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QwikCheck Gold Скачать руководство пользователя страница 4

QwikCheck™

Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012

4

SECTION 1: System Overview

The QwikCheck™

is a high performance, menu driven analytical medical device for

assessing human semen.  The combination of technology in electro-optics and computer
algorithms results in a precise and accurate 75-second semen analysis.  The system is
self-testing and self-calibrating and runs latex beads or stabilized sperm quality controls.

QwikCheck™

Keypad

QwikCheck™

Testing

Capillary

Keypad Navigation



Use

NUMERIC

keys to enter data;

ARROW

keys to move to the next field.



Press

ENTER

to select menu options, confirm data entries and to move to the

next screen or field.



Use the

ESC

button to return to the previous screen or field.

Testing Capillary



Disposable, designed to collect and test samples in a biologically safe manner.



Motility is measured in the 0.3 mm (thin) "Capillary Section." This section
requires 20 micro liters of semen.



Concentration is measured in the 10 mm (tall) "Cuvette Section." This section
requires 450 microliters of semen.

Automated

Measurement

compartment

Power

Indicator

Operational

display

I-Button

Keypad

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Содержание Gold

Страница 1: ...er User Guide Version 1 00 I Button WHO 5th _06_AUG_2012 1 QwikCheck S p e r m Q u a l i t y A n a l y z e r U S E R G U I D E W H O 5 t h V e r s i o n V e r s i o n 1 0 0 I B u t t o n Catalog F A 0...

Страница 2: ...ing 12 SECTION 5 Controls and QC Control Set Up and Testing 13 Set Up Assayed Control 13 Set Up Non Assayed Control 13 Running CONTROLS 14 Electronic Self Test and Auto Calibration 15 SECTION 6 I Butt...

Страница 3: ...DIX 7 Dilution Media QwikCheck Dilution 28 APPENDIX 8 Treating Viscous Samples QwikCheck Liquefaction 29 APPENDIX 9 Assayed Control QwikCheck beads 30 APPENDIX 10 Service Report 31 APPENDIX 11 QwikChe...

Страница 4: ...d QwikCheck Testing Capillary Keypad Navigation Use NUMERIC keys to enter data ARROW keys to move to the next field Press ENTER to select menu options confirm data entries and to move to the next scre...

Страница 5: ...OT SPERM M Immotility IMMOTILTIY IM Progressively Motile Sperm Concentration PMSC M ml Sperm Morphology normal forms MORPH NORM FORMS WHO 5th Total Progressively Motile Sperm ejaculate PROG SPERM M Mo...

Страница 6: ...ed on proprietary algorithms Step 3 Motility Tens of thousands of sperm cells are analyzed in the thin section of the testing capillary as they move through a light beam in the system causing light di...

Страница 7: ...key on the keypad and auto calibration will begin This process takes 5 7 minutes When the system stabilization and auto calibration processes are complete a series of tests will be run Do not insert...

Страница 8: ...perm product labeling Select the type of controls to be run Latex Beads Stabilized Sperm Select the LEVEL 1 2 or NEGATIVE Enter the LOT EXPIRATION DATE and TARGET VALUE from the product labeling The Q...

Страница 9: ...Low volume samples diluted 1 1 with QwikCheck dilution media can be used according to User Guide instructions WASHED Sample enriched or prepared for artificial insemination using a commercial media to...

Страница 10: ...y with a Normal Volume Sample Insert the testing capillary into the measurement chamber of the QwikCheck GOLD when instructed by the screen below Testing will begin automatically do not touch the syst...

Страница 11: ...report accurate results only if the sample has been diluted 1 1 prcisely and the sample is adequate to fill the testing capillary after dilution To run a LOW VOLUME sample select option 2 from the scr...

Страница 12: ...N MENU TEST NEW PATIENT ENTER SAMPLE DATA screen Follow the on screen instructions FROZEN samples require only 20 microliters of sample and motility parameters only are reported WASHED sample can be r...

Страница 13: ...set up updated To do this Go to MAIN MENU SERVICE SET UP CONTROLS to view the screen below Select the type of control LATEX BEADS or STABILIZED SPERM Select the level of the control LEVEL 1 LEVEL 2 or...

Страница 14: ...MAIN MENU RUN CONTROLS and press ENTER When the screen below is displayed Select the CONTROL LEVEL 1 2 or NEGATIVE LEVEL 3 that is being tested Press ENTER to continue Fill the testing capillary with...

Страница 15: ...k will report failures see section on error and warning messages and freeze the system if the system is not within the established self test ranges Prior to testing a sample Auto calibration verificat...

Страница 16: ...1 0 1 M ml 8 CONC 2 50 150 M ml 9 CONC 3 300 600 M ml 10 Count Service Data Item 12 26 36 I Button loading SECTION 6 Add I Button Tests To add I button tests go to MAIN MENU ADD I BUTTON TESTS and pre...

Страница 17: ...S Service Personnel A code is required to access SERVICE PERSONNEL This option allows a qualified service technician to access calibration and maintenance settings Print system Default Settings The sy...

Страница 18: ...ion Call technical support if failure recurs Self test Failed Ensure there is no testing capillary in the measurement compartment Remove the QwikCheck from sources of electronic noise cell phones etc...

Страница 19: ...rt if this message is displayed again Prepare for technical support by printing a copy of the SERVICE DATA Press the SERVICE key on the keypad to activate the SERVICE MENU screen Select PRINT SELF TES...

Страница 20: ...elow the piston head and pull the piston back slowly while keeping the tip of the capillary well below the sample level and below any surface bubbles Figure 1 Continue to aspirate the sample until it...

Страница 21: ...Fill only the thin capillary chamber with 20 micro liters of semen Figure 1 3 The quantity aspirated can be determined by the gradations on the 1 ml syringe Aspirate the sample until it just appears...

Страница 22: ...ibrous material capillary fig 1 Moisten with ONE drop of cleaning fluid shaking off excess fluid Insert into the measurement compartment fibrous material facing up Move back and forth a few times Repe...

Страница 23: ...M FORMS WHO 5th 4 WHO 5th manual Motile Sperm Concentration MSC 6 M ml MES Progressively Motile Sperm Concentration PMSC 5 M ml MES Functional Sperm Concentration FSC Velocity Average path velocity VA...

Страница 24: ...s of concentration In accordance with CLIA regulations such a control is used to demonstrate operator proficiency using the microscope and for validation of automated sperm counting methods The latex...

Страница 25: ...The coefficients of variation CV characterizing precision were calculated for Sperm Concentration and Motility and were below 6 Specificity To achieve analytical specificity a specific wave length of...

Страница 26: ...ntrifuged at 600g for 15 minutes The seminal plasma was decanted and the pellets were re suspended in washing media DPBS HepesHTF Sequential dilutions were run in 4 SQA systems Limitations of method D...

Страница 27: ...by bacteria trichomonads or erythrocytes present in the specimen QwikCheck test strips were evaluated by Medical Electronic Systems Ltd MES for use as a qualitative indicator WBC s 1M ml of WBC s in h...

Страница 28: ...onged exposure to light Do not use if the solution contains precipitate or is cloudy INSTRUCTIONS FOR USE AUTOMATED SQA V 1 Measure the volume of the neat semen sample 2 If the volume is less than 0 5...

Страница 29: ...e stored at room temperature INSTRUCTIONS FOR USE 1 Select one vial of Chymotrypsin 2 Tap the vial to move the contents to the bottom of the vial prior to opening 3 Add the entire contents of one vial...

Страница 30: ...ion please refer to the QwikCheck beads Material Safety Data Sheet QCB 001 Basic Instructions for using QwikCheckTM beads 1 Mix the beads in the closed container before use to evenly distribute the be...

Страница 31: ...he QwikCheck GOLD Contact your local distributor for the initial calibration parameters These parameters should not have changed Parameter Service Report Item User Report Initial Calibration settings...

Страница 32: ...LT SETTINGS SELF TEST DATA Verify that the parameters listed below fall within the established range Highlight the discrepancies and report to MES Parameter S W Ver 2 48 Criteria SYSTEM Self Test Para...

Страница 33: ...TA REF1 230 REF2 2925 LED1 9 LED2 24 AMP 65 CONC1 0 0 SMI 409 CONC2 104 6 ZL 508 CONC3 418 9 AW 14987 SERVICE DATA 1 16 7 0 000 13 100 2 5 8 115 14 100 3 150 9 10 15 1 70 4 28 10 6 16 100 5 0 95 11 13...

Страница 34: ...ly run semen samples based on that standard SQA V Set Up From the MAIN MENU select SERVICE SET UP SYSTEM DEFAULTS to view the screen below Select a CONC concentration STD standard 1 or 2 based on the...

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