Summary of Contents for Mallinckrodt NELLCOR NPB-195
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NPB-195 Pulse Oximeter Caution: Federal law (U.S.) 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, Nellcor Puritan Bennett, Durasensor, and Oxisensor II are trademarks of Mallinckrodt Inc. To obtain information about a warranty, if any, for this product, contact Mallinckrodt's Technical Services or your local Mallinckrodt representative.
TABLE OF CONTENTS List of Figures List of Tables Table of Contents ..................List of Figures................... List of Tables .................... Section 1: Introduction ................Manual Overview................NPB-195 Pulse Oximeter Description.......... Power-On Self Test..............Related Documents..............Section 2: Routine Maintenance ............... Cleaning ..................
Table of Contents Section 9: Specifications ................General ..................Electrical..................Physical Characteristics ............... Environmental ................Alarms ..................Factory Default Settings ............... Performance ................Section 10: Serial Port Interface Protocol..........10-1 10.1 Introduction .................. 10-1 10.2 Enabling the Serial Port..............10-1 10.3 Connecting to the Serial Port ............
Table of Contents LIST OF TABLES Table 3-1: Dynamic Operating Range ............Table 3-2: Earth Leakage Current Limits ............. 3-10 Table 3-3: Enclosure Leakage Current Limits ..........3-11 Table 3-4: Patient Leakage Current Limits........... 3-11 Table 3-5: Patient Leakage Current Test Configurations - Mains Voltage on the Applied Part..........
SECTION 1: INTRODUCTION 1.1 Manual Overview 1.2 NPB-195 Pulse Oximeter Description 1.3 Power-On Self Test 1.4 Related Documents MANUAL OVERVIEW This manual contains information for servicing the Nellcor model NPB-195 pulse oximeter. Only qualified service personnel should service this product. Before servicing the NPB-195, read the operator’s manual carefully for a thorough understanding of operation.
If the start-up sequence is not completed as described above, do not use the monitor. The software version is often needed when calling Mallinckrodt's Technical Services Department or your local Mallinckrodt representative for technical assistance. Record the software version and have it available prior to requesting technical assistance.
BATTERY Mallinckrodt recommends replacing the instrument battery every 2 years. When the NPB-195 is going to be stored for 3 months or more, remove the battery prior to storage. To replace or remove the battery, refer to Section 6, Disassembly Guide.
It should also be performed before returning the instrument to use. Note: This section is written using Mallinckrodt factory-set defaults. If your institution has preconfigured custom defaults, those values will be displayed. Factory defaults can be restored using the configuration...
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Section 3: Performance Verification 3.3.1 Battery Charge Perform the following procedure to fully charge the battery. Connect the monitor to an AC power source. Verify that the monitor is off and that the AC Power/Battery Charging indicator is lit. Charge the battery for at least 14 hours in standby. 3.3.2 Power-up Performance The power-up performance tests (3.3.3.1 through 3.3.3.3) verify the following monitor functions:...
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Section 3: Performance Verification Observe the monitor front panel. With the monitor off, press the Power On/Standby button. See Figure 3-1. The monitor must perform the following sequence. Within 2 seconds all LEDs are illuminated, then all pixels on the LCD display are illuminated, after which, the backlight comes on.
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Section 3: Performance Verification Press the Limits softkey. Press and hold the Down Arrow button. Verify that the boxed number for %SpO upper alarm limit reduces to a minimum of “85.” Note: A decimal point in the display indicates that the alarm limits have been changed from factory default values.
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Section 3: Performance Verification Press and hold the Down Arrow button. Verify that the boxed Pulse lower alarm limit display reduces to a minimum of “30.” Press and hold the Up Arrow button and verify that the boxed Pulse lower alarm limit display cannot be adjusted above the Pulse high limit of “40.”...
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Section 3: Performance Verification Move the modulation switch on the SRC-2 to LOW. Verify the following monitor reactions: The plethysmograph waveform begins to track the artificial pulse signal from the SRC-2. The pulse tone is heard. Zeroes are displayed in the %SpO and Pulse displays.
Section 3: Performance Verification 3.3.3.1.2 Alarm Volume Control After completing the procedure in paragraph 3.3.3.1.1 above: Press and hold the Alarm Silence button and verify the following: “OFF” is displayed for approximately 2 seconds. After 2 seconds, a steady tone is heard at the default alarm volume setting, the %SpO display indicates “VOL,”...
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Section 3: Performance Verification 3.3.3.1.5 Nurse Call Note: The Nurse Call tests must be performed with the instrument operating on AC power. Connect the negative lead of a voltmeter to pin 10 and positive lead to pin 11 of the serial port on the back of the instrument (Figure 10-1). Ensure that the audible alarm is not silenced or turned off.
Section 3: Performance Verification Slowly move the sensor LED in proximity to the photodetector element of the sensor. Verify, as the LED approaches the optical sensor, that the LED intensity decreases. Open the sensor and notice that the LED intensity increases. Repeat step 7 and the intensity will again decrease.
Section 3: Performance Verification 3.4.2 Electrical Leakage The following tests verify the electrical leakage of the monitor: • Earth Leakage Current • Enclosure Leakage Current • Patient Applied Risk Current • Patient Isolation Risk Current (Mains on Applied Part) Note: For the following tests, ensure that the AC switch on the rear of the instrument is configured for the AC voltage being supplied.
Section 3: Performance Verification Table 3-3: Enclosure Leakage Current Limits AC LINE NEUTRAL POWER IEC 601-1 AAMI/ANSI CORD LINE LINE CORD GROUND STANDARD CABLE Closed Closed Closed 100 µA 100 µA Closed Closed Open 500 µA 300 µA Closed Open Closed 500 µA 300 µA...
Section 3: Performance Verification 3.4.2.4 Patient Isolation Risk Current - (Mains Voltage on the Applied Part) This test is in compliance with AAMI Standard ES1 (patient isolation risk current [sink current]), and IEC 601-1 (patient leakage current). Patient Leakage Current is the measured value in a patient connection if mains voltage is connected to that patient connection.
SECTION 4: POWER-ON SETTINGS AND SERVICE FUNCTIONS 4.1 Introduction 4.2 Power-on Settings 4.3 Service Functions INTRODUCTION This section discusses how to reconfigure power-on default values, access the service functions, and set the clock. POWER-ON SETTINGS The following paragraphs describe how to change power-on default settings. Through the use of softkeys shown in Figure 1-2, the user can change alarm limits, the type of display, baud rate, time and date, and trends to view.
4.3.1 Introduction Service functions can be used to select institutional defaults, and to access information about the patient or instrument. Only a Mallinckrodt Customer Service Engineer should access some of the items available through the service functions. These functions will be described in the text to follow.
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Section 4: Power-On Settings and Service Functions Figure 4-2 can be used as a quick reference showing how to reach different softkey functions. Items reached through the Param softkey can be accessed during normal operation. Functions provided by the Print and Next softkeys cannot be accessed when a sensor cable is connected to the instrument.
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Section 4: Power-On Settings and Service Functions NPB-195 - - - %SP02 - - - RESET SAVE EXIT Figure 4-3: Param Softkeys RESET The Reset button can be used if alarm values stored in memory have been changed from factory default values. If Yes is pressed, the instrument sounds three tones and the alarm limits return to factory default values.
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Section 4: Power-On Settings and Service Functions TREND A Trend printout will include all data recorded for up to 24 hours of monitoring since the last Clear data was performed. A trend line is recorded every 5 seconds or whenever an alarm condition has occurred. Figure 4-5 is an example of a Trend printout.
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Section 4: Power-On Settings and Service Functions NPB-195 Version 1.0.0.000 Error Log Time: 14600:00:07 Op Time Error Task Addr Count 10713:21:03 48F9 00634:26:01 31A2 Output Complete Figure 4-6: Errlog Printout INSTAT A Delete softkey, described in the Operator's manual, allows the user to clear the most recent trend data.
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Section 4: Power-On Settings and Service Functions 4.3.2.4 Next Additional options can be accessed from the main Service Functions menu by pressing the Next softkey. When Next is pressed, the softkeys change to the functions shown in Figure 4-8. NPB195 DOWNLD ALARMS NEXT EXIT...
WHO SHOULD PERFORM REPAIRS Only qualified service personnel should open the monitor housing, remove and replace components, or make adjustments. If your medical facility does not have qualified service personnel, contact Mallinckrodt's Technical Services or your local Mallinckrodt representative. REPLACEMENT LEVEL SUPPORTED The replacement level supported for this product is to the printed circuit board (PCB) and major subassembly level.
Taking the recommended actions discussed in this section will correct the majority of problems you may encounter. However, problems not covered here can be resolved by calling Mallinckrodt's Technical Services Department or your local Mallinckrodt representative. Table 5-1: Problem Categories...
Section 5: Troubleshooting 5.6.1 Power Power problems are related to AC and/or DC. Table 5-2 lists recommended actions to resolve power problems. Table 5-2: Power Problems Condition Recommended Action 1. Battery Low 1. Ensure that the NPB-195 is plugged into an indicator lights operational AC outlet and the AC indicator is on.
Section 5: Troubleshooting 5.6.2 Buttons Table 5-3 lists symptoms of problems relating to non-responsive buttons and recommended actions. If the action requires replacement of a PCB, refer to Section 6, Disassembly Guide. Table 5-3: Button Problems Condition Recommended Action 1. The NPB-195 responds 1.
Section 5: Troubleshooting 5.6.4 Operational Performance Table 5-5 lists symptoms of problems relating to operational performance (no error codes displayed) and recommended actions. If the action requires replacement of a PCB or module, refer to Section 6, Disassembly Guide. Table 5-5: Operational Performance Problems Condition Recommended Action 1.
Section 5: Troubleshooting 5.6.5 Serial Port Table 5-6 lists symptoms of problems relating to the serial port and recommended actions. If the action requires replacement of the PCB, refer to Section 6, Disassembly Guide. Table 5-6: Serial Port Problems Condition Recommended Action 1.
Section 5: Troubleshooting ERROR CODES An error code is displayed when the NPB-195 detects a non-correctable failure. When this occurs, the unit will stop monitoring, sound a low priority alarm that cannot be silenced, clear patient data from the display, and display an error code. Table 5-7 provides a complete list of error codes and possible solutions.
Section 6: Disassembly Guide FUSE REPLACEMENT Complete procedure in paragraph 6.2. Disconnect the power cord from the back of the monitor. Remove the fuse drawer from the power module by pressing down on the tab in the center and pulling out as shown in Figure 6-1. Figure 6-1: Fuse Removal Put new fuses of equivalent size and rating in the drawer and reinsert the drawer in the power module.
Section 6: Disassembly Guide MONITOR DISASSEMBLY Set the NPB-195 upside down, as shown in Figure 6-2. Corner screws Figure 6-2: NPB-195 Corner Screws Remove the four corner screws. Caution: Observe ESD (electrostatic discharge) precautions when disassembling and reassembling the NPB-195 and when handling any of the components of the NPB-195.
Section 6: Disassembly Guide Power supply harness Figure 6-3: Separating Case Halves MONITOR REASSEMBLY Connect the Power Supply to J6 on the UIF PCB. Place the top case over the bottom case, being careful to align the lens, Power Entry Module, and the fan with the slots in the top case. Caution: When reassembling the NPB-195, tighten the screws that hold the cases together to a maximum of 10 inch-pounds.
Figure 6-4: NPB-195 Battery The lead-acid battery is recyclable. Do not dispose of the battery by placing it in the regular trash. Dispose of battery in accordance with local regulations or return to Mallinckrodt's Technical Services Department for disposal. Installation Connect the leads to the battery.
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Section 6: Disassembly Guide Equipotential Equipotential "L" on "N" on + Red -Black Figure 6-5: Internal Power Connections Complete the procedure in paragraph 6.5. Turn the monitor on and verify proper operation.
Section 6: Disassembly Guide POWER ENTRY MODULE (PEM) REMOVAL/INSTALLATION Removal Complete the procedures in paragraphs 6.4. Push the top of the Power Entry Module (PEM) in from the outside of the case, and lift up. Use needle-nose pliers to disconnect the leads from the PEM (see Figure 6-6).
Section 6: Disassembly Guide Position the AC lines from the PEM so that they do not come into contact with components on the Power Supply PCB. Complete procedure in paragraph 6.5. POWER SUPPLY REMOVAL/INSTALLATION Removal Complete the procedures in paragraphs 6.2 and 6.4. Complete steps 2 through 4 in paragraph 6.7.
Section 6: Disassembly Guide Install the seven screws in the Power Supply and tighten. Connect the fan harness to J1 on the Power Supply. 10. Complete steps 4 through 6 in paragraph 6.7. 11. Complete procedure in paragraph 6.5. COOLING FAN REMOVAL/INSTALLATION Removal Complete the procedures in paragraphs 6.2 and 6.4.
Section 6: Disassembly Guide 6.10 DISPLAY PCB REMOVAL/INSTALLATION Removal Note: The LCD panel contains toxic chemicals. Do not ingest chemicals from a broken LCD panel. Complete procedures 6.2 and 6.4. Disconnect the CCFL harness (two white wires) from J5 of the UIF PCB. See Figure 6-9.
Section 6: Disassembly Guide Separate the adhesive connection of the double-sided tape and lift the Display PCB up to remove it from the top case. Remove the used double-sided tape. Installation Install new double-sided tape located as shown in Figure 6-9. Slide the Display PCB into the grooves in the top case.
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Section 6: Disassembly Guide Figure 6-10: UIF PCB Installation Caution: When installing the UIF PCB, hand tighten the five screws to a maximum of 4 inch-pounds. Over-tightening could strip out the screw holes in the top case, rendering it unusable. Place the UIF PCB in the top case.
Section 6: Disassembly Guide 6.12 ALARM SPEAKER REMOVAL/INSTALLATION Removal Complete the procedures in paragraphs 6.2 and 6.4. Disconnect the speaker wire harness from J13 on the UIF PCB (see Figure 6-11). Pull the retaining tab back from the speaker and lift the speaker out of the top case.
SECTION 7: SPARE PARTS 7.1 Introduction INTRODUCTION Spare parts, along with part numbers, are shown in Table 7-1. Item numbers correspond to the callout numbers in Figure 7-1. Table 7-1: Parts List Item Description Part No. Top Case Assembly (Membrane Panel Included) 048451 Fuse Drawer 691500...
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Section 7: Spare Parts Figure 7-1 shows the NPB-195 expanded view with numbers relating to the spare parts list. Figure 7-1: NPB-195 Expanded View...
GENERAL INSTRUCTIONS Pack the monitor carefully. Failure to follow the instructions in this section may result in loss or damage not covered by any applicable Mallinckrodt warranty. If the original shipping carton is not available, use another suitable carton; North American customers may call Mallinckrodt's Technical Services Department to obtain a shipping carton.
Section 8: Packing for Shipment REPACKING IN ORIGINAL CARTON If available, use the original carton and packing materials. Pack the monitor as follows: Place the monitor and, if necessary, accessory items in original packaging. Figure 8-1: Repacking the NPB-195 Place in shipping carton and seal carton with packing tape. Label carton with shipping address, return address and RGA number, if applicable.
Section 8: Packing for Shipment REPACKING IN A DIFFERENT CARTON If the original carton is not available, use the following procedure to pack the NPB-195: Place the monitor in a plastic bag. Locate a corrugated cardboard shipping carton with at least 200 pounds per square inch (psi) bursting strength.
SECTION 9: SPECIFICATIONS 9.1 General 9.2 Electrical 9.3 Physical Characteristics 9.4 Environmental 9.5 Alarms 9.6 Factory Default Settings 9.7 Performance GENERAL Designed to meet safety requirements of: UL 2601-1 CSA-C22.2 No. 601-1-M90, IEC 601-1 (Class I, type BF), ISO 9919, EMC per EN 60601-1-2.
Section 9: Specifications PHYSICAL CHARACTERISTICS 9.3.1 Dimensions 3.3 in. H x 10.4 in. W x 6.8 in. D 8.4 cm H x 26.4 cm W x 17.3 cm D 9.3.2 Weight 5.7 lbs 2.6 kg ENVIRONMENTAL 9.4.1 Operating Temperature 5°C to 40°C (+41°F to +104°F) 9.4.2 Storage Temperature -20°C to +70°C (-4°F to +158°F) 9.4.3 Operating Altitude...
SECTION 10: SERIAL PORT INTERFACE PROTOCOL 10-1 Introduction 10-2 Enabling the Serial Port 10-3 Connecting to the Serial Port 10-4 Real-Time Printout 10-5 Trend Data Printout 10-6 Nurse Call 10.1 INTRODUCTION When a printer is connected to the serial port on the back of the NPB-195, a real- time printout can be obtained.
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Section 10: Serial Port Interface Protocol 9 10 11 12 13 14 15 Figure 10-1: Serial Port Pin Layout The serial cable can be a maximum of 25 feet and must be shielded. Connectors at both ends of the serial cable must have the shield terminated to the full 360 degrees of the connector’s metal shell.
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Section 10: Serial Port Interface Protocol 10.4.1 Column Heading To explain the printout it will be necessary to break it down to its key components. The first two lines of the chart are the Column Heading shown below. Every 25th line is a Column Heading. A column heading is also printed whenever a value of the Column Heading is changed.
Section 10: Serial Port Interface Protocol 10.4.2.2 Patient Data NPB-195 VERSION 1.0.0.1 CRC: XXXX SpO2 Limit: 30-100% PR Limit: 100-180 bpm TIME %SpO2 Status 01-Jul-97 14:00:06 190* Patient data and the operating status of the unit are highlighted in the display above.
Section 10: Serial Port Interface Protocol 10.5 TREND DATA PRINTOUT The format of data displayed when a trend printout is requested is similar to that of the real-time data. The only differences are that “TREND” is displayed in the top row instead of the “CRC:XXXX” software verification number, and there is no “Status”...
SECTION 11: TECHNICAL SUPPLEMENT 11-1 Introduction 11-2 Oximetry Overview 11-3 Circuit Analysis 11-4 Functional Overview 11-5 AC Input 11-6 Power Supply Theory of Operation 11-7 Battery 11-8 User Interface PCB (UIF) 11-9 Front Panel Display PCB and Controls 11-10 Schematic Diagrams 11.1 INTRODUCTION This Technical Supplement provides the reader with a discussion of oximetry principles and a more in-depth discussion of NPB-195 circuits.
Section 11: Technical Supplement Consequently, before comparing NPB-195 measurements with those obtained by an instrument that measures fractional saturation, measurements must be converted as follows: functional fractional saturation = saturation x 100-(% carboxyhemoglobin +%methemoglobin) 11.2.2 Measured Versus Calculated Saturation When saturation is calculated from a blood gas measurement of the partial pressure of arterial oxygen (PaO ), the calculated value may differ from the NPB-195 SpO...
Section 11: Technical Supplement The Display module includes the Membrane Panel and the LCD Display. The Membrane panel contains enunciators and push buttons, allowing the user to access information and to select various available parameters. The LCD Display PCB contains the LCD that presents the patient data. Power Power Supply Entry...
Section 11: Technical Supplement Two outputs from the bridge rectifier are used in the NPB-195. The fan control circuit uses the negative output. The positive output is the Main DC ranging from 7 to 18 VDC. This positive voltage is used for the battery circuit and to power the UIF PCB.
Section 11: Technical Supplement The 331 CPU on the UIF PCB monitors the charge level of the battery. If the voltage of the battery falls below 5.85 ± 0.1 VDC, a low battery alarm is declared. The instrument will continue monitoring and alarming for 15 minutes then power down.
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Section 11: Technical Supplement When the 331 sends a signal to the alarm speaker, three items are used to determine the tone that is sent. First, pulse tones change with the %SpO value being measured. The pulse beep tone will rise and fall with the measured %SpO .
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Section 11: Technical Supplement 11.8.4 Input Conditioning Input to the SpO analog circuit is the current output of the sensor photodiode. In order to condition the signal current, it is necessary to convert the current to voltage. Because the IR and red signals are absorbed differently by body tissue, their received signal intensities are at different levels.
Section 11: Technical Supplement The LCD will display real time when trends are selected. A time stamp is printed for each line of data on a printout. Real-time data is displayed and printed as Day, Month, Year, Hours, Minutes, and Seconds. 11.8.9 Patient Data Storage Patient data is stored once every 5 seconds.
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Section 11: Technical Supplement Figure 11-8: CPU Core Schematic Diagram A Figure 11-9: CPU Core Schematic Diagram B Figure 11-10: MC331 CPU Core Schematic Diagram A Figure 11-11: MC331 CPU Core Schematic Diagram B Figure 11-12: Display Driver Schematic Diagram Figure 11-13: Speaker Driver Schematic Diagram Figure 11-14: Core Power Supply Schematic Diagram Figure 11-15: Power On/Off Circuit Schematic Diagram...