Test procedure - vet-med
Contents
1. D O C T BLOOD ANALYSIS Veterinary User Guide nal Epocal Inc Emergo Europe 2060 Walkley Road Molenstraat 15 2513 BH Ottawa Ontario The Hague Netherlands Canada K1G 3P5 Tel 31 70 345 8570 Tel 613 738 6192 Fax 31 70 346 7299 Fax 613 738 6195 E mail service emergogroup com 51005304 Rev 01 w epoc e Veterinary User Guide BLOOD ANALYSIS epoc System Page 2 of 35 51005304 01 August 2012 amp epoc e Veterinary User Guide BLOOD ANALYSIS epoc System The epoc System is a breakthrough blood analysis system providing state of the art lab results within seconds quick turnaround time with no refrigeration This portable device consists of the blood analyzer mobile computer and disposable test cards and requires blood samples as small as 100 microliters This Veterinary User Guide describes the proper use and operation of the epoc Blood Analysis System as applied to veterinary purposes An extensive epoc system Manual describing the system as applied to treating human patients is available for reference in English and many other languages This manual also includes full epoc System specifications in Section 13 Fven though the epoc System is designed to be user friendly all operators require training by authorized personnel prior to conducting patient testing Page 3 of 35 51005304 01 August 2012 Ta epoc e Veterinary User Guide BLOOD ANALYSIS POS System Table of Con2. continuous motion until prompted to stop Figure 3 The Reader provides an audible beep and the Test Status Indicator flashes green indicating enough sample for analysis was received The Host also displays sample acceptance Learn to use the audio and visual feedback to perform this step easily and reliably A normal dispense operation takes about 1 second or less Page 21 of 35 51005304 01 August 2012 epoca 2 P Veterinary User Guide BLOOD ANALYSIS 499 System Sample introduction should never exceed 2 seconds Failure to heed the audio or visual prompts may cause the sample to flow from the vent hole at the end of the Test Card waste chamber and possibly into the epoc Reader Avoid rapid sample introduction because it can cause fluid segmentation This condition is detected by the system The test is aborted and the Host displays an error message Never attempt to clean inside the Reader Sample Analysis The Reader automatically analyzes the test sample The analysis process takes about 40 seconds Test Completion Once the analysis is complete Us LEX 1 The poc Host displays the Test Results from the Reader Screen ta i Il on left Test results can be 10 Jul 12 12 40 01 viewed in three 3 sub tabs Gases Chem and Gases theme Meta Meta t pH 7 526 pCO 16 3 mmHg poa 217 4 mmHg The Test Status Indicator on epoc Reader will flash cHcos 14
3. ne 3 X x 1 qm qi ted 1 MEL a WE a am 1 j d 4 m L at ates REN TEM y Page 6 of 35 51005304 01 August 2012 l e poc e Veterinary User Guide BLOOD ANALYSIS POC System OPE Test Process Overview 1 The initiation of a test starts with establishing a communications link between the Host and Reader 2 A Test Card is removed from its Card Pouch 3 The Test Card should be inserted immediately into the Reader 4 During the 165 second calibration period the User acquires a blood sample for the test 5 After calibration is complete the Reader Indicator and epoc Host inform User that the Test Card is ready to receive a blood sample The sample can be introduced at any time thereafter within 7 5 minutes After 450 seconds the sample introduction period times out and the Test Card can no longer accept a sample 6 Approximately 40 seconds after sample introduction the Host displays analytical Test Results 7 The Test card can be removed from Reader It must be discarded as biohazard waste fz obtain results EN B asus re Q epoc ge introduce let sample into Card aif FE insert Test Card li P into Reader Mes the if calibration h Ta EX Page 7 of 35 51005304 01 August 2012 Ta epoc Veterinary User Guide BLOOD ANALYSIS POS em User Interface The epoc Host Application has a simple intuitive user interface The Tabs within the software allow the User to n
4. ON and then try to connect to the Reader again If still unable to connect reset the Host and log into epoc Host application again Connection Failure Connection to Reader Verify the Reader is always in range and always turned ON lost Reconnect to the Reader by pressing the reconnection Button that appears on the Reader Screen when connection is lost to the right of the Patient ID Lot Number Entry Box OR by closing the Reader Screen using the red X in the top right corner pressing on the Reader Icon and selecting Run blood test or Run QA test Reader Failure General error 1 Remove the Test Card 2 Close the Reader Tab then turn the Reader OFF and ON again Reconnect and insert another Test Card to begin a new test Unable to read barcode Remove the Test Card and insert it again with a swift smooth motion If unsuccessful after multiple attempts use another Test Card Invalid barcode Remove the Test Card check that the Barcode is not damaged If the Barcode is damaged use another Test Card If the Barcode appears to be undamaged insert the Test Card again with a swift smooth motion If unsuccessful after multiple attempts use another Test Card Page 33 of 35 51005304 01 August 2012 amp l e poc e Veterinary User Guide BLOOD ANALYSIS EPOC System Ambient temperature too low to use Move the Reader to a location where the ambient temperature Is within Reader acceptable limits d
5. Technical Support representative little slower Is fully injected within 3 4 seconds from the start of sample injection Remove the Test Card Insert a new card and repeat test Ensure a smooth steady injection Avoid injecting air into the Test Card 2 Insert a new Test Card into Reader Qut Of Range Results on the Test Card From the epoc Host disconnect from the Reader and then reconnect If the wireless for Liquid Quality Control connection is successful and the electronic QC passes verify the following 1 Is the Control Value Assignment Datasheet correct 2 Has the Use by Date of Controls been exceeded 3 Have the Controls been handled correctly 4 Have Test cards and Controls been stored correctly Repeat the test If the repeat results are in range the cards are acceptable for use If the results are still out of range despite meeting the above criteria repeat the test using a new box of control solutions and or Test Cards Page 34 of 35 51005304 01 August 2012 amp l e poc e Veterinary User Guide BLOOD ANALYSIS EPOC System Failed iOC on Result Display Remove the Test Card Insert a new card and repeat the test sometimes Failed iQC is reported next to certain results sample bubbles contaminated sensor etc whereas other parameters on the same test report OK The reason for this could be non conformities in individual sensors of the Test Card Because each sensor is checked individually after sa
6. or Ranges from the package insert included with control fluids elem Reference Ranges RECOMMENDED REFERENCE RANGES T aa Page 31 of 35 51005304 01 August 2012 epoca 2 P Veterinary User Guide BLOOD ANALYSIS P System Chemistry Hematology eens ee E Blood Gases Arterial Lex i 7350 7450 7 450 k T 7 400 7 320 7 440 REL 8 0 3 m 90 100 a m poe e cm Note These reference ranges have been provided by Woodley Equipment Company Ltd Page 32 of 35 51005304 01 August 2012 Ta epoc Veterinary User Guide BLOOD ANALYSIS POS System IKOM Troubleshooting The epoc System has no User serviceable parts or adjustments Do not attempt to open the Reader or Host or tamper with epoc Test Cards oelected epoc Host Application Messages are listed in the table below To resolve errors encountered while using the epoc Host Application first attempt solutions in the Response section in the order recommended If the problem persists contact your Technical Support representative Error message Action Unable to connect to Reader Verify that the Reader is turned ON Verify that the Reader is not connected to another epoc Host If used by another Host wait until test is complete Verify that that the Reader is within range Repeat discovery by tapping the Reader Discovery Icon at top right of the screen If the Reader is not discovered turn the Reader OFF and
7. 0 mmolit green indicating the Test Card can be removed ie Bee Motorized mechanism is heard briefly as the Calibration Fluid Plungers are disengaged Remove the Test Card from the Reader and dispose HEBES LORS of it using appropriate biohazard precautions Q The Patient ID must be entered before the test results are displayed Once saved the Patient ID textbox and Save button are disabled again Always wear protective gloves when removing a Test Card from the Reader Page 22 of 35 51005304 01 August 2012 epoc ge Veterinary User Guide BLOOD ANALYSIS P gt ystem Print Results To print a Test Result Opona 1 Ensure all desired data fields have been completed 2 Tap the Print Button E 3 Follow the on screen instructions select a printer from the drop down list and tap on the Print Button Results will be printed along with the appropriate reference ranges for the species selected Running Another Test After a used Test Card is removed the Reader s Test Status Indicator will turn solid green indicating that the Reader Is ready to perform another test Repeat same procedure to complete another test Never reuse a Test Card Test Cards are designed for single use only Starting a new test permanently saves the previous test record Changes to that test are no longer possible Test cannot be modified after printing Continue c50 99 9 Yo Rd775 00775 Tools
8. 2 epoc ge Veterinary User Guide BLOOD ANALYSIS Charge Host Battery using Reader Charge Host Battery using Host AC Adaptor Replace Host Battery epoc System The epoc Host contains a Lithium lon Rechargeable Battery To re charge the battery insert the epoc Host Cradle Blade into the epoc Reader Docking Pivot Connect the Reader AC Adaptor to the Power Jack at the rear of the Reader and also into the wall receptacle Up to four 4 hours may be required to fully recharge the battery The Host can be operated normally while it Is being charged The red Charging Indicator turns ON indicating that the Host battery is charging The indicator turns solid green when charging is complete A separate AC Adaptor is available for use with the epoc Host as an accessory The adaptor allows the User to separately recharge the battery in the epoc Host when outside the Patient s vicinity Replacing the Battery To remove the cradle for epoc Host Version B Plastic Back one piece Turn off epoc Host Undo two 2 Screws using a correct screwdriver so that they remain captive in plastic housing Unclip the Cradle from the Barcode Scanner and lift the Host up and out to remove from the Cradle The SD slot is beneath the Barcode Scanner If needed carefully pull the Barcode Scanner from its slot to gain access Use the Stylus to release the Battery Cover Remove the Battery Cover from the back of the Host Rem
9. C Host If the system administrator has configured the system to connect with a single Q epoc Reader the POC Host will automatically connect to that DOC Reader only 26 May 11 SY E io When there are multiple Readers EIN If the system administrator has configured the system for 3 multiple epoc Readers all epoc Readers available for SF S S Rdr775 54321 connection are shown 00775 03444 The Reader Icon S displays the Reader Name above and the serial number below epoc Readers eee Page 14 of 35 51005304 01 August 2012 Ta epoc Veterinary User Guide BLOOD ANALYSIS POS stem Once the desired Reader is displayed epoc Vet lt amp Wi bu il 1 Press and hold the Reader Icon to select it for testing A drop down menu is displayed For a blood test select Run blood test Run QA test OR j Status For a QA test if authorized select Run QA test Page Run Thermal QA Only epoc Readers that are turned ON will be located by the epOC Host The Discovery icon can also be tapped to find discover more readers Tapping the discovery icon when inactive will initiate this discovery epoc Readers process Tapping the discovery icon while discovering will end the discovery Initialization of Test e Atwo level internal Electronic QC Test of Reader is x m Cycle run automatically e Configuration data are sent by the Host to the Reader 26 May 11 10 32 36 M Blood e he moto
10. View Help cIB Tq SUS UEE D 2 1242 Close x 10 Select printer pco poz BE E coc Gat DH Rdz75 0077s Tools View Help Rma Page 23 of 35 51005304 01 August 2012 Ta epoc Veterinary User Guide BLOOD ANALYSIS POS System Close Test and When all testing with a Reader is complete and all data Disconnect Reader entries are made the test is closed by tapping on the Close Button in the top right to close the Reader Screen for that Reader Disconnecting a Reader does not affect the connection or test status of other Readers already discovered or connected Closing the test and disconnecting the Reader permanently saves the test and changes to that test are no longer possible EDM For epoc Data Manager EDM users only Synchronization Disconnect all readers from running the tests 3 3 r m test Rdr775 Rdr211 Press the EDM Synchronization Button on the ioe ae TAM Host Synchronizing with the EDM may also be SF fF accessed from the Tools menu lower left corner OA rdr1000 Rdi279 The epoc Host also retrieves configuration as information such as operator lists by using this feature epoc Readers The System Administrator may configure the epoc Host to synchronize upon closing a test In this configuration the EDM synchronization procedure occurs immediately after the Reader Screen is closed at the end of a test Log out of the epoc Host Application when finished testi
11. ard The epoc Reader will reject any Test Card past the Use By date on the Test Card The Use By date is based upon continuous storage of the Test Cards between 15 and 30 C Page 9 of 35 51005304 01 August 2012 epoca S Veterinary User Guide BLOOD ANALYSIS POS System epoc BGEM Test Card Specifications Test Name Measured Calculated Measurement Range Carbon Dioxide CO ix Partial Pressure ponz 0 7 33 3 5 760 Partial Pressure 0 7 100 NEN mkg l 805 180 ee CC o uem po DCN lonized Calcium Ca EN fal e NH y Lac V mg dL 0 30 15 00 lt Hemoglobin oM om Actual Bicarbonate mEq L Total Carbon Dioxide mEq L Page 10 of 35 51005304 01 August 2012 Ta epoc e Veterinary User Guide BLOOD ANALYSIS amp P9 System L INNER Santee ou C om S e aX o o9 eons aca e Only veterinary test cards must be used in veterinary blood analyzers and vice versa Blood Collection The epoc System is designed for point of care blood analysis In general it is recommended to test samples immediately after drawing a sample to obtain results that represent the Patient s status with the greatest accuracy Sample Type e Fresh whole blood from arterial venous or capillary sources Sample Volume e 92uL non volumetric quantity Sample Collection e 23 gauge or larger needle See table below for details on sample tubes and syringes Ant
12. ard isi 3 The Test Status Indicator on the Reader flashes 26 May 11 10 13 41 green to indicate the start of the test calibration Blood BGEM d sequence Calibration 150s g u 1 The Host confirms the start of the test by entering EDEN the calibration mode and displays the calibration a rani progress The calibration process takes approximately 165 seconds to complete epo Re test 00263 11777773 During the calibration sequence the User can prepare the patient and obtain the Tus onem ue blood sample The Reader must rest on a flat horizontal surface without movement for the duration of the test Page 18 of 35 51005304 01 August 2012 Ta epoc Veterinary User Guide BLOOD ANALYSIS POS System Read information on Sample Collection in BGEM Test Card Specifications Section of this Guide to ensure that blood samples are properly collected and handled for testing Test information can be entered at any time during the test x The Patient ID may be entered using the stylus and text input jJ X display accessible from the bottom of the screen or using the barcode scanner see below pto O ID2 For a Blood Test Hemodilution Yes O No Sample Select the Test Information Tab 2h on the Reader Tem je Reject test ocreen to enter the Patient ID Species type and B veni i related information The system administrator may require the Hemodilution settings _e
13. ars and then disappears Release the two buttons when the GREEN Windows Mobile startup screen appears Page 25 of 35 51005304 01 August 2012 epoc ge Veterinary User Guide BLOOD ANALYSIS epoc System Charge Reader The epoc Reader contains a Lithium lon Rechargeable Battery The battery compartment is not Battery available to the User with AC 1 Adaptor 2 3 2 The AC Adaptor recharges the Reader when the Reader is either ON or OFF The AC Adapter plugs into the Power Jack located at the rear of the Reader Exercise caution if using an Extension Cord or Power Bar with the Reader AC Adaptor These devices may void the product safety certification if not appropriately certified or approved for medical use The Reader Battery must be replaced by authorized Epocal service personnel only Use only the AC Adapter as specified by the label on the bottom of the Reader When the Reader is charging the amber Battery Status Indicator will flash When charging Is complete this indicator will stay solid amber L1 p r amber On AC penwer Fully changed a e flashing amber On AC power charging Q olf On battery power harery tibri ieee When the indicator is off it indicates that the AC Adaptor is not connected and the Reader is operating on battery power It takes approximately four hours to recharge a fully discharged Reader Battery Page 26 of 35 51005304 01 August 201
14. ate and time displayed become part of the test record Contact the administrator prior to running a test if adjustment of the date and or time is required Obtain Test Card select a properly stored veterinary Test Card otarting at the Notch tear open the Card Pouch as shown The card pouch should be opened only when conducting blood or QA testing to assure a low humidity environment for the test card Page 16 of 35 51005304 01 August 2012 epoc ge Veterinary User Guide BLOOD ANALYSIS P gt ystem Remove Test Card from Pouch Carefully read cautions below remove the Test Card from the card pouch Place the test card directly into the epoc Reader s Card Insertion Slot details below Discard the empty pouch Always take the Test Card directly from the Pouch before inserting it into the Reader Never touch the Sensor Module s contact surface or Blood Sample Entry Port Never place the Test Card on any surface before running a test Insert Test Card into Reader Position the Test Card with the Blue Label side facing upwards and the Sensor Module towards the Reader Test Cards are keyed using a Notch in the corner to ensure correct card orientation during insertion The epoc Reader must be placed on a stable horizontal surface such as a tabletop prior to inserting the Test Card Never insert anything except a Test Card into the Reader s Card Insertion Slot Sensor IIodule Contac
15. avigate to different parts of the application using the Stylus The Buttons perform actions and enable fields for text input An Example Screenshot shows the basic elements of the user interface 26 May 11 10 07 26 May 11 10 06 26 Blood L Calibration n J Insert test card to begin test epoc Readers test 00263 Tools View Help IB The user interface is context dependent and changes depending on where and what a User is doing here is always a Toolbar Tools view Help Fe at the bottom of the Screen that contains Menu Items and Toolbar Buttons The Text Input Button is located in the bottom right corner of the screen Select different screens by tapping the Screen Tabs Epot Readers Rdr319 00319 at the bottom of the Screen Screens are available for each connected Reader and for each opened Test Record Navigate multiple pages within each Screen by tapping on the Page Tabs lg E across the upper left corner of the Screen Additional Buttons are located in the upper right corner of the screen which are unavailable for use when colored gray The interface varies depending on whether the User is using an Operator or Administrator Account Page 8 of 35 51005304 01 August 2012 T epoc Veterinary User Guide BLOOD ANALYSIS P9c 5rsem eM Test Cards Storage and Handling Always store Test Cards at room temperature 15 30 C Never fridge
16. escribed in this User Guide OR 2 Allow the Reader enough time to adjust to the new temperature Ambient temperature too high to use If the actual ambient temperature is within specified limits contact your Reader Technical Support representative Ambient pressure too low to use Reader Move the Reader to a location where the atmospheric pressure is within OR acceptable limits Ambient pressure too high to use Reader 2 Allow Reader enough time to adjust to the new environment If the actual atmospheric pressure is within specified limits contact your Technical Support representative Ambient pressure sensor failed QC Close the Reader Tab turn the Reader OFF and ON and then try again Failed Reader Electronic QC If a Reader fails electronic QC then first confirm failure Close the Reader Screen Turn the Reader OFF and ON and then try to connect to the Reader again If the Reader connects successfully and therefore passes the electronic QC It is acceptable for use Failed iQC Calibration fluid not detected Remove the old Test Card and insert a new Test Card to begin another test Fluidics check If this message persists try using a different Reader or contact your Technical Support Humidity check representative Farly injection Resistance check sensor check Failed iQC Thermal check Use a different Reader If the Reader is well equilibrated within environmental limits but this message persists on Reader contact your
17. f necessary tap the Ampoule tip to return Fluid into the bottom section of the Ampoule Protect your fingers with gauze tissue or glove or use an ampoule breaker to snap off the Ampoule tip at neck Immediately transfer Fluid from the Ampoule into a plain sterile 1 mL or 3 mL syringe with a 16 20 gauge blunt needle When loading the syringe slowly draw about 1mL of Fluid from the bottom of the Ampoule Never invert the Syringe to expel the air trapped between the leading edge of Fluid and Syringe plunger this will not affect the solution near the Syringe tip If air bubbles are continually drawn into the Syringe or if a bubble is trapped near the Syringe tip discard the Ampoule and the Syringe Begin the process again with a fresh Ampoule and Syringe Before injecting Fluid in the Test Card expel one 1 or two 2 drops from the Syringe Transfer Fluid immediately into the Test Card remove the blunt needle and apply the Syringe luer in the Test Card s oample Introduction Port as during a normal Blood Test procedure Page 29 of 35 51005304 01 August 2012 Ta epoc e Veterinary User Guide BLOOD ANALYSIS P9c sem Temperature Correction for Blood Gas QC Fluids It is well established that pCO and pO results are inversely affected by temperature Targets and ranges in Value Assignment Sheets can be adjusted to account for ambient temperature effects using the following table Temperature Correction for pCO and pO Target
18. icoagulant e When needed use Li or Na heparin only See table below for restrictions on Heparin use e Cat blood should be drawn into anticoagulant to prevent clotting IV or indwelling line e Avoid using line if possible If using draw and discard 3 6 times the volume of the line to avoid contamination of sample EMEN Always wear protective gloves when handling blood samples Page 11 of 35 51005304 01 August 2012 epoc ge Veterinary User Guide epoc System BLOOD ANALYSIS Blood samples must be collected according to the facility s policies and procedures Always follow the specific instructions provided by other medical manufacturers when considering information in this section Sample Collection Method see table below for options for specific tests and sample collection methods 1 or 3ml plastic non iced e Not recommended Test in less than 30 min 1 or 3ml plastic Without anticoagulant Test in less than 30 min With Li or Na heparin lonized 1 or 3ml plastic Without anticoagulant Calcium Ca Without anticoagulant With Li or Na heparin only if 10 IU ml With Li or Na heparin only if 10 IU ml With balanced heparin only if 70 IU ml Hematocrit 1 or 3ml plastic Without anticoagulant Hct Immediate testing is recommended in order With Li or Na heparin only do not use EDTA Cat to avoid RBC settling Note Re blood should be drawn into anticoagulant to suspension of RBC requires an air bubble pre
19. mple injection the User is still able to see valid test results obtained on remaining good sensors cnc on Result Display Remove the Test Card Insert a new card and repeat the test This message means Could not calculate Component required for calculation was not available It should be noted that if the response of a failed sensor is needed to compute the result of a good sensor the iQC failure may trigger cnc This would happen even when the User had not selected the sensor which eventually failed the iQC Page 35 of 35 51005304 01 August 2012
20. ng and Power OFF viewing test results select Tools then Logout on the menu at the bottom left corner of the screen or press the Logout button El Use the Power Button on the Host to turn the device OFF The Reader automatically powers OFF after 20 minutes of idle time to conserve battery power but only if a The Reader is NOT plugged in and b The Reader is NOT connected to a Host Page 24 of 35 51005304 01 August 2012 w l e poc e Veterinary User Guide BLOOD ANALYSIS POC System 07A Routine Procedures Soft Reset A Soft Reset is like rebooting a computer It is useful if the EDOC Host is non responsive Data will not be lost after a Soft Reset Using the tip of the stylus lightly press and release the Soft Reset button located inside the hole on the bottom of the EDOC Host Hard Reset Performing a Hard Reset is also like rebooting a computer It is useful if the EPOC Host is non responsive and a Soft Reset proves ineffective The data will not be lost after a Hard Reset but the date and time may need to be reset Using your index and middle finger press and hold the two Hard Reset buttons located below the LCD screen see diagram above While continuing to hold these two buttons use the tip of the stylus to lightly press and release the Soft Reset button located inside the hole on the bottom of the EPOC Host Continue pressing the two buttons while the Socket splash screen appe
21. oc Host displays the message Inject sample The screen has a bar indicating the time remaining to introduce a sample The blood sample must be introduced into the card during this 7 5 min 450s period Introducing the sample too soon or too late will cause an error and abort the test In this case a new Test Card must be inserted and the test procedure started again Pat ID 98765 26 May 11 10 19 23 Blood Time left to introduce Inject sample Tools View Help ZB Page 20 of 35 51005304 01 August 2012 T epoc Veterinary User Guide BLOOD ANALYSIS P9c rsen Sample Introduction Method Hold the syringe barrel vertically between finger tips and thumb Figure 1 Keep the Syringe vertical and perpendicular to the Test Card to avoid sample spillage Complete steps 2 and 3 below in one continuous motion to ensure best performance of sample introduction Using slight downward pressure secure the syringe luer s tip into the center recess of the blood sample entry port of the Test Card Rotate the syringe up to 1 4 turn to ensure a good seal Figure 2 The User should feel the Syringe Tip engage with the Rubber Seal of the Test Card Entry Port Press the oyringe with enough downward force to engage Syringe Tip with Blue Rubber Seal While maintaining downward pressure use the index Figure 3 finger of your other hand to steadily depress the Syringe Plunger with a single smooth
22. ove the Battery Replace the Battery in accordance with replacement battery information found in Section 13 of the epoc oystem Manual Replace the Battery Cover and fasten securely Insert the Barcode Scanner in the Host Re assemble the Host into the Cradle Carefully align Host with the Cradle Connector Fasten two 2 attachment Screws Page 27 of 35 51005304 01 August 2012 Ta epoc Veterinary User Guide BLOOD ANALYSIS POS em Only replace with a Battery designated for use Always dispose of batteries in accordance with local regulations Never place a Battery in municipal waste 08 QA Testing Aqueous Blood Gas Electrolyte and Metabolite Control Fluids are commercially available for verifying integrity of newly received Test Card Lots Recommended products are described in the table below Control Fluids do not contain animal serum or serum products but do contain buffers and preservatives OA Test feature of the epoc System provides following characteristics e Ranges are increased so the User can test analyte levels at or just outside of the Measurement Range e OA Test Results are stored separately from Blood Test Results in the epoc Data Manager QC Fluids Recommended for Verification of epoc Test Cards Eurotrol Inc Ede Eurotrol GAS ISE Tha Nethedands Metabolite OC 179 1 B913 BGEM 12 Ampoules CC 0007 00 00 oe i 12 Ampoules CC 0008 00 00 Eurotrol Inc Ede Eurotrol GAS ISE The Ne
23. poc Readers test oe Tools View Help Using the arrow additional settings related to respiratory therapy may be entered For a QA Test not shown Select the Test Information Tab on the Reader ocreen to enter the QA fluid Lot Number to identify the test results for the card under test The Test Information Page for QA tests contains only the Comments field not shown X f the Patient ID is not entered prior to completion of the test the User is prompted to enter the Patient ID when the test results are displayed Patient information entered prior to completion of the test is saved automatically with the test results when the test is complete Patient information entered after the test is complete but before the next test starts must be saved by tapping the Save button Exercise care when entering the patient IDs and other information Ensure the correct Reader is selected by verifying that the Reader name corresponds with the Reader used to conduct the test Page 19 of 35 51005304 01 August 2012 epoc ge Veterinary User Guide BLOOD ANALYSIS Using Barcode Scanner Sample Introduction Window epoc System Press the stylus in the Patient ID field A cursor will appear Activate the Barcode Scanner by pressing the Read Barcode Button at the left or right side of the epoc Host The Barcode Icon at the top of the screen Indicates when the barcode scanner is ready to scan The ep
24. rized mechanism inside the Reader can be pss encudiastian heard as It resets Configuring Reader e Reader information name serial number is displayed on the bottom tab e he Test Status Indicator of the Reader turns on and stays green test 00263 ER 8 Hour Electronic QC Check The epoc Host checks that the Electronic QC Test of the Reader has been run within the past 8 hours If the eppoc Host has been connected to the Reader continuously for 8 hours or more the Host will disconnect from the Reader and inform the User they must reconnect to the Host so that another Electronic QU Test could be performed 26 May 11 I 10 13 The Host Screen displays 7 E e he Patient ID or Lot Number field 26 May 11 10 12 36 Current Date and Time Blood Calibration The type of test Blood test or amp OA test L Insert test card to begin test e he battery charge level of the Reader 3 Tools View Help ZB Page 15 of 35 51005304 01 August 2012 w epoc e Veterinary User Guide BLOOD ANALYSIS epoc System If running test cards on the Use By date allow sufficient time to complete the test before midnight Test results do not display after midnight of the Use By date car Additional tabs E for accessing other test information entries that may be used to ensure a complete test record Always verify that current date and time are correct before running a test The d
25. s for Aqueous Control Fluids mi dene den pun ae pee pmo p b n m m T sm B ob oh m B w9 B RR je e m dem en pun pee pee pmo sasea pz 0 11 bm fon 0 20 0 27 zeea og 0 46 bm fos 0 84 1 15 Hsm s fi 0 63 bm foss 1 16 1 59 For example if ambient temperature in the laboratory is 15 17 C and pO range is 135 to 155 mmHg the Range can be adjusted by adding 9 5 mmHg to upper and lower limits to obtain the Adjusted Range 135 9 5 to 15549 5 144 5 to 164 5 mmHg Value Assignment Datasheets The Value Assignment Datasheets contain target values and acceptable ranges for aqueous control and calibration verification fluids specific to the epoc System Download the current Value Assignment Datasheets at http www epocal com or contact your epoc Distributor Page 30 of 35 51005304 01 August 2012 epoca S Veterinary User Guide BLOOD ANALYSIS POS System Each Value Assignment Datasheet VAD is identified by Fluid Name Level Lot Number and epoc System Sensor Configuration Version Assure all information is correct when using VAD to determine acceptability of results The epoc System Sensor Configuration version is located in the epoc Host Help About Menu Ranges displayed represent the maximum deviation expected when Fluids and Test Cards are performing properly If the results are outside the specified ranges refer to the Troubleshooting Section of this Guide or of the epoc System Manual Never use Target Values
26. store or allow Test Cards to freeze The shipping boxes are not to be used for storage It is the responsibility of the customer facility to constantly maintain the temperature above 15 and below 30 C The temperature monitors are for shipping use only Test card pouches provide a low humidity environment for card storage The card pouch should be opened and the Test Card removed only when conducting blood or QA testing Never store Test Cards outside of the card pouch or near intense light or heat sources Never use a Test Card if the card pouch seal has been compromised in any way The low humidity threshold within the pouch may have been exceeded For a blood or QA test a Test Card must be taken directly from the card pouch Never place a Test Card on any surface prior to use Test Cards brought from a warmer or colder storage environment even within the same building must be allowed to adjust to the same temperature as the testing room ambient temperature before use The testing environment epoc Reader and epoc Test Cards must all be at the same temperature before conducting any testing otrong mechanical shocks to the card container may induce bubbles in the Test Cards Never drop or otherwise mechanically stress the Test Cards or pouches All epoc Test Cards have a limited shelf life Test cards must be used before the end of the Use By date printed on each Test Card The Use By date is encoded into the Barcode on each Test C
27. t Surface T k L LOC BAIT I LS u P oh PP A IU r F 1 2 Tenn nes j i ues N E i A Sample Ente Port SPA SE eo Lk l be This Side Up Page 17 of 35 51005304 01 August 2012 T epoc Veterinary User Guide BLOOD ANALYSIS P9c rsen Insert Test Card Push the Test Card into the Reader s Card Insertion olot at the front of the Reader with a smooth single motion Continue inserting the Test Card until the slight resistance is felt Push the Test Card past this point to lock it into place This is the final Test Card position The Reader beeps once and the Test Status Indicator turns solid green to notify the User that the Test Card has been successfully inserted Insertion of a Test Card causes the Barcode Header in the Reader to turn ON Avoid abrupt stops or unevenness in speed during Test Card insertion in order for the Barcode to be successfully read Any problem reading the Barcode or any other error causes the Test Status Indicator to turn solid red Check the Host for an error message and completely remove the Test Card from the Reader Upon correct Test Card insertion the Reader is configured for the card type indicated by the Test Card Barcode The Reader performs a series of card integrity checks Test Sequence The motorized mechanism in the Reader can be epoc vet IX EE TCTET heard as calibration fluid is released over the ENS aua aa E sensors within the Test C
28. tents l epoc System Components 5 2 Test Process Overview 7 3 User Interface 8 4 Test Cards 9 5 Blood Collection 11 6 Running a Test 13 qs Routine Procedures 25 8 QA Testing 28 9 Reference Ranges 31 10 Troubleshooting 33 Page 4 of 35 51005304 01 August 2012 epoc ee Veterinary User Guide epoc System BLOOD ANALYSIS epoc System Components Test Cards rii sensor module sensor madule contet surface Sensor surface test panel type valve bar code blaod waste chamber ie Dydat sealed calibratar reservoir mE FOR VETERINARY USE ONLY Storage Tem pe ra tre Rage sample entry port Reader Test Status Indicator Solid ready for use s Flashing busy processing Fed error condition Off not connected Reader is ON O Reader is OFF L Battery Status Indicator Card Insertion Slot Solid on AC fully charged Flashing on AC power charging C Off on battery power Page 5 of 35 51005304 01 August 2012 T epoc geo BLOOD ANALYSIS epoc Host epoc System assembled Veterinary User Guide epoc System Barcode Scanner Stylus socket d Status Indicators Power button Loft Wi Fi amp Bhuesocth Right Battery ES a ae Bore Gia Barcode Scanner button Sih oni sido odgo Cradle Blade 1 b jf te TER x Jj 1s
29. therlands Metabolite QC Mae BSS BGEM Eurotrol Inc Ede Eurotrol GAS ISE The N therlands Metabolite OC 179 3 B913 BGEM 12 Ampoules CC 0009 00 00 Page 28 of 35 51005304 01 August 2012 epoc ge Veterinary User Guide BLOOD ANALYSIS epoc System Always follow Manufacturer s Storage Instructions All Aqueous Control Fluids must be run as QA Test when using epoc System Quality Control Fluids with Blood Gases Quality Control Fluids contain dissolved gases so they become very unstable over time after opening the Ampoule Always use a fresh Ampoule for each Test Card tested when testing multiple Test Cards using a single epoc Reader Multiple Test Cards can be tested using one Ampoule only if tested at same time on multiple Readers Once opened Fluid should be analyzed immediately Never use the last 0 5 mL of Control Fluid in Syringe Gas Levels in Fluids vary with temperature Deviation from room temperature affects gas levels in Fluid Always handle Fluid carefully to avoid any heating or cooling Procedure if If ampoules are taken from a cool storage equilibrate the Ampoule to room temperature 20 25 C Equilibration time for blood gas QC Fluids is four 4 hours minimum Immediately before use shake the Ampoule vigorously for 5 to 10 seconds to equilibrate liquid and gas phases Always hold the Ampoule at the tip and bottom with your forefinger and thumb to minimize the increase in Fluid temperature I
30. vent clotting of significant volume All other 1 or 3ml plastic tests Page 12 of 35 51005304 01 August 2012 Ta epoc e Veterinary User Guide BLOOD ANALYSIS POS System Running a Test Power Up Host and Reader Turn ON epoc Press the Power Button to turn ON the Reader Reader he Power indicator will turn green indicating the epOC Reader is ON and ready for use Press and hold the Power Button for several seconds to turn OFF the Reader when not in use to conserve battery power The Reader can be operated on battery power only or while the battery is being charged using the AC Adapter provided with the Reader Turn ON epoc Press the Power Button to wake up the epoc Host if the Host screen is blank Button Page 13 of 35 51005304 01 August 2012 Ta epoc Veterinary User Guide BLOOD ANALYSIS POS System Enter a valid User ID and Password and press the Login button If no User ID and Password have been assigned users Enter user ID and password can login by inputting any character into each field User ID Password epoc veterinary analyser 3 8 12 Begin a Test When there is a single dedicated Reader rT We l 10 0 The epoc Host will automatically connect to its dedicated Connecting to Rara epoc Reader Please wait The Host Reader connection can be cancelled by tapping the Cancel button Only epoc Readers that are turned ON will be located by the epO
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