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Appendix 2 Labelling And Information

Symbol for the marking of electrical and electronics devices according to Directive

2012/19/EU.The device accessories and the packaging have to be disposed of waste

correctly at the end of the usage.Pleases follow Local Ordinances of Regulations for

disposal

Do not reuse

Keep dry

CE marking

Biological risks

Consult instructions use

Authorised representative in the European Community

In vitro diagnostic medical device

Caution, the user must be consulted in all cases where this symbol is marked

Use by

Manufacturer

Batch code

Catalogue number

RFM-101 insert 20191125.indd 37

2019/11/27 10:42:08

Summary of Contents for Lysun RFM-101

Page 1: ...Renal Function Analysis Meter RFM 101 User s Manual RFM 101 insert 20191125 indd 1 2019 11 27 10 41 57 ...

Page 2: ...RFM 101 insert 20191125 indd 2 2019 11 27 10 41 57 ...

Page 3: ...se 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 bein...

Page 4: ...ction 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 Specifications 36 Appendix 2 Labelling And Information 37 Appendix 3 Warranty 38 RFM 101 insert 20191125 indd 2 2019 11 27 ...

Page 5: ...g 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 photochemist...

Page 6: ... 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 Chip Safety Lancet Capillary Transfer Tube Dropper Carrying Case Front Back Test Strip RFS 101 ...

Page 7: ...gs 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 acc...

Page 8: ...uld 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 RFM 101 insert 20191125 indd 6 2019 11 27 10 41 58 ...

Page 9: ... 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 ...

Page 10: ...hat 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 RFM 101 insert 20191125 indd 8 2019 11 27 10 41 59 ...

Page 11: ...d 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 filled with the correct amount After applying the specimen ensure that the Specimen Application Area is completely covered The...

Page 12: ...led 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 first being opened The opened expiration date is 3 months after the date the canister was first opened Write the opened expiration date on the canister label after opening Disc...

Page 13: ...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...

Page 14: ...on 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 ...

Page 15: ...lution 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 i...

Page 16: ...he 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 sta...

Page 17: ... 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 O...

Page 18: ... 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 fixed as mmol L or mg dL RFM 101 insert 20191125 indd 16 2019 11 27 10 42 06 ...

Page 19: ...nous 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 dist...

Page 20: ... blood covers the air vent of the tube or it will be difficult 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...

Page 21: ... push it until the lancet comes to a complete stop in the lancet holder Hold the lancet firmly in the lancet holder and twist the safety tab of the lancet until it loosens Then pull the safety tab off of the lancet Save the safety tab for lancet disposal Carefully screw the cover back onto the lancing device Avoid contact with the exposed needle Make sure the cover is fully seated on the lancing d...

Page 22: ...se the puncture depth Pull the cocking barrel back to set the lancing device A click may be heard The device is now loaded and ready to obtain a drop of blood Prior to testing make sure the patient s hand is warm and relaxed before collecting the capillary blood specimen Use warm water to increase blood flow if necessary Massage the hand from the wrist up to the fingertip a few times to encourage ...

Page 23: ...on in pain lance the sides of the fingertips Rotation of sites is recommended Repeated punctures in the same spot can make the fingers sore and callused Note Make sure the hand is warm and relaxed before collecting a capillary blood specimen Use warm water to increase blood flow if necessary Don t use an infection swab containing iodine This can give inaccurate results Disposal of the Lancet Unscr...

Page 24: ...nce the skin Discard the lancet in an appropriate sharps container 04 Gently massage the surrounding area toward the puncture site to collect the required blood volume Test Processing Ensure the meter is set up properly as described in previous sections Turn the meter on Ensure the code chip is inserted Compare the number showed in the display with the code number printed on the box label or foil ...

Page 25: ...test strip is inserted all the way to the end of the Test Strip Holder Note For testing capillary blood use the second drop of blood for accurate results The blood drop symbol will flash when the meter is ready for the specimen to be applied Apply the blood specimen to the center region of the Specimen Application Area of the test strip RFM 101 insert 20191125 indd 23 2019 11 27 10 42 07 ...

Page 26: ...he meter will return to the Initial Screen and is ready for another test strip to be inserted and to perform a new test Note Discard all blood specimens used Test strips and materials carefully Treat all blood specimens as if they were infectious material Follow proper precautions and obey all local regulations when discarding blood specimens and materials Perform daily cleaning when testing is co...

Page 27: ...same time to enable data deletion Press to return to Setting screen Communication If Bluetooth is turned on the Bluetooth icon is displayed when querying record at the MEM mode the meter will send the current record to Bluetooth If Printeris turned on the Printer icon is displayed when querying record at the MEM mode the meter will print out the current RFM 101 insert 20191125 indd 25 2019 11 27 1...

Page 28: ...ptical verify strip is intended to check the optical system Allow the optical verify strips and the meter to reach operating temperature 10 35 C prior to testing The optical check should be performed under normal lab lighting conditions Do not perform under sunlight or extreme lighting conditions If the meter displaysFL check the optical verify strip for contamination or to check if it is damaged ...

Page 29: ...ister or package Ensure that the controls are not expired Repeat the test to ensure no errors were made during the test Control Solution Testing Renal Function Control Solution testing is performed in a very similar manner to blood tests The Renal Function Control Solution is used instead of blood Note Make sure the control solution and all the test materials reach operating temperatures of 10 35 ...

Page 30: ...d the first drop If there are bubbles in the previous drop squeeze the bottle and discard another drop until there are no bubbles in the drop Apply the next drop to the specimen well on the test strip while keeping the bottle vertically upside down Use about 35μL of control solution for the test strip Make sure the control solution is applied directly into the specimen well and that there is no bu...

Page 31: ... If the results fall within the specified control range it indicates the Renal Function Analysis Meter is working correctly and the procedures are being performed properly If the results do not fall within the respective range s refer to the Control Solution Package Insert for further instructions RFM 101 insert 20191125 indd 29 2019 11 27 10 42 07 ...

Page 32: ...that the meter be stored in the carrying case after each use Avoid getting liquids or residue entering the meter through the Test Strip Holder or Code Chip Slot Test strip Holder Wipe it down with a damp cloth or a mild detergent Dry it with a dry soft cloth Meter Sensor Area Wipe down the Test Strip Holder with a cotton swab Do not scratch the transparent window covering the sensors Caution Do no...

Page 33: ...g the other end to the PC s USB port or adapter output 5V 0 5A can charge the meter The meter can not be tested when it is charging Equipment with overcharge and over discharge protection device Caution The adapter or computer should meet the requirements of current edition of the IEC60950 1 Lithium batteries meet the standard requirements of the IEC62133 2012 Battery Maintenance Lithium batteries...

Page 34: ... requirements Keep the meter clean Wipe it frequently with a soft clean and dry cloth Use a damp cloth when needed Do not clean the meter with substances such as gasoline paint thinner or other organic solvents to avoid any damage to the meter Do not clean the LCD or sensor area with water Lightly wipe with a soft clean dry cloth The test strip holder must be kept clean Lightly wipe with a soft cl...

Page 35: ...opamine 5 87 μmol L 0 09mg dL Methyldopa 71 μmol L 1 5mg dL High concentrations of uric acid and ascorbic acid can lead to low measurements Anticoagulants such as heparin and EDTA are recommended for use with venous whole blood Do not use EDTA plasma which lead to higher results Do not use other anticoagulants such as iodoacetate sodium citrate or those containing fluoride Arterial blood isn t rec...

Page 36: ...trip remains in place E 3 Test strip expired Replace test strips and code chip Check their expiry date E 4 Battery power is low The meter can not be tested until it is charged Charging post test E 6 Code chip was removed Insert proper code chip Confirm the code chip matches the test strip code and repeat the test E 7 The environment temperature is higher than 35 C or lower than 10 C Get the meter ...

Page 37: ...g dL 60 06mg dL 2 00mmol L 12 01mg dL 10 01mmol L 40 00mmol L 60 07mg dL 240 24mg dL 20 The Precision Iterm Range of sample SD UA 0 090mmol L 0 300mmol L 1 51mg dL 5 04mg dL SD 0 023mmol L 0 38mg dL 0 301mmol L 1 200mmol L 5 05mg dL 20 17mg dL CV 7 5 CR 0 044mmol L 0 150mmol L 0 50mg dL 1 70mg dL SD 0 011mmol L 0 13mg dL 0 151mmol L 1 320mmol L 1 71mg dL 14 93mg dL CV 7 5 UR 0 90mmol L 10 00mmol L...

Page 38: ...te during charging the meter is non operational Units of Measurement mg dL or mmol L Memory 500 records Automatic Shut Off After 5 minutes of inactivity Meter Size 135 mm 66mm 19 mm Weight 90g Meter storage and transportation t conditions 0 C 55 C 90 RH System Operating Conditions 10 C 35 C 80 RH indoor only pollution degree of the intended environment 2 System operating altitude Max 2000 m Test s...

Page 39: ...tly at the end of the usage Pleases follow Local Ordinances of Regulations for disposal Do not reuse Keep dry CE marking Biological risks Consult instructions use Authorised representative in the European Community In vitro diagnostic medical device Caution the user must be consulted in all cases where this symbol is marked Use by Manufacturer Batch code Catalogue number RFM 101 insert 20191125 in...

Page 40: ... the repair of a meter This warranty is subject to the following exceptions and limitations This warranty is limited to repair or replacement due to defects in parts or workmanship Parts required which were not defective shall be replaced at additional cost Lysun Biotechnology Co Ltd shall not be required to make any repairs or replace any parts that are necessitated by abuse accidents alteration ...

Page 41: ...ct special or consequential damages even if Lysun Biotechnology Co Ltd has been advised of the possibility of such damages For warranty service please contact your local distributor Hangzhou Lysun Biotechnology Co Ltd 6th Floor 6th Building No 95 Binwen Road Xixing Street Binjiang District Hangzhou Zhejiang P R China Tel 0086 571 86716518 Lotus NL B V Koningin Julianaplein 10 1e Verd 2595AA The Ha...

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