Home
        FORE-SIGHT ® MC-2000 Series Cerebral Oximeter User Manual
         Contents
1.       Place     Place the Event mark on the trace  see Placing an  Event Mark on the Patient Record  page 60     Delete     Delete the Event Mark from the Menu list  CANCEL     Exit Event Mark menu    21 02 0217 Rev 08 03 09 Page 61    Basic Operations FORE SIGHT MC 2000 Series Monitor    Event Action       What would you like to do with the event  Y    PLACE   PERETE   CANCEL         Figure 33  Event Action  Undo the Last Event Mark    To undo the last Event Mark placed in the Patient Record   1 Turn the rotary control knob to select the Event menu   2 Press the rotary control knob to open the Event menu   3 Turn the rotary control knob to select the Undo last event   4 Press the rotary control knob and the last event placed shall  be removed from the Patient Record    Note  Only the Last Event entered can be undone  The Undo last  event selection will be unavailable once the last Event is undone     Switching between Active and Historical Mode    You can switch the current display between the active mode   showing data in real time  and the historical mode  showing data  previously captured during the current session      Note  When you are in the historical mode  data continues to be  collected and saved to memory  No data is lost and you can switch  back to active mode at any time     To switch between modes  turn the rotary control knob to highlight  the active  historical mode selection button at the upper right of  the screen  see Figure 5  page 32  and press the rotar
2.     uc 7 Warning  Conductive Connections     Extreme care must be exer   cised when applying medical electrical equipment  Many parts of  the human   machine circuit are conductive  such as the patient   connectors  electrodes  and transducers  It is very important that  these conductive parts do not come into contact with other  grounded  conductive parts when connected to the isolated patient  input of the device  Such contact would bridge the patient s isola   tion and cancel the protection provided by the isolated input  In  particular  there must be no contact of the neutral electrode and  ground     17 Caution  Service performed by unauthorized personnel could be  damaging to the monitor and may void the warranty  Internal Bat   teries are intended to be replaced by authorized personnel only   For service  contact your CAS Representative     w 7 Caution  Inspect the cables and sensors for damage prior to op   eration  If any damage is noted  the cables or sensor should not be  used until it has been serviced or replaced     on Caution  Do not kink or bend cables     Maintenance Intervals    Preventive maintenance of the monitor is an important function  that should be performed routinely to ensure safe and efficient  monitor operation  The following maintenance intervals are rec   ommended     e Monitor  No user calibration is required   e Batteries  Should be replaced every 2 years     Note  To maintain proper battery charge  plug the FORE SIGHT  cerebral oximeter into
3.    Exceptions    21 02 0217 Rev 08 03 09    The FORE SIGHT MC 2000 Series Monitor 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 this directive     None    Page T    FORE SIGHT MC 2000 Series Monitor    General Information    This manual is an integral part of the product and describes its in   tended use  Compliance with the manual is a prerequisite for  proper product performance and correct operation and ensures  patient and operator safety        The symbol means ATTENTION  Consult accompanying docu   ments     JENIS Indicates protection  BF  of the applied part against the effects of  RK electrical shock     CLASS 1 LASER l l  PRODUCT Indicates unit contains a Class 1 Laser Product    The warranty does not cover damages resulting from the use of  accessories and consumables from other manufacturers     CAS Medical Systems  Inc   is responsible for the effects on  safety  reliability  and performance of the product only if     e Assembly  operations  extensions  readjustments  modifica   tions  or repairs are carried out by persons authorized by CAS  Medical Systems  Inc     e The electrical installation of the relevant room complies with the  requirements of the appropriate regulations     e The device is used in accordance with the instructions for use     e All publications conform to the product specifications and appli   cable IE
4.    Right key          rrrnrrrrarernrennnnennre 48  Figure 21  SctO   Limits dialog           rrrarrrnrrrrnneranrrnnnnranennnnnnnnrnnnnnnnne 49  Figure 22  Preferences dialog                ccccccccseccceseeeeeeceeeeeseeeeeesaees 50  Figure 23  Brightness ialOg                cccccsecceseceeecseeceeeceeeeueeeeeeaeees 51  Figure 24  Auto Dim dialog            annannannannannenonnnnnnnnnnnnnnnnnnnnnnnnnnnnne 52  Figure 25  Languages dialog            ranrnnrrnnnrnnnrnnnnnnnnnnrnnnrnnnrnnnrnannnnnen 52  Foure 263  FORMS dialaan eateries desea ietsiceteeee es 53  Figure 27  Date  amp  Time dialog               ccccccccseccceeeeeeeeceeeseeeeeeesaees 57  Figure 28  Positioning Event CUrSor           rrananannnnnnnnnnnnrnnnrvnnrnnnennnrr 59  Figure 29  Add Event Mark to Menu          rarrnnrnnnrrnnrnnrrnnrrnnnrnnnrnnnnn 60  Figure 30  Vertical Position of Event Mark          rrrrnnrrnnnnnnrnnnrvnnnennn 60    Figure 31   Figure 32   Figure 33   Figure 34   Figure 35     Horizontal Position of Event Mark        rrrrnnrnnnroranennnnrr  61  Final Position of Event Mark                 cccccccseeeeeeeeeeeees 61  EVEN AO NR 62  Start FS Data Collection popup dialog                      6 70  Stop FS Data Collection popup dialog                     06 71    21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor    Figure 36 a  FS Data Review    dialog         rrrerernrrrnnrrrnrrvrarernnrnnnre 71  Figure 37  Save to USB    dialog          rrrrnrrrnnrrvvnnnrnnnnvrnnnrnvnnrnvnnnnnn 73  F
5.    e Power on the FORE SIGHT Monitor by pressing the On Standby  button on the front of the Monitor    Refer to page 94 for explanations of the Printer Icon displayed in the   upper right corner of the Main screen     Continuous Tabular Print    When the Continuous Tabular Print selection is enabled  the monitor  will continuously transmit Left  Right and Average  SctO gt    values  every 20 seconds along with a timestamp  Hour Minute Second      A header  consisting of the date and column identifiers  is printed at  the start of data and periodically every 20 lines  A sample printout of  real time numerics is shown below  see Figure 45  page 80      Note  Each time the Monitor is turned on and the Printer is connected  and on  the following FORE SIGHT logo is printed automatically on the  paper     21 02 0217 Rev 08 03 09 Page 79    Printer FORE SIGHT MC 2000 Series Monitor    FORE S GHT     A LASMED SOLUTION    2007 04 30 L R AVG  16 29 20 69 69 69  16 29 40 69 69 69  16 30 00 69 69 69  16 30 20 69 69 69  16 30 40 69 69 69  16 31 00 69 69 69  16 31 20 68 69 69  16 31 40 68 69 69  16 32 00 67 69 68  16 32 20 67 69 68  16 32 25 PROCEDURE  16 32 40 66  69 68  16 33 00 66  69 68  16 33 20 65  69 67  16 33 40 65  69 67  16 34 00 64  69 67  16 34 20 64  69 67  16 34 40 64  69 67  16 35 00 64  69 67  16 35 20 64  69 67  2007 04 30 L R AVG  16 35 40 64  69 67      Figure 45  Tabular Print Example    Note  An asterisk     after the L eft  or R ight  value indicates an alarm  conditi
6.   Left patient cable is disconnected   Check left patient cable connections       disconnect Clean fiber optic connections using CASMED   supplied cleaning tips  then reconnect left patient  cable  Replace left patient cable if necessary  L Invalid Sensor   An invalid sensor has been Unplug this sensor and plug in a valid sensor    plugged into the Left monitor Contact CAS Customer Service if this should be a  cable valid sensor for your unit    L Not calibrated   An sensor has been plugged into   Unplug this sensor and plug in a valid sensor    for probe type the Left monitor cable thathas   Contact CAS Customer Service if this should be a  no Calibration information valid sensor for your unit    R SctO gt  M cable   Right monitor cable is discon   disconnect    Check right monitor cable connections    Clean fiber optic connections using CASMED   supplied cleaning tips  then reconnect right moni   tor cable    Replace right monitor cable if necessary    R SctO   P cable   Right patient cable is discon  Check right patient cable connections    disconnect nected Clean fiber optic connections using CASMED   supplied cleaning tips  then reconnect right pa   tient cable    Replace right patient cable if necessary    R Invalid Sen  An invalid sensor has been Unplug this sensor and plug in a valid sensor    sor plugged into the Right monitor   Contact CAS Customer Service if this should be a  cable valid sensor for your unit    R Not calibrated   An sensor has been plugged into   U
7.   SctOz alarm will annunciate immediately      Setting the Alarm Delay to 10 Seconds will delay the annuncia   tion of a limit violation for 10 seconds   e g  If the Low Limit is  set to 50 and the  SctO   value falls below 50  and remains  continuously below 50 for 10 seconds  the Low  SctO   alarm  will annunciate  In this example the  SctO2 value must remain  less than the Low limit for 10 continuous seconds     Note  You can also access the SctO gt  Limits dialog by turning the  rotary control knob until the  SctO   display area is highlighted   bright blue background  and pressing the rotary control knob     Moving a Slider    To move a Slider to adjust a limit or to adjust speaker volume   1 Turn the rotary control knob to select the slider   2 Press the rotary control knob to activate the slider   3 Turn the rotary control knob left or right to adjust the level   4 Press the rotary control knob to set the selected level   5 Turn the rotary control knob to navigate away from the slider     Setting Miscellaneous Preferences    You can set preferences for horizontal and vertical grid lines on  the plot area or use of the standard or extended keyboard  see  page 36    To set miscellaneous display preferences    Turn the rotary control knob to select the Setup menu    Press the rotary control knob to open the Setup menu    Turn the rotary control knob to the right to select Preferences     Press the rotary control Knob a second time to open the Pref   erences dialog  Figure
8.  01 06 2010 FORE SIGHT MC 2010 Cerebral Oximeter with Backup Battery  Provided  2  FORE SIGHT Universal Monitor Cable with Pre amp  With   1  FORE SIGHT Abbreviated Biomedical Kit    1  FORE SIGHT Laminated Intervention Card w Velcro dots   1  FORE SIGHT CD User Manual   1  Hospital Grade AC Power Line   1  Cable Bundler   1  Service Card  amp  Sleeve    01 06 2020 FORE SIGHT MC 2020 Universal Cerebral Oximeter  Provided  2  FORE SIGHT Universal Monitor Cable with Pre amp  With   1  FORE SIGHT Abbreviated Biomedical Kit   1  FORE SIGHT Laminated Intervention Card w Velcro dots   1  FORE SIGHT CD User Manual   1  Hospital Grade AC Power Line   1  Cable Bundler   1  Service Card  amp  Sleeve    01 06 2030  FORE SIGHT MC 2030 Universal Cerebral Oximeter with Backup Battery  Provided  2  FORE SIGHT Universal Monitor Cable with Pre amp  With   1  FORE SIGHT Abbreviated Biomedical Kit    1  FORE SIGHT Laminated Intervention Card w Velcro dots   1  FORE SIGHT CD User Manual   1  Hospital Grade AC Power Line   1  Cable Bundler   1  Service Card  amp  Sleeve    Re order No   01 06 0005  FORE SIGHT Universal Monitor Cable with Pre amp  01 06 0021  FORE SIGHT Single Sensor Kit   Carton  Small  5 kits carton  01 06 0022  FORE SIGHT Dual Sensor Kit   Carton  Small  5 kits carton  01 06 0017 FORE SIGHT Single Sensor Kit   Carton  Large  5 kits carton  01 06 0018  FORE SIGHT Dual Sensor Kit   Carton  Large  5 kits carton  01 06 0035  FORE SIGHT Abbreviated Biomedical Kit     21 05 0173 FORE
9.  22 below      Make any desired changes     6 Select the DONE button and press the rotary control knob to  save your changes  Select the CANCEL button to cancel your  changes     Preferences         Display vertical lines    KR ON        O1      Display horizontal lines      Use extended keyboard  wW Enable FS DATA collection reminders  DONE   CANCEL         Figure 22  Preferences dialog    Page 50 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Setting Display Brightness  You can adjust the monitor brightness to a comfortable level with  respect to ambient light   To set the display brightness   Turn the rotary control knob to select the Setup menu   Press the rotary control knob to open the Setup menu   Turn the rotary control knob to the right to select Brightness     Press the rotary control knob a second time to open the   Brightness dialog  Figure 23 below     5 Press the rotary control knob a third time to activate the  brightness slider    6 Turn the rotary control knob to the left to reduce brightness or  to the right to increase It    7 Press the rotary control Knob again to deactivate the bright    ness slider     8 Select the DONE button and press the rotary control knob to  save your changes  Select the CANCEL button to cancel your  changes     AR QN        Brightness       an  100        DONE   CANCEL      Figure 23  Brightness dialog       Setting Auto Dim    You can set the display to dim automatically after a specified pe   ri
10.  61000 4 2    Electrical fast tran   sient burst  IEC 61000 4 4    Surge  IEC 61000 4 5    Voltage dips  short  interruptions and  voltage variations on  power supply input  lines   IEC 61000 4 11    Power frequency   50 60 Hz  magnetic  field   IEC 61000 4 8    Level 3     2 kV for power supply  lines    1 kV for input output  lines     1 kV line s  to line s   mode    2 kV line s  to earth  mode    lt  5  Ur   gt  95  dip in  Ur  for 0 5 cycle    40  Ur  60  dip in Ur   for 5 cycles    70  Ur  30  dip in Ur   for 25 cycles     lt  5  Ur   gt  95  dip in  Ur  for 5s    Level 3     2 kV for power supply  lines    1 kV for input output  lines     0 5 kV line s  to line s   mode    2 kV line s  to earth  mode    lt  5  Ur   gt  95  dip in  Ur  for 0 5 cycle    40  Ur  60  dip in Ur   for 5 cycles    70  Ur  30  dip in Ur   for 25 cycles     lt  5  Ur   gt  95  dip in  U   for 5s    NOTE  Ur is the A C  mains voltage prior to application of the test level     21 02 0217 Rev 08 03 09    The FORE SIGHT MC 2000 Series  Monitor is designed for use in con   trolled environments only  Per OSHA  guidelines for operating rooms  the  area must employ adequate static  electricity controls  The relative hu   midity should be maintained at about  50      The FORE SIGHT MC 2000 Series  Monitor is designed for use in con   trolled environments only  Per OSHA  guidelines for operating rooms  the  Mains power quality should be that  of a typical commercial or hospital  environment     Mains pow
11.  Adapter  Model    TRC 09 1100 M from GROUP WEST  or equivalent  included with the  Printer     e Plug the battery charger s cord into the Printer battery charger jack   located on the rear panel     e Plug the charger into an AC wall outlet of the appropriate voltage   e Verify the Charge LED is lit red     Page 83    Printer FORE SIGHT MC 2000 Series Monitor    e Charge the battery a room temperature  5 35  C   41 95  F     Battery charge time is approximately 3 hours  Once the battery is fully  charged  the Charge LED switches to green     107 Caution  After completion of battery charging  Do Not try recharging   Battery performance may be deteriorated    Installing Paper    Note  A red line appears when the remaining supply of thermal paper  becomes low     e Switch the Printer off     e Press the Cover Open button to access the paper compartment   Remove any remaining paper before installing the new roll     e Place the new paper roll as shown on the illustration and pull out  enough paper to reach out over the control panel of the Printer   see Figure 52  page 84      e Close the paper door        Figure 52  Paper Installation    Note  Make sure that the paper is correctly placed  If it is tilted in one  or another direction and does not come out straight from under the  cover  open the door and reposition the roll again     yc 7 Warning  Do not touch the print head or paper cutter while replacing  the Printer paper     Removing the Battery Pack    w 7 Warning  Do not o
12.  Citizen CMP 10   SE UIR 9600 8 N 1 SETUF 19200 8 N 1   Simple comma text  None    DONE CANCEL         Figure 26 a  Ports dialog    21 02 0217 Rev 08 03 09 Page 53    Basic Operations FORE SIGHT MC 2000 Series Monitor    Port Setup       Baud rate   Data bits  6  Parity  None  stop bits  1    Flow control  None    DONE   CANCEL    Figure 26 b  Port Setup dialog    You can change the Setup for the Port settings  While in the Ports  dialog  to change the Setup for a serial port     1 Turn the rotary control knob to select the desired SETUP but   ton     2 Press the rotary control knob to open the Port Setup dialog   Figure 26 b  above      3 Turn the rotary control knob to highlight the Baud Rate Setup  selection        4 Press the rotary control knob and the focus will change to the  Baud Rate selection     5 Turn the rotary control knob to select the Baud Rate of the  Port  Baud Rate selections are   1200  2400  4800  9600  19200  38400  57600  or 115200   Note  The default Baud Rate selection to interface to the Philips  VueLink is 19200  When interfacing to a Philips VueLink System  the valid selections are 4800  9600 or 19200 baud     6 Press the rotary control knob and the focus shifts to the Setup  selections     7     Turn the rotary control knob to DONE button to save your se   lections or to the CANCEL button to cancel your changes     8 Press the rotary control knob to save or cancel your changes   Note  Configuring an unused Port to a non None selection may    resul
13.  Data Review    dialog       Additional information including Cumulative Saturation below 60   to 30   in 5  increments  as well as the Liner Time the Saturation  is below 60  to 30   in 5  increments  is displayed in the FS  Data Review dialog  The total number of minutes the left   right dif   ferential is  gt 10  and the average left   right differential is also  available for analysis in the FS Data review dialog     21 02 0217 Rev 08 03 09 Page 7 1    Basic Operations FORE SIGHT MC 2000 Series Monitor    In the event measured data is not available for the right or left sen   sor  the appropriate text box will display dashes  Refer to Figure 36  b below  Possible causes include     e No sensor attached  e Laser was not fired  e Data capture interrupted       Pre Induction Baseline Regional Oxygen Saturation    Left            2 Right   84 26    Cumulative Saturation Below Threshold    Left            minute   Right   134 634 minute 24    Skin Closure Regional Oxygen Saturation    Left              Right   pa    Figure 36 b  FS Data Review    dialog    Page 72 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor USB Operations    USB    Memory Sticks    The FORE SIGHT Series monitor is equipped with a USB port connec   tor on the front of the unit  Refer to Figure 2     The USB port connection is designed for use to save patient data from  a FORE SIGHT Series monitor to FORE SIGHT Series USB Memory  stick for review on an IBM compatible PC or MAC PC     Caution  Th
14.  Options on the View and Setup Menus    This section explains how to configure the options you can select  on the View and Setup menus  You can save these options as a  profile  see page 38  or you can make temporary changes during a  monitoring session  as needed     Selecting a View    The View menu  see page 34  lets you choose the time interval  spanned by the plot area     To choose a time interval   1 Turn the rotary control knob to select the View menu   2 Press the rotary control knob to open the View menu   3 Turn the rotary control knob to highlight the desired interval   4 Press the rotary control knob to select the interval     Setting Up SctO2 Alarm Limits and Speaker Volume    You can set the lower and upper limits of acceptable SctO gt  per   centages on the left and right sensors independently or in unison   You can turn off the lower and upper limits of the SctO2 percent   ages on the left and right sensors independently  When the limits  are turned off  no visual or audible alarms are generated  When  the monitor detects a level below the Low limit or above the High  limit  it sounds an alarm at the speaker volume you set  and  flashes a visible alarm on the screen  You can set a delay so that  transient conditions do not trigger alarms  You can also adjust the  left to right differential alarm setting to detect an increasing differ   ence in saturation between the right and left sensors  The default  differential alarm setting is 10  but this setting can be
15.  Priority Alarms    System Error   Internal component failure Contact CASMED customer service    HH   HHH Left or Right near infrared spec    For Error 02 018  Install the Battery fuse  See page    troscopy signal acquisition 90   module  NSAM  error       Note  Priorities of these Alarm Conditions are Factory configured  and cannot be altered by the user    Note  The alarm delay remains constant during any alarm condi   tion  The alarm delay may be altered by the User at any time and  only affect alarms yet to happen    A High Priority auditory signal is characterized by 10 beeps re   peated every 10 seconds at a frequency of 880 Hz    A Medium Priority auditory signal is characterized by 3 beeps  re   peated every 20 seconds at a frequency of 440 Hz     Page 68 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    The following table indicates the conversion of User Messages to  text displayed on the Philips IntelliVue    Note  Alarm messages from the monitor may appear different on   the Philips IntelliVue Patient Monitor due to text length limitations     Table 2  User messages on Philips IntelliVue    Call Service FS System Error  Internal Temp Error   Dead Battery   Battery supply inoperative   System memory full   Internal Temp Warning FS System Warning  Low Battery   Loss of AC Power   System memory nearly full   Set Clock   Clock Battery    L Ambient Light Warning FS L Chk Sensor  L Excessive Ambient Light FS L Amb Light    No Signal     Le
16.  SIGHT Laminated Common Intervention Card  01 06 0036  FORE SIGHT User Manual CD  Multi Language         Sensor Kits include  1  Alcohol prep   1  Light block  2  fiber optic cleaning  tips and one or two sensors  depending on kit       Abbreviated Biomedical Kit  10 Male Orange Fiber Optic Cleaning Tips  10  Male Clear Fiber Optic Cleaning Tips  and 1 can Fiber Connector Cleaner     21 02 0217 Rev 08 03 09 Page 103    Appendix FORE SIGHT MC 2000 Series Monitor    Other Accessories and Options    Catalog No  Description  01 02 0395 Replacement Power Cord  North America  01 02 0384 Replacement Power Cord  U K   01 02 0385 Replacement Power Cord  Australian  01 02 0386 Replacement Power Cord  European  01 06 0031  FORE SIGHT SctO  Simulator  01 06 0032  FORE SIGHT Biomedical Kit  50 Male Orange Fiber Optic Cleaning Tips  50  Male Clear Fiber Optic Cleaning Tips  and 1 can Fiber Connector Cleaner   01 06 0006  FORE SIGHT Laminated Quick Reference Guide   English  01 06 0034  FORE SIGHT USB Memory Drive  01 06 0231 Giraffe Dovetail Attachment  01 06 0232 3 inch Utility Basket for 01 06 0234  01 06 0235 or 01 06 0236 Arms  01 06 0233 6 inch Utility Basket for 01 06 0234  01 06 0235 or 01 06 0236 Arms  01 06 0234 FORE SIGHT 16 inch Arm Wall Mount  requires 01 06 0237 Adapter Plate   01 06 0235 FORE SIGHT 8 inch Arm Giraffe Bed Mount  requires 01 06 0231 Giraffe  Dovetail Attachment and 01 06 0237 Adapter Plate   01 06 0236  FORE SIGHT 16 inch Arm Pole Mount  requires 01 06 0237 Ada
17.  This manual  accessory direc   tions for use  all precautionary information  and specifications  should be read before use     107 Warning  Do not expose the FORE SIGHT MC 2000 Series Moni     tor to excessive moisture such as direct exposure to rain  Exces   sive moisture can cause the FORE SIGHT MC 2000 Series Moni   tor to perform inaccurately or fail     Page 18 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Safety    uc 7 Warning  Do not place containers containing liquids on or near the  FORE SIGHT MC 2000 Series Monitor  Liquids spilled on the  monitor may cause it to perform inaccurately or fail     uc 7 Warning  Patient Safety     If a sensor is damaged in any way  dis   continue use immediately     107 Warning  The FORE SIGHT MC 2000 Series Monitor is not     Category AP or APG Equipment        IF Warning  Explosion Hazard     Do not use the monitor in the pres   ence of a flammable anesthetic mixture with air or with oxygen or  nitrous oxide     uc   Warning  Electromagnetic Compatibility  EMC      The equipment  needs special precautions if it is placed close to a strong transmit   ter such as X ray equipment  MRI devices  TV  AM FM radios  po   lice fire stations  an amateur     ham     radio operator  an airport  or a  cellular phone  Their signals could interfere with the monitor  which  may result in disruption of performance of this device or prevent  the clear reception of signals by the monitor  This equipment has  been tested and found to co
18.  Universal Cerebral Oximeter  CAS MC 2030 Dual Channel Universal Cerebral Oximeter  with internal batteries option    Monitor Configuration Record       Monitor Model    CAS MC  20    Serial Number     Installed Options  a Batteries    21 02 0217 Rev 08 03 09 Page 99    Appendix FORE SIGHT MC 2000 Series Monitor    Specifications  SctO Measurement   Method  Modified Beer Lambert Law Near Infrared Spec   troscopy  NIRS    Information output  Absolute cerebral tissue oxygenation saturation   SctO gt     Measurement range  0 to 100    Accuracy  40   100     4  to 1 standard deviation  0 39   unspecified   Display resolution  1    Data rates  Acquisition  lt  100 Hz  numeric display    5 Hz    Laser Information    EQUIPMENT MANUFACTURE INFORMATION   DATA SHEET    ABOUT THE COMPONENT CONTAINING LASER    Type designation BM4 690 779 808 850 10SM  4 Color Beam Combiner with Power Monitor    Max Output Power       Patient Alarms    Adjustable alarms  High and low alarms for left  right and differential  SctO    Alarm indicators  e Left  amp  Right Visual  e Audible    e Text in alarm message window  Audible sound pressure High Priority Alarms   100  Volume 58db  Fast A    1m directly in front of monitor    Medium Priority Alarms    lt 54db  Fast A    1m directly in front of monitor    Differential SctO      Each patient parameter may also be selected    OFF    individually   Low limits cannot be set above the associated high limit   High limits cannot be set lower than the associated
19.  and Indicators           Charge LED  red   charging  green   fully charged     Power LED  green   power on  red green blinking fast   end of  paper  red green blinking slow   print head overheated     RS232 serial interface   Power ON OFF button   Line Feed button   Paper Cover Release Button  press down to open cover   Paper Cutting Edge   Paper Cover         EE a    Printer Operation    The Printer cable connects to a DB9 connector  located on the rear  panel of the Monitor  Use the cable  supplied with the Printer  to inter   face to the Monitor on the Printer     To operate the Printer perform the following steps     e Configure the monitor for Continuous Tabular Printing under the  Patient Print menu     Check the Continuous Tabular Print selection to enable trans   mission of  SctO gt  values every 20 seconds     Un check the Continuous Tabular Print selection to enable user  initiated printing    e Connect the Printer to the FORE SIGHT Monitor with the cable  provide with the Printer to the connection  see Figure 3  page 29      Page 78 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Printer  Ei    Print type Print length  C Graphic fr Screen    w Tabular t Full case    Time scale    W Continuous Tabular Print    PRINT   CANCEL   DONE         Figure 44  Patient  gt  Print Menu dialog    Note  Connect the Printer to an AC power supply if charging of the   Printer battery is required    e Power on the Printer by pressing power ON OFF button on the  Printer 
20.  and try another  If condition continues  contact the appropriate service personnel     Memory stick open file error Remove USB memory stick and try another  If condition continues  contact the appropriate service personnel     Unknown USB error Remove USB memory stick and try another  If condition continues  contact the appropriate service personnel     21 02 0217 Rev 08 03 09 Page  5    USB Operations FORE SIGHT MC 2000 Series Monitor    Save to USE       File Name   2007 07 30 1D 01 65     Save rate U    2 Seconds         save rate other than   seconds may result in some alarms and    event marks not to be saved in the file saved on the USB  memory stick      File exists     cannot overwrite    DOMNE CANCEL      Figure 41  USB Status message display       Screen Snapshots    Insert the USB memory stick into the USB port connection on the front  of the FORE SIGHT monitor  Refer to the previous section  Saving  Patient Data for additional details     To enable saving a Screen Snapshot to the USB memory stick  select  Snapshot to USB    under the Patient menu  refer to Figure 6     The FORE SIGHT Series monitor shall generate a unique default file   name  The file saved will be 256 color Bitmap type   bmp   To change  this file name  select EDIT and then alter the filename  see Entering  Text  page 35      To enable saving a Screen Snapshot to the USB memory stick  select  DONE  Refer to Figure 42     Snapshot to USB       File Mame   2007 07 30 10 01  BMP      Select Done wi
21.  changed us   ing the slider bar from a minimum of 1 to a maximum of 50     To set up SctO2 alarm limits and speaker volume   1 Turn the rotary control Knob to select the Setup menu   2 Press the rotary control knob to open the Setup menu     3 Press the rotary control Knob a second time to open the  SctO   Limits dialog  see Figure 21  page 49      4 Make any desired changes     5 Select the DONE button and press the rotary control knob to  save your changes  Select the CANCEL button to cancel your  changes     Page 48 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Left limit   Off Right limit   Off    Limits    High   kW Right limits equal left  Yolume     Alarm Delay    OSeconds    10 Seconds    Left Right Alarm Differential    HELF   DONE   CANCEL      Figure 21  SctO gt    Limits dialog       Use the rotary control knob to move the cursor  highlight  around  the dialog box  Press the rotary control knob to check or clear an  item     Clear the    Right limits equal left    checkbox to adjust the left and  right limits independently  Check the box to adjust the left and right  limits in unison     7 Caution  Setting the High SctO2 Alarm limit to the extreme high  value  98  can render the High Limit detection ineffective     uc  7 Caution  Setting the Low SctO gt  Alarm limit to the extreme low  value  2  can render the Low Limit detection ineffective     Note  For proper identification of the Alarm signals generated by  the unit  the ope
22.  disconnect the power cord   e Locate the Battery Fuse on the rear panel  see Figure 3 page  25    e Using a screwdriver  gently press in and turn the locking tab  counterclockwise to release  see Figure 56a below    e Gently slide the fuse holder tray out of the receptacle as far as it  will go   Note  The fuse holder tray is designed not to be removed from the    fuse holder  Do not attempt to pull the fuse holder tray out of the fuse  holder or permanent damage to the fuse holder may occur     e Remove the fuse completely from the fuse holder tray  see  Figure 56b below    e Place a new fuse directly into the fuse holder tray  see Figure 56c  below     e Rotate and align the fuse holder tray so that the fuse lies on top  of the fuse holder    e Gently slide the fuse holder tray back into the receptacle    e Using a screwdriver  gently press in and turn the locking tab  clockwise to secure    e Reconnect the power cord back to the monitor    pr Caution  For continued protection against fire hazard  replace only   with identically rated fuses  see Power section  page 101     Note  Do not apply excessive force when removing or installing the   fuse holder tray into the receptacle    Note  When the battery fuse is re installed  the monitor may auto    matically turn    ON           Figure 56  Battery Fuse Placement    21 02 0217 Rev 08 03 09 Page 91    Maintenance FORE SIGHT MC 2000 Series Monitor    This page is intentionally left blank    Page 92 21 02 0217 Rev 08 03 09    A
23.  ground or to a high volt   age power source which can cause serious injury or death to the  patient     yc 7 Warning  As with all medical equipment  carefully route and se   cure all patient cables to reduce the possibility of patient entan   glement or strangulation     my   Warning  Always remove sensors from the patient and completely  disconnect the patient from the FORE SIGHT MC 2000 Series  Monitor before bathing the patient     w 7 Warning  The SctO  sensor site must be inspected at least every  eight hours  to ensure adequate adhesion  circulation  skin integ   rity  and correct optical alignment  If the circulatory condition or  skin integrity has deteriorated  the sensor should be applied to a  different site     uc Warning  Interfering substances  Carboxyhemoglobin may erro   neously increase SctO   readings  The level of increase is ap   proximately equal to the amount of carboxyhemoglobin present   Dyes or any substance containing dyes that change usual blood  pigmentation may cause erroneous readings     Page 22 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Safety    1   Warning  Sensors are not sterile and therefore should not be ap   plied to sites with compromised skin integrity  Exercise caution  when applying sensors to a site with compromised skin integrity   Applying tape or pressure to such a site may reduce circulation  and or cause further skin deterioration     w 7 Warning  For patients experiencing complete bilateral ECA occlu     sio
24.  it to the monitor cable  Do  not kink or bend cables     The connector end of the patient cable has two parts  The fiber  optic connector has a  non black  colored plastic overmold and a  protective rubber cap     Note  Remove the rubber cap from the fiber optic connector and  discard before attempting to connect the patient cable to the moni   tor cable  If you do not remove this tip  you will not be able to con   nect into the receptacle on the monitor cable     Connecting the Patient Cables    To connect the patient cables to the monitor cables    1 Remove the left patient cable from the packaging  see Figure  17a  page 43     2 Remove and discard the protective cap that covers the fiber  optic connector  being careful not to touch the fiber optic tip  with your fingers  see Figure 17b  page 43     3 Open the door on the monitor cable connector  preamplifier    see Figure 17c  page 43     4 Using the Clear Male Fiber Optic Cleaning Tip found in the  sensor packaging  clean the fiber optic connector on the  monitor  preamplifier  cable end by inserting gently into the fi   ber optic receptacle and rotating clockwise 360 degrees  see  Figure 17d  page 43      Page 42 21 02 0217 Rev 08 03 09       FORE SIGHT MC 2000 Series Monitor Basic Operations    5 Using the Clear Female Fiber Optic Cleaning Tip found in the  sensor packaging  clean the fiber optic connector on the pa   tient cable by gently making contact with the connector and  rotating clockwise 360 degrees  see Figur
25.  low limit     There is a minimum of 5  difference between the Low and High limit  values at any time                   Page 100 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Appendix    Display    Display  LCD display of measurement results  instruc   tions  troubleshooting messages  wave   forms  and signal strength bar     Numerics  SctO    from left  right or average of left and  right channels    Trace  1 corresponding to associated SctO gt    nu   meric value   Views  15 or 30 min  1  2  3  4  8 or 24 hr   Events  May be placed anywhere on trace area     Physical Dimensions and Weight    H x W x D   without feet   8in  x 8in  x 13 in    20 3 cm x 20 3 cm x 33 0 cm  Weight  MC 2000 or 2020   16 0 Ibs  7 3 kg   Weight  MC 2010 or 2030   21 9 Ibs  9 9 kg     Operating Environment    Operating temperature  10   40  C  50   104 F    Humidity  30 75  RH  non condensing   Altitude  10 000 to    1 000 ft  680 to 1060 hPa   Monitors may not meet performance specifications if stored or used out   side temperature and humidity ranges  When moving the monitor from a    storage location  wait at least one hour prior to use to allow the monitor to  adjust to room temperature     Storage Transport Environment    Storage transport    20 to 60  C   4  F to 149  F   temperature    Humidity  15 95  RH  non condensing   Altitude  10 000 to    1 000 ft  680 to 1060 hPa     Power    External power     AC  100 240 VAC  50 60 Hz  1 5A  Fuse rating  T3 15AH250V  two provided     
26.  mains power when not in use  Failure to do  so may diminish the service life and function of the battery     Note  Monitor cables should be replaced annually or when no  longer properly functioning  Keep track of cable installation date  and usage  See Accessories on page 103 for reorder information     21 02 0217 Rev 08 03 09 Page 89    Maintenance FORE SIGHT MC 2000 Series Monitor    Fuse Replacement    The FORE SIGHT MC 2000 Series monitor has a dual fuse AC  power input receptacle  Both AC lines are fused     The FORE SIGHT MC 2000 Series monitor has a single fuse DC  receptacle for the internal batteries     7 Caution  The Battery fuse must be installed for the unit to operate  with the internal batteries  If the unit is not to be used for periods  greater than 1 week  the battery fuse should be removed  refer to  Battery Power Fuse section on 91           a Caution  For continued protection against fire hazard  replace only    with identically rated fuses  see Power Section  page 101      T    A fuse may need to be replaced if the monitor is plugged into an  electrical outlet but the Battery Power Visual Indicator is not illumi   nated green     Warning  Before changing any fuse  unplug the power cord   Note  The FORE SIGHT MC 2000 Series monitor models have    multiple fuses located inside the monitor  These fuses are not  user replaceable     T    i     AC Power Fuse    To replace the AC Power fuses  proceed as follows   e Turn the monitor off and disconnect the powe
27.  of strangulation     oc 7 Warning  Conductive Connections     Extreme care must be exer   cised when applying medical electrical equipment  Many parts of  the human   machine circuit are conductive  such as the patient   connectors  electrodes  and transducers  It is very important that  these conductive parts do not come into contact with other  grounded  conductive parts when connected to the isolated patient  input of the device  Such contact would bridge the patient s isola   tion and cancel the protection provided by the isolated input  In  particular  there must be no contact of the neutral electrode and  ground     Caution  Inspect the cables and sensors for damage prior to op   eration  If any damage is noted  the cables or sensor should not be  used until it has been serviced or replaced     Note  Skin pigmentation does not affect the validity of collected  data  The FORE SIGHT MC 2000 Series Monitor compensates  automatically for skin pigmentation     Note  The sensor must be flush with clean  dry skin  Any oil  per   spiration  or hair that prevents good contact between the sensor  and the skin will affect the validity of the data collected and may  result in an error message             Page 44 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Note  If possible  locate the sensor away from the midline of the  forehead or over a sinus cavity     Patient cables  see Figure 17a  page 43  connect the monitor ca   bles to the patient  Pa
28.  on the monitor end of the monitor cable  see Figure  16c below     4 Open the left patient monitor connection door on the monitor  and clean the fiber optic connection on the monitor using the  Clear Male Fiber Optic Cleaning Tip supplied with the FORE   SIGHT Biomedical Kit  see Figure 16d  page 41     Orient the monitor cable connector with the arrow up   6 Firmly push the monitor cable connector into the left monitor   connection  see Figure 16e  page 41     7 Repeat the above steps for the right monitor cable     O1    Removing the Monitor Cables    To remove a monitor cable from the monitor   1 Squeeze the locking tabs on the sides of the connector   2 Pull straight out             i      Fiber optic f  Locking Tabs      gr      Electrical pr  Connections         CASMED supplied Orange    Male Fiber Optic Cleaning Tip Electrical       Connections  4      Page 40 21 02 0217 Rev 08 03 09       FORE SIGHT MC 2000 Series Monitor Basic Operations       CASMED supplied Clear Fiber Optic Fiber optic Electrical  Cleaning Tip Connection Connections    Monitor Cables    Patient Cable       Push monitor cable firmly into left or right receptacle  on front of monitor  Arrow must be on top        Squeeze Locking Tabs to release plug and from receptacle  when removing monitor cable from monitor    Figure 16  Connecting and disconnecting the monitor cable    21 02 0217 Rev 08 03 09 Page 41    Basic Operations FORE SIGHT MC 2000 Series Monitor    Connecting the Patient Cables to the Mo
29.  or therapy  The value of data  from the Cerebral Oximeter has not been demonstrated in disease  states     Contraindications    e The FORE SIGHT MC 2000 Series Monitor sensor is contrain   dicated for use on patients with limited skin access or allergic  reaction to electrode adhesive     e Disposable SctO2 sensors are contraindicated for use for pro   longed periods  The sensor site must be checked at least every  eight hours  and if the circulatory condition or skin integrity has  deteriorated  the sensor should be applied to a different site    e Do not adhere sensors to underdeveloped  immature  compro   mised  or healing skin     e No other contraindications are known at this time     21 02 0217 Rev 08 03 09 Page 17    Safety FORE SIGHT MC 2000 Series Monitor    Installation and Setup    gc Warning  The FORE SIGHT MC 2000 Series Monitor is defibrilla   tor proof  It may remain attached to the patient during defibrillation   but the readings may be inaccurate during use and less than  twenty  20  seconds thereafter     w 7 Warning  The FORE SIGHT MC 2000 Series Monitor is intended  only as an adjunct in patient assessment  It must be used in con   junction with clinical signs and symptoms     w Warning  Do not rely exclusively on the audible alarm system for  patient monitoring  Adjustment of alarm volume to a low level dur   ing patient monitoring may result in a hazard to the patient  Re   member that the most reliable method of patient monitoring com   bines close per
30.  serial ports located on the rear of the  monitor  refer to Figure 3  page 29      To select a serial port    Turn the rotary control knob to select the Setup menu   Press the rotary control knob to open the Setup menu   Turn the rotary control knob to the right to select Ports     Press the rotary control knob a second time to open the   Ports dialog  Figure 26a  below     5 Turn the rotary control Knob to select the desired Port to con   figure    6 Press the rotary control knob and the focus shifts to the Port  Configuration selections    7 Turn the rotary control knob to display the desired Port Con    figuration selection     8 Press the rotary control knob and the focus will change back  to the Port selection     9 Turn the rotary control knob to select the Setup of the Port to  configure    10 Press the rotary control knob and the focus shifts to the Port  Setup selections     11 Turn the rotary control knob to display the desired Port  Setup  Baud Rate  selection     12 Press the rotary control knob to select the desired Port  Setup and the focus will change back to the Port selection     13 Turn the rotary control knob to select another Port to config   ure    14 When all the ports have been configured  turn the rotary con   trol Knob to DONE button to save your selections or to the  CANCEL button to cancel your changes     15 Press the rotary control knob to save or cancel your  changes     As seen from rear view    AR ON        SE JU 19200 8 N 1   Philips Yue Link 
31.  stored in files using comma separated values  CSV   format  Figure 40 illustrates an example of patient data stored in a  USB memory stick      23 59 56  67  69  68 0    23 59 58  67 69  68 0   2007 07 16 00 00 00  67  69  68 0    00 00 02  67 69  68 0    00 00 04  66  69  68  1  PROCEDURE   00 00 06  65  69  67 5     Figure 40  USB Memory File Example    Note  Saving patient data in excess of 1 5 days may exceed the capa   bility of some spread sheet applications     USB Status  While attempting to save patient data to a USB memory stick  certain  conditions may present themselves that will require intervention by the  user  refer to Figure 41  Table 3 lists of the possible USB Status Mes   sages and their recommended actions you should take   Table 3  USB Status Messages  USB Status Message Recommended Action  File exists     cannot overwrite Edit name of file to be stored on the USB memory stick   Remove USB memory stick and use PC to remove un necessary files  from USB memory stick   Memory Stick not plugged in No USB installed  plug in USB Memory stick     Not enough room on memory stick   Remove USB memory stick and use PC to remove un necessary files  from USB memory stick     A non memory stick detected Non USB Memory stick installed  remove device and plug in USB  Memory stick   Memory stick write error Remove USB memory stick and try another  If condition continues    contact the appropriate service personnel     Memory stick install failure Remove USB memory stick
32.  the Profiles menu  select Save As     3 Enter the name of the new profile  up to 30 characters includ   ing spaces  see Entering Text  page 35    4 Select the DONE button when you are done     Either procedure automatically selects the new profile     Connecting the Monitor Cables    Monitor cables  see Figure 16a d  page 41  connect the monitor to  the patient cables  Monitor cables are reusable     w 5 Warning  Do not lift the monitor by any cable or line as they could  disconnect from the monitor  causing the monitor to fall on the pa   tient     w 5 Warning  Route and secure all cables away from patient s throat  to reduce the possibly of strangulation     w 5 Warning  Conductive Connections     Extreme care must be exer   cised when applying medical electrical equipment  Many parts of  the human   machine circuit are conductive  such as the patient   connectors  electrodes  and transducers  It is very important that  these conductive parts do not come into contact with other  grounded  conductive parts when connected to the isolated patient  input of the device  Such contact would bridge the patient s isola   tion and cancel the protection provided by the isolated input  In  particular  there must be no contact of the neutral electrode and  ground     w 7 Caution  Inspect the cables and sensors for damage prior to op   eration  If any damage is noted  the cables or sensor should not be  used until it has been serviced or replaced     pw 7 Caution  Do not kink or bend ca
33.  the printing will continue     Note  To cancel the printing  select CANCEL or navigate to the Patient   gt  Print menu and then select CANCEL to stop the printing     Note  The Time scale selection is not available when Tabular print is  selected     21 02 0217 Rev 08 03 09 Page 81    Printer FORE SIGHT MC 2000 Series Monitor  Graphic Print    The user may initiate Graphic printing by navigating to the Patient  gt   Print menu     To print the graphic data associated with information displayed on the  screen  Select Graphic Print type  Screen Print length  and then select  PRINT  see Figure 48  page 82      Print type Print length    Tabular t Full case    Time scale        Continuous Tabular Print    PRINT   DONE   CANCEL      Figure 48  Graphic Screen Print dialog       Note  The Time scale selection is not available when Graphic   Screen  print is selected     10 08 13 10 15 43 10 23 13    IFraocedure 1    GHT     4 CASMED SOLUTION    PATIENT ID  _A123456709  Start Time  06 27  2007 10 00 49    End Time  06 27  2007 10 30 49    FORE S    Left Sct02       Right SetOz            Figure 49  Graphic Screen Print Example  Note  Event text is printed on the paper as it appears on the screen     Note  If the Event text is too long  the printing of the text continues  past the edge of the halted trace printing as shown in Figure 49 above     To print all the graphic data associated with this patient  select  Graphic Print type  Full case Print length and then select PRINT as  sho
34.  the text  will not be visible  Changing the View to 15  30 min or 1 hour will  allow the text to be visible     1 Turn the rotary control knob left or right to position the vertical  line correctly on the trace  see Figure 30  below      Patient Profiles View Event Setup Help     SctO          0 Days 04 45 16 07 23 32   67     Sep 28 08 03  Figure 30  Vertical Position of Event Mark    2 Press the rotary control knob once more to add a horizontal  line to the trace  see Figure 31  page 61      3 Turn the rotary control knob left or right to position the hori   zontal line correctly on the trace     Page 60 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Patient Profiles View Event Setup Help        SctO      30 Minutes        0 Days 04 45 16  07 23 32   67 fo Sep 28 08 03  Figure 31  Horizontal Position of Event Mark       4 Press the rotary control knob once more to place the Event  Mark on the trace where the two lines intersect  see Figure 32  below      Patient Profiles View Setup Help    T p  ACTIVE       Figure 32  Final Position of Event Mark    Placing or Deleting Existing Event Marks    To place or delete an existing Event Mark   1 Turn the rotary control knob to select the Event menu   2 Press the rotary control knob to open the Event menu   3 Turn rotary control knob to highlight the desired Event Mark     4 Press the rotary control knob to select the Event Mark and se   lect 1 of the following Event Actions  see Figure 33  page 62
35.  tissue mainly at the microcirculation level   capillary  arteriole  and venula  based on different absorption  characteristics of the chromophores oxyhemoglobin  HbO2  and  deoxyhemoglobin  Hb  in the near infrared spectrum  A biological  spectroscopic window exists at the wavelength range 660   940 nm  in which Hb and HbO  can be differentiated and measured  Brain  tissue oxygen saturation  SctO gt   is determined from the ratio    HbO2   HbO2   Hb   x 100     The FORE SIGHT MC 2000 Series Monitor uses LASER LIGHT  Technology to project light into tissue to measure oxygen satura   tion     The FORE SIGHT MC 2000 Series Monitor uses COOL LIGHT  Sensor Technology to transmit light from the monitor to the patient  contact site via fiber optics  thereby eliminating light induced heat  generation at the patient site     The Model MC 2010  amp  2030 are equipped with a rechargeable  backup battery pack that allows the monitor to be used independ   ently from an external power source     The Model MC 2000  amp  2020 are equipped with a rechargeable  backup battery pack that allows the monitor to automatically shut   down safely during extended power loss  These units are not de   signed to run independently from an external power source     Getting Started    Before you operate the monitor  you must thoroughly familiarize  yourself with     e All of the warnings and cautions in the Safety section  pages 17    23    The physical configuration of the monitor  page 28   The use of th
36. 0   1 10  solution of chlorine bleach in  tap water  When all of the surfaces have been disinfected   wipe the entire surface of the monitor using a soft cloth damp   ened with fresh water to remove any trace amounts of residue  and or fumes     e Display  Clean the display window using a soft  lint free cloth  sprayed with an alcohol free glass cleaner  The use of paper  towels is not recommended as it may scratch the surface     Note  Thoroughly wipe off any excess cleaning solutions  Care  should be taken to prevent water or cleaning solution to run into  connector openings or crevices     21 02 0217 Rev 08 03 09 Page 87    Cleaning FORE SIGHT MC 2000 Series Monitor    Cleaning Monitor Cables    Note  Cables contain fiber optic elements  Care should be  taken to avoid kinking or bending cables during cleaning    Prior to each patient use  inspect the Monitor Cable for damage   Using the male fiber optic cleaning stick  provide in the Biomedical   amp  Abbreviated Biomedical Kits  clean the fiber optic connections in  each monitor cable   The fiber optic connection is surrounded by  green plastic     Clean the Monitor Cable using a soft cloth dampened with a 10    1 10  solution of chlorine bleach in tap water  Do not use alcohol     105 Caution  If the Monitor Cable should become grossly contami   nated with blood or other bodily fluids  it should be discarded     Note  Do not soak or submerse the Monitor Cable in any liquid  solution  Liquid should not be permitted to ent
37. 0 Series Monitor Basic Operations    Confirm       stop FS Data collection  Y  YES HO      Figure 35  Stop FS Data Collection popup dialog  Reviewing FS Data Information    Note  Starting and Stopping of FS Data collection can be selected  at any time  The user does not need to wait for the automatic  popup reminders     Note  Displaying the FS Data Review can be done after the FS  Data collection has started or after the FS Data collection has  been stopped     Selecting the FS Data Review    under the Patent menu  refer to  page 33  will display the collected FS Data information  The FS  Data information includes the Pre Induction Baseline Regional  Oxygen Saturation  the Cumulative Saturation Below Threshold  and the Skin Closure Regional Oxygen Saturation  if FS Data  collection has been stopped  Refer to Figure 36 a  below     Pre Induction Baseline Regional Oxygen Saturation    Left    3 2 Right   84 ri    Cumulative Saturation Below Threshold    Left   134 578 minute 2  Right   134 634 minute      Skin Closure Regional Oxygen Saturation  Left     Right   kin   Cumulative Saturation Below  minute 22  Linear Time Saturation Below  minutes     Left Right Left Right    60   96 743  96 743 60   127 3  127 5  Hao  25 673  25 673 ah  98 2   98 6    50   8 574  3 574 BG   64 5   64 2  4524  3 588  3 588 45   35 6   35 3    A0  A0   35  35   302 30     Linear Time UR Differential  gt 10  24 minute  Average LUR Differential 8 5 26  HELP   PRINT   DONE   CANCEL    Figure 36 a  FS
38. 2000 Series Monitor    Initial Inspection    Before unpacking the monitor  inspect the packaging for damage   If there are any signs of damage to the package  a claim should be  filed immediately with the shipping agent  It is the receiver s re   sponsibility to notify the carrier s local office to arrange for the  pickup of the damaged items  Save the damaged shipping carton  as evidence     Contact your distributor  CAS Medical Systems sales representa   tive  or CAS Medical Systems  Inc   to report external damage and  to arrange for repair or replacement of damaged equipment     The shipping carton should contain the items listed below  Unpack  the monitor and account for each item  Inspect each item for signs  of external damage  dents  cracks  scratches  etc  If an item is  missing or damaged  contact your distributor  CAS Medical Sys   tems sales representative  or CAS Medical Systems  Inc     Record the monitor model  serial number  and date of purchase at  the back of this manual     Monitor Checklist  e 1 FORE SIGHT MC 2000 Series Monitor  e 2 FORE SIGHT Monitor Cables  e 1 FORE SIGHT Abbreviated Biomedical Kit  1 FORE SIGHT Laminated Intervention Card w Velcro dots    1 FORE SIGHT MC 2000 Series Cerebral Oximeter User  Manual    e 1 Hospital Grade AC Power Cord  e 1 Cable Bundler  e 1 Service Card and Insert Sleeve    w F Caution  Use only the CASMED approved power cord that was  shipped with the monitor  to preserve the electromagnetic com   patibility of the moni
39. 217 Rev 08 03 09 Page 43    Basic Operations FORE SIGHT MC 2000 Series Monitor    Removing the Patient Cables    To remove a patient cable from the monitor cable   1 Pull the electrical connector straight out     2 Grasp the fiber optic connector by the colored  non black   overmold and pull straight out     3 Snap the door closed over the end of the preamplifier   4 Discard the patient cable    Affixing the SctO2 Sensor or Sensors to the Patient    gc Warning  As with all medical equipment  carefully route and se   cure all patient cables to reduce the possibility of patient entan   glement or strangulation     07 Warning  Always remove the sensor from the patient and com   pletely disconnect the patient from the FORE SIGHT MC 2000 Se   ries Monitor before bathing the patient     w 7 Warning  The sensor site must be inspected at least every eight  hours  and if the circulatory condition or skin integrity has deterio   rated  the sensor should be applied to a different site     yc 7 Warning  The site must be checked at least every eight hours to  ensure adequate adhesion  circulation  skin integrity  and correct  optical alignment     uc 7 Warning  Patient Safety     If a sensor is damaged in any way  dis   continue use immediately     yc 7 Warning  Do not lift the monitor by any cable or line as they could  disconnect from the monitor  causing the monitor to fall on the pa   tient     w 7 Warning  Route and secure all cables away from patient s throat  to reduce the possibly
40. C publications on safety and essential performance of  electro medical equipment as well as with applicable UL re   quirements and AHA recommendations valid at the time of  printing     For complete warranty information  refer to the Warranty Policy  located on page 97     The CAS Medical System  Inc   quality management system com   plies with the international standards ISO 13485 and the Council  Directive on Medical Devices 93 42 EEC     Note  Due to continuing product innovation  specifications in this  manual are subject to change without notice     In the U S  the following caution applies   1   Caution  Federal law restricts this device to sale by or on the or   der of a physician or properly licensed practitioner     is Warning  Before using the monitor for the first time  please read  the information given in section Safety  starting on page 17     Page 8 21 02 0217 Rev 08 03 09    About This Manual    This User Manual describes the features and operation  of the FORE SIGHT MC 2000 Series Cerebral Oximeter     Software Version 4 4    Note  This manual addresses all parameters a FORE SIGHT MC   2000 Series Monitor can have installed  It remains suitable for use  if the monitor has a sub set of parameters only  Please refer to  those sections that are applicable for the model in use     Manual Purpose    This manual contains the instructions necessary to operate the  FORE SIGHT MC 2000 Series Monitor safely and in accordance  with its functions and intended use     Int
41. Chassis leakage current  100 pA  maximum     Model MC 2010 or 2030  Battery  2 sealed lead acid batteries  Fuse rating  F8AL250V  one provided   Charge Time  16 hours  with unit on   Operating Time  17  hr  minimum     21 02 0217 Rev 08 03 09 Page 101    Appendix FORE SIGHT MC 2000 Series Monitor    Serial Interface    Interface type  Bi directional serial communication  Speed  User programmable   Signal level  RS 232C   Data length  8 bits   Start bit  1 bit   Stop bit  1 bit   Parity  None   Flow control  None    Standards    Units comply with the following requirements   CE marking according to Directive 93 42 EEC  IEC 60601 1  EN 60601 1 2  IEC 60601 1 1  IEC 60601 1 4  IEC 60601 1 8  UL classified  UL 60601 1  CAN CSA C22 2 No  601 1 M90  IEC 60825 1    All units covered by U S  patents 6 456 862  7 047 054  7 072 701   Other patents pending     Page 102 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Appendix    Accessories    Contact our Customer Service department or see our website for  the latest product information  Refer to on page 3 for e mail and  phone number information     SctO  Accessories    Catalog No  Description  01 06 2000 FORE SIGHT MC 2000 Cerebral Oximeter  Provided  2  FORE SIGHT Universal Monitor Cable with Pre amp  With   1  FORE SIGHT Abbreviated Biomedical Kit   1  FORE SIGHT Laminated Intervention Card w Velcro dots   1  FORE SIGHT CD User Manual   1  Hospital Grade AC Power Line   1  Cable Bundler   1  Service Card  amp  Sleeve   
42. FORE SIGHT   MC 2000 Series  Cerebral Oximeter          Patient Profiles Event Setup Help gi PP nl i       Mar 25 ACTIVE                              Bs  SctO     AY        anal aff  LEFT S    hSctOrz    FS DATA 8 Hours                                     68      0 Days 07 16 56       Mar 25 17 33                   User Manual    ol CASMED    FOR WHAT S VITAL       This User Manual describes the features and operations of FORE SIGHT MC 2000  Series Cerebral Oximeter  Software Version 4 4    21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor    Page 2 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor    Trademarks    Trademarked names appear throughout this document  Instead of  inserting a trademark symbol with each mention of the trademarked  name  the publisher states that it is using the names only for edito   rial purposes and to the benefit of the trademark owner with no in   tention of improperly using that trademark     CASMED is a registered trademark of CAS Medical Systems  Inc     FORE SIGHT  is a registered trademark of CAS Medical Systems  Inc        LASER SIGHT  is a registered trademark of CAS Medical Systems  Inc   COOL LIGHTT  isa trademark of CAS Medical Systems  Inc     Contact Addresses    CAS Medical Systems  Inc   44 East Industrial Road EC   REP  Branford  CT 06405  U S A  MediMark  Europe     Phone  11 rue E  Zola 38100    in the US   800  227 4414 Grenoble  France   1  203  488 6056    Fax      1  203  488 9438    E Mail   custsrv 
43. SENSOR Havre A 45  Removing the SENS OMS vsesceesmsnsace dons yvensuscnesmaosendssiteannsenseebadexs 45  Starting the Monitor           rrrarernnrrnanenanernnnrvanennnnnnanennnnnnanennnennanennnne 46  Tong ME MONO ON uer 46  Starting to Monitor a Patient          rrrrrrranornnrrrarernnrrnnnrrnnnnnnnennnnnn 46  Configuring Options on the View and Setup Menus                     48  SAUENE VEN ae 48  Setting Up SctO gt  Alarm Limits and Speaker Volume                48  MOVING    older sara enepder 50  Setting Miscellaneous Preferences           rrraranaranarenarennrnnarnnnnnnn 50  Setting Display Brightness               rrnrrrrarrrnnrrnnnrrnnnnvanrnnnnnnanennnnnn 51  SENG AUTO DIM uer 51  Deactivating Auto Dim Temporarily            rnrrnnrrnnrrnnrrnnrrnnrnnnennnnr 52  Selecting the Language               cccccccceecceeeeceeeeceeeseeeseeseeeeeeees 52  Selecting the Serial Ports          r  anrrnanrnnnnnnanennnnnranennnnnnannnannnnnnen 53  Connecting to Philips IntelliVue           rrrrrrrnrennnrnrarernrennannrnnennnnn 55  FORE SIGHT Serial Port Data Output             cece sees eees 56  Setting the Date and Time        rrranrnnnnnnanennnnnnnnennnnnnanrnnannnanennnnnn 57  MOMITONING the Fatent  eccriene scone eveneienewesdentwedansincituccieens 58  Selecting Average  Auto  Left or Right           rrrrrrnrrrnrrnnrnrarerannns 58  CONTPOMMG TS Am sercis 58  Positioning an Event Cursor over the Patient Data                   59  Adding an Event Mark to Menu           arrrarnnannna
44. Serial Number 0651362   Boot Version 1 0 Nov 26 2007 09 57 53  Software Version 4 4 Nov 12 2006 10 14 07  PIC Version 1 5   Left SAM Boot 1 2   Left SAM Version 3 1 Aug 27 2008 12 36 23  Right SAM Boot 1 2   Right SAM Version 3 1 Aug 27 2008 12 36 23    Visit us at vww casmed com DONE       Figure 13  The About menu    Note  The displayed Serial Number and Software versions may be  different than your FORE SIGHT unit     21 02 0217 Rev 08 03 09 Page 35    Basic Operations FORE SIGHT MC 2000 Series Monitor    Entering Text    Several of the menu options give you the opportunity to enter a  short text label  For example  you can create and name profiles  and you can enter a patient name to identify a data record     You have the option of using the default keyboard layout  see  Figure 14 below  or the extended keyboard layout  see Figure 15  below     Specifying the Extended Keyboard layout may be done under  Setup  gt  Preferences  see Figure 22  page 50      Note  Selecting a language  on the Setup menu  that uses ac   cented characters automatically enables the extended keyboard     Enter in an event name   Remaining Characters  20      AJ 2  cf of ef Fj  sf wy 1  sf Kf of Hj  peeeeleedleu BEE    stede HE ES BB EEE  Space     ges ee   ENE   Backspace   ClearAll   DONE    CANCEL      Figure 14  The default keyboard layout       The extended layout provides accented characters that should be  sufficient to write names encountered in most European lan   guages     Use the keybo
45. a patient  identifier to a recording of measured values over time  It also al   lows you to print and save data  and to operate and review FS  Data collection measurements     The Profiles Menu    The Profiles menu  see Figure 7 below  lets you set up  name  and  manage profiles for different monitor configurations and use situa   tions  to accommodate a user s preferences     Patient Eifiiies  View Event Setup Help    New     Save   Save as     Rename     Delete                Restore to hospital defaults  Restore to factory defaults    Main Menu    Figure 7  The Profiles menu    21 02 0217 Rev 08 03 09 Page 33    Basic Operations FORE SIGHT MC 2000 Series Monitor    The View Menu    The View menu  see Figure 8 below  lets you choose the time in   terval spanned by the plot area     Patient Profiles Event Setup Help          15 Minutes  30 Minutes  1 Hour      Hours  3 Hours  4 Hours              4 Hours    Main Menu    Figure 8  The View menu    The Event Menu    The Event menu  see Figure 9 below  lets you mark events on the  plot area and record them with the patient data     Patient Profiles View setup Help    Event cursor    Add new event                 Add event to menu       Main Menu    Figure 9  The Event menu    The Setup Menu    The Setup menu  see Figure 10 below  lets you set up alarm limits  and alarm volume  graph style  keyboard style  monitor brightness   monitor interface language  and current date and time information   You can save a setup  once configur
46. ard as you would a hand operated label maker  dial   click  dial  click         1 Rotate the control knob to the desired key   2 Press the knob to select the letter or function     Enter in an event name  Remaining Characters  20   m   Ay ef ef of ef Fj ef Hj tf sf Kf 1   peers eeeee eee    conto  1  2  3  4  sj ef 2  ef ef oi  el of of ef ef sf sf of 2  a  of of   de  Backspace   Clear All   DONE   CANCEL         Figure 15  The extended keyboard layout    Page 36 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Note  To type an accented letter  first select the appropriate ac   cent shift key  The letters to which that accent may be applied light  up in yellow  Next select one of the highlighted letters  If you se   lected the accent in error  click it again to return the keyboard to  the unselected state     Note  The keyboard opens initially in all caps mode  as shown in  figure 12  with the green Caps Lock indicator on  To access lower   case letters  rotate the control knob to select the Caps Lock key  and press the knob  The green indicator toggles off and the letters  on the key caps change to lowercase     Note  The default keyboard layout has the advantage that you can  select letters faster  because you have to rotate the knob through  fewer selections  If you do not need to use accented characters to  identify patients  profiles  or events  there is no reason to select  the extended layout     Note  The number of characters that may 
47. be allowed to be entered  will be limited based on the type of information being entered     Note  Not all characters in the default or extended keyboard may  be available based on the type of information being entered     21 02 0217 Rev 08 03 09 Page 37    Basic Operations FORE SIGHT MC 2000 Series Monitor    Setting Up the Monitor for the Patient    The procedures in this section are optional  The FORE SIGHT  MC 2000 Series Monitor will operate immediately after being con   nected to the patient and powered on  If desired  you can bypass  the following steps and begin monitoring immediately     Note  Nothing in this user guide is intended to override procedures  and regulations imposed at the institutional level or above  Your  hospital s quality system  privacy rules  or other legal or policy re   quirements may govern whether and how you implement any spe   cific procedure in this section     Note  When you first power up the system  you will be asked  if you are starting a new patient  Answering no will add the new  data that you are collecting to the end of the previous data stored  on the unit  Answering yes will delete prior data stored in the  unit     Note  When printing on demand Graphic or Tabular information or  while saving patient data to a USB Memory stick  the ability to la   bel data with a Patient Identifier is disabled     Labeling the Data with the Patient Identifier    You can display the patient identifier on the monitor screen and  save the patient ide
48. blank     The new Event Mark text just entered will now appear under the  Event Mark Menu  see Figure 29  page 60      Caution  Placing an Event Mark in the blank area prior to the start  of displayed traces will result in the Event not being saved     AR QN        T    C    21 02 0217 Rev 08 03 09 Page 59    Basic Operations FORE SIGHT MC 2000 Series Monitor    Patient Profiles View Setup Help          Event cursor    Start Procedure    Add new event     Undo last event  Add event to menu           Main Menu    Figure 29  Add Event Mark to Menu  Adding a new Event Mark to the Patient Record  You can label a point on the patient trace with an Event Mark  You  can add an Event Mark in either Active or Historical mode   To add a new Event Mark   1 Turn the rotary control knob to select the Event menu   2 Press the rotary control knob to open the Event menu   3 Turn the rotary control knob to select Add new event   4    Press the rotary control knob and enter text to be placed on  the trace  up to 20 characters including spaces  see Entering  Text  page 35   Note the Event name can be left blank     5 Press the rotary control knob and select one of the following   Yes     Add Event Mark to List and place on trace  No     Place Event Mark on trace   see Placing an Event Mark on the Patient Record below     Placing an Event Mark on the Patient Record    Note  Adding an Event Mark on the screen  in a View greater than  1 hour  2  3  4  8 or 24   will only place a dot for the Event 
49. bles   Maintain a minimum bend    radius of 1 inch     Note  Monitor cables should remain connected to the monitor be   tween uses     Note  Monitor cables contain fiber optic elements  Care should be  taken to prevent damage to the monitor cables     Note  Monitor cables should be replaced annually or when no  longer properly functioning Keep track of cable installation date  and usage  See Accessories on page 103 for reorder information     Note  The monitor cable includes both an electrical cable and a  fiber optic cable  You must take care to ensure that the entire fiber  optic pathway is kept clean  Keep the door on the end of the moni   tor cable  preamplifier  snapped shut whenever the monitor cable  is disconnected from the patient cable  If monitor cables are dis   connected between uses  clean the fiber optic connections on both  the monitor and monitor cable before re insertion  using CASMED     21 02 0217 Rev 08 03 09 Page 39    Basic Operations FORE SIGHT MC 2000 Series Monitor    supplied fiber optic cleaning tips found in the FORE SIGHT Bio   medical Kit     Connecting the Monitor Cables for the First Time    To connect the monitor cables to the monitor    1 Remove the left monitor cable from the packaging  see Figure  16a  page 40     2 Remove the black protective cover from the monitor connec   tor cable  see Figure 16b  page 40     3 Using an Orange Male Fiber Optic Cleaning Tip supplied with  the FORE SIGHT Biomedical Kit  clean the fiber optic con   nector
50. but the patient cable is not connected  A colored face   blue for left  green for right  with a smiling mouth indicates that the  cables are fully connected     Left Patient  Connection    Controlling the Alarm    You can disable or enable audible alarms by pressing the Alarm  Silence   Reset key on the monitor front panel  When no alarms  are present  pressing the Alarm Silence   Reset key disables the  audio associated with high or low limit violations and equipment  alarms for two minutes  This does not affect the visual alarms for  most conditions  See Responding to System Messages on page  64 for a list of alarm conditions and the actions you can take     Pressing the Alarm Silence   Reset key  when a Limit Violation  alarm condition exists and the alarm is sounding  mutes the audi   ble portion of the alarm condition for up to 30 seconds  If the alarm  condition persists at the end of that period  the audible alarm re   sumes     Pressing the Alarm Silence   Reset key when an equipment alarm  condition exists and the alarm is sounding turns off the audible  portion of the alarm condition  and in some cases removes the  visible portion     Note  Limit violation alarm icons are indicated by a flashing red  alarm status  Equipment alarm icons are indicated by a flashing  yellow alarm status  Refer to Screen Indicators on page 93     Page 58 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Positioning an Event Cursor over the Patient Data  Yo
51. casmed com  sales casmed com  techsrv casmed com    Web   www casmed com       Please contact the distributor in the country of purchase if product informa   tion or service should be required     21 02 0217 Rev 08 03 09 Page 3    FORE SIGHT MC 2000 Series Monitor    This page is intentionally left blank    Page 4 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor          Manufacturers Declaration of Conformity    Manufacturers Declaration of Conformity  Electronic Emissions and Immunity       The FORE SIGHT MC 2000 Series Monitor is intended for use in the electromagnetic environment specified below   The customer or the user of the FORE SIGHT MC 2000 Series Monitor should assure it is used in such an environ   ment     Electromagnetic Environment    RF emissions     CISPR 11 Group 1 The FORE SIGHT MC 2000 Series Monitor uses RF energy only for  its internal function  Therefore  its RF emissions are very low and are  not likely to cause any interference in nearby electronic equipment    MU Ed The FORE SIGHT MC 2000 Series Monitor i itable f in all   l  o e     eries Monitor is suitable for use in a   SE ial establishments other than domestic establishments and those di       rectly connected to the public low voltage power supply network that   Voltage fluctuations   flicker supplies buildings used for domestic purposes    emissions    Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment  Guidance    Electrostatic dis   charge  ESD   IEC
52. ce with appli   cable safety and regulatory requirements  and that replacements  and repairs are made in accordance with the instructions provided  by CAS Medical Systems  Inc     The same warranty conditions are made for a period of twelve  12   months with respect to the battery  A ninety  90  days warranty is  provided for non disposable accessories such as reusable monitor  cables and other accessories provided by CASMED as part of the  original purchase  CASMED warrants disposable or single patient   use products  including SctO2 sensors for out of box failure only   Where the accessory is not a CAS Medical Systems  Inc   manu   factured product  the manufacturer s own warranty applies  War   ranty of accessories purchased separately from listed suppliers will  be the responsibility of such listed suppliers  Damage to any part  through misuse  neglect  or accident  or by affixing any accesso   ries or attachments other than CASMED manufactured accesso   ries or attachments  is not covered by this warranty     The foregoing warranties shall not apply if the product has been  configured  modified  adjusted or repaired other than by CAS  Medical Systems  Inc   or by persons expressly authorized by CAS  Medical Systems  Inc   or not in accordance with written instruc   tions provided by CAS Medical Systems  Inc   or if the product has  been subjected to misuse  negligence  or accident     CASMED reserves the right to perform warranty service operations  in its own factory  a
53. close to the green face illuminated should be  attached to the patient s right side     Note  Sensors are labeled with green and blue face icon stickers  identifying patient right and patient left  Be sure to match the left  and right sensors to the appropriate illuminated face icons on the  preamplifier  This will help to identify the appropriate side on which  to place the sensors     1 Verify the correct patient ID is displayed on the monitor screen   page 38  and that the desired profile is selected  page 38      2 Press the Sensor Start   Restart key     O  Figure 19  Sensor Start   Restart key    Note  Fire laser reminder   low priority audio alert  If one or both  lasers are not firing  a low priority audio alert is generated 90 sec   onds after    Press sensor start start 1X    or        2X    is displayed     e The low priority alarm is audio only  no flashing triangle  and  repeats every 10 minutes     e This alarm is meant to be a gentle reminder that sensors are  set correctly on the patient  but on or both lasers are not firing     e Any other alarm in the system overrides this audio alarm     Page 47    Basic Operations FORE SIGHT MC 2000 Series Monitor    3 Press the Avg   Auto   Left   Right key to select the initial view     Figure 20  Average   Auto   Left   Right key  4 Verify that there are no user messages in the message area     see Figure 5  page32   If there is a message in the message  area  see Responding to System Messages on page 64     Configuring
54. ded Separation Distances Between Portable and Mobile RF Communications Equipment and the Model MC   2000 Series Monitor  The Model MC 2000 Series Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are  controlled  The customer or the user of the Model MC 2000 Series Monitor can help prevent electromagnetic interference by main   taining a minimum distance between portable and mobile RF communications equipment  transmitters  and the Model MC 2000  Series Monitor as recommended below  according to the maximum output power of the communications equipment     Separation distance according to frequency of transmitter  Meters     Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz  power of transmitter   Watts  d 1 2VP d 2 3VP       For transmitters operating at a maximum output power not listed above  the recommended separation distance din meters can be  estimated using the equation applicable to the frequency of the transmitter  where P is the maximum output power rating of the  transmitter in watts according to the transmitter manufacturer   NOTE 1 At 80 MHz and 800 MHz  the separation distance for the higher frequency range applies   NOTE 2 These guidelines may not apply in all situations  Electromagnetic propagation is affected by absorption and reflection  from structures  objects  and people        Page 6 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor    CE Marking Information    Compliance 
55. des the information  reported in the FS DATA review dialog  Refer to Figure 36 a and b     Data is saved to the USB memory stick at a rate of approximately 1  hour of patient date every 30 sec  e g  an 8 hour case will take ap   proximately 4 minutes to save  at a Save rate of 2 Sec     To return to the Main screen select DONE    Note  Once saving has started  the user may exit the dialog via the  DONE selection at any time and the saving will continue    Note  To stop the saving  select CANCEL or navigate to Save to USB  under the Patient menu and then select CANCEL to stop the saving   Note  If saving is cancelled  the file that was initially saved will be de   leted from the USB memory stick    17 Caution  Do not remove the USB memory stick while data is being  saved to it  Removing the USB memory stick from the monitor  while  data is being saved  may cause permanent damage to the USB mem   ory stick     Once the progress bar has indicated that 100  of the data has been  saved  the USB memory stick may be safely removed  refer to Figure  39     Page 74 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor USB Operations    Save to USB       File Name   2007 07 30 1D 01  054    Save rate I            2 Seconds      Asave rate other than   seconds may result in some alarms and  event marks not to be saved in the file saved on the USB  memory stick      Data saved  Memory stick may now be removed     CANCEL         Figure 39  Saving to USB Completed    Patient data is
56. e 17e below      6 Push the fiber optic connector into the receptacle with the  matching colored label as far as possible  It is keyed to fit only  one way  The key is also identified on the colored label  You  should hear or feel a slight click when connector is seated   see Figure 17f below     7 Hold the electrical connector with the arrow  rounded side  up  and push it into the receptacle as far as possible  You should  hear or feel a slight click when the connector is seated  see  Figure 179 below     8 Repeat the above steps for the right patient cable        Fiber optic connector with Remove  amp  discard    Patient cable protective cap protective cap    Patient cable end of a a  Monitor Cable   Preamplifier     Keep door snapped  shut when not in  use       Use CASMED sup   plied Clear Male Fiber  Optic Cleaning Stick  to clean fiber optic  connection in pream   plifier    Open door to connect  to patient cable          Use CASMED supplied  Clear Female Fiber Optic    AER  Cleaning Stick to clean     a     fiber optic connection in FS  ke e    on patient cable                oN       Hold the electrical  connector arrow   rounded side up  and  push into receptacle  until clicked in place    Align key on fiber  optic connector with  key surrounding re   ceptacle and push  until clicked in place       Figure 17  Connecting the Patient cable    Clean fiber optic tip and receptacle before connecting   Connect fiber optic connector and then electrical connector     21 02 0
57. e USB connector accommodates a USB Flash Memory  stick  do not connect any other USB device or cable to the USB port     Caution  For safe and proper usage of USB memory sticks  please ob   serve the following     e When not in use  remove the USB memory stick from the monitor  and place the protective cap on the USB memory stick     e Avoid places subject to high or low temperature extremes   e Avoid dusty places and where corrosive gasses are generated   e Never attempt to dismantle or repair the USB Memory Stick     e Verify patient data is stored on the USB memory stick prior to eras   ing the patient data within the FORE SIGHT monitor     Saving Patient Data    21 02 0217 Rev 08 03 09    Insert the USB memory stick into the USB port connection on the front  of the FORE SIGHT monitor  If the USB memory stick will not insert   rotate the USB memory stick 7 turn and re attempt to insert it into the  USB port connection  If the USB memory stick fails to insert  contact  the appropriate service personnel     Caution  If resistance is encountered  do not attempt to force the USB  memory stick into the FORE SIGHT monitor  The USB memory stick is  keyed to only be inserted one way  Attempting to force the USB mem   ory stick into the monitor the wrong way  may cause permanent dam   age to the monitor and or the USB memory stick    Refer to page 94 for explanations of the USB Icon displayed in the up   per right corner of the Main screen    To save patient Data to the USB memory 
58. e monitor switches and controls  page 30   The content and use of the monitor display  page 32   The procedures described in this guide  pages 38 and following    To use the monitor    1 Set up the monitor for the patient  optional   See page 38    2 Connect the monitor cable s  to the monitor  See page 39    3 Connect the patient cable s  to the monitor cable s   See  page 42    4 Affix the SctO2z sensor s  to the patient  See page 44    5 Begin monitoring  See page 46    6 Saving Patient Data to USB memory when case is completed   See page 73    7 Printing Patient Data  See page 77     21 02 0217 Rev 08 03 09 Page 27       Basic Operations FORE SIGHT MC 2000 Series Monitor    Physical Configuration    Front View    Display screen Alarm Silence Reset key         Average Auto Left Right key    On Standby key  Sensor Start Restart key    AC line indicator LED    Rotary control knob    Battery indicator LED  MC 2010  amp  MC 2030    USB memory stick connection       ket pallentconnection Right patient connection    Figure 2  Front view    Page 28 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Rear View    AC Fuse Compartment Battery Fuse        Receptacle for AC power cord    Dr inima    Ethernet connection       Pae Mn  Pa  ami LSF   amm lean  nanan    BEG MIDO he IE TK GEN NCEE    Connector for CASMED  supplied printer    Grounding terminal    Serial n  mber label External device interface  RS 232     Figure 3  Rear view  Note  The Ethernet c
59. ed  using the Profiles menu     Patient Profiles View Event PHU Help    SctO  Limits       Preferences     Brightness     Auto Dim     Languages     Ports                 Date  amp  Time       Main Menu    Figure 10  The Setup menu    Page 34 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    The Help Menu    The Help menu  see Figure 11 below  provides useful tips regard   ing icons  buttons  symbols  and settings     Patient Profiles View Event Setup DAM  symbols      Power Indicators      Error Message Help     sctO 2 Limits Help     system Information     About                    View log     CAS login           Main Menu       Figure 11  The Help menu    Note  You may see a more selections in the Help menu  with addi   tional functions  when you are being trained to use the monitor  or  when a system administrator or service technician is working with  the machine  If you see these extended functions in normal use   contact your system administrator or technical service department  to correct the condition  Most of the Help screens have a selection  that allows that Help screen to be displayed on start up  See Figure  12 below   The default selection is off for all Help screens       Display at system start  DONE    Figure 12  Help Menu   Display at system startup     To obtain information specific to your FORE SIGHT unit  including  serial number and software version number  select Help  gt  About  menu in Figure 11 below     FORE S GHT    
60. ed information on the Citizen Model CMP 10 Mobile  Printer  refer to the User s Manual that was supplied with the Printer     This section contains the instructions necessary to operate the FORE   SIGHT MC 2000 Series Printer safely and in accordance with its func   tions and intended use     The Printer interfaces to the Monitor via the direct connect RS232 cable   supplied with Printer      Caution  For safe and proper usage of the Printer  please observe the  following     e Avoid places where fluid may enter the Printer opening accidentally   e Avoid places subject to high or low temperature extremes    e Avoid dusty places and where corrosive gasses are generated    e Never attempt to dismantle or repair the Printer mechanism    e Do not drop or bump the Printer     When handling the thermal paper   e Store in a dark  cool and dry place   e Do not place near organic solvents     e Avoid contact with vinyl chloride films erasers or adhesive tapes for  extended periods     e Avoid exposure to high temperature  humidity  liquid  or sunlight     e Always use specified thermal paper  Refer to Other Accessories  and Options on page 104 for order information     Note  Refer to Selecting the Serial Ports Section on page 53 for addi   tional information on configuring the rear panel Serial Ports     Page T1    Printer FORE SIGHT MC 2000 Series Monitor    Printer Controls and Indicators    Figure 43 below shows the printer controls and indicators        Figure 43  Printer Controls
61. ee a dEr 84  Removing the Battery Pack         rrrnnrnnnrnnnrnnnrnannnnnnnnnnnnnnnnnnnnrnnnennnen 84  Installing the new Battery Pack        rrrrnnnnnnnnrnannrannnannnannnnnnnnnnnennnnn 85    Page 12 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor    Cleaning 87  Cleaning the Monit  r suuvuspersansersenseasavheendesneseundenn 87  Cleaning Monitor Gables sauser eder 88  Cleaning Patient G  bles   saa 88  Cleaning the Printer              rarrnnrnrranornnrrnanennnnnvanrnnnnnnanennnnnnnnennnnnnnne 88   Maintenance 89  Maintenance Interval            rranrrarrnnrnnrranrnnrnannnnrnnrnannnernannnnnnnennnener 89  Fuse Replacement uvel 90   AC PU orne 90  Battery Power FUSE   ass eee TA 91   Appendix 93   SIDON reser 93  Front Panels yinbo saadan 93  Screen NACA NPR einernie a AS 93  Symbols near Accessory Connections         rrnnrrnnrannnrnnnnrnnnnnnnnnr 94  SVIMDOIS ON MONO aars 94  Symbols on Packaging          rrrrareranernarnranennnnrnnnnnnnnnnnnennannnnnennennn 95  Location of Laser Labels sron iiio 96   Warranty PO vase 97  Monitors  FORE SIGHT Cerebral Oximeter               rrrranernnnrnnre 97   Monitor CONTIQUIATIONS eeren oni E 99  FORE SIGHT MC 2000 Series Monitor Models                    0  99   Monitor Configuration Record            rranannnrnrarennnrrnnnrnnnnnnanennnnnnanennne 99   SPECMICAUONS sanere aE 100   PCCCSS ONC NNN 103  SCIO AES SONGS 103  Other Accessories and Options        rrranrnnnrnnnennrnnnnnnnnnnnrnnnennnnr 104  Philips IntelliVue VueLin
62. en sent from the FORE SIGHT monitor to the Philips Patient  Monitor  Refer to Table 2 for FORE SIGHT Text messages dis   played on the Philips IntelliVue Patient Monitor     FORE SIGHT Serial Port Data Output  Simple Comma Text  The monitor allows you to configure the RS 232 serial ports on the  back of the monitor to output a live stream of data that us being  acquired and displayed on the monitor   1  Select an unused communications port  located on the rear  of the monitor  refer to Figure 3  page 29    2  Configure the selected communications port to Simple  Comma Test format using the procedure outlined in the  Selecting the Serial Ports  on page 53     Serial Port Data Output  1  Minimum software requirements  Version 4 4  2  Data is output in a simple comma separated value  CSV   text format  i e  Left  Right  Avg  Alarm values     3  Left  Right  Avg and Alarm values are outputted once every  two  2  seconds     4  Invalid values  e g  no sensor  are outputted as  1  5  Set the Serial Port Baud to the desire rate   Refer to the Selecting the Serial Ports section  on page 53     6  Alarm status value transmitted   0   No Violation  1   Low Left SctO    2   Low Right SctO    4   High Left SctO    8   High Right SctO gt     16   SctO gt  Differential    Examples   57   1   1 0  Left   57  Right   no value  Avg   no value  no limit violation  57  49  53  4  Left   57  Right   49  Avg   53  Low Right violation  57  49  52  20  Left   57  Right   49  Avg   52  Low Right  am
63. ended Audience    This manual is written for clinical professionals  Clinical profes   sionals are expected to have working knowledge of medical pro   cedures  practices  and terminology as required for monitoring of  critically ill patients     W  Caution  For continued safe use of this equipment  it is necessary  that the listed instructions be followed  However  instructions listed  in this manual in no way supersede established medical practices  concerning patient care     IT Warning  Directions that warn of conditions that put the patient or  the caregiver at risk     W  Caution  Directions that help to avoid damaging the monitor or  losing data     Note  Directions that make it easier to use the monitor  something  not readily apparent     Figures  All illustrations in this manual are provided as examples  only  They may not necessarily reflect your monitoring setup or  data displayed on your monitor     21 02 0217 Rev 08 03 09 Page 9    FORE SIGHT MC 2000 Series Monitor    Revision History    This manual has a revision number located at the bottom of each  page  It changes whenever the manual is updated     Rev 00 04 2007  Rev 01 05 2007  Rev 02 05 2007  Rev 03 07 2007  Rev 04 10 2007  Rev 05 12 2007  Rev 06 02 2008  Rev 07 06 2008  Rev 08 03 2009    Read this manual carefully before patient use of the monitor    CAS Medical Systems  Inc   reserves the right to make changes to  this manual and improvements to the product it describes at any  time without notice or obl
64. entered a  device  take it out of service and have it checked by a service  technician before it is used again     107 Warning  The FORE SIGHT MC 2000 Series Monitor provides     DRIP PROOF       level of protection from ingress to moisture     uc 7 Warning  Do not place liquids on top of the monitor  Do not im   merse the monitor or power cord in water or any liquid     uc 7 Warning  Do not gas sterilize or autoclave the monitor    gt     Warning  After removal of covers  connectors  etc   do not touch  any part of non medical electrical equipment and the patient at the  same time     5 Warning  Where the integrity of the external protective conductor  in the installation or its arrangement is in doubt  EQUIPMENT shall  be operated from its INTERNAL ELECTRICAL POWER SOURCE     uc 7 Warning  Isolation of product from mains can only be achieved by  removal of external power cord     w 5 Warning  Route and secure all cables away from patient s throat  to reduce the possibly of strangulation     Page 20 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Safety          ic 7 Caution  Pressing the front panel keys with a sharp or pointed in   strument may permanently damage the switch membrane  Press  the keys using only your finger     i 5 Caution  If the monitor is accidentally wetted  take it out of opera   tion  It should be thoroughly dried     107 Note  There are no known risks with common disposal of equip   ment or accessories  however  the disposing of accessori
65. er quality should be that of  a typical commercial or hospital envi   ronment     Mains power quality should be that of  a typical commercial or hospital envi   ronment  If user of the FORE SIGHT  MC 2000 Series Monitor requires  continued operation during power  mains interruptions  it is recom   mended that the FORE SIGHT MC   2000 Series Monitor be powered  from an uninterruptible power supply  or a battery     Power frequency magnetic fields  should be at levels characteristic of a  typical location in a typical commer   cial or hospital environment        Page 5    FORE SIGHT MC 2000 Series Monitor  Guidance and Manufacturer s Declaration     Electromagnetic Immunity    The FORE SIGHT MC 2000 Series Monitor is intended for use in the electromagnetic environment specified below  The customer  or the user of the FORE SIGHT MC 2000 Series Monitor should insure that it is used in such an environment     Immunity Test IEC 60601 Test Level Electromagnetic Environment     Guidance  Level    Portable and mobile RF communications equipment  should be used no closer to any part of the Model  MC 2000 Series Monitor  including cables  than the  recommended separation distance calculated from  the equation applicable to the frequency of the  transmitter     Conducted RF 3 Vrms Recommended separation distance     IEC 61000 4 6 150 kHz to 80 MHz  d 1 2VP  Radiated RF 3 V m    IEC 61000 4 3 80 MHz to 2 5 GHz d   1 2VP 80 MHz to 800 MHz  d   2 3VP 800 MHz to 2 5 GHz    Where P is the max
66. er the ends of the  Monitor Cable because instrument damage may occur  Monitor  Cable should be allowed to thoroughly dry before use     Cleaning Patient Cables    Using the female fiber optic cleaning stick  provide in the Biomedi   cal  amp  Abbreviated Biomedical Kits  clean the fiber optic connections  on the patient cables     mu   Caution  The Patient Cable is designed for single patient use  and  is not to be reprocessed     17 Caution  Do not soak or immerse the patient cable and sensor in  any liquid solution  Do not attempt to sterilize it     Cleaning the Printer  Refer to the Printer User   s Manual for more information   jc F Caution  Before cleaning the Printer  disconnect the AC adapter   e Wipe with a soft dry cloth   To remove extreme dirt buildup     e Soak a cloth with mild detergent  wring well and wipe  Dry by  wiping with a soft dry cloth     wm 7 Caution  Do not use volatile chemicals such as thinner  benzene   etc     107 Caution  Never wet the inside of the Printer mechanism     Page 88 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Maintenance    Maintenance    i 7 Warning  Do not  under any circumstances  perform any testing or  maintenance on the monitor while the monitor is being used to  monitor a patient  The monitor must be turned off  Unplug the  monitor from the AC power source     yc 7 Warning  Do not lift the monitor by any cable or line as they could  disconnect from the monitor  causing the monitor to fall on the pa   tient 
67. erage indicator    SctO   Low  Alarm Limit a   0   Plot area 3  SctO gt  Cable connection    indications area  FS DATA      0 Days 07 26 36 EACEA EA     FORE SIGHT  FS   Data Collection  indicator          Right Cable status    Mar 25 17 45 Left Cable status       Date and time    Duration of Event time of occurrence Message Current Historical bar  length of bar is pro   current case and measurement area View portional to fractional of total history    representation by visible trace   Figure 5  Main areas of monitor display    Menu Navigation    You can control most operations of the FORE SIGHT MC 2000  Series Monitor through the menu system  The procedures in this  manual make frequent reference to the menu system  This section  explains how to navigate through it     Page 32 21 02 0217 Rev 08 03 09       FORE SIGHT MC 2000 Series Monitor Basic Operations    CAH Profiles View Event Setup   save to USB      Print     Turn the rotary control Snapshot to USB     knob to Main Menu on any  drop down list and press  the knob to return to the FS Data Review     Main Menu FS Data Print             Start FS DataCollection       Main Menu    Figure 6  The Patient menu    The following paragraphs briefly describe what you can do from  the various menus  This section serves as an orientation to the  menu system  Specific procedures making use of the menu system  are found in later sections of this user guide     The Patient Menu    The Patient menu  see Figure 6 above  lets you attach 
68. erclockwise   advances the selection on screen to the left when you are naviga   tion the menu  When you are navigating selections on a specific  menu  turning the knob counterclockwise advances the selection  up until you reach the top of the menu  then it starts over at the  bottom  When you are not on the menu bar  turning the knob coun   terclockwise advances the selection to the next section of the dis   play  in a counterclockwise direction     Page 30 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations  On   Standby Key    IN Press to toggle between Standby and On  Press and hold for 2  o  seconds to toggle between on and standby  Unit will remain in  standby mode when connected to AC power     w 7 Warning  Isolation of product from mains can only be achieved by  removal of external power cord     Alarm Silence   Reset Key    alarm condition  When no alarms are present  the alarm silence    X Press once to silence the audio for the alarm or acknowledge an     period will start for two minutes     my 7 Warning  Do not rely exclusively on the audible alarm system for  patient monitoring  Adjustment of alarm volume to a low level dur   ing patient monitoring may result in a hazard to the patient  Re   member that the most reliable method of patient monitoring com   bines close personal surveillance with correct operation of monitor   ing equipment    w F Warning  Do not place the FORE SIGHT MC 2000 Series Monitor  face against a surface  This wil
69. es should  follow in accordance with local hospital policies  The user should  ensure these policies do not conflict with any local  state  or fed   eral guidelines     Safety Checks    uc 7 Warning  Do not  under any circumstances  perform any testing or  maintenance on the monitor or power cord while the unit is being  used to monitor a patient  Unplug the power cord before cleaning  or servicing the monitor  The operator should not perform any ser   vicing except as specifically stated in this manual     w 5 Warning  The functions of the alarm system for monitoring of the  patient must be verified at regular intervals     w 5 Warning  Periodically  and whenever the integrity of the product is  in doubt  test all functions     yc 7 Warning  Do not use a frayed or damaged power supply cord or  any accessory if you notice any sign of damage  Contact CAS  Medical Systems  Inc   for assistance     uc 7 Warning  The use of accessory equipment not complying with the  equivalent safety requirements of this equipment may lead to a  reduced level of safety of the resulting system  Consideration relat   ing to the choice shall include       Use of the accessory in the patient environment       Evidence that the safety certification of the accessory has been  performed in accordance to the appropriate IEC 60601 1 and or  IEC 60601 1 1 harmonized national standard     w 7 Caution  Inspect the monitor  cables  and sensors for damage  prior to operation  If any damage is noted  the monit
70. eseeeesseeeenees 90  Figure 56  Battery Fuse Placement         rrrrarnnnnnnnnrrnnnrnnnnrnnrnnnnrnnnrr 91  Figure 57  Location of Internal Laser Labels            rrrrnnrnrnnrrrnnnennn 96  Tables  Table 1  User MCSSAGCS EA 64  Table 2  User messages on Philips IntelliVue            rrarrnrennrrnnrnnrn  69  Table 3  USB Status Messages           rarrrnnnrnnrnnranenanrrnnnnvanennnnnnnnnnnn 75  Table 4  FORE SIGHT MC 2000 Series Monitor Models              99    21 02 0217 Rev 08 03 09 Page 15    FORE SIGHT MC 2000 Series Monitor    This page is intentionally left blank    Page 16 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Safety  Safety    The operator must comply with the following Warnings  Cautions   and Notes to guarantee safe operation of the monitor  Additional   Warnings  Cautions  and Notes  which apply to specific parame    ters  are listed in the sections that pertain to each parameter     Indications for Use    The non invasive FORE SIGHT Cerebral Oximeter Monitor  MC   2000 Series should be used as an adjunct monitor of regional he   moglobin oxygen saturation of blood in the brain  When used with  FORE SIGHT Large sensors  the Cerebral Oximeter Monitor is  indicated for use with adults and children over 40 Kg  When used  with FORE SIGHT Small sensors  the Cerebral Oximeter Monitor  is indicated for use with infants and neonates 2 5 Kg and above   The Cerebral Oximeter Monitor should not be used as the sole ba   sis for decisions as to the diagnosis
71. ferent than the ones indicated in this section     You can change the language used for menus  dialogs  and  screen display     Note  After you change the language  menus display in the lan    guage you selected  You should select a language you can read at  least well enough to restore the display to the original language  as  the names of languages listed in the Language dialog change  too     To select a language    Turn the rotary control knob to select the Setup menu    Press the rotary control knob to open the Setup menu    Turn the rotary control knob to the right to select Languages     Press the rotary control knob a second time to open the  Languages dialog  Figure 25  page 52      Turn the rotary control knob to select the desired language     6 Press the rotary control knob to confirm the selection  The  focus shifts to the DONE button     7 Turn the rotary control knob to select the word    DONE    at  the bottom of the list of languages     8 Press the rotary control knob to change the focus to the  DONE button     9 Press the rotary control knob to save your changes  Select  the CANCEL button to cancel your changes     WN        O1    CANCEL    Figure 25  Languages dialog       Page 52 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Selecting the Serial Ports     Port selections may be different than the ones indicated in this section     You can change the Port settings for information transmitted and  received in and out the 4
72. ft FS L Signal Err  L Signal out of range    L Check tissue under sensor  L Not calibrated for probe type    R Ambient Light Warning FS R Chk Sensor  R Excessive Ambient Light FS R Amb Light    No Signal     Right FS R Signal Err  R Signal out of range    R Check tissue under sensor  R Not calibrated for probe type       21 02 0217 Rev 08 03 09 Page 69    FORE SIGHT  FS  Data Collections    FS information may be collected on a case by case basis  The  user will be reminded to start and stop data collection based on  current equipment state  Under the Miscellaneous Preferences  selection  refer to page 50  the user may choose to display auto   matic start stop FS Data collection reminders on the main screen     Note  Patient data for Left and or Right channels will be collected  based on the connection of the cables sensors and the laser state  at the start of FS Data collection  If one side is not connected or  the laser has not been turned on when FS Data collection is  started  data from that side will not be included in the FS Data Re   view     Note  If FS Data information is being collected  the FS Data text in  the bottom left corner of the trace area shall be green  If FS Data  information is not being collected  the FS Data text shall be white     Note  Starting and Stopping of FS DATA collection can be se   lected at any time  The user does not need to wait for the auto   matic popup reminders     Starting FS Data Collection    Note  Starting of the FS Data collectio
73. gineering personnel only must   g interface monitoring equipment with other types of medical equip   ment  Be certain to consult manufacturers    specifications to main   tain safe operation     21 02 0217 Rev 08 03 09 Page 19    Safety FORE SIGHT MC 2000 Series Monitor    IK Caution  Measurements may be affected in the presence of strong  electromagnetic sources such as electro surgery equipment     Note  The FORE SIGHT MC 2000 Series Monitor is designed for  continuous operation     Note  The FORE SIGHT MC 2000 Series Monitor is suitable for  use in the presence of electro surgery  however  measurements  may be inaccurate during use of such equipment     Note  The FORE SIGHT MC 2000 Series Monitor can remain  connected to the patient during cardio defibrillation  All applied  parts are  Type BF Defibrillation Proof        The monitor has been designed to promote patient safety  All  equipment parts are protected against the effects of the discharge  of a defibrillator  No separate actions are required when using this  equipment with a defibrillator     Device Handling    7 Warning  To ensure patient safety  do not place the monitor in any  position that might cause it to fall on the patient     w 5 Warning  Do not lift the monitor by any sensor cable or line as  they could disconnect from the monitor  causing the monitor to fall  on the patient     uc 7 Warning  To avoid electric shock or device malfunction  liquids  must not be allowed to enter the device  If liquids have 
74. igation     Copyright 2007 CAS Medical Systems  Inc  All rights reserved  No  part of this manual may be reproduced without the written permis   sion of CAS Medical Systems  Inc     Page 10 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor    Contents   TEEN save Ree a 3  CONAN Addres SES see 3  Manufacturers Declaration of Conformity 5  CE Marking Information             oraronrrrarernnrrrnnrranernnnrranrnnannnanennnnnnnnennn T  General Information            rrrarernnonnrrnnrrnnrnnnrrnnrnnnenanennnenannnnennuennnenneen 8  ABOUT I NIS Mantal oenen OO 9  Manual PUDOSE anne ER 9  intended AUdIENCE vi srieireni aay 9  CONIVEMMONS gerra A A 9  REVISION HISION usensurerte 10  Safety 17  indications for USErsesnsssane en annens ae 17  Coen SA 17  Installation  and SeUP anda 18  Device Handling 4 eee 20  SEN CMOCKS uekte 21  MONO id nate caesar octet ee cect nee Veneers Sets tn Peso ase se eases 22  Mial INSPEC oMr aa a G 24  MONGOLENE Sue 24  Patent EN ONE npor ite aoletuneae eteteh aa eeueteaweess 25  Monitor Classifications of Electrical Insulation                rrrrnrrrnnererr  25  Basic Operations 27  INFOAUCUON saadan EEEE EE dd 27  Geno Arned REESE EE EN SEE TEEN 27  PAYySiCal Gonlgualoh save win ies Meola sahel so teteutes  28  FONN ee en re ee 28  REE EN REE EE teat ota eho naan eta MG 29  Monitor Switches and Controls               ccccccceecceceseeeseeeeseeeeeeeeeeeeees 30  ROGEN CONMIGO  IK MOD 2 30  ON SUA DY K EY ere 31  Alarm Silence   Reset Key       rrr
75. igure 38  Saving to USB Progress         rrrrararanrrnnrrvnrrnrarernnnnnanennnr 74  Figure 39  Saving to USB Completed        rrrrrrrnnrrrnnrernnrennnrrnvnnernnn 75  Figure 40  USB Memory File Example                 ccccccseeeeseeeeneeeeeees 75  Figure 41  USB Status message display           rrrrnrrrnrrnrarernnrrnnnnnnre 76  Figure 42  Snapshot to USB    dialog           rrrrorrrnnrrnnrernrrnrarennnrnnnrr 76  Figure 43  Printer Controls and Indicators             rrrnrrrnnrrnnnrnvvnnrennn 78  Figure 44  Patient  gt  Print Menu dialog                 cccecceseeeeeeeeeeeeeeees 19  Figure 45  Tabular Print Example               ccccseccceeeeseeeseeeeeeeneeesaees 80  Figure 46  Tabular Screen Print dialog               ccccccceseeeeeeeeeeaeeeees 81  Figure 47  Tabular Full Case Print dialog                 ccccecceseeeeneeeees 81  Figure 48  Graphic Screen Print dialog                 ccceccseeeeeeeeeeeeeaees 82  Figure 49  Graphic Screen Print Example                     cccceeeeeeeeeees 82  Figure 50  Graphic Full Case Print dialog                 ccccccceeeeeeeeeeees 83  Figure 51  Graphic Full Case Print Example                    ccccseeeeeees 83  Figure 52  Paper Installation              rranrrnrrnnrrnnrrnnrrnnrnnervnnrrnnnrnnennnnn 84  Figure 53  Opening the Battery DOOr           rarrrararnnnnnanennnnrnnnrnnnnnnnnr 85  Figure 54  Installing the New Battery           rrrnrrnnrrnnrrnrrnnrrrnnrrnnnnnnnn 85  Figure 55  AC Fuse Placement                  ccccccseeeceeeeceee
76. imum output power rating of the  transmitter in watts according to the transmitter  manufacturer and dis the recommended separation  distance in meters     Field strengths from fixed RF transmitters  as deter   mined by an electromagnetic site survey    should  be less than the compliance level in each frequency  range     Interference may occur in the vicinity of equipment  marked with the following symbol      C D   NOTE 1 At 80 MHz and 800MHz  the higher frequency range applies   NOTE 2 These guidelines may not apply in all situations  Electromagnetic propagation is effected by absorption and reflection from  structures  objects and people     Field strengths from fixed transmitters  such as base stations for radio  cellular   cordless  telephones and land mobile radios   amateur radio  AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy  To assess the elec   tromagnetic environment due to fixed RF transmitters  an electromagnetic site survey should be considered  If the measured field  strength in the location in which the Model MC 2000 Series Monitor is used exceeds the applicable RF compliance level above   the Model MC 2000 Series Monitor should be observed to verify normal operation  If abnormal performance is observed  additional  measures may be necessary  such as re orienting or relocating the Model MC 2000 Series Monitor         Over the frequency range 150 kHz to 80 MHz  field strengths should be less than 3 V m     Recommen
77. in your area     21 02 0217 Rev 08 03 09 Page 85    Printer FORE SIGHT MC 2000 Series Monitor    This page is intentionally left blank    Page 86 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Cleaning    Cleaning    w 7 Warning  Do not  under any circumstances  perform any cleaning  while the monitor is being used to monitor a patient  The monitor  must be turned off  Unplug the monitor from the AC power source  and disconnect all accessories     w 7 Caution  Do not open the monitor to clean it     Caution  Do not immerse any part of the electrical connector of  the cable or accessories in the cleaning or disinfection solution at  any time  This may cause internal damage and reduce the prod   uct life     Em  hl    7 Caution  Do not use abrasive cleaners  isopropyl alcohol or or   ganic solvent for cleaning  Use of these cleaners can cause dam   age  stiffness and brittleness to the monitors    surface and to cables  and wires     Cleaning the Monitor    1    I Caution  Disconnect all accessories from the monitor before  cleaning     Examine the monitor s case for damage and check the AC power  cord for bent or broken prongs  cracks or fraying  Neither the  monitor nor the power cord should be used if damaged  If any  damage is noted  contact the appropriate service personnel     7 Caution  Do not spray or pour any water or cleaning solution di   rectly onto the monitor     e Housing  The monitor surfaces may be disinfected using a soft  cloth dampened with a 1
78. ion returns to normal range  i e     patient is no longer edemic   alarm message will  disappear and SctO2 measurement will return    Check patient for scalp edema    When tissue condition returns to normal range  i e     patient is no longer edemic   alarm message will  disappear and SctO2 measurement will return    21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations  Message Recommended Actions    System Alarms  Red on White      High Priority Alarms  Dead Battery Battery needs to be recharged Plug unit into outlet    Internal Temp Monitor is over operating tem  Shut down monitor and contact CASMED customer  Error perature range service    System Alarms  Yellow on Black      Medium Priority Alarms    Power Failure External power interruption or Press the alarm silence button to clear the mes   disconnected power cord  Ap  sage or turn monitor off and on again  plies only to units w o batteries       System Memory   Data storage has reached capac    Data is no longer being stored  Save your data and    Set Clock Clock has not been set Set date and time  See page 53   Clock Battery Clock battery needs to be re  Contact CASMED customer service  placed  Low Battery Battery needs to be recharged Plug unit into outlet  Loss of AC AC power loss  Unit operating on   Plug unit into outlet  Power Battery power  system Memory   Data storage is near capacity Save your data and clear the current data by se   Nearly Full lecting new patient  Full clear the curre
79. k Accessories and Options               104    21 02 0217 Rev 08 03 09 Page 13    FORE SIGHT MC 2000 Series Monitor    Page 14    Figures    Figure 1  Patient environment         rrnanrnnnnnnnnnnnnnnnnnnrnnnnnnnrnnnrnnnennnen 25  Figure 2  FONT VEN usciu aa a e aa 28  FOUE o  REA VEN LES 29  Figure 4  Clockwise and counterclockwise directions                    30  Figure 5  Main areas of monitor display                ccccccceecceeeeeeeeeeees 32  Figure 6  The Patient menu                    cccsccceecceeeceeeceeeceeeeeeeaeeeaees 33  Figure 7  The Profiles menu                ccccccceecceececeeeeeeeeceeseeeeseeeeaaes 33  Figure 8  The View menu        rrnnrrnnnrnnnnnnnnnnnnnnnnnnnnnnnnnnnnanenanennnennnen 34  Figure 9  The Event menu                  cccccccececeeeceeeceeeceeeseeseueeeeeeaeees 34    Figure 10   Figure 11   Figure 12   Figure 13     TRE Stup MeEN  keasian covacswun duets 34  TRE Help Men  er aenean 35  Help Menu   Display at system startup                   06  35  TMG Ao MEL 35    Figure 14  The default keyboard layout          rranrrnnnrrnnrnnnnrnnnnnnnnnnnnr 36  Figure 15  The extended keyboard layout        rrrrrnnnrnnnnnnrnnnrvnnennnrr 36  Figure 16  Connecting and disconnecting the monitor cable         41  Figure 17  Connecting the Patient cable            rrrnrrrnnrnrarernnrnnnnnnnre 43  Figure 18  On   Standby Key cecs ninaa aiei 46  Figure 19  Sensor Start   Restart key         rarrrarrrnnrrrarernnrrrarrrnnnnnnrr 47  Figure 20  Average   Auto   Left
80. l     Right sensor misplacement Reduce patient movement or patient sensor cable  Right Excessive patient sensor cable movement    movement  Right partial cable disconnections    Right patient sensor cable is de   fective    Right monitor cable is defective    L Ambient Light  Warning    Left Ambient light approaching  maximum value    R Ambient Light  Warning    Right Ambient light approaching  maximum value    L Signal out of  Range    Left Sensor on inappropriate ob   ject    R Signal out of    Range object    Tissue under sensor may have    under sensor fluid accumulation edema    Tissue under sensor may have  fluid accumulation edema    under sensor    Page 66       Right Sensor on inappropriate       Check to be sure that sensor is in direct contact  with the skin on the patient s forehead     do not  place over hair    Disconnect  clean fiber optic connection and re   connect monitor cable and patient sensor cable  connections    Replace patient sensor cable   Replace monitor cable   Check that sensor is in direct contact with skin and  that light block is in place    Readjust light block position to more fully cover  sensors    Check that sensor is in direct contact with skin and  that light block is in place    Readjust light block position to more fully cover  sensors    Remove sensor from inappropriate object and  place on patient forehead    Remove sensor from inappropriate object and  place on patient forehead    Check patient for scalp edema    When tissue condit
81. l cause the alarm to be muffled     Average   Auto   Left   Right Key       s Press to switch the current display to show patient readings for   A mi e Simple average of the left and right sensors     Automatic toggle between the right and left sensors  Left sensor  Right sensor    Note  The currently selected sensor is shown on the monitor     Note  When Auto numeric toggle is selected  the icon is shown  to the right of the currently displayed left or right sensor indicator     Note  FORE SIGHT software detects if a single sensor is con   nected to the monitor and will automatically display the numeric for  the side in use    Sensor Start   Restart Key    KR Press to start or restart sensors  You will be prompted with a mes       sage if you need to restart sensors     21 02 0217 Rev 08 03 09 Page 31       Basic Operations FORE SIGHT MC 2000 Series Monitor    Monitor Display    Parts of the Display Screen    The main elements of the monitor display are shown below in  Figure 5     Snapshot status indicator    USB status indicator  if USB  memory stick is installed                      Printer status indicator    Event Marker  if printer is installed     Main menu Patient    mode Battery status indicator    Patient Profiles View Event Setup Welp Mode selection button     Active or Historical   SctO2 High    Alarm Limit Left and Right    Alarm indicator area    SctO   High to  Low Alarm  Range    Data acquisition indicator    Auto Numeric toggle indicator    Left   Right   Av
82. ll enable snapshot of the screen to the USB memory ig  stick  When ready press the Alarm Silence Reset key to take a   snapshot     camera icon  as seen here to the right  will appear in the   tool bar when the snapshot is enabled  Once the snapshot is taken   the camera icon is removed     CANCEL    Figure 42  Snapshot to USB    dialog       Note  A camera icon  amp  will be displayed in the tool bar whenever the  Screen Snapshot feature is    On        Note  If    Done    is selected and no USB memory stick is installed  the  Screen Snapshot feature will not be enabled     Note  If the Screen Snapshot feature is On and the USB Stick is  pulled out before a Screen Snapshot is taken  the Screen Snapshot  feature will be turned Off     Pressing the Alarm Silence   Reset key will take a snapshot of the cur   rent screen and save it to the USB Memory Stick    If the Screen Snapshot feature is enabled  and an Alarm condition oc   curs  pressing the Alarm Silence   Reset key will take the snapshot   pressing the Alarm Silence   Reset key again will then acknowledge  that Alarm condition     Note  If a Screen Snapshot is not taken within 5 minutes  the Screen  Snapshot feature will be turned off     Page 76 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Printer    Printer    Introduction    21 02 0217 Rev 08 03 09    In the context of this Manual the FORE SIGHT Series Printer  the  Printer  refers to the Citizen Mobile Thermal Printer  Model CMP 10     For more detail
83. mount of charge  If the battery is at more than  30  of capacity  the amount of charge remaining is shown in  green  If it is at less than 30   it is shown in red  If the battery is  completely discharged  the battery icon is empty  with neither red  nor green showing  A fully charged battery will operate the Model  MC 2010 or 2030 unit for approximately 2 hours     Note  While the monitor software initializes  the monitor displays a  brief diagnostic text screen  then an animated FORE SIGHT  splash screen and then switches to the regular display  ready to  begin normal operation  You can dismiss the splash screen before  the animation finishes by pressing the rotary control Knob once     Note  A help dialog may open at system start  You can dismiss  this dialog by pressing the rotary control knob once  You may un   check the    Display at system start     to disable displaying this dia   log on system startup     Starting to Monitor a Patient    To start monitoring a patient   1 Ensure that all cables and sensors are in place    Note  Verify that right and left cables are properly connected by  noting the illuminated LED on each preamplifier box  The LED that  is illuminated indicates the cable connection at the monitor  If the  LED close to the blue face icon is illuminated  it indicates that the  monitor cable is connected for the patient s left side  If the LED  close to the green face icon is illuminated  it indicates that the  monitor cable is connected for the patient 
84. mply with the limits for medical devices  to the EN 60601 1 2  2002  Medical Device Directive 93 42 EEC   These limits are designed to provide reasonable protection against  harmful interference in a typical medical installation  This equip   ment generates  uses  and can radiate radio frequency energy  and  if not installed and used in accordance with the instructions   may cause harmful interference to other devices in the vicinity   However  there is no guarantee that interference will not occur in a  particular installation  If this equipment does cause harmful inter   ference to other devices  which can be determined by turning the  equipment off and on  the user is encouraged to try to correct the  interference by one or more of the following measures   e Reorient or relocate the receiving device   e Increase the separation between the devices   e Consult the manufacturer for help     IT Warning  If the integrity of the protective earth conductor is in  doubt  the unit may be operated from the internal batteries by dis   connecting the AC line cord completely from the unit     7 Caution  The Battery fuse must be installed for the unit to operate  with the internal batteries  If the unit is not to be used for periods  greater than 1 week  the battery fuse should be removed   refer to  page 89  Fuse Replacement     07 Caution  The USB connector accommodates a CASMED USB  memory stick  do not connect any other USB type device or cable     7 Caution  Qualified biomedical en
85. n  SctO2 measurements may be lower than expected     my   Warning  Misapplied sensors or sensors that become partially dis   lodged may cause either over  or under reading of oxygen satura   tion     w 5 Warning  To prevent damage  do not soak or immerse the sen   sors in any liquid solution  Do not attempt to sterilize     Kr Warning  Intravascular dyes or externally applied coloring may  lead to inaccurate measurements     uc 7 Warning  Elevated levels of carboxyhemoglobin  COHb  may lead  to inaccurate measurements     yc 7 Warning  Elevated levels of methemoglobin  MetHb  will lead to  inaccurate measurements     uc 7 Warning  Failure to apply sensors properly may cause incorrect  measurements     w 5 Warning  Do not modify or alter the SctO gt  sensor in any way  Al   terations or modification may affect performance and or accuracy     w 5 Warning  Do not apply the SctO gt  sensor to the patient s forehead  that has an internal temperature of greater than 39 2   C to prevent  possible damage to the patient s skin     17 Caution  Use only accessories and sensors approved by CAS  Medical Systems  Inc   to ensure patient safety and to preserve the  integrity  accuracy  and electromagnetic compatibility of the moni   tor     uc 7 Caution  Electrocautery     To prevent unwanted skin burns  apply  electrocautery electrodes as far as possible from all other sensors   a distance of at least 15 cm  6 in   is recommended     21 02 0217 Rev 08 03 09 Page 23    Safety FORE SIGHT MC 
86. n can only be selected if the  FS Data collection has been stopped     Once the sensor s  have been applied to the patient and the la   ser s  have been turned on for a set period of time  an automatic  popup reminder to Start FS Data collection may appear on the  main screen  refer to Figure 34  below   Selecting Yes  shall start  the collection of FS Data information and remove the popup re   minder  Selecting No shall remove the popup reminder and not  start the collection of FS Data information  Starting FS Data collec   tion may be accomplished by selecting Start FS Data Collection     under the Patent menu  refer to page 33      Start FS Data collection   lt  gt     HO      Figure 34  Start FS Data Collection popup dialog       Stopping FS Data Collection    Note  Stopping of the FS Data collection can only be selected if  the FS Data collection has been started     Once the sensor s  have been removed from the patient or the la   ser s  have been turned off for a period of time  an automatic  popup reminder to Stop FS Data collection may appear on the  main screen  refer to Figure 35  page 71   Selecting Yes  shall  stop the collection of FS Data information and remove the popup  reminder  Selecting No shall remove the popup reminder and con   tinue the collection of FS Data information  Stopping FS Data col   lection may be accomplished by selecting FS Data collection     under the Patent menu  refer to page 33      Page 70 21 02 0217 Rev 08 03 09    FORE SIGHT MC 200
87. ned to exclude ambient light   sensors  R Excessive Right patient sensor is not in cor    Check that sensor is in direct contact with skin and  Ambient light    rect contact with patient that light block is in place    Light block is not properly posi  Readjust light block position to more fully cover  tioned to exclude ambient light sensors    L SctO   cable     Left patient sensor or monitor Replace left patient cable if necessary  Sensor Error cable is defective Replace left monitor cable if necessary  R SctO   cable     Right patient sensor or monitor Replace right patient cable if necessary   Sensor error cable is defective Replace right monitor cable if necessary    L SctO gt  M cable   Left monitor cable is discon  Check left monitor cable connections    disconnect nected Clean fiber optic connections using CASMED   supplied cleaning tips  then reconnect left monitor  cable    Replace left monitor cable if necessary          1  Red on White  indicate Red text on White background  2  Yellow on Black  indicates Yellow text on Black background    3 After pressing the Alarms  Silence Reset  button  the   Excessive Ambient light  or No Signal     message may  be replaced with Press sensor start reset 1X 2X message  where   represents L Left or R Right     Page 64 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Message Recommended Actions  SctO  Equipment Alarm Messages  Yellow on Black      Medium Priority Alarms Continued    L SctO2P cable 
88. nitor Cables    Patient cables  see Figure 17a g  connect the monitor cables to  the patient  Patient cables are single use items  Use new patient  cables for every patient and discard after use     uc Warning  Do not lift the monitor by any cable or line as they could  disconnect from the monitor  causing the monitor to fall on the pa   tient     uc 7 Warning  Route and secure all cables away from patient s throat  to reduce the possibly of strangulation     uc 7 Warning  Conductive Connections     Extreme care must be exer   cised when applying medical electrical equipment  Many parts of  the human   machine circuit are conductive  such as the patient   connectors  electrodes  and transducers  It is very important that  these conductive parts do not come into contact with other  grounded  conductive parts when connected to the isolated patient  input of the device  Such contact would bridge the patient s isola   tion and cancel the protection provided by the isolated input  In  particular  there must be no contact of the neutral electrode and  ground     7 Caution  Inspect the cables and sensors for damage prior to op   eration  If any damage is noted  the cables or sensor should not be  used until it has been serviced or replaced     Note  The patient cable includes both an electrical cable and a  fiber optic cable  You must take care to ensure that the entire fiber  optic pathway is kept clean  Keep the patient cable in its original  package until you are ready to connect
89. normally blank   Sometimes a condition arises that causes the system to display a  message there  Table 1 lists the User Messages  the conditions  they signify  and the recommended action you should take  This  information can also be found in the Help Menu by pressing Error  Message Help     Table 1  User Messages    Message Condition Recommended Actions    SctO   Patient Alarms  Red on White      High Priority Alarms    Left SctO   Left SctO gt  reading exceeds user    Press alarm silence button to mute alarm for 30  HIGH selected High alarm limit seconds   Left SctO  Left SctO gt  reading is below user    Press alarm silence button to mute alarm for 30  LOW selected Low alarm limit seconds   Right SctO   Right SctO gt  reading exceeds Press alarm silence button to mute alarm for 30  HIGH user selected High alarm limit seconds   Right SctO   Right SctO gt  reading is below Press alarm silence button to mute alarm for 30  LOW user selected Low alarm limit seconds   R L SctO   Right Left SctO gt  differential ex  Press alarm silence button to mute alarm for 30  differential ceeds user selected differential seconds    alarm alarm limit       SctO  Equipment Alarm Messages  Yellow on Black       Medium Priority Alarms    L Excessive Left patient sensor is not in cor  Check that sensor is in direct contact with skin and  Ambient Light   rect contact with patient that light block is in place  Light block is not properly posi  Readjust light block position to more fully cover  tio
90. nplug this sensor and plug in a valid sensor    for probe type   the Right monitor cable that Contact CAS Customer Service if this should be a    SctO2 sensor Incorrect patient cable attached Discard incorrect patient cable and replace with  mismatch correct patient cable   Acquiring L Informational message Wait for message to clear  SctO   signal   Acquiring R Informational message Wait for message to clear  SctO   signal   Press sensor A single laser is off Press Sensor Start   Restart key twice  start restart 2X   Press sensor Both lasers are off Press Sensor Start   Restart key once  start restart 1X    Note A reminder tone of 2 quick beeps will be generated when the  Press sensor start restart  2X  or      1X  message is displayed  This tone is repeated every 10 minutes and can   not be muted     21 02 0217 Rev 08 03 09 Page 65    Basic Operations FORE SIGHT MC 2000 Series Monitor    SctO  Equipment Alarm Messages  Yellow on Black      Medium Priority Alarms Continued    Message Recommended Actions    L Check tissue    R Check tissue    No Signal     Left sensor Misplacement Reduce patient movement or patient sensor cable  Left Excessive patient sensor cable movement  movement Check to be sure that sensor is in direct contact    place over hair  Left patient sensor cable is de       fective Disconnect  clean fiber optic connection and re   PET NE AER connect monitor cable and patient sensor cable  connections  Replace patient sensor cable  Replace monitor cable  No Signa
91. nt data by selecting new patient  Internal Temp Monitor is beginning to overheat   Check for free flow of temperate air around monitor   Warning Move monitor away from wall or other obstruc     tion  Move it to a cooler area  If condition per   sists  contact CASMED customer service       Battery Supply Battery Fuse missing or blown  or   Install Battery fuse  See page 90   Inoperative battery harness disconnected   Contact CASMED customer service    Check Serial P1   Serial Communications problem Inspect the Serial P1 cable connections  Make sure  the Serial P1 cable connectors are properly en   gaged    Verify the FORE SIGHT Serial P1 settings are cor   rect     Verify target device is turned on and actively dis   playing information            Check Serial P2   Serial Communications problem Inspect the Serial P2 cable connections  Make sure  the Serial P2 cable connectors are properly en   gaged    Verify the FORE SIGHT Serial P2 settings are cor   rect     Verify target device is turned on and actively dis   playing information     Check Serial P3   Serial Communications problem Inspect the Serial P3 cable connections  Make sure  the Serial P3 cable connectors are properly en   gaged    Verify the FORE SIGHT Serial P3 settings are cor   rect     Verify target device is turned on and actively dis   playing information     21 02 0217 Rev 08 03 09 Page 67    Basic Operations FORE SIGHT MC 2000 Series Monitor  Message Recommended Actions    Popup Alarm  Red on White      High
92. ntifier with the data     To label data with the patient identifier     1 On the Patient menu  select New  The system asks if you  want to start a new patient and cautions you that answering  Yes erases all acquired data and starts a new session     Note  If a New Patient is selected  all collected FS Data informa   tion will be erased  refer to FORE SIGHT  FS  Data Collections on  page 70    2 Select Yes  The keyboard opens     3 Enter the patient identifier  up to 30 characters including  spaces  see Entering Text  page 35      4 Select the DONE button when you are done     5 Check the Enable FS Data collection box to enable FS Data  collection  refer to FORE SIGHT  FS  Data Collections on  page 70      Selecting a User Profile    On the Profiles menu  select the profile that you wish to use  If  none of the existing profiles is suitable  you can create and save a  new profile     To create and save a new profile   1 On the Profiles menu  select New   2 Enter the name of the new profile  up to 15 characters includ   ing spaces  see Entering Text  page 35    3 Select the DONE button when you are done     4 On the View and Setup menus  make any desired changes to  the current settings  See pages 48 and following      Page 38 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    5 On the Profiles menu  select Save     Alternate method   1 On the View and Setup menu  make any desired changes to  the current settings  see pages 48 and following    2 On
93. o USB enabled     Press Alarm Silence   Reset key to  save screen image to USB Memory stick    Battery Charge Level Indicator  Model MC 2010  amp  2030 only     Symbols near Accessory Connections    JEN Patient connections are Type BF   gt  Communication port RS 232 Connector    Symbols on Monitor    AN CAUTION  read instructions before using    Y Potential equalization post  This symbol appears here instead of on the unit   The first two digits of the unit s serial number indicate the year of  manufacture in the 21  century     PX Protection against ingress of water     The CE Mark and Notified Body Registration Number signify the de   C 4 0086 vice has met all essential requirements of European Medical De   vice Directive 93 42 EEC     x  Indicates this monitor is subject to the Waste Electrical and Elec   tronic Equipment Directive in the European Union     He   Ny Alternating current    fv    ve y Recycling suggested    Page 94 21 02 0217 Rev 08 03 09       FORE SIGHT MC 2000 Series Monitor Appendix    Symbols on Packaging    Lot number    Relative humidity for storage and transport    Do not reuse    Storage and transport temperatures       Do not Discard     Intended for multiple use    21 02 0217 Rev 08 03 09 Page 95    Appendix FORE SIGHT MC 2000 Series Monitor    Location of Laser Labels    Figure 57 below shows the location of the laser labels located in   side the monitor     pr Caution  Service performed by unauthorized personnel could be     damaging to the monit
94. od  This is appropriate  for example  if you are using the monitor  in a patient room and the bright display might interfere with the pa   tient s rest     To set the auto dim feature    Turn the rotary control knob to select the Setup menu    Press the rotary control knob to open the Setup menu    Turn the rotary control knob to the right to select Auto Dim   Press the rotary control knob a second time to open the Auto  Dim dialog  Figure 24  page 52     Press the rotary control knob to turn auto dim on or off    Turn the rotary control knob to the right to select the slider   Press the rotary control knob to activate the delay slider     Turn the rotary control knob to the left to reduce the delay or  to the right to increase it     9 Press the rotary control knob again to deactivate the delay  slider   10 Select the DONE button and press the rotary control knob to    save your changes  Select the CANCEL button to cancel  your changes     RR QN        CON    GO    21 02 0217 Rev 08 03 09 Page 51    Basic Operations FORE SIGHT MC 2000 Series Monitor  Auto Dim    Auto Dim   On         5 Minutes  DONE   CANCEL      Figure 24  Auto Dim dialog       Deactivating Auto Dim Temporarily    To temporarily deactivate the auto dim function  push any key or  turn the rotary control Knob  The monitor screen automatically re   turns to full brightness  Activation of an alarm also temporarily de   activates the auto dim function     Selecting the Language     Language selections may be dif
95. on  High Low limit violation  has occurred  An exclamation mark   1  after the AVG Average  value indicates the differential alarm condi   tion has occurred     Note  Event entries are indicated at the time they are entered     Page 80 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Printer    Tabular Print    When the Continuous Tabular Print selection is disabled  the user  must initiate the printing     To print the tabular data associated with information displayed on the  screen  Select Tabular Print type  Screen Print length  and then select  PRINT  see Figure 46  page 81      Print type Print length  C Graphic    Screen    w Tabular t Full case    Time scale        Continuous Tabular Print    PRINT   DONE   CANCEL      Figure 46  Tabular Screen Print dialog       To print all the tabular data associated with this patient  select Tabular  Print type  Full case Print length and then select PRINT as shown in  Figure 47 below     Print type Print length  C Graphic C Screen    w Tabular   Full case    Time scale        Continuous Tabular Print    PRINT   DONE   CANCEL         Figure 47  Tabular Full Case Print dialog    pr    7 Caution  Attempting to print a Full Case longer than 24 hours in tabu   lar mode will require more than 1 roll of 80  thermal paper     The progress bar will indicate the amount of data printed as a percent   age and a solid bar shall fill in from the left     Note  Once printing has started the user may exit this dialog at any  time and
96. onnection is for the use of CASMED service  personnel only     Note  The male RS 232 connector  upper right hand corner  can  be used to connect to the CASMED supplied printer  The remain   ing RS 232 ports are reserved for future applications     21 02 0217 Rev 08 03 09 Page 29    Basic Operations FORE SIGHT MC 2000 Series Monitor    Monitor Switches and Controls    Rotary Control Knob    The rotary control knob gives you access to on screen monitor  functions  You can     e Navigate through all menu selections   e Choose optional settings   e Enter data   The rotary control knob has two modes of operation     e Turn the knob to step through choices on the screen  e Push the knob to select a highlighted choice    You can turn the rotary control knob to the right  clockwise  or to  the left  counterclockwise           gt       Right  clockwise  rotation Left  counterclockwise  rotation    Figure 4  Clockwise and counterclockwise directions    Note  Turning the rotary control knob to the right  clockwise  ad   vances the selection on screen to the right when you are navigat   ing the menu  When you are navigating selections on a specific  menu  turning the knob clockwise advances the selection down  until you reach the bottom of the menu  then it starts over at the  top  When you are not on the menu bar  turning the knob clock   wise advances the selection to the next section of the display  in a  clockwise direction     Note  Turning the rotary control knob to the left  count
97. or and may void the warranty  Only person   nel authorized to do so by CAS Medical Systems  Inc   should re   pair the monitor    CAUTION CLASS 3B RADIATION WHEN  OPEN  AVOID EXPOSURE TO BEAM       Labels are located on each NSAM Board    Figure 57  Location of Internal Laser Labels    Note  CLASS 1 LASER PRODUCT   This product is designated for use solely as a component of the  Model MC 2000 Series Monitor and therefore does not comply with  the appropriate requirements of 21 CFR part 1040 10 for complete  laser products     This product complies with IEC 60825 1 2001    Page 96 21 02 0217 Rev 08 03 09    Warranty Policy    Monitors  FORE SIGHT Cerebral Oximeter     All products are sold by CAS Medical Systems  Inc   CASMED       under the warranties set forth in the following paragraphs  Such  warranties are extended only with respect to the purchase of this  product directly from CAS Medical Systems  Inc   or CASMED s  Authorized Distributors as new merchandise and are extended to  the first buyer thereof  other than for resale     The CASMED FORE SIGHT    Cerebral Oximeter monitor is war   ranted for a period of twelve  12  months  All products  if applica   ble  are warranted to be free from functional defects in materials  and workmanship and to conform to the description of the product  contained in the User Guide  published specifications  and accom   panying labels and or inserts  provided that the same is properly  operated under conditions of normal use in accordan
98. or should not  be used until it has been serviced  Only personnel authorized to do  so by CAS Medical Systems  Inc   should repair the monitor     p 7 Caution  If the monitor fails to respond  do not use it until the  situation has been corrected by qualified CAS Medical Systems   Inc   personnel     21 02 0217 Rev 08 03 09 Page 21    Safety FORE SIGHT MC 2000 Series Monitor    Monitoring    1   Warning  Conductive Connections     Extreme care must be exer   cised when applying medical electrical equipment  Many parts of  the human   machine circuit are conductive  such as the patient   connectors  electrodes  and transducers  It is very important that  these conductive parts do not come into contact with other  grounded  conductive parts when connected to the isolated patient  input of the device  Such contact would bridge the patient s isola   tion and cancel the protection provided by the isolated input  In  particular  there must be no contact of the neutral electrode and  ground     7 Warning  Do not come into contact with patients during defibrilla   tion  Otherwise serious injury or death could result     w 5 Warning  If the accuracy of any value displayed on the monitor is  questionable  determine the patient s vital signs by alternative  means  Verify that all equipment is working correctly     uc 7 Warning  Only use CASMED supplied patient cables with this  monitor  The use of unprotected patient cables creates the poten   tial for making an electrical connection to
99. p  Differential violation    Page 56 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Setting the Date and Time  You can change the date and time shown on the screen display  and associated with collected data        A Caution  You are not able to change the Time Date while monitor   ing a patient  Press the Sensor Start   Restart key once to stop  monitoring  select New Patient  refer to page 38  and then you can  change the Time Date     Note  Time is kept on a 24 hour clock     To change the date and time   1 Turn the rotary control knob to select the Setup menu   2 Press the rotary control knob to open the Setup menu   3 Turn rotary control Knob to the right to select Date  amp  Time   4    Press the rotary control knob a second time to open the Date   amp  Time dialog  Figure 27 below      Turn the rotary control knob to select the field to change   Press the rotary control knob to activate the selected field     7 Turn the rotary control knob left to lower the value in the field  or right to increase the value in the field    8 Press the rotary control knob again to deactivate the se   lected field    9 Repeat steps 6 through 8 to change any other fields that you  wish to change     10 Select the DONE button to save your changes  Select the  CANCEL button to cancel your changes     oO oO    Time  ER   25    9    Date   September    25    2007  DONE   CANCEL      Figure 27  Date  amp  Time dialog       To start monitoring a patient  refer 
100. perate the Printer or connect it to the Monitor with  the battery pack is removed      7 Warning  Never change the battery pack while the battery charger is  plugged in and or the Monitor is being operated     e Switch the Printer off     Page 84 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Printer    e Disconnect the Printer from the Monitor and unplug the wall  charger cord     e Open the battery door by pressing in on the battery cover and  pushing upward as shown in Figure 53 below        Figure 53  Opening the Battery Door  e Remove the battery cover     e Remove the battery pack from the compartment and disconnect its  connecting cable     Installing the new Battery Pack        Figure 54  Installing the New Battery  e Connect the battery cable into the battery connector     e Insert the battery and its connecting cable into the battery com   partment as shown in Figure 54 above     e Replace the battery cover by sliding it in from the back of the  Printer and pushing down to lock it in place      7 Warning  Do not disassemble the battery pack or batteries  The bat   teries contain electrolytes  which can cause injury to eyes  skin and  clothing       lt 7 Caution  Be sure to place the battery cover firmly in its position after  installing the new battery pack     Note  Under various state and local laws  it may be illegal to dispose  of this battery into the municipal waste stream  Check with your local  authorities for instructions on recycling options 
101. ppendix  Symbols    The following is a summary of all symbols used on the monitor and  accessories  Symbols may occur on the product or on its packaging     Front Panel Symbols    Power Indicator       Battery Indicator  Model MC 2010  amp  2030 only         Power  On  Standby     Alarms  Silence Reset     ir Left Right  Average        Sensor Start  Restart    Screen Indicators    Alarm turned off  yellow   Alarm paused  yellow     High Priority Alarm activated  flashing red     Medium Priority Alarm activated  flashing yellow     Laser active indicator  drop from the top down     Auto numeric toggle selected     left and right numeric values alter   nate automatically every few seconds        21 02 0217 Rev 08 03 09 Page 93    Appendix FORE SIGHT MC 2000 Series Monitor    ats Large Sensor connected to unit    Small Sensor connected to unit       White FS DATA     FS Data not being collected  Green FS DATA     FS Data being collected    Printer w White paper     Printer is available for printing   Printer w Green paper     Printer is currently printing   Printer w Yellow paper     The printer is either out of paper or the  cover is open  Add paper or close cover to resolve this problem   Printer w Red paper     Cannot communicate with printer  Check  printer cable and power    FS DATA    PP White USB memory stick     USB memory connected to monitor  Green USB memory stick     Currently saving data to USB memory  Red USB memory stick     USB memory stick error    ig Snapshot t
102. pter Plate   01 06 0237 FORE SIGHT Adapter Plate  01 06 0238  FORE SIGHT Roll Stand  with basket  amp  Handle  requires 01 06 0237 Adapter  Plate   01 02 0189 Citizen CMP 10 Mobile Printer  01 02 0188 Printer Battery  01 02 0481 Printer Paper 10 Cs  01 02 0266 Adapter for Printer Europe  01 02 0267 Adapter for Printer UK  01 02 0268 Adapter for Printer Australia  25 01 0124  FORE SIGHT Cable Bundler    Philips IntelliVue VueLink Accessories and Options    Description   Purchased directly from Philips  Philips VueLink Module AUXPLUS PN  M1032A  A05  Philips Interface Cable PN  M1032A  K6C  M1032 61699    Note  Philips contact information     www medicalphilips com  medical philips com    Catalog No  Description  01 06 2133  FORE SIGHT VueLink Extension Cable    Page 104 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Appendix    Notes     21 02 0217 Rev 08 03 09 Page 105    Appendix FORE SIGHT MC 2000 Series Monitor    Notes     Page 106 21 02 0217 Rev 08 03 09    
103. r cord     e Using a small screw driver  open the fuse cover on the AC Fuse  Compartment  see Figure 3  page 25     e Using a small screw driver  pull out the red fuse holder from the  AC Fuse compartment     e Remove the suspect fuse     e Place the new fuse into the fuse holder as indicated by the ori   entation in Figure 55 below     e Repeat this process for the fuse on the other side of holder     e Insert the fuse holder back into the power input receptacle  the  fuse holder can be inserted in either orientation      e Close the fuse cover on the AC Fuse Compartment   e There should be an audible click when it is secured   e Reconnect the power cord back to the monitor        Correct Placement Incorrect Placement    Figure 55  AC Fuse Placement    Page 90 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Maintenance    Battery Power Fuse    Note  Some units maybe equipped with an automatic Battery cut off  circuit that will disconnect the batteries when they are not being  charged  If this feature is installed  the removal of the Battery Power  Fuse is unnecessary  Please contact our Customer Service depart   ment to determine if your unit has this feature     Note  Failure to insert replace the Battery Power Fuse will result in  the following error messages   e System error has occurred     Please call service 1 800 227 4414  e Battery Supply Inoperative Call Service 1 800 227 4414  To replace the Battery fuse  proceed as follows   e Turn the monitor off and
104. rator should be positioned directly in the front of  the unit  facing the unit   s front panel     Note  To test the Alarm operation  connect a SctO   simulator   available through CAS  to the patient connection of the monitor   Set the High SctO gt  Alarm limits to at least 1  less than the current  displayed value and verify the activation of the High limit detection   Reset the High SctO   Alarm limits to the desired level  Set the Low  SctO   Alarm limits to at least 1  more than the current displayed  value and verify the activation of the Low limit detection  Reset the  Low SctO gt    Alarm limits to the desired level  Testing of the Alarm  operation should be done at least once every 6 months    Note  The High SctO    Left or Right channel  Limit can not be set  less than the Low SctO gt  Limit  for the same channel   The Low  SctO    Left or Right channel  Limit can not be set greater than the  High SctO gt  Limit  for the same channel   There is always 5  dif   ference between the Low and High limits  same channel      21 02 0217 Rev 08 03 09 Page 49    Basic Operations FORE SIGHT MC 2000 Series Monitor    Note  The alarm delay remains constant during any alarm condi   tion  The alarm delay may be altered by the User at any time and  only affects alarms yet to happen     Setting the Alarm Delay to 0 Seconds will cause an alarm to  immediately annunciate when a limit violation occurs   e g  If  the Low Limit is set to 50 and the  SctO   value falls below  50   the Low
105. rnnarnnnnnernnennnnnnnnnn 59  Adding a new Event Mark to the Patient Record                       60  Placing an Event Mark on the Patient Record                      0088 60  Placing or Deleting Existing Event Marks           rrranrnnnonnnrnnnrnnrr  61  Undo the Last Event Mark                  c ccccscccececeeeceeeceeecueeeeneaaees 62  Switching between Active and Historical Mode                     006 62  Reviewing Patient History                  ccccccceecceeeceeeceeeceeeseeseensaeees 63  Responding to System Messages                cccceeeeeeeeeeeeneeeeeeenees 64  FORE SIGHT  FS  Data Collections           rararnnrnnnrernnrrrarrrnrrnnnnnnnrr 70  Starting FS Data Collection             rrrrrrrarernnrrrnrrrrarevnnrnnannrnnennnnnn 70  Stopping FS Data Collection         rrrrrrrrnnrrnnrrnarernrerareranerarnnnnnn 70  Reviewing FS Data Information           rrrranoranrrnnrnranernnnnvnnennannnnnr 71  USB 73  MEMNON SUCKS i cee palate oe otis Goran sie coe at cnc oy alte Ra le cig a Needle ame 73  Saving Patient Data isc sseteesede teat et ahooduomlerueneuedcesun hatin biente  73  USB SPES Lue 75  Screen SNADSMOMS svar gade ed 76  Printer 77  MNLF OGUCUOM eee IT  Printer Controls and Indicators            rarrrnrrrrarernnrrrnnrranrnnnnrrnnrnnnnnnnne 78  PrinerOPreBAlonu drasse AS 78  Continuous  Tabular Pint urussaptaradeesasremiesdnad  n 79  Tabular Purse de  81  SPENNE 82  Charging the Printer Battery              rranrrnanrnnnnrnanrrnrnnranernnnrnanrnnnrnnnne 83  MSAMI PE e
106. rnnnrnnnnnnanenanrnnnnnnanennnnrnnnrnnnnennne 31  Average   Auto   Left   Right Key        rrrrarrnanrrnnnnnarrrnnrrnnnrnnnnnnnrr 31  Sensor Start   Restart Key        rrrarrnnnrnnnnornrnnrnnernnrrnanrnnnrnnnnennnnnn 31  Montor DISP   ee 32  Parts of the Display Screen           ranrrnanrnnnnnnanrnnnnevnnennnnnnanennnnennne 32  MENT NEVA er 32  The Patent MENS 33  The ProfileS  Meni circonda 33  The View Men avvek 34  TRE Event Menuuusuassutesrasbaududgdudjenidee dessadeontntl 34  TRE SEUP MON uns aged D 34  Te REID MENE 35  ENE TET 36  Setting Up the Monitor for the Patient            rrrrrrnnrnnrerarerareraneranenn 38  Labeling the Data with the Patient Identifier               rrrarerererirr  38  Selecting a User Profile             rrannnnnnnrnnnnrnnnrnnnnnnnnvnnnnnnnnnnnnnnnnnr 38  Connecting the Monitor Cables            arrranrrnnroranernnrrrnnrnranennnnnnannnnnr 39  Connecting the Monitor Cables for the First Time                     40  Removing the Monitor Cables         rrarrnnnrnnnnannnrnranennnnnnnnennannnnnr 40  Connecting the Patient Cables to the Monitor Cables                   42  Connecting the Patient Cables          rrrarrnnnrrrnnnnrarennnrnnannnanennnnnn 42    21 02 0217 Rev 08 03 09 Page 11    FORE SIGHT MC 2000 Series Monitor    Removing the Patient Cables         rrranrnnnnnnanrrnnnnvnnrnnnnnnnnrnnnnnnnnr 44  Affixing the SctO2 Sensor or Sensors to the Patient                     44  Preparing the Patent  sciteeistes eerste ceed ees 45  AD DIVING IDE 
107. s port can not be configured for  the Philips VueLink protocol     Note  The Baud Rate selection to interface to the Philips VueLink  defaults to 19200  The valid selections  when interfacing to a Phil   ips VueLink System  are 4800  9600 or 19200     6 Insert the VueLink Module into an unused slot on the Philips  IntelliVue Monitor     7 Connect the Philips Interface Cable to the VueLink Module     8 Connect the FORE SIGHT Extension Cable to the Philips In   terface Cable and then to the appropriate RS 232 communi   cation port on the rear of the monitor     9 Configure the Philips IntelliVue Patient Monitor to display  FORE SIGHT SctO gt  numeric  The following options are  available     LSctO   Left   RSctO    Right   ASctO    Average     21 02 0217 Rev 08 03 09 Page 55    Basic Operations FORE SIGHT MC 2000 Series Monitor    Note  Touch the area on the Philips Patient Monitor where the  FORE SIGHT numeric is to be displayed  The chosen FORE   SIGHT numeric label  amp  value will appear in the selected area   Note  If the FORE SIGHT value is invalid  dashed   a blank value  will appear on the Philips screen    Note  If the FORE SIGHT value is in alarm  the value will flash and  a corresponding red alarm message will be displayed on the Phil   ips IntelliVue Patient Monitor   Note  For additional information  refer to instructions supplied with  the Philips IntelliVue Patient Monitor and VueLink Module    Note  Limit violations have higher priority over equipment alarms  wh
108. s right side     Page 46 21 02 0217 Rev 08 03 09       FORE SIGHT MC 2000 Series Monitor Basic Operations    21 02 0217 Rev 08 03 09        3                 Note  The cable connection indicators  face icons  located on the  monitor screen under the SctO2 measurement indicate the connec   tion status of the cables  The black cutout indicates which cable the  icon pertains to  A colored face  blue for left  green for right  with a  smiling mouth indicates that the cables are fully connected     Left monitor cable connected  left patient cable not connected   A white face with a flat line for the mouth indicates that the monitor  cable is connected but the patient cable is not connected     Left cables fully connected  The blue face icon with the black  cutout on the right side of the icon pertains to the left patient con   nection     Right monitor cable connected  right patient cable not con   nected  A white face with a flat line for the mouth indicates that the  monitor cable is connected but the patient cable is not connected     Right cables fully connected  The green face icon with the black  cutout at the left side of the icon pertains to the right patient con   nection     Note  Be sure that the sensors are placed on the correct side of the  patient   s head  The patient sensor connected to the preamplifier  with the LED close to the blue face illuminated should be attached  to the patient   s left side  The patient sensor connected to the pre   amplifier with the LED 
109. sonal surveillance with correct operation of monitor   ing equipment     107 Warning  Do not place the FORE SIGHT MC 2000 Series Monitor  face against a surface  This will cause the alarm to be muffled     w 5 Warning  Do not place the FORE SIGHT MC 2000 Series Monitor  back against a surface  This will block the fan and cause the unit  to overheat  shutting it off     w 5 Warning  Do not place the FORE SIGHT MC 2000 Series Monitor  or accessories in any position that might cause it to fall on the pa    tient  Do not lift the FORE SIGHT MC 2000 Series Monitor by any   cable     uc 7 Warning  Do not place the FORE SIGHT MC 2000 Series Monitor    where the controls can be changed by the patient     107 Warning  Do not use the FORE SIGHT MC 2000 Series Monitor  for any purpose other than specified in this manual  Doing so will  invalidate the monitor s warranty     w 5 Warning  Do not connect more than one patient to a monitor        Warning  Leakage Current Test     The interconnection of auxiliary  equipment  including a patient monitor or other patient connected  equipment  with this device may increase the total leakage current   When interfacing with other equipment  qualified biomedical engi   neering personnel must perform a test for leakage current before  using it with patients  Serious injury or death could result if the  leakage current exceeds applicable standards     107 Warning  The FORE SIGHT MC 2000 Series Monitor is to be op   erated by qualified personnel only 
110. stick  select Save to USB     under the Patient menu  refer to Figure 37     Save to USE       File Name   2007 07 30 1D0 01  CSV EDIT    Save rate  gt  gt  gt     2 Seconds         save rate other than   seconds may result in some alarms and  event marks not to be saved in the file saved on the USB    memory stick     File Save   DONE CANCEL      Figure 37  Save to USB    dialog       Page 73    USB Operations FORE SIGHT MC 2000 Series Monitor    The FORE SIGHT Series monitor shall generate a unique default file   name  To change this default file name  select EDIT and then alter the  filename  see Entering Text  page 35      To change the Save rate  navigate to the slider bar and choose the  appropriate rate  2  4  6  8  10  12  14  16  18  or 20 sec     Note  Data is collect at a rate of 2 seconds  A save rate other than 2  seconds will not capture the entire data set and can result in some  alarms and event marks being lost    To save the patient data to the USB memory stick  select File Save   The progress bar will indicate the amount of data saved as a percent   age and a solid bar shall fill in from the left  refer to Figure 38     Save to USB       File Name   2007 07 30 I1D 01 CSV    Save rate LETE    2 Seconds         save rate other than 2 seconds may result in some alarms and  event marks not to be saved in the file saved on the USB    memory stick      QT SY  EEG    CANCEL      Figure 38  Saving to USB Progress       Note  Data saved to the USB memory stick inclu
111. t an authorized repair facility  or at the custom   ers    site  The sole and exclusive obligation of CAS Medical Sys   tems  Inc   and Buyer s sole and exclusive remedy under the  above warranties  is limited to repairing or replacing  free of  charge  a product which is reported in writing or via telephone to  CAS Medical Systems  Inc   has a Return Material Authorization   RMA  number assigned and which is returned during normal  business hours  transporting charges prepaid to     21 02 0217 Rev 08 03 09 Page 97    Appendix FORE SIGHT MC 2000 Series Monitor    CAS Medical Systems  Inc   44 East Industrial Road  Branford  CT 06405 USA    Telephone   1 203 488 6056  Fax   1 203 488 9438  E mail  custsrv casmed com    CAS MEDICAL SYSTEMS  INC  SHALL NOT BE OTHERWISE  LIABLE FOR ANY DAMAGES INCLUDING  BUT NOT LIMITED  TO  INCIDENTAL DAMAGES  CONSEQUENTIAL DAMAGES OR  SPECIAL DAMAGES     THERE ARE NO EXPRESS OR IMPLIED WARRANTIES WHICH  EXTEND BEYOND THE WARRANTIES HEREINABOVE SET  FORTH  CAS MEDICAL SYSTEMS  INC  MAKES NO  WARRANTY OF MERCHANTABILITY OR FITNESS FORA  PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCT  OR PARTS THEREOF     Page 98 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Appendix    Monitor Configurations    FORE SIGHT MC 2000 Series Monitor Models  Table 4  FORE SIGHT MC 2000 Series Monitor Models    CAS MC 2000 Dual Channel Cerebral Oximeter  CAS MC 2010 Dual Channel Cerebral Oximeter  with internal batteries option    CAS MC 2020 Dual Channel
112. t in an error message indicating the inability to connect to the  Port to the selected device     Page 54 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Connecting to Philips IntelliVue    The FORE SIGHT MC 2000 Series monitor may be connected to  a Philips IntelliVue Patient Monitor allowing remote display of cur   rent SctO gt  values and alarm messages     The FORE SIGHT MC 2000 Series monitor can interface with the  following Philips Patient Monitors using the proper VueLink module  and cables     Philips IntelliVue   MP40 50 60 70 80 and 90    Connecting FORE SIGHT to the Philips IntelliVue Patient Monitor  requires the following     1 FORE SIGHT minimum software requirements Version 4 4  2 Philips Hardware Requirements  e Philips IntelliVue Patient Monitor MP40 thru MP 90  e Philips VueLink Module AUXPLUS  PN M1032A  A05  e Philips VueLink Interface Cable  PN M1032A  K6C  Note  Philips contact information     www medicalphilips com  medical philips com  3 FORE SIGHT VueLink Adapter Cable  PN 01 06 2113  Note  Refer to Philips IntelliVue VueLink Accessories and Options  on page 104  for order information     4 Select an unused communications port  located on the rear  of the monitor  refer to Figure 3  page 29   for connection to  the Philips VueLink     5 Configure the selected communications port to Philips  VueLink using the procedure outlined in the Selecting the  Serial Ports section  on page 53     Note  The top right communication
113. ter  proper connection of both the monitor and patient cable to the  monitor  a low priority audio alert will be sounded  two quick  beeps   The audio alert is generated after 90 seconds has lapsed  with the cables and sensors set correctly but one or both lasers  are not firing  The alert repeats every 10 seconds and cannot be  muted     Removing the Sensors    If sensor is applied to the skin with an adhesive  carefully peel the  sensor from the patient to avoid damaging the skin  Discard ad   hesive sensors and used light block     If sensor is applied to the skin without an adhesive  carefully re   move the attachment mechanism from the patient to avoid damag   ing the skin  Discard attachment mechanism and used light block     21 02 0217 Rev 08 03 09 Page 45    Starting the Monitor    Turning the Monitor On    Note  You may turn the monitor on before or after connecting ca   bles and sensors     To turn the monitor on   1 Plug the AC power cord into a power outlet     2 Press the On   Standby key on the front of the monitor  The  unit will power up within a few seconds     C     Figure 18  On   Standby key    Note  Models MC 2010  amp  2030 are equipped with an optional in   ternal battery that allows you to turn the unit on without plugging it  into an outlet  The battery status indicator shows the amount of  charge remaining in the form of a colored bar filling the battery icon  at the upper right of the monitor screen  with the amount of fill cor   responding to the a
114. tient cables are single use items  Use new  patient cables for every patient and discard after use     Preparing the Patient  To prepare the patient   s forehead for placement of the sensor     1 Make sure the skin area where the sensor is to be placed is  clean  dry  intact and free of powder  oil or lotion     2 If necessary  shave hair from skin at chosen site     3 Use an appropriate cleanser to gently clean the intended  sensor site  Allow the skin to dry completely before applying  the sensors    Applying the Sensors    Apply sensor using the instructions provided in the sensor kit  package     1 Be sure that all cables are fully connected and sensors are  placed on the correct side of the patient s head   See Starting  to Monitor a Patient  page 46     2 Use the clip hook on the back of the preamplifier box  located  at the patient end of the monitor cable  to secure the cable to  a fixture  such as a rail  to prevent the cable from being pulled  away from the patient     Note  Apply the light block over the sensors before monitoring  If  the light block is not in place  an alarm will alert you that there is  too much ambient light     Note  The monitor can be used on one or both cerebral hemi   spheres  In most situations it is advisable to monitor both sides  as  some conditions can give rise to desaturation of one hemisphere     See sensor packaging for instructions on how to apply sensors to  patient     Note  As a reminder  if one or both lasers are not firing  af
115. to the Starting to Monitor a Pa   tient section on page 46 for more details     21 02 0217 Rev 08 03 09 Page 57    Basic Operations FORE SIGHT MC 2000 Series Monitor    Monitoring the Patient    This section assumes that you are familiar with the front panel con   trols  see Figure 2  page 28  and the parts of the display screen   see Figure 5  page 32      Selecting Average  Auto  Left or Right    You can switch the current display to show readings from the pa   tient s left hemisphere  readings from the patient s right hemi   sphere  a simple average of the two  or to automatically toggle be   tween the right and left hemisphere readings  Press the Avg   Auto    Left   Right button on the monitor front panel to rotate among  these views     Note  The monitor detects if a single sensor is connected to the  monitor and will automatically display the numeric from the side in  USE     Note  The cable connection indicators located on the monitor un   der the SctO  measurement indicate the connection status of the       cables  see Starting to Monitor a Patient  page 46  for more de     Right Patient  Connection        tails  The black cutout indicates which cable the icon pertains to   The icon with the black cutout at the left side of the icon pertains to  the right patient connection  the icon with the black cutout on the  right side of the icon pertains to the left patient connection  A white  face with a flat line for the mouth indicates that the monitor cable is  connected 
116. tor     7 Caution  Grounding reliability can only be achieved when the  equipment is connected to an equivalent receptacle marked    Hos   pital Grade        Note  The monitor is shipped with the appropriate line cord for the  country and voltage being used     Page 24 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Safety    Patient Environment    The FORE SIGHT MC 2000 Series Monitor has been tested with  specific parts of the system used within the patient environment   These parts are    e The FORE SIGHT MC 2000 Series Monitor    e Appropriate accessories as listed under Accessories  on page  103  at the back of this manual     e AC Power Cord       Figure 1  Patient environment    Monitor Classifications of Electrical Insulation    The FORE SIGHT MC 2000 Series Monitor  monitor version with  integrated AC power supply  is a Class I device  It is certified in  conformance with applicable portions of CFR Title 21 Chapter 1  subchapter J  Radiological Health     21 02 0217 Rev 08 03 09 Page 25    Safety FORE SIGHT MC 2000 Series Monitor    This page is intentionally left blank    Page 26 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Basic Operations    Introduction    The FORE SIGHT MC 2000 Series Monitor is a pre configured  monitor that can include the following measurement functions     e Absolute cerebral tissue oxygen saturation  SctO gt      The FORE SIGHT MC 2000 Series Monitor detects oxygenation  changes in biological
117. u can examine data on the patient trace of either Active or His   torical mode patient data with an event cursor   To select the event cursor    Turn the rotary control knob to select the Event menu    Press the rotary control knob to open the Event menu    Turn rotary control knob to the right to select Event cursor     Press the rotary control knob and an Event cursor is placed  over the trace     5 Turn the rotary control knob left or right to position the Event  cursor over the trace  A window along the bottom of the trace  will indicate the corresponding time and value of where the  Event cursor is positioned     6 Press the rotary control knob once more to exit  The Event  cursor and information window will be removed     KR QN        Patient Profiles View Event Setup Help    ACTIVE        SctO       0 Days 04 45 26   12 28 12   67     Jun 13 12 46  Figure 28  Positioning Event cursor  Adding an Event Mark to Menu    You can create a list of Event Marks to be used at any time  The  Event Marks shall be saved to the active Profile and can be used  to mark either Active or Historical mode patient data     To add a new Event Mark     Turn the rotary control knob to select the Event menu   Press the rotary control knob to open the Event menu   Turn the rotary control knob to select Add event to Menu     Press the rotary control knob and enter text to be placed on  the trace  up to 20 characters including spaces  see Entering  Text  page 35   note the Event name can be left 
118. wn in Figure 50 below     Page 82 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Printer    GHT     4 CASMED SOLUTION    PATIENT ID  _A123456 759  start Time  06 27  2007 10 00 49    End Time  06 27  2007 11 50 19    FORE S       Left Sctle     Right SetOz         Print type Print length    TEA    C Tabular Full case    Time scale        Continuous Tabular Print    FRINT   DONE   CANCEL      Figure 50  Graphic Full Case Print dialog       Note  If a graphic Full Case print is selected  the Time scale selections  are valid and the user is allowed to print the Full Case in a time scale  different than the current screen time scale  see Figure 50 above      10 08 13 10 15 43 10 23 13 10 30 43 11 37 13 11 44 43                      Figure 51  Graphic Full Case Print Example    The progress bar will indicate the amount of data printed as a percent   age and a solid bar shall fill in from the left     Note  Once printing has started the user may exit this dialog at any  time and the printing will continue     Note  To cancel the printing  select CANCEL or navigate to the Patient   gt  Print menu and then select CANCEL to stop the printing     Charging the Printer Battery    21 02 0217 Rev 08 03 09    The Printer is equipped with a rechargeable Lithium lon  LIION  bat   tery pack  When the Printer detects a Low Battery condition  the mes   sage    Low Battery    is printed and an audio indicator sounds three  times     7 Warning  Charge the Printer battery using the AC
119. y control  knob     Note  You can also switch into historical mode by selecting the  historical bar at the bottom of the plot area and pressing the rotary  control knob  However  you can only return to the active mode by  using the active  historical mode selection button     Page 62 21 02 0217 Rev 08 03 09    FORE SIGHT MC 2000 Series Monitor Basic Operations    Reviewing Patient History    The historical bar at the bottom of the plot area changes in length  as the session goes on  The length of the bar is proportional to the  fraction of the total history represented by the visible trace  For ex   ample  if you have selected to view a 30 minute interval and the  session has gone on for two hours  then the currently visible trace  represents one fourth of the total data and the historical bar is one   fourth the width of the window  The Active and Historical modes  have their own time scales  see The View Menu  page 34     To review patient history   1 Turn the rotary control knob to select the historical bar   2 Press the rotary control knob to activate the historical bar     3 Turn the rotary control knob left to scroll back through the  data or right to scroll forward toward the present     4 Press the rotary control knob again to release the historical  bar and navigate to another part of the screen     21 02 0217 Rev 08 03 09 Page 63    Basic Operations FORE SIGHT MC 2000 Series Monitor    Responding to System Messages    The message area at the bottom of the screen is 
    
Download Pdf Manuals
 
 
    
Related Search
    
Related Contents
Calefacción de apoyo  世知原地区公民館だより(PDF:1692KB)  Kanex HDMDPUS video converter  モバイルプロジェクター取扱説明書  TGL/TGM Edizione 2014 V1.0  ATOM 2.0 Operating Manual - 12-2698-r03    L150h L180H L220H - Volvo Construction Equipment  Operating Manual R&S UPV-K9/-K91  Drake Software User`s Manual: Tax Year 2010    Copyright © All rights reserved. 
   Failed to retrieve file