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Quality Control Test

The following section explains how to run a Quality Control 

Test  with  one  of  the  2  Nova  StatStrip  Lactate  Control 

Solutions.

Read the StatStrip Lactate Control Solution package 

insert sheet for complete instructions, indications, 

precautions, and limitations of the system.

1.  From the Patient Test screen, press the QC soft key.

2.  The Enter Strip Lot screen displays. Enter the Strip Lot 

Number or scan the barcode. To scan the barcode, press 

the Scan soft key.

Summary of Contents for STATSTRIP

Page 1: ...ctate Hospital Meter Refer to the StatStrip Lactate Hospital Meter Instructions for Use Manual and Package Inserts for complete instructions for use indications precautions and limitations of the system LAC Lac For Export Only ...

Page 2: ......

Page 3: ... Hospital Meter QR 2 Barcode Scanning QR 3 Quality Control Test QR 4 Add Comment to a Result Patient QC Linearity QR 12 Running a Patient Sample QR 13 Docking Charging Station QR 23 Changing the Battery QR 24 Cleaning the Meter QR 26 Troubleshooting QR 27 Table of Contents ...

Page 4: ......

Page 5: ...ivedetermina tion of Lactate Lac in fresh whole blood venous and arterial blood samples It is intended to provide plasma equivalent results to laboratory methods The Nova StatStrip Lactate Hospital Meter System is indicated for use in a clinical setting by healthcare professionals as an aid to evaluate the acid base status of patients suspected of having lactic acidosis ...

Page 6: ...o this Quick Reference Manual only after you have become familiar with all of the instructions in the Instruc tions for Use Manual Test Strip Port Sleep Mode Button Laser Barcode Scanner OK Enter Button Scan Home Buttons one on each side Touch Screen ...

Page 7: ... the barcode label parallel to and approximately 2 to 6 inches from the scanner Press either the left or right side scan button If the information appears on the screen at the top Screen Title the barcode has been successfully scanned Press the OK button WARNING Do Not stare into the laser light or point the light towards anyone s eyes while scanning a barcode ...

Page 8: ...ntrol Solutions ReadtheStatStripLactateControlSolutionpackage insert sheet for complete instructions indications precautions and limitations of the system 1 From the Patient Test screen press the QC soft key 2 The Enter Strip Lot screen displays Enter the Strip Lot Number or scan the barcode To scan the barcode press the Scan soft key ...

Page 9: ...n 3 Press the Accept soft key if the lot number is correct OK _________________________ Back 1 2 3 4 5 6 7 8 9 0 Scan Scan Op 8636 Enter Strip Lot 13 42 Name ED OK _________________________ Clear 1 2 3 4 5 6 7 8 9 0 Erase Accept 0206506089 Op 8636 Enter Strip Lot Name ED 13 42 Accept Soft Key Scan Soft Key Data Entry Field ...

Page 10: ... QC Lot List screen press the List soft button or scan the barcode To scan the barcode press the Scan soft key NOTE If the QC Lot Number is invalid the screen dis plays the invalid number with is not a valid QC Lot Try again 5 Press the Accept soft key if the lot number is correct ...

Page 11: ...n OK _________________________ Back 1 2 3 4 5 6 7 8 9 0 Scan Scan L1 L2 L3 Enter QC Lot Op 8636 13 42 Name ED OK _________________________ Clear 1 2 3 4 5 6 7 8 9 0 Scan Accept 0207406081 List L1 L2 L3 Enter QC Lot Op 8636 13 42 Name ED Accept Soft Key Scan Soft Key Data Entry Field ...

Page 12: ...he Apply Sample screen displays 8 Gently shake the StatStrip Lactate Control Solution before each use 9 Discardthefirstdropofcontrolsolution fromthebottletoavoidcontamination Insert Test Strip in meter Cancel Op 8636 Insert Strip 13 42 Name ED ...

Page 13: ...thestrip an audible beep is sounded by the meter 11 Recap the control solution The Testing Sample screen displays The screen shows a clock with seconds remaining below the clock 12 Whenthemetercompletesthetest theQCResultscreen displays with the results in mg dL or mmol L Touch test strip to Level 1 QC drop Remove test strip to cancel test Op 8636 Apply Sample 13 42 Name ED ...

Page 14: ...Lactate Result Accept Soft Key Comment Soft Key LAC Lac mmol L QC Lot 0213806081 Level 1 Range 0 3 1 0 PASS OK Accept Strip Lot 0206806099 Comment Op 8636 QC Result 13 42 Name ED 0 8 LAC Lac mg dL QC Lot 0213806081 Level 1 Range 3 9 PASS OK Accept Strip Lot 0206806099 Comment Op 8636 QC Result 13 42 Name ED 7 ...

Page 15: ...RNING Do not test patient sample until a control solution test result is within expected range 13 To add a comment to the result press the Comment soft key 14 To accept the results press the Accept soft button ...

Page 16: ...s screen e g Notified Dr Smith or press the List soft key for list of comments Toaddthecommenttothe result and have it become part of the record press the Accept soft key Data Entry Field List Soft Key OK _________________ Clear 1 ABC 2 DEF 3 GHI 4 JKL 5 MNO 6 PQRS 7 TUV 8 WXYZ 9 Flag space 0 Chart Accept NOTIFIED DR SMITH List Op 8636 Free Text Comment 13 42 Name ED Accept Soft Key ...

Page 17: ... package insert sheet for com plete instructions indications precautions and limitations of the system 1 From the Patient Test screen press theAccept soft key Review Lac Manual QC MENU Logout OK Accept Op 8636 Patient Test 13 42 Name ED Accept Soft Key ...

Page 18: ...as been added press theAccept soft key OK _________________________ Back 1 2 3 4 5 6 7 8 9 0 Scan Scan Op 8636 Enter Strip Lot 13 42 Name ED OK _________________________ Clear 1 2 3 4 5 6 7 8 9 0 Erase Accept 0206506089 Op 8636 Enter Strip Lot Name ED 13 42 Scan Soft Key Accept Soft Key Data Enter Field ...

Page 19: ... soft key or by scanning the barcode ID 5 If the diagnosis code is enabled the Enter Diagnosis Code screen displays next Enter the code from Diag nosis Code List screen press List soft key by pressing numeric alphanumeric soft keys press the ABC soft key or by scanning the barcode ID 6 Depending on what is enabled to the meter one of 3 screens will display Enter Patient ID Enter Accn Num or Sample...

Page 20: ...en will display 8 From the Enter Patient ID screen enter the Patient ID from Patient ID List screen press List soft key by press ing numeric alphanumeric soft keys press the ABC soft key or scanning the barcode ID 9 From the Enter Accn Num screen enter the Accession Number by pressing numeric alphanumeric soft keys press the ABC soft key or by scanning the barcode ID ...

Page 21: ...e ID with the bot tom of the meter Scan Soft Key Accept Soft Key ABC Soft Key Data Entry Field OK _________________________ Back 1 2 3 4 5 6 7 8 9 ABC 0 Scan List Scan Op 8636 Enter Patient ID 13 42 Name ED OK _________________________ Clear 1 2 3 4 5 6 7 8 9 ABC 0 Erase Accept 54821 Op 8636 Enter Accn Num 13 42 Name ED List Soft Key ...

Page 22: ...ered press the Accept soft key 11 The Insert Strip screen displays Insert a test strip as shown on the meter screen Op 8636 13 42 Meter Name NICU 1 Insert Strip Insert Test Strip in meter Cancel Insert Test Strip in meter Cancel Op 8636 Insert Strip 13 42 Name ED ...

Page 23: ...r a vein 13 Use either the syringe or a pipette to add a blood drop to the Lactate test strip Remove test strip to cancel test Touch test strip to blood drop from a syringe or pipette Op 8636 Apply Sample 13 42 Name NICU 1 Venous or Arterial Blood Only ...

Page 24: ... the blood drop until the well of the test strip is full and the meter beeps WARNING The test strip must fill completely upon touching the blood droplet If the test strip does not fill completely do not touch the test strip to the blood droplet a second time Discard the test strip and repeat the test with a new strip ...

Page 25: ...E Do not remove the test strip while the count down is in progress NOTE A single up arrow displays for abnormal high result and 2 up arrows for critical high value A single down arrow displays for abnormal low result and 2 down arrows for critical low value ...

Page 26: ...FU Manual All data are stored into memory OK Pt ID 194546646 Darryl Smith Reject Accept Comment Strip Lot 0206806099 LAC 2 5 mmol L Normal 0 2 20 0 Lac Op 8636 Patient Result Name ED 13 42 Lac Result Reject Soft Key Accept Soft Key Comment Soft Key OK Pt ID 194546646 Darryl Smith Reject Accept Comment Strip Lot 0206806099 LAC 22 mg dL Normal 2 180 Lac Op 8636 Patient Result Name ED 13 42 ...

Page 27: ...omputer network When the Battery LOW symbol displays on the screen place the meter into the Docking Charging Station If you have a spare battery that is already fully charged change the battery The left green light is on if the station is connected to the network The middle green light is on if data is transferring The right light is green for fully charged or amber for charging ...

Page 28: ... battery may present a risk of fire or explosion If discarding dispose of the battery promptly Keep the battery away from children 1 Press the Power button to enter the Sleep Mode This will allow the operator approximately 20 seconds to change the battery and not lose date time settings NOTE If it takes longer than 20 seconds to change the battery power up the meter relogin and set the ...

Page 29: ...h down on the 2 cover latches to releasethecover Takethebatterycover off the back of the meter 3 Push up on the battery latch Remove the drained battery 4 Replace with a fully charged battery NOTE The battery is keyed to allow only insertion from bottom first then push in top ...

Page 30: ... immersed in any cleaning agent Always apply the cleaning agent to a soft clothtowipethemetersurface Oncecomplete immediately dry thoroughly When cleaning the meter please follow the guidelines listed below Dilute Bleach A 10 solution of household bleach So dium Hypochlorite may be used 70 Isopropyl rubbing Alcohol may be used ...

Page 31: ...use by your facility can be used Apply to a small test area first to ensure surface finish integrity Avoid harsh solvents such as benzene and strong acids CAUTION DO NOT immerse the meter or hold the meter under running water DO NOT spray the meter with a disinfectant solution ...

Page 32: ...ospital Meter displays screen alerts 1 Battery Low Change thebatteryorplace themeterinto the Charging Station Battery Low Icon ED Batt Mem Review LOW Battery Low Charge Replace Battery Location ED Facility Your Facility View Setup Welcome 13 42 Name ED ...

Page 33: ...s Removed The test has been cancelled repeat the test with a new test strip Leave the test strip in place until the result is displayed on the screen Analysis CANCELED OK Continue Analysis Error Op 8636 13 42 Name ED 13 42 ...

Page 34: ...thin the temperature range of 59 F to 104 F 15 C to 40 C Return the meter to an environment within the specified temperature range of 59 F to 104 F 15 C to 40 C Remove strip to Continue OK Continue Temperature Error Analysis Error Op 8636 13 42 Name ED ...

Page 35: ...nsert a new strip and rerun the test If the error code persists perform the test using an alternate test strip vial or alternate method Bad Sample B OK Continue Remove strip to Continue Analysis Error Op 8636 13 42 Name ED ...

Page 36: ...trip or occurs during analysis Insert another strip and retest If the error code persists perform the test using an alternate test strip vial or alternate method Replace Strip A OK Continue Remove strip to Continue Op 8636 Analysis Error 13 42 Name ED ...

Page 37: ... the test strip due to either insufficient or incorrect sample application Repeat the test with a new strip If the error code persists perform test using an alternate method Remove strip to Continue OK Continue Flow Error C Op 8636 Analysis Error 13 42 Name ED ...

Page 38: ...ectiontoserverwasbroken Pleasecheck the network settings status of your network or contact your administrator for assistance Connection to server was broken Op 8636 Transfer Failed 13 42 Name ED Server refuses to allow dialog with meter Op 8636 Transfer Failed 13 42 Name ED ...

Page 39: ...ata transfer was complete Please re dock the meter 13 42 Name ED OK The meter was un docked before data transfer was completed Please re dock to finish data transfer Welcome Or press Welcome button to continue without data transfer Op 8636 Transfer Failed ...

Page 40: ...QR 36 ...

Page 41: ...00 Vienna Austria Tel 43 1 603 09700 Nova Biomedical KK B 3F Omori Bellport 26 Minami Oi 6 chome Shinagawa ku Tokyo 140 0013 Japan Tel 813 5471 5461 REP EC Authorized Representative Nova Biomedical UK Telephone 44 1244 287087 C3 5 Evans Business Centre Fax 44 1244 287080 Deeside Industrial Park Deeside Flintshire CH5 2JZ Nova Biomedical Canada Ltd 17 2900 Argentia Road Mississauga Ontario L5N 7X9 ...

Page 42: ... Web www novabiomedical com 200 Prospect Street Waltham MA 02454 9141 U S A Made in the USA by Nova Biomedical Corporation StatStrip is a registered trademark of Nova Biomedical Copyright 2011 Nova Biomedical Corporation REF 47643B 2011 03 ...

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