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Standards Compliance

The FORE-SIGHT ELITE Oximeter complies with the following requirements:

CE marking according to Directive 93/42/EEC

IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
CAN/CSA C22.2 #60601-1
ANSI/AAMI ES60601:2005

CAS Medical Systems, Inc.

Specifications

Summary of Contents for fore-sight elite

Page 1: ...The confidence of knowing User Manual PN 21 22 3000 Rev 07 ThisUserManualdescribesthefeaturesandoperationsoftheFORE SIGHTELITE TissueOximeter SoftwareVersion3 0orabove...

Page 2: ...mark owner with no intention of improperly using that trademark CASMED devices are patent protected in the United States see www casmed com site info patents cfm for more information Revision History...

Page 3: ...t burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines The Oximeter is designed for use in controlled environments only P...

Page 4: ...magnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Oximeter is used exceeds the applicabl...

Page 5: ...ITE Oximeter bears the CE mark CE 0086 indicating conformity with the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfills the essential requirements of Annex I of thi...

Page 6: ...warn of conditions that put the patient or caregiver at risk Caution Directions that help to avoid Oximeter damage or data loss Note Directions that make it easier to use the Oximeter which may not be...

Page 7: ...essing On Screen Help 6 Installing the Oximeter 7 Initial Inspection 7 Installation Considerations 8 Electrical Connections 8 Electromagnetic Interference 8 Physical Placement 9 Mounting Solutions 9 P...

Page 8: ...e Oximeter Display 29 Reading the Channel Display 30 Monitoring TPI 31 Reading the Trace Display 32 Changing the Trace Display Mode 32 Capturing the Oximeter Display 33 Starting a New Case 34 Respondi...

Page 9: ...e 57 Setting the Alarm Delay 58 Managing Patient Data 59 Collecting STS Data 59 Stopping STS Data Collection 59 Starting STS Data Collection 59 Viewing STS Data 60 Viewing Trend Data 60 Managing Patie...

Page 10: ...Menu Reference 69 Alarms and Messages 73 Event Index 79 Symbol Reference 81 Specifications 89 Parts 93 Warranty Policy 95 Index 99 x CAS Medical Systems Inc Contents...

Page 11: ...g Sensors Cerebral 26 Figure 17 Sensor Placement Non Cerebral 27 Figure 18 Connecting a Sensor to the Preamp Cable 28 Figure 19 Sensor connected to Channel 1 28 Figure 20 Oximeter Display Main Areas 2...

Page 12: ...Options 69 Table 15 Patient Menu Options 70 Table 16 Events Menu Options 70 Table 17 Data Menu Options 71 Table 18 Setup Menu Options 71 Table 19 Help Menu Options 72 Table 20 Oximeter System Messages...

Page 13: ...eserves the right to make changes to this manual and improvements to the product it describes at any time without notice or obligation This manual has a revision number in the page footer that indicat...

Page 14: ...indicated for use on adults and transitional adolescents 40 kg 88 2 lbs When used with Medium Sensors the FORE SIGHT ELITE Oximeter is indicated for use on pediatric subjects 3 kg 6 6 lbs When used w...

Page 15: ...d Environment The Oximeter is intended to be used in the following environments operating exam procedure rooms surgical recovery critical care emergency room and long term care Likely Misuse Warning T...

Page 16: ...thetic mixture with air or with oxygen or nitrous oxide Note The Oximeter can remain connected to the patient during cardiac defibrillation All applied parts are Type BF Defibrillation Proof Patient E...

Page 17: ...ED authorized service technician before it is used again Parts and Warranty CAS Medical Systems Inc CASMED is responsible for the effects on safety reliability and performance of the product only if A...

Page 18: ...ound treatment of WEEE information will be made available for current CASMED products upon request EU distributors and treatment facility personnel may contact techsrv casmed com to obtain relevant in...

Page 19: ...ths through the scalp and skull and into the brain via a disposable Sensor on the patient s forehead Reflected light is captured by detectors positioned on the Sensor for optimal signal collection Aft...

Page 20: ...ew Caution The USB ports must only be connected to a USB Flash Drive Do not connect any other type of device or cable to the USB ports Alarm Indicator page 35 Display Touchscreen page 29 Front USB por...

Page 21: ...ot required the null modem adapter may be removed To remove the null modem adapter unscrew the jackscrews projecting from the DCE adapter Be careful not to unscrew the jackscrews associated with the m...

Page 22: ...air intake vents and exhaust vents on the right side of the Oximeter clear of obstructions to allow for proper cooling Air Intake Vents Preamp connections page 13 Preamp Cable Guides page 13 4 CAS Me...

Page 23: ...on Pressing on the Oximeter display with a sharp or pointed instrument may permanently damage the touchscreen membrane Use your finger only Channel Status page 30 Trace Display page 32 Event Area page...

Page 24: ...ays a matrix of appropriate Sensor size by patient weight Monitoring Displays a list of tasks to complete before monitoring begins Apply Displays instructions on selecting a Sensor site and applying a...

Page 25: ...meter and account for each item FORE SIGHT ELITE Absolute Tissue Oximeter FORE SIGHT ELITE Battery The Battery packaging includes installation instructions or see Installing the Battery on page 66 FOR...

Page 26: ...ed biomedical engineering personnel must perform a test for leakage current before using the Oximeter with patients Serious injury or death could result if the leakage current exceeds applicable stand...

Page 27: ...ent entanglement or strangulation Avoid placing the Oximeter where a patient could access the controls Caution Avoid placing either side of the Oximeter against objects that could restrict air flow th...

Page 28: ...meter 2 Position the Battery near the Battery Compartment with the arrow on the outside cover pointing up Figure 6 Figure 6 Battery Compartment 3 Gently slide the Battery into the Battery Compartment...

Page 29: ...ll power on with the Battery installed 6 Reconnect the AC power cord to the Oximeter Caution To maintain proper battery charge plug the Oximeter into main power when not in use Failure to do so may di...

Page 30: ...n When not connected to AC power the Oximeter may not turn on if the battery charge is less than 60 Connect AC power to turn on the Oximeter Table 2 Battery Status Indicators Icon Status Charge Chargi...

Page 31: ...the Oximeter on page 64 Preamp cables should be replaced when they no longer properly functioning Keep track of cable installation date and usage See Appendix F Table 32 on page 93 for reorder inform...

Page 32: ...Attaching the Preamp Cable Figure 11 Disconnecting the Preamp Cable Plug Guide Cable Guide Side view of Plug Guide from rear of Oximeter 14 CAS Medical Systems Inc Installing the Oximeter Testing the...

Page 33: ...O2 Alarm Limits on page 45 for instructions on changing alarm limits 3 Reset the High Alarm limits to the desired level 4 Set the Low Alarm limits to at least 1 more than the current displayed value a...

Page 34: ...of port A when looking at the back of the Oximeter shown in Figure 14 that may be used to interface with other medical equipment see Table 4 on page 19 Contact your CASMED representative for addition...

Page 35: ...the male DTE port The adapter may be reinstalled on a male port by reversing this procedure Configuring Serial Ports Serial ports A and B may be configured independently as follows 1 From the Main Men...

Page 36: ...see the FORE SIGHT ELITE EMR Protocol User Guide CAS P N 21 03 0368 7 Touch to save changes and close the Ports screen or touch to cancel Saving changes will automatically power off and restart the Ox...

Page 37: ...MS AIMS Dr ger Innovian Anesthesia PDMS Excel Medical Electronics BedMaster iMDsoft MetaVision Maquet JOCAP XL DMS Nihon Kohden CAP 2500 Philips CompuRecord Sorin DMS Spectrum Medical Viper DMS Terumo...

Page 38: ...edec View MainCare Blocqual Cora Crossway Marand Ispek McKesson Horizon Cardiology Paragon Medasys DxCare Meditech Magic Client Server Meierhofer ISOP ANA plus Mindray Panorama Nexus GMT Medfolio Niho...

Page 39: ...imeter is in the appropriate monitoring Mode Adult or Pediatric page 22 4 Attach Sensors to the patient page 23 5 Connect Preamp cables to the Sensors page 28 6 If necessary start a new patient case I...

Page 40: ...ts default Normal for Adult or Fast for Pediatric Selecting the StO2 Averaging Mode The Oximeter measures StO2 constantly and updates the display every 2 seconds with the average of multiple consecuti...

Page 41: ...be able to rest flush with clean dry skin Any debris lotion oil powder perspiration or hair that prevents good contact between the Sensor and the skin will affect the validity of the data collected a...

Page 42: ...lert If this is the only sensor connected the Oximeter will prompt you to select a different body location or use a different sensor size Touch to dismiss the prompt Warnings Use only CASMED supplied...

Page 43: ...ow the skin to dry completely before applying the Sensors Applying Sensors 1 Select the appropriate Sensor see Table 5 on page 24 and remove it from the package 2 Remove and discard the protective lin...

Page 44: ...ffects of vascular obstruction in a limb place a Sensor on both the limb of concern and in the same location on the opposing limb Warnings Exercise extreme care when applying Sensors Sensor circuits a...

Page 45: ...Figure 17 Sensor Placement Non Cerebral adult pediatric neonatal Non Adhesive Small Sensor PN 21 22 3000 Rev 07 27 FORE SIGHT ELITE User Manual...

Page 46: ...or place the Oximeter or accessories in any position that might present a risk that the Oximeter may fall on the patient bystander or operator 3 Position the Sensor connector in front of the Preamp Se...

Page 47: ...n Areas Caution Pressing on the Oximeter display with a sharp or pointed instrument may permanently damage the touchscreen membrane Use your finger only Event Area page 47 Channel Status page 30 Syste...

Page 48: ...l to set the limits see Configuring StO2 Alarm Limits on page 45 Channel High Low Alarm Limits Displays the upper and lower StO2 limits outside which an alarm will sound Touch the numbers to change th...

Page 49: ...bars No Sensor or Preamp connected or Sensor and Preamps connected but Sensor off patient POOR one White bar three Gray bars Indicates that the Sensor should be moved as monitoring will soon stop Aft...

Page 50: ...and or and the lower portion shows and or Changing the Trace Display Mode You can toggle the display for each channel pair to show the trace display in separate areas or overlapping each other For 2 c...

Page 51: ...Oximeter display 1 Insert a CASMED approved USB flash drive into one of the two USB ports you may use either the front or rear USB port though only one may be active at a time 2 Verify that the USB ic...

Page 52: ...not read Sensor data properly after starting a new patient the message Verify Sensors are properly applied to the patient may be displayed Confirm that Sensors are properly adhered to the patient and...

Page 53: ...ppendix B Alarms and Messages on page 73 for a complete list of alarms and messages and recommended actions should they occur Warning Avoid placing anything in front of the Oximeter that might cause t...

Page 54: ...anually or change the timer interval on a per patient basis 1 From the Main Menu touch Patient and then touch Skin Check Note If you do not see Skin Check on the Patient menu it has been disabled It c...

Page 55: ...terference Warnings Measurements may be affected in the presence of strong electromagnetic sources such as electro surgery equipment and measurements may be inaccurate during use of such equipment Ele...

Page 56: ...Medium Co oximetry of internal jugular vein and arterial blood samples Co oximetry of central venous and arterial blood samples Single Point 3 kg Pediatric Adolescents Children Infants Neonates Small...

Page 57: ...able Optionally you can disconnect the Preamp cable from the Oximeter see Disconnecting the Preamp Cables on page 15 but most medical personnel prefer to keep the cable connected to the machine Discon...

Page 58: ...40 CAS Medical Systems Inc Monitoring Essentials Disconnecting Sensors After Monitoring...

Page 59: ...side of the display above the Trace area It is also used to identify patient data files in addition to the file date see Managing Patient Data Files on page 61 1 Touch the upper left corner of the dis...

Page 60: ...ontal color coded dotted line across each channel s trace touch a channel s Reference value circled below to toggle the display Toggling the Trace Display between individual and overlay modes page 32...

Page 61: ...of the following methods From the Channel Status area touch the StO2 reading body location icon e g or or High Low limit indicator e g From the Main Menu touch Patient and then touch Setup Figure 27...

Page 62: ...igure 29 describe the Sensor location options for each Patient Mode Figure 28 Sensor Location Setup Screen Adult Mode Figure 29 Sensor Location Setup Screen Pediatric Mode 4 Touch to save your changes...

Page 63: ...ineffective To change an StO2 alarm limit 1 Access the Patient Setup screen by touching a numeric or location icon in the Channel Status area You can also from the Main Menu touch Patient and then to...

Page 64: ...h Events 2 Touch to display a list of OR CCU PICU or Custom events touch Next Page to access the Vascular list Events are listed alphabetically and are color coded as shown in Table 11 See Appendix C...

Page 65: ...area as do others that you may place afterward Touch anywhere in the Event area to place the cursor dashed green line there and display the Event Navigator touching close to an event marker will posit...

Page 66: ...e increment scales accordingly Moves the cursor to the next event in either direction These buttons are disabled if there are no events visible in the current Trace view change the Trace View scale pa...

Page 67: ...age 51 To create a custom event from the Oximeter 1 From the Main Menu touch Events 2 Touch Next Page 3 Touch Custom The Custom Setup screen appears If this is the first time you have added custom eve...

Page 68: ...d events Editing Custom Events To edit a custom event name from the Oximeter 1 From the Main Menu touch Events 2 Touch Next Page 3 Touch Custom 4 Touch the event you wish to edit 5 Touch to acknowledg...

Page 69: ...reate a plain text file named events txt in either UNICODE or ASCII format and type one event per line Only the first 40 events will be imported Event names longer than 16 characters will be truncated...

Page 70: ...display the View settings You may also from the Main Menu touch Setup and then touch View Options range from 15 minutes to 24 hours 2 Touch the desired time scale to set it or touch to cancel Changin...

Page 71: ...that the language setting will not be affected 1 From the Main Menu touch Setup 2 Touch Log In to display the Password keyboard 3 Enter the password 2466 and touch to access the Biomed submenu 4 Touc...

Page 72: ...attery power 1 Touch the current time date at the top of the display to display the Time Date settings You may also from the Main Menu by touch Setup and then touch Time Date Each component month day...

Page 73: ...yboard 3 Enter the password 2466 and touch to access the Biomed submenu 4 Touch Skin Check 5 Touch a new Skin Check interval to select it and reset the timer touch Disable to disable the timer or touc...

Page 74: ...nded averaging menu 1 From the Main Menu touch Setup 2 Touch Log In to display the Password keyboard 3 Enter the password 2466 and touch to access the Biomed submenu 4 Touch Averaging 5 Touch Enable t...

Page 75: ...lenced icon disappears and audible alarms are re enabled You can also re enable alarms by touching Silence again Setting the System Volume To adjust the system volume 1 From the Main Menu touch Setup...

Page 76: ...d delay An alarm delay may be set that requires an active alarm condition for some period of time before the alarm sounds Using the Low StO2 example above if the alarm delay were set to 10 seconds the...

Page 77: ...stop and resume STS data collection at any time Also data is collected only for channels that are connected at the time data collection is started to add or remove channels you must stop and then res...

Page 78: ...mmarizes current data Fields are blank for channels not being monitored 2 Touch to dismiss the STS Data screen Viewing Trend Data You can display StO2 levels for the current patient in tabular form to...

Page 79: ...e active at a time A maximum of 20 cases over the past 28 days are available in the Files menu for saving The oldest cases are removed as new cases are added if either threshold is reached 2 Verify th...

Page 80: ...in memory The Patient ID column displays the patient name or patient identifier if entered 2 Touch one or more files to select them 3 Touch Delete The Oximeter prompts you to confirm the deletion 4 To...

Page 81: ...tient and the AC power cord disconnected There is a risk of serious injury or death if this procedure is not followed The operator must not perform any servicing on the Oximeter except as specifically...

Page 82: ...vice technician before it is used again Cautions Do not open the Oximeter to clean it Do not attempt to sterilize gas sterilize or autoclave the Oximeter or accessories Do not use abrasive cleaners is...

Page 83: ...charged battery without an external power source As with all batteries its capacity will diminish over time It is recommended that properly maintained batteries be replaced every 2 years replacement b...

Page 84: ...wards the top of the pack 4 Using equal force on both sides of the Battery push it into the Battery compartment until the outside of the Battery is flush with the rear of the Oximeter 5 Hand tighten t...

Page 85: ...AC power fuses 1 Turn the Oximeter off disconnect the AC power cord and remove the Battery as described on page 65 2 Insert a small flat screwdriver under the edge of the AC fuse cover indicated by t...

Page 86: ...gh Limit 90 Low Limit 50 Trace View scale 30 minutes Language English Brightness 100 Volume 100 Serial Port A Serial Port B Protocol None Baud Rate 115200 Alarm Limit Delay 0 seconds immediate Patient...

Page 87: ...Events Lets you select specific events that can occur during a monitoring session and mark that spot on the patient s trace record Table 16 on page 70 Data Lets you collect patient monitoring data Ta...

Page 88: ...Averaging mode page 22 Events Menu Table 16 Events Menu Options Button Description Page Events Menu Page 1 Home Displays the Main Menu View Displays the Event Log for the current case page48 OR CCU P...

Page 89: ...2 values over a given time interval page 60 Files Menu Touching Files displays the Manage Patient Cases screen See Managing Patient Data Files on page 61 for more information Setup Menu Table 18 Setup...

Page 90: ...omed Submenu Page 2 Defaults Restores most system settings to their default values page 68 Sys Info Provides system information for troubleshooting and debugging Next Page Displays Page 1 of the Biome...

Page 91: ...ppendix B Alarms and Messages This Appendix describes the Oximeter Alarms and Messages System Messages page 74 Channel Messages page 76 Philips Patient Monitor Messages page 78 PN 21 22 3000 Rev 07 73...

Page 92: ...ed Plug Oximeter into AC outlet Max Internal Temp Unit is above maximum operating temperature Shut down Oximeter or unit will shut down automatically If condition persists contact CASMED technical sup...

Page 93: ...ion persists contact CASMED technical support Set Time Date Time Date not set Clock Battery not capable of retaining Time Date values Enter Setup screen and set correct Time Date see page 54 If condit...

Page 94: ...rdingly Low StO2 Reading is below user selected Low alarm limit Assess the patient and physiologic Oximeter to verify the condition and then respond accordingly Medium Priority Alarms Black on Yellow...

Page 95: ...or is connected to the channel No action required simulated data generated Unstable Signal Interference from outside source Move Sensor away from interfering source Informational Alarms White on Black...

Page 96: ...1 Low StO2 Low rSO2 1 System Error E Max Internal Temp Check Battery Depleted Battery Low Battery High Internal Temp FS Sys Warning Faulty Preamp2 Faulty Sensor FS Error1 Preamp Disconnected Sensor Di...

Page 97: ...s CCU Events PICU Events Vascular Events Note Event markers for Pediatric Mode are in the PICU list Events in each group are listed alphabetically and are color coded as follows Cell Shading Definitio...

Page 98: ...alloon Deflated Venous Return Down Dialysis CRRT Afterload Reduction Balloon Inflated Afterload Reduction Diuretic Airway Suctioned BiVAD On Off Antegrade SCP ON ECLS Off Anti Arrhythmic Blood Transfu...

Page 99: ...On Off Caution Left Side Patient connections are Type BF Warning yellow background Channel numbers Rear Caution Potential Equalization Post Grounding Terminal Manufacturer and Date of Manufacture The...

Page 100: ...ble 25 Symbols on the Oximeter Display Symbol Description STS Data Collection STS data is being collected STS data is not being collected Patient Mode The Oximeter is in Adult Mode The Oximeter is in...

Page 101: ...eps or brachioradialis Right Shoulder deltoid Right Arm biceps or brachioradialis Left Flank Abdomen latissimus dorsi or external oblique Central Abdomen Right Flank Abdomen latissimus dorsi or extern...

Page 102: ...r White bars Ideal monitoring state For subjects that become hemodiluted e g initiation of CPB the TPI may decrease this change in level is understandable without need to assess the Sensor site Batter...

Page 103: ...p to previous event Skip to next event disabled if there are no visible events Delete current event Delete current event disabled if no event is selected Close the Event Navigator Battery Table 26 Sym...

Page 104: ...This end up Preamp Table 28 Symbols on the Preamp Symbol Description The CE Mark and Notified Body Registration Number signify the device has met all essential requirements of European Medical Device...

Page 105: ...ures Assess the Sensor site at least every 12 hours or more often as required by the institution s protocol Latex free PVC free Use only once Non Sterile Do not apply prolonged pressure to the Sensor...

Page 106: ...88 CAS Medical Systems Inc Symbol Reference...

Page 107: ...ter from a storage location wait at least one hour prior to use to allow it to adjust to room temperature Measurement Method Modified Beer Lambert Law Near Infrared Spectroscopy NIRS Information outpu...

Page 108: ...t Parameter Low Default 50 High Default 90 Range Ch1 Ch2 Ch3 Ch 4 3 to 93 8 to 98 Notes A channel s Low limit cannot be set above its High limit A channel s High limit cannot be set lower than its Low...

Page 109: ...Operating Time 0 5 hour minimum with new and properly maintained battery Note The life of batteries is influenced by actual use temperature charging discharging cycles and mechanical abuse Serial Int...

Page 110: ...ITE Oximeter complies with the following requirements CE marking according to Directive 93 42 EEC IEC 60601 1 IEC 60601 1 2 IEC 60601 1 6 IEC 60601 1 8 CAN CSA C22 2 60601 1 ANSI AAMI ES60601 2005 92...

Page 111: ...try specific Accessories Detachable Parts and Materials Table 32 Oximeter Accessories Catalog No Description 01 02 0395 Replacement power cord North America 01 02 0384 Replacement power cord U K 01 02...

Page 112: ...a the web at www medicalphilips com or by email at medical philips com Table 33 Philips Accessories Philips Part Number Description 865114 104 Philips IntelliBridge EC 5 Module 865115 A01 101 Philips...

Page 113: ...amp patient cables One hundred eighty 180 days Single patient use products Out of box failure StO2 Sensors Out of box failure Damage to any part through misuse neglect or accident or by affixing any a...

Page 114: ...tient data prior to the return of the repaired unit CAS MEDICAL SYSTEMS INC SHALL NOT BE OTHERWISE LIABLE FOR ANY DAMAGES INCLUDING BUT NOT LIMITED TO INCIDENTAL DAMAGES CONSEQUENTIAL DAMAGES OR SPECI...

Page 115: ...d to misuse negligence or accident Monitor Warranty CASMED will be responsible for any electronic failures with this product for two 2 years CASMED reserves the right to repair the equipment at an aut...

Page 116: ...tient data prior to the return of the repaired unit CAS MEDICAL SYSTEMS INC SHALL NOT BE OTHERWISE LIABLE FOR ANY DAMAGES INCLUDING BUT NOT LIMITED TO INCIDENTAL DAMAGES CONSEQUENTIAL DAMAGES OR SPECI...

Page 117: ...feedback 57 brightness 52 channel settings 43 display settings 52 language 53 Sensor location 44 serial ports optional 17 StO2 alarm limits 45 reference level 42 system volume 57 time and date 54 trac...

Page 118: ...34 O operating environment 89 optional equipment second monitor 16 serial devices 16 USB device 16 options Philips IntelliBridge 94 OR events 80 Oximeter accessories 93 attaching Sensors 23 battery i...

Page 119: ...time and date 54 trace view scale 52 Setup menu 71 silencing alarms 35 Skin Check timer per patient 36 setting default 55 specifications 89 display 90 measurement 89 operating environment 89 patient...

Page 120: ...44 EAST INDUSTRIAL ROAD BRANFORD CT 06405 800 227 4414 WWW CASMED COM PN 21 22 3000 Rev 07...

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