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1.               2  The monitor will be reset to the factory defaults     20 Model 515B C User s Manual Rev  02    SpO gt  Sensors    This section explains how to select an SpO  sensor  how to connect the sensor to the monitor   and how to apply the sensor to the patient        CAUTION  Connect only Novametrix saturation sensor extension cables and or  SuperBright    SpO  sensors to the Model 515B C Do not use other SpO  sensors or  accessories with Model 515B C  Before connecting to the patient or to the monitor   ensure that sensor extension cables and or sensors are physically intact  with no  broken  frayed or damaged components        To attach a SuperBright sensor or sensor extension cable to Model 515B C   1  Plug the connector into the front panel SoO   sensor input           SuperBright     SERIES CONNECTOR    The connector clicks into place when properly seated  Do not twist the connector  Sensors may  be connected or removed whether or not the monitor is turned on     2  To disconnect  press the latch release lever then pull the connector from the  monitor     PRESS DOWN ON LATCH RELEASE       THEN PULL OUT    Em mii    tit             Do not twist the connector     Rev  02 Model 515B C User s Manual 21    6 SpO gt  Sensors OxySnap    Connectors  OxySnap     Connectors    To connect an OxySnap extension cable to an OxySnap SuperBright sensor   1  Align the arrows on the OxySnap connectors and press the connectors together     FINGER GRIPS    AGDIIGOD GZ  mm EE le    O
2.             2  Set the rear panel power entry module switch to OFF     O      Remove the line  cord from the power entry module  if connected      3  Using a flat blade screwdriver  pry the fuse access door open to expose the  fuse housing  Note the orientation of the fuse housing  this determines the  mains operating voltage                                                   FUSE HOUSING       FUSE ACCESS DOOR    Model 515B C User s Manual 37    8 Maintenance Mains Voltage Configuration    4  Pry the fuse housing out from the power entry module                     FUSE HOUSING  NOTE  5mm X 20mm fuses are    installed toward the    back    of the  fuse housing as shown    3AG TYPE 5 X 20mm TYPE    5  Replace the blown fuse s  with the proper type and rating     6  Re install the fuse housing  When positioning the housing into the power entry  module ensure that it is oriented correctly  Press the fuse housing back into the    power entry module   7  Close the fuse access door and verify the proper mains operating voltage is  displayed   MAINS OPERATING VOLTAGE                      Changing the Mains Voltage Setting       CAUTION  Replace fuses with same type and rating  Verify proper fuse value for  mains voltage setting  see table below                  Mains Voltage   Fuses  Slo Blo   100 120 VAC 0 5 A 250V  200 240 VAC 250mA 250V                      1  Check that the monitor is OFF     2  Set the rear panel power entry module switch to OFF     O      Remove the line  cord 
3.   4    3  Gently squeeze the end of the ear clip  shown in diagram   and apply the  sensor to the patient   If a satisfactory reading cannot be obtained  rub the site and or use adhesive dots for better  response  The adhesive dots  PN  8700 00  included with the ear clips will also help in  preventing the ear clip from falling off  e g  during exercising         ADULT EAR    OPTIONAL PLACEMENTS       WARNING  Inspect the site often for adequate circulation   at least once every four  hours  When applying sensors take note of patients physiological condition  For  example  burn patients may exhibit more sensitivity to heat and pressure and therefore  additional consideration such as more frequent site checks may be appropriate              28 Model 515B C User s Manual Rev  02    Y Sensor Quick Check SpO gt s Sensors 6    Y Sensor Quick Check    1  With the Y Sensor connected to monitor but not applied to patient  position the  sensor heads so that they face each other  the red light shines at the detector    Is the d on the front panel flashing     2  Tape the Y Sensor to your index finger  Does the monitor show reasonable  SpO gt  and pulse rate values     3  A YES to BOTH  1 and  2 indicates that the sensor is OK  Apply the sensor to  the patient as instructed above  The quick check also tests the functionality of  the extension cable     Single Patient Use SpO  Sensors  The Single Patient Use SpO  sensors  Catalog Nos  6480 and 6455  can be used when    monitoring adult  
4.   The measured SpO  will appear in the display at the upper left of the front panel  the pulse rate  in the display at the lower left  The Model 515B C ensures that only valid pulsatile signals are  processed  Bad or invalid data causes alerts to occur and may also cause the displays to show              and             in the SpO  and pulse rate displays respectively     SpO   DISPLAY    Model 515C pulse oximeti    jae A8       A  a    S      PULSE BAR            PULSE RATE DISPLAY       The displays are updated once per second as the monitor is acquiring data  If the monitor cannot  detect a regular and rhythmic pulsatile signal for periods longer than 45 seconds  the display will  blank out              will be displayed in the SpO  and             in the Pulse rate displays   If the signal  should return  regular and rhythmic pulsatile data detected   then the display will update with  the new values     Rev  02 Model 515B C User s Manual 13    5 Monitor Operation    Pulse Activity Bar    When the Model 515B C detects a pulsatile signal that is too low to be processed after  previously receiving an acceptable signal and displaying data  the icon will illuminate  This  indicates that the SpO  and pulse rate data has been held since the last acceptable signal  If an  acceptable signal is not detected within 30 seconds  dashes will be displayed  the Ly  icon will  flash  and the appropriate status code will appear   See    Troubleshooting    on page 33      When the monitor 
5.   low alert limit can be adjusted from 95 50     5  Press the    key to increase the alert limit  or W to decrease the alert limit     6  Press the key again to exit the alert limits mode  or the monitor will  automatically return to normal display mode after ten seconds     16 Model 515B C User s Manual Rev  02    Alert Limits    Rev  02    Monitor Operation 5    To set the Pulse Rate alert limits       Press the  QJ  key once for setting the upper alert limit     To advance to setting the lower alert limit without adjusting the upper limit  proceed to step 4       The pulse rate display will show the currently set upper alert limit       Press the    key to increase the alert limit  or W to decrease the alert limit     The    in the pulse rate display area will illuminate red indicating that the upper alert limit  can be adjusted  The Pulse Rate upper alert limit can be adjusted from 250 35       Press the VC key again for setting the lower alert limit     The W in the pulse rate display area will illuminate red indicating that the lower alert limit  can be adjusted  The Pulse rate lower alert limit can be adjusted from 245 30       Press the    key to increase the alert limit  or W to decrease the alert limit       Press the VC key again to exit the alert limits mode  or the monitor will    automatically return to normal display mode after ten seconds     Auto Alert Limits    The auto alert limits can be set as soon as valid patient data is displayed     To set SpO  auto a
6.   monitor     2  To disconnect AC mains power  set the rear panel power switch to OFF  O    Check that the front panel    wu icon is not illuminated     NOTE  Removing the AC mains power will not charge the battery  See    Battery Operation    on  page 11     10 Model 515B C User s Manual Rev  02    Battery Operation    Rev  02    Preparing For Use 4    Battery Operation    The Model 515B C uses battery power if the line cord is disconnected or the rear panel power  switch is OFF  O   The monitor can operate for up to 8 hours while powered from its internal  battery  fully charged battery   The battery is charging only when the monitor is connected to  AC power  the rear panel power switch is ON  I   and the front panel     y icon is green        NOTE  Excessive alerting reduces battery life when operating on battery power        When the monitor is operating on battery power  and the battery is sufficiently charged  the  battery icon ES will be green  Should the battery power run low the icon will turn orange  If  the AC line is not connected and the monitor continues to run  the battery will become exhausted  and the icon will begin flashing red  the monitor will sound an audible alert then shortly turn  itself off        NOTE  This alert cannot be silenced by pressing the key  The monitor must be  connected to AC power to silence the alert condition and recharge the battery        If the monitor is allowed to continue operation while the battery is in the exhausted state  
7.   only set the alert volume  pulse volume and contrast cannot be adjusted when the monitor is  alerting    Contrast Control   Contrast adjustment for the graphics display on Model 515C monitors  not available on Model  515B  can be adjusted to the user   s needs  The contrast varies the difference in intensity between  the background and graphics in the graphics display window  This allows controlling the clarity  of the display in different lighting and temperature conditions   To adjust the contrast level    1  Press and hold the a key for three seconds     Rev  02    The SpO  window will display    Con     for contrast  while the monitor is in the contrast adjust  mode     Model 515B C User s Manual 19    5 Monitor Operation    Resetting to Factory Defaults    2  Press  4 to increase or w to decrease the contrast level     View the display with each depression to check if the contrast level is desirable       The Model 515C will return to normal display mode ten seconds after the last       or V key press  or sooner by pressing the or     keys   The new setting will remain in effect even after the monitor is turned off  This parameter is  stored in battery backed memory and will be reset to its default value if the monitor is reset to  factory defaults  see    Resetting to Factory Defaults    on page 20     Resetting to Factory Defaults    The monitor is set to the default values when shipped from the factory  Any changes made to  these values are retained even after the u
8.  3 boxes of any Y Strip Taping Systems  8793 24 Y 24 Plan  The plan warranty is 24 months   Includes 6 boxes of any Y Strip Taping Systems  8793 36 Y 36 Plan  The plan warranty is 36 months   Includes 9 boxes of any Y Strip Taping Systems  8744 12 Finger 12 Plan  The plan warranty is 12 months   8744 24 Finger 24 Plan  The plan warranty is 24 months   8744 36 Finger 36 Plan  The plan warranty is 36 months   Y SENSOR APPLICATORS  tapes  wraps  earclip   8828 20mm Wrap Style Y Strip Taping System  100 per box   Use on neonatal foot and hand  or on pediatric toe or finger  color coded blue   8829 25mm Wrap Style Y Strip Taping System  100 per box   Use on neonatal foot and hand  color coded green  8831 20mm Finger Style Y Strip Taping System  100 per box   Use on pediatric finger or on small adult finger  color coded blue  8832 25mm Finger Style Y Strip Taping System  100 per box   Use on adult finger  color coded green  8836 Non Adhesive Foam Wraps  25 per box   6131 50 Ear Clip  Pkg of 5   Includes 10 adhesive dots  6131 25 Ear Clip  Pkg of 25   Includes 50 adhesive dots  8700 00 Adhesive dots  Pkg of 200   For use with ear clip  MOUNTING SYSTEMS  140030 Wall Mount  140031 Wall Mount  less wall channel   140032 Pivot Block Mount  140033 Transport Mount  without swivel head        44 Model 515B C User   s Manual Rev  02    Accessories 1 0                                        Catalog No  Description   140034 Transport Mount  with swivel head    140035 Countertop Mount  11 inch
9.  Muting    The Model 515B C will sound an audible alert when any type of alarm condition is detected   This audible alert can be muted for a two minute duration  or disabled for the monitoring  session  The volume level of the audible alert tone can also be adjusted by use of the front panel  arrow keys     When the audible alert is disabled  there will be no sample tones when adjusting the alert  volume or pulse beep volume  See    Alert Volume Control    on page 18 and    Pulse Beep Volume  Control    on page 19        NOTE  Alarm tone for low battery cannot be silenced  To silence this alarm  connect the  monitor to AC power and set the rear panel power switch ON      Check that the AU icon  on the front panel is green              To mute the audible alert for two minutes     1  Press the key   2  The CH icon flashes yellow and any audible alerts sounding are muted     To cancel two minute mute     1  Press the key   2  The CH icon is off  any alerts that are active will sound an alarm tone      To disable alert audio     1  Press and hold the key until the    icon illuminates  approximately three  seconds      To enable alert volume   1  Press the key  andthe E icon will turn off     Alert Volume Control    The volume level of the monitor   s audible alert is user adjustable  from level one through level  seven   The alert volume feature cannot be used to eliminate audible alerts because the alert is  still audible at its lowest setting  To silence audible alerts  use th
10.  base    140036 Countertop Mount  5 inch base    140037 Portable Instrument Housing   140038 Rollstand   7106 10 Transport Pouch  for monitor    7104 10 Side Accessory Pouch   6318 00 Kickstand Kit for Model 515B or 515C monitors  600026 Power cord  included with monitor    6342 32 English   6436 32 Spanish   6435 32 French   6365 32 German   280022 13    chain  used to attach reference card to the monitor    EXTENDED WARRANTY     Normal warranty on monitor   1 year                    6500 81 Model 515B warranty extended an additional 1 year   6500 82 Model 515B warranty extended an additional 2 years   6550 81 Model 515C warranty extended an additional 1 year   6550 82 Model 515C warranty extended an additional 2 years   5530 00 TB500B SpO  Test Box   9999 96    focus    Technical Training Seminars  Pulse Oximetry  1 day course        Rev  02 Model 515B C User s Manual 45    10 Accessories     This page intentionally blank      46 Model 515B C User s Manual Rev  02    
11.  battery power is required              NOVAMETRIX MEDICAL SYSTEMS INC   WALLINGFORD  CONNECTICUT U S A        CAUTION  FEDERAL  U S A  LAW RESTRICTS ia  TO SALE  DISTRIBUTION  OR USE BY Qi  A LICENSED MEDICAL PRACTITION                   CAUTION  EQUIPMENT MS  RA DANGEROUS E          The AC power line cord shipped with monitors for North America is a Hospital Grade  SJT style  cord with a 120 VAC plug  All power line cords shipped with monitors for Europe are the  European style with a 220 240 VAC plug  All other style power line cords  as required by the  country of destination  are provided by the distributor of that country        1  The internal battery may slowly discharge over long periods of non use     36 Model 515B C User s Manual Rev  02    Mains Voltage Configuration Maintenance 8    Rev  02    Mains Voltage Configuration    The rear panel power entry module indicates the mains voltage setting for the monitor  Check  that the voltage is correct before attaching the line cord and powering the monitor  The Model  515B C can be set to operate from 100 120 VAC 50 60Hz or 200 240VAC 50 60Hz     Refer to the following sections for fuse replacement and changing the mains voltage setting     Fuse Replacement       CAUTION  Replace fuses with same type and rating  Verify proper fuse value for  mains voltage setting  see table below                  Mains Voltage   Fuses  Slo Blo   100 120 VAC 0 5 A 250V  200 240 VAC 250mA 250V    1  Check that the monitor is OFF           
12.  beat is proportional to the strength of the signal  for low to medium signals  and is adjusted to fit the graph for large signals  This pulse activity  bar represents the patient   s pulse and should show regular rhythmic movement  Erratic or non   rhythmic movement may indicate a poorly positioned or applied sensor  or may be indicative of  excessive patient movement at the sensor site  Check the sensor site and if necessary  attempt to  reduce patient movement            SIGNAL BAR         A    S aed  Ie  waa BY    Plethysmogram Display    The Model 515C version includes a display for a plethysmogram  pulsatile waveform   The  plethysmogram display is a graphic representation of the pulsatile signal as detected by the  sensor  The display is continually updated from left to right  The amplitude of the  plethysmogram is proportional to the strength of the pulsatile signal for low to medium signals   and is scaled to fit the window for large signals     14 Model 515B C User s Manual Rev  02    Alert Limit Violations    Rev  02    Monitor Operation 5    PLETHYSMOGRAM DISPLAY   MODEL 515C ONLY           Alert Limit Violations    When the Model 515B C detects SpO  or pulse rate values that exceed either the high or low  limits  both an audible alert tone and visual alerts are generated  The audible alert can have its  volume adjusted  be muted for two minutes  or be disabled  see    Audible Alert Muting    on page  18   The visual alerts are the red alert bar  the limit arrows 
13.  e Do not attempt to sterilize Y Sensor except as stated above    e Do not immerse connector on the Y Sensor    e After cleaning sterilizing the Y Sensor  verify the sensor is physically intact  with no  broken frayed wires or damaged parts  Ensure the connectors are clean and dry  with no  signs of contamination or corrosion  Do not use a broken or damaged sensor or one with  wet  contaminated  or corroded connectors     Model 515B C User s Manual 35    8 Maintenance Battery Maintenance    e Perform a    Quick Check    to verify the integrity of the sensor  See    Y Sensor Quick  Check    on page 29     Y Sirip Tapes and Single Patient Use SpO  Sensors    e Treat Y Strip tapes and Single Patient Use sensors in accordance with hospital protocol  for single patient use items     Ear Clip    e Clean the ear clip with a cloth dampened with 70  isopropyl alcohol  After cleaning  wipe the ear clip down thoroughly with a clean water dampened cloth to rinse     e Do not immerse the ear clip    Battery Maintenance    If the monitor has not been used or powered by AC mains for an extended time   3 months or  more  allow the battery to charge for 12 hours before use  The monitor may not power up on  battery power if the battery is not sufficiently charged     To charge the battery  connect the AC mains and set the rear panel power switch ON  I   Check  that the front panel    Wy icon is green  Allow the battery to charge for 12 hours to ensure a fully  charged battery in the event that
14.  functional saturation     Pulse Rate is calculated by measuring the time interval between peaks of the infrared light  waveform  The inverse of this measurement is displayed as pulse rate     The oxygen saturation and pulse rate values are updated once each second  Presence of a pulse  is indicated visibly by a bar graph display  a plethysmogram graphic display  Model 515C only    and audibly by a    beep        The Model 515B C must be used in conjunction with SuperBright    Sensors  See     Accessories    on page 43 for a list of available sensors and accessories     Model 515B C User s Manual 1    1 Description Trademark Acknowledgments    Trademark Acknowledgments    SuperBright  Y STRIP and Y SENSOR are trademarks of Novametrix Medical Systems Inc     2 Model 515B C User s Manual Rev  02    Rev  02    Patient Safety    Pulse oximetry is a non invasive method of monitoring the oxygen saturation of arterial blood   Pulse oximeters display oxygen saturation of functional hemoglobin and therefore the accuracy  may be interfered with by carboxyhemoglobin or other dyshemoglobins present in significant  concentrations  Oxygen saturation monitoring is intended to be used in a variety of clinical  situations  including  but not limited to respiratory therapy  anesthesia  intensive care  and  emergency     The Model 515B C Pulse Oximeter has electrically isolated inputs  Patient leakage current  flowing from the instrument to ground is limited to less than 10 uA at 120 V  60 Hz  
15.  high or low   and the out of range  numeric value  The red alert bar will flash indicating an alert condition  A limit arrow  either  high or low  will flash in the violated parameter   s window  either SpO  or pulse rate   The  numeric value which is out of range will also flash     If the alert condition no longer exists  the alerts will stop  however the limit arrow will flash until  acknowledged  by pressing the alert reset key el  Pressing the la  key while the alert  condition exists will temporarily disable the red alert bar for ten seconds  after which the bar  will begin to flash again if an alert condition is still present  NOTE  Pressing the lx  key will  also affect the two minute silence or audio disable     HIGH LOW INDICATORS ALERT BAR         olaja als                  ALERT RESET AUDIO KEY    For example  if the monitor detects a violation of the lower SpO  value  An audible alert tone  will sound  provided the audio has not been muted or disabled   The red alert bar  the low limit  indicator W in the SpO  display window  and the SpO  numerical value will flash  Assuming  the audio has not been disabled or muted  pressing the Ed key will silence the alert tone and  temporarily disable the alert bar flashing  If the violation is not corrected  the red alert bar will  begin to flash again after ten seconds from the release of the la  key  If the la  key is not  pressed when the alert occurs  and the violation is corrected  only the low indicator arrow and  the
16.  numeric value will flash until the lx  key is pressed to acknowledge the alert violation     Model 515B C User s Manual 15    5 Monitor Operation Alert Limits    Alert Limits    The monitor is shipped from the factory set to the default alert limits  SpO   high   100  low    85  Pulse Rate  high   150  low   40   If the limits are changed and the monitor is turned off  the  changed values will be used when power is reapplied  alert limits are retained in battery backed  memory   The alert limits can be reset to the factory defaults at any time when the monitor is  powered up  see    Resetting to Factory Defaults    on page 20     The Model 515B C SpO  and pulse rate alert limits can be set manually  or the monitor can  automatically set these limits based upon the values being detected  When any alert limit is  violated  the monitor will indicate an alarm condition  The red alert bar  the arrow that  corresponds to the violated alert  upper or lower arrow   and the corresponding numeric value   SpO  or pulse rate  will flash  An audible alert will also sound  provided it has not been  disabled        NOTE  The SpO   sensor must be connected to the monitor  then attached to a patient   and valid SpO  data must be acquired before the alert audio will sound or the alert bar  will flash to indicate any alert conditions that may exist              Manually Setting Alert Limits   Once the monitor has completed its power up sequence and is operating normally  the alert limit  value
17.  which  occur during monitoring        LGS E    SpO  key   Sets saturation alert limits when  used with the   a w keys  Press and hold  to set auto alert limits     Hand icon   Yellow when monitor is search   ing for valid signal and data is being held        Increase decrease keys   Press to set pulse  and alert audio level  Sets alert limits when  used in conjunction with SpO  and Pulse  keys  Press and hold to control graphics dis   play contrast on Models 515C  Model 515B  does not have graphics display option      Audio disabled icon   Flashes yellow when  the audio has been disabled        Two minute silence indictor   Illuminates  yellow when the audio has been muted for  two minutes        Go       Saturation and pulse rate displays   Satura   tion and pulse rate values will appear  Status  messages will appear if necessary  see     Troubleshooting    on page 33  Arrows indi   cate alert status or that alerts are being set        MMM  e A eSB                   Signal bar   Pulses with respect to moni   tored pulse rate  Amplitude corresponds to  signal strength        Model 515B C User s Manual 7       3 Front and Rear Panel Illustrations       NOVAMETRIX MEDICAL SYSTEMS INC   WALLINGFORD  CONNECTICUT U S A     ene   aS  S A  LAW RESTRICTS THIS DEVICE  O SALE  DIS ION  OR USE BY OR ON THE ORDER OF  D UCENSED MEDICAL PRACTITIONER     CAUTION  EQUIPMENT MUST BE GROUNDED AT ALL TIMES  TO AVOID DANGEROUS ELECTRICAL SHOCK HAZARD     POWER PATENT  1p0 120 200 240 VAC 50 60H
18. 5B C in the presence of flammable  anesthetics  Use of this instrument in such an environment may present an explosion  hazard    Electrical Shock Hazard  Always turn the oximeter off  and remove the AC power cord  before cleaning it  Do NOT use a damaged sensor or one with exposed electrical contacts   Refer servicing to qualified service personnel    Patient Safety  Extreme care should be exercised with neonates to assure continued  circulation distal to the sensor site after application     Failure of Operation  If the oximeter fails to respond as described  do not use it until  the situation has been corrected by qualified personnel   Data Validity  The Pulse Oximeter should NOT be used as a substitute for an ECG  monitor  The oximeter   s Pulse Rate display reflects the pulsatile flow found at the patient  extremity connected to the sensor  This rate can be affected by many factors and may  occasionally be    frozen      Care should be exercised to assure continued peripheral perfusion distal to the SpO   sensor site after application   Data Validity  Do NOT attach a sensor distal to a blood pressure cuff  Valid data  CANNOT be processed when the cuff is inflated  Attach the sensor to the limb opposite  to the site used for the blood pressure cuff   Data Validity  Inaccurate SpO  and or Pulse Rate measurements can be caused by any  of the following   e Incorrect application or use of a sensor  e Significant levels of dysfunctional hemoglobins such as  carboxyhemoglobin o
19. An audible    beep    occurs with each detected pulse  beat  The time between beeps indicates the pulse rate     The pitch of the beep varies with the SpO  value  While SpO  is greater than or equal to three  digits below the SpO  high alert limit setting  the highest pitch tone sounds  The beep   s pitch  decreases with each one digit drop in SpO gt  below that level  If the SpO gt  value drops more than  28 percent below the SpO  high alert limit setting  the beep remains at the lowest pitched level     To adjust the pulse beep volume     1  Press the e key to display the current pulse volume level    The SpO  window will display    PUL     for pulse   and the pulse window will display the pulse  volume level that is currently selected    2  Press    to increase or we to decrease the pulse volume level  Each time  the    or w key is pressed  a short sample tone will sound at the current  volume level   The sample tones will not occur if the audible alert is disabled   di illuminated     3  The Model 515B C will return to normal display mode ten seconds after the last      of e key press  or sooner by pressing the or  Q  keys   The new value will remain in effect even after the monitor is turned off  This parameter is stored  in battery backed memory and will be reset to its default value if the monitor is reset to factory  defaults  see    Resetting to Factory Defaults    on page 20   NOTE  If the    and     keys are pressed while the monitor is sounding an alert  they will
20. Model 515B and 515C    Pulse Oximeter    This manual covers Model 515B  Cat  No  6500 00  and Model 515C  Cat  No  6550 00     April 17  1996  Catalog No  6500 23 02  6550 23 02    Novametrix Medical Systems Inc  Wallingford  Connecticut  U S A  06492   Copyright   1995  1996  All rights reserved  No part of this manual may be reproduced  without the written permission of Novametrix Medical Systems Inc  Printed in U S A     Revision History    29 Mar 95 Release at revision 00  11 Apr 95 Updated to revision 01  corresponds to software version 02    17 Apr 96 Updated to revision 02  R N389   Addendums A and B incorporated  also Single  Patient Use SpO  sensor information added  use with software version 04     Rev  02 Model 515B C User s Manual H     This page intentionally blank      iii  Model 515B C User s Manual Rev  02    Rev  02    G Guarantee    Equipment manufactured or distributed by Novametrix Medical Systems Inc   is fully  guaranteed  covering materials and workmanship  for a period of one year from the date of  shipment  except for certain disposable products and products with stated guarantees other than  one year  Novametrix reserves the right to perform guarantee service s  at its factory  at an  authorized repair station  or at the customer   s installation     Novametrix    obligations under this guarantee are limited to repairs  or at Novametrix    option   replacement of any defective parts of our equipment  except fuses  batteries  and calibration  gasses  
21. NOT force the sensor onto  large objects such as a bedrail              Finger Sensor Quick Check  1  Is the d flashing when the sensor is connected to the monitor but not  applied to the patient     2  Apply the sensor to your index finger  Are reasonable SpO   and pulse rate  values displayed     3  A YES to BOTH  1 and  2 indicates that the sensor is OK  Apply the sensor to  the patient as instructed above  The quick check also tests the functionality of  the extension cable     Rev  02 Model 515B C User s Manual 23    6 SpO gt    Sensors Y Sensor    Y Sensor    The reusable Y Sensor is a flexible sensor designed for use on any patient                                      The Y Sensor   s Center Strip is not a functional part of the sensor  Its twofold purpose is to aid  in the placement of the sensor into the Y Strip or other securing system and to limit the distance  between the sensor heads to no more than 25 mm  The center strip may be removed  carefully  cut away  if the distance between the sensor heads needs to be reduced to less than 25 mm               SENSOR HEADS          STRIP MAY BE REMOVED       24 Model 515B C User s Manual Rev  02    Y Sensor Application using Y Strip Tapes  or Foam Wrap SpO gt s Sensors 6    Y Sensor Application using Y Strip Tapes  or Foam Wrap  1  Select a Y Strip or foam wrap based on the patient type and intended sensor  location     Y Strips come in two color coded sizes  25 mm tapes have green liners  and 20 mm tapes have  blue liner
22. Patient  isolation is greater than 10 MQ  2500 V rms at 60 Hz  For maximum patient and operator safety   the following procedures are recommended     e Failure of Operation  If the monitor fails to respond as described  do not use until the  situation has been corrected by qualified personnel    e Keep the monitor and its accessories clean    e Do not operate the monitor when it is wet due to spills or condensation    e Do not operate the monitor if it appears to have been dropped or damaged     e Connect the line cord only to a grounded hospital grade outlet  The Model 515B C  should be connected to the same electrical circuit as other equipment in use on the  patient  Outlets on the same circuit can be identified by the hospital   s engineering  department     Indications and Usage    The Model 515B C is intended to be used for monitoring functional oxygen saturation and  pulse rate in circumstances where it is desirable to monitor patient oxygenation  The monitor is  designed to monitor all patients including adult  pediatric  and neonatal  The Model 515B C is  not intended for any other purpose        NOTE  Components of this product and its associated accessories which may have patient  contact are free of latex              Model 515B C User s Manual 3    2 Patient Safety    Warnings    Warnings    4 Model 515B C User s Manual       Warning  Indicates a potentially harmful condition  that can lead to personal injury              Explosion Hazard  Do NOT use the Model 51
23. ads are directly opposite each other through the tissue  This prevents  the sensor from being placed on a site too thick  high arch  for proper operation     Position the sensor so that the tape does not extend over the space between the fingers or toes  to insure that there will be no light transmission through this space     6  To maximize sensor life  secure the cable along the limb with tape as shown in  the illustrations     26 Model 515B C User s Manual Rev  02    Y Sensor Application using Ear Clip SpO gt s Sensors 6    Leave slack in the wires between the tape and the sensor     ADULT PEDIATRIC FINGER NEONATAL HAND          NEONATAL PEDIATRIC FOOT PEDIATRIC TOE       WARNING  Do not wrap the tape around the limb so tightly that circulation is restricted   Inspect the site often for adequate circulation   at least once every four hours  When  applying sensors take note of patient   s physiological condition  For example  burn  patients may exhibit more sensitivity to heat and pressure and therefore additional  consideration such as more frequent site checks may be appropriate              Y Sensor Application using Ear Clip    1  Remove center strip from the Y Sensor                  SENSOR HEADS    Rev  02 Model 515B C User   s Manual 27    6 SpO gt  Sensors Y Sensor Application using Ear Clip    2  Slide each Y Sensor head into the ear clip   s receptacles  the heads should face  each other     ey SENSOR HEAD     A    EAR CLIP RECEPTACLE    SQUEEZE HERE TO APPLY D gt
24. attery                  NOVAMETRIX MEDICAL SYSTEMS INC   WALLINGFORD  CONNECTICUT U S A   CAUTION  FEDERAL LAW RESTRICTS THIS DEVICE    DE LSA   WEIT DISTRIBUTION OR USE BY OF ON THE ORDER OF  A LICENSED MEDICAL PRACTITIONER          CAUTION  EQUIPMENT MUST BE GROUNDED AT ALL TIMES    TO AVOID DANGEROUS ELECTRICAL SHOCK HAZARD   POWER  100 120 200 240 VAC 80 80Hz WVA    d     5 190 038             REAR PANEL POWER SWITCH    f  A AC POWER CORD    3  Press the front panel power key cl The monitor will power up in the following  sequence   e An audible series of beeps will be produced   e All displays and LEDs will briefly illuminate           TT    aus             The monitor will perform a self test  then the revision level will appear in the saturation  display  the model number    515    will appear in the pulse rate display  and a beep will  coincide with a flash of the alert bar            OH  515             The monitor will enter normal operating mode  With the sensor disconnected  or  connected but not applied to a patient  the SpO  and pulse rate windows will  display                 4  Ensure that the monitor is operating in accordance with the above listed steps  before applying the sensor to the patient     Monitor Power Down    1  To turn the Model 515B C off  press the key     Pressing the front panel power key will turn the monitor on off  The green AC indicator will stay  illuminated signifying that although the monitor is off  AC mains is still connected to the
25. cm   Width  9 inches  22 86 cm   Depth  8 inches  20 32 cm     Electrical   e Power  100 120 220 240 VAC   10   50 60 Hz  30VA   e Fuse Rating   U S  specification  0 5 A  250 V  Slo Blo  x2   European specification  T 250 mA 250 V  x2    e Battery   Sealed lead acid gel cell  8 hr  life  12 hr  recharge   Indicators for battery charging  battery operation  low battery  and extremely low battery     42 Model 515B C User s Manual Rev  02    1 0 Accessories                                           Model 515B C PULSE OXIMETER  Catalog No  Description   6500 00 Model 515B Pulse Oximeter   6550 00 Model 515C Pulse Oximeter with graphic display   8793 OxySnap Y Sensor  use with OxySnap extension cable    8744 OxySnap Finger Sensor  use with OxySnap extension cable    8853 OxySnap Extension Cable  8ft   use with OxySnap sensors    8898 OxySnap Long Extension Cable  12 ft   use with OxySnap sensors    8894 00 OxySnap Connector Strap  25 per box    4941 Saturation Sensor Extension Cable  4 feet  use with non OxySnap sensors   4942 Saturation Sensor Extension Cable  6 feet  use with non OxySnap sensors   4943 Saturation Sensor Extension Cable  10 feet  use with non OxySnap sensors   5266 Saturation Sensor Extension Cable  25 feet  use with non OxySnap sensors   8776 SuperBright    Finger Sensor  10 ft sensor cable    8791 SuperBright    Y Sensor  10 ft sensor cable    8789 Special use SuperBright    Finger Sensor  8 inch sensor cable    5238 Special Use SuperBright    Finger Sensor  a
26. d its accessories     Monitor  e Turn the monitor off and unplug the line cord from the AC mains before cleaning   e Clean the monitor surface with a damp cloth   e Do not immerse the monitor     e Do not attempt to sterilize the monitor     Finger Sensor    e Clean the Finger Sensor surface with a cloth dampened with an isopropyl alcohol 70   solution or bleach 10  solution or with the cold liquid sterilants Cidex     or  Sporicidin     After cleaning wipe the sensor down thoroughly with a clean water  dampened cloth to rinse    e Ensure that the finger sensor windows are clean and dry before reuse    e Do not immerse the finger sensor    e Do not attempt to sterilize the finger sensor     e After cleaning the Finger Sensor  verify the sensor is physically intact  with no broken   frayed wires or damaged parts  Ensure the connectors are clean and dry  with no signs of  contamination or corrosion  Do not use a broken or damaged sensor or one with wet   contaminated or corroded connectors     e Perform a    Quick Check    to verify the integrity of the sensor  See    Finger Sensor Quick  Check    on page 23     Y Sensor    e The Y Sensor may be immersed   up to  but not including  the connector  in a  glutheralhyde solution  10  bleach solution or Sporicidin     Refer to manufacturer   s  instructions and standard hospital protocols to determine recommended times for  disinfection sterilization    e Rinse thoroughly with water and dry before use  do not rinse the connector    
27. e key to select the two  minute mute or press and hold for audio disable  See    Audible Alert Muting    above for more  information     To adjust the alert volume     1  Press the key to display the current alert volume level     The SpO  window will display    ALr     for alert   and the pulse window will display the alert  volume level that is currently selected     2  Press  toincrease or w to decrease the alert volume level  Each time the     or V key is pressed  a short sample tone will sound at the new volume  level   The sample tones will not occur if the audible alert is disabled   di illuminated      18 Model 515B C User s Manual Rev  02    Pulse Beep Volume Control    3     Monitor Operation 5    The Model 515B C will return to normal display mode ten seconds after the last     or V key press  or sooner by pressing the or     keys     The new value will remain in effect even after the monitor is turned off  This parameter is stored  in battery backed memory and will be reset to its default value if the monitor is reset to factory  defaults  see    Resetting to Factory Defaults    on page 20    NOTE  Ifthe    and        keys are pressed while the monitor is sounding an alert  they  will only set the alert volume  pulse volume and contrast cannot be adjusted when the  monitor is alerting      Pulse Beep Volume Control    The Model 515B C is equipped with an audible pulse beep feature that allows the user to    hear     changes in the patient   s SpO  and pulse rate  
28. from the power entry module  if connected      38 Model 515B C User s Manual Rev  02    Mains Voltage Configuration Maintenance 8    3  Using a flat blade screwdriver  pry the fuse access door open to expose the  fuse housing  Pry the fuse housing out from the power entry module                                      FUSE HOUSING       FUSE ACCESS DOOR             CH  ogi  E             D  4  Install the proper type and rating fuse for the mains voltage setting required     5  Position the housing into the power entry module so that the desired voltage is  furthest away from the switch  see below                                                      SET FOR 100 120V OPERATION SET FOR 200 240V OPERATION    6  Close the fuse access door and verify the proper mains operating voltage is  displayed     MAINS OPERATING VOLTAGE       gt   a   I    Rev  02 Model 515B C User s Manual 39                               8 Maintenance Mains Voltage Configuration     This page intentionally blank      40 Model 515B C User s Manual Rev  02    Specifications    Below are specifications for the Novametrix Model 515B C Pulse Oximeter  These  specifications are listed for informational purposes only  and are subject to change without  notice     Pulse Oximeter    Principle of Operation  e Red Infrared absorbtion    SpO gt   Oxygen Saturation    Range  0 100    Accuracy   for   standard deviation or 68  of sample distribution     2  SpO   for 80 100  SpO gt     unspecified for 0 79     Display Resol
29. ing sensors take note of patient   s physiological condition  For example   burn patients may exhibit more sensitivity to heat and pressure and therefore additional  consideration such as more frequent site checks may be appropriate              Single Patient Use SpO2 Sensor Quick Check    1  With the sensor connected to monitor but not applied to patient  position the  sensor heads so that they face each other  the red light shines at the detector    Is the d on the front panel flashing     2  Tape the Y Sensor to your index finger  Does the monitor show reasonable  SpO gt  and pulse rate values     3  A YES to BOTH  1 and  2 indicates that the sensor is OK  Apply the sensor to  the patient as instructed above     This quick check also test the functionality of the extension cable     32 Model 515B C User s Manual Rev  02    Troubleshooting    Certain conditions may evoke special messages in the saturation and pulse rate displays  These  displays and the conditions are listed below  Note that    Err    stands for error  but does not  necessarily indicate a malfunction  Also  error conditions one and two are internal only  and are  not displayed           E A  Low signal strength  Pulse strength as detected by the sensor is too small  CF ol for proper monitor operation  This message will disappear once the prob     lem is corrected     E Af Insufficient light  Sensor is placed on a site too thick  or opaque  for ade   Crev quate light transmission  This message will disappea
30. is not detecting a valid signal  the display will react in a particular manner  relative to the condition that exists  When the monitor is operating normally and no probe is  connected  or if a probe is connected but not attached to a patient  the displays will show dashes              and the I  icon will also flash     Conditions may occur that require certain status messages to be displayed  In these cases the  SpO  display will show    Err     indicating that a particular condition exists and requires  correction  In addition  the monitor will display a number in the pulse rate display that  corresponds to the condition at hand  See    Troubleshooting    on page 33 for more information     The SpO  and pulse rate displays will also show the alert limits when set manually or when auto  limits are enabled  See    Alert Limits    on page 16 for more information on setting alert limits     When the alert or pulse beep volumes are adjusted  the SpO  display will show    PUL     if pulse  volume was selected   or    ALr     if alert volume was selected   and the pulse rate display will  show the volume level   See    Pulse Beep Volume Control    on page 19 and    Alert Volume  Control    on page 18   When in the contrast adjust mode  the SpO  display will show    Con     see     Contrast Control    on page 19     Pulse Activity Bar    The signal bar or pulse activity bar is derived from the pulsatile signal that is measured by the  monitor  The height of the bar with each pulse
31. lert limits       Press and hold the key for three seconds  the monitor will beep twice     The monitor will set the upper SpO  alert limit to 5 more than the value displayed when the key  was pressed  maximum setting of 100   The lower SpO  alert limit will be set to 5 less than the  displayed value when the key was pressed  minimum setting of 50      For example  if the SpO    98  and the auto limits are set  the system will set the upper alert  limit to 100  98 5 103  but maximum limit of 100   and the lower limit to 93  98 5 93        The SpO   display shows the new upper alert limit for three seconds  then the    new lower alert limit for three seconds  The monitor will then return to normal  operation     To set the Pulse Rate auto alert limits       Press and hold the iw  key for three seconds  the monitor will beep twice     The pulse rate high limit will be set 25  more than  and the low limit 25  less than  the pulse  rate value displayed when the key was pressed  The maximum value that can be set is 249  and  the minimum is 30     For example  if the pulse rate was 72 when the key is pressed  the system will set the upper pulse  rate limit to 90  72 25  90  and the lower alert to 54  72 25  54        The Pulse Rate display shows the new upper alert limit for three seconds  then    the lower alert limit for three seconds  The monitor will then return to normal  operation     Model 515B C User   s Manual 17    5 Monitor Operation Audible Alert Muting    Audible Alert
32. mp  25 ft  shielded cable    Single Patient Use Sp  Sensors    6455  6480  8933    8936    Rev  02    Pediatric Adult Single Patient Use SpO  Sensor       Neonatal Pediatric Single Patient Use SpO  Sensor       DB 9 Extension Cable  use with Single Patient Use SpO  sensors only        DB 9 to OxySnap Connector Cable  use with Single Patient Use SpO  sensors only     Model 515B C User s Manual 43    1 0 Accessories    Catalog No  Description    OxySnap SENSOR MANAGEMENT PLANS    Select an OxySnap Finger Sensor or Y Sensor Management Plan for each SuperBright    Pulse Oximeter   The plan you select determines the warranty period   12  24 or 36 months    How the plans work  Included in each plan are TWO sensors   one for immediate use  the other one for  backup  If a sensor becomes inoperative  place the backup sensor into use and return the inoperative sensor in  the convenient prepaid mailer  A replacement sensor will be shipped within two business days of receipt of the  inoperative sensor  This simple return replacement method will be used for the entire warranty period  thereby  guaranteeing your costs and virtually eliminating sensor tracking hassles    Warranty  The plan warranty  not individual sensors  is 12  24 or 36 months  Replacement sensors provided  under terms of the plan shall carry the remaining plan warranty   replacements do not extend the warranty                                                     8793 12 Y 12 Plan  The plan warranty is 12 months   Includes
33. nit is shut off  If desired  the monitor can be reset to the  default values when power is applied  see below      NOTE  If the battery backed memory is lost  battery disconnected  then the monitor will  automatically reset to the factory defaults when power is applied     The default values are     Parameter Default Value  High SpO  Alert Limit  100  Low SpO  Alert Limit  85  High Pulse Rate Alert Limit  150  Low Pulse Rate Alert Limit  40  Alert Volume  3  Pulse Volume  0  off     To reset the monitor to the default values       With the monitor off  press and hold the key while momentarily pressing    the key to turn the monitor on  Release the key when    515    is  displayed in the pulse rate display     e An audible series of beeps will be produced    e The monitor will perform a self test  the revision level will appear in the saturation  display  the model number    515    will appear in the pulse rate display  and a beep will  coincide with a flash of the alert bar     The audible series of beeps will occur a second time  All displays and LEDs will briefly  illuminate  The revision level will appear in the saturation display  the model number     515    will appear in the pulse rate display  This second occurrence of the power up  routine indicates that the monitor is reset to the factory defaults     The monitor will enter normal operating mode  With the sensor disconnected  or  connected but not applied to a patient  the SpO  and pulse rate windows will  display   
34. pediatric or neonatal patients with Novametrix Pulse Oximeters  SuperBright  series   These sensors are used with the DB 9 extension cable        PEDIATRIC ADULT  SENSOR       J  NEONATAL PEDIATRIC  SENSOR       WARNING  Use the Single Patient Use sensor and DB9 extension cable only with  Novametrix SuperBright compatible pulse oximeters  Use with any other device may  result in equipment damage or patient injury           CAUTION  These SpO  sensors are intended for single patient use  The sensors can be  reapplied to various sites on the same patient but should not be used on multiple  patients  Do not attempt to clean or disinfect the sensor  as system performance will be  compromised           NOTE  The Single Patient Use sensor should be discarded if sensor integrity becomes  questionable              Rev  02 Model 515B C User s Manual 29    6 SpO gt  Sensors Single Patient Use SpO   Sensor Application    Single Patient Use SpO  Sensor Application    1  Connect the DB 9 extension cable to the Model 515B C front panel connector        Model 515C pulse oximeter NONAMETRIXE3       SuperBright     SERIES CONNECTOR    2  Press the black connector on the end of the extension cable into the black  connector on the end of the Single Patient Use sensor          DB 9 CONNECTOR  ON EXTENSION CABLE    SENSOR  CONNECTOR    3  To disconnect the DB 9 extension cable from the sensor  grasp the connectors  and pull them apart   To disconnect the DB 9 connector from the Model 515B C  pres
35. r methemoglobin  e Significant levels of indocyanine green  methylene blue  or other  intravascular dyes  e   Exposure to excessive illumination such as surgical lamps   especially ones with  a xenon light source  or direct sunlight  e Excessive patient movement  venous pulsations  electrosurgical  interference  Do Not apply Y Sensor tapes or wraps so tightly that circulation is restricted  Inspect site  often for adequate circulation   at least once every four hours  When applying sensors  take note of patient   s physiological condition  For example  burn patients may exhibit  more sensitivity to heat and pressure and therefore additional consideration such as more  frequent site checks may be appropriate     Rev  02    Cautions    Rev  02    Cautions    Patient Safety 2          Caution  Indicates a condition that may lead to  equipment damage or malfunction           Do not operate the Model 515B C when it is wet due to spills or condensation    Do not operate the Model 515B C if it appears to have been dropped or damaged   Never sterilize or immerse the monitor in liquids    Do not sterilize or immerse sensors except as directed in this manual    Excessive tension should not be applied to the sensor cable    Do not store the monitor or sensors at temperatures less than 14   F   10   C  or greater  than 131   F  55   C     Do not operate the monitor or sensors at temperatures less than 50   F  10   C  or greater  than 104   F  40   C     Federal  U S A   law restricts thi
36. r once the problem is    corrected     A  E el wf Pulse out of range  Pulse must be within 30  250 beats per minute inclu   sive  This message will disappear once the problem is corrected     Rev  02 Model 515B C User s Manual 33    7 Troubleshooting    Light interference  Ambient light source  sunlight  warming lights  etc    are interfering with sensor operation  Shield sensor from these light  sources  This message will disappear once the problem is corrected     mi   lt    lt    lt   gt     Sensor fault  Remove sensor from use and contact qualified service per   sonnel     mi   lt    lt    lt   gt         x       lt  gt     A   Monitor fault  Record the error number that appears in the pulse rate dis   E ef wf play  XX will vary  depending upon the fault   Remove the monitor from  use and contact qualified service personnel  report the number that    9 X X A  appears in the pulse rate display    v    A   Bad Signal  Monitor not receiving valid signals from sensor  May be  E ef wf caused by excessive motion  cardiac arrhythmia or other situations lead   ing to poor signal  Check patient status  reposition sensor  This message  Si q A will disappear once the problem is corrected   v    34 Model 515B C User s Manual Rev  02    Rev  02    8 Maintenance    This section contains the Model 515B C monitor and accessory maintenance information     Cleaning and Sterilization    Follow the cleaning and sterilization instructions listed below to clean and or sterilize the  monitor an
37. ract   Part Insurance Plans  e On Site Technical Support  e 24 hr  telephone support  e    Demand Services     Flat rate parts exchange   Flat rate return for repair  Time and Material   Full warranty  discounted replacement sensors     V Model 515B C User s Manual Rev  02    Rev  02    C Contents    Section Title Page  Description ME 1  Principles Of Operation EE 1  Trademark Acknowledgments                ccccceeeeeseeecceeeeeeeeeeeeeeeeeeeeeeeeneeees 2  Patient ele iess ccdeneasccatieianbiutiendececitedindetalaiandshtaaoetuubinadate 3  Indications and BET EE 3  WMA EE 4  E E 5  Front and Rear Panel Illustrations              ccccccssssseeeeeeeeeeeeeeeees 7  Preparing For USC    segsueeeegceeoeeuugessueuessegeue  esgeukkuEgeuegEuegRECebeer 9  Monitor  Power EE 9  Monitor Power Dow EE 10  Battery Operation Senden 11  Long Term Storage E 11  Monitor Operation wvcseiccisccsesiesiiwcacedssenscewieivescasesawesdwunvnnunadinesss 13  SpO   and Pulse Rate Displays              cccceeeeseeeeeeeeeeeeeeeeeeeeeeeesneeeees 13  INDIEN 14  Plethysmogram Display cei ccc tein dene eege 14  Alert Limit EE deeg gedet e ect eg 15  PSU BTA ATI EE 16  Manually Setting Alert Limits kee 16   Aut Alert Bi  EE 17  Audible Alert  MUOLING EE 18  Alert Vol  me Control gegen ee 18  Pulse Beep Volume Control AE 19  Contrast CONE  WEE 19  Resetting to Factory Defaults e eege csc coteades neces aaclecnistdeecessneesetiertace 20  ET ENEE 21  OxySnap M ele e 22  le En EE 22  Finger Sensor Quick Check siticsa
38. s  The size refers to the distance between the holes in the tape          Wrap Style Tape Finger Style Tape  Cat  No  8829 Cat  No  8828 Cat  No  8832 Cat  No  8831  25 mm  Green  20 mm  Blue  25 mm  Green  20 mm  Blue   Neonatal Foot  Hand   Neonatal Foot  Hand Adult Finger Pediatric Finger  Pediatric Toe  Finger Adult Finger                         2  Remove the portion of the release liner containing the holes   REMOVE RELEASE LINERS WITH HOLES    2 EE    WRAP STYLE TAPE       PPD    FINGER STYLE TAPE    3  Skip this step if using the 25 mm Y Strip tape or foam wrap   If using the 20 mm Y Strip tape  carefully remove the Y Sensor   s center strip  using a pair of scissors or a sharp blade        The center strip does not effect sensor operation  its purpose is to aid putting the sensor into the  25 mm tape and to limit the distance between the sensor heads to no greater than 25 mm     4  Press the    button     on the back of each sensor head  through a hole in the tape  or foam wrap     Rev  02 Model 515B C User s Manual 25    6 SpO gt    Sensors Y Sensor Application using Y Strio Tapes  or Foam Wrap    Press in from the sticky side of the tape  The tape will stretch to fit the sensor button     Y SENSOR PLACED ON Y STRIP TAPE       LINERTHS Qa  SIDE  TOP        S A  gt  HEAD    BUTTON          Y STRIP TAPE  CROSS SECTION       Y SENSOR PLACED ON FOAM WRAP       5  Remove the remaining release liner s  and apply the sensor tape to the patient     Ensure that the sensor he
39. s can be changed  The Model 515B C will not allow a parameter   s upper and lower alert  limits to be set to within 5 digits of each other     For example  High Pulse Rate alert limit is at 50  low Pulse Rate alert limit at 40  If the high  Pulse Rate limit is lowered to 44  the Pulse Rate low limit will change from 40 to 39 in order to  maintain the 5 digit difference between limits        Care should be exercised to ensure that clinically reasonable alert limit settings are  selected  Novametrix does not recommend the setting of limit values to such a wide  span as to effectively render the alert limit feature useless  Once the limit values are  properly set  the user should periodically confirm patient status by alternate means and  not rely solely on alerts generated from violated limits              To set the SpO    alert limits   1  Press the key once for setting the upper alert limit   To advance to setting the lower alert limit without adjusting the upper limit proceed to step 4     2  The SpOs display will show the currently set upper alert limit     The inthe SpO  display area will illuminate red indicating that the upper alert limit can  be adjusted  The SpO  upper alert limit can be adjusted from 100 55     3  Press the    key to increase the alert limit  or w to decrease the alert limit     4  Press the key again for setting the lower alert limit     The W inthe SpO  display area will illuminate red indicating that the lower alert limit can  be adjusted  The SpO
40. s device to sale  distribution  or use by or on the order  of a licensed medical practitioner     Overstretching the pulse oximeter finger sensor can damage the sensor and potentially  affect pulse oximeter readings  Do not stretch the finger sensor open beyond the limit for  which it was designed  Overstretching can be prevented  avoid opening the sensor by any  means other than squeezing the grips  DO NOT force the sensor onto large objects such  as a bedrail     Model 515B C User   s Manual 5    2 Patient Safety Cautions     This page intentionally blank      6 Model 515B C User s Manual Rev  02    Front and Rear Panel Illustrations       WAVEFORM DISPLAY ON MODEL 515C ONLY    ALERT BAR SENSOR INPUT       ES    POWER button   Press to turn the monitor  on or off     AC indicator   Green when the monitor is  connected to AC power and rear panel  power entry module switch is set to    P   ON   Also indicates the battery is charging        E    Audio key   Press to toggle two minute  silence  and reset alert conditions  when  active   Press and hold for audio disable     Battery icon   Green when operating on bat   tery with a charged battery  orange when  battery power is diminished  flashes red  when battery power is at a critical low        Pulse Key   Sets pulse rate alert limits when  used with the   a w keys  Press and hold  to set auto alert limits     Finger probe icon  Flashes red when no  probe is connected or the probe is off the  patient  Red for any sensor errors
41. s manual is written for users of the Novametrix Model 515B or 515C Pulse Oximeter  The  Model 515B C provides reliable continuous measurement  display  and alerts for oxygen  saturation  SpO   and pulse rate  The monitor can be powered from its rechargeable internal  battery or from the AC Mains     Principles of Operation    The Model 515B C measures oxygen saturation using sensors that contain red and infrared  660  and 940 nanometer  light sources  called LEDs  The light energy from each LED is beamed  through a sample cell   a pulsating vascular bed  the patient   s finger or toe for example  The  remaining light energy not absorbed by the sample cell reaches a light receptor in the sensor   called a photodiode  Oxygen saturated blood absorbs different amounts of light at each  wavelength as compared to unsaturated blood  Therefore  the amount of light absorbed by the  blood in each pulse can be used to calculate oxygen saturation     The Model 515B C is calibrated to display    functional    saturation  This differs from the     fractional    saturation value displayed by most co oximeters  Functional saturation is defined  as     HbO   100    COHb   METHb     Functional Saturation         HbO    Fractional Hemoglobin  COHb   Carboxyhemoglobin  METHb   Methemoglobin    This can be considered to represent the amount of oxyhemoglobin as a percentage of the  hemoglobin that can be oxygenated  Dysfunctional hemoglobins  COHb and METHb  are not  included in the measurement of
42. s the latch    30 Model 515B C User s Manual Rev  02    Single Patient Use SpOz Sensor Application SpO gt s Sensors 6    release lever on the extension cable connector and pull the connector straight  back away from the monitor  DO NOT twist the connector     PRESS DOWN ON LATCH RELEASE    V  E             THEN PULL OUT  e         ai          4  Select the appropriate size sensor based on the patient type     PEDIATRIC ADULT SENSOR    l ADULT TOE  ADULT FINGER    NEONATAL PEDIATRIC SENSOR    NEONATAL HAND  S    NEONATAL FOOT       PEDIATRIC TOE    5  To apply the sensor  place the blue side of the sensor wrap against the skin   wrap it around the site and secure with Velcro   tab  The Velcro tab on the    Rev  02 Model 515B C User s Manual 31    6 SpO gt    Sensors Single Patient Use SpO Sensor Quick Check    neonatal pediatric version is removable to allow the foam wrap to be cut before  applying to the patient     NEONATAL PEDIATRIC  SENSOR    CT NELCRO TAB       Ensure that the sensor heads are positioned directly opposite each other through the tissue  The  adhesive dots  Catalog No  8700  which are included with each sensor can be applied to the  sensor before patient application for additional adhesion to the site     6  For additional support  secure the cable along the limb with tape        WARNING  Do not wrap the sensor around the limb so tightly that circulation is  restricted  Inspect the site often  at least every four hours  for adequate circulation   When apply
43. sferring return materials to local sales or dealer representatives does not absolve return  responsibility     Novametrix manufactures equipment that is generally    user serviceable    and can usually be  repaired with the replacement of a plug in electro mechanical assembly by the clinical end user   When repair parts are provided  the recipient can call into Novametrix for on line replacement  assistance and repair assurance  In the event a replacement part requires increased technical  capability  Technical Support may request Biomedical assistance  provide on site technical  support or complete replacement equipment  If the customer requires the return of their original  product  the exchange material will be considered    loaner material    and exchanged again after  the customer equipment is repaired     Novametrix promotes customer participation in warranty repairs should they become necessary   This program allows for customer training and a smooth transition into self maintenance after  warranty  which can provide substantial cost savings on repairs throughout the product   s life     The Novametrix Technical Support Department can provide technical product support at a level  appropriate to most customers protocol and budget requirements  Please contact the Technical  Support Group at Novametrix for additional information     Additional Novametrix Technical Support Programs   e Focus Series Technical Training Seminars  e Test Equipment and Test Kits  e Service Cont
44. tccathss teas sant eee eee ee eae 23  E E 24  Y Sensor Application using Y Strip Tapes  or Foam Wrap          ss     25  Y Sensor Application using Ear Clm  27    Model 515B C User   s Manual Vi    Y Sensor Quick Check  29    Single Patient Use SPO   Sensors           eccceeeeeeeeeeeeeeceeeseeeeeteeeeeeeeeees 29  Single Patient Use SpO   Sensor Application   0 0 0    eee eeeeeeeee 30  Single Patient Use SpO   Sensor Quick Check 0 0 0    eee 32   7 Troubleshooting Zenger tee tee ER ee 33  8 Maintenance a ieccce cave ccscdsvesscasvdcavseeseatbnanscasusncenseansoainestdeantenssnteds 35  Cleaning and Sterilization EE 35  MONILON EE 35  ein EE 35  Ken 35   Y Strip Tapes and Single Patient Use SpO   Sensors     seccnee  36   ele e WEE 36   Battery Maintenance     sictetesstcccecanaes cae eadenteee i icensdaeeveaveleieeceeneteeeerst 36  Mains Voltage Configuration RE 37   Fuse Replacement ciccscdeiccchossnicsicessapesnsaeonnieesiande EEAN NN 37  Changing the Mains Voltage Setting      38   9  Specifications EE 41  Pulse Oximeter ege ege 41  Principle of Operation eebe ee eenegen Ee 41   SpOs  Oxygen Saturation  0    eee eeeeeeesseeeeeeeeeeseeeeneeeeeneees 41   Pise Raie ageet Eed aa a a a a e E Eat 41   SEIO e E E E E E TA E T 41  Plethysmogram  Model 5150 only  A 41  ENEE EE 41  LCE 41   Display  onina tates e ae ie hth team on ot tue Cie eA eae s 42   Physical sisii iane oa ES atest 42  Ste WEE 42   10 E 43    vii Model 515B C User s Manual Rev  02    Rev  02    Description    Thi
45. the  displays will blank out and the audible tone will stop  Reconnect the monitor to the AC line to  recharge the battery  The battery will be fully recharged in 12 hours     Long Term Storage   If the monitor has not been used or powered by AC mains for an extended time   3 months or  more  allow the battery to charge for 12 hours before use  The monitor may not power up on  battery power if the battery is not sufficiently charged     To charge the battery  connect the AC mains and set the rear panel power switch ON  I   Check  that the front panel    Wy icon is green  Allow the battery to charge for 12 hours to ensure a fully  charged battery in the event that battery power is required              1  The internal battery may slowly discharge over long periods of non use     Model 515B C User   s Manual 11    4 Preparing For Use Battery Operation     This page intentionally blank      12 Model 515B C User s Manual Rev  02    5 Monitor Operation    Once an SpO  sensor is connected to the monitor and properly applied to the patient  the Model  515B C displays SpO   pulse rate  and a signal bar that gives qualitative indication of the  strength of the pulsatile signal which the monitor is receiving  In the case of the Model 515C  a  plethysmogram  pulsatile waveform  will be displayed on the LCD screen  The SpO  and pulse  rate display also indicate status messages and audio levels  These functions are described in  detail in this section     SpO gt  and Pulse Rate Displays  
46. ther style power line cords  as required by the country of destination  are provided by the distributor of that country     8 Model 515B C User s Manual Rev  02    Preparing For Use    Monitor Power Up    NOTE  Before using the monitor for the first time  attach the line cord to the rear panel power  entry module  then connect to a proper AC mains outlet  Set the rear panel power switch to           ON   check that the front panel NU icon is illuminated  Allow the battery to charge for 12  hours  See    Long Term Storage    on page 11     1  Plug the connector end of a SuperBright    series sensor or extension cable  into the front panel connector of the monitor  The sensor will    click    into place  when properly seated           SuperBright     SERIES CONNECTOR       NOTE  To disconnect the saturation sensor from the monitor  press the latch release lever  on the sensor connector and pull the connector straight back and away from the monitor   DO NOT twist the connector        PRESS DOWN ON LATCH RELEASE       THEN PULL OUT                EE  gt  ER                  d      SH             2  If the monitor is to be operated from the AC line  plug the power cord into a  properly grounded three wire outlet and set the rear panel power switch to the    Rev  02 Model 515B C User s Manual 9    4 Preparing For Use Monitor Power Down    ON     position  The green AC indicator  L on the front panel will illuminate to  show that AC current is reaching the monitor and charging the b
47. tory Technical Support Department in  Wallingford  Connecticut  Novametrix provides factory direct technical support to its customers  through a technical support group located in Wallingford  Connecticut and company service  representatives located throughout the United States  All Technical Support for Novametrix  products is provided    Factory Direct        Novametrix provides 24 hour a day technical support accessibility via telephone numbers  800   243 3444 or  203  265 7701  After hours technical support requests  before 8 00 AM and after  5 00 PM Eastern Time  will be responded to promptly by the Technical Support On Call staff   It is suggested that any person calling in for technical support have the inoperative equipment  available for preliminary troubleshooting as well as product identification  Novametrix reserves  the right to repair or replace any product found to be defective during the warranty period   Repair may be provided in the form of replacement exchange parts or accessories  on site  technical repair assistance or complete system exchanges  Repairs provided due to product  abuse or misuse will be considered    non warranty    and invoiced at the prevailing service rate   Any replaced defective material is expected to be returned to Novametrix within 10 days of  being provided in order to avoid additional charges  Exchanged material should be returned  promptly and directly to Novametrix using the return paperwork and shipping label s  provided   Tran
48. ution  1     Averaging  8 seconds    Audio  Pitch of pulse tone varies with SpO  value    Pulse Rate  e Range  30 250 beats per minute  bpm   e Accuracy   1 standard deviation     1  of full scale  e Display Resolution  1 bpm  e Averaging time  8 seconds    Sensors    e Reusable Y Sensor     can be sterilized and used with all patient populations  and  reusable adult finger sensor    e Neonatal Pediatric and Pediatric Adult Single Patient Use SpO  Sensors    Plethysmogram  Model 515C only     e Pulsatile waveform  General Specifications    Alerts    e Limits  Automatic and adjustable limits for SpO  and Pulse Rate  values are retained in  memory when the monitor is turned off  or can be reset to factory defaults when the  monitor is turned on    Rev  02 Model 515B C User s Manual 41    9 Specifications General Specifications    e Audio  Adjustable volume  2 min  silence or OFF  LED indicators    e Visual  Flashing numerics upon violated limit s   amp  red    Alert Bar    with limit  high or  low  violation indicator   e Messages  Sensor disconnected  sensor off patient  low signal  insufficient light  high  ambient light  pulse out of range  sensor faulty  monitor faulty     Display  e Numerics  7 Segment LED   s  e Plethysmogram  Model 515C   Liquid crystal graphic module  2     W X 1 3   H    Physical  e Operating Environment   10 40   C  50 104   F   0 90  relative humidity  non condensing   e Weight  approximately 6 lbs   2 72 kg   e Dimensions   Height  3 3 inches  8 38 
49. without charge  if said defects occur during normal service     Claims for damages during shipment must be filed promptly with the transportation company   All correspondence concerning the equipment must specify both the model name and number   and the serial number as it appears on the equipment     Improper use  mishandling  tampering with  or operation of the equipment without following  specific operating instructions will void this guarantee and release Novametrix from any further  guarantee obligations     Service Department  For factory repair service  call toll free  1 800 243 3444    In Connecticut  call Collect  203  265 7701  Telex 956 054  Facsimile  203  284 0753       Caution  Federal  U S A   law restricts this device to sale  distribution  or use by or on the order  of a licensed medical practitioner     Copyright    1995  1996  Novametrix Medical Systems Inc  This document contains  information which is proprietary and the property of Novametrix Medical Systems Inc   and  may not be reproduced  stored in a retrieval system  translated  transcribed  or transmitted  in  any form  or by any means  without prior explicit written permission from Novametrix Medical  Systems Inc     Model 515B C User s Manual iV    Service Policy    Novametrix Medical Systems Inc  will provide Warranty Service Support to its customers  within 48 hours of receiving a telephone request for technical support  This 48 hour period  begins once a service request is placed through the Fac
50. xySnap CONNECTOR    2  To disconnect  grasp the connectors at the finger grips and pull them apart     Finger Sensor    The reusable Finger Sensor is intended for adult or appropriate size pediatric fingers and is not  designed for neonatal applications                             22 Model 515B C User s Manual Rev  02    Finger Sensor Quick Check SpO gt s Sensors 6    To apply the finger sensor to the patient   1  Gently squeeze the grips at the rear of the sensor  indicated by arrows below            PLACEMENT GUIDE CABLE EXITS ABOVE FINGER    2  Position fingertip against placement guide with fingernail towards the red light     Do not position the finger so as to protrude past the placement guide     3  Release the finger grips        WARNING  Inspect the site often for adequate circulation   at least once every four  hours  When applying sensors take note of patient   s physiological condition  For  example  burn patients may exhibit more sensitivity to heat and pressure and therefore  additional consideration such as more frequent site checks may be appropriate              4  To remove sensor  gently squeeze grips and slide the sensor from the finger        CAUTION  Overstretching the pulse oximeter finger sensor can damage the sensor and  potentially affect pulse oximeter readings  Do not stretch the finger sensor open beyond  the limit for which it was designed  Overstretching can be prevented  avoid opening the  sensor by any means other than squeezing the grips  DO 
51. z 30A 5 190 038             L    Ground stud   Use to connect monitor   s chassis to earth  ground        Rear panel power switch   Set to    I    allows AC mains  to power monitor  set to    O    switches AC mains power  off           Voltage select fuse compartment   Sets mains operating  voltage and houses mains fuses        Power cord entry   Plug power cord into this receptacle   Use only hospital grade three wire plugs for connection  via supplied power cord              SYSTEMS INC   WALLINGFORD  CONNECTICUT U S A     CAUTION  FEDERAL  U S A  LAW RESTRICTS THIS DEVICE   TO   DISTRIBUTION  OR USE BY OR ON THE ORDER OF  ALICENSED MEDICAL PRACTITIONER     CAUTION  EQUIPMENT MUST BE GROUNDED AT ALL TIMES  TO AVOID DANGEROUS ELECTRICAL SHOCK HAZARD     PATENTS 5 190 038 5 398 680             L    Ground stud   Use to connect monitor   s chassis to earth  ground           Voltage select fuse compartment   Sets mains operating  voltage and houses mains fuses        Rear panel power switch   Set to    I    allows AC mains  to power monitor  set to    O    switches AC mains power  off           Power cord entry   Plug power cord into this receptacle   Use only hospital grade three wire plugs for connection  via supplied power cord        AC Power cord  The AC power line cord shipped with monitors for North America is a Hospital Grade  SJT style cord with  a 120 VAC plug  All power line cords shipped with monitors for Europe are the European style with a 220 240 VAC plug   All o
    
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