NephroCheck ® Calibration Verification (Cal Vers
Contents
1. a FR Buffer Vial A pe Step 2 Step 4 i Step 5 Step 6 na Pipette 100 pl Tj Pipette 100 pl I Place cartridge j 20 minutes of buffer into ULUM of control sample l in meter f F to results conjugate vial solution into cartridge i l co eionized Water eas 7 N w Conjugate Vial D Pipette 500 ul of Step 3 deionized water al Pipette 100 ul of reconstituted into one of the NK cal vers into the conjugate vial cal vers vials Q J and mix Cal Vers Vial Results The ASTUTE140 Meter automatically calculates a single numerical risk result for each NEPHROCHECK Calibration Verification level that is tested This result is displayed on the ASTUTE140 Meter screen after the NEPHROCHECK Test procedure is completed results for the individual markers are not displayed Compare the displayed result with the information provided on the back of the NEPHROCHECK Expected Values Card to ensure the results fall within the published ranges If any of the levels fall outside the acceptable range test that specific level again using a new NEPHROCHECK Test Kit If it does not fall into the assigned range after re testing contact Astute Medical Technical Support The NEPHROCHECK Test results are also stored in the ASTUTE140 Meter memory and may be accessed at any time See Review and Management of Test Results in the ASTUTE140 Meter User Manual Expected Results Expecte2. s sssssssessessseesesseessecseees 1 Materials Required But Not Provided ASTUTE140 Meter Kit PN 500017 NEPHROCHECK Test Kit PN 500011 NEPHROCHECK Test Buffer Solution included in the NEPHROCHECK Test Kit Calibrated precision pipette capable of dispensing 100 uL and 500 uL Quality Control Considerations Good Laboratory Practice suggests that the NEPHROCHECK Calibration Verification Kit should be tested At least once every 6 months After ASTUTE140 Meter maintenance or servicing In accordance with local state and or federal regulations or accreditation requirements Calibration and Verification Procedure NOTE THE NEPHROCHECK Calibration Verification vials should be prepared following the procedures for preparing and testing patient samples with the NEPHROCHECK Test For more details see the NEPHROCHECK Test Package Insert Prepare each NEPHROCHECK Calibration Verification Kit Vial as follows 1 Configure the ASTUTE140 Meter to test the Calibration Verification vial See Testing a Patient Sample in the ASTUTE140 Meter User Manual for detailed instructions NOTE When prompted for Patient ID enter 001 002 003 004 or 005 corresponding to each NEPHROCHECK Calibration Verification Vial level to be run Astute Medical Inc 2014 PN 300039 Rev E 2014 09 05 NEPHROCHECK Calibration Verification Kit Package Insert oar WO DY 10 11 12 13 14 Remove the
3. methods For in vitro diagnostic use Do not use the kit beyond the expiration date printed on the outside of the box The NEPHROCHECK Calibration Verification Kit contains materials of human origin urine Handle these materials as if they are potentially infectious Proper handling and disposal methods in compliance with federal and local regulations should be established The NEPHROCHECK Calibration Verification Kit is to be used only with the NEPHROCHECK Test and ASTUTE140 Meter Use only NEPHROCHECK Calibration Verification Kits with the NEPHROCHECK Test System Astute Medical Inc 2014 PN 300039 Rev E 2014 09 05 NEPHROCHECK Calibration Verification Kit Package Insert 2 The NEPHROCHECK Calibration Verification Kit requires the use of calibrated precision pipette s It is recommended that the users review the proper procedures for the use of these devices in order to ensure accurate dispensing of volumes Storage and Stability The NEPHROCHECK Calibration Verification material is lyophilized Prior to opening the NEPHROCHECK Calibration Verification Kit inspect the vials for cracks chips or broken seals Do not use any vials if you encounter any damage Prior to opening the NEPHROCHECK Calibration Verification Kit verify that the contents within each vial appear dry Do not use any Calibration and Verification kit vial if the contents appear to be wet Ensure the reconstituted
4. NEPHROCHECK Test cartridge Wait approximately one minute for the sample to be absorbed into the round well a Using the grips on the side of the NEPHROCHECK Test cartridge position the cartridge inside the ASTUTE140 Meter drawer with the Astute Medical logo towards the inside of the meter drawer Keep the NEPHROCHECK Test cartridge horizontal and avoid tipping the test cartridge during placement into the ASTUTE1 40 Meter drawer Close the ASTUTE140 Meter drawer In approximately 20 minutes the Calibration and Verification result will be displayed The NEPHROCHECK Test incubation time must be lt 25 minutes from the sample incubation time set in the ASTUTE140 Meter The ASTUTE140 Meter will display a single numerical value per level run Press the key to open the ASTUTE140 Meter drawer Each calibration verification vial and conjugate vial is intended for single use only Remove the NEPHROCHECK Test cartridge and discard the cartridge the Calibration Verification Vial and the conjugate vial in accordance with local regulations The NEPHROCHECK Calibration Verification Kit Vial is intended for single use only Repeat steps 1 13 for the remaining four levels of NEPHROCHECK Calibration Verification Kit Vials Astute Medical Inc 2014 PN 300039 Rev E 2014 09 05 NEPHROCHECK Calibration Verification Kit Package Insert 4 NEPHROCHECK Calibration Verification Preparation Process
5. use use inconsistent with the product manual or insert fraud tampering unusual physical stress negligence or accidents Any warranty claim pursuant to the Limited Warranty shall be made in writing within the applicable Limited Warranty period You agree to use this product in strict accordance with all applicable local state and federal laws regulations and guidelines and industry practices You further agree that you shall not resell or otherwise transfer this product to any other person or entity without the prior express written approval of Astute Medical Inc Information about commercial resale or distribution of the products of Astute Medical Inc may be obtained by e mailing us at info astutemedical com or by writing to us at Astute Medical Inc General Atomics Court MS 02 641 San Diego CA 92121 USA No amendment or addition to this End User License Agreement shall be binding upon the parties unless reduced to writing and signed by the respective authorized officers of the parties 2014 Astute Medical Inc Astute Medical the AM logo ASTUTE140 NEPHROCHECK and the NEPHROCHECK logo are registered trademarks of Astute Medical Inc in the United States AKIRISK is a trademark of Astute Medical Inc in the United States For information regarding trademarks and other intellectual property applicable to this product please see AstuteMedical com US About IntellectualProperty PN 0311 Rev A 2014 07 23 Astute Medic
6. FECTS B FUNCTION IN ACCORDANCE WITH THE MATERIAL SPECIFICATIONS REFERENCED IN THE PRODUCT MANUAL AND C APPROVED BY THE PROPER GOVERNMENTAL AGENCIES REQUIRED FOR THE SALE OF PRODUCTS FOR THEIR INTENDED USE AS DESCRIBED IN THE APPLICABLE PRODUCT MANUAL OR INSERT THROUGHOUT THE PRINTED EXPIRATION DATE OR IN THE CASE OF THE ASTUTE140 METER FOR A PERIOD OF TWELVE 12 MONTHS FROM THE DATE OF SHIPMENT THE LIMITED WARRANTY IF THIS PRODUCT FAILS TO MEET THE REQUIREMENTS OF THIS LIMITED WARRANTY THEN AS YOUR SOLE REMEDY ASTUTE SHALL EITHER REPAIR OR REPLACE AT ASTUTE DISCRETION THIS PRODUCT Astute Medical Inc 2014 PN 300039 Rev E 2014 09 05 NEPHROCHECK Calibration Verification Kit Package Insert 6 EXCEPT FOR THE LIMITED WARRANTY STATED IN THIS SECTION TO THE EXTENT PERMITTED UNDER APPLICABLE LAW ASTUTE DISCLAIMS ANY AND ALL WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NON INFRINGEMENT REGARDING THIS PRODUCT ASTUTE S MAXIMUM LIABILITY FOR ANY CUSTOMER CLAIM SHALL NOT EXCEED THE NET PRODUCT PRICE PAID THEREFOR NO PARTY SHALL BE LIABLE TO ANY OTHER PARTY FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSS OF BUSINESS PROFITS DATA OR REVENUE EVEN IF A PARTY RECEIVES NOTICE IN ADVANCE THAT THESE KINDS OF DAMAGES MIGHT RESULT The Limited Warranty above shall not apply if this product has been subjected to physical abuse misuse abnormal
7. NEPHROCHECK Calibration Verification Material is completely dissolved prior to use Do not use if contents do not appear to be fully dissolved Once opened and reconstituted each NEPHROCHECK Calibration Verification Kit Vial is stable for 8 hours when stored capped at room temperature 20 25 C 68 77 F Each NEPHROCHECK Calibration Verification Kit Vial is intended for single use only Each NephroCheck Calibration and Verification Kit Vial should not be stored after opening or use Each unopened NEPHROCHECK Calibration Verification Kit Vial is stable until the expiration date printed on the box when stored refrigerated or frozen between 20 C 4 C 4 F 39 2 F Materials Provided NEPHROCHECK Calibration and Verification Kit part number 500009 containing NEPHROCHECK Calibration Verification Vial Level 1 carvers 1 1 x 500 uL lyophilized NEPHROCHECK Calibration Verification Vial Level 2 cat vers 2 1 X 500 pL lyophilized NEPHROCHECK Calibration Verification Vial Level 3 cat vers 3 1X 500 uL lyophilized NEPHROCHECK Calibration Verification Vial Level 4 cat vers 4 1 X 500 uL lyophilized NEPHROCHECK Calibration Verification Vial Level 5 cat vers 5 1 X 500 yL lyophilized NEPHROCHECK Calibration Verification Kit Package Insert sccssssssesssesssecstesseesseesseecseeens 1 NEPHROCHECK Calibration Verification Expected Values Card
8. SN Boos NephroCheck MEDICAL NEPHROCHECK Calibration Verification Kit Package Insert Manufactured for Astute Medical Inc 3550 General Atomics Ct Building 2 San Diego CA 92121 USA Intended Use The NEPHROCHECK Calibration Verification Cal Vers Materials are to verify calibration of the NEPHROCHECK Test System Reagents The NEPHROCHECK Calibration Verification Kit includes five levels of lyophilized material prepared from human urine collected from apparently healthy donors as well as human TIMP 2 Tissue Inhibitor of Metalloproteinase 2 and human IGFBP 7 Insulin like Growth Factor Binding Protein 7 proteins with protein stabilizers TIMP 2 and IGFBP 7 proteins have been added to the urine to achieve specified target concentration levels that evenly span the reportable ranges The expected concentrations and standard deviations are printed on the NEPHROCHECK Expected Values Card enclosed with the NEPHROCHECK Calibration Verification Kit Warnings and Precautions The operator should use Standard Precautions when performing the NEPHROCHECK Test or operating the ASTUTE140 Meter All human source material used to manufacture this product was non reactive for antigens to Hepatitis B HBsAg negative by tests for antibodies to HIV HIV 1 HIV s and Hepatitis C HCV non reactive for HIV 1 RNA and HCV RNA by licensed NAT and non reactive to Serological Test for Syphilis STS using FDA approved testing
9. al Inc 2014 PN 300039 Rev E 2014 09 05
10. cap from a single NEPHROCHECK Calibration Verification Vial Level 1 2 3 4 or 5 Add 500 uL deionized water using a calibrated precision pipette Recap the vial and invert the vial three times to mix Visually confirm the lyophilized material is completely dissolved before use Remove a new NEPHROCHECK Test Cartridge and NEPHROCHECK Test Conjugate Vial from the foil pouch and place on a flat surface Each NEPHROCHECK Test Conjugate Vial contains a single conjugate bead Remove the cap from the NEPHROCHECK Test Conjugate Vial Visually inspect the cap and vial to ensure that the conjugate bead has not adhered to the cap and is present in the vial If the bead has adhered to the cap place the cap on the vial and tap three times Repeat if necessary until the bead drops into the vial Do not touch the bead or attempt to remove the bead from the cap by any other means Pipette 100 uL of NEPHROCHECK Test Buffer Solution included in the NEPHROCHECK Test Kit into the conjugate vial containing the conjugate bead This will result in reconstitution of the conjugate bead into solution Pipette 100 uL of reconstituted NEPHROCHECK Calibration Verification solution into the NEPHROCHECK Test Conjugate Vial that now contains the reconstituted conjugate bead solution Mix thoroughly mix at least three times using the pipette tip Pipette 100 uL of mixed Conjugate Vial solution into the designated sample port on the
11. d values are determined by testing the NEPHROCHECK Calibration Verification materials with the NEPHROCHECK Test during product manufacturing The expected value ranges are determined from the average and standard deviation of these testing results Standardization The NEPHROCHECK Calibration Verification Kit is traceable to reference standard solutions that contain defined mass concentration of TIMP 2 and IGFBP 7 proteins in accordance with EN ISO 17511 The NEPHROCHECK Calibration Verification materials and NEPHROCHECK Test cartridges are traceable to the same reference standard solutions Limitations of the Procedure The ranges given for the expected values are intended only as guidelines Laboratories should determine their ranges and standard deviations based on their own testing policies and tolerance limits Ordering and Contact Information NEPHROCHECK Calibration Verification Kit PN 500009 For questions regarding the use or performance of the NEPHROCHECK Calibration Verification Kit or any Astute Medical Inc product please contact Astute Technical Support Contact Information Astute Medical Inc 3550 General Atomics Ct Building 2 San Diego CA 92121 USA Phone 1 855 317 2788 Monday thru Friday 8am 5pm PST Fax 1 858 332 0690 Email technicalsupport astutemedical com Website www astutemedical com Astute Medical Inc 2014 PN 300039 Rev E 2014 09 05 NEPHROCHECK Calibration Ver
12. ification Kit Package Insert Symbol Glossary Manufacturer k Consult instructions for use a m a Catalog number Batch code Use by YYYY MM DD Do not reuse gt pal Temperature limitation Biological risks Average Q x Standard deviation CONTENTS Contents of package EXPECTED VALUES Expected value Calibration Verification Kit Calibration Verification Vial 1 Calibration Verification Vial 2 Calibration Verification Vial 3 Calibration Verification Vial 4 Calibration Verification Vial 5 End User License Agreement PURCHASE AND OR USE OF THIS PRODUCT SHALL CONSTITUTE ACKNOWLEDGMENT AND ACCEPTANCE OF THE TERMS AND CONDITIONS OF THIS END USER LICENSE AGREEMENT Astute Medical Inc together with its affiliates Astute hereby grants to the purchaser user you your of this product the limited license to use this product solely for the purpose as specified on the approved label therefor You hereby agree that you shall use this product solely for such purpose and for no other purpose If you do not agree with each of the terms and conditions set forth in this End User License Agreement please contact Astute within ten 10 days after receipt of this product to return the unused and unopened product for a full refund LIMITED WARRANTY FOR THE APPLICABLE WARRANTY PERIOD ASTUTE WARRANTS THAT THIS PRODUCT SHALL BE A OF GOOD QUALITY AND FREE OF MATERIAL DE
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