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OPERATIONS MANUAL

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1. Getting Started WARNING THE SOMASENSOR IS DESIGNED FOR USE WITH THE INVOS CEREBRAL OXIMETER MODEL 4100 AND 5100 SERIES USE OF THE SOMASENSOR WITH ANY OTHER DEVICE MAY COMPROMISE PATIENT A visual inspection of the INVOS System and SomaSensor must be performed prior to use Visually inspect the following a The INVOS System case and screen should be clean and show no signs of damage The Power Cord and Preamp cable should show no signs of damage The Sensor Connector and Preamp receptacle should be clean and show no signs of damage Check the Bilateral Reusable Sensor Cable connector pins should not be bent INVOS System Setup Figure 6 1 Oximeter Preamp Connection Connect the Preamp to the front panel connection on the INVOS Oximeter To do this hold the connector at the end of the Preamp cable with the red dot facing up Align the red dot on the connector with the red dot on the front panel connection Insert the cable connector into the front panel connection while keeping the red dots aligned Be sure fo fully insert the connector until it locks 22 CHAPTER 6 OPERATING THE UNIT lf the connector will not fully enter the front panel connection remove it and examine for any defects in both components If both components show no signs of damage realign the red dots and try again To disconnect the Preamp draw back on the locking sleeve and detach Preamp Connect the Bilateral Reusable SomaSensor
2. The printer is not online Press the On Line button on the printer 58 CHAPTER 10 MAINTENANCE Troubleshooting the Disk Drive The chart below provides problems that may be encountered while using the Disk Drive and a list of the possible Causes and action to correct for each See Chapter 8 for Disk Drive setup instructions and INVOS System status codes INDICATION PROBLEM ACTION Pressing the TURN DISK ON or CASE HISTORY key in the DISK DRIVE menu does not produces the disk storage rate menu DISK ERROR message appears on the Disk Drive is not connected Verify connection of printer to Oximeter to Oximeter Check the status of the drive Insert a disk with IBM formatting The disk is not formatted screen Check the status of the drive Insert a blank disk The disk is not inserted into the drive Slide the write protection _ tab back on the disk The disk is write protected Troubleshooting the Digital Output The chart below provides problems that may be encountered while Outputting Data and a list of the possible causes and action to correct for each See Chapter 8 for Digital Output setup instructions and INVOS System status codes INDICATION PROBLEM ACTION Pressing the TURN DIGITAL ON or CASE HISTORY key in the DIGITAL OUTPUT menu produces the COM PORT Verify connection of Oximeter to PC with a null Digital Output Port is not conn
3. 52 CHAPTER 10 MAINTENANCE Bilateral Reusable Sensor Cable Grip the connector while pulling out Do not pull the cable Inspection Points NOTE THE INVOS SYSTEM SHOULD BE INSPECTED AT LEAST ONCE EVERY YEAR FOR SAFETY AND NORMAL OPERATION Mechanical Inspection Points Inspect the following for loose screws cracks dirt loose connectors or damaged cords Power cord Bilateral Reusable Sensor Cable Preamp Battery check for leakage or corrosion Chassis screws Rubber feet replace if missing Keypad Fan Internal components NOTE THE AIR INTAKE ON BOTTOM OF UNIT AND THE FAN SHOULD BE INSPECTED AND VACCUMED IF DUST OR DEBRIS IS PRESENT Electrical Inspection Points Inspection Point Method lt 5 Power Up Power 1 Observe screen for proper functioning and display Down Battery Backup 1 Fully charge the battery Turn the unit on 3 Unplug line cord AC Power and observe that the unit continues to run and that the battery capacity indicator on the screen shows a full charge The unit should operate for about 2 hours on a fully charged battery Unit Self Diagnostics 1 Observe that the unit boots up to the NEW PATIENT PREVIOUS PATIENT screen following power up Sensor Operation 1 Follow instructions in Chapter 6 2 Perform Functional Test with Optional Field Test Device Optional Field Test Device Operation NOTE ONLY A SOMANETICS SUPPUED FIELD TEST DEVIC
4. EXCEEDING THE COST OF PERFORMING THE OBLIGATIONS CONTAINED IN THE WARRANTY ACCORDING TO ITS TERMS AND IN NO EVENT SHALL SOMANETICS LIABILITY EXCEED THE VALUE OF THE PRODUCT GIVING RISE TO SUCH LIABILITY UNDER NO CIRCUMSTANCES SHALL SOMANETICS BE LIABLE FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION LOSS DAMAGE OR EXPENSE ATTRIBUTABLE TO A LOSS OF USE OF THE PRODUCT A LOSS OR DAMAGE TO PROPERTY OTHER THAN THE PRODUCT A LOSS OF EXPECTED INCOME LOSS FROM BUSINESS DISRUPTION OR OTHER COMMERCIAL LOSS DUE TO ANY CAUSE EVEN IF SOMANETICS HAS BEEN ADVISED OF THE IPOSSIBILITY OF SUCH DAMAGES IN CONNECTION WITH THIS AGREEMENT THE PRODUCTS OR ANY USE OF THE PRODUCTS EXCEPT FOR LIABILITY FOR CONSEQUENTIAL DAMAGES WHICH BY LAW MAY NOT BE DISCLAIMED Failure of Product Somanetics shall not be responsible for failure of Products and the warranty provided herein will not apply if such failure is attributable to accident including without limitation damage during shipment neglect misuse abuse or exposure of the Products to conditions beyond the environmental and operating constraints specified by Somaneftics INVOS CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL 47 Purpose of Product This Limited Warranty is given on the basis that Somanetics INVOS System is designed and intended solely for the purpose of providing patients and physicians with information concerning r
5. The disk drive duplicates the storage function available in the INVOS 4100 Cerebral Oximeter with the exceptions that it offers greater capacity selectable storage rates and stores on a nonvolatile medium suitable for archiving The disk drive allows Regional Oxygen Saturation rSO readings to be stored for future review and archiving It supports the following features and functions Storage capacity of 3 to 18 days depending on storage rate selected Four different storage rates Non volatile medium suitable for archiving Stored data can be plotted in a variety of formats RON 400304 Rev B l Disk Type 3 5 Floppy Double Sided High Density Disk Capacity 1 44 MByte Storage Rate User selectable storage every 10 15 30 or 60 seconds Storage Format ASCII Text File IBM Compatible Total Storage Capacity 3 to 18 days depending on storage rate Power Derived from Oximeter Setup Installation 1 Place the unit on a flat surface where it is protected against falling 2 Attach the disk drive cable to the connector labeled DISK DRIVE on the back panel of the Oximeter 3 The disk drive is now ready to operate 1 Make sure the Disk Drive is installed as described above and the Oximeter is operating Run or Pause mode in the Main Menu Display Screen 2 Insert a blank formatted disk into the disk slot Use only IBM formatted DS HD 3 5 Floppy Disks 1 44Mb Press the front panel menu key on the Oximeter
6. the INVOS Thermal Printer available from Somanetics Data can be stored in real time up to 12 or 24 hours depending on the user selectable TRENDING RATE and printed after the fact Data collected previous to the 12 or 24 hour periods will not be stored The time required for all ttended data to be printed in Case History mode depends on the printer that is being used The INVOS Thermal Printer print time is approximately 60 00 minutes for 24 hours of data If the printer is operated in Real Time mode the printer report will be complete at the end of the case Setup Installation 1 Place the unit on a flat surface where it is protected against falling 2 Attach the printer cable to the printer and the connector labeled PRINTER on the back panel of the INVOS Cerebral Oximeter Connect the power cord to the printer and plug the AC adapter into an AC outlet 3 Turn on the printer and make sure that it is on line 36 CHAPTER 8 STORING PRINTING OUTPUTTING AND REVIEWING Printing Data in Real Time 1 Press the OPTIONS MENU key on the main display screen 2 Press OUTPUT SELECT from the Options Menu The following menu will appear PRINTER DISK DRIVE DIGITAL OUTPUT REVIEW 3 Press the PRINTER option key The following menu will appear Figure 8 1 Output Options Figure 8 2 Real Time Data or Stored Data Option TURN PRINTER ON MAIN MENU 4 Press TURN PRINTER ON to enable real time printing At completion
7. values or collect data when outside interference is too great Removing the Sensor USE CARE WHEN REMOVING THE SENSOR FROM THE PATIENT IF DIFFICULT TO REMOVE USE A COMMERCIAL ADHESIVE SOLVENT TO LOOSEN THE SENSOR AND PEEL BACK SLOWLY TO PREVENT DAMAGE TO THE PATIENT S SKIN Commercially available adhesive solvents include the following Uni solve Smith and Nephew in the Netherlands Tel 31 20 654 3999 or htto www smith nephew com Detachol Ferndale Laboratories Inc Ferndale Michigan USA Tel 248 548 0900 or http www ferndalelabs com 3M Remover Lotion 3M Health Care in The Netherlands Tel 01 1 31 715 450 450 or htto www 3m com healthcare INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 25 Screen Format The display screen on the INVOS System is composed of several elements See Figure 6 6 for a detailed guide Figure 6 6 Display Screen zZz rozc rQO mon gt Trend High and Low Scale Chapter 7 Adult or Pediatric Indication Trend Data Chapter 7 Date and Time Chapter 7 Alarm Limits Chapter 7 Time Window Scale variable up to 24 hours Chapter 7 Battery Powered Status Message Chapter 6 Digital rSO2 reading updated continuously while monitoring Status Messages Chapter 6 Baseline Status Chapter 4 Menu Options Chapter 7 Trending Rate Message Area Chapter 7 Event Mark Screen Messages There are two types of messages that ap
8. 3050 ext 255 or via the Internet at http www somanetics com WARNING ACCESSORIES NOT SUPPLIED BY SOMANETICS MAY NOT MEET EN60601 1 2 IEC 601 1 2 STANDARDS CONTACT SOMANETICS CUSTOMER SERVICE DEPARTMENT AT 248 689 3050 EXT 255 OR customerservice somanetics com FOR COMPATIBLE PRODUCTS THAT MAY MEET THESE REQUIREMENTS INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 15 Chapter 5 Interfacing with the INVOS System Chapter Overview This chapter provides information on the features and specifications of the front and back panel buttons and connections of the INVOS System WARNING ALL EQUIPMENT USED WITHIN TWO 2 METERS OF THE PATIENT PATIENT ENVIRONMENT MUST BE IEC 60 APPROVED ALL EQUIPMENT USED OUTSIDE THE PATIENT ENVIRONMENT MUST BE APPROVED TO THE APPROPRIATE IEC OR ISO STANDARDS E G IEC 950 FOR OFFICE EQUIPMENT Front Panel A Display Screen Displays the rSO2 trend data system status alarm limits rSO2 limits date and time Also displays menus for default parameter changes alarm messages and data trending rate B Menu Keys Allows the operator to change available options as needed CS Q RUN PAUSE The INVOS System will not display rSO2 alarm or store data in the Pause mode Pause mode will read PAUSED on the display The RUN PAUSE key must be pressed again to resume monitoring and information storage D O ON OFF Lower left key turns power to the INVOS System on and
9. CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL 43 STATUS MESSAGE ian Preamp Not Check Preamp connection at monitor Connected Replace Preamp Com Port Check connections with Com Port device PC Unavailable Printer Unavailable Check connections with Printer Disk Error _Check connections with Disk Drive Replace sensor l ni Check for correct sensor type Connect new sensor Replace Reusable Cable Interference Noise corrupting rSO2 data electrocautery Move or turn off source Detected of interference Disk Full Ta l4 E i 1 ___ a 2 Replace disk Figure 8 19 Status Codes for Disk Drive and Digital Output Review Mode The review mode allows review of 12 hours 2 min trending rate or 24 hours 1 min trending rate of stored data trends on the INVOS Oximeter screen It reviews in one or two hour increments in a page format Access Review Mode Press the OPTIONS MENU key on the main display screen Press OUTPUT SELECT from the Options Menu The following menu will appear PRINTER DISK DRIVE DIGITAL OUTPUT REVIEW Figure 8 20 Output Options Press the REVIEW option key The ee menu will appear MAIN MENU NOTE MORE THAN ONE 1 HOUR OF DATA 2 MIN STORAGE RATE MUST BE STORED TO ACTIVATE REVIEW Figure 8 21 Review Mode MODE DATA CAN ONLY BE REVIEWED IN ONE 1 HOUR OR TWO 2 HOUR INCREMENTS DEPENDING ON STORAGE
10. SOMANETICS OPERATIONS MANUAL INVOS CEREBRAL OXIMETER MODEL 51008 Cerebral Oximeter Serial Number OS HSA Preamp Serial Number O5 amp as a a WHENEVER THIS SYMBOL IS SEEN ON THE DEVICE THIS MANUAL SHOULD BE CONSULTED FOR A COMPLETE EXPLANATION PLEASE READ THIS MANUAL COMPLETELY BEFORE ATTEMPTING TO OPERATE THE DEVICE P N 312971 Rev A Somanetics Corporation 1653 East Maple Road Troy MI U S A 48083 4208 Phone 248 689 3050 ext 255 Fax 248 689 4272 http www somanetics com Property of Somanetics Corporation Duplication of this manual is prohibited without written authorization from Somanetics Corporation INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL Description of Symbols Attention consult this manual for a complete explanation Potential Equalization gt Printer Fuse Recording on an information carrier Disk Drive Alternating Current Pause Interruption Dangerous Voltage Stand by Type BF Equipment Alarm Do Not Reuse Silence Alarm Preamp xDEeCO tL Ver xs et Digital Output I Backup Battery vis rex Sensor Light Source Table of Contents Chapter 1 Warnings Cautions Key Terms Warnings Precautions Indications For Use Contraindications Chapter 2 Specifications Chapter Overview Specifications Physical Operational Electrical Environmental Requirements Default Settings Compliance With
11. Standards Chapter 3 Before You Begin Chapter Overview How to Use this Manual Background Application to the INVOS SomaSensor Use of Product Customer Inquiries Service and Repair Chapter 4 Installation Chapter Overview Unpacking Installation Basics Accessories Chapter 5 Interfacing with the INVOS System Chapter Overview Front Panel Preamp Bilateral Reusable Sensor Cable Back Panel Printer Output Port Disk Drive Port Digital Output Port AC Input and Fuse Potential Equalization Connector Alarm Speaker Output Cooling Fan nk bh BR WW WH WH W oO NO OON NNN Chapter 6 Operating the Unit Chapter Overview Getting Started INVOS System Setup Software Version Serial Numbers Sensor Lot Number Applying the Sensor Removing the Sensor Screen Format Screen Messages Operating Messages Status Messages Setting a Baseline Alarms Patient Alarm Notification Battery Capacity Alarm Notification Event Mark Chapter 7 Changing the Settings Chapter Overview Changing Alarm Limits Changing Alarm Volume Equipment Alarms Changing the Trend Scale rSO2 Scale Time Scale Changing the Trending Rate Changing Time Setting Changing Date Setting Chapter 8 Storing Printing Outputting and Reviewing 35 Chapter Overview Printing Data Setup installation Printing Data in Real Time Printing Stored Data Disk Drive Operation Setup Installation Storing Data In Real Time to the Disk Drive Sending Stored Data to
12. TURN DISK ON to enable real time data storage The following menu will appear EVERY 10 SECONDS EVERY 20 SECONDS EVERY 30 SECONDS EVERY 60 SECONDS Figure 8 7 Data Storage Rate Option 5 Choose the desired storage rate the disk drive will begin to store data at the appropriate intervals INVOS System Setting Every 10 seconds Every 20 seconds Every 30 seconds Every 60 seconds Figure 8 8 Data Storage Capacity NOTE IF THE DISK DRIVE IS TURNED ON WHEN THE DISK DRIVE IS NOT ATTACHED OR A DISKETTE IS NOT IN THE DRIVE A DISK ERROR MESSAGE WILL APPEAR ON THE OXIMETER SCREEN 38 CHAPTER 8 STORING PRINTING OUTPUTTING AND REVIEWING 6 Toggle the first option key TURN DISK OFF to disable real time storage before removing the diskette Data can be stored in real time indefinitely The stored data can be accessed on any IBM or compatible personal computer using a common spreadsheet program like Lotus 1 2 3 or Microsoft Excel The file will be named DATA DAT and will be stored in a space delimited ASCII text file in the data format given below Date Time Left rSO2 Event Status A B C D Right rSO2 Event Status AlB CID Lot Serial Lot Serial Marker Marker Figure 8 9 ASCII text file data format It is necessary to parse the data when entering it into a spreadsheet Follow the software supplier s directions to proceed Sending Stored Data to the Disk Drive 1 Press the OPTIONS MENU key on the
13. USING THE DISK DRIVE UNIT CONTACT SOMANETICS CUSTOMER SERVICE DEPARTMENT AT 248 689 3050 EXT 255 OR customerservice somanetics com FOR COMPATIBLE PRODUCTS THAT MAY MEET THESE REQUIREMENTS Digital Output Port 1010 This port provides real time and stored digital data communications with other devices such as a PC Consult Somanetics for compatibility with other commercial devices See Chapter 8 for instructions AC Input and Fuse A The AC Input provides a connection for AC power The INVOS System will operate on 100 240 V VU witha frequency of 50 60 Hz The AC Input also has an ON OFF switch which turns AC power to the unit on and off When AC power is connected this switch must be in the ON position to run the unit from AC power When the switch is in the ON position the blue CHARGE light will be illuminated on the front panel If this switch is in the OFF position the unit can only be operated from battery power CAUTION WHEN THE INVOS SYSTEM IS NOT IN USE THE AC POWER SWITCH MUST BE TURNED ON WITH AC POWER CONNECTED IN ORDER TO KEEP THE BATTERY CHARGED Above the ON OFF switch is the external access fuse compartment The AC input line is fused with 2 5A 250V fuses WARNING DISCONNECT AC POWER CORD BEFORE OPENING FUSE COMPARTMENT DOOR Remove the fuse holder by inserting a jeweler s size flat blade screwdriver into the slot at the top of the holder and pry out Remove the fuse holder from the line
14. continued INDICATION PROBLEM ACTION Follow on screen instructions Preamp not connected to Sensor or Connect sensor or Oximeter preamp Apply sensor to patient Reboot INVOS Service INVOS See Error Messages No rSO9 Reading Sensor not connected to patient Unit locked up n Defective CPU Defective Preamp Cable or connector Service INVOS Service INVOS Blown Fuse on DIB Board Defective Preamp g Service INVOS No Display Defective CPU Service INVOS Defective Display Service INVOS i Defective Inverter Board Service INVOS To service the INVOS System contact Somanetics Customer Service at 248 689 3050 ext 255 email at customerservice somanetics com or website at http www somanetics com Troubleshooting the Printer The chart below provides problems that may be encountered while using the Printer and a list of the possible causes and action to correct for each See Chapter 8 for Printing Data setup and instructions INDICATION PROBLEM ACTION Pressing the TURN PRINTER ON or CASE HISTORY key in the PRINTER menu produces the PRINTER UNAVAILABLE message on the screen Printer is not connected to Oximeter Verify connection of printer to Oximefter Connect power cord and plug AC adapter to AC power The printer is not plugged into AC power and turned on
15. continuously measure and monitor changes in the approximate regional hemoglobin oxygen saturation in the microvasculature of the brain The device is intended for use on any and all patients for whom there is concern regarding the potential for cerebral oxygen imbalances It is intended for use by trained medical personnel It uses the principle of near infrared spectroscopy similar to pulse oximetry but does not depend on a pulsatile signal to provide approximate measurement and trending of changes over time of regional oxygen saturation in the brain Therefore the device could be expected to operate effectively during periods of peripheral shutdown low blood pressure hypothermia cardiopulmonary bypass and circulatory arrest i e periods when pulse oximeters may fail No effort is made to separate pulse gated changes in optical absorption caused by arterial blood from the background absorption making the measurement an aggregate of the arterial venous and capillary oxygen saturation However since 75 of the blood in the field of measurement is venous 23 the measurement provides a predominantly venous saturation reflecting the balance between cerebral oxygen delivery and oxygen consumption A small medical grade adhesive single patient use sensor is attached to the forehead and serves as the emitter and detector of the light At the wavelengths of interest the light penetrates skin bone and tissue relatively easily 4 The predominant c
16. filter To replace the fuses place the new fuse in the side of the holder with one end closest to the four posts at the back of the holder The other end of the fuse should go to the middle of the fuse holder and latch into the middle fuse holder spot When both fuses are installed place the fuse holder back in the line filter and push it in completely Close the fuse compartment door See Figure 5 5 Insert end of jewelers screwdriver here and pry tab up Figure 5 5 AC Input Line Filter Fuse INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 19 Potential Equalization Connector ke4 The Potential Equalization Connector Grounding Post provides a redundant external connection to earth ground if necessary Alarm Speaker Output The Alarm Speaker Output provides an audio output signal to alert the operator to problems and alarms that may occur while monitoring See Chapter 6 Cooling Fan The Cooling Fan provides air circulation through the INVOS Oximeter Cooling air enters through the vents in the bottom of the monitor and exhausts through the fan Do not block the cooling air intake vents or fan exhaust The no maintenance ball bearing fan rotates at 1500 rom Ea INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 21 Chapter 6 Operating the Unit Chapter Overview This chapter provides instructions on how to operate the INVOS System Read this chapter completely before attemptina to operate the unit
17. key from the left to SET BASELINE The baseline value s will be set at the current rSO2 value s and the menu will return to the MAIN MENU Also a two 2 will be placed in the EVENT MARKER column of the digital output and disk drive output data to signify the time and r O2 value at baseline capture See Chapter 8 for output formats Alarms Alarm messages and tones alert the INVOS System operator of a condition in the patient or the INVOS System requiring attention Upon alarm the operator should check the patient s condition first to determine the cause of alarm Sensor attachment upper and lower alarm limits battery capacity and other messages that may appear on the display should be verified to validate the alarm condition Patient Alarm Notification When the rsO2 exceeds the upper or lower alarm limits the INVOS System alerts the operator to this condition Trend data continues to be gathered l Analarm tone sounds Immediately profile the patient 2 Abell A appears in the center of the screen 3 The alarm is non latching if the condition passes the alarm will automatically reset a To permanently silence the alarm touch the ALARM SUSPEND option from the main display screen A bell appears for both channels The following screen appears LEFT RIGHT ares MAIN MENU Press the MAIN MENU option key to return to the main menu display screen Figure 6 6 Alarm Suspend Menu leaving both channels suspen
18. labeled OUTPUT SELECT then DISK DRIVE The Disk Storage Control menu will appear on the Oximeter s screen Disk Slot Disk Access Light ANDINA Rav R gt EEE ane Note Ifthe DISK DRIVE menu key is pressed when the disk drive is not attached a Disk Drive Error message will appear on the Oximeter screen 3 Use the menu keys to toggle STORAGE ON and select the desired STORAGE RATE Press MAIN MENU or RUN PAUSE to return to Main Menu Display screen Disk storage is indicated by the flashing Disk Access Light on the front of the disk drive It will flash at the storage rate interval 4 When storage is complete return to the disk drive control menu and turn off storage before removing the disk The stored data can be accessed on any IBM or compatible personal computer using a common spreadsheet program like Lotus 1 2 3 or Microsoft Excel The file will be named STUFFL DAT and will be stored in an ASCII text file in the following format ee MINaDIDIIY2_ RZ Note The data will be preceded by a LEFT or RIGHT corresponding to the Oximeter channel that is outputting the data It is necessary to parse the data when entering it into a spreadsheet Follow the software supplier s directions to proceed CAUTION ELECTRICAL SHOCK WARNING Disconnect the Disk Drive fom the Oximeter before cleaning it 1 Clean the disk drive cabinet with a dampened cloth Isopropyl alcohol 70 or mild soap and
19. off E PREAMP This is the input for the Preamp See Chapter 5 F CHARGE A blue LED indicates when the unit is receiving sufficient voltage to charge the battery When this light is ON the unit is operating from AC power When this light is OFF the unit is operating from battery power NOTE CHECK THE REAR PANEL POWER SWITCH AND POWER CORD IF THE CHARGE UGHT IS NOTON 16 CHAPTER 5 INTERFACING WITH THE INVOS CEREBRAL OXIMETER Preamp The Preamp provides an electrically isolated connection for the SomaSensor The 15 foot long Preamp cable attaches to the PREAMP connection on the front panel of the INVOS Oximeter At the other end of the Preamp is the patient connection to attach the bilateral reusable cable and SomaSensors A diagram of the Preamp is shown in Figure 5 2 For complete setup information see Chapter 5 Figure 5 2 Preamp Bilateral Reusable Sensor Cable The Bilateral Reusable Sensor Cable connects the SomaSensors to the Preamp The Sensor Cable is intended for multiple use and should not be discarded However the SomaSensor is single patient use only Figure 5 3 Bilateral Reusable Sensor Cable a INVOS CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL 17 Back Panel The INVOS System back panel Figure 5 4 contains the following elements Printer Output Port Parallel Digital Output Port RS 232 1010 Cooling Fan Disk Drive Port 4 moO gt AC Input Fuse Ny and Power Switc
20. on a nonvolatile medium suitable for archiving The disk drive allows rSO2 readings to be stored for future review and archiving It supports the following features and functions a INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 37 Storage capacity of 1 to 6 days depending on storage rate selected a Four different storage rates Non volatile medium suitable for archiving a Stored data can be plotted in a variety of formats Setup Installation 1 Place the unit on a flat surface where it is protected against falling 2 Attach the disk drive cable to the connector labeled DISK DRIVE on the back panel of the INVOS Oximeter Power to the Disk Drive is derived from the INVOS System 3 Insert a blank formatted disk into the disk slot Use only IBM formatted DS HD 3 5 Floppy Disks 1 44Mb 4 If there is a previous case stored on the disk not blank the new data will be appended to the end of the older file The 2 cases can be separated after the fact using date and time to identify the break point Storing Data In Real Time to the Disk Drive 1 Press the OPTIONS MENU key on the main display screen 2 Press OUTPUT SELECT from the Options Menu The following menu will appear PRINTER DISK DRIVE DIGITAL OUTPUT REVIEW Figure 8 5 Output Options 3 Press the DISK DRIVE option key The following menu will appear TURN DISK ON CASE HISTORY a MAIN MENU Figure 8 6 Real Time Data or Stored Data Option 4 Press
21. panel The Preamp serial number appears on the back of the Preamp NOTE UPON INITIAL UNPACKING THE BATTERY MAY BE PARTIALLY DISCHARGED BEFORE ATTEMPTING BATTERY OPERATION THE BATTERY MUST BE CHARGED BY CONNECTING THE UNIT TO AC POWER IN EITHER OPERATIONAL OR NON OPERATIONAL MODES A CHARGE TIME OF 15 HOURS IS REQUIRED TO RECHARGE A DISCHARGED BATTERY THE BLUE V INDICATOR ON THE KEY PANEL INDICATES WHEN THE BATTERY IS RECEIVING VOLTAGE TO CHARGE 12 CHAPTER 4 INSTALATION FEZ Se ne F he ee nN A i RR a s As J d A gt rhe ja pi s p d 4 gt T gt ta jll A a Feras ica A ETS rarai aia S iny mbs oi a H g A a lt j te EJ Q TG INFOS Cocchvat Okaneter ow pes Cx port ets CN pl ien A Aa pe Figure 4 2 Front Panel Connections 1 mo pe g Printer Disk Drive Personal Computer AC Mains Power Switch INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 13 installation Basics 1 Place the INVOS System on a sturdy flat surface or attached to optional stand WARNING IF THERE IS A CHANCE OF THE UNIT FALLING IT MUST BE PERMANENTLY SECURED 2 Attach appropriate cables to connections shown in Figures 4 1 and 4 2 3 Power up the unit by turning on the line power switch on the rear panel indicated by the blue light on front panel and pressing the power button on the front panel NOTE THE LINE POWER SWITCH ON THE BACK PANEL OF THE UNIT MUS
22. tissue to produce r502 1 Moskalenko YE Weinstein GB Demchenko IT et al Biophysical aspects of the cerebral circulation In Cooper R ed The biophysical organization of the system of the cerebral circulation Oxford Pergamon 1980 41 37 2 Mchedlishvili G Arterial behavior and blood circulation in the brain New York Plenum Press 1986 55 60 3 Wiederhold KH Bielser W Schultz U Veteau MJ Hunziker O Three dimensional reconstruction of brain capillaries from frozen serial sections Microvasc Res 1976 11 175 180 4 Eggert HR Blazek V Optical properties of human brain tissue meninges and brain tumors in the spectral range of 200 to 900 nm Neurosurgery 1987 21 459 464 5 Van der Jee P Delpy T Simulation of the point spread function for light in tissue by a Monte Carlo Model Adv Exp Med Biol 1987 215 191 198 Bonner RF Nossal R Weiss GH The influence of path length on remote optical sensing of properties of biological tissue App Optics 1989 28 2238 2244 Application to the INVOS The INVOS Cerebral Oximeter provides noninvasive continuous and direct information on regional cerebral oxygen saturation The measurement takes place in real time providing an immediate indication of a change in the critical balance of oxygen delivery and oxygen consumption Spectroscopic measurements are collected continuously averaged numerically and used to calculate data points After approximately 5 seconds the screen is updated
23. water solution 2 Allow the disk drive to dry before using it 3 Ifnecessary the disk drive and cable can be wiped clean with commercial germicidal agents Do Not Autoclave the disk drive Do Not Gas Sterilize the disk drive Do Not Immerse the disk drive in any liquids 400304 Rev B 3 There are no user serviceable parts inside the disk drive _ _ r a l Have all repairs done by Somanetics authorized repair personnel 2 Damaged or faulty parts will be replaced by Somanetics using original equipment parts or equivalent Contact your local Somanetics distributor for assistance If you need further assistance contact Somanetics by phone fax or mail Customer Service Department Phone 248 689 3050 or 800 359 SOMA Somanetics Corporation Fax 248 689 4272 1653 East Maple Road Troy MI 48083 4204 If you are returning the disk drive ship it prepaid in the original container as received Call and request a return material authorization RMA from Somanetics before shipping Include in Shipment A detailed description of the damage and or malfunctions The purchase order number or a copy of the purchase order or shipping invoice The name and phone number of the person to contact within your department The address of your department and a contact name for the return of the Oximeter to your institution e Wh Limited Warranty Somanetics warrants th
24. with agreements between the manufacturer and the representative SO Regional Saturation of Oxygen Indicates approximate saturation of oxygen within the region being monitored by the INVOS Cerebral Oximeter Run The operation mode The Cerebral Oximeter is able to monitor and store data in this mode S sensor The SomaSensor is a disposable non sterile device applied to the patient and used for transmitting and receiving light Skin Prep Kit A pre moistened pad included with the disposable SomaSensor containing a solution for cleaning the patient s forehead prior to application of the sensor Ead INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL III Status Line U Condition or state as relating to y operations of the Cerebral Oximeter The Status Box continually updates and W displays the status of the Cerebral Wavelength Oximeter Messages on the status line The distance within the progression of notify the operator of an error i e Prog a wave from one point to its Check Sensor corresponding point in the next wave T X Trending Rate y Describes the rate at which data is stored in the Cerebral Oximeter The Z Operator has the option of one 1 or two 2 samples per minute One sample per minute mode has a 24 hour storage limit Two 2 samples per minute mode has a 12 hour storage limit Trend Data The course of events relating to rSO levels as monitor
25. Cable to the Preamp as shown in Figure 6 2 CAUTION MAKE CERTAIN TO CONNECT THE SENSOR CABLE CONNECTOR MARKED LEFT TO THE PREAMP CONNECTOR MARKED LEFT AND THE SENSOR CABLE CONNECTOR MARKED RIGHT TO THE PREAMP CONNECTOR MARKED RIGHT Figure 6 2 Preamp Connection Turn the INVOS System ON The INVOS System will sequence through a series of start up and self test screens and will stop at the following screen Figure 6 3 NEW PATIENT PREVIOUS PATIENT Screen Select NEW PATIENT or PREVIOUS PATIENT by pressing the button beneath the appropriate prompt Monitoring will begin Take care to place the sensor to be adhered to the right forehead in the Preamp connector labeled RIGHT and the sensor to be adhered to the left forehead in the Preamp connector labeled LEFT F INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 23 Software Version The INVOS Cerebral Oximeter application software version appears on the Start Screen where XX XX XX is shown in Figure 6 3 Serial Numbers The INVOS System serial number appears on the Cerebral Oximeter back panel The Preamp serial number appears on the back of the Preamp Sensor Lot Number The sensor lot number appears on the individual sensor packaging Applying the Sensor The sensor is supplied pre calibrated and is easily and quickly applied to the patient s forehead with self contained medical grade adhesive Remove two sensors from their packages and examin
26. D SETTINGS Press X AXIS HOURS The following screen will appear X AXIS HOURS 2 INCREASE DECREASE PREVIOUS MENU Fig ure 7 10 X Axis Settings Use the INCREASE and DECREASE menu option keys to change the hours viewed When trend rate is set for 1 minute the view options are 2 4 8 12 and 24 hours When trend rate is set for 2 minute the view options are 1 2 4 8 and 12 hours To change another value press the PREVIOUS MENU option key Choose another parameter Changes made fo settings are not activated until return to the MAIN MENU When the value has been updated to the desired level press the PREVIOUS MENU option key Press the MAIN MENU option key to return to the main display screen and activate settings 32 CHAPTER 7 CHANGING THE SETTINGS Changing the Trending Rate The INVOS system can trend up to 24 hours and store up fo 1440 data points in memory This corresponds to one point per minute for 24 hours or one point every 30 seconds for 12 hours user selectable The selected trending rate will be displayed just below the trend display To Change Trending Rate press the OPTIONS MENU key from the main display screen Press the third key from the left TREND SETTINGS The following screen will appear Y AXIS VALUES X AXIS HOURS TRENDING RATE MAIN MENU Figure 7 11 System Setup Settings Press TRENDING RATE The following screen will appear 1 PER MINUTE 2 PER MINUTE iis PREVIOUS MENU Figu
27. E SHOULD BE USED WITH THE INVOS CEREBRAL OXIMETER NO OTHER FIELD TEST DEVICES SHOULD BE CONNECTED TO THE CEREBRAL OXIMETER FOR ADDITIONAL INFORMATION ON ACQUIRING AND USING A FIELD TEST DEVICE CONTACT SOMANETICS CUSTOMER SERVICE DEPARTMENT AT 248 689 3050 EXT 255 VIA WEBSITE AT http www somanetics com OR VIA EMAIL AT customerservice somanetics com INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 53 The field test device allows for functional testing of the INVOS System To perform a functional test with the Field Test Device 1 Place the unit on a flat surface where it is protected against falling 2 Attach appropriate cables to connections shown in Figure 10 1 Figure 10 1 Field Test Device Front Pane Connections 3 Turn on the INVOS System by turning on the line power switch on the rear panel and press ON OFF on the front panel NOTE THE MAINS POWER SWITCH ON THE BACK PANEL OF THE UNIT MUST BE LEFT ON AND AC POWER MUST BE CONNECTED AT ALL TIMES TO MAINTAIN THE BATTERY AT FULL CHARGE THE y BLUE AC POWER INDICATOR SHOWS POWER SWITCH IS ON 4 When the INVOS System has finished booting up the NEW PATIENT PREVIOUS PATIENT screen will appear Press NEW PATIENT key to continue past screen 5 Two channels for data should appear on the screen The status message will be SYSTEM SIGNAL OK and an rSO2 of 5041 for both channels 54 CHAPTER 10 MAINTENANCE Block Diagram Fig
28. INVOS Cerebral Oximeter membrane switches Keypad The group of keys on the front of the INVOS Cerebral Oximeter L LED Light Emitting Diode A semiconductor diode that emits light when voltage is applied M Menu A detailed list of options available to the user Menus are found within the Cerebral Oximeter to assist the operator in functions of and variables that can be adjusted Multimeter A meter with voltage current and resistance measurement functions N O Optical Spectroscopy Study of the spectra series of colors Relates to the theories behind the INVOS Cerebral Oximeter and the interactions between matter and light P Pause A stand by mode during which no data is gathered or stored Photodiode A light sensitive semi conductor diode used for measurement of light intensity Plotting Scales X and Y Coordinates Refers to Y Scale rSO and X Scale hours viewed The two scales combine on the monitor for display of SO levels over time Power Supply Board Board that accepts incoming AC power from 100 240 volts and converts it to correct DC levels Preamp Pre Amplifier Provides connection of flex sensor cable and initial amplification of patient signal Q R Real Time Refers to information displayed immediately on the monitor relating to oxygen saturation levels Representative Any of various persons companies authorized to represent the INVOS System in conjunction
29. IONS MANUAL 29 Chapter 7 Changing the Settings Chapter Overview This chapter describes how to change the following settings on the INVOS System Alarm Limits Alarm Volume Trend Scales X and Y Axes Trending Rate Date and Time Changing Alarm Limits To change either the upper or lower Alarm Limit start by pressing the OPTIONS MENU key below the main display screen BASELINE MENU ALARM SUSPEND OPTIONS MENU Figure 7 1 Main Menu After pressing the OPTIONS key The following menu options will appear OUTPUT SELECT ALARM SETTINGS TREND SETTINGS MAIN MENU Figure 7 2 Options Menu Press the ALARM SETTINGS key and the following menu options will appear ALARM LIMITS ALARM VOLUME i MAIN MENU Figure 7 3 Alarm Limits Press the ALARM LIMITS key and the following menu options will appear BOTH CHANNELS LOWER LIMIT CHANGE LIMIT MAIN MENU Figure 7 4 Change Limits The first key from the left toggles between BOTH CHANNELS RIGHT or LEFT channels Default is BOTH CHANNELS Choose accordingly The second key from the left toggles between UPPER or LOWER alarm limit Default is LOWER LIMIT Choose accordingly 30 CHAPTER 7 CHANGING THE SETTINGS After choosing between channels and UPPER or LOWER alarm limit press the key CHANGE LIMIT The following screen will appear BOTH LOWER 40 INGEN DECREASE PREVIOUS MENU Figure 7 5 Change Limits Use the INCREASE and DECREASE option keys
30. NDER WARRANTY YOU SHOULD NOT ATTEMPT TO REPAIR THE UNIT BUT SHOULD RETURN IT TO SOMANETICS CORPORATION FOR REPAIR SEE WHO TO CONTACT FOR AUTHORIZED REPAIR REPAIRS MADE BY ANYONE NOT AUTHORIZED BY SOMANETICS DURING THE WARRANTY PERIOD WILL VOID THE PRODUCT WARRANTY Who to Contact for Authorized Repair For authorized repair of a Somanetics INVOS System contact Customer Service Department Somanetics Corporation 1653 East Maple Road Troy MI 48083 4208 Phone 248 689 3050 ext 255 Fax 248 689 4272 Email customerservice somanetics com Website http www somanetics com INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 49 Chapter 10 Maintenance Chapter Overview 4 IWARNING 4 ELECTRIC SHOCK HAZARD BEFORE PERFORMING ANY SERVICE TURN OFF UNIT THEN DISCONNECT AC POWER See Figure 5 4 for location REMOVE THE ENCLOSURE AND DISCONNECT THE BATTERY CABLE FROM THE DIB BOARD Electrostatic Discharge ESD protection also is required before performing any service on the unit MAKE SURE ALL CABLES ARE CONNECTED AND ALL COMPONENTS ARE INSTALLED CORRECTLY BEFORE ATTEMPTING TO APPLY POWER OR TURN ON THE UNIT IICAUTION Do not attempt to perform any service or tamper with the warranty seal unless you have been authorized in writing by Somanetics Repairs made by anyone not authorized by Somanetics during the warranty period will void the product warranty Maintenance Chapter Overv
31. NT ENVIRONMENT MUST BE IEC 601 APPROVED ALL EQUIPMENT USED OUTSIDE THE PATIENT ENVIRONMENT MUST BE APPROVED TO THE APPROPRIATE IEC OR ISO STANDARDS E G IEC950 FOR OFFICE EQUIPMENT INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 39 This port provides real time and stored digital data communications with other devices such as a personal computer PC Data is outputted during every screen update approximately every 5 seconds by connecting the INVOS System to a receiving device via a 9 pin to 9 pin serial null modem cable It can also send all stored data to the receiving device Figure 8 12 shows pin out information for the digital output connector Consult Somanetics for compatibility with other commercial devices or to order the Null Modem Cable Digital Output Port Back Panel Connection Pin Description Data Carrier Detect Receive Data Transmit Data Data Terminal Ready Ground Data Set Ready Request to Send Clear to Send Ring Indicator oonwsrsts3oouwkb wh Figure 8 13 Digital Oufput Port The Digital Output Port can be attached to a variety of external serial devices such as a serial printer modem or computer terminal Figure 8 13 shows two cable diagrams for connecting the INVOS System to external devices INVOS pc Cerebral Oximeter Computer Digital Output Port DE9 Connector OR INVOS PC Cerebral Oximeter Computer Digital Output Port DBS Connector Figure 8 14 Cable Di
32. RATE Use the option key and the option key to scroll trend lines across the INVOS Oximeter screen in the Review Mode When you have completed reviewing press the MAIN MENU option key to return to the main display screen INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 45 Chapter 9 Warranty Information Chapter Overview This Chapter details the INVOS Cerebral Oximeter Warranty INVOS Cerebral Oximeter Warranty Key Points The INVOS System is warranted free of defects for one year from date of delivery to the customer Warranty repairs can be obtained by calling Somanetics Customer Service Department All returned merchandise shipments must be prepaid and have a Return Materials Authorization RMA number Certain software and or hardware upgrades may be provided free of charge during the warranty period when units are returned to Somanetics Unauthorized repairs misuse or abuse of the device will void the warranty CAUTION DO NOT ATTEMPT TO PERFORM ANY SERVICE OR TAMPER WITH THE WARRANTY SEAL UNLESS YOU HAVE BEEN AUTHORIZED IN WRITING BY SOMANETICS REPAIRS MADE BY ANYONE NOT AUTHORIZED BY SOMANETICS DURING THE WARRANTY PERIOD WILL VOID THE PRODUCT WARRANTY Limited Warranty and Disclaimer Somanetics warrants the Products to be free of defects in material or workmanship resulting in the Products failing to meet Somanetics published specifications at the time of delivery Claims may be made under this w
33. Reusable Sensor Cable that may occur during patient The shielded cable attached to the monitoring sensor Connect this cable to the External Preamp Cable Fea External cable connecting the Preamp C port on the faceplate to the Connection Port Preamplifier Any of the various inputs or outputs on or F relating to the SomaSensor and the G Cerebral Oximeter CPU Board H Central Processing Unit Board Uses l application software to control Infrared Light sequencing of the unit and perform l Light waves just beyond the red end of diagnostic functions the visible spectrum D INVOS Default In Vivo Optical Spectroscopy INVOS is Indicates the automatically pre set the name of the patented technology parameters field entries relating to the that Somanetics Corporation uses in the Cerebral Oximeter The parameters are operation of the Cerebral Oximeter adjustable within established limits INVOS Cerebral Oximeter DIB PDB Board A noninvasive self contained portable Digital Interface and Power Distribution unit that measures the changes in the Board Controls communication regional oxygen saturation in the brain between the Preamp connection the of adults and pediatrics Intended for operator and CPU Board Distributes use with adults and pediatric patients power to components and provides weighing 4 40 kg voltage to charge the battery J il GLOSSARY OF TERMS K Key Any of the contro push buttons on the
34. T BE LEFT ON AND AC POWER MUST BE CONNECTED AT ALL TIMES TO MAINTAIN THE BATTERY AT FULL CHARGE THE Y BLUE AC POWER INDICATOR SHOWS POWER SWITCH IS ON 4 Verify that the screen displays system messages 5 Connect two SomaSensors to the Preamp Refer to Chapter 6 for complete information 6 Check for light in the sensor LED compartment the opening farthest from the cable 7 Complete the Pre use Checklist in Chapter 6 NOTE FOR COMPLETE SETUP AND OPERATING INSTRUCTIONS SEE CHAPTERS 5 6 7 AND 8 Accessories Order Number Description BRCB Bilateral Reusable Sensor Cable for use with SomaSensor Models SAFB and SPFB only SAFB SomasSensor for Adults gt 40 kg SPFB somasSensor for Pediatrics 4 40 kg 312970 Additional Operations Manual INVOS Cerebral Oximeter Model 5100B 312988 service Manual INVOS Cerebral Oximeter Model 5100B 4100 FTD Field Test Device INVOS Model 4100 5100 and 5100B 5100B W One Year Warranty Extension INVOS Mode 51008 4100 STD Portable Stand INVOS Models 4100 5100 and 5100B 4100 TC Travel Case INVOS Models 4100 5100 and 51008 4100 DPU 414 Thermal Printer INVOS Models 4100 5100 and 51008 312109 Thermal Paper Case of 5 rolls 4100 DD Disk Drive INVOS Models 4100 5100 and 51008 DB9DB9I Null Modem Cable for Digital Output INVOS Models 4100 5100 and 5100B Accessories can be ordered by contacting Somanetics Customer Service at 800 359 7662 in the United States or 248 689
35. a bits 8 8 Parity None 9 Stop bits 10 Flow Control Hardware 11 Click OK 12 Under File select Save and Exit When prompted to disconnect Click Yes Now when Hyper Terminal is selected an icon for INVOS will be displayed Double clicking this icon will automatically restore all entered properties NOTE THE INVOS ICON CAN BE DRAGGED TO THE DESKTOP WHERE IT WILL BE EASY TO ACCESS To Collect Data 1 Make sure a null modem cable is connected to the COM or 2 port on the computer and the 1010 port on the back of the INVOS Oximeter Power up both the computer and the INVOS System On the computer click Start Programs Accessories Hyper Terminal and double click INVOS Or if INVOS terminal icon is on the desktop double click it 4 Tosave data Select Transfer Capture Text In the Capture Text window enter the file name and directory in which you wish to save the file Click Start INVOS CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL 41 5 Allow the INVOS System to calibrate the SomaSensor and begin monitoring Data will begin to transfer to the PC 6 See instructions below for Case History data collection mode 7 When monitoring is complete Select Call disconnect and close the INVOS window Data can be stored in real time indefinitely The data can be accessed using a common spreadsheet program like Lotus 1 2 3 or Microsoft Excel The fi
36. able non sterile transducer capable of producing and detecting optical data from the patient converting that data to electrical signals and sending them to the INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 9 INVOS System It is applied to the forehead via self contained medical grade adhesive Electrical signals from the photodiodes are sent through the shielded cable to the INVOS System for processing The SomaSensor is designed for single use only and may not be reused Reuse of the SomaSensor may cause inaccurate readings erratic readings or no readings at all Also reuse may cause an increased risk of cross contamination Detectors Light Emitting Diodes Use of Product Do not use this product if it is found defective in any way contact a Somanetics Customer Service Representative for repair or replacement If the INVOS System is not operated maintained and repaired in compliance with this manual including product inserts and warnings if will not function as described The user is responsible for operating and maintaining the INVOS System according to instructions outlined in this manual The manufacturer Somanetics is not responsible for injury or losses if the INVOS System is not used in compliance with instructions Customer Inquiries For any questions regarding the INVOS System safety and effectiveness or any other information please contact the Somanetics Customer Service Department at 248 689 3050 e
37. ables can be wiped clean with commercial germicidal agents S Allow unit to completely dry before reconnecting AC Power Cleaning the Printer CAUTION ELECTRICAL SHOCK WARNING DISCONNECT THE PRINTER FROM THE INVOS SYSTEM BEFORE CLEANING WARNING DO NOT AUTOCLAVE THE PRINTER DO NOT GAS STERIUZE THE PRINTER DO NOT IMMERSE THE PRINTER IN ANY LIQUIDS l Disconnect AC Power from the printer Turn power off 2 Clean the printer cabinet with a cloth dampened with Isopropyl alcohol 70 or mild soap and water solution 3 Allow the printer to dry before using it a INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 51 4 If necessary the printer and cable can be wiped clean with commercial germicidal agents Cleaning the Disk Drive CAUTION ELECTRICAL SHOCK WARNING DISCONNECT THE DISK DRIVE FROM THE INVOS SYSTEM BEFORE CLEANING WARNING DO NOT AUTOCLAVE THE DISK DRIVE DO NOT GAS STERILIZE THE DISK DRIVE DO NOT IMMERSE THE DISK DRIVE IN ANY UQUIDS 1 Clean the disk drive cabinet with a dampened cloth Isopropyl alcohol 70 or mild soap and water solution Allow the disk drive to dry before using it if necessary the disk drive and cable can be wiped clean with commercial germicidal i agents Have all repairs performed by Somanetics authorized repair personnel Care of the SomaSensor Although the SomaSensor is a non sterile disposable item it should be treated with proper ca
38. age EXCESSIVE LIGHT Indicates the SomaSensor is properly connected to the Preamp but not to the patient or that there is too much outside light No digital rSO2 will appear Check the connection to patient and replace sensor if necessary If the sensor is properly adhered to the patient try draping the sensor A tone accompanies the message SENSOR NOT CONNECTED Indicates the SomaSensor is not connected to the Preamp No rSO2 value will appear Re attach the sensor to the bilateral reusable cable or check the reusable cable connection to the Preamp A tone accompanies the message REPLACE SENSOR This message will appear if the INVOS System cannot read calibration data from the SomaSensor Mixed adult and pediatric sensor types using pediatric sensors in the adult Model 4100 a defective sensor or a defective bilateral reusable cable could cause this INTERFERENCE DETECTED There is excessive electromagnetic noise caused by another instrument Normal operation of the INVOS System will resume when the excessive noise stops PREAMP NOT CONNECTED Indicates the Preamp is not properly connected to the INVOS Cerebral Oximeter Make sure the Preamp connector is locked into the Cerebral Oximeter front panel Normal operation of the INVOS System will resume when the Preamp is reconnected Additional status message that appears when power is coming from the internal back up battery Battery Symbol Gauge m Appears when the INVOS System i
39. agram for Connection to Digital Output Port by a Null Modem Cable The digital communications output uses the following protocol 9600 Baud No Parity 8 Data Bits Stop Bit 40 CHAPTER 8 STORING PRINTING OUTPUTTING AND REVIEWING During real time outputting the data is transmitted asynchronously using no hand shaking approximately every 5 6 seconds in an ASCII character string The Digital Output Port also allows stored data from the INVOS System to be transferred to other devices Setup Receiving Digital Data on a PC Storing INVOS System Data using a Portable Computer PC with Windows 95 or later can be completed by obtaining the equipment listed and the instructions following to complete initial computer set up APC with Windows Operating System and Hyper Terminal Program A compatible spread sheet program that can import text files such as Microsoft Excel or Lotus ANull Modem Cable Somanetics Model DB9DB9I Using Hyper Terminal 1 In Windows select or click Start Programs Accessories Communications if necessary and Hyper Terminal 2 Double Click on Hyper Terminal icon i 3 In the window Connection Description under Name Enter INVOS and select an icon 4 In the window Phone Number under Connect using Select Direct to Com 1 or 2 Click OK 5 In the window COMI Properties Enter the following 6 Bits per second 9600 Baud 7 Dat
40. an electrosurgical electrocautery instrument in the vicinity of the INVOS System may interfere with the signal and result in no readings Environments with excessive ambient light such as bright sunlight or strong operating room lighting may require covering the area of the SomaSensor with an opaque drape e n order to maintain full backup battery charge the INVOS System must be plugged into AC mains power with the back panel AC mains power switch turned on The front panel blue light will be illuminated on in this condition Disconnect the INVOS System and briefly operate the unit periodically to check the charge condition of the backup battery Adult and Pediatric SomaSensors cannot be used simultaneously on the same monitor or a REPLACE SENSOR status message will appear indications For Use The noninvasive INVOS Cerebral Oximeter System is designed to noninvasively directly and continuously measure and monitor changes in the approximate regional hemoglobin oxygen saturation in the microvasculature of the adult and pediatric brain Since the hemoglobin in the sensor s field is made up of approximately 75 venous blood 20 arterial blood and 5 capillary blood the clinical interpretation of the readings is consistent with that of a venous measurement The device is intended for use on any and all patients for whom there is concern regarding the potential for cerebral oxygen imbalances It is intended for use by trained medical personn
41. arranty only in the event of failure due to such defect within one year of delivery Somanetics sole and exclusive obligation customer s sole and exclusive remedy with respect to this warranty shall be to repair or at Somanetics sole discretion replace products which prove to be defective in material and workmanship resulting in the products failing to meet Somanetics published specifications during the one year warranty period from delivery to the customer provided they are returned to Somanetics prepaid CUSTOMER S SOLE AND EXCLUSIVE REMEDY FOR SOMANETICS LIABILITY OF ANY KIND INCLUDING WITHOUT LIMITATION NEGLIGENCE WITH RESPECT TO ANY ITEM FURNISHED UNDER THIS AGREEMENT SHALL BE LIMITED TO THE REMEDY PROVIDED IN THE PRECEDING SENTENCE NO OTHER WARRANTY OR REMEDY IS EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ANY WARRANTY IMPLIED BY CUSTOM OF TRADE OR COURSE OF DEALING OR ANY WARRANTY AGAINST HIDDEN DEFECTS NO REPRESENTATIONS CONCERNING THE PRODUCTS ARE OR WERE MADE OR RELIED UPON WITH RESPECT TO THE QUALITY OR FITNESS 46 CHAPTER 9 WARRANTY INFORMATION OF THE PRODUCTS DISTRIBUTOR AND ITS ULTIMATE CUSTOMERS WAIVE THE RIGHT TO ANY CLAIMS BASED ON AN ALLEGED BREACH OF WARRANTY BY SOMANETICS EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT Customer shall immediately notify Somanetics of any claims under any of the foregoing warranti
42. ded Or press the LEFT or RIGHT menu option keys to toggle the alarm ON OFF for the individual channel 28 CHAPTER 6 OPERATING THE UNIT b To activate alarms again when both channels are silenced touch the ALARM SUSPEND option from the main display screen If an individual channel is silenced touch the ALARM SUSPEND option from the main display screen to suspend BOTH CHANNELS Press the MAIN MENU option key to return to the main menu display screen CAUTION USING THE ALARM SUSPEND KEY WILL SILENCE THE AUDIBLE ALARMS PERMANENTLY UNTIL RE ACTIVATED OR THE INVOS SYSTEM IS REBOOTED NOTE TO CHANGE THE ALARM LIMITS SEE CHAPTER 7 Battery Capacity Alarm Notification A Battery Symbol Gauge appears in the upper right corner of the display if the INVOS System is operating on battery power An alarm tone accompanies the depleted Battery Symbol Gauge if the battery power is critical Event Mark An Event Mark may be stored in memory and displayed on the screen to mark any significant event A vertical dashed line will appear on the screen at the current time and a one 1 will appear in the EVENT MARK column of the digital output or disk drive output data See Chapter 8 for output formats To set an Event Mark press the EVENT MARK MENU key on the MAIN MENU below the display screen BASELINE MENU EVENT MARK ALARM SUSPEND OPTIONS MENU Figure 6 9 Main Menu INVOS CEREBRAL OXIMETER MODEL 51008 OPERAT
43. dges of the sensor are sealed to forehead to prevent light from entering Secure the cable to a fixed object to avoid strain on tne sensor to skin interface using strain relief clips Sry web et il ri Figure 6 5 Strain Relief C lips Connect SomaSensors to the Bilateral Reusable Sensor Cable as illustrated in Figure 6 4 CAUTION HOLD SENSOR CONNECTOR AND DO NOT BEND THE RIBBON CABLE WHILE INSERTING CAUTION MAKE SURE ALL CONNECTORS ARE FULLY ENGAGED AND FREE FROM MOISTURE MOISTURE INTRUSION MAY CAUSE INACCURATE READINGS OR NO READINGS AT ALL The INVOS System is now ready for use When the SomaSensors are properly attached the real time display of rSO2 can be viewed following a five 5 second delay which allows the INVOS System to read the sensor calibration data The INVOS System will automatically re read the sensor calibration data and continue running if communication with the Preamp is interrupted NOTE MAKE SURE SYSTEM SIGNAL OK APPEARS IN THE STATUS AREA ABOVE EACH rSO2 VALUE WHEN THIS MESSAGE IS DISPLAYED THE SYSTEM IS FUNCTIONING PROPERLY WARNING STRONG OUTSIDE LIGHT SOURCES MAY PREVENT THE DISPLAY OF rSO2 READINGS ENVIRONMENTS WITH EXCESSIVE AMBIENT LIGHT SUCH AS BRIGHT SUNUGHT OR STRONG OPERATING ROOM LIGHTING MAY REQUIRE COVERING THE SOMASENSOR WITH AN OPAQUE DRAPE OR BLANKET To further assist the operator in eliminating false readings the INVOS System will not display rSO2
44. e Products to be free of defects in material or workmanship resulting in the products failing to meet Somanetics published specifications at the time of delivery Claims may be made under this warranty only in the event of failure due to such defect within ninety days of delivery Terms and conditions of this warranty are detailed in the INVOS Cerebral Oximeter Users Manual 40030d Rev A 4 i Tro ublesh ooting __INDICATION B Pressing the DISK DRIVE key Disk drive is not connected to Verify connection of disk drive in the OUTPUT SELECT menu Oximeter to Oximeter see p 2 of this does not produce the disk storage control menu instruction sheet The disk is not formatted Check the status of the drive Insert a blank disk The disk is not inserted into the drive Slide the write protection tab back on the disk The disk is Write protected INVOS CEREBRAL OXIMETER OPERATIONS MANUAL RESET BASELINE ADDENDUM Setting a Baseline The Baseline Status can be set to display relative rSO2 changes from baseline Both decreases and increases from baseline may signify dysfunction and developing pathology Changes in S O2 of 20 from baseline are considered clinically significant and cause for concern See Operations Manual Frequently Asked Questions Appendix B for more information When trend data begins to be gathered and patient cond
45. e for visual signs of damage If any signs of damage are observed select another sensor Remove any moisture or perspiration from the patient s forehead with a dry gauze pad Then degrease the skin using the enclosed skin prep pad Discard skin prep pad after single use Ensure the patient s forehead is completely dry and remove any degreaser residue if any with a dry gauze pad Figure 6 4 Sensor Placement for SomasSensor Select sensor site on right or left or both sides of forehead site selection will determine which region of the brain is monitored Placement of the sensor in other locations or over hair may cause inaccurate readings erratic readings or no readings at all Do not place the SomaSensor over sinus cavities the superior sagittal sinus subdural or epidural hematomas or other anomalies such as arteriovenous malformations as this may cause readings that are not reflective of brain tissue or no readings at all Remove the protective backing label from the adhesive side of the sensor and apply fo the forehead as illustrated in Figure 6 4 The edge of the sensor opposite the cable exit must be positioned medially with the cable placed laterally To avoid positioning over sinus cavities keep the sensor high and lateral on the forehead above the eyebrow without positioning over hair 24 CHAPTER 6 OPERATING THE UNIT Continue applying the sensor by smoothing it to the forehead from the center outward Make certain e
46. ected to the PC witha null modem cable modem cable Verify correct COM port is specified Wrong COM port specified in the Hyper Terminal program UNAVAILABLE message on the screen Hyper Terminal settings not correct No data received or transmission is scrambled Terminal settings See Tem correct Hyper Chapter 8 Zz INVOS CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL Glossary of Terms A Distributor AC Power Any of various persons companies authorized to distribute the INVOS Cerebral Oximeter in conjunction with agreements between the manufacturer Alternating electric current Alarm Limits Preset and adjustable limits for alarm and the distributor messages Alarm tones and a bell E symbol will activate if the limits are exceeded ESD Authorized Somanetics Repair Personnel Electrostatic Discharge Those individuals authorized by Event Somanetics to service the INVOS An important occurrence relating to Cerebral Oximeter medical operations such as meds B administration cross clamp etc that ae can be marked on the INVOS Cerebral Battery Operation Time Oximeter The battery has an approximate 2 hours Event Marker operation capacity Recharge time from discharge to full charge is approximately A built in feature of the Cerebral Oximeter allowing time marking of 15 hours i various events on a graph or display Bilateral
47. ections with Disk Drive Replace Sensor Check for correct sensor type Connect new sensor Replace Sensor Cable Interference Noise corrupting rSO2 data electrocautery Move or turn off source of Detected interference Disk Full Replace disk 56 CHAPTER 10 MAINTENANCE Troubleshooting Chart The chart below provides symptoms that may be encountered while using the INVOS System and a list of the possible causes for each INDICATION Does not Power Up ACTION Plug INVOS into hospital grade electrical outlet bee x O oo m No AC Power Turn on back panel AC power switch Battery not charged Charge battery Defective CPU Board Service INVOS Defective Keypad Service INVOS Blown Fuse in Battery Cable or Line Service INVOS Filter Erratic AC Power Input Change electrical outlet Defective CPU Card Service INVOS Battery not charged Charge battery Defective Battery Service INVOS a o aaaeeeaa Defective Power Distribution Section Service INVOS on DIB PDB Board Blown Fuse in Battery Cable Service INVOS PRINT option key is pressed Wait for print out or turn printer off Defective Keypad Service INVOS Unit locked up Reboot INVOS Defective DIB PDB Board Service INVOS Locks Up Intermittent No Battery Power Keypads Do Not Function INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 57 Troubleshooting chart
48. ed and displayed by the INVOS Cerebral Oximeter Trend Memory Data generated by the Cerebral Oximeter and displayed chronologically this data may be printed out for further review 312971 SMS3209 Pnted in the U S A Somanetics Corporation 1653 East Maple Road Troy MI 48083 4208 U S A Phone 248 689 3050 Fax 248 689 4272 http www somanetics com Nasdaq SMITS Customer Service 248 689 3050 ext 255 E mail customerservice somanetics com SOMANETICS Disk Drive Operating Instructions Cautions Warnings Note Only a Somanetics supplied disk drive should be used with the INVOS Cerebral Oximeter No other disk drive devices should be connected to the Cerebral Oximeter For additional information on acquiring and using a disk drive unit contact your local Somanetics authorized distributor or call Somanetics Corporation at 800 359 7662 in the USA or 248 689 3050 outside the USA CAUTION DO NOT COVER There are no user serviceable parts inside disk drive rr a uree we CAUTION ELECTRICAL SHOCK WA RN IN G Unplug the disk drive before I Do not insert or remove the disk Disk Access Light is illuminated Damage to the disk or the drive could result _ Se Ss Do Not Autoclave the disk drive Do Not Gas Sterilize the disk drive Do Not Immerse the disk drive in any liquids About the Somanetics Disk Drive
49. egional oxygen changes in the brain Accordingly Somanetics makes no claim or warranty express or implied related to the use of Somanetics INVOS System as a test for a patient s overall condition or any specific disease Returning a Unit for Service When returning an INVOS System ship it prepaid in the original container as received if possible It is important fo use the original container and packing material to prevent damage to the unit in shipping Somanetics will not assume responsibility for damage caused in shipment if the customer does not use original shipping materials Shipping materials can be obtained by contacting Somanetics Customer Service Department Call and request a Return Materials Authorization RMA number from Somanetics Customer Service Department before shipping Include the following with the shipment Detailed description of the problem or need RMA number and serial number of the unit on outside of the box Name and phone number of the person to contact within your facility Information regarding where and to whom to address the return of the INVOS System All accessories that came with the product Preamp Bilateral Reusable Sensor Cable AC Line Cord and any other optional attachments Warnings about Unauthorized Repair Performing unauthorized service or repairs not described in this manual on any Somanetics INVOS System will void the product s warranty NOTE IF THE UNIT IN QUESTION IS U
50. el only Contraindications None INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 3 Chapter 2 Specifications Chapter Overview This chapter provides product specifications for the INVOS System Specifications Physical Oximeter __ Preamp Dimensions height 8 38in 21 29 cm 1 4in 3 56 cm Width 9 63 in 24 46 cm 3 75 in 9 53 cm Depth 8 5 in 21 59 cm 7 65 in 19 43 cm Weight 14 Ibs 6 5 kg 1 5 Ibs 75 kg Preamp Cable Length 15 ft 5 m SomaSensor Cable Length 5 ft 1 52 m Operational Range 15 95 updated every 5 6 seconds Repeatability Hardware repeatability is within 1 rsO2 index point from unit to Unit including SomaSensor measured in vitro Alarm Limit Range High 20 95 Low 15 90 High and low limits cannot cross Trend Memory 24 hours at sample per minute 12 hours at 2 samples per minute Diagnostics Automatic self test Safety Class Continuous Operation Type BF i Class External AC mains or backup battery 4 CHAPTER 2 SPECIFICATIONS Electrical Input Voltage 100 240 V Frequency 50 60 Hz Current 1 0A 0 5A maximum at 100 and 240 volts respectively Fuse F2 5A 250V Backup Battery SIF Approximately 2 hours Digital Output R5 232 communications Environmental Requirements Storage Temperature AQF to 100F 40C to 43C Humidity 20 80 non condensing Altitude To 10 000 feet 3 048 m Default Settings Defa
51. erms rSO2 Regional Saturation of Oxygen INVOS Used in reference to the INVOS Cerebral Oximeter System SomaSensor Used in reference to the patient applied component Pediatric application for INVOS Pediatric SomaSensor has been designed for use with pediatric patients weighing 4 40 kilograms Warnings s Shock hazard Do not attempt to perform any service or tamper with the warranty seal unless you have been authorized in writing by Somanetics Repairs made by anyone not authorized by Somanetics during the warranty period will void the product warranty Explosion hazard Do not use the INVOS System in the presence of flammable anesthetics or in other flammable environments Cross contamination hazard The SomaSensor is designed for single use only and may not be reused Reuse may cause inaccurate readings erratic readings or no readings at all Also reuse may cause an increased risk of cross contamination among patients Do not autoclave or gas sterilize the INVOS System or SomaSensor a Patient hazard The SomaSensor is designed for external use only as described in the instructions Do not use the SomaSensor internally for any reason Shock hazard Do not immerse the INVOS System in any liquids as they may cause electric shock hazard or damage the device If the integrity of the external protective earth ground is in doubt the INVOS System should be operated from the internal backup battery power source Onl
52. es All of the Products are warranted to Distributor and its ultimate Customers as set forth herein and to no other persons Somanetics and Designees may alter modify or deviate from this warranty with respect to any Products sold to Customer after Customer receives written notice of the revised warranty This Limited Warranty specifically excludes disposable sensors accessory items and fuses Warranty Labor lf Somanetics determines that the Product is defective and that the claim was made within the warranty period Somanetics shall satisfy its obligations under this warranty by repairing or replacing the Product and returning it to Customer within the parameters established above at Somanetics expense If Somanetics determines that the Product is not defective or that the claim was not made within the warranty period Somanetics will return the Product to Customer and charge the Customer for shipping handling and diagnostic fees specified in the Somanetics Terms and Conditions of Sale Disclaimer of Consequential Damages SOMANETICS LIABILITY OF ANY LOSSES DAMAGES OR EXPENSES OF ANY KIND WHICH ARISE OUT OF OR WHICH ARE IN CONNECTION WITH THE PRODUCTS COVERED BY THE WARRANTY SET FORTH HEREIN OR THEIR DESIGN MANUFACTURE LOR SALE WHETHER THE CLAIM IS IN CONTRACT TORT OR OTHERWISE INCLUDING WITHOUT LIMITATION LIABILITY FOR BREACH OF THE WARRANTY PROVIDED HEREIN IS LIMITED UNLESS OTHERWISE PROHIBITED BY LAW TO AN AMOUNT NOT
53. ettings Y AXIS VALUES changes the r50 value X AXIS HOURS represents hours displayed a INVOS CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL 31 rSO2 Scale Press Y AXIS VALUES key The following screen will appear BOTH CHANNELS LOWER LIMIT CHANGE LIMIT MAIN MENU Figure 7 8 Y Axis Settings The first key from the left toggles between BOTH CHANNELS RIGHT or LEFT channels Default is BOTH CHANNELS Choose accordingly The second key from the left toggles between UPPER or LOWER Y axis limit Default is LOWER LIMIT Choose accordingly After choosing between channels and UPPER or LOWER Y axis limit press the key CHANGE LIMIT The following screen will appear BOTH LOWER 30 INCREASE DECREASE PREVIOUS MENU Using the INCREASE and DECREASE keys Adjust the maximum or minimum values Figure 7 9 Minimum Value To change another value press the PREVIOUS MENU option key Choose another parameter Changes made fo settings are not activated until return to the MAIN MENU When the value has been updated to the desired level press the PREVIOUS MENU option key Press the MAIN MENU option key to return to the main display screen and activate settings SELECTED ALARM UMIT RANGE IT MAY BE NECESSARY TO ADJUST THE ALARM LIMITS FIRST IN ORDER TO SELECT THE DESIRED SCALE CHAPTER 7 Time Scale To adjust the time scale press the OPTIONS key on the main screen display Then press the third key from the left TREN
54. h must be turned on to keep battery charged F Potential Equalization Connector Y A CG D B E F Figure 5 4 Oximeter Back Panel WARNING ACCESSORIES NOT SUPPUED BY SOMANETICS MAY NOT MEET EN60601 1 2 IEC 601 1 2 STANDARDS CONTACT SOMANETICS CUSTOMER SERVICE DEPARTMENT AT 248 689 3050 EXT 255 OR customerservice somanetics com FOR COMPATIBLE PRODUCTS THAT MAY MEET THESE REQUIREMENTS Printer Output Port The printer output allows data from the INVOS System to be transferred to paper This port is a standard centronics parallel output The printer communication protocol is designed to support the INVOS Thermal Printer available from Somanetics Other printers that meet the appropriate IEC or ISO standards and emulate the Seiko graphics character set also may be suitable The maximum time required to print a 24 hour record for the INVOS Thermal Paper Printer is approximately 60 minutes See Chapter 8 for instructions Disk Drive Port 4 The disk drive port allows data from the INVOS System to be transferred to an IBM formatted 18 CHAPTER 5 INTERFACING WITH THE INVOS CEREBRAL OXIMETER DS HD 3 5 floppy disk The communication protocol is designed to support the INVOS Disk Drive available from Somanetics See Chapter 8 for instructions NOTE USE ONLY A SOMANETICS SUPPLIED DISK DRIVE WITH THE INVOS SYSTEM NO OTHER DISK DRIVE DEVICES SHOULD BE CONNECTED TO THE INVOS SYSTEM FOR ADDITIONAL INFORMATION ON ACQUIRING AND
55. hromophore hemoglobin absorbs specific wavelengths of light in a manner which enables the measurement of oxygen bound hemoglobin and reduced hemoglobin in the field generating a number intended to represent the approximate oxygen saturation of the predominantly venous microvasculature Near infrared light of suitable wavelengths is produced by miniature light emitting diodes in the sensor The scattering nature of the sampled tissues causes the photons to travel random paths through the brain however computerized simulations reveal an average path consisting of an ellipse between emitter and detector Two photodiodes serve as the detectors and are arranged on the sensor at different distances from the light source Since the depth of penetration of the average light beam is proportional to the distance from the light source the 8 CHAPTER 3 BEFORE YOU BEGIN measurement can be depth resolved allowing simultaneous monitoring of differing tissue strata The farther detector measures the saturation in all of the tissue penetrated by the light beam including skin skull and muscle tissue as well as brain The closer detector makes much the same measurement except it receives light which has not penetrated as deeply The two photon paths are most alike for small tissue depths but are quite different at the maximum depth of penetration as related to the farther spacing The common path can be used to suppress signals not representative of brain
56. iew This chapter defines the product in terms of functional units and replaceable parts It includes a block diagram for clarity NOTE THE INVOS SYSTEM IS CALIBRATED DURING MANUFACTURING AND DOES NOT REQUIRE ADDITIONAL ADJUSTMENTS THE SOMASENSOR ALSO IS CALIBRATED DURING MANUFACTURING A SELF CONTAINED SENSOR ID NUMBER IN THE SOMASENSOR CALIBRATES THE INDIVIDUAL SENSOR TO THE INVOS SYSTEM ADDITIONAL CALIBRATION IS NOT REQUIRED 50 CHAPTER 10 MAINTENANCE Software Upgrades Software upgrades are performed using the optional Disk Drive To inquire about software upgrades contact Somanetics Customer Service Department at 248 689 3050 ext 255 or consult Somanetics website at http www somanetics com Repair Policy Have all repairs performed by Somanetics authorized repair personnel Cleaning Cleaning the INVOS System CAUTION ELECTRICAL SHOCK WARNING DISCONNECT THE INVOS SYSTEM FROM THE AC POWER BEFORE CLEANING WARNING DO NOT AUTOCLAVE THE INVOS SYSTEM DO NOT GAS STERILIZE THE INVOS SYSTEM DO NOT IMMERSE THE INVOS SYSTEM IN ANY LIQUIDS l Disconnect AC Power from the unit Turn power off 2 Clean the outside surface of the enclosure with a cloth dampened with Isopropyl alcohol 70 or mild soap and water solution 3 Clean the faceplate and screen with a clean soft cloth and isopropyl alcohol or commercial glass cleaner Do not use acetone or abrasives 4 If necessary the INVOS System and c
57. ition is stable e g for surgical patients prior to induction a baseline reading should be obtained To set the baseline start by pressing the BASELINE MENU key on the MAIN MENU below the display screen ALARM SUSPEND OPTIONS MENU Press the BASELINE MENU key and the following menu options will appear Figure 1 2 Baseline Menu The first key from the left toggles between BOTH CHANNELS RIGHT or LEFT channels Default is BOTH CHANNELS Choose accordingly Press the second key from the left to SET BASELINE The baseline value s will be set at the current rsO2 value s and the menu will return to the MAIN MENU Also a two 2 will be placed in the EVENT MARKER column of the digital output and disk drive output data to signify the time and rSO2 value at baseline capture See Chapter 8 for output formats BASELINE MENU Figure 1 1 Main Menu Press RESET BASELINE to restore the most recently set baseline value s in the event that a sensor is disconnected and the baseline value erased The baseline value s will not be saved if the INVOS System is turned off PN 313064 REV A Operations Manual INVOS Cerebral Oximeter Model 5100B SOMANETICS
58. le will be stored as a space delimited ASCII text file in the data format given below Date Time Left rSO2 Event Status A B C D Right rSO2 Event Status A B C D Lot Serial Lot Serial Marker Marker Figure 8 15 ASCII text file data format It is necessary to parse the data when entering it into a spreadsheet Follow the software supplier s directions to proceed Graph rSOz vs Time with Microsoft Excel 1 Open Excel program Under File Open select file name and directory from above make sure all files or text files is selected Excel will disolay the Text Import Wizard dialog box 2 Under Original Data Type select Delimited remove Tab and select Space The data should now be parsed into Individual cells 3 Insert an empty row at the top of the data by selecting Row from the Insert menu Enter column headings in row The data format and column headings are displayed in Figure 8 15 4 Press CTRL on the keyboard and select or highlight the time column starting from row to the end of the data Without releasing the CTRL key select or highlight the left and right r O2 data columns from row to the end of the data 5 Select the Chart icon Ty in the tool bar or select Chart from the Insert menu The Chart Wizard will appear 6 Choose Chart Type by selecting XY Scatter as the Chart type and Scatter with data poin
59. main display screen 2 Press OUTPUT SELECT from the Options Menu The following menu will appear s Figure 8 10 Output Options E E 3 Press the DISK DRIVE option key The following menu will appear TURN DISK ON CASE HISTORY ae MAIN MENU Figure 8 11 Real Time Data or Stored Dafa Option 4 Press CASE HISTORY to send stored data to the Disk Drive If real time disk storage is on it will be automatically shut off The data will output until complete The time required is short there is no cancel option DISK DRIVE Up to 24 hours of data may be stored after the fact Data collected previous to the 12 hour 2 min trending rate or 24 hour 1 min trending rate periods will not be stored While outputting stored data monitoring will cease and the INVOS System will display the last rS O2 value measured before the output started Monitoring will resume when the outputting function is complete Case history data can be accessed on any IBM or compatible personal computer using a common spreadsheet program like Lotus 1 2 3 or Microsoft Excel The file will be named HIST DAT and will be stored in a space delimited ASCII text file in the data format given below Figure 8 12 ASCII text file data format It is necessary to parse the data when entering it into a spreadsheet Follow the software supplier s directions to proceed Digital Output Port WARNING ALL EQUIPMENT USED WITHIN TWO 2 METERS OF THE PATIENT PATIE
60. oblem or need RMA number and serial number of the unit Name and phone number of the person to contact within your facility Information regarding where and to whom to address the return of the INVOS System All accessories that came with the product Preamp AC Line Cord and any other optional attachments INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 11 Chapter 4 Installation Chapter Overview This chapter provides information for unpacking and setting up the INVOS System Unpacking NOTE BE SURE YOU MEET ALL ENVIRONMENTAL REQUIREMENTS BEFORE UNPACKING THE UNIT SEE THE SPECIFICATIONS IN CHAPTER 2 FOR MORE DETAILS l Inspect the shipping container visually for signs of damage or abuse during transit 2 Carefully unpack the unit and all accessories Be sure you have the following pieces Cerebral Oximeter Preamp Bilateral Reusable Sensor Cable Power Cord Operations Manual Any other accessories you may have ordered NOTE SAVE THE BOX AND PACKING MATERIAL FOR ANY FUTURE TRANSPORT 3 Remove all tape and packing materials from the unit and accessories 4 Visually inspect the unit and accessories for signs of shipping damage If there is damage report it to the shipping carrier UPS FedEx or other immediately 5 Record the Cerebral Oximeter and Preamp serial numbers on the inside cover page of this manual The INVOS System serial number appears on the Cerebral Oximeter back
61. of the case toggle the first option key TURN PRINTER OFF to disable real time printing Printing Stored Data 1 Press the OPTIONS MENU key on the main display screen 2 Press OUTPUT SELECT from the Options Menu The following menu will appear PRINTER DISK DRIVE DIGITAL OUTPUT REVIEW Figure 8 3 Output Options l 3 Press the PRINTER option key The following menu will appear Figure 8 4 Real Time Data or Stored Data Option 4 Press CASE HISTORY to enable stored data printing If real time printing is on it will be automatically shut off Toggle the second option key PRINT CANCEL to cancel printing of stored data Disk Drive Operation NOTE ONLY A SOMANETICS SUPPLIED DISK DRIVE SHOULD BE USED WITH THE INVOS CEREBRAL OXIMETER NO OTHER DISK DRIVE DEVICES SHOULD BE CONNECTED TO THE CEREBRAL OXIMETER FOR ADDITIONAL INFORMATION ON ACQUIRING AND USING A DISK DRIVE UNIT CONTACT SOMANETICS CUSTOMER SERVICE DEPARTMENT AT 248 689 3050 EXT 255 VIA THE INTERNET AT hf tp www somanetics com OR VIA EMAIL AT customerservice somanetics com The disk drive port allows data from the INVOS System to be transferred to an IBM formatted DS HD 3 5 floppy disk The communication protocol is designed to support the INVOS Disk Drive available from Somanetics The disk drive duplicates the storage function available in the INVOS System with the exceptions that it offers greater capacity selectable storage rates and stores
62. pear on the screen Operating Messages and Status Messages These messages are described below Operating Messages ADULT or PEDIATRIC This message will be located in the top left corner of the display screen It indicates that the INVOS System is in ADULT or PEDIATRIC mode depending on the model SomaSensor PAUSED The PAUSED message will be located in place of the rSO2 value It indicates that the INVOS System is in PAUSE mode The device will not operate or store data in PAUSE mode Push RUN PAUSE to begin monitoring Status Messages During normal monitoring situations one of the following status messages will appear above each rSO2 value SYSTEM SIGNAL OK Indicates proper connection and functioning of the SomaSensor and the INVOS System Digital rSO2 readings should appear below this message ALARM HIGH This message along with a bell will appear if the Upper Alarm Limit is exceeded A tone accompanies the message ALARM LOW This message along with a bell w will appear if the Lower Alarm Limit is exceeded A tone accompanies the message During situations when readings cannot occur the following status messages may appear POOR SIGNAL QUALITY System is operating but readings will not appear because they are unstable or may be corrupted by a noisy power source or a very weak signal Try another hospital grade electrical outiet or make sure there is no hair under the sensor A tone accompanies the mess
63. re to prevent damage or data corruption To remove the sensor from the Bilateral Reusable Sensor Cable grip both SomaSensor and cable connectors while pulling out Do not pull on any cables Avoid straining or twisting the Bilateral Reusable Sensor Cable Remove the protective backing from the adhesive side of the sensor only when the sensor is ready to apply to the patient Battery Recharge WARNING BATTERY BACKUP IS NOT USER REPLACEABLE The battery charges itself while the INVOS System is connected to AC power It acts as a backup for data storage power outages and patient transport The battery operation time without AC power is approximately 2 hours starting from a fully charged condition Recharging time is 15 hours from a full discharge NOTE UPON INITIAL UNPACKING THE BATTERY MAY BE PARTIALLY DISCHARGED BEFORE ATTEMPTING BATTERY OPERATION THE BATTERY MUST BE CHARGED BY CONNECTING THE UNIT TO AC POWER IN EITHER OPERATIONAL OR NON OPERATIONAL MODE A CHARGE TIME OF 15 HOURS IS REQUIRED TO RECHARGE A DISCHARGED BATTERY THE BLUE CHARGE INDICATOR ON THE FRONT PANEL INDICATES WHEN THE BATTERY IS RECEIVING VOLTAGE TO CHARGE Disconnecting Patient Cables Preamp Cable Pull the metal outer shell of the connector straight out from the front panel connection on the INVOS Oximeter The outer shell has a mechanism used to disengage the locking of the two connectors together Do not pull on the cable or twist the connector
64. re 7 12 Trending Rate Trending Rate options are 1 or 2 per minute Touch the key below the option you choose This will activate the new trending rate and return to the main display screen Changing Time Setting After you turn the INVOS System ON the unit will sequence through a series of start up and self test screens and will stop at a NEW PATIENT PREVIOUS PATIENT screen To change the time from this screen Press the tra dikey from the left RAREN IME The ii screen will be displayed Figure 7 13 System Setup Press TIME option ney The following screen will appear HOURS 14 INCREASE DECREASE PREVIOUS MENU Figure 7 14 Time Setting Toggle the first option key to select HOURS MINUTES or SECONDS Use the INCREASE or DECREASE option keys to change the time When the time has been updated press the PREVIOUS MENU option key to return to the NEW PATIENT PREVIOUS PATIENT display screen and activate settings INVOS CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL 33 Changing Date Setting After you turn the INVOS System ON the unit will sequence through a series of start up and self test screens and will stop at a NEW PATIENT PREVIOUS PATIENT screen To change the date from this screen Press the third key from the left DATE TIME The following screen will be displayed Figure 7 15 Date Time Menu Press DATE option key The following screen will appear DAY 26 INCREASE DECREASE PREVIOUS MENU Figu
65. re 7 16 Date Setting Toggle the first option key to select DAY MONTH or YEAR Use the INCREASE or DECREASE option keys to change the date When the date has been updated press the PREVIOUS MENU option key to return to the NEW f PATIENT PREVIOUS PATIENT display screen a INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 35 Chapter 8 Storing Printing Outputting and Reviewing Chapter Overview This chapter addresses the optional disk drive describes how to perform printing and digital outputting functions and activate review mode WARNING ACCESSORIES NOT SUPPLIED BY SOMANETICS MAY NOT MEET EN60601 1 2 IEC 601 1 2 STANDARDS CONTACT SOMANETICS CUSTOMER SERVICE DEPARTMENT AT 248 689 3050 EXT 255 VIA FAX AT 248 689 4272 OR VIA EMAIL AT customerservice somanetics com FOR COMPATIBLE PRODUCTS THAT MAY MEET THESE REQUIREMENTS Printing Data NOTE ONLY A SOMANETICS SUPPLIED PRINTER SHOULD BE USED WITH THE INVOS CEREBRAL OXIMETER NO OTHER PRINT DEVICES SHOULD BE CONNECTED TO THE CEREBRAL OXIMETER FOR ADDIMONAL INFORMATION ON ACQUIRING AND USING A PRINTER CONTACT SOMANETICS CUSTOMER SERVICE AT 248 689 3050 EXT 255 VIA THE INTERNET AT hitp www somanetics com OR VIA EMAIL AT customerservice somanetics com The printer output allows data from the INVOS System to be transferred to paper This port is a standard centronics parallel output The printer communication protocol is designed to support
66. s operating on battery power The symbol fill indicates approximate battery capacity When the fill inside the battery begins to disappear the battery is getting closer to depletion A tone indicates when the unit battery power is critically depleted No battery symbol appears when the INVOS System is not operating on battery power NOTE REFER TO ERROR STATUS MESSAGES TO TRY TO CORRECT A PROBLEM SEE CHAPTER 10 INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 27 Setting a Baseline The Baseline Status can be set to display relative rSO2 changes from baseline Both decreases and increases from baseline may signify dysfunction and developing pathology Changes in rSO2 of 20 from baseline are considered clinically significant and cause for concern See Frequently Asked Questions Appendix B for more information When trend data begins to be gathered and patient condition is stable e g for surgical patients prior to induction a baseline reading should be obtained To set the baseline start by pressing the BASELINE MENU key on the MAIN MENU below the display screen BASELINE MENU EVENT MARK ALARM SUSPEND OPTIONS MENU Figure 6 7 Main Menu Press the BASELINE MENU key and the following menu options will appear BOTH CHANNELS SET BASELINE Ria MAIN MENU Figure 6 8 Baseline Menu The first key from the left toggles between BOTH CHANNELS RIGHT or LEFT channels Default is BOTH CHANNELS Choose accordingly Press the second
67. the Disk Drive Digital Output Port Setup Receiving Digital Data on a PC Using Hyper Terminal To Collect Data Graph rSO2 vs Time with Microsoft Excel Outputting Stored Data INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL Status Codes for Disk Drive and Digital Output Review Mode Access Review Mode Chapter 9 Warranty Information Chapter Overview INVOS Cerebral Oximeter Warranty Key Points Limited Warranty and Disclaimer Warranty Labor Disclaimer of Consequential Damages Failure of Product Purpose of Product Returning a Unit for Service Warnings about Unauthorized Repair Who to Contact for Authorized Repair Chapter 10 Maintenance 42 43 43 45 45 45 45 46 46 46 47 47 47 49 Chapter Overview Software Upgrades Repair Policy Cleaning Cleaning the INVOS System Cleaning the Printer Cleaning the Disk Drive Care of the SomaSensor Battery Recharge Disconnecting Patient Cables Inspection Points Mechanical Inspection Points Electrical Inspection Points Optional Field Test Device Operation Block Diagram Error Status Messages Troubleshooting Chart Troubleshooting the Printer Troubleshooting the Disk Drive Troubleshooting the Digital Output Glossary a INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 1 Chapter Warnings Cautions NOTE FEDERAL REGULATIONS IN THE UNITED STATES RESTRICT THE SALE OF THIS DEVICE TO OR ON THE ORDER OF UCENSED MEDICAL PRACTITIONERS Key T
68. to adjust the value To change another alarm limit press the PREVIOUS MENU option key Choose another parameter Original settings will be stored in memory and will remain active until all changes to the alarm limits are completed When the value has been updated to the desired level press the PREVIOUS MENU option key Press the MAIN MENU option key to return to the main display screen and activate settings Changing Alarm Volume Press OPTIONS key on the main display screen Press the ALARM SETTINGS key on the Options Menu Press the ALARM VOLUME sf The tal menu Spiers will appear VOLUME MEDIUM INCREASE DECREASE MAIN MENU Figure 7 6 Alarm Volume Adjust the volume by pressing either the INCREASE or DECREASE keys When the INCREASE or DECREASE keys are pressed the corresponding alarm volume will increase or decrease to HIGH or LOW When the Alarm Volume has been updated to the desired level press the MAIN MENU option key to return to the main display screen Equipment Alarms see Chapter 6 for a description of equipment alarms status messages Changing the Trend Scale Both the X and Y axes of the trend display can be adjusted based on patient condition or anticipated length of monitoring To begin changing the plotting scales press the OPTIONS key on the main display screen Then press TREND SETTINGS The following screen will appear Y AXIS VALUES X AXIS HOURS TRENDING RATE MAIN MENU Figure 7 7 Trend S
69. to display a new rSO9 saturation value Alarm notification consisting of visual and audible indicators appears immediately following display of a saturation value outside the user adjusted high or low limits An on screen trend display is updated every 30 or 60 seconds user selectable and each point represents the most recent displayed saturation value at the time it is added This trend can be adjusted to display variable lengths of stored data from one hour to 24 hours A real time and stored data RS 232 output is available for communication with other devices In real time RS 232 sends a new saturation value approximately every 5 seconds which also represents the most recent displayed value It will download a full memory in about 1 5 minutes A printer and disk drive output is included which allows connection of a compatible printer or disk drive for documentation purposes The printer and disk drive outputs are designed to download all of the stored data on command producing a record of up to 24 hours of cerebral saturation monitoring on paper or 3 5 floppy disk in ASCII text file data format The printer will download in real time approximately every 5 seconds or a full memory in approximately 45 minutes In real time the disk drive will store data at a storage rate of every 10 20 30 or 60 seconds The disk drive will download full memory up to 24 hours of stored data in approximately minute SomaSensor The SomaSensor is a dispos
70. trending rate periods will not be stored While outputting stored data monitoring will cease and the INVOS System will display the last rSO2 value measured before the output started Monitoring will resume when the outputting function is complete The stored data can be accessed on any IBM or compatible personal computer using a common spreadsheet program like Lotus 1 2 3 or Microsoft Excel The file will be stored as an ASCII text file in the data format given below Figure 8 18 ASCII text file data format It is necessary to parse the data when entering it into a spreadsheet Follow the software supplier s directions to proceed Status Codes for Disk Drive and Digital Output Status codes appear in the data shown above for real time disk drive and digital outputs These codes correspond to status messages that appear above the rSO2 value on the display screen as follows Drape sensor Poor Signal Quality Use another medical grade electrical outlet CODE STATUS MESSAGE _ ACTION Reduce room light 4 System Signal OK System operating normally z ank Excessive Light Check sensor adhesion Remove hair under sensor B Nons o i E E Po i Battery Low Check mains power switch on Back Panel Connect to AC Line Press RUN PAUSE key Sensor Not Check sensor connection Connected Check Reusable Cable connection at Preamp Check sensor connection for fluid contamination P Profile patient INVOS
71. ts connected by smooth lines as the Chart sub type Other Chart sub types may be chosen for different graph line formats Select Next 7 Chart Source Data with the data range and columns previously selected in step 4 Select Next 8 Enter Chart Options such as Chart title Value X axis and Value Y axis Other parameters may also be entered if desired After completing all of the Chart Options select Next 9 Select Finish and save the file as an Excel Workbook To further format the graph you may now double click on either axes and a dialogue box will appear fo allow changes to font scale alignment etc Outputting Stored Data 1 Press the OPTIONS MENU key on the main display screen 42 CHAPTER 8 STORING PRINTING OUTPUTTING AND REVIEWING 2 Press OUTPUT SELECT from the Options Menu The following menu will appear PRINTER DISK DRIVE DIGITAL OUTPUT REVIEW Figure 8 16 Output Options 3 Press the DIGITAL OUTPUT option key The following menu will appear Figure 8 17 Stored Data Option 4 Press CASE HISTORY to send stored data to the Digital Output Port Real time output will be shut off and resume when the Case History output is complete The data will output until complete The time required is brief there is no cancel option Up to 24 hours of data may be outputted after the fact Data collected previous to the 12 hour 2 min trending rate or 24 hour 1 min
72. ult High tSQ2 Scale Limit H 60 100 in increments of 10 _ 5 above High Alarm Limit Low r502 Scale Limit 30 0 60 in increments of 10 5 below Low Alarm Limit High Alarm Limit 90 20 95 Low Alarm Limit 40 15 90 Trend Scale 1 hour 2 4 8 12 24 hours Trending Rate 2 per minute or 2 per minute Alarm Volume Medium Low Medium High Disk Storage No Default 10 20 30 or 60 seconds INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 5 Compliance With Standards The INVOS System complies with the following U S and international regulatory standards for medical equipment E 0197 EN60601 1 2 IEC 601 1 2 UL2601 1 CSA 22 2 No 601 1 somanetics Corporation s quality system is registered to the ISO 9001 standard INVOS CEREBRAL OXIMETER MODEL 51008 OPERATIONS MANUAL 7 Chapter 3 Before You Begin Chapter Overview This chapter provides information that the user should know before attempting to operate the INVOS System How to Use this Manual As well as complying with the warnings previously listed in Chapter please consult this manual for operation and maintenance instructions Read the manual completely before using the INVOS System to ensure proper safe operation Do not attempt to repair the INVOS System during the warranty period Somanetics should make repairs during the warranty period Background The INVOS Cerebral Oximeter is designed to noninvasively directly and
73. ure 10 2 shows the block diagram of the INVOS Cerebral Oximeter This illustration can be used when attempting to isolate the cause of a problem AC Power an dS Zero Crossing Detector Section on Power Distribution Section Backup auory Hi aF e Battery Charge Section Line Filter Power Supply Key Panel Digital Interface Board Power Distribution Board TFT Color Display AIBIPSB Inverter Y CPU Board Digital Interface i Y Disk Digital Printer Speaker Fan Drive Output Output Preamp n T 4 Figure 10 2 Block Diagram of System 7 INVOS CEREBRAL OXIMETER MODEL 5100B OPERATIONS MANUAL 55 Error Status Messages The following actions are displayed on the INVOS System screen in response to their respective Error Status Messages These are actions the user can take to try to correct a problem ACTION Sensor Not Check sensor connection Connected Check Reusable Cable connection at Preamp Excessive Light Check sensor adhesion Drape sensor Reduce room light Poor Signal Quality Check sensor connection for fluid contamination Remove hair under sensor Use another medical grade electrical outlet System operating normally Preamp Not Check Preamp connection at monitor Connected Replace Preamp Com Port Check connections with Com Port device PC Unavailable Printer Unavailable Check connections with Printer Check conn
74. xt 255 or 800 359 7662 or customerservice somanetics com Service and Repair lf the INVOS System fails to operate as stated it should be taken out of service immediately See Chapter 10 for troubleshooting techniques WARNING DO NOT ATTEMPT TO PERFORM ANY SERVICE OR TAMPER WITH THE WARRANTY SEAL UNLESS YOU HAVE BEEN AUTHORIZED IN WRITING BY SOMANETICS REPAIRS MADE BY ANYONE NOT AUTHORIZED BY SOMANETICS DURING THE WARRANTY PERIOD WILL VOID THE PRODUCT WARRANTY lf the problem cannot be solved follow the steps below to obtain service 1 Contact a Somanetics Customer Service Representative at Customer Service Department Somanetics Corporation 1653 East Maple Road Troy MI 48083 4208 Phone 248 689 3050 ext 255 Fax 248 689 4272 Email customerservice somanetics com Website http www somanetics com 10 CHAPTER 3 BEFORE YOU BEGIN 2 Obtain a Return Material Authorization RMA number from the Somanetics Customer Service Representative When returning an INVOS System ship it prepaid in the orginal container as received if possible It is important to use the original container and packing material to prevent damage to the unit in shipping Somanetics will not assume responsibility for damage caused in shipment if the customer does not use original shipping materials Shipping materials can be obtained by contacting Somanetics Customer Service Department Also include a Detailed description of the pr
75. y make external connections to the types of equipment specified in the interfacing chapter of this manual See Chapter 5 Connecting any other types of equipment may result in damage to the INVOS System or compromise its safety Fire hazard Do not block airflow to the bottom of the unit Patient hazard Preamplifier is magnetized Do not place near pacemaker or implantable cardioverter defibrillator ICD Backup battery is not user replaceable 2 CHAPTER 1 WARNINGS CAUTIONS Precautions INVOS System readings represent a small volume of brain tissue beneath the SomaSensor and may not reflect oxygenation disturbances that occur elsewhere Make sure all connectors are fully engaged and free from moisture Moisture intrusion may cause inaccurate readings erratic readings or no readings at all Donot place the SomaSensor over sinus cavities the superior sagittal sinus subdural or epidural hematomas or other anomalies such as arteriovenous malformations as this may cause readings that are not reflective of brain tissue or no readings at all Use only Somanetics Corporation recommended or provided accessories Use of the INVOS System with any untested sensor may compromise accuracy f presentin the blood the following may cause inaccurate readings Cardiogreen or other intravascular dyes Carboxyhemoglobin and other dyshemoglobins a Hemoglobinopathies Bilirubinemia and or icterus jaundice Use of

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