Accurex Lysun RFM-101 User manual

Renal Function
Analysis Meter
(RFM-101)
User’s Manual
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Renal Function Analysis Meter
Identication
Meter: RFM-101
Test strips: RFS-101,CRS-101,UAS-101,URS-101
Important Safety Instructions
• Misuse of electrical meter can cause electrocution, burns, fire and other
hazards.
• Do not place the meter in liquid, nor put it where it could fall into liquid. If the
meter becomes wet, unplug it before touching it.
• Use the meter only for the purpose described in the instructions for use.
• Failure to use the meter in the manner specified by the manufacturer may
damage the protection provided by the meter.
• Do not use accessories which are not supplied or recommended by the
manufacturer.
• Do not use the meter if it is not working properly or if it has suffered any
damage.
• Do not let the meter come into contact with surfaces which are too hot to
touch.
• Do not use the meter where aerosol sprays are being used or where oxygen is
being administered.
• Do not use the meter out of doors.
• Control solution only purchased from local distributor or manufacturer
• Keep these instructions.
• For profesional use.
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Table of Contents
Renal Function Analysis Meter ������������������������������������������������������������������������������ 1
Section 1 Introduction �������������������������������������������������������������������������������������������� 3
Section 2 Getting Started ��������������������������������������������������������������������������������������� 4
Section 3 Components ������������������������������������������������������������������������������������������� 7
Section 4 Initial Setup ������������������������������������������������������������������������������������������ 14
Section 5 Meter Setup and Options �������������������������������������������������������������������� 15
Section 6 Testing �������������������������������������������������������������������������������������������������� 17
Section 7 Memory/Communication ��������������������������������������������������������������������� 25
Section 8 Optical Verify Strip Test ���������������������������������������������������������������������� 26
Section 9 Quality Control ������������������������������������������������������������������������������������� 27
Section 10 Maintenance ��������������������������������������������������������������������������������������� 30
Section 11 Precautions ���������������������������������������������������������������������������������������� 32
Section 12 Limitation ������������������������������������������������������������������������������������������� 33
Section 13 Troubleshooting �������������������������������������������������������������������������������� 34
Section 14 Meter Performance ���������������������������������������������������������������������������� 35
Appendix 1 Meter Specications ������������������������������������������������������������������������ 36
Appendix 2 Labelling And Information ��������������������������������������������������������������� 37
Appendix 3 Warranty �������������������������������������������������������������������������������������������� 38
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Section 1 Introduction
The Renal Function Analysis Meter is intended for the quantitative determination
of Uric Acid (UA), Creatinine (CR) and Urea (UR) in capillary blood, venous whole
blood, plasma and serum. The easy to operate system consists of a portable meter
that analyzes the intensity and color of light reected from the reagent area of a Test
strip, ensuring quick and accurate results.
The Renal Function Analysis Meter provides results. The Renal Function Analysis
Meter can store up to 500 results and records. The meter can be operated by
charging battery.
To ensure accurate results:
• Read instructions carefully and complete any necessary training before use.
• Use the code chip that is included in each box of test strips.
• Only use the Renal Function test strips with the Renal Function Analysis Meter.
• For in vitro diagnostic use only. Renal Function Analysis Meter is only to be
used outside the body for testing purposes.
• For professional use.
• Keep out of reach of children.
Principle of measurement
The analyzer applies the principle of photochemistry and is used with Renal
Function test strips (RFS-101, UAS-101, CRS-101, URS-101) .The whole blood
sample to be tested is added into the sample area of the strip. In the process of
rapid inltration, blood cells are ltered out or dissolved. The substrate reacts with
enzymes and chemicals in the reaction layer and lead to the color change, then the
color intensity is proportional to the concentration of the substance.
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Section 2 Getting Started
Please check the following requirements when you first receive our products:
Unpacking, Checking delivery for completeness, Checking for damage during
transport. If you have any question, please contact the manufacturer.
Before testing, read the instructions carefully and learn about all the components
of the Renal Function Analysis Meter. Depending on the package type, some of the
components may need to be purchased separately. Please check the list of contents
on the outer box for details on which components are included with your purchase.
The following items are needed to perform a test:
Front Back Front Back
Code ChipSafety Lancet
Capillary Transfer Tube/Dropper Carrying Case
Front Back
Test Strip
( RFS-101)
Test Strip
(UAS-101, CRS-101, URS-101)
Optical Verify Strip
Renal Function Analysis Meter
Lancing Device
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Component Descriptions
01� Renal Function Analysis Meter: Reads the test strips and displays the
concentrations of UA, CR, UR.
02� Test Strips: Part of the system, these are inserted into the meter to measure
the concentrations of Uric Acid (UA), Creatinine (CR) and Urea (UR).
03� Optical Verify Strip: Veries the proper operation of the meter by checking
that the meter can detect a pre-calibrated value.
04� Safety Lancets: Used to draw blood specimens. Discard after use.
05� Code Chip: Automatically calibrates the meter with the code number when
inserted into the meter.
06� Lancing Device: Used with sterile lancets to prick the fingertip for blood
specimen collection. The packaged lancing device has multiple depth settings,
allowing users to adjust the depth of the puncture and minimize discomfort. It
can also eject the used lancets.
07� Sterile Lancets: Used with the lancing device to draw blood specimens for
individual test. Sterile lancets are inserted into the lancing device for each
blood draw and discarded after use.
08� Capillary Transfer Tubes/Droppers: Collects capillary blood from fingertip
blood testing for accurate results.
09� Carrying Case: Provides portability for testing.
10� Instructions For Use: Provides detailed instructions on using the Renal
Function Analysis Meter.
11� Test Strips Package Insert: Provides detailed instructions on using the Renal
Function test strips.
12� Control Solution: Verifies the proper operation of testing and validates the
test strip and meter are working together properly.
13� Control Solution Package Insert: Provides detailed instructions on how to
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use the Control solution.
14� Warranty Card: Card included in the package, which should be completed
and returned to the distributor to qualify for the 2-year meter warranty.
Caution:Test strip, safety lancets, sterile lancets and capillary transfer
tubes/droppers are disposable materials� Please use them before the
expiration date�
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USB Port
Liqiud Crystal Display (LCD)
Left Key
Power Key
Right Key
Code Chip Slot
Test Strip Holder
Section 3 Components
The Renal Function Analysis Meter reads the test strips and displays the
concentrations of Uric Acid (UA), Creatinine (CR) and Urea (UR). Use this diagram
to become familiar with all the parts of the meter.
Meter Use and Precautions
• Do not get water or other liquids on or inside the meter.
• Keep the Test Strip Holder clean.
• Keep the meter dry and avoid exposing it to extreme temperatures and
humidity.
• Do not drop the meter or get it wet. If the meter is dropped or has gotten wet,
ensure the meter is working properly by running an Optical Check. Refer to
optical verify strips for details.
• Do not take the meter apart. Taking the meter apart will void the warranty.
• Refer to Maintenance for details on cleaning the meter.
• Keep the meter and all associated parts out of reach of children.
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Note: Follow proper precautions and all local regulations when disposing of the
meter.
Test strips
The Renal Function test strips are plastic devices that work with the Renal Function
Analysis Meter to measure the UA, CR, UR concentration in whole blood, plasma
and serum.
Test strip appears as shown below:
Test Area
Insert Arrow
Specime
Application Area
Handle
Front Back
Test Area
Insert Arrow
Specime
Application Area
Handle
Front Back
RFS-101
UAS-101, CRS-101, URS-101
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Test strips can detect Uric Acid (UA), Creatinine (CR) and Urea (UR).
Insert Arrow: Located on the front of the test strip, the arrows indicate the direction
in which the test strip should be inserted into the meter.
Specimen Application Area: After the strip is inserted into the Test Strip Holder,
apply the correct specimen volume to the region in the center of the test strip.
Handle: Located on the end of the test strip, the handle is used to insert and
remove the test strip from the meter.
Test Area: Located on the back of the test strip. The meter will detect and read this
area to give results of UA, CR and UR levels.
Specimen Application
For best results, fill the Specimen Application Area with the correct specimen
volume. Incorrect results may occur if the specimen is not applied correctly or if the
Specimen Application Area is not lled with the correct amount.
After applying the specimen, ensure that the Specimen Application Area is
completely covered. The Specimen Application Area should remain covered
throughout the entire test. If the Specimen Application Area is not covered or if there
is too much specimen covering the Specimen Application Area, repeat the test with
Correct Incorrect-
Not enough Blood
Incorrect-
Too much Blood
Front Side Front Front Side
Before Testing
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a new test strip.
Note: If the specimen applied to the Specimen Application Area is not enough,
do not add more specimens to the test strip. Instead, retest with a new strip. If
the E-2 Error or another error appears on the display, please discard the used
strip and retest with a new strip.
Code Number
Printed on each package of test strips is a code number , lot number, unopened
expiration date, and test quantity.
Test strip Precautions and Instructions for Use
• Test strips should be stored in their tightly capped protective canister or foil
pouch to keep them in working condition.
• Do not store test strips outside of their package. Test strips must be stored in
the original package and sealed tightly.
• Do not transfer test strips to a new package or any other container.
• Replace the cap on the test strip canister immediately after removing a test
strip.
• A new canister of test strips may be used for 3 months after rst being opened.
The opened expiration date is 3 months after the date the canister was rst
opened. Write the opened expiration date on the canister label after opening.
Discard the canister 3 months after it is rst opened. Usage after this period
may result in inaccurate readings.
• For in vitro diagnostic use. Test strips are to be used only outside the body for
testing purposes.
• Do not use test strips that are torn, bent, or damaged in anyway.
• Do not reuse test strips.
• Before performing a test, make sure that the code number on the meter display
matches the number shown on the test strip canister or foil pouch and on the
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The optical verify strip appears as shown below:
Precautions
• Store in the closed canister at room temperature or in the refrigerator within
2-30°C. Avoid exposure to direct sunlight, extreme temperatures, and humidity.
• Optical verify strip should be stored in their tightly capped canister to keep
them in working condition.
• Keep the optical verify strip clean. Do not touch the test area of the strip.
• Take the optical verify strip out of the canister. Put the optical verify strip back
and close the canister tightly immediately after use. Do not use contaminated,
ink-jet printing on the code chip.
• Refer to the test strip package insert for more details.
Optical verify strip
The Renal Function optical verify strips work with Renal Function Analysis Meter to
ensure the optical part is working properly. After the optical verify strip is inserted
into the meter, the meter’s optical part detects the color intensity of the optical verify
strip. The meter displays OH or FL to indicate whether the meter is functioning
properly.
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discolored, or damaged optical verify strip.
• Do not use it after the expiration date.
• For in vitro diagnostic use only.
Storage and Handling
• Store optical verify strips in a cool, dry place. Store away from heat and direct
sunlight.
• Transport and store in its closed canister within 2-30°C with less than 90%
humidity.
• Replace the cap on the strip canister immediately after removing a strip.
Expired strip may produce incorrect test results.
Control Solution
The Renal Function Control Solution contains stabilizers, preservatives and added
chemicals. To conrm that the test strip and meter are working together properly
and that the test is being performed correctly, the control solution is applied to the
specimen well of a test strip that has been inserted in the meter. Refer to the "CTR"
section in the instructions for use for more information.
Note: The Renal Function Control Solution is intended for validating Renal
Function testing while using the Renal Function Monitoring System. Both levels
of control solutions must be tested and fall within the assigned values printed on
the bottles.
Refer to the control solution package insert before using the controls. The control
solution bottle is labeled with the acceptable range that is specific for that lot of
control solution. The system is working properly if the control value displayed by the
meter is within the acceptable range printed on the bottle label. If the value does
not fall within the range, refer to the Control Solution Package Insert for further
instructions.
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Precautions
Make sure the control solution and all the test materials reach operating temperature
of 10 - 35°C prior to testing. The control solutions and test materials are only
accurate within this temperature range.
Use the control solution before the expiration date shown on the bottle.
Discard the control solution if it appears cloudy.
Use the Renal Function Control Solution with the Renal Function Analysis Meter
and test strip.
Storage and Handling
• Store the control solution either refrigerated or at room temperature 2 - 30°C.
• Do not freeze.
• If the control solution has been refrigerated, allow it to warm up to a
temperature of 10 – 35°C before use.
• Each control solution will expire 3 months after the bottle is opened for the rst
time. Record this expiration date on the bottle label.
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Section 4 Initial Setup
Before testing, ensure the following procedures are followed.
Turn on Meter
Press to turn the meter on.
The meter will automatically turn off after 5 minutes of inactivity.
Coding the Meter
Each time a new box of test strips is used, the new code chip included in the box
must be inserted into the meter. Compare the code number on the code chip with
the code number printed on the test strip box or the foil pouch. Results may be
inaccurate if the two numbers are not identical. Insert the new code chip into the
code chip slot of the meter. It should easily snap into place. The code chip should
remain in the meter. Do not take it out until a new box of test strips is needed. The
code number will appear on the Initial Screen after startup.
If the code chip is not properly inserted into the code chip slot or if it is missing, the
meter will display E-6.
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Section 5 Meter Setup and Options
With the meter turned on, press and hold for 2 seconds to enter the Setting
mode. Press ◄ or ► to display several setup sub-modes.
SET
Press to enter the SET item.
Year Setup
As the year is displayed, please press ◄ or ► to switch. Press to save.
Month Setup
As the month is displayed, please press ◄ or ► to switch. Press to save.
Day Setup
As the day is displayed, please press ◄ or ► to switch. Press to save.
Hour Setup
As the hour is displayed, please press ◄ or ► to switch. Press to save.
Minute Setup
As the minute is displayed, please press ◄ or ► to switch. Press to save.
Sound Setup
As the sound is diaplayed, press ◄ or ► to switch between On and oFF.
Press to save.
Bluetooth Setup
As the bluetooth is diaplayed, press ◄ or ► to switch between On and oFF.
Press to save.
Printer Setup
As the Printer is diaplayed, press ◄ or ► to switch between On and oFF.
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Press to save.
Sample Select
As the sample shows FB, VB or SP, please press to enter the Sample Set. Press
◄ or ► to switch between the Capillary Blood(FB), Venous Blood(VB) and Plasma
and serum(SP).
Press to save and enter the setup mode after selected.
Caution: The Capillary Blood(FB) is the meter default�
Note: The units are xed as mmol/L or mg/dL.
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Section 6 Testing
The following steps show how to use each component to measure the sample
concentration.
Specimen Collection
01.Use fresh capillary blood from the ngertip.
02.Use heparinized or EDTA venous whole blood. Please refer to Professional
Testing below.
Caution: Before testing, choose a clean, dry work surface� Review the
procedure and make sure all of the items needed to obtain a sufcient amount
of blood are available�
Testing with heparinized or EDTA venous whole blood, plasma
and serum
For heparinized or EDTA venous whole blood, mix the specimen well, then collect
specimen into a plastic/glass capillary transfer tubes or pipette. Apply it to the center
region of the Specimen Application Area of the strip. Do not touch the test strips with
the pipette or tube.
• Specimen must be tested within 8 hours after collection.
• Mix the specimens well before testing in order to ensure the cellular
components are evenly distributed.
• Allow the specimen to come to operating temperature (10-35°C) for
approximately 15 minutes if the specimen has been refrigerated.
• Anticoagulants other than EDTA and heparin are not recommended.
Note: Refer to NCCLS Documents H3-A6, Collection of Diagnostic Blood
Specimens by venipuncture.
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Testing with ngertip blood
Wipe away the rst drop of blood. Apply light pressure to obtain a second drop of
blood. Use a capillary transfer tube or pipette to collect capillary blood.
For use with the capillary transfer tube, hold the tube slightly downward and touch
the tip of the capillary transfer tube to the blood specimen. Capillary action will
automatically draw the specimen to the ll line and stop.
Note: The capillary transfer tube will fill automatically. Make sure the blood
covers the air vent of the tube, or it will be difcult to squeeze the blood out.
Never squeeze the capillary transfer tube while sampling.
Align the tip of the capillary transfer tube with the center hole of the Specimen
Application Area of the test strips to apply the second drop of blood.
Note: Do not touch the test strip with the capillary transfer tube or pipette. The
capillary blood should be tested immediately after collected. Use of a capillary
transfer tube or pipette is recommended for accurate results.
Blood specimens can be obtained by using a lancing device or a safety lancet.
Note: Please use the safety lancet.
Lancing Device
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