Sapphire 200 User - S Manual V1.5

Sapphire 200
Clinical Chemistry
Automated Analyzer
Users Manual V1.5

Sapphire 200 Users Manual
ii
Sapphire 200
Clinical Chemistry
Automated Analyzer
Audit Diagnostics
Business & Technology Park
Carrigtwohill, Co.Cork
Ireland
Phone +353 21 4533 652
Fax +353 21 4533 653
Email: info@auditdiagnostics.ie,
Website: http://www.auditdiagnostics.ie
ISO13485:2003 CERTIFIED DIAGNOSTICS MANUFACTURER
i
SYMBOLS
Legend of electrical and safety symbols used on the equipment:
Warning, danger of electric shock.
Carefully read the manual and follow the applicable safety signs.
Warning, contains combustible materials.
Biohazard, danger of contamination with potentially infectious substances.
Legend of symbols used in the document:
ATTENTION, potential for personal injury, all instructions indicated in the

relevant text must be known and understood before proceeding.
CAUTION, potential risk of damage to the equipment, all instructions

indicated in the relevant text must be known and understood before
proceeding
BIOHAZARD, danger of contamination with potentially infectious

substances.
ii
CONTENT
CONTENT
SYMBOLS ........................................................................................................................................................... ii
CONTENT...........................................................................................................................................................iii
SAFETY AND WARNING ................................................................................................................................. v
1 OVERVIEW.................................................................................................................................................. 1
1) Technical specifications ..................................................................................................................... 2
2) Basic Principle..................................................................................................................................... 2
3) Front View of Analyzer ....................................................................................................................... 3
4) Rear View of Analyzer ........................................................................................................................ 4
5) Side View of Analyzer......................................................................................................................... 4
6) How does the system work? ............................................................................................................. 5
7) Light System ........................................................................................................................................ 5
8) Software Function ............................................................................................................................... 6
2 ANALYZER INSTALLATION .................................................................................................................... 9
1) PRE-INSTALLATION PREPARATION AND CHECKS.................................................................. 9
2) Packing List........................................................................................................................................ 10
3) INSTALLATION ................................................................................................................................. 11
3 DAILY WORKING PROCEDURE .......................................................................................................... 15
1) Preparation before Power on .......................................................................................................... 15
2) Power on ............................................................................................................................................ 15
3) Sample Test ....................................................................................................................................... 15
4 ROUTING OPERATION .......................................................................................................................... 19
1) Flow chart........................................................................................................................................... 19
2) PREPARATION JOB ........................................................................................................................ 20
3) Order................................................................................................................................................... 20
4) Testing ................................................................................................................................................ 22
5) Repeat Test........................................................................................................................................ 23
6) Report ................................................................................................................................................. 24
5 PARAMETER SETTING.......................................................................................................................... 25
1) Item Parameters................................................................................................................................ 25
2) Special parameters ........................................................................................................................... 27
6 SPECIAL TEST......................................................................................................................................... 29
1) Calibration and QC ........................................................................................................................... 29
2) Reagent Status.................................................................................................................................. 34
3) Reading Absorbance ........................................................................................................................ 35
7 DATA MANAGEMENT............................................................................................................................. 37
1) Result Query...................................................................................................................................... 37
2) QC Query ........................................................................................................................................... 38
3) Reaction Curve.................................................................................................................................. 39
4) Data Maintenance............................................................................................................................. 40
8 SERVICE AND ADJUST ......................................................................................................................... 41
1) Initialization ........................................................................................................................................ 41
2) single reagent .................................................................................................................................... 41
3) Parts Testing ...................................................................................................................................... 41

4) Adjustment ......................................................................................................................................... 42
9 MAINTENANCE........................................................................................................................................ 45
1) Daily maintenance ............................................................................................................................ 45
2) Weekly maintenance ........................................................................................................................ 45
3) Half year maintenance ..................................................................................................................... 45
4) Yearly maintenance .......................................................................................................................... 45
5) Cuvette washing procedure............................................................................................................. 45
6) Part replacement............................................................................................................................... 45
10 MALFUNCTION ANALYSIS ............................................................................................................... 47
1) No power after switching on............................................................................................................ 47
2) Power lamp isn't light........................................................................................................................ 47
3) No washing water for dispensing needle ...................................................................................... 47
4) Incorrect dispensing volume ........................................................................................................... 47
5) Incorrect dispensing position........................................................................................................... 47
6) Incorrect result when test some items ........................................................................................... 47
Sapphire 200 Warranty Card........................................................................................................................ 49
iv
SAFETY AND WARNING
SAFETY AND WARNING
Before installing and using the instrument and for a correct and safe use of the same, we
recommend to carefully read the warnings and instructions contained in this instruction
manual.
It is important to keep this manual together with the instrument for future consultation.
Should the unit be sold or transferred, make sure that the manual always accompanies
the Sapphire 200 in order to inform the new owner of its functioning and relevant
warnings.
The instrument should be used only by qualified and competent personnel.
NOTICE: Storage and transportation requirement

- Temperature: 4~40
- Relative humidity: 30%~80%
- Atmospheric pressure: 860hPa~1060hPa
NOTICE: Installation requirement

- Power supply: 220V, 50Hz
- Temperature: 15~30
- Relative humidity: 40%~80%
- Far away from the disturbance of electric magnetic field, good ground
connection
- The UPS supply should be more than 1KW
CAUTION: Biohazard contaimination caution

The reagents and samples used on the system may be causticity and
infectivity. Users should take good care during operation. Please consult
local waste disposal regulations for all the waste solutions process.
CAUTION: Hight voltage caution

High temperature and high voltage may occur during the analyzer working.
Please pay attention to the labels on the instrument to avoid any damage.
CAUTION: Moving parts caution

Please do not touch the moving parts and its covering area during instrument
running. Please pay attention to the labels on the instrument to avoid any
damage to analyzer or user.
v
NOTICE: Warranty Information

All analyzers are warranted against defective materials or workmanship for a
period of one year commencing from the date of the shipment of the
analyzer.
This warranty does not cover any defect, malfunction, or damage due to:
- Accident, neglect or willful mistreatment of the product
- Failure to use, operate, service, or maintain the product in accordance
with the applicable Sapphire 200 Users Operation Manual and Service
Manual
- Instrument is maintained and revised by unauthorized person
- Use of reagents or chemicals of corrosive nature, though the unit is an
open system allowing the use of any commercial reagents from any
manufacturer that are meant for such an automated clinical chemistry
analyzer
* The information contained in this manual can be changed without notice. No part of the
manual can be reproduced with electronic or mechanical means, for any whatsoever purpose,
without the written authorization of Audit Diagnostics.
vi
OVERVIEW
1 OVERVIEW
First of all, thank you for choosing Audit Diagnostics products.
Sapphire 200 is a random access automated clinical chemistry analyzer. It adapts 120
cuvettes as reaction and test container and has the feature of suitable throughput, no cross
contamination and low consumable with open reagent channels.
Sapphire 200 intend to use in vitro quantitative determination of a wide range of chemistry
assays in various body fluids.
1
Sapphire 200 Users Manual Chapter 1
1) Technical specifications
System Type Open, Automated, Discrete, Random access, Patient

Prioritized, Clinical Chemistry Analyzer
Throughput 200 tests/hour
Display Resolution 1024 x 768
Reagents on Board Maximum 45
Analytical Method End point, Kinetics, Fixed time, Linearity and Non-linearity
Analysis
Calibration Linear (two point and multipoint), Factorized, and
Non-linear multipoint
Sample (Tubes/Cups) Primary tubes of 5, 7 or 10 ml & sample cups
Sample Volume (l) 2 - 50l (adjustable in 0.1 l step)
Sample Tray 60 positions/disk, non-fixed sample positions including
calibrator and control positions
Stat Sampling Immediate access at any positions
Reagent Tray 45 positions with Peltier cooling
Reagent Volume (l) R1: 25 - 350l
R2: 0 or 10 - 150l (adjustable in 1 l step)
Reaction Volume (l) 180 - 500 l
Reagent Bottles 50ml, 20ml
Programmable Parameters No limit
Photometry Optics Mono/bi-chromatic measurement

8 Wavelengths: 340, 405, 450, 510, 546, 578, 600, 700nm
Absorbance Range 0 2.5
Light Source Halogen lamp (12V/35W)
Reaction Tray 120 reusable (5Sets) PMMA cuvettes
Washing Unit 7 Stages automatic laundry unit
Water Consumption 8Lt/Hour
Auxiliary Data No limit
Mains Supply 220 5 V AC (or 110 3 V AC, optional), 250 VA, 50/60 Hz
Software Windows 2000 or higher
Interface RS-232 C port for Bi-directional Communication
Dimensions 680 (W)x420(D)x280(H) mm
Approximate Weight 70kg (main unit with CPU)
2
OVERVIEW
2) Basic Principle
Beers Law
If light is allowed to pass trough a coloured solution, the solution will absorb some light while
the rest of it will be transmitted. The amount of light absorbed is proportional to the nature,
concentration and colour of the solution. (Light absorbed Concentration of the solution).
Lamberts Law
The light absorbed by the coloured solution is directly proportional to the light path of the
colour solution (diameter of the cuvette): that is if the cuvette diameter is doubled, the light
absorbed will be doubled.
Cuvette diameter
Incident light Transmitted light

(Io) (Ie)
`
-
Photo sensor Meter
Light Absorbed
By the colored solution
Fig.1-1 Lamberts Law
Since the total incident light = light absorbed + light transmitted, it follows that:
1
Absorbed light
Transmitted light
Therefore as the absorbed light (Absorbance) increases, the transmitted light will decrease
As we increase the concentration of the colored solution, the light absorbed increases, and
we find that the transmittance varies inversely and logarithmically with concentration.
1
Absorbance (Absorbed light) = Log
Transmittance
100 1
Absorbance (Absorbed light) = Log *
100 Transmittance
100
Absorbance (Absorbed light) = Log
% Transmittance
Absorbance (Absorbed light) = Log 100 Log % Transmittance
Absorbance (Absorbed light) = 2 Log10 % Transmittance
3
3) Front View of Analyzer
Stirrer
Reagent/Sample Arm
Washing Unit
Reagent/Sample Tray
Reaction Tray
4) Rear View of Analyzer
Back Cover Lock
Tubing
Fans
Back Board
4
OVERVIEW
5) Side View of Analyzer
Power Switch
Power Cable
RS232
6) How does the system work?
PC Sapphire
Software
Reagent/Sample Reagent/Sample
Arm Controller Tray Controller
Main Board
CPU
Optic Receiver Syringe Controller
Controller
Reaction Tray
Controller
Fig. 1-2 Block Diagram
As Block Diagram showed above, the PC Sapphire Software communicates with the
analyzer main board through RS-232.
5
The Main Board CPU controls all the Step Motors, Syringes, Optic Receiver and instruct the
parts orientation/speed/round steps. The Sample & Reagent Arm are controlled by two step
motors control with two home sensors. Stirrer Arm, Cuvette Tray, Reagent Tray, Sample
Tray are all controlled by one Step Motor and one home sensor controls. Sample & Reagent
Syringes are controlled by 2 Step Motors.
The liquid level sensor controls the sample & reagent level and calculate test amount. Data
Collection Controller takes the electrical signal of each photoelectricity sensor by using 8
single pre-circuit, the hexadecimal A/D is transferred as the analog signals into digital
signals.
The Heating and the Lamp are supplied with stable power of 12V35W. Two semiconductor
refrigeration power supply and circuit of temperature control to make sure the refrigeration of
reagent tray.
7) Light System
44 55
6
2 3
1
Divided to 8 light route
1. Lamp 2. Optical fiber 3. Cuvette

4. Interference filter 5. Optic receiver 6. Amplifier
Fig. 1-3 Light System
As Light System showed above, the Lamp send out light into the optical fiber, then divided to
8 beam, and the cuvette get the incidence of light, permeate the solution into the interference
filter, dispart the light into homochromy light, set it into the Optic Receiver.
We have chosen quartz glass halogen lamp which is 12V35W, collimated by the optical fiber
into parallel beam of light which diameter is 2.5mm.
There are totally 120 cuvettes on reaction tray. Every cuvette is cuboid structure, diameter
6mm, made of organic glass euphotic ultraviolet radiation. It requests every cuvette should
be uniformity, no nick, and the light reveal slot should aim at the middle of the cuvette to
make sure sampling reading is accurate.
The minimum volume is 180ul. Its priority is no across contaminated. To considered about
the speed of reading when the cuvette tray is turning, we adopt 8 routes of light disparting
static system, using the component which integrated the imported filter and the Optic
Receiver, the wavelength is between 340-700nm.
6
OVERVIEW
8) Software Function
Software
Routine Operation Parameter Specific Test Data Management Service & Adjust
Sample Order Edit Password Calib.&QC Result inquiry Daily maintain

Repeat Test Item Parameter Reagent status Reaction curve Adjusing
Testing Special Washing & Data Mechanical
Report Parameter Blank Maintenance inf.
Reading Abs.
Fig. 1-4 Software Function
The software includes two parts, the calculation operate software, and the SCM control
software.
The User Interface is based on Windows 2000(or above), under the uniformity user interface,
each single module will finish its special function.
Routine Operation menu mainly finish the daily work, includes 4 sub-menus.
- Sample Order is to record the information of patients, choose the test project, and
detect the sample.
- Repeat test is to input and test of sample which need to be test again, and you can
retest the unsatisfied special sample then cover the original result.
- Testing is to start testing when finish the sample input or repeat test sample, then get
the real result.
- Report is to review and print out the results of tested sample.
Parameter menu is a module to finish every parameter, includes 3 sub-menus.

- Edit Password is to change the password when you want to setup the test project
parameter, avoid to the wrong operate on parameter then influence the test result.
- Item Parameters for setup the parameter of each test sample volume, reagent volume,
wavelength, test method, etc.
- Special Parameters is mainly to setup 3 projects:
Calculated Item: according to the pre-set formula to calculate the results, to get a
new item result.
Profile Order: which convenient for the group/panel order, such as Liver function,
Kidney function, etc.
Input Item: input the results (which tested by other instruments) into this sample,
then print together.
- Specific Test is the special test beside the normal patient test.
- Calibration & QC is to run calibration and QC test. You can set up the calibration and
control parameters here, and review the calibration curve here.
- Reagent Status is to setup the reagent tray position of reagent of each test, then the
instruments will find its needed reagent exactly. The instruments will sense every
reagent volume before test.
- washing & Blank is to wash the cuvettes and affirm & reserve the original blank.
- Reading Absorbance is to test the instrument performance, test the
absorbance/stability, convenient for calculate and some users special needs.
7
Data Management can inquire about the test results of any patient randomly, even the QC
result, and statistic these results, describe the trend, provides some valued statistic
documents to clinical laboratory.
- Result Inquire including test result inquire and QC result inquire, you can get sample
test result and QC result of any of days.
- Reaction Curve can display any test reaction curve at anytime.
- Data Maintenance can setup the arrange and basic information of result for print (ex.
Calculate unit, sample category)
- Service & Adjust is to provide some measure to operator for check the instrument.
Initialization can furbish every mechanical structure to the original before leave factory,
mainly used for orientation mistake caused by wrong operation.
- Single/Double reagent can be used to switch single/double test modes. When all the
tests are single reagent, we can choose single reagent mode to increase the test speed.
NOTICE: Single/Double Reagent Mode

If there is any double reagent test on test list, you should choose the double
reagent mode
- Parts Testing is to check analyzer moving parts alignment and functions.

- Adjustment is to adjust & test some moving parts and light signal by authorized
engineer.
8
ANALYZER INSTALLATION
2 ANALYZER INSTALLATION
1) PRE-INSTALLATION PREPARATION AND CHECKS

Installation Environment
y Avoid direct sun light.
y Low dust, libration and noise.
y Far away from strong electric disturbance.
Temperature and Humidity

y Working temperature: 15-30.
y Humidity: 40 - 80.
y Keep aeration.
Power supply and ground connection

y Power supply: 220V10% 50Hz, 250VA.
y Ground resistance: <4.
Installation space
100cm 100cm
20cm PC Printer
60cm 60cm
Sapphire 200
90cm
Hydraulic requirements
y De-ionized water 10 liter (NCCLS Type II or better).
y Cleaning solution for cuvettes rinse.
PC & Printer
y 1.3 GHz processor or higher
y Windows 2000, or Windows XP.
y 128 MB of installed RAM (256 MB or higher recommended).
y 10 MB of available hard disk space (Note: The data saved will grow after running tests
so the actual hard disk space required at that time is greater than the values listed.)
y 1028 x 768 screen resolution or higher
y Epson LX-300+ printer or optional.
9
2) Packing List
CAT NO Description QTY Check

ADS200 Sapphire 200 Main Unit 1
A300040 Users Manual 1
Accessories Box
A300032 Sample Cup 500pcs 1
A300002 Flowcell Set 120pcs 4
A300034 Software Disk 1
A300035 RS232 Cable 1
A300036 Power Supply Cable 1
A300020 Halogen Lamp 12V/35W 1
A300037 Fuse 2
A300038 Waste Tube 4pcs 1
A300028 Reagent Bottle15pcs 3
A300029 Reagent Bottle 15pcs 3
A300031 Reagent Rack 45pcs 1

A300041 Waste Container 1
A300042 Washing Container 1
A300043 Tool Box 1
10
3) INSTALLATION
Receiving inspection
The instrument should be packed very carefully and gently during transportation, and
handling. Before unpacking, please inspect if the out package has any apparent damaged.
Please refer to carriers or your service representative if the any of above mentioned
happened.
Unpacking steps
y Un-screw the top board of the wooden box first.
Take off top board.
y Take out the analyzer.
CAUTION: Handle with care

Allow at least 2 person to carry out the analyzer prevending any damages
caused to analyzer or personel.
y Please put the analyzer on a stable table. At least 30cm distance behind the instrument.
y Unpack the moisture proof cover.
y Unpack the Appendix and check the Packing List.
CAUTION: Pre-install Checking

The power supply must be compatible with the voltage and current
specifications indicated on the label affixed to the back of the instrument. It is
advisable to periodically check the efficiency of the electric wiring. The main
and the plugs must have efficient grounding in accordance with regulations
regarding electric wiring systems.
11
Wiring connection
y Connect DI Water Container.
y Connect Waste Container.
Water Tubing For Syringe Water Tubing For Washing
Waste Tubing For Waste
Waste Tubing For Leakage
12
y Connect power cable and RS-232 cable.
Power Switch
Power Cable
RS232
CAUTION: Pre-install Checking

Before connecting external instruments (computer, bar code reader), verify
compatibility (see the relevant instruction manuals) with the specifications
noted, and verify continuity of the grounding between the instruments.
Install computer and printer

y Connect RS-232 into PC COM port.
y Connect EPSON XL-300+ to PC.
y Install Sapphire 200 software and printer driver accordingly.
y Run Sapphire 200 Setup from provided Software Disk, and install the Sapphire 200
software on PC.
REMOVAL FROM SERVICE AND SHIPPING

y Use new distilled water filling in the tank.
y Enter System Maintenance, wash cuvette twice or more.
y Before putting away the instrument, remove all liquid from its hydro-pneumatic system.
y Switch off the instrument and disconnect the power cable and RS232 cable from the
instrument.
y Disconnect the tubes of the Distill Water and Waste containers.
y Clean the instrument and all accessories (including tubes and containers).
y Well packed with original package.
13
14
DAILY WORKING PROCEDURE
3 DAILY WORKING PROCEDURE
1) Preparation before Power on

y Check the DI Water Container and make sure volume up to 10L.
y Prepare the Reagents for testing.
y Prepare samples, add them in sample cups and put into sample plate holder.
y Check the voltage of the power supply.
2) Power on
y Switch on the power of the Sapphire 200.
Switch is on the right hand side of the analyzer.
y Turn on the computer and printer.
Click the shortcut icon of Sapphire 200, pop up log on screen.
y Enter the user name and password.
The initial user name and password are both 1000.
y The analyzer is available for test after about half an hour to warm up.
NOTICE: Initial Password

- User name: 1000
- Password: 1000
3) Sample Test
y The working menus are as following:
y Press the icon Routine Operation, then click the Sample Order:
15
y Enter the interface:
y Enter the information of the patients & test items:

- Click the icon <Add>, to add new patient.
- Enter the information of the patients & samples.
- Also can input the information in Profile function. (The detail described in the after
chapter )
- Select the tests from Item List.
Click the item, and press to add test to Test Item.
Multi tests can also be chosen by click the Profile from Profile order list, and click
to add.
Click <OK> to confirm the order.
- Edit Test Item
To delete items, click <Edit> and press to eliminate the chosen items.
- Click <Profile> to order samples by batch.
- Choose Stat to make the sample prior test.
16
DAILY WORKING PROCEDURE
y Run test: click Routing Operation \ Testing to enter the following screen:
- Check Reagent and Sample Cup on the screen, and press <Start> if all
information is correct.
- Please ensure the reaction cuvettes clean. Click <Yes> to begin test.
- The screen will show testing status.
17
y Report & results print

- Click Routing Operation \ Report to enter the following screen:
- Select the sample number in Results list.

- Enter patient information in Information area if necessary.
- Press <Print> to print out Current selected results or All results.
- In Input Results area, can <Add Input Items> or add <Calculate> items.
- Sapphire 200 also show the Reaction Curve of the test.
y Exit the system
- After all daily work, press or click Exit to exit the system.
- Turn off the PC.
- Power off the instrument.
18
ROUTING OPERATION
4 ROUTING OPERATION
1) Flow chart Turn on
Warm up 30 minutes
NO
Calibration?
YES
Calibration
NO
Control?
YES
Control
NO
W.Blank?
YES
Save Water blank
Input the info.
Sample test
Test completed
Check results
Print
Shut down
19
2) PREPARATION JOB
y Sample prepare:
Take centrifugal serum; add enough sample into the sample cup. The serum shall be
without fibrinogen or haemolysis, and no bubble in the sample cups.
y Reagent prepare:
Add enough qualified reagents in the reagent bottles.
y DI Water prepare:
10 litres of DI water with conductance less than 2.0us/cm.
3) Order
Press the icon Routine Operation, then click the Order:
Enter below screen:
1) Click <Add> to add sample.

2) Sample No: is lab assigned number which can not be re-used in the same day.
System can increase the number by one for each new sample automatically.
3) Name: enter patient name.
20
ROUTING OPERATION
4) Sex: Choose M for male, F for female.
5) Age: Patient age by year.
6) Sample Cup No: Enter the sample position on the sample tray. It can be re-used
during the same day.
7) Sample Type: Choose Serum, Urine and Others.
8) Doctor: Either by typing or choosing doctors name.
9) Bed No: The patient Bed No if available.
10) Department: Either by typing or choosing Department where samples from.
11) Diagnose: Either by typing or choosing clinical description.
12) Patient ID: Enter assigned patient ID, maximum 10 numbers.
13) Profile: Press to order tests by batch which has the same test items and to be put in
consequently on sample tray.
Enter the Start Sample No and Start Sample Cup No, then enter the Number of
samples to be test.
14) Item List: select item to be test.
Click the item, and press to add test to Test Item.
Press <OK> to confirm the order.
15) Profile Order: Add multi tests by profile.
Choose pre-edit Profile and click to add.
Click <OK> to confirm the order.
16) Edit: To delete items, click <Edit> and press to eliminate the chosen items
from Test Item.
17) Delete: To delete samples, choose the Sample No on No Test and press
Delete.
18) Stat: make the sample prior test.
19) Exit: to exit the Sample Order screen.
NOTICE: By Path
Patients information can be entered on Sample Order screen here, or on
Report screen.
21
4) Testing
Click Routing Operation \ Testing will enter the following screen:
1) Reagent: to check reagent position and status by different color.

2) Sample Cup: to check sample and tests status by different color.
3) Start: to start tests had been chosen.
4) Pause: to pause the dispensing temporarily. This may affect the test results.
5) Continue: to continue the paused dispensing.
6) Stop: to stop all actions. Please be very careful to perform this step which will
eliminate all tests and results undergoing.
7) Start Cuv. No: Please enter the cuvette number you want to begin with. The system
will remember the dirty cuvettes after test.
NOTICE: Test Monitor

- All alayser actions will be shown on the situation column.
- All results and Absorbance information will be shown real time on the
results column. It will take about 18s to genarate a new result.
22
ROUTING OPERATION
5) Repeat Test
Click Routing Operation \ Repeat Test will enter the following screen:
This is to re-run tests, if the results are not satisfied or high concentration. The new results
will cover the old ones.
1) Select the sample number need-repeating test in the Order List.

2) Press <Edit> and choose the items need to be repeat.
3) Press <OK> to confirm the order.
23
6) Report
Click Routing Operation \ Report to enter the following screen:
1) Information: Enter patient information in the area if necessary. This can be entered
in Sample Order screen as well.
2) Results: here shows the results of the date. Select the sample number to see
results in details.
3) Print: Press <Print> to print out Current selected results or All results. Enter the
Range of Sample No, a sequence results will be printed.
4) Input Results: here can <Add Items> or add <Calculate> items manually.
5) Reaction Curve: here can show the reaction curve of the selected test.
24
PARAMETER SETTING
5 PARAMETER SETTING
NOTICE: Password required

- To avoid revising the parameters at a venture, system set a password to
enter Parameters.
- The initial password is 00000000.
- User can change the password through Parameter \ Edit Password.
1) Item Parameters
Click Parameter \ Item Parameters will enter the following screen:
1) Press <Add> to add a new item in Item List.

2) Item No.: Enter 1 99 items number. This will give the sequence to the item on Item
List.
3) Item Name: Enter 4 characters stand for items name.
4) Full Name: Enter the items full name.
5) Sample Vol (l): Enter sample volume, range 2 - 50l.
6) R1 Vol (l): Enter Reagent 1 volume, range is 25 - 300l.
7) R2 Vol (l): Enter Reagent 2 volume, range is 10 - 150l.
8) Wavelength (nm): main Wavelength can be chose from 340, 405, 450, 510, 546,
578, 630, 700nm. Please refer to the reagents Instruction For Use and get this
information accordingly.
25
9) Sub-Wavelength (nm): Sub-Wavelength can be chose from 0, 340, 405, 450, 510,
546, 578, 630, 700nm. Please refer to the reagents Instruction For Use and get this
information accordingly.
10) Method: Choose from End, Rate and Fixed. Please refer to the reagents Instruction
For Use and get this information accordingly.
Typical reaction curve is as following:
OD OD
End Rate
2.0 2.0
1.0 1.0
0.0 0.0
0 10 20 30 40 50 0 10 20 30 40 50
11) Sample Type: Choose from Serum, Urine or Others.

12) Decimal: Choose from 0, 1 or 2.
13) Units: the concentration unit, can be chosen in pull-down list.
14) Min. OD (A): When the absorbance of negative reaction item goes down to the
setting value, it will give a warning that the concentration it too high, user should
dilute it and test the sample again.
15) Max. OD (A): When the absorbance of some positive reaction items is over the
setting value, it will give a warning that the reagent is out of expiration date.
16) Reading Points: main reading section is to define the beginning reading time and
reading period.
- There are 40 points in whole reading period, 18s between two points. So, the
whole period is 40x18=720s (about 12min).
- For example, if the beginning reading point is at 3min and the reading alternation
time is 3min, the Start Point is 10 and End Point is 20.
- When adapt sample blank, system will take the method of two section read. The
Sub-Points section will read sample blank and Pri-Points section will read
reaction data.
- Take below graph for example, If the Sub-Points section read is from point 10
to point 18, the Pri-Points section is from 35-40:
OD R2
1.5
1.0
Sub-Points Pri-Points
0.5
0 5 10 15 20 25 30 35 40 45
17) Normal Range: Enter the test result reference range. System will flag the results out
of range.
18) Corrected: Correlation between alternation analyzer. If the test result of this machine
has difference with the expectation value, it can be revised by way of formula
Y=AX+B, which through changing coefficient A and B to revise the test result.
26
PARAMETER SETTING
19) Press <Save> to store the parameter entered.
20) Press <Cancel> to abort the parameter entered.
21) Press <Delete> to delete items entered.
2) Special parameters
Click Parameter \ Special Parameters will enter the following screen:
y Profile Parameters setup

1) In Profile Items area, click<Add> to add new Profile.
2) Number: allow to put sequence number for the Profile.
3) Item Name: enter profile name, less than 10 characters.
4) Full Name: enter a full name for the Profile.
5) Click the wanted item and transfer to Item column by clicking button. to add
the items into profile.
6) Press button to eliminate chosen item from Item column.
7) Press <OK> to save the profile parameters.
8) <Edit> to change the profile.
9) <Delete> to delete the profile.
y Calculated Item setup

1) In Calculated Item area, click<Add> to add new Calculated Item.
2) Number: allow to put sequence number for the item.
3) Item Name: enter item name, less than 10 characters.
4) Full Name: enter a full name for the item.
5) Units: the concentration unit, can be chosen in pull-down list.
6) Low: enter the lower reference range of the item.
27
7) High: enter the higher reference range of the item.

8) Decimal: Choose from 0, 1 and 2.
9) Edit calculation formula: select items in the selectable items column, double click the
Item.
10) Press <OK> to save the Calculated Item.
10) <Edit> to change the Calculated Item.
11) <Delete> to delete the Calculated Item.
NOTICE: Error Careful

For any delete of the Calculated Item, the item sequence in Printer must be
deleted at same time. Otherwise, system error will occur.
y Input Item setup

1) In Input Item area, click<Add> to add new Input Item.
2) Number: allow to put sequence number for the item.
3) Item Name: enter item name, less than 10 characters.
4) Full Name: enter a full name for the item.
5) Units: the concentration unit, can be chose in pull-down list.
6) Low: enter the lower reference range of the item.
7) High: enter the higher reference range of the item.
8) Decimal: Choose from 0, 1 and 2.
9) Press <OK> to save the Input Item.
11) <Edit> to change the Input Item.
10) <Delete> to delete the Input Item.
NOTICE: Error Careful

For any delete of the Input Item, the item sequence in Printer must be
deleted at same time. Otherwise, system error will occur.
28
SPECIAL TEST
6 SPECIAL TEST
Special Test includes Calibration, Control Test, Reagent Status, and Reading Absorbance.
1) Calibration and QC
Click Specific Test \ Calibration And QC will enter the following screen:
29
y Calibration test
1) In Mode area, choose Calibration.
2) Press Calibration Parameter, enter calibration parameter setting screen:
3) Select an item from Item List.

4) Press <Edit> to change the parameter.
30
SPECIAL TEST
5) Calibration Type: enter calibration type by choosing from pull-down list:

- One Point
- Two Points
- Multi-Points1 (from zero point)
- Multi-Points2 (away from zero point)
- Factor
Conc. Conc.
40.0 40.0
20.0 20.0
0.00 0.00
0.4 0.8 1.2 1.6 1.8 OD 0.4 0.8 1.2 1.6 1.8 OD
a) One Point Calib. Curve b) Two Point Calib. Curve
Conc. Conc.
40.0 40.0
20.0 20.0
0.00 0.00
0.4 0.8 1.2 1.6 1.8 OD 0.4 0.8 1.2 1.6 1.8 OD
c) Multi-Points1 (from zero point) d) Multi-Points2 (away from zero point)
Conc.
40.0
20.0
0.00
0.4 0.8 1.2 1.6 1.8 OD
e) Factor Calib. Curve
6) Repeat Counts: Repeat times of calibration tests. System will take average value
as calibration results.
7) Standard Counts: Enter the number of calibrator for the test, max 6.
8) Sample Type: Serum, Urine or Others.
9) Lot: enter the Lot No of calibrators.
10) ABS: will appear after calibration done.
11) Factor: It is a coefficient that the system calculates according to the concentration of
standard, OD value, reagent blank.
12) Conc Volume: enter the concentration of the calibrator.
13) Cup: enter the calibrator position number on the sample tray.
14) Press <Change> to save 9) 12) calibrator information to the column.
15) Calibration Curve: in the drawing column, the horizontal axis is OD value and
vertical one is concentration value.
16) Current Data: Its to select current available calibration results in all the calibration
lists.
31
17) Press <Delete> to delete the selected results.

18) Press <OK> to save the calibration parameter.
19) <Edit> to change the calibration parameter.
20) Press <Detail> to review previous calibration data.
21) Close the Calibration Parameter windows and back to Calibration and QC.
y Run calibration:
1) Select the calibration item in the Items Lists.
2) Press to add into Calib-Item.

3) Start Cuvette No.: define cuvette No to begin with the calibration test, make sure
the cuvettes used are clean.
4) Press <Start> to begin calibration.
5) During calibration, user can press <Stop> button to stop the test.
6) Calibration results are available after test complete on Calibration Parameter
screen.
y Quality Control test

1) In Mode area, choose QC.
2) Press QC Parameter, enter QC parameter setting screen:
3) Click<Add> to add new QC Lot number.

4) Enter the <QC Lot> name.
5) Select analyte from Item column and enter the Mean and Standard Deviation for it.
6) Press to add into QC Item.
7) Press <OK> to save the QC item.
8) <Edit> to change the QC item.
32
SPECIAL TEST
9) <Delete> to delete the QC item.
10) Close the QC Parameter windows and back to Calibration and QC.
y Run QC:
1) Press <Add> in QC column.
2) QC Order No.: allow to give an order No for the test.
3) QC Cup No.: define cuvette No to begin with the QC test.
4) QC Lot: select QC Lot name.
5) Select the QC item in the Items Lists
6) Press to add into Item.
7) Press <OK> to save the QC item.
8) <Edit> to change the QC item.
9) <Delete> to delete the QC item.
10) Press <Start> to begin calibration.
11) During QC test, user can press <Stop> button to stop the test.
12) QC results are available after test complete on Data Management \ Query \ QC
Query screen.
y Calibration and QC can be test at the same time

Select Calibration + QC model in Model area, enter the calibration and QC data as
above steps.
33
2) Reagent Status
Click Specific Test \ Reagent Status will enter the following screen:
Sapphire 200 can hold up to 45 reagent bottles on one reagent tray. The analyzer is able to
detect the reagent volume with level sensing probe.
1) Click reagent position No on the screen.

2) Choose Item from pull-down list.
3) Define the Bottle Type of 15ml.
4) Define R1 or R2.
5) Press <Modify> to save the reagent status.
6) Residual will show current reagent volume in the bottles.
7) Amount will estimate the test number left in the bottles.
34
SPECIAL TEST
3) Reading Absorbance
NOTICE: Be careful
- Please be very careful to use this funtion.
- Only authorized personel can run this Reading Absorbance test.
- For engineering personel use only.
y Select <Wavelength>, input the reaction cup number for test and select interval <Time>
between two readings. (max 1hour)
y Press Test after confirms. User can select to make water blank refer to the sample test.
y After test, the data will be refreshed in 12s. There is a record value in every 5min till the
set interval time. Watch the data variation and judge the stability of the instrument.
35
y Press Test <Abs> to see the following display:
y Select the <Wavelength> in the pull-down list. After prepare the sample, press <Test>,
the instrument begins to reading. Then the cuvette cup number and corresponding
absorbance value will be displayed in the list. User can select the absorbance value in
this list.
36
DATA MANAGEMENT
7 DATA MANAGEMENT
Data Management is for inquire or process the data which includes Result Query, QC Query,
Reaction Curve, and Data Maintenance.
1) Result Query
Click Data Management \ Query \ Results Query will enter the following screen:
y Query by Date:
1) Enter an exactly date or select the initial and end date at the right up corner of the
screen.
2) All samples will be shown in Sample No column.
3) Select a sample No, the corresponding result will be listed in the Results column.
4) Press <Print> to print out the results report.
y Query by Name:
1) Click the Name circle, enter the exactly name and Query.
2) The result will be listed in the Results column.
3) Press <Print> to print out the results report.
37
2) QC Query
Click Data Management \ Query \ QC Query will enter the following screen:
1) Select an item to review QC results.

2) Select the analyse date by enter initial date and end date.
3) All control value, date and lot number for this item in this period will be displayed in
the control value column.
4) If several controls are made in the same day, need to select a proper value as
control chart parameter. (The first value is default). The mean value, SD and CV will
be calculated automatically. The control chart will be displayed.
5) If need printing, press <Print>.
6) Press <Add> to add new QC data.
7) Press <Delete> to delete the QC data not satisfied.
8) Press <Edit> to revise QC data.
38
DATA MANAGEMENT
3) Reaction Curve
Click Data Management \ Reaction Curve will enter the following screen:
y System will read each of six wavelengths ABS data every 18s during the test. Total 40
points ABS value will be read and store to data base.
y All the datas date which has been saved will be listed in Date column. If press <Delete>
current date data, system will delete all the data of that day.
NOTICE: Be careful
Please use this function very carefully, because the data cant be recovered
after delete.
y Select curve type in sample, calibration and control column.

y If select a sample, select it in the single optional column. Current day's Sample No. is
displayed in sample column. Select correct sample No., then an items list of it will be
showed in Items Column.
y After selection, system will show the reaction curve in Curve drawing. Here can adjust
the Y-coordinate display rate.
y If need to review the ABS value corresponding to the reaction curve, press <Data>
button.
Single click the right up corner symbol "X". Exit the reaction curve watching screen.
39
4) Data Maintenance
Click Data Management \ Data Maintenance will enter the following screen:
y Title: In Report Format area, enter the report title or hospital name.
y Select Print Operators Name will allow to print out operators name on the report.
y Item Order: allow to sort out the print sequence of the items.
NOTICE: Careful System Error

Please keep all items on the list, including calculated items and input items.
Otherwise, system error will occur.
Items been deleted in Parameter, must be deleted in the print Item Order.
Otherwise, system error will occur.
y In Data setup column, user can define:

- Units
- Department
- Diagnose
- Doctor
- Sample Type
40
AND ADJUST
8 SERVICE AND ADJUST
1) Initialization
Click on the menu Service and Adjust \ Initialization to reset the instrument.
2) single reagent
Click on the menu Service and Adjust \ Single Reagent, system will only test single
reagent items.
If all the test items use single reagent, the analyzer throughput will be increased.
NOTICE: Be careful
Double reagent option must be chosen if there is any double reagent item in
the test items.
3) Parts Testing
Click on the menu Service and Adjust \ Parts Testing, below screen will display:
NOTICE: Be careful
- Only authorized personel can run this Parts Testing.
y Syringe Test
There are two kinds of syringes, one is for reagent and the other for sample. User can
see a blank beside the every syringe name. Input the volume that the syringe will absorb.
Then press Executing button, syringe begins to running and absorb the solutions on
request.
Then press Reset, it will reset to initial position. If the syringe can't run or the volume is
41
not right, the syringe encountered malfunction.
y Mechanical arm Test

User can test the mechanical movement by the Test buttons listed in the screen, which
include horizontal reset, horizontal reagent test, sample position test, and cuvette
position test. After horizontal test, vertical test can be executed.
y Rotating plate Test

There are three rotating plates in the instrument. They are sample plate, reagent plate
and reaction plate. There is a blank beside the plate name. Input the position number,
and press Execute button, the plate will turn to the corresponding position. Then press
Reset to reset the plate.
y A/D Reading
Press the button beside the A/D Reading. Then the reading value of each wavelength is
shown in each blank. It is abnormal if the value is lower than 20 thousand, which means
the light source or data channel encountered malfunction.
4) Adjustment
NOTICE: Be careful
- This is to adjust the volume of washing solutions and initial position of all
the tray.
- Only authorized personel can run this Parts Testing.
Click on the menu Service and Adjust \ Adjustment, below screen will display:
NOTICE: Password required

- To enter Adjustment, Password: 666666
y Horizontal Adjustment for dispensing arm
42
AND ADJUST
1) Adjust the steps to sample position, reagent position and cuvette position by
pressing < Add > and < Minus > to go each step forward or back.
2) Press <OK> to store the steps value.
3) Press <Cancel>, the value is abandoned.
y Vertical Adjustment
1) Adjust the depth that the dispensing needle, washing needle or mixing arm steps by
pressing < Add > and < Minus > to go each step forward or back.
2) If no reagent or sample at this depth, system will give a warning.
3) Press <OK> to store the steps value.
4) Press < Cancel >, the value is abandoned.
5) It's better to adjust the dispensing needle to the bottom of the sample cups or tubes.
y Optical system adjustment
NOTICE: Service required

The optical system adjustment must be executed by the qualified engineers
who are authorized by the manufacturer.
y Sample, reagent and reaction tray adjustment

Adjust probe position to make sure all centralized.
43
44
MAINTENANCE
9 MAINTENANCE
1) Daily maintenance
y Check washing solutions bottle and empty the waste bottle.
y Check the dispensing needle position and keep the tip fluent.
y Check if block happened in the washing in-way.
2) Weekly maintenance
y Wash the dispensing needle by detergent solutions.
y Clean the surface of the instrument.
y Washing reagent containers.
3) Half year maintenance

y Check lamp. If abnormal, replace a new one.
y Check if water pump runs normally.
y Check if syringe leaked. If necessary, replace a new one.
4) Yearly maintenance
y Check the power voltage and ground connection.
y Maintain the mechanical arm.
y Replace the tubes.
y Adjust the mechanical positions.
5) Cuvette washing procedure

y Configure 0.525% Hypochlorous Na solutions.
y Prepare three bottles for washing the cuvettes. No.1 contains antisepsis solutions; the
other two contain distilled water.
y Put the solutions in cuvettes into the antisepsis cells.
y Rinse the cuvettes at least three times user water.
y Put the cuvettes into No.1 bottle. We suggest immersing them in the water in 10-30min
or a little longer.
y Then rinse the cuvettes at least three times.
y Put the cuvettes into No.2 bottle (distilled water). We suggest immersing them in the
water in 10-30min or a little longer.
y After immersing, please repeat the action of take out and put in at least three times in the
distilled water.
y Put the cuvettes into No.3 bottle (distilled water).We suggest immersing them in the
water in 10-30min or a little longer.
y After immersing, please repeat the action of take out and put in at least three times in the
distilled water. After washing, throw off the water in the cuvettes.
y Put the cuvettes on the absorbent material or holders with mouth down till it is dried
naturally.
y Heating method is forbidden, which will influence the cuvettes quality.
The cuvette must be tested after 50 times repetition use. Only the one which passed the test
can be used again.
6) Part replacement
y Lamp replacement
Normally, lamp should be replaced in six months or after 1500h working.
1) Open the back cover
2) Take out the light cover.
3) Take out the lamp and replace a new one (GE, 12V /30W). Pay attention the
45
connector. Please fix it.

4) Install the light cover.
5) Restore the back cover.
NOTICE: Be careful
- The replacement should be executed after lamp is cool. Otherwise it will
hurt operator.
y Syringe replacement
1) Open the back cover
2) Replace the leaked syringe. Note to fix the screw.
3) Recover the back cover.
y Dispensing needle replacement

1) Take out the up-cover of the needle
2) Unscrew the fixed screw.
3) Replace a new one.
4) Fix the new needle.
5) Adjust the needle position in the mechanical adjustment menu.
6) Recover the up-cover.
NOTICE: Be careful
The position adjustment should be executed carefully and exactly. Otherwise
it will damage the needle.
46
MALFUNCTION ANALYSIS
10 MALFUNCTION ANALYSIS
1) No power after switching on.

Please check the power plug and fuses.
2) Power lamp isn't light

Check if the lamp burnt. The voltage for lamp should be 12V. IF so, please replace a new
one.
3) No washing water for dispensing needle

Check if the connecting tube well connected or blocked. If so, clean it. Then check if the
rinse pump works well. If so, replace it.
4) Incorrect dispensing volume

Check if syringe leaked, if connect tube leaked or the dispensing needle blocked. Then
handle the tubes or replace syringe.
5) Incorrect dispensing position

Adjust the position.
6) Incorrect result when test some items

Check reagent and sample. Then check if the other items tested by the same wavelength is
normal. If abnormal, please try to replace the filter.
NOTICE: Service required

If can't solve the problem, please contact our service engineers in time.
47
48
Sapphire 200 Warranty Card
For Customers Records
Purchase date: Serial number:
Customers name: Phone number:
Customers
address:
Customers email address:
Distributors name: Phone number:
For Distributors Records
Purchase date: Serial number:
Customers name: Phone number:
Customers
address:
Customers email address:
Distributors name: Phone number:
Manufactured by: Audit Diagnostics

Business and Technology Park, Carrigtwohill, Co. Cork, Ireland
Tel: +353 (0) 21 453 3652 Fax: +353 (0) 21 453 3653
E-mail: info@auditdiagnostics.ie Website: www.auditdiagnostics.ie
49

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Sapphire 200

Users Manual V1.5

ISO13485:2003 CERTIFIED DIAGNOSTICS MANUFACTURER

Legend of electrical and safety symbols used on the equipment:

Warning, danger of electric shock.

Warning, contains combustible materials.

Biohazard, danger of contamination with potentially infectious substances.

Legend of symbols used in the document:

ATTENTION, potential for personal injury, all instructions indicated in the

CAUTION, potential risk of damage to the equipment, all instructions

BIOHAZARD, danger of contamination with potentially infectious

SAFETY AND WARNING

NOTICE: Storage and transportation requirement

NOTICE: Installation requirement

CAUTION: Biohazard contaimination caution

CAUTION: Hight voltage caution

CAUTION: Moving parts caution

NOTICE: Warranty Information

First of all, thank you for choosing Audit Diagnostics products.

System Type Open, Automated, Discrete, Random access, Patient

Photometry Optics Mono/bi-chromatic measurement

Incident light Transmitted light

Fig.1-1 Lamberts Law

Absorbance (Absorbed light) = Log 100 Log % Transmittance

Absorbance (Absorbed light) = 2 Log10 % Transmittance

3) Front View of Analyzer

4) Rear View of Analyzer

Back Cover Lock

6) How does the system work?

Fig. 1-2 Block Diagram

Divided to 8 light route

1. Lamp 2. Optical fiber 3. Cuvette

Fig. 1-3 Light System

Sample Order Edit Password Calib.&QC Result inquiry Daily maintain

Fig. 1-4 Software Function

Parameter menu is a module to finish every parameter, includes 3 sub-menus.

NOTICE: Single/Double Reagent Mode

- Parts Testing is to check analyzer moving parts alignment and functions.

1) PRE-INSTALLATION PREPARATION AND CHECKS

Temperature and Humidity

Power supply and ground connection

CAT NO Description QTY Check

A300029 Reagent Bottle 15pcs 3

A300031 Reagent Rack 45pcs 1

Take off top board.

y Take out the analyzer.

CAUTION: Handle with care

CAUTION: Pre-install Checking

Water Tubing For Syringe Water Tubing For Washing

Waste Tubing For Waste

Waste Tubing For Leakage

y Connect power cable and RS-232 cable.

CAUTION: Pre-install Checking

Install computer and printer

REMOVAL FROM SERVICE AND SHIPPING

3 DAILY WORKING PROCEDURE

1) Preparation before Power on

NOTICE: Initial Password

y Enter the interface:

y Enter the information of the patients & test items:

y Report & results print

- Select the sample number in Results list.

y Exit the system