur. DO NOT touch the
sample, mixed solution and waste solution directly. Be sure to put on protective
gloves, clothes, or even goggles if necessary. If the sample splashes to the skin
accidentally, please treat immediately according to the working standards and
consult a doctor.
CAUTION
Some reagents are strong acid or alkaline. Please use them carefully avoiding
direct contact. If the reagent spill to the human body, immediately washes it off
with water and soap. If the reagent splashes into eyes accidentally, wash it off
with water and consult an oculist.
Handle Waste Solution

Please comply with the following matters when handle the waste solution in order to avoid
personal injury and protect environment.
5
Biological Hazard
1) Some substances contained in QC solution, standard solution and waste

solution are regulated by discharge standards and pollution control
regulations, waste must be disposed according to the relevant
environmental protection regulations.
2) Be sure to put on protective gloves, clothes, or even goggles if necessary

when dispose waste solution.
System Dispose Hazards

Please comply with the following matters to dispose of the waste analyzer.
CAUTION
Materials of the analyzer are subject to contamination regulations. Dispose of the

waste analyzer in accordance with your local or national rule for waste disposal.
Fire and Explosion Hazards

Observe the following instructions to prevent fire and explosion.
CAUTION
Alcohol is flammable substance. Please exercise caution while using alcohol.
1.2 Using Precaution
Systematic Usage
CAUTION
1) Automatic Chemistry Analyzer is intended use for medical institution and

laboratory to analyze some specific chemical composition of human body
fluid. If the instrument to be used beyond this scope, consult NEOMEDICA
firstly.
2) Please consider together with the clinical symptom or other analyzing result
when make the clinical judgment.
Operator
CAUTION
The instrument is operated only by technicians, doctors and laboratory
personnel that trained by NEOMEDICA.
6
Operational Environment
CAUTION
1) Please install the instrument according to the specified installed instruction

in the manual. Otherwise, the results may not reliable even may cause
system damage.
2) Please contact NEOMEDICA if system state is changed.
Caution on Electromagnetic Wave Interference
CAUTION
1) Keep the instrument away from strong noise source and electromagnetic
wave. Turn off mobile phones and transmitter-receiver when operating the
instrument since the electromagnetic wave may cause an adverse effect
on instrument.
2) Do not use other medical instrument around the system that may generate
electromagnetic wave interfere with their operations.
Indication for System Use
CAUTION
1) The operator must training before operating the instrument. Please follow
the instruction of manual to operate. Improper operation may cause
personal injury, system damage and improper result.
2) Please make a calibration and quality-control test before use the system
for the first time to ensure it can be used normally.
3) A quality-control test must be done when use the system. Otherwise, the
reliability of the result could not be guaranteed.
4) Do not open the sample/reagent cover while in the analyzing process.
5) The communication joint of analytical part is set to connect with the
communication joint of operational part. Please use the cables of
NEOMEDICA for connecting.
6) The operation part is an external computer which is installed the specified
operational software. The computer should be for the instrument exclusive
use. DO NOT run any other software when it is connected with the
instrument. Inappropriate manner may result in computer virus infection
7) DO NOT touch the keyboard, indicator and mouse when your hands is
wet, also includes the chemistry.
7
System Maintenance
CAUTION
1) Maintaining according to the instruction. Incorrect maintenance may lead to
wrong result even caused system damage and personal injury.
2) Dust may be there after long-time placement. Cleaning the surface by soft
cloth or little soap solution if necessary. Never use organic solvent such as
alcohol. Wipe the surface after cleaning. Please turn off all the power supply
and pull up the plug before cleaning. Take measures to prevent water into the
system, otherwise, will cause system damage or personal injury.
3) Calibration analyses must be done when changed the light source, optical
system, sample needle, reagent needle, stirrer and any other major
component.
4) Please turn off the power and wait the light is cooled down to avoid scald.
Setup of Parameters
CAUTION
To define such parameters as sample volume, reagent volume and wavelength,

follow the instructions in this manual and the instruction of reagents.
Precaution for Handling Samples
CAUTION
1) Sample must not contain insoluble substances such as fibrin and dust.
Coagulation and impurity may block the aspirating probe thus causing bad
effect on tests. Medicine, anticoagulant, preservative exist in sample may
influence test result, hemolytic, icterus and chyle also will cause incorrect
result. Suggest do background test.
2) Store the sample correctly. Sample structure will change and even caused
incorrect result in wrong storage.
3) DO NOT expose samples in the air for a long time because they may be
contaminated or boiled off and thus erroneous test result may occur.
4) Certain sample can not be analyzed please contact reagent supplier for
details.
5) Certain sample need to be preprocessed please contact reagent supplier

or distributor.
6) Consult manual for sample volume when do the test.
7) Ensure sample positioned correctly before test, if not bad result may occur.
8
Handling Reagents, Calibration and Control
CAUTION
1) Proper reagent, calibration solution and control solution are needed for
analyses.
2) Please choose correct reagent. Consult the manufacturer or distributor if

uncertain about the usage of reagent
3) For storage, handling and usage of reagent, standard solution and control
serum, refer to the Instruction for Use provided by their manufacturers.
Improper storage may not guarantee the accuracy of test result even
though they are not expired.
4) Be sure to perform calibration when replacing reagent. Otherwise, inexact

test result may occur.
5) Cross-contamination among reagents may influence test results. Contact

your reagent supplier for details.
Data Back Up
CAUTION
Please backup the analysis data and measurement parameters regularly.
Other Cautions
CAUTION
1) DO NOT touch the keyboard, indicator and mouse when your hands is
wet, also includes the chemistry.
2) Check samples for contamination (dust, or fibrinogen) and air bubble

before analyses.
3) For replacements of major parts, such as light source lamp, aspirating
probe, reaction cuvette, etc., please contact NEOMEDICA.
4) For settings of sample volume, reagent volume, wavelength, standard

values, etc., Please refer to the instruction in reagent kit as well as this
operating manual. Checking the quality of distilled water and detergent,
check calibration results, control results, and sample results after
analyses. Make sure there is no air bubble in the flow paths.
9
1.3 Installation
CAUTION
Only the NEOMEDICA technician can perform the installation of instrument.
Only the NEOMEDICA technician can perform the installation of instrument, users shall
make preparation for satisfying the installation requirements in accordance with this
manual before installation. If relocation is necessary, please contact your local distributor
or NEOMEDICA.
1.3.1 Instrument Inspection
Please check the carton according to the following procedures:
1) Carefully unpack the package and take out the NEOMEDICA-Neo Chem 40 Automatic
Chemistry Analyzer and the accessories.
2) Inspect the instrument and accessories for quantity and visible signs of damage
according to the accompanying Packing List.
3) If any loss or damage exists, contact the distributor or manufacturer immediately.
1.3.2 Installation Requirement
NOTE
The instrument is high sophisticated thus proper installation is very important to

its performance. User should guarantee the environment and electrical
condition are comply with the recommended conditions. Provide a distance of
50cm at least for each side for operating and maintaining.
Keep away from direct sunlight

Dust free
Installed on horizontal ground
Ground load capacity: 500kg
Room temperature: 10℃～35℃
Relative Humility: 40%～85%（No condensation）
Atmosphere Pressure: 86kPa～106kPa
The reliability of data could not be guaranteed if the fluctuation of temperature and humility
exceeded the certain range.
Good ventilation does not face air conditioner
No obvious vibration
Keep away from electromagnetic field and electricity interruption
10
The instrument should be near to the power.
1.3.3 Location Requirements
The instrument installation layout is below. Surrounding distance is the recommended

maintenance space.
Measurement: cm
Instrument Dimension: 110cm×74cm×112cm (L×W×H)
Dimension of Operating Board (Only for reference): 70cm×50cm×80cm (L×W×H)
1.3.4 Power Requirements
The following power must be prepared; switchboard should be located within 10m.
1) Power
Voltage 230V～, 50/60Hz
2) Grounding
Adapt to local power needs, using three-pin power plug
3) Plug board
A 20A output plug board with more than three 5A sockets. Heavy-duty devices should
not share the plug board with the instrument, such as refrigerator, air conditioner etc.
4) 3 core power cable cat is using; the type of wire and plug is depended on voltage.
CAUTION
11
Make sure the instrument is grounded properly. Poor grounding may cause
bad effects on test result and even damage to the instrument.
1.3.5 Instrument Connection
1) Take out the power line, one end insert into the power interface of instrument, the
other end connected to the power.
2) Using the communication line which provided by NEOMEDICA for connection. One
end connects to the COM serial port of computer; the other end connects to the COM
serial port of instrument. And please tighten by the screws.
3) Distilled water and detergent are needed for analyses; meanwhile, the waste solution
will discharge. There are liquid-level inductive interfaces on the rear of instrument for
connecting to distilled water barrel and waste barrel, and there is a drawer on the front
of instrument for replacing detergent bottle. Connect one end of tube and liquid-level
inductive line to the instrument, the other end connects to the corresponding barrel.
Please see figure 1.3.5-1 and 1.3.5-2 for the connection of instrument.
Figure 1.3.5-1 (NEOMEDICA-Neo Chem 40)
12
Figure 1.3.5-2 (NEOMEDICA-Neo Chem 40)
CAUTION
Please connect the flow path tubes under the instruction of NEOMEDICA
service engineer or the personnel authorized by NEOMEDICA.
NOTE
Do not locate the instrument on a place where difficult to operate cutoff device.
13
CHAPTER 2 INSTRUMENT INTRODUCTION
2.1 Brief Introduction
Automatic chemistry analyzer is a clinical chemistry instrument with the characteristics of

open, full-automatic, discrete/optional, STAT priority and controlled by computer. It is
intended for use in conjunction with reagents to measure quantitatively certain chemical
items in serum, urine and cerebrospinal fluid. Please read the operating manual carefully
before using since it is a high sophisticated instrument.
Work Unit consists of optical unit, mechanical operation unit, liquid path control unit,
hardware circuit unit and operating unit.
1) Optical unit consists of 120 cuvettes. The light source is long lifetime halogen light; the
optical system is concave holographic aberration-reduced grating, rear light-splitting
optical system.
2) The mechanical unit consists of sample processing system and reagent processing
system. The sample processing system includes sample tray, sample arm, sample
syringe and sample probe washing pool; reagent processing system includes reagent
tray, reagent arm, reagent syringe and reagent probe washing pool. The instrument
also includes a unique stirring arm and eight-step washing system
3) The operating unit is an external computer (CPU: Intel Pentium 4, rate: 2.4 GHz or
above, Hard disk: 120G or above, memory: 1Gor above, resolution: 1024*768 or
above, and there are serial port, net mouth and CD-ROM drive), the application
software should be setup under the Windows XP (Home/Professional SP1) or the
above operation system.
4) The liquid path control unit consists of vacuum pump, solenoid valve, syringe, rinse
system and pipeline system, etc.
5) The hardware circuit unit consists of power board, main board, terminal board and
transfer board, etc.
6) The instrument is easy to operate. The layout of the screen menu is reasonable,
name is simple. Such as testing parameter setup, patient’s information input,
quality-control, reagent, data query, standard, running test and hardware parameter.
After setting, put the sample and reagent to the instrument and begin to analyzing.
Print out the result by the external printer at last.
14
2.2 Intended Use
The instrument is applied for professional, in vitro use in hospitals, clinics and laboratories.
CAUTION
Some samples may not be analyzed according to the tested parameter and
reagent. For the case of these samples, please contact reagent manufacturer
or distributor.
2.3 Main Structure
2.3.1 Performance and Composition
The analyzer is mainly consisting of analytical unit, computer and printer. The computer
and printer are optional accessories.
The analysis unit is composed of reagent tray, sample tray, reaction tray, aspirating
mechanism, stirring mechanism, optical system, liquid path system and hardware circuit.
The instrument supports the scanning system of sample barcode, reagent barcode and
electrolyte testing system.
NOTE
Computer is a part of analysis system; customer could prepare by themselves

or purchase it from manufacturer.
Figure 2.3.1-1 Overview of Analysis Unit (NEOMEDICA-Neo Chem 40)
15
2.3.2 Top View
Washing station Reagent probe 1
Reagent tray 1
Reaction tray
Sample probe Reagent stirrer
ISE aspirating port

Reagent probe 2
Sample stirrer
Sample tray Reagent tray 2
Figure 2.3.2-1 Top View of Analytical Unit (NEOMEDICA-Neo Chem 40)
2.3.3 Rear View
Figure 2.3.3-1 Rear View of Analytical Unit (NEOMEDICA-Neo Chem 40)
16
2.3.4 Function of Main Part
1) Sample Tray: Convey sample cup to sample aspirating point and place cup.
2) Reagent Tray: Convey reagent to aspirating arm. The reagent tray with 24 hours
non-stop refrigeration function, and the temperature keep in the range of 2-8℃.
3) Reaction Tray: Fixed the cuvette. Sample and reagent reacted in the fixed cuvette in
37℃ thermostat meanwhile colorimetric directly.
4) Barcode scanning function (support): to indentify the sample test tube and reagent
bottle, and coding for the tube and bottle.
5) ISE module (support): measuring the concentration of Li+ ion, Na+ ion, K+ ion and CL+
ion of serum, blood plasma and urine.
6) Aspirating mechanism: aspirating quantitative volume of reagent from reagent bottle

and inject to cuvette; then aspirating quantitative sample from sample cup and inject
to cuvette. The aspirating mechanism with liquid level sensing function.
7) Stirring Mechanism: Stirs the reaction solution contained in reaction cuvettes.
8) Rinsing Mechanism: Drains out reaction solution and washes the cuvettes, Adding
and drain out the pure water. The design of eight-step washing can clean the cuvettes
adequately.
9) Stirrer Washing Pool: Omni directionally wash the stirrer.
10) Sample Probe Washing Pool: Omni directionally wash the inside and outside of
sample probe by distilled water.
11) Reagent Probe Washing Pool: Omni directionally wash the inside and outside of
reagent probe by distilled water.
2.4 Function and Specification
1) System: Full-automatic, discrete/optional, STAT priority, with reset function.
2) Stand-by: 24 hours stand-by, auto-sleep and one key startup function.
3) Rinse: Rinsing the inside and outside of aspirating probe (sample probe and reagent
probe) with constant-temperature distilled water, and omni directionally clean the
stirrer; washing station of eight-step rinse the cuvettes with detergent, and provides
two paths detergent system; separate rinse available among items.
4) Distilled water: Distilled water for washing is treated by constant-temperature and

preheating system and water degasser.
5) Backup reagent position: Three reagent positions available for the same item. When
the first alarm to lack of reagent occurs, aspirating probe will turn to the second
reagent position to aspirate reagent automatically, and the second alarm occurs,
aspirating probe will turn to the third reagent position to aspirate reagent.
17
6) Waste disposal: Two-stage distributaries for high and low concentration waste.
7) Sample probe: With liquid level sensing, volume tracking function, auto-protective
function to prevent from collision. The function of probe-clog detected is optional.
8) Reagent probe: With liquid level sensing, volume tracking function, auto-protective
function to prevent from collision. The preheating function is optional.
9) Light source: Long-life halogen lamp, auto-sleep, cooling by water.
10) Item sequence: Item print and measuring sequence could be programmed.
11) Alarm: Alarm automatically when reagent, sample, distilled water or detergent is
shortage and waste solution is overfull; display reagent allowance and available tests
number in real time; when the absorbance is out of range, the system will alarm.
12) Test method: End point, rate assay(kinetic method), 2-point end point(2-point kinetic
method), dual-wavelength, blank method(reagent blank, sample blank and water
blank), immune turbidimetry, double reagent and electrode, etc.
13) Calibration method: At least linearity (single point or multi points) and non-linearity
calibration. Multiple calibration formula including Logit-Log4P, Logit-Log5P and
exponential function etc.
14) QC rule: At least including westgard and levey-Jennings QC rules.
15) Colorimetric method: Colorimetric in reaction cup directly, and single-hole detection.
16) Monitor: Monitoring cuvette online, display whole reaction process in real time, skips
and marks the unqualified cuvette automatically.
17) QC Predefine different controls. More than 8 controls can be tested simultaneously
and QC could be insert randomly in the course of testing. QC diagram could be
storage, displayed and printed.
18) Pre-diluents/Retest: The software could identify the sample which substrate is use up
and linearity is over range, for these samples, system could select pre-diluents test
and retest manually or automatically. The diluents time could be programmed. Max
dilute multiple is up to 250.
19) Data reset: Reselect measure point against abnormal sample (Substrate use up, over
range of linearity) and recount without retest.
20) Calibration system: Selecting best test point according to reaction curve, not need to
calibrate for second time; Calibration time is selectable and result is calculated
automatically. Tracking calibration function, the change of K value is presented on a
drawing. 12 calibrations in different concentration can be used for each item.
21) User mode: Hospital mode, blood station mode, physical examination center mode etc.
22) Printing function: Various printing format, support Serbian/English printing. User could
edit the format of report.
23) Patient result and data storage: store and backup automatically and permanently in
18
infinite quantity.
24) Software management: Multilevel authority management to guarantee the

secNeoMedicay of information.
25) Network: Data exchange between LIS and HIS automatically
26) Barcode reader: The instrument supports the barcode scanning function. Supporting
codabar, interleaved 2of 5, code128, code39, code93, UPC/EAN and any other
barcode rules.
27) ISE: Support ISE.
28) QC method: Real-time QC, within-day QC, between-days QC.
29) Reagent capacity expansion: It’s provides the function that a reagent position can be
set to test several items but once only test one item, and four reagents item test.
2.5 Technical Parameter
1) Reagent tray: two specification bottles are available.
2) Sample tray: 99 sample positions, they are consist of routine sample positions,
standard positions, quality control positions, probe washing position and STAT
position; Various samples can be put together, sample cups, neonate ultramicro
quantity cup, primitive tube and plastic tube is appropriate for those positions. Offer up
to 20 virtual sample trays, 1320 samples could be edited simultaneously in single time.
3) Cuvette: Holds120 UV hardish cuvettes (quartz cup is optional)
4) Optical system: concave holographic aberration-reduced grating, array photodiode,

rear spectrophotometry optical system with12 wavelength (340nm, 405nm, 450nm,
480nm, 505nm, 546nm, 570nm, 605nm, 660nm, 700nm, 750nm, 800nm)
5) Absorbance range: -0.5Abs-6.0Abs.
6) Reagent refrigeration: With 24 hours non-stop refrigeration function , and refrigerate

temperature is 2℃-8℃.
7) Sample Volume per test: 2 to 100μL , variable in 0.1μL
8) Reagent Volume per test: 5 to 500μL, variable in 0.5μL
9) Reaction Volume: 150μL~600μL (light path is 5mm), 750μL (light path is 6mm),
900μL (light path is 7mm).
10) Wavelength accuracy: ±1nm
11) Half broadband: ≤6nm
12) Light source: 12V/20W
13) Temperature control: 37℃±0.1℃
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14) Item storage: up to 1200
15) Power voltage: 230V~, 50/60Hz
16) Relative humidity: 40%～85％
17) Environmental temperature: 10℃～35℃
18) The outside insulated resistance of single fault: ≤0.1Ω.
19) Cuvette light path: It’s provides 5mm, 6mm and 7mm light path to select.
20) The test speed, maximum reaction time, position of reagent, water consumption,
power and structure are shown in the following table:
Maximum Reagent Water

Model Test speed Power Structure
reaction time positions consumption
Double stirrers, reagent
480 tests/h (pure probes and reagent
Neo Chem
biochemistry), 12.1min 120 ≤18 L/h 1300VA trays, single sample
40
720 tests/h (with ISE) probe, reaction tray and
sample tray
Double stirrers and
420 tests/h (pure reagent probes, single
Neo Chem
biochemistry), 14.2min 82 ≤15 L/h 1100VA sample probe, reaction
40/8261
660 tests/h (with ISE) tray, reagent tray and
sample tray
Double stirrers and
360 tests/h (pure reagent probes, single
8236/8238 biochemistry), 16.5min 82 ≤12 L/h 1100VA sample probe, reaction
600 tests/h (with ISE) tray, reagent tray and

sample tray
20
CHAPTER 3 MEASURING PRINCIPLE
3.1 Principle
Lambert’s Beer Law:
When a parallel monochrome light beam goes through a light-absorbing object (gas, liquid
or solid), some photons are absorbed and the light intensity decreases from I0 to I, the
formula is:
I
 lg = εLC
I0
ε: Proportionality factor
I: Intensity of shoot-out light
I0: Intensity of shoot-in light
Measure I, I0, and L, and then calculate the concentration C according to the formula
above.
3.2 Test Methods
3.2.1 Endpoint method
Endpoint method means the concentration of measured item is calculated according to the
absorbance at the end of the reaction process.
1-point of Endpoint method
Endpoint method in which absorbance is measured at a time point when absorbance

stops changing at the end of the reaction process. The reaction curve below explains the
method.
Formula: Concentration= (calculated absorbance - absorbance of reagent blank) ×K
[K is the absorbance coefficient i.e., Standard factor]
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Figure 3.2.1-1 1-point of Endpoint Method
2-point Endpoint Method
Selecting the first absorbance (A1) before reaction, and selecting the second one (A2)
when the reaction is balanced or has completed, the difference between two absorbance
is used for calculating result.
Formula: Concentration= (Absorbance 2 - Absorbance 1) ×K
[K is the absorbance coefficient i.e. standard factor]
Figure 3.2.1-2 2-point Endpoint Method
3.2.2 Two-point Method
To select two points, which absorbance is not at beginning and also not at the end of
reaction, then use the difference between the two values to calculate result, this is
two-point method.
The formula is the same as 2-point endpoint method.
This method is helpful to solve some non-specificity problem in some reactions.
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Figure 3.2.2 2-Point Method
3.2.3 Rate Method (Kinetic Method)
Continuously select the absorbance in linear period in linear period when test the
enzymatic activity and metabolism, and use the change of absorbance value in linear
period to calculate result.
Linearity Range of Enzymatic Reaction
Figure 3.2.3 Rate Method (Single Reagent)
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Figure 3.2.3 Rate Method (Double Reagent)
CHAPTER 4 OPERATION
4.1 Operating Step
Following show the operation step of instrument. Suggesting perform standard analyses
everyday after start-up and do control analyses.
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4.1.1 Operating Step
Power on
4.2.1 Check before powering on
4.2.2 Power on
Start the operating software

4.2.3 Start operating software
Preparation of sample and reagent

4.2.5 Sample Preparation
4.2.4 Reagent Preparation
Create standard curve and
QC test
Put reagent and sample on the tray
Put reagent on instrument
Put reagent on the instrument
Put sample on instrument
Put sample on the instrument
4.2.6 Standard and QC apply
4.2.8 Start analysis
Routine operation
4.2.6 Standard apply
4.2.6 QC analyses apply
4.2.7 Routine apply Preparation of routine sample
Put reagent on instrument
Put sample on instrument
Start analysis 4.2.7 Routine
4.2.8 Start analysis 4.2.8 Start analysis
4.2.10 Finish
Analysis
Finish
4.2.10 Finish
4.2.9 STAT analyses
4.1.2 Start up
Firstly check whether the distilled water and detergent is sufficient, and be sure the waste
solution barrel is empty. Then turn on power switch of analyzer and computer. Wait about
30 minutes for instrument preheating.
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CAUTION
1) There are three switches, main switch, testing switch and power switch.
After turning on main switch, and then turn on power switch, the
refrigeration system starts to work; after turning on main switch, and then
turn on testing switch, the analyzer could test.
2) Please put on the cap of reagent tray to keep the cooling effect.
4.1.3 Create Standard Curve
It is suggested to perform standard analyses every day to obtain preferable result. The
following are the steps for standard analyses.
1) Place reagent on reagent tray and put a known concentration standard solution on
standard position of sample tray.
2) Apply to system for standard analyses.
3) Click “test” to start standard analyses.
4) Confirm new standard curve is created.
4.1.4 QC Test
After standard analyses, it is necessary to perform QC analyses to check the instrument’s

precision. Data of QC are saved in everyday operation to take as QC analyses basis.
There are two kinds of QC analyses: within-day variation QC and between-days variation
QC. Within-day QC is to check the data measured within a day. Between-days QC is to
check the data measured within different days. It is suggested to measure two control
samples in different concentrations every day, and each control sample should be
measured at least twice.
The following are the steps for QC analyses.
1) Place control sample in the control position of sample tray.

2) Apply to system for control analyses.
3) Click “test” to start QC analyses.
4) Check the QC chart.(Refer to 5.7.2.2 for QC chart and 6.3 for QC rules)
4.1.5 Test Patient’s Sample
Operating steps are as following:
1) Put patient’s serum, urine or other samples on sample tray.

2) Apply system for routine item analyses.
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3) Click “test” to start.

4) Repeat 1-3 steps if necessary.
5) Check the result and if necessary, review and modify it.
4.1.6 Finish
Perform rinse and log off the system after finishing analyses and then turn off power
switch.
4.2 Basic Operation
4.2.1 Check Before Powering On
Please check the instrument status before powering on.
1) Check the distilled water, detergent and waste solution, if distilled water or detergent
is insufficient, replenish it. Empty the waste barrel before analyses.
Biological Hazard
DO NOT touch the detergent or waste solution. If it adheres to hands or clothes,

wash it off with water immediately. If it splashes into eyes, wash it off with water
immediately and consult a doctor.
2) Verify that reagent lids have been removed and the rest of reagent volume is sufficient
for your analyses.
CAUTION
If the rest volume in reagent bottle is insufficient for analyses, replace the whole
reagent bottle. DO NOT refill the reagent to the bottle. If refilled, data error may
be caused.
3) Check aspirating probes and stirrer. Verify that the aspirating probes are not blocked.
Make sure there are no stains and crystals adhere on the surface of probes and
stirrer.
4.2.2 Power On
After connecting correctly the system to the power sockets, switch on the power in the
sequence presented below:
1) Turn on the main switch.

2) Turn on the power switch.
27
3) Turn on the test switch.

4) Turn on the display monitor of computer of the operation unit.
5) Turn on the computer of operation unit.
6) Turn on the printer.
4.2.3 Starting the Operating Software
1) Open the upper cover.

2) Starting the operating system, the login window as follows, figure 4.2.3:
Figure 4.2.3
3) Input the registered doctor’s name and the corresponding password to enter system
to operate analyzer.
4) Switch to another user: System allows different users to login by clicking “ ” on

the main interface.
CAUTION
User authority management is applied to limit certain function for low

permission user, which is benefit for user to manage the software reasonably.
There are three user groups, user, administrator and guest.
NOTE
Instrument with the function of 24 hours stand-by, auto sleep and one-key setup.
4.2.4 Preparation of Reagent
1) Be sure to use the certified reagents. Read through the reagent instructions and set
28
up parameters properly before analyses. For item parameter setup, refer to 5.5.1 and
5.5.2.
2) If reagent is insufficient, replace it with a whole new bottle. Place the reagent bottle in
the specified position according to the preset reagent parameters.
3) Reagent should be stored at temperature of 2-8 ℃. Long-time exposure in the air may
deteriorate the reagents.
Biological Hazard
Be careful not to spill out reagent. If reagent is spilled, wipe the area by dry fabric
immediately.
4.2.5 Preparation of Sample, Standard Solution and Detergent
4.2.5.1 Sample Preparation
Add samples into special sample cups or tubes, and then select corresponding sample
position at test interface.
CAUTION
Before transferring samples, observe their appearances and shapes to see if
icterus, hemolysis or chyle exists.
4.2.5.2 Preparation of Standard Solution
Add proper volume of standard solution into sample cup and place the cup in the standard
position.
4.2.5.3 Preparation of detergent
Dilute detergent proportionally, and then add into the detergent bottles, sample cup (tube)
which on the position for detergent of sample tray and reagent bottle which on the position
for detergent of reagent tray.
NOTE
1) DO NOT mistake the detergent, e.g., acid solution and alkaline solution
will produce toxic gas when they are mixed.
2) If detergent is spilled, wipe the area by dry fabric or tissue. Leaving the
spill will erode the parts of the instrument.
3) Be sure the solution level not exceeds the marked highest line on
detergent barrel.
29
Biological Hazard
1) When opening the lid of detergent barrel, be careful to avoid touching the
solution. If the detergent adheres to your skins or clothes, wash it off with
water.
2) If the detergent splashes into eyes, wash it off with water immediately and
consult a doctor.
4.2.6 Registration of Standard and QC
4.2.6.1 QC Registration
1) Select “QC —> QC setup” to set the QC parameter

2) Select “Routine —> QC”, then apply QC item test.
3) QC data is automatically processed by system after finishing analyses.
4.2.6.2 Standard Registration
1) Click “Reagent—>Normal Item—> Standard”, then set the parameter of standard

solution.
2) Click “Routine—>Standard” to apply standard.
3) Save data automatically after finishing test.
4.2.7 Routine Sample Registration
It is necessary to register analytical items and patient information for each routine sample
before analyses according to application form.
1) Click “Data—>Sample Registration” to register patient information.

2) Click “Routine—>sample” to apply items and test.
3) Save data automatically after finishing test.
NOTE
1) If the “Use Same Pos” is selected, it indicates that the system will
repeatedly test a sample and each test for the same items.
2) The “Use Same Pos” is grey and not optional when the figures in the
boxes “sample ID” are the same.
30
NOTE
System provides more than 20 simulative sample tray, 1320 samples could be input for
each time.
4.2.8 Analyses
Do the following after finishing preparation:
1) Check parameter setup, sample positions and reagent positions.

2) Check list of item, contents of standard and QC.
3) Click “TEST” to enter the Testing Screen.
4.2.9 STAT Analyses
For sample that needs to be tested emergently, you can use the function of STAT
analyses.
Click “STAT” to perform emergent sample test. Specific operation is the same as routine
sample.
CAUTION
1) The STAT Entry Screen is similar to the Routine Entry Screen. Pay
attention not to confuse them when doing analyses.
2) STAT samples must be placed at the STAT positions, such as E1,E2 etc.
CAUTION
The STAT analysis is performed only after routine test started.
4.2.10 End of Analyses
1) Routine
Upon measurement of the last sample, sampling automatically stops and data are
processed and stored.
2) Emergent Exit
3) If you have to abort the measurement in processing, click the “Emergent exit” key. In
this case, measurement is cancelled.
31
CAUTION
If the emergent exit function is executed, all the sample tests which applied will
stop and data will loss. Re-applied if it is need to test these samples
continuously.
4.3 Obtain Result
Check test result after finishing analyses.
4.3.1 Registration of Sample Information
After measurement, enter the corresponding patient’s information to complete the test
report.
Select “Data—>Sample Registration” to enter the registration interface. The sample

information could be registered in this interface, such as “Report Date”, “Sample ID”,
“Name”, “Sex”, “age”, “Outpatient ID”, “Inpatient ID”, “Department”, etc.
The “Calculated Item” which has been set will display.
Printout: offer various print formats for different needs. Support Serbian/English printing
mode.
4.3.2 Modification of Test Result
Click “Data—>Result Review—>Show By Item” to modify the result. System will display
the data of selected item.
Input calculated data into “Modify” column, then click “Modify” or “Batch Amending”,
system will modify all intraday data under this item automatically, and then click “SAVE” to
save the data.
CAUTION
Take objective factors, such as clinical symptoms or sample characters into
consideration before deciding to modify test results. The modified coefficient
should be calculated combined with QC results in recent days. To avoid
misdiagnosis, doctor or lab personnel should supervise the modification of test
results.
4.4 Query of Analytical Result
Select “Data—>Result Review” to enter the query interface. The analytical result could be
queried in this interface. System provided various index functions, such as query by
analytical date, barcode, patient’s name, outpatient and operator etc. It’s convenient for
32
laboratory to perform statistics and analysis of data.
NOTE
Reports can also be printed out in accordance with the laboratory’s requirement
in this screen
4.5 Analytical Curve Display
System provides the interface of “Data—>Sample Registration” for lab to depth analyze
the result. Select “Curve” to query reaction curve to analyze the analytical data.
The interface of “Standard”, select “Calib Curve” to query calibration curve to analyze the
accuracy of the standard.
4.6 Database Maintenance
Backup or reduction various test data to avoid data loss. Database maintenance consists
of two parts. Operating as following steps:
4.6.1 Database Backup
1) Select “Maintenance”.
2) Select “Database Backup”, and then click “Execute”, “Database Backup” dialog box
will be appeared.
3) Keep a backup of the data by time according to the lab requirement.
4) Select “Backup” and exit.
4.6.2 Database Reduction
2) Select “Database Reduction”, then click “execute”, “Database reduction” dialog box
will be appeared.
3) Recovery the data by time according to the lab requirement.
4) Select “Restore” and exit.
4.6.3 Automatic Backup
It’s convenient for experimenter to work that the system provides the functional of
automatic backup.
33
2) Select “Automatic Backup”, then click “execute”, “Automatic Backup” dialog box will be
appeared.
3) Keep a backup of the data by time according to the lab requirement.
4) Click “SAVE” and exit.
CHAPTER 5 OPERATION
5.1 System Menu
Routine Sample, Standard, QC

STAT Sample, Standard, QC
Data Sample Registration
Result Review
Reagent Normal Item
Manual Item
Calculate Item
Combinate Item
Standard
QC QC Setup
QC Data
Maintenance Reset
Probe and Stirrer Cleaning
Cuvette Rinsing
Cuvette Signal
A/D Value
ISE Maintenance
Maintenance of Barcode Scanner
5.2 Chemistry Analyses
System Parameter System Parameter
Click “Routine” in the main interfaceUser Setup

to enter routine interface which is used for applying
“Routine”Setup
sample, standard and QC test. Operator interface is composed of “Sample”, “List”,
“Standard” and “QC” interface, “Sample” interface is default.
Dictionary
Print Setup
5.2.1 Sample
Barcode
Exit
ISE Setup
Click “Sample”
Help in the “Routine” interface to enter “Sample” interface which is used for
applying sample test, see figure 5.2.1.LIS Setup
34
Chemistry Item Region
ISE Item Region

Combined Item Region
Figure 5.2.1
The meanings of main parameters of “Sample” interface as follows:
Parameter Meaning
Sample ID Sample ID includes start and end codes.
Sample ID could be added automatically by system, and also entered manually.
Input the start code in the first edit box and end code in the second when enter
sample ID manually.
It indicates that apply a sample test when the two codes are the same; it indicates
that apply the all samples tests which the sample ID in this code range and each
test for the same items.
NOTE
1) If the “Use Same Pos” is selected, it indicates that the system will
repeatedly test a sample and each test for the same items.
2) The “Use Same Pos” is grey and not optional when the figures in
the boxes “sample ID” are the same.
Position The position of sample tray for placing sample. It can be added automatically by
system or selected manually from pull-down menu.
NOTE
1) For single sample, it’s the sample position.
2) For batch samples, it' the position for the sample of start code and
positions of other samples will be generated automatically
according to this position.
3) As long as a position in the current sample tray is used, the option
of position will not include this position.
Size of Cuvette The size of the sample cup for test. There are three sizes, standard, 75mm and
60mm.
Testing Date The data of applying sample.
Samsel The position of virtual sample tray for sample.
Barcode The barcode information of sample. It can be obtained by sample barcode system
or scanner, or input by hands.
ISE Item Region The ISE item region will become visible only after configuring the ISE module.
35
Parameter Meaning
Combined Item The corresponding sub-items in the chemistry item region are selected after
Region selecting a combined item.
If an item which included in the combined item is forbidden to select, then this
combined item is in grey and forbidden to select too.
If all items that included in the combined item are deselected, then this combined
item is deselected too.
The functions of main keys of “Sample” interface as follows:
Key Function
NEW Creating a new sample application.
ADD Click “ADD” to complete the application or save the change after applying a new sample
test or modifying the test information of the sample which has been applied.
Pre-dilute Pre-dilute the sample.
Delete After selecting the sample in the “Sample Application List” on the left of “Sample”
interface, click “Delete” to cancel the application of sample. This button is forbidden to use
to the sample which waits for applying and in the end status.
Test Click “Test” to enter testing system after completing sample application.
5.2.2 Standard
Click “Standard” in the “Routine” interface to enter “Standard” interface which is used for
applying standard test.
CAUTION
It is suggested to perform standard analyses everyday after start-up to obtain
accurate results and new calibration curve.
NOTE
It needs to perform calibration when modifying parameter, replacing light source,
changing reagent batch number and other test conditions.
The functions of main keys of “Standard” interface as follows:
Key Function
ADD Click “ADD” to complete the standard application after selecting one or more items in item
region.
Delete After selecting the record in the “Standard Application List”, click “Delete” to cancel the
application of standard.
CAUTION
1) It’s allowed to delete the standard application which is waits for test or in
the abnormal state.
2) The button is unavailable for the standard application which is in the end
status.
36
Key Function
Test Click “Test” to enter testing system after completing standard application.
5.2.3 QC
Click “QC” in the “Routine” interface to enter “QC” interface which is used for applying QC test.
The functions of main keys of “Standard” interface as follows:
Key Function
ADD Click “ADD” to complete the QC application after selecting one or more items in item region.
Delete After selecting the record in the “QC Application List”, click “Delete” to cancel the application of
QC.
CAUTION
1) It’s allowed to delete the standard application which is waits for test or in the
abnormal state.
2) The button is unavailable for the standard application which is in the end
status.
Test Click “Test” to enter testing system after completing QC application.
5.3 STAT Analyses
Click “STAT” in the main interface to enter “STAT” interface which is used for applying
emergency samples. The STAT Entry Screen is similar to the Routine Entry Screen.
CAUTION
1) The STAT Entry Screen is similar to the Routine Entry Screen. Pay
attention not to confuse them when doing analyses.
2) STAT samples must be placed at the STAT positions, such as E1,E2 etc.
CAUTION
The STAT analysis is performed only after routine test started.
5.4 Data
Click “Data” in the main interface to enter “Data” interface which is used for registering
patient information, querying and modifying the results of items. “Data” interface is
composed of “Sample Registration” and “Result Review” interface, “Sample Registration”
interface is default.
5.4.1 Sample Registration
Click “Sample Registration” in the “Data” interface to enter “Sample Registration” interface
37
which is used for registering patient information.
The meanings of main parameters of “Sample Registration” interface as follows:
Parameter Meaning
Report Date The print date of report.
Inspection Date The date of testing sample. The current date is default.
Sam ID The ID number of sample.
Name Patient’s name.
Sex The sexuality of patient.
Age The age of patient. Enter the patient age in the first box and select age unit in
the pull-down list. The unit options include year, month, day and hour. The
default is year.
OutPatient ID The outpatient number of patient.
InPatient ID The inpatient number of patient.
Bed No. The bed number of patient in the hospital.
Sample Type Serum, urine, cerebrospinal fluid(CSF), etc.
Department The department from which the sample is ordered for analysis.
Doctor The doctor who orders the sample for analysis.
Comment The comments for sample.
The functions of keys of “Sample Registration” interface as follows:
Key Function
Modify Result Adding the corresponding results to the list in the right of “Sample Registration”
interface.
Delete Delete the sample information.
Curve The reaction curve of sample that is to analyze the analytical results for lab.
Retest System will retest the sample.
CAUTION
Click “Retest”, the system will delete the previous results and retest.
Print Print the analytical results.

Print preview Print preview analytical results.
5.4.2 Result Review
Click “Result Review” in the “Data” interface to enter “Result Review” interface which is
used for querying analytical results. “Result Review” interface is composed of “Show By
Sample” and “Show By Item” interfaces. The default is “Show By Sample” interface.
5.4.2.1 Show by Sample
Select “Show By Sample” to enter “Show By Sample” interface. The modes of query result
in this interface including:
38
Query by Date: Query the results by analytical date.

Query by Barcode: Query the results by barcode.
Query by Name: Query the results by the name of patient.
Query by Operator: Query the results by the name of operator.
Query by Doctor: Query the results by the name of doctor.
Query by Outpatient: Query the results by outpatient.
Query by Inpatient: Query the results by inpatient.
5.4.2.2 Show by Item
Click “Show By Item” to enter “Show By Item” interface. Select the analytical date, then
click “Refresh” to query the desired result.
It’s allowed to modify single result or bath results in “Show By Item” interface.
5.5 Reagent
Click “Reagent” in the main interface to enter “Reagent” interface which is used for setting
and calculating the parameters of item. “Reagent” interface is composed of “Normal Item”,
“Manual Item”, “Calculate Item” and “Combinate Item” interfaces. The default is “Normal
Item” interface.
5.5.1 Normal Item
Click “Reagent” to enter “Reagent” interface which is used for parameter setup. “Normal
Item” is composed of “General”, “Reagent, Sample”, “Referent”, “Standard” and
“Remainder of reagent” interfaces. The default is “General” interface.
NOTE
The five interfaces of “Normal Item” share the “NEW”, “SAVE” and “Delete”
buttons.
39
Key Function
New Click “New”, the system will purge the parameter quickly and add a new
interface of parameter setup.
Save Click “SAVE” to save your setup.
Delete Select the item in the left item list, then click “Delete” to delete it.
5.5.1.1 General parameter
Click “General” in the “Normal Item” to enter “General” interface which is used for setting
reagent parameters of items. See figure 5.5.1.1.
Figure 5.5.1.1
The meanings of parameters of “General” interface as follows:
Parameter Meaning
Item The name of item.
Other name The other name of item.
Decimal Decimal place for test results.
Check method The test method of item, includes: kinetic, end point, 2-point endpoint, etc.
Main wave Measured wavelength. For Dual-wavelength Method, “Main wave” is the
primary wavelength.
Sub wave Secondary wavelength for Dual-wavelength Method. If “NONE” is
selected, Single-wavelength method is valid.
Unit Unit for analytical result.
Modify factor Modifies the standard factor of item.
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Parameter Meaning
Direction of reaction Direction of reaction includes: positive and negative.
Reagent blank Absorbance value of reagent.
Clean after test Click “Clean after test”, the system will automatically wash the sample
probe and reagent probe with detergent after sampling. It’s used for the
highly contamination item.
Factor Calibration factor(K)
Priority PRI-1with the highest priority level; PRI-9 with the lowest priority level.
Linear range The linearity range indicates the measurable range of the item.
CAUTION
The accuracy of result can not be guarantee if the result out of
linear range. Please select “Sample R” or “Pre-dilution R” to
retest if it occurred.
Substrate exhaustion Substrate exhaustion is that the substrate consumed completely, and not
continues to react in chemistry reaction when test enzymes, and the
results of enzymes may be low or close to zero.
CAUTION
If the substrate exhaustion occurred, the sample must be
retested. There are “Sample R” and “Pre-dilution R” for
selecting.
Dilution tim The dilution factor for sample.
The functions of keys of “General” interface as follows:
Key Function
New Click “New”, the system will purge the parameter quickly and add a new
interface of parameter setup.
Save Click “SAVE” to save the setup to “Item” list.
CAUTION
Click “SAVE”, the item is also saved to the item region of
“Sample”, “Standard” and “QC” interfaces, and the “Item” list of
“QC—> QC Setup” interface.
Delete Select the item in the left item list, then click “Delete” to delete it.
5.5.1.2 Reagent and Sample Setup
Click “Reagent, Sample” in the “Normal Item” to enter “Reagent, Sample” interface which
is used for setting the parameters of reagent and sample.
The meanings of parameters of “Reagent, Sample” interface as follows:
Parameter Meaning
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Parameter Meaning
R1 1) The reagent volume to be aspirated into cuvette in the Single Reagent Method.
About the reagent volume in the Dual-Reagent Method, please refer to the
reagent instruction and lab requirement.
2) Incubation Time: For endpoint method, incubation time is from the mix of
sample and reagent to the end of reaction process. For Two-point method,
incubation time is from the first measured point to the second measured point.
Two incubation times has to be set in the Dual-Reagent method. Please refer to
the reagent instruction and lab requirement.
3) Position: The position of reagent tray for the first reagent.
4) Barcode: The bar code of reagent bottle for the first reagent.
R2 Parameter of the second reagent.
CAUTION
It’ not needed to set in single reagent method.
S 1) Sample Volume: the sample volume to be aspirated into cuvette.
2) Test Point: the number of test points when reading absorbance continuously
after incubation.
5.5.1.3 Referent
Select “Referent” to enter “Referent” interface which is used for setting the reference
range, and in comparison with test results.
5.5.1.4 Standard Setup
Select “Standard” to enter “Standard” interface, see figure 5.5.1.4. The setup of calibration
parameters could be done in this interface.
Figure 5.5.1.4
The meanings of parameters of “Standard” interface as follows:
Parameter Meaning
Calibmethod It’ provides linearity calibration, non-linearity calibration and linearity/ non-
linearity multi points calibration. Multiple calibration formula including
linearity(single point, two points or multi points), Logit-Log4P, Logit-Log5P,
exponential function etc.
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Parameter Meaning
STD Number
If the standard number is more than“1”(not include “1”), that is the
multi-standard method, so the Multi-standard method could be used.
Test times The number of testing calibration repeatedly.

(1) (2) (3) (4) (5) (6) Concentration: The concentration of calibration.
Pos: The positions of calibrations in sample tray.
CAUTION
Please select the groups according to STD number. For
example: single point calibration need to select a group to fill in.
5.5.1.5 Remainder of Reagent
Select “Remainder of reagent” to enter the interface which is used for checking the
remainder of current reagent.
5.5.2 Manual Item
The manual item which can not be detected directly by our product, but its result should be
printed to a report with the results of items detected by our analyzers; or print the test
report of other instruments with our product.
1) Select “Manual Item” in “Reagent” interface to enter “Manual Item” interface. Operator
could set the basic information and reference range of manual item.
2) Input the corresponding item name and other name.
3) Select the data type between “Char” and “Float”.
Float: Test results will be indicated with numerical data. The decimal, normal high
value and normal low value of result could be input.
Char: Test results will be indicated with character system, such as “+”, “_”, “Negative”
or “Positive”.
4) Click “SAVE” button to complete all setup.
5.5.3 Calculate Item
Calculation item can derive new chemistries of clinical purposes, such as A/G, ALT/AST, etc.
Select “Calculate Item” in “Reagent” interface to enter “Calculate Item” interface. Setup of
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basic information and reference range of calculate item could be done in this interface.
The meanings of parameters of “Calculate Item” interface as follows:
Parameter Meaning
Formula The formula between different items. Such as ALB/ (TP-ALB).
Name The name of calculate item. Such as A/G.
Other name Other name of calculate item.
Unit Unit for calculate item.
Normal L The lowest value of normal concentration of item.
Decimal Decimal place for test results.
Normal H The highest value of normal concentration of item.
The functions of keys of “Calculate Item” interface as follows:
Parameter Function
New Create a new formula.
Save Click “SAVE”, the calculate item will be added to the list.
Delete Select the item in calculate item list, then click “Delete” to delete this item.
5.5.4 Combinate Item
A couple of chemistries combined together for certain clinical purposes can constitute a
panel, such as liver function, kidney function, etc. Panels can help fast programming of
samples.
Select “Combinate Item” in “Reagent” interface to enter “Combinate Item” interface which
is used for combinate item setup, see figure 5.5.4.
Figure 5.5.4
The meanings of parameters of “Combinate Item” interface as follows:
Parameter Meaning
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Parameter Meaning
Profile Name The name of combinate item, such as liver function, kidney function, etc.
The functions of keys of “Combinate Item” interface as follows:
Parameter Function
New Create a combinate item
Save Click “SAVE”, the combinate item will be added to the left “Item” list.
CAUTION
The name of combinate item will be appeared in the corresponding
region of “Routine—>Sample” interface after clicking “SAVE”. See
figure 5.2.1.
Delete Select the item in “Item” list, then click “Delete” button to delete this item.
5.6 Standard
Click “Standard” in main interface to enter “Standard” interface which is used for querying
calibration results and data.
The functions of keys of “Standard” interface as follows:
Key Function
Review Select the desired date, then click “Review” to start query.
CalibCurve Select calibration result in the “Calibration Result” list, Click “CalibCurve” button to check
the calibration curve.
CAUTION
This button is only used in the successful or calculative calibration results.
Default Click this button, set calibration result as default value.
Setting
DEL Select the result in “Calibration Result” list, then click “DEL” to delete this result.
CAUTION
The successful calibration results are not allowed to delete.
Send Send the results to LIS system.
5.7 QC
Some relevant parameter materials will be accompanied with QC materials when delivery.
The general characteristics of the QC material could be confirmed by input its basic data.
The laboratory personnel could input the basic parameter into the system when introduce
the new QC materials. The “QC setup” includes the basic setting of target value, SD value
and batch number.
Click “QC” in main interface to enter “QC” interface which is used for setting quality
controls and querying QC results. “QC” interface is composed of “QC Setup” and “QC
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Data” interfaces. “QC Setup” is default interface.
5.7.1 QC Setup
Click “QC Setup” in “QC” interface to enter “QC Setup” interface which is used for setting
parameters of quality control.
NOTE
The laboratory should set the target value and SD value for the new QC
material. The target value must be defined according to the presented
determination method. The parameter which supplied by manufacturer only for
reference. See 6.2.3 for specific setup steps of target value and SD value.
The meanings of parameters of “QC Setup” interface as follows:
Parameter Meaning
Lot The lot number of quality control.
Validity The period of validity of quality control.
QC Manufact The manufacturer of quality control.
Target Value Average concentration of QC item.
SD Value Standard deviation of QC item.
Level The level of concentration of quality control.
The functions of keys of “QC Setup” interface as follows:

Key Function
Valuation After setting “Target Value”, “SD Value” and “Level”, click this button to complete
the assignment.
Del Item Delete the selected item from “QC List”.
Add Item Select the item in “Item List”, then click “Add Item”, the selected item will be
added to “QC List”.
Add QC Lot Click “Add QC Lot” button after setting “Lot”, “Validity”, “QC Manufacturer”, the
quality control will be added to “Lot” list.
Del QC Lot Delete the lot number of quality control from “Lot” list.
Save Save the parameters of quality control to “Routine—> QC” interface.
5.7.2 QC Data
Click “QC Data” in “QC” interface to enter “QC Data” interface which is used for querying
QC results and data. “QC Data” interface is composed of “Daytime QC” and “Historical QC”
interface. “Daytime QC” is default interface.
5.7.2.1 Between-Days QC
Click “Daytime QC” in “QC Data” interface to enter “Daytime QC” interface which is used
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for querying QC results and data in a day.
The meanings of parameters of “Daytime QC” interface as follows:
Parameter Meaning
Date Select the date of desired QC results.
Item Select the item of desired QC results.
QC Manufact The manufacturer of quality control.
Lot Select the lot number of desired QC results.
Result Judge the results according to all the test points of Westergard rule or
accumulated in a day, and QC rules.
The functions of keys of “Daytime QC” interface as follows:
Key Function
Save Save the QC results.
Del Delete the QC results.
5.7.2.2 History QC
Click “Historical QC” in “QC Data” interface to enter “Historical QC” interface which is used
for querying the history QC results and data. The system could analyze the QC chart for a
period of time.
5.8 Maintenance
Click “Maintenance” in main interface to enter “Maintenance” interface. It’s mainly used for
instrument and data maintenance. Please refer to “Chapter 7 Maintenance” for more
information about it.
5.9 System Parameter
Click “SysPara” in main interface to enter “system parameter” interface which is used for
parameter setup. “System Parameter” interface is composed of eight interfaces, “System”,
“User”, “Operator”, “Dictionary”, “Print”, “BarCode”, “ISE” and “LIS”.
NOTE
The “BarCode” and “LIS” interfaces are invisible if the system not configure
barcode and ISE modules.
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5.9.1 System Parameter
Click “System” in “System parameter” interface to enter “System” interface which is used
for configuring accessories, selecting version pattern and serial port.
5.9.2 User Setup
Click “User” in “System parameter” interface to enter “User Setup” interface which is used
for setting hospital’s name, address, telephone number, ward, department, doctor etc.
5.9.3 Operator Setup
Click “Operator” in “System parameter” interface to enter “Operator Setup” interface which
is used for setting user’s name, user ID and password etc.
5.9.4 Dictionary
Click “Dictionary” in “System parameter” interface to enter “Dictionary” interface which is

used for setting sample type, result type, sample state, qualitative result and age unit etc.
5.9.5 Print Setup
Click “Print” in “System parameter” interface to enter “Print Setup” interface which is used
for setting the information to display.
5.9.6 Bar Code Setup
Click “BarCode” in “System parameter” interface to enter “Bar Code Setup” interface
which is used for setting the format and code system of sample and reagent barcode.
5.9.7 ISE Setup
Click “ISE” in “System parameter” interface to enter “ISE Setup” interface which is used for
setting ISE.
5.9.8 LIS Setup
Click “LIS” in “System parameter” interface to enter “LIS Setup” interface which is used for
setting LIS.
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CHAPTER 6 QUALITY CONTROL ANALYSES AND

CALIBRATION
6.1 General Information
The reliability of test result is determined by two aspects: One is the precision, which
means test results are stable in repeatability. Precision can be guaranteed by establishing
perfect room quality control system; the other one is accuracy, which means test results
close to target value. Accuracy can be guaranteed by proper method and calibration. It is,
therefore, necessary to select certified control sample and calibration solution, and use
them strictly according to their instructions.
6.2 Quality Control
6.2.1 Type of Quality Control Materials
1) Freeze-dry control, liquid control and mixed control serum, classified according to
physical property.
2) Fixed value and non-fixed value control sample, classified according to the presence
and absence of fixed value. Different inspection body can choose more than one
quality control as quality control.
6.2.2 Use and Storage
1) Use control sample following the Instructions for Use provided by control supplier.
2) Make sure the quality of control solution redissolved from freeze-dry control sample is
stable.
3) Make sure the dilution ratio is accurate and consistent each time redissovling
freeze-dry control sample.
4) DO NOT shake control sample fiercely when redissovling freeze-dry control sample.
49
5) Store control sample according to requirement. DO NOT use expired product.
6) Perform QC analyses under the same operating conditions as that of sample

analyses.
6.2.3 Setup of Target Value, SD and Control Limit
QC target value and control limit are usually provided by the control samples supplier, also,
you can determine them through the following methods:
1) Setup of interim target value (mean value) and SD
Perform QC analyses at least 20 times with a new batch of control sample. Calculate
the mean value and standard deviation from the obtained QC data.
2) Setup of regular target value (mean value) and SD
Obtain the accumulated mean value of original 20 QC data as the target value while
the accumulated mean value of 3~5 month QC data as the standard deviation.
3) Setup of control limit
Control limit is the multiplier of standard deviation. Control limit of analytical item is
determined according to different QC rules.
6.2.4 QC Procedures
QC procedure consists of two systems; they are “Chemistry QC Management” and “QC
Analyses”. Select “Chemistry QC Management” in the “Chemistry Analyses”, its function is
setup the parameter before QC Analyses and process the QC data, such as setup the QC
target value, QC batch number and SD value etc. Select “QC Analyses” in “Special
Analyses” to begin QC Analyses, QC data will saved in system automatically and a QC
diagram will generate for chemistry analyses; QC Analyses could be add to routine test
interface. See 4.2.5 for application of QC Analyses.
6.3 Quality Control Method
6.3.1 Levey-Jennings Method
1-2S rule exceed the average value ±2SD is judged as out of control.
1-3S rule exceed the average value ±3SD is judged as out of control.
6.3.2 Westgard QC Rule
1-2S Warning
1-3S Random Error
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2-2S Systematic Error

R-4s Random Error
4-1S Systematic Error
10X Systematic Error
Figure 6.3-1 Westgard Method of Multi-rule Quality Control
1-2s Rule: When one QC result exceeds ±2SD, regard as “warning” into next standard.
Figure6.3-2, 1-2s QC rule
1-3S Rule: When one QC result exceeds ±3SD limit, this is judged as random error.
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2-2S Rule: The QC result of two successive are both exceed +2SD or -2SD, this is judged
as systematic error.
Figure 6.3-4, 2-2s QC rule
R-4s rule: When one QC result exceeds mean value +2SD, and the other exceeds -2SD,
this is judged as random error.
Figure6.3-5, R-4s QC rule
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4-1s rule: When four consecutive QC results exceed +1SD or -1SD, this is judged as
systematic error.
10X Rule: When 10 consecutive QC result fall on the + or – side, this is judged as
systematic error.
Figure6.3-7,10x qualify control rule
6.3.3 Reasons of Random Error
Below are the possible reasons of random error.
1) Inaccurate dispensing volume (sample, reagent)

Aspirating mechanism is leakage; air bubbles in flow path; contaminated probe;
deflective injection of reagent, etc.
2) Optical system failure

Lamp is faulty.
3) Metamorphic Reagent
Metamorphic Reagent
4) Adverse quality-control samples

Use of wrong control sample;
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5) Inadequate wash
Stirrer wash is inadequate.
6) Adverse mixture
The depth of stirrer to cuvette is excursion; stirrer mechanism faulty.
6.3.4 Reason of Systematic Error
1) Inaccurate standard
The dissolvent of standard solution is inappropriate
2) Metamorphic reagent
The reagent is metamorphic, and the batch number is various.
3) Temperature
The temperature control is inappropriate
6.4 How to Deal With Out-of-Control
1) Fill in Out-of-Control report and report to your lab supervisor.

2) Simply and quickly review the operating procedure to find out the possible reasons.
3) If no evident error is found, move to the following steps for further checkup.
 Retest the out-of-control item by using the same bottle of control sample. Strictly obey
the operation flow to check if the out-of-control is due to operation incorrectly or
random error. If retest result falls outside the acceptable range, proceed to the next
step.
 Retest the out-of-control item by using a new bottle of control sample (same lot). If
retest result is in control, the previous bottle of control sample may be to blame. If
retest result still falls outside the allowable range, proceed to the next step.
 Retest the out-of-control item by using a new lot of control sample. If retest result is in
control, the previous lot of control sample may be deteriorated. Then check the
expiration date and storage condition. If retest result still falls outside the allowable
range, proceed to the next step.
 Perform instrument maintenance; retest the out-of-control item. Check the instrument
state; check whether the light source is changed or not; and whether the cuvette need
to wash or replaced. Furthermore, replacing reagent. If the retest result still falls
outside range, proceed to the next step.
 Recalibration and retest out-of-control item. Perform calibration by using new

calibrating solution. Proceed to the next step if the result still falls outside range.
 Obtain technical help. If you cannot get the in-control result after performing the above
five steps, contact reagent manufacturer or NEOMEDICA to get more technical
support.
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6.5 Calibration and Procedures
Calibration solution contains the known quantity object, which is used for calibrating the
value of this method; the calibration solution is concerned with the method, reagent and
instrument. The function of calibration solution is to reduce or eliminate systematic error
caused by instrument and reagent. It should be better to use human serum matrix to
reduce matrix effect.
6.5.1 When to calibrate
It is suggested to perform calibration every six months or under the following situations:
 When initially installing and running the instrument.
 When changing reagent batch number or type, unless specified by the lab that the
change will not influence the precision.
 After replacing the major components, such as lamp, sampling mechanism, probe, or
cuvette etc.
 After performing a preventive maintenance on the instrument.
 When control result shows abnormal offset, tendency, or falls out of the acceptable
range and it cannot be corrected by routine tests.
6.5.2 Calibrate Procedures
There are two ways to carry out calibration:
1) Applying standard analyses in “Special Analyses”
Select “Special Analyses” to applying standard analyses for each item, analytical data
will save in system automatically and for analyzing.
2) Select the item which need to be calibrated in “Routine Item Parameter”
a) Input and save the concentration value of calibration material into the standard
column.
b) Enter “Routine Analyses” interface, if “Concentration of Standard Material” has

been input when setup the parameter of analytical item, the selection of this item
will be appeared in the “Standard list”.
c) Select the item in the “Standard” list for standard analyses. Analytical result will
be processed and saved automatically and to be the standard of this item
(standard factor).
NOTE
See 4.2.5 for standard application and Test.
55
NOTE
System default the value of “Standard Factor” as 1 when newly built a item;
and system will calculate the result according to the standard factor “1” if not
modified.
NOTE
It is suggested that all calibration work should be written down and complied
into documents. What should be emphasized is that the fixed-value control
serum should never be used as standard solution.
NOTE
The calibration cycle could be set manually or automatically.
CHAPTER 7 MAINTENANCE
This chapter is mainly introducing the knowledge of maintenance; involve the

maintenance of main components.
7.1 Reset
Operator could perform reset manually to make the analyzer return to normal from the
trouble when fail to initialize.
1) Click “Maintenance” in main interface to enter “Maintenance” interface.

2) Select “Reset”.
3) Click “Execute”, the system perform reset automatically.
7.2 Probe and Stirrer Rinse
“Probe and Stirrer Cleaning” is to rinse the probes and stirrers. It is aimed at ensuring
cleanness and avoiding resides in tubing.
2) Select “Probe and Stirrer Cleaning”, and click “Execute”, then a “Probe and Stirrer
Cleaning” dialog will be appeared, see figure 7.2:
56
Figure 7.2
3) Input the wash times.
4) Click “Wash”, the system will wash automatically.
NOTE
Please perform at least 5 times rinse when turn on and turn off instrument.
7.3 Cuvette Rinse
“Cuvette Rinsing” is to rinse the cuvette. It is aimed at keeping cleanness and avoiding
solution resides.
2) Select “Cuvette Rinsing”, and click “Execute”, then a “Cuvette Rinsing” dialog will be
appeared, see figure 7.3:
57
Figure 7.3
3) Click “Reaction Cuvette Cleaning” to wash all cuvettes.
The function of main keys:
Reaction Cuvette Cleaning: Wash all cuvettes.
Water Injection: Fill all cuvettes with distilled water.
Pump Water: Pump off all the distilled water from cuvette. (The function is effective only
there is water in the cuvette)
7.4 Cuvette Signal
“Cuvette Signal” is aimed at eliminating the difference among cuvettes. System test and
save blank absorbance of each cuvette separately also participate calculation of
retrospective chemical test.

2) Select “Cuvette Signal”, and click “Execute”, then the “Cuvette Signal” dialog will be
appeared, see figure 7.4:
Figure 7.4
3) Click “Fill Water”.
4) Click “Cuv. Blank Reading” when the system finishes filling water.
5) Click “SAVE” to save the results.
58
The function of main keys:
: Page turning, display absorbance of 15 cuvettes and totally 120.
Fill Water: Full filled all cuvette with distilled water
Cuv. Blank Reading: Reading the absorbance of all cuvette and result will not be saved
SAVE: Repeat reading absorbance of all cuvette, averaged value and save them.
RETURN: Return “Maintenance” interface.
7.5 Reading of A/D Value
CAUTION
1) This function only for the personnel who authorized by NEOMEDICA to
debugging.
2) NEOMEDICA is not responsible for any consequence resulting from

changed A/D values without permission or authorization by NEOMEDICA.
“A/D Value” is to determine whether the cuvette is clean or not; or to judge whether the
light source is attenuated to threshold or even lower; and to check whether the
fibre-optical is broken, or the problem of low transmittance. The clean level and light
intensity of lamp will directly influence the stability of absorbance of the analyzer.

2) Select “A/D Value”, and click “Execute”, then the “A/D Value” interface will be
appeared.
3) Reading A/D signal value after the signal is stability.
7.6 ISE Maintenance
Before performing ISE maintenance, please check if your system is equipped with ISE
module.
User could perform ISE maintenance to make sure the ISE module work properly in this
interface. See figure 7.6:
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Figure 7.5
The ISE maintenance interface includes “ISE Calib”, “WASH”, “Pump Calibration”, “Bubble
calibration”, “Maintenance” orders etc.
The function of main keys as follows:
Key Function
Query reagent Send the order for querying reagent, reading reagent information and
refreshing the state of new reagent.
Replace reagent module The system prompts whether to replace reagent module after clicking
this button. And the system will refresh automatically the state of
reagent after replacing reagent module and clicking “OK”.
Replace component Select a component in “ISE Maintenance” interface, then click this
button, the “Replacing component” dialog will be appeared. The system
will refresh the state of component after replacing.
Return Return “Maintenance” interface.
7.6.1 ISE Calibration
ISE calibration is to calibrate the ISE electrode.

2) Select “ISE Maintenance”, and then click “Execute”, the “ISE Maintenance” interface
will be appeared.
3) Select “ISE Calib”, and then click “Execute”, a confirmation dialog will be appeared.
4) Click “OK” start to ISE calibration. The status box will close automatically after
finishing.
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7.6.2 Wash
The wash order is to clear away the protein on the electrode.

will be appeared.
3) Select “Wash”, and then click “Execute”, system starts to wash the ISE electrode. The
status box will close automatically after finishing.
7.6.3 Pump Calibration
The order of pump calibration is to calibrate the peristaltic pump of ISE module.

will be appeared.
3) Select “Pump Calibration”, and then click “Execute”, system start to calibrate
peristaltic. The status box will close automatically after finishing.
7.6.4 Bubble Calibration
The order of bubble calibration is to calibrate the bubble detector to make sure the
accuracy.

will be appeared.
3) Select “Bubble Calibration”, and then click “Execute”, the system starts to calibrate.
The status box will close automatically after finishing.
7.6.5 Maintenance
The order of maintenance is to repair ISE module.

will be appeared.
3) Select “Maintenance”, and then click “Execute”, a dialog box will be appeared.
4) Click “OK” start to maintenance. The status box will close automatically after finishing.
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7.7 Maintenance of Barcode Scanner
Before performing barcode scanner maintenance, please check if your system is equipped
with barcode scanner module.
The maintenance of barcode scanner is to make sure the barcode work properly.
7.8 Daily Maintenance
1) Before daily work, verify that detergent and distilled water are enough for your
analyses. If insufficient, replenish the detergent barrel and distilled water barrel.
2) Empty the waste barrel if waste solution exceeds the warning line marked on the
waste barrel.
3) Check the mechanical movement of aspirating probe and stirrer. Check if probe is
clogged or not. Inspect the exterior of probes and stirrer for contamination and dirty.
Clean them if necessary.
Biological Hazard
Put on protective gloves to avoid contacting chemical solution. If it spill to

human body, wash it off with water immediately consult doctor if necessary.
4) Perform at least 5 times “aspirating probe and stirrer rinse” and one time “cuvette
rinsing”. Consult 7.2 and 7.3 for details.
5) Wash ISE module and calibrate pump. Consult 7.6.2 and 7.6.3 for details.
6) Perform “Water Injection” before power off to guarantee the cuvette full of distilled
water. See 7.3 for specific operation.
7.9 Weekly Maintenance
1) To reduce cross-contamination, it is necessary to wash aspirating probe and stirrer

weekly. Probe and stirring rod can be washed automatically through the maintenance
procedure, or manually according to following steps:
a) Preparing items: Alcohol, Fabric, nozzle cleaner.
b) Wipe the exterior of aspirating probe and stirrer using a fabric moistened with
alcohol.
c) Introduce nozzle cleaner from the probe end to clean it.

2) Rinse the needle according to the method that rinses the aspirating probe and stirring
rod.
62
NOTE
Take care not to bend or scratch the probe when cleaning them.
3) Select “Cuvette Signal” to check if cuvette blank value is within acceptable range or
not. If outside the range take out the relevant reaction cuvettes together with the
cuvette racks from the reaction tray. Observe the cuvettes carefully and replace them
if necessary.
NOTE
To get optimum data, do not read the cuvette blank until the light source lamp is
stable. It may take 25 minutes to complete a warm up time.
NOTE
Be careful not to scratch the reaction cuvettes when taking them out.
Biological Hazard
Put on protective gloves to avoid contacting chemical solution. If it spill to

human body, wash it off with water immediately.
4) Clean the window of sample/reagent barcode scanner according to following steps:
a) To make sure the test switch is off.

b) Take off the covers of sample tray and reagent tray, and then take out sample
tray and reagent tray.
c) Wipe the windows softly using a fabric moistened with distilled water.
d) Reload the sample tray, reagent tray and covers.
CAUTION
1) DO NOT directly look at the light emitting from the lamp source when the
barcode scanner is in work.
2) DO NOT touch the window with sharp objects.
5) Turn off the refrigeration switch of the instrument. Using fabric moistened with water
or detergent; wipe the instrument’s panel board.
CAUTION
Operate carefully to avoid scratch to instrument.
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7.10 Monthly Maintenance
1) Do as weekly maintenance.
2) Check flow paths and tube connectors for leakage or clogs.
7.11 Longtime Disuse Maintenance
If instrument has been disused over two days, perform the following steps before turning
off and after starting up.
1) Empty the tubes (but it’s depends on circumstance to empty the circular fluid), distilled
water barrel, waste solution barrel, detergent bottle, and wash clean the barrels before
turning off.
2) Clean distilled water barrel and detergent bottle before turning on. Add new distilled
water to distilled water barrel, meanwhile, add detergent to detergent bottle.
3) Enter the maintenance program to wash the flow paths and cuvettes at least twice.
7.12 Preventive Maintenance
Periodic checkup and inspection ensure the instrument performance. It is recommended,

therefore, to carry out preventive maintenance periodically.
The preventive maintenance includes not only checkup and repair, but also the following.
1) Routine checkup and periodic checkup.
2) Periodic maintenance for parts subjected to long-term use or abrasion.
3) Secure a sufficient quantity of spare parts.
4) Improvement and control of operating conditions, such as temperature, humidity,

water quality, dust and gas, insects, foreign matter, etc.
7.13 Replace Component
7.13.1 Replace Lamp
The lamp is aging gradually during use, and it will lead to increase the noise in
measurement. If the cuvette blank and light intensity are out of its range or the lamp works
more than 2000 hours, please replace it.
CAUTION
64
It’ must be approved by NEOMEDICA to replace lamp. Replacing the

components by service personnel who authorized by NEOMEDICA or under the
guidance of NEOMEDICA’s engineer.
7.13.2 Replace Tube
The replacement of tube is only performed by service personnel who authorized by

NEOMEDICA. If it’s necessary, please contact NEOMEDICA.
7.13.3 Replace Cuvette
It suggests replacing the cuvettes and brackets for every three months. The operations of
replacing single cuvette as following:
1) Screw off the fixed screws on the cuvette bracket.

2) Take out cuvette bracket.
3) Pull upward the cuvette gently from bottom, and take out cuvette.
4) Put the new cuvette into bracket, and confirm it’s not loose.
5) Put the cuvette bracket to the incubation slot, the location hole fixed to location pin.
6) Screw on fixed screws and tighten.
CAUTION
1) DO NOT touch the smooth walls of cuvette to avoid leaving any fingerprints
behind. If it is polluted, the test result may be inaccurate.
2) It suggests replacing cuvettes and brackets together, if most of cuvettes are
polluted.
7.13.4 Replace Vacuum Pump
The replacement of vacuum pump is only performed by service personnel who authorized
by NEOMEDICA. If it’s necessary, please contact NEOMEDICA.
7.13.5 Replace Solenoid Valve
The replacement of solenoid valve is only performed by service personnel who authorized
by NEOMEDICA. If it’s necessary, please contact NEOMEDICA.
7.13.6 Replace Aspirating Probes
The replacement of aspirating probe (Sample probe and reagent probe) is only performed
by service personnel who authorized by NEOMEDICA. If it’s necessary, please contact
NEOMEDICA.
65
CHAPTER 8 TROUBLESHOOTING
This chapter lists the various malfunctions, along with probable causes and recommended
remedies to correct the problem quickly and easily. If the problem still exists after following
the recommended remedy, contact NEOMEDICA for Technical support.
CAUTION
Handle malfunction with utmost care and confirm if it is necessary to cut off the
power supply at the first.
Biological Hazard
Put on protective gloves to avoid contacting chemical solution. If it spill to human

body, wash it off with water immediately.
8.1 Troubleshooting Guide
To eliminate malfunction easily and correctly, users should read through the Operating
Manual and be familiar with the routine operation and maintenance of analyzer.
In general, there are three steps to handle with malfunction:
66
 Step 1: Confirming Malfunction
Users should not only confirm the malfunction, but also clearly know what the normal
status should be when the malfunction is eliminated.
 Step 2: Classifying Malfunction
Malfunction can be categorized into three types.
 Malfunction relating to hardware

 Malfunction relating to software
 Malfunction relating to operation and analyses.
If malfunction relates to the hardware or software, contact your local distributor or

NEOMEDICA. If malfunction relates to the operation and analyses, refer to the
troubleshooting table below for solution.
 Step 3: Eliminating Malfunction
The maintenance engineer authorized by NEOMEDICA takes proper measures to correct

the problem.
Users can also eliminate the malfunction under the directions of maintenance engineer.
8.2 Obtaining Technical Help
Our Customer Service Office is available to help if the problem is beyond the scope of this
manual or if you need more technical assistance from NEOMEDICA. Before calling,
please identity the following information:
1) The instrument’s model;

2) The serial number of instrument;
3) The specific symptom and operating condition;
4) The data and report relating to the problem.
8.3 Troubleshooting Method
The troubleshooting table below presents the various problems and malfunctions that may
occur during operation. If the problem can not be solved through the recommended
methods, contact NEOMEDICA please.
NOTE
For replacing parts of the instrument, refer to Appendix A.
Table 1 Troubleshooting
67
SN PHENOMENON POSSIBLE CAUSE REMEDY

1) Connect power cord correctly.
2) Check if the power receptacle is in
1) Incorrect connection with
good condition.
power cord.
3) Replace fuse(8A)
2) No electricity with power
Instrument is not 4)Confirm select the correct connector at
receptacle.
1 active when power [System parameter—instrument
3) The safety fuse is fusing
is on. parameter— COM set]
4) Improper COM interface is
5) Make sure the RS232 communication
selected.
cable is connected to PC correctly.
5) Communication cable error.
If the problem still persists, contact your
local distributor or NEOMEDICA.
1) Select [Maintenance—Cuvette rinse],
Check if reaction cuvettes are dirty or
Cuvette dirty or damage damage. Replace them if necessary
2 Cuvette blank error
Light source aging 2) Replace light source.
3) If the problem persists, contact your
1) Check or replace the lamp holder
1) Bad contact of lamp holder. 2) Replace the lamp.
3 Lamp is dark
2) Lamp is burned out. 3) If the problem persists, contact your
1) Check flow path tubes. Reconnect or
replace tubes if necessary.
1) Air leaks in the flow paths. 2) Reconnect meter regulator. Eject air
Inaccurate aspirated 2) Air bubbles are formed in bubbles.
4 volume of reagent or meter regulator. 3) Unclog or replace probe.
sample. 3) Probe is clogged. 4) Check magnetic valve and replace it if
4) Magnetic valve problem. necessary.
Water or detergent 1) Reconnect the tube or replace it.
1) Flow path tube is leaky.
does not come out 2) Unclog the tube.
2) Flow path tube is clogged.
5 through the probe 3) Replenish water or detergent.
3) Water or detergent is used
washing pool or 4) If the problem persists, contact your
up.
stirrer washing pool. local distributor or NEOMEDICA.
1) Reconnect the tube or replace it.
2) Unclog the tube.
1) Flow path tube is leaky.
Adding or draining 3) Check the vacuum pump and replace it
6 2) Flow path tube is clogged.
water is abnormal if necessary.
3) Vacuum pump error.
1) Check the wire of light coupling or
A certain movable Light coupling is short circuited
7 replace the light coupling.
part is out of control. or broken.
68
1) Check the liquid level sensor board and

1) Liquid level sensor board is replace it if necessary.
Liquid level sensor defective. 2) Reconnect the liquid level sensor
8
is out of order 2) Bad contact with liquid level board.
sensor board. 3) If the problem persists, contact your
1) Select “maintenance” –-- “cuvette rinse”
to check whether cuvette is dirty. Clean or
1) Cuvette is dirty or breakage. replace the cuvette.
2) Inaccurate aspirated volume 2) Check sample injector and tube
of reagent or sample. whether leakage existed.
Inaccurate test 3) Lamp is deteriorated. 3) Replace the lamp.
9 result or poor 4) Parameters of analytical 4) Set the parameter follows the operation
repeatability. item are set improperly. manual. Make sure the instrument is well
5) Ground wire is absent with grounded by means of the ground pole.
power supply. 5) Check if the reagent is certified.
6) Reagent problem. Perform recalibration.
1) Turn the refrigeration switch off, slowly
rotate the problem parts and observe if
there is abnormal noisy or if it is stuck.
1) Communication error.
2) Enter into system parameter” interface,
2) Mechanical parts are loose
select “Engineer set” to adjust parameter.
Abnormal motor or stuck.
10 (Only accessible to professional person
movement 3) Light coupling joint of motor
authorized by NEOMEDICA).
is loose.
3) Check the light coupling and replace it if
4) Light coupling is defective.
necessary.
1) Replace the stirrer motor.
Stirrer does not 1) Stirrer motor is broken. 2) Reinstall the stirrer motor.
11
work. 2) Bad contact of stirrer circuit. 3) If the problem persists, contact your
1) Check the flow path tube. Reconnect or
replace the tube if necessary.
2) Check the magnetic valve and replace
Water leaks from 1) Flow path tube is leaky.
it if necessary.
12 nozzles of cuvette 2) Magnetic valve problem.
3) Check the vacuum pump and replace it
cleaner. 3) Vacuum pump problem.
if necessary.
69
1) Check the flow path tube. Reconnect or

replace the tube if necessary.
1) Flow path tube is leaky. 2) Check the magnetic valve and replace
Water drops adhere 2) Magnetic valve problem. it if necessary.
13
to the tip of probe. 3) The exterior of probe is dirty 3) Check the exterior of probe. Clean or
or scathed. replace the probe if necessary.
1) Check if the reagent tray is sealed
completely.
2) Check if the heat dissipation device
works normally.
The cooling system is failed or
Reagent tray can 3) Check if the refrigerants are used up.
14 cooling temperature is not low
not be cooled. 4) Check if the circulation system of the
enough.
cooling device works normally.
5) Replace the peltier.
1) Enter into system parameter” interface,
select “Engineer set” to adjust parameter.
(Only accessible to professional person
1) Instrument parameters are
authorized by NEOMEDICA).
set improperly.
2) Read through the Operating Manual
2) Human carelessness, such
and avoid human mistake.
as reagent bottle lid is not
Probe and stirrer 3) Do not put foreign objects on the
15 opened.
collision operation panel.
3) Put foreign objects on the
4) Check if the motor is installed and
operation panel.
works properly.
4) Motor problem.
5) Check the light coupling and replace it if
5) Light coupling error.
necessary.
70
CHAPTER 9 STORAGE AND TRANSPORTATION
9.1 Storage
The wrapped instrument should be stored at a ventilated room, with temperature range
from -40℃ to 55℃, ambient humidity not exceeding 95%. DO NOT store the instrument
along with any poison or corrosive. The instrument stored for over one year may fall short
of the precision of measurement. Therefore, it is suggested to perform mechanical
calibration and alignment procedure when using the instrument.
CAUTION
Please contact NEOMEDICA to perform calibration for mechanism of the

instrument.
9.2 Transportation
The transportation must strictly follow the terms and conditions specified in the order
contract.
Do not ship the instrument along with any poison or corrosive.
CAUTION
Under the packing sound condition, the transport temperature is -40℃~55℃

and the relative Humidity is ≤95%.
71
Appendix A Replaceable component
SN Name Remark
1 Fuse T8AL 250V
2 Reaction Cuvette Replacing the cuvettes every 3 months or by needs
3 Reaction Cuvette bracket Replacing the cuvettes every 3 months or by needs
Replacing when its using time exceeded 2000 hours
4 Light Source Lamp
or system prompt to replace
5 Teflon Tube
6 PU Tube
Sample probe, reagent probe; replacing when it is
7 Probes
damaged or bend
8 Step Motor Replacing when it is failure
9 Vacuum Pump Replacing when it is failure
10 Solenoid Valve Replacing when it is failure
11 Temperature Sensor Replacing when it is failure
12 Temperature Controller Replacing when it is failure
Replacing when its working time exceeded 40,000
13 Cooling fan
hours
Main Replaceable Optional Accessories
14 K electrode（optional）
15 Li electrode（optional）
16 Na electrode（optional）
17 Cl electrode（optional）
18 Reference electrode（optional）
19 Isolation electrode（optional）
NOTE
Please use the replaceable component provided by NEOMEDICA. Replacing the

components by service personnel who authorized by
NEOMEDICA.NEOMEDICA is not responsible for any consequences resulting
from using parts or accessories not specified by NEOMEDICA.
72
NOTE
This replaceable component list just for reference. NEOMEDICA reserves the
right to change the list without notice.
73

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Neo Chem 40

Automatic Chemistry Analyzer

COPYRIGHT AND DECLARATION .......................................................................................... 1

CHAPTER 1 SAFETY GUIDELINES......................................................................................... 4

1.1 Safety Cautions ................................................................................................................ 4

1.2 Using Precaution .............................................................................................................. 6

1.3 Installation ....................................................................................................................... 10

1.3.1 Instrument Inspection ............................................................................................... 10

1.3.2 Installation Requirement .......................................................................................... 10

1.3.3 Location Requirements ............................................................................................. 11

1.3.4 Power Requirements ................................................................................................ 11

1.3.5 Instrument Connection ............................................................................................. 12

CHAPTER 2 INSTRUMENT INTRODUCTION ....................................................................... 14

2.1 Brief Introduction............................................................................................................. 14

2.2 Intended Use .................................................................................................................. 15

2.3 Main Structure ................................................................................................................ 15

2.3.1 Performance and Composition ................................................................................ 15

2.3.2 Top View ................................................................................................................... 16

2.3.3 Rear View ................................................................................................................. 16

2.3.4 Function of Main Part ............................................................................................... 17

2.4 Function and Specification ............................................................................................. 17

2.5 Technical Parameter ....................................................................................................... 19

CHAPTER 3 MEASURING PRINCIPLE.................................................................................. 21

3.1 Principle .......................................................................................................................... 21

3.2 Test Methods................................................................................................................... 21

3.2.1 Endpoint method ...................................................................................................... 21

3.2.2 Two-point Method..................................................................................................... 22

3.2.3 Rate Method (Kinetic Method) ................................................................................. 23

CHAPTER 4 OPERATION ....................................................................................................... 24

4.1 Operating Step................................................................................................................ 24

4.1.1 Operating Step ......................................................................................................... 25

4.1.2 Start up ..................................................................................................................... 25

4.1.3 Create Standard Curve ............................................................................................ 26

4.1.4 QC Test .................................................................................................................... 26

4.1.5 Test Patient’s Sample............................................................................................... 26

4.1.6 Finish ........................................................................................................................ 27

4.2 Basic Operation .............................................................................................................. 27

4.2.1 Check Before Powering On ..................................................................................... 27

4.2.2 Power On ................................................................................................................. 27

4.2.3 Starting the Operating Software .............................................................................. 28

4.2.4 Preparation of Reagent ............................................................................................ 28

4.2.5 Preparation of Sample, Standard Solution and Detergent ...................................... 29

4.2.6 Registration of Standard and QC ............................................................................. 30

4.2.8 Analyses ................................................................................................................... 31

4.2.9 STAT Analyses ......................................................................................................... 31

4.2.10 End of Analyses ..................................................................................................... 31

4.3 Obtain Result .................................................................................................................. 32

4.3.1 Registration of Sample Information ......................................................................... 32

4.3.2 Modification of Test Result ....................................................................................... 32

4.4 Query of Analytical Result .............................................................................................. 32

4.5 Analytical Curve Display ................................................................................................. 33

4.6 Database Maintenance ................................................................................................... 33

4.6.1 Database Backup ..................................................................................................... 33

4.6.2 Database Reduction ................................................................................................ 33

4.6.3 Automatic Backup .................................................................................................... 33

CHAPTER 5 OPERATION ....................................................................................................... 34

5.1 System Menu .................................................................................................................. 34

5.2.1 Sample ..................................................................................................................... 34

5.2.2 Standard ................................................................................................................... 36