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Operator Manual - Datrend Systems Inc.

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1. Variable from 55 to 100 in steps of 1 SpO presets at 55 70 80 90 93 and 97 All other manufacturers and models Variable from 70 to 100 in steps of 1 SpO presets at 70 80 90 93 and 97 1 2 SpO Accuracy All supported oximeters except Datex and Invivo oximeters 55 to 100 SpO2 1 at specified SpO presets 35 SpO2 2 Nellcor accuracy specified with either DS100A sensor ot with SpO calibration selected via Nellcor Pott Specifications Chapter 1 Page 1 OXITEST PLUS 7 OPERATING MANUAL Datex and Invivo oximetets 1 at 97 93 SpO 12 at 90 80 70 SpO 1 3 Heart Rate Variable from 20 to 250 beats per minute BPM in 1 BPM steps Presets 30 60 90 120 180 240 BPM Accuracy 1 BPM 1 4 Pulse Amplitude Variable from zero no blood flow to 100 normal adult pulse in 1 steps Presets 100 30 10 and 5 Accuracy E 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 Preset parameters may be user programmed via the RS 232 port SpecificationsIChapter 1 Page 2 OXITEST PLUS 7 OPERATING MANUAL 1 7 Alarm Tests Five automated test sequences for determining oximeter alarm
2. Battery 7 2V rechargeable Capacity 1 4 Ah Battery life 40 hours continuous 1 14 Environment 15 C to 40 C 10 to 90 RH Indoor Use Only Category II Pollution Degree 2 Altitude 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 available accessories visit www datrend com or contact Datrend Customer Service see section 6 2 for contact details Specifications Chapter 1 Page 4 OXITEST PLUS 7 OPERATING MANUAL 2 Overview 2 1 General Description The Oxitest Plus 7 Pulse Oximeter Tester is a portable battery operated device designed to test the operation of pulse oximeters and their optical sensors In use a pulse oximeter sensor is placed on the Oxitest Plus 7 probe Oxitest Plus 7 transmits an optical signal to the pulse oximeter sensor which simulates a predetermined oxygen saturation SpO level at a given heart rate and signal strength pulse amplitude Proper operation of the pulse oximeter is confirmed if the parameters measured by the oximeter match those generated by Oxitest Plus 7 Oxitest Plus 7 provides four simulations of patient m
3. is a registered trademark of Microsoft Corp OXITEST PLUS 7 OPERATING MANUAL Table of Contents 1 Specifications z is at A AAA ES Ee Oe ao eges Ncc PAM dS 1 2 OVeIVIGW ii tdo send Led Lecta rb dehet d ek die su a d eld Loto ir Mete dM tel 5 2 1 General Description 000 cette rs 5 22 Detailed Description ren 6 3 Operation uei Rex eA neue i veu sid E ita atras 9 3 1 General Description sn olio d edad b berti ese ode spe Ev RETE TS 9 3 2 Powering Up and Modifying the Oxitest Plus 7 Menu 11 3 3 Setting Display Contrasti 12 3 4 Choosing an Oximeter 2 20 00 rn 13 3 5 Selecting an SpO level hn 14 3 6 Selecting a Heart Rate hn 15 3 7 Selecting a Pulse Amplitude sslsslsslseeseee ren 15 3 9 Status Indicator corti Leila a card 16 3 9 Selecting Motion Artifact Simulation illie 17 3 10 Selecting Auto Pr se ts 3 ois costola Sota peek Rr Boh 244 Vac DR Notas 18 3 11 Selecting Alarm Tests 18 3 12 Saving and Printing Test Results 0 000 tenes 22 3 13 Using the Nellcor Sensor Port 24 3 14 ECG Trigger Output 26 3 15 Recharging the Battery 27 4 Computer Control and RS 232203 1 401 i lepri fel at bas 29 4 1 Electrical mienas ios d dunes aden ipa iii tea eine els 29 4 2 Mechanical Interface 0 0 eae 30 4 3 Functional Description o 30 4 4 Command Definitions l l mr 31 4 4 1 Select Oximeter and Initialize
4. 5 Page 45 OXITEST PLUS 7 OPERATING MANUAL Position 1 is achieved by simply sliding the 511 sensor onto the tip of the Oxitest Plus 7 probe until the sensor just comes to a stop Position 1 is a good starting position but it is not the best position as interference from the 511 s LEDs can leak around the Oxitest Plus 7 probe tip to reach the 511 s photodiode upsetting the calibration of the SpO simulation POSITION 1 SIDE VIEW Figure 13 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 surface of the probe Try Position 2 after the pulse oximeter has stabilized for at least 30 seconds in response to the Oxitest Plus 7 s signal PUSH n POSITION 2 SIDE VIEW Figure 14 Test UseagelChapter 5 Page 46 OXITEST PLUS 7 OPERATING MANUAL b Criticare 934 Sensor Generally a good position for the 934 sensor appears as follows when viewed from the top TO PULSE OX approx 0 1 inch Figure 15 A simple way to apply the 934 sensor is to slide it over the end of the Oxitest Plus 7 probe stopping when you feel that the Oxitest Plus 7 probe tip just reaches but does not ride over the
5. 5 DA TREND Systems Inc Oxitest Zs Pulse Ox meter Tester Operating Manual Oxitest Plus Pulse 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 To order this manual use Part Number 6100 105 Revision History Revision Description Date E New Corporate Address 2014 Dec 09 Copyright Datrend Systems Inc DSI agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications If you would like other reproductions or distributions submit a written request to Datrend Systems Inc Unpacking and Inspection Follow standard receiving practices upon receipt of the instrument Check the shipping carton for damage If damage is found stop unpacking the instrument Notify the freight carrier and ask for an agent to be present while the instrument is unpacked There are no special unpacking instructions but be careful not to damage the instrument when unpacking it Inspect the instrument for physical damage such as bent or broken parts dents or scratches Claims Our routine method of shipment is via common carrier Upon delivery if physical damage is found retain all packing materials in their original condition and contact the carrie
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7. Spo for 55 SpO for 35 SpO AavuPWDNH Selected models only see Section 1 1 Example S04 sets the SpO to 80 4 4 3 Set Heart Rate Command Format HRrrr where rrr 20 to 250 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 to 100 per cent Examples PAT sets the Pulse Amplitude to 7 PA42 sets the Pulse Amplitude to 42 PA100 sets the Pulse Amplitude to 100 Computer ControllChapter 4 Page 32 OXITEST PLUS 7 OPERATING MANUAL 4 4 5 Activate Artifact Simulation Format AFn activate artifact simulation n where n for OFF 1 for movement 2 for spike 3 for tremor Examples AF sets the Artifact Simulation off AF3 sets the Tremor 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 Computer ControllChapter 4 Page 33 OXITEST PLUS 7 OPERATING MANUAL 4 4 8 Download Manual Record Format GMNrr download Manual record rr where l lt rr lt 20 Example GMN12 downloads the 12 Manual test record 40 characters 4 4 9 Do
8. The Pulse Amp A or Y keys will single step through the menu sequentially moving up or down respectively To move mote rapidly through the different menu selections the Heart Rate A or W keys will move in steps of two entries at a time The previous display indicates if the oximeter is currently ENAbled or DISabled Press the Pulse Ox key to toggle the ENAbled or DISabled status of the displayed oximeter When only the relevant oximeters are ENAbled press the SpO key and Oxitest Plus 7 will revert to normal operation The only oximeters that will now be available for selection in the menu of Pulse Ox s will be those that have been ENAbled This process may be 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 SpO 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 display will appear as shown below In response to the LCD prompt the factory defaults are loaded by pressing the YES Pass key or the No Fail key 3 3 Setting Display Contrast Display contrast for Oxitest Plus 7 is pre set at the factory Should it become necessary to adjust the display contrast the adjustment control is located in the probe storage compartment r
9. This stops the timer and records the alarm OFF TIME in the Oxitest Plus 7 memory The LCD automatically displays the final test results as follows Pressing any key except Alarm Test at this point will exit the Alarm Test Mode Pressing Alarm Test with the LCD in the state shown above causes the display 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 also abort an alarm test which is in progress When exiting the Alarm Test Mode the test parameters are set to default values of 97 SpO 60 BPM heart rate and 100 pulse amplitude The parameters of the Alarm Test Mode may be programmed to alternative values via the RS 232 port using the Ox Edi software which is available at www datrend com The factory default Alarm Test parameters can be reloaded by powering up the unit while holding down the Alarm Test key In response to the LCD prompt press the Yes Pass key to reload the test default test settings or No Fail to abort the reload Operation Chapter 3 Page 21 OXITEST PLUS 7 OPERATING MANUAL 3 12 Saving and Printing Test Results Up to 20 PASS FAIL results from
10. be pre formed before the sensor is applied to the Oxitest Plus 7 and the cable routed via the probe compartment before leading off to the oximeter under test Other sensor styles may also require careful placement Finger Depression Figure 7 Test UseagelChapter 5 Page 42 OXITEST PLUS 7 OPERATING MANUAL 3 Hewlett Packard Agilent Philips M1190A and M1191A sensors The Hewlett Packard M1190A and M1191A sensors are made from a pliable rubber compound with a slit opening at the distal end of the sensor Slide the sensor onto the Oxitest Plus 7 probe with the LEDs shining toward you Push the sensor onto the probe until the probe tip extends out of the sensor slit by about 1 8 Ensure that the photodetector the bulge on the top of the sensor is located on the centerline of the test probe Correct placement of the Hewlett Packard M1190A can be seen in Figure 8 with the sensor cable leading off to the oximeter via the probe compartment of the Oxitest Plus 7 4g Probe Tip Figure 8 Correct Placement of HP M1190A sensor 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 probe with the LED portion of the sensor ending up
11. 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 not display an SpO or heart rate indication or a proper pleth waveform Test UseagelChapter 5 Page 47 OXITEST PLUS 7 OPERATING MANUAL 5 2 Diagnosing Sensor Faults Use the following table when troubleshooting pulse oximeter sensor and cable problems with the help of the Oxitest Plus 7 s STATUS display STATUS PROBABLE FAULT S DISPLAY NO RED NO IR NO SIGNAL RED IR OK Intermittent contacts in the cable or connectors can be confirmed by twisting the cable hold the sensor on the test probe if twisting near the sensor The LCD STATUS display will change from the error code listed above to TESTING When TESTING the Oxitest Plus 7 has recognized a new signal and is checking to confirm that both RED and IR signals are present and correctly timed for the oximeter under test RED LED is defective This is normally evident if RED LED is not visible when viewing sensor sensor cable s have an open or intermittent wire contact or cable connectot s are defective RED LED drive signal from oximeter is missing INFRARED LED is defective This is NOT
12. of the display as follows The SpO preset on power 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 SpO and Pulse Ox keys simultaneously The display will then change to the following Use the A and W keys associated with the Heart Rate key or the Pulse Amp key to adjust the oxygen saturation as desired Continuous adjustment is possible in 1 steps from 100 down to the lowest SpO preset provided which may be either 70 55 or 35 depending on the oximeter model and or sensor as described above To exit the ADJUST SPO2 menu and return to the standard operating screen press either the SpO key or the Pulse Ox key OperationIlChapter 3 Page 14 OXITEST PLUS 7 OPERATING MANUAL 3 6 Selecting a Heart Rate Oxitest Plus 7 provides a pulse repetition rate of 20 to 250 beats per minute bpm with six preset values of 30 60 90 120 180 and 240 bpm To select a new preset value press the key labelled Heart Rate on the front panel The Heart Rate indicator in the middle of the second line of the LCD screen will change to indicate the selected rate as shown For values between the preset rates use the A and W keys associated with the Heart Rate key The Heart Rate can be changed in increments of 1 bpm over the full range of 20 250 bpm The A and Y keys may be held down to change the
13. rate continuously The Heart Rate value on power up will be the one retained from the last test performed 3 7 Selecting a Pulse Amplitude Oxitest Plus 7 provides pulse amplitude settings from 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 simulates no distal blood flow To select a new preset value press the key labelled Pulse Amp on the front panel The Pulse Amplitude indicator at the lower right of the LCD screen will change to indicate the selected percentage value as shown below For values between the preset amplitudes use the A and W keys associated with the Pulse Amp key The Pulse Amplitude can be changed in increments of 1 over the full range of 0 100 The A and Y keys may be held down to change the pulse amplitude continuously The Pulse Amplitude value on power up will be the one retained from the last test performed Operation Chapter 3 Page 15 OXITEST PLUS 7 OPERATING MANUAL 3 8 Status Indicator The STATUS indicator in the upper right corner of the standard operating screen as shown below provides user feedback on the test in progress The f
14. response time to Low SpO Low Heart Rate High Heart Rate Low Perfusion and Motion Artifact conditions Also determines time required for oximeter alarm to self clear after test conditions are returned to normal Alarm Test parameters may be user programmed via the RS 232 port 1 8 Memory Auto Preset and Alarm Test results saved in battery backed non volatile Memory along with up to 20 PASS FAIL records from manually conducted tests Test results 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 SPO HEART RATE preset HRA HRW PULSE AMP preset PULA PULY PASS FAIL AUTO preset ALARM TEST START STOP alarm test ERASE memory PRINT 1 11 Nellcor Port Allows temporary connection of Nellcor pulse oximeter sensors for selection of sensot specific SpO calibration curve Intended for high accuracy testing of all Nellcor disposable and re usable sensors Specifications Chapter 1 Page 3 OXITEST PLUS 7 OPERATING MANUAL 1 12 Serial Printer Interface Mechanical 5 Pin Mini DIN Electrical Bi directional RS 232 9600 baud 8 bits no patity 1 stop 1 13 Power Supply
15. y Ww 5 Test Usage Guidelines 5 1 General Rules In an ideal world testing a pulse oximeter would simply involve placing the oximeter sensor on the test probe and observing the results However due to the many implementations of the basic oximetry technology and many configurations of sensors there are some practical problems you will inevitably run into in testing oximeters The problems generally fall into two categories 1 interpretation of results and 2 the probe sensor interface 5 1 1 Interpretation of Results Although pulse oximeters provide an indication of heart rate it is the oxygen saturation estimated by these devices SpO which is of greater concern when discussing the accuracy of a particular make or model Manufacturer s accuracy specifications for SpO can be confusing just what does 2 1 standard deviation actually mean In developing 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 has very little to do with what you should expect from testing the oximeter with a tester The R Curve is well defined in the oximeter s electronics An oximeter tester s
16. 6 baud OPEN COMI 9600 N 8 1 CDO CS DS OPO RB32 TB32 FOR OUTPUT AS 1 Select NELLCOR N 200 pulse oximeter Note the following command may change with changes in Oxitest software revision The command OX 35 is used here only as an example PRINT 1 OX 35 INPUT 41 C Spo2 1 DO Set the SpO2 PRINT 1 SO PRINT 1 USING Sp02 INPUT 1 C GOSUB CommDelay Sweep the heart rate from 60 to 140 BPM FOR HeartRate 60 TO 140 STEP 20 PRINT 1 HR IF HeartRate lt 100 THEN PRINT 1 USING HeartRate ELSE PRINT 1 USING HeartRate END IF INPUT 1 C Display current SpO2 and HR on PC screen SELECT CASE Sp02 CASE 2 O2sat 93 Computer ControllChapter 4 Page 37 OXITEST PLUS 7 OPERATING MANUAL CASE 3 02sat 90 CASE 4 02sat 80 CASE 5 02sat T CASE ELSE O2sat 97 END SELECT PRINT 02sat HeartRate Delay 20 sec before next heart rate increment FOR 1 1 TO 100 GOSUB CommDelay Quit if user presses ESCape key IF INKEY CHR 27 THEN CLOSE END END IF NEXT 1 NEXT HeartRate Select next saturation level Sp02 Sp02 1 IF Sp02 gt 5 THEN Sp02 1 END IF LOOP WHILE Sp02 gt END 1 This subroutine produces a timed delay of 200 msec CommDe lay TeeZero TIMER DO WHILE TIMER TeeZero lt 2 LOOP RETURN Computer ControllChapter 4 Page 38 OXITEST PLUS 7 OPERATING MANUAL Chapter I _ Ns gt
17. A battery discharged to this level may require replacement or reconditioning to ensure optimal portable operation of the unit Oxitest Plus 7 may also be powered with the supplied switch mode AC adapter Having the Oxitest Plus 7 powered up will have no effect on the amount of time required to recharge the battery Note Older Oxitest Plus 7 units were supplied with linear AC adapters refer to Section 1 15 for replacement part numbers and serial number effectivity For older model Oxitest Plus 7 units recharging the battery while powered up requires somewhat more time than with the unit powered down Unless portable operation is not required it is not recommended that Oxitest Plus 7 be connected to the AC Adapter continuously as this may reduce the life of the battery The battery will maintain its capacity longer if Oxitest Plus 7 is routinely run until LO BATTERY is indicated on the STATUS display and then fully recharged All NiCad batteries however will degrade over time OperationlChapter 3 Page 27 OXITEST PLUS 7 OPERATING MANUAL Newer Oxitest Plus 7 units feature battery monitoring and protection circuitry In the event the Oxitest Plus 7 battery becomes deeply discharged the protection circuit will disconnect the battery internally when the battery voltage falls below a set threshold voltage This typically occurs when a unit with an older battery is left on the shelf for a prolonged period of time Notes If the battery is
18. D This is because some pulse oximeters can be used with more than one make of sensor many oximeters are compatible with Nellcor as well as their own brand of sensor When selecting the oximeter be sure to choose the correct sensor as well as the appropriate make and model as sensors from different manufacturers may have different SpO calibration curves R Curve Oximeters manufactured by BCI International and Nonin are operable with sensors made by another leading pulse oximeter manufacturer These cross combinations of oximeter and sensor make are identified in the Oxitest Plus 7 menu by the SENSOR Non OEM designation As it is common practice to use BCI and Nonin oximeters with the other oximeter manufacturer s sensor the Oxitest Plus 7 provides for testing this combination It should be noted however that BCI Nonin and the other leading oximeter manufacturers do not recommend use of their respective products in such combination Operation Chapter 3 Page 13 OXITEST PLUS 7 OPERATING MANUAL 3 5 Selecting an SpO level Oxitest Plus 7 simulates five 5 preset levels of oxygen saturation 97 93 90 80 and 70 Additional preset levels of 55 and 35 may also be provided according to pulse oximeter manufacturer model number and sensor see Section 1 1 The SpO preset is changed by pressing the SpO key on the front panel The selected SpO preset will be indicated on the standard operating screen at the lower left corner
19. MANUAL SENSOR TEST PROBE RED 8 IR LEDs PHOTODIODE DETECTOR CIRCUITRY LCD DISPLAY PHOTODIODE ELEMENT MICRO PROCESSOR CONTROL SENSOR CABLE KEYPAD PULSE OXIMETER Figure 1 Block Diagram A photodiode in the Oxitest Plus 7 probe intercepts the oximeter s red and infrared light signals and generates an electrical signal which is analysed 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 SpO and heart rate indications Overview Chapter 2 Page 7 OXITEST PLUS 7 OPERATING MANUAL Overview Chapter 2 Page 8 OXITEST PLUS 7 OPERATING MANUAL 3 3 1 Operation General Description The Oxitest Plus 7 provides a quick and efficient method of testing the overall operation of a pulse oximeter its cable and sensor A test is performed by applying the oximeter sensor to the Oxitest Plus 7 probe after first setting up the test parameters on Oxitest Plus 7 The features of Oxitest Plus 7 are depicted in Figure 2 and Figure 3 and are referred to throughout the rest of section 3 The following procedure should be followed for correct operation 1 Turn the Oxitest Plus 7 ON by rotating t
20. 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 manufacturers 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 UseagelChapter 5 Page 49 OXITEST PLUS 7 OPERATING MANUAL Test UseagelChapter 5 Page 50 OXITEST PLUS 7 OPERATING MANUAL Chapter Aug DN a 4 N Ww y 6 Routine Maintenance 6 1 Probe Cleaning Over a period of time a build up of residue may be noticed on the optical windows at the probe tip This is normal and is due to contact with dirty sensors and disposable sensors which rely on adhesive application To ensure the probe receives maximum light from sensors under test and also to ensure that the optical power emitted 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
21. Simulation o 31 4 4 22 Set SpO Command ee 32 4 4 3 Set Heart Rate Command ees 32 4 4 4 Set Pulse Amplitude Command 0 0c ees 32 4 4 5 Activate Artifact Simulation o 33 4 4 6 Activate Auto Preset Protocol 33 44 7 Download Test Report nnne 33 4 4 8 Download Manual Record 34 4 4 9 Download Auto Preset Test Record eae 34 4 4 10 Download Alarm Test Record 34 4 4 11 Erase All Test Records o 34 4 4 12 Command Summary i 35 4 5 Programming Example i ser pr Rel dea ae Paes de add ASQ 36 5 Test Usage Guidelines iii E pA Ro A 39 Bal General Rules ione ei a Rd a ei 39 5 1 1 Interpretation of Results 39 5 1 2 Probe Sensor Interface teens 40 5 2 Diagnosing Sensor Faults tenet eee 48 5 3 Cross Manufacturer Compatibility LL 49 Table of Contents Page i OXITEST PLUS 7 OPERATING MANUAL 6 Routine Maintenance 6 1 Probe Cleaning 6 2 Calibration Table of Contents Page ii OXITEST PLUS 7 OPERATING MANUAL Chapter gt d 1 Specifications 1 1 Saturation SpO Range of adjustment is according to pulse oximeter manufacturer and or model Masimo Mindray Nellcor and Nellcor OEM s e g Critikon Protocol Philips etc Variable from 35 to 100 in steps of 1 SpO presets at 35 70 80 90 93 and 97 Selected EnviteC Hewlett Packard Nihon Kohden and Philips models
22. Start Stop key on the tester depends on the Alarm Test selected by the user as follows Prior to pushing Start Stop Alarm Test SpO Hrt Rate P Amp Artifact All Tests 97 72 BPM 100 off Effect of pushing Start Stop Alarm Test Sp0 Hrt Rate P Amp Artifact 1 LOW SAT 70 72 BPM 100 off 2 HI RATE 97 180 BPM 100 off 3 LO RATE 97 40 BPM 100 off 4 LOW SIG 97 72 BPM 3 off 5 ARTIFACT 97 72 BPM 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 2 The user starts the LOW SAT test by pressing Start Stop The alarm test immediately switches the SpO from 97 to 70 and the timer at the top right of the LCD begins incrementing in 0 1 second steps 3 When the oximeter under test produces an audio alarm the user presses the Start Stop key to stop the timer and save the alarm ON TIME in the Oxitest Plus 7 memory Operation Chapter 3 Page 20 OXITEST PLUS 7 OPERATING MANUAL 4 To allow the oximeter under test to stabilize to the abnormal patient simulation a delay of 5 seconds is introduced at this point as shown above 5 After this delay the alarm test automatically resets the SpO to the normal patient level 97 The timer is automatically reset to zero at this point and begins counting up again 6 When the oximeter alarm shuts off the user presses Start Stop for the third time
23. TEST PLUS 7 OPERATING MANUAL 3 15 Recharging the Battery Oxitest Plus 7 is powered by an internal NiCad battery with sufficient capacity to provide approximately 40 hours of operation When the Oxitest Plus 7 is OFE the battery powers a non volatile memory which retains the test settings the ENAable DISable status of the pulse oximeter menu and any Pass Fail test results which may have been saved in memory Power drain from the battery in this case is negligible When the battery approaches full discharge the STATUS display as shown in Section 3 8 Status Indicator will alternate with a LO BATTERY indication To recharge the battery plug the supplied AC adapter into a wall outlet and the Oxitest Plus 7 DC ADAPTOR input see Figure 2 Use only the adaptor supplied with the Oxitest Plus 7 to recharge the battery A full battery recharge will require approximately 14 hours If the Oxitest Plus 7 battery reaches full discharge during use the unit will stop operating and the message shown below will appear on the display In this case the Oxitest Plus 7 should be powered down and the battery given a full recharge as soon as possible 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
24. a FAIL due to a potentially defective infrared LED in the oximeter sensot If the printer is not attached or not on line when the Print key is pressed then the error message shown below will be displayed The off line condition is tested immediately after pressing the Print key and periodically while the printing is in progress The Erase key permits the erasure of the last test record saved in case PASS or FAIL was pressed at the wrong time or under the wrong conditions or the erasure of all test records When the Erase key is pressed the display as shown below results Operation Chapter 3 Page 23 OXITEST PLUS 7 OPERATING MANUAL Pressing the Yes key erases the last test record while pressing the No key leaves the saved information unchanged In both cases the following display results All test records will be erased if the Yes key is pressed or no records will be erased if the No key is pressed After printing the Test Report only the second display appears 3 13 Using the Nellcor Sensor Port Inside every sensor manufactured by Nellcor yco is a unique resistor which is used by Nellcor technology oximeters in selecting a particular SpO calibration curve R Curve to match the oxygen saturation characteristic of the sensor The Nellcor Port located 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 r
25. ace a product that proves to be defective at no charge provided you return the product shipping duty brokerage and taxes prepaid to DSI Any and all transportation charges incurred are the responsibility of the purchaser and are not included within this warranty This warranty extends only to the original purchaser and does not cover damage from abuse neglect accident or misuse or as the result of service or modification by other than DSI INNO EVENT SHALL DATREND SYSTEMS INC BE LIABLE FOR CONSEQUENTIAL DAMAGES No warranty shall apply when damage is caused by any of the following e Power failure surges or spikes Damage in transit or when moving the instrument Improper power supply such as low voltage 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 COVERED UNDER THE WARRANTY Items such as cables and non serialized modules are not covered under this warranty This warranty gives you specific legal rights and you may have other rights which vary from province to province state to state or country to country This warranty is limited to repairing the instrument to DSl s specif
26. ale pin 5 TXD to pin 3 RXD pin 2 RXD pin 2 3 RXD to pin 2 TXD pin 3 TXD pin 1 CTS to pin 4 RTS pin 7 RTS pin 4 BUSY to pin 20 DTR pin 4 DTR shield GND to pin 7 GND pin 5 GND 5 Front View 4 Figure 5 Connector Pin outs 4 3 Functional Description Oxitest 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 OD hex or by carriage return followed by the line feed character OA hex The Oxitest Plus 7 has a bidirectional RS 232 port and monitors the RTS and DTR lines when handshaking with external serial printers Control programs should ensure that COM port RTS and DTR lines are set high and that at least 100 msec is allowed between transmissions to accommodate command execution time A delay of less than 100 msec between transmissions may produce unexpected results If Oxitest Plus 7 receives a valid RS 232 command Oxitest Plus 7 will execute the command update the LCD to reflect the change and transmit the character via its RS 232 port If Oxitest Plus 7 receives an invalid or erroneous command the command will not be executed the Oxitest Plus 7 will transmit the character via its RS 232 port Computer ControllChapter 4 Page 30 OXITEST PLUS 7 OPERATING MANUAL 4 4 Command Definitions For all RS 232 commands be sure to follow the prescribed
27. and Modifying the Oxitest Plus 7 Menu To turn on the Oxitest Plus 7 rotate the test probe which is visible from the right hand side of the Oxitest Plus 7 90 degrees clockwise from its storage compartment Oxitest Plus 7 will go through a powet on self test POST The LCD display will appear as shown below When initially delivered the default test parameters are set to Nellcor N 200 97 SpO 60 BPM and 100 pulse amplitude If the parameters are changed the Oxitest Plus 7 will retain the settings in memory 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 depress the SpO button while turning on the power to the Oxitest Plus 7 The display shown below will appear for about 2 seconds The pulse oximeter information will then be displayed as shown below The oximeter information includes the manufacturer name model number s and the type of sensor used manufacturers may use more than one type of sensor each of which may require a different SpO curve or R Curve Operation Chapter 3 Page 11 OXITEST PLUS 7 OPERATING MANUAL The menu of oximeters provides up to 128 entries
28. be connected to a Citizen 1DP 3110 serial printer or to a personal computer Refer to section 4 2 for the interconnection cable details The format of the Test Report is similar to the following example printout Operation Chapter 3 Page 22 OXITEST PLUS 7 OPERATING MANUAL Oxitest PLUS 7 Pulse Oximeter Tester PULSE OX TEST REPORT Time Date Control No Serial No Location Department Technician Oxitest settings PULSE OX Nellcor N 200 N 100C SENSOR Nellcor W SELECTED R CURVE Oxitest Status Rec SpO Rate Amp Artf LEDs e 97 5BPM 100 Off OK PASS 2 93 75BPM 100 Off OK PASS 3 90 75BPM 100 Off OK PASS 1 97 150BPM 30 Off OK PASS 5 97 240BPM 15 MOVM NORD FAIL Auto SpO Rate Amp Artf LEDs 97 2BPM 100 Off OK PASS 4 97 38BPM 100 Off OK PASS 6 97 60BPM 0 Off NoIR FAIL 9 97 89BPM 52 TREM OK PASS ALARM TEST ON TIME OFF TIME LOW SAT 9 8 sec 7 1 sec HI RATE 10 6 sec 8 5 sec LO RATE 17 4 sec 15 1 sec LOW SIG 23 1 sec 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 also recorded as
29. clean the acrylic probe as it will introduce stress cracks over time The Oxitest probe incorporates urethane acrylic and mylar components Therefore under no citcumstances should reactive solvents adhesive remover varsol turpentine etc be used to clean the probe MaintenancelChapter 6 Page 51 OXITEST PLUS 7 OPERATING MANUAL 6 2 Calibration Calibration of Oxitest Plus 7 by a Datrend Authorized Service facility is recommended on an annual basis and is required to extend the product warranty The basic one 1 year warranty can be extended to a maximum of five 5 years provided that annual calibration is performed by a Datrend Authorized Service Center on an annual basis The Oxitest Plus 7 can only be CALIBRATED with specialized equipment and software found 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 is due contact Datrend Customer Setvice to determine the authorized service facility nearest your location and to obtain an RMA number In North America 1 800 667 6557 Outside North America 604 291 7747 e Mail customerservice datrend com Maintenance Chapter 6 Page
30. correctly recognize the red and IR light flashes produced by the oximeter In this case Oxitest Plus 7 status display will show RED IR OK but the oximeter saturation reading will significantly disagree with the Oxitest Plus 7 SpO setting The simplest solution is to remove the oximeter sensor from the Oxitest Plus 7 probe wait a few seconds and then re apply the sensor to Oxitest Plus 7 Alternatively the Operation Chapter 3 Page 16 OXITEST PLUS 7 OPERATING MANUAL oximeter can be powered up afer applying the sensor to Oxitest Plus 7 Positioning the sensor properly may be mote difficult for short stubby sensors Section 5 1 2 offers some advice on how to position some specific types of sensors 3 9 Selecting Motion Artifact Simulation Oxitest Plus 7 provides four waveforms for simulating various motion artifact conditions The MV wave adds low frequency noise to the normal patient signal simulating slow whole body movements The SP wave adds sharp noise spikes to the patient signal simulating the oximeter sensor being struck or tapped at random times The TR wave simulates patient tremor or shivering The Sn waveis a high amplitude 2 5 Hertz sinewave interference simulating a shake table laboratory test of a pulse oximeter as described by Barker et al in The effects of motion on the performance of pulse oximeters in volunteers Anesthesiology 1997 86 101 8 The motion artifact simulation is activated by pressing the Heart Rat
31. discharged to the point where the protection circuitry activates reconditioning of the battery may be indicated if an overnight charge does not restore the battery to full capacity Once the protection circuitry has internally disconnected the battery Oxitest Plus 7 will not power up by turning the finger probe To 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 battery can be removed for replacement or reconditioning through the battery compartment access door on the underside of the unit Notes Once the battery has been physically disconnected from the unit Oxitest Plus 7 will not power up by turning the finger probe To reset the unit the switch mode AC adapter must be plugged in to the AC mains and connected to Oxitest Plus 7 This can be done with the Oxitest Plus 7 ON or OFF When the battery is physically disconnected from the unit all saved data and settings will be lost OperationIChapter 3 Page 28 OXITEST PLUS 7 OPERATING MANUAL Chapter 4 Computer Control and RS 232 The operating parameters of Oxitest Plus 7 can be controlled by an externa
32. e and Pulse Amp keys simultaneously In response to this key combination the Oxitest Plus 7 will emit a double beep M n and activate the MV wave as indicated by the characters displayed to the left of the pulse amplitude on the LCD 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 5p TR and 9 as for the MV wave above A fifth press of Heart Rate with Pulse Amp will de activate the motion artifact simulation In Auto Preset mode two of the nine factory default presets include motion artifact simulations The Alarm Test Mode also provides one alarm test in which the MV wave is turned on and then off by the Start Stop key This allows measurement of the oximeter s alarm response to motion artifacts In manual mode SpO heart rate and pulse amplitude settings on Oxitest Plus 7 may be independently varied while the motion artifact simulation is active Stability and accuracy of a pulse oximeter under motion artifact conditions is highly dependent on the noise to signal ratio NSR that is the relative strength of the artifact signal to the uncorrupted patient signal When motion artifact is activated on Oxitest Plus 7 simulated NSR may be continuously varied by means of the Pulse Amp controls For example with the pulse amplitude set to 20 the NSR would be 5 1 OperationlChapter 3 Page 17 OXITEST PLUS 7 OPERATING MANUAL 3 10 Se
33. efer to Figure 4 Oxitest Plus 7 must be powered ON finger probe extended in order to access this adjustment Figure 4 OperationlChapter 3 Page 12 OXITEST PLUS 7 OPERATING MANUAL 3 4 Choosing an Oximeter The oximeter currently selected is displayed on the standard operating mode screen as shown below To change oximeters press the Pulse Ox key The current oximeter sensor selection appearing in the previous display will then be displayed in full detail across the LCD as follows To scroll through the oximeters which have been ENAbled through the process described in section 3 2 press the Pulse Ox key repeatedly to move forward through the available oximetets one step at a time until the oximeter of interest is displayed Alternately the Pulse Amp A or Y keys will single step through the menu moving up or down respectively and the Heart Rate A or W keys will move in steps of two entries at a time Either A or V key may be pressed and held to continuously scroll forward or backward through the menu To finalize the selection press the SpO key and Oxitest Plus 7 will return to the standard operating screen Note Only those oximeters 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 LC
34. esistor can be measured and the SpO 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 the entire range of simulated SpO levels 35 to 100 At power up reset or when a Nellcor or Nellcor OEM pulse oximeter is selected from the Oxitest Plus 7 Pulse Ox menu the default Nellcor R Curve is selected After selecting the Nellcor N 200 for example the Manual Mode display would appear as follows on the LCD As long as the STATUS display remains in the NO SIGNAL state the Nellcor port is sampled by Oxitest Plus 7 To use the Nellcor Port perform the following steps Operation Chapter 3 Page 24 OXITEST PLUS 7 OPERATING MANUAL 1 Selecta Nellcor compatible pulse oximeter from the menu 2 Disconnect the sensor from the pulse oximeter and connect it to the Nellcor Port DB9 connector at the top of Oxitest Plus 7 3 Oxitest Plus 7 will measure the resistance in the Nellcor compatible sensor If the resistance is acceptable a sensor detect beep is produced and the following message is displayed on the LCD for as long as the sensor remains connected to the Nellcor Port 4 Disconnect the sensor from the Oxitest Plus 7 s Nellcor Port and reconnected to the oximeter The display returns to the Manual Mode with the alternate R Curve being indicated by a R on the LCD as s
35. evident when viewing sensor sensor cable s have an open or intermittent wire contact or cable connector s are defective INFRARED LED drive signal from oximeter is missing both RED and INFRARED LEDs ate faulty sensor cable 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 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 or out of calibration For testing of the probe sensor cable see Datrend s companion test instrument Sensitest Test UseagelChapter 5 Page 48 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 portion of such monitors using one of the Nellcor or Ohmeda settings on
36. he LCD end of Oxitest Plus 7 rather than toward the bottom of the tester The Oxitest Plus 7 probe incorporates a cutout designed to accommodate stiff or long strain reliefs found on some oximeter cables This helps prevent stiff cables from inadvertently pushing the sensor off the probe Stiff cables or long strain reliefs can be pre formed to the desired shape before application to the probe Test UseagelChapter 5 Page 41 OXITEST PLUS 7 OPERATING MANUAL 2 Ohmeda Datex Style The Ohmeda style sensor uses a harder rubber like material to surround the finger taking the finger shape into consideration with a depression in the material The outside of the sensor is commonly a hard plastic molded in the shape of a clothes pin Examples of this type include Ohmeda SiMed and Physio Control finger clip sensors The depression of the Ohmeda finger clip sensor can be seen in Figure 7 With the LEDs shining toward you as in the Nellcor example place the sensor on 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 top As with the Nellcor style sensor a stiff sensor cable or long strain relief can
37. he test probe 90 degrees from its protective storage compartment Following power up select an oximeter make Pulse Ox from the menu Set the SpO Heart Rate and Pulse Amp to the desired settings using the appropriately labelled push button keys on the front panel See sections 3 2 through 3 7 for further details Default values for SpO Heart Rate and Pulse Amp on selection of a new oximeter are 97 60 BPM and 100 respectively 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 underside of the probe Wait for the Oxitest Plus 7 to display RED IR OK on its LCD Change Oxitest Plus 7 SpO and Heart Rate and note the oximeter s response Verify the oximeter alarms when SpO and or heart rate exceed corresponding alarm thresholds Optionally decrease the Pulse Amp and note how the oximeter s SpO and heart rate may be affected by low tissue perfusion Remove the oximeter sensor from the test probe Select a new oximeter if required and go back to step 3 or turn Oxitest Plus 7 OFF by rotating the test probe back into the storage compartment OperationlChapter 3 Page 9 OXITEST PLUS 7 OPERATING MANUAL Figure 2 Oxitest Plus 7 Side Panel Nellcor Port Figure 3 Oxitest Plus 7 Front Panel Operation Chapter 3 Page 10 OXITEST PLUS 7 OPERATING MANUAL 3 2 Powering Up
38. hown below 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 connected to the Nellcor port In this case the default Nellcor R Curve will be selected when the sensor is removed from the Nellcor Port An error beep is produced in response to the following error conditions e detection of a resistance at the Nellcor Port when the pulse oximeter selected from the menu is not compatible with Nellcor sensors or Operation Chapter 3 Page 25 OXITEST PLUS 7 OPERATING MANUAL detection of a resistance at the Nellcor Port when a Nellcor compatible oximeter selected from the menu does not make use of the Nellcor R Curves or O the signal STATUS is something other than NO SIGNAL For any of the above conditions the following message is displayed for as long as the sensor remains connected to the Nellcor Port The Nellcor Port is also sampled in Auto and Alarm Test modes and the same rules apply for allowable selection of the Nellcor R Curve as with Manual Mode However as the pulse oximeter name is not displayed on the LCD in Auto and Alarm Test modes no indication is given that an alternate R Curve is currently in use Note that the LCD will still display the process of selecting the curve via the RCAL OK me
39. ications When you return a DSI instrument for service repair or calibration we recommend shipment using the original shipping foam and container If the original packing materials are not available we recommend the following guide for repackaging e Use a double walled carton of sufficient strength for the weight being shipped e Use heavy paper or cardboard to protect all instrument surfaces Use non abrasive material around all projecting parts e Use at least four inches of tightly packed industrial approved shock absorbent material all around the instrument DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper packaging or handling All warranty claim shipments must be made on a prepaid basis freight duty brokerage and taxes No returns will be accepted without a Return Materials Authorization RMA number Please contact Datrend at 1 800 667 6557 to obtain an RMA number and receive help with shipping customs documentation Warranty Disclaimer Should you elect to have your instrument serviced and or calibrated by someone other than Datrend Systems please be advised that the original warranty covering your product becomes void when the tamper resistant Quality Seal is removed or broken without proper factory authorization We strongly recommend therefore that you send your instrument to Datrend Systems for service and calibration especially during the original warranty peri
40. ion to an abnormal patient simulation and allowing the user to measure the time the oximeter takes to produce an audio visual alarm After the user records the time of the oximeter alarm the tester is reset back to the normal patient simulation and the user then records time required for the oximeter to shut off the alarm The Alarm Test Mode therefore determines bot the alarm ON TIME and also the length of time the alarm persists under normal patient conditions the OFF TIME Operation Chapter 3 Page 18 OXITEST PLUS 7 OPERATING MANUAL Pressing the Alarm Test key produces the following LCD display As shown above the LCD displays the name of the alarm test at the upper left a timer counter at the upper right and the test settings corresponding to the normal patient condition on the lower line By pressing the Alarm Test key the user can select one of the four remaining alarm tests In addition to the test above the remaining tests appear as follows 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 Start Stop key immediately initiates the selected alarm test by switching the test parameters to the abnormal patient setting and starts the timer counting in the top right corner of the LCD OperationlChapter 3 Page 19 OXITEST PLUS 7 OPERATING MANUAL The effect of the
41. l device through an RS 232 serial communications port This allows Oxitest Plus 7 to be interfaced to an automated tester or PC for automated oximeter testing It also allows the control of the test parameters data transfer and remote editing of Oximeter 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 SpO 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 automated safety analyzers 4 1 Electrical Interface RS 232 Bidirectional 9600 baud 8 bits No parity 1 stop bit Maximum cable length restricted to 10 feet Computer ControllChapter 4 Page 29 OXITEST PLUS 7 OPERATING MANUAL 4 2 Mechanical Interface The Oxitest Plus 7 RS 232 port located on the right side of the unit is a 5 pin mini DIN female connector The R 103 DB9 RS 232 accessory cable P N 7100 248 is available to connect to the 5 pin mini DIN female connector A cable made to the specifications in the table following may be used to connect Oxitest Plus 7 to the COM port of a PC or medTester Oxitest Plus 7 mates with the 5 pin miniDIN male connector and the PC or medTester mates with the DB 9 female connector Oxitest medTester PC 5 pin miniDIN DB 25 female DB 9 fem
42. lecting Auto Presets The Auto Preset selections are selectable by pressing the Auto key on the front panel until the desired preset selection appears Each Auto Preset specifies the SpO level heart rate pulse amplitude and signal artifact settings as a group The nine default Auto Preset selections are listed in the table below These selections may be programmed to alternative values via the RS 232 port using the Ox Edit software which is available at www datrend com Auto Heart Pulse Spo Rate Amp Artifact Title 1 97 72bpm 100 Off Normal Adult 2 80 95bpm 100 off Hypoxia 3 97 157bpm 100 off Tachycardia 4 97 38bpm 100 off Bradycardia 5 97 66bpm 4 Off Low Perfusion 6 97 60bpm 0 Off No Perfusion 7 93 145bpm 40 off Neonate 8 97 70bpm 33 Movement Movement 9 97 89bpm 52 Tremor Shivering The factory default Auto Preset settings can be reloaded 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 are provided low saturation high pulse rate low pulse rate low signal level and motion artifact The Alarm Test Mode works by switching Oxitest Plus 7 from a normal patient simulat
43. manually conducted tests may be saved in the memoty of Oxitest Plus 7 for later printout or downloading to a personal computer PC In addition to the 20 manual test results Oxitest Plus 7 can also save the results of Auto Preset tests and Alarm Tests Manual test and Auto Preset test results are saved to Oxitest Plus 7 memoty by pressing either the Pass or Fail key on the front panel keypad The information saved includes the test SpO heart rate pulse amplitude and motion artifact settings plus the PASS or FAIL status of the test and the oximeter signal status displayed at the upper right corner of the Oxitest Plus 7 LCD The oximeter signal status is saved in abbreviated 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 ate 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 by battery back up when the power is switched off This allows test results to be acquired over a period of time and then printed out or downloaded later Pressing the Print key causes the test results saved in the memory to be transmitted from the Oxitest Plus 7 RS 232 Port as a formatted Test Report The Oxitest Plus 7 RS 232 Port may
44. n used with compatible oximeters For instance Nellcor makes a disposable finger sensor which due to the cable connector can be attached to many other manufacturer s oximeters In order to have a better manufacturing yield Nellcor codes the disposable sensor with a resistor which the Nellcor oximeter uses to adjust the R Curve for the sensor In effect this is providing compensation for the optical response of the sensor However even though the Nellcor disposable sensor fits on other manufacturet 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 ProbelSensor Interface The single most variable parameter in testing oximeters is the fit between the tester probe and the oximeter sensor Due to the wide variety of sensor shapes a test probe which provides an excellent fit with a Nellcor sensor may not be as good a fit to a Nonin sensor The Oxitest Plus 7 probe has been designed to provide the best compromise fit for testing both disposable and nondisposable sensors across many brands Most nondisposable sensors fit into two categories of design 1 Nellcor style with an end stop for the finger or 2 Ohmeda style with a finger depression molded in the sensor In many cases the sensor can be simply slid over the test probe and will sit naturally in place If you do not get good results with this method the follo
45. ne 660 nm light emitting diode LED and one 940 nm LED on the transmitting side of the sensor and one broad spectrum photosensitive element on the receiving side of the sensor The pulse oximeter activates the LEDs in a particular sequence which allows the received signals to be correctly interpreted The light passes through a portion of the body of the patient commonly the finger 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 Knowing Your Pulse Oximetry Monitors S Ackerman and P Weith Medical Electronics February 1995 pp 82 86 A block diagram of the Oxitest Plus 7 is provided in Figure 7 The Oxitest Plus 7 incorporates a probe resembling a finger which is placed between the transmitting and receiving elements of the oximeter The Oxitest Plus 7 probe intercepts the light signals produced by the pulse oximeter and generates pulses of light that are controlled in level and which simulate the light levels which would normally be received by the pulse oximeter s photosensitive element at predetermined oxygen saturation levels Overview Chapter 2 Page 6 OXITEST PLUS 7 OPERATING
46. od In all cases breaking the tamper resistant Quality Seal should be avoided at all cost as this seal is the key to your original instrument warranty In the event that the seal must be broken to gain internal access to the instrument e g in the case of a customer installed firmware upgrade you must first contact Datrend Systems 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 interruption WARNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation Datrend Systems will not be responsible for any injuries sustained due to unauthorized equipment modifications DSI DISCLAIMS ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION THIS PRODUCT CONTAINS NO USER SERVICEABLE COMPONENTS UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES Nellcor is a registered trademark of Tyco Healthcare QBasic and Visual Basic are trademarks of Microsoft Corp MS DOS
47. ollowing STATUS messages may be displayed NO SIGNAL No optical signal is currently being received by Oxitest Plus 7 from the oximeter under test Possibly the oximeter sensor has not been applied to the Oxitest Plus 7 probe Testing Oxitest Plus 7 has detected an optical signal and is testing the signal to see if it is consistent with the selected oximeter NO RED An optical signal has been detected but there is no signal which corresponds to the output of the RED LED Probable sensor or cable failure NO IR An optical signal has been detected but there is no signal which corresponds to the output of the infrared IR LED Probable sensor or cable failure RED IROK The optical signal detected by Oxitest Plus 7 is consistent 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 Jower surface of the Oxitest Plus 7 probe If the STATUS message enters the Testing phase and then begins to rapidly change it is probable that the oximeter under test is not the same make and model as the oximeter selected in Oxitest Plus 7 Change the Oxitest Plus 7 Pulse Ox selection to match the oximeter and retry the test When testing some oximeters Oxitest Plus 7 may not at first
48. otion artifacts gross body movement tapping the oximeter 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 downloaded to a PC or automated tester for easy documentation Most problems with pulse oximeters can be traced to complete or partial failure of the oximeter sensor the photo sensor one of the two light transmitting elements LEDs the cable or the connector Oxitest Plus 7 will assist in diagnosing sensor failures by providing an indication of the status of the oximeter s LEDs For comprehensive testing of sensors when no pulse oximeter is available Datrend provides a companion test instrument Sensitest Overview Chapter 2 Page 5 OXITEST PLUS 7 OPERATING MANUAL 2 2 Detailed Description Pulse oximeters commonly utilized in hospitals are based on the principle of the absorption of light by blood at two separate wavelengths 660 nm and 940 nm Specifically the relationship between the absorption of light for Oxygenated Haemoglobin HbO and reduced Haemoglobin Hb allows the calculation of HbO and subsequently oxygen saturation A typical pulse oximeter probe incorporates o
49. r immediately to file a claim If the instrument is delivered in good physical condition but does not operate within specifications or if there are any other problems not caused by shipping damage please contact your local sales representative or DSI immediately Standard Terms and Conditions Refunds amp Credits Please note only serialized products products labeled with a distinct 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 new and resalable condition The Return Procedure must be followed Return Procedure Every product returned for refund credit must be accompanied by a Return Material Authorization RMA number obtained from Datrend Customer Service All items being returned must be sent prepaid freight duty brokerage and taxes to our factory location Restocking Charges Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 Products returned in excess of 30 days after purchase but prior to 90 days are subject to a minimum restocking fee of 20 Additional charges for damage and or missing parts and accessories
50. rogramming Example Microsoft QBasic is an easy to use BASIC interpreter which is supplied as part of Microsoft DOS versions 5 and later Using QBasic you can write simple programs on your IBM PC or compatible to control Oxitest Plus 7 automatically via a COM port Below is a simple program written in Microsoft QBasic which causes Oxitest Plus 7 to select a NELLCOR N 200 pulse oximeter for testing and automatically sweep the N 200 through a range of SpO and heart 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 the program and so on After you have typed in the program save it by typing aF followed by S To run the example connect Oxitest Plus 7 to COM1 set up the NELLCOR N 200 and then type aR followed by S To stop the program press the key To quit QBASIC type aF followed by X Computer ControllChapter 4 Page 36 OXITEST PLUS 7 OPERATING MANUAL Program Example CLS PRINT NELLCOR pulse oximeter Sp02 Heart Rate sweep PRINT Press lt ESC gt to quit PRINT PRINT SpO2 Heart Rate BPM VIEW PRINT 5 TO 6 Open COM1 for serial communications at 9
51. somewhere on the lower optical window of the probe it is not critical where The sensor can be held in place with tape if required Regardless of the actual design of the sensor the key to good readings is to develop a tight intimate contact on the photodetector side of the sensor probe interface to prevent leakage of light from the sensor LEDs reaching the photodetector Test UseagelChapter 5 Page 43 OXITEST PLUS 7 OPERATING MANUAL Correct placement of typical flexible sensors is shown in Figure 9 through Figure 11 Photodiode centered on optical window Wrap sensor lt around test probe Figure 9 Nellcor N 25 neonatal disposable Photodiode centered Wrap Figure 10 Nellcor Oxi A N sensor Test UseagelChapter 5 Page 44 OXITEST PLUS 7 OPERATING MANUAL V Figure 11 Obmeda Flex II sensor 5 Application of Criticare Sensors Although the Criticare 511 and 934 sensors are generally compatible with the Oxitest Plus 7 probe ie 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 TO PULSE OX POSITION 1 TOP VIEW Figure 12 Test UseagelChapter
52. ssages etc 3 14 ECG Trigger Output Some pulse oximeters provide an input for a high level ECG signal such as may be output by a patient monitor Such oximeters use the QRS complex of the ECG to synchronize 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 TRIGGER signal is not a simulated ECG waveform but simply a logic pulse of width and timing comparable to the ORS which is appropriate for triggering the pulse oximetet The ECG TRIGGER pulse is output from a 3 5 mm miniature mono phono jack located on the right panel as indicated in Figure 2 The sleeve is grounded and the tip is the trigger signal The Oxitest Plus 7 ECG TRIGGER output is intended to drive high impedance loads and will deliver 2 5 volts into a 10K ohm load This is optimal for driving the Nellcor N 200 via the ECG IN OUT interface a 2 5 mm sub miniature mono phono jack located on the rear panel of the oximetet Refer to the manufacturer s Service Manual for the pulse oximeter when interfacing the ECG input of the unit under test to the Oxitest Plus 7 ECG TRIGGER output Operation Chapter 3 Page 26 OXI
53. syntax including leading zeros where indicated Failure to do so may result in unexpected operation of the Oxitest Plus 7 4 4 1 Select Oximeter and Initialize Simulation Command Format Oxmmm where mmm 051 for BCI 3300 002 for BCI 3300 Nellcor 003 for BCI 3302 59 for SpaceLabs Scout with Nellcor sensor Example 0XB32 causes Oxitest Plus 7 to select and initialize the Nellcor N 20P patient simulation Note the value of mmm corresponding to the oximeter make model listed above is also 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 SpO heart rate and pulse amplitude to default values of 97 60 BPM and 100 respectively The status display is reset to NO SIGNAL Note As oximeters are added to the Oxitest Plus 7 menu by firmware upgrade the number mmm may change Be sure to check the number of any oximeter following a new software release and update any software programs as necessary The numbers given above ate for example only and may not be representative of the current software version Computer ControllChapter 4 Page 31 OXITEST PLUS 7 OPERATING MANUAL 4 4 2 Set SpO Command Format son where n for 97 Spo for 93 Spo for 90 Spo for 80 Spo for 70
54. uch as Oxitest Plus 7 is microprocessor controlled and as a result outputs a precisely regulated calibrated optical signal Therefore although there may be some uncertainty introduced by the sensor and the sensot tester interface the response from an electro optical simulation should be within the tester s specification limits of 1 In some cases a response outside of these limits is an indication that the sensor is slightly out of tolerance and replacement should be considered Test UseagelChapter 5 Page 39 OXITEST PLUS 7 OPERATING MANUAL When using Oxitest Plus 7 the primary consideration is to first choose the correct make model and sensor type for the device under test Many manufacturers of oximeters use another company s technology for instance Tyco provides Nellcor technology on an OEM basis to a large number of physiological monitor manufacturers Each of these individual manufacturers may use the R Curve developed by Nellcor or they may decide to develop their own curve In addition they may use the Nellcot sensors or manufacture a sensor under their own brand name These same manufacturers may use both Nellcor sensors and their own implementing a different R Curve for each sensor With all of these combinations possible it is very important to select the correct pulse oximeter and sensor type in the menu to ensure that the simulation is correct for the unit under test Disposable sensors can produce questionable results whe
55. will be applied to all returns Products which are not in as new and resalable condition are not eligible for credit return and will be returned to the customer at their expense Certification This instrument was thoroughly tested and inspected and found to meet DSl s manufacturing specifications when it was shipped from the factory Calibration measurements are traceable to the National Research Council of Canada NRC and or the National Institute of Standards and Technology NIST Devices for which there are no NRC NIST calibration standards are measured against in house performance standards using accepted test procedures Warranty Warranty and Product Support Datrend Systems Inc DSI warrants this instrument to be free from defects in materials and workmanship under normal use and service for one 1 year from the date of original purchase This warranty will be automatically extended to a maximum of five 5 years from the date of original purchase provided that calibration is performed on an annual basis by a Datrend Authorized Service Center refer to Section 6 2 of this manual This warranty is subject to the following limitations e Oxitest Battery Pack 90 day limited warranty e Standard Accessories 90 day limited warranty e Re calibration of the instrument which has a recommended annual calibration frequency is not covered under the warranty During the warranty period DSI will at our option either repair or repl
56. wing instructions should improve the results 1 Nellcor Tyco Style The Nellcor style sensor generally utilizes a soft cushiony material to surround the finger with a hard plastic or metal outer shell Inside there is an end stop to prevent the finger from going too far into the sensor Examples of this type include Nellcor Nonin and SpaceLabs Novametrix finger clip sensors The end stop of the Nellcor DS 100A finger clip sensor can be seen in Figure 6 Test UseagelChapter 5 Page 40 OXITEST PLUS 7 OPERATING MANUAL End stop Figure 6 Nellcor DS 100A finger clip sensor With the oximeter turned ON hold the sensor in the open position with the LEDs they should be glowing red shining toward you the photo detector will be closest to you hidden by the hard sensor shell Place the photo detector on the Oxitest Plus 7 probe with the end of the probe touching the end stop Allow the sensor to close around the test probe keeping intimate contact on the upper photodetector side Tt is important to retain the tight intimate contact on the photodetector side to 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 t
57. wnload Auto Preset Test Record Format GAUX download Auto Preset test record x where 1 lt x lt 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 for LOW SAT for HI RATE for LOW RATE for LOW SIG and for ARTFACT where t OU WN Example GAT1 downloads the LOW SAT Alarm Test Record 35 characters Computer ControllChapter 4 Page 34 OXITEST PLUS 7 OPERATING MANUAL 4 4 11 Erase All Test Records Format EALL erase all test records manual Auto Preset and Alarm Tests 4 4 12 Command Summary Command Function AFn Activate artifact signal n where n for OFF n 1 for movement n 2 for spike n 3 for tremor APn Activate preset protocol n where 1 7 lt 9 DLTR Download test report complete EALL Erase all test records manual Auto Preset and Alarm Tests GATt Download Alarm Test record 7 1 lt 7 5 GAUx Download Auto Preset record x 1 x lt 9 GMNtr Download Manual record m 1 rr lt 20 HRrrr Set heart rate to ny BPM 20 lt rrr lt 250 OXmmm Set Pulse Ox to wmm and restart simulation PAaaa Set pulse amplitude to aaa per cent Y lt aaa lt 100 SOx Set SpO to level x where x 1 for 97 x 2 for 93 x 3 for 90 x 4 for 80 x 5 for 70 x 6 for 55 x 7 for 35 Computer ControllChapter 4 Page 35 OXITEST PLUS 7 OPERATING MANUAL 4 5 P

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