Summary of Contents for Mallinckrodt Nellcor N-20PA
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N-20PA Portable Pulse Oximeter Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. To contact Mallinckrodt’s representative: In the United States, call 1.800.635.5267 or 314.654.2000; outside the United States, call your local Mallinckrodt representative.
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4280 Hacienda Drive Pleasanton, CA 94588 USA Nellcor Puritan Bennett Inc. is a wholly owned subsidiary of Mallinckrodt Inc. Nellcor and Nellcor Puritan Bennett are trademarks of Mallinckrodt Inc. To obtain information about a warranty, if any, for this product, contact Nellcor Technical Services or your local Nellcor representative.
SECTION 1: INTRODUCTION 1.1 Manual Overview 1.2 Warnings, Cautions, and Notes 1.3 Description of the N-20PA Portable Pulse Oximeter MANUAL OVERVIEW This manual contains information for servicing the N-20PA portable pulse oximeter. Only qualified service personnel should service this product. Before servicing the device, read the operator’s manual carefully for a thorough understanding of its operation.
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Section 1: Introduction Standard user controls consist of a measure button and a check-battery button. The measure button signals the power control circuit to switch on the power supply. The power supply then provides regulated power to the unit. Once power is on, both the measure and check battery buttons are read by the CPU for user commands.
The following checks should be performed at least every 2 years by a qualified service technician. Inspect the exterior of the N-20PA for damage. Inspect safety labels for legibility. If the labels are not legible, contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative. BATTERY When the N-20PA is going to be stored for 3 months or more, remove the battery prior to storage.
The SRC-2 plugs into the DB-9 sensor connector and uses the instrument’s power supply and diagnostic software to test the display and the operation of the instrument. Mallinckrodt recommends routine performance testing at 1-year intervals. Refer to the SRC-2 operator’s manual for details on performance...
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Performance Verification To enter the diagnostic mode, connect the SRC-2 to the N-20PA while the oximeter is off; then, turn the oximeter on. While in the diagnostic mode, a “d” is displayed in the leftmost segment of the display. Note: No alarms sound while in the diagnostic mode.
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Performance Verification 4. The monitor must operate for at least 37 hours with no printer activity. 5. Verify that the LOW BATTERY indicator lights sometime after 35 hours of operation. 6. Verify that the LOW BATTERY indicator starts flashing after 36 hours of operation.
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Performance Verification SRC-2 Settings Monitor Indications RATE LIGHT MODULATION HIGH1 HIGH 81+ 2 112+ 2% (110 - 114) 81+ 2 201+ 3% (195 - 207) HIGH 81+ 2 201+ 3% (195 - 207) 3.3.2.2 Adult Defaults and Alarm Limit Ranges The following procedure will allow verification of the monitor’s adult factory defaults, adjusting those defaults, and automatic reset to factory defaults.
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Performance Verification / min 5. Press the PRINTER ON button and reduce the High Saturation Alarm limit below the live subject’s value; typically 90 will be sufficient. 6. Momentarily press the DAY/DATE button and verify that the “90” in the display stops flashing and the “170”...
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Performance Verification 15. Press and hold the BATTERY CHECK button and then momentarily press the DAY/DATE (D/D) button on the top of the monitor. Verify that the following display is shown and that the “90” is flashing. / min 16. Momentarily press the DAY/DATE button and verify that the “90” in the display stops flashing and that the “190”...
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Performance Verification 21. Press the MEASURE button, and verify the following power-up sequence: a. All indicators--OXYGEN SATURATION, PULSE RATE, PULSE SEARCH, LOW BATTERY, and the PULSE BARS --light for a few seconds. Verify that the OXYGEN SATURATION and PULSE RATE displays indicate "888."...
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Performance Verification / min 25. Momentarily press the DAY/DATA button and verify that the “85” in the display stops flashing and that the “40” Rate Default starts flashing. 26. Momentarily press the DAY/DATE button and verify that the monitor returns to the normal monitoring display and indicates the live subject’s saturation and pulse rate.
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Performance Verification d. The monitor will begin to track the pulse and after a few beats will display the subject’s Oxygen Saturation and Pulse Rate. 4. Press and hold the BATTERY CHECK button and then momentarily press the DAY/DATE (D/D) button on the top of the monitor. Verify that the following display is shown and that the “95”...
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Performance Verification 12. Momentarily press the DAY/DATE button and verify that the monitor returns to the normal monitoring display and indicates the live subject’s saturation and pulse rate. 13. Press and hold the BATTERY CHECK button and then momentarily press the DAY/DATE (D/D) button on the top of the monitor.
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Performance Verification 19. Momentarily press the BATTERY TEST button and verify that the alarm remains silent for 2 minutes and that the number representing the live subject’s saturation and pulse rate continues to flash. The alarm may be silenced as necessary for remainder of the test. 20.
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Performance Verification / min 25. Momentarily press the DAY/DATA button and verify that the “85” in the display stops flashing and that the “40” Rate Default starts flashing. 26. Momentarily press the DAY/DATE button and verify that the monitor returns to the normal monitoring display and indicates the live subject’s saturation and pulse rate.
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Performance Verification b. The OXYGEN SATURATION display momentarily indicates the monitor 3-digit software version. The other displays are not lit. Note: Software versions may vary depending on the date of manufacture. The N-20PA will display the letters “PA” in the PULSE RATE display while the software version is being displayed in the OXYGEN SATURATION display.
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Performance Verification To test for proper operation of the display backlight, observe the N-20PA in a darkened room. If any backlight section is not working correctly, contact Mallinckrodt’s Technical Services Department or your local Mallinckrodt representative for assistance. 3.3.5 Low Battery Test The N-20PA CPU monitors the battery voltage level and alerts the user via the Low Battery indicator when voltage is getting low.
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Overall printout darkness can be adjusted; to adjust printer darkness, see paragraph 0. If printout darkness is either irregular or dots are missing, contact Mallinckrodt’s Technical Services Department or your local Mallinckrodt representative for assistance. 4. Press the printer ADV button: “Ad” appears in the Oxygen Saturation display.
OBTAINING REPLACEMENT PARTS Mallinckrodt Technical Services provides technical assistance information and replacement parts. To obtain replacement parts, contact Mallinckrodt. Refer to parts by the part names and part numbers listed in Section 6, Spare Parts. TROUBLESHOOTING GUIDE Table 4-1 this section discusses potential symptoms, possible causes, and actions for their resolution.
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Troubleshooting If the N-20PA does not perform as expected, the problem may be related to the following: • Incorrect sensor placement. • Depending on concentration, indocyanine green, methylene blue, and other intravascular dyes may affect the accuracy of a measurement. •...
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Mallinckrodt does not recommend using a sensor on the same limb as these three devices. 8. Replace the DB-9 connector.
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Troubleshooting Dashes (- - -) appear in The sensor is not connected Check all sensor the display. to the instrument. connections; try substituting another sensor. Check all extension cables. If an extension cable is in use, remove it and plug the sensor directly into the instrument.
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Troubleshooting 4.7.1 Installing Batteries The N-20PA operates on four 1.5-V alkaline “C” cell batteries. Do not use off-the-shelf rechargeable batteries; this type of battery can cause the Low Battery indicator to be inaccurate. To install the batteries: 1. Remove the battery access door by pressing the battery compartment access door latch.
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Troubleshooting 3. When dashes appear in the Oxygen Saturation and Pulse Rate displays, press the D/D (day/date) button once. At this point, the Oxygen Saturation display shows “txx”, with “t” representing time; “xx” representing hours, and “yy” representing minutes. Note that “xx” (hours) is flashing. 4.
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Troubleshooting 6. Reset the clock (see paragraph 4.7.3, Setting Date and Time). 4.7.5 Replacing Fuses Two fuses (F1 and F2) are located on the auxiliary PCB. Fuse F1 may open to protect the CPU and its associated components from damage if the power supply malfunctions.
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3-digit error code number appears in the Pulse Rate display. If an error message appears, record the error code number. Match the number to the description in the following table, and contact Mallinckrodt’s Technical Services Department or your local Mallinckrodt representative for assistance.
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Troubleshooting Category 1 — Microprocessor Errors Errors in the CPU (main PCB). Likely action is replacement of the CPU. Error in internal RAM register test Error in zero register test Error in register contents clearing test Error in register contents increment test Error in register contents decrement test 106–109 Errors in logical operations test...
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Troubleshooting Category 6 — Clock Errors Failure of the real-time clock (auxiliary PCB), or timing differences between the CPU clock and the real-time clock. Likely action is replacement of the main or auxiliary PCB. Failure of real-time clock 602, 603 Errors in real-time clock Category 7 —...
Section 5: Disassembly Guide 1. Remove the battery door (19) and batteries. 2. Remove the sensor lock (34) by lightly pressing in on its ears and pulling out from the sensor shroud. 3. Remove the paper door (20), paper roll, and the printer door (21). 5.2.1 Removing the Covers Figure 5-2: N-20PA Covers with the PCB and Display Assembly...
Section 5: Disassembly Guide 2. Separate the front cover (16) from the rear battery cover by wedging a thin flat-head screw driver between the covers at the base of the instrument and slowly prying them apart. Note: The covers are hinged at the top end in a different way; do not attempt to separate the covers using this technique at the top of the instrument.
Section 5: Disassembly Guide DISASSEMBLYING THE PRINTER/FLEX CIRCUIT ASSEMBLY Figure 5-4: Printer and Flex Circuit Assembly Figure 5-4 shows how to disassemble the printer and flex circuitry. 1. Remove the printer button stiffener (37). 2. Disconnect the two flex-circuit headers of the printer (29) from the connectors on the printer flex circuit (28) by slowly pulling them outward from side to side at alternating ends of the connectors.
SECTION 6: SPARE PARTS 6.1 Introduction 6.2 Spare Parts List INTRODUCTION Spare parts, along with corresponding part numbers, are shown below. To order replacement parts, contact Mallinckrodt’s Technical Services Department and order by part number. SPARE PARTS LIST Item Designator...
GENERAL INSTRUCTIONS Pack the monitor carefully. Failure to follow the instructions in this section may result in loss or damage not covered by the Mallinckrodt warranty. If the original shipping carton is not available, use another suitable carton or call Mallinckrodt Technical Services to obtain a shipping carton.
Section 7: Specifications PHYSICAL 8.5.1 Weight (with batteries installed) 0.6 kg (1.3 lb) 8.5.2 Size 19.0 cm high × 7.6 cm wide × 6.35 cm deep (7.5 in. × 3.0 in. × 2.5 in.)
SECTION 9: TECHNICAL SUPPLEMENT 9-1 Introduction 9-2 Functional Overview 9-3 Definition of Terms 9-4 Overall Block Diagram 9-5 SpO Analog Circuitry 9-6 Digital Circuitry 9-7 Circuitry Illustrations INTRODUCTION This Technical Supplement provides the reader with a discussion of the N-20PA circuits.
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Technical Supplement • Analog Block Diagram (Figure 9-2) — Analog circuitry has high signal sensitivity and reduced susceptibility to noise. Its design allows for a wide range of input signal levels and a broad range of pulsatile modulation. The SpO analog circuit consists of four subsections: 1.
Technical Supplement Analog Ambient Battery Ambient Reference Light Voltage Temperature Voltage Analog Battery Serial Power Interface Control Power SpO2 Power Patient Analog Analog Control Sensor Control AD Bus Section Power Control Address Address Demultiplexing Decoding Power Supply AD Bus Enables Standard User Supply...
Technical Supplement On/Off button AUX PCB Main PCB +5 VDC Microprocessor Power shutoff Power Power Disposable +70 VDC circuits control supply Display drivers batteries (fuse; 4–6 VDC circuits circuits AUX PCB EMI protect; AUX PCB ESD protect) Display backlight –5 VDC +12 VDC Analog section...
Technical Supplement Main PCB AUX PCB Printer Printer flex Microprocessor Printer interface circuit User push buttons Figure 9-6: Printer Control Block Diagram DEFINITION OF TERMS Analog to Digital (A/D) converter. The CPU has a 10-bit A/D converter on board. Up to eight different analog inputs can be provided to the A/D converter for measurement.
Technical Supplement OVERALL BLOCK DIAGRAM Exclusive of covers, buttons, and external connectors, the N-20PA consists of three main components: the main PCB, the auxiliary PCB, and the display assembly and analog shield. • Main PCB — Contains the SpO analog circuitry; the CPU; support memory circuits;...
Technical Supplement The relationship of these subsections is shown in Figure 9-7. Input signal Signal gain AC Ranging Patient conditioning sensor photocurrent variable gain, offset to voltage filtered for substraction; conversion LEDs each LED additional gain demutiplexed channel and filtering to 2 channels Main PCB Main PCB...
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Technical Supplement The IR and red LEDs are separately controlled with their drives currents multiplexed over two shared wires. Current to the IR LED is in the range of 4.3-50.0 mA; and, current to the red LED is in the range of 6.5-75.0 mA. Currents are limited to less than 100 mA for two reasons: (1) slight excess current can potentially change the emission characteristics of the LEDs, and (2) large excess current could create excessive heat at the sensor site.
Technical Supplement If the instantaneous average photocurrent (DC offset) is excessive and U1D cannot bring it to VREF, the PHOTOI line to the CPU (HSI0) is activated. This action is an indication of excess ambient light into the photosensor, or the occurrence of excess noise in the input circuit.
Technical Supplement The two variable gain circuits are functionally equivalent. The gain of each circuit is contingent upon the signals received level and is controlled to bring each signal to approximately 3.5 V. Each circuit uses an amplifier and one switch in the triple SPDT analog multiplexing unit U2.
Technical Supplement 9.5.4 AC Ranging In order to achieve a specified level of oxygen saturation measurement and to still use a standard-type combined CPU and A/D converter, the DC offset is subtracted from each signal. Because the DC portion of the signal can be on the order of one thousand times the AC modulation, 16 bits of A/D conversion would otherwise be required to accurately compare the IR and red modulations between the combined AC and DC signals.
Technical Supplement • System memory — System memory is external to the CPU and consists of an 8K × 8 static RAM and a 64K × 16 EPROM. • Real-Time Clock (RTC) — The RTC keeps track of date and time, which is printed on each printout.
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Technical Supplement The CPU is capable of running up to 16 MHz; however, it is run at 10 MHz for decreased power consumption. All unused inputs are tied to either Vcc or ground through resistors—this prevents unused inputs floating to any voltage and causing excess power drain.
Technical Supplement ADDRESS DEMUX TP39 74HC573 R108 AD10 AD11 AD12 AD13 AD14 AD15 TP40 74HC573 R109 Figure 9-16: Address Demultiplexing Circuit U13 and U33 are transparent latches that latch the address portion of the AD bus data on the falling edge of ALE; the outputs are always enabled. The outputs of U13 and U33 are always the address portion of the AD bus.
Technical Supplement EXINEN EXOUTEN 20 HDR ADDRESS DECODING TO: N-20 AUX PCB DC00-DFFF 74HC138 U30A E000-FFFF RAMEN 74HC10 TP74 U30B U30C 0000-DBFF ROMEN 74HC10 74HC10 TP71 R134 Figure 9-17: Address Decoding Circuit U30B and U28 are used to generate the input port and output port active low enable signals EXINEN and EXOUTEN.
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Technical Supplement U30C generates the EPROMs active low enable signal, ROMEN. The active low signals RAMEN and EXINEN are basically used as EPROM disable signals. When RAMEN or EXINEN or test point TP71 are low, the output of U30C, ROMEN, is forced high, disabling the ROM. Therefore, the EPROM is disabled for the range DC00-FFFF and enabled for the 55 Kbyte address range of 0h-DBFF.
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Technical Supplement The program that the CPU runs is stored in U15. U15 is a 16-bit wide output, one-time programmable (OTP) EPROM. During 16-bit wide bus accesses, the CPU uses address line A0 for low/high byte selection. A0 is not used as a normal address line.
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Technical Supplement The signal PR_STROBE controls U17’s output drivers. Under normal operation, the outputs are tristated and resistors R148-R154 pull the outputs low. PR_STROBE is driven low to turn on the output drivers of U17. Signals PR_DOT0-PR_DOT6 (pins Q1-Q7) drive the 7 print dots of the optional printer. PR_STROBE pulses all 7 of the dot lines for a specific time period (see also Printer Interface, Section 6.14).
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Technical Supplement Crystal Y1 provides an accurate 32.768 KHz clock input whenever the timekeeping circuitry of U29 is activated. The CPU only enables the timekeeping function when an optional printer is installed. If no printer is installed, the CPU switches off timekeeping, thereby extending battery life. Also, with no printer installed, the RTC clock is only used during diagnostic testing to verify the CPU clock timing.
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Technical Supplement • High Voltage Control Circuit (auxiliary PCB) — The high-voltage control circuit allows the CPU to switch on or off the display’s high-voltage input. 9.6.5.1 Control Conditioning Circuit The CPU generates a 400 µs low-pulse train at a 160 Hz rate on signal DISP_PHASE.
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Technical Supplement 9.6.6 Standard User Controls The user-controls circuit is illustrated in Figure 9-24. The standard user controls consist of two momentary push-button switches (On/Off and battery-check). The Of/Off button is an elastomeric contact switch, and the battery-check button is a mechanical momentary switch. The CPU input lines BAT_BTN and GO_BTN are normally pulled to the high state by R71 and R78.
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Technical Supplement TP72 GO BTN R102 TEST VCON To U21 pin 4 GO_BTN 150K TO: N-20 MAIN PCB 3.32K .01UF JP18 GO_SW TP71 C123 TEST 100PF CHECK BATTERY 150K TP88 TP81 BAT_BTN TEST TEST C126 100PF .01UF TO: N-20 AUX PCB GO_SW MEASURE BUTTON...
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Technical Supplement • Power shutoff circuit — This circuit controls power to all circuits except the power control circuit. In addition, a fuse protects the power supply from excessive current draw. The power supply is also protected against electrostatic discharge and electromagnetic interference. •...
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Technical Supplement 9.6.7.2 Power Shutoff Circuit This circuit is illustrated in Figure 9-25, Power Supply Circuit. Fuse F1 protects the unit from excessive current draw. CR24 protects against large voltage transients caused by ESD, EMI, and so on. Q15 is a dual-channel FET; the drain of Q15 part 2 (pin D2) is connected to battery ground;...
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Technical Supplement 9.6.7.5 High Voltage Supply This circuit is illustrated in Figure 9-25, Power Supply Circuit. The batteries (VBAT) provide the input power for the high-voltage supply. The high-voltage supply is a switched-inductor voltage regulator (U26) that operates in conjunction with a capacitive voltage doubler to output 72 VDC ± 5%. To protect against a runaway voltage condition, CR25 clamps U26 output to a safe level.
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Technical Supplement 9.6.9 Ambient Light The ambient light circuit is illustrated in Figure 9-28. LIGHT SENSOR VTB8442B MMBTA13L TP72 2.2M R136 33.2K .01UF Ambient Light Figure 9-28: Ambient Light Circuit Diode D8 is a photodiode that is used to measure ambient light. Q8, R68, and R136 provide current gain for D8’s photocurrent.
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Technical Supplement 9.6.11 Battery Voltage The battery voltage circuit is illustrated in Figure 9-30. VBAT TP73 15.8K BATTERY BAT_VOLT VOLTAGE SENSE 47.5K .01UF Figure 9-30: Battery Voltage Circuit The analog input voltage range of the CPU is 0-5 VDC. Because the battery voltage may be as high as 6.2 V, R69 and R70 form a voltage divider to decrease the measured battery voltage to a usable level.
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Technical Supplement The nominal voltages and voltage discharge curves are significantly different between rechargeable and disposable batteries. In order for the CPU to predict how much “battery life” remains, the nominal voltage and discharge curves must be known; the BAT_TYPE signal provides that information 9.6.13 Printer Control Printer circuitry is divided into two subsections: the printer interface and the printer flex circuit.
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Technical Supplement Inside the print head are seven resistors that heat up when power is applied, and in turn create dark dots on the thermal paper. One lead of the print-head resistors is connected to the printer supply voltage VPRN; the other lead is connected to the driver chip (see “Optional Printer Flex Circuit with User Controls”).
Technical Supplement The large bulk capacitor C3 is required due to the large current spikes that are required by the printer and the large internal series resistance of disposable batteries. Bulk capacitance is required to lessen the battery voltage drop caused by the current spikes.