INVOS® Cerebral/Somatic Oximeter Quick Reference Guide for Pediatric Use a ati aoe ed ES SXIMETER REFLECTING THE OF LIFE®((W/OS}8XIMETER Key Code CEREBRAL / SOMATIC Operating Basics Science and Interventions Case Examples ‘These guidelines are not designed to replace clinical judgment or individual patient needs. For complete instructions, indications for use, warnings and precautions, see the Operations Manual. Property of Somanetics Corporation. Duplication of this guide is prohibited without written authorization from ‘Somanetics Corporation.-SOMANETICS Description of Symbols OXIMETER ENCLOSURE DISPLAY ° Blue LED — indicating AC lon vg Power Supply and charge Alarm ON = A Caution; consult B lesen accompanying documents IOIOL Digital Output Gum Batfery e Green LED — indicating power ON f Signal Strength Indicator SSI HOME aX Silence Alarm © ON/OFF OTHER LABELS — Consult operating a LJ instructions IO | VGA Port @ Do not reuse The noninvasive INVOS Cerebral / Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain of an individual. It is also intended for use as an adjunct trend monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in infants, children or adults at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the INVOS System has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.( }OXIMETER CEREBRAL / SOMATIC [li] Initial Setup 1. Plug in INVOS Monitor to power source. THE BLUE ,Q, LED ILLUMINATES TO INDICATE THE POWER IS CONNECTED AND THE BATTERY IS CHARGING. IF BLUE LIGHT IS NOT ON, TURN BACK PANEL MASTER (MAINS) POWER SWITCH ON. 2. Connect Preamplifier(s) to INVOS Monitor. Align red dot on the silver connector with red dot on side panel input connection. Insert cable connector into side panel connection while keeping the dots aligned. Be sure to fully insert the connector until it locks. 3. Connect the Reusable Sensor Cable Connectors to Preamplifier(s). Use color-coding.-SOMANETICS’ Initial Setup (continued) 4. Attach Sensors to Reusable Sensor Cables. Hold blue connectors. (Sensor cable can be connected to sensors before or after placement). Different INVOS System sensors (adult, pediatric and neonatal) cannot be used on the same monitor. 5. Connect any optional accessories, including the Somanetics USB Flash Drive. ay THE INVOS SYSTEM BEFORE TURNING ON THE MONITOR. OR, THE USB FLASH DRIVE CAN BE CONNECTED ANYTIME, PROVIDED THE INVOS MONITOR IS RE-BOOTED TO INITIALIZE THE USB FLASH DRIVE BY PRESSING THE ON/OFF KEY. IF REMOVED DURING A CASE, THE ORIGINAL SOMANETICS USB. FLASH DRIVE CAN BE RE-INSERTED TO CONTINUE DATA COLLECTION OF THE SAME CASE BY RE-BOOTING THE MONITOR AND PRESSING THE “PREVIOUS. PATIENT” MENU OPTION ON THE START SCREEN. 6. Tur power ON by selecting the green C ON/OFF key. 7. After displaying the Welcome Screen, the INVOS System performs a 10-second self-test, stopping at the Start Screen. 8. Ifnecessary, set the DATE/TIME by following the options menus. The date and time may only be changed from the Start Screen. 9. Press NEW PATIENT. Monitoring begins. 10. If desired, set alarms, scales, data channel labels and other modifiable preferences via the User Configuration Menu Screen.((W/OS}8XIMETER CEREBRAL / SOMATIC Back Panel Connections and Elements 1. Digital Output Port tolol 6. AC Mains (Master) Power 2. VGA Output Port |(>] Switch 3. Potential Equalization & 7. AC Input, Power Cord (Grounding Post) Connector Connector 4. Alarm Speaker and Cooling Fan 8. Serial Number 5. Fuse ==}-SOMANETICS’ Side Panel Connections and Elements rT EY ‘7 . z x rE z= 1. USB Connector <> 2. Preamplifier A, Channel @ Connector 3. Preamplifier B, Channel €) @ Connector To connect Preamplifier(s) to INVOS Monitor, align red dot on the silver connector with red dot on side panel input connection. Insert cable connector into side panel connection while keeping the dots aligned. Be sure to fully insert the connector until it locks. To disconnect the Preamplifier, unlock the connection by drawing back on the ridged, silver outer sleeve of the connector. Then pull the cable out of the Preamplifier connection.((W/OS}8XIMETER CEREBRAL / SOMATIC | lil Start Screen: Date and Time Setting 1. Software Version 5. Date and Time on 2. Navigation Bar (menu options) Navigation Bar 3. Blue, LED charge indicator 6. Menu keys 4. ON/OFF cy key 7. Home @ key For changing the date or time, after the INVOS System is turned ON c+, follow these navigation menu options: NEW PATIENT PREVIOUS PATIENT DATE/TIME NEXT MENU DATE TIME |__| PREvious MENU DAY = XX INCREASE DECREASE PREVIOUS MENU Select DAY, MONTH or YEAR followed by the INCREASE or DECREASE options to adjust the date as necessary. Select HOURS, MINUTES or SECONDS followed by the INCREASE or DECREASE options to adjust the time as necessary. Press PREVIOUS MENU again to return to the Start Screen.A To ensure good contact, clean/degrease the skin using mild soap and water. Ensure patient's skin is completely dry with a gauze pad. Select sensor site on right and/or left 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 sensor 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. Peel off backing label from sensor and apply to the forehead as illustrated. Secure the cable to a fixed object to avoid strain on the sensor to skin interface. (Sensor cable can be connected to sensors before or after placement. Hold blue connectors, not the black flex circuit.) Press NEW PATIENT. FOR EXTENDED MONITORING, SOMANETICS RECOMMENDS USING A NEW SOMASENSOR EVERY 24 HOURS AND FOLLOWING YOUR INSTITUTION'S GUIDELINES FOR SKIN INTEGRITY. CAUTION: TO AVOID PRESSURE SORES, DO NOT APPLY EXTERNAL PRESSURE (E.G. HEADBANDS, WRAPS, TAPE) TO SENSOR. = nN =o oa SENSORS MAY OVERLAP, PROVIDED THE THREE OPTICAL WINDOWS ON EACH PAD REMAIN UNOBSTRUCTED.((W/OS}8XIMETER CEREBRAL / SOMATIC Somatic Sensor Placement Select sensor site over skeletal muscle tissue (site selection will determine which body region is monitored). Avoid placing the sensor over thick fatty deposits, hair or bony protuberances. Do not place the sensor over nevi, hematomas or broken skin, as this may cause readings that are not reflective of tissue or no readings at all. Typical monitoring locations include: Renal area: over the latissimus dorsi muscle, T10-L2, posterior flank, right or left of midline Abdomen/gut: over the external abdominal oblique muscle Chest: over the pectoralis major muscle Forearm: over the brachioradialis muscle Upper arm: over the biceps muscle Calf: over the gastrocnemius muscle Upper leg: over the quadriceps muscle-SOMANETICS Somatic Sensor Placement (continued) FOR EXTENDED MONITORING, SOMANETICS RECOMMENDS USING A NEW SOMASENSOR EVERY 24 HOURS AND FOLLOWING YOUR INSTITUTION'S GUIDELINES FOR SKIN INTEGRITY. CAUTION: TO AVOID PRESSURE SORES, DO NOT APPLY EXTERNAL PRESSURE (E.G. WRAPS, TAPE) TO SOMASENSOR. SENSORS MAY OVERLAP, PROVIDED THE THREE OPTICAL WINDOWS ON EACH PAD REMAIN UNOBSTRUCTED. 1. To ensure good contact, wash area with mild soap and water and dry thoroughly. 2. Peel off backing and place SomaSensors. (Sensor cable can be connected to sensors before or after placement. Hold blue connectors, not the black flex circuit.) 3. Press NEW PATIENT.The User Configuration Menu can be used to adjust a variety of settings including 2 or 4 channel monitoring, Alarms, rsO, Scale, Time Scale, USB Storage Rate, Event Mark Lists, color coding and naming of Channel Labels. Assuming you have connected INVOS System components, the Monitor is ON and in Run Mode, press the HOME @)key to display the Main Screen and follow these navigation bar options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF OUTPUT SELECT TIME SCALE PREVIOUS MENU In the User Configuration Menu, select NEXT and PREVIOUS to scroll to the setting you wish to change. Adjust the setting. When finished, press the HOME @key to return to the Main Screen. On the Main Screen, adjustments will appear. a) ee ee eo) a ay Ce ae ae o) Cee) Cae) Page Oneren USER CONFIGURATION SCREEN Lad a) Page Two. The User Configuration Menu default settings are: DEFAULT RANGE Upper Alarm Limit OFF 20-95 Lower Alarm Limit 40 15-90 Alarm Volume Medium Low, Medium, High Upper rSO, Scale Limit | 100 60-100 in increments of 10; 5 above High Alarm Limit Lower rSO, Scale Limit | 30 0-30 in increments of 10; 5 below Low Alarm Limit Trend (Time) Scale 1 hour 1,2, 4, 8, 12, 24 hours USB Storage Rate 5 seconds 5,30, and 60 seconds Event Mark List OR OR, ICU, VASCULAR, NICU Channel Labels L,R,S,, §. A-Z, S,-S, Color Coded Labels NO YES, NO((W/OS}8XIMETER CEREBRAL / SOMATIC User Configuration Menu (2- or 4-Channel Monitoring) THE INVOS SYSTEM MUST BE RESTARTED FOR THIS CHANGE TO TAKE EFFECT. To change the software version from two to four channel monitoring (assuming you have connected INVOS System components, the Monitor is ON and in Run Mode), press the HOME @)key to display the Main Screen and follow these navigation bar options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU OUTPUT SELECT wet | PRewous [CREASE [DECREASE Next NEXT PREVIOUS INCREASE DECREASE In the User Configuration Menu, select NEXT to scroll to the 2 OR 4 CHANNELS setting. Select INCREASE and DECREASE to choose the number of channels monitored and displayed. When finished, press the HOME @key to return to the Main Screen. Press the ON/OFF) key twice to restart the system. When the Monitor has returned to Run Mode, the number of channels selected should be displayed. SEPARATE SETS OF USER CONFIGURATION PARAMETERS ARE STORED FOR 2- AND 4-CHANNEL MONITORING. PREVIOUS SETTINGS FOR 2-CHANNEL MONITORING WILL RESUME WHEN THIS CONFIGURATION IS SELECTED, AND VICE VERSA.SOMANETICS’ Main Screen (Two-Channel Monitoring) 1 SOMANETICS ,a z 1 . Date and Time . Adult, Pediatric or Neonatal Indication . Upper and Lower Alarm Limits . Trend Data Graph (Channel 1) . Trend Data Graph (Channel 2) 6. 180, Trend Scale (High & Low) 7. Time Scale; in hours 8. Menu Options (Navigation Bar) 9. Alarm Status Message 10. Alarm Symbol nm on ow Giraanacrer » 9 11. Signal Strength Indicator 12. 150, Baseline and Symbol 13. 180, Relative (%) change from Baseline 14. Real-Time rSO, (index) Values 15. Data Channel Label (e.g. L; left cerebral, R; right cerebral, S; somatic) 16. Event Mark line and numerical code 17. Battery Power Status( }OXIMETER CEREBRA L / SOMATIC Main Screen (Four-Channel Monitoring) a SOMANETICS 1 > a 38 43 y 6 4 =) . Date and Time . Adult, Pediatric or Neonatal Indication . Upper and Lower Alarm Limits . Trend Data Graph (for Channels 1&2) Trend Data Graph (for Channels 3&4) 6. SO, Trend Scale (High & Low) 7. Time Scale; in hours 8. Menu Options (Navigation Bar) 9. Alarm Status Message nN = wo 5. 10. Alarm Symbol 11. Signal Strength Indicator 12. SO, Baseline and Symbol 13. rS0, Relative (%) change from Baseline 14. Real-Time rsO, (index) Values 15. Data Channel Label (e.g. L; left cerebral, R; right cerebral, S; somatic) 16. Event Mark line and numerical code 17. Battery Power Status-SOMANETICS B Setting rSO, Baselines Anrs0, Baseline should be set so subsequent rSO, changes from baseline can be measured. rSO, numbers will turn red if rSO, is above or below set alarm thresholds. Baseline status will turn red if rSO, is < 20% below set baseline. In the Baseline Menu, baseline(s) may be set for all channels in use at once, individually for selected channel(s) or manually to a previous rSO, value. IF A BASELINE CANNOT BE SET PRE-INDUCTION FOR PEDIATRIC PATIENTS, IT IS RECOMMENDED THAT A VALUE OF 50 IS USED FOR THE DESATURATION THRESHOLD. Setting an Awake rSO, Baseline for All Channels: Recommend Prior To Pre-op or 0, Mask As soon as rSO, trend data begins to be gathered and patient condition is stable, an awake baseline reading should be obtained (e.g. for surgical patients, prior to induction). To set a baseline for all channels, press the HOME @) key to display the Main Screen, then follow these navigation menu options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF} — NEXT MENU SET BASELINES | RESTORE BASELINES SET CHANNEL MANUAL SET Set Individual Channels to Current rS0, Baseline To set an individual channel baseline, press the HOME @ key to display the Main Screen, then follow these navigation menu options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF} = NEXT MENU SET BASELINES | RESTORE BASELINES SET CHANNEL MANUAL SET CHANNEL 1SET | CHANNEL 2 SET CHANNEL 3 SET CHANNEL 4 SET Select the channel(s) to set the baseline at the current rSO, value. This will display an event mark line and code on the display screen. When finished, press the HOME @ key to exit the Baseline Menu and return to Main Screen.((W/OS}8XIMETER CEREBRAL / SOMATIC B Setting rSO, Baselines (continued) WHEN USING THE MANUAL SET BASELINE FEATURE, THE NEW BASELINE VALUES WILL NOT BE REFLECTED IN ANY REAL-TIME DATA OUTPUT, INCLUDING TO THE USB FLASH DRIVE, OR WHEN REVIEWING CASES IN CASE ARCHIVE MODE. FOR ARCHIVING PURPOSES, THE CASE SHOULD BE DOWNLOADED IN CASE HISTORY, BEFORE TURNING OFF THE MONITOR, IMMEDIATELY AT THE COMPLETION OF THE CASE. Manually Set Baselines to Previous rSO, Value The manually set baseline feature is used when previous rSO, values are to be set as baselines (e.g., an awake baseline was forgotten to be set prior to induction). To select and manually set previous rSO, values, press the HOME @) key to display the Main Screen, then follow these navigation menu options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU SET BASELINES | RESTORE BASELINES SET CHANNEL MANUAL SET NEXT PAGE PREVIOUS PAGE LAST PAGE SCROLL MENU Select NEXT PAGE, PREVIOUS PAGE or LAST PAGE to review pages of rs0, data and locate the desired time and value to set baselines to. Once the time and data on the page being displayed has been located, follow these navigation bar menu options: NEXT PAGE PREVIOUS PAGE LAST PAGE SCROLL MENU Select NEXT or PREVIOUS to scroll to the desired line of rSO, data, then SELECT BASELINES to manually set the baseline.-SOMANETICS’ B Setting rSO, Baselines (continued) Restoring a Baseline/Replacing a Sensor To restore a baseline or replace a sensor, press the HOME @ key to display the Main Screen. If necessary, select the ALARM AUDIO ON/OFF option to deactivate audible alarms. CAUTION: SELECTING THE ALARM AUDIO ON/OFF >X OPTION WILL SILENCE THE AUDIBLE ALARMS PERMANENTLY UNTIL RE-ACTIVATED OR THE INVOS SYSTEM IS REBOOTED. FOR CONTINUOUS MONITORING WHILE CHANGING MULTIPLE SENSORS, REMOVE ONE SENSOR FOLLOWED BY SENSOR PREP AND PLACEMENT INSTRUCTIONS BEFORE REPLACING OTHER SENSORS. Prep the patient, apply sensors, then follow these navigation menu options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF} — NEXT MENU SET BASELINES |RESTORE BASELINES} SET CHANNEL MANUAL SET Select ALARM AUDIO ON/OFF to re-activate audible alarms, if necessary.((W/OS}8XIMETER CEREBRAL / SOMATIC Event Marking An Event Mark may be used to mark significant occurrences. It is displayed on the screen or stored in memory for later review. A vertical dashed line and event code will appear on the trend graph at the marked time. An event code will also appear at that time in the line of tabular trends screen or stored and outputted data. To mark an event, press the HOME @ key to display the Main Screen, then follow these navigation menu options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF | — NEXT MENU NEXT EVENT PREVIOUS EVENT SELECT EVENT PREVIOUS MENU From the Event Mark List, select NEXT EVENT and PREVIOUS EVENT to highlight the desired event code or description. SELECT EVENT to choose the highlighted event code and return to the trend data graph. Press the HOME @ key to return to the trend data graph without storing an event code.-SOMANETICS Oa eed 1 Miscellaneous PAR Neon cele lu Paes Gets 13) 22 Blood Transfusion RM rice) 23 Cardioversion CS oy 24 Cell saver blood PRE lty 25 Cerebral Perfusion On nba :] Pg eR) PMG ae kt OT Se el 2) 8 Cooling 28 Aluid/Volume Expander PRED eu loe | 29 Hemoconcentrate / MUF a te) 30 Inotrope SPE TE ki 31 Increase Anesthetic 12 Off CPB 32 Increase CO2 13 Closing Stemum 33 Increase FO2 ae ules eee SEE el closes 35 Paced 16 Hypocapnia 36 Reposition Cannula Pa ers 37 Reposition Clamp cea ert) 38 Reposition Head aR 39 Reposition Heart 20 Reduced Venous Return CUA ec phos ee oem ce Me RErel epee eRe games cd listed in the order they typically occur during a case. STU Lae Ue mee TOA aes Rl Cees eer Mer Roce uinatesl im PU eC CR Ei lcite:m(WVOS}8XIMETER Pa ee we SPU e/ NOU MeO le od 41 Miscellaneous 42 Set Baseline Cees oni) Desi ca| CM Mees] Ces lone CVS Su mB le) Coral ce Ty 50 Bradycardia EY Mb ce et LY eRe sy 53 LOC Changes eT ane TC) Rss ee VT BSS EIU noe) 57 Afterload Reduction BSUS CULL eS a uie ea a SG peed ROMs ie) LYAG cabs) ee eae 64 Diuretic 65 ECLS On eSB ERO Nae) mH ea Me Rstetei | CSM emer lty eed AR ee Acs PPA eC l FEM oes reac 75 Paralytic rR UR 77 Prostaglandin ieee) FER eine 80 Ventilator Change Dee oem Ree ees Mor ee R BURL Bes eee STU Lae Ue mee TOA aes Rl Cees eer Mer Roce uinatesl im PU eC CR Ei lcite:m-SOMANETICS Net Se easy 121 Miscellaneous Spee sg sce 1 123 Enteral Feeding SPL Sei ioe 125 Bag Mask Ventilation 126 Conventional Vent 127 Hi Frequency Vent 128 Position Change 129 Sensor Change aR ace y 131 Apnea 132 Arrhythmia 133 Cardiac Arrest/CPR ae Rey BRS ROGER es aR eal) 137 Tamponade SR ee ue 139 Anti-Epileptic Se eM cede sy SG peed Dee oem Ree ees Mor ee R BURL Bes eee STU Lae Ue mee TOA aes Rl 141 Cooling Cap On-Off cD oa ede 143 ECLS On pC SOR Reet ae rut Ces Rae seen iy Sy a eu ese e 148 Fem Art CutDwn Stop 149 Hypothermia 150 Nitric Oxide On — Off Bey SM eee aya 153 PDA Ligated 154 Prostaglandin SMO Maur lcms ele Sbeeiee Lie 157 Suction ET Tube Show ois ae imei eeeys a eden a eee lie Cees eer Mer Roce uinatesl im PU eC CR Ei lcite:m((WVOS}8XIMETER CEREBRAL / SOMATIC Alarms and Status Messages with rSO, Values Displayed During normal monitoring situations when rSO, values are being displayed, alarm and status messages may appear at the top of the Main Screen. Additional operating indications to assist the user will appear on the display screen at the right of the affected channel label (e.g. 2-digit SO, values tum red when value is below baseline desaturation threshold.) ‘STATUS MESSAGE COLOR, CAUSE ACTION LOCATION ALARM HIGH Red, top right Upper Alarm Limit is Profile Patient accompanied by alarm fone exceeded STATUS CODE: 5 ALARM LOW Red, top right Lower Alarm Limit is Profile Patient accompanied by alarm tone exceeded. STATUS CODE: 6 BATTERY LOW Red, botiom pa Battery power is critical. } Plug in A/C Power and accompanied by alarm fone | above navig: tum master (mains) STATUS CODE: 9 bi itch COM PORT UNAVAILABLE Yellow, top right | Output device not Check connections with STATUS CODE: 12 connected. Com Port device (PC). USB FULL Yellow, top right | USB Flash Drive memory | Insert a blank Hash STATUS CODE: 20 is full. Drive. USB STORAGE ERROR Yellow, top right | USB Flash Drive error. Check USB Flash Drive STATUS CODE: 14 connection. Insert a Hash Drive. DATE AND TIME Green, top left ‘ADULT, PEDIATRIC or Green, top left Adult, Pediatric or NEONATAL Neonatal application dependent on sensor model used. ‘SYSTEM SIGNAL OK No text message | SSI at full strength STATUS CODE: 4 displayed on screen-SOMANETICS’ Alarms and Status Messages without rSO, Values Displayed During situations when rSO, values cannot be calculated, status messages may appear in place of the rSO, values at the right of the corresponding affected channel label indicator. ‘STATUS MESSAGE ‘SENSOR NOT CONNECTED Disconnect at sensor (patient) or | Check Sensor to Reusable Sensor accompanied by alarm tone | cable. No rS0, value will appear. | Cable connection. STATUS CODE: 1 Check Sensor Cable connection to the Preamplifier. Restore baseline values. EXCESSIVE LIGHT Sensor has lifted off the patient, Check the connection to patient and accompanied by alarm tone | or there is too much outside light. | replace sensor, if necessary. STATUS CODE: 2 No rSO, will appear. If the sensor is properly adhered to the patient, try loosely draping the sensor. POOR SIGNAL QUALITY INVOS System is operating, ‘Try another hospital grade electrical accompanied by alarm tone | but r80, values will not appear | outlet. STATUS CODE: 3 because they are unstable or may | Relocate sensor, if possible. be corupted by a noisy power source or a very weak signal. PREAMP NOT CONNECTED | Preamplifier is not connected to Make sure the Preamplifier STATUS CODE: 11 ‘the INVOS Monitor. connector is locked into the side of the monitor. Normal operation of the INVOS System will resume when the Preamplifier is reconnected. REPLACE SENSOR INVOS System cannot read Check for correct sensor model type. accompanied by alarm tone | calibration data from the sensor. | Connect new SomaSensor. STATUS CODE: 17 Mixed adult, pediatric and Replace Reusable Sensor Cable. neonatal sensor models, moisture intrusion, a defective sensor, or a defective Reusable Sensor Cable could cause this. INTERFERENCE DETECTED | Noise corrupting rSO, data (e.g. Move or turn off source of accompanied by alarm fone } electrocautery). interference. Normal operation of the STATUS CODE: 19 INVOS System will resume when the excessive noise stops.correct for each. SSI INDICATION ((WVOS}8XIMETER CEREBRAL / SOMATIC Troubleshooting Signal Strength Indicator (SSI) The Signal Strength Indicator (SSI) reflects the strength and stability of the signal that is used to make an rSO.,, measurement. The SSI depends on physiological factors (different from individual to individual) and possible disturbances from secondary sources/influences in the monitor's environment. An inherent benefit of the technology is the ability of the device to determine rSO,, values from very small signals. The chart below provides SSI ranges and a list of the possible causes and action to DESCRIPTION/CAUSE ACTION 5 bars STATUS CODE: 4 1 through 4 bars - stable through 4 bars - fluctuating and unstable 0 bar Full strength signal Signal is weaker, but is strong and stable enough to generate an accurate 150, value. Signal is weak and unstable. Signal Interference. Sensor application over nevi, sinus cavities, the superior sagittal sinus, subdural or epidural hematomas or other anomalies such as arteriovenous malformations, broken skin, thick fatty deposits, hair or bony protuberances, or area contaminated with residue. No action required. No action required. identify any possible sources of interference, such as electro-cautery or similar electrical equipment interferences, intense light or radiation sources, moving artifacts or perturbations on the mains. Clean the area, re-apply SomaSensor to patient in an adjacent area; follow the sensor application instructions and make sure no hair, anomalies or residues are under the sensor. Defective Sensor. ‘Apply new Sensor to patient. Moisture in sensor connection ‘See Error Messages in data channel area on display screen (See Status Messages — without TSO, Values Displayed) Dry the cable and sensor connectors. Make sure the connection is not exposed to moisture. Follow on screen instructions.The INVOS System offers several different options to store, output and review data collected. One option is Case Archive Mode, allowing review of up to 28 cases of 24-hour duration. When data storage exceeds 24-hours or midnight is reached, a new case will be started. Case History data files are selected for review in the Case Archive File List. Data files created by the INVOS System are automatically named by the software using the date (YYMMDD) followed by a letter indicating the type of recording (N = Normal Run Mode, C = Control, | = Intervention) and a file extension consisting of a letter (H = History, or R = Real-time) and a sequence number. For example, a CASE HISTORY file recorded on November 13, 2007 in Normal Run Mode would have a filename of 071113N.H1. An asterisk (*) indicates a desaturation of 20% or more from baseline or < 40 rSO, values occurred during the case. Pm me Be ee ec | Ce ee ee en eo ee eTtia mgs L310 3]MORE THAN ONE (1) HOUR OF DATA MUST BE STORED TO SCROLL IN CASE ARCHIVE MODE. To access Case Archive Mode in graphical format, press the ON/OFF (4 key to display the Start Screen and follow these navigation menu options: NEW PATIENT | PREVIOUS PATIENT | DATE/TIME —— Select NEXT FILE or PREVIOUS FILE to scroll through the Case Archive File List. SELECT FILE will load and display the entire patient file graphically. Select ~<-TREND GRAPH and TREND GRAPH —> to scroll in one-hour increments. Select FULL GRAPH to display the entire case.-SOMANETICS’ Downloading Cases Via USB Flash Drive The USB Flash Drive allows data from the INVOS System to be collected and transfered to other devices such as a PC. Data may be collected in REAL-TIME or CASE HISTORY formats. Once the INVOS System and USB Flash Drive are connected and in Run Mode, the Monitor will begin data outputting to the USB Flash Drive automatically. Up to 24 hours of data may be stored per case file. When data storage exceeds 24 hours or midnight is reached, a new case file will be started. FOR DATA COLLECTION, THE USB FLASH DRIVE MUST BE CONNECTED TO THE INVOS SYSTEM BEFORE TURNING ON THE MONITOR. OR, THE USB FLASH DRIVE CAN BE CONNECTED ANYTIME, PROVIDED THE INVOS MONITOR IS RE-BOOTED TO INITIALIZE THE USB FLASH DRIVE BY PRESSING THE ON/OFF @ KEY. The stored data can be accessed and graphed on a personal computer using a common spreadsheet program like Microsoft Excel. The file will be stored as an ASCII text file. See the Operations Manual for the data format. Downloading an Individual Case from Archive List Access Case Archive Mode to download a desired file in the Case Archive File list. Assuming you have connected INVOS System components and connected the USB Flash Drive, press the ON/OFF ad key to display the Start Screen and follow these navigation menu options: NEW PATIENT PREVIOUS PATIENT DATE/TIME NEXT MENU CASE ARCHIVE START SCREEN PREVIOUS MENU NEXT FILE PREVIOUS FILE SELECT FILE NEXT MENU “<—TREND GRAPH | TREND GRAPH» | FULLGRAPH | NEXT MENU TABULAR TRENDS DOWNLOAD | PREVIOUS MENU | NEXT MENU USB STORAGE oieitaLouteuT | ————__‘_ PREVIOUS MENU(/WVOS}8XIMETER Downloading Cases Via USB Flash Drive (continued) Downloading All Stored Cases from Archive List Access Case Archive Mode to download all files in the Case Archive File list. Assuming you have connected INVOS System components and connected the USB Flash Drive, press the ON/OFF key to display the Start Screen and follow these navigation menu options: NEW PATIENT | PREVIOUSPATIENT | DATE/TIME | NEXT MENU | CASEARCHIVE | STARTSCREEN | | PREVIOUSMENU NEXT FILE PREVIOUS FILE SELECT FILE NEXT MENU DOWNLOAD FILES DELETE FILES START SCREEN | PREVIOUS MENU DOWNLOAD ALL FILES} CASE ARCHIVE MENU | PREVIOUS MENU All files except EXAMPLE.1 and EXAMPLE.2 will be transferred to the USB Flash Drive in a maximum of four minutes (28 cases of 24-hour duration). As the files are downloading, the file currently being transferred appears above the Case Archive File List. Downloading Case Data at the End of a Case Assuming you have connected INVOS System components and connected the USB Flash Drive, press the HOME @)key to display the Start Screen and follow these navigation menu options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU OUTPUT SELECT |USER CONFIGURATION PREVIOUS MENU | usb | _ DIGITAL OUTPUT REVIEW PREVIOUS MENU CASEHIsTORY | Ss PREVIOUS MENU | MAIN MENU The Case History data will output until complete.-SOMANETICS Site-Specific Saturation Data With Near-infrared RU grime eit) es) STOLE eel mrs cen) Us| SUC ce ei e aescLcLn e Deep >) USES CUO ROU m Le rule ORT Hic cg err MTR eR ROCs RG) Ne gic g gs oo(WVOS}SXIMETER CS eee Ua Regional Oximetry Vs. Other Oximetry Pee aed OAT ese ees a fers tiny tecnica LC ate RE es ae Hofiman GM, et al. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2005:12-21.-SOMANETICS Factors That Can Affect Cerebral Oxygenation Tailoring Oxygen Delivery Se iss ee values help to tailor individual PIs CO, - Higher CO, causes Peer M ren een Oe |e ecg ecm em RiL enc STE etre MT SNe eRe Tend ese Sew ne ea unee nce eS M eri ear MUO tf) Carrying capacity; the addition abu te etry Lo Mechanical Issues - Cannula Sums Mee eee and other issues can cause PUT TO CT Leas changes. Tailoring Oxygen Consumption esi er ee P Pes nicole eC MOC eg Bes es UCN CREA Ue Cone © Temperature - Temperature changes can cause rapid 10, changes. Cooling usually ese) Tene(WVOS}SXIMETER CS eee Ua rsO, Reflects Oxygen Balance rs0. fs Increases with rise in delivery or fall in demand © Decreases when delivery falls or if there is an uncompensated rise in demand Oe MRNA a) Vy Influenced by: SRE CL SU eULEH ON REOLecuiClley BILE Once) Beanie Se ey Ba ec Pe cat - Improve contractility Be eM at rcltewe icles | Oy eM E UO eN SO Ue Tilecsc cic) ea mont Bea v= ) Cold stress (neonates) She rls estate ails} Wounds and bums Pain Decreased by: SU LenS TnL BESO rics) SPS Re mi emia sity cle)-SOMANETICS The Cerebral - Somatic Relationship The INVOS System provides perfusion data from vascular beds that LUO Ces CRON MUM He cimeRlclni elem UCR I CCLLe extraction ratios. © Cerebral - High flow, high extraction organ SON eens w MRC SLs Cre Non cee ite ® flow-metabolism coupling BAe rele eet rele ee ae Be eae [eC Espen ames teucie noel clin) Mr eg Bruce BCU A main) See ASM Meares yee Tl eli ey (sympathetic) tone - Somatic desaturations may be an early indicator of shock ((.e., peripheral CeeN ese nee RU) preserve the brain) i JA, at al. Shock. 2005 Sep-24(3)-270-5. Fries M, et al. Crit Care Med. 2006 Feb;34(2):446-52. Hofiman GM, et al. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2005:12-21.(WVOS}SXIMETER CS eee Ua rSO, Targets and Thresholds PEER U aie eeu Lele ae ULe| BMRB UM es MM SMe rele emer MUL CltL based on each patient's unique physiology and clinical anomalies. As Treen eo Ue Cm UBL Lt fase cum OR LCR teem (ei (anc: SRM eNO UROL © Typical range: 60-80 Pees Serb Ow US Ua Eee La bs ee ES are PAR aU Ee te BSL) Sica Se CW AURA ROME BUC R CURE SUA RUC: | ie SU EMR CUE ena ee Ie lel em mele (tem Oe UA es me tie cooks ce elt ig Alco eg BL el ea Reece eee Pal Weer eee ae a aac eek en CeSOMANETICS’ rSO, Reactions to Common Intra-Op Events Rastoration of = Right Cerebral systemic perfusion — Left Cerebral Cooling; detivery: exceeds demand Propofol balances delivery anid demand Onset of cire arrest with retrograde Rewarming; demand exceeds delivery Hypotension This aortic arch reconstruction with deep hypothermic circulatory arrest demonstrates common times when cerebral perfusion can be rte Memes ie irl M Teele meee Lich ace Oa eee) TUR AUR CER mauled cso near or past the patient's desaturation threshold indicate opportunities Pm ene nts Edmonds HL Jr, et al. Semin Cardiothorac Vasc Anesth 2004;8:147-66.(WVOS}SXIMETER 0 ee Operating Room Interventions to Improve rs0, SESE Tes ye RRR Une mec me SM eR ONL) CNSR ORC cal eeu eel Nee) Os) (ess e:) © Mechanical obstruction (cannula position) © Increase cardiac output (pump flow) } See ei H Une (0) f SA EU PRO stele ea 7) PCR ee aries) © Neuroprotective Agent ° Additional cooling SATS Le antes aU © Whole blood Sauer) Insufficient Anesthetic Depth © Increase anesthetic delivery PSR eee ee ee-SOMANETICS PICU Interventions to Improve rSO, - Cerebral SESE Tes ye RRR Une mec me SM eR ONL) CNSR ORC cal (eel ¢-)) Increase cerebral perfusion pressure © Increase arterial blood pressure SA etre CUI ea Challe resistance © Increase cardiac output Reduce central venous pressure Liters toei tate MOA H MRO UL Ba [ec rsee (ners |y © Raise arterial partial pressure Oc eer Clic Mosel lm Coil yes © Raise arterial partial pressure of carbon dioxide Reduce cerebral metabolic rate PU RPh ena ts oma eC a Eee Molt AR, et al. Pediatr Grit Care Med 2006;7:346-350.(WVOS}SXIMETER CS eee Ua PICU Interventions to Improve rSO, - Somatic While each hospital will have its own care protocols, the following ea A ELAR OU ce od a Somatic Increase total cardiac output SAU em Cele CUCL rhythm and contractility Reduce sympathetic outflow © increase inotropes decrease Nitroprusside Vier em Lente VET M Cut eee 0 em) | Consider regional vasodilation eee er esi bee MALE Ce Gye cia eau Pee meetin ets ty Pediatr Card Surg Annu. 2005-12-21. Jonassen AE and Young WL. Anesthesiology 1994;81:A61.-SOMANETICS Patient Care The care team should follow its institution's own protocols for patient monitoring and skin integrity. Some examples pertaining to INVOS BS sree LT BAR ec RSs CUR M lal - Recommended every 24 hours Seas NCHA Sem eR ae og SR Re ree eR es 0h Ole te oe BEPC Re pee Se eB CRORES CRO else enone] See Rae Oe ER eecl Mee LN ae Dest UL} relate] The care team should follow its institution's own protocols for patient CeCe EMCI eM rem OR LO lish es CsI M rl toa RUE ORn icles elem s i bale nel from the patient's baseline Sue R UR eM Oar Cum lee cle ny interventions SSC ann ESTMe Ie Oi cu) rounds, etc. See RESUME Re ey(WVOS}SXIMETER CS eee Ua 7 acuta lcy PSUR eect SA ue OU) BCR cl wet ii] Ba (ees se ceo (lise eet esl)-SOMANETICS’ Reversal of Shock ‘Sedation/Intubation Blood transfusion 30 Inotropes given — Somatic 20 —= Cerebral 1 Cerebral 2 ra Resuscitation 397) 437037) GF 7BF BSF FUT 11:87 «12:87 13:37 This infant with septic/cardiogenic shock and severe global hypoperfusion presented with below critical SO, levels. Subsequent rSO, values reflect patient responses to a series of interventions. Regional oxygenation was normalized at higher levels, including restoration of typical somatic oxygenation at 5 - 20 points greater than cerebral." ‘Hoffman GM, et al. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2005:12-21. ? Petrova A and Mehta R. Pediatr Crit Care Med Cee ita on file.((W/OS}BXIMETER CEREBRAL / SOMATIC Detection of Mechanical Obstructions - 5 kg Infant Incision = Cerebral 752 806 0 BDSG NDOT. During this BT shunt case, initial intubation was difficult and the ET tube later became dislodged. This mechanical obstruction caused an immediate ~20 point drop in cerebral rSO, to a critical level of 45. SpO, values remained normal until about 1 minute later. Similarly, after cross clamping the right subclavian artery, cerebral rSO,, fell ~40 points over a period of 12 minutes, again dipping below critical. The perfusionist changed flow and pressure with no improvement. The surgeon then checked the cross clamp which had inadvertently included the innominate artery occluding some flow to the brain. Upon clamp repositioning, cerebral rS0, immediately improved. There were no other hemodynamic indicators that the innominate artery was partially occluded. Without cerebral rS0, values, the brain would have had inadequate oxygenation for ~25 minutes. Data on file.-SOMANETICS’ Effect of Organ Compression / Manipulation - Two-day-old Infant episodes of significantly reduced ‘0 a a ap a ca sca onl © _ Somatic (Right Flank) Cerebral This giant omphalocele repair case emphasizes the potentially negative effects of organ compression and manipulation on regional oxygen saturation. Somatic monitoring enabled clinicians to visualize compromise to peri-renal perfusion in real-time and adjust their surgical approach to provide immediate relief of abdominal compression. Interventions included repositioning the omphalocele, spacing their manipulations to allow for perfusion recovery in between, vent changes and PRBCs to replace losses. Without placement of the peri-renal sensor, prolonged desaturation of the kidney area may have continued without notice for a significant period of time, increasing the risk of post-op renal dysfunction. This same desaturation threat can occur in similar compression-prone scenarios such as lifting/manipulating the heart and closure of the chest. Data on file.((W/OS}BXIMETER CEREBRAL / SOMATIC Oscillations and Desaturation Associated with Seizures 6 Right Cerebral —Left Cerebral 55 50 5 40 35 13:30 1345 14:00 14415 1-5. Episodes of Seizure; data recorded every 10 seconds for best resolution An EEG monitoring study detected seizure activity in 26% of circulatory arrest infants during and after surgery, which can result in serious developmental consequences.’ This cerebral oximetry trend graph is marked at the times of EEG documented seizures.’ Note the transition from a smooth line to one with oscillations and a desaturation. The INVOS System can help identify potential seizure activity--even silent seizures and hemisphere of origin.** ‘Newburger JW, et al. New Engl J Med 1993;329:1057-1064. ? Courtesy of HL Edmonds, Jr, PhD. Diaz GA, et al. Eur J Paediatr Neurol. 2006;10(1):19-21. Epub 2006 Mar 10. ‘Shuhaiber H, et al. J Child Neurol. 2004 Jul;19(7):539-40.-SOMANETICS ECMO Management rsO, values are useful in determining the need to initiate ECMO therapy as well as in providing immediate patient response to separation from ECMO. Initiating ECMO + ECMO Row Cerebral values exceed Tuning of ECMO parameters ip | Peti-renal; a potential early restores proper cerebral and indicator of shock Cannulation peri-renal variance with 0 absolute values WNL 2 Pal —Cerebral = Somatic / Peri-Renal S15 GSD 825 101 TG 1941 1447 1622 1800 19:96 211 24S O21 156 3 S05 Separation from ECMO ‘ECMO Wean: 55 MAP 47, CVG, + ‘SpO2 96%, CaCl gtt, Fentanyl git as Midazolam, gtt, Lasix gt & T T T T T —r T 28 2158S 71ST SA 1250 TETRA 037 Data on file((W/OS}BXIMETER CEREBRAL / SOMATIC Sole Early Indicator of Low Cardiac Output Syndrome - 10 kg Child Poor cardiac output indicated by lower than expected somatic trends and frequent desaturations with any stress = Somatic / Peri-Renal —Corebral Pleural effusion found, chest tube insertion with asp of hemothorax; immediate cardiac output response Frequent r302 desats without desaturation of pulse and venous ‘oximetry; staff documented ‘SpO2 88% on 100% Fi02; bilateral breath sounds stat CXR noted in improved somatic r302; increased PEEP and PS; MAP 52; Sp02 100% t T T T T T T T T T a 0 8g] 0D Roughly 24 hours after ASD/ VSD repair, somatic and cerebral rSO, values frequently dipped to sub-optimal levels, while venous and pulse oximetry remained stable. Nursing and respiratory staff documented bilateral breath sounds throughout the night. By early morning, a critical desaturation of both SpO, and rSO, occurred with recovery of SpO, to only 88% despite increasing FiO, to 100%. A stat CXR was obtained revealing significant pleural effusion that was tapped and drained. This enabled the heart to pump sufficiently to perfuse the somatic/peri-renal area, as evidenced by the dramatic rise in somatic rSO,. This case demonstrates the unique value of site- specific oxygenation data to aid in the detection of low cardiac output syndromes and limited regional perfusion. Data on file.-SOMANETICS Ordering Information eee Disposable Adult SomaSensor sees) Bet lee ee Dot INVOS 5100C Cerebral/Somatic Oximeter Preamplifier with Gable, Channel 1 & 2 (Preamp) UO MURS MEE Re eo (ete) esc Bech me MTL (TC) is eee tml) MEIC EE) Reusable Sensor Cable, Channel 3 (Orange) ii eee tm) MAIR) Power Cord samy DR eel Mme ce RAUL ce em eH) DT ee Meester rel Celn eA) Portable Roll Stand (for 5100C) Swivel Arm (for 5100C) (yee Quick Reference Guide for Adults Ce die emer mm act tlesy ee Tg ‘SAFB-SM Baa] 5100C-USA 5100C-PA Pye) i isd RS-3 ise SUE 5100C-USB i 312170 YUU Pets) PUL ey BULLS ETI tEY SLU tia Peron eR MMe oe then Pacem PIs meow emit Um! M tira erect aM UIs Waming: Accessories not supplied by Somanetics may not meet EN60601-1-2 (EC 601-1- 2) standards. Contact Somanetics’ Customer Service Department for compatible products Pea Peaster Cu iePoP rember cm eM no Oem Ue OM Mico ae Om MMe cae BIE aU St ‘Somanetics Corporation. NIRSensor is a trademark of Somanetics Corporation. All other trademarks DeLee UE RUB Bot ee oe USS. patents 5139025, 5140989, 5217013, 5349961, 5469714, 5477853, 5482034, 5584296, aE ee eRe Met ee Mt eee Rx ONLY PN 313380, rev. A BS ee a MLK Pe ee eRe