ATAGO RX-5000i User manual

P-OQ1011-3276-J01
1
Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
Performance Test of RX-5000i Automatic Digital Refractometer
Preface
The Operational Qualification (OQ) procedures of the RX-5000i Automatic Digital
Refractometer are described herewith.
The OQ performance test is to be executed by an operator who is familiar with the operation
of the RX-5000i. For daily inspection and maintenance, refer to the Standard Operational
Procedure (SOP).
1.Test Environment and Preparation
Turn the power on to the RX-5000i Automatic Digital Refractometer and let it warm up
for at least 20 minutes in an environment that satisfies the following conditions before
initiating the OQ test. The instrument may not perform to the required specifications if
tested in an environment that deviates from the criteria below.
Performance Test Environment
Ambient temperature:
15.0-30.0℃
Relative humidity:
Below 85%
Power supply:
AC 100V, 50/60Hz
※The RX-5000i should be placed indoors on a level surface, such as a desk or table.
2.Standard of Evaluation
A performance test requires a standard of evaluation.
Consider the stated accuracy level of the RX-5000i as well as the accuracy level required
Caution
The refractive index of a solution (standard sucrose solution, calibration
liquid) changes with temperature.
Ideally, the temperature of: 1) the prism of the RX-5000i; 2) the solution
(standard sucrose solution, calibration liquid); and 3) the test environment
should be equal for accurate measurements. It is recommended to maintain
the prism and the solution at a temperature that is within 4
℃
away from the
ambient temperature.

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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
for actual use before setting a standard. Refer to the product literature and/or
instruction manual for the specifications of the RX-5000i. These specifications are
guaranteed at the time brand-new instruments are shipped out by the manufacturer. It is
extremely difficult to produce an accuracy level that is better than the stated
specifications due to various environmental factors of the end-user’s site. A standard of
evaluation equal to or lower than the specifications is generally considered reasonable.
An example of such standard is: ±0.00006 nD, ±0.05% Brix accuracy.
3.Validation of Measurement Accuracy and Repeatability
Measurement values of the RX-5000i may be checked for accuracy and repeatability by
measuring a sample of known concentration.
The optical system of the RX-5000i based on the principle of light refraction operates in
conjunction with the electric elements, electronic circuit, etc. to calculate the refractive
index.
Select points within the measurement range to test the accuracy, repeatability, and span.
This procedure almost replicates the performance tests executed for calibration
purposes.
The accuracy of the RX-5000i is expressed as ±0.0000X for refractive index and ±0.0X%
for Brix.
4.Necessary Items
1) Samples: distilled water, 10.00% Brix standard sucrose solution, 30.00% Brix standard
sucrose solution, 1.51 nD standard liquid, round sheets
2) Plastic spoon or pipette, tissue paper, ethyl alcohol, USB flash drive
3) Measurement data log sheet
5.Instrument Preparation
1) Turn the power on to the RX-5000i. The opening (home) screen will be displayed. If
connecting a printer, turn on the printer first. The printer will print the opening
message.
2) Let the instrument warm up for at least 20 minutes. Touch “MEASUREMENT,” and the
measurement screen will appear. Check the MODE settings in the lower left corner of
the screen. It should be in MODE1, and the target temperature should be 20.00℃.
Touch “MODE” to adjust the settings.
3) Make sure that the date and time displayed are correct.
4) Check the print settings. From the set up screen, touch “PRINTER,” and the print
settings screen will appear. Set it to print measurement values in nD and Brix as well as
measurement temperature.
5) Make sure that the default scale on the measurement screen is Brix.

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
6) Make sure that the target temperature (TARGET) is set to 20.00℃.
6.Measurement
1) Apply distilled water on the prism and touch “ZERO.” “WAITING” will be displayed, and
once the prism temperature (PRESENT) reaches the target temperature (TARGET),
“READING” will appear and then “ZERO SET END” will appear in a few seconds. When a
printer is connected, “ZERO SET END” will be printed.
2) Measure distilled water and record the measurement value in the measurement data
log sheet. The measurement values in nD and Brix as well as the measurement
temperature will be printed for all subsequent measurements taken.
3) Measure the 10.00% Brix standard sucrose solution and record the measurement value
in the log sheet.
4) Measure the 30.00% Brix standard sucrose solution and record the measurement value
in the log sheet.
5) Place a round sheet and measure the 1.51 nD standard liquid. Record the measurement
value in the log sheet.
6) Repeat the steps 2) through 5) for 4 times. Record the measurement value each time.
7.Recorded Data
Review the recorded measurement data.
1) Cross-reference the data recorded on the log sheet and the data printed from the
printer.
2) The RX-5000i stores the last 500 measurement data. Once the maximum memory
capacity is reached, the instrument will automatically delete the oldest measurement
value to accommodate a new measurement value.
3) The stored data may be recalled on the measurement screen. Cross-reference with the
data recorded on the log sheet.
4) The stored data may be printed out at a later time.
Using the methods described above, check the consistency between the “recorded” and
“recalled” data.
8.Publication to Operational and Performance Qualification Test Results
Report
1) Record the measurement data on the Operational and Performance Qualification Test
Results Report (found at the end of this document).
2) Calculate and add the average values as well as the margin of error.
3) Compare with the standard of evaluation.

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
4) Lastly, have the operator and an approver sign the report.

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
Function Test of RX-5000i Automatic Digital Refractometer
Preface
The RX-5000i has many more functions in addition to measuring refractive index. For example,
an error message will be displayed and printed when zero-setting is attempted with a solution
other than distilled water. The function test is to be executed by an operator who is familiar
with the operation of the RX-5000i. Abnormal operations, such as purposefully causing error
messages to display, are involved. Have the RX-5000i instruction manual ready.
1.Instrument Preparation
1) If using a printer, connect it to the RX-5000i and turn the power on.
2) Turn the power on to the RX-5000i. If a printer is connected, the opening message will
be printed.
3) Let the instrument warm up for at least 20 minutes.
4) Set the target temperature (TARGET) to 20.00℃in mode 1. Make sure that the
measurement values are displayed in Brix.
5) Make sure that the date and time displayed are correct.
6) Check the print settings. Touch “SET UP” on the home screen. Touch “PRINTER,” and the
print settings will be displayed. Check the following items to be printed: DATE, TIME,
ATAGO, RX-5000i, SERIAL NO, MODE, NOTE, and Brix and nD in PRINT DATA. Touch
“ENTER.” The set up screen will appear. Touch “HOME” on the upper left corner.
7) The home screen will appear. Touch “MEASUREMENT” to display the measurement
screen.
2.Necessary Items
1) Distilled water, 30.00% Brix standard sucrose solution, 1.51 nD standard liquid, round
sheets
2) A solution with 1.585 nD or above, such as monobromonaphthalene and methylene
iodide containing sulfur solution
3) Ethyl alcohol, tissue paper
3.Function Test
The performance test was carried out in MODE-1 at 20.00℃, and the RX-5000i is set to
measure in the Brix scale.

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
Apply distilled water on the prism and press “ZERO SET.” Touch “START” and measure the
distilled water. Wipe the water off the prism.
3-1. Display Test
After the instrument is turned on, the opening message will be displayed, and then the
home screen will appear. Make sure that no truncated or garbled letters are found on the
screen.
3-2. Touch Key Test
1) Touch “HOME” on the measurement screen. Touch “SET UP” to display the set up
screen. Touch each icon and check the values against the factory default values found
in the instruction manual. Once the contents of each menu have been checked, return
to the set up screen.
2) Touch “HOME” on the set up screen to display the home screen. Touch
“MEASUREMENT” to return to the measurement screen.
3-3. Error Message Test
The measurement screen is currently displayed.
1) Make sure that the prism is clean and touch “ZERO.” “WAITING,” and then “READING”
will be displayed. “OUT OF WATER” will be displayed and printed.
2) Make sure that the prism is clean and touch “START.” “WAITING,” and then “READING”
will be displayed. After a few seconds, “OUT OF RANGE” will be displayed and printed.
3) Apply the 30.00% Brix standard sucrose solution and touch “ZERO.” “WAITING,” and then
“READING” will be displayed. A few seconds later, “OUT OF WATER” will be displayed.
Wipe the solution off the prism.
4) Place a round sheet and apply the solution with 1.585 nD or above, such as
monobromonaphthalene, on the prism and touch “START.” “WAITING,” and then
“READING” will be displayed. A few seconds later, “OUT OF RANGE” will be displayed.
Wipe the solution off the prism.
●The RX-5000i is currently in MODE-1. Program a user scale and check the “OUT OF
SCALE” error message and WAIT TIME function.
1) Touch “HOME” on the measurement screen to display the home screen. Touch “SCALE”
and select the uppermost empty row with the smallest scale number on the scale list.
Touch “EDIT” at the bottom of the screen. The scale-edit screen will be displayed.
2) Touch the scale number on the upper left corner of the screen. Enter the name of the
scale in SCALE NAME, using the alphabet & number keys. In this case, type in “Brix050.”
Touch “USER” from the scale types. Touch “ENTER,” and the user scale data screen will
appear.
3) Enter the refractive index in “nD” and the corresponding concentrations in “DATA,”
using the ten-key pad.

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
1. nD [1.33299] DATA [0.00]
2. nD [1.34782] DATA [10.00]
3. nD [1.36384] DATA [20.00]
4. nD [1.38115] DATA [30.00]
5. nD [1.42009] DATA [50.00]
4) Touch “%mass” in “UNIT” and touch “ENTER.” Programming the user scale “Brix050”
is now complete. The scale-edit screen will appear, and the “Brix050” scale will be
displayed. Touch “ENTER.” The scale name list will be displayed. Touch “HOME” to
return to the home screen. Touch “MEASUREMENT” to display the measurement
screen.
5) Touch “MODE” to display the MODE screen. Touch “MODE” and then “3.” Touch
“WAIT TIME” and then “5.” Touch “ENTER.” The measurement screen will appear.
Make sure that “MODE 3” and “WAIT TIME 5S” are displayed.
6) Place a round sheet and apply the 1.51 nD standard liquid on the prism and touch
“START.” “WAITING TIME” will be displayed, and the countdown starts from “05.”
Once it reaches “00,” “READING” is displayed on the measurement screen. If “OUT
OF SCALE” is displayed in a few seconds, the RX-5000i is functioning properly. Wipe
the solution off the prism.
3-4. Printer Output Test (When Printer is Connected)
1) Referring to the instructions in “1. Instrument Preparation” above, connect a printer
and turn the power on. Turn the power on to the RX-5000i. Make sure that the
opening message is printed.
2) Apply distilled water on the prism and zero-set the instrument. Make sure that
“ZERO SET END” is printed.
3) Measure the 30.00% Brix standard sucrose solution. Make sure that the sample
number, measurement values in nD and Brix, and measurement temperature are
displayed. (The items to be printed are selected in “1. Instrument Preparation.”)
3-5. RS-232C Output Test (When RS-232C Cable is Connected)
For Windows 95 / 98 / 2000 / XP
1) Connect the RX-5000i and a PC with a RS-232C cable, referring to the instruction
manual. Make sure that both units are turned off while connecting the cable.
2) From the PC menu, select Accessories > Communications > HyperTerminal. Connect
directly to COM1. Set up the communication parameters as follows:
●Baud rate: 9600 ●Data: 7 bit ●Stop: 1 bit ●Parity: odd
3) Set the baud rate of the RX-5000i in the same manner. Touch “SET UP” on the home
screen. Touch “SERIAL,” and the protocol setting screen will appear.
4) Apply distilled water on the prism and zero-set the instrument.
5) Type in the zero-setting command “*ZERO” and press “ENTER” on the PC. Zero-setting
will be carried out.
6) Measure the 30.00% standard sucrose solution. The measurement data will be
displayed on the PC. Make sure that the format is as outlined in the instruction

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
manual.
7) Type in the start command “*START” and press “ENTER” on the PC. A measurement
will be taken.
3-6. USB Data Storage Test
1) Connect an USB flash drive with enough space to the instrument.
2) Touch “DATA” on the home screen.
3) The past measurement data will be recalled. Touch “RESULT” on the bottom of the
screen.
4) The file name screen will appear. Type in the file name to be saved on the USB drive
and touch “ENTER.”
5) “SAVING” will be displayed on the screen. The data have successfully been copied to
the USB drive once “COMPLETED” is displayed.
6) Disconnect the USB drive from the instrument and connect it to a PC to check the
contents.
4.Publication to Operational and Performance Qualification Test Results
Report
Record the function test items on the Operational and Performance Qualification Test
Results Report.
Evaluating Performance of RX-5000i Automatic Digital Refractometer
Compare and evaluate the performance and function test results recorded on the
Operational and Performance Qualification Test Results Report against the standard of
evaluation. Have the operator and an approver sign the report.

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
Operational and Performance Qualification Test Results Report
Results
Notes
Test date
Model name
Serial number
Printer name
Serial number
Ambient
Condition
Temperature
℃
Relative Humidity
%
1.Performance Test Results (20℃)
Distilled water
(1.33299 nD)
10.00% Brix
standard
sucrose
solution
30.00% Brix
standard
sucrose
solution
1.51 nD
standard liquid
1st
measurement
2nd
measurement
3rd
measurement
4th
measurement
Average
Margin of error
Standard of evaluation = ±0.05% Brix, ±0.00006 nD accuracy
2.Function Test Results
Items
Results
Switch
□
Power switch
Screens and icons
□Home screen □Set up screen
□ZERO icon
□START icon
Display
□Opening message
□Date and time
□Display
Messages
□ZERO SET END □OUT OF WATER
□OUT OF RANGE
□OUT OF SCALE
Output
*1
□Printer □USB flash drive
RS-232C
*1
□Data output
□Operation
*1 Test items when connecting to a printer or PC.
3.Final Evaluation
Evaluate the performance and function test results and make the verdict.
□ Pass□ No-Pass
Test Date:
Approval Date:

P-OQ1011-3276-J01
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Operational
Qualification (OQ)
Automatic Digital
Refractometer RX-5000i
(yyyy / mm / dd)
(yyyy / mm / dd)
Operator Signature:
Approver Signature:
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