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124

t r o u b l e s h o o t i n g

ELECTRODES

*****

Quality control or patient sample result is not reported.

•

The electrode is not calibrated.

•

An error occurred during sample analysis. Repeat sam-

ple analysis.

•

If the error persists, recalibrate.

ELECTRODES

<LIMIT

↑↑

>LIMIT

↓↓

Quality control or patient sample result is not reported.

•

The result is not within the operating limits of the analyze

Summary of Contents for EasyStat

Page 1: ...EDIC EasyStat Operator s Manual...

Page 2: ...NALYZE CONTROL 1 USER OPTIONS 2 CONFIGURATION 3 PRINTER OPTIONS 4 SET REFERENCE LIMITS 5 PATIENT INFORMATION 6 DELETE DATA SETUP MENU 1 PUMP 2 VALVE 3 SAMPLER SWITCHES 4 DOOR SWITCH 5 REAGENT READER T...

Page 3: ...TS 2 2 QC LEVEL 1 LOT XXXXXXX SET REFERENCE LIMITS 1 6 Rili BAK LEVEL 1 LOT XXXXXXX pH SET REFERENCE LIMITS Rili BAK LEVEL 1 LOT XXXXXXX Hct SET REFERENCE LIMITS Rili BAK LEVEL 2 LOT XXXXXXX Hct TARGE...

Page 4: ...EVIATION X XX RILIBAK X XXX X XXX mmHg REFERENCE LIMITS 2 6 Rili BAK LEVEL 1 LOT XXXXXXX pCO2 REFERENCE LIMITS Rili BAK LEVEL 1 LOT XXXXXXX Hct REFERENCE LIMITS Rili BAK LEVEL 2 LOT XXXXXXX Hct REFERE...

Page 5: ...Operator s Manual EDIC EasyStat Ref 7415 003770 901R1 2015 07...

Page 6: ...2513 BH The Hague The Netherlands EasyStat and EasyQC are registered trademarks of Medica Corporation The information in this manual was correct at the time of printing However Medica Corporation con...

Page 7: ...the written instructions for quick reference Symbols used throughout the manual EasyStat display messages important information conditions which may cause data loss or analyzer malfunction biohazard w...

Page 8: ...stallation Unpacking 14 Location 15 Power Up 16 Date Time 17 Components 18 4 Operating the Analyzer Calibrate 22 Analyze Sample 24 Analyze QC 32 Daily Cleaner 40 Second Menu 42 Standby 43 Replace Comp...

Page 9: ...agents 103 Calculations 104 7 Specifications 110 8 EasyStat Setup Defaults 114 9 Troubleshooting Introduction 115 Electrodes 117 Flow 125 Reagent Module 134 Sensor Module 136 Valve Module 139 Printer...

Page 10: ...4...

Page 11: ...s the Ca electrode This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte blood gas and or acid base distur...

Page 12: ...dule valve mod ule and pump tubing There are no operator serviceable parts inside the analyzer When electromechanical problems beyond the scope of this Operator s Manual are suspected DO NOT open the...

Page 13: ...ed under Replace Components in Operating the Analyzer To clean any component use only water or bleach NaClO solu tions DO NOT use solvents examples methyl alcohol ethyl alcohol isopropyl alcohol s BIO...

Page 14: ...8 Front View 2 Analyzer Layout...

Page 15: ...or s manual for instructions RS 232 serial interface connection Barcode reader connection Use only an EasyStat barcode reader Battery port connection Use only an EasyStat battery module Fuse Voltage F...

Page 16: ...a y o u t Press to correct an entry or return to the previous screen In addition to numerical inputs the 0 and 9 keys each have one additional function Press to return to HOME MENU Press to advance p...

Page 17: ...l a y o u t r To adjust the display proceed to the SECOND MENU and select ADJUST DISPLAY Press the number 1 or number 2 keys to adjust the brightness Press the number 3 key to reverse the contrast of...

Page 18: ...12 a n a l y z e r l a y o u t Fluid Path Module Description s Cl electrode should be installed when Cl mode is selected Ca Cl ELECTRODE...

Page 19: ...or a minimum of four hours When the center of the indica tor on the back of the reagent module becomes dark the module has been exposed to excessive heat and must not be used After initial installatio...

Page 20: ...dule Sensor Module Pump Tubing Power Cord 3 Analyzer Installation PO2 Electrode PCO2 Electrode pH Electrode Unpacking Carefully remove the EasyStat analyzer and accessories from the shipping container...

Page 21: ...trols Bi Level Location The analyzer operates in the ambient room temperature range from 15 to 30 C 59 to 86 F with a maximum relative humidity of 85 and a barometric pressure range of 500 800 mmHg Th...

Page 22: ...rrect date and time Power Up Before connecting the analyzer to power confirm that the factory set voltage 110V or 220V of the EasyStat analyzer matches the ground ed outlet supplying the power When fa...

Page 23: ...OFF CONFIRM CONFIGURATION 2 2 s s Ca is replaced with Cl when Cl mode is selected Date Time The EasyStat analyzer has a 24 hour internal clock At the DATE TIME display press NO to change the month an...

Page 24: ...es push the compression plate down until the latch locks into the open position Install the reference electrode first pushing it in above the compression plate The handle snaps into the sensor module...

Page 25: ...19 a n a l y z e r i n s t a l l a t i o n r s Pump Tubing Install the pump tubing Push the two middle collars completely into the back of the slots on the pump shelf...

Page 26: ...he analyzer The guide arrow must point to the right side of the reagent module Push the module straight back then firmly to the right to lock it into place against the valve module When correctly inst...

Page 27: ...odule reaches 37 0 C and the valve module reaches 39 0 C approximately 30 minutes from a cold start the WARMING UP message disappears Calibration can now be performed Refer to Calibrate in Operating t...

Page 28: ...the SETUP MENU Automatic Hct calibrations are included in each two point calibration On demand two point calibrations can be initiated in the HOME MENU by choosing CALIBRATE If not calibrated the HOM...

Page 29: ...RETURN SAMPLER When the sampler is returned to the closed position the message SYSTEM CALIBRATION INTERRUPTED appears for 10 seconds before returning to the HOME MENU No more than three interruptions...

Page 30: ...LER ONE MOMENT ANALYSIS RESULTS 001 pH 7 403 PCO2 32 5 mmHg PO2 118 mmHg Hct 45 Na 140 1 mmol L K 4 02 mmol L Ca 1 33 mmol L 1 s Ca is replaced with Cl when Cl mode is selected Analyze Sample The ACCE...

Page 31: ...two separate sample entry modes To select the sampling mode place your thumb on the raised dots under the corresponding symbol and push up to lift the sampler for syringe or capillary samples Thumb pl...

Page 32: ...ent information 2 minutes is allowed or NO to continue Analysis begins when the sample is automatically positioned inside the electrodes When using a syringe it is important that the sample probe does...

Page 33: ...ults are expressed in KPa and electrolytes are expressed in mEq L Results are automatically printed after each analysis if the printer is turned on under CONFIGURATION in the SETUP MENU The measured r...

Page 34: ...A aDO2 RI and Ca 7 4 The calculated results use the following default values if patient values were not entered see PATIENT INFORMATION screen in the SETUP MENU Patient Temp 37 C Hb 14 5 g dL FIO2 21...

Page 35: ...mode is selected Push the sampler down into the closed position If PATIENT INFORMATION settings are turned ON in the SETUP MENU the ENTER PATIENT DATA screen displays for 30 seconds Press YES to enter...

Page 36: ...alysis if the printer is turned on under CONFIGURATION in the SETUP MENU The measured results are compared to the normal and critical limits set under SET REFERENCE LIMITS in the SETUP MENU When analy...

Page 37: ...lts for BEecf SBC SO2c O2ct A aDO2 RI and Ca 7 4 In Cl mode Ca 7 4 is replaced with Anion Gap The calcu lated results use the following default values if patient values were not entered see PATIENT IN...

Page 38: ...SECOND MENU QC LEVEL 1 LOT XXXXXXXX LIFT SAMPLER TO ANALYZE CONTROL QC LEVEL 1 LOT XXXXXXXX PROBE IN CONTROL QC LEVEL 1 LOT XXXXXXXX ASPIRATING QC LEVEL 1 LOT XXXXXXXX REMOVE CONTROL RETURN SAMPLER Q...

Page 39: ...tion factors applied to quality control samples The hematocrit controls are assayed quality control materials used to monitor the measurements of hematocrit in the EasyStat analyzer Electrical conduct...

Page 40: ...e settings can be corrected Repeat for each level of control To proceed with quality control analysis press to return to HOME MENU If RiliBAK feature is on press NO and use the number keys to enter th...

Page 41: ...the sampler and PROBE IN CONTROL is displayed Place the probe in the quality control material and press YES Hold the ampule in place keeping the probe submerged in the ampule until REMOVE CONTROL RETU...

Page 42: ...fficient of variation for the stored quality control results PLOT QC CHARTS prints the stored quality control results as a Levey Jennings chart The statistics are calcu lated according to the followin...

Page 43: ...stored quality control results The maximum number of stored results is 93 for each level Levey Jennings Chart Levey Jennings charts plot the measured quality control results for each day The calculate...

Page 44: ...d Systematic Errors A recurring measurable deviation from the mean is classified as a sys tematic error One example of a systematic error is when a progres sive increase or decrease in control results...

Page 45: ...recautions Refer to the package insert provided with the quality control material Recommended Procedure Run all control levels each day the analyzer is in use Data is stored for future statistical ana...

Page 46: ...DAILY CLEANER The display shows LIFT SAMPLER TO USE CLEANER The sampler must be in the syringe mode position Lift the sampler until PROBE IN CLEANER appears Insert the probe into the cleaning solutio...

Page 47: ...aced a more aggressive cleaning procedure can be performed to remove accumulated protein within the sampler and preheater The fre quency of this procedure is dependent on the number and quality high p...

Page 48: ...ALYZE QC 3 CALIBRATE 4 DAILY CLEANER 5 SECOND MENU SECURITY CODE CONFIRM 1 Default off DIAGNOSTICS 1 TEST COMPONENTS 2 TEST FLUIDICS 3 SENSOR STATUS 4 PRIME FLUIDS 5 PRINTOUTS REPLACE COMPONENTS 1 REA...

Page 49: ...ion Turn AUTO STANDBY ON under CONFIGURATION in the SETUP MENU The analyzer will enter STANDBY at the next scheduled calibration if no patient or quality control samples have been analyzed since the l...

Page 50: ...2 Na K Ca Cl and Reference and reagent module The replacement schedule below must be followed to properly maintain the EasyStat analyzer It is recommended that quality control material be analyzed aft...

Page 51: ...RODE Replace as required PCO2 ELECTRODE Replace as required PO2 ELECTRODE Replace as required Na ELECTRODE Replace as required K ELECTRODE Replace as required Ca ELECTRODE Replace as required Cl ELECT...

Page 52: ...E is displayed Press YES to return to the previous screen When all replacements are complete press the HOME key to return to the HOME MENU After any component replacement procedure the WARMING UP mess...

Page 53: ...nstall a new reagent module Select REAGENT MODULE from the REPLACE COMPONENTS menu Fluid is automatically purged from the sample path The display prompts you to REMOVE REAGENT MODULE Open the access d...

Page 54: ...dule contains encoded information which is read by the analyzer upon installation of the reagent module This information includes reagent pH PCO2 PO2 Hct Na K Ca and Cl val ues and install by date of...

Page 55: ...mpress the electrodes within the sensor module Press YES to REPLACEMENT COMPLETED Reagents are auto matically primed from the reagent module When priming is complete the display indicates the detectio...

Page 56: ...eagent module When priming is com plete the display indicates the detection of each fluid with PASS then automatically returns to the REPLACE COMPONENTS screen Pump Tubing Replace the pump tubing ever...

Page 57: ...sample position Using the tool supplied in the probe wiper replacement kit turn the probe wiper 90 to unlock This will align the notches on the probe wiper with the notch on the sampler Use the tool...

Page 58: ...eplacement is necessary if the sample probe is bent dam aged or obstructed refer to FLOW in Troubleshooting or if the sam pler movement is defective Select SENSOR MODULE SAMPLER Fluid is automatically...

Page 59: ...53 o p e r a t i n g t h e a n a l y z e r r Pull the release lever and the sensor module is disengaged Remove from the analyzer...

Page 60: ...Remove the screw mount includes spring Rotate the sampler into the capillary mode position then pull it out of the sensor module Installation Install the new sampler includes sample probe and wiper i...

Page 61: ...h e a n a l y z e r r After installing a new sampler reinstall the complete sensor module Lift the sampler up slightly Place the sensor module on the alignment pin and using your thumb push it straig...

Page 62: ...ule When prim ing is complete the display indicates the detection of each fluid with PASS then automatically returns to the REPLACE COMPONENTS screen A WARMING UP message may appear for up to 30 minut...

Page 63: ...ally purged from the sample path REMOVE REAGENT MODULE is displayed Remove the reagent module PURGE WITH AIR READY is displayed Connect the tub ing from the troubleshooting kit to the valve module was...

Page 64: ...t h e a n a l y z e r Slightly Lift Sampler Disengage the sampler by slightly lifting the sampler until it unlocks from the valve module Pull the release lever and the sensor module is disengaged Remo...

Page 65: ...59 o p e r a t i n g t h e a n a l y z e r r Remove the valve module by pulling it straight out To install a new valve module place the valve module onto the align ment pin and push straight back...

Page 66: ...sampler down into the closed position Close the access door Reinstall the reagent module Press YES to REPLACEMENT COMPLETED Reagents are automatically primed from the reagent module When priming is co...

Page 67: ...electrodes This will ensure that all fluids are purged from the sample flow path Release the compression plate Grasp the compression plate and pull it out of the sensor module To install the compressi...

Page 68: ...fed through the printer The paper roll rests in the tray behind the printer Close the printer door to protect the paper roll To advance the paper press the button Operation of the printer without pape...

Page 69: ...lace the fuse s remove the power cord then push down on the fuse holder release tab and pull straight out The EasyStat analyzer will only accept slow blow or time delay fuses Remove the fuse s from th...

Page 70: ...6 NaClO solution Apply the solution to a cloth to wipe down all outside surfaces DO NOT use solvents examples methyl alcohol ethyl alcohol iso propyl alcohol or cleaning agents containing benzalkoniu...

Page 71: ...in this manual 4 3 2 3 1 SECOND MENU 1 STANDBY 2 REPLACE COMPONENTS 3 DIAGNOSTICS 4 STORED INFORMATION 5 SETUP MENU 6 ADJUST DISPLAY DIAGNOSTICS 1 TEST COMPONENTS 2 TEST FLUIDICS 3 SENSOR STATUS 4 PR...

Page 72: ...cali brate the analyzer and resume operation If the test fails contact your EasyStat dealer VALVE Select VALVE to verify valve function The screen displays ROTATING then FULL ROTATION Look for rotati...

Page 73: ...o the capil lary mode and press YES SAMPLER CLOSED is displayed Push the sampler down into the closed position SYRINGE MODE is displayed Lift the sampler to the syringe mode and press YES RETURN SAMPL...

Page 74: ...fy access door switch function When DOOR OPEN is displayed open the access door and press YES When DOOR CLOSED is displayed close the access door and press YES The screen displays PASS or FAIL When th...

Page 75: ...READER Select REAGENT READER to verify reagent reader function REAGENT MODULE REMOVED is displayed Remove the reagent module and press YES REAGENT MODULE INSTALLED is displayed Reinstall the same rea...

Page 76: ...module and clean the metal contacts on the analyzer with a damp cloth Then dry the contacts thoroughly Repeat the REAGENT READER test If it fails again contact your EasyStat dealer Prior to installati...

Page 77: ...fails refer to FLOW in Troubleshooting for further instructions SAMPLE FLOW Select SAMPLE FLOW to verify the flow of the sample path During testing the screen will display LIFT SAMPLER TO TEST SAMPLE...

Page 78: ...ect PUMP CAL to verify proper pump calibration The pump calibration counts the number of steps required to move fluid from the valve module to the bubble detector The screen displays PUMP CAL When tes...

Page 79: ...o a local refer ence barometer The proper operation of the analyzer depends on a correct barometric pressure setting TEMPERATURE Select TEMPERATURE to view the sensor valve and room tem peratures The...

Page 80: ...ST DISPLAY CAL SAMPLE DATA 1 SLOPES 2 mV s 3 PUMP BUBBLE DETECTOR 4 SAMPLE COUNTER PATIENT RESULTS 1 LAST 2 ALL 3 ENTER ID PRINTOUTS 1 USER OPTIONS 2 CONFIGURATION 3 PRINTER OPTIONS 4 PATIENT LIMITS 5...

Page 81: ...l results as well as view the reference limits calibration and reagent module information PATIENT RESULTS View or print stored patient results Up to 64 results are stored LAST View and print the last...

Page 82: ...Level 1 or Hct Level 2 PRINT QC STATS Print the statistics for stored quality control data by level Printing can be cancelled by pressing NO PRINT QC RESULTS Print the results for stored quality cont...

Page 83: ...0 mmol L K 3 5 5 1 mmol L 3 5 5 1 mmol L 3 5 5 1 mmol L Ca 1 05 1 32 mmol L 1 05 1 32 mmol L 1 05 1 32 mmol L Cl 98 0 106 0 mmol L 98 0 106 0 mmol L 98 0 106 0 mmol L REFERENCE LIMITS View the limits...

Page 84: ...0 8 3 0 mmol L 0 8 3 0 mmol L Cl 90 0 112 0 mmol L 90 0 112 0 mmol L 90 0 112 0 mmol L CRITICAL View the analyzer s critical limits for arterial2 mixed venous3 or venous2 samples These limits have be...

Page 85: ...ul and the electrode is currently cali brated A FAIL status indicates that an error occurred during the last calibration INVALID indicates that the calibration status has become invalid after the cali...

Page 86: ...ber of samples that have been performed on analyzer REAGENT MODULE Verify the status and the concentrations of the reagents in the reagent module STATUS View the current reagent module serial number a...

Page 87: ...USER OPTIONS Print the User Options settings CONFIGURATION Print the Configuration settings PRINTER OPTIONS Print the Printer Options settings PATIENT LIMITS Print the normal and critical patient ref...

Page 88: ...RENCE LIMITS 1 PO 2 PCO2 BP mmHg 2 Na K Ca mmol L 3 Hct 4 Hb g dL 5 BC CHECKSUM OFF CONFIRM CONFIGURATION 1 2 1 CAL FREQUENCY 8 HRS 2 AUTO STANDBY OFF 3 TEMPERATURE C 4 Rili BAK OFF 5 AMR OFF CONFIRM...

Page 89: ...DATA BAROMETRIC PRESSURE SECURITY CODE Make sure you remove the reagent Module when changing the DATE TIME DATE TIME Set the month day year and time expressed as a 24 hour clock Press NO to edit the c...

Page 90: ...The correlation values can be applied to patient and quality control results First analyze a minimum of 10 patient samples in each of the low abnormal normal and high abnormal ranges for each of the a...

Page 91: ...mistakes press NO to return to the top of the list and re enter numbers Press YES to confirm your entries The pH PCO2 PO2 Hct Na K Ca and Cl slope input range is 0 90 to 1 10 The acceptable intercept...

Page 92: ...r press YES to CONFIRM When it does not match a reference barometer press NO Press the number keys to enter the actual barometric pres sure Press YES when the entry is complete If the barometric press...

Page 93: ...ts select or V V for hematocrit Hb Change the measurement units for Hb Select mmol L g L or g dL BC Checksum Turn the feature ON or OFF When the feature is ON the analyzer has the uses the last digit...

Page 94: ...range for each parameter The ranges can be changed to ranges within the default limits PRINTER OPTIONS Select printing options PRINTER Turn the printer ON or OFF When the analyzer runs out of printer...

Page 95: ...ion using the barcode reader EasyQC quality controls must be used To enter quality control information using the barcode reader select QC LEVEL 1 2 3 Hct 1 or 2 LOT is high lighted on the display Usin...

Page 96: ...rm each individual setting and advance to the next entry When all limits are entered press YES to CONFIRM to accept all entries When NO is pressed as a response to CONFIRM entries can be cor rected Wh...

Page 97: ...within the critical range will be flagged as low or high on the display and printout RILIBAK Set the RiliBAK target percent deviation and range for each param eter To change the setting press NO to C...

Page 98: ...S to CONFIRM When any options are turned ON the EasyStat displays ENTER PATIENT DATA after sample aspiration Press YES to enter patient information Use the number keys to enter values and press YES to...

Page 99: ...ter an operator ID for each patient and quality control sam ple A maximum of 14 digits is accepted The barcode reader may be used to enter the operator ID DELETE DATA Delete all stored patient or qual...

Page 100: ...of the patient sample Syringe Sample 1 Draw blood into a syringe which is pretreated with liquid heparin or use a prepackaged syringe treated with dry lyophilized heparin The syringe must be completel...

Page 101: ...urces of error non heparinized samples incor rect heparin concentration syringe filling speed syringe mixing method sample storage technique delayed sample analysis multiple samples from the same syri...

Page 102: ...ed with a known concentration of a reference ion usually cesium is aerosol ized and passed through a flame which excites the cations The cation re emits the energy as light of different frequencies th...

Page 103: ...ponds The relationship between the voltage developed and the concentration of the sensed ion is logarithmic as expressed by the Nernst equation Nernst equation nF E E RT Log C where E The potential of...

Page 104: ...ir respective concentrations in the Calibrant solution Since the difference in potentials and the concentration of the sodium potassium calcium or hydrogen ions in the Calibrant solution are known the...

Page 105: ...mes S the slope is determined during calibration using Calibrants A B or C for calcium which have known levels of sodium potassium calcium or pH When an automatic calibration is initiated the slope is...

Page 106: ...arbonate solution The change in pH is in proportion to the PCO2 creating a voltage change which is then converted into PCO2 units PO2 Electrode1 The PO2 electrode uses Clark electrode technology A pos...

Page 107: ...tal blood volume is defined as hematocrit It is quantified by measuring the electrical impedance of a blood sample Two standard solutions are used to calibrate the hematocrit sensor The analyzer then...

Page 108: ...es Internal Fill Solution pH Sensitive Glass Internal Reference Electrode Anode Glass Cathode Internal Fill Solution Porous Spacer Gas Permeable Membrane pH PCO2 PO2 Na K Ca Cl pH PCO2 PO2 The pH Na K...

Page 109: ...n partial pressures of PO2 and PCO2 Tonometry is the process of bubbling a gas through a liquid until equi librium is reached Equilibrium is when the partial pressures of the gases dissolved in the li...

Page 110: ...a ture The temperature corrected results more accurately reflect the in vivo conditions The EasyStat analyzer performs these calculations using the following equations1 pH T 0 0065 7 4 pH 0 0147 log P...

Page 111: ...late the total carbon dioxide concentration1 TCO2 HCO3 0 0307 PCO2 where TCO2 and HCO3 are expressed in mmol L PCO2 is expressed in mmHg THb The hemoglobin is calculated based on the following calcula...

Page 112: ...using the following equation 1 This parameter is defined as the titratable base of blood which may be determined by titration with strong acid or base to plasma pH 7 400 and PCO2 40 mmHg at 37 0 C BE...

Page 113: ...mHg at 37 0 C BEecf HCO3 25 16 2 pH 7 4 where BEecf is expressed in mmol L HCO3 is expressed in mmol L SBC The bicarbonate concentration in plasma from a blood sample that is equilibrated to 37 0 C wi...

Page 114: ...ntent of blood is expressed as the volume of oxy gen mL per 100 mL or dL of blood The oxygen content is the sum of the amount of oxygen bound to hemoglobin and the amount of dis solved oxygen The foll...

Page 115: ...oxygen partial pressure PAO2 TC and arte rial oxygen partial pressure PaO2 TC PO2 T are expressed at the patient corrected temperature PAO2 TC FIO2 BP TC PaCO2 TC FIO2 1 FIO2 R where A aDO2 is expres...

Page 116: ...ure 20 45 C Time Drawn 00 00 Hemoglobin 3 0 30 0 g dL Sample Source arterial mixed venous venous FIO2 Fraction Inspired Oxygen 10 100 Sample Type radial brachial femoral arterial line cord Patient ID...

Page 117: ...PO2 PCO2 pH Na K Ca Cl N 80 80 80 80 80 80 80 Mean 64 73 5 7 171 114 6 1 96 1 35 71 1 SD 1 8 0 82 0 003 0 3 0 02 0 004 0 49 CV 2 8 1 1 0 3 0 8 0 3 0 7 Level 2 PO2 PCO2 pH Na K Ca Cl N 80 80 80 80 80...

Page 118: ...011 0 95 0 057 0 005 0 29 CV 0 8 2 2 0 6 0 9 1 0 0 2 Day to Day precision of duplicates NCCLS EP 5 using EasyQC Hematocrit controls Level 1 Hct N 80 Mean 32 SD 0 5 CV 1 6 Level 2 Hct N 80 Mean 51 SD 0...

Page 119: ...n precision of duplicates NCCLS EP 5 using whole blood and serum PO2 PCO2 pH Na K Ca Cl N 20 20 20 20 20 20 20 Mean 102 37 1 7 423 142 6 4 23 1 37 102 0 SD 0 9 0 57 0 008 0 67 0 020 0 010 1 00 CV 0 9...

Page 120: ...curity Code Off Calibration Frequency 8 hours Auto Standby Off Printer On Calculated Values On Printouts 1 PO2 PCO2 BP units mmHg Na K Ca Cl mmol L Temperature units C Hct Hb g dL calculated QC refere...

Page 121: ...ols to help diagnose and correct problems Syringe Tubing Segments Electrode O rings Red Test Dye Solution 50mL 0 1 mmol L amaranth dye in electrolyte solution Blunt Needles Test Block Introduction To...

Page 122: ...IN CONTROL AIR IN CALIBRANT C AIR IN CLEANER MOVEMENT OF CALIBRANT A MOVEMENT OF SAMPLE MOVEMENT OF CALIBRANT B MOVEMENT OF CONTROL MOVEMENT OF CALIBRANT C QUALITY CONTROL QC ERROR Troubleshooting is...

Page 123: ...esence of moisture in these areas will interfere with normal calibration and sample analysis It is recommended that quality control material be analyzed after troubleshooting to verify performance To...

Page 124: ...eference elec trode pin for corrosion Clean the pin with warm water if necessary Inspect inside the sensor module for liquid and or salt deposits Inspect the compression plate surfaces and the area ar...

Page 125: ...tion analysis If the error remains remove the sensor module from the analyzer and examine the exterior surface of the sensor module and Hct sensor for liquid or salt deposits Examine the sensor module...

Page 126: ...low problem Remove the electrodes from the sensor module Inspect the O ring connections and replace any cracked O rings Inspect the sensor module surfaces that surround the electrodes for salt deposit...

Page 127: ...or the red ball is not floating Wipe dry all electrodes before reinstallation Reinstall the electrodes and confirm that they are correctly aligned Each electrode is keyed to assist with correct place...

Page 128: ...ec trode mV readings If the electrode mV readings are out of range first verify that the reference electrode is within its use period refer to the Replacement Schedule in Chapter 11 In the case of mul...

Page 129: ...tion under Analyze QC in Operating the Analyzer Perform DAILY CLEANER twice Recalibrate Condition the electrodes by twice analyzing a serum or blood sample ignore the results Repeat analysis of contro...

Page 130: ...is not reported The electrode is not calibrated An error occurred during sample analysis Repeat sam ple analysis If the error persists recalibrate ELECTRODES LIMIT LIMIT Quality control or patient sa...

Page 131: ...valve module pump tubing and reagent module are installed correctly Confirm that the sampler is down Open the access door Perform the PUMP CAL test under TEST FLUIDICS in the DIAGNOSTICS menu Look for...

Page 132: ...is present the bubble detector cir cuit is defective or the bubble detectors require cleaning Proceed to the troubleshooting instructions Sample Probe Sensor Module obstructions and clean the flow pa...

Page 133: ...ils remove then reinstall the reagent module Repeat the REAGENT FLOW test If any reagent fails remove the valve mod ule and flush with water as described under VALVE MODULE VALVE ERROR Repeat the REGA...

Page 134: ...e top of the valve module for debris Clean these areas with a 10 bleach 0 4 0 6 NaClO solution on a damp cloth then repeat the SAMPLE FLOW test If the error persists replace the probe wiper and retest...

Page 135: ...e compression plate is closed and verify that the bar at the rear of the sensor module is snapped inside the com pression plate hinge tabs If not snap the bar inside the hinge tabs then gently push do...

Page 136: ...he electrodes for worn or cracked O rings Replace O rings if necessary If an elecrode appears to be obstructed replace that electrode DO NOT attempt to remove an obstruction from an electrode If you c...

Page 137: ...roubleshooting kit into the sensor module Release the compression plate Disconnect the pump tubing from the bottom of the sensor module Lift the sampler to the syringe mode position Attach the large t...

Page 138: ...er and attach with small tub ing segment to the sampler in the syringe mode and flush the flow path Install a new sampler if the obstruction cannot be removed Confirm a successful SAMPLE FLOW test wit...

Page 139: ...OW in this chapter These messages indicate a small movement of cali brant patient sample or quality control material dur ing the measurement period of a calibration or analysis cycle When any of these...

Page 140: ...nt Module procedure in Operating the Analyzer The installed reagent module is consumed or has exceeded its expiration date or usage period Install a new reagent module REAGENT MODULE RGNT MODULE INVAL...

Page 141: ...to an atmospheric air environment 21 O2 and recalibrate If the error continues install a new reagent module and recalibrate If the error continues contact your EasyStat dealer The reagent module is no...

Page 142: ...e and sensor module are pushed in completely Perform the SAMPLER SWITCHES test Follow the display instructions Remove the sensor module Check the tightness of the thumb screw on the sampler DO NOT ove...

Page 143: ...or WARMING UP to disappear If WARMING UP remains displayed after 30 minutes remove the sensor module check and clean the contacts reinstall and wait up to 30 minutes If WARMING UP remains displayed af...

Page 144: ...or must be closed during EasyStat operation Verify that all electrodes are installed properly If any electrode is not pushed in completely the door will not close properly Perform the DOOR SWITCH test...

Page 145: ...aving solids try and rotate the valve manually with a pair of pliers Fill the syringe from the troubleshooting kit with 3mL of warm water Attach the blunt needle and the large tubing segment Connect t...

Page 146: ...of the valve module Retest If these steps returned the valve module to operation it is strongly advised that a replacement valve module be obtained as the valve errors recently cured may return perma...

Page 147: ...and select CONFIGURATION Turn the printer on If printer failure continues carefully inspect the printer mechanism for paper obstructions Remove any obstruc tions using caution not to damage the printe...

Page 148: ...om temperature or barometric pressure by proceeding to DIAGNOSTICS and selecting SENSOR STATUS Move the analyzer to a location where the temperature and barometric pressure fall within the operating l...

Page 149: ...guration 8 data bits 1 stop bit no parity Interface requires the EasyStat serial cable A telephone style connec tor at one end of the cable plugs into the receptacle labeled on the back of the analyze...

Page 150: ...Accessories Communications HyperTerminal Choose any name and Direct to Com1 under Connect using Use the RS 232 protocol stated above Under Flow control use the Hardware setting From the File Properti...

Page 151: ...ranty 4 months use PO2 ELECTRODE Replace as required Warranty 4 months use Na ELECTRODE Replace as required Warranty 6 months use K ELECTRODE Replace as required Warranty 6 months use Ca ELECTRODE Rep...

Page 152: ...146...

Page 153: ...CLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES WHETHER STATUTORY EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND ALL WARRAN...

Page 154: ...148...

Page 155: ...o not freeze Batch code Use by Catalog Number Manufacturer Authorized Representative CE Mark Biohazard Serial Number UL Fuse Barcode connection Battery port connection RS 232 serial interface connecti...

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Page 158: ...0 001 R1 For Service or Technical Assistance 800 777 5983 In Continental US 781 275 4892 International 781 275 2731 Fax medica medicacorp com E mail Medica Corporation 5 Oak Park Drive Bedford MA 0173...

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