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OXITEST PLUS 7 OPERATING MANUAL

5.3

Cross-Manufacturer Compatibility

Nellcor and Ohmeda are examples of two leading pulse oximeter manufacturers which license the
use of their technology to other medical device companies, primarily manufacturers of patient
monitoring systems. Pulse oximeters which employ licensed technology can sometimes (but not
always) be identified by the oximeter sensor - if the device is compatible

only

with a Nellcor (or

Ohmeda) sensor, it is possible that the unit contains a licensed OEM version of the Nellcor (or
Ohmeda) technology.

It may be possible to test the SpO

2

portion of such monitors using one of the

Nellcor

or

Ohmeda

settings on

Oxitest Plus 7

. As products mature, manufacturers modify the electronics or the

software of newer models to improve performance.  As a result, not every model from one
manufacturer can be tested using the same setting.  OEM versions of a manufacturer’s product will
also exhibit the same type of variations.  Therefore, even though two companies have licensed
Nellcor technology, one may be a N-200 type implementation, and the other may be a N-180 type
implementation.  If you are trying to test an OEM product, try each of the OEM original model
settings to determine which one performs best.

Test Useage/Chapter 5

#

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Summary of Contents for Oxitest Plus 7

Page 1: ...Operating Manual OxitestPlus7 Pulse Oximeter Tester ...

Page 2: ......

Page 3: ...e Oximeter Tester Operating Manual 2003 2014 Datrend Systems Inc Unit 130 4020 Viking Way Richmond BC CANADA V6V 2L4 Tel 800 667 6557 North America Only or 604 291 7747 Fax 604 294 2355 e mail customerservice datrend com ...

Page 4: ......

Page 5: ...serial number and accessories are eligible for partial refund and or credit Non serialized parts and accessory items cables carrying cases auxiliary modules etc are not eligible for return or refund In order to receive a partial refund credit the product must not have been damaged and must be returned complete meaning all manuals cables accessories etc within 90 days of original purchase and in as...

Page 6: ...e incorrect voltage defective wiring or inadequate fuses Accident alteration abuse or misuse of the instrument Fire water damage theft war riot hostility acts of God such as hurricanes floods etc Only serialized products those items bearing a distinct serial number tag and their standard accessory items are covered under this warranty PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVER...

Page 7: ...ms at 1 800 667 6557 You will be required to provide us with the serial number for your instrument as well as a valid reason for breaking the Quality Seal You should break this seal only after you have received factory authorization Do not break the Quality Seal before you have contacted us Following these steps will help ensure that you will retain the original warranty on your instrument without...

Page 8: ...Nellcor is a registered trademark of Tyco Healthcare QBasic and Visual Basic are trademarks of Microsoft Corp MS DOS is a registered trademark of Microsoft Corp ...

Page 9: ...charging the Battery 27 4 Computer Control and RS 232 29 4 1 Electrical Interface 29 4 2 Mechanical Interface 30 4 3 Functional Description 30 4 4 Command Definitions 31 4 4 1 Select Oximeter and Initialize Simulation 31 4 4 2 Set SpO2 Command 32 4 4 3 Set Heart Rate Command 32 4 4 4 Set Pulse Amplitude Command 32 4 4 5 Activate Artifact Simulation 33 4 4 6 Activate Auto Preset Protocol 33 4 4 7 D...

Page 10: ...OXITEST PLUS 7 OPERATING MANUAL 6 Routine Maintenance 51 6 1 Probe Cleaning 51 6 2 Calibration 52 Table of Contents Page ii ...

Page 11: ...d EnviteC Hewlett Packard Nihon Kohden and Philips models Variable from 55 to 100 in steps of 1 SpO2 presets at 55 70 80 90 93 and 97 All other manufacturers and models Variable from 70 to 100 in steps of 1 SpO2 presets at 70 80 90 93 and 97 1 2 SpO2 Accuracy All supported oximeters except Datex and Invivo oximeters 55 to 100 SpO2 1 at specified SpO2 presets 35 SpO2 2 Nellcor accuracy specified wi...

Page 12: ...ult pulse in 1 steps Presets 100 30 10 and 5 Accuracy 1 1 5 Signal Artifact Four preset simulations Movement Tapping Spike artifact Shivering Tremor artifact Shake Table 2 5Hz Sinewave 1 6 Auto Presets Nine preset patient simulations Factory default Auto Presets are Normal Adult Hypoxia Tachycardia Bradycardia Low Perfusion No Perfusion Movement Artifact Neonate Tremor Shivering Artifact Auto Pres...

Page 13: ...ts in Memory may be printed as a Test Report via optional external Printer or may be downloaded via RS 232 port to personal computer or automated tester 1 9 Pulse Oximeter Make Model Major makes and models supported Refer to the Oxitest Plus 7 product CD or www datrend com for a detailed listing 1 10 User Interface Display LCD 20 character x 2 line Keypad 15 keys PULSE OX SPO2 HEART RATE preset HR...

Page 14: ...ltitude 2000m max Note Mains supply voltage fluctuations not to exceed 10 of the nominal supply voltage 1 15 Standard Accessories AC Adapter all models 100 240 VAC 50 60 Hz to 12 VDC adaptor P N 3000 025 And one of the Blade Sets for P N 3000 025 North America P N 3000 401 Europe P N 3000 402 United Kingdom P N 3000 403 Australia P N 3000 404 1 16 Optional Accessories For a complete list of availa...

Page 15: ... sensor shivering or trembling and shake table laboratory test Oxitest Plus 7 also provides 9 preset simulations to test oximeters under realistic clinical conditions and five automated oximeter alarm tests High accuracy testing of Nellcor sensors is available through the use of Nellcor s sensor specific calibration curves Auto Preset Alarm and manual test results may be output to a printer or dow...

Page 16: ...r ear toe scalp etc and falls on the photosensitive element which translates the attenuated light signals into electrical signals Using various means the pulse oximeters interpret the ratio of the attenuated signals at the two wavelengths as a percentage of oxygen saturation A more detailed description of the process and the scientific principles of pulse oximetry can be found in the article Knowi...

Page 17: ...lysed by the Oxitest Plus 7 microprocessor The microprocessor in turn produces control signals to drive an LED in the Oxitest Plus 7 probe with the correct timing and amplitude appropriate to the oximeter under test Light from the Oxitest Plus 7 LED is detected by the photodiode in the oximeter sensor causing the oximeter to display simulated SpO2 and heart rate indications Overview Chapter 2 Page...

Page 18: ...OXITEST PLUS 7 OPERATING MANUAL Overview Chapter 2 Page 8 ...

Page 19: ...led push button keys on the front panel See sections 3 2 through 3 7 for further details Default values for SpO2 Heart Rate and Pulse Amp on selection of a new oximeter are 97 60 BPM and 100 respectively 3 Turn on the oximeter and examine the sensor to determine which side has the LEDs this side will radiate red light Apply the sensor to the test probe orienting the sensor with the LEDs on the und...

Page 20: ...OXITEST PLUS 7 OPERATING MANUAL Figure 2 Oxitest Plus 7 Side Panel Figure 3 Oxitest Plus 7 Front Panel Operation Chapter 3 Page 10 ...

Page 21: ... and power up with those parameters on next use When received from the factory all pulse oximeters with which Oxitest Plus 7 is compatible will be ENAbled in the Pulse Ox menu list Not all oximeters will be pertinent to every user To reduce the number of oximeters presented in the menu list individual oximeters can be DISabled with the Setup Function described below To enter the Setup Function dep...

Page 22: ... repeated at any time to ENAble or DISable other oximeters In the event of a loss of battery power Oxitest Plus 7 will revert to the factory default settings all oximeters ENABLED Pulse Ox Nellcor N 200 SpO2 97 Heart Rate 60 BPM Pulse Amp 100 If it is desirable to reset Oxitest Plus 7 to the factory default settings for any reason hold down the Heart Rate preset key while powering up the unit The ...

Page 23: ...ters that have been ENAbled as in section 3 2 will be available for selection Repeat the setup process at any time to enable or disable oximeters in the menu list Oxitest Plus 7 will display the make of the oximeter sensor used with the device under test on the lower line of the LCD This is because some pulse oximeters can be used with more than one make of sensor many oximeters are compatible wit...

Page 24: ...r up will be the one retained from the last test performed The oxygen saturation simulation can be fine tuned in steps of 1 by means of the ADJUST SPO2 menu To access this menu press the SpO2 and Pulse Ox keys simultaneously The display will then change to the following ADJUST SPO2 97 Use the and keys associated with the Heart Rate key or the Pulse Amp key to adjust the oxygen saturation as desire...

Page 25: ... 0 to 100 percent with four preset values of 100 30 10 and 5 The pulse amplitude control provides a means of simulating various levels of tissue perfusion or peripheral pulse strengths An Oxitest Plus 7 pulse amplitude of 100 corresponds to a normal adult pulse in the index finger A pulse amplitude of 5 simulates poor distal circulation or a very weak peripheral pulse and a pulse amplitude of zero...

Page 26: ...sistent with the oximeter selected and Oxitest Plus 7 is outputting a simulated signal to the oximeter INV SENSOR Oxitest Plus 7 has detected an external optical signal on the upper probe surface indicating that the oximeter sensor has probably been applied upside down Remove and replace the sensor with the sensor LEDs on the lower surface of the Oxitest Plus 7 probe If the STATUS message enters t...

Page 27: ...ouble beep and activate the MV wave as indicated by the M V characters displayed to the left of the pulse amplitude on the LCD N 200 NO SIGNAL 97 60 BPM M V100 In manual mode successive presses of Heart Rate with Pulse Amp will activate the SP TR and Sn waves in turn indicated on the display as S P T R and S n as for the MV wave above A fifth press of Heart Rate with Pulse Amp will de activate the...

Page 28: ...aded by powering up the unit while pressing the Auto key In response to the displayed LCD prompt press the Yes Pass key to reload the default Auto parameters shown in the table above or No Fail to abort the reload 3 11 Selecting Alarm Tests The Alarm Test Mode provides the capability of performing autosequenced tests of the alarm functions on a pulse oximeter Five different kinds of Alarm Tests ar...

Page 29: ...ts In addition to the test above the remaining tests appear as follows HI RATE ALM T 00 0 97 72 BPM 100 LO RATE ALM T 00 0 97 72 BPM 100 LOW SIG ALM T 00 0 97 72 BPM 100 ARTFACT ALM T 00 0 97 72 BPM 100 As long as the user refrains from pressing the Start Stop key Oxitest Plus 7 continuously outputs the simulation corresponding to the parameters shown on the lower line of the LCD Pressing the Star...

Page 30: ...20 MV For example the LOW SAT alarm test operates as follows 1 The user presses the Alarm Test key until the LOW SAT alarm test is shown on the LCD LOW SAT ALM T 00 0 97 72 BPM 100 2 The user starts the LOW SAT test by pressing Start Stop The alarm test immediately switches the SpO2 from 97 to 70 and the timer at the top right of the LCD begins incrementing in 0 1 second steps LOW SAT ALM T 00 1 7...

Page 31: ... to return to the state shown in step 1 The HI RATE LO RATE and LOW SIG tests operate in a similar manner to the above except that the tester heart rate HI LO RATE pulse amplitude LOW SIG or motion artifact ARTFACT is varied accordingly with the remaining test parameters left constant The Alarm Test Mode exits to the Manual Mode if any key other than Alarm Test or Start Stop is pressed This will a...

Page 32: ...eviated format as follows OK RED IR OK NoRD No Red NoIR No IR and NO SIGNAL or Testing For each Alarm Test performed the oximeter ALARM ON and ALARM OFF times are automatically saved in the Oxitest Plus 7 memory if the Alarm Test is run through to completion There is no need to press Pass or Fail to save the results of an Alarm Test All test results saved in the Oxitest Plus 7 memory are retained ...

Page 33: ...ec 7 4 sec In the prior example the results of five manual tests four Auto Preset tests and four Alarm Tests were saved As shown the Oxitest Plus 7 signal status appears under the LEDs column and the PASS or FAIL status of the test result appears at the far right Manual test 5 shows that the oximeter s red LED may have been defective which was recorded as a FAIL Similarly Auto Preset test 6 was al...

Page 34: ... at the top of the Oxitest Plus 7 enclosure DB9 female allows temporary connection of Nellcor sensors to the Oxitest Plus 7 so that the sensor s calibration resistor can be measured and the SpO2 calibration curve corresponding to the resistor selected Use of the Nellcor Port thus facilitates high accuracy testing of both disposable and re usable Nellcor sensors with an accuracy of 1 to 2 across th...

Page 35: ...ter The display returns to the Manual Mode with the alternate R Curve being indicated by a R on the LCD as shown below N 200 R NO SIGNAL 97 60 BPM 100 5 Apply the sensor to the Oxitest Plus 7 probe and commence testing If the detected resistance lies outside the acceptance range for Nellcor sensors an error beep is produced and the following error message is displayed as long as the sensor remains...

Page 36: ...and validate data acquisition from the oximeter sensor thereby improving signal to noise ratio under conditions of low perfusion or motion artifact On Nellcor oximeters e g models N 200 and up this feature is called C LOCK Oxitest Plus 7 provides an ECG Trigger output signal which may be used to test the Nellcor C LOCK function and similar capabilities on other oximeters e g Nonin 8800 The ECG TRI...

Page 37: ...DISCHARGED Recharge immediately If the Oxitest Plus 7 battery is near deep discharge at power up the LCD will remain blank and the Low Battery alarm LED on the front panel will illuminate see Figure 3 The Oxitest Plus 7 will not be operable in this case and should be powered down and the battery given a full recharge prior to further use A battery discharged to this level may require replacement o...

Page 38: ... reset the unit the switch mode AC adapter must be plugged into the AC mains and connected to Oxitest Plus 7 This can be done with the Oxitest Plus 7 ON or OFF Once reset Oxitest Plus 7 can be used with the AC adapter or without the AC adpater once the battery has been fully charged When the protection circuitry disconnects the battery all saved data and settings will be lost The Oxitest Plus 7 ba...

Page 39: ...er Menu Auto Preset and Alarm Test settings Oxitest Plus 7 may be operated via the front panel keypad while simultaneously responding to commands via the RS 232 port The five control commands Select Oximeter Set SpO2 Set Heart Rate Set Pulse Amplitude and Activate Artifact Simulation and three of the download commands Download Manual Auto Preset and Alarm Test Record are all compatible with most a...

Page 40: ... Plus 7 RS 232 commands are ASCII strings consisting of two to four upper case letters followed by zero to three numeric digits Command strings are terminated with the carriage return character ØD hex or by carriage return followed by the line feed character ØA hex The Oxitest Plus 7 has a bidirectional RS 232 port and monitors the RTS and DTR lines when handshaking with external serial printers C...

Page 41: ...so displayed at the bottom right corner of the Oxitest Plus 7 LCD when the user presses the Pulse Ox key on the front panel The OX command will cause Oxitest Plus 7 to select the specified oximeter whether or not the oximeter has been ENAbled via the PULSE OX SETUP menu The OX command also initializes SpO2 heart rate and pulse amplitude to default values of 97 60 BPM and 100 respectively The statu...

Page 42: ... 1 Example SO4 sets the SpO2 to 80 4 4 3 Set Heart Rate Command Format HRrrr where rrr 2Ø to 25Ø BPM Examples HR62 sets the Heart Rate to 62 BPM HR175 sets the Heart Rate to 175 BPM 4 4 4 Set Pulse Amplitude Command Format PAaaa where aaa Ø to 1ØØ per cent Examples PA7 sets the Pulse Amplitude to 7 PA42 sets the Pulse Amplitude to 42 PA1ØØ sets the Pulse Amplitude to 100 Computer Control Chapter 4...

Page 43: ...emor Artifact simulation on 4 4 6 Activate Auto Preset Protocol Format APn Oxitest Plus 7 reverts to manual control mode with the test protocol defined by Auto Preset protocol n where 1 n 9 Examples AP2 sets Sp02 80 HR 95 BPM PA 100 AP8 sets Sp02 97 HR 70 BPM PA 33 ART Movement 4 4 7 Download Test Report Format DLTR download test report complete Example See example Test Report in Section 3 12 Comp...

Page 44: ...eset Test Record Format GAUx download Auto Preset test record x where 1 x 9 Example GAU3 downloads the 3rd Auto Preset test record 40 characters 4 4 10 Download Alarm Test Record Format GATt download Alarm Test record t where t 1 for LOW SAT 2 for HI RATE 3 for LOW RATE 4 for LOW SIG and 5 for ARTFACT Example GAT1 downloads the LOW SAT Alarm Test Record 35 characters Computer Control Chapter 4 Pag...

Page 45: ... 9 DLTR Download test report complete EALL Erase all test records manual Auto Preset and Alarm Tests GATt Download Alarm Test record t 1 t 5 GAUx Download Auto Preset record x 1 x 9 GMNrr Download Manual record rr Ø 1 rr 2Ø HRrrr Set heart rate to rrr BPM 2Ø rrr 25Ø OXmmm Set Pulse Ox to mmm and restart simulation PAaaa Set pulse amplitude to aaa per cent Ø aaa 1ØØ SOx Set SpO2 to level x where x ...

Page 46: ...t rate settings Run Microsoft QBasic from the DOS prompt by simply typing QBasic followed by f you can also run QBasic from Windows double click on the QBasic icon in the APPLICATIONS group QBASIC should boot showing the Welcome screen Press to clear the screen or press f to view the QBasic HELP index When typing the following example be sure to include all the punctuation marks which appear in th...

Page 47: ...llowing command may change with changes in Oxitest software revision The command OXØ35 is used here only as an example PRINT 1 OXØ35 INPUT 1 C SpO2 1 DO Set the SpO2 PRINT 1 SO PRINT 1 USING SpO2 INPUT 1 C GOSUB CommDelay Sweep the heart rate from 60 to 140 BPM FOR HeartRate 6Ø TO 14Ø STEP 2Ø PRINT 1 HR IF HeartRate 1ØØ THEN PRINT 1 USING HeartRate ELSE PRINT 1 USING HeartRate END IF INPUT 1 C Dis...

Page 48: ...ncrement FOR i 1 TO 100 GOSUB CommDelay Quit if user presses ESCape key IF INKEY CHR 27 THEN CLOSE END END IF NEXT i NEXT HeartRate Select next saturation level SpO2 SpO2 1 IF SpO2 5 THEN SpO2 1 END IF LOOP WHILE SpO2 Ø END This subroutine produces a timed delay of 200 msec CommDelay TeeZero TIMER DO WHILE TIMER TeeZero 2 LOOP RETURN Computer Control Chapter 4 Page 38 ...

Page 49: ...loping the calibration curve for an oximeter commonly known as the R Curve the response of the device is statistically compared to the response from invasive oxygen content readings from a large population of individuals The specification cited above can be translated as the oxygen saturation value measured by this oximeter will be accurate to within 2 for 65 of the population This specification h...

Page 50: ...sation for the optical response of the sensor However even though the Nellcor disposable sensor fits on other manufacturer s cables it may not provide reliable results especially at the lower saturation levels if the R Curve variation is not taken into account 5 1 2 Probe Sensor Interface The single most variable parameter in testing oximeters is the fit between the tester probe and the oximeter s...

Page 51: ...prevent leakage of light from the sensor LEDs on the bottom reaching the photodetector on the top Most finger clip sensors are configured such that when applied to the test probe the cable will lead off toward the Oxitest Plus 7 In this case the sensor cable should be routed via the probe compartment so that the cable leads off toward the the LCD end of Oxitest Plus 7 rather than toward the bottom...

Page 52: ...n the test probe so that the upper bulge on the probe fits into the sensor depression Allow the sensor to close maintaining intimate contact between the photodetector side of the sensor and the upper side of the test probe It is important to retain the tight intimate contact on the photo detector side to prevent leakage of light from the sensor LEDs on the bottom reaching the photodetector on the ...

Page 53: ...or cable leading off to the oximeter via the probe compartment of the Oxitest Plus 7 4 Disposable and Flexible Sensors Disposable and flexible sensors come in many shapes and sizes depending on their use neonatal flexible finger sensor ear clip etc In applying these sensors to the test probe place the photodetector on the center of the upper optical window of the probe Wrap the sensor around the p...

Page 54: ...US 7 OPERATING MANUAL Figure 10 Nellcor Oxi A N sensor Figure 9 Nellcor N 25 neonatal disposable Correct placement of typical flexible sensors is shown in Figure 9 through Figure 11 Test Useage Chapter 5 Page 44 ...

Page 55: ...he Oxitest Plus 7 probe i e the Oxitest finger the fit is less than ideal Despite this fairly good results can be obtained when testing Criticare pulse oximeters by following these rules note in all cases the sensor LEDs are on the bottom and the sensor s photodiode is on top a Criticare 511 Sensor An acceptable position for the 511 sensor is as follows Test Useage Chapter 5 Page 45 ...

Page 56: ...ode upsetting the calibration of the SpO2 simulation Position 2 illustrated below is preferable since it achieves better optical isolation between the 511 s LEDs and photodiode Position 2 is achieved by pushing the 511 from Position 1 until the sensor comes to a solid stop The lower jaw of the 511 will swing down to accommodate the probe tip and the upper jaw will lie flatter along the upper surfa...

Page 57: ...tip just reaches but does not ride over the end of the finger depression inside the sensor The position of the 934 sensor will be roughly as shown in the above diagram Note that if the 934 sensor is jammed all the way onto the Oxitest Plus 7 probe most of the optical signal radiated from the probe will be blocked and will not reach the photodiode of the sensor In this case the pulse oximeter will ...

Page 58: ...le s have an open or intermittent wire contact or cable connector s are defective both RED and INFRARED LED drive signals from oximeter are missing RED IR OK Oximeter displays Low Light or Insufficient Light and may alarm Photo detector in sensor is faulty sensor cable s have an open or intermittent wire contact or cable connector s are defective Photo detector circuitry in oximeter is defective o...

Page 59: ... Ohmeda technology It may be possible to test the SpO2 portion of such monitors using one of the Nellcor or Ohmeda settings on Oxitest Plus 7 As products mature manufacturers modify the electronics or the software of newer models to improve performance As a result not every model from one manufacturer can be tested using the same setting OEM versions of a manufacturer s product will also exhibit t...

Page 60: ...OXITEST PLUS 7 OPERATING MANUAL Test Useage Chapter 5 Page 50 ...

Page 61: ...itted by the probe remains within its calibrated range the probe should be cleaned regularly Normally simply wiping the optical windows with a soft cloth dampened with water is all that is required Detergent solutions are rarely required but acceptable at low concentrations DO NOT use isopropyl alcohol to clean the acrylic probe as it will introduce stress cracks over time The Oxitest probe incorp...

Page 62: ...d at Datrend authorized service facilities This equipment allows proper adjustment of the internal electronics of the instrument Independent service providers may be able to perform a performance VERIFICATION however they will NOT be able to perform repairs or adjustments to your Oxitest Plus 7 Use of an unauthorized facility for service and or calibration will void your warranty When calibration ...

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