Model 511 User`s Manual Pulse Oximeter
Contents
1. r1 Power On Off control NOVAMETRIX DC Input MEDICAL SYSTEMS INC Jack Model 511 User s Manual 01 May 96 5 Section 3 llustrations Display Illustrations Typical display Typical alert condition display All displays illuminated sS A E m Saturation display 0 100 14 Pulse Rate display 30 250 LN Pulse Activity Bar 16 bars 41 Audible Alert Disabled Icon ill Battery Indicator 3 levels d ill Full Half Low ea y bias blanked dashes Message displayed as needed SENSOR OFF PATIENT a7 Y status number IP e UNIT SENSOR a REPOSITION SENSOR SENSOR OFF PATIENT SENSOR DISCONNECT 01 May 96 displayed as needed Model 511 User s Manual Section 4 Monitor Operation Battery Installation The Model 511 operates on four 4 1 5 volt AA alkaline batteries Other battery types should not be used with the Model 511 WARNING Use of improper batteries may present a risk of fire or explosion Top of monitor To install batteries into the monitor 1 Locate the battery compartment cover on the back side of the monitor 2 Press the OPEN area of the compartment cover slide the cover in the direction indicated by the arrow and remove the cover 3 Install new batteries according to the and symbols on the bottom of the battery2. Unplug any sensor that may be connected from the PATIENT SERIAL INTERFACE connector 2 Connect the 6293 01 interface cable to the PATIENT SERIAL INTERFACE connector on the monitor plug the other end into the communication device Connecting the Model 511 for serial communication Model 511 k 6293 01 cable Connection to computer or communication device ooooo opes Jo 3 If using the NovaCARD Data Archive System please refer to the NovaCARD User s Manual Cat No 6066 23 for set up and operation of the NovaCOMM interface See NovaCOMM Setup Direct Cable page 13 under the Hardware Setup section 4 If you are using a communications package other than NovaCARD send the appropriate commands from the device to the monitor as instructed in the next section titled NOVACOMM Interface 24 01 May 96 Model 511 User s Manual INFO record byte assignment Model 511 User s Manual NOVACOMM I Interface NOVACOMM1 Interface The NOVACOMM I interface is designed to output data in formats easily read by a computer or data logging device The computer interface provides the user the ability to dump trend information to a computer file for later analysis The communication format is 9600 baud 8 bits no parity 1 stop bit and XON XOFF handshaking Trend Dump Trend data is transmitted as a succession of records The record size for Model 511 is 16 bytes of ASCII Hexadecimal da
3. continued next page 01 May 96 3 Section 2 Patient Safety Exposure to excessive illumination such as surgical lamps especially ones with a xenon light source or direct sunlight Excessive patient movement Venous pulsations Electrosurgical interference Cautions Caution Indicates a condition that may lead to equipment damage or malfunction Do not operate the Model 511 when it is wet due to spills or condensation Do not operate the Model 511 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 No tension should be applied to any 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 32 F 0 C or greater than 130 F 54 4 C Caution Federal U S A law restricts this device to sale distribution or use by or on the order of a licensed medical practitioner 01 May 96 Model 511 User s Manual Section 3 Illustrations Front Panel Illustration Front Panel Illustration d N por ud a gt Saturation and SpO2 beats min Pulse Rate SATURATION PULSE RATE display identifiers it LI N X UR m Display see next section A X STI Pulse Oximeter D TH Audible Alert Enable disable Key
4. 30 250 beats per minute bpm Accuracy 1 of full scale Approximately 6846 of the observations are within the accuracy claim Display Resolution 1 bpm Averaging Time fixed at 8 seconds Settling Time Display settles to within 1 of the final reading less than 15 seconds after the sensor is properly applied General Specifications Operating Environment 50 104 F 10 40 C 0 90 relative humidity non condensing Weight 13 ounces including batteries Dimensions Height 6 25 inches Width 3 75 inches Depth 1 3 inches Model 511 User s Manual 01 May 96 31 Section 7 Specifications 32 Battery Type four AA alkaline cells Life 12 hours External power supply Input 105 130 VAC 50 60Hz or 230 VAC 50 60Hz Output 6VDC 150ma Cord length 6 ft 105 130 volt unit designed to meet electrical tests of U L 544 Patient Care Equipment Patient Connected Isolated 230 volt unit designed to IEC601 Electrical Specification 01 May 96 Model 511 User s Manual
5. briefly illuminated the software version is displayed the number 1 will be displayed in the alert triangle it will then sequence through to 4 Release the power control key when the desired number is displayed illumination pulse beep options Reference the next section Display Illumination and Pulse Beep for an explanation on the options available If the power control key is pressed but not held the monitor will power up as described above and will default to selection of 1 for the illumination pulse beep options both OFF SpO and pulse rate information will be displayed within 20 seconds of power up provided the sensor is properly applied to the patient prior to power up or prior to the completion of any monitor self test 2 To turn the monitor off press the power control Display Illumination and Pulse Beep Options The Model 511 is supplied with a display illumination option this is designed for better viewability under low ambient lighting conditions A pulse beep option is also available this will emit a tone with each pulse detected by the monitor These options are selected or deselected at power up by holding the power control key until the desired option combination number is displayed then releasing the power control key to select that number There are four possible options in regards to display illumination and pulse beep when powering on the Model 511 The four options will appear in sequence
6. by most co oximeters Functional saturation represents the amount of oxyhemoglobin as a percentage of the hemoglobin that can be 01 May 96 1 Section 1 Introduction Calculating Functional Oxygen Saturation oxygenated Dysfunctional hemoglobins COHb and METHb are not included in the measurement of functional saturation HbO Fractional Hemoglobin Functional Saturation HbO COHb Carboxyhemoglobin 100 COHb METHb METHb Methemoglobin Pulse Rate is calculated by measuring the time interval between the peaks of the infrared light waveform The inverse of this measurement is displayed as pulse rate The Model 511 must be used in conjunction with OxySnap SuperBright saturation sensors Indications and Usage The Model 511 Pulse Oximeter is intended to be used for monitoring of oxygen saturation and pulse rate The Model 511 is designed to monitor all patient areas including adult pediatric and neonatal 01 May 96 Model 511 User s Manual Section 2 Model 511 User s Manual Patient Safety For maximum patient and operator safety the following are recommended Failure of Operation If the monitor fails to respond as described do not use it until the situation has been corrected by qualified personnel Keep the Model 511 and its accessories clean Do not operate the Model 511 when it is wet due to spills or condensation Do not operate the Model 511 if it appears to have been dropped or damaged Care s
7. cold liquid sterilants Cidex or Sporicidin then wipe down with a clean water dampened cloth and dry before use Do not immerse the monitor Do not attempt to sterilize the monitor Finger Sensor 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 M After cleaning wipe the sensor down thoroughly with a clean water dampened cloth to rinse Ensure the Finger Sensor windows are clean and dry before reuse Do not immerse the Finger Sensor Do not attempt to sterilize the Finger Sensor 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 Perform a Finger Sensor Quick Check test before returning the sensor to patient use Refer to Finger Sensor Quick Check on page 14 Y Sensor 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 Rinse thoroughly with water and dry before use Do not attempt to sterilize Y Sensor except as stated
8. in the status field as numbers one through four these are identified below Option Number Illumination Pulse Beep 1 Illumination OFF Pulse Beep OFF 2 Illumination OFF Pulse Beep ON 3 Illumination ON Pulse Beep OFF 4 Illumination ON Pulse Beep ON To select one of the four display illumination pulse beep options press and hold the power control key when the monitor is off The monitor will power up as described in Power On Off on page 8 The status number field will display 1 inside the alert triangle it will then change to 2 and sequence through to 4 If the power control key is still held after the 4 is displayed the monitor will shut off To select the desired option release the power control key when the appropriate number is displayed inside the alert triangle To select another option press the power control to turn the monitor off Press and hold the power control to turn the monitor back on and select another option number 01 May 96 Model 511 User s Manual Audible Alarms Audible Alarms 1 To toggle between enabled and disabled audible alarms press and release the N alarm key If pressing and releasing the alarm key causes the alarms to be enabled the monitor shall display the saturation auto alert limit settings in the SpO and pulse rate displays for three seconds beep once and turn off the alarm icon The alarm display icon will not be displayed while audible alarms are e
9. 1 User s Manual 01 May 96 Section 4 Monitor Operation 10 2 To display limits without setting new limits if audio is enabled press and release the alarm key twice The first press turns off the alarms and the second turns them back on and causes the high and low limits to be displayed for three seconds The monitor will then return to normal operation To display limits without setting new limits if the audio is disabled audible alert icon visible press and release the alarm key The high and low limits will be displayed for three seconds before the monitor returns to normal operation Press and release the alarm key to disable the audible alarms Battery Life The Model 511 displays a battery icon to indicate lli fully charged batteries over 4 hours of battery life mu less than 4 hours of battery life e 1 indicates less than 2 hours of battery life OX flashing less than 15 minutes of battery life vt When the battery voltage reaches the 2 hour level the battery is very low As the battery reaches near depletion the battery icon will flash at a rate of once per second and the alert audio will sound this alert tone cannot be muted even if alerts are disabled Continued use of the monitor at this point will result in the monitor shutting itself off NOTE The above information is based upon normal monitoring conditions e g sensor on patient new alkaline batteries Use of non alkaline
10. May 96 Model 511 User s Manual Alerts If the Model 511 cannot detect valid saturation data with which to update the display the previous contents of the display shall be held Should the display be held for more than ten seconds a character will start to flash within the borders of the display alarm icon even if the alarm icon itself is disabled If the Model 511 cannot detect valid pulsatile data from the sensor within sixty seconds the saturation and pulse rate displays will blank out display and respectively If the display is held longer than ninety seconds the Model 511 will emit an audible unlatched alarm if enabled and REPOSITION SENSOR along with the number 9 will appear in the display If at any time the monitor processes valid data with which to update the display the will stop flashing the display will be updated the timer reset to zero seconds and the audible alarm if active will be reset Alerts Typical status message and number display Summary of status messages and numbers Model 511 User s Manual Status Messages and Numbers The Model 511 will display status messages and related status numbers under certain conditions gt 4 Lo 4 Message displayed as needed 1 SENSOR OFF PATIENT T status number M A The following table lists the conditions that cause status messages to be displayed Message Numbe
11. Model 511 User s Manual Pulse Oximeter May 01 1996 Catalog No 6116 23 01 6416 23 01 Copyright 1993 1996 Novametrix Medical Systems Inc Wallingford Connecticut U S A 06492 All rights reserved No part of this manual may be reproduced without the written permission of Novametrix Medical Systems Inc This page intentionally blank ii Model 511 User s Manual Rev 01 Manual Revision History Section i Manual Revision History 21 July 93 Release at revision 00 01 Mayr 96 Revision 01 R N389 Includes Addendums A through D from revision 00 Single patient use sensor information included Rev 01 MOdel 511 User s Manual iii Section Model 511 User s Manual 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 Contact the Novametrix Technical Service Department at the numbers listed below to arrange for warranty repair and to receive a Repair Order Number prior to returning any equipment to Novametrix Novametrix obligations under this guarantee are limited to repairs or at Novametrix option replacement of any defective
12. above Do not immerse the connector on the Y Sensor 01 May 96 29 Section 6 Cleaning amp Sterilization 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 Perform a Y Sensor Quick Check test before returning the sensor to patient use Refer to Y Sensor Quick Check on page 18 Y Strip Tapes Treat Y Strip Tapes in accordance with hospital protocol for single patient use Ear Clip Clean the ear clip with a cloth dampened with 7096 isoprophyl alcohol After cleaning wipe the ear clip down thoroughly with a clean water dampened cloth to rinse Do not immerse the ear clip 30 01 May 96 Model 511 User s Manual Section 7 Specifications General Specifications for the Novametrix Model 51 Pulse Oximeter are listed for informational purposes only and are subject to change without notice Oxygen Saturation SpOz2 Range 0 100 Accuracy 80 100 296 0 79 unspecified Approximately 68 of the observations are within the accuracy claim Display Resolution 196 Averaging Time fixed at 8 seconds Settling Time Display settles to within 1 of the final reading less than 15 seconds after the sensor is properly applied Pulse Rate Range
13. compartment and on each battery WARNING Alkaline batteries may explode or leak if recharged inserted improperly or disposed of in a fire Do not open batteries 4 Slide the battery cover back into place The cover latches into place when properly seated A Bottom of monitor External DC Supply The Model 511 can be powered by an external DC supply The supply plugs into the small DC power jack located on the lower right side of the monitor The external supply draws its power from the mains Both 105 130 VAC and 230 VAC 50 60Hz versions are available When the external power supply is used the batteries are disconnected from the monitor internally however the battery icon displays a fully charged condition While powered from the external supply the battery icon does not reflect the condition of the batteries When changing operation from the external supply to battery external supply disconnected allow the monitor to run for one minute after which the icon will reflect the true battery charge WARNING Use only Novametrix supplied external power supplies The use of other external power sources may jeopardize patient safety or may damage the Model 511 Model 511 User s Manual 01 May 96 7 Section 4 Monitor Operation Power On Off 1 To turn the monitor on press and hold the power control A tone sounds to verify audio is functional the monitor performs a system self test all display segments are
14. e Finger Sensor to the Patient 14 To apply the finger sensor to the patient Gently squeeze the grips at the rear of the sensor indicated by arrows below Placement Guide Cable exits above finger Position fingertip against placement guide with fingernail towards the red light Do not position the finger so as to protrude past the placement guide Release the finger grips Inspect the site often for adequate circulation at least once every four hours 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 affest pulse oximeter readings Do not stretch the finger sensor open beyond the limit for which it was designed Overstretching can be preventerd avoid opening the sensor by any means other than squeezing the grips DO NOT force the sensor onto large objects such as bedrails Finger Sensor Quick Check Is Probe Off Patient illuminated when the sensor is connected to the monitor but not applied to the patient Apply the sensor to your index finger Are reasonable SpO and pulse rate values displayed A YES to BOTH 1 and 2 indicates the sensor is OK Apply the sensor to the patient as instructed above The quick check also tests the functionality of the extension cable 01 May 96 Model 511 User s Manual Y Sensor Y Sensor OxySnap Y Sensor Y Sensor showing Cen
15. e ana ale cela ened Ae hamidd bn o bna Ds ot iv COntenis so eov NEE EEA E SEEE tases Rubeo oan ean vi FitFOdHCHOH cipia E E E mena Mod DL eee 1 Principles of Operation wc ioc ceci ae eee etie rettet abies kebabs oye east 1 Indications and Usage iret t d tee ene dente eer ee esee toes 2 Patient Safety ooo OPER ap m antonio Pu eO IURE E 3 Warnings deeper dette e si P e Ie Abies 3 CEDAT nS 4 BIIGSEESPOHS uoo tte etaed ten ut ani dates tut ism i eet DN Decal 5 Front Panel Illustration ae eerte etie tube rete idet qb ierit 5 bisplay Ilustrations reine tie tri ree etit dte ent eee fent 6 Monitor Operation o vn eene tp or er Ra FAM er ied sert ae Rand 7 B ttery Installation 3 a A e d ae b ed eee es dtd 7 External DG Supply eee teet esee ce rie tsi e teens 7 Power OPOE ie RE aa se E E Ret e 8 Display Illumination and Pulse Beep Options 0 0 0 eee cesses ceeceeeeeeeeeeeeaeeseecaecsaecaeesseeseeneens 8 Audible Alatms dee pie te pie tette eig bee rie etie e d 9 Saturation Auto Alert Limits essent enne ener ks eso nennen nennen nete tenerent 9 Battery Life onse umo deben men T E ESES 10 Select and Apply a Sensor to the Patient essere enne nemen 10 Monitoring Saturation and Pulse Rate sssseeesseseeeeeeeeeenenre nennen nennen 10 Alertscccnsee eene en HS ERA 11 Status Messages and Numbers sse enne eren entren nennen 11 SpO2 SelSOES ee E ut ru
16. eceive buffer will not overflow When the monitor has received the complete command it will echo the date in the format described in the section above Clear Trends Clear Trends mode allows the user to remotely clear the Model 511 trend memory This action has the same result as the monitor s Clear Trend function in that trend memory and the Trend Page displays are cleared Use this remote Clear Trends function with care as there is no way to undo the clear command once issued To clear the Model 511 trend memory the computer must send an ASCII c character The Model 511 will echo the c followed by a lt cr gt lt 1f gt and then the trend memory will be cleared Exit Command To exit the NOVACOMMI I mode the computer must send an x or X character The Model 511 will echo the x and then stop communication Sending a new valid command character will start communication again Model 511 User s Manual 01 May 96 27 Section 4 Serial Communication Option This page intentionally blank 28 01 May 96 Model 511 User s Manual Section 6 Model 511 User s Manual Cleaning amp Sterilization Follow the cleaning and sterilization instructions listed below to clean and or sterilize the Model 511 and its accessories Model 511 Monitor Turn the monitor off before cleaning Clean the monitor surface with a cloth dampened with an isopropyl alcohol 70 solution or bleach 10 solution or with the
17. ecord byte 0 Kec geweckt ue onec deo Ao on AO OUR BER OO Ote us byte 15 where T Trend mode identifier INFO byte starting at byte 0 and ending at byte 15 see below byte 0 flag byte FF for INFO record byte 1 information type FE power on FD limit change FC time stamp byte 2 model code 2 byte 3 compression ratio 8 i e 1 point 8 seconds byte 4 seconds 0 59 byte 5 minute 0 59 byte 6 hour 0 23 byte 7 day 1 31 01 May 96 25 Section 4 Serial Communication Option DATA record byte assignments 26 byte 8 month 1 12 byte 9 year 0 99 byte 10 unused byte 11 unused byte 12 unused byte 13 unused byte 14 unused byte 15 unused cr carriage return f line feed DATA record byte 0 F1 TARAKKKKKKKKKKK KK KK X k k kk kkkkk k k cor lf L byte 15 T Trend mode identifier _ DATA byte starting at byte 0 and ending at byte 39 see below byte 0 7 8 byte SpO2 data range 01 28 Hex 1 40 decimal corresponds to 60 100 i e a value of 1E Hex that corresponds to 30 decimal will indicate an SpO2 value of 9096 00 no data available The MSB and second MSB bits 7 amp 6 of the SpO2 bytes are not used in this monitor and should be masked out byte 8 15 8 byte pulse rate data range 00 FA Hex 0 250 decimal FB Hex 251 decimal no data available
18. ee RD ume eee 29 Finger Sensor eee cete eroe Deui rea r aa pe S e Ee eie 29 PII mU 29 XsStrip Tapes ERO RR T AEE EE 30 Bar Clip re gedaan ce ae Ae ais MEAs is es hes BE RA ee 30 Specifications uxori etate uM URS DON DIU ede ately Winrar ae mee SN ime 31 General netic cig rut eiit Hp er HE DRE ROS 31 Oxygen Saturation SpO2 sssssessesssseeeeee eene enne enne rennen trennen nennen nennen nee 31 Pulse Rate pete ber rh ee edite ed repute fonde 31 General Specifications oerte tee Merge tetro Re o iEn deti ET Eel 31 01 May 96 Model 511 User s Manual Section 1 Model 511 User s Manual Introduction This manual describes the use and operation of the Model 51 Pulse Oximeter from Novametrix Medical Systems Inc The Model 511 is a lightweight easy to use pulse oximeter that provides reliable measurement and displays for functional pulsatile oxygen saturation SpO and pulse rate The monitor is powered from four standard AA size alkaline batteries or may be connected to an optional external power source for continuous mains operation Numerical SpO and Pulse Rate information is presented on a liquid crystal display LCD A pulsatile signal activity bar battery strength indicator and general alarm indicators are also displayed on the LCD The Model 511 controls include a power on off switch that also controls display illumination and an alarm key that enables disables audible alarms and sets a
19. ensor 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 Probe Off Patient illuminated 2 Tape the Y Sensor to your index finger Does the monitor shows reasonable SpOs and pulse rate values 3 A YES to BOTH 1 and 2 indicates the sensor is OK Apply the sensor to the patient as instructed above The quick check also tests the functionality of the extension cable 18 01 May 96 Model 511 User s Manual Model 511 Model 511 User s Manual Single Patient Use SpO Sensors Single Patient Use SpO Sensors Intended Use The Single Patient Use SpO sensors Catalog Nos 6480 and 6455 can be used when monitoring adult pediatric or neonatal patients with Novametrix Pulse Oximeters SuperBright series These sensors are used with the DB 9 connector cable WARNING Use the Single Patient Use sensor and DB 9 connector 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 become
20. er Adult Finger 2 Remove the portion of the release liner containing the holes Remove release liner with holes Cat No 8831 8832 Cat No 8828 8829 3 Skip this step if using the 25 mm Y Strip tape If using the 20 mm Y Strip tape carefully remove the 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 4 Press the button on the back of each sensor head through a hole in the tape 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 Liner this side top Y Strip Tape Cross Section Button 5 Remove the remaining release liner and apply the sensor tape to the patient 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 Ensure that the sensor heads 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 there will be no light transmission through this space 6 To maximize sensor life secure the sensor to the patient with additional tape 16 01 May 96 Model 511 User s Man
21. hould be exercised to assure continued peripheral perfusion distal to the SpO sensor site after application Do NOT attach an SpO 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 Warnings Warning Indicates a potentially harmful condition that can lead to personal injury Explosion Hazard Do NOT use the Model 511 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 Model 511 off before cleaning it Do NOT use a damaged sensor or one with exposed electrical contacts Do not use with a damaged external power source or one with a damaged cord Refer servicing to qualified service personnel Failure of Operation If the monitor fails to respond as described do not use it until the situation has been corrected by qualified personnel Patient Safety Care should be exercised to assure continued peripheral perfusion distal to the SpO sensor site after application Data Validity As with all pulse oximeters inaccurate SpO and Pulse Rate values may be caused by ncorrect application or use of a sensor Significant levels of dysfunctional hemoglobin carboxyhemoglobin or methemoglobin Significant levels of indocyanine green methylene blue or other intravascular dyes
22. lert limits Model 511 monitors Cat No 6416 00 are available with a serial communications option which allows patient trend information to be downloaded into the Novametrix NovaCARD Data Archive System or other communicating devices Interfacing between the communicating device and the monitor is via a simple cable connection See Serial Communication Option on page 23 for more information Principles of Operation The Model 511 measures oxygen saturation and pulse rate with sensors that contain red and infrared light sources called LEDs Since oxygen saturated blood absorbs different amounts of light at each wavelength red and infrared as compared to unsaturated blood the amount of light absorbed by the blood in each pulse can be used to calculate oxygen saturation The light energy from red 660 nm and infrared 940 nm LEDs 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 called a photodiode on the opposing side of the sensor The data received at the photodiode is sent back to the monitor where it is split into its red and infrared components digitized processed by a microprocessor chip and finally displayed as a numerical value for oxygen saturation and a plethysmogram The Model 511 is calibrated to display functional saturation This differs from the fractional saturation value displayed
23. nabled All visible alerts continuously active for longer than 10 seconds will cause an unlatched audible alarm to sound a JW Display showing alert limits i i j i h when audible alert is enabled DE E A Alert limits shown for 3 seconds default values shown here NOTE Disabling and re enabling the audible alarms will reset the ten second delay clock when an alert condition exists If pressing and releasing the alarm key causes the alarms to be disabled the monitor shall beep once and turn on the alarm icon The alarm display icon will illuminate as a warning that the audible alarms are disabled a WA Typical display with audible i i i i wA w alert icon displayed D 209P i S IX Audible alert icon O shown when audible alert is disabled J NOTE With the audible alarms disabled the audible alarm will not sound under any alert condition Saturation Auto Alert Limits 1 To set alert limits press and hold the alert key for more than 2 5 seconds The um monitor will beep twice if new limits are set based on valid SpO values If no SpO is displayed the monitor will use default limits and will beep three times The Model 511 will display the high limit in the SpO display and the low limit in the pulse rate display for three seconds The monitor will then return to normal operation NOTE Setting alert limits automatically enables the audible alarms Model 51
24. over period cr carriage return If line feed Date and Time Date and Time mode causes the Model 511 to transmit on request the date and time as calculated by the monitor s internal calendar clock To request the date and time the computer must send an ASCII d character The monitor echoes back the d character and sends the date and time on the same line The Mode d data format is de MMM DD YY hh mm ss cr lf where d the echoed command character is an ASCII space character MMM a 3 character month Jan Dec DD a 2 digit ASCII day 01 31 YY the last 2 digits of the year 1990 is 90 hh a 2 digit hour based on a 24 hour clock 00 23 01 May 96 Model 511 User s Manual NOVACOMM I Interface mm a 2 digit minute SS a 2 digit second cr lf isacarriage return line feed sequence Setting Date and Time 66 S To set the date and time the computer must send the ASCII character The s is the command to set the time The mode of the data format is sMM DD YY hh mm ss where is an ASCII space character s the echoed command character MM a 2 digit month number 01 12 DD a 2 digit ASCII day 01 31 YY the last 2 digits of the year 1990 is 90 hh a 2 digit hour based on a 24 hour clock 00 23 mm a 2 digit minute ss a 2 digit second There must be a delay of at least 20 msec between bytes so the data r
25. parts of our equipment except fuses batteries and calibration gasses 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 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 1993 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 01 May 96 iv Section ii Guarantee This page intentionally blank V 01 May 96 Model 511 User s Manual Contents Section Manual Revision History s ic c cedinicnarccands dace ine Wet aies iti SH ATATICS nZone
26. previously used alkaline or rechargeable alkaline batteries will affect the battery life times Prolonged use of the backlight can significantly reduce overall battery life The battery icon may appear fully charged for the first minute after power up after which it will reflect the true battery charge NOTE When operating from the external power supply the battery icon does not reflect the condition of the batteries See External DC Supply Select and Apply a Sensor to the Patient Refer to Section 5 Monitoring Saturation and Pulse Rate Once the Model 511 is powered on and a sensor is connected to the monitor and properly applied to the patient numerical SpO and Pulse Rate values appear on the monitor s display A pulse activity bar derived from the pulsatile signal is also displayed The monitor automatically adjusts the activity bar s length to produce an easily visible display Verify the pulse activity bar reflects the patient s pulse The bar should show regular rhythmic movement Erratic or non rhythmic pulse bar activity may indicate a poorly positioned or applied sensor or may be indicative of excess patient movement at the sensor site Check the sensor site and if necessary attempt to reduce patient movement Violation of the upper or lower saturation auto alert limits shall immediately cause a H or L to flash within the borders of the display alarm icon even if the icon itself is disabled 01
27. pto einen Pp MER P prati pe 13 Finger Sensotas es eni e E ABRIR ORE UIS e te eo ee 13 Finger Sensor Quick Check esee enne nennen 14 N SODS OL ss secihctese tee qr eee pi e pP nee ees ceeds 15 Y Sensor Application using Y Strip Tapes cece eecseseecseceeececsseesecescesecnseneeeeees 15 Y Sensor Application using Ear Clip eene 17 Y Sensor Quick Check upon ARIES 18 single Patient Use SpOs Sensors a due roe prenom e erede eser 19 Instructions for Use e erp e PP RERO De RERO e PER 19 Model 511 User s Manual 01 May 96 vi Section ii Contents vii Connecting the sensor ze o ee prd eue enon ta an ese ie pps 19 Sensor Application ipee eiue van eet ehe pe Baie 21 Single Patient Use SpO Sensor Quick Check sess 22 Serial Communication Option 1 sse tenete 23 Connecting a sensor to the Model 511 sese 23 Connecting the Model 511 for serial communication eeeeeeeeeeeen 24 NOVACOMM 1 Tnterface ttn et tie deti o E Tr DURER ELDER ERR snes 25 Trend Dump 5 eben e e ih Sib AS lentes aei tee ges 25 Date and TIM Ekee en it er tro e ed e eO HERREN 26 Setting Date and Time ERR EE 27 Clear Tends cinan eiaa a sarki e eas oer vaca S eed teed desea tag toeee 27 Exit Command need eee tee chest eee ede oer 27 Cleaning amp Sterilization cao OP oii Gnisinakina nina IM d TU aes 29 Model LI MOtNtOF id
28. r Condition Sensor Disconnect 1 Sensor not connected to monitor Sensor Off Patient 2 Sensor not applied to the patient Reposition Sensor 3 Low signal strength Pulse strength as detected by the sensor is too small for proper monitor operation Reposition Sensor 4 Insufficient light Sensor placed on a site too thick or opaque for adequate light transmission Reposition Sensor 5 Pulse out of range Pulse must be 30 250 bpm inclusive Reposition Sensor 6 Light Interference Ambient light sources sunlight warming lights etc are interfering with sensor operation Shield sensor from these light sources Unit Sensor Error 7 Sensor fault Remove sensor from use and contact qualified service personnel Unit Sensor Error 8 Monitor fault Record the error number that appears in the pulse rate display Remove the monitor from use and contact qualified service personnel Reposition Sensor 9 Bad signal monitor not receiving valid signals from sensor May be caused by excessive motion cardiac arrhythmia or other situations leading to poor signal Check patient status reposition sensor 01 May 96 11 Section 4 Monitor Operation All status conditions except for Unit Sensor Error will reset automatically once the condition is corrected Unit Sensor Error conditions are latching conditions that is you must replace the sensor for a sensor fault or turn the Model 511 off and fix the problem before the monitor fault is re
29. s a question Instructions for Use Connecting the sensor Attach the DB 9 to OxySnap connector cable to the Model 511 Align the arrows on the OxySnap connectors and press the connectors together Model 511 DB 9 Connector D A Cable 01 May 96 19 Section 5 SpO2 Sensors Model 511 with RS232 Model 511 with RS232 option I 4 DB 9 to OxySnap Connector Ae rnm E _ pen 2 Press the black connector on the end of the DB 9 to OxySnap extension cable into the black connector on the end of the Single Patient Use SpO sensor DB 9 connection DB 9 to OxySnap connector Sensor connector 20 01 May 96 Model 511 User s Manual Single Patient Use SpO Sensors 3 To disconnect the DB 9 to OxySnap connector cable grasp the connectors and pull them apart the DB 9 to OxySnap connector can remain attached to the Model 511 as long as single patient use sensors will be used Sensor Application 1 Select the appropriate size sensor based on the patient type PEDIATRIC ADULT SENSOR ADULT TOE ADULT FINGER NEONATAL PEDIATRIC SENSOR NEONATAL HAND PEDIATRIC TOE NEONATAL FOOT 2 Apply the sensor by placing the blue side of the sensor wrap against the skin wrap it around the site cut excess foam if necessary and secure with Velcro tab The Velcro tab on the neonatal pediatric version is removable to allow the foam wrap to be cut before appl
30. set 12 01 May 96 Model 511 User s Manual Section 5 SpO Sensors The Model 511 Pulse Oximeter requires OxySnap SuperBright SpO Sensors WARNING Connect only Novametrix OxySnap SuperBright saturation sensors to the Model 511 DO NOT use other sensors or accessories with the Model 511 Before connecting to the patient or to the Model 511 ensure sensors are physically intact with no broken frayed or damaged components 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 To attach an OxySnap SuperBright sensor to the Model 511 1 Align the arrows on the Oxy Snap connectors and press the connectors together d CIO QE A 0 000007 D Model 511 zero SG amp Eaa Sensor 2 To disconnect grasp the connectors at the finger grips and pull them apart OxySnap Connector Finger Sensor The Finger Sensor is intended for adult fingers and not designed for neonatal or pediatric applications OxySnap Finger Sensor Before applying the sensor to the patient 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 511 User s Manual 01 May 96 1 3 Section 5 SpO2 Sensors Applying th
31. ta A record can be one of two types an INFO record or a DATA record The INFO record contains monitor information such as time of day date limit settings and units The DATA record contains event marker audio disable SpO and pulse rate values The first record sent is always an INFO record This record reflects the oldest data in the buffer then records would continue being sent in chronological order from the oldest record to the newest record In normal monitoring use an INFO record would be followed by 15 data records followed by another INFO record and then another 15 data records etc Turning the monitor off or changing the limits will disrupt this sequence When this occurs anew INFO record will be sent and indicate the time and date along with the current limits At this point unless another exception occurs the next INFO record will be followed by 15 DATA records An INFO record can be distinguished from a DATA record by the first byte The first byte of an INFO record is FF the first byte of a DATA record is 00 C8 0 200 decimal or FB pen lift or no data available Any other values are not applicable The DATA record uses 8 data points per parameter at 8 second resolution for a total of 64 seconds of trend data per data record To request trend dump the computer must send an ASCII 6 character The monitor echoes back the 6 character and transmits the first INFO record The Mode 6 data format is INFO r
32. ter Strip removed Y Strip Application Sites and Catalog Numbers Model 511 User s Manual The reusable Y Sensor is a flexible versatile sensor designed for use on any patient Before applying the sensor to the patient 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 The Y Sensor s Center Strip is not a functional part of the sensor Its purpose is to aid in the placement of the sensor into the tape or other securing system The center strip may be removed carefully cut away if the distance between the sensor heads needs to be changed from 25 mm Sensor Heads Strip may be removed Y Sensor Application using Y Strip Tapes Select a Y Strip based on the patient type and intended sensor location Y Strips come in two color coded sizes 25 mm tapes are coded green and 20 mm tapes are coded blue The size refers to the distance between the holes in the tape Wrap Style Tape Cat No 8829 Cat No 8828 Cat No 8836 25 mm Green 20 mm Blue INon adhesive Foam Neonatal Foot Neonatal Foot Hand Wrap Hand Pediatric Toe Finger 01 May 96 15 Section 5 SpO2 Sensors Finger Style Tape Cat No 8832 Cat No 8831 25 mm Green 20 mm Blue Adult Finger Pediatric Fing
33. ting a sensor to the Model 511 Model 511 User s Manual Serial Communication Option Model 511 monitors Cat No 6416 00 are available with a serial communications option which allows patient trend information to be downloaded into the Novametrix NovaCARD Data Archive System or other communicating devices A 15 pin mini D connector PATIENT SERIAL INTERFACE on the top panel indicates the option is installed An interface cable Novametrix Cat No 6493 01 is required for connection between the monitor and the communicating device The PATIENT SERIAL INTERFACE connector is shared between patient monitoring and serial communication When attaching a sensor for patient monitoring the 6292 01 cable must be connected to the PATIENT SERIAL INTERFACE the sensor will plug into the other end of the cable When utilizing the monitor for serial communication the 6293 01 interface cable must be used this cable terminates in a 9 pin D female for connection to the communication device Connecting a sensor to the Model 511 1 Plug the 6292 01 cable into the PATIENT SERIAL INTERFACE connector Model 511 6292 01 cable OxySnap connection for SuperBright sensor 2 Connect an OxySnap Finger or Y sensor into the end of the cable 3 Apply the sensor as described in Y Sensor on page 15 01 May 96 23 Section 4 Serial Communication Option Connecting the Model 511 for serial communication 1
34. ual Y Sensor Leave slack in the wires between the tape and the sensor Y Sensor applied to patient Adult Pediatric Finger Neonatal Hand E Neonatal Pediatric Foot Pediatric Toe 7 Inspect the site often for adequate circulation at least once every four hours Y Sensor Application using Ear Clip 1 Remove center strip from the Y Sensor Y Sensor before attachment to Ear Clip 5 SENSOR HEADS 2 Slide each Y Sensor head into the ear clip s receptacles the heads should face each other Y Sensor placed on Ear Clip 9 L SENSOR HEAD EAR CLIP RECEPTACLE SQUEEZE HERE TO APPLY gt 3 Gently squeeze the end of the ear clip shown in diagram and apply the sensor to the patient Model 511 User s Manual 01 May 96 17 Section 5 SpO2 Sensors 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 Y Sensor with Ear Clip placed on patient ear ADULT EAR OPTIONAL PLACEMENTS 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 Y S
35. ying to the patient A VELCRO TAB NEONATAL PEDIATRIC SENSOR Ensure that sensor heads are positioned directly opposite each other through the tissue The adhesive dots Cat No 8700 which are included with each sensor can be applied the sensor before patient application for additional adhesion to the site Model 511 User s Manual 01 May 96 21 Section 5 SpO2 Sensors 22 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 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 Single Patient Use SpO Sensor Quick Check With the sensor connected to the monitor but not applied to the patient position the sensor heads so that they face each other the red light shines at the detector Is PROBE OFF PATIENT displayed Apply the sensor to your index finger Are reasonable SpO and pulse rate values displayed A YES to BOTH 1 and 2 indicates the sensor is OK Apply the sensor to the patient as instructed above This quick check also tests the functionality of the DB 9 to OxySnap connector cable 01 May 96 Model 511 User s Manual Section 4 Connec
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