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User`s Manual - Integra LifeSciences

1. Problem Cause Recommendation Integra Licox PtO2 Monitor does not operate on battery power Battery not installed e Attach AC power adapter to Integra Licox PtO2 Monitor see page 13 e On touch screen check battery indicator on status bar to ensure the battery is installed see page 30 e If not install the battery see page 102 Battery not charged e Attach AC power adapter to Integra Licox PtO2 Monitor see page 27 e On touch screen check battery indicator on status bar to ensure the battery is being charged see page 30 Faulty battery e Attach AC adapter cord to Integra Licox PtO2 Monitor page 27 e Perform battery charge test on page 101 to ensure battery holds charge properly e Contact Integra to order new battery Touch screen freezes System hardware error e Press and hold the power button for several seconds to perform a forced shutdown of the system e Press the power button to turn on the system Integra Licox PtO2 Monitor does not power on or off when power button is pressed Firmware error e Disconnect AC adapter cord from Integra Licox PtO2 Monitor and remove battery see page 102 e Re insert the battery and then re connect AC adapter cord to Integra Licox PtO2 Monitor e Press the power button The PtO2 value on the touch screen displays two dashes No Smart Card is inserted into slot Firmly insert the design
2. 34 Chapter 4 Setting Up System for Clinical Use Step 3 Insert the PtO2 Probe into Patient and Connect the Probe to the Monitor Depending on hospital protocol you may either insert the PtO2 probe into the patient before see Option 1 or after see Option 2 connecting the PtO2 probe to the monitor Options Procedure 1 A Insert the PtO2 probe into the patient For instructions see the instructions for use supplied with the probe B Connect the blue PtO2 probe to the blue PtO2 probe cable see Figure 4 1 verify that they are connected securely OR 2 A Connect the blue PtO2 probe to the blue PtO2 probe cable see Figure 4 1 verify that they are connected securely B Insert the PtO2 probe into the patient For instructions see the instructions for use supplied with the probe Notice The purpose of connecting the PtO2 probe to the monitor prior to implantation is to verify the functionality of the probe before clinical use it is not a requirement for calibration as each PtO2 probe includes a designated Smart Card When connecting the probe to the monitor prior to implantation ensure that sterility is maintained For sterilization instructions see page 81 Figure 4 1 Connecting the PtO2 Probe to the PtO2 Probe Cable oF a O UOO T A Blue PtO2 probe cable Blue PtO2 probe Step 4 Allow Stabilization Time for Microtrauma After probe insertion allow stabilization tim
3. Dimensions 240 mm x 165 mm x 185 mm Width x Height x Depth Weight 3 0 kg 6 7 Ibs Display e 7 0 WVGA color TFT LCD display 800 x 480 pixel resolution e The numeric parameters displayed on the touch screen can be read from a distance of 10 feet up to a 30 angle off center Power Supply Use only Integra supplied AC power adapter REF MONPWR 18 V DC 1 67 A 30 W Battery Use only Integra supplied 14 4 V lithium ion battery REF BAT1001 e Charge time No more than 5 hours while the monitor is plugged into an AC power outlet and the monitor is turned off e Operation time is at least 1 5 hours Principle Technology PtO2 Measurement e Polarographic electrochemical sensor Temperature Measurement Type K thermocouple Low PtO2 Alarm Limit e 1t0 125 mmHg 1mm increments e Factory default set to 15 mmHg Appendix A Technical Specifications e 107 Item Specification Pressure PtO2 Excitation Voltage from Patient Bedside Monitor DC 2 to 10V single ended DC 2 5V differential AC 2 to 10V RMS up to 5000 Hz sine wave Output to Patient Bedside Monitor PtO2 Measurement 5 0 u V V mmHg Temperature Measurement Conforms to a standard YSI 400 thermistor interface PtO2 1 mmHg or 1 of monitor reading whichever is greater Temperature 0 2 C to YSI 400 standard Data Extraction Operating Pressure USB USB 1 11 e RS232 9600 baud 8 data bits 1
4. Arrows for selecting language 4 Press Accept the Integra Licox PtO2 Monitor will display all of the text that appears on the touch screen in the selected language Step 7 Use AC Power to Charge the Battery to Full Capacity 1 Turn off the monitor On the front of the monitor press the power button 2 Keep the Integra Licox PtO2 Monitor on AC power with the monitor turned off for 5 hours This will re charge the battery to full capacity 3 After 5 hours turn on the monitor by pressing the power button 4 On the touch screen view the battery power symbol on the status dD bar to verify the symbol displays four green bars this indicates the battery has full charge 20 Chapter 2 Setting Up System for the First Time CHAPTER 3 ABOUT THE PTO2 MEASUREMENTS Relationship Between Oxygen Pressure and Oxygen Conient 21 PtO2 A Measure of Cellular Oxygen Availability ccseeessseeeeeees 21 Temperature Effect cccccesseeeeeecesseceeeeeenseeeeeeensneeeseeensceeeesesseeeeeeensaeeeeeeesans 21 Microtrauma Caused from Probe Insertion ccessessseeeeeseeeseeeneeeees 22 Optimal Clinical Readings When Using Temperature Probes 0 22 Relationship Between Oxygen Pressure and Oxygen Content Gases which are in contact with the surface of a liquid become physically dissolved in the liquid If the pressure the composition and the temperature of the gas atmosphere ov
5. Notice The purpose of connecting the probes to the monitor prior to implantation is to verify the functionality of the probes before clinical use it is not a requirement for calibration as each PtO2 probe includes a designated Smart Card When connecting the probes to the monitor prior to implantation ensure that sterility is maintained For sterilization instructions see page 81 4 cable probe Step 5 Allow Stabilization Time for Microtrauma After probe insertion allow stabilization time to address microtrauma normally between 20 minutes and 2 hours this will ensure the PtO2 values reported by the monitor for tissue are accurate For details see page 22 40 Chapter 4 Setting Up System for Clinical Use Step 6 Check PtO2 and Temperature Values On the touch screen press the Main tab and view the PtO2 and Temperature values Synchronize to Trend Alarm Settings me 4 Monitor Temperature 1 C 37 2 Note that when using a temperature probe the temperature measurement being continuously reported by the monitor with an accuracy of 1 C will be applied to the calculation for PtO2 measurements Chapter 4 Setting Up System for Clinical Use 41 Connecting the Combined PtO2 Temperature Probe Connecting the combined PtO2 temperature probe requires the following components Measurements Components REF PtO2 and Temperature e Combined PtO2 temperature probe and Smart
6. Customer shall provide a technical counterpart to Integra s Service Agent for assistance in Integra s telephonic diagnosis of the malfunction with the Equipment Customer shall reasonably accept Integra s determination whether a repair or service is an in warranty repair or an out of warranty repair THE WARRANTIES DESCRIBED IN SECTION 1 HEREOF ARE EXCLUSIVE AND ARE GIVEN AND ACCEPTED IN LIEU OF ALL OTHER WARRANTIES OF INTEGRA OR ITS SERVICE AGENTS WITH RESPECT TO THE QUALITY PERFORMANCE AND OPERATION OF THE EQUIPMENT WRITTEN OR ORAL EXPRESSED OR IMPLIED AND WHETHER OR NOT ATTRIBUTABLE TO SERVICE PERFORMED PURSUANT TO THE WARRANTY ALL OTHER REPRESENTATIONS OR WARRANTIES OF INTEGRA OR ITS REPRESENTATIVES EXPRESS OR IMPLIED WITH RESPECT TO THE EQUIPMENT OR THE SERVICES DIAGNOSES ADVICE ASSISTANCE OR PARTS TO BE TENDERED PURSUANT TO THE WARRANTY INCLUDING WITHOUT LIMITATION THOSE OF MERCHANTABILITY AND FITNESS FORA PARTICULAR PURPOSE ARE HEREBY EXPRESSLY DISCLAIMED IN NO EVENT SHALL INTEGRA ITS AFFILIATES ASSIGNEES OR SERVICE AGENTS BE LIABLE FOR LOSS OF USE REVENUE OR PROFIT OR ANY OTHER DIRECT INDIRECT INCIDENTAL EXEMPLARY CON SEQUENTIAL SPECIAL OR OTHER DAMAGES WHETHER ARISING IN CONTRACTOR IN TORT BY VIRTUE OF THE WARRANTY OR ANY PERFORMANCE OR BREACH BY INTEGRA ITS AFFILIATES ASSIGNEES OR SERVICE AGENTS HEREUND ER OR PURSUANT HERETO IN EXCESS OF THE AMOUNTS PAID BY CUSTOMER TO INTEGRA DURING THE WARRANTY PERIOD
7. Connect the and leads of the DMM to pins 2 and 3 of the six pin cannon connector respectively 4 Turnonthe monitor On the touch screen press Synchronize to Monitor to test the following PtO2 values Simulated Pressure mmHg Simulated Voltage mVDC o 0 000 25 25 1 250 25 50 2 500 25 100 5 000 25 Chapter 10 Testing and Preventive Maintenance 95 Note that pressing Check Additional Values each time will advance to the next fixed PtO2 value 5 If any of the values exceed their tolerance criteria contact Integra 6 Turn off all test equipment power down monitor and then disconnect all test equipment Testing Temperature Input and Output Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Required Equipment Digital Multimeter DMM 1 mV minimum reading of 1k and 2 k ohms having an accuracy of 1 ohm e Water bath or beaker e Reference Thermometer between 30 and 40 C e 1Smart Card not the test Smart Card e 1 Integra Licox temperature probe e Green temperature probe cable BC10TA e PMIO cable PMIOMPM Notice Before performing this test verify that the Integra Licox PtO2 Monitor is turned off and not connected to any cables 1 Plug the Integra Licox PtO2 Monitor to an AC wall outlet 2 Turnonthe monitor and allow the monitor to warm up for 3 hou
8. E0011 E3002 E3003 E3004 E3008 E3025 Sensor board failure e Turn off Integra Licox PtO2 E3026 E3032 E3037 E3038 E3039 E3041 Monitor and then turn back E3042 E3044 E3045 E3046 E3047 E3048 on E3051 E3057 E3061 E3101 E3103 E3104 E3105 If error persists contact Integra E3051 Sensor board failure caused Remove USB drive from by USB drive that is monitor connected to monitor during startup Turn off Integra Licox PtO2 Monitor and then turn back on After the monitor completes the startup process and displays the Main panel re connect USB drive to monitor see page 75 If error persists contact Integra 90 Chapter 9 Troubleshooting the System Error Codes Cause Recommendation E0012 E1002 E1003 E1004 E1008 E1032 E1033 E1041 E1042 E1044 E1045 E1046 E1047 E1050 E1057 E1061 E1101 E1103 E1104 E1105 Power board failure e Turn off Integra Licox PtO2 Monitor and then turn back on e If error persists contact Integra E0013 General software error Turn off Integra Licox PtO2 Monitor and then turn back on e If error persists contact Integra E0015 Incompatible firmware error e Turn off Integra Licox PtO2 Monitor and then turn back on e If error persists contact Integra E0019 Calibration self test failure Turn off Integra Licox PtO2 Monitor and then turn back on e If erro
9. PtO2 Monitor Refer all servicing to qualified service personnel at Integra Warning No modification of the Integra Licox PtO2 Monitor is allowed About Annual Maintenance The Integra Licox PtO2 Monitor requires annual maintenance to be performed by Integra at their service center to ensure proper function and calibration of the monitor During this process Integra will also replace the battery with a new one if necessary e To determine the next due date for annual maintenance see the label aan that appears on the rear panel NEXTSCHEDULED MAINTENANCE DUE e To schedule the Integra Licox PtO2 Monitor for annual maintenance contact Integra 72903759 Rev1 Chapter 11 Contacting Integra for Technical Support and Annual Maintenance 105 This page is intentionally left blank 106 Chapter 11 Contacting Integra for Technical Support and Annual Maintenance APPENDIX A TECHNICAL SPECIFICATIONS List of Technical Specifications cccceecesssceesneeeeeeesesseeeeeneeeeeseeeeeneees 107 Classifications and Standards c cccceseecescecececsesssseessseeenseeeeeeeeeeeseees 109 Manufacturer s Declaration Table c ccccssseeeeeececsssseeeseneenseeesseenaes 110 List of Technical Specifications The following table lists the technical specifications for the Integra Licox PtO2 Monitor Item Specification Monitor Type Integra Licox PtO2 Monitor
10. Step 3 Prepare the AC Power Adapter with Region Specific Plug 1 Remove the AC power adapter from the package and attach the region specific adapter plug to the backside of the AC power adapter UK Europe Australia Region Specific Adapter Plugs Backside of AC power adapter Chapter 2 Setting Up System for the First Time 17 A Align the two slots on the adapter plug over the two prongs on the AC power adapter Tv Slots on adapter plug Prongs on AC power adapter B Push the adapter plug down over the two prongs until the entire base of the plug sits flush against the AC power adapter C Gently slide the adapter plug forward until it snaps into place gt 2 To remove the adapter plug press the release button on the AC power adapter and pull the plug away from the adapter Press the release button to remove adapter plug 18 Chapter 2 Setting Up System for the First Time Step 4 Plug the Monitor to AC Power Perform the following steps with the Integra supplied AC power adapter 1 Place the monitor on a flat surface 2 Connect the AC power adapter to the Integra Licox PtO2 Monitor A On the back of the monitor attach the red connector end of the AC power adapter into the red port labeled Input 18 V Connector end of AC power adapter B Insert the plug end of the AC power adapter into an AC wall outlet 3 Turn on the monitor On
11. Symbol Definition Active alarm AC power not being used available Audio paused Inactive alarm Battery charge indicator No battery connected or faulty battery wd Low PtO2 alarm limit S 2 8 Battery being charged T AC power being used System information panel On Off power vi e List of Symbols and Abbreviations List of Abbreviations Abbreviation Definition ul Microliters ABP Arterial Blood Pressure AC Alternating Current C Degrees Celsius CPP Cerebral Perfusion Pressure CSV Comma separated values CT Computer tomography dB Decibels DC Direct Current DMM Digital Multimeter EtO Ethylene oxide F Degrees Fahrenheit hPa Hectopascal pressure unit IFU Instructions for use IPA Isopropyl alcohol IV Intravenous LED Light Emmitting Diode mm Millimeters mmHg Millimeters of mercury MR Magnetic resonance OR Operating Room PMIO Patient Monitor Input Output PtO2 Partial pressure of oxygen in tissue TBI Traumatic Brain Injury USB Universal Serial Bus V Volt W Watt List of Symbols and Abbreviations vii This page is intentionally left blank viii e List of Symbols and Abbreviations CHAPTER 1 SYSTEM OVERVIEW Indications for Use Intended USC ccccssseeecesseeeeeeeenseeeneeeenseeeeeenseeenenens 1 ContralndiCation ossea betes ecient ceed
12. Tullamore County Offaly Ireland Distributed by Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro NJ 08536 USA Tel 1 800 654 2873 USA only 1 609 275 0500 Fax 1 609 275 5363 Internet Address http www integralife com Made in Ireland Printed in Ireland This page is intentionally left blank TABLE OF CONTENTS List of Symbols and Abbreviations Packaging and Label SyMbols ccccccececeeceeeeeeeeeeeeeeeeeeeceaaeeeceeeeecaaeeseeeeeeecaaesdeeeeesaeeeseneeesiaaeeeeeeesaas v Sofware Sy NOE m r ara aa rer aa rataan an aaae a Ara da aTe ar ana Aa aana a tebe anaa a AT EERTSE vi USTO ADOS VINOS sesasi an E ENAT E AAE EA TTE ANAA NE vii Chapter 1 System Overview dications for Use y Intended Use wuic s5 ncvns ish airs edie nel eli Aves 1 COMPAINGIGATIONS e aaaea i tai stecatapa teens capessiaa R AAA aE S Ee Aa R A aavasee 1 lintend d User Saen i aidia a ek Ae ae eee 1 Intended Patent Population scenie aa a a a ebb a R 2 Description of the Integra Licox PtO2 Monitor sesssseesssesssesssiesiirssrrnsrnnstrnsttnnstnnntnnnstnnstnnnssrnssrnnnsrnnsnns 2 Key Functions of Montois naan aae a ia i i a 2 Reviewing the Users Manual ares stastia a A aS N EAA REAA EEEE AA nin elias 3 List of Warnings for Using the Monitor sseasssssesessrnnesssnrneesrennnesrnnnnnnstnnnnennnnnnnnntnunnnuntnnnnnnnnannnnnnnnennnenne 3 Risks to Patient oeron id i i li eens Hee a iaaiiai i cee 5 General Risks to
13. dry the unit thoroughly and send to biomed staff for evaluation before reapplying power Notice All probe cables must be sterilized whenever they are to be used in the sterile field Prior to sterilization clean the probe cables using the guidelines listed on page 79 Limits on Sterilization Each of the following probe cables and probe extension cables may be sterilized ten 10 times Notice The Y Adapter cable for the blue combined PtO2 temperature probe cable BC10 PMO cannot be sterilized e Blue PtO2 probe cable BC10PA e Green temperature probe cable BC10TA e Blue PtO2 probe extension cable BC10PV e Green temperature probe extension cable BC10TV e Blue combined PtO2 temperature probe cable PMOCAB Do not use the cables after reaching these this reprocessing limit For tracking purposes use the Reprocessing Record Sheets supplied with your cables Sterilization Parameters Each probe cable and probe extension cable supports steam sterilization only Prior to sterilization the cables should be packaged individually in a self sealing pouch with dimensions 7 5 x 13 or larger Steam Pre Vacuum Sterilization Parameters Option 1 US Option 2 EU Option 3 EU Parameters Specifications Parameters Specifications Parameters Specifications Temperature 132 C 270 F Temperature 134 C to 137 C Temperature 134 C 273 F 273 F to 279 F Exposure Time 4
14. low e Flashes the battery symbol in yellow on the status bar These audible and visual alarms indicate that the battery has approximately 5 minutes or less of remaining charge before the monitor shuts off If problems with the low battery alarm persist contact Integra Run the Integra Licox PtO2 Monitor on battery power until the remaining battery charge is depleted Note the when the battery power falls to approximately 5 minutes or less of remaining charge the monitor will activate an audible alarm After the alarm sounds for approximately 5 minutes the monitor will automatically shut down Plug the monitor into an AC adapter outlet to start re charging the battery Press the power button to turn on the monitor On the touch screen verify that the battery power symbol that appears on the status bar displays the electrical charge symbol Press the power button again to turn off the monitor Continue charging the battery to full capacity The time for re charging the battery while the monitor is turned off will take less than 5 hours Notice If the battery takes more than 5 hours to charge to full capacity try replacing the battery with a new one To order a battery contact Integra 5 Once the battery reaches full charge the battery power symbol will display four green bars qi Unplug the monitor and run it on battery power only and verify that the battery charge lasts a minimum of 1 hour and 30 minutes If the bat
15. AENA TEN a ANE 94 Testing Accuracy of PtO2 Measurement c cccceeceeeeeeeeeeeeeeeeeeeeseaaeeeeeeeeeseaeeeeeaeeeeeeeesenaeetee 94 Testing Pressure OutQUt cceceeeeesceeceneeeeeeeeeeeaeeeeeaaeeceaeeeeaeeeeeaeeseeaaeeeaeeeeeaaeeseeaeesseaaesseeeeesaeseenneeees 95 Testing Temperature Input and Output eee eceeee cece eee caeeeeeeeeecaaaeeeeeeeeecaaeeseceeeeseaaeseeneeeesiaeeeeeneeees 96 Testing Low PtO2 Alarm Limitearen innsetning aaaea a arada Aaa aea aag ARE te abel 99 Testing AC Power and Battery Charge ccccceeeceeeeeeeeneeeeeeeeeceaaeeeceeeeesaaeeeeeeeeesaeeeseeeesesaeeeseeeeeaes 100 AG POWer iohanni iea Nae a ae a Gan ds a ENa NaN aaa 100 Low Battery SiM aeei EER E A a a A 100 Battery Gharger naunan a e aa E E cee aT RETE 101 Inserting A New Battery eccnecrnieniini iorra NENE Eea NE Na CE Er NEE ENA 102 Determining Software Versio Nemse riean a aa n aara aa aaa aa a n raa aa aan aeieea sets 103 Testing Synchronizing to Patient Bedside Monitor ccccceceeeeeeeeeeeeeeeaeeeeeeeeeceaeeeseaeeesecaeeeeeaeeeeaas 103 Chapter 11 Contacting Integra for Technical Support and Annual Maintenance About Technical SUP OTE e a a e aetna bia aed aa Eaa a a eed E a 105 About Annual Maintenance 2 c cececceeceeeeeeeeeeeeeeeaaeaaeeeeceeeeeeeeaaeaaaaeaesaeceeeeeeeeeseseceaceaaeeeeeeeeess 105 Appendix A Technical Specifications List of Technical Specifications seeiis nai naaa aa a aa aeaa eee eta a
16. BEWAREN VOOR GEBRUIK BEWAREN VOOR GEBRUIK Smart Card Front Smart Card Back Probe Serial KEEP FOR USE GUARDAR PARA SU USO A CONSERVER Chapter 4 Setting Up System for Clinical Use 31 Warning N Only use the designated Smart Card supplied with the PtO2 probe Using the wrong Smart Card will produce incorrect PtO2 measurements When using the Smart Card note the following guidelines e Do not discard PtO2 probe packaging before removing the Smart Card Each Smart Card contains calibration data specific to that probe e Inserting a new Smart Card during the recording of trend data will reset the trend data e Only use the Smart Card supplied with the PtO2 probe For verification cross check the probe serial number SN that appears on the Serial Number SN i following items to ensure they match on probe s label e Probe s packaging e Probe s label e Back of Smart Card and the D e Probe field that appears on the touch screen after the Smart Card in inserted into the monitor The Integra Licox PtO2 Monitor also includes a test Smart Card and test probe for use when testing the calibration of system For instructions see page 94 32 Chapter 4 Setting Up System for Clinical Use Connecting a Single PtO2 Probe Connecting a single PtO2 probe to the Integra Licox PtO2 Monitor requires the following components Measurements Components PtO2 e Single PtO2 pr
17. Card CC1P1 e Y adapter cable for combined PtO2 temperature BCioPMO probe cable e Blue PtO2 temperature probe cable PMOCAB When using both probes the Integra Licox PtO2 Monitor measures the tissue temperature compensation for the PtO2 calculations automatically Notice If you are measuring temperature compensation with a probe do not touch the connector on the probe cable for a prolonged period of time prior to connecting it to the Temperature port on the Integra Licox PtO2 Monitor Touching this connector may affect the initial temperature compensation readings If this temperature fluctuation occurs the PtO2 measurements will be unreliable Step 1 Connect the Y Adapter Cable BC10PMO to the Monitor 1 On the monitor s right side connect the blue and green ends of Y adapter cable into the following ports e Connect the blue end into the blue port labeled PtO2 e Connect the green end into the green port labeled Temperature PtO2 port Temperature port Y adapter cable BC10PMO 2 When connecting verify each probe cable snaps into place 42 Chapter 4 Setting Up System for Clinical Use Step 2 Connect the Y Adapter Cable BC10PMO to the Combined PtO2 Temperature Probe Cable PMOCAB 1 Connect the blue single end of the Y adapter cable to the blue combined PtO2 temperature probe cable 2 When connecting verify the single end of the Y adapter cable snap into place Y adapter
18. Chapter 2 Setting Up System for the First Time 15 Measurements Content Item Combined PtO2 and Temperature e Blue combined PtO2 temperature probe cable length 2 2m REF PMOCAB Quantity 1 For use with combined PtO2 temperature probes Y adapter cable for blue combined PtO2 temperature probe cable length 0 3 m REF BC10PMO Quantity 1 For use with combined PtO2 temperature probes After unpacking the contents inspect the shipment for any signs of damage or loss If any damages are discovered notify the carrier the supplier and retain all shipping cartons for examination Step 2 Install the Battery Perform the following steps with a Phillips screwdriver and the Integra supplied 14 4 V lithium ion battery 1 Make sure the monitor is unplugged and turned off 2 Turn the monitor upside down so the handle is facing downward 3 Remove the two screws to take off the battery cover 16 Chapter 2 Setting Up System for the First Time 4 Verify the Integra logo on the battery is facing up and insert the battery A Align the battery s connector on the front of the battery to the connector slots on the monitor INTEGRA Lame B Slide the battery s connector into the monitor s connector slots until the battery is fully inserted into place cP INTEGRA elie 5 Secure the battery cover to the monitor by re inserting the two small screws
19. Customer agrees that notwithstanding the technical assistance provided pursuant to the Warranty by Integra or its representatives Customer shall be fully responsible for all treatments performed or attempted with the Equipment INTEGRA MAKES NO REPRESENTATION OR WARRANTY AS TO THE EFFICACY OF THE EQUIPMENT OR OF THE TECHNICAL ASSISTANCE TO BE RENDERED BY INTEGRA ITS AFFILIATES ASSIGNEES OR SERVICE AGENTS FOR PURPOSES OF THE PARTICULAR TREATMENT THAT CUSTOMER UNDERTAKES TO PERFORM FOR THIRD PARTIES Moreover Customer shall not make any claim against Integra or any of its affiliates assignees or representatives with respect to the efficacy of the Equipment or of said technical assistance or with respect to any claims by third parties related to any treatment undertaken by Customer Force Majeure Notwithstanding anything to the contrary herein contained if the performance of the Warranty by Integra or Customer or any obligation of Integra or Customer hereunder is prevented restricted or interfered with by Appendix B Integra Warranty 117 reason of fire explosion act of God labor disputes or accidents affecting performance under the Warranty or war mobilization civil commotions blockade or embargo or any future law regulation ordinance or requirement of any government or regulatory agency or any other act whatsoever similar to those above enumerated or any other circumstance being beyond the reasonable control of Integra or Cus
20. DISTRIBUTORS DISCLAIM ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR OF FITNESS FORA PARTICULAR PURPOSE AND ANY IMPLIED WARRANTY ARISING FROM COURSE OF PERFORMANCE COURSE OF DEALING USAGE OR TRADE OR OTHERWISE OR APPLICATION OR WARRANTY OF QUALITY AS WELL AS ANY EXPRESS OR IMPLIED WARRANTY TO PATIENTS No warranty or guarantee may be created by any act or statement nor may this Standard Warranty be modified in any way except as a result of a writing signed by an officer of INTEGRA These limitations on the creation or modification of this warranty may not be waived or modified orally or by any conduct 2 Service Repairs and Replacement 2 1 2 2 2 3 3 Repair Parts and Services 3 1 Service and Repairs All service and repairs covered by this Warranty may be referred to hereinafter as in warranty repairs and all service and repairs not covered by this Warranty may be referred to as out of warranty repairs Customer shall be responsible to pay Integra s then standard charges for any out of warranty repairs performed by Integra Integra s sole obligation for Equipment defects and failures of performance shall be to make all necessary adjustments and repairs in accordance with this Warranty Equipment Replacement The defective Equipment or part thereof that is replaced in accordance with the Warranty shall be the property of Integra Integra reser
21. Extension Cables 0 cccccccccessssceeeeeeesneeeeeeessneeeeeessnseeeeenens 81 Limits OnStenliZati Ones satis Gerd Lanedse ita is es a AN Medi ted Lae Mein added 81 Sterilization Parameters citecccecd seretaceed anatevest satelevcicastacecttaghs canseed ad leveenaattabvons ghatancedeanmaaneedaetecueread 81 Following Sterilization of Probe Cables and Probe Extension Cables c cscccccssssseeeeeeeenaes 82 About Single Use Only Probes 0 cccccceeeseeeeeceeeeeenee cece eeeeaeeeeaeeeeeaaeeeeaeeseaaaeseceeeeseaaeeseeeeeesiaeesseneeess 82 Disposal of the Monitor System and Components ccccecceceeceeeeeeeeeeeeeseeeeeeeaaeeseeeeeeaeeeseeeeeeaeeees 82 Chapter 9 Troubleshooting the System About the Troubleshooting Process ccceceeeeeceeeeeeeeeeeeeeeeeeeee eee eeeeaaeeeeeeeaaeeeeeeeeaaeeeeeeeaaaeeeenseaeeeeneaaes 83 Responding to System Status Messages cccceeeceeeeeeceeeceeeeeeceaaeeeeaeeeseaaeeeeeeeeeseaeeeseaeesecaeessnaaeessaees 83 Responding to Problems During USC ccc cceeeeceeeeeeeeeneeeeeeeaaeeeeeeeaaaeeeeeeeaaeeeeeesaaaeeeeeeeaaaeeeeeeeaeeeeenaaes 85 Responding to System Failure Messages ccccceeeseeececeeeeeeeeeceaeeeeseeeeeceaeeeeeaaeescaeeessaaeeseeneeeseaaeeeeaees 90 Chapter 10 Testing and Preventive Maintenance About These Procedures erion o toebidiesd ohana scan anaadasia obagastseh begaduachemeadestacebadeasdens 93 Testing Pressure IMput 02 2 c s4c0is eee
22. Monitor This applies in particular to probes probe cables battery AC power adapter and USB to RS232 adapter cable Content Description Integra Licox PtO2 Monitor Quantity 1 AC power adapter 18 V DC 1 67 A 30 W REF MONPWR Quantity 1 14 4 V lithium ion battery REF BAT1001 Quantity 1 Chapter 2 Setting Up System for the First Time 13 Content Description Integra PMIO patient bedside monitor cable REF PMIOMPM Quantity 1 USB to RS232 adapter cable REF EXPORTCAB Quantity 1 Test Set test Smart Card test probe REF BC10R Quantity 1 e User manual e REF UM LCXO2XX where XX refers to the country s language code e Quantity 1 14 Chapter 2 Setting Up System for the First Time List of Probe Cables The kit also includes the following probe cables included in the Probe Cable Kit BC10 Measurements Content Item PtO2 Only Blue PtO2 probe cable length 2 3m REF BC10PA Quantity 1 For use with single PtO2 probes Blue PtO2 probe extension cable length 1 6 m REF BC10PV Quantity 1 For use with single PtO2 probes Temperature Only Green temperature probe cable length 2 3 m REF BC1OTA Quantity 1 For use with single temperature probes Green temperature probe extension cable length 1 6 m REF BC1IOTV Quantity 1 For use with single temperature probes
23. Patients ostian eenaa Eas Na EEA ANR raana led thal cabelas aAA nee the 5 Special Coagulation Problems cccccecscceceeeeeeeeeeceaeeeeeeeeeeeaeeeeseeeeseaaeseseaeeeseaeeeseeaeesecaeeeseaeeeeeas 5 Risk of Invasive Monitorning crs censnidonorianien ia i i i ra a 5 ROLANI E TASEA TE E EA E EA AE E AS 6 Parts ofthe MON O aara pa naaa a ra a ra A aa bade aaa rOn a aa aa aee Aa dalanadi adada ea 7 About t he Front Panel esgid eieiei iddaa iiia eee 7 About the Rear Panel i e a a ar aaa eect aaa a Geeta belie aroa taati 8 Apor me RINE Fane henee aE E A E Ea EARE ARSA 9 Abo tthe Bottom Panel 2 wicecwii ngs cin lene eve cone Ae ene ee 10 Aboutithe Lett Pamelics sc tccvistieccits a e a aw aa nts a e aaa at ae eta a taaa an anaran tadaa 11 Chapter 2 Setting Up System for the First Time Procedures for Initial SetU riiisiare sari aaien aaa aE ia aa aaae 13 Chapter 3 About the PtO2 Measurements Relationship Between Oxygen Pressure and Oxygen Content cccccssccceessssseeeeeeseseeeesesssaeeeeeseeaaes 21 PtO2 A Measure of Cellular Oxygen Availability 0 ccccccceeeceeeeceeeeeeeeeeeecaeeeeaaeeesaeeeeeaeeesncaeeeeeneeees 21 Temperature Effect ei a o a eek teers eh cea AA era AE S eter ead seul a ey 21 Microtrauma Caused from Probe INSertion ccccceeceeeeeeeeeeeeceeeeeeeaeeeceeeeecaaeeeeeeeeeseaeeeseaeeeseaeesseeeeeeaees 22 Effects of Microtrauma on PtO2 Measurement 0 c ccccceececcsesceeeeeeceseeaeeueeeeee
24. Temperature C manuel Controls for specifying temperature measurements 3 manually P Manual Temperature mput By default this value is set to 37 C For instructions on setting the temperature manually see page 35 Monitoring Trend Data Press the Trend tab to view a graph of recorded PtO2 trend data in mmHg at one minute intervals The Integra Licox PtO2 Monitor stores up to five days of trend data that may be viewed in specific ranges of time This data may also be extracted from the monitor to other media types by either USB transfer or by digital streaming For instructions on extracting data see Chapter 7 Synchronize to Main Monitor Extract Data Data Strearang 58 Chapter 5 Monitoring the Patient s PtO2 and Temperature The information on this panel includes Items Description 1 Extract Data Copies the patient s trend data to a USB drive that has been connected to the USB port on the rear of the monitor see page 75 2 Data Streaming Enabled Indicates that the feature for streaming patient trend data digitally to another media type has been activated This feature requires the use of the USB to RS232 adapter cable see page 77 3 PtO2 Scale Specifies the range of the PtO2 values displayed on the Trend graph see page 60 4 Time Scale Specifies the range of time displayed on the Trend graph page 60 5 Displays graph of PtO2 versus time 6 Displays the low
25. accuracy ranges for the 3 minutes the alarm will reactivate Responding to Battery Failure Alarm If the battery control system inside the Integra Licox PtO2 Monitor fails during the use of the monitor the monitor will no longer be able to report the amount of remaining charge that battery has If this problem occurs the monitor will activate a low priority technical alarm that will e Sound an alarm containing a burst of one single pulse every 16 seconds e Battery power symbol on the touch screen will appear crossed out e Displays the following message on the status bar Battery Failure If this battery failure alarm activates do not run the monitor on battery power If necessary plug the monitor into an AC outlet to maintain power After patient treatment try the following e Turn off the monitor and then turn it back on e Replace the battery If this alarm condition persists contact Integra for service Silencing the Battery Failure Alarm Temporarily Press the yellow alarm symbol on the touch screen This will silence the alarm for 3 minutes If the monitor remains on for 3 minutes while there is still a reported battery failure the alarm will reactivate 74 Chapter 6 e Responding to Physiological and Technical Alarms CHAPTER 7 EXTRACTING TREND DATA FOR REMOTE EVALUATION About Data Extraction E chece ces custeh evel Mech E T eeu Ace hte tee te 75 Extracting Data to USB Drive s cccsseeeeeeeeeeeseeese
26. adapter must be returned to Integra for disposal or disposed according to the hospital recommended procedure The devices must be clean and free from blood or other biological contaminants when returned for disposal Please contact Integra for further details 82 Chapter 8 Cleaning and Sterilizing the System CHAPTER 9 TROUBLESHOOTING THE SYSTEM About the Troubleshooting Process cccceceseecceeeeseeeeseeeesneeeseeeeeeneeseeeeeenes 83 Responding to System Status MeSSages ccccessseeeeesessceneeeeescenees 83 Responding to Problems During US6 ecccseeeeeeeesseeeeeeeeseeneeeeenseeeenes 85 Responding to System Failure Messages cccssssecneeessseeeneeseeeeeees 90 About the Troubleshooting Process This chapter provides guidelines for responding to technical errors system failures and system messages that appear on the touch screen For instructions on responding to alarms see Chapter 6 Responding to System Status Messages The following table lists each error message alphabetically that appears on the touch screen System Message Cause Recommendation Battery failure Battery s control system has failed e Plug Integra Licox PtO2 Monitor into AC power outlet see page 27 After patient treatment turn off Integra Licox PtO2 Monitor and then turn back on Replace the battery see page 102 If problem persists contact Integra B
27. and Responding to Technical Alarms on page 71 Priorities of Physiological and Technical Alarms The Integra Licox PtO2 Monitor includes one medium priority physiological alarm that gets activated if a patient s low PtO2 value falls below the user specified limit for more than 5 seconds there are no other physiological alarms If two or more error conditions occur simultaneously that can activate a physiological alarm and a technical alarm the physiological alarm will always take precedence unless the technical alarm is caused by an irreversible system failure which results in the monitor being unusable see page 71 for details The remaining technical alarms will only become announced after the physiological alarm is resolved How the Monitor Prioritizes Between Two Technical Alarms If two or more error conditions of the same clinical priority occur simultaneously that can activate different technical alarms the Integra Licox PtO2 Monitor prioritizes which alarm it activates based on how the alarm condition affects the safety of the patient or stability of the equipment Note that a technical alarm with a higher priority will always be activated over a technical alarm with a lower priority a lower priority alarm will not be announced until the higher priority alarm is resolved Chapter 6 Responding to Physiological and Technical Alarms 69 List of Priorities for Each Alarm Notice If any of the software firmware or elect
28. cable Combined PtO2 Temperature probe cable BC10PMO PMOCAB Step 3 Insert the PtO2 Probe s Smart Card into the Monitor 1 Remove the single PtO2 probe and accompanying Smart Card from its packaging 2 Onthe monitor s right side insert the Smart Card into the Smart Card slot by aligning the arrow on the card with the arrow on the label Smart Card Smart Card inserted into slot Chapter 4 Setting Up System for Clinical Use 43 3 When inserting the Smart Card verify the card is positioned securely into its slot This will activate a temporary alarm and display the following message No temperature probe detected Use Marua Temperature input 4 Press Accept Notice After pressing Accept the monitor will trigger an alarm that indicates the Smart Card is measuring a PtO2 value of zero which is lower than the PtO2 Alarm Limit value specified on the Alarm tab This alarm will be silenced in the following step 5 Silence the alarm by pressing the flashing alarm symbol Es Step 4 Connect the PtO2 Temperature Probe to the PtO2 Temperature Probe Cable Depending on hospital protocol you may either insert the combined PtO2 temperature probe into the patient before see Option 1 or after see Option 2 connecting it to the monitor Options Procedure 1 A Insert the combined PtO2 temperature probe into the patient For instructions see the instructions for use supplied with
29. closed at all times during use of the monitor Notice If the monitor is not used the battery will lose charge Always make sure the battery is charged to full capacity prior to use The Integra Licox PtO2 Monitor will charge the battery while the monitor is plugged into AC power 102 Chapter 10 Testing and Preventive Maintenance Determining Software Version On the touch screen press the Settings tab and select the information symbol and verify the software version Testing Synchronizing to Patient Bedside Monitor Perform the procedures for synchronizing the Integra Licox PtO2 Monitor to a patient bedside monitor on page 48 Chapter 10 Testing and Preventive Maintenance 103 This page is intentionally left blank 104 Chapter 10 Testing and Preventive Maintenance CHAPTER 11 CONTACTING INTEGRA FOR TECHNICAL SUPPORT AND ANNUAL MAINTENANCE About Technical Support If the Integra Licox PtO2 Monitor fails to perform as specified and the cause cannot be determined do not use or attempt to repair it Instead contact Integra for technical service Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro NJ 08536 USA Tel 1 800 654 2873 USA only 1 609 275 0500 Fax 1 609 275 5363 For service and repairs outside the United States contact your local authorized Integra representative Warning To reduce the risk of electric shock do not disassemble the Integra Licox
30. minutes Exposure Time 3 minutes Exposure Time 18 minutes Dry Cycle Time 20 minutes Dry Cycle Time 16 minutes Dry Cycle Time 20 minutes Chapter 8 Cleaning and Sterilizing the System 81 The Option 2 and Option 3 sterilization cycles are not considered by the United States Food and Drug Administration US FDA to be standard sterilization cycles Users should only use sterilizers and accessories such as sterilization wraps sterilization pouches chemical indicators biological indicators and sterilization containers that have been cleared by the US FDA for the selected sterilization cycle specifications time and temperature Following Sterilization of Probe Cables and Probe Extension Cables Allow the cables to cool down to ambient temperature before starting the monitoring process Before each use visually inspect the sterilized cables for any possible defects and check the functionality of the cables by performing checks as described on page 94 Do not use defective cables About Single Use Only Probes Integra probes are intended for single use only Reuse of the device can result in contamination and or disease transmission This product should not be resterilized Resterilization may affect the performance characteristics and the safety of the device Disposal of the Monitor System and Components Unless stipulated otherwise in the sales contract the end of life Integra Licox PtO2 Monitor cables and AC power
31. of the transmitter Recommended separation distance Conducted RF 3Vrms 3 Vrms d 1 17 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3V m d 1 17 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 33 P 800 MHz to 2 5 GHz 80 MHz to 95 MHz 110 MHz to 2 5 GHz 3 V m where Pis the maximum output power rating of the transmitter in watts W according to the 95 to 110 MHz 1 8 V m transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range gt Interference may occur in the vicinity of equipment marked with the following symbol Ko NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Integra Licox PtO2 Monitor is used e
32. remains on for 3 minutes while there is still a cooling fan error condition the alarm will reactivate Responding to Accuracy Range Alarm The Integra Licox PtO2 Monitor is designed to provide accurate measurements of PtO2 and tissue temperature between specific clinical ranges Measurements Range PtO2 Between 0 mmHg to 150 mmHg that include the following levels of accuracy e 0 20 mmHg 2 mmHg e 21 50 mmHg 10 e 51 150 mmHg 13 Temperature Between 30 C to 42 C 1 C Chapter 6 Responding to Physiological and Technical Alarms 73 If the measured PtO2 or tissue temperature falls outside these ranges the monitor will activate a low priority alarm that will e Sound an alarm containing a burst of one single pulse every 16 seconds e Display one of the following messages on the status bar PtO2 is out of accuracy range or Temperature is out of accuracy range e Display the current PtO2 or temperature value in yellow on the Main Trend and Alarm screens To resolve this problem the PtO2 or tissue temperature must fall within the rated accuracy ranges listed in the above table Silencing the PtO2 and Temperature Accuracy Range Alarm Temporarily Press the yellow alarm symbol on the touch screen This will silence the alarm for 3 minutes while the PtO2 or temperature values fall back within the rated accuracy ranges displayed in the above table If the PtO2 or temperature values remain outside the rated
33. sure that the battery cover is closed securely during monitor use 4 Chapter 1 System Overview Warnings e The Integra Licox PtO2 Monitor will only store the PtO2 data from the most recent 5 days All stored trend data older than 5 days will be lost If monitoring is continued for more than 5 days placement of a new PtO2 probe and Smart Card under sterile conditions is recommended Note that replacing a probe and Smart Card with a new probe and Smart Card will reset the trend data Please extract any data that you wish to retain prior to replacing the probe and Smart Card Do not autoclave or immerse the Integra Licox PtO2 Monitor in liquid as damage may occur If the monitor is exposed to liquids turn off the unit remove the AC power adapter remove the battery dry the unit thoroughly and send to biomed staff for evaluation before reapplying power Only use the cleaning agents listed in Chapter 8 for cleaning and disinfecting the Integra Licox PtO2 Monitor system Using solvents or cleaning agents not listed in Chapter 8 may damage the plastic exterior of the Integra Licox PtO2 Monitor Risks to Patients General Risks to Patients Integra Licox products are intended for use by qualified physicians or surgeons only They must ensure sterile technique and general surgical precautions when penetrating human tissue Contraindications for needle insertion into the body also apply e g coagulopathy and or susceptibility to inf
34. temperature compensation tissue contraindications 1 cooling fan failure alarm responding to 72 73 D date and time setting for first time 19 specifying current 65 definitions of abbreviations vii digital streaming trend data 77 disabling low PtO2 limit alarm 63 disinfection methods recommended 80 disposal monitor 82 E error codes list of 90 error messages list of 83 85 Extract Log button 66 F fan failure alarm responding to 72 G GUI symbols vi H halothane risks of 6 l icons list of software vi inactive alarm symbol 68 infections risks of 5 intended patients 2 intended use and indications for use 1 intended user 1 L label symbols v languages selecting 65 setting up for first time use 20 log files extracting 66 losing trend data 77 Index 119 low battery responding to alarm for 72 testing 100 low priority alarms 69 low PtO2 alarm limit testing 99 M maintenance annual 105 Manual Temperature Input controls for 35 medium priority alarms 69 microtrauma effects on PtO2 measurements 22 monitor about the 2 O On and Off turning low PtO2 alarms 62 64 turning monitor 27 28 overheating monitor responding to 72 oxygen cellular availability 21 pressure and content 21 P package symbols v parts of monitor bottom panel 10 front panel 7 left panel 11 rear panel 8 right panel 9 patient bedside monitor connecting to 48 51 patient population intended 2 physio
35. the defined range of 15 C to 30 C 6 Chapter 1 System Overview Parts of the Monitor The Integra Licox PtO2 Monitor contains hardware software and electrical components that support specific Integra probes for monitoring the patient s PtO2 and temperature values The following section provides information on the different parts of the monitor About the Front Panel The front panel contains Number Item Description 1 Handle 2 AC Power Indicator 3 Power Button 4 Touch Screen Handle used for carrying the monitor Green LED that indicates the monitor is being powered by the AC power adapter Note that this button does not illuminate if the monitor is being powered by the battery Turns the monitor on and off Note that this button will illuminate if the monitor is turned on Provides software tools for viewing data and controlling parameters for monitoring the patient s PtO2 and tissue temperature levels Chapter 1 System Overview 7 About the Rear Panel The rear panel contains Number Item Description 1 USB Port 2 AC Power Adapter Port 3 PMIO Port 4 Pole Clamp 5 Air Vent 6 Cable Strap Connection port for extracting trend data via USB transfer or digital streaming Connection port for the AC power cord Connection port for PMIO cable This cable is used to connect the Integra Licox PtO2 Monitor to a patient monitor Clamping system for securi
36. the front of the monitor press the power button the Integra Licox PtO2 Monitor will display the Integra logo before initiating the monitor startup process 4 After the initial setup process completes the Integra Licox PtO2 Monitor sounds a one second startup tone and displays the Main panel on the touch screen The purpose of the startup tone verifies that the audio alarms are functioning correctly If this tone does not sound during the startup process contact Integra for service Step 5 Set the Time and Date The Integra Licox PtO2 Monitor provides tools for setting the current time and date that appears on the touch screen To set this information 1 On the touch screen press the Settings tab Synchronize to onitor Settings Time and Date Chapter 2 Setting Up System for the First Time 19 2 Press the Set Time and Date button 3 On the displayed panel press the desired field hour minutes date month or year and use the arrows to specify the appropriate setting Note that you may adjust each of these settings prior to accepting them in the following step 4 Press Accept the Integra Licox PtO2 Monitor will display the selected time date on the touch screen Step 6 Specify the Language 1 Onthe touch screen press the Settings tab fourth tab from the left 2 Press Set Language Set Language button 3 Inthe displayed Language menu use the arrows to select the desired language
37. with an accuracy of 1 C e Use of touch screen controls for specifying temperature values manually Depending on which option is being used the monitor s touch screen will display the temperature value as either continuous measurements Temperature 1 C or user specified measurements Temperature C manual Display of Continuous Temperature Measurements with Temperature Probes If a single Licox temperature probe or combined PtO2 temperature probe is connected to the Temperature connector the Integra Licox PtO2 Monitor will measure the patient s tissue temperature continuously with an accuracy of 1 C display the temperature value on the touch screen and apply this value to the calculation for PtO2 measurements Reporting of continuous temperature measurements from use of temperature probe Synchronize to Settings aitia Monitor Temperature 1 C 37 2 For instructions on connecting these probes see page 37 and page 42 Chapter 5 Monitoring the Patient s PtO2 and Temperature 57 Display of Manual Temperature Measurements If a single PtO2 probe is connected to the monitor without a separate temperature probe the Integra Licox PtO2 Monitor activates the Manual Temperature Input control for specifying tissue temperature values between 30 C and 42 C The specified value will be applied as temperature compensation to the calculation for PtO2 measurements Synchronize to Monitor Settings
38. 0 19 to 21 Effects of Tissue Microtrauma on PtO2 Measurements Immediately after inserting the PtO2 probe the PtO2 readings are influenced by evolving microtrauma When this occurs tissue is affected in a region concentrically surrounding the probe This normally applies to the first 20 minutes to 2 hours after insertion During this phase the PtO2 values may not display optimal information about tissue oxygenation Using the Battery for Power The Integra Licox PtO2 Monitor includes a rechargeable 14 4 V lithium ion battery that supplies power to the monitor for at least 1 5 hours when the battery is fully charged the battery is only intended for use during patient transport e To charge the battery to full capacity turn off the monitor and plug it into an AC outlet for at least 5 hours prior to use e To ensure the battery maintains charge during patient use always plug the monitor to an AC outlet whenever possible If the battery exhibits problems powering the monitor for 1 5 hours perform the Battery Charge test on page 101 to ensure the battery is functioning properly Chapter 4 Setting Up System for Clinical Use 29 Battery Power Indicator On the touch screen a battery power indicator appears in the status qo bar that displays the amount of battery charge available see page 55 e Ifthe battery charge level drops to 15 minutes or less the monitor will activate visual warnings e Ifthe battery c
39. 53 About the Synchronize to Monitor Button ssssssseeesssessseeesssssiesiissrisssrnsssrrnentnntnnstnnnernnsennnennnne 54 Reviewing the Status Bar eiae eine i eine alan Ghee Ae 54 Verifying Status of Battery and AC POWET ccecccceeeseceeeeeeeeeaeeeeeeeeecaeeeseaeeesaeeeeeaaeeseieeeetaeetees 54 Verifying Amount of Battery Charge Available cccccececcececeeeeeeeeeeceaeeeeeneeesaaeeeeaeeesecaeessnaeeeeaas 55 About the Alarms 2 0 G athe tite ie aac i wed eet tS eet ay 55 Monitoring the Patient S PtO2 cccccecceeeseeeeeeeeeeeeeeceaeeeeeaaeeeeeeeeeeaaeeseceeeeseaaeseceeeeesaaeeseeeeeessaeeeseeeesaas 55 How the Monitor Reports PtO2 Values cccceceeeeeeeeeneeceeeeeeceaeeeeeeeeecaaaeseceeeesaaeeeeaeeeseeeeesaeees 56 How the Monitor Applies Tissue Temperature Compensation cccccesccececeeeeeneeeeeteeeteeeeees 56 Monitoring Trond D atten sonic nies enar eng Aa A Shag Hd sence a Ghadbentcnded Fiaeside ated dated 58 Conditions that Reset Trend Data ou cece cccccceececccesceeeececeeeeaeaeeseseeesuueeseceseaeaaeaeseseeaaeaseeesesaeas 61 Setting the Low POZ Alarmi Limit teisseire ae NEE ATA EATE ENE E OAE AA DATAE ATAR EE EE 61 Specifying the Low PtO2 Limit Value cece ccessseceeeeeeeneceeeeceeeeeeeeeseeeeeeeescseeseeesseeeaeeseeseeaeenes 62 Silencing the Low PtO2 Alarm Temporarily cccccccesceceeeeeeeeceeeeeeeeeeeaaeeeeeeeeesaeseeeeeesecaeeesaaeees 63 Customizing the User Set
40. Card that contains calibration data A Only use the designated Smart Card supplied with the PtO2 probe Using the wrong Smart Card will produce incorrect PtO2 measurements Key Functions of Monitor During clinical use the Integra Licox PtO2 Monitor provides several key functions to facilitate the process for monitoring and analyzing patient data e Touch screen interface for evaluating patient data and setting patient parameters see page 53 e Physiological alarm that activates if the patient s PtO2 value falls below a user specified limit for more than 5 seconds see page 55 e Rechargeable lithium ion battery that supplies power to monitor during patient transport see page 29 e Storage of patient s trend data for up to 5 days see page 58 e Outputs for transferring patient data to a patient bedside monitor see page 48 2 Chapter 1 System Overview Outputs for extracting patient data to remote media types via USB drive or digital streaming see page 75 For instructions on using the Integra probes that work with the Integra Licox PtO2 Monitor see the instructions for use supplied with each respective probe Reviewing the User s Manual Integra recommends that all physicians nurses and technicians who will be using operating and maintaining the Integra Licox PtO2 Monitor review this user s manual prior to using the system If there are additional questions after reading this manual contact In
41. Integra USER S MANUAL Licox ROP Monitor Oxygen Partial Pressure and Temperature Monitor for Neurosurgical Applications LCX02 f Synchronize to f f Trend Alarm Settings anar Temperature 1 C 37 2 ai ato pal gas E 7 g Probe 817 44 22 29 June 2012 o ci TTH gt Fi F WP C INTEGRA f INTEGRA A C 0086 Federal USA law restricts this device to sale by or on the order of a physician Publication Name Integra Licox PtO2 Monitor User s Manual for Neurosurgical Applications Integra Part Number 60904052 Rev A Effective Date August 2013 Trademark Acknowledgements Integra the Integra logo and Licox are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and or other countries Sani Cloth is a registered trademark of Professional Disposables International Inc Copyright Information 2013 Integra LifeSciences Corporation All rights reserved No part of this document may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without the expressed written consent of Integra LifeSciences Corporation Additional copies of this document can be ordered from Integra LifeSciences Corporation Manufacturer Integra LifeSciences Ireland Limited IDA Business and Technology Park Sragh
42. Integra Licox PtO2 Monitor the status bar on the bottom of the touch screen will display messages to indicate the current states of alarms probes Smart Cards and AC battery power PtO2 below alarm limit Status bar Verifying Status of Battery and AC Power The Integra Licox PtO2 Monitor may be powered by either AC power or battery charge To determine the status of power for the monitor view the battery and plug symbols that appear on the bottom right of the touch screen Symbol Status Indicates AC power is in use Indicates AC power is not in use available Indicates battery power is being used to power the monitor Each green bar represents the level of remaining battery charge see following section Indicates AC power is being used to charge the battery Indicates that either a battery is not connected or a battery is not functioning properly TEE For instructions on powering the monitor see page 27 1 The accuracy range stated in this description does not include the accuracy of the patient bedside monitor which may vary between manufacturers If drift occurs persistently between the two monitors that exceeds the stated accura cy range contact the biomed department to determine the cause of drift 54 Chapter 5 Monitoring the Patients PtO2 and Temperature Verifying Amount of Battery Charge Available The Integra Licox PtO2 Monitor displays the following symbols on the status bar to indic
43. Note that the pole clamp supports equipment poles between 0 5 and 1 2 inches 12 7 and 30 5 mm in diameter To prevent injury to the patient user or other persons or to prevent damage to the monitor always verify that the monitor is clamped securely to the equipment pole N To prevent liquid from dripping inside the monitor and damaging the internal components do not mount the monitor underneath an IV bag or tube feed If liquid does drip onto the monitor dry the monitor immediately 26 Chapter 4 Setting Up System for Clinical Use Powering the System On and Off Turning On the System A To prevent electrical shock only use the AC power adapter supplied by Integra REF MONPWR Using a different AC power adapter may not provide protection against electric shock 1 Plug the monitor to an AC power outlet A On the back of the monitor attach the red connector end of the AC power cord into the red port labeled Input 18 V Connector end of AC power adapter AC power adapter B Insert the plug end of the AC power adapter into an AC wall outlet 2 Turn on the monitor A On the front of the monitor press the power button B Once the button illuminates the Integra logo will appear on the touch screen for a few seconds before initiating the setup process Power Button 3 After the setup process completes A Listen for aa one second startup tone that verifies the audio alarms are f
44. O2 Monitor press Synchronize to Monitor to re calibrate the two monitors see page 48 Incorrect patient bedside monitor adapter cable is used PMIO cable or patient bedside monitor adapter cable is faulty Verify correct patient bedside monitor cable is being used see page 48 Replace PMIO cable or patient bedside monitor adapter cable see page 48 PMIO cable or patient bedside monitor adapter cable is loose Check cable connections between Integra Licox PtO2 Monitor and patient bedside monitor see page 48 Patient bedside monitor has malfunctioned Refer to manufacturer s troubleshooting guide for the patient bedside monitor Patient bedside monitor is not compatible with the Integra PtO2 monitor e See the patient bedside monitor specifications in Appendix A see page 108 e See the manufacturer s troubleshooting guide for the patient bedside monitor Discrepancy of temperature measurements between the Integra Licox PtO2 Monitor and the patient bedside monitor Incorrect patient bedside monitor adapter cable is used Verify correct patient bedside monitor cable is being used see page 48 PMIO cable or patient bedside monitor adapter cable is faulty Replace PMIO cable or patient bedside monitor adapter cable see page 48 PMIO cable or patient bedside monitor adapter cable is loose Check cable connections between Integra Licox PtO2 Monitor and patient b
45. PtO2 alarm limit value will be restored To restore the low PtO2 alarm limit from a customized setting to the factory default setting 15 mmHg press Restore Defaults and then Accept Note that pressing Restore Defaults button will also activate the Alarm On mode automatically Customizing the User Settings Press the Settings tab to control the appearance of specific graphical and textual information that appears on the touch screen This panel also includes a button for determining system information regarding software and firmware Synchronize to Monitor Settings Time and Date Set Language The information on this panel includes Item Description 1 Set Time and Date Specifies the time and date that is displayed on the monitor The purpose of the time date display is for the Extract Data feature see page 65 2 Set Language Specifies the language that is displayed on the software interface see page 65 64 Chapter 5 Monitoring the Patients PtO2 and Temperature Item Description 3 System Information Displays information regarding the system s software and firmware see page 66 Service Mode Provides diagnostic information for errors This mode appears on the System Information panel This mode is password protected and is only accessible by Integra staff see page 66 Specifying Time and Date The Integra Licox PtO2 Monitor provides tools for setting the current time and dat
46. PtO2 limit If the patient s PtO2 falls below this limit for more than 5 seconds an alarm will sound To specify this limit see page 62 7 Displays the current PtO2 in mmHg 8 Displays the current tissue temperature in degrees Celsius C with an accuracy of 1 C when a temperature probe is connected to the monitor If no temperature probe is connected this value represents the tissue temperature specified manually by the user see page 58 Chapter 5 Monitoring the Patient s PtO2 and Temperature 59 Scaling Time Ranges for Trend Data On the Trend panel press the Time Scale button to view the history of PtO2 trend data in different ranges of time 3 hours 12 hours 24 hours 48 hours and 120 hours Note that pressing the Time Scale button each time will change the display of PtO2 trend data in the graph to the next time range selection The current time range that is specified by the PtO2 Scale button is listed under the PtO2 graph Main Trend Alarm Sattins Synchronize to Montor Extract Data Time Scale Range Scaling the PtO2 Ranges for Trend Data If the PtO2 graph on the Trend panel requires resizing for optimal viewing press the PtO2 Scale button to change the range of PtO2 measurements that is displayed along the Y axis of the graph The ranges that can be displayed on the graph include the following Ranges mmHg Increments mmHg oto 30 5 oto 50 5 oto 100 10 Oto 150 25 Note that p
47. a Licox PtO2 Monitor is not used for a long duration of time the battery will lose charge Always make sure the battery is charged to full capacity prior to use The Integra Licox PtO2 Monitor will charge the battery while the monitor is plugged into AC power About the Integra Probes The Integra Licox PtO2 Monitor supports three types of disposable Integra probes for measuring PtO2 temperature or both PtO2 and temperature Integra Licox Probe Types Description Supported Probes Single PtO2 Measures PtO2 only e CC1 SB PtO2 probe 0 8 mm diameter 150 mm with Smart Card length Single Temperature Measures tissue e C8 B temperature probe 0 8 mm diameter 126 mm temperature only length Combined PtO2 and Temperature Measures both PtO2and CC1 P1 combined PtO2 temperature probe with Smart Card tissue temperature For complete instructions on using the probes see the instructions for use supplied by Integra with each respective probe About the Integra PtO2 Probes and Smart Cards Each PtO2 probe is filled with an electrolyte solution that requires refrigeration between 2 C and 10 C Each probe also includes a Smart Card that stores calibration data for that specific probe INTEGRA m 4 LICOX Monitor Number SN Calibration Smart Card KEEP FOR USE GUARDAR PARA SU USO FUR DEN GEBRAUCH AUFBEWAHREN A CONSERVER FUR DEN GEBRAUCH AUFBEWAHREN MANTENERE PER L USO MANTENERE PER L USO
48. alarm press the Alarm tab and select Alarm Off If this option is selected the monitor will display PtO2 Alarm Off in the status bar The monitor will also remove the corresponding low PtO2 alarm limit indicator labels from the Main and Trend screens To turn on the low PtO2 alarm limit press Alarm On and then Accept Warning N Selecting the Alarm Off feature on the Alarm panel will disable the physiological alarm indefinitely Use caution if this feature is selected Silencing the Low PtO2 Alarm Temporarily To silence the physiological alarm temporarily press the active alarm symbol on the status bar This will silence the alarm for either 3 minutes or until the patient s PtO2 value falls within the specified limit In this silenced state the status bar will display Audio Paused the alarm symbol will change from active to inactive see page 68 and the PtO2 value Chapter 5 Monitoring the Patients PtO2 and Temperature 63 if still lower than the user specified low PtO2 Alarm limit will continue to flash yellow If the patient s PtO2 value does not rise above the specified low PtO2 alarm limit the alarm tone will resume Restoring Default Low PtO2 Alarm Limit Values After specifying the low PtO2 alarm limit value on the Alarm tab asters the Integra Licox PtO2 Monitor saves this current value into memory If the monitor is turned off for any duration of time and then turned back on the last saved low
49. alue of ambient air When performing this check after monitoring make sure to remove blood and tissue remains from the PtO2 probe with a gauze pad soaked in water This check requires either of the following probes e PtO2 probe and temperature probe or e Combined PtO2 temperature probe Note that this check is only intended to verify that the PtO2 probe is functioning correctly it does not test the accuracy of the PtO2 probe 1 Leaving the probes in their protector tubes place the probes into the sterile field to allow them to reach ambient temperature 2 Connect the probes to the Integra Licox PtO2 Monitor 3 Prior to implanting the probes into the patient remove the PtO2 probe from its protector tube and expose it to ambient air for at least one minute 4 Using the following table compare the PtO2 values reported by the monitor with those listed in the table Barometric Pressure Ranges PtO2 mmHg at 22 C mmHg 740 to 780 150 to 159 700 to 740 142 to 150 660 to 700 134 to 142 5 Evaluate the results e Ifthe PtO2 values on the monitor are close or trending close to the PtO2 values listed in the table the PtO2 probe is functioning correctly e Ifthe PtO2 values on the monitor are significantly different from the PtO2 values listed in the table the PtO2 probe is not functioning correctly If the check results in failure replace the PtO2 probe and re do steps 1 through 5 in this secti
50. an alarm is triggered for an overheating monitor while a Licox temperature probe is being used the excessive heat from inside the monitor may affect the monitor s temperature measurements If this condition occurs the calculations for the PtO2 measurements which require temperature compensation values may be unreliable until the overheating monitor condition has been resolved Silencing the Monitor Overheating Alarm Temporarily Press the flashing alarm symbol on the touch screen This will silence the alarm for 3 minutes while you clean the vent from any obstructions If the temperature inside the monitor does not fall below 80 C within 3 minutes the alarm will reactivate Fan Failure Alarm The Integra Licox PtO2 Monitor contains an internal fan that circulates air to cool the internal electronic components If the monitor detects the cooling fan has stopped running the monitor will activate a low priority technical alarm that will e Sound an alarm containing a burst of one pulse every 16 seconds e Display the following error message on status bar Cooling fan failure If this problem occurs turn off the monitor to prevent possible overheating After turning off the monitor contact Integra for service Silencing the Cooling Fan Alarm Temporarily Press the yellow alarm symbol on the touch screen This will silence the alarm for 3 minutes while you turn off the monitor s power to prevent possible overheating If the monitor
51. ar panel see page 75 On touch screen press Trend tab and select Extract Data button Verify confirmation message appears that indicates successful USB transfer see page 76 USB drive has been removed before completion of data transfer Re connect USB drive to rear panel see page 75 On touch screen press Trend tab and select Extract Data button Verify confirmation message appears that indicates successful USB transfer see page 76 Chapter 9 Troubleshooting the System 89 Problem Cause Recommendation USB drive is corrupted e Connect new USB drive to Integra Licox PtO2 Monitor see page 75 e On touch screen press Trend tab and select Extract Data button e Verify confirmation message appears that indicates successful USB transfer see page 76 Brand of USB drive is not Insert different brand of USB drive into rear recognized by Integra Licox PtO2 panel of Integra Licox PtO2 Monitor see page Monitor 76 USB drive is not formatted with Insert a USB drive with a FAT FAT16 or FAT32 the FAT FAT16 or FAT32 formatted formatted file system drive Responding to System Failure Messages If a system failure occurs the Integra Licox PtO2 Monitor will display a message window that identifies an error code and description of the problem The following table lists each error code associated with a system failure Error Codes Cause Recommendation
52. at you wish to retain prior to replacing the probe and Smart Card 76 Chapter 7 Extracting Trend Data for Remote Evaluation Extract Data via Digital Streaming Use the streaming data feature to export PtO2 trend data digitally from the Integra Licox PtO2 Monitor to a remote device via a USB to RS232 adapter cable Note that the Integra supplied USB to RS232 adapter cable is required to use this feature When streaming data the monitor reports the PtO2 value in mmHg of the current PtO2 trend data in one minute intervals The USB to RS232 adapter cable delivers the information as 9600 baud 8 data bits 1 stop bit even parity configurations To connect the USB to RS232 adapter cable to a computer you need a female to female null modem RS232 cable To extract the data via digital streaming 1 Onthe rear panel attach the USB end of the USB to RS232 adapter cable to the USB connector USB end of adapter cable USB to RS232 adapter cable 2 On the touch screen press Trend and verify the following message appears on screen data streaming enabled 3 Connect the other end of the USB to RS232 adapter cable to the external monitoring device Condition That Resets Trend Data During Recording Replacing a smart card with a different smart card will reset the trend data Chapter 7 Extracting Trend Data for Remote Evaluation 77 This page is intentionally left blank 78 Chapter 7 Extrac
53. ate battery charge levels Symbol Color Available Charge dam Green 75 to 100 q1 Green 50 to 75 i Green 25 to 50 qi Green Less than 25 a Flashing Yellow Less than 5 minutes If the level of battery charge falls to 15 minutes or less the monitor will display an error message on the status bar If the level of battery charge falls to 5 minutes or less the monitor will activate a technical alarm For more information see page 72 About the Alarms The Integra Licox PtO2 Monitor activates one physiological alarm for falling under the low PtO2 alarm limit and several technical alarms for indicating equipment related problems For instructions on setting the low PtO2 alarm limit see page 61 For detailed information on responding to each of these alarm types see Chapter 6 Monitoring the Patient s PtO2 Press the Main tab to view the patient s current PtO2 and temperature values Synchronize to Settings p Monitor Temperature 1 C 37 2 Chapter 5 Monitoring the Patients PtO2 and Temperature 55 The information on this screen includes Parameter Description 1 Displays current PtO2 value in mmHg 2 Identifies the current PtO2 probe number that appears on the probe s designated Smart Card and packaging Users must confirm that the probe number that appears on the screen the Smart Card and the packaging all match see page 31 3 Displays the low PtO2 limit for the patien
54. ated Smart Card into the slot page 33 Smart Card orientation is incorrect or Smart Card is not seated properly in the slot e Remove the Smart Card from the slot see page 33 e Check orientation of the Smart Card by aligning the arrows on the card with the red arrow next to slot e Firmly re insert the Smart Card into the slot 86 Chapter 9 Troubleshooting the System Problem Cause Recommendation PtO2 value on the touch screen displays zero 0 mmHg or less No PtO2 probe is connected to the Integra Licox PtO2 Monitor Connect a PtO2 probe to the Integra Licox PtO2 Monitor see page 33 Poor connection between the PtO2 probe cable and the Integra Licox PtO2 Monitor Make sure the cable is properly connected to the Integra Licox PtO2Monitor see page 33 Poor connection between the PtO2 probe cable and the PtO2 probe Make sure the probe cable is properly connected to the probe see page 33 Damaged PtO2 probe cable Replace PtO2 probe cable see page 33 Faulty PtO2 probe Replace the probe and Smart Card with a new probe and Smart Card see the instructions for use supplied with the probe The temperature value on the touch screen displays two dashes No Smart Card is inserted into the slot Firmly insert the designated Smart Card into the slot page 33 Smart Card orientation is incorrect or Smart Card is not seated prop
55. attery is low Battery has 15 minutes or less of Plug Integra Licox PtO2 Monitor into AC charge power outlet see page 27 Battery has 5 minutes or less of Plug Integra Licox PtO2 Monitor into AC charge accompanied by alarm power outlet see page 27 tone Calibration test failure Test probe is not connected Connect test probe to the blue probe cable e If failure persists contact Integra Chapter 9 Troubleshooting the System 83 System Message Cause Recommendation Faulty test probe cable e Swap the blue probe cable that the test probe is connected to e Connect the test probe into the new blue probe cable e If failure persists contact Integra Cannot write to log file Cannot write data to log file that is used by Integra for servicing Not resolvable Contact Integra Cooling fan failure Cooling fan inside of Integra Licox PtO2 Monitor has stopped running Turn off the Integra Licox PtO2 Monitor to prevent overheating and contact Integra see page 73 Data export failed Could not detect or write toa USB drive Problem with the connection or compatibility of USB drive See troubleshooting details on page 89 No transfer of trend data via USB connection Insert Smart Card for Probe Monitor overheating check vent Smart Card not inserted into slot Temperature inside Integra Licox PtO2 Monitor has exceeded 80 C Firmly insert the PtO2 pro
56. be s designated Smart Card into slot page 33 Check air vent on rear panel of Integra Licox PtO2 Monitor If anything is blocking vent remove it see page 72 No temperature probe detected Use Manual Temperature Input A PtO2 probe and Smart Card is connected to the Integra Licox PtO2 Monitor without a temperature probe e Select Accept button and use the Manual Temperature Input arrows to specify the temperature see page 58 e If temperature will be measured with a probe attach a temperature probe to the Temperature port on the Integra Licox PtO2 Monitor PtO2 below alarm limit Patient s PtO2 value has fallen below the user specified low PtO2 alarm limit for more than 5 seconds Respond to patient s need immediately Once the patient s PtO2 value moves within the alarm limit the alarm will turn off see page 71 PtO2 is out of accuracy range PtO2 value has exceeded the range that the Integra Licox PtO2 Monitor can measure accurately between o mmHg and 150 mmHg Do not rely on PtO2 measurements until the PtO2 value is within the accuracy range see page 73 84 Chapter 9 Troubleshooting the System System Message Cause Recommendation Smart Card Failure Smart Card orientation is incorrect or Smart Card is not seated properly in the slot e Remove the Smart Card from the slot see page 33 e Check orientation of the Smart Card by align
57. be re connected e If during use the reported PtO2 values between the Integra Licox PtO2 Monitor and the patient bedside monitor exceeds the stated accuracy range 1 The accuracy range stated in this description does not include the accuracy of the patient bedside monitor which may vary between manufacturers If drift occurs persistently between the two monitors that exceeds the stated accura cy range contact the biomed department to determine the cause of drift 48 Chapter 4 Setting Up System for Clinical Use Step 1 Connect the Two Monitors Notice To cancel the synchronization process during any of the following steps press Done 1 Connect the Integra Licox PtO2 Monitor to the patient bedside monitor A On the rear panel of the Integra monitor attach the connector end of the PMIO cable to the port labeled PMIO Align the red dot on the PMIO cable connector with the red triangle on the monitor s port and push firmly Verify the cable is completely connected to the monitor before proceeding h IN AC power adapter cable PMIO cable B On the other end of the PMIO cable attach the monitor adapter cable for pressure and temperature if applicable C Attach the PMIO cable and adapter cable to the temperature pressure modules on the patient bedside monitor Notice The Integra Licox PtO2 Monitor does not measure Cerebral Perfusion Pressure CPP As a result the ABP connector o
58. cal alarms cannot be disabled with this option see page 63 Low PtO2 Alarm Limit Specifies the minimum PtO2 value for the patient that the monitor will tolerate before activating the physiological alarm To specify this limit press the arrows to set a value between 1 mmHg and 150 mmHg in 1 mmHg increments see page 62 Chapter 5 Monitoring the Patients PtO2 and Temperature 61 Item Description 4 Restore Defaults Restores customized settings for the low PtO2 alarm limit to the original factory default settings 15 mmHg Pressing this button also activates the Alarm On button see page 64 5 PtO2 Displays PtO2 in mmHg 6 Temperature Displays the current tissue temperature in degrees Celsius C with an accuray of 1 C when a temperature probe is connected to the monitor If no temperature probe is connected this value represents the tissue temperature specified manually by the user see page 58 About the Low PtO2 Alarm Limit Calculation The Integra Licox PtO2 Monitor bases the low alarm limit on the patient s PtO2 value which is represented by the numerical PtO2 value that appears on the touch screen see page 53 The low PtO2 alarm is triggered if the patient s displayed PtO2 value continuously remains below the low PtO2 alarm limit for a period of at least 5 seconds Specifying the Low PtO2 Limit Value A Warning Always verify the low PtO2 alarm limit is set appropriately for each pa
59. cordance with the instructions furnished by Integra THIS LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON INTEGRA S PART OR ON THE PART OF DISTRIBUTORS AND INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY REPRESENTATIVE OR OTHER PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH INTEGRA PRODUCTS IN NO EVENT SHALL INTEGRA AUTHORIZED DISTRIBUTORS BE LIABLE TOWARDS THE ORIGINAL PURCHASER FOR ANY INCIDENTAL INDIRECT CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THE ACQUISITION OR USE OF Appendix B Integra Warranty 115 ANY INTEGRA PRODUCT Further this warranty shall not apply to and INTEGRA authorized distributors shall not be responsible towards the original purchaser for any loss arising in connection with the purchase or use of any INTEGRA product that has been repaired by anyone other than an authorized INTEGRA service representative or altered in any way so as to affect its stability or reliability or which has been subject to misuse negligence or accident or which has been used otherwise than in accordance with the instructions furnished by INTEGRA THIS INTEGRA DISTRIBUTOR LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES TOWARDS THE ORIGINAL PURCHASER EXPRESS OR IMPLIED AND OF ALL OTHER OBLIGATIONS OR LIABILITIES TOWARDS THE ORIGINAL PURCHASER ON INTEGRA AUTHORIZED DISTRIBUTOR S PART INTEGRA AND ITS AUTHORIZED
60. cox PtO2 Monitor you may need to provide Integra with information regarding the system s software and firmware versions To determine this information press the information symbol About Extract Log and Service Mode Buttons The Extract Log button only appears on the System i 3 ar Extract Information panel if a USB drive is connected to the Integra Licox PtO2 Monitor Note that when attaching a USB drive this button may take several seconds to appear Pressing the Extract Log button will copy system log information from the monitor to the USB drive During a troubleshooting session the Integra technical staff may request this log file The Service Mode button provides diagnostic information for paeme Integra staff to troubleshooting errors This button is only intended for Integra staff 66 Chapter 5 Monitoring the Patients PtO2 and Temperature CHAPTER 6 RESPONDING TO PHYSIOLOGICAL AND TECHNICAL ALARMS About the TWo Alarm ypes ceseccceceseeeeeeeeeeseeeeeeeeeseeeeeeeenseaeeeeeenseeeeeeeennes 67 About the Technical Messages csssesccccesseeeeeeeeeseeeneeeensneeneeeeenseeneeeeeneees 67 Understanding the Alarm SyMboIS cceccceseeeseeeeeeseesesneeeeeseeeeeneeeeneeees 68 How the Monitor Prioritizes the AlarimS cccsseeeessseeeeeseeseeeeeneeeseeneeeens 68 Responding to the Physiological Alarm PtO2 below alarm limit 71 Responding to Technical Alarms ccces
61. duct that is placed by Integra under a lease rental or installment purchase agreement and that requires repair service during the term of such placement agreement shall be repaired in accordance with the terms of such agreement If any covered defect occurs during the warranty period or term of such placement agreement the purchaser or distributor should communicate directly with Integra If purchaser or distributor seeks to invoke the terms of this warranty the product must be returned to Integra The defective product should be returned promptly properly packaged and postage prepaid Loss or damage in return shipment to Integra shall be at sender s risk Integra sole responsibility under this warranty shall be repair or replacement at the sole discretion and expense of Integra subject to the terms of this warranty and applicable agreements IN NO EVENT SHALL INTEGRA BE LIABLE FOR ANY INCIDENTAL INDIRECT CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THE ACQUISITION OR USE OF ANY INTEGRA PRODUCT Further this warranty shall not apply to and Integra shall not be responsible for any loss arising in connection with the purchase or use of any Integra product that has been repaired by anyone other than an authorized Integra service representative or altered in any way so as in Integra judgment to affect its stability or reliability or which has been subject to misuse negligence or accident or which has been used otherwise than in ac
62. due to the effects of monitor warm up The majority of this error will be observed during the first hour and the remaining error will continue to resolve until the 3 hour monitor warm up time is complete The following table lists example patient PtO2 values and readings that may be displayed in the first 3 hours due to this error Maximum PtO2 Value Actual Patient PtO2 Value Displayed as Result of Warm Up mmHg H mmHg 5 6 10 12 15 7 20 23 28 Chapter 4 Setting Up System for Clinical Use To avoid the need to repeat the warm up procedure Integra recommends leaving the monitor on for the duration of a patient s observation including those times when a patient may be disconnected from the monitor Notice The recommended warm up time for optimal clinical readings is independent of stabilization time required for reducing the effects of tissue microtrauma following probe insertion Temperature Effect on PtO2 Readings Once the warm up time is complete there is potential for a 1 C measurement variation when using temperature probes The effect of this variation equates to a PtO2 error of approximately 4 The following table lists example patient PtO2 values and readings that may be displayed as a result of a temperature accuracy of 1 C Actual Patient PtO2 Value PtO2 Values Displayed with a 1 C Temperature Variation mmHg H mmHg 5 5 10 10 15 14 to 16 2
63. e BC10PV Blue combined PtO2 temperature probe cable PMOCAB Green temperature probe cable BC10TA e Y adapter cable for blue combined PtO2 temperature probe cable BC1OPMO Note that each of these components should be cleaned immediately after contamination Only use the cleaning agents listed in this section for cleaning and disinfecting the Integra Licox PtO2 Monitor system Using solvents or cleaning agents not listed in the cleaning guidelines may damage the plastic exterior of the Integra Licox PtO2 Monitor Chapter 8 Cleaning and Sterilizing the System 79 A Do not clean the probe cables or probe extension cables in an automatic disinfector Item Guideline Preparation for Cleaning Ensure that all the connections between the cables probe cable strap AC power adapter USB to RS232 serial adapter Smart Card and monitor have been removed before cleaning the Integra Licox PtO2 Monitor Limits on Reprocessing e The probe cables and probe extension cables may be sterilized ten 10 times Do not use the cables after reaching this reprocessing limit For tracking purposes use the Reprocessing Record Sheets supplied with your cables e There are no limits on reprocessing the Integra Licox PtO2 Monitor and cable strap Recommended Manual Cleaning Methods Using either 70 IPA with a lint free wipe or a Super Sani Cloth or equivalent solution thoroughly wipe all surfaces at l
64. e that appears on the touch screen Synchronize to M Settings Time and Dato Sot Language To set this information 1 On the touch screen press the Settings tab 2 Press the Set Time and Date button 3 On the displayed panel press the desired field hour minutes date month or year and use the arrows to specify the appropriate setting Note that you may adjust each of these settings prior to accepting them in the following step 4 Press Accept the Integra Licox PtO2 Monitor will display the selected time date on the touch screen Specifying Languages The Integra Licox PtO2 Monitor provides options for displaying onscreen text in different languages Synchronize to Sottings z g Monitor Set Time and Date Language The list of supported languages include e English German e Danish Japanese Portuguese Brazilian e French Spanish Polish e Korean e Italian e Dutch e Russian Chinese Simplified Chapter 5 Monitoring the Patients PtO2 and Temperature 65 To change languages from any screen 1 Onthe touch screen press the Settings tab 2 Onthe left side of the panel press Set Language 3 Inthe displayed Language menu use the arrows to select the desired language 4 Press Accept the Integra Licox PtO2 Monitor will display all onscreen text to the selected language Determining System Information If you experience technical problems with your Integra Li
65. e to address microtrauma normally between 20 minutes and 2 hours this will ensure the PtO2 values reported by the monitor are accurate For details see page 22 Step 5 Enter Tissue Temperature Compensation Value Manually 1 Enter the tissue temperature compensation that will be used during PtO2 measurements A On the touch screen press Main Chapter 4 Setting Up System for Clinical Use 35 B On the Temperature manual panel adjust the Manual Temperature Input arrows to the desired temperature to the nearest whole number Sere Monitor Temperature C manual 37 a Manual Temperature input v Synchronize to lt q Temperature manual Panel C Note that the accepted range is between 30 C and 42 C the monitor s default value is 37 C 2 Press Accept The calculations for PtO2 measurements require tissue temperature A compensation If you are not measuring the tissue temperature with a probe the temperature has to be entered manually Make sure to check the patients tissue temperature either hourly or prior to recording the PtO2 values for intervention If any changes in temperature occur use the Manual Temperature Input arrows to specify the new temperature value accordingly 36 Chapter 4 Setting Up System for Clinical Use Connecting a Single PtO2 Probe with a Single Temperature Probe Connecting separate probes for measuring PtO2 and temperature req
66. east three 3 times and then inspect the surfaces for visible residues e If residues remain use a new Super Sani Cloth or equivalent solution or lint free wipe soaked with 70 IPA and continue wiping the surfaces until they are visibly free of residues Recommended Disinfection Methods Inspection and Functional Testing e Using either 70 IPA with a lint free wipe OR Super Sani Cloth or equivalent solution thoroughly wipe all surfaces once e Ensure that the surfaces remain visibly wet for a minimum of two 2 minutes and use additional wipe s if needed to ensure continuous two 2 minute wet contact time e Let the Integra Licox PtO2 Monitor and any of its system components air dry prior to reuse After each reprocessing event visually inspect the Integra Licox PtO2 Monitor and any of its system components for any wear and tear Containment and Transportation It is recommended that the Integra Licox PtO2 Monitor and any of its system components be cleaned and disinfected as soon as is reasonably practical after use 80 Chapter 8 Cleaning and Sterilizing the System Sterilizing the Probe Cables and Probe Extension Cables The probe cables and probe extension cables are provided non sterile Warning Do not autoclave or immerse the Integra Licox PtO2 Monitor in liquid as damage may occur If the monitor is exposed to liquids turn off the unit remove the AC power adapter remove the battery
67. ections or infected tissue A platelet count of less than 50 000 per pL is considered a contraindication This value may differ according to different hospital protocols Special Coagulation Problems To avoid hemorrhage related complications blood coagulation must be carefully monitored when measuring in the tissue during hypothermia This also applies to patients in hepatic coma or other conditions which could impair coagulation or those patients who receive any substances that interfere with blood hemostasis Risk of Invasive Monitoring There is a general risk of infection with the use of introducer systems and probes The risk for infection increases after a certain period of time depending on the application Please refer to the corresponding probe s Instructions for Use IFU Chapter 1 System Overview 5 Risks of Artifacts Note the following warnings Halothane N Halothane interferes with polarographic PtO2 probe measurements It causes an overestimation which is usually reversible within 20 minutes after discontinuation Other commonly used anesthetic gases e g N2O Enflurane or Isoflurane are not known to interfere with polarographic PtO2 probe measurements Temperature Gradient Temperature measurements may be inaccurate if the connector of the temperature sensing probe is subjected to considerable changes in ambient temperature or if the ambient temperature of the Integra Licox PtO2 Monitor lies outside
68. ed aetna 1 Intended USE ar teorierne nenea AKEE ESANEAN EENE A EE EEA Aan N TAREE eTA SR ANSA 1 List of Warnings for Using the Monitor ccccsssseecessseeeeeeenseeeeeeeneeeeenenenes 3 Risks t Patients conssi ii 5 Parts ofthe MOmiton cc2c coe cee cesece cick ech a cdtecadacecitcgishccdideasscceceengsceccaceesssccdivedss 7 Indications for Use Intended Use The Integra Licox PtO2 Monitor measures oxygen partial pressure PtO2 and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement Monitor values are relative within an individual and should not be used as the sole basis for determining a diagnosis or therapy It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern Contraindications The Integra Licox PtO2 Monitor and its accessories are contraindicated for use ina Magnetic Resonance MR environment Intended User The Integra Licox PtO2 Monitor is intended to be used by the following qualified medical and biomedical professionals e Aqualified neurosurgeon should perform the placement and handling of the probes e Designated qualified hospital staff i e neurosurgeon nurse intensivist trauma physician or physician s assistant should perform the operation of the monitor Chapter 10 provides instructions for te
69. edside monitor see page 48 Patient bedside monitor has malfunctioned Refer to manufacturer s troubleshooting guide for the patient bedside monitor 88 Chapter 9 Troubleshooting the System Problem Cause Recommendation Patient bedside monitor is not compatible with the Integra PtO2 monitor e See the patient bedside monitor specifications in Appendix A see page 108 e See the manufacturer s troubleshooting guide for the patient bedside monitor No transfer of trend data via digital streaming with USB to RS232 adapter cable Loose USB to RS232 adapter cable Reconnect USB to RS232 adapter cable see page 77 On touch screen press Trend tab and verify Data Streaming Enabled message appears Faulty USB to RS232 adapter cable External monitoring device is not configured correctly for digital streaming Replace USB to RS232 adapter cable see page 77 On touch screen press Trend tab and verify Data Streaming Enabled message appears See digital streaming requirements on page 77 No transfer of trend data via USB connection No USB drive is connected Connect USB drive to rear panel see page 75 On touch screen press Trend tab and select Extract Data button Verify confirmation message appears that indicates successful USB transfer see page 76 USB drive not seated properly in monitor Check connection of USB drive on re
70. eeeeeseeseseeeeeeeeensneeeeneeeees 75 Extract Data via Digital Streaming cceccseseeeeseeeeeeseeseseeeeeeeeeeeeneeneneeeees 77 Condition That Resets Trend Data During Recording ccs ccssseeeeee 77 About Data Extraction The Integra Licox PtO2 Monitor provides two options for extracting PtO2 trend data for remote evaluation e External USB Drive e Digital Streaming via USB to RS232 Serial Cable Both media types are connected to the monitor via a USB connection that is located on the rear panel Notice The USB connector port on the Integra Licox PtO2 Monitor is only intended for connecting a USB drive and USB to RS232 adapter cable for extracting PtO2 trend data The USB port is not intended to be connected to a network connection e g USB bluetooth adapter USB ethernet adapter etc Extracting Data to USB Drive Use the Extract Data feature to export up to 5 days worth of PtO2 trend data from the monitor to an external USB drive When using this feature the Integra Licox PtO2 Monitor exports the data to the USB drive as a comma separated value csv file This csv file records the date time and PtO2 values in one minute intervals and displays the information as ASCII text The following text provides a sample csv trend data entry 2011 04 20 13 38 18 3 Day PtO2 mmHg Month Time Year Notice The external USB drive needs to be a FAT FAT16 or FAT32 formatted drive Ot
71. eeeseeseeeeeeeeseeeeeseeseeeneneeeeeeeeneees 71 About the Two Alarm Types The Integra Licox PtO2 Monitor activates two types of audio visual alarms to indicate problems that require immediate attention Alarm Type Description Physiological Alerts the nurse physician that the patient s PtO2 value being monitored has fallen under the specified limit continuously for more than 5 seconds Technical Alerts the nurse physician that there is a problem with the monitor s battery electrical components software version or probe connections These technical alarms include e Irreversible System Failures e PtO2 is out of accuracy range e Low battery level 5 minutes or less e Temperature is out of accuracy range e Monitor overheating e Battery failure e Cooling fan failure Do not block the alarm speaker with any materials that might muffle the alarm sound About the Technical Messages In addition to the technical alarms the Integra Licox PtO2 Monitor also displays technical messages on the status bar to indicate problems with e Low battery level 15 minutes or less e Smart Card failure e Insert Smart Card for probe e Probe initialization failure e Calibration test failure e Cannot write to log file For information on responding to these messages see page 83 Chapter 6 e Responding to Physiological and Technical Alarms 67 Understanding the Alarm Symbols On the status bar the Integra Licox PtO2 Mo
72. ees 72 Responding to Monitor Overheating Alarm ccccccccscececeeeeeeceeseceeeeeeaaeeeceeeeeeeaeeeseeeesecaeeeseeeeeaas 72 Responding to Cooling Fan Failure Alarm cccccccccseeceeeeeeeeeeeeceeeeeeaaaeeeeeeeesaeeeeeeeeesecaeeeeeneeesaas 73 Responding to Accuracy Range Alarm c cccececscceeeeenneeeeeeeeneeeeeeeeaaeeeeeeeaaeeeeeeeeaeeeeseeeaeeeeeneaaees 73 Responding to Battery Failure Alarim eccceeeeeeseeceeeeeeneeeeeeeenaeeeeeeeaeeeeeeeeaaeeeeeeeeaaeeeeseeaeeeeeeenaaees 74 Chapter 7 Extracting Trend Data for Remote Evaluation About Data Extraction weaved feeececee Rae enn etn ee ence vente tae dene ee ay 75 Extracting Data to USB Drive ceeeccceceeeeeceeeeeeeeeeeeeeeceaaeeeeeaeeseaaeeeeeeeeeceaeeeseaeesecaeeeseaaeeseeeessaeeeeeneeess 75 How the Monitor Stores Trend Data for Up to 5 DayS cccceceeceeeseeeeeeeeeeeeneeeeeaeeteeeeeetaaeeeeeeeees 76 Extract Data via Digital Streaming cccceeeeeeeeeeeeeeeeeeeeeeceaeeeeeeeeecaaaeeseneeeeceaeeseceeesaaeeeeeeeeesiaeeeeeneeess 77 Condition That Resets Trend Data During ReECOrding ccccccceeeeeeeeeeeeeeeeeeeeeeeesaeeeeeaeeeeeeeeeseneeeeaas 77 Chapter 8 Cleaning and Sterilizing the System Cleaning the System and COMponentts cccecceeeececeeeeeeeeeeeeeeaeeeseaeeeceaeeeeeaaeeseaeeeesaaaeseeeeeessaeeeteneeteaes 79 Cleaning Guidelines eriin anna ia aa a a a aae aa a arae e an aa a eka aurian 79 Sterilizing the Probe Cables and Probe
73. er the liquid remain constant over time a stable equilibrium of diffusion is established between the gas and the liquid Ultimately the pressure of the gas dissolved in the liquid reaches the pressure of the gas above the liquid As partial pressure increases the amount of gas that is dissolved in a particular volume of liquid also increases The higher the partial pressure of a gas in solution the higher the concentration PtO2 A Measure of Cellular Oxygen Availability The partial pressure of the oxygen physically dissolved in brain tissue corresponds to the availability of oxygen at the cellular level since the cell membranes do not represent a functionally variable O2 diffusion barrier and because the diffusion distance between the interstitial space and the mitochondria is short As a result the PtO2 value reflects the balance between O2 supply and O2 demand of the oxidative energy metabolism directly at the target of the complex oxygen transport An increase in the PtO2 balance might be due to an increase in the oxygen transport rate to tissue or to a decrease of the tissue oxygen consumption Temperature Effect The signal of a polarographic PtO2 probe the probe current changes depending on the temperature even if the PtO2 value in the environment remains constant The change in probe PtO2 sensitivity with change in temperature is approximately 4 per degree centigrade The probe s zero signal current without oxygen does no
74. erly in the slot e Remove the Smart Card from the slot see page 33 e Check orientation of the Smart Card by aligning the arrows on the card with the red arrow next to slot Firmly re insert the Smart Card into the slot Poor connection between the temperature probe cable and the Integra PtO2 monitor Poor connection between the temperature probe cable and the temperature probe e Make sure the cable is properly connected to the Integra Licox PtO2 Monitor see page 38 e Replace the probe see the instructions for use supplied with the probe Damaged temperature probe cable e Replace the probe cable Faulty temperature probe e Replace the probe see the instructions for use supplied with the probe Time date appears incorrectly Time and or date is set incorrectly On touch screen press the Settings tab and select Set Time and Date to specify current time and date see page 65 Chapter 9 Troubleshooting the System 87 Problem Incorrect language is displayed Cause Recommendation Choice of language is set incorrectly On touch screen press the Settings tab and select Set Language to specify language see page 65 Discrepancy of PtO2 measurements between the Integra Licox PtO2 Monitor and the patient bedside monitor Patient bedside monitor is not synchronized to the Integra Licox PtO2 Monitor correctly On the Integra Licox Pt
75. ges in ambient temperature or if the ambient temperature of the Integra Licox PtO2 Monitor lies outside the defined range of 15 C to 30 C If an alarm is triggered for an overheating monitor while a Licox temperature probe is being used the excessive heat from inside the monitor may affect the monitor s temperature measurements If this condition occurs the calculations for the PtO2 measurements which require temperature compensation values may be unreliable until the overheating monitor condition has been resolved Only use Integra supplied accessories on the Integra Licox PtO2 Monitor This applies in particular to probes probe cables battery AC power adapter and USB to RS232 adapter cable If the Integra Licox PtO2 Monitor loses power and shuts down while it is connected to a patient bedside monitor do not use the PtO2 values on the patient bedside monitor for patient measurements the PtO2 values on the patient bedside monitor will be invalid Connect the monitor to an AC power supply immediately if the low battery alarm is activated When using the battery Donot heat above 80 C Donot open battery Do not dispose of in fire Donot short circuit as battery may ignite explode leak or get hot causing personal injury Replace battery with same part number only REF BAT1001 Use of another battery may present a risk of fire or explosion To prevent injury to the patient user or other persons make
76. harge level drops to 5 minutes or less the monitor will sound an alarm For more information on responding to low battery alarms see page 72 For specific information on testing replacing the battery see page 100 AN En When using the battery Do not heat above 80 C Do not open battery Do not dispose of in fire Do not short circuit as battery may ignite explode leak or get hot causing personal injury Replace battery with same part number only REF BAT1001 Use of a battery not supplied by Integra may present a risk of fire or explosion A To prevent injury to the patient user or other persons make sure that the battery cover is closed securely during monitor use A N To ensure appropriate battery power with use of the Integra Licox PtO2 Monitor only use batteries supplied by Integra REF BAT1001 To order replacement batteries contact Integra Notice The Integra Licox PtO2 Monitor has been designed to operate during use while a battery is installed in the unit even if the battery is not being used for power As a result always use the monitor with a battery installed 30 Chapter 4 Setting Up System for Clinical Use Storing the Battery If the Integra Licox PtO2 Monitor will not be used for several months or longer remove the battery from the monitor prior to storing the monitor Ensure the battery is stored in a cool dry and well ventilated area Notice If the Integr
77. he blue probe cable that was used in step 2 B Insert the test Smart Card into the slot and verify it is positioned securely see page 33 4 Turnon the monitor 94 Chapter 10 Testing and Preventive Maintenance 5 Onthe touch screen press the Main tab and verify the PtO2 value appears as 154 7 mmHg 0 4 mmHg 6 If the touch screen displays the message Calibration Test Failure in the status bar A Make sure that the test probe is inserted firmly into the blue PtO2 probe cable that was used in step 2 B Ifthe touch screen still displays the Calibration Test Failure message contact Integra Testing Pressure Output Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment e Digital Multimeter DMM 1 mV resolution e PMIO cable part PMIO MPM DC bench power supply 10 V DC Notice Before performing this test verify that the Integra Licox PtO2 Monitor is turned off and not connected to any cables 1 Plug the Integra Licox PtO2 Monitor to an AC wall outlet 2 Onthe rear of the monitor connect a PMIO cable to the PMIO connector but not to an external patient bedside monitor 3 Using the DC bench power supply and the Digital Multimeter DMM do the following A Set DC power supply to 10 0 1 volts and connect and leads to pins 1 and 4 of the six pin cannon connector respectively B
78. her file system formats are not supported Chapter 7 Extracting Trend Data for Remote Evaluation 75 To extract the data to a USB drive 1 Onthe rear panel attach the USB drive to the USB connector USB drive AC power adapter PMIO cable 2 Onthe touch screen press Trend and select Extract Data 3 Verify the following message appears Data export successfully completed Remove the USB drive 4 Press Accept remove the USB drive and view the csv file in the desired output device e g laptop Notice To ensure the complete transfer of trend data to the USB drive do not remove the USB drive until the message specified in the above step 3 appears confirming the extraction Note In the csv file the timestamp for the data extraction is based on the monitor s date time settings that are specified on the Settings tab In countries where daylight savings are observed the time must be adjusted manually For instructions see page 65 How the Monitor Stores Trend Data for Up to 5 Days The Integra Licox PtO2 Monitor will only store the PtO2 data from the most recent 5 days All stored trend data older than 5 days will be lost Warning N If monitoring is continued for more than 5 days placement of a new probe under sterile conditions is recommended Note that replacing an existing probe and Smart Card with a new probe and Smart card will reset the trend data Please extract any data th
79. in this document and the remainder of the instructions for use this device Portable and mobile RF communications equipment can affect medical electrical equipment Cables and accessories not specified within the instructions for use are not authorized Using other cables and or accessories may adversely impact safety performance and electromagnetic compatibility increased emission and decreased immunity Care should be taken if the equipment is used adjacent to or stacked with other equipment if adjacent or stacked use is inevitable the equipment should be observed to verify normal operation in the configuration in which it will be used 110 Appendix A Technical Specifications Guidance and manufacturer s declaration electromagnetic emissions The Integra Licox PtO2 Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Integra Licox PtO2 Monitor should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Integra Licox PtO2 Monitor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any CISPR 11 interference in nearby electronic equipment RF emissions Class A The Integra Licox PtO2 Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low
80. ing the arrows on the card with the red arrow next to slot e Firmly re insert the Smart Card into the slot Faulty Smart Card If problem persists attach a new PtO2 probe and designated Smart Card see page 33 e Ifthe problem does not resolve after attaching multiple Smart Cards contact Integra Temperature is out of accuracy range Temperature value is outside the range that the Integra Licox PtO2 Monitor can measure accurately between 30 C and 42 C Do not rely on the PtO2 measurements until the temperature value is within the accuracy range see page 73 e Enter temperature manually by unplugging temperature probe see page 58 e On the touch screen use the Manual Temperature Input arrows to specify the temperature Responding to Problems During Use The following table provides guidelines for responding to technical problems that may occur with the Integra Licox PtO2 Monitor during use Problem Cause Recommendation Integra Licox PtO2 Monitor does not operate with AC power AC power adapter not connected Attach AC power adapter to Integra Licox PtO2 Monitor see page 27 Faulty AC power adapter cord e Attach AC adapter cord to Integra Licox PtO2 Monitor page 27 e Perform AC power test to ensure AC power works see page 100 e Contact Integra to order new AC power adapter cord Chapter 9 Troubleshooting the System 85
81. inical alarm that will e Sound an alarm containing a burst of three pulses e Display the following error message on status bar PtO2 below alarm limit e Flash the alarm symbol on status bar e Flash the current PtO2 value in yellow on the Main Trend and Alarm screens To silence the alarm temporarily press the flashing alarm symbol on the touch screen This will silence the alarm for either 3 minutes or until the patient s PtO2 value rises above the low PtO2 alarm limit for at least one measurement After 3 minutes the alarm will reactivate To turn off the alarm completely press the Alarm tab and select Alarm Off and Accept For instructions on specifying the low PtO2 alarm limit see page 61 Selecting the Alarm Off feature will disable the low PtO2 alarm limit indefinitely Use caution if this feature is selected Responding to Technical Alarms Use the following guidelines to respond to each technical alarm Responding to System Failure Alarms If any of the software firmware or electrical components inside the monitor suffers a serious malfunction during use the Integra Licox PtO2 Monitor will stop reporting measurement values on the touch screen and activate a medium priority technical alarm During this alarm mode the monitor will e Sound an alarm containing a burst of three pulses e Display a standalone message window that specifies an error code anda description of the applicable system failure which include the f
82. ionson for 0 5 cycle the Integra Licox PtO2 Monitor requires power supply input continued operation during power mains lines 40 U 40 U interruptions it is recommended that the Integra 60 dip in U for 5 cycles Licox PtO2 Monitor be powered from an IEC 61000 4 11 for 5 cycles uninterruptible power supply or a battery 70 U 70 U 30 dip in U for 25 cycles for 25 cycles lt 5 U lt 5 U gt 95 dip in U for 5 sec for 5 sec Power frequency 3 A m 3 A m Power frequency magnetic fields should be at 50 60 HZ levels characteristic of a typical location in a magnetic field IEC 61000 4 8 typical commercial or hospital environment Note U is the a c mains voltage prior to application of the test level 112 Appendix A Technical Specifications Guidance and manufacturer s declaration electromagnetic immunity The Integra Licox PtO2 Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Integra Licox PtO2 Monitor should assure that it is being used in such an environment Compliance level Electromagnetic environment guidance Immunity test IEC 60601 test level Portable and mobile RF communications equipment should be used no closer to any part of the Integra Licox PtO2 Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency
83. l in yellow on status bar If this occurs plug in the monitor to an AC power outlet immediately This alarm will stop once the monitor is connected to AC power A Connect the monitor to an AC power supply immediately if the low battery alarm is activated Silencing the Low Battery Alarm Temporarily Press the flashing alarm symbol on the touch screen This will silence the alarm for 3 minutes while you plug the monitor into an AC power outlet to charge the battery If the battery does not receive charge within 3 minutes the alarm will reactivate The Integra Licox PtO2 Monitor battery may be replaced by the hospital s biomedical engineer For instructions see page 102 Responding to Monitor Overheating Alarm If the temperature inside the Integra Licox PtO2 Monitor exceeds 80 C the monitor will activate a medium priority alarm that will e Sound an alarm containing a burst of three pulses e Display the following error message on status bar Monitor overheating check vent 72 Chapter 6 e Responding to Physiological and Technical Alarms Responding to Cooling To resolve this problem check the vents on the rear and bottom panels of monitor to ensure nothing is blocking them If something is blocking them remove it immediately Once the temperature inside the monitor falls below 80 C this alarm will stop and the message will disappear If this problem continues to occur turn off the monitor and contact Integra If
84. lay the amount time left to confirm that the value is also displayed on the patient bedside monitor 2 Once the PtO2 value on the patient bedside monitor stabilizes verify that the patient bedside monitor reads the same value as the Integra Licox PtO2 Monitor 25 mmHg 1 mmHg 3 Repeat steps 1 to 2 in this section for each additional value that you want to check 50 Chapter 4 Setting Up System for Clinical Use Step 5 Complete the Synchronization Process After completing the synchronization process press Done Once the PtO2 value on the patient bedside monitor stabilizes verify that the patient bedside monitor reads the same PtO2 value as the Integra Licox PtO2 Monitor within 1 mmHg for PtO2 values between o and 100 mmHg or 2 mmHg for PtO2 values over 100 mmHg During patient treatment Integra recommends comparing the PtO2 values between the two monitors per the guidance of the hospital s unit policy or while the clinical staff is recording PtO2 or treating PtO2 If the Integra Licox PtO2 Monitor loses power and shuts down while it is connected to a patient bedside monitor do not use the PtO2 values on the patient bedside monitor for patient measurements the PtO2 values on the patient bedside monitor will be invalid Notice After completing the synchronization process always use the Integra Licox PtO2 Monitor s measurements over the patient bedside monitor s measurements If drift occurs between the t
85. logical and technical alarms 67 74 plugs region specific power 17 power adapter preparing the AC 17 preventive maintenance tests 93 103 priorities alarm 68 70 probe cable kit BC10 15 probe functionality verifying PtO2 47 probes Integra connecting single PtO2 33 36 connecting single PtO2 and temperature 37 41 connecting the combined PtO2 temperature 42 46 supported 31 PtO2 accuracy range of 73 disabling alarm for 63 effecs of microtrauma on 22 effects of temperature probes on 22 23 effects of warm up time 22 silencing alarm temporarily for 68 testing accuracy of 94 verifying probe functionality for 47 R repairs Integra 105 restore defaults button 64 S service mode accessing 66 service contacting Integra 105 setup for clinical use 25 51 for first time use 13 20 silence alarm symbol 68 Smart Cards about 31 32 software symbols vi software version determining 103 status messages responding to 83 reviewing the 54 sterilization of cables 81 82 storage battery 31 monitor 52 trend data limits 76 streaming trend data 77 symbols alarm 68 packaging v software vi synchronizing two monitors about the Synchronize to Monitor button 54 accuracy ranges of 48 connecting to a bedside monitor 48 51 system failures list of error codes 90 responding to 71 system information checking 66 system messages responding to 83 T technical and physiological alarms 67 74 technical support c
86. ms Audio and Visual Indicators for Medium and Low Priority Alarms Depending on the clinical priority of the error condition that is causing the alarm the Integra Licox PtO2 Monitor activates audio and visual indicators to alert the user of the condition Clinical Priority Audio Indicators Visual Indicators Medium e Sounds an alarm containing a burst A message will appear on the status bar that of three pulses with a pulse identifies the error oe of 180 eee anda If a system failure occurs a standalone message urst separation 0f3 seconds window will appear that identifies an error code and e The volume of each alarm pulse description of the failure measures a Sound pressure Or 7o aB o ie borders surrounding specific symbols e g alarm battery on the touch screen will flash yellow For some error conditions the patient values will flash yellow Low e Sounds an alarm containing a single A message will appear on the status bar that The volume of the single alarm pulse measures a sound pressure of 69 dB pulse with a burst separation of 16 identifies the error The patient values will appear yellow not flashing e For battery related errors the battery symbol indicates the battery has no remaining charge For specific information on which audio visual indicators occur for each medium priority and low priority alarm type see Responding to the Physiological Alarm PtO2 below alarm limit on page 71
87. n the PMIO cable will not be used Step 2 Press the Synchronize to Monitor Button 1 On the Integra Licox PtO2 Monitor s touch screen press the Synchronize to Monitor button Note the following actions The Integra monitor will transmit an PtO2 value of O mmHg for up to one minute A countdown will appear to display the amount of time left to zero the patient bedside monitor Step 3 Zero the Patient Bedside Monitor to the Integra Monitor On the patient bedside monitor follow the manufacturer s instructions to zero the monitor Chapter 4 Setting Up System for Clinical Use 49 Step 4 Check Additional Values to Confirm Synchronization Notice The following synchronization checks at 25 mmHg 50 mmHg and 100 mmHg are not required but are recommended by Integra On the Integra Licox PtO2 Monitor s touch screen press the Check Additional Values button to transmit additional PtO2 values to the patient bedside monitor for scaling verification e 25mmHg e 50mmHg e 100 mmHg Note that pressing Check Additional Values each time advances to the next PtO2 value If you are not checking additional values proceed to the final step Complete the Synchronization Process on page 51 1 Press the Check Additional Values button to transmit an PtO2 value at 25 mmHg for up to one minute to the patient bedside monitor Confirm value on the patient monitor within the nort A countdown will appear to disp
88. neneeeeeeeneees 25 Optimal Clinical Readings When Using Temperature Probes 0 28 Using the Battery for POWEF cccceseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeseeseeneneees 29 About the Integra Probes cccccsssecceeesseeeeeeeeesneeeeeeesnneeeeeensneeeeeeeesneeeeeeenenes 31 Connecting a Single PtO2 Probe s sccesscceseeeeeseseeeeseeeesseseeeeeeeeseeeeneeeees 33 Connecting a Single PtO2 Probe with a Single Temperature Probe 37 Connecting the Combined PtO2 Temperature Probe csseeessseeseeees 42 Verifying the PtO2 Probe Functionality c ccsseeeessseesseeeeeeseeesneeeeeees 47 Connecting to a Patient Bedside Monitor if applicable 00 48 Storing TNE Syst m iieii aa a eer aaa aas anaana eae iaai aaaea 52 Setting Up System for Clinical Use AN Positioning the Monitor A The following section provides instructions for positioning the monitor powering the monitor and connecting probes to the monitor prior to clinical use The Integra Licox PtO2 Monitor is a sensitive electronic device When using the monitor always handle with care If damage is suspected contact Integra The Integra Licox PtO2 Monitor is intended to be positioned ona hard flat surface or securely clamped to an equipment pole or bed support next to the patient The distance between the patient and the monitor is restricted by the length of the Integra probe cable It is not permit
89. ng e Onthe front of the monitor check that the LED AC power indicator that appears above the power button is illuminated e Onthe touch screen check that the plug icon appears in the status P bar 3 Onthe rear of the monitor disconnect the power cord and verify the following e Onthe front of the monitor check that the green LED AC power indicator turns off AC power indicator e Onthe touch screen verify the plug icon appears crossed out in F ra the status bar 4 f any of the AC power checks listed in steps 2 and 3 fail contact Integra Low Battery Alarm Notice Before performing these tests verify that the Integra Licox PtO2 Monitor is turned off and not connected to any cables 100 Chapter 10 Testing and Preventive Maintenance Battery Charge Integra recommends performing this test once every three months 1 Run the Integra Licox PtO2 Monitor on battery power until the following message appears Battery is low indicating that the battery has 15 minutes or less of remaining charge before the monitor shuts off Note a fully charged battery will take over an hour before falling to the charge level that displays the Battery is low message Keep running the monitor on battery power for another 10 minutes After approximately 10 minutes verify that the monitor Sounds an alarm containing a burst of three pulses e Continues to display the following alarm message on status bar Battery is
90. ng monitor to an equipment pole Grated opening that allows air being circulated by the internal cooling fan to leave the monitor Rubber strap used to secure AC power adapter and other cables during transport 8 Chapter 1 System Overview About the Right Panel The right panel contains Number Item Description 1 PtO2 Port Connection port for the PtO2 probe 2 Temperature Port Connection port for the temperature probe 3 Smart Card Slot Slot for inserting the designated Smart Card for the PtO2 probe Chapter 1 System Overview 9 About the Bottom Panel The bottom panel contains Number Item Description 1 Battery Cover 2 Air Vent Removable cover for accessing replacing the 14 4 V lithium battery Grated opening that allows air intake for internal cooling fan 10 Chapter 1 System Overview About the Left Panel The left panel does not contain any usable connector ports or buttons inTE cud We et ot Fe eg ee s re men oe Ae Chapter 1 System Overview 11 This page is intentionally left blank 12 Chapter 1 System Overview CHAPTER 2 SETTING UP SYSTEM FOR THE FIRST TIME Procedures for Initial Setup Step 1 Unpack the System REF LCX02 Remove the contents from the Integra Licox PtO2 Monitor shipping box and verify the following items are included Warning Only use Integra supplied accessories on the Integra Licox PtO2
91. ng the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 114 Appendix A Technical Specifications APPENDIX B 1 Warranty INTEGRA WARRANTY Integra LifeSciences Corporation and its wholly owned subsidiaries Integra warrants to Integra authorized distributors and the original purchaser only that each new Integra product is free from manufacturing defects in material and workmanship under normal use and service for a period of one 1 year except as otherwise provided as to accessory items from the date of delivery by Integra or its authorized distributor to the original purchaser but in no event beyond the expiration date stated on any product labeling For purposes of products sold by Integra through an authorized distributor of Integra original purchaser shall include the purchaser of Integra products to whom the distributor first sells the product e Surgical instruments are guaranteed to be free from defects in material and workmanship when maintained and cleaned properly and used normally for their intended purpose e Any covered pro
92. nian 107 Classifications and Standards cccccccceccsesceceeeeeeeeeeeeceeeeeeeescseeaeeesseseeaaeeeseseaaaeeeseseaaeeeessensaeeseeeaas 109 Manufacturer s Declaration Table ccccccceeceeeeececcnceeceeeeeeeeeeeeeeeaaeaaeaeeeeeeeeeeeeeeeeceaaeaeeeeeeeeeeteeeees 110 Generali NOS sasefs escsseetscredtleccteteesecat a aA Eea dete aadden uae hides el ead etstetaaw ied neienee teats 110 Appendix B Integra Warranty Warranty score tiara E cae Sane ctharhs bare E E AAE ERE 115 LIST OF SYMBOLS AND ABBREVIATIONS Packaging and Label Symbols Software Symbols iss i aeaaaee aarda aaa aeai ea List of Abbreviations Packaging and Label Symbols Symbol Definition Symbol Definition Follow instructions for use Defibrillation proof type CF applied part gt Caution Direct current Rx ONLY Caution Federal USA law restricts this device to sale by or on the order of a physician Class Il equipment g Serial number Waste Electronics and Electrical Equipment Batch code USB connection Manufacturer CATION 7 ie ene j Rees Safety information for transporting lithium ion batteries Date of manufacture CALIBRATION NEXT SCHEDULED MAINTENANCE DUE 1903759 Rev 1 Due date for annual maintenance HINES SiE Catalogue number List of Symbols and Abbreviations v Software Symbols Symbol Description
93. nitor displays different variations of the alarm bell symbol to indicate three different alarm states Active Audio Paused and Inactive Symbol State Description Active yellow borders Audio Paused crossed out yellow borders Inactive greyed out How the Monitor Prioritizes the Alarms Indicates an active physiological or technical alarm In this state the status bar displays the description of the error that activated the alarm Indicates an active physiological or technical alarm that has been paused temporarily by pressing the active alarm symbol In this state the status bar displays Audio Paused After 3 minutes of silence the Audio Paused message disappears and the alarm will re activate automatically Indicates no physiological or technical alarms are active The Integra Licox PtO2 Monitor assigns each error condition that may activate a physiological or technical alarm type with a range of clinical priorities between medium and low These priorities are determined by two factors e The potential harm that may occur to the patient e How quickly the onset of potential harm may occur if the user fails to respond to the cause of the alarm Clinical Priority Potential Harm If Alarm Is Ignored Timeframe for Potential Harm to Occur Medium Low Reversible injury Reversible injury Prompt Delayed 68 Chapter 6 e Responding to Physiological and Technical Alar
94. nthe Low PtO2 Alarm Limit field specify 15 mmHg D Press Accept 4 Onthe right side of the monitor insert the Smart Card into the slot this will produce a PtO2 measurement of approximately o mmHg 5 After approximately 5 seconds verify the monitor Sounds an alarm containing a burst of three pulses e Displays the following error message on status bar PtO2 below alarm limit e Flashes the alarm symbol on status bar e Flashes the PtO2 value in yellow on the Main Trend and Alarm screens 6 Silence the alarm temporarily On the touch screen press the flashing alarm symbol and verify the monitor Es e Silences the audio alarm e Changes the active alarm symbol to the silenced alarm symbol e Displays Audio Paused on the status bar 7 Wait approximately 3 minutes and verify the monitor re activates the alarms specified in step 5 8 Reset the low PtO2 alarm limit back to the value specified by the clinician see see Step 3B A Inthe Low PtO2 Alarm Limit field specify 15 mmHg B Press Accept Chapter 10 Testing and Preventive Maintenance 99 Testing AC Power and Battery Charge AC Power Notice Before performing these tests verify that the Integra Licox PtO2 Monitor is turned off and not connected to any cables Integra recommends performing this test once every three months 1 Plug the Integra Licox PtO2 Monitor to an AC power outlet 2 Press the power button to turn on the monitor and verify the followi
95. ny order Chapter 10 Testing and Preventive Maintenance 93 Testing Pressure Input Perform the following procedures to test the calibration accuracy of the PtO2 measurements Testing Accuracy of PtO2 Measurements Note the following testing guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment e Test Set BC1OR containing the test Smart Card and test probe e Blue PtO2 probe cable BC10PA or e Blue combined PtO2 temperature probe cable PMOCAB with the required Y adapter cable BC10PMO Notice Before performing this test verify that the Integra Licox PtO2 Monitor is turned off and not connected to any cables 1 Plug the Integra Licox PtO2 Monitor to an AC wall outlet 2 Onthe right side of the monitor connect one of the following probe cables to the monitor e The blue PtO2 probe cable BC10PA to the port labeled PtO2 or e The blue combined PtO2 temperature probe cable PMOCAB with the required Y adapter cable BC1OPMO to the monitor This requires the following steps A Connect the blue and green ends of the Y adapter cable into the ports labeled PtO2 for blue end of cable and Temperature for green end of cable B Connect the blue PtO2 probe cable PMOCAB into the Y adapter cable 3 Onthe right side of the monitor attach the following components that are supplied in the test set BC1OR A Connect the test probe to t
96. obe and Smart Card CC1 SB e Blue PtO2 probe cable BC10PA e Blue PtO2 extension cable if necessary BC10PV Step 1 Connect the PtO2 Probe Cable BC10PA to the Monitor 1 Onthe monitor s right side connect the larger plug of the blue PtO2 probe cable into the blue port labeled PtO2 PtO2 port Blue PtO2 probe cable BC10PA 2 When connecting verify the probe cable snaps into place 3 If additional cable length is required attach the blue PtO2 extension cable BC10PV to the blue PtO2 probe cable Step 2 Insert the PtO2 Probe s Smart Card into the Monitor 1 Remove the single PtO2 probe and designated Smart Card from its packaging Chapter 4 Setting Up System for Clinical Use 33 2 Onthe monitor s right side insert the Smart Card into the Smart Card slot by aligning the arrow on the card with the arrow on the label Smart Card Smart Card inserted into slot 3 When inserting the Smart Card verify the card is positioned securely in its slot and the following message appears No temperature probe detected Use Manual Temperature input 4 Press Accept Notice After pressing Accept the monitor will trigger an alarm that indicates the Smart Card is measuring a PtO2 value of zero which is lower than the PtO2 Alarm Limit value specified on the Alarm tab This alarm will be silenced in the following step 5 Silence the alarm by pressing the flashing alarm symbol
97. ollowing e Sensor board failure e Power board failure e General software programming error e Incompatible firmware error e Sensor board calibration self test failure For a complete list of error codes see page 90 If any of these alarms occur turn off the monitor and then turn back on If the error alarm persists tend to the patient s need note the specific error code and contact Integra for service Chapter 6 e Responding to Physiological and Technical Alarms 71 Responding to Low Battery Alarm The Integra Licox PtO2 Monitor includes a replaceable 14 4 V lithium ion battery that supplies power to the monitor for at least 1 5 hours The battery is intended to power the monitor during patient transport only use AC power whenever possible 15 Minutes or Less of Remaining Power If the battery power level drops to 15 minutes or less of remaining charge the Integra Licox PtO2 Monitor will display the following message on status bar Battery is low If this occurs plug inthe monitor to an AC power outlet This warning message will not disappear until the monitor is connected to AC power 5 Minutes or Less of Remaining Power If the battery power level drops to 5 minutes or less of remaining charge the Integra Licox PtO2 Monitor will activate a medium priority alarm that will e Sound an alarm containing a burst of three pulses e Display the following message on the status bar Battery is low e Flash the battery symbo
98. om the monitor prior to storing the monitor During storage keep the monitor in a dry location that meets the following environmental conditions e Temperature 20 C to 50 C e Humidity 25 to 80 RH non condensing Also ensure the storage location is safe from any liquids that may drip inside the monitor and damage its internal components Using the Cable Strap to Wrap the AC Power Adapter The Integra Licox PtO2 Monitor also includes an adjustable strap for securing the AC power adapter cord and other cables during patient transport or storage To use this cable strap wrap the rubber strap around the bundled adapter cord and secure it by inserting the round plastic fastener through the desired hole Cable strap AC power adapter cord 52 Chapter 4 Setting Up System for Clinical Use CHAPTER 5 MONITORING THE PATIENT S PTO2 AND TEMPERATURE About the Touch Screen scccceeeeeeeeeeeeeeeeeneeeeesseeeeeeeneesenaeseeneeeseceeseseeeeenees 53 About the Alanis oaceces con cct ted ccc cceee ete cece esac ANNAN eens accede wendiecele settee cess cues 55 Monitoring the Patient S PtO2 cccccsseessseeeeeseeeeseeeeeeeeeeeseesenseeeesneeeneeeeaes 55 Monitoring Trend Data cccesseeeeeeeesseeeseeeeeeeeseeseseeeeseseeseeeeseseseneeeeeseeeneneees 58 Setting the Low PtO2 Alarm Litmit ccccseeeesseeeseeeeeseeeseeseeeeeeseesenneeeeeees 61 Customizing the User SettingS ccsecccesscsseeceesseeseseeeeee
99. on Chapter 4 Setting Up System for Clinical Use 47 Connecting to a Patient Bedside Monitor if applicable The Integra Licox PtO2 Monitor provides outputs for connecting to a patient bedside monitor This connection requires two Integra cables Cables REF Description PMIO PMIOMPM Main cable for connecting Integra monitor to patient monitor Monitor Adapter Cable ICP XX and ICT XX Adapter cables that fit between the PMIO cable and the vendor specific patient bedside monitor Note that XX refers to the vendor specific patient bedside monitor code To determine which monitor adapter cables are required for your particular patient monitor contact Integra Warning N Read the user s manual from the patient bedside monitor s manufacturer before connecting the Integra Licox PtO2 Monitor to a patient bedside monitor Procedures for Synchronizing the Two Monitors Perform the following steps to verify that both the Integra Licox PtO2 Monitor and the patient bedside monitor report the same PtO2 values within 1 mmHg for PtO2 values between o and 100 mmHg or 2 mmHg for PtO2 values over 100 mmHg Note that these steps should be performed in each of the following situations e When first connecting the Integra Licox PtO2 Monitor to a patient bedside monitor e Ifthe Integra Licox PtO2 Monitor becomes disconnected from a patient bedside monitor e g due to patient transport to CT or OR and then needs to
100. onitor Options Procedure 1 A Insert the PtO2 probe and temperature probes into the patient For instructions see the instructions for use supplied with each probe B Connect the blue PtO2 probe to the blue PtO2 probe cable see Figure 4 2 verify that they are connected securely C Connect the green temperature probe to the green temperature probe cable see Figure 4 2 verify that they are connected securely OR Chapter 4 Setting Up System for Clinical Use 39 Options Procedure 2 Figure 4 2 Connecting the PtO2 Probe and Temperature Probe to Their Probe Cables rg A Blue PtO2 probe cable W Blue PtO2 probe Green temperature probe Green temperature A Connect the blue PtO2 probe to the blue PtO2 probe cable see Figure 4 2 verify that they are connected securely Connect the green temperature probe to the green temperature probe cable see Figure 4 2 verify that they are connected securely Note that the when the temperature probe is first connected to the monitor and in open air room temperature the monitor e Sounds an alarm and Displays Temperature out of accuracy range on the status bar To silence the alarm temporarily 3 minutes while the temperature probe is still in the air press the yellow alarm Ea button Insert the PtO2 probe and temperature probe into the patient For instructions see the instructions for use supplied with each probe
101. ontacting 105 Temperature manual panel 35 temperature compensation tissue about 56 58 entering manually 35 optimal clinical readings with probes 28 testing input and output 96 temperature probes effects on PtO2 readings 29 optimal clinical readings for 22 23 sensitivity of probe signal 21 warm up time for 22 time and date setting for first time 19 setting the current 65 tissue temperature compensation See temperature 120 Index compensation tissue trend data conditions that reset 77 extracting 75 77 monitoring 58 61 troubleshooting 89 90 troubleshooting 83 91 problems during use 85 90 system failure messages 90 91 system messages 83 85 U USB drives external 75 76 users intended 1 Vv version of software determining 103 WwW warm up time temperature probe readings 22 28 warnings list of general 3 5 warranty Integra 115 Index 121 This page is intentionally left blank 122 Index Integra Licox PtO Monitor For more information or to place an order please contact Integra 311 Enterprise Drive Plainsboro NJ 08536 N T E RA USA and Canada 800 654 2873 609 275 0500 Outside USA wa 609 275 5363 Fax E Fi E integralife com 60904052 Rev A
102. or the temperature value that is displayed on the monitor B If any of the values exceed their tolerance criteria contact Integra 8 Filla water bath or beaker with warm water at approximately 38 C and do the following A Place the Licox temperature probe in the water B Place the reference thermometer in the water C Allow arun in period of at least 15 minutes after the temperature reaches approximately 38 C D On the touch screen press the Main tab and verify the Temperature value matches the reference thermometer reading to an accuracy of 1 C E Ifthe measured temperature on the monitor and the reference thermometer differs by more than 1 C contact Integra 9 Using the DMM measure the resistance in Ohms between the tip and barrel on the quarter inch temperature plug on the PMIO cable 10 Using the table that appears on page 98 A Verify that the measured resistance is between the low and high limits for the temperature value that is displayed on the monitor B If any of the values exceed their tolerance criteria contact Integra 11 Disconnect DMM and turn off monitor Chapter 10 Testing and Preventive Maintenance 97 Temperature vs Resistance Table Output Temperature Range 31 C to 33 C Output Temperature Range 37 C to 39 C Temperature C Lo
103. ple patient PtO2 values and readings that may be displayed in the first 3 hours due to this error Maximum PtO2 Value Actual Patient PtO2 Value Displayed as Result of Warm Up mmHg H mmHg 5 6 10 12 15 17 20 23 To avoid the need to repeat the warm up procedure Integra recommends leaving the monitor on for the duration of a patient s observation including those times when a patient may be disconnected from the monitor Notice The recommended warm up time for optimal clinical readings is independent of stabilization time required for reducing the effects of tissue microtrauma following probe insertion Temperature Effect on PtO2 Readings Once the warm up time is complete there is potential for a 1 C measurement variation when using temperature probes The effect of this variation equates to a PtO2 error of approximately 4 The following table lists example patient PtO2 values and readings that may be displayed as a result of a temperature accuracy of 1 C Actual Patient PtO2 Value PtO2 Values Displayed with a 1 C Temperature Variation mmHg H mmHg 5 5 10 10 15 14 to 16 20 19 to 21 Chapter 3 About the PtO2 Measurements 23 This page is intentionally left blank 24 Chapter 3 About the PtO2 Measurements CHAPTER 4 SETTING UP SYSTEM FOR CLINICAL USE Setting Up System for Clinical USC ccc cccceesseeeeeeeseeeeeee
104. plies to the first 20 minutes to 2 hours after insertion During this phase the PtO2 values do not provide reliable information about tissue oxygenation After the initial phase is over the PtO2 measurements will reflect undamaged tissue Allowing Stabilization Time for Microtrauma After probe insertion allow stabilization time to ensure the PtO2 values represent the oxygen partial pressure of the surrounding tissue accurately Note that this stabilization time may take between 20 minutes and 2 hours To determine if the microtrauma values have stabilized perform an oxygen challenge on the patient per the hospital s recommended procedure Optimal Clinical Readings When Using Temperature Probes Warm up Time Integra recommends turning on the monitor as soon as it is determined that PtO2 readings will be required for a patient Once the power is turned on the Integra Licox PtO2 Monitor requires a maximum 3 hour warm up time if temperature compensation will be measured with a Licox temperature probe Monitoring may begin anytime during device warm up Before the 3 hour warm up time is complete the monitor may read up to 16 higher than the actual PtO2 due to the 22 Chapter 3 About the PtO2 Measurements effects of monitor warm up The majority of this error will be observed during the first hour and the remaining error will continue to resolve until the 3 hour monitor warm up time is complete The following table lists exam
105. probe before clinical use itis not a requirement for calibration as each combinPtO2 probe includes a designated Smart Card When connecting the probe to the monitor prior to implantation ensure that sterility is maintained For sterilization instructions see page 81 Figure 4 3 Connecting the Combined PtO2 temperature Probe to the Combined PtO2 Temperature Probe Cable G F White end of combined White end of combined PtO2 temperature probe PtO2 temperature probe cable Step 5 Allow Stabilization Time for Microtrauma After probe insertion allow stabilization time to address microtrauma normally between 20 minutes and 2 hours this will ensure the PtO2 values reported by the monitor are accurate For details see page 22 Chapter 4 Setting Up System for Clinical Use 45 Step 6 Check PtO2 and Temperature Values On the touch screen press the Main tab and view the PtO2 and Temperature values Synchronize to larm Se s f Ala Setting Monitor Temperature 7 C 37 2 Note that when using a temperature probe the temperature measurement being continuously reported by the monitor with an accuracy of 1 C will be applied to the calculation for PtO2 measurements 46 Chapter 4 Setting Up System for Clinical Use Verifying the PtO2 Probe Functionality Notice The functionality of the PtO2 probe may be verified before and after monitoring by allowing the probe to measure the PtO2 v
106. r persists contact Integra Chapter 9 Troubleshooting the System 91 This page is intentionally left blank 92 Chapter 9 Troubleshooting the System CHAPTER 10 TESTING AND PREVENTIVE MAINTENANCE About These Procedures ccccesseeecceeeseeeeeeeeesneeeseeensnneeeeeeenseeeeeeeeseeeeeeeenees 93 Testing Pressure INMpUut ccccccsseeeeceeesseceeeeeesseceeeeeenseeeseeeenseeseeensseceeeeenenes 94 Testing Pressure OUtpUt ccccscccessseeeeeseeesneeeeeseneeesneeeenseeeseseaeeeeseesesneenenees 95 Testing Temperature Input and Output cceeeesseeeeeeeseeeeeeeeeseeeeeeeeenes 96 Testing Low PtO2 Alarm Limit cccceseseeceeeeseeeeeeeenseeeeeeensenneeeeeneees 99 Testing AC Power and Battery Charge ccccssccsseeeeessceesseeeeeeseeseneneneees 100 Inserting A New Battery ccccsseececeeseeeeeeeeeeneeseeeeseneeseeeeseeeseeeesneeseeeesnene 102 Testing Synchronizing to Patient Bedside Monitot cssssceee 103 About These Procedures Notice The procedures in this chapter are intended for the hospital s biomedical staff Perform the following operational checks periodically to verify that the Integra Licox PtO2 Monitor is operating safely and effectively Some checks may be helpful to diagnose problems that may occur with the system None of these checks require disassembling the monitor Notice The operational checks may be performed in a
107. rature probe cable BC10TA 2 When connecting verify the probe cable snaps into place If additional cable length is required attach the green temperature probe extension cable BC1OTV Step 3 Insert the PtO2 Probe s Smart Card into the Monitor 1 Remove the single PtO2 probe and accompanying Smart Card from its packaging 2 Onthe monitor s right side insert the Smart Card into the Smart Card slot by aligning the arrow on the card with the arrow on the label Smart Card Smart Card inserted into slot 38 Chapter 4 Setting Up System for Clinical Use 3 When inserting the Smart Card verify the card is positioned securely into its slot This will activate a temporary alarm and display the following message No temperature probe detected Use Manual Temperature input 4 Press Accept Notice After pressing Accept the monitor will trigger an alarm that indicates the Smart Card is measuring a PtO2 value of zero which is lower than the PtO2 Alarm Limit value specified on the Alarm tab This alarm will be silenced in the following step 5 Silence the alarm by pressing the flashing alarm symbol Es Step 4 Insert the PtO2 and Temperature Probes into Patient and Connect the Probes to Monitor Depending on hospital protocol you may either insert the PtO2 probe and temperature probe into the patient before see Option 1 or after see Option 2 connecting the two probes to the m
108. ressing the PtO2 Scale button each time will advance the graph to the next range of PtO2 measurements Main Alarm Sattine Synchronize to 7 Montor Extract Data PtO2 Scale Range 60 Chapter 5 Monitoring the Patients PtO2 and Temperature Conditions that Reset Trend Data Some conditions may result in the loss of trend data during the recording process For details see page 77 Setting the Low PtO2 Alarm Limit Press the Alarm tab to specify settings for controlling the physiological alarm This panel includes controls for specifying the low PtO2 limit value turning the alarm on and off and restoring low PtO2 limit from a customized setting to the original default setting 15 mmHg Main Trend Settings Synchronize to Monitor Low PtO2 Alarm Limit 5 Alarm Off Restore Defaults The information on this panel includes Item Description Alarm On Activates the physiological alarm settings If this option is selected the monitor will sound an alarm if the patient s PtO2 value falls below the specified low PtO2 limit value for more than 5 seconds By default this option is selected and set to 15 mmHg see page 62 Alarm Off Deactivates the physiological alarm settings If this option is selected the monitor will disable the current low PtO2 limit value and prevent a low PtO2 alarm from sounding In this mode the monitor will display PtO2 Alarm Off in the status bar Note that techni
109. rical components inside the monitor suffers a serious malfunction during a physiological alarm the Integra Licox PtO2 Monitor will activate a technical alarm that will override the physiological alarm and indicate a system failure If this irreversible technical alarm is activated the monitor will no longer report patient values and the user will need to contact Integra for service For more information on this error condition see page 71 The following table lists the priorities of each alarm condition Alarm Priority Type of Error Condition Type of Clinical Priority 1 System Failures see page 71 PtO2 below alarm limit see page 71 Low battery level 5 minutes or less see page 72 Monitor overheating see page 72 Cooling fan failure see page 73 PtO2 is out of accuracy range see page 73 Temperature is out of accuracy range see page 73 Battery failure see page 74 Low Battery level 15 minutes or less Smart card failure Insert smart card for probe Calibration test failure Cannot write to log file Medium Medium Medium Medium Low Low Low Low N A N A N A N A N A 70 Chapter 6 Responding to Physiological and Technical Alarms Responding to the Physiological Alarm PtO2 below alarm limit If the patient s low PtO2 value falls below the specified limit continuously for more than 5 seconds the Integra Licox PtO2 Monitor will activate a medium priority cl
110. rs see page 28 for details 3 Onthe right side of the monitor A Connect the green temperature probe cable BC10TA to the port labeled Temperature B Connect the Licox temperature probe to the temperature probe cable BC10TA C Insert the Smart Card into the Smart Card slot by aligning the arrow on the card with the arrow on the label Verify that the card is positioned securely into the slot 4 Onthe rear of the monitor connect a PMIO cable PMIOMPM to the port labeled PMIO but not to an external patient bedside monitor 5 Fill a water bath or beaker with warm water at approximately 32 C and do the following A Place the Licox temperature probe in the water 96 Chapter 10 Testing and Preventive Maintenance Place the reference thermometer in water w C Allowarun in period of at least 15 minutes after the temperature reaches approximately 32 C D Onthe touch screen press the Main tab and verify the Temperature value matches the reference thermometer reading to an accuracy of 1 C E If the measured temperature on the monitor and the reference thermometer differs more than 1 C contact Integra 6 Using the DMM measure the resistance in Ohms between the tip and barrel on the quarter inch temperature plug on the PMIO cable Barrel Temperature plug on PMIO cable 7 Using the table that appears on page 98 A Verify that the measured resistance is between the low and high limits f
111. seeseeseeeeeseeeseseeeees 64 About the Touch Screen The Integra Licox PtO2 Monitor includes a touch screen for evaluating and controlling parameters for monitoring the patient s PtO2 The touch screen provides the following tabs for accessing and activating different parameters Synchronize to Settings f Monitor Temperature 1 C 37 2 Tab Description Main Provides tools for evaluating the patient s PtO2 mmHg For details see page 55 Trend Provides tools for monitoring a 5 day history of the patient s PtO2 values For details see page 58 Alarm Provides tools for specifying low PtO2 limits the monitor will tolerate before sounding an alarm For details see page 55 Settings Provides tools for specifying languages date and time For details see page 64 Chapter 5 Monitoring the Patients PtO2 and Temperature 53 About the Synchronize to Monitor Button If you are planning to display patient data from the Integra P OTE Licox PtO2 Monitor to a patient bedside monitor press the Preme Synchronize to Monitor button to initiate the process of synchronizing the two monitors with each other This process ensures that both monitors are displaying the same PtO2 values for the patient within 1 mmHg for PtO2 values between o and 100 mmHg or 2 mmHg for PtO2 values over 100 mmHg For instructions on synchronizing the monitors see page 48 Reviewing the Status Bar When using the
112. sting and maintaining the monitor The procedures in Chapter 10 are intended to be performed by the hospital s biomedical engineering staff Chapter 1 System Overview 1 Intended Patient Population Patients undergoing treatment with this monitor under the cranial applications are expected to have had a traumatic brain injury undergone a major neurosurgical procedure or some other traumatic ischemic or hemorrhagic incident requiring controlled monitoring of PtO2 Description of the Integra Licox PtO2 Monitor The Integra Licox PtO2 Monitor provides functionality for continuously monitoring oxygen partial pressure PtO2 in brain tissue Tissue temperature compensation which is required for the calculation of PtO2 measurements may also be continuously measured with an accuracy of 1 C To measure PtO2 and temperature tissue compensation continuously the Integra Licox PtO2 Monitor supports a series of minimally invasive probes that are inserted directly into the patient e The PtO2 probe uses an electrochemical polarographic micro cell for oxygen measurements e The temperature probe uses a thermocouple type K for temperature measurements In place of a temperature probe the monitor also provides an option for entering tissue temperature compensation values manually for the calculation of PtO2 measurements PtO2 Probe s Calibration Data Stored on Smart Card Each Integra PtO2 probe includes a designated Smart
113. stop bit even parity configurations 700 to 1060 hPa Shipping Storage Pressure 500 to 1060 hPa Operation Limits e Temperature 15 C to 30 C e Humidity 30 to 75 relative humidity non condensing Shipping Storage Limits e Temperature 20 C to 50 C e Humidity Relative humidity ranging from 25 to 80 Accuracy in Long Term Operation PtO2 Probe e Range o 20 mmHg 2 mmHg e Range 21 50 mmHg 10 e Range 51 150 mmHg 13 Temperature Probe e 1 C Test Probe 154 7 0 4 mmHg at 22 C Rated PtO2 Accuracy Range o to 150 mmHg Rated Temperature Accuracy Range 30 to 42 C Factory Default Temperature for Manual Setting Factory default is 37 C when setting the temperature manually 108 Appendix A Technical Specifications Item Specification Protection Against Electric Shock Class Il type CF defibrillation proof applied parts PtO2 probe temperature probe Protection Against Harmful IPXO Ingress of Water Mode of Operation Continuous Fire Hazard Not suitable for use in the presence of flammable anesthetics mixture with air oxygen or nitrous oxide Languages English Danish Dutch French German Italian Polish Spanish Portuguese Brazilian Chinese Simplified Japanese Korean Russian 1 This accuracy range does not include the accuracy of the patient bedside monitor which may
114. t If the patient s PtO2 falls below this limit for more than 5 seconds an alarm will sound To specify this limit see page 62 4 Displays the current tissue temperature in degrees Celsius C with an accuracy of 1 C when a temperature probe is connected to the monitor This value which represents tissue temperature compensation will be applied to the calculation of PtO2 measurements see page 56 5 Provides controls for specifying the tissue temperature manually if no temperature probe is connected to the monitor see page 35 Manca Temperature input This value will be applied to the calculation of PtO2 measurements How the Monitor Reports PtO2 Values The patient s continuously measured PtO2 value that is displayed on the touch screen is rounded to the nearest 1 mmHg If the patient s rounded PtO2 value falls below the user specified low PtO2 alarm limit for more than 5 seconds the monitor will trigger an alarm For example if the low PtO2 alarm limit is set to 18 mmHg the alarm will trigger when the PtO2 value is less than 17 5 mmHg for more than 5 seconds How the Monitor Applies Tissue Temperature Compensation The Integra Licox PtO2 Monitor provides two options for applying the tissue temperature compensation value that is required for the calculation of PtO2 measurements 56 Chapter 5 Monitoring the Patient s PtO2 and Temperature e Use of temperature probes to measure temperature continuously
115. t depend on temperature The temperature sensitivity of the probe signal is compensated for when the Integra Licox PtO2 Monitor calculates the PtO2 value Therefore the temperature of the PtO2 probe must be supplied to the Licox PtO2 monitor by either of the following methods Chapter 3 About the PtO2 Measurements 21 e Using an Integra temperature probe to measure the tissue temperature continuously to an accuracy of 1 C recommended when the tissue temperature is variable or unknown or e Using the Manual Temperature Input controls on the monitor s touch screen to specify the tissue temperature manually Note that the second bullet point above may be preferred when the patient s core temperature is continuously monitored by other means for example with a foley catheter thermistor Microtrauma Caused from Probe Insertion During the start of patient treatment a local microtrauma results from the insertion of the PtO2 probe When this occurs tissue is affected in a layer concentrically surrounding the probe Effects of Microtrauma on PtO2 Measurements The measured PtO2 value corresponds to the mean value of the local PtO2 levels at the interface between the damaged tissue around the probe and the surrounding undamaged tissue Tissue without oxidative metabolism is transparent to PtO2 measurements Immediately after inserting the PtO2 probe the PtO2 readings are influenced by the evolving microtrauma This normally ap
116. ted to extend the Integra probe cable with non Integra extension cables To prevent the Integra Licox PtO2 Monitor from overheating e Donot block the air vents on the rear and bottom of the unit e Donot place the monitor on a soft or uneven surface which may result in blockage of the monitor s air vents For example do not place the monitor on the bed during patient transport Chapter 4 Setting Up System for Clinical Use 25 Notice If you are using probes to measure temperature the Integra Licox PtO2 Monitor contains sensitive electrical components that are susceptible to ambient temperature changes To ensure optimal performance for measuring tissue temperature compensation e Do not position the monitor near equipment that generates air turbulence e g fans heaters air conditioners etc e Donot position the monitor near equipment or in a location that generates heat e g laptop or direct sunlight Do not position in an environment that exceeds the monitor s operation limits for temperature between 15 C and 30 C Attaching to Equipment Pole if applicable The Integra Licox PtO2 Monitor includes a pole clamp for attaching the monitor to an equipment pole To attach 1 On the rear of the monitor fit the pole clamp around the equipment pole 2 Tighten the knob on the pole clamp to secure the monitor to the equipment pole Pole clamp attached to equipment pole Pole Clamp
117. tegra List of Warnings for Using the Monitor A Failure to observe one or more of the following warnings could compromise patient safety or result in measurement errors Warnings Use of the Integra Licox PtO2 Monitor is restricted to one patient at a time The Integra Licox PtO2 Monitor and its accessories are contraindicated for use in a Magnetic Resonance MR environment This equipment is not a bloodgas device Always verify the low PtO2 alarm limit is set appropriately for each patient prior to treatment Selecting the Alarm Off feature on the Alarm panel will disable the low PtO2 alarm limit indefinitely Use caution if this feature is selected To re enable this alarm select the Alarm On and Accept buttons No modification of the Integra Licox PtO2 Monitor is allowed Only use the designated Smart Card supplied with the PtO2 probe Using the wrong Smart Card will produce incorrect PtO2 measurements The Integra Licox PtO2 Monitor is a sensitive electronic device When using the monitor always handle with care If damage is suspected contact Integra The calculations for PtO2 measurements require tissue temperature compensation If you are not measuring the tissue temperature with a probe the temperature has to be entered manually Make sure to measure the patient s tissue temperature either hourly or prior to recording the PtO2 values for intervention If any changes in temperature occur use the Manual Tempera
118. tery charge does not last a minimum of 1 hour and 30 minutes contact Integra to order a new battery Chapter 10 Testing and Preventive Maintenance 101 Inserting A New Battery The Integra Licox PtO2 Monitor requires the Integra supplied 14 4 V lithium ion battery REF BAT1001 to provide battery power to the monitor during transport To order a replacement battery contact Integra To insert the battery 1 Verify that the Integra Licox PtO2 Monitor is turned off and the AC power adapter is unplugged 2 Turn the monitor upside down so the handle is facing downward 3 Remove the 2 screws and take off the battery cover 4 Remove the old battery by gently pulling the battery from the monitor s connector slots Make sure to dispose of the old battery according to local regulations 5 Insert the new battery A Verify the Integra logo on the battery label is facing up B Align the battery s connectors on the front of the battery to the connector slots on the monitor C Slide the battery s connector into the monitor s connector slots until the battery is fully inserted into place Notice The battery for the Integra Licox PtO2 Monitor can only be inserted in one orientation 6 Secure the battery cover to the monitor by re inserting the two small screws N To prevent injury to the patient user or other persons make sure to close the battery cover securely Note that the battery cover should remain
119. the probe B Connect the white end of the combined PtO2 temperature probe to the white end of the combined PtO2 temperature probe cable see Figure 4 3 verify that they snap into place C Note that the when the combined PtO2 temperature probe is first connected to the cable and in open air room temperature the monitor e Sounds an alarm and e Displays Temperature out of accuracy range on the status bar To silence the alarm temporarily 3 minutes while the temperature probe is still in the air press the yellow alarm Es button OR 44 Chapter 4 Setting Up System for Clinical Use Options Procedure 2 A Connect the white end of the combined PtO2 temperature probe to the white end of the combined PtO2 temperature probe cable see Figure 4 3 verify that they snap into place B Note that the when the temperature probe is first connected to the cable and in open air room temperature the monitor e Sounds an alarm and e Displays Temperature out of accuracy range on the status bar To silence the alarm temporarily 3 minutes while the temperature probe is still in the air press the yellow alarm Es button C Insert the combined PtO2 temperature probe into the patient For instructions see the instructions for use supplied with the probe Notice The purpose of connecting the combined PtO2 temperature probe to the monitor prior to implantation is to verify the functionality of the
120. tient prior to treatment Notice The default setting for the Low PtO2 Alarm Limit is15 mmHg If a new low PtO2 limit is specified the Restore Default button which appears on the Alarm panel can be used to restore the low PtO2 limit back to 15 mmHg 1 On the touch screen press the Alarm tab 2 Press the Alarm On button this will activate the alarm settings Main Low PtO2 Alarm Limit Alarm Off 62 Chapter 5 Monitoring the Patient s PtO2 and Temperature 3 Inthe Low PtO2 Alarm Limit field use the arrows to specify the low PtO2 limit value for the patient Note that the range limits are 1 mmHg and 150 mmHg 4 Press Accept If the patient s PtO2 value falls below this specified limit for more than 5 seconds the monitor will activate the physiological alarm To respond to this alarm see page 71 Touch Screen Labels Indicating Low PtO2 Limit Note that the PtO2 value specified in the above step 3 appears in the Main and Trend screens as the following indicator labels e A horizontal line in the graph corresponding to the specified low PtO2 limit value e Anumber value next to the active alarm symbol Synchronize to Monitor Main Alarm Settings Extract Data Data Low PtO2 Streaming alarm limit Low PtO2 set alarm limit Temperature 1 C 37 0 Disabling the Low PtO2 Alarm To turn off the low PtO2 limit and prevent the Integra Licox PtO2 Monitor from sounding a physiological
121. ting Trend Data for Remote Evaluation CHAPTER 8 CLEANING AND STERILIZING THE SYSTEM Cleaning the System and Component s seceeseesseeeeeseeeesseeeeeseeeeenees 79 Sterilizing the Probe Cables and Probe Extension Cables 0 0 81 About Single Use Only Probes cccseccssseeeeeeeeeesnaeeeeeeeeesseaeeneeneesneaeeensees 82 Disposal of the Monitor System and Components ccsseeesseeeeeeeees 82 Cleaning the System and Components Cleaning Guidelines Before cleaning the surface and touch screen of the Integra Licox PtO2 Monitor note the following Turn off the monitor before cleaning To reduce the risk of shock follow all safety notices and never open the monitor case e The monitor is designed for surface cleaning only do NOT immerse e Never spray cleaning agents or other fluids directly onto the monitor e Use particular care when cleaning around the vents connectors Smart Card slot and USB slot Be sure to wipe any excess fluid that accumulates in these areas e When cleaning the touch screen do not use cloth or sponges that could scratch the surface Use the following guidelines when cleaning the Integra Licox PtO2 Monitor and each of its system components that are listed in the box below e External surface e Touch screen e Cable strap Blue PtO2 probe cable BC10PA e Green temperature probe extension cable BC10TV Blue PtO2 probe extension cabl
122. tings r a aia a a aaa enaa aa aaa aa a Anaa KREE T EEE eee 64 Chapter 6 Responding to Physiological and Technical Alarms About the Two Alarm Typos cccssssseceeseseseeeeeeeeseceeeeeeeseaeaeeeeeaaeeseeensaaaeaeeeeseaaeeeeseseaaaeseseeeeeeeeneeeseeees 67 About the Technical Messages cccecceeeeeeeeeeeeeeeceeeeeeeeeeaeeeeeeeaeeeeeeseaaeeeeeeseaaeeeeeeseneeeeesseeeeaeeseneeaeees 67 Understanding the Alarm SyMboIs cccccceceeeeeeeeneeeeecaeeeeaaeeeeaeeeceaaeeseaaeeeeaaaeeseaeeessaaeeseeeeeeseaetenees 68 How the Monitor Prioritizes the Alarms c ceeeeseeeeeeecee eter tees ee ee etna eee eee aae ee eee eaaeeeeeeeeaaeeeeeeeaeeeenee 68 Audio and Visual Indicators for Medium and Low Priority Alarms ceeeeeeeeeeeeeeeeeeeeeeeeeeeees 69 Priorities of Physiological and Technical Alar ccceceeeeeeeeeeeeeeeeeeeeeeeaeeeeeteeaaeeeeeeeaaeeeeeeeaaas 69 List of Priorities tor Bach Alarm esenea i cestode eens T bie scale ees ee tec AE 70 Responding to the Physiological Alarm PtO2 below alarm limit ccccccseeeeeeeeeeeceeeeeeeeeteeeeseneees 71 Responding to Technical Alarims aceroana anae kini asia RARI eatae NOE e saia Ei p raie LAARS CEARA E Ta R eTR 71 Responding to System Failure Alarms cc cccccecceeeeeeeeeeeeeeeaeeseneeeeeaaeeeseeeeesaaaeseeaaeeseeeeseaeetees 71 Responding to Low Battery Alarm eeeeecccceeeeesneeeeeeeenaeeeeeeeaaeeeeeeeeaaeeeeeeeaaeeeeeeseaaeeeeeneeaeeeeeneaa
123. tomer then and in that event Integra or Customer as the case may be shall promptly notify the other party hereto of the resulting difficulties therefrom and any of the foregoing events shall excuse any performance required under the Warranty 118 Appendix B Integra Warranty INDEX Numerics 3 hour warm up time temperature probes 28 A abbreviations list of vii AC power connecting to 27 preparing the plug for 17 testing 100 accuracy ranges PtO2 and temperature 73 PtO2 readings with temperature probe 22 23 synchronize to monitor feature 48 alarms about the 67 disabling low PtO2 limit 63 priorities of 68 70 silencing temporarily 68 symbols for 68 testing low PtO2 limits 99 alarms responding to battery failure 74 cooling fan failure 73 exceeding accuracy range 73 74 low battery 72 monitor overheating 72 system failure 71 ambient temperature effects of 6 annual maintenance 105 assembly for clinical use 25 51 for first time use 13 20 audio paused symbol 68 B battery alarms responding to failure 74 responding to low charge 72 charging determining status of 54 55 indicator symbols for 55 testing 101 installing for first time 16 replacing 102 storage 31 BC10 probe cable kit 15 bedside monitor connecting to 48 51 biomed tests 93 103 c calibration annual monitor 105 cleaning sytem components 79 80 clinicians intended 1 coagulation problems 5 compensation tissue temperature See
124. ture Input arrows to specify the new temperature value accordingly Read the user s manual from the patient bedside monitor s manufacturer before connecting the Integra Licox PtO2 Monitor to a patient bedside monitor To prevent injury to the patient user or other persons or to prevent damage to the monitor always verify that the monitor is clamped securely to the equipment pole Chapter 1 System Overview 3 Warnings e To prevent injury to the patient user or other persons or to prevent damage to the monitor make sure to position the cables so that they are free from all foot traffic To reduce the risk of electric shock do not disassemble the Integra Licox PtO2 Monitor Refer all servicing to qualified service personnel at Integra To prevent electrical shock only use the AC power adapter supplied by Integra REF MONPWR Using a different AC power adapter may not provide protection against electric shock Danger Possible explosion hazard if used in the presence of flammable anaesthetics Halothane interferes with polarographic PtO2 probe measurements It causes an overestimation which is usually reversible within 20 minutes after discontinuation Other commonly used anesthetic gases e g N20 Enflurane or Isoflurane are not known to interfere with polarographic PtO2 probe measurements Temperature measurements may be inaccurate if the connector of the temperature sensing probe is subjected to considerable chan
125. ueaueeeeeeseeaaaeeeeees 22 Allowing Stabilization Time for Microtrauma 0 ccccececeeeeeeceeeeeeeeeeeeeaeeeeeeeeeseaeeeseaeeeeeeeeeseaeeeee 22 Optimal Clinical Readings When Using Temperature Probes cccccceceeeeeeeeneeececeeeeeeeeeseeeeteeeeees 22 Warm up DIME icra ees A Se A ar EAA EA AEA T aE A AAEE E TEA RE EARE 22 Temperature Effect on PtO2 ReadingS sesseseeesseeesseesssesssnssrietsessstnssstnsetnnstnnnetnnnnnnnennnnnnnnne 23 Chapter 4 Setting Up System for Clinical Use Setting Up System for Clinical USC ececcececeeeeeeeee cece eeeeeee eee aeeeseaeeeeeeaeeesaaeeeseaeeeseaaeseeeeeessaeeeeeneeees 25 Positioning the MOnitor aariin iei a ENE E NE NEE A E ENEE 25 Attaching to Equipment Pole if applicable ee ecceeeeeeeeeeeeeeeeeeaeeeeeeeeaaeeeeeeeaaaeeeeeneeaeeeeeneaaes 26 Powering the System On and Off cccceceeeeeeeeeeeeeeeeeeeee cee eeeeeaeeeeeeeeeesaaeeseneeeesaaaeseceeeeesaeeeeeneeess 27 Optimal Clinical Readings When Using Temperature Probes cccccceceeeeeeeeneeeeeceeeeeeeeeseeeeeeeeeees 28 Warm Up slime oaiae de Sus AOA aE ASENA A Eae AEEA TOE PEE da beatae dada OE AEREE RESOR ER 28 Temperature Effect on PtO2 ReadingS cccceecceceeeeeceeeeeeseeeeeeeaeeeceaaeeeseaeeseaeeeseaeeseeeeeeeiaeeeee 29 Effects of Tissue Microtrauma on PtO2 Measurements ccccecceeeeeeeeeeeeeeeeeeeeeeaeeeeeaeeeteaeeeees 29 Usingthe Battery for POWEL caccfcecicscccccesssadcccess
126. uire the following components Measurements Components PtO2 e Single PtO2 probe and Smart Card CC1 SB e Blue PtO2 probe cable BC10PA Blue PtO2 probe extension cable if necessary BC10PV Temperature e Single temperature probe C8 B e Green temperature probe cable BC10TA Green temperature probe extension cable if necessary BC10TV Notice If you are measuring temperature compensation with a probe do not touch the connector on the probe cable for a prolonged period of time before connecting it to the Temperature port on the Integra Licox PtO2 Monitor Touching this connector may affect the initial temperature compensation readings If this temperature fluctuation occurs the PtO2 measurements will be unreliable Step 1 Connect PtO2 Probe Cable BC10PA to the Monitor 1 On the monitor s right side connect the large plug of the blue PtO2 probe cable into the blue port labeled PtO2 PtO2 port Blue PtO2 probe cable BC10PA 2 When connecting verify the probe cable snaps into place 3 If additional cable length is required attach the blue PtO2 extension cable BC10PV to the blue PtO2 probe cable Chapter 4 Setting Up System for Clinical Use 37 Step 2 Connect the Temperature Probe Cable BC10TA to the Monitor 1 Onthe monitor s right side connect the green temperature probe cable into the green port labeled Temperature Temperature port Green tempe
127. unctioning correctly Ifthe one second startup tone does not sound during the startup process contact Integra for service Notice There is a short beep when the monitor is first turned on this is not the one second startup tone Chapter 4 Setting Up System for Clinical Use 27 B Verify the monitor s screen displays the Main panel AN The purpose of the startup tone is to verify that the audio alarms are functioning correctly If this tone does not sound during the startup process contact Integra for service To prevent injury to the patient user or other persons or to prevent damage to the monitor make sure to position the cables so that they are free from all foot traffic Turning Off the System On the front of the monitor press the power button If the monitor ever freezes and does not turn off press and hold the power button for several seconds to perform a forced shutdown of the system Optimal Clinical Readings When Using Temperature Probes Warm Up Time Integra recommends turning on the monitor as soon as it is determined that PtO2 readings will be required for a patient Once the power is turned on the Integra Licox PtO2 Monitor requires a maximum 3 hour warm up time if temperature compensation will be measured with a Licox temperature probe Monitoring may begin anytime during device warm up Before the 3 hour warm up time is complete the monitor may read up to 16 higher than the actual PtO2
128. vary be tween manufacturers If drift occurs persistently between the two monitors that exceeds 1 mmHg or 1 of the Integra monitor s reading contact the biomed department to determine the cause of drift Classifications and Standards The Integra Licox PtO2 Monitor has been designed for continuous operation The Integra Licox PtO2 Monitor meets the safety and essential performance requirements for medical electrical equipment e 60601 1 1 4 1 8 2 49 2nd edition EMI EMC e EN60601 1 2 2nd edition 2001 e EN60601 2 49 2nd edition 2001 Safety and Essential Performance e EN60601 11990 with A1 1993 and A2 1996 e UL IEC 60601 1 2003 e CSA 60601 1 1990 with A1 1994 and A2 1998 e EN UL IEC CSA 60601 1 4 1996 with A1 1999 e EN60601 1 8 2004 with A1 2006 e UL IEC 60601 1 8 2003 with A1 2006 e CSA 60601 1 8 2003 e EN UL IEC 60601 2 49 2001 e CSA 60601 2 49 2004 Appendix A Technical Specifications 109 Manufacturer s Declaration Table General Notes The information contained in this section such as separation distances is in general specifically written with regard to the Integra Licox PtO2 Monitor The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such Medical electrical equipment requires special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into service according to the EMC information provided
129. vastccpeesteaddcenevbeace cezeresaucecditvaadeteeed ssacceesdetuvdsbestaadeenetnnaes 29 Battery Power Marat cc sraa E E E cats Sees daihen gives idaasane 30 storing the Battery Aiticeiiin snd aici cai eet ca cv en atlases 31 About the Integra ProB Si visi feepeccencccetbon ceed eeuescce anar EATA Clap Ge dawebeniae dekavatcatenstustac cdusssuetecebaustdeeseecatens 31 About the Integra PtO2 Probes and Smart CardsS cceccccceseeeeeeeeeeeceeeeeeeeeeceaeeeseeeeeeeeeeseaeetee 31 Connecting a Single PtO2 Probe ccccceceeeeeeeeeeeeeeeeeeeeaeeeeeeeeeceaeeeeeneeeseaaeeeeaaeeseaaeeesaaeeseeeeeeeeaeeeeeeeees 33 Connecting a Single PtO2 Probe with a Single Temperature Probe cceeseceeeeeeeeeeeeeeseteeeeeeeeeees 37 Connecting the Combined PtO2 Temperature Probe ccccccceeeeeeeeeeeeeeeseeeeeeeeeeeaeeeeneeeeseaeeseeneeess 42 Verifying the PtO2 Probe Functionality ccccccccsseeceeeeeeeeneeeeeeeeeeeeaeeseeeeeeesaaeeeeneeeesaeeeseeeeeeseaeeeeeeeeees 47 Connecting to a Patient Bedside Monitor if applicable c ceceeeeeeeeeeeeeeeeeeeeeeeeeaeeeseeeeseceeeeeeeeees 48 Procedures for Synchronizing the Two Monitors 0 ccc cccceeeeeeeeeeeeeeeeeeeseeeeeeeeeeeseaaeesecaeeeeeneeeees 48 storing the System t e a a ihe aa ae wah Ailton a eer eatin fade Aerated 52 Chapter 5 Monitoring the Patient s PtO2 and Temperature About the TOUCH Oore G a aa aa a a a aa aa a a a a a a a A Aaaa a Aa E Eai
130. ves the right to fill spare parts requests using refurbished sub assemblies provided that such sub assemblies are functionally equivalent to new sub assemblies and carry the same warranty as the replaced sub assemblies Notification In order to avail itself of its rights under the Warranty Customer must immediately notify Integra of any defects and provide Integra every opportunity to inspect and remedy defects Included under the Warranty are the following services 3 1 1 Modifications to Covered Equipment From time to time at its sole discretion Integra may propose modifications to the covered Equipment and to the specifications for the Equipment Specifications Subject to Customer s approval and at its sole expense the Customer may request 116 Appendix B Integra Warranty 4 Quality Control 4 1 4 2 5 Limitation of Liability 5 1 5 2 5 3 Integra to make such modifications to the covered Equipment and to the Specifications Integra shall make such modifications for the Customer which modifications may include the installation of new parts in the Equipment at a price equal to the then current list price for such modifications as such list price is established by Integra in its sole discretion Customer shall maintain reasonable standards of quality control operations procedures safety testing and inspection of Equipment to ensure that unnecessary service or maintenance is not required hereunder
131. voltage power CISPR 11 supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Appendix A Technical Specifications 111 Guidance and manufacturer s declaration electromagnetic immunity The Integra Licox PtO2 Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Integra Licox PtO2 Monitor should assure that it is being used in such an environment IEC 60601 Compliance Electromagnetic environment Immunity test test level level guidance Electrostatic 6 kV contact 6 kV Floors should be wood concrete or ceramic tile If discharge ESD floors are covered with synthetic material the 8 kV air 8 kV relative humidity should be at least 30 IEC 61000 4 2 Electrical fast 2 kV for power supply 2 kV Mains power quality should be that of a typical transient burst lines commercial or hospital environment IEC 61000 4 4 1 kV for input output lines 1kV Surge 1 kV line s to line s 1 kV Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 5 2 kV line s to earth 2 kV Voltage dips short lt 5 U lt 5 U Mains power quality should be that of a typical interruptions and gt 95 dip in U for 0 5 cycle commercial or hospital environment If the user of voltage variat
132. w Q High Temperature C Low Q High Q 31 1727 1751 37 1337 1367 311 1718 1751 371 1335 1361 31 2 1709 1742 37 2 1330 1359 31 3 1692 1742 37 3 1325 1354 31 4 1692 1733 37 4 1320 1349 31 5 1684 1716 37 5 1310 1344 31 6 1676 1708 37 6 1305 1334 31 7 1676 1700 37 7 1300 1329 31 8 1668 1700 37 8 1295 1324 31 9 1660 1692 37 9 1290 1319 32 1652 1684 38 1285 1314 32 1 1635 1684 38 1 1280 1309 32 2 1635 1676 38 2 1275 1304 32 3 1627 1659 38 3 1270 1299 32 4 1627 1651 38 4 1266 1294 32 5 1620 1651 38 5 1261 1290 32 6 1612 1644 38 6 1256 1285 32 7 1604 1636 38 7 1251 1280 32 8 1597 1628 38 8 1242 1275 32 9 1582 1628 38 9 1238 1266 33 1582 1621 39 1233 1262 98 Chapter 10 Testing and Preventive Maintenance Testing Low PtO2 Alarm Limit Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment 1 Smart Card not the test Smart Card Notice Before performing this test verify that the Integra Licox PtO2 Monitor is turned off and not connected to any cables Also verify that no Smart Card is inserted into the monitor 1 Plug the Integra Licox PtO2 Monitor to an AC wall outlet 2 Turnon the monitor 3 On the Alarm tab A Press the Alarm On button B Note the current Low PtO2 Alarm Limit value specified by the clinician After completing this test you will reset the alarm limit to this value C I
133. wo monitors use the Integra Licox PtO2 Monitor s PtO2 values for the patient s measurements and repeat the procedures for synchronizing the two monitors see page 48 About PtO2 and Temperature Measurements on the Patient Bedside Monitor The Integra Licox PtO2 Monitor is designed to measure PtO2 between the range of o mmHg and 150 mmHg and tissue temperature with an accuracy of 1 C between the range of 30 C and 42 C If the PtO2 or temperature value is outside these specific ranges on the Integra Licox PtO2 Monitor while it is connected to the patient bedside monitor the Integra monitor will activate a low priority alarm for either the PtO2 or temperature accuracy range alarm condition see page 73 Depending on the type of alarm condition the Integra monitor will also transmit either a PtO2 value of 15 mmHg or a temperature value of 15 C to the patient bedside monitor to indicate that the Integra monitor is unable to make accurate measurements 2 Theaccuracy range stated in this description does not include the accuracy of the patient bedside monitor which may vary between manufacturers If drift occurs persistently between the two monitors that exceeds the stated accura cy range contact the biomed department to determine the cause of drift Chapter 4 Setting Up System for Clinical Use 51 Storing the System If the Integra Licox PtO2 Monitor will not be used for several months or longer remove the battery fr
134. xceeds the applicable RF compliance level above the Integra Licox PtO2 Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Integra Licox PtO2 Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Appendix A Technical Specifications 113 Recommended separation distances between portable and mobile RF communications equipment and the Integra Licox PtO2 Monitor The Integra Licox PtO2 Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Integra Licox PtO2 Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Integra Licox PtO2 Monitor as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 80 MHz to 800MHz 800 MHz to 2 5 GHz w d 1 17 P d 1 17 P d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated usi

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