Nellcor SRC-MAX Technical Manual

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SRC-MAX
Pulse Oximetry Functional Tester Technical Manual
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This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 Canada. To obtain information about a warranty, if any, contact Nellcor’s Technical
Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any
Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett.
Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; Re.35,122 ; 4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,368,026; 5,485,847; 5,533,507; 5,662,106; and 5,853,364.
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Contents
Contents .................................................................................i
Figures ................................................................................. iii
Tables .................................................................................. iv
Safety Information ........................................ ..... ..... ............. 1
Cautions ......................................................................... 1
Introduction .......................................................................... 3
Intended Use .................................................................. 3
Controls, Indicators, and Symbols ....................................... 5
Front Panel ..................................................................... 5
Back Panel ..................................................................... 6
Side View ...................................................................... 6
SRC-MAX Buttons and Symbols .................................. 7
Select Options ................................................................ 8
SRC-MAX Components and Accessories ...........................9
List of Components ....................................................... 9
Optional Accessories: .................................................... 9
SRC-MAX Operation with a Pulse Oximeter or Monitor . 11
ON / OFF Operation .................................................... 11
Power-Saving Mode .................................................... 11
Introduction ................................................................. 11
Routine Maintenance .............................................. ........... 17
Cleaning ....................................................................... 17
Battery Replacement .................................................... 18
Performance Verification ................................................... 21
Introduction ................................................................. 21
Equipment Required .................................................... 21
LED Current to Photodetector Current Test ................ 22
Testing the RED LED .................................................. 23
Testing the IR LED ...................................................... 25
BPM (Beats per Minute) Test ...................................... 27
Three-Lead ECG Cable ........................................... 9
C-Lock Cable ........................................................ 10
Test Setup .............................................................. 12
Test 1: BPM (Beats per minute) ........................... 14
Test 2: Saturation (Sp0
2) ....................................... 15
Test 3: Modulation ................................................ 15
Test 4: Light .......................................................... 16
Equipment Required ............................................. 27
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Contents
Setup ......................................................................27
BPM Test (Alternate Method) ......................................29
Equipment Required: .............................................29
Setup ......................................................................29
Troubleshooting ..................................................................31
Introduction ..................................................................31
Obtaining Technical Assistance ...................................31
Troubleshooting ...........................................................31
Electromagnetic Interference .......................................32
Packing for Shipment ..........................................................35
Introduction ..................................................................35
Returning the SRC-MAX .............................................35
Specifications ......................................................................37
Controls ........................................................................37
Rate ........................................................................37
Light ....................................................................... 37
Modulation ............................................................. 37
Saturation ............................................................... 37
Performance .................................................................38
Saturation (SpO2) ..................................................38
Pulse Rate ..............................................................38
Light Levels ...........................................................38
Modulation (%MOD) ............................................38
ECG .......................................................................38
C-Lock ...................................................................38
Timing ....................................................................39
Simulated Waveform .............................................39
Power ............................................................................ 39
Physical Characteristics .........................................39
Environmental Conditions ............................................40
Standards ......................................................................40
Electrical Safety Requirements ..............................40
EMC/EMI ..............................................................41
International and European Union Compliance ....41
Index ...................................................................................43
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Figures
Figure 1: Front Panel..............................................5
Figure 2: Back Panel..............................................6
Figure 3: SRC-MAX Tester Side View ................... 6
Figure 4: Three-Lead ECG Cable .......................... 9
Figure 5: ECG Cable Warning Label...................... 9
Figure 6: C-Lock Cable ........................................ 10
Figure 7: DOC-10 Sensor Cable..........................13
Figure 8: SpO2 sensor/cable connector............... 13
Figure 9: Battery Compartment Access ............... 18
Figure 10: Pinout Reference SRC-MAX................. 21
Figure 11: Block Diagram....................................... 22
Contents
Figure 12: RED LED Low Light Setting..................24
Figure 13: RED LED High Light Setting................. 25
Figure 14: IR LED Low Light Setting...................... 26
Figure 15: IR LED High Light Setting..................... 27
Figure 16: 3 Volts Peak-to-Peak at 3 Hz................28
Figure 17: 200 BPM ............................................... 29
SRC-MAX iii
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Contents
Tables
Table 1: Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . 32
SRC-MAX iv
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Safety Information
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O
monitors refer to OEM O
monitors.
Cautions
Cautions are identified by the CAUTION symbol shown above.
XIMAX technology-based
Cautions alert the user to exercise care necessary for the safe and effective use of the SRC-MAX.
Caution: The case of the SRC-MAX should be opened only by qualified service personnel. There are no user serviceable parts inside. Opening the battery compartment does not constitute opening the tester case.
Caution: Use your institution’s appropriate bench test procedures when using the SRC-MAX functional tester.
Caution: Install batteries into the SRC-MAX before using. See Routine Maintenance, page 17.
Caution: Do not open the case of the unit, as the device could be damaged.
Caution: Do not connect ground directly to any pins on the DB 9, as the device could be damaged. Refer to Block Diagram, Figure 17 on page 22.
SRC-MAX 1
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Safety Information
Caution: Prior to connecting the oscilloscope’s negative terminal to the +5 volt supply (+) terminal, ensure that the oscilloscope negative is isolated from the +5 volt supply ground.
Caution: This device has been designed to provide resistance to electromagnetic interference. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in the health-care environment (for example, cellular phones, mobile two-way radios, electrical appliances), it is possible that high levels of such interference due to close proximity or strength of a source, may result in disruption of performance of this device. Disruption may be evidenced by erratic readings, cessation of operation, or other incorrect functioning. If this occurs, the site of use should be surveyed to determine the source of disruption, and actions taken to eliminate the source. If assistance is required, contact Nellcor Puritan Bennett’s Technical Services Department or your local Nellcor Puritan Bennett representative.
Caution: Do not spray, pour, or spill any liquid on the SRC-MAX, its accessories, connectors, switches, or openings.
Caution: Do not use the SRC-MAX to test non-O pulse oximeters or non-O
XIMAX OEM monitors.
XIMAX
Caution: Dispose of batteries in accordance with local requirements and regulations.
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Introduction
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O
monitors refer to OEM O
monitors.
Intended Use
The SRC-MAX is intended for qualified technicians to functionally test Nellcor O oximeters and OEM O The SRC-MAX tester will perform the following tests:
Red and infrared light-emitting diode (LED) drive circuitry
XIMAX technology-based
XIMAX technology-based pulse
XIMAX technology-based monitors.
Heart rate (beats per minute, BPM)
Oxygen saturation (Sp0
2)
Light level
Percent modulation
The SRC-MAX functional tester is designed to simulate an operational Nellcor O
XIMAX compatible sensor and check
performance of the pulse oximeter or monitor.
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Controls, Indicators, and Symbols
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O monitors refer to OEM O monitors.
Front Panel
XIMAX technology-based
1. Pulse oximeter/monitor cable connector 6. % Modulation select button
2. RED LED drive indicator 7. % Sp0
3. C-LOCK output connector port 8. Light level output button
4. ECG output connector port 9. Pulse rate beats per minute (BPM) button
5. Battery low indicator 10. INFRARED LED drive indicator
SRC-MAX 5
2 select button
Figure 1: Front Panel
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Controls, Indicators, and Symbols
Back Panel
Side View
1. C-LOCK connector port 2. ECG Port
Figure 2: Back Panel
Figure 3: SRC-MAX Tester Side View
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Controls, Indicators, and Symbols
SRC-MAX Buttons and Symbols
Front panel symbology for the SRC-MAX are as follows: Pulse rate/beats per minute (BPM) selector Button
Light output selector button
Percentage of Sp0
2 selector button
Modulation selector button
Feature not available at this time
Battery low indicator
Red LED indicator
C-Lock port symbol
ECG Port symbol
IR (infrared) LED indicator
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Controls, Indicators, and Symbols
Select Options
There are four button switches on the SRC-MAX Front Panel with two associated LEDs.
Pulse/Beats per Minute
Light Level
% Sp0
2
Percent Modulation
The pulse oximeter or monitor will display readings for both Saturation (Sp0
2) and Pulse Rate. The numeric displays will
correlate with the SRC-MAX control panel.
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SRC-MAX Components and Accessories
List of Components
(1) SRC-MAX Functional Tester (2) AA Alkaline Batteries (1) Technical Manual
Optional Accessories:
Three-Lead ECG Cable
See Figure 4. The three-lead ECG cable is shipped with a warning label, Figure 5. Attach the warning label to the three­lead ECG cable before using the cable.
Figure 4: Three-Lead ECG Cable
SRC-MAX 9
Figure 5: ECG Cable Warning Label
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SRC-MAX Components and Accessories
C-Lock Cable
See Figure 6.
Figure 6: C-Lock Cable
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SRC-MAX Operation with a Pulse Oximeter or Monitor
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O monitors refer to OEM O monitors.
ON / OFF Operation
The SRC-MAX will automatically turn ON when connected to the sensor/patient cable and a pulse oximeter or monitor that is turned on.
The SRC-MAX will automatically turn OFF when detached from the pulse oximeter or monitor, or if the pulse oximeter or monitor is turned off.
XIMAX technology-based
Install two AA batteries in the battery compartment of the SRC-MAX before connecting to the sensor/patient cable and the pulse oximeter or monitor. Refer to Battery Replacement on page 18.
Power-Saving Mode
When the SRC-MAX is connected to a pulse oximeter or monitor and no buttons are pressed for 2 minutes the SRC­MAX goes into the power-saving mode. All of the LEDs turn off, with the exception of the IR and RED LEDs. The SRC­MAX continues to function normally . Press any button on the SRC-MAX and the LEDs will illuminate.
Introduction
The SRC-MAX functional tester allows qualified technicians to functionally test Nellcor O oximeters and OEM O
SRC-MAX 11
XIMAX technology-based pulse
XIMAX technology-based monitors.
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SRC-MAX Operation with a Pulse Oximeter or Monitor
The technician must perform the test setup procedure before performing tests 1 through 4. The following is a brief description of each test:
Test Setup — This procedure establishes the
baseline for all the other tests. The Test Setup procedure must be performed before performing any or all of the SRC-MAX tests.
Test 1: BPM — This procedure simulates an
O
XIMAX sensor attached to a patient indicating 60
BPM and 200 BPM. The test setup procedure sets up Test 1 for 60 BPM.
Test Setup
Test 2: SpO
XIMAX sensor attached to a patient ,indicating 75
O
2 — This procedure simulates an
percent blood oxygen saturation and 90 percent blood oxygen saturation. The test setup procedure sets up Test 2 for 75 percent blood oxygen saturation.
Test 3: Modulation — This procedure simulates an
O
XIMAX sensor attached to a patient indicating low
and high pulse strength. The test setup procedure sets up Test 3 for low pulse strength.
Test 4: Light — This procedure simulates an
O
XIMAX sensor attached to a patient indicating low
and high light level passing throug h the patien t at the sensor site. The test setup procedure sets up Test 4 for low light level.
Note: Refer to the applicable pulse oximeter or monitor
1. Locate the Sp0 pulse oximeter or monitor.
2. Connect a DOC-10 pulse oximetry cable to the pulse oximeter’s Sp0 to the monitor’s Sp0
12
operator’s manual for the pulse oximeter or monitor operation and test procedures.
2 Sensor Port on the front panel of the
2 sensor port or the ap plicable OEM cable
2 sensor port. See Figure 7.
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SRC-MAX Operation with a Pulse Oximeter or Monitor
Figure 7: DOC-10 Sensor Cable
3. Connect the SRC-MAX Sp0
2 sensor/cable connector to
other end of the DOC-10 cable or applicable OEM cable. See Figure 8.
Figure 8: SpO
2 sensor/cable connector
4. Turn on the pulse oximeter or monitor. Refer to the applicable pulse oximeter or monitor operator’s manual.
5. The IR and RED LEDs will alternately flash, turn off, turn on and remain lit once the SRC-MAX is powered up.
6. The Green and Amber LED ( ) and the Red Battery Low LED will illuminate for 2 seconds and turn off, indicating the LEDs are functioning properly.
7. The four selectable parameters (BPM, light level, %SpO condition (LED will be lit closest to the selector button).
SRC-MAX 13
2, and percent modulation) will initiate to a default
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SRC-MAX Operation with a Pulse Oximeter or Monitor
Pulse/Beats per Minute
Light Level
% Sp0
2
Percent Modulation
8. The SRC-MAX is ready to test the pulse oximeter or monitor.
Test 1: BPM (Beats per minute)
The BPM test checks the pulse oximeter or monitor beats per minute operation at 60 and 200 BPM.
Prerequisite ProcedureTest Setup on page 12.
1. The pulse oximeter or monitor should be displaying a BPM of 60 (57 to 63 BPM).
2. Press and release the SRC-MAX Heart Rate/BPM button.
3. The BPM LED indicator on the SRC-MAX will switch to illuminate the 200 numeric reading.
4. Observe the display of the pulse oximeter or monitor. The numeric reading for BPM will gradually rise to the 200 (197 to 203 BPM) level. Allow the pulse oximeter or monitor 10-30 seconds to achieve the test result.
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SRC-MAX Operation with a Pulse Oximeter or Monitor
Test 2: Saturation (Sp02)
The saturation test checks the operation of the pulse oximeter or monitor percent of blood oxygen saturation at 75% and 90%.
Prerequisite ProcedureTest Setup on page 12.
1. The pulse oximeter or monitor should be displaying a %SpO
2 of 75 (72 to 78).
2. Press and release the SRC-MAX %Sp0
3. The %Sp0 from a value of 75 and illuminate the 90 value.
4. Observe the display of the pulse oximeter or monitor. The numeric reading for %Sp0 (87 to 93). Allow the oximeter several seconds to achieve the test result.
Test 3: Modulation
The modulation test checks to ensure that the pulse oximeter or monitor is functioning properly under low and high modulation conditions. The pulse oximeter or monitor shall display the correct %SpO in tests 1 and 2, under low and high modulation conditions.
2 button.
2 LED indicator on the SRC-MAX will switch
2 will flash and change to 90
2 and pulse rate reading, as defined
Prerequisite ProcedureTest Setup on page 12.
1. Perform Test 1: BPM on page 14.
2. Perform Test 2: %SpO
3. Press and release the SRC-MAX MOD button.
SRC-MAX 15
2 on page 15.
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SRC-MAX Operation with a Pulse Oximeter or Monitor
4. The Modulation LED indicator on the SRC-MAX will switch from the low (arrow down) value and illuminate the high value (arrow up).
5. The Plethysmographic waveform or blip bar on the pulse oximeter or monitor display will increase in amplitude within a few seconds.
6. Perform Test 1: BPM on page 14.
7. Perform Test 2: %SpO
Test 4: Light
The light test checks to ensure that the pulse oximeter or monitor is functioning properly under low and high light conditions. The pulse oximeter or monitor shall display the correct %SpO and 2, under low and high light conditions.
Prerequisite ProcedureTest Setup on page 12.
1. Perform Test 1: BPM on page 14.
2. Perform Test 2: %SpO
3. Press and release the Light button on the SRC-MAX.
2 on page 15.
2 and pulse rate reading, as defined in tests 1
2 on page 15.
4. The HIGH (arrow up) LED will illuminate.
5. Pleth View — The Plethysmographic waveform on the pulse oximeter display may briefly disappear and then reappear slightly altered from the previously displayed waveform. Blip View — The blip display will saturate momentarily and then return to normal indications.
6. Perform Test 1: BPM on page 14.
7. Perform Test 2: %SpO
16
2 on page 15.
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Routine Maintenance
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O monitors refer to OEM O monitors.
Cleaning
Caution: Do not spray, pour or spill any liquid on the SRC-MAX, its accessories, connectors, or openings in the chassis.
The SRC-MAX may be surface-cleaned by using a soft cloth dampened with either a commercial, non-abrasive cleaner or a solution of 70% alcohol in water, and lightly wiping the surface of the unit.
XIMAX technology-based
SRC-MAX 17
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Routine Maintenance
Battery Replacement
Figure 9: Battery Compartment Access
Press and slide the battery compartment door down to expose the batteries. See Figure 9, above.
The SRC-MAX requires two AA alkaline batteries. The unit will run continuously for a minimum of 45 hours with a new set of batteries.
Caution: Install the batteries in the unit according to polarity markings within the battery compartment.
When the SRC-MAX is connected via cable to a pulse oximeter or monitor, the SRC-MAX will automatically power on. The unit will turn off within two seconds of being disconnected from the pulse oximeter or monitor.
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Routine Maintenance
The Low Battery Indicator LED will illuminate and blink when the voltage drops below 1.75 volts. There is approximately 15 minutes of use after first indication of low battery LED. It is recommended to cease operation as soon as possible and replace the batteries in the SRC-MAX.
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Performance Verification
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O monitors refer to OEM O monitors.
Introduction
This section describes the procedures for verifying specified functionality of the SRC-MAX.
All measurements/tests shall be performed through the 9-pin sensor/cable connector. See Figure 10.
Caution: Do not open the case of the SRC-MAX. The device could be damaged.
XIMAX technology-based
Figure 10: Pinout Reference SRC-MAX
Caution: Do not connect ground to any pins on the SRC­MAX 9 pin connector or the 9-pin D-sub female connector used in the test set up. The device could be damaged. Refer to Block Diagram, Figure 11 on page 22.
Equipment Required
Oscilloscope; 20 MHz bandwidth, 2 channels, able to resolve 500 millivolts peak-to-peak to 3 volts peak­to-peak at 1,000 Hz, 1 and 3 Hz
10 ohm ±1% resistor; 1/10 Watt Metal Film
1 meg-ohm ±1% resistor; 1/10 Watt Metal Film
Power Supply, able to deliver +5 volts 100 mA
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Performance Verification
Signal/Function Generator, able to deliver 0 to ±5 volts peak-to-peak at 1,000 Hz, 100 mA
Pulse oximeter or monitor
ECG monitor (RA, LA, LL)
LED Current to Photodetector Current Test
Note: The initial setting on the Signal Generator is 1000
Hz, Square wave, 0 to 5 volts peak-to-peak. The RED and IR LEDs will be tested separately.
1. Connect a 10 ohm resistor (R1 in Figure 11) to pin 3 of a 9-pin D-sub female connector. The other side of the 10 ohm resistor should be connected to the Signal Generator’s ground. See Figure 11.
2. Connect the positive side of the Signal generator to pin 2 of the 9 pin D-sub female connector.
3. Connect the oscilloscope channel 1 (+) to the junction of pin 3 and the 10 ohm resistor.
4. Connect the oscilloscope channel 1 (-) to the junction of the Signal Generator’s ground and the 10 ohm resistor.
22
Figure 11: Block Diagram
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Testing the RED LED
1. Turn on the signal generator.
2. Adjust the output until there is 475 to 525 millivolts peak across the 10 ohm resistor.
3. Connect one end of a 1 meg ohm resistor (R2 in Figu re
11) to pin 9 of the 9 pin D-sub female connector.
4. Connect the other end to the positive terminal of the power supply set for +5 volts.
5. Connect the negative terminal of the +5 volt supply to pin 5 of the 9 pin D-sub female connector.
Performance Verification
Caution: See Figure 11. Prior to connecting the oscilloscope’s negative terminal to the +5 volt supply (+) terminal, ensure that the oscilloscope negative is isolated from the +5 volt supply ground.
6. Connect the oscilloscope channel 2 (+) lead to the junction of pin 9 and the 1 meg ohm resistor.
7. Connect the oscilloscope channel 2 (-) lead to the junction of the positive terminal of the power supply (set for +5 volts) and the other end of the 1 meg ohms.
8. With Low-Light setting selected on the SRC-MAX, measure the peak-to-peak voltage across the 1 meg ohm resistor on channel 2 of the oscilloscope. the peak-to­peak voltage should be 600 to 900 millivolts peak-to­peak. See Figure 12. The peak-to-peak voltage tolerance includes a possible probe impedance error.
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Performance Verification
Figure 12: RED LED Low Light Setting
Note: This figure and the following waveform figures
represent typical measurements. The actual measured waveforms may vary in amplitude and scale.
9. Select the High Light setting on the SRC-MAX. Measure the peak-to-peak voltage across the 1 meg ohm resistor on Channel 2 of the oscilloscope. The peak-to-peak voltage should be 2.4 to 3.6 volts peak-to-peak. See Figure 13.
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Performance Verification
Figure 13: RED LED High Light Setting
Note: The peak-to-peak voltage tolerance includes a
possible probe impedance error.
Testing the IR LED
1. Turn on the signal generator.
2. Adjust the signal generator output until there is -475 to ­525 millivolts peak across the 10 ohm resistor (R1 in Figure 11).
3. Select the Low Light setting on the SRC-MAX.
4. Measure the peak-to-peak voltage across the 1 meg ohm resistor (R2 in Figure 11) on Channel 2 of the oscilloscope. The peak-to-peak voltage should be 600 to 900 volts peak-to-peak . See Figure 14.
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Performance Verification
Figure 14: IR LED Low Light Setting
Note: The peak-to-peak voltage tolerance includes a
possible probe impedance error.
5. Select the High Light Setting on the SRC-MAX.
6. Measure the peak-to-peak voltage across the 1 meg ohm resistor on Channel two of the Oscilloscope. The peak-to­peak voltage should be 2.4 to 3.6 volts peak-to-peak. See Figure 15.
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Performance Verification
Figure 15: IR LED High Light Setting
Note: The peak-to-peak voltage tolerance includes a
possible probe impedance error.
BPM (Beats per Minute) Test
Equipment Required
Pulse oximeter or monitor
Oscilloscope
Sub-mini 3/32” phone plug (Tip = signal, Sleeve = ground)
Setup
1. Connect the SRC-MAX to the powered up pulse oximeter or monitor. The SRC-MAX should power up normally.
2. Select the BPM for 60 on the SRC-MAX.
3. Connect a Sub-mini 3/32” phone plug to the C- Lock output of the SRC-MAX.
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Performance Verification
4. Connect the oscilloscope positive lead to the phone plug’s tip and the ground to the sleeve.
5. Adjust the oscilloscope for 3 volts peak-to-peak at 1 Hz. See Figure 16.
.
Figure 16: 3 Volts Peak-to-Peak at 3 Hz
Note: The period of the signal should be 0.96 to 1.04
seconds.
6. The pulse width of the signal should be 50 to 100 milliseconds.
7. Select 200 BPM on the SRC-MAX.
8. Adjust the Oscilloscope for 3 volts peak-to-peak at 3 Hz. See Figure 17.
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Performance Verification
Figure 17: 200 BPM
9. The period of the signal should be 0.27 to 0.33 seconds.
10. The pulse width of the signal should be 50 to 100 milliseconds.
BPM Test (Alternate Method)
Equipment Required:
Pulse oximeter or monitor
ECG monitor
Three lead ECG cable
Setup
T olerances for this procedure are in the Specifications section, page 37.
1. Connect the SRC-MAX to the powered-up pulse oximeter or monitor. The SRC-MAX should power up normally.
SRC-MAX 29
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Performance Verification
2. Select 60 BPM on the SRC-MAX.
3. Connect the 3-Lead ECG cable to the ECG monitor and the ECG port of the SRC-MAX.
4. Select Lead 1 on the ECG monitor.
5. Verify the 60 BPM reading on the ECG monitor.
6. Repeat step 5 for Lead selection 2 and 3.
7. Select 200 BPM on the SRC-MAX.
8. Select Lead 1 on the ECG monitor.
9. Verify the 200 BPM reading on the ECG monitor.
10. Repeat step 9 for Lead selection 2 and 3.
30
Page 37
Troubleshooting
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O monitors refer to OEM O monitors.
Introduction
Caution: The case of the SRC-MAC should be opened only by qualified service personnel. There are no user­serviceable parts inside.
Obtaining Technical Assistance
XIMAX technology-based
Contact Nellcor Technical Services Department,
1.800.635.5267 or your local Nellcor representative.
Troubleshooting
Troubleshooting symptoms, causes, and fixes are provided in Table 1.
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Troubleshooting
Table 1: Troubleshooting
Symptom Cause/Fix
SRC-MAX does not power­up when attached to a pulse oximeter or monitor.
SRC-MAX powers on and turns off after about 3 seconds.
All the LEDs turn off, with the exception of the IR and RED LEDs; functionality continues.
1. Batteries not installed, inserted incorrectly, or discharged.
2. Pulse oximeter or monitor is not powered-on.
3. Sensor/patient cable not connected.
4. Non-compatible pulse oximeter or monitor.
5. Disconnect and reconnect the SRC-MAX.
1. Disconnect and reconnect SRC-MAX.
2. Pulse oximeter or monitor has shutdown or reset.
Normal operation, the SRC­MAX goes into power-saving mode after about 2 minutes. Press any button and the LEDs will illuminate.
All of the LEDs turn on and then turn off; this action repeats.
Electromagnetic Interference
This device has been tested and found to comply with the limits for medical devices to the IEC 60101-1-2: 1993, EN60601-1-2:1994, Medical Device Directive 93/42/EEC. These limits are designed to provide rea sonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise
32
Batteries are too low for normal operation. Replace batteries.
Page 39
Troubleshooting
in the health-care environment (for example, cellular phones, mobile two-way radios, electrical appliances), it is possible that high levels of such interference due to close proximity or strength of a source, may result in disruption of performance of this device.
This equipment generates, uses and can radiate radio frequency energy and if not used in accordance with the instructions, may cause harmful interference with other devices in the vicinity. Disruption or interference may be evidenced by erratic readings, cessation of operation, or other incorrect functioning. If this occurs, the site of use should be surveyed to determine the source of this disruption, and actions taken to eliminate the source.
The user is encouraged to try to correct the interference by one or more of the following measures:
Turn equipment in the vicinity off and on to isolate the offending equipment
Reorient or relocate the other receiving device
Increase the separation between the interfering equipment and this equipment
If assistance is required, contact Nellcor Puritan Bennett’s Technical Services Department or your local Nellcor Puritan Bennett representative.
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Packing for Shipment
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O monitors refer to OEM O monitors.
Introduction
To return the tester for any reason, follow the instructions in this section.
Returning the SRC-MAX
Contact Nellcor Technical Services Department,
1.800.635.5267 or your local Nellcor representative for shipping instructions including a Returned Goods Authorization (RGA) number. Unless Otherwise instructed by Nellcor T echnical Services Department, it is not necessary to return any other accessory item with the tester.
XIMAX technology-based
If the original carton is not available, use a suitable carton with appropriate packing material to protect the unit during shipping.
Mark the shipping carton and any shipping documents with the Returned Goods Authorization (RGA) number . Return the SRC-MAX by any method that provides proof of delivery.
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Specifications
Note: In this manual, pulse oximeters refer to Nellcor
XIMAX technology-based pulse oximeters and
O monitors refer to OEM O monitors.
Controls
Rate
Two positions, Simulated Heart Rate: 60 BPM 200 BPM
XIMAX technology-based
Light
Two Positions, Simulated light attenuation level : Low light level High light level
Modulation
Two positions, Simulated Pulse Strength: Low % Modulation High % Modulation
Saturation
Two Positions: 75 % Sp02 90 % Sp02
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Specifications
Performance
Saturation (SpO2)
75% ±1 Sat Point 90% ±1 Sat Point
Pulse Rate
60 bpm ±1 bpm 200 bpm ±2 bpm
Light Levels
Low Level = 750 nAi ±10% High Level = 3,000 nAi ±10%
(nAi = nano-Amperes photodetector current)
Modulation (%MOD)
Low Modulation = 0.4% to 0.6% High Modulation = 4.5% to 5.5%
ECG
Analog Outputs (R-Wave) Output 1: = RA (White) Output 2: = LA (Black) Output 3: = LL (Red) This is a 3 lead ECG compatible output.
C-Lock
Output 1: SRC-MAX System Ground
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Output 2: CMOS Compatible Output
Timing
C-Lock timing is synchronous with each optical pulse. C-Lock synchronization signals start to 45-55 msec prior to
the optical pulse. C-Lock synchronization signal is 50 msec to 100 msec in
width.
Simulated Waveform
Rise Time = 95 msec to 105 msec for all heart rates. Fall Time = 190 msec to 210 msec for 200 BPM.
Specifications
Fall Time = 855 msec to 945 msec for 60 BPM.
Power
2 AA Alkaline Batteries Minimum of 45 hours of continuous operation with new
batteries. Typical power consumption: 80 milliwatts
Physical Characteristics
Overall Dimensions: 7 inches x 3.52 inches x 1.45 inches Weight: .45 pounds
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Specifications
Environmental Conditions
Temperature 0 ºC to 40 ºC (32 ºF to 104 ºF) Relative Humidity 15% to 95% non-condensing Altitude 2,000 m (6,561.6 feet)
Transport and Storage (not in shipping container)
Temperature -20 ºC to 70 ºC
Operation
(-4 ºF to 158 ºF)
Relative Humidity 15% to 95% non-condensing
Transport and Storage (in shipping container)
Temperature -20 ºC to 70 ºC
Relative Humidity 15% to 95% non-condensing
Standards
Electrical Safety Requirements
UL 3101-1/UL 3111-1: Safety Requirements for Electrical Equipment for measurement, control and laboratory use.
(-4 ºF to 158 ºF)
IEC 61010-1 (EN61010): Safety Requirements for Electrical Equipment for measurement, control and laboratory use.
CSA 22.2 No. 1010.1: Safety Requirements for Electrical Equipment for measurement, control and laboratory use.
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EMC/EMI
Specifications
IEC 61326-1, Amendment 1 (EN 61326-1): Electrical Equipment for measurement, control and laboratory use ­EMC Requirements.
Radiated emissions per Federal Communication Commission (FCC) part 15.
This ISM device complies with Canadian ICES-001, (CISPR 11, Class b, Group 1).
CISPR 11: Industrial, Scientific and Medical (ISM) Radio­Frequency Equipment - Electromagnetic Disturbance Characteristics - Limits and Methods of Measurement.
IEC 61000-4-2: Electromagnetic Comparability (EMC) ­Testing and Measurement Techniques - Electrostatic Discharge Immunity Test.
IEC 61000-4-3: Electromagnetic Comparability (EMC) ­Testing and Measurement Techniques - Radiated, Radio Frequency, Electromagnetic Field Immunity Test.
International and European Union Compliance
CB Scheme (Certified Body for non-North American Certification) for Electrical Safety requirements under the IEC for international compliance.
CE-Mark requirements to meet the Electromagnetic Compatibility Directives (EMCD), 89/336/ECC.
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Index
A
Accessories 9
B
Batteries disposal 2 Battery Low indicator 5 Battery replacement 18 Beats per minute test 14, 27 Buttons 7
C
Cautions 1 Cleaning 17 C-Lock cable 10 C-LOCK connector port 6 C-LOCK output connector port 5
D
Dispose of batteries 2 DOC-10 sensor cable 13
E
ECG output connector port 5 ECG Port 6 Electrical safety requirements 40 EMC/EMI 41 Environmental conditions 40
F
Front panel 5
I
INFRARED LED drive indicator 5 Intended use 3 IR LED test 25
L
LED current to Photodetector current test 22 Light level output button 5 Light test 16 List of components 9
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M
Modulation test 15
N
Non-OXIMAX OEM monitors 2 Non-OXIMAX pulse oximeters 2
O
Opening the SRC-MAX 1 Operating
Relative Humidity 40 Temperature 40
Operation 11
P
Packing 35 Percent Modulation Select Button 5 Percent Sp02 Select Button 5 Performance specifications 38 Performance verification 21 Power specifications 39 Pulse oximeter/monitor cable connector 5 Pulse rate beats per minute button 5
Index
R
RED LED Drive Indicator 5 Returned Goods Authorization number 35 Returning the SRC-MAX 35 Routine maintenance 17
S
Safety Information 1 Saturation test 15 Setup 12 Specifications
Environmental 40
Storage
Relative Humidity 40 Temperature 40
Symbols 7
T
Technical assistance 31 Testing the RED LED test 23
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Three-Lead ECG cable 9 Transport
Relative Humidity 40 Temperature 40
Troubleshooting 31
Index
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Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton, CA 94588 USA Toll Free: 1.800.635.5267
Authorized Representative T yco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS, U.K.
© 2002 Nellcor Puritan Bennett Inc. All rights reserved. 065696A-0602
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