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User`s Manual - Integra LifeSciences

1. sssssssseeeene eene ener enne nenne 73 Chapter 9 Testing and Preventive Maintenance About These ProCedUtes 2 ccrtc sede pec let us te bo ceeds dans pc DEAD RR AE RD ie be aides 75 Use Fiber Optic Catheters for Each Test enn 75 Testing Pressure Input eiecit Led eet ce t dede e et Le deu o bet Fe a ende 76 Using a Graduated Drainage Bag oisein da ienna AE AAEE E EEE EE 76 Using a Pressure Simulator preferred method sssssssssseeeenne enn 78 Testing Pressure NPU ioan i en he e OTT i RE E ER HERE ceed REESE peat e 79 Testing TemperatutreInpUut ideo udo reet bn bit on iE me Ende ctun Ad diae aeta aad e nec ai aed 80 Testing Temperature Output eene nennen rente nnns nennen nnn en nenne nrt enter ness n nnn 81 Testing High ICP Alarm LIMIT ae en A ecce nnne nnne nne nnn nennen nnne netten nnne nn 84 Testing AC Power and Battery Charge sssssssssssseseeeeene enne eren nennen nennen nennen 85 AG POWGM gm MEINE 85 Low Battery ui niaii ad eh dai Aa E aA Aina deh Sane inven We 85 Battery Charge a 5a tie bt b Pod edt tad epa tie rbi n te E be tub reiecta tee 86 sening A New Batteby itp e p e i E ee p Es 86 Determining Software Version cccccccceecccceeeeeeececeeeseeeceeeeeseceeceeeneetaceeeesadaceeeesseaeeceeesensaeeeeesndecenetenaes 87 Testing Synchronizing to Patient Bedside Monitor emen 87 Chapter 10 Contacting Integra for Technical Support and Annual Maintena
2. ccccceesccccceeeeeccceceesesececeeesnececeeenssaaecensanacecensngeaeceesesnececeeeneseeeneetaaes 47 About the Technical Messages erani n e EEEE EAF EEEE EREA AE EA AAG 47 Understanding the Alarm Symbols ssssssssseseeen enne nenne nennen nene enne 48 How the Monitor Prioritizes the Alarms sssssseseeenenen een ennemis 48 Audio and Visual Indicators for Medium and Low Priority Alarms sseeeeeee 49 Priorities of Physiological and Technical Alarms ssssseeem em 49 List of Priorities for Each AlAT irni eriin a e ae nere nnne nene nennen 50 Responding to the Physiological Alarm ICP above alarm limit e 51 Responding to Technical Alarms sssssssssseeeneeeeee enemies eren nenne ener nnn 51 Responding to Irreversible System Failure Alarms sssseeeen 51 Responding to ICP Catheter Failure Alarm sessssseeeeene emen 52 Responding to Temperature Sensor Failure Alarm sssssssseseseeee 52 Responding to Low Battery Alarm ssssssessseee enne ennemis 52 Responding to Monitor Overheating Alarm enne 53 Responding to Cooling Fan Failure Alarm essen nemen nens 53 Responding to Accuracy Range Alarm sse enemies 54 Responding to Battery Failure Alarm sssssssseeenne eene rennen 55 Chapter 6 Extracting T
3. Testing Pressure Input Perform the following ICP input tests with either a graduated drainage bag or a pressure simulator Using a Graduated Drainage Bag Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment Integra Camino Fiber Optic Catheter Cable New Integra Camino Fiber Optic Catheter 110 4 series ICP measurements only IV bag with water IV pole Y hemostasis valve Ruler Notice Before performing this test verify that the Integra Camino ICP Monitor is turned off and not connected to any cables 1 Plug the Integra Camino ICP Monitor to an AC wall outlet 2 Ontheright side of the monitor attach the Fiber Optic Catheter Cable and a functional Fiber Optic Catheter to the ICP CAMCABL port 3 Fill half of the IV bag with water 4 Connect one end of the tubing to the IV bag and the other end to a Y hemostasis valve Y Hemostasis Valve Catheter s Tip 76 Chapter 9 Testing and Preventive Maintenance 5 Insert thetip of the Fiber Optic Catheter into the Y hemostasis valve through the duckbill valve 6 Open the valve from the IV bag and remove the end of the cap from the Y hemostasis valve Let water flow until the tubing and Y hemostasis valve fill with water 7 Verify that air bubbles are not present and replace the end cap 8 Verify that the water level from the IV bag and the ti
4. Setting the High ICP Alarm Limit Press the Alarm tab to specify settings for controlling the physiological alarm This panel includes arrows for specifying the high ICP alarm limit value turning the alarm on and off and restoring the high ICP alarm limit from a customized settin g to the factory default setting 20 mmHg Synchronize to Monitor Trend Settings High ICP Alarm Limit 5 Alarm Off Restore Defaults The information on this panel includes Item Description 1 Alarm On Activates the physiological alarm settings If this option is selected the monitor will sound an alarm if the patient s displayed Mean ICP exceeds the specified high ICP alarm limit for more than 5 seconds By default this option is selected and set to 20 mmHg 2 Alarm Off Deactivates the physiological alarm settings If this option is selected the monitor will disable the high ICP alarm and prevent a high ICP alarm from sounding In this mode the monitor will display ICP Alarm Off in the status bar Note that technical alarms cannot be disabled with this option 3 High ICP Alarm Limit Specifies the maximum ICP value that the monitor will tolerate before activating the alarm To specify this limit press the arrows to a value between 10 mmHg and 125 mmHg in 1 mmHg increments 4 Restore Defaults Restores customized settings for the high ICP alarm limit to the factory default settings 20 mmHg Pressing this button also activat
5. jack connector e Setredtotip e Set black to barrel Set DMM to ohms 6 Fill a water bath or beaker with warm water at approximately 32 C and do the following A Placethe Fiber Optic Catheter in the water B If necessary place thermometer in water C Onthetouch screen press the Main tab and verify the Temperature value matches the thermometer reading to 3 of a degree C 7 Usingthe table that appears after step 10 verify that the measured resistance is between the low and high limits for the displayed temperature value 8 Fill a water bath or beaker with warm water at approximately 38 C and do the following A Placethe Fiber Optic Catheter in the water B Onthetouch screen press the Main tab and verify the Temperature value match the thermometer reading of 3 of a degree C 9 Using the table that appears after step 10 verify that the measured resistance is between the low and high limits for the displayed temperature value 10 Disconnect DMM and turn off monitor 82 Chapter 9 Testing and Preventive Maintenance Temperature vs Resistance Table Output Temperature Range 31 C to 33 C Output Temperature Range 37 C to 39 C Temperature C Low Q High Temperature C Low Q High Q 31 1727 1751 37 1337 1367 31 1 1718 1751 371 1335 1361 31
6. The Integra Camino ICP 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 Camino ICP Monitor will display the following message on status bar Battery is low If this occurs plug in the monitor to an AC power outlet This warning message will not disappear until the monitor is connected to AC power 52 Chapter 5 Responding to Physiological and Technical Alarms 5 Minutes or Less of Remaining Power If the battery power level drops to 5 minutes or less of remaining charge the Integra Camino ICP 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 symbol 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 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 3minutes while you plug the monitor into an AC power outlet to c
7. Width x Height x Depth Weight 3 0 kg 6 7 Ibs Display 7 0 WVGA color TFT LCD display 800 x 480 pixel resolution 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 30W Battery Use only Integra supplied 14 4 V lithium ion battery REF BAT1001 Charge time No more than 5 hours while the monitor is plugged into an AC power outlet and the monitor is turned off Operation time 1 5 hours Principle Technology Pressure Sensor Type Fiber optic pressure transducer and Strain gauge pressure transducer Temperature Sensor Type Thermistor Transducer Transient Response Time for Temperature The transient response time for a 2 C step change in temperature displayed 30 seconds maximum Appendix A Technical Specifications 91 Item Specification High ICP Alarm Limit 10 to 125 mmHg 1 mm increments Factory default set to 20 mmHg Output to Patient Bedside Monitor ICP Measurement 5 0 uV V mmHg Temperature Measurement Conforms to a standard 3 wire YSI 400 thermistor interface ICP x1 mmHg or 196 of monitor reading whichever is greater Temperature 0 2 C to YSI 400 standard Data Extraction USB USB 1 1 RS232 9600 baud 8 data bits 1 stop bit even parity configurations Operating
8. er tie HEIDE LER ORE PRETI Ana 6 About the Rear P nel 2251 tei uten ande ume eec 7 About the Right Panel ritos tate tede acer e eed tdt pr eds tinae duced 8 About the Bottom Panel eine teenies deed ed a et a de a T db ee Ahn d e HR da a 9 Aboutthe Eeft Panel het tdt n aei 9 Chapter 2 Setting Up System for the First Time Procedures for Initial Setup iiec teet ii aD sede donee e asa Do Lee ae and rada ah 11 Chapter 3 Setting Up System for Clinical Use Setting Up System for Clinical Use sssssssseeeeeenee enne nennen a a enne enn 19 Positioning tlie Monito sii ecrire pr t ER E URP Ide eerie 19 Attaching to Equipment Pole if applicable eccccececceeceeeeeeeeeeeeeceeceaaeaeceeeeeeeeeseeeeetentieaeees 19 Powering the System On and Off ee eeeeceeeeeeene eee ee tenet ee enne nennen nenne 20 Using the Battery for POWST einean ra A A E A 21 Storing the Battery ao idee t e LE E it ep ide ae n et AE ed 22 About the Integra Catheters lesseiieisseiseeeesese tenen nennt nennen teta Ekiti aieea niaaa nnns nana Dena 23 Connecting the Integra Camino Fiber Optic Catheters 110 4 Series sssseess 24 Connecting the Integra Camino Flex Catheters sssssssse eene eene 27 Connecting to a Patient Bedside Monitor if applicable sse 30 Procedures for Synchronizing the Two Monitors sessssee emen 30 About Pressu
9. 75 Testing Pressure Input 1neeeeeeeeeeeeeeeeeee nennen nennen nnne nnne nnn 76 Testing Pressure Output esee esee ee ener nnn nnnm 79 Testing Temperature Input 11leeeeeeeeeee eese eeeeeeeenenn nennen nennt 80 Testing Temperature Output eese eee seeeeee nene nennen nnne 81 Testing High ICP Alarm Limit c ccceceseseeceeeeseneeeeeensnneeeeeensneeeeeeenens 84 Testing AC Power and Battery Charge eere 85 Inserting A New Battery eeeseseeeeeeeeeeeeee nennen nennen nennt 86 Testing Synchronizing to Patient Bedside Monitor 87 About These Procedures Notice The procedures in this chapter are intended for the hospital s biomedical engineering staff Perform the following operational checks to verify that the Integra Camino ICP 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 any order Use Fiber Optic Catheters for Each Test Each of the following tests requires the use of the Integra Camino Fiber Optic Catheters 110 4 series Integra Camino Fiber Optic Catheter Cable Integra Camino Fiber Optic Catheter Cable Chapter 9 Testing and Preventive Maintenance 75
10. Camino Fiber Optic Catheter part 110 4BT ICP temperature measurements PMIO cable Resistors 10kQ x2 Potentiometer 10K 2 x1 10 turn Notice Before performing this test verify that the Integra Camino ICP Monitor is turned off and not connected to any cables 1 Plug the Integra Camino ICP Monitor to an AC wall outlet 2 Ontheright side of the monitor connect a Fiber Optic Catheter Cable to the ICP and Temperature connectors 3 Using a functional Fiber Optic Catheter firmly connect the pressure transducer connector to the Fiber Optic Catheter Cable 4 Connect the leads of the Digital Multimeter DMM to pins 1 1 Volt and 3 GND of the Fiber Optic Catheter Cable temperature connector 5 Turnonthe monitor Verify the DMM reads 1 0000 0 002 VDC 80 Chapter 9 Testing and Preventive Maintenance 6 Turn off the monitor and remove the DMM leads from the Temperature connector 7 Connect two 10KO resistors and a 10KQ potentiometer to the temperature transducer connector Connect the leads of the DMM to pins 2 Vin and 3 GND Temperature Transducer Connector Test Circuit Diagram 2 Vin 350V 30 0 C 438V 40 0 C 3 GND 10KQ m 10KQ Adjust this pot for the voltages at Pin 2 above 1 1 Volt 8 Turn on the monitor and adjust the 10KQ potentiometer to produce a reading on the DMM of 0 350 VDC Onthe touch screen the Temperature v
11. For tracking purposes use the reprocessing record sheet doc MANooo0005 supplied with your cable The Flex Extension Cable supports steam sterilization only Prior to sterilization the cables should be packaged individually in a self sealing sterilization 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 minutes Exposure Time 3 minutes Exposure Time 18 minutes Dry Cycle Time 20 minutes Dry Cycle Time 16 minutes Dry Cycle Time 20 minutes Following Sterilization 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 Allow cables to cool down to ambient temperature before starting the monitoring process Before each use visually inspect the sterilized cables for any possible defects Do not use defective cables Cont
12. 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 CONN ECTION 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 accordance 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 THE PART OF INTEGRA AND INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY REPRESENTATIVE OR OTHER PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH INTEGRA PRODUCTS INTEGRA DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A 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
13. Optic Catheter has been zeroed to the Integra Camino ICP Monitor do not replace the Fiber Optic Catheter Cable being used for patient measurement Replacing the Fiber Optic Catheter Cable with a different cable after the ICP catheter has already been zeroed may result in inaccurate patient measurements Once the Fiber Optic Catheter has been zeroed to the Integra Camino ICP Monitor do not transfer this zeroed catheter to any other monitor Transferring a zeroed catheter to a different monitor may result in inaccurate ICP measurements Notice If the patient only requires an ICP catheter the temperature value on the touch screen will appear blank with two dashed lines 26 Chapter 3 Setting Up System for Clinical Use Connecting the Integra Camino Flex Catheters Connecting the Integra Camino Flex Catheter to the Integra Camino ICP Monitor requires the Integra Camino Flex Extension Cable REF FLEXEXT To prevent possible patient injury resulting from incorrect ICP measurements always perform each of the following steps before implanting a new Integra Camino Flex Catheter into the patient In particular always leave the Flex Catheter in the air until the monitor successfully completes the initialization i e autozero process To connect 1 Onthe monitor s right side attach the end of the Flex Extension Cable closest the black barrel to the port labeled ICP FLEXEXT Black Barrel Connect to Monitor
14. Use eene 1 ContraifidiCatlons 5 nene Die rri iac eric cad eerie enc capac neste 1 Intended User 5 eerte uere eterne enter gne prn 1 Intended Patient Population eee 1 Description of the Integra Camino ICP Monitor eee 2 Reviewing the User s Manual eene 2 List of Warnings for Using the Monitor eren 3 Parts of the Monitor eese eene enne nnne nennen nnns 6 Indications for Use Intended Use The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature Contraindications The Integra Camino ICP Monitor and its accessories are contraindicated for use in a Magnetic Resonance MR environment Intended User The Integra Camino ICP 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 catheters e Designated qualified hospital staff e g neurosurgeon nurse intensivist trauma physician or physician s assistant should perform the operation of the monitor Chapter 9 provides instructions for testing and maintaining the monitor The procedures in this chapter are intended to be performed by the hospital s biomedical
15. exceeds a user specified limit for more than 5 seconds see page 41 e Rechargeable lithium ion battery that supplies power to monitor during patient transport see page 21 Storage of patient s ICP trend data for up to 5 days see page 39 Outputs for transferring patient data to a patient bedside monitor see page 30 Outputs for extracting patient data to remote media types via USB drive or digital streaming see page 57 For instructions on using the Integra catheters see the directions for use supplied with each respective catheter Reviewing the User s Manual Integra recommends that all physicians nurses and technicians who will be using operating and maintaining the Integra Camino ICP Monitor review this user s manual prior to using the system If there are additional questions after reading this manual contact Integra 2 Chapter 1 System Overview List of Warnings for Using the Monitor Failure to observe one or more of the following warnings could compromise patient safety or result in measurement errors Warnings Use of the Integra Camino ICP Monitor is restricted to one patient at a time The Integra Camino ICP Monitor and its accessories are contraindicated for use in a Magnetic Resonance MR environment Always verify the high ICP alarm limit is set appropriately for each patient prior to treatment Selecting the Alarm Off feature on the Alarm panel will disable the high ICP alarm lim
16. firmly connect the pressure transducer connector to the Fiber Optic Catheter Cable Do not connect the temperature transducer connector if you are using a 110 4BT or 110 4HMT model catheter 4 Useone of the following pressure sources to provide pressure to the catheter by using any of the methods described in the ICP Input Tests section e Graduated Drainage Bag page 76 Pressure Simulator page 79 5 Turn on the monitor On the touch screen press the Alarm tab and set the High ICP Alarm Limit to 4 mmHg 6 Setthe pressure source to 10 mmHg 7 Onthetouch screen press the Main tab and verify the ICP value displays approximately 10 2 mmHg After about 5 seconds verify the monitor Sounds an alarm containing a burst of three pulses e Displays the following error message on status bar ICP above alarm limit e Flashes the alarm symbol on status bar e Flashes the current ICP value in yellow on the Main Trend and Alarm screens 8 Silence the alarm temporarily On the touch screen press the flashing alarm symbol and verify the monitor e Silences the alarm 84 Chapter 9 Testing and Preventive Maintenance 9 e Changes the active alarm symbol to the silenced alarm symbol Displays Audio Paused on the status bar Wait approximately 3 minutes and verify the monitor re activates the alarms specified in step 7 10 Decrease simulated pressure to o mmHg and verify the alarms turn off 11 On the touch screen
17. one pulse every 16 seconds e Display the following error message on status bar Cooling fan failure Chapter 5 Responding to Physiological and Technical Alarms 53 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 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 Camino ICP Monitor is designed to measure ICP and tissue temperature between specific clinical ranges Measurements Range ICP Between 10 to 125 mmHg that includes the following levels of accuracy depending on catheter type Fiber Optic Catheter 10 to 5o mmHg 2 mmHg e 51to 125 mmHg 6 Flex Catheter 10to 10 mmHg x2 mmHg 11 to 33 mmHg x3 mmHg 34to 125 mmHg 6 1 mmHg Temperature Between 30 C to 42 C 0 3 C If the measured ICP or temperature falls outside these ranges the monitor will activate a low priority alarm that will Sound an alarm containing a burst of one single pulse every 16 seconds e Display one of the following messages on the status bar ICP is out of accuracy range or Temperature is o
18. personnel at Integra No modification of the Integra Camino ICP Monitor is allowed About Annual Maintenance The Integra Camino ICP 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 evaluate the battery s usage number of re charge cycles and calibration status and replace it with a new one if necessary e To determine the next due date for annual maintenance see the label EATON that appears on the rear panel NEXT SCHED LED MAINTENANCE DUE e Toschedulethe Integra Camino ICP Monitor for annual maintenance contact Integra 72903759 Revi Chapter 10 Contacting Integra for Technical Support and Annual Maintenance 89 This page is intentionally left blank 90 Chapter 10 Contacting Integra for Technical Support and Annual Maintenance APPENDIX A TECHNICAL SPECIFICATIONS List of Technical Specifications eese 91 Classifications and Standards Lecce ceesseeeeeeeeen nnne 93 Manufacturer s Declaration Table 11 ceeeeee ere eee eere 94 List of Technical Specifications The following table lists the technical specifications for the Integra Camino ICP Monitor Item Specification Monitor Type Integra Camino ICP Monitor Dimensions 240 mm x 165 mm x 185 mm
19. press the Alarm tab and select Alarm Off Testing AC Power and Battery Charge AC Power Integra recommends performing this test once every three months 1 2 3 Low Battery Alarm Plug the Integra Camino ICP Monitor to an AC power outlet Press the power button to turn on the monitor Verify the following Onthefront of the monitor check that the LED AC power indicator that appears above the power button is illuminated Onthetouch screen verify the plug icon appears in the status bar B On the rear of the monitor disconnect the power cord and verify the following Onthefront of the monitor check that the green LED AC power indicator turns off Onthetouch screen verify the plug icon appears crossed out in S a the status bar If you experience AC power problems contact Integra Integra recommends performing this test once every three months 1 Run the Integra Camino ICP 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 10 minutes verify that the monitor will e Sound an alarm containing a burst of three pulses Display the following error message on status bar Ba
20. problems that may occur with the Integra Camino ICP Monitor during use Problem Cause Recommendation Integra Camino ICP Monitor does not operate with AC power Integra Camino ICP Monitor does not operate on battery power AC power adapter not connected Attach AC power adapter to Integra Camino ICP Monitor see page 20 Faulty AC power adapter cord Battery not installed Attach AC adapter cord to Integra Camino ICP Monitor Perform AC power test to ensure AC power works see page 85 Contact Integra to order new AC power adapter cord Attach AC power adapter to Integra Camino ICP Monitor see page 13 On touch screen check battery indicator on status bar to ensure the battery is installed see page 36 Install battery see page 86 Battery not charged Attach AC power adapter to Integra Camino ICP Monitor see page 13 On touch screen check battery indicator on status bar to ensure the battery is installed see page 36 Faulty battery Attach AC adapter cord to Integra Camino ICP Monitor Perform battery charge test to ensure battery holds charge properly see page 86 Contact Integra to order new battery Chapter 8 Troubleshooting the System 69 Problem Cause Recommendation Touch screen freezes System hardware error Press and hold the power button for several seconds to perform a forced shutdown of the system Pres
21. software interface 4 System Information Displays information regarding the system s software and firmware 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 44 Chapter 4 Monitoring the Patient s ICP and Temperature Specifying Waveform Type The Integra Camino ICP Monitor provides options for displaying the ICP waveform as either a line or filled graph Synchronize to Monitor Trend Alarm Settings Temperature Waveform set to Fill mode 1 Onthethe touch screen press the Settings tab 2 Press Set Waveform 3 Specify the waveform type by selecting either Line or Fill 4 Press Accept The selected waveform type will appear on the Main panel Specifying Time and Date The Integra Camino ICP Monitor provides tools for setting the current time and date that appears on the touch screen Synchronize Settings Monitor Set Waveform Time and Date Set Language To set this information 1 Onthe 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 Camino ICP Monitor will display the
22. 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 317 1676 1700 377 1300 1329 31 8 1668 1700 37 8 1295 1324 31 9 1660 1692 37 9 1290 1319 32 1652 1684 38 1285 1314 321 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 Chapter 9 Testing and Preventive Maintenance 83 Testing High ICP Alarm Limit Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment Integra Camino Fiber Optic Catheter Cable Integra Camino Fiber Optic Catheter either part 110 4BT or 110 4HMT Pressure source device either graduated drainage bag pressure gauge between o and 125 mmHg minimum or electronic pressure simulator 0 to 125 mmHg minimum Notice Before performing this test verify that the Integra Camino ICP Monitor is turned off and not connected to any cables 1 Plug the Integra Camino ICP Monitor to an AC wall outlet 2 Onthe right side of the monitor connect a Fiber Optic Catheter Cable to the ICP and Temperature connectors 3 Using a functional Fiber Optic Catheter
23. 30 PMIO cable or patient bedside monitor adapter cable is faulty Replace PMIO cable or patient bedside monitor adapter cable see page 30 PMIO cable or patient bedside monitor adapter cable is loose Check cable connections between Integra Camino ICP Monitor and patient bedside monitor see page 30 Patient bedside monitor has malfunctioned Refer to manufacturer s troubleshooting guide for the patient bedside monitor Discrepancy of temperature measurements between the Integra Camino ICP Monitor and the patient bedside monitor Incorrect patient bedside monitor adapter cable being used PMIO cable or patient bedside monitor adapter cable is faulty Verify correct patient bedside monitor cable is being used see page 30 Replace PMIO cable or patient bedside monitor adapter cable see page 30 PMIO cable or patient bedside monitor adapter cable is loose Check cable connections between Integra Camino ICP Monitor and patient bedside monitor see page 30 Chapter 8 Troubleshooting the System 71 Problem Cause Recommendation Patient bedside monitor has malfunctioned Refer to 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 59 Ontouch screen press Tr
24. 32 adapter cable USB end of adapter cable i NN hw NN 2 Onthe 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 Conditions That Reset Trend Data During Recording Depending on the catheter type being used to record the patient s Mean ICP trend data the following conditions will result in trend data being reset for that patient Catheter Conditions Integra Camino Fiber Optic 110 4 Series Monitor is turned off and then turn back on Battery discharges completely resulting in the monitoring being turned off and then turned back on Thecurrent ICP catheter is disconnected from the monitor and then re connected Thecurrent temperature catheter is disconnected from the monitor and then re connected Thecurrent catheter is replaced by a different catheter Integra Camino Flex The current catheter is replaced by a different catheter Chapter 6 Extracting Trend Data for Remote Evaluation 59 Replacing a catheter will reset the trend data Please extract any data that you wish to retain prior to replacing the catheter 60 Chapter 6 Extracting Trend Data for Remote Evaluation CHAPTER 7 CLEANING AND STERILIZING THE SYSTEM Cleaning the System and Components eene 61 Sterilizing
25. 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 FOR A 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 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 ASSI
26. BL Quantity 1 Integra Camino Flex Extension Cable REF FLEXEXT Quantity 1 USB to RS232 adapter cable REF EXPORTCAB Quantity 1 User manual REF UM CAMO2XX where XX refers to the country s language code Quantity 1 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 12 Chapter 2 Setting Up System for the First Time 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 2 screws to take off the battery cover 4 Verify the Integra logo on the battery is facing up and insert the battery A Alignthe battery s connectors on the front of the battery to the connector slots on the monitor B Slide the battery s connector into the monitor s connector slots until the battery is fully inserted into place Ice os INTEGRAM LLL elllllllle M ve 5 Secure the battery cover to the monitor by re inserting the two small screws Chapter 2 Setting Up System for the First Time 13 Step 3 Prepare the AC Power Adapter with Region Specific Plug 1 Removethe AC power adapter from the package and attach the region s
27. Flex Extension Cable 2 Remove the Flex Catheter from its packaging For complete instructions on using this catheter see the directions for use supplied in the Flex Catheter packaging Chapter 3 Setting Up System for Clinical Use 27 3 When operating in the sterile field attach the male end of the Flex Catheter connector to the female end of the Flex Extension Cable connector note the alignment arrows on each connector Male end of Flex Catheter Female end Flex Extension Cable 4 When attached correctly the Integra Camino ICP Monitor will display Catheter is initializing in the status bar 5 Verify the following message appears to ensure that the initialization i e autozero process has successfully completed The catheter has been successfully initialized and is ready for implantation ICP reading wil solf adjust when the catheter is implanted If the monitor reports a Catheter failure message in the status bar replace with a new catheter 6 Press Accept the ICP value which may be non zero will appear on the Main panel Alarm Settings v ICP value on Main panel 28 Chapter 3 Setting Up System for Clinical Use Notice Note the ICP value displayed may be non zero this value reflects the hydration offset of the catheter while it is still in air This value will self adjust automatically when the catheter is implanted into the patient 7 Prior to
28. For tracking purposes use the reprocessing record sheet doc MANo000005 supplied with your FLEX Extension Cable There are no limits on reprocessing the Integra Camino ICP Monitor and cable strap Using either 7096 IPA with a lint free wipe or a Super Sani Cloth or equivalent solution thoroughly wipe all surfaces at least three 3 times and then inspect the surfaces for visible residues If residues remain use a new Super Sani Cloth or equivalent solution or lint free wipe soaked with 7096 IPA and continue wiping the surfaces until they are visibly free of residues If the Flex Extension Cable or the Fiber Optic Catheter Cable cannot be thoroughly cleaned discard and replace the cables Using either 7096 IPA with a lint free wipe OR Super Sani Cloth or equivalent solution thoroughly wipe all surfaces once 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 Let the Integra Camino ICP Monitor and any of its system components air dry prior to reuse After each reprocessing event visually inspect the Integra Camino ICP Monitor and any of its system components for any wear and tear It is recommended that the Integra Camino ICP Monitor and any of its system components be cleaned and disinfected as soon as is reasonably practical after use 62 Chapter 7 Cleaning and Sterilizing the System Sterilizing th
29. GNEES 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 NeuroSciences 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 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 Customer 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 Appendix B Integra Warranty 101 This page is intentionally left blank 102 Appendix B Integra Warranty INDEX A abbreviations list of vii AC p
30. Integra USER S MANUAL Camino ICP Monitor Intracranial Pressure and Temperature Monitor INTEGRA m C 0086 Federal USA law restricts this device to sale by or on the order of a physician Publication Name Integra Camino ICP Monitor User s Manual Integra Part Number 60903733 Rev B Effective Date September 2012 Trademark Acknowledgements Integra the Integra logo and Camino are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and or other countries Delta Cal is a trademark of Utah Medical Products Inc Sani Cloth is a registered trademark of Professional Disposables International Inc Aptimax Sealsure and Sterrad are registered trademarks of Johnson and Johnson Tyvec is a registered trademark of E I duPont Kimguard and One Step are registered trademarks of Kimberly Clark Worldwide Inc Copyright Information 2012 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 Tullamore County Offaly Ireland Distribute
31. 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 being used Indicates AC power is not being used 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 a8 ety Indicates that either a battery is not connected or a battery is not functioning properly For instructions on powering the monitor see page 20 36 Chapter 4 Monitoring the Patient s ICP and Temperature Verifying Amount of Battery Charge Available The Integra Camino ICP Monitor displays the following symbols on the status bar to indicate battery charge levels Symbol Color Available Charge qo Green 75 to 100 T Green 50 to 7596 a Green 2596 to 5096 Wa Green Less than 2596 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 52 About the Alarms The Integra Camino ICP Monitor activates one physiological alarm for exceeding the high ICP alarm limit and
32. Pressure 700 to 1060 hPa Shipping Storage Pressure 500 to 1060 hPa Operation Limits e Temperature 15 C to 40 C Humidity 30 to 75 relative humidity non condensing Shipping Storage Limits e Temperature 20 C to 50 C Humidity Relative humidity ranging from 25 to 80 Accuracy in Long Term Operation ICP catheter linearity with Integra Camino Flex Catheter e Range 10 to 10 mmHg 2 mmHg e Range 11 to 33 mmHg 3 mmHg e Range 34 to 125 mmHg 6 1mmHg ICP catheter linearity with fiber optic catheter Range 10 to 50 mmHg 2 mmHg Range 51to 125 mmHg 6 Temperature catheter 0 3 C Rated ICP Accuracy Range 10 to 125 mmHg Rated Temperature Accuracy Range 30 C to 42 C Protection Against Electric Shock Class Il type CF defibrillation proof applied parts ICP catheter connections temperature catheter connections 92 Appendix A Technical Specifications Item Specification 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 Classifications and Standards The Integra Camino ICP monitor has
33. Type of Clinical Priority 1 Irreversible System Failures see page 51 High ICP alarm see page 51 ICP catheter failure see page 52 Temperature sensor failure see page 52 Low battery level 5 minutes or less see page 52 Monitor overheating see page 53 Cooling fan failure see page 53 Mean ICP is out of accuracy range see page 54 Temperature range is out of accuracy range see page 54 Battery failure see page 55 Low Battery level 15 minutes or less Multiple catheters are connected Catheter initializing No catheter is connected Catheter initialization failure Cannot write to log file Medium Medium Medium Medium Medium Medium Low Low Low Low N A N A N A N A N A N A 50 Chapter 5 Responding to Physiological and Technical Alarms Responding to the Physiological Alarm ICP above alarm limit If the patient s Mean ICP value exceeds the specified limit for more than 5 seconds the Integra Camino ICP Monitor will activate a medium priority physiological alarm that will e Sound an alarm containing a burst of three pulses Display the following error message on the status bar ICP above alarm limit e Flash the alarm symbol on status bar e Flash the Mean ICP 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 un
34. a Camino ICP Monitor is intended for use in the electromagnetic environment specified below The customer or the user ofthe Integra Camino ICP Monitor should assure that it is being used in such an environment 30 96 dip in U for 25 cycles for 25 cycles 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 x 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 5 96 U 5 96 U Mains power quality should be that of a typical interruptions and gt 95 96 dip in U for 0 5 cycle commercial or hospital environment If the user of voltage variations on for 0 5 cycle the Integra Camino ICP Monitor requires power supply input continued operation during power mains lines 40 96 U 40 96 U interruptions it is recommended that the Integra 60 96 dip in U for 5 cycles Camino ICP Monitor be powered from an IEC 61000 4 11 for 5 cycles uninterrupti
35. act or statement nor may this Appendix B Integra Warranty 99 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 4 Quality Control 4 1 4 2 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 reserves 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 a
36. ainment and Transportation of Sterilized Cables It is recommended that the FLEX Extension Cable be sterilized as soon as possible after use Storage of Sterilized Cables Sterilized cables should be stored at room temperature in sterile pouches Chapter 7 Cleaning and Sterilizing the System 65 About Single Use Only Catheters Integra catheters 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 Camino ICP Monitor cables and AC power 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 66 Chapter 7 Cleaning and Sterilizing the System CHAPTER 8 TROUBLESHOOTING THE SYSTEM About the Troubleshooting Process eeeeeeeeeeenenn 67 Responding to System Status Messages eese 67 Responding to Problems During Use eene 69 Responding to System Failure Messages cesses 73 About the Troubl
37. alue should read 30 0 0 3 C 9 Adjust the 10KO potentiometer to produce a reading on the DMM of 0 438 VDC T On the touch screen the Temperature value should read 40 0 0 3 C 10 Turn off monitor On the right side of the monitor remove all components from the Temperature connector Testing Temperature Output Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment Digital Multimeter DMM 1 mV minimum reading of 1kand 2 k ohms having an accuracy of 1 ohm Water bath or beaker with thermometer between 30 and 40 C Fiber Optic Catheter Cable Integra Camino Fiber Optic Catheter part 110 4BT ICP temperature measurements PMIO cable part PMIO MPM Chapter 9 Testing and Preventive Maintenance 81 Notice Before performing this test verify that the Integra Camino ICP Monitor is turned off and not connected to any cables 1 Plug the Integra Camino ICP Monitor to an AC wall outlet 2 Ontheright side of the monitor connect a Fiber Optic Catheter Cable to the ICP and Temperature connections of the Camino 3 Using a functional Fiber Optic Catheter firmly connect the pressure transducer connector to the Fiber Optic Catheter Cable 4 Onthe rear of the monitor connect a PMIO cable to the PMIO connector but not to an external patient bedside monitor 5 Connect the Digital Multimeter DMM leads to a 1 4
38. apter 6 ICP Scale Specifies the range of the ICP values displayed on the Trend graph Time Scale Specifies the range of time displayed on the Trend graph Displays the patient s ICP trend data Displays Mean ICP in mmHg as a numerical value Displays the high ICP alarm limit If the patient s Mean ICP value exceeds this limit for more than 5 seconds an alarm will sound To specify this limit see page 42 Displays tissue temperature in degrees Celcius C Chapter 4 Monitoring the Patient s ICP and Temperature 39 Scaling Time Ranges for Trend Data Press the Time Scale button to specify different time ranges to view MIU the trend data The time ranges include 3 hours 12 hours 24 hours 48 hours 120 hours Pressing the Time Scale button each time advances to the next time range Scaling the ICP Ranges for Trend Data If the ICP waveforms on the Trend panel require resizing for optimal ICP viewing press the ICP Scale button to specify different waveform Scale ranges The ranges include Ranges mmHg Increments mmHg oto30 5 oto 50 10 oto 100 10 Oto 150 25 10 to 20 5 Pressing the ICP Scale button each time advances to the next waveform range Conditions that Reset Trend Data Depending on the catheter type some conditions may result in the loss of trend data during the recording process For details see page 59 40 Chapter 4 Monitoring the Patients ICP and Temperature
39. attery cover securely Note that the battery cover should remain closed at all times during the monitor use 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 Camino ICP Monitor will charge the battery while the monitor is plugged into AC power Determining Software Version On the touch screen press the Settings tab and select System Information Testing Synchronizing to Patient Bedside Monitor Perform the procedures for synchronizing the Integra Camino ICP Monitor to a patient bedside monitor on page 30 Chapter 9 Testing and Preventive Maintenance 87 This page is intentionally left blank 88 Chapter 9 Testing and Preventive Maintenance CHAPTER 10 CONTACTING INTEGRA FOR TECHNICAL SUPPORT AND ANNUAL MAINTENANCE About Technical Support If the Integra Camino ICP 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 To reduce the risk of electric shock do not disassemble the Integra Camino ICP Monitor Refer all servicing to qualified service
40. been designed for continuous operation The Integra Camino ICP Monitor meets the electrical safety requirements for 606014 1 4 1 8 2 49 2nd edition EMI EMC EN60601 1 2 2nd edition 2001 e EN60601 2 49 2nd edition 2001 Electrical Safety e EN60601 1 1990 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 UL IEC 60601 1 8 2003 with A1 2006 CSA 60601 1 8 2003 e EN UL IEC 60601 2 49 2001 e CSA 60601 2 49 2004 Appendix A Technical Specifications 93 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 Camino ICP 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 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
41. ber optic 25 trend data conditions that reset 59 extracting 57 59 monitoring 39 40 troubleshooting 67 73 problems during use 69 73 system failure messages 73 system messages 67 69 U USB extracting trend datato 57 W warranty Integra 99 waveforms scaling 38 specifying 45 Index 105 This page is intentionally left blank 106 Index Integra Camino ICP Monitor For more information or to place an order please contact o Integra 311 Enterprise Drive Plainsboro NJ 08536 N T E RA USA and Canada 800 654 2873 609 275 0500 Outside USA 609 275 5363 Fax Bn m integralife com 3 60903733 Rev B
42. ble power supply or a battery 70 U 70 96 U magnetic field IEC 61000 4 8 5 96 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 typical commercial or hospital environment Note U is the a c mains voltage prior to application of the test level 96 Appendix A Technical Specifications Guidance and manufacturer s declaration electromagnetic immunity The Integra Camino ICP Monitor is intended for use in the electromagnetic environment specified below The customer or the user ofthe Integra Camino ICP Monitor should assure that it is being used in such an environment Immunity test IEC 60601 test level Sa Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Integra Camino ICP monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 JP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V 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 where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recom
43. ccessful USB transfer see page 57 72 Chapter 8 Troubleshooting the System Problem Cause Recommendation Brand of USB drive is not Insert different brand of USB drive into rear recognized by Integra Camino ICP panel of Integra Camino ICP Monitor see Monitor page 57 Responding to System Failure Messages If a system failure occurs the Integra Camino ICP 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 E0011 E2002 E2003 E2004 E2008 E2011 Sensor board failure Not resolvable contact Integra E2024 E2025 E2026 E2032 E2037 E2041 E2042 E2044 E2045 E2046 E2047 E2048 E2049 E2051 E2057 E2061 E2101 E2103 E2104 E2105 E0012 E1002 E1003 E1004 E1008 E1032 Power board failure Not resolvable contact Integra E1033 E1041 E1042 E1044 E1045 E1046 E1047 E1050 E1057 E1061 E1101 E1103 E1104 E1105 E0013 General software error Not resolvable contact Integra E0015 Incompatible firmware error Not resolvable contact Integra Chapter 8 Troubleshooting the System 73 This page is intentionally left blank 74 Chapter 8 Troubleshooting the System CHAPTER9 TESTING AND PREVENTIVE MAINTENANCE About These Procedures eese eene nnn nnne nnn na
44. d 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 iioii neiaa eradan eea a rarai AEE enhn AKAA AA A RE nnns V Software Symbols edi I d recreo ze Evi reped rtc pedea eee ae te pues tn pee ee rd ek vi Listot Abbrevialioris e dte e cH RH Hb e ahd RE estela baee ie odd obe lg studs vii Chapter 1 System Overview Indications for Use Intended Use sssssssssssssssssssseeeeeeeee em enenn nnn nn nennen nennen n nnne 1 Contralndicatlorns teet tut biete a t erae on secet Tite iM edid det ied 1 Intended Ser 3 orte Rte mer e edet tee aee ette atra e alates 1 Intended Patient Population ssssssssssssssssssseneneneene nennen nenne Iren nen n nnne en nnn ten er trs n sns s nnns nnn 1 Description of the Integra Camino ICP Monitor sss nemen nnne enne 2 Key Functions of MonlitOF cies cii trente nt tree Poen eee de nade nein deae sa e kde dues 2 Reviewing the User s Mangal oreina E TA 2 List of Warnings for Using the Monitor eccerre Ea EE T A EEE ETER ERE ETATE 3 Parts of the MONItOr aanne aeea a aa a e a aa eaa a a aa ea taae Aasmaan 6 Aboutthe Front Panels isd 2 2 m
45. ds to perform a forced shutdown of the system Using the Battery for Power The Integra Camino ICP 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 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 86 to ensure the battery is functioning properly 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 36 e Ifthe battery charge level drops to 15 minutes or less the monitor will activate visual warnings e Ifthe battery charge level drops to 5 minutes or less the monitor will sound an alarm Chapter 3 Setting Up System for Clinical Use 21 Storing the Battery For more information on responding to low battery alarms see page 52 For specific information on testing replacing the battery see page 85 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 ignit
46. dside monitor B Once the ICP value on the patient bedside monitor stabilizes verify that the patient bedside monitor reads the same value as the Integra Camino ICP Monitor 25 mmHg 1 mmHg C Repeat steps A to Bin this section for each additional value that you want to check Step 5 Complete the Synchronization Process After completing the synchronization process press Done Once the ICP value on the patient bedside monitor stabilizes verify that the patient bedside monitor reads the same ICP value as the Integra Camino ICP Monitor 1 mmH or 1 of monitor reading whichever is greater During patient treatment Integra recommends comparing the ICP values between the two monitors while the clinical staff is e Recording ICP Treating ICP e Per the hospital s unit policy If the Integra Camino ICP Monitor loses power and shuts down while it is connected to a patient bedside monitor do not use the ICP values on the patient bedside monitor for patient measurements the ICP values on the patient bedside monitor will be invalid 32 Chapter 3 Setting Up System for Clinical Use Notice After completing the synchronization process always use the Integra Camino ICP Monitor s measurements over the patient bedside monitor s measurements If drift occurs between the two monitors use the Integra Camino ICP Monitor s ICP values for the patient s measurements and repeat the procedures for synchronizing the two monitor
47. e 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 sure that the battery cover is closed securely during monitor use To ensure appropriate battery power with use of the Integra Camino ICP Monitor only use batteries supplied by Integra REF BAT1001 To order replacement batteries contact Integra Notice The Integra Camino ICP 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 If the Integra Camino ICP 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 Integra Camino ICP 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 Camino ICP Monitor will charge the battery while the monitor is plugged into AC power 22 Chapter 3 Setting Up System for Clinical Use About the Integra Catheters The Integra Camino ICP Monitor supports the following Integra catheters Catheter Measurements Description Integra Camino F
48. e Integrae Camino Fiber Optic Catheter Cable The Fiber Optic Cable REF CAMCABL is provided non sterile Notice The Fiber Optic Catheter Cable must be sterilized whenever it is to be used in the sterile field Prior to sterilization clean this cable using the guidelines listed on page 61 Limits on Sterilization The Fiber Optic Catheter Cable may be sterilized thirty 30 times and cleaned disinfected one hundred 100 times Do not use the cable after reaching these reprocessing limits For tracking purposes use the reprocessing record sheet doc 92903867 supplied with your cable Sterilization Parameters The Integra Camino Fiber Optic Catheter Cable supports EtO and Sterrad sterilization methods Notice Prior to EtO sterilization the cable should be individually packaged in a self sealing sterilization pouch with dimensions 10 x 15 or equivalent pouches designed for EtO gas sterilization Notice Prior to Sterrad sterilization e The cable should be placed in a 12 x 15 Tyvek Self Seal Pouch or equivalent pouches designed for Sterrad sterilization or e The cable should be placed in a 23 x 11 x 4 Sterrad compatible Aptimax tray or an equivalent instrument tray designed for Sterrad sterilization and wrapped in Kimguard One Step Kc400 Sterilization Wrap then secured with Sterrad compatible Sealsure chemical indicator tape or equivalent sterilization wrap and indicator tape designed
49. e appears during patient treatment do not rely on ICP measurements until the Mean ICP value falls within the accuracy range Monitor overheating check vent Temperature inside Integra Camino ICP Monitor has exceeded 80 C Check air vent on rear panel of Integra Camino ICP Monitor If anything is blocking vent remove it see page 53 More than one catheter connected Two ICP catheters types Fiber Optic and Flex are connected simultaneously Remove the ICP catheter that will not be used during patient treatment No catheter is connected No ICP catheter is connected to Integra Camino ICP Monitor Connect ICP catheter see page 24 for connecting fiber optic catheters see page 27 for connecting Integra Camino Flex Catheters 68 Chapter 8 Troubleshooting the System System Message Cause Recommendation Temperature is out of accuracy range Temperature value has fallen under range that the Integra Camino ICP Monitor can measure accurately between 30 C to 42 C Do not rely on temperature measurements until the temperature value falls within the accuracy range see page 54 Temperature sensor failure Temperature catheter broken Disconnect temperature catheter and replace with new one see directions for use supplied with catheter Responding to Problems During Use The following table provides guidelines for responding to technical
50. e limitation List of Symbols and Abbreviations v Software Symbols Symbol Description Symbol Definition Active alarm M AC power not being used available Audio paused Inactive alarm Battery charge indicator No battery connected or faulty battery y High ICP alarm limit BOB Battery being charged AC power being used G System information panel On Off power vi List of Symbols and Abbreviations List of Abbreviations Abbreviation Definition AC Alternating Current C Celsius CAMCABL Preamplification cable used with Integra fiber optic catheters CSV Comma separated values CT Computer tomography dB Decibels DC Direct Current DMM Digital Multimeter EtO Ethylene oxide F Fahrenheit FLEX Flex Catheter FLEXEXT Flex Extension Cable hPA Hectopascal pressure unit ICP Intracranial pressure ICT Intracranial temperature IPA Isopropyl alcohol LED Light Emmitting Diode mm Millimeters mmHg Millimeters of mercury MR Magnetic resonance OR Operating Room PMIO Patient Monitor Input Output 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 List of Symbols and Abbreviations CHAPTER 1 SYSTEM OVERVIEW Indications for Use Intended
51. e 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 Integra staff to troubleshooting errors This button is only Mode intended for Integra staff 46 Chapter 4 Monitoring the Patients ICP and Temperature CHAPTER 5 RESPONDING TO PHYSIOLOGICAL AND TECHNICAL ALARMS About the Two Alarm Types eeeeeeereeenennnennnnnn nnne nnn nnne 47 Understanding the Alarm Symbols seen 48 About the Technical Messages eren 47 How the Monitor Prioritizes the Alarms eene 48 Responding to the Physiological Alarm ICP above alarm limit 51 Responding to Technical Alarms eene 51 About the Two Alarm Types The Integra Camino ICP 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 Mean ICP value being monitored has exceeded the specified limit 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 catheter connections These technical alarms include Irreversible System Failures Cooling fan failure CP catheter fai
52. e patient and the monitor is restricted by the length of the Integra catheter cable It is not permitted to extend the Integra catheter cable with non Integra extension cables To prevent the monitor from overheating e Do not 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 Attaching to Equipment Pole if applicable The Integra Camino ICP Monitor includes a 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 Chapter 3 Setting Up System for Clinical Use 19 2 Tighten the knob on the pole clamp to secure the monitor to the equipment pole Pole clamp attached to equipment pole Pole Clamp Note that the pole clamp supports equipment poles between 0 5 and 1 2 inches 12 7 and 30 5 mm in diameter Warning To prevent injury to the patient user or other persons or damage to the monitor always verify that the monitor is clamped securely to the equipment pole Caution 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 Powering the System On and Off Turn
53. e to Monitor Button On the Integra Camino ICP Monitor s touch screen press the Synchronize to Monitor button the Integra monitor will transmit an ICP value of O mmHg for up to one minute A countdown will appear to display the amount time left to zero the patient bedside monitor Step 3 Zero the Patient Bedside Monitor to the Integra Monitor Onthe patient bedside monitor follow the manufacturer s instructions to zero the monitor Step 4 Check Additional Values to Confirm Synchronization Notice The following synchronization checks at 25 mmHg 5o mmHg and 100 mmHg are not required but are recommended by Integra On the Integra ICP Camino s touch screen press the Check Additional Values button to transmit additional ICP values to the patient bedside monitor for scaling verification 25mmHg 5ommHg 100mmHg Chapter 3 Setting Up System for Clinical Use 31 Note that pressing Check Additional Values each time advances to the next ICP value If you are not checking additional values proceed to the final step Complete the Synchronization Process on page 32 A Onthe Integra Camino ICP Monitor s touch screen press the Check Additional Values button to transmit an ICP value at 25 mmHg for up to one minute to the patient bedside monitor Contr value on the patent montor within the next Acountdown will appear to display the amount time left to confirm that the value is also displayed on the patient be
54. ecified alarm limit the alarm tone will resume Restoring Default High ICP Alarm Limit Values After specifying the high ICP alarm limit value on the Alarm tab Im the Integra Camino ICP 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 high ICP alarm limit value will be restored To restore the high ICP alarm limit from a customized setting to the factory default settings 20 mmHg press Restore Defaults and then Accept Note that pressing Restore Defaults button will also activate the Alarm On mode automatically Chapter 4 Monitoring the Patient s ICP and Temperature 43 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 Main Trend Alarm Settings Waveform Style Set Time and Date Set Language 4 The information on this panel includes Number Description Set Waveform 1 Specifies the type of ICP waveform line or fill that is displayed on the Main panel 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 57 3 Set Language Specifies the language that is displayed on the
55. ects and people 98 Appendix A Technical Specifications APPENDIX B 1 Warranty INTEGRA WARRANTY Integra LifeSciences Corporation Integra warrants to 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 year from the date of delivery by Integra to the first purchaser but in no event beyond the expiration date stated on any product labeling 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 product 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 should communicate directly with Integra home office If purchaser seeks to invoke the terms of this warranty the product must be returned to Integra at its home office The defective product should be returned promptly properly packaged and postage prepaid Loss or damage in return shipment to Integra shall be at Customer s risk Integra sole responsibility under this warranty shall be repair or replacement at the sole discretion and expense of
56. eep the Integra Camino ICP Monitor on AC power with the monitor turned off for 5 hours This will re charge the battery to full capacity After 5 hours turn on the monitor by pressing the power button On the touch screen view the battery power symbol on the status qo bar to verify the symbol displays four green bars this indicates the battery has full charge Chapter 2 Setting Up System for the First Time 17 This page is intentionally left blank 18 Chapter 2 Setting Up System for the First Time CHAPTER 3 X SETTING UP SYSTEM FOR CLINICAL USE Setting Up System for Clinical Use ceeeeeeeeeeeeenes 19 About the Integra Catheters esses eeeeee ennt nnne nnn 23 Connecting the Integra amp Camino Fiber Optic Catheters 110 4 Series 24 Connecting the Integra amp Camino Flex Catheters 27 Connecting to a Patient Bedside Monitor if applicable 30 Storing the System nuuc dei ee ien esee inedite 33 Setting Up System for Clinical Use The following section contains instructions for positioning the monitor powering the monitor and connecting catheters to the monitor prior to clinical use Positioning the Monitor The Integra Camino ICP Monitor is intended to be positioned on a hard flat surface or securely clamped to an equipment pole or bed support next to the patient The distance between th
57. 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 94 Appendix A Technical Specifications Guidance and manufacturer s declaration electromagnetic emissions The Integra Camino ICP Monitor is intended for use in the electromagnetic environment specified below The customer or the user ofthe Integra Camino ICP Monitor should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Integra Camino ICP 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 Camino ICP Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low 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 95 Guidance and manufacturer s declaration electromagnetic immunity The Integr
58. end tab and verify Data Streaming Enabled message appears see page 59 Faulty USB to RS232 adapter cable Replace USB to RS232 adapter cable see page 59 Ontouch screen press Trend tab and verify Data Streaming Enabled message appears see page 59 External monitoring device is not configured correctly for digital streaming See digital streaming requirements on page 59 No transfer of trend data via USB connection No USB drive is connected Connect USB drive to rear panel see page 57 On touch screen press Trend tab and select Extract Data button Verify confirmation message appears that indicates successful USB transfer see page 57 USB drive not seated properly in monitor Check connection of USB drive on rear panel see page 57 On touch screen press Trend tab and select Extract Data button Verify confirmation message appears that indicates successful USB transfer see page 57 USB drive has been removed before completion of data transfer Re connect USB drive to rear panel see page 57 On touch screen press Trend tab and select Extract Data button Verify confirmation message appears that indicates successful USB transfer see page 57 USB drive is corrupted Connect new USB drive to Integra Camino ICP Monitor see page 57 On touch screen press Trend tab and select Extract Data button Verify confirmation message appears that indicates su
59. engineering staff Intended Patient Population Patients undergoing treatment with this monitor under the cranial applications are expected to have had a TBI undergone a major neurosurgical procedure or some other traumatic ischemic or hemorrhagic incident requiring controlled monitoring of ICP and brain temperature Chapter 1 System Overview 1 Description of the Integra Camino ICP Monitor The Integra Camino ICP Monitor is a compact portable device that provides tools for continuously determining and monitoring intracranial pressure ICP and intracranial temperature ICT directly in the brain depending on which catheters are connected to the system This monitor supports the following catheters Series of Integra Camino Fiber Optic Catheters 110 4 series for measuring both ICP and temperature Integra Camino Flex Catheter for measuring ICP values All Integra catheters measure their respective values at thetip ofthe catheter This design eliminates the need for a fluid filled system to communicate pressure and carry pressure waves to an external transducer Key Functions of Monitor During clinical use the Integra Camino ICP Monitor provides several key functions to facilitate the process for monitoring and analyzing patient data Touch screen interface for evaluating patient ICP ICT data and setting patient parameters see page 35 e Physiological alarm that activates if the patient s Mean ICP value
60. es on the patient bedside monitor will be invalid Connect the monitor to an AC power supply immediately if the low battery alarm is activated Chapter 1 System Overview 3 Warnings When using the battery Donotheat above 80 C Donotopen battery Do not dispose of in fire Donotshort circuit as battery may ignite explode leak or get hot causing personal injury Replace battery with same part number only REF BAT1001 Useofanother battery may present a risk of fire or explosion To prevent injury to the patient user or other persons make sure that the battery cover is closed securely during monitor use Do not connect an Integra Camino Fiber Optic Catheter and an Integra Camino Flex Catheter simultaneously to the monitor The Integra Camino ICP Monitor is designed to report ICP measurements with either the Flex Catheter or Fiber Optic Catheter connected to the monitor but not both together To prevent possible patient injury resulting from incorrect ICP measurements always perform the steps listed on page 23 before implanting a new Integra Camino Fiber Optic Catheter into the patient In particular always make sure to adjust the new Fiber Optic Catheter s ICP value to zero before implantation while the catheter is in the air Never attempt to re zero a catheter while the catheter is inside the patient Once the Integra Camino Fiber Optic Catheter has been zeroed to the Integra Camino ICP Monitor do no
61. es the Alarm On button 5 ICP Displays the Mean ICP in mmHg as numerical values 6 Temperature Displays tissue temperature in degrees Celsius C Chapter 4 Monitoring the Patient s ICP and Temperature 41 About the High ICP Alarm Limit Calculation The Integra Camino ICP Monitor bases the high alarm limit on the patient s Mean ICP value which is represented by the numerical ICP value that appears on the touch screen see page 38 The high ICP alarm is triggered if the patient s displayed Mean ICP value continuously remains above the high ICP alarm limit for a period of 5 seconds Specifying the High ICP Alarm Limit Always verify the high ICP alarm limit is set appropriately for each patient prior to treatment 1 Onthe touch screen press the Alarm tab 2 Pressthe Alarm On button this will activate the alarm settings Main Trend High ICP Alarm Limit Alarm Off 3 Inthe High ICP Alarm Limit field use the arrows to specify the high ICP alarm limit value for the patient Note that the range limits are between 10 to 125 mmHg in 1 mmHg increments 4 Press Accept If the patient s Mean ICP value exceeds this specified limit for more than 5 seconds the monitor will activate the physiological alarm Note that pressing Cancel will revert all changes back to the previous values To respond to this alarm see page 51 Touch Screen Labels Indicating High ICP Alarm Limit Note that the alarm limit specified i
62. es the error If a system failure occurs a standalone message window will appear that identifies an error code and description of the failure The 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 Sounds an alarm containing a single pulse with a burst separation of 16seconds The volume of the single alarm pulse measures a sound pressure of 69 dB A message will appear on the status bar that identifies the error The patient values will appear yellow not flashing 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 ICP above alarm limit on page 51 and Responding to Technical Alarms on page 51 Priorities of Physiological and Technical Alarms The Integra Camino ICP Monitor includes one medium priority physiological alarm that gets activated if a patient s Mean ICP value exceeds 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
63. eshooting 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 5 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 Plug Integra Camino ICP Monitor into AC power outlet see page 20 After patient treatment turn off Integra Camino ICP Monitor and then turn back on Replace the battery see page 86 If problem persists contact Integra Battery is low Battery has 15 minutes or less of Plug Integra Camino ICP Monitor into AC charge power outlet see page 20 Battery has 5 minutes or less of Plug Integra Camino ICP Monitor into AC charge accompanied by alarm power outlet see page 20 tone Cannot write to log file Cannot write data to logfile thatis Notresolvable Contact Integra used by Integra for servicing Catheter failure Sudden pressure change that may Disconnect and re connect Flex Catheter occur during implantation or after completing the implantation or removal of Flex Catheter removal process see page 29 Chapter 8 Troubleshooting the System 67 System Message Cause Recommendation Catheter breaks durin
64. for Sterrad sterilization Chapter 7 Cleaning and Sterilizing the System 63 EtO Sterilization Cycle Parameters for Fiber Optic Cable Sterrad 100S Cycle Parameters for Fiber Optic Cable Parameter Specification Stage Cycle Duration Temperature 55 3 C Pre Conditioning Pre Plasma 10 minutes Exposure Time 60 minutes Injection 6 minutes Humidity 50 80 RH Phase 1 Exposure 1 Diffusion 2 minutes Aeration at 559C 8 hours Plasma 2 minutes Concentration 725 25 mg L Injection II 2 minutes Phase 2 Exposure 2 Diffusion II 2 minutes Plasma Il 2 minutes Injection H202 Volume 1800 pl 50 pl 5996 nominal concentration by weight Following Sterilization Allow cables to cool down to ambient temperature before starting the monitoring process Before each use visually inspect the sterilized cables for any possible defects Do not use defective cables 64 Chapter 7 Cleaning and Sterilizing the System Sterilizing the Integrae Camino Flex Extension Cable Limits on Sterilization Sterilization Parameters The Flex Extension Cable REF FLEXEXT is provided non sterile A sterile Flex Extension Cable is required during implantation of the catheter Prior to sterilization clean this cable using the guidelines listed on page 61 The Flex Extension Cable may be sterilized thirty 30 times Do not use this cable after reaching the sterilization limit
65. g the Integra Camino ICP Monitor system Using solvents or cleaning agents not listed in the cleaning guidelines may damage the plastic exterior of the Integra Camino ICP Monitor Chapter 7 Cleaning and Sterilizing the System 61 Do not autoclave or immerse the Integra Camino ICP Monitor in liquid as damage may occur If the monitor is exposed to liquids turn off the unit remove the AC power adapter dry the unit thoroughly and send to biomed staff for evaluation before reapplying power The Fiber Optic Catheter Cable and Flex Extension Cable should not be cleaned using automated cleaning methods Item Guideline Preparation for Cleaning Limits on Reprocessing Recommended Manual Cleaning Method Recommended Disinfection Method Inspection and Functional Testing Containment and Transportation Ensure that all the connections between the cables catheter cable strap AC power adapter USB to RS232 serial adapter and monitor have been removed before cleaning the Integra Camino ICP Monitor The Fiber Optic Catheter Cable may be sterilized thirty 30 times and cleaned disinfected one hundred 100 times Do not use the cable after reaching these reprocessing limits For tracking purposes use the reprocessing record sheet doc 92903867 supplied with your Fiber Optic Catheter Cable The Flex Extension Cable may be sterilized thirty 30 times Do not usethe cable after reaching this sterilization limit
66. g use Disconnect catheter and replace with new one see directions for use supplied with catheter Catheter fails during initialization Disconnect catheter and replace with new one see directions for use supplied with catheter Catheter is initializing Integra Camino ICP Monitor is in process of initializing new catheter connection Wait until Integra Camino ICP Monitor completes catheter initialization process Cooling fan failure Cooling fan inside Integra Camino ICP Monitor has stopped running Turn off Integra Camino ICP Monitor to prevent overheating and contact Integra see page 53 Data export failed Could not detect or write to a USB drive Problem with connection or compatibility of USB drive See troubleshooting details on page 72 No transfer of trend data via USB connection ICP above alarm limit ICP is out of accuracy range Patient s Mean ICP value has exceeded user specified high ICP alarm limit for more than 5 seconds Mean ICP value has exceeded the range that the Integra Camino ICP Monitor can measure accurately between 10 mmHg to 125 mmHg Respond to patient s need immediately Once the patient s Mean ICP value falls within the alarm limit the alarm will turn off see page 51 If message appears during implantation or removal of the Flex Catheter disconnect and re connect the Flex Catheter to the Flex Extension Cable see page 29 If messag
67. ges If the ICP waveforms on the Main panel require resizing for clarity press the Scale button to specify different waveform ranges The Scale ranges include Ranges mmHg Increments mmHg Oto 30 5 oto50 10 Oto 100 10 Oto 150 25 10 to 20 5 Pressing the Scale button each time advances to the next range Note that the purpose of the 10 to 20 mmHg range is to provide appropriate scaling when zeroing the Fiber Optic Catheter see page 24 instructions on zeroing the Fiber Optic Catheter 38 Chapter 4 Monitoring the Patients ICP and Temperature Monitoring Trend Data Press the Trend tab to view a graph of recorded Mean ICP trend data in mmHg at one minute intervals The Integra Camino ICP 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 page 57 Synchronize to Seungs Monitor Temperature JAM x The information on this panel includes Items Description 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 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 Ch
68. harge the battery If the battery does not receive charge within 3 minutes the alarm will reactivate The Integra Camino ICP Monitor battery may be replaced by the hospital s biomedical engineer For instructions see page 86 Responding to Monitor Overheating Alarm If the temperature inside the Integra Camino ICP 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 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 Silencing the Monitor Overheating Alarm Temporarily Press the flashing alarm symbol on the touch screen This will silence the alarm for 3minutes 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 Responding to Cooling Fan Failure Alarm The Integra Camino ICP Monitor contains an internal fan that circulates air to cool the internal electronic components Ifthe 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
69. iber Optic ICP Temperature Fiber optic pressure temperature catheters and 110 4 Series pressure transducer tipped catheters Integra Camino Flex ICP A silicon strain gauge pressure transducer tipped 9 10 FR catheter For complete instructions on using catheters see the directions for use supplied by Integra with each respective catheter Warning Do not connect a Fiber Optic Catheter and a Flex Catheter simultaneously to the monitor The Integra Camino ICP Monitor is designed to report ICP measurements with either the Flex Catheter or Fiber Optic Catheter connected to the monitor but not both together Chapter 3 Setting Up System for Clinical Use 23 Connecting the Integra Camino Fiber Optic Catheters 110 4 Series Connecting the Fiber Optic Catheters 110 4 series to the Integra Camino ICP Monitor requires the Integra Camino Fiber Optic Catheter Cable REF CAMCABL To prevent possible patient injury resulting from incorrect ICP measurements always perform each of the following steps before implanting a new Fiber Optic Catheter into the patient In particular always make sure to adjust the new Fiber Optic Catheter s ICP value to zero before implantation while the catheter is in the air Never attempt to change the zero adjustment while the catheter is inside the patient Notice Before implanting the catheter into the patient ensure that the temperature is at a reasonable value such as room temperature To con
70. implanting the catheter into the patient disconnect the Flex Catheter from the Flex Extension Cable This will prevent the monitor from measuring ICP while the catheter is traveling which may trigger alarms caused by the sudden changes in pressure see the following section for details eo After implanting the catheter into the patient reconnect the Flex Catheter to the Flex Extension Cable Once the Flex Catheter has been initialized i e autozeroed by the Integra Camino ICP Monitor do not transfer this initialized catheter to any other monitor Transferring an initialized catheter to a different monitor may result in inaccurate ICP measurements Once the Flex Catheter has been initialized i e autozeroed by the Integra Camino ICP Monitor do not replace the Flex Extension Cable being used for patient measurement Replacing the Flex Extension Cable with a different cable after the Flex Catheter has already been initialized may result in inaccurate ICP measurements Transient Pressure Changes During Implantation or Removal of Catheter May Trigger Alarm If the Flex Catheter is connected to the monitor during the implantation or removal of a catheter a sudden change in ICP measurements may occur while the catheter is traveling Depending on the level of pressure change the ICP measurements may temporarily exceed the ICP accuracy range for the monitor between 10 mmHg and 125 mmHg and trigger one of the following alarms ICP
71. ing On the System Warning 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 connector end of the AC power adapter into the port labeled Input 18 V Connector end of AC power adapter AC power adapter 20 Chapter 3 Setting Up System for Clinical Use B Insert the plug end of the AC power adapter into a grounded AC wall outlet 2 Turn on the monitor A On the front of the monitor press the power button B Oncethe button illuminates the Integra logo will appear on the touch screen for a few seconds before initiating the setup process Power Button 3 Afterthe setup process completes the monitor will sound a one second startup tone and display the Main panel 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 Warning To prevent injury to the patient user or other persons or 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 secon
72. ing cables 63 fill waveforms specifying 45 Flex catheter connecting 27 29 Flex extension cable cleaning 61 sterilization 65 FLEXEXT see Flex Extension Cable G GUI symbols vi H high ICP alarm limit disabling 43 responding to alarm 51 specifying 42 testing 84 l IV pole attaching to 19 icons list of software vi ICP alarms responding to accuracy range 54 responding to high 51 setting limits for 42 triggered during implantation 29 ICP output testing 79 Index 103 implantation ICP pressure changes during 29 preparing fiber optic catheters for 24 26 preparing Flex catheters for 27 29 inactive alarm symbol 48 indications for use 1 L label symbols v languages setting up for first time use 16 specifying 46 line waveforms specifying 45 log files extracting 46 losing trend data 59 low battery alarm for 52 testing 85 low priority alarms 49 M Main tab using the 37 maintenance tests preventive 75 87 Mean ICP Values about the 38 medium priority alarms 49 monitor overheating alarm responding to 53 O on off powering the system 20 turning ICP alarm off 43 turning ICP alarm on 42 overheating monitor 53 P package symbols v parts of monitor 6 9 bottom panel 9 front panel 6 left panel 9 rear panel 7 right panel 8 patient bedside monitor connecting to 30 33 patient population intended 1 physiological alarm about 47 responding to 51 pole attaching to IV 19 positioning m
73. it indefinitely Use caution if this feature is selected To re enable this alarm press the Alarm On and Accept buttons No modification of the Integra Camino ICP Monitor is allowed The Integra Camino ICP Monitor is a sensitive electronic device When using the monitor always handle with care If damage is suspected contact Integra Read the user s manual from the patient bedside monitor s manufacturer before connecting the Integra Camino ICP Monitor to a patient bedside monitor To prevent injury to the patient user or other persons or damage to the monitor always verify that the monitor is clamped securely to the equipment pole To reduce the risk of electric shock do not disassemble the Integra Camino ICP 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 Only use Integra supplied accessories on the Integra Camino ICP Monitor This applies in particular to catheters catheter cables battery AC power adapter and USB to R232 adapter cable Ifthe Integra Camino ICP Monitor loses power and shuts down while it is connected to a patient bedside monitor do not use the ICP values on the patient bedside monitor for patient measurements the ICP valu
74. itor 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 Chapter 5 Responding to Physiological and Technical Alarms 55 This page is intentionally left blank 56 Chapter 5 Responding to Physiological and Technical Alarms CHAPTER 6 EXTRACTING TREND DATA FOR REMOTE EVALUATION About Data Extraction 2 iui cpu igs ceeceanectueedceesesee 57 Extracting Data to USB Drive eeeeseeeeeeeseeeeennnnen nnns 57 Extract Data via Digital Streaming eese 59 Conditions That Reset Trend Data During Recording 59 About Data Extraction The Integra Camino ICP Monitor provides two options for extracting Mean ICP trend data e External USB Drive e Digital streaming via the USB to RS232 adapter 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 Camino ICP Monitor is only intended for connecting a USB drive and USB to RS232 adapter cable for extracting ICP trend data The USB port is not intended to be connected
75. lure Mean ICP is out of accuracy range Temperature sensor failure Temperature range is out of accuracy range Low battery level 5 minutes or less Battery failure Monitor overheating 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 Camino ICP Monitor also displays technical messages on the status bar to indicate problems with Low battery level 15 minutes or less Nocatheter is connected Multiple catheters are connected Catheter initialization failure Catheter initializing Cannot write to log file For information on responding to these messages see page 67 Chapter 5 Responding to Physiological and Technical Alarms 47 Understanding the Alarm Symbols On the status bar the Integra Camino ICP Monitor 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 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 A
76. mall or too large ICP waveform not scaled correctly On touch screen press Main tab and use the Scale button to adjust scaling factor see page 38 70 Chapter 8 Troubleshooting the System Problem ICP waveform appears as a solid wave instead of a line wave Cause Recommendation Waveform Style is set to Fill mode On touch screen press Settings tab and select Set Waveform gt Line see page 45 ICP waveform appears as a line wave instead of solid wave Waveform Style is set to Line mode On touch screen press Settings tab and select Set Waveform Fill see page 45 Time date appears incorrectly Time and or date is set incorrectly On touch screen press Settings tab and select Set Time and Date to specify current time and date see page 45 Incorrect language is displayed Choice of language is set incorrectly On touch screen press Settings tab and select Set Language to specify language see page 46 Discrepancy of ICP measurements between the Integra Camino ICP Monitor and the patient bedside monitor Patient bedside monitor is not synchronized to the Integra Camino ICP Monitor correctly On the Integra Camino ICP Monitor press Synchronize to Monitor to re calibrate the two monitors see page 30 Incorrect patient bedside monitor adapter cable being used Verify correct patient bedside monitor cable is being used see page
77. mended 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 b 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 Camino ICP Monitor is used exceeds the applicable RF compliance level above the Integra Camino ICP 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 Camino ICP Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Appendix A Technical Specifications 97 Recommended separation distance
78. n step 3 appears in the Main and Trend screens as the following indicator labels e Ahorizontal line in the graph corresponding to the specified high ICP alarm limit Anumerical value next to the alarm limit symbol Synchronize to Trend Alarm Settings Monitor high ICP alarm limit high ICP alarm limit Scale ICP above alarm limit 42 Chapter 4 Monitoring the Patients ICP and Temperature Disabling the High ICP Alarm To turn off the high ICP alarm and prevent the Integra Camino MM ICP Monitor from sounding a physiological alarm press Alarm UJ Off and then Accept If this option is selected the monitor will display ICP Alarm Off in the status bar The monitor will also remove the corresponding high ICP alarm limit indicator labels from the Main and Trend screens To turn on the high ICP alarm press Alarm On and then Accept Warning Selecting the Alarm Off feature will disable the physiological alarm indefinitely Use caution if this feature is selected Silencing the High ICP Alarm Temporarily To silence the physiological alarm temporarily press the active alarm symbol on the status bar This will silence the alarm for ES either 3 minutes or until the patient s Mean ICP value falls within the specified limit In this silenced state the status bar will display Audio Paused and change the alarm symbol from active to inactive see page 48 If the patient s Mean ICP value does not fall to within the sp
79. nce About Technical Supports cte rette he an eaves aa dave ete de e aeten sessed ese ded 89 About Annual Maintenance ei r ar aa aa Taa aa aa aTa E araa ia aa E Daia Daai E aaa Eaa iaa 89 Appendix A Technical Specifications List of Technical Specifications yarri a aa T aa a a eE 91 Classifications and Standards sss errem ener nnne nennen nennt 93 Manufacturer s Declaration Table cccceccecceceeeneeceeeeeeeeeeeeeeeeaaaeaecaeeeeeeeeeeeeeceeccasaeeeeeeeeeeeeeessnsnaeess 94 General Notes orbem cater nep eite ide eee t dte eder reus 94 Appendix B Integra Warranty Warranty dt inta Re FL de d e RE e dot e de da e Ee Fee d eed Ed e Leere E Road 99 LIST OF SYMBOLS AND ABBREVIATIONS Packaging and Label Symbols Symbol Definition Symbol Definition Follow instructions for use Defibrillation proof type CF applied part HM Catalogue number Direct current Rx ONLY Caution Federal USA law restricts this device to sale by or on the order of a physician Class Il equipment B Serial number Waste Electronics and Electrical Equipment Batch code Manufacturer USB connection Safety information for transporting lithium ion batteries ESE SEE of Date of manufacture CALIBRATION VERIFIED NEXT SCHEDULED MAINTENANCE DUE 72903759 Rev 1 Due date for annual maintenance 50 C N 2 Temperatur
80. nd provide Integra every opportunity to inspect and remedy defects Included under the Warranty are the following services 3 11 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 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 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 100 Appendix B Integra Warranty 5 Limitation of Liability 5 1 5 2 5 3 THE WARRANTIES DESCRIBED IN SECTION 1 HEREOF ARE EXCLUSIVE AND ARE GIVEN AND
81. nect 1 Onthe monitor s right side connect the Fiber Optic Catheter Cable to the ICP and temperature ports Temperature connector from catheter cable Pressure connector from catheter cable Fiber Optic Catheter Cable A Attach the cable s ICP connector P into the port labeled ICP CAMCABL To attach Align the red dot on the 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 B If temperature will be monitored for the patient attach the cable s temperature connector T into the port labeled ICT CAMCABL To attach Align the red dot on the 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 24 Chapter 3 Setting Up System for Clinical Use 2 When operating in the sterile field select the desired Integra Camino Pressure Monitoring Kit model 110 4 series For instructions on using the kit see the directions for use supplied with each kit 3 Remove the catheter from its sterile tray and firmly attach its ICP and temperature connections to the Fiber Optic Catheter Cable A Attach the ICP transducer from the catheter to the ICP connector on the Fiber Optic Catheter Cable B If applicable attach the temperature thermistor from the catheter to the temperature connector
82. ological and Technical Alarms 51 Responding to ICP Catheter Failure Alarm If the ICP catheter fails during initialization or use the monitor will activate a medium priority alarm that will e Sound an alarm containing a burst of three pulses Display the following error message on status bar Catheter failure e Remove the ICP and temperature values from the screen To resolve this problem disconnect the catheter To resume monitoring ICP the entire catheter must be replaced Silencing the Catheter Failure Alarm Temporarily Press the flashing alarm symbol on the touch screen This will silence the alarm for 3minutes If the catheter is not disconnected within 3 minutes the alarm will reactivate Responding to Temperature Sensor Failure Alarm If the temperature catheter fails during use the monitor will activate a medium priority alarm that will e Sound an alarm containing a burst of three pulses Display the following error message on status bar Temperature sensor failure e Remove the ICP and temperature values from the screen To resolve this problem disconnect the temperature cable To resume monitoring temperature the entire catheter must be replaced Silencing the Catheter Failure Alarm Temporarily Press the flashing alarm symbol on the touch screen This will silence the alarm for 3minutes If the catheter is not disconnected within 3 minutes the alarm will reactivate Responding to Low Battery Alarm
83. on the Fiber Optic Catheter Cable Temperature thermistor from Temperature connector from catheter catheter cable ICP connector from catheter cable ICP transducer from catheter 4 Notethat when the temperature catheter is first connected and in open air room temperature the Integra Camino ICP Monitor will e Sound an alarm and Display Temperature out of accuracy range on the status bar To silence the alarm temporarily 3 minutes while the ES catheter is still in air press the yellow alarm button 5 Verify that the ICP value reads O mmHg on the monitor To verify press the Main tab on the touch screen and view the ICP value If the ICP value does not read O mmHg A Press the Scale button on the Main tab to select a waveform range of 10 to 20 mmHg Note that pressing the Scale button each time advances tothe next range B Remove the black zero adjustment tool from the catheter kit C Usethe tool to adjust the screw located on the bottom of the catheter s transducer to increase decrease the ICP value Transducer from catheter Zero adjustment tool D Set the ICP value to O mmHg Chapter 3 Setting Up System for Clinical Use 25 o Prior to implanting the catheter into the patient disconnect the Fiber Optic Catheter from the Fiber Optic Catheter Cable N After implanting the catheter into the patient reconnect the catheter to the Fiber Optic Catheter Cable Once the Fiber
84. onitor 19 power status AC and battery 36 powering the system AC power 20 battery 21 pressure catheters attaching fiber optic 24 attaching Flex 27 pressure input testing 78 pressure output testing 79 pressure spikes Flex catheter 29 preventive maintenance tests 75 87 priorities alarm 48 50 R restore defaults 43 RS232 adapter cable streaming trend data 59 S scaling ICP waveforms 38 trend data ICP 40 trend data time 40 service mode accessing 46 settings customizing 44 setup for clinical use 19 33 for first time use 11 17 silence alarm symbol 48 single use only about 66 software symbols vi software version checking 87 status messages responding to 67 using the status bar 36 sterilization fiber optic catheter cable 63 Flex extension cable 65 storage battery 22 monitor 33 trend data limits 58 streaming extracting trend data 59 symbols packaging v software vi synchronizing two monitors about the Synchronize to Monitor button 36 connecting to a bedside monitor 30 33 system failures list of error codes 73 responding to 51 system information checking 46 system messages responding to 67 T technical alarms list of 47 priorities of 50 temperature alarms responding to 54 temperature input testing 80 temperature output testing 81 104 Index tests preventive maintenance 75 87 thermistor temperature fiber optic 25 time and date setting 45 touch screen about the 35 transducer ICP fi
85. onitor is being powered by the AC power adapter Note that this button does not illuminate if the monitor is being powered by the battery 3 Power Button Turns the monitor on and off This button is illuminated when the power is on 4 Touch Screen Provides software tools for viewing data and controlling parameters for monitoring the patient s ICP and ICT levels 6 Chapter 1 System Overview About the Rear Panel The rear panel contains Number Item Description 1 USB Port Connection port for extracting trend data via USB transfer or digital streaming 2 AC Power Adapter Port Connection port for the AC power cord 3 PMIO Port Connection port for PMIO cable This cable is used to connect the Integra Camino ICP Monitor to a patient bedside monitor 4 Pole Clamp Clamping system for securing monitor to an equipment pole 5 Air Vent Grated opening that allows air being circulated by the internal cooling fan to leave the monitor 6 Cable Strap Rubber strap used to secure AC power adapter during transport Chapter 1 System Overview 7 About the Right Panel The right panel contains Number Item Description 1 Temperature Port Connection port for the temperature connector on the Fiber Optic Catheter Cable 2 Pressure Port Connection port for the ICP connector on the Integra Camino Flex Extension Cable pressure only 3 Pressure Port Connection port for the ICP connector on the Fiber Optic Ca
86. onnected to any cables N Oo GO Ss Plug the Integra Camino ICP Monitor to an AC wall outlet On the right side of the monitor attach the Fiber Optic Catheter Cable and a functional Fiber Optic Catheter to the ICP CAMCABL port Turn on the monitor On the touch screen press the Main tab and verify the ICP value reads o If not use the black zero adjustment tool from the Fiber Optic Catheter kit to set the ICP value to o mmHg Insert the Fiber Optic Catheter into the manifold Connect the other end of the manifold to the pressure simulator If necessary adjust the pressure simulator to o mmHg Verify that the ICP values on both the pressure simulator and the Integra monitor s touch screen read o mmHg 78 Chapter 9 Testing and Preventive Maintenance 8 Adjust the pressure simulator control knob to the following pressures and verify the Integra ICP monitor displays the ICP value within the stated limits It will also be necessary to take into account the settings accuracy of the pressure simulator Applied Pressure mmHg ICP Monitor mmHg 0 2 to 2 20 18 to 22 40 38 to 42 60 56 to 64 100 94 to 106 125 117 to 133 Testing Pressure Output Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment Digital Multimeter DMM 1 mV resolution PMIO cable part PMIO MPM DC bench powe
87. out of accuracy range or ICP catheter failure If either of these alarms is triggered during implantation or removal of the catheter disconnect and re connect the Flex Catheter to the Flex Extension Cable Chapter 3 Setting Up System for Clinical Use 29 Connecting to a Patient Bedside Monitor if applicable The Integra Camino ICP 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 bedside monitor Monitor Adapter Cable ICPXX and ICTXX Adapter cables that fit between the PMIO cable and the vendor specific patient bedside monitor To determine which monitor adapter cables are required for your particular patient bedside monitor contact Integra see page 89 Read the user s manual from the patient bedside monitor s manufacturer before connecting the Integra Camino ICP Monitor to a patient bedside monitor Procedures for Synchronizing the Two Monitors Perform the following steps to verify that both the Integra Camino ICP Monitor and the patient bedside monitor report the same ICP values 1 mmHg or 1 96 of monitor reading whichever is greater Note that these steps should be performed in each of the following situations e When first connecting the Integra Camino ICP Monitor to a patient bedside monitor e Ifthe Integra Camino ICP Monitor becomes di
88. ower checking status of 36 connecting to 20 testing 85 accuracy ranges ICP and temperature 54 alarm priorities 48 50 alarm symbols 48 alarms accuracy range for ICP and temperature 54 battery failure 55 catheter failure ICP 52 cooling fan failure 53 ICP above alarm limit 51 low battery 52 monitor overheating 53 sensor failure temperature 52 system failure 51 assembly for clinical use 19 33 for first time use 11 17 audio paused symbol 48 B battery alarm for low charge 55 installing for first time 13 replacing 86 storage 22 usage 21 battery charge determining status of 36 indicator symbols for 37 testing 86 bedside monitor connecting to 30 33 biomed tests 75 87 C CAMCABL See Fiber Optic Extension Cable catheter failure alarms responding to ICP 52 temperature sensor 52 catheters connecting fiber optic 24 26 connecting Flex 27 29 cleaning sytem components 61 62 contraindications 1 cooling fan failure alarm responding to 53 customizing user settings 44 D date and time setting for first time 16 specifying 45 defaults restoring 43 definitions of abbreviations vii digital streaming extracting trend data 59 disposal monitor 66 E equipment pole attaching to 19 error codes list of system 73 error messages list of 67 69 extracting log information 46 F factory default restoring 43 fan failure cooling 53 fiber optic catheters connecting to monitor 24 26 requirement for biomed tests 75 steriliz
89. p of the Fiber Optic Catheter are at the same level In this example the catheter s tip and the water are leveled with the 10 inch mark of the ruler Water level and catheter tip 3ight scale in ce End Cap PE me rS 7 mmHg position 18 mmHg position 9 Turn on the monitor On the touch screen press the Main tab and verify the ICP value reads o If not use the black zero adjustment tool from the catheter kit to set the ICP value to o mmHg 10 Raise the IV bag 4 inches The water level should be leveled with the 6 inch mark of ruler Note the following unit conversion 1 inch H20 1 8683 mmHg On the touch screen verify the ICP value reads 7 2 mmHg 11 Raise IV bag for another 6 inches 12 On the touch screen verify the ICP value reads 18 2 mmHg Chapter 9 Testing and Preventive Maintenance 77 Using a Pressure Simulator preferred method Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment Integra Camino Fiber Optic Catheter Cable New Integra Camino Fiber Optic Catheter part 110 4BT ICP temperature measurements Pressure simulator between o and 125 mmHg e g Delta Cal 650 950 Tubing and manifold assembly Tubing Catheter Tip Pressure Simulator Notice Before performing this test verify that the ICP Monitor is turned off and not c
90. pecific adapter plug to the backside of the AC power adapter US UK Europe Australia Region Specific Adapter Plugs Backside of AC power adapter A Align the two slots on the adapter plug over the two prongs on the AC power adapter y 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 14 Chapter 2 Setting Up System for the First Time C Gently slide the adapter plug forward until it snaps into place I 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 Step 4 Plug the Monitor into 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 Camino ICP Monitor A Onthe back of the monitor attach the connector end of the AC power adapter into the port labeled Input 18 V Connector end of AC power adapter B Insertthe plug end of the AC power adapter into a grounded AC wall outlet 3 Turn on the monitor On the front of the monitor press the power button the Integra Camino ICP Monitor will display the Integra logo before initiating the monitor setup process Chapter 2 Setting Up Sys
91. r supply 10 V DC Notice Before performing this test verify that the Integra Camino ICP Monitor is turned off and not connected to any cables 1 Plug the Integra Camino ICP Monitor to an AC wall outlet 2 Ontherear ofthe 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 Connect the and leads of the DMM to pins 2 and 3 of the six pin cannon connector respectively Chapter 9 Testing and Preventive Maintenance 79 4 Turnonthe monitor On the touch screen press Synchronize to Monitor to test the following ICP values Simulated Pressure mmHg Simulated Voltage mVDC 0 0 000 25 25 1 250 25 50 2 500 25 100 5 000 25 Note that pressing Check Additional Values each time will advance to the next fixed ICP value 5 Turn off all test equipment power down monitor and then disconnect all test equipment Testing Temperature Input Note the following test guidelines Guidelines Requirements Maintenance Interval Once every three months is suggested Equipment Digital Multimeter DMM 1 mV resolution Integra Camino Fiber Optic Catheter Cable Integra
92. re and Temperature Measurements on the Patient Bedside Monitor 33 storing the Systelm ei e o n P dde PE EU ERE LE eL rus 33 Chapter 4 Monitoring the Patient s ICP and Temperature About the TOUCH Screen iiec nter te dedu eee deed v ee dua e ted ud ev atre d vede dd d ede 35 About the Synchronize to Monitor Button ssssssssseeeeneemmeen nennen 36 Reviewing the Status Bal e REPRE AERA YR E EROR DOR T taaiaes 36 Verifying Status of Battery and AC Power ssssssssssesee nennen nnne nennen nens 36 Verifying Amount of Battery Charge Available sss eene 37 About the Alarms iter Er da bier EE DUI hear EP ou etr ete ex ERE Or ERRORES 37 Monitoring the Patient s ICP and Temperature ssssssssee enne nennen 37 Monitoring Trend BEST 39 Conditions that Reset Trend Datas baerii ranni Ein AEAEE EAA ennemi nnn nennen nennen 40 Setting the High ICP Alarm Limit eese eene nente etienne eintreten inb the nen rebns eire nnn 41 Specifying the High ICP Alarm Limit sese emm enne rennen 42 Disabling the High ICP Alartm itt ERRARE E 43 Silencing the High ICP Alarm Temporarily seen 43 Restoring Default High ICP Alarm Limit Values sseeen emm em 43 Customizing the User Settings senmi n aA E A AE E TA 44 Chapter 5 Responding to Physiological and Technical Alarms About the Two Alarm Types
93. rend Data for Remote Evaluation About Data Extraction ec ade tiene store dde esee e nage ae nime S a aee Les dien na Dedi 57 Extracting Data to USB Drive opererad a e ea a OE e ATA a E a T 57 How the Monitor Stores Trend Data for Up to 5 Days 58 Extract Data via Digital Streaming oerrinne ERAEN AE enne nnne nnns 59 Conditions That Reset Trend Data During Recording sese 59 Chapter 7 Cleaning and Sterilizing the System Cleaning the System and Components ssssssssssssseeseeeeeeeeen nemen nennen nennen nnne 61 Cleaning Guldellries iit MH Lg ree LU ERE DUE a ER HE Dre DU cetus 61 Sterilizing the Integra Camino Fiber Optic Catheter Cable ssssse 63 Sterilizing the Integra Camino Flex Extension Cable ssesssseee een 65 oterilization Parameters i PI He te prat LO SER M PS pee ils PR eb ed gts 65 About Single Use Only Catheters ssssssssssssse eene nennen nnne nenne nennen enne 66 Disposal of the Monitor System and Components sssssssssssssssseseeeeen eene 66 Chapter 8 Troubleshooting the System About the Troubleshooting Process ssssssssssseee eene nnne nre nnne enne rne nnns 67 Responding to System Status Messages ssssssssssseeeeeeneeeeeeene emen ener nnne rne 67 Responding to Problems During Use sssssssssseneeeeene nennen ennemis 69 Responding to System Failure Messages
94. s see page 30 About Pressure and Temperature Measurements on the Patient Bedside Monitor Storing the System The Integra Camino ICP Monitor is designed to measure tissue pressure between the range of 10 mmHg to 125 mmHg and tissue temperature between the range of 30 C and 42 C If the pressure or temperature value is outside these specific ranges on the Integra Camino ICP Monitor while it is connected to the patient bedside monitor the Integra monitor will activate a low priority alarm for either an ICP or temperature accuracy range alarm condition see page 54 Depending on the type of alarm condition the Integra monitor will also transmit either a pressure 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 If the Integra Camino ICP Monitor will not be used for several months or longer remove the battery from 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 Camino ICP Monitor also includes an adjustable strap for securing the AC power adapter cord during patient tran
95. s between portable and mobile RF communications equipment and the Integra Camino ICP Monitor The Integra Camino ICP Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Integra Camino ICP Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Integra Camino ICP Monitor as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800MHz 800 MHz to 2 5 GHz w d 1 17 P d 1 17 JP 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 using 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 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 obj
96. s the power button to turn on the system Integra Camino ICP Monitor does not power on or off when power button is pressed The Mean ICP value on the touch screen displays two dashes Firmware error Poor connection between Fiber Optic Catheter Cable and Integra Camino ICP Monitor Disconnect AC adapter cord from Integra Camino ICP Monitor and remove battery Re insert battery Reconnect AC adapter cord to Integra Camino ICP Monitor Press the power button Make sure the cable is properly connected to the Integra Camino ICP Monitor Poor connection between Fiber Optic Catheter Cable or Flex Extension Cable and the catheter Replace the catheter see directions for use supplied with catheter Faulty catheter Replace the catheter see directions for use supplied with catheter Damaged Fiber Optic Catheter Cable Replace Fiber Optic Catheter Cable see page 24 Damaged Integra Camino Flex Catheter Cable Replace Integra Camino Flex Catheter Cable see page 27 The temperature value on the touch screen displays two dashes Faulty catheter Replace the catheter see directions for use supplied with catheter ICP only catheter in use Replace the catheter with ICP temperature catheter see directions for use supplied with catheter Damaged Fiber Optic Catheter Cable Replace Fiber Optic Catheter Cable see page 24 ICP waveform appears too s
97. sconnected from a patient bedside monitor e g due to patient transport to CT or OR and then needs to be re connected f during use the reported ICP values between the Integra Camino ICP Monitor and the patient bedside monitor differ by more than x 1 mmHg or 1 96 of monitor reading whichever is greater Step 1 Connect the Two Monitors Notice To cancel the synchronization process during any of the following steps press Done Connect the Integra Camino ICP 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 1 Ifthe ICP value is above 100 mmHg the difference between both monitors can differ by 2 mmHg 30 Chapter 3 Setting Up System for Clinical Use Align the red dot on the PMIO cable connector with the red triangle on the monitor s port and push firmly e Verify the cable is completely connected to the monitor before proceeding AC power adapter cable PMIO cable B Onthe 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 Camino ICP Monitor does not measure Cerebral Perfusion Pressure CPP ranges As a result the CPP connector on the PMIO cable will not be used Step 2 Press the Synchroniz
98. selected time date on the touch screen Chapter 4 Monitoring the Patient s ICP and Temperature 45 Specifying Languages The Integra Camino ICP Monitor provides options for displaying the onscreen text indifferent languages Trend Settings Set Waveform Set Time and Date The list of supported languages include e English Spanish Danish Chinese Simplified French e Dutch e Polish Portuguese Brazilian Italian e Japanese Korean e German Russian To change languages from any screen 1 Onthe touch screen press the Settings tab 2 Ontheleft 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 Camino ICP Monitor will display all onscreen text to the selected language Determining System Information If you experience technical problems with your Integra Camino ICP Monitor you may need to provide Integra with information regarding D 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 HU Extract Information panel if a USB drive is connected to the Integra Camino ICP 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 th
99. several technical alarms for indicating equipment related problems For instructions on setting the high ICP alarm limit see page 41 For detailed information on responding to each of these alarm types see Chapter 5 Monitoring the Patient s ICP and Temperature Press the Main tab to view the patient s Mean ICP and temperature values as numerical data The ICP may also be viewed as an animated waveform Trend Alarm Settings Synchronize to Monitor Temperature Chapter 4 Monitoring the Patient s ICP and Temperature 37 The information on this screen includes Parameter Description 1 Displays a graph showing the ICP in mmHg versus time as an animated waveform solid or line To specify the waveform type press the Settings tab For instructions see page 45 2 Displays the Mean ICP in mmHg as numerical values 3 Displays the high ICP alarm limit for the patient If the patient s Mean ICP exceeds this limit for more than 5 seconds an alarm will sound To specify this limit see page 42 4 Displays tissue temperature in degrees Celsius C 5 Specifies the scales of pressure ranges for the ICP waveform About the Numerical Display of Mean ICP Values The numerical ICP value that is displayed on the touch screen is the patient s Mean ICP value which is a time averaged representation of the continuously measured ICP This displayed value is rounded to the nearest 1 mmHg Scaling the ICP Waveform Ran
100. sport 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 Chapter 3 Setting Up System for Clinical Use 33 This page is intentionally left blank 34 Chapter 3 Setting Up System for Clinical Use CHAPTER 4 MONITORING THE PATIENT S ICP AND TEMPERATURE About the Touch Screen sccccseeeceeseeeeeneeeneeeeesseeeeeeeeeesesaeensneeesecueseseeeeeenees 35 About the Alanim s 5 citer eie Lene De eere erlernen 37 Monitoring the Patient s ICP and Temperature 37 Monitoring Trend Data eese ennemi 39 Setting the High ICP Alarm Limit cssseeceeeeseseeeeeenseeeeeeeenseeeeeeeenees 41 Customizing the User Settings esce 44 About the Touch Screen The Integra Camino ICP Monitor includes a touch screen for evaluating and controlling parameters for monitoring the patient s ICP and temperature The touch screen provides the following tabs for accessing and activating different parameter Synchronize to Monitor Trend Settings Temperature 37 0 Scale ICP above alarm limit Tab Description Main Provides tools for evaluating the patient s Mean ICP mmHg and temperature C For details see page 37 Trend Provides tools for moni
101. t replace the Fiber Optic Catheter Cable being used for patient measurement Replacing the Fiber Optic Catheter Cable with another cable after the catheter has already been zeroed may result in inaccurate patient measurements Once the Integra Camino Fiber Optic Catheter has been zeroed to the Integra Camino ICP Monitor do not transfer this zeroed catheter to any other monitor Transferring a zeroed catheter to a different monitor may result in inaccurate ICP measurements To prevent possible patient injury resulting from incorrect ICP measurements always perform each of the steps listed on page 26 before implanting a new Integra Camino Flex Catheter into the patient In particular always leave the Flex Catheter in the air until the monitor completes the autozero i e initialization process successfully Once the Integra Camino Flex Catheter has been initialized autozeroed by the Integra Camino ICP Monitor do not replace the Integra Camino Flex Extension Cable being used for patient measurement Replacing the Flex Extension Cable with another cable after the Flex Catheter has already been initialized may result in inaccurate ICP measurements Once the Integra Camino Flex Catheter has been initialized i e autozeroed by the Integra Camino ICP Monitor do not transfer this initialized catheter to any other monitor Transferring an initialized catheter to a different monitor may result in inaccurate ICP measurements 4 Chapter 1 Sys
102. tab In countries where daylight savings are observed the time must be adjusted manually For instructions see page 45 How the Monitor Stores Trend Data for Up to 5 Days The Integra Camino ICP Monitor will only store the Mean ICP 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 catheter under sterile conditions is recommended Note that replacing a catheter will reset the trend data Please extract any data that you wish to retain prior to replacing the catheter 58 Chapter 6 Extracting Trend Data for Remote Evaluation Extract Data via Digital Streaming Use the streaming data feature to export Mean ICP trend data digitally from the Integra Camino ICP 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 mean ICP value in mmHg of the current ICP 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 to RS2
103. tem Overview Warnings The Integra Camino ICP Monitor will only store the Mean ICP 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 catheter under sterile conditions is recommended Note that replacing a catheter will reset the trend data Please extract any data that you wish to retain prior to replacing the catheter Do not autoclave or immerse the Integra Camino ICP Monitor in liquid as damage may occur If the monitor is exposed to liquids turn off the unit remove the AC power adapter dry the unit thoroughly and send to biomed staff for evaluation before reapplying power Only use the cleaning agents listed in Chapter 7 for cleaning and disinfecting the Integra Camino ICP Monitor system Using solvents or cleaning agents not listed in Chapter 7 may damage the plastic exterior of the Integra Camino ICP Monitor Chapter 1 System Overview 5 Parts of the Monitor The Integra Camino ICP Monitor contains hardware software and electrical components that support specific Integra catheters for monitoring the patient s ICP and temperature The following section provides information on the different parts of the monitor About the Front Panel The front panel contains 4 INTEGRA Number Item Description 1 Handle Handle used for carrying the monitor 2 Power Status Green LED button that indicates the m
104. tem for the First Time 15 4 Afterthe initial setup process completes the Integra Camino ICP 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 1 Onthe touch screen press the Settings tab and select Set Time and Date Syec een to Trend Alarm Settings Montor 2 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 3 Press Accept the Integra Camino ICP 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 D 2 Press Set Language Set Language button 16 Chapter 2 Setting Up System for the First Time 3 In the displayed Language menu use the arrows to select the desired language Press Accept the Integra Camino ICP 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 2 Turn off the monitor On the front of the monitor press the power button K
105. the Integra amp Camino Fiber Optic Catheter Cable 63 Sterilizing the Integra amp Camino Flex Extension Cable 65 About Single Use Only Catheters eese 66 Disposal of the Monitor System and Components 66 Cleaning the System and Components Cleaning Guidelines Before cleaning the surface and touch screen of the Integra Camino ICP 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 The monitor is designed for surface cleaning only do NOT immerse Never spray cleaning agents or other fluids directly onto the monitor e Use particular care when cleaning around the vents connectors and USB slot Be sure to wipe any excess fluid that accumulates in these areas When cleaning the touch screen do not use cloth or sponges that could scratch the surface Use the following guidelines when cleaning the Integra Camino ICP Monitor and each of its system components that are listed in the box below e External surface Integra Camino Fiber Optic Catheter Cable Cable Strap Touch screen Integra Camino Flex Extension Cable Note that each of these components should be cleaned immediately after contamination Only use the cleaning agents listed in this section for cleaning and disinfectin
106. the battery charge lasts a minimum of 1 hour and 30 minutes If the battery charge does not last a minimum of 1 hour and 30 minutes contact Integra to order a new battery Inserting A New Battery The Integra Camino ICP 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 Camino ICP Monitor is turned off and the AC power adapter is unplugged Turn the monitor upside down so the handle is facing downward Remove the 2 screws and take off the battery cover If necessary remove the old battery by gently pulling the battery from the monitor s connector slots Make sure to dispose ofthe old battery according to local regulations Insert the new battery A Verify the Integra logo on the battery label is facing up B Alignthe battery s connectors on the front of the battery to the connector slots on the monitor 86 Chapter 9 Testing and Preventive Maintenance C Slidethe battery s connector into the monitor s connector slots until the battery is fully inserted into place Notice The battery for the Integra Camino ICP Monitor can only be inserted in one orientation 6 Secure the battery cover to the monitor by re inserting the two small screws To prevent injury to the patient user or other persons make sure to close the b
107. theter Cable 8 Chapter 1 System Overview About the Bottom Panel The bottom panel contains Number Item Description 1 Battery Door Cover Removable cover for accessing replacing the 14 4V lithium ion battery 2 Air Vent Grated opening that allows air being circulated by the internal cooling fan to leave the monitor About the Left Panel The left panel does not contain any usable connector ports or buttons Chapter 1 System Overview 9 This page is intentionally left blank 10 Chapter 1 System Overview CHAPTER2 SETTING UP SYSTEM FOR THE FIRST TIME Procedures for Initial Setup Step 1 Unpack the System REF CAMO2 Remove the contents from the Integra Camino ICP Monitor shipping box and verify the following items are included Warning Only use Integra supplied accessories on the Integra Camino ICP Monitor This applies in particular to catheters catheter cables battery AC power adapter and USB to R232 adapter cable Content Description Integra Camino ICP 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 t gt INTEGRA Quantity 1 Chapter 2 Setting Up System for the First Time 11 Content Description Integra PMIO patient bedside monitor cable REF PMIOMPM Quantity 1 Integra Camino Fiber Optic Catheter Cable REF CAMCA
108. til the patient s Mean ICP value falls within the specified alarm limit for at least one measurement After 3minutes 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 high ICP alarm limit see page 41 Selecting the Alarm Off feature will disable the high ICP 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 Irreversible System Failure Alarms If any of the software firmware or electrical components inside the monitor suffers a serious malfunction during use the Integra Camino ICP 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 and a description of the applicable system failure which include the following Sensor board failure e Power board failure e General software programming error e Incompatible firmware error For a complete list of error codes see page 73 Please note that each of these alarm conditions are irreversible If any of these alarms occur tend to the patient s need note the specific error code and contact Integra for service Chapter 5 Responding to Physi
109. 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 Mean ICP trend data from the monitor to an external USB drive When using this feature the Integra Camino ICP Monitor copies the data to the USB drive as a comma separated value csv file This csv file records the date time and Mean ICP 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 Year Day Mean ICP mmHg Month Time To extract the data to a USB drive Chapter 6 Extracting Trend Data for Remote Evaluation 57 1 Onthe rear panel attach the USB drive to the USB connector USB drive AC power adapter Z PMIO cable f i vi M 2 On the touch screen press the Trend tab 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 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
110. toring for up to a 5 day history of the patient s intracranial pressure values For details see page 39 Alarm Provides tools for specifying a high ICP alarm limit the monitor will tolerate before sounding an alarm For details see page 37 Settings Provides tools for specifying languages date and time This panel also contains settings for specifying the animated waveform graph that appears on the Main panel For details see page 44 Chapter 4 Monitoring the Patient s ICP and Temperature 35 About the Synchronize to Monitor Button If you are planning to display patient data from the Integra rum Camino ICP Monitor to a patient bedside monitor press the m Synchronize to Monitor button to initiate the process of synchronizing the two monitors with each other This process ensures that both monitors are displaying identical ICP values for the patient Note that this feature provides synchronization checks at o mmHg 25 mmHg 50 mmHg and 100 mmHg Pressing the Check Additional Values button each time will advance to the next measurement For instructions on synchronizing the monitors see page 30 Reviewing the Status Bar When using the Integra Camino ICP Monitor the status bar on the bottom of the touch screen will display messages to indicate the current states of alarms catheters and AC battery power Scale ICP above alarm limit Status bar Verifying Status of Battery and AC Power The Integra Camino ICP
111. ttery is low e Flash 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 low battery alarm persist contact Integra Chapter 9 Testing and Preventive Maintenance 85 Battery Charge Runthe Integra Camino ICP 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 qo display four green bars Unplug the monitor and run it on battery power only and verify that
112. udio 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 How the Monitor Prioritizes the Alarms The Integra Camino ICP 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 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 48 Chapter 5 Responding to Physiological and Technical Alarms 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 Camino ICP Monitor activates audio and visual indicators to alert the user of the condition Clinical Priority Audio Indicators Visual Indicators Medium Sounds an alarm containing a burst of three pulses with a pulse separation of 180 milliseconds and a burst separation of 3 seconds The volume of each alarm pulse measures a sound pressure of 70 dB Amessage will appear on the status bar that identifi
113. ut of accuracy range Display the Mean ICP or temperature value in yellow on the Main Trend and Alarm screens To resolve this problem the Mean ICP or temperature must fall within the rated accuracy ranges listed in the above table Silencing the ICP 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 Mean ICP or temperature values fall back within the rated accuracy ranges displayed in the above table If the Mean ICP or temperature values remain outside the rated accuracy ranges for the 3 minutes the alarm will reactivate 54 Chapter 5 Responding to Physiological and Technical Alarms Responding to Battery Failure Alarm If the battery control system inside the Integra ICP Camino 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 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 mon
114. which results in the monitor being unusable see page 51 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 Camino ICP 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 5 Responding to Physiological and Technical Alarms 49 List of Priorities for Each Alarm Notice If any of the software firmware or electrical components inside the monitor suffers a serious malfunction during a physiological alarm the Integra Camino ICP Monitor will activate an irreversible 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 51 The following table lists the priorities of each alarm condition Alarm Priority Type of Error Condition

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