- Frank`s Hospital Workshop
Contents
1. To clean the display panel use a cotton swab moistened with 70 isopropyl alcohol and gently wipe the panel 3800 User s Manual To clean the outer surface of the oximeter use a soft cloth dampened with a mild soap and water solution or one of the following solutions 70 vol96 isopropyl or ethyl alcohol quaternary ammonia 3 vol hydrogen peroxide in water 100 1 bleach solution Cidex plus activator ready solution contains 2 vol glutaraldehyde Recharging the battery The oximeter s internal battery a sealed pack of 8V lead acid batteries provides the following operation times when it is new used at normal temperatures and charged to full capacity atleast 5 1 2 hours of continuous operation A LOW BATTERY message appears when 5 to 15 minutes of battery operation remain When the alarm message CONNECT UNIT TO LINE POWER appears during operation on battery power an audible alarm sounds and the oximeter automatically shuts off in approximately 10 seconds Important To prevent permanent damage to the battery recharge a discharged battery within eight hours after the LOW BATTERY message is displayed To recharge the battery plug the oximeter into the AC power supply The oximeter is operational while recharging the battery The battery charging times are approximately e 4hours for 80 battery capacity e 8 hours for 100 battery capacity Under normal conditions the battery lasts for several hundre2. Disconnected or failed speaker Unit requires service Dashed display waveform may appear erratic various alarm messages Sensor failure Replace sensor See CHECK SENSOR SITE under Messages in this chapter 3 6 4 Maintenance and Service This chapter covers Cleaning Oximeter Maintenance procedures Cleaning the oximeter as necessary Recharging the battery as necessary Replacing the fuses in the power module as necessary The Datex Ohmeda repair policy A list of items you may order for the oximeter To clean a reusable sensor refer to the instructions for the sensor WARNING Electrical shock and flammability hazard Before cleaning the oximeter always turn it off and disconnect the power cord from the AC power supply CAUTION Do not autoclave pressure sterilize or gas sterilize this oximeter Use cleaning solution sparingly Do not soak or immerse the monitor in liquid Excessive solution can flow into the monitor and damage internal components When cleaning the display area do not use abrasive cleaning compounds or other materials that could damage the screen Do not use petroleum based solutions acetone solutions or other harsh solvents to clean the oximeter These substances may damage the oximeter and cause a malfunction Be sure that the oximeter is turned off and unplugged from the AC power supply before cleaning and that the unit is completely dry before use
3. CP lt enter gt Warranty The 3800 Pulse Oximeter the product is sold by Datex Ohmeda Inc only under the warranties set forth in the following paragraphs Such warranties are extended only with respect to the purchase of the product directly from Datex Ohmeda Authorized Dealers as new merchandise and are extended to the first Buyer thereof other than for resale Limited warranty Datex Ohmeda warrants that the product meets the published specifications at the time of shipment from the factory Products not under warranty The following items are not covered under this warranty disposable items accessories service kits and replacement parts These items may be covered under a separate warranty Consult Datex Ohmeda for details Duration The product is warranted against defects in materials and workmanship for a period of three 3 years from the date of delivery to the user in no event for a period of more than four 4 years from the date of original delivery by Datex Ohmeda to an Authorized Dealer The battery is warranted against defects in materials and workmanship for one 1 year from the date of delivery to the user If any part of the product proves defective under proper and normal use within the warranty period as the purchaser s exclusive remedy Datex Ohmeda will repair or replace at its sole discretion the product or any defective part provided it is returned to Datex Ohmeda Service within 30 days of the fai
4. see Setup in chapter 2 Other features 1 2 e PerfTrakG amp waveform display an automatic scale of the plethysmographic waveform to provide a relative indication of the sensor site perfusion level e Large SpO digital display for clear differentiation from the pulse rate value e Backlit display and contrast control for excellent visibility in subdued lighting conditions adjustable viewing angle using the pull down feet under the monitor Direct access to user selectable high and low alarm limits for SpOz and pulse rate e An audible pulse indicator with an adjustable volume the automatic pitch modulation reflects changing SpO level e Visual and audible adjustable volume alarms e An alarm silence feature that silences audible alarms for 120 seconds e An all mute feature that silences audible alarms until deactivated e Automatic tiered alarm messages e Short medium or long SpO response averaging modes e Adult or neonatal patient modes for default pulse rate alarm settings e Automatic storage of up to 12 hours of SpO pulse rate and alarm limit violations data in trend memory which can be output through the RS 232 serial connector e An automatic self test and calibration check at start up After start up the oximeter continuously performs background self tests e Rechargeable sealed lead acid battery operation including battery status reporting 1 Overview Functional components The
5. 3800 oximeter uses the following key electrical component elements to determine SpO pulse rate and PI pulsatile values e The sensor e Sensor signal processing Microprocessor calculations The sensor consists of e The light source red and infrared light emitting diodes LEDs The photodetector an electronic device that produces an electrical current proportional to incident light intensity Timing Control Analog x A D Digital Input Processing Converter Processing Output Sensor Figure 1 1 Signal processing block diagram The two light wavelengths generated by the LEDs pass through the tissue at the sensor site The photodetector collects this light partially absorbed and modu lated and converts it into an electronic signal that is sent to the oximeter for further processing The electronic circuitry receives the photodetector s electronic signal processes it and passes it on to the microprocessor for calculation of the SpO pulse rate and PI pulsatile value 1 3 3800 User s Manual Principles of operation 1 4 The 3800 pulse oximeter uses a two wavelength pulsatile system red and infrared light to distinguish between oxygenated O2Hb and reduced HHb hemoglobin each of which absorbs different amounts of light emitted from the oximeter sensor The system then calculates the relative percentage of these two constituents and displays SpO o 5 Variable absorption gt A v
6. complete information about the safe and appropriate use of a sensor consult the instructions for that sensor CAUTION Do not apply tension to the sensor cable sensor damage may result Check that the sensor is a compatible model before connecting it to the oximeter Only Datex Ohmeda OxyTip sensors can be used with this monitor If you re using a reusable sensor make sure it opens and closes smoothly Remove substances that may interfere with the transmission of light between the sensor s light source and detector Connect the sensor cable to the sensor connector on the monitor Make sure it is a firm connection and that the cable is not twisted sliced or frayed Attach the sensor to a finger or an ear depending on the sensor you are using 2 5 3800 User s Manual 5 Toturn on the oximeter press the power button The first screen shows the Datex Ohmeda logo and the model name Model 3800 The next screen shows the averaging mode in effect the patient mode the progress of the self test and the status of the battery charge Averaging Mode Long Patient Mode Adult Self test in progress o 0 indicates battery charge status Below the bar graph the version number of the unit s system and oximetry software appears as Version X XXX YY YYY where X s represent the system software version and Y s the oximetry software version Diagnostic self test During this time the system performs a diag
7. motion include clenching pressing and rubbing as well as extending flexing and kicking Unlike motion technologies that use only a single method to correct for motion TruTrak selects one of many proprietary motion correction algorithms depending on the type and intensity of the motion TruTrak technology employs a patented five step process that consists of 1 high speed data sampling 2 motion identification quantification and 1 Anesthesia amp Analgesia 2002 94 1S 54 S60 1 1 3800 User s Manual correction 3 calculation of the SpO value 4 weighting and averaging of the SpO value and 5 the display of an improved SpO value The result of this process is a more accurate and stable displayed SpO value with fewer false alarms or dashed displays Important For TruTrak performance the averaging mode must be set to Long See Setup in chapter 2 PI pulsatile value The PI pulsatile value indicates the strength of the pulse signal at the sensor site the higher the PI value the stronger the pulse signal A strong pulse signal increases the validity of SpOz and pulse rate data PI is a relative value that varies from patient to patient Clinicians can use the PI value to compare the strength of the pulse signal at different sites on a patient in order to locate the best site for the sensor the site with the strongest pulse signal You can choose to display or not display the PI value
8. 3800 Pulse Oximeter TruTrak User s Manual ll spo 45 IZ Y a o Datex Ohmeda aoe e 6050 0006 380 Printed in USA Important This device performs as described in this manual and in accompanying labels and inserts when assembled operated maintained and repaired in accordance with the instructions provided Attention Consult the accompanying instructions before using this N device The safety reliability and performance of this device can be assured only under the following conditions e fitis used according to the accompanying operating instructions e If fittings extensions readjustments changes or repairs are carried out by agents authorized by Datex Ohmeda e fitis used in buildings having ground equalization wiring that complies with relevant local standards and regulations CAUTION US Federal law restricts this device to sale by or on the order of a licensed medical practitioner Outside the USA check local laws for any restriction that may apply This device must be cleaned and checked periodically Do not use a defective device Parts that are broken missing plainly worn distorted or contaminated should be replaced immediately If repair or replacement becomes necessary request service advice from Datex Ohmeda information is listed on the back cover Do not repair this device or any of its parts other than in accordance with written instructions provided
9. For Japanese data transmissions are in English only Switches Language 123 English 123 D nBEERE French 123 German 123 mi ttt Italian 123 an s Japanese 123 Portuguese 123 FIMILIS Spanish 123 Swedish 2 3 3800 User s Manual Averaging mode Switches 4 and 5 set the averaging mode The averaging mode selects the time period of data used to calculate a weighted average SpO value to be displayed by the oximeter Switches Sp02 and Pulse Rate Averaging TruTrak 45 45 Long 12 seconds Yes enabled 45 HHHH Medium 6 seconds No 45 HHHH Short 3 seconds No Patient mode Switch 6 sets the patient mode Switch Patient mode Low pulse rate alarm limit High pulse rate alarm limit 6 HHHH Adult 40 bpm 130 bpm 6 HHHH Neonate 100 bpm 200 bpm Pl pulsatile value display Switch 7 sets the display of the PI pulsatile value Switch Display Pl value 7 7 HHHH No EMI line frequency Switch 8 sets the EMI line frequency To optimize EMI electromagnetic interference immunity make sure switch 8 is in the correct position for the AC power line frequency in use Switch EMI Line Frequency 8 8 2 4 2 Setup and Operations Checkout procedure WARNING Failure of operation If the oximeter fails any part of the checkout procedures or current leakage tests remove it from ope
10. R SpO2 94 PR HIGH PR SpO2 89 PR LOW SPO2 HIGH PR BUTTON STUCK SpO2 92 PR 100 HIGH PR BUTTON STUCK SpO2 95 PR 99 SpO2 95 PR 98 SpO2 PR NO SENSOR END TREND DATA Auto output mode This is the default mode which transmits monitoring data being currently collected It is present when the oximeter begins communication with a computer and is the mode the oximeter returns to when exiting from other modes Messages relating to SpOg pulse rate and alarm limits violations that appear on the oximeter also appear on the computer B 3 3800 User s Manual Trend output mode B 4 This mode allows up to 12 hours of trend data to be output to a computer NOTE 12 hours of trend data are output in approximately 5 minutes To enter trend output mode Enter lt esc gt CJ lt enter gt While trend data are being output messages that appear on the oximeter do not appear on the computer but they are stored in trend To exit trend output mode while trend data are being output Enter lt esc gt CK lt enter gt After trend data are output auto output mode automatically resumes Trend data are still in memory and can be output again without turning the oximeter off and on again NOTE No other modes can be activated through the computer interface while in trend output mode only the trend output exit command is recognized To clear trend data in the oximeter s memory using the computer Enter lt esc gt
11. Recharging the batter yonini ei eaae SNTE Replacing tbe battery sscsss ctscscossncsoescscannnasesaroeanviasvets esnnnesserssenoniasvetsbernhnasseneegonniuavetsoeeninesseaseenoniasveistenansed Replacing the f ses cesceovceseensessvsssscersesinsasscnnoesonuassonesesonanasenaserinanssespsesiuanssenacerbuanseesgcesbnnoseagacepnaupssasnecbbanntess Repair policy and procedure csssssssssssssssssssssssssssssosssssssssssossessssssssssssssssssssesssesssssessssesssnssessssssessseeess Packaging and return procedure Parts Strasserin UU M e ii Table of Contents A Compliance and Specifications Compliance with standards A 1 General safety requireMents ccsssssssssssssseseccssssssssssssssssessccsssssssssssssssssesseeesssn A 1 Electromagnetic Compatibility EMQC ettet A 2 Electromagnetic effects cssnssesssecsscssssssesscsssssseessesssssscessecssseessesseessnesseessessseeesees A 2 Safety checks for Software aec tette etienne iub debe utter A 2 Specifications a m M M A 3 CiTG Pp A 3 A digindicatOt Ssns te tete idee mcdio doce eee du A 3 Audible alarms te bU HA IDA GHI MADRE A 3 Alarm limits eee A E eeidee it didietesse A 3 Displays RR RR RR RR ERR EORR ERA ERR DAR A4 Numeric display Light Emitting Diodes LEDs s A4 Graphic display Liquid Crystal Display LCD s A4 Mode switchin meenesii AA Sep A4 Interfering substances a A tttttt nnn non
12. Reference Manual Electromagnetic effects Electromagnetic interference including interference from portable and mobile radio frequency RF communications equipment can affect this monitor Indications that the 3800 is experiencing electromagnetic interference include the following e Variations in the PerfTrak waveform display e Sudden increases or decreases in the waveform height that do not correlate to the physiological condition of the patient e Sensor related messages that are not resolved by the instructions found in this manual The display of dashes on numeric LEDs when a valid physiological signal is present This interference may be intermittent and careful correlation between the effect and its possible source is important Indications of interference should not occur if the monitor is used within its intended electromagnetic environment Safety checks for software A 2 The Datex Ohmeda software design controls include performance of a risk analysis using methods consistent with EN 1441 Medical devices Risk analysis To ensure proper operation of the software the 3800 employs three separate watchdog circuits for the microprocessors power on self tests including memory checksum and calibration verification and memory tests during monitoring The software continuously monitors the patient sensor and if a failure is detected discontinues power to the sensor A Compliance and Specifications Specific
13. TE Figure 2 3 Low perfusion waveform 2 Setup and Operations Signal noise The following conditions can cause noisy waveforms e Poor sensor placement e Motion at the sensor site e Electrical interference Figure 2 4 Noisy plethysmographic waveform If three easily identifiable passes of a typical waveform do not occur Make sure the sensor s detector is flush with the sensor site for sensor application see the instructions for the sensor you are using e Make sure the light source and detector are directly opposite each other e Select a site where the distance between the light source and the detector is less e Make sure the patient site is stable minimize movement of the sensor site Massage the sensor site with a 7096 isopropyl alcohol pad or rubefacient cream 10 3096 methyl salicylate and 2 1096 menthol for 20 30 seconds Strong vasodilator creams such as nitroglycerin paste are not recommended e f possible remove electrical noise sources such as electrosurgery or electrical electronic devices e g fans If these solutions are not possible operate the oximeter on battery power or try plugging the oximeter into a different electrical outlet e f artificial nails or excessive fingernail polish are present select another site or remove the polish artificial nails Numeric display Sp02 Stability of the SpO readings is a good indicator of signal validity Although stabilit
14. atex Ohmeda Pulse Oximeter Empirical Calibration Study 1 5 3800 User s Manual Front panel 1 6 ae O O Datex Ohmeda 9 8 7 Figure 1 4 3800 Pulse Oximeter front panel Alarm silence button Numeric display LED Graphic display LCD SpO alarm limits high low setting buttons Pulse rate alarm limits high low setting buttons Display contrast adjust slide Power Standby button Carrying handle oO c N O Ci FF c N e Sensor connector 10 Pulse beep volume button 11 Alarm volume button 1 Overview Alarm silence button This button has two functions 120 second alarm silence activated by a single press Continuous all mute activated by three quick presses if the all mute feature is enabled Press once to deactivate Alarm silence When an active alarm condition exists press this button to silence the audible portion of the alarm for 120 seconds The flashing red or yellow alarm light becomes a steady light If an alarm condition still exists after 120 seconds the audible tone and flashing light resume Exceptions Both NO SENSOR and SENSOR OFF audible alarms will not be activated until after the unit obtains a valid signal The same conditions apply to an active audible alarm for NO SENSOR SENSOR OFF or SENSOR FAILURE that has been silenced i e once the sensor alarm condition is acknowledged by silencing the audible alarm a new audible alarm will not sound until the cond
15. ations Unless otherwise indicated all specifications are nominal and are subject to change without notice Circuitry Microprocessor controlled Automatic self test of oximeter when powered on Automatic setting of default parameters Automatic alarm messages Trend data output of SpO pulse rate and alarm messages via RS 232 serial port up to 12 hours of stored data Audio indicators Adjustable volume audible pulse Adjustable volume audible alarm tone Pitch modulation reflects changing SpO levels Alarm silence 120 seconds all mute continuous silence Pulse rate out of limits alarm SpOz level out of limits alarm Sensor condition alarms System failure and recharge battery alarms Audible alarms Setting levels available Alarm 1 through 5 Pulse beep OFF and 1 through 5 Intensity at 1 meter distance Volume setting of 1 55 decibels minimum Volume setting of 5 85 decibels maximum Alarm limits SpO alarm limit range High 50 to 100 or OFF Low OFF or 50 to 100 Pulse rate alarm limit range in beats per minute BPM High 30 to 235 or OFF OFF or 30 to 235 Low 3800 User s Manual Displays The displayed SpOz pulse rate and PI values are updated every second The plethysmographic waveform sweep is updated every 4 seconds Numeric display Light Emitting Diodes LEDs Arterial oxygen saturation SpO 2 reading Pulse rate reading Graphic display Liquid Crystal Display LCD Plethysmogra
16. attery power Because the unit is not grounded when it is operating on battery power do not connect any equipment to the RS 232 connector on the rear panel unless the unit is connected to the AC power supply 1 12 1 Overview Data validity Conditions that may cause inaccurate readings and impact alarms include interfering substances excessive ambient light electrical interference excessive motion low perfusion low signal strength incorrect sensor placement poor sensor fit and movement of the sensor on the patient To prevent erroneous readings do not use an inflated blood pressure cuff or arterial blood pressure measurement device on the same limb as the oximeter sensor Patient safety The correct use of the oximeter is to measure only arterial oxygen saturation SpOg pulse rate and Relative Perfusion Index pulsatile value e A pulse oximeter does not measure respiration and should never be used as a substitute for an apnea monitor or as the primary monitor for infants being monitored for apnea e A pulse oximeter may be used during sleep studies of adults only to gather information regarding SpO pulse rate and PI pulsatile value This device is not intended for use in a magnetic resonance imaging MRI environment Patient safety sensors Patient conditions such as reddening blistering skin discoloration ischemic skin necrosis and skin erosion may warrant changing the sensor site frequently or us
17. by Datex Ohmeda The user of this device shall have the sole responsibility for any malfunction that results from improper use faulty maintenance improper repair unauthorized service damage or alteration by anyone other than Datex Ohmeda Trademarks Datex amp Ohmeda OxyTip PerfTrak TruTrak and PI 7M are the property of Instrumentarium Corp or its subsidiaries Cidex is a registered trademark of Johnson amp Johnson Microsoft Windows Terminal is a trademark of Microsoft Corporation ProComm is a trademark of DataStorm Technologies All other product and company names are the property of their respective owners Text revised October 2002 2002 Datex Ohmeda Inc All rights reserved Table of Contents 1 Overview Product AeScription scscscsissesscccsssssnusseccsocnsneascccssssvvussccssossnnaiscessessinusscessatipnaiscccsetvunasscesSotinnaiscessetnuaussecseotiueas 1 1 Intended use 141 TruTrak technology 1 1 Prepulsstle walle eis 5e tette een eere ee ederent 12 Other features ceteris pe eter beer eve e N 12 Functional components e tete e e eiecit ieeeriitd 13 Principles of operation eterne benennen tie erected beaaat 14 Galibration i eet ebd teo een ette usted eddie 15 PrOmt pase M 1 6 Alarm silence Button ci 3 oae eel acento nen dtr bet 17 Alarm silenece scie deae si aee ecce at nuieutedet 17 All Ute eh i euet iie a uideo ren H
18. c 17 Numeric displayed e HRS E AERE HER UR RENS URS RR 17 Graphic display 18 SpO alarm limits high and low Pulse rate alarm limits high and low 1 9 Display contrast dJUsterz ott ente de tbt dd 19 Power Standby button AC power light sss 19 Battery operation eei taieececstidees n testes a sen ee rie oe seb ete eebo babe Garrying handle eie tette an ii i dan eniras Sensor connector Pulse beep volume button n Alarm volume button scere ete tei t tede n e e diede Orig curn Power entry module Equipotential ground connector Product information label s Mode Switch e tete tte tette tee tute e eie R5 232 serial connectors IRURE XR RR e n ine eec Precautions WATTLES c cosssasseccosstnersvecccotsennseee Failure of operation Explosion hazard ss Electrical shock and flammability hazard 1 12 Electrical shock Da zara t tte EA Data validity entier eR rre Patient Safety cte e cach ton ie bt tite Patient safety sensors RS 232 system interconnection CGU TOTIS sente qe coeli ei ee edes Handle the monitor with Care ssesscsssssssseessseccssnseescccecsnsssesecsecssssseeceseesnseesees Cleaning socero aaa aaa etr R dte pnta eed Edid dece eek ead loli cc NISI M DE AEE EESE ESE ENEE EEE E Disposal Miscellaneou
19. connections A third party communication program Procedure 1 Locate the serial connector on the rear panel of the oximeter and connect the male end of the RS 232 interface cable to it 2 Locate the RS 232 interface connector on the rear panel of the computer and connect the female end of the RS 232 interface cable to it 3 Make sure that the RS 232 interface cable is securely connected on both ends 4 Make sure the computer s communication program is running and ready to receive data at the correct baud rate B Communications Serial communication output The oximeter is capable of two way communication with computers e Auto output mode default current data Trend output mode trend data stored in the oximeter s memory To use these modes The oximeter must be connected to the computer The computer must be running a communications program SpO pulse rate and alarm conditions are transmitted and updated every two seconds in auto output mode or every six seconds in trend output mode One line of ASCII data is output to the computer every two seconds in auto output mode or every six seconds in trend output mode The information sent to the computer screen is formatted similarly to the following example Model 3800 Pulse Oximeter TREND DATA OUTPUT 6 SECONDS PER DATA POINT POWER ON SpO2 PR SpO2 PR SENSOR OFF SpO2 95 PR LOW PR SpO2 95 PR LOW PR SpO2 95 PR SpO2 95 P
20. d charge discharge cycles The battery will not overcharge Batteries stored for extended periods of time should be recharged every six months to maintain the charging capacity of the battery Replacing the battery 4 2 If the battery will no longer recharge with AC power connected it should be replaced Battery replacement should be performed by authorized service personnel only 4 Maintenance and Service Replacing the fuses Should a power problem blow one or both of the fuses in the power input module on the rear panel you ll need to replace them Tool required Small flat blade screwdriver 5 mm 3 16 inch WARNING To protect against fire hazard replace only with fuses of the same type and voltage rating 1 Power off the oximeter and unplug the power cord from the back of the oximeter 2 Insert the small flat blade screwdriver into the center slot of the fuse holder Gently pry loose and remove the fuse holder Fuse holder LE EE EE 3 Note how the fuses are placed in the fuse holder for installation of the new fuses Fuses 4 To remove the fuses from the fuse holder use the edge of the screwdriver blade to pry against the bottom of the metal portion of the fuse where it is secured to the glass portion of the fuse 5 Place the new fuse s T2 0AH 250V in the fuse holder properly orienting them as shown above 6 Slide the fuse holder back into the power entry module and
21. duced hemoglobin HHb oxyhemoglobin O2Hb carboxyhemoglobin COHb and methemoglobin MetHb Datex Ohmeda pulse oximeters use two wavelengths ranges 650 nm 665 nm and 930 nm 950 nm both with an average power of less than 1 mW These wavelengths are used to calculate the presence of O2Hb and reduced HHb Because of this pulse oximetry readings will be different than CO oximetry readings in situations where a patient s COHb or MetHb are increased Two different methods of calibration are currently used by manufacturers of pulse oximeters fractional and functional Important This pulse oximeter uses the functional calibration method The user cannot change the calibration method to fractional e Fractional saturation is represented mathematically as the percentage of the total amount of hemoglobin carrying oxygen It is determined by dividing the oxyhemoglobin by the total hemoglobin O Hb O Hb Fractional SpO x 100 x 100 HbrorAL QO Hb HHb COHb MetHb e Functional saturation is represented mathematically as the percentage of hemoglobin capable of carrying oxygen that is carrying oxygen O Hb O Hb Functional SpO x 100 x100 Hbrzora COHb MetHb O5Hb HHb The calculation of SpOz assumes 1 696 carboxyhemoglobin COHb 0 4 methemoglobin MetHb and no other pigments Appreciable variation from these values will influence SpO2 accuracy These values are based on the D
22. ent alarms are functional by setting the high and low SpO and pulse rate alarm limits beyond the current readings Make sure e An alarm tone sounds e The violated alarm limit and reading flash on the display Depending on the priority of the alarm a red or yellow alarm light flashes Verify the sensor alarms are functional by removing the sensor from the sensor site Make sure SENSOR OFF or CHECK SENSOR SITE appears in the message area of the graphic display e The alarm tone sounds the alarm light flashes Unplug the sensor from the oximeter Make sure e NO SENSOR appears The alarm tone sounds the alarm light flashes Press the alarm silence button Make sure e The alarm tone ceases The alarm light is steady To begin patient monitoring connect the desired Datex Ohmeda sensor to the oximeter Attach that sensor to the patient To verify the sensor is on correctly and that the data are verifiable see Signal and data validity in this chapter WARNING Patient safety Patient conditions such as reddening blistering skin discoloration ischemic skin necrosis and skin erosion may warrant changing the sensor site frequently or using a different style of sensor 2 7 3800 User s Manual Signal and data validity Plethysmographic waveform The oximeter s PerfTrak waveform display provides a visual indicator of the validity of the values that appear on the display The waveform is scaled to corresp
23. ep beep beep beep sound every 10 seconds until the condition is removed or the alarm is silenced e A violation of the low or high SpO limit violated limit flashes e BUTTON STUCK e CONNECT UNIT TO LINE POWER If the following alarms occur during active monitoring they also fall into the high priority category e AMBIENT LIGHT e CHECK SENSOR SITE e INSUFFICIENT LIGHT NO SENSOR e SENSOR FAILURE e SENSOR OFF NO SENSOR and SENSOR OFF alarm conditions are not active until after the oximeter displays an initial valid reading Medium priority 3 4 Requires prompt operator response Yellow alarm button light flashes One three tone sequence beep beep beep every 20 seconds until the condition is removed or the alarm is silenced e A violation of the low or high pulse rate limit violated limit flashes e INTERFERENCE DETECTED LOW BATTERY 3 Messages and Troubleshooting If the following alarms occur before active monitoring these alarms are considered to be of medium priority e AMBIENT LIGHT e CHECK SENSOR SITE e INSUFFICIENT LIGHT NO SENSOR e SENSOR FAILURE SENSOR OFF Low priority Requires operator awareness Yellow alarm button light illuminates continuously One tone beep sounds no repetition e INTERFERENCE DETECTED Requires operator awareness Yellow alarm button light illuminates continuously e LOW QUALITY SIGNAL System failure A special category of alarms exists for syste
24. ets the low alarm limit For either limit press the side to raise the value or the side to lower it As you press one of these buttons the values do not cycle through the available settings e g when you reach 235 the value does not cycle or wrap to 30 or OFF Display contrast adjuster Use this sliding lever to adjust the vertical viewing angle of the graphic display Slide the lever to the left to reduce the contrast and to the right to increase it Power Standby button AC power light This button toggles between On operational mode and Off standby mode The battery recharges as long as the unit is plugged into the AC power supply No displays are visible in the Off Standby mode The green light to the right of the button is lit when the unit is connected to an AC power supply Battery operation The oximeter runs for at least five and one half hours on a new fully charged battery at normal operating temperatures LOW BATTERY appears when between 5 and 15 minutes of battery operation time remain Plug the monitor into AC power to continue monitoring and recharge the battery The unit will operate with a dead or defective battery when it is connected to the AC power supply When the CONNECT UNIT TO LINE POWER message appears you must immediately plug the oximeter into the AC power supply or the unit turns itself off after 10 seconds When operating on battery power an icon appears between the two pairs of alarm limit
25. from the product
26. ge internal components When cleaning the display area do not use abrasive cleaning compounds or other materials that could damage the screen Do not use petroleum based solutions acetone solutions or other harsh solvents to clean the oximeter These substances may damage the oximeter and cause a malfunction Battery The 3800 internal battery containing lead and acid is a hazardous waste Dispose of the battery through an approved hazardous materials disposal facility or return it to Datex Ohmeda for disposal To prevent damage to the lead acid battery do not turn the monitor on after the LOW BATTERY message appears without first plugging it in to the AC power supply Sensors Do not apply tension to the sensor cable sensor damage may result Disposal Dispose of this medical device and its packing materials according to local requirements Miscellaneous US Federal law restricts this device to sale by or on the order of a licensed medical practitioner 1 14 2 Setup and Operations This chapter provides the following information and instructions e Powering the oximeter Selecting the language averaging mode patient mode PI pulsatile value display and EMI electromagnetic interference line frequency e Checkout procedure to determine that all functions of the oximeter are working properly e Signal and data validity guidelines Trend data To operate the oximeter effectively you must Know
27. herefore responsible that the system complies with the requirements of IEC EN 60601 1 1 If in doubt call your local authorized service office as listed on the back cover of this manual The 3800 is referred to as an IEC EN 60601 F device in the summary of situations table contained in IEC EN 60601 1 1 Serial device communications Requirements Connect the oximeter only to computers with e An RS 232 interface e The ability to accept ASCII formatted data at a baud rate of 9600 The settings on the computer must be 9600 baud 8 bit data No parity 1 stop bit 1 start bit Full duplex Handshaking CTS RTS B 1 3800 User s Manual B 2 RS 232 interface cable serial pinout Important Use only a cable designed to interface directly between your computer s connector and the RS 232 connector on the oximeter Configure the RS 232 interface cable as follows RS 232 Pin 2 Oximeter receives data 1 Pin 3 Oximeter transmits data Pin 5 Signal ground Flo Pin7 RTS Pin 8 CTS Pins 1 4 6 and 9 are not used Connection To acquire trend data on the computer the computer must be running a third party communications program such as ProCcomm or Microsoft Windows Terminal set to receive at 9600 baud Equipment needed A board for the computer that supports serial communication with the same serial port connections as the oximeter A male DB 9P to female DB 9P interface cable with the proper pin
28. how the oximeter derives its readings see Principles of operation in chapter 1 e Be familiar with its controls and components see chapter 1 Understand its messages see chapter 3 Powering the oximeter The 3800 pulse oximeter is designed to operate on battery power and on all commonly available voltage supplies Your oximeter was shipped with the correct power cord for your local AC power supply Any hospital grade power cord however with the female connector end that fits into the power module IEC 320 type on the 3800 can be used the male connector that plugs into the grounded wall outlet may be whatever is needed locally The oximeter accepts a range of AC mains power see Appendix A for details To protect data validity in cases of possible electromagnetic interference make sure the EMI line frequency mode switch is set to the same frequency as your local AC power supply before using the unit for patient monitoring see EMI line frequency under Mode switch settings later in this chapter A battery does not need to be installed for the oximeter to operate on the AC power supply 2 1 3800 User s Manual Setup Factory settings and default settings When you turn on the oximeter the following settings are in effect and remain in operation until you change them Before powering on the oximeter Use the mode switches in the oximeter s rear panel to set the language averaging mode patient mode PI pulsatile
29. ing a different style of sensor To prevent patient injury or equipment damage use only Datex Ohmeda oximeter sensors approved for use with this oximeter For complete information about the safe and appropriate use of a sensor consult the instructions for that sensor Discard a damaged sensor immediately Do not repair a damaged sensor or use a sensor repaired by others RS 232 system interconnection Accessory equipment connected to the RS 232 serial connector must be certified according to the current version of the respective IEC EN standards e g IEC 60950 for data processing equipment and IEC EN 60601 1 for medical equipment All configurations shall also comply with IEC EN 60601 1 1 Anyone who connects additional equipment to the RS 232 serial connector configures a medical system and is therefore responsible that the system complies with the requirements of IEC EN 60601 1 1 If in doubt call your local authorized service office as listed on the back cover of this manual The 3800 is referred to as an IEC EN 60601 F device in the summary of situations table contained in IEC EN 60601 1 1 1 13 3800 User s Manual Cautions Handle the monitor with care Improper handling can cause damage or inaccurate results Cleaning Do not autoclave pressure sterilize or gas sterilize the oximeter Use cleaning solution sparingly Do not soak or immerse the monitor in liquid Excessive solution can flow into the monitor and dama
30. io due to arterial pulse rem Se Ka qo uy 79 EM MEGA Arterial blood absorption Venous blood absorption Absorption Other tissue absorption Time Figure 1 2 Comparative light absorption Arterial blood pulsation at the test site modulates transmission of the oximeter sensor s light Since other fluids and tissues present generally don t pulsate they don t modulate the light passing through that location The attenuation of light energy due to arterial blood flow is detected and isolated by using the pulsatile portion of the incoming signal PI pulsatile value is a measure of the relative size of this portion of the signal 1 Red Infrared 660 nm 940 nm Extinction 10X 600 700 800 900 1000 Wavelength nm Figure 1 3 Extinction versus wavelength graph The sensor s photodetector converts the light which is partially absorbed and modulated as it passes through the tissue sample into an electronic signal Since O2Hb and HHb allow different amounts of light to reach the photodetector at the selected wavelengths the electronic signal varies according to the light source that 1 Overview is on and the oxygenation of the arterial hemoglobin Analog and digital signal processing then converts the light intensity information into SpO pulse rate and PI pulsatile values for display on the monitor Calibration A CO oximeter typically uses four or more wavelengths of light and calculates re
31. ition has been cleared and the unit obtains a valid signal NOTE Pressing the alarm silence button produces 120 seconds of silence regardless of other alarm conditions that may occur during this 120 second interval except for the SYSTEM FAILURE CONNECT UNIT TO LINE POWER and BUTTON STUCK alarms All mute To continuously silence any alarm that can be silenced press the alarm silence button three times within three seconds After you have activated all mute the all mute icon flashes between the SpO and pulse rate alarm limit settings on the right side of the screen display When an alarm condition occurs the alarm button light flashes and the alarm message appears on the waveform display but no audible alarm sounds When all mute is active press the alarm silence button once to deactivate this feature and enable all audible alarms Numeric display CH ll spo SpO numeric area calculated SpO2 l yY H Pulse rate numeric area calculated pulse rate IL 1 7 3800 User s Manual 3 Graphic display 1 Plethysmographic waveform The PerfTrak waveform display appears after the monitor has detected data from the sensor It represents the blood volume change of the hemodynamic system assuming no other factors e g motion artifact are present This waveform scales automatically to the perfusion level or strength of the signal being received at the patient monitoring site 2 Message a
32. le alarm volume level in incremental steps from 1 to 5 default is 3 You cannot set the alarm volume to OFF Press the side of the button to increase the alarm volume or the side to decrease it you will hear the volume level as you press the button As you press one of these buttons the values do not cycle through the available settings e g when you reach 5 the value does not cycle or wrap to 1 As you adjust the volume the volume setting is shown in the message area above the waveform 1 10 1 Overview Rear panel Mode Switch COT 100 240V 50 60 Hz 0 45 A 12 0AH 250V o Datex Ohmeda 1315 West Century Drive Louisville CO 80027 9560 USA Made in USA Figure 1 5 3800 Pulse Oximeter rear panel WARNING Electrical shock hazard Because the unit is not grounded when it is operating on battery power do not connect any equipment to the RS 232 connector on the rear panel unless the unit is connected to the AC power supply 1 Power entry module This module contains e Fuses e Power connector for the power cord that connects the oximeter to the AC power supply for continuous operation and or battery recharging Equipotential ground connector In locations where this type of ground is required connect your grounding system here Product information label The following symbols may appear on the monitor on labels affixed to the monitor and or
33. lure Limitation Datex Ohmeda may at any time discharge its warranty obligation by repairing and returning the product to original factory performance This may be accomplished by installing new or remanufactured assemblies or by other repairs deemed appropriate by Datex Ohmeda The choice of repair or replacement by Datex Ohmeda shall be the sole remedy of the buyer or user Conditions This warranty is valid only when qualified personnel have performed installation and service on the product and when all recommended planned maintenance procedures have been completed during the warranty period Damage caused by the abuse or misuse of the product is not covered by this warranty Datex Ohmeda shall not be liable for damage resulting from the improper installation or the misuse of the product Exclusion of warranties Oral statements about the product do not constitute warranties shall not be relied on by the buyer or user and are not part of any warranty extended by Datex Ohmeda Except as set forth in this limited warranty Datex Ohmeda makes no warranties expressed or implied including the implied warranty of merchantability and the implied warranty of fitness for a particular purpose Except for the obligations under this limited warranty Datex Ohmeda shall not have any obligation or liability for any incidental or consequential damages including those from commercial loss or other loss damage or injury resulting directly or indirectly
34. m failure and the imminent failure of pulse oximeter operation Requires immediate operator response Red alarm button light continuously flashes A continuous tone sounds overrides all mute condition e SYSTEM FAILURE XXX SERVICE UNIT For more information refer to the 3800 3900 3900P Technical Reference Manual 3 5 3800 User s Manual Troubleshooting The following chart list some conditions that may occur with the oximeter along with the cause s and recommended action s for correcting them Condition Possible cause s Recommended action s Unit does not power on The battery is fully discharged or disconnected and or the unit is not plugged into the AC power supply One or both of the fuses have blown To charge the battery and begin monitoring plug the unit into the AC power supply If the condition persists the unit requires service Replace the fuse s See Replacing the fuses in chapter 4 If the new fuse blows shortly after installation the unit requires service Unit powers on but the graphic display is blank The viewing contrast is not correct Use the display contrast adjust slide to adjust the viewing angle If the condition persists the unit requires service Continuous speaker tone Internal failure Unit requires service Buttons don t work when pressed Internal failure Unit requires service Unit doesn t beep when powered on
35. nate plethysmographic waveform Low perfusion waveform ee Noisy plethysmographic waveform ertet 1 Overview This chapter Introduces the product including the principles of its operation e Describes the oximeter s controls and features Lists the precautions you must take when using the oximeter Product description The Datex Ohmeda Model 3800 pulse oximeter with TruTrak technology features two easy to read displays that present patient data and status information e The numeric display shows the SpO and pulse rate values The graphic display shows the plethysmographic waveform messages the Relative Perfusion Index PI 7M pulsatile value and the high and low alarm limit settings for SpO and pulse rate Intended use The 3800 pulse oximeter with TruTrak technology is indicated for spot checking and continuous monitoring of functional oxygen saturation and pulse rate including monitoring during conditions of clinical patient motion This device is intended for use with adult pediatric and neonatal patients in both hospital and non hospital environments Important Only Datex Ohmeda OxyTip sensors can be used with this monitor TruTrak technology TruTrak technology improves pulse oximetry performance during conditions of clinical patient motion In the clinical environment oximetry readings are affected by several types of patient motion The types of
36. nostic self test electronics battery status analog signal path integrity calibration check and sets the default parameters This self test takes approximately 10 seconds e A start up tone sequence tests the audio circuit all display LEDs and the LCD backlight are illuminated then blanked The alarm LED toggles between red and yellow while a numeric countdown from 9 to 0 occurs on each seven segment LED display ending with a decimal point e lt A battery icon is displayed to indicate the battery condition as either charged depleted or defective missing see chapter 3 Upon successful completion of all diagnostic self tests the unit is considered to be in calibration and begins normal operation This message is displayed Test passed In calibration If the unit does not pass the self test an error message is displayed and the unit is inoperable 6 Onthe displays verify e The high and low alarm limits for SpO and pulse rate e Dashes appear for any limit set to OFF The readings for SpOg pulse rate and PI pulsatile value Dashes may appear on the display until the SpO pulse rate and PI pulsatile value readings have stabilized approximately 12 seconds 2 6 2 Setup and Operations NOTE The audible alarm feature for all alarm conditions is silenced for the first two minutes after powering on 7 10 11 If two minutes have elapsed since you powered on verify that the pati
37. nsor placement Check patient and oximeter setup NO SENSOR Sensor not connected or not fully Insert sensor cable into the also see inserted into the sensor connector CHECK SENSOR SITE Connect May be an incorrect sensor Refer to the instructions for the sensor you are using SENSOR FAILURE The connected sensor is not an Connect a Datex Ohmeda OxyTip sensor OxyTip sensor Oximeter can t identify the Replace sensor Refer to the connected sensor instructions for the sensor you are using Broken sensor cable wire Replace sensor inoperative LEDs or faulty detector the sensor has failed SENSOR OFF Sensor off patient Reattach the sensor SYSTEM FAILURE XXX An internal component of the Unit requires service SERVICE UNIT unit has failed XXX represents the error code TruTrak OFF TruTrak technology is not active the averaging mode is not set to Long For TruTrak performance set the averaging mode to Long see Setup in chapter 2 3 3 3800 User s Manual Alarm categories 3800 oximeter tiered alarms fall into three priority categories high medium and low Depending on what is occurring at the time an alarm may fall into more than one category NOTE The audible alarm feature for all alarm conditions is silenced for the first two minutes after powering on High priority Requires immediate operator response Red alarm button light flashes Two five tone sequences beep be
38. on shipping materials Refer to Compliance with standards in Appendix A for definitions of symbols that indicate compliance with standards set by regulatory agencies R ONLY CAUTION US Federal law restricts this device to sale by or on the order of a licensed medical practitioner Outside the USA check local laws for any restriction that may apply SN The serial number for this product appears as SN AAAYxxxxx The first three letters are specific to the product type the fourth letter indicates the year of manufacture F 2002 G 2003 etc I and O are not used The last five digits are the sequential number for the unit as produced in the indicated year The warranty expiration date for this product is printed near this symbol Mode Switch This symbol identifies the two position switches that set the display language the averaging mode the patient mode the display of the PI pulsatile value and the EMI line frequency See chapter 2 for instructions 1 11 3800 User s Manual RS 232 5b RS 232 serial connector C This 9 pin connector provides serial digital information on SpO pulse rate Oo Oo alarm limit violations and alarm messages It is compatible with most RS 232 devices capable of accepting a 9600 baud input See Appendix B for instructions Precautions Two types of precautions appear in this manual warnings and cautions e A WARNING indicates the possibility of injury to the patient or operat
39. ond to the perfusion level or strength of the signal being received at the patient monitoring site NOTE When a message appears in the upper portion of the LCD the waveform rectangle becomes smaller but the correspondence between signal strength and waveform height is maintained You should be able to easily identify three complete passes of the plethysmographic waveform Although the waveform shape may vary from patient to patient under normal conditions it corresponds to the arterial pressure waveform Use Figures 2 1 adult and 2 2 neonate as guidelines to determine a sensor placement that generates the fewest noise spikes Figure 2 1 Typical adult plethysmographic waveform Figure 2 2 Typical neonate plethysmographic waveform The typical neonate waveform differs from that of an adult including the absence of a dicrotic notch a notch on the descending limb of the normal arterial pulse tracing that corresponds to aortic valve closure Low perfusion 2 8 As the perfusion at the patient monitoring site decreases so will the height of the waveform The PI pulsatile value is a numeric representation of the relative height of the waveform The height will decrease to the point where the signal quality becomes too small or too poor for accurate reliable readings At that point the message CHECK SENSOR SITE appears in the message area and an alarm is generated The waveform will be similar to Figure 2 3 CHECK SENSOR SI
40. or e A CAUTION indicates a condition that may lead to equipment damage or malfunction Warnings Failure of operation If the oximeter fails any part of the checkout procedures or current leakage test remove it from operation until qualified service personnel have corrected the situation It is possible for any device to malfunction therefore always verify unusual data by performing a formal patient assessment Explosion hazard Do not use the monitor in the presence of any flammable anesthetic mixture Electrical shock and flammability hazard Before cleaning or servicing the oximeter always turn it off and disconnect the power cord from the AC power supply Electrical shock hazard Do not remove the monitor cover An operator may perform only maintenance procedures specifically described in this manual Refer servicing to qualified service personnel trained in the repair of this equipment Measure the oximeter s leakage current whenever an external device is connected to the RS 232 port Forward and reverse polarity 100 microamperes maximum This equipment must be properly grounded e Electrical safety specifications e g current leakage and ground resistance can be assured only when the monitor is connected to a three wire grounded receptacle without the use of extension cords or adapters e fthere is any doubt about the integrity of the AC power supply protective earth conductor operate the monitor on internal b
41. oughly familiar with this information before using the oximeter to monitor a patient The pulse oximeter acknowledges your actions and the monitor s conditions by displaying messages in the waveform screen message display area Alarm messages appear when any alarm condition occurs The following chart alphabetically lists the messages that may appear on the oximeter why the message appears and the action s to take if the message indicates a problem Message Possible cause s Recommended action s D Appears between the alarm deactivate limit settings The all mute feature is activated No action required Press the alarm silence button once to gm c m Appear on status screen mains power during power on sequence and on right side of LCD during battery operation Indicates a fully charged battery No action required Indicates a low charged battery To recharge plug the unit into AC aa Indicates battery failure or a To recharge plug the unit into AC depleted or missing battery mains power If the condition Appears on status screen persists the unit requires service during power on sequence aom COL The alarm or pulse tone volume No action required To adjust Appears in message area on waveform screen is being adjusted audio volume see Front panel in chapter 1 3800 User s Manual Message Possible cause s Recommended action s AMBIENT LIGHT Exces
42. phic waveform PI pulsatile value High and low SpOz alarm limits settings High and low pulse rate alarm limits settings Sensor condition alarms System operational status messages Alarm messages Contrast adjustment for best viewing Mode switch SpO Language English factory setting French German Italian Japanese Portuguese Spanish or Swedish Averaging mode Long TruTrak 12 seconds factory setting Medium 6 seconds or Short 3 seconds Patient mode Adult factory setting or Neonate PI pulsatile value display Yes factory setting or No EMI line frequency 60 Hz factory setting or 50 Hz Range 0 to 10096 Accuracy Arms previously represented by 1 Standard Deviation 70 to 100 2 digits 70 to 100 3 digits during conditions of clinical patient motion with TruTrak enabled Below 7096 unspecified Resolution 196 Interfering substances Carboxyhemoglobin may erroneously increase readings The level of increase is approximately equal to the amount of carboxyhemoglobin present Dyes or any substances containing dyes that change usual arterial pigmentation may cause erroneous readings A Compliance and Specifications Pulse rate Range 30 to 250 bpm Accuracy assuming a constant pulse rate 2 or 2 bpm whichever is greater Accuracy during conditions of clinical patient motion unspecified Resolution 1 bpm PI pulsatile value Range 0 00 to 9 99 Averaging interval 12
43. press firmly to make sure it is fully inserted NOTE If the fuses blow shortly after replacement the unit requires service 4 3 3800 User s Manual Repair policy and procedure Contact Datex Ohmeda or your authorized service office see the back cover of this manual to order parts or for assistance 4 4 Do not use malfunctioning equipment Have the unit repaired by Datex Ohmeda After repair perform the Checkout procedure in chapter 2 to verify the unit is fully functional WARNING Do not remove the cover of the monitor An operator may only perform maintenance procedures specifically described in this manual Refer servicing to qualified service personnel trained in the repair of this equipment Packaging and return procedure If you are instructed to ship the monitor to Datex Ohmeda or to an authorized service office for repair follow these steps 1 Clean the monitor Make sure it is completely dry before you pack it for shipment Package the monitor carefully for shipment in the original shipping container if possible You may be required to enclose the following items when you call for assistance verify the shipping requirements e A letter describing the problem in detail Person name telephone fax number and country to contact for questions about necessary repairs e Ship to and bill to information e Purchase order number for tracking purposes or to cover repairs if the oximete
44. r is not under warranty Ship the monitor as directed by your service office 4 Maintenance and Service Parts list Description REF Sensors Refer to the sensor chart that accompanies this manual for a list of the sensors you can use with the 3800 Only Datex Ohmeda OxyTip sensors can be used with this monitor Battery pack 6050 0004 277 Carrying case 3800 6050 0004 610 3800 User s Manual Danish 6050 0006 382 English 6050 0006 380 Finnish 6050 0006 384 French 6050 0006 386 German 6050 0006 388 Italian 6050 0006 390 Japanese 6050 0006 392 Polish 6050 0006 394 Portuguese 6050 0006 396 Spanish 6050 0006 398 Swedish 6050 0006 400 3800 3900 3900P Technical Reference Manual English 6050 0006 404 Service kit PCA drawings 6050 0006 476 Power cord Socket Type Commonly Used In Australia China 6030 0000 001 Canada Japan Latin America USA Continental Europe Italy United Kingdom 0208 0943 300 6030 0000 006 6030 0000 002 6050 0002 259 3800 User s Manual 4 6 A Compliance and Specifications This chapter contains Information about the tests that were conducted and the regulations with which the oximeter complies to assure its safe use Performance specifications for the oximeter Compliance with standards The presence on the monitor of any symbol described below indicates compliance with the standard represented by that symbol C Medical Device Directi
45. ration until qualified service personnel have corrected the situation WARNING Explosion hazard Do not use the monitor in the presence of any flammable anesthetic mixture WARNING Electrical shock hazard This equipment must be properly grounded Electrical safety specifications e g current leakage and ground resistance can be assured only when the monitor is connected to a three wire grounded receptacle without the use of extension cords or adapters If there is any doubt about the integrity of the AC power supply protective earth conductor operate the monitor on internal battery power Because the unit is not grounded when it is operating on battery power do not connect any equipment to the RS 232 connector on the rear panel unless the unit is connected to the AC power supply If you plan to send serial data to another device make sure the connection between the device and the rear panel connector is made before you power on the monitor and make sure the monitor is connected to the AC power supply Important For TruTrak performance the averaging mode must be set to Long Inspect the oximeter case for damage Make sure the display windows are clean WARNING Sensors Discard a damaged sensor immediately Do not repair a damaged sensor or use a sensor repaired by others To prevent patient injury or equipment damage use only Datex Ohmeda oximeter sensors approved for use with this oximeter For
46. rea Status and alarm messages appear above the waveform area on the waveform display the height of the waveform is reduced while messages are displayed Status messages give you information about the oximeter s operating condition Alarm messages alert you to conditions that need your attention See chapter 3 for complete alarm and status message information 3 SpOsand pulse rate alarm limits The high and low alarm limit settings appear here If a limit is set to OFF three dashes appear in the location for that limit When an SpOz or pulse rate limit is violated the LED on the numeric display and the LCD s limit value flashes for that alarm 4 PI pulsatile value Dashes appear if the following conditions exist no sensor is connected to the unit the sensor is not attached to the patient the sensor has failed there is insufficient light penetrating the tissue site or there is too much ambient light CE 4 SpO0 alarm limits high and low Spo The top button sets the high alarm limit and the bottom button sets the low alarm limit For either limit press the side of the button to raise the value or the side to lower it As you press one of these buttons the values do not cycle through the available settings e g when you reach 100 the value does not cycle or wrap to 50 or OFF 1 8 1 Overview 5 Pulse rate alarm limits high and low The top button sets the high alarm limit the bottom button s
47. s Table of Contents 2 Setup and Operations Powering the Oximeter ccssssssssssssssssssssssesssssssssssssssssssssessssssssssssssossssssssssssssssssnssssosssssssseessssssssssssssssss 2 1 r 2 2 Factory settings and default settings eterne ttes 22 Before powering on the oximeter eerte tnnt 22 After powering on the oximeter eerte ttti 22 Mode switch settings eee etd nde EA need nee 2 3 Language Averaging mode eet estilos eese gea 24 Patient mode ERAI RAI A AIRES Eo d ck REESE DR 24 PI pulsatile value display 24 EMI line frequency 424 Checkout procedure isisisi EE a aE EES a 2 5 Signal and data validity E AAEN 2 8 Plethysmographic waveform eese ttteeennnntttttetnnnnnnitttetennnsictttotnnnnanos 2 8 RON perbusioIiz eee ee ee ge te tegi e ce ERR 2 8 Signal noise Numeric display Trend data 3 Messages and Troubleshooting Cr 3 1 Alarm Cate E S 3 4 High PHOT aeter Pete Rer nennt eer e ERE eene eie 34 Medium priority aue ete eee tie eet dnd deett 34 Low priority is SySLeni Fallir8 enacted p eee dice n bac b A 3 5 Troubleshooting m 3 6 4 Maintenance and Service eri E 4 1 XTC COTS EP 4 1
48. seconds Resolution 0 01 Sensor emitter wavelength ranges Red LED peak wavelength range 650 to 665 nm Infrared IR LED peak wavelength range 930 to 950 nm Average power lt 1mW Environmental Parameter Operating Transport and Storage Temperature 0 to 50 C 40 to 70 C 32 to 122 F 740 to 158 F Relative humidity 596 to 9596 noncondensing 596 to 9596 condensing Pressure Approximate elevation Electrical Battery 106 to 47 kPa 378 to 6000 m 71240 to 19 686 ft Type pack of 8 volt sealed lead acid 106 to 47 kPa 378 m to 6000 m 1240 to 19 686 ft Capacity 3 2 ampere hours Operation time for a new battery at normal operating temperatures at least 5 1 2 hours with all functions operative from a fully charged battery Low battery indicator LOW BATTERY when the battery has between 5 and 15 minutes remaining capacity Charge time 4 hours 80 capacity 8 hours 100 capacity Life several hundred charge discharge cycles 3800 User s Manual Power Consumption typical 15 watts Input voltage range 90 to 264 VAC at 47 63 Hz Current typical 0 45 A rms at 100 V 0 37 A rms at 120 V 0 25 A rms at 220 230 240 V Current leakage With power on forward or reverse polarity 100 microamperes maximum Ground resistance less than 0 1 Q Fuses T2 0AH 250V 5 mm OD x 20 mm length Serial output RS 232 Data output every 2 seconds auto outp
49. sive ambient light Relocate the sensor to a site more shielded from light or reduce the amount of light shining on the sensor BUTTON STUCK Appears if something is pressing Make sure nothing is pressing against the buttons on the against the front of the unit monitor Appears when the last button Press that button again or turn the you pressed has not released power off and then on If the properly or has been pressed for condition persists the unit more than 30 seconds requires service CHECK SENSOR SITE Appears when SpO readings may For all causes reposition or be invalid due to motion an unacceptable sensor site poor placement low perfusion or because the sensor is off the patient relocate the sensor and or increase perfusion see the sensor user instructions Clear Trend Data YES NO Appears when the alarm silence button is held down while you re turning on the oximeter Press the high SpO alarm limit button or to clear trend data from memory YES Press the low pulse rate alarm limit button or to retain trend data in memory NO If you take no action within 10 seconds the trend data are retained in memory CONNECT UNIT TO LINE POWER The battery needs immediate recharging Plug the oximeter into the AC power supply otherwise the unit will turn itself off in 10 seconds INSUFFICIENT LIGHT Dirt on the sensor emitter or detector Sensor detector failure Test si
50. te dirty Misaligned or poorly positioned sensor Insufficient light penetrating the tissue site Dark pigmentation Fingernail polish present Clean the sensor if reusable or replace it Clean the test site Reposition the sensor or select another test site Reposition the sensor or select another test site Remove polish or select another test site 3 2 3 Messages and Troubleshooting Message Possible cause s Recommended action s INTERFERENCE DETECTED Appears when the signal Is too No action required May be erratic to be processed due to caused by strong radio frequency proximity of other electrical RF interference possibly equipment generating high generated by electrosurgery frequency electromagnetic noise SpOz and PR readings do not change during detected inter ference or become dashes if interference persists When interference ceases signal processing resumes LOW BATTERY Appears when 5 to 15 minutes of Plug the oximeter into the AC battery operation remain power supply to recharge the battery and continue monitoring Important To prevent permanent damage to the battery recharge a discharged battery within eight hours after the LOW BATTERY message is displayed LOW QUALITY SIGNAL Sensor off patient Reattach the sensor appears only in serial communication output Perfusion not sufficient for valid readings Motion at sensor site electrical noise or incorrect se
51. tttn A4 Pulsa TAi niire i ERORO EEEREN A 5 PIs pulsatil val ue seinieni EA a eon A 5 Sensor emitter wavelength ranges scsssssssssssscccssssssssssssssssessssccessssssssssssssssesseesseen A5 Environmental Electrical etie ERE ERU ARRENE ONENOTE Serial output RS 232 de dise tede oie aedis dit ie tuts A 6 Dimensions and Weight sssssssessscccssseesesceccsssssecceccsssssecceecssssssecesessssseseceseessnsssseeseessnsneeeeeeen A 6 B Communications Serial device COMMUMICATIONS csssssssssssssssssosssesssssseosssessssnssoessesssssseoessesssssseossssssssnsessssesssssseossseseeene B 1 Requirements ge E M BA RS 232 interface cable serial pinout 1 eeseeeeettennnnnnttnns B2 COMME euo B2 Serial communication output ssiri eiai iia B 3 Auto outp t Modessa a a R A B 3 Trend output iode uere tee E de puedo B4 Warranty iii List of Figures iv Name Figure 1 1 Figure 1 2 Figure 1 3 Figure 1 4 Figure 1 5 Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Signal processing block diagram Comparative light absorption Extinction versus wavelength graph 14 3800 Pulse Oximeter front panel ssssssssssssssssssssssssssseeesecssssssssssssseeeee 16 3800 Pulse Oximeter rear panel seeeeeeettennnnnnttnns 1 11 Typical adult plethysmographic waveform Typical neo
52. ty and the validity of the SpOz and pulse rate data This value is useful when determining that the sensor is correctly attached and that the data are verifiable It is also an indicator of relative perfusion at the sensor site Trend data The oximeter stores a maximum of 12 hours of trend data The process maintains the lowest SpO2 value that occurs during each 6 second interval along with the corresponding pulse rate and highest priority error message and all alarm limit violations You can access the trend data stored in the 3800 through the serial port on the rear of the oximeter See Appendix B for details The trend data are maintained as long as the unit s battery is connected and charged to minimum operating level To clear trend data 1 Hold down the alarm silence button while you power on the oximeter 2 Atthe Clear Trend Data prompt e To select YES to clear all data from the trend buffer press the high SpO2 button or e To select NO to retain the data press the low pulse rate limit button or If you don t press either button within 10 seconds the trend data are retained and the unit proceeds with the power on sequence 2 10 3 Messages and Troubleshooting Messages This chapter contains Descriptions of the messages and indicators that appear on the screen Alarm categories and their characteristics Achartfor troubleshooting situations that may occur while using the oximeter Become thor
53. ut mode or 6 seconds trend output mode SpO pulse rate alarm limit violation messages and displayed alarm error messages 9600 baud Full duplex Number of bits per character 8 Parity none Bits 1 start 1 stop Handshaking CTS RTS Connector type 9 pin standard D female Connector pin functions 2 oximeter receives data 3 oximeter transmits data 5 signal ground 7 RTS 8 CTS Dimensions and weight Height 9 4 cm 3 7 in Width 24 4 cm 9 5 in Height 22 5 cm 8 9 in Weight 2 9 kg 6 5 Ib B Communications This appendix covers serial device connections for computer oximeter communication WARNINGS Electrical shock hazard Measure the oximeter s leakage current whenever an external device is connected to the RS 232 Forward and reverse polarity 100 microamperes maximum Because the unit is not grounded when it is operating on battery power do not connect any equipment to the RS 232 connector on the rear panel unless the unit is connected to the AC main power supply WARNING RS 232 system interconnection Accessory equipment connected to the RS 232 connector must be certified according to the current version of the respective IEC EN standards e g IEC 60950 for data processing equipment and IEC EN 60601 1 for medical equipment All configurations shall also comply with IEC EN 60601 1 1 Anyone who connects additional equipment to the RS 232 connector configures a medical system and is t
54. value display and EMI line frequency 2 2 Parameter Factory Setting Range Language English English French German Italian Japanese Portuguese Spanish or Swedish Averaging mode Long TruTrak Long TruTrak 12 seconds 12 seconds Medium 6 seconds or Short 3 seconds Patient mode Adult Adult or Neonate PI pulsatile value display Yes Yes display Pl value or No EMI line frequency 60 Hz 50 Hz or 60 Hz After powering on the oximeter Changes you make to the parameters shown below take effect immediately Parameter Default Setting Range High SpOg limit OFF 50 to 100 or OFF appears as Low SpO limit 8596 5096 to 10096 or OFF High pulse rate 130 bpm 30 to 235 bpm or OFF adult mode 200 bpm neonatal mode Low pulse rate 40 bpm adult mode 30 to 235 bpm or OFF 100 bpm neonatal mode Alarm volume 3 1to5 Pulse volume 2 1to 5 or OFF bpm beats per minute 2 Setup and Operations Mode switch settings A bank of eight numbered two position switches is accessed through the rear panel The up position is ON and the down position is OFF Wo Bj Important If you change the switch settings while the oximeter is on the new settings do not take effect until you power off then on again Language Switches 1 2 and 3 set the language used for the display and data transmitted through the RS 232 port
55. values on the right side of the LCD This icon indicates the battery condition as follows gr Charged not low 8 c MEM Low If the all mute condition exists the display of this icon alternates with the display of the all mute icon This icon appears on the status screen EX Depleted not installed or defective Carrying handle The lower front portion of the oximeter s case is designed to be a carrying handle for ease of moving the unit from one place to another 1 9 3800 User s Manual 9 Sensor connector The sensors for this oximeter plug into this nine contact connector Use only Datex Ohmeda sensors compatible with this oximeter see Parts list in chapter 4 29 10 Pulse beep volume button CAN This button adjusts the volume level for the pulse indicator in incremental steps from OFF to level 5 default is 2 Press the side of the button to increase the volume or the side to decrease it you will hear the volume level as you press the button As you press one of these buttons the values do not cycle through the available settings e g when you reach 5 the value does not cycle or wrap to OFF As you adjust the volume the volume setting is shown in the message area above the waveform NOTE The pitch of the pulse tone changes as the SpO value increases or decreases the higher the SpOz value the higher the pitch of the pulse tone m 11 Alarm volume button CN This button adjusts the audib
56. ve 93 42 EEC of the European Union for a 0197 class I with a measuring function IIa IIb or III device LR 87853 Medical electrical equipment classified in the US and Canada GF with respect to electric shock fire and mechanical hazards only c Us in accordance with the Canadian Standards Association CAN CSA C22 2 No 601 1 and Underwriters Laboratories Inc UL 2601 1 General safety requirements The 3800 complies with the requirements of IEC EN 60601 1 Part 1 General requirements for safety of medical electrical equipment e Type BF applied part Type of protection against electric shock Class I Internal electrical power source Degree of protection against ingress of liquids Ordinary IPX0 Mode of operation Continuous The monitor also complies with the following EN 865 Pulse oximeters Particular requirements EN 475 Medical devices Electrically generated alarm signals 3800 User s Manual Electromagnetic compatibility EMC The 3800 complies with the requirements of IEC EN 60601 1 2 Electromagnetic compatibility Requirements and tests Emissions IEC EN 55011 Group I Class B The 3800 pulse oximeter was tested with an RS 232 cable attached when operating on AC power It was tested with no peripheral devices when operating on battery power When installing and using this monitor take precautions to ensure electromagnetic compatibility For more information refer to the 3800 3900 3900P Technical
57. y is a relative term with practice you ll get a good feeling for changes that are artifactual or physiological and the speed of each The stability of the readings over time is affected by which averaging mode you re using In Long TruTrak mode 12 second averaging the readings tend to be more stable because the signal is averaged over a longer period of time than the Short 3 seconds or Medium 6 seconds modes Too great a distance between the sensor emitter and detector can reduce signal strength and result in a poor signal When the value is too low the message CHECK SENSOR SITE may appear to alert you that the SpOz value may not be accurate Perfuse the sensor site or relocate the sensor to a site with higher blood flow 3800 User s Manual Pulse rate Compare the displayed pulse rate to the patient s palpated pulse rate If the unit s rate varies significantly from the palpated rate the data may be less accurate due to motion artifact or other noise A cough or other hemodynamic pressure disturbance can disrupt the pulse rate which is determined from the plethysmographic waveform The time span between the waveform s peaks determines the pulse rate The unit uses the same averaging mode long medium or short as that selected for SpO PI pulsatile value The PI pulsatile value is a measurement of the strength of the photoplethysmo graphic signal read by the oximeter The greater the number the greater the pulsatili
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