Manual de Operaciones

TC Series Automatic Biochemistry Analyzer (TC6030)
User Manual
Tecom Science Corporation
Contents
Preface and Safety 1. System Introduction 1.1 Brief Introduction .. 1-1 1.2 Reagent1-6 1.3 Calibrator & Control1-7 2. Installation 2.1 Preparation 2-1 2.2 Installation2-5 3. System Description 3.1 System Structure 3-1 3.2 Software Operations 3-4 4. Basic Operations 4.1 General Operation Procedure 4-1 4.2 Operation Rule 4-2 5. Advance Operations 5.1 Work Menu 5-1 5.2 Menu Introduction 5-4 6. Instrument Maintenance 6.1 Maintenance 6-1
Preface
Thank you for purchasing TC series Chemistry Analyzer TC6030.
Before using the Chemistry Analyzer TC6030, please read this operation manual first, and understand the relevant operation instructions.
Please keep this manual properly for convenient use.
To ensure the safe operation, please read the following notes

This user manual contains all the optional fittings and optional functions (sell separately), if you do not purchase them, you can just skip that content. Chemistry Analyzer TC6030 is intended for in vitro diagnostic use in clinical laboratories and designed for quantitative determination of clinical chemistries in serum, plasma, urine and cerebrospinal fluid samples. Please consult us first if you want to use it for other purposes. The Chemistry Analyzer is to be operated only by clinical professionals, doctors or experimenters trained by TECOM or appointed distributors. Please do not try methods not indicated by this manual, for it may lead to unreliable results and even device damage. While operating, please first check whether this analyzer works normally by testing QC material. Information on the storage requirement (both for sealing and unsealing), usage and precaution for reagent, QC materials and calibration liquid, please refer to this manual provided by TECOM. Please do not try to disassemble or reassemble the unit of Chemistry Analyzer TC6030 for it may lead to unreliable results and even device damage. To disassemble or reassemble the unit, please contact our Customer Service Department or appointed distributors Assembling, augment, reassembling, improvement and repair of the analyzer should be conducted by the technicians approved by TECOM. Otherwise, we shall not be responsible for the damage The power switch must be easy to reach and be convenient and safe to power the analyzer off. Do not place the analyzer at a site that is difficult to power on and off. The analyzer is not for family use. The analyzer is not for outdoor use.
Product Information
Sign Meaning Description
In Vitro Diagnostic equipment CE is the sign EU protect in accord, CE marking. product should comply with the
requirement of Directive 98/79/EC. Authorized Representative in the
European Community Measurement sign
Serial Number
Date of Manufacture
Manufacturer
Warning Admonish users pay attention to the potential dangers, electronic rubbish, easy to pollute environment. Fragile mark
Contact the manufactory to recycle or deal with them according to the demand of local government.
Guard against damp
This side up
Copyright & Declaration

Tecom Science Corporation has the copyright of this unpublicized manual and has the rights to treat it as confidential data. This manual is only used as references for operating and maintaining analyzer or other TECOM products. Others have no rights to make it public.
This manual contains some proper data protected by the copyright law. It can not be duplicated, or translated into other languages without written consent from Jiangxi Tecom Science Corporation.
TECOM does not make any guarantee to this material, including guarantee responsibility of implied merchantability proposed to it for some specific purpose. Tecom is not responsible for the mistakes in the material and the accidental or indirect loss caused by the actual use of this manual.
The display figure in this book may be a little different from the actual one.
Due to the upgrade of products, sometimes there would be some situations in which products disagree with the content of this manual, please pardon us for not giving notice separately.
TECOM assumes no responsibility for the computer operating systems used by users or the use involved copyright of other enterprises.
Warranty Policy
Warranty period
One year from the date of complete installation or conforming to the contract stipulations.
Guarantee
Tecom should take responsibility for security, reliability and performance of analyzer while the following requirements are met: 1. Assembling, augment, readjustment, improvement and repair should be conducted by technician authorized by Tecom. 2. 3. Concerning electric equipment meets national standard. Chemistry Analyzer TC6030 is operated according to the operation manual.
Tecom will supply customers free repair service when the breakdown is caused by the defect of our design or manufacturing during the guarantee period, and adopt relevant maintenance solutions according to trouble.
Non-guarantee Items
If the following situations occur, it is not included in the guarantee range even within guarantee period: 1. The trouble caused by operating chemistry analyzer beyond the requirements of operating environment mentioned in this operation manual. 2. The trouble caused by improper maintenance or maintaining companies which are not appointed by Tecom. 3. The trouble caused by not replacing the consumables or spare parts that have life period in time. 4. The trouble caused by using hardware, software or assistant products not supplied by Tecom. 5. The trouble caused by using reagent not authorized by Tecom. 6. Circuit corrosion, optics component aging in evidence by strong corrosive gas in the air. 7. The trouble caused by using condemned instrument or buy secondhand instrument without connecting with Tecom. 8. The data loss caused by instrument damage (data backup or exporting are recommended). 9. The trouble caused by the methods of removing, transporting, installation of chemistry analyzer that go against with the operation manual. 10. The trouble caused by self disassembly or reassembly instrument. 11. The trouble caused by fire, earthquake, wind harm, flood, lighting strike, crime, terrorism, war and other irresistible natural disasters. 12. The trouble caused by other improper operations that go against with the operation manual.
Use and Storage Environment

The service department appointed by our company carries on the installation at purchasing time. Analyzer should only be used when the following conditions and the corresponding environment are met.
1. Safety conditions
1) 2) 3) 4) Use indoor; The altitude height is lower than 3000 meters; The temperature is between 5~40; The maximum humidity is 80% when temperature is lower than 31; and the humidity drops to 50% by linear when temperature is 40; 5) 6) 7) Power supply voltage fluctuates within 10%; The typical transient voltage surge on the electrical net; Applicative class of rating pollution.
2. Normally working conditions

1) 2) 3) 4) 5) 6) 7) 8) 9) Use indoor; Power supply rating voltage: 100-240V 50/60Hz; Power supply rating voltage fluctuation: 110-220V10 50/60Hz1Hz; Work temperature: 10~35; Work relative humidity (extended condition): 90%, no dew; Storage temperature: -10~55 Storage relative humidity (extended condition): 95%; Altitude height is lower than 3000 meters; Class of pollution: class II.
3. Others environment conditions

1) 2) 3) Few dust and well-ventilated. Avoid direct sunshine. The room temperature should be kept between 10~35, and the fluctuation of room temperature shall be within 2 during testing. 4) It is prohibited to use the instrument in the environment where the humidity is above 90%. When the instrument is used in the environment where the temperature is below 10 or above 30, it is necessary to install an air conditioner. 5) 6) 7) No perceptible vibration. No acute fluctuation in power supply. There is no device generated high frequency wave nearby (like centrifuge, discharge equipment etc.). 8) There is sole grounding terminal (the grounding resistance should be below 10 ).
9)
The instrument is disturbed by electromagnetic waves. The data and operation mistakes may occur, thus, it must keep instrument far away high intensity electromagnetic wave generator.
10) The instrument should be stored in the environment where: the temperature is between -10and 55; the relative humidity is no higher than 95%; the altitude is under 3000m. And free of causticity gas, well-ventilated and clean.
Reader
Before using the analyzer, please read and understand this manual first. The below clinical laboratory professionals-----this manuals readers are as follows: 1. 2. 3. The person who operates TC series analyzer daily; The person who maintains TC series chemistry analyzer and handles troubles; The person who learns the operation of the TC series analyzer.
WARNING
This analyzer is operated by the people trained and authorized by Tecom company or our distributor only.
Service Department
Customer Service Department of Jiangxi Tecom Science Co., LTD Address: Telephone: Fax: Postal code: No. 555, Gaoxin Ave., National Hi-tech Industrial Development Zone, Nanchang, Jiangxi, P.R.China 86-79188111991 86-79188111989 330096
Operation Manual Use

This manual is TC series Automatic Chemistry Analyzer operation manual.
It mainly helps users to know the content covering operating principle, structure, operation, daily maintenance, simple trouble disposal, etc.
Analyzer should be operated according to this operation manual.
Safety Use Notes

Before using, please read Safety Use Notes and operation manual first and properly conduct the operation.
To ensure safe and proper operation and protect you and your possession from the damage, please read and understand below symbols and signs.
Please first fully understand their meaning, and then read the main body of this manual.
Signs & Meaning

Sign
Meaning
Alternating current shut
Description
down(electrical source cut) Alternating current turn
on(electrical source turn on) Alternating current source
Warning: risk of electric shock
Remind user to avoid shock
Warning: risk of burn
Remind user to avoid scald
grounding
equipotential Explain the important information in the operating process and some special operating Attention skills. Failure to observe the manual may lead to unreliable results or device damage. Read the statement following the symbol. The Warning statement is alerting you to an operating hazard that can cause personal injury Read the statement following the symbol. The Biohazardous Warning statement is alerting you to a potentially
biohazardous condition.
Helpful Explanation process Some Importance
information
during
the
operation
important
information
to
ensure
performance of the instrument and avoid damage
Safety Precautions
Observe the following safety precautions when using the Chemistry Analyzer. Ignoring any of these safety precautions may lead to personal injury or equipment damage.
WARNING
If the analyzer is used in a manner not specified by our company, the protection provided by the system may be impaired.
Preventing Electric Shock

Please observe the following instructions to prevent electric shock.
WARNING
When the MAIN POWER is on, users must not open the rear cover or side cover. Spillage of reagent or sample on the analyzer may cause equipment failure and even electric shock. Do not place sample and reagent on the analyzer. In case of spillage, switch off the power immediately, remove the spillage and contact our Customer Service Department or your local distributor.
Preventing Personal Injury Caused by Photometer Lamp

Please observe the following instructions to prevent personal injury caused by photometer lamp.
WARNING
Light emitted by the photometer lamp may hurt your eyes. Do not stare into the lamp when the analyzer is in operation.
If you want to replace the photometer lamp, first switch off the MAIN POWER and then wait at least 15 minutes for the lamp to cool down. Do not touch the lamp before it cools down, or you may get burned.
Preventing Personal Injury Caused by Moving Parts

Please observe the following instructions to prevent personal injury caused by moving parts.
WARNING
Do not touch such moving parts as sample probe, reagent probes, mixers and wash probe when the analyzer is in operation. Do not put your fingers or hands into any open parts when the analyzer is in operation. The moving parts will stop working when there is any mechanical faults; in order to prevent other faults, please switch off the power immediately, and contact our Customer Service Department or your local distributor.
Preventing Infection
Please observe the following instructions to protect against the biohazardous infection.
BIOHAZARD
Inappropriately handling samples, controls and calibrators may lead to biohazardous infection. Do not touch the sample, mixture or waste with your hands. Wear gloves and lab coat and, if necessary, goggles. In case your skin contacts the sample, control or calibrator, follow standard laboratory safety procedure and consult a doctor.
Handling Reagents and Wash Solution

WARNING
Reagents and enhanced wash solution are corrosive to human skins. Exercise caution when using the reagents and enhanced wash solution. In case your skin or clothes contact them, wash them off with soap and clean water. In case the reagents or wash solution spill into your eyes, rinse them with much water and consult an oculist.
Treating Waste Liquids & Waste Parts

Please observe the following instructions to prevent environmental pollution and personal injury caused by waste.
BIOHAZARD
Some substances in reagent, control, enhanced wash solution and waste are subject to regulations of contamination and disposal. Dispose of the waste in accordance with your local or national rule for biohazard waste disposal and consult the manufacturer or distributor of the reagents for details.
Dispose of the waste parts, such as reaction cuvette, sample tube or the analyzer in accordance with your local or national guidelines for biohazard waste disposal. While disposing of the waste parts or entire analyzer, wear gloves and lab coat and, if necessary, goggles.
Preventing Fire or Explosion

Please observe the following instructions to prevent fire and explosion.
WARNING
Ethanol is flammable substance. Please exercise caution while using the ethanol.
The surface of instrument adopts antiflaming material, when fire or explosion occurs; please use common civil products to quench the fire (using water or fire extinguisher).
Preventing Empyrosis
Please observe the following instructions to prevent empyrosis.
WARNING
Please dont touch the heat devices such as the heating water pot when the instrument is operating. After switching off the power supply, please wait at least 15 minutes for analyzer to cool down, and then maintain the instrument or replace components.
Precautions on Use
To use the Chemistry Analyzer safely and efficiently, please pay attention to the following operation notes.
Intended Use
WARNING
The analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories and designed for in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebrospinal fluid samples. Please consult us first if you want to use the analyzer for other purposes. To draw a clinical conclusion, please also refer to the patients clinical symptoms and other test results.
Operator
WARNING
The Chemistry Analyzer is to be operated only by experimenters trained by our company or our authorized distributors.
Environment
CAUTION
Please install and operate the analyzer in an environment specified by this manual. Installing and operating the analyzer in other environment may lead to unreliable results and even equipment damage. To relocate the analyzer, please contact our Customer Service Department or your local distributor.
Preventing Interference by Electromagnetic Noise

CAUTION
Do not install devices generating excessive electromagnetic noise around the analyzer. Do not use such devices as mobile phones or radio transmitters in the room housing the analyzer. Do not use other CRT displays around the analyzer. Electromagnetic noise may interfere with operations of the analyzer. Do not use other medical instruments around the analyzer that may generate electromagnetic noise to interfere with their operations.
Operating the Analyzer

CAUTION
Operate the analyzer strictly as instructed by this manual. Inappropriate use of the analyzer may lead to unreliable test results or even equipment damage or personal injury. Before using the analyzer for the first time, run the calibration program and QC program to make sure the analyzer is in proper state. Be sure to run the QC program every time you use the analyzer, otherwise the result may be unreliable. Do not uncover the sample/reagent disk when the analyzer is in operation. Keep the cover closed. The RS-232 port on the analyzing unit is to be used for connecting with the operation unit only. Do not use it for other connections. Only use the supplied cable from TECOM or our distributor for the connection. The operation unit is a personal computer with the operating software installed. Installing other software or hardware on this computer may interfere with the analyzer operation. Do not run other software when the analyzer is working. Do not use this computer for other purposes. Inappropriate use of the computer may lead to virus infection. Computer virus may spread and infect by floppy, software, network, etc. Do not touch the display, mouse or keyboard with wet hands or hands with chemicals. Do not turn the MAIN POWER to ON again within 10 seconds after placing it to OFF; otherwise the analyzer may enter the protection status. If it does so, place the MAIN POWER to OFF and place it to ON again.
Samples
CAUTION
Use samples that are completely free of insoluble substances like fibrin, or suspended matter; otherwise the probe may be blocked and lead to unreliable result. Check the hematocyte agglutinate or not before separate serum. Remove fibrin suspended before analyzing.
If there are suspended matter in urine sample, sediment urine sample by centrifugation before analyzing. Medicines, anticoagulants or preservative in the samples may lead to unreliable results. Hemolysis, icterus or lipemia in the samples may lead to unreliable test results, so sample blanks are recommended. Store the samples properly. Improper storage may change the compositions of the samples and lead to unreliable results. Sample volatilization may lead to unreliable results. Do not leave the sample uncovered for a long period. Some samples may not be analyzed on the analyzer based on parameters the reagents claim capable of testing. Consult the reagent manufacturer or distributor for details. Certain samples need pretreatment before being analyzed by the analyzer. Consult the reagent suppliers for details. The analyzer has a specific requirement on the sample volume. Refer to this manual for proper sample volume. Load the sample to proper tube position on the sample disk before the analysis begins; otherwise you will not obtain correct results.
Reagents, Calibrators and Controls

CAUTION
Select appropriate reagents according to performance characteristics of the analyzer. Consult the reagent suppliers, our company or our authorized distributor for details, when you are not sure the reagent is available or not. Store and use the reagents, calibrators and controls strictly as instructed by the suppliers. Improper storage or use of reagents, calibrators and controls may lead to unreliable results and bad performance of the analyzer even in validity period. Perform calibration after changing the reagents. Otherwise, you may not obtain reliable results. Contamination caused by carryover among reagents may lead to unreliable test results. Consult the reagent suppliers for details.
Setting up the Analyzer

CAUTION
To define such parameters as sample volume, reagent volume and wavelength, follow the instructions in this manual and the instructions of reagents.
Backing up Data
NOTE
The analyzer automatically stores the data to the built-in hard disk. However, data loss is still possible due to deletion or physical damage of the hard disk or other reason. We recommend you to regularly back up the data to such medium as CDs.
Computer and Printer

NOTE
Refer to their operation manuals for details.
External Equipment
WARNING
Accessory equipment connected to the analyzer interfaces, e.g. computer, printer, must be complied with the requirement of IEC 60950 or EN 60950.
Chapter One. System Introduction
1.1 Brief Introduction

1.1.1 Appearance
The chemistry analyzer is composed of main unit (upper one) and bottom cabinet.
1-1
1.1.2 Parts & Consumables

To ensure your safety and system function, please use the spare parts which manufactured or recommended by Tecom. Please contact with Service Department of TECOM or your local distributor if necessary.
Description
Position
Note
Light bulb (20W 12V halogen lamps)
Light source
Change regularly Running time >2000 hour or system alarms
Syringe piston assembly (PLUNGER ASSEMBLY 24400 'KLOEHN) Syringe shim 500L PG
Syringe
Change regularly Running time >3 months or 100,000 times or has visible damage
Connecting between syringe and three-way
Change regularly Replace when syringe have been disassembled for 2-3 times Change regularly Running for one year or bended
Sample probe assembly
Sample probe arm
Sample probe shim
Sample probe
Change regularly Replacing when sample probe has been disassembled for 2-3 times
Stirring probe
Stirring probe arm
Change regularly Replace when it is damaged
Reaction cuvette 24ml reagent bottle Reagent bottle cover A4 paper
Reaction disc Reagent disc Reagent disc Printer
Consumable Consumable Consumable Consumable
1-2
1.1.3 Technical Specification

Throughput Parameter Analysis method 260 tests/h At most 40 testing items online End points, Fix-time (two points) , Kinetic, Colorimetry, Turbidimetry, Two wavelength, Double reagent, multi-standard and so on 40 sample positions (can be expanded); sample can be placed Sample disc randomly; include standard QC, emergency , can use original tube or serum cup Reagent disc Sample volume Reagent volume Emergency sample Sample probe 40 sample positions (can be expanded) , 24ml reagent bottle with refrigerated compartment 1-50l, 0.1l step 10-400l, 1l step Insert emergency sample randomly and can be tested with priority Automatic liquid level detection; collision protection; probe block detecting 8-steps Cleaning system 0.1% Mixing System Reaction disc Reaction Tem. Reaction cuvette Reaction volume Longest reaction time liquid Independent stirring arm, stirring immediately when sample is added; For double reagent, stirring immediately after R2 is added 90 cuvettes 370.1C, temperature fluctuating is 0.1C 5mm6mm25mm, optical path :6.1mm 150~500l cleaning, cuvette dry automatically, spring style
internal/external auto cleaning, cross-contamination rate less than
8-10 min
Optical system
Static
optical
fiber
transit
system,
optical
filter
style
multi-wavelength spectrophotometer; back light style Multi QC function, can insert QC randomly; QC diagrams can be stored, displayed and printed; Can pre-set up different QC material;
QC
1-3
every test can take 3 different QC material. Light source Wavelength Measuring period Absorbency linearity Wavelength accurate CV% Stability Power Fuse Input Power Software Data processing Printer 12V, 20W halogen lamp, halogen lamps, tungsten iodine lamp 9 wavelengths340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 620nm, 660nm, 690nm 12 seconds
0.00004.0000Abs
2nm 1% within one hour , the change of absorbance is less than 0.01 ~198-242V50/60Hzthree-cores power cordgood grounding T10A 250V 1000VA Window XP or 2000 friendly interface with Chinese/English Can edit and store more than 300 testing parameter Multi-format printing modes are available Temperature: -10C55C
Storing environment
Humidity: 95%RH, no condensation Atmospheric pressure: 50kPa106kPa Altitude: below 3000 m Temperature: 10C 35C
Working environment
Humid: 90%RH, no condensation Atmospheric pressure: 70.0kPa106.0kPa Altitude: below 3000 m
Main Dimension Main Unit Weight Cabinet
Unit
700mmW*650mmL*530mmH
Net
62 Kg 700mmW*705mmL*620mmH 1-4
Dimension Cabinet Weight Net 47 Kg PC keyboard Exporting accessory PC mouse Printer Screen Communication port Instrument / computer : RS-232C,LAN port (can be expanded) Against electric strike style: external electrical supply Against electric strike level: B Hazardous liquid protection: general equipment Safety class Sterilization disinfection : not application Not suitable for environment with inflammable anesthetic gas Continuous running equipment
1-5
1.2 Reagent
Reagent use please refer to the operation manual, and we will give the simple introduction on reagent classification and its principle
1.2.1 Reagent classification

Reagent can be divided into below types.
1.2.1.1
Powder reagent
Reagent need to be dissolved with buffer solution or distilled water (deionized water) in operation, then start testing
1.2.1.2
Single liquid reagent
Reagent can be directly used without any prior treatment and only one style is enough
1.2.1.3
Double (multi) reagent
Reagent can be directly used without any prior treatment, but need two or more reagents are used together The superiorities of double reagent are as follows
1.2.1.3.1 1.2.1.3.2 1.2.1.3.3 1.2.1.2.4 Storage stability can be improved; Two-point method can be used; In some tests, interference of non-specific chemical reaction can be eliminated. The double reagents method can eliminate non-specified chemistry:
For example: when testing serum ALT, the original keto-acid in serum can react with reagent LDH to lead to result on the high side. However, you add non -ketoglutaric acid reagent (R1) firstly getting the original keto-acid reacting with LDH, then you add reagent with -ketoglutaric acid (R2) and ALT enzyme catalysis begins and pyruvic acid is created. The pyruvic acid will react with LDH, and the consumed NAD+ can reflect the ALT activity, so the interference will be eliminated.
1-6
1.2.2 Automatic monitoring of the testing procedure

1.2.2.1 Reagent blank testing
1.2.2.1.1 Each bottle reagent should automatic test its reagent blank absorbency before testing; 1.2.2.1.2 Each sample should test the reagent blank absorbency.
1.2.2.2 Monitoring the rate of the reagent blank

By set-up this function, analyzer will deduct the reagent blank rate in calculating the result. In monitoring the activity of the enzyme testing which use NAD (p) H decreasing as indication, rate-blank can be monitoring and eliminate the effects of absorbency reducing which cause by the NADHs self oxidation reaction
1.2.2.3 Sample information monitoring

Hemolysis, icterus, lipid of the sample will interface the non-chemical reaction, so usually sample will be justed its affecting level of the hemolysis, icterus, lipid at 600nm/570nm 700nm/660nm and 505nm/480nm, then automatically deduct this part to improve the reliability.
1.2.2.4 Reliability monitoring

1.2.2.4.1 End point monitoring 1.2.2.4.2 Linearity monitoring
1.3 Calibrator & Control

1.3.1 Conception
Calibrator: Calibrate the system with 2nd standard substance and conventional method. It is used for calibration instrument with conventional method. Control: it is characterized with brought in line with measuring process. Its ingredients is the same or similar to matrix of sample. Control should be of good stability. The variation between several bottles should be less than expectant variation of observation system. Its conventional detection helps to confirm report scope. Potential difference of result is likely to occur due to different measurement principles and 1-7
reagent produced by different manufacturers. Especially for some special sample, the value got from different measuring systems sometimes would be different with the true value. Therefore, manufacturer and distributor should chronically and stably provide the special sample of this measuring system, measuring result and other relevant information. Besides, to keep this traceability for a long time, all measuring systems in this traceability system should be kept under stable state every year, day and hour. So once all detection systems enter traceability system, it is necessary to actively conduct control indoor and among doors.
1.3.2 Packages and Expiration Date of Calibrator and Control

1.3.2.1 Concerning reagent package, attention should be paid to the manufacturer mark, which is supposed to meet the requirements of law and regulations. 1.3.2.2 Package should meet the requirements of industrial standard and enterprise standard. 1.3.2.3 Reagent should have proper service life, which should be indicated clearly and conspicuously on the package.
1.3. 3 Precautions of Calibrator and Control

1.3.3.1 Reagent should be used within the expiration date. 1.3.3.2 Reagent should be used together with analyzer to form integrated system. 1.3.3.3 Reagent should be stored properly under the storage condition required by manufacturer. 1.3.3.4 Reagent should be used in accordance with service conditions and range of application required by the manufacturer. 1.3.3.5 Reagent is only for in vitro diagnostic use.
1-8
Chapter Two. Installation

2.1 Preparation
The system should be installed by our authorized personnel only, and you should prepare a proper site for installation. If you need to move the system to another site, please contact our Customer Service Department or your local distributor.
Warning
The system should be installed by personnel authorized by TECOM only.
2.1.1 Unpacking
When you receive the system, carefully inspect the package. If you see any signs of damage, file a claim immediately with our Customer Service Department or your local distributor. After opening the package, check the delivered goods against the packing list as well as the appearance of the system. If you find anything missing or damaged, alert our Customer Service Department or your local distributor immediately.
2.1.2 Installation Requirements Warning

Make sure the system is installed in a place meeting the following requirements. Otherwise, it will not perform as promised.
2.1.2.1
Installation Environment Requirements

The system is for indoor use only. The bearing platform (or ground) should be level (gradient less than 1/200). The bearing platform (or ground) should be able to bear 220Kg weight. 2-1
The installation site should be well ventilated.
Warning
The system radiates heat while operating. A well-ventilated environment helps keep the room temperature stable. Use ventilation equipment if necessary. But if so, be sure not to expose the system to the direct draft that may lead to unreliable results.
The installation site should be free of dust as much as possible. The installation site should not be in direct sun. The site should not be near a heat or draft source. The installation site should be free of corrosive gas and flammable gas. The bearing platform (or ground) should be free of vibration. The site should not be disturbed by large noise or power supply. The system should not be placed near brush-type motors and electrical contacts that are frequently turned on and off. Do not use such devices as mobile phones or radio transmitters near the system. Electromagnetic waves generated by those devices may interfere with operation of the system. The altitude height of the installation site should be lower than 3000 meters.
Warning
The risk of falling down may lead to instrument damage, when inclination more than 8 degree. The protective measurement should be implied during storage, transit, etc.
2.1.2.2
Power Requirement
Power supply: AC 100-240V, 50/60Hz, with voltage fluctuation of 10%. Three-wire power cord should be grounding properly. The system should be connected to a properly-grounded power socket. The distance between the power socket and the system should be less than 3 meters.
Warning
2-2
Make sure the power socket is grounded correctly. Improper grounding may lead to electric shock and/or equipment damage. Be sure to connect the system to a power socket that meets the above-mentioned requirements and has a proper fuse installed.
2.1.2.3
2.1.2.3.1
Temperature and Humidity Requirements

Storage Temperature and Humidity Storage temperature: -10~55,with fluctuation less than 2/H;
Storage relative humidity: 95%RH, no dew.
Caution
The system will be damage in the environment that temperature and relative humidity is beyond requirements mentioned above.
2.1.2.3.2
Working Temperature and Humidity Working temperature: 10~35, with fluctuation less than 2/H; Working relative humidity: 90%RH, no dew.
Caution
Operating the system in an environment other than the specified may lead
to unreliable test results. If the temperature or relative humidity does not meet the above-mentioned requirements, be sure to use air-conditioning equipment.
2.1.2.4
Water Supply and Drain Requirements

The water must meet requirements of the GB-6682 grade water. The water temperature should be 5-50 . If water-purifying equipment is used, the pressure at water source should be within 49kPa-392kPa.
2-3
Biohazard
Be sure to dispose of the waste according to the local regulations.
Caution
The water must meet requirements of the GB-6682 grade water;
otherwise insufficiently purified measurement.
water may result in misleading
2.1.2.5
Space and Accessibility Requirements
The system should be installed and used meeting the space and accessibility requirements as shown below. The laboratory should be large enough, so that the analyzer and computer will not be crowded.
2-4
2.2
Installation
After unpacking, unlock the locks on the wheels at the bottom of instrument and be sure the instrument is portable. Move the instrument to the place prepared, and lock the locks to keep the instrument importable.
2.2.1 Connecting Water Supply Bucket
Biohazard
Wear gloves and lab coat and, if necessary, goggles.
Caution
Keep the top of water bucket is not higher than the bottom panel of the upper part of instrument. To keep the outlet tubing smooth, do not bend or twist it.
2.2.2 Connecting Waste Bucket
Biohazard
2-5
Caution
Keep the top of waste bucket is not higher than the bottom panel of the upper part of instrument. Ensure all the waste tubing is above the top of waste bucket and smooth without bending or twisting. Otherwise liquid may overflow from panel due to unsmooth drainage. The analyzer may be damaged if the problem gets serious.
Ensure the power supply is off. Choose an appropriate site in the right side cabinet to place the waste bucket. Plug the three-hole to outlet on the bottom panel. Insert three short tubes into the bucket.
2.2.3 Installing/Removing Sample-Reagent Disk Warning

Before installing/removing the sample-reagent disk, make sure the system is power off and the sample-reagent disk has stopped.
Biohazard
2-6
To install the sample-reagent disk, align the hole of the disk to the pin of the rotor, gently lower the disk all the way down and tighten (clockwise) the two retaining screws on the sample-reagent disk to secure it to the rotor. To remove the sample-reagent disk, loosen (counterclockwise) the two retaining screws on the sample-reagent disk to separate it from the rotor, then grab the handle and pull the disk upward to remove it.
Caution
The sample-reagent disk may be contaminated when being used. If samples spill in the compartment or on the disk, wipe them with cloth soaked with water or disinfector after placing the Power to OFF.
2.2.4 Installing/Removing Sample Tubes Warning

Before installing/removing the sample tubes, make sure the
sample-reagent disk and sample probe have been stopped and the system is in Standby status. Do not use sample tubes other than the specified.
Biohazard
To load sample tubes, insert the tube into the tube holder until the bottom of the tube contacts the groove of the tube rack. To remove sample tubes, grab the tube and pull it upward to remove it from the tube holder. 2-7
2.2.5 Installing/Removing Reagent Bottles Warning

Before installing/removing the reagent bottles, make sure the reagent disk and reagent probes have been stopped and the system is in Standby status. Do not use reagent bottles other than the specified.
Biohazard
To load reagent bottles, insert the bottle into the bottle holder until the bottom of the bottle contacts the groove of the holder. To remove reagent bottles, grab the bottle and pull it upward to remove it from the bottle holder.
2.2.6 Installing/Removing Reaction Cuvette
Biohazard
Wear gloves and lab coat and, if necessary, goggles. Be sure to dispose of the waste according to the local regulations.
To load reaction cuvettes, insert cuvettes into one of the cuvette holder arc until the edge of the cuvettes contact the arc. Then align the hole of the arc to the pin of the rotor, gently lower the arc down and tighten (clockwise) the two retaining screws on the arc to secure it to the rotor. Finally load others like that. To remove reaction cuvettes, loosen (counterclockwise) the two retaining screws on the 2-8
holder arc to separate it from the rotor, and pull the arc upward. Then pull cuvettes upward from the arc separated to remove them. Finally remove others like that. To replace old cuvette with the new one, please refer to above operation instructions.
2.2.7 Install Reagent Alarm System

Please connect one end of the alarm component to the buckets (detergent, waste and distilled water bucket) accordingly, and the other end to the interfaces (shown in the following picture) accordingly. Please see following picture:
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Chapter Three. System Description

3.1 System Structure
The full name of the system is TC series Automatic Chemistry Analyzer TC6030. It is intended for in vitro diagnostic use and quantitative determination of clinical chemistries in serum, plasma, urine or cerebrospinal fluid samples. This part describes the structure and operating procedure of the system. The system consists of the analyzing unit, operation unit, output unit, replacing parts and consumables.
TC series Automatic Chemistry Analyzer Model

Type Disks area Reagent position Sample position Reaction position Throughput (Tests/h) Programed project Measurement method End-point, Fix-time, Discrete, integrative optional Reagent disk, sample disk, reaction disk in the same table 40 40 90 260 300 Kinetic, Multi-standard,
Blank-sample, Dual-wavelength
NOTE
Some samples may not be analyzed on the system based on parameters the reagents claim capable of testing. Consult the reagent manufacturer or distributor for details.
3.1.1 Analyzing Unit

The analyzing unit consists of the sample-reagent disk, sample-reagent dispenser, mixer, reaction disk, photometer for analyzing operation. The cabinet below the analyzing unit is optional.
3.1.1.1
Sample-reagent disk
Sample-reagent disk holds sample and reagent. The outer circle positions hold sample and QC. The inner circle positions hold single/dual reagent. 3-1
The sample position can holds the following container: Micro tube, Centrifugal tube Blood collecting tube 12100 The Tecom reagent tubes are used only. The volume of the tube is 24ml. Sample-reagent disk places in the sample-reagent storage. The storage supports refrigeration to keep temperature between 2~8.
NOTE
The reagent positions are for TECOM reagent bottles only. Please use specified sample tubes; otherwise, it may cause system damage.
3.1.1.2
Sample dispenser
The sample dispenser is composed of a sample probe, probe arm, probe rotor. It aspirates certain amount of sample from the designated tube and then dispenses it into the designated reaction cuvette on the reaction disk. After each aspiration and dispensing, the sample dispenser moves automatically to probe washing well for cleaning. Volume of sample: 1~50l, 0.5l step; Volume of reagent: 10~400l, 1.0l step. Dispenser system is capable of pre-heating, liquid level detection and tracking, vertical collision protection.
WARNING When the analyzing unit is in operation, do not place any part of your body or any obstacle in the route the arm moves. Otherwise, it may lead to personnel injury or equipment damage.
3.1.1.3
Mixer Assembly
The mixer assembly consists of mixer, mixer arm and rotor. It stirs the reaction liquid evenly in the reaction cuvette until reacting completely. For single-reagent test, the mixer works once sample is dispensed. For double-reagent test, the mixer works after dispensing sample and R2 respectively. When stirring is finished, the mixer moves automatically to the wash well for cleaning.
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WARNING When the analyzing unit is in operation, do not place any part of your body or any obstacle in the route the arm moves. Otherwise, it may lead to personnel injury or equipment damage.
3.1.1.4
Reaction Disk Assembly
The reaction disk holds the cuvettes. The cuvettes are designed for reaction of sample and reagents, and colorimetric measurement. The reaction disk can hold 90 cuvettes. In analyzing, the reaction disk carries the specified cuvette to dispensing position (mixing position the same) for dispensing and stirring, and then carries it to the axis of corresponding light path for absorbency measurement. The cuvette is able to use permanently and is replaced manually if necessary. The reaction disk is placed in temperature-controlled storage provided the steady temperature at 370.1. BIOHAZARD
Wear gloves and lab coat and, if necessary, goggles. Be sure to dispose of the used cuvette according to the local regulations.
3.1.1.5
Photometer Assembly
The photometer assembly, which locates in the analyzing unit, measures the absorbance of the reaction mixture in the cuvette. The photometer assembly provides 9 wavelengths (can extended) as follows, 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 620nm, 660nm, 690nm BIOHAZARD
Light sent by the photometer lamp may hurt your eyes. Do not stare into the lamp when the system is in operation. If you want to replace the photometer lamp, first switch off the MAIN POWER and then wait at least 30 minutes for the lamp to cool down before touching it. Do not touch the lamp before it cools down, or you may get burned.
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3.1.2 Operation System

The operation system is a computer, installed control software for running, operation and data processing. WARNING Accessory equipment connected to the system interfaces, e.g. computer, printer, must be complied with the requirement of IEC 60950 or EN 60950.
3.1.3 Output System

Output System is a printer for printing data. WARNING Accessory equipment connected to the system interfaces, e.g. computer, printer, must be complied with the requirement of IEC 60950 or EN 60950.
3.2 Software Operation

3.2.1 Screen Layout
This section introduces the screen layout of the operating software. The figure below shows the interface of the operating software, which is divided into five areas.
Main Screen 3-4
Functional button area

It is set on the top of screen, including User, Parameter, QC, Report, Statistic and Maintenance submenus. When you click one of them, the relevant working page will display.
Biochemical test area

It is set on the leftmost and rightmost columns of screen, designed for both regular and emergency test.
Working status area

The area below the Functional Button Area is working status area, which displays patient information, test date, sample ID and start position etc.
Working page area

The middle part of the screen is the working page area. It displays relevant figure like parameter, process, result and graph etc.
Operator area
The bottom area is operator area, which displays current operators information.
3.2.2 Screen Elements

Dialog box The dialog box is one of the most common interfaces for man-machine interaction. Please see the following example
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Tab Click a tab and you will enter its corresponding index working page. See the figure below for an example.
Drop-down list box Click and a list will display, as the figure below shows. Click the desired item
to select it.
Button Click a button and you can access the function it indexes, as the figure below shows.
Radio button Click a radio button to select the option it represents. Note that for a given group of radio buttons, you can only select one of them. See the figure below.
Edit box You can enter characters in the edit box from keyboard. See the figure below. The edit box can accept characters directly input from the keyboard.
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Scroll bar When the content is beyond the size that screen can display, scroll bar will appear. Move the pointer to the scroll bar, press left button of the mouse and hold it, then you can drag the scroll bar left/right or up/down to see the hidden contents.
List The list displays the name of one or multi items or combination of them. The example is showed as below. Click to select it, and click it again to deselect.
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Chapter Four. Basic Operations

4.1 General Operating Procedure
Checking Switch on
Run software
Parameter set Y
No
Set-up
Testing preparation
Calibration(Y/N Y
Calibration
QC
Sample testing
Result editing(Y/N) Y N
Editing result
Print
Exit software
Switch off
Checking
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4.2 Operation Rule

4.2.1 Preparation for Analysis
4.2.1.1 Checking
To ensure that the system works normally after switching on, please check what stated below before powering on
BIOHAZARD Wear gloves and lab coat and, if necessary, goggles.
1) 2)
Check the power supply, ensure power supply and voltage is ok Check the data line and power cord which connect the analyzer, computer and printer
3) 4)
Check printer Check detergent NOTE Tecom recommends below detergent Strong acidity detergent: 0.1mol/l muriatic acid Strong alkalescency detergent0.5(V/V) hypochlorous acid Do not mix the two detergents together Tecom recommends to use the two detergents interchangeably, For example this time use Strong alkalescency detergent, then next time use Strong alkalescency detergent
5) 6) 7) 8) 9)
Make sure the sample probe is at the right position (cleaning position) Make sure stirring probe is at the right position (cleaning position) Make sure enough distilled water in the water tank Emptying the waste tank Prepare enough reagent
4.2.1.2
Switch On
Connect the power supply and switch on each part as follows:
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1) 2) 3) 4)
Analyzer Computer screen Computer Printer
4.2.1.3
1)
Run Software
After starting Windows Operation System, you can startup control software by double clicking the shortcut icon of the software on the desktop or from software package. When startup, system will check the operation system, screen resolution, close screen protection program, check color configure, initial database, check printer. After checking, dialog box will pop-up and you can input administrator name and password and click OK.
NOTE The screen resolution must be 1024x768 and color must be 8 or above. The administrator name is aaa and original password is 8888.
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2)
Click MAINTENANCE and Initialize buttons successively, the moving parts begin to initialize and the screen is shown as below.
NOTE To obtain reliable result, please power on the system for at least half an hour before starting analysis.
4.2.1.4
Setting Up the Analyzer
The analyzer will not function as promised if it is improperly set up. Please complete all the following settings if it is the first time that the analyzer being used. To setup below settings, select User---Customer Data Hospital data setting Department and doctor data setting To setup below settings, select Test---Calibration Setup Programming Calibration To setup below settings, select Test---QC Programming QC To setup below settings, select Test---Edit Programming routine sample
4.2.1.5
Preparing the reagent
Load reagent bottles to their designated positions on the reagent disk, and then open the 4-4
bottles. Please select correct bottle type as configured so that the reagent inventory can be checked accurately.
WARNING
Exercise caution to prevent puncture wound by the probe tip.
The reagents are corrosive. Exercise caution when handling the reagents
BIOHAZARD
4.2.2 Starting Analysis

When you finish all the preparations stated in previous sections and the system is in still state, you may proceed to the programming operation and then start the analysis.
4.2.2.1
Programming Calibrators
Perform calibration before the test, and select as below.
NOTE
The change of reagent lot No., test parameter, source lamp or other analysis conditions will result in measurement situation change, so calibration should be performed.
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Please observe following steps to perform the calibration

Load corresponding calibrators to their assigned positions on the sample disk. Select Test---Calibration Setup, and request calibration run for desired tests, and click Update Back to Work List, click Test, next click Item Check to start running the calibrators, To view calibration status or results, you can click Cuvette
4.2.2.2
Programming Controls
You are recommended to run two quality controls for each test everyday and check if the system is running normally and steadily.
Follow this procedure to perform quality controls: Load corresponding controls to their assigned positions on the sample disk. Select Test---QC, and request calibration run for desired tests, and click Update Back to Work List, click Test, next click Item Check to start running the controls, To view calibration status or results, you can click Cuvette
4.2.2.3
Analyzing sample
Set the samples parameter as below. After sample request, load sample bottles in the sample-reagent disk as programmed, and click TEST.
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NOTE Emergent sample function is designed for the operators who are not familiar with the analyzer and have emergent samples to analyze. You are not recommended to use the emergent sample function in normal situation. Be sure the sample tube is placed the correct position, otherwise it may not have the reliable result.
Follow this procedure to analyze routine samples: Load corresponding sample and reagent to their assigned positions on the sample/reagent disk. Setup the reagent positions by selecting Parameter---Biochemistry, select desired item, click Volume Position, and then set. Select Test---Edit, and request calibration run for desired tests, and click Update--New Back to Work List, click Test, next click Item Check to start running the controls. To view calibration status or results, you can click Cuvette
4.2.3 Result Follow-up

4.2.3.1 Editing test results CAUTION
Sample results can only be edited by authorized personnel.
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To edit results of one or more sample runs, you can: Select Report---Check Results Display, then select item and edit desired test result on the popup dialog box, then click OK
4.2.3.2
Printing test results NOTE
The system automatically stores the data to the built-in hard disk. However, data loss is still possible due to deletion or physical damage of the hard disk or other reason. We recommend you to regularly back up the data to such medium as CDs.
Select Report---Patient Information, then select desired sample No. and click the Print button.
4.2.4 Finishing Analysis

4.2.4.1
software.
Quit the operation software
When all tests are finished and the system is in still status, click EXIT to quit the operation
4.2.4.2
1) 2) 3)
Shut down
The printer The computer The analyzer
After exiting the Windows operating system, switch off the powers as below in order
4.2.4.3
Checking after powering off
BIOHAZARD
1)
Cap the sample/reagent tube/bottle on sample/reagent disks and cover the disks.
NOTE: If the MAIN POWER is placed to OFF, take the reagents from the
reagent disk and put them into an external refrigerator. 2) 3) 4) Remove the calibrators, QCs, samples and reagents. Empty the waste bucket. Check the surface of the analyzer, if any stains, wipe them off with clean soft cloth.
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Chapter Five. Advanced Operations

The chapter presents an introduction of function buttons in the operating software of the analyzer.
5.1 Work Menu

5.1.1 Menu
Main menu First class menu Customer data 1. User Operator setup Data setup Basic Parameter Biochemistry Volume Position Reference Range Calibration Result The result Set the parameter can be measured. dictionary Second class menu Function Edit information for hospital and doctor Edit one operator Edit medical term
measured by other instrument can be Other Parameter typed and printed with that measured 2. Parameter Bio-Calculator Profile Setup Used for select all items in a group Used Check Order preventing d Print Order for from by the instrument together
cross-contaminate
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QC SN. setup 3.QC QC data QC in same day QC in different day Patient Information Check 4.Report Display Measured Display Modify Historical Data 5.Statistics Charges Statistics Query Patient Information Column Initialize Modify the results with modify factor. Graph Results
Character Setup
Wash Cuvette of them Parameter setup 6.Maintenan ce A/D Signal Arm Test
cuvettes
and test the quality
Test signal value Check valve and pump
Temperature Pressure Print Setup
and
Display pressure Modify template
and
set and
temperature
printing
6.Test
Edit Work List Calibration Setup
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QC Reagent Vol. Calculator Cancel 9.Stop commands initialize instrument 10.Exit Quit the software. all and Check remaining
7.Function
reagent volume
5.1.2 Check the version number

Click Ver button on the right bottom to check the version number.
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5.2 Menu Introduction

5.2.1 Customer Data
Click Customer Data and then the window is showed as below. Its used for setting information about hospital, operator and dictionary.
5.2.1.1 Customer Data Setup

The Customers Data dialog box is showed as above for setting hospital name, address, contact telephone, department name, doctor name and etc.
5.2.1.2 Operator Setup

Click Operator Setup page to pop up operator setup dialog box. Only administrator and super user is authorized to edit biochemistry parameter, general user can not.
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5.2.1.3 Data Dictionary Setup

Click Data Dictionary Setup page to pop up data dictionary setup dialog box.
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5.2.2 Parameter
Click Parameter to pop up the screen showed below. Its used to set parameter of biochemistry item. This is the uppermost step to obtain reliable result. When inputting parameter for each item, please be careful to set them one by one according to the user manual of chemistry reagent.
IMPORTANT
Setting parameter like sample volume, sample volume, filter and other should be done, please abide by the description in this user manual and refer to manual along with reagent when setting these parameters.
5.2.2.1 Biochemistry parameter setup

The window is showed as above. It is designed to set basic parameter, reagent and sample positions of the item and other parameters.
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5.2.2.1.1 window.
Basic Parameter Setup
Method, main filter, sub-filter, decimal, unit, standard factor and standard can be set in the
Click the method to pull-down menu to select desired method.
Click the Main Filter to pull-down menu to select desired wavelength.
Click the Sub Filter to pull-down menu to select desired wavelength.
Click the Unit to pull-down menu to select desired unit.
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5.2.2.1.2
Volume Position Setup
Click Volume Position to pop-up the window showed as below.
Set the first and second reagent volume, position, incubation time, sample volume and check point in this window. 5.2.2.1.3 Reference Range Setup
Select one of the items, and click Reference Range submenu and the window is showed as below. The parameter can be edited in this window.
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5.2.2.1.4
Calibration Result Setup
Once the standard substance parameter has been programmed in the basic sub-page, the calibration result will be displayed in the window.
5.2.2.2 Other Parameter

Click Other Parameter and pop-up the window showed as below. It is designed to inquire or edit other parameter.
It is used to print the result measured by other instrument with result measured by this 5-9
instrument, if necessary. For the result, it can be showed by data or character.
5.2.2.3 Bio-Calculator Setup

Some results of items can be got by calculating other than analysis. For example: Globin = Total Protein Albumin.
5.2.2.4 Profile Setup

a) Click Profile Setup to show the window below. Profile item can be edited in the window.
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b) c)
Click Add and type the profile name in Profile Name box and select desired item and click Save. It will display in the Profile Name list on the left. Profile setup could simplify the operation. During the analysis, all the items desired in a group will be selected by clicking a profile only once.
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5.2.2.5 Check Order Setup

a) In this window the check order could be programmed. All item is listed on the left box and there are items allowed for analysis on the right.
b)
Select one of items on the left and click ADD and the item will be added to the left list and display on the bottom. To program the check order, select one item and click Topmost, Up, Down or Downmost to change the order. Click Up or Down once, the selected item will move up to the upper position or down to the lower position by one line.
c)
The system will start analysis from No.1 downward based on the programmed order.
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5.2.2.6 Print Order Setup

Programming print order is like programming the check order stated in the previous part.
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5.2.3 QC
5.2.3.1 Test QC
Click Test to pop up biochemistry test window and click QC to access to QC test page. Select desired item keys and click Update and Save, they will be saved in the Work List page. Then click Test to request analysis. The picture is showed below.
5.2.3.2
and chart. 5.2.3.2.1 as below.
QC Setup
Click QC to pop up the QC window. It is used to program QC parameter, review QC result QC Serial No. Setup
It is used to program QC SN, QC Target value, Validity, Density, etc. The window is showed
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5.2.3.2.2
QC data display
Click QC data and the QC result can be reviewed with data in the page showed below.
Click QC graph and the QC graph can be displayed with graph showed below.
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5.2.3.2.3 QC in same day and in different day
QC in same day: QC performed in same day. QC in different day: QC performed in different day.
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5.2.4 Report
5.2.4.1 Patient Information Register
During the analysis, patient details can be input and saved. Click Report and Patient Information to pop up the window. Input patient details and click Save. Before clicking Print to print analysis report, please click Preview to view and change, if necessary, the printing format. The window is showed as below.
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5.2.4.2 Check Results Display

Click Check Results Display to pop up the window below. The results can be inquired or edited in this window.
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5.2.4.3 Measured Graph Display

The measured graph is displayed in the window. Based on the graph, you can check whether the instrument or reagent works or parameter is programming normally or not, and then you can judge whether the result is credible or not.
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5.2.5 Statistics
Click Statistics to pop up the window below. The historical data can be reviewed or edited in the window. The charge statistics of items can be calculated. The results can be queried in multiple ways. The queried and edited results can be printed.
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5.2.5.1 Modify
5.2.5.1.1 5.2.5.1.2 Click Modify page to pop up the window below. It is used to edit the results. Select the desired items and the Sample ID and input the correct value in Result edit box and click Save.
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5.2.5.2 Historical Data

5.2.5.2.1 In Historical Data page, the sample or QC results tested in specified day can be displayed below.
5.2.5.2.2. The reaction curve of result can be displayed, edited and calculated. 5.2.5.2.3 The results will be re-calculated by resetting the first and end check points. It is used to check the results.
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5.2.5.3 Charges Statistics

Click Charges Statistics tab to check total charge. It helps to get charge statistics. The window is displayed below. Please review Patient Charge Statistics, Hospital Charge Statistics, and Item Charge Statistics by selecting corresponding tab and then click Statistics.
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5.2.5.4 Query
Select a desired query way and click Search to index to results. The window is displayed below.
Please query relevant information by Query Way List. a) b) c) d) e) f) Query by Check Date, Query by Patient Name, Query by No. Records, Query by Doctor, Query by Operator, Query by Display All.
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5.2.6 Maintenance
Click Maintenance button to pop up the window below. It is used to maintain system and data.
5.2.6.1 Initialize
Click Initialize to pop up the window below. Click Initialize to initial instrument. It is used to reset instrument when instrument is in uncertain status.
5.2.6.2 Character Setup

Click Character Setup to pop up the window below. It is used to setup system.
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Input the password 777 and click OK to pop up the window below. It is used to set serial port No. and instrument model.
NOTE: - To select reagent alarm function in this interface by click YES (means this function is on and NO (means this function is off) in Liquid Alarm option. . - To sst washing function during starting up and shutting down the instrument by select YES or NO in start program and end program.
5.2.6.3 Cuvette
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Click Cuvette to pop up the window below.
a) b) c) d) e) f) g)
Wash is used to wash cuvettes specified, Stop Wash is used to stop washing, Wash All Cuvettes is used to wash all cuvettes, Add Water is used to fill all cuvettes with distilled water, Pump Water is used to drain all cuvettes, Test Cuvette is used to evaluate the quality of cuvette by water blank absorbency and replace it, Save Cuvette is used to save absorbency value detected last time.
Note: Remember to run Pump Water to drain all cuvettes before requesting analysis and Add Water to fill them after finishing analysis everyday.
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5.2.6.4 Parameter Setup

Click Parameter Setup to pop up the window below.
Input the password 999 to access to the movement parameter setting window. It is used to program parameter of mechanical arm movement and test mechanical arm when first installation, mechanical arm replacement or sites change.
Note:
The parameter setup must be done by engineer authorized by our company. Otherwise, it may lead to unexpected damage.
5.2.6.5 A/D Signal

a) Click A/D Signal to pop up the window below. It is used to test the stability of each
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wavelength. b) The linearity range can be measured in this window.
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5.2.6.6 Arm Test

Click Arm Test to pop up the window below.
Warning
When the system is in operation, dont touch the moving parts including sample-reagent dispenser, mixer and wash unit. When system is in operation, dont place your finger or hand into the open parts.
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5.2.6.7 Temperature and Pressure

Click Temperature and Pressure to pop up the window below. It is used to program parameter of temperature and pressure.
Once the difference that between temperature value displayed on the screen and the real one measured by thermometer occurs, please modify the Correct to eliminate it The Correct can be modified until temperature reaches the balance. If the real temperature cant be obtained, please set the Correct to 0 FORMULA: Temperature display = Temperature measured by system + Correct Value
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5.2.6.8 Print Setup
a) b) c) d) e) f) g) h)
Project: it is used to select the print format; Apply: click it to apply current format to print; Preview: click it to preview current print format; Save: click it to save modification into current print format; Left aligned, Right aligned, Bottom aligned, Top aligned: select the terms desired and click one aligned button and the according operation will be performed; Same horizontal spacing, Same vertical spacing: select the terms desired and click one spacing button and the according operation will be performed; Font type: it is used to modify the selected words size and type; Exit: click it to exit the window.
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5.2.7 Test
5.2.7.1 Bio-test
The analysis request can be operated in the Test menu. Click it to pop up four submenus: Edit, Work List, Calibration Setup and QC. 5.2.7.1.1 Edit The figure is shown below.
a) New and Add First, input sample ID ID, sample cup Sample Cup, original reaction cuvette NO. Start. The ID and Sample Cup will be added by one automatically as click New each time. Then, select items need to analyze for one sample and click Add to add them to Work List. If more than one sample need to analyzer, click New to add ID and Sample Cup by one automatically and select items need to analyzer and click Add. It must NOT to use one ID for two Sample Cup, or the former sample result will be covered by the latter one.
Note
The items list in the Edit submenu, the button status stands for the item status: Pressing down stands for being selected; Pressing up stands for being unselected.
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b) Copy Click COPY to pop up the window below after selecting items. It can test the same item(s) for different samples or test one sample repetitiously according to the number input.
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c) Test Click TEST to pop up the window below after selecting items.
The menu is used to confirm regular analysis, QC, calibration before performing operation, and check the remaining reagent volume in bottle.
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d) Reagent Test Click Reagent Test, then instrument can check automatically whether the volume is enough or not for the analysis each time. Then click Item Check to enter below window, click Test to start the analysis.
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5.2.7.1.2 Work List

As the auxiliary menu of biochemical test, Work List shows items that will be tested or being tested. Check whether there are test requests in list or not before adding item into it, and delete them if required. Then add test items in the biochemical item menu and they could be inquired in Work List by ID. The test Work List screen is shown below.
NOTE: Please delete all the items in the work list before the last tests is finished and start new ones, or the last ones will be tested again.
Click Delete All to pop up the window shown below. And click OK to finish, or Cancel to cancel.
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5.2.7.1.3 Calibration Setup

Click Calibration Setup to pop up the window shown below. It is used to edit calibration item desired.
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5.2.7.1.4 QC
Click QC to pop up the window shown below. It is used to edit QC items desired.
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5.2.7.1.5 Emergency Test

The emergency test menu is same as regular one. It can add a sample with priority when the analysis is performing. Function ID Sample Cup Start NEW ADD Description One ID is for only one sample in a day. The number position loading the sample bottle in the sample-reagent disk The cuvette number test beginning. It can be any number (1-90). A new sample will be tested and click this button. Click the item button and the item will be added to work list for this patient ID. When there are same items tests for X samples, click this button with COPY same blood serum cup number deselected. When one sample will be tested more than one time, click it with same blood serum cup number selected. DELETE DELETE ALL Emergency Test SAVE TEST Save items edited. Begin a regular test or emergent test. Delete the ID added (the grounding color is blue). Delete all the IDs added Add a analysis request with priority which can be test first.
5.2.7.1.6 Revising the sample test information

Input the sample ID to be revised under the window of change the test information of this sample, and then click Add. (If analysis has started, you can not revise it.)
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5.2.7.1.7 Test
a) Test preview Click Test in the Test menu after all of samples and QCs have been edited to pop up the window below.
Notice
Please confirm that sample, calibrator, QC and reagent have been placed correctly before clicking Test button.
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b) Testing Click Test to start to test. There are Sample, Reagent and Reflact Pane three submenus in this window. Click one of working elements to show its status. For example, click one of the cuvettes in the virtual disk on the right and its current detail will be showed.
c) Query in the test window When test is finished, the test results and wash status of cuvettes is showed in Sample Check Result List under the Sample submenu. The test results could be checked in STATISTICS menu. Function Sample Reagent Reflact Pane Pause/Continue Detergent Water Waste Description Show the information of each sample Show the information of each reagent Show the information of each cuvette Pause/continue the operation Liquid alarm. Yes stands it is enough, No stands it isnt enough. Liquid alarm. Yes stands it is enough, No stands it isnt enough. Liquid alarm. Not Full stands for OK, Full stands it need to drain.
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5.2.7.2
5.2.7.2.1
Calibration
Calibration Setup
Click Parameter, Biochemistry and Basic Parameter to pop up the window below. Calibration can be programmed in this window.
Select one item in the left box and input the number of standard substance St. Number and its position No. Position and click Save. The standard substance must be placed in the appointed position when the calibration is performed. There may be more than one standard substance for some items. When a number what is more than one be input, like 3, it will pop up the window below.
Input the number in Position boxes and standard value to in relevant Value boxes. Then
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select suitable formula in drop-down list box for the correct calibration method. The calibration result could be reviewed in the Calibration Result subpage.
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5.2.7.2.2
Calibration Test
Click Test and Calibration Setup to pop up the window below.
Select items desired and click Add and the selection could be checked in the Work List sub-page below, then click Test to start calibration.
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5.2.7.2.3
Calibration Result Check
The factor will be modified automatically after calibration and could be check in the Basic Parameter submenu. The calibration result is shown below.
Note:
The system will obtain the sample concentration result according to the default factor. The system will set the new factor including one that obtained from calibration or edit as the default factor.
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5.2.7.3
5.2.7.3.1
QC
QC Setup
Click QC and QC SN. Setup to pop up the window below. It is used to program the parameter of QC SN., Density, Validity, etc. Select the items that QC controls, and then input target value, SD, unit and name for relevant items. Remember to click Modify and Save after all have been programmed correctly.
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5.2.7.3.2
QC Test
Click Test and QC to pop up the window below. Select the correct SN. and items which need to request QC runs. Click Add and check them in Work List submenu for sure, then click Test to start to perform QC runs.
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5.2.7.3.3
QC Results Review
Click QC and then QC data to pop up the window below. The QC results can be seen in this window.
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5.2.8 Function
The Function menu includes Reagent Vol. and Calculator.
5.2.8.1 Reagent Vol.

Click Reagent Vol. to pop up the window below. It is used to check the remaining volume of reagents that have been programmed and so that can refill them in time.
5.2.8.2 Calculator
This function is used to launch the calculator in our computer.
5.2.9 Stop
It is used to stop all analysis. The system will cancel all requests and initialize again after clicking Stop. 5-52
5.2.10 Exit
Click EXIT to pop up the window below. And click OK to exit the software or Cancel to cancel this operation.
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Chapter Six. Instrument Maintenance

To ensure reliability, good performance and service life of the system, regular maintenance is required.
6.1 Instruction for operating and maintaining

1) 2) 3) 4) 5) 6) 7) 8) 9) Keep the instrument powering on for 30 minutes before analysis every morning. Check and make sure the reagent and serum are enough. Check and make sure the pump pipe is at the bottom of the distilled water bucket, and can pump enough water for analysis. Check and make sure the drain pipe is in the waste bucket after emptying and moving the waste bucket. Clean the cuvettes not less than once before analysis. Move the reagent, standard substance and QC serum to external refrigerator after analysis everyday. Do not touch the moving arm (moving parts) during analysis to avoid injury and damage. Add distilled water to the cuvettes to keep them wet after analysis is finished. Check and make sure that the distilled water and detergent in buckets are enough and avoid overflow of waste bucket everyday. 10) Check whether the probe is blocked periodically in the screen below.
Click Arm Test and test 6-1
If the probe does NOT inject water, please unblock the probe with thin wire. Please contact us when you need help. 11) If you notice that wash unit can not drain the cuvettes completely or can not inject water into cuvettes, please contact us. 12) The flaw or stain on the optical path of the cuvettes will affect the measurement of absorbency; please replace it with a new one. 13) QC serum should be tested to calibrate the precision of the instrument. 14) The Position No. 40 cuvette as the beginner of the test is recommended, because the Position No. 40 cuvette is already dry when washing procedure finishes. 15) Do not switch the instrument power on or off frequently, it will cause damage of the power module. 16) Stabilized voltage supply should be used if the network voltage is not steady or on the low side. 17) The reagent stored in the refrigerator should be placed outside to wait to warm up to the room temperature before the analysis. Or reliable results may not be obtained. 18) Cap the reagent bottles in the disk when the instrument is in the idle status and uncap it before analysis. 19) Please pay attention to below notices when printing report
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There are 3 default formats and 3 user-defined formats for printing, please see the pull-down menu of Project. Please click Apply to choose the format you prefer.
20) Check 4 electrical valves in the instrument periodically as below: 6-3
Click Maintenance and then Arm Test.
Find the Reagent valve detect menu.
Click Reagent, Sample, Wash Needle and Triple to open valves respectively; Repeat the step above to close the valves; Voice like valve-open or valve-close heard means they work normally, otherwise, please contact us. 21) Click mix needle to check whether mix needle is rotating, otherwise contact us. 6-4
22) Do not press SPACE and Enter on computer keyboard during analysis; otherwise, test will stop immediately. 23) Replace with distilled water when detergent is used up. Please insert detergent pipe into the distilled water bucket in this case.
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Product name: TC Serial Automatic Biochemistry Analyzer (TC6030) Input supply: ~220V 50Hz Input power: 1000VA Input current: 10A Overvoltage classify: class II Pollution class: 2 Manufacturer: Tecom Science Corporation
Address: 555#, Gaoxin Ave., Nanchang National Hi-tech Industry Development Zone, Nanchang, Jiangxi Tel: +86-791-88110293 / 88111402 Fax: +86 791 88110293

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TC Series Automatic Biochemistry Analyzer (TC6030)

Tecom Science Corporation

Please keep this manual properly for convenient use.

To ensure the safe operation, please read the following notes

requirement of Directive 98/79/EC. Authorized Representative in the

European Community Measurement sign

Guard against damp

Copyright & Declaration

Use and Storage Environment

2. Normally working conditions

3. Others environment conditions

Operation Manual Use

Analyzer should be operated according to this operation manual.

Safety Use Notes

Signs & Meaning

down(electrical source cut) Alternating current turn

on(electrical source turn on) Alternating current source

Warning: risk of electric shock

Remind user to avoid shock

Warning: risk of burn

Remind user to avoid scald

Helpful Explanation process Some Importance

performance of the instrument and avoid damage

Preventing Electric Shock

Preventing Personal Injury Caused by Photometer Lamp

Preventing Personal Injury Caused by Moving Parts

Handling Reagents and Wash Solution

Treating Waste Liquids & Waste Parts

Preventing Fire or Explosion

Preventing Interference by Electromagnetic Noise

Operating the Analyzer

Reagents, Calibrators and Controls

Setting up the Analyzer

Computer and Printer

Chapter One. System Introduction

Chapter One. System Introduction

1.1 Brief Introduction

Chapter One. System Introduction

1.1.2 Parts & Consumables

Light bulb (20W 12V halogen lamps)

Change regularly Running time >2000 hour or system alarms

Connecting between syringe and three-way

Sample probe assembly

Sample probe arm

Sample probe shim

Stirring probe arm

Change regularly Replace when it is damaged

Reaction cuvette 24ml reagent bottle Reagent bottle cover A4 paper

Reaction disc Reagent disc Reagent disc Printer

Consumable Consumable Consumable Consumable

Chapter One. System Introduction

1.1.3 Technical Specification

internal/external auto cleaning, cross-contamination rate less than

Chapter One. System Introduction

Humid: 90%RH, no condensation Atmospheric pressure: 70.0kPa106.0kPa Altitude: below 3000 m

Main Dimension Main Unit Weight Cabinet

Chapter One. System Introduction

Chapter One. System Introduction

1.2.1 Reagent classification

Single liquid reagent

Double (multi) reagent

Chapter One. System Introduction

1.2.2 Automatic monitoring of the testing procedure