Page 2
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.
Page 5
Contents General Instructions .................... 85 Repacking in Original Carton ................85 Repacking in a Different Carton ................87 Specifications ..........89 Performance .......................
I n t r o d u c t i o n Warnings Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user. WARNING: The sensor extrapolates from the date and time provided by the N-595 when recording the sensor event record to the sensor.
Manual Overview This manual contains information for servicing the Nellcor model N-595 pulse oximeter. Only qualified service personnel should service this product. Before servicing the N-595, read the operator's manual carefully for a thorough understanding of safe operation of the N-595.
Use with any particular patient requires the selection of an appropriate oxygen sensor as described in the N-595 Operator's Manual. Motion performance claims are applicable to models MAX-A, MAX-AL, MAX-P, MAX-N, and MAX-I Nellcor O oximetry sensors. Through the use of the four softkeys, the operator can access trend information, select an alarm limit to be changed, choose the language to be used, adjust the internal time clock, and change communications protocol.
Introduction Softkey Menu The N-595 hierarchy is outlined below. The user chooses the type of trend data to view by selecting either Monitor trend or Sensor trend data in the Trend menu. Sensor sub-menu choices differ depending on what type of in-sensor data is stored in the sensor chip, such as, event or loop.
Page 14
Introduction ZOOM (Monitor Trend Zoom Menu) TIME (for current view, cycle through 48h, 36h, 12h, 8h, 4h, 2h, 1h, 30m, 15m, 40s, 20s) SCALE (for current view, cycle through ±5, ±10, ±15, ±20, ±25, ±30, ±35, ±40 and ±50 of the max and min. values under the cursor, default to 10 to 100 if there is no data point under the cursor) AUTO (based on all of the graphed trend data: maximum value,...
Page 15
Introduction DATA (On-screen options for SENSOR-R (Write-once Sensor) sensor are: “SPO2, SPO2+BPM, DEFAULT.” On-screen options for SENSOR-RW (rewritable sensor) are: “SPO2, SPO2+BPM, DEFAULT.” SELECT toggles SENSOR-R or SENSOR-RW sensor type; up/down keys scroll through options in order.) The SENSOR-R feature supports all of the current O sensors.
Refer to the N-595 operator's manual. To understand the various Nellcor approved O sensors that work with the monitor, refer to the individual O sensor's directions for use.
The following checks should be performed at least every 24 months by a qualified service technician. 1. Inspect the equipment for mechanical and functional damage. 2. Inspect safety labels for legibility. If the labels are damaged, contact Nellcor’s Technical Services Department, 1.800.635.5267, or your local Nellcor representative.
2. Inspect the fuses for proper value and rating (F1 & F2 = 0.5 amp, 250 volts). Battery Nellcor recommends replacing the instrument's battery every 2 years. When the N-595 is going to be stored for 3 months or more, remove the battery prior to storage.
The battery charge procedure should be performed before monitor repairs whenever possible. Note: This section is written using Nellcor factory-set defaults. If your institution has pre configured custom defaults, those values will be displayed. Factory defaults can be restored (see Reset Softkey on page 40).
The monitor must perform the following: • Within 2 seconds all LEDs are illuminated, all pixels on the LCD display are illuminated, and the backlight comes on. • The indicators remain lighted. • The LCD display shows NELLCOR and the software version of the N-595.
Page 21
Performance Verification Note: The software “Version” displayed in the example below is X.X.X.X.The actual software version will be displayed on your monitor. • A 1-second beep sounds, indicating proper operation of the speaker, and all indicators turn off except the AC Power/Battery Charging indicator and the LCD screen.
Page 22
Performance Verification The steps for changing an alarm limit are the same if the view being used is Blip (Magnified) view. Note: Power-on defaults will be the factory-set defaults or the defaults set by your institution. 1. Turn on the N-595 by pressing the ON/STANDBY button. 2.
Page 23
Performance Verification 6. Press and hold the ADJUST UP button and verify that the %SpO lower alarm limit display cannot be raised past the upper alarm limit setting of “85.” 7. Press the EXIT softkey. EXIT 8. Press the LIMITS softkey LIMITS 9.
Page 24
Performance Verification 14. Press the SELECT softkey four times. Verify that the pulse rate lower alarm SELECT limit display indicates an alarm limit of “40” and is boxed. 15. Press and hold the ADJUST DOWN button. Verify that the boxed pulse rate lower alarm limit display reduces to a minimum of “30.”...
Performance Verification 23. Press the LIMITS softkey. Verify that the %SpO upper alarm limit display is LIMITS boxed and indicates an alarm limit of “100.” 24. Verify that the %SpO lower alarm limit display is boxed and indicates an alarm limit of “85.” 25.
Page 26
Performance Verification Alarms and Alarm Silence 1. Sensor Port 1. Connect the DOC-10 monitor cable to the monitor sensor port. 2. Connect the DS-100 O sensor to the DOC-10 cable and your finger. 3. Press the ON/STANDBY button to turn the monitor on. 4.
Page 27
Performance Verification • The plethysmograph waveform tracks your pulse rate. • The pulse tone is heard. • Your SpO and pulse rate are flashing in the %SpO and BPM displays. • The audible alarm sounds, indicating that both parameters have violated the alarm limits.
Page 28
Performance Verification Alarm Volume Control After completing Alarms and Alarm Silence on page 18, perform the following procedure. 1. Press and hold the ALARM SILENCE button and verify the following: • “OFF” is displayed for approximately 3 seconds. • After 3 seconds, a steady tone is heard at the default alarm volume setting, the %SpO display indicates “VOL,”...
Page 29
Performance Verification 4. Remove the O sensor from your finger. Disconnect the DOC-10 monitor cable and the O sensor. Nurse Call 1. Data Port Connector 1. Connect the negative lead of a voltmeter to pin 5 and positive lead to pin 11 of the data port connector (1) on the back of the monitor.
Page 30
Performance Verification 9. Use a DVM to verify that there is continuity between pins 8 and 15 and that there is no continuity between pins 7 and 15. This verifies the solid state Nurse Call function. Analog Output 1 Data Port Connector 1.
Page 31
Performance Verification Note: If step 8 takes more than 2 minutes to complete, the analog output will time out. Repeat steps 2 through 6 to initiate the analog output. 10. Move the positive lead back to pin 6. 11. Press the SETUP softkey. SETUP 12.
LED Excitation Test This procedure uses normal system components to test circuit operation. A Nellcor O oxygen sensor, model MAX-A, is used to examine LED intensity control. The red LED is used to verify intensity modulation caused by the LED intensity control circuit.
Page 33
1 Sensor Port 1. Ensure that the monitor is connected to an AC power source. 2. Connect a DOC-10 pulse oximetry cable to the monitor sensor port. 3. Connect a Nellcor O MAX-A oxygen O sensor to the pulse oximetry cable.
30 seconds. Verify that the oxygen saturation and pulse rate values are reasonable for the subject. Pulse Oximetry Functional Tests These tests utilize the pulse oximetry functional tester (Nellcor model SRC-MAX) to verify the performance of the N-595 monitor. See Figure 3. All of these tests should be done in sequence.
Page 35
Performance Verification 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.
Page 36
Performance Verification 4. After the monitor completes POST, the monitor will: • be in SpO alarm • display an %SpO of 75 (pass criteria is 73 to 77 %SpO inclusive) • display a pulse rate of 60 (pass criteria is 57 to 63 BPM inclusive) •...
Page 37
Performance Verification 4. Press the SRC-MAX Pulse Rate select button. The SRC-MAX Pulse Rate 60 LED will light. 5. The monitor pulse rate will decrease to 60 and stabilize at 60 BPM. The test pass criteria is 57 to 63 BPM inclusive. 6.
Page 38
Performance Verification 3. The monitor will display: • 90 %SpO (pass criteria is 88 to 92 %SpO inclusive) • 60 BPM • no alarm • pulse amplitude indicator - low level modulation 4. Press the SRC-MAX %SpO select button. The SRC-MAX %SpO 75 LED will light.
Page 39
Performance Verification 2. The monitor pulse amplitude waveform will initially increase in amplitude and then stabilize. 3. The monitor will display: • 75 %SpO (test pass criteria is 73 to 77 %SpO inclusive) • 60 BPM (test pass criteria is 57 to 63 BPM inclusive) •...
Page 40
Performance Verification 8. The monitor will display: • 75 %SpO • 60 BPM • alarm • pulse amplitude indicator - low level modulation 9. Perform Test #1: BPM on page 28. The pulse amplitue indicator should indicate low level modulation. 10.
Performance Verification 4. Perform Test #1: BPM on page 28. The pulse amplitue indicator should indicate high level modulation. 5. Perform Test #2: SpO2 on page 29. The pulse amplitue indicator should indicate high level modulation. 6. Press the SRC-MAX Light Level selection button. The SRC-MAX Light Level LED will light.
Page 42
N-595 Sensor Port through the DOC-10 pulse oximetry cable using a male 9-pin “D” type connector that has all pins shorted together. During these tests the monitor will display “EEE 10,” after the “Nellcor” screen.
P o w e r - O n S e t t i n g s a n d S e r v i c e F u n c t i o n s Introduction This section discusses how to reconfigure power-on default values and access the service functions.
Page 44
Power-On Settings and Service Functions Table 2: Neonate Alarm Limit Factory Defaults Monitoring Mode Setting Note: Bold entries are different than adult default settings. %SpO Upper Alarm Limit Alarm Silence Duration 60 seconds Alarm Silence Duration Off Setting Disabled Alarm Silence Reminder Enabled Alarm Volume 7 of 10...
Service Functions Service functions can be used to select institutional defaults and to access information about the patient or instrument. Only a Nellcor Customer Service Engineer should access some of the items available through the service functions. These items will be noted in the text that follows.
Power-On Settings and Service Functions Accessing the Service Functions All service functions are accessible when the DOC-10 pulse oximetry cable is disconnected from the monitor. Disconnect the O sensor from the MC-10 extension cable; or, disconnect the MC-10 extension cable from the instrument. 1.
Power-On Settings and Service Functions EXIT (back to Main menu, sounds three tones to indicate that defaults have reset) BACK (back to Service menu) PRINT TREND ERRLOG INSTAT INFO NEXT DOWNLD (for downloading monitor software) ALARMS SELECT ALLOW OFF? (Allows alarms to be turned off) (up/down buttons select Yes/No) OFF REMINDER? (enables/disables Alarm Off reminder) (up/ down buttons select Yes/No)
Power-On Settings and Service Functions Param Softkey Menu When the PARAM softkey is pressed, the function of the softkeys changes as PARAM shown below. These options can be accessed without disconnecting the pulse oximetry cable from the instrument. Reset Softkey The RESET softkey can be used if any settings stored in memory have been RESET changed from factory default values.
Power-On Settings and Service Functions Print Softkey Menu Accessing the PRINT softkey makes four printouts available. See Data Port PRINT Interface Protocol on page 105, for information about how to make connections to the data port and how data is presented in a printout. The appropriate printout can be selected by pressing the corresponding softkey.
Page 50
If the Output Complete statement is not printed at the end of the printout, the data must be considered invalid. ERRLOG Softkey This softkey is for Nellcor’s Customer Service Engineering Only. A list of all the errors recorded in memory can be obtained by pressing the ERRLOG ERRLOG softkey.
Page 51
If nothing prints out, there have been no errors. An example of an Errlog printout is shown below. INSTAT Softkey This softkey is for Nellcor’s Customer Service Engineering Only. The DELETE softkey, described in the operator's manual, allows the user to delete DELETE the most recent trend data.
Page 52
Power-On Settings and Service Functions INFO Softkey This softkey is for Nellcor’s Customer Service Engineering Only. Pressing the INFO softkey produces a single line printout of instrument INFO information as illustrated below. The data presented in the printout, going from...
Power-On Settings and Service Functions Next Softkey Menu Additional options can be accessed from the main Service Functions menu by NEXT pressing the NEXT softkey. When NEXT is pressed, the softkeys change to the functions shown below. DOWNLD Softkey When the DOWNLD softkey is selected, the instrument will display the revision DOWNLD of the Boot Code.
Page 54
Power-On Settings and Service Functions Use the following procedure to select and set the monitor’s ALLOW OFF and OFF REMINDER: 1. Disconnect the O sensor from the monitor. Note: If the O sensor is not disconnected, the only softkeys on the monitor’s screen will be PARAM and EXIT.
Power-On Settings and Service Functions 6. Use the ADJUST UP or ADJUST DOWN button to change selected parameter. 7. Press the BACK softkey. BACK When ALLOW OFF is selected, a choice is given between allowing an audible Alarm Off or disabling the audible alarm OFF. Pressing the ADJUST UP or ADJUST DOWN button cycles between YES and NO.
Page 56
Power-On Settings and Service Functions • Data Port Mode (ASCII, OXINET, CLINICAL, GRAPH, AGILENT [Agilent HP monitor], SPACELB [SpaceLabs monitor], MARQ [GE Marquette monitor], DATEX [Datex-Ohmeda AS/3 monitor]). Available selections depend on the software installed in your N-595. • Upper Alarm Limit (lower limit plus 1 to 100%) •...
Page 57
Power-On Settings and Service Functions 5. Press the SAVE softkey. SAVE 6. Press the YES softkey. The monitor will sound three beeps indicating that defaults have been saved. N-595...
Note: 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 Nellcor’s Technical Services or your local Nellcor representative. N-595...
Troubleshooting Table 4: Problem Categories Problem Area Refer To 1. Power Power on page 53 • No power-up on AC and/or DC • Fails power-on self-test • Powers down without apparent cause 2. Buttons Buttons on page 54 • Monitor does not respond properly to buttons being pressed 3.
Troubleshooting Power Power problems are related to AC and/or DC. Table 5 lists recommended actions to power problems. Table 5: Power Problems Condition Recommended Action Battery Low indicator • Ensure that the N-595 is plugged into an lights steadily while operational AC outlet and the AC indicator is on.
Troubleshooting Table 5: Power Problems Condition Recommended Action Battery does not charge. • Replace battery if it is more than 2 years old. • If the battery fails to hold a charge, replace the battery as indicated in Battery Replacement on page 67.
Troubleshooting Display/Alarms Table 7 lists symptoms of problems relating to non-functioning displays and audible tones or alarms, and recommended actions. If the action requires replacement of a PCB or module, refer to Disassembly Guide on page 63. Table 7: Display/Alarms Problems Symptom Recommended Action Display values are...
Troubleshooting Operational Performance Table 8 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 Disassembly Guide on page 63. Table 8: Operational Performance Problems Symptom Recommended Action The Pulse Amplitude...
Troubleshooting Data Port Table 9 lists symptoms of problems relating to the data port and recommended actions. If the action requires replacement of the User Interface PCB, refer to Disassembly Guide on page 63. Table 9: Data Port Problems Symptom Recommended Action No printout is being •...
Troubleshooting Table 10 provides a list of error codes for the N-595. Table 10: Error Codes Error Meaning Code front end RAM error front end ROM/code integrity error. front end reported a bad CRC front end reported FSP message not allowed front end reported illegal value sent in FSP messageSpO front end front end reports calibration (offset) failure...
Page 67
Troubleshooting Table 10: Error Codes Error Meaning Code back end reports corrupted variable back end reports memory overflow back end reports bad pointer back end reports parameter value out-of-range back end reports reset detected back end reports unexpected value back end reports time-out back end reports not ready/not initialized back end reports double fault back end reports date out-of-range error...
Troubleshooting Table 10: Error Codes Error Meaning Code The operation just attempted was not completed successfully - for example, Institutional Defaults could not be reset An unexpected value was received - for example, an out-of-range parameter was passed to a function EEPROM CRC failure module not responded Institutional parameters lost - e.g.
Page 69
Troubleshooting Adjust Contrast Up, Down When the user attempts to adjust the contrast of the display by pressing or pressing and holding the CONTRAST button. Clock Settings Lost If the N-595 detects that the real time clock has stopped running. This will usually occur when both battery and AC power are lost.
Page 70
Troubleshooting Invalid Silence Duration An attempt has been made to set the alarm silence duration power-on default to “OFF.” The power-on default cannot be set to “OFF.” Invalid SpO Limit An attempt has been made to set either the upper or lower alarm limit power-on default below 80.
D i s a s s e m b l y G u i d e Introduction The N-595 can be disassembled down to all major component parts, including: • PCBs • battery • cables • chassis enclosures The following tools are required: •...
Disassembly Guide that was installed when you started troubleshooting) and continue troubleshooting as directed in this section. Prior to Disassembly 1. Turn the N-595 off by pressing the ON/STANDBY button. 2. Disconnect the monitor from the AC power source. Fuse Replacement 1.
Disassembly Guide Monitor Disassembly 1. Complete the procedure in paragraph Prior to Disassembly on page 64. 2. Set the N-595 upside down, as shown in Figure 5. Figure 5: Corner Screws 3. Remove the monitor’s four corner screws. Caution: Observe ESD (electrostatic discharge) precautions when disassembling and reassembling the N-595 and when handling any of the components of the N-595.
Disassembly Guide Figure 6: Separating Case Halves Monitor Assembly 1. Connect the monitor’s Power Supply to J16 on the User Interface PCB. 2. Place the monitor’s top case over the bottom case, being careful to align the Display PCB, Power Entry Module, and the fan with the slots in the case halves.
Figure 7: Removing the Battery 4. The lead-acid battery is recyclable. Do not dispose of the battery by placing it in the regular trash. Dispose of the battery in accordance with local guidelines or return it to Nellcor’s Technical Services for disposal. N-595...
Disassembly Guide Replacement 5. Connect the leads to the battery. The red wire connects to the positive terminal, and the black wire connects to the negative terminal. 6. Insert the new battery into the bottom case with the negative terminal towards the outside of the monitor.
Disassembly Guide 3. Use needle-nose pliers to disconnect the leads from the PEM (see Figure 8). Figure 8: Power Entry Module Replacement 4. Reconnect the three power supply leads as indicated in Table 11 on page 71. 5. Install the PEM in the bottom case with the fuse drawer facing down. A tab in the bottom case holds the PEM in place.
Disassembly Guide Power Supply Removal/Replacement Removal 1. Follow the procedure in paragraphs Prior to Disassembly on page 64, and Monitor Disassembly on page 65. 2. Push the top of the Power Entry Module (PEM) in from the outside of the case, and lift up.
Disassembly Guide 7. Lift the Power Supply out of the bottom case. Figure 9: Power Supply Replacement 8. Reconnect the leads to the PEM following the instructions in Table 11, and Figure 8. Table 11: Power Supply Lead Connections Wire Color / Label Connect To Green &...
Disassembly Guide Caution: When installing the Power Supply, tighten the seven screws to a maximum of 4 inch-pounds. Over-tightening could strip out the screw holes in the bottom case, rendering it unusable. 10. Install the seven screws in the Power Supply and tighten. 11.
Disassembly Guide 3. Lift the cooling fan from the slots in the bottom case. Figure 10: Cooling Fan Replacement 4. Connect the cooling fan wire harness to J1 on the Power Supply PCB. 5. Insert the cooling fan into the slots in the bottom case with the padded sides on the top and bottom and the fan's harness to the handle side of the case.
Disassembly Guide Display PCB Removal/Replacement Removal WARNING: The LCD panel contains toxic chemicals. Do not ingest chemicals from a broken LCD panel. 1. Complete the procedures in paragraphs Prior to Disassembly on page 64, and Monitor Disassembly on page 65. 2.
Disassembly Guide 5. Remove and discard the used double-sided tape. Figure 11: Display PCB Replacement 6. Install new double-sided tape as shown in Figure 11. 7. Slide the Display PCB into the grooves in the top case. Check to make sure the Display PCB is firmly seated in the top case.
Disassembly Guide 9. Connect the Display PCB ribbon cable to J13 of the User Interface PCB. Install the clip over the J5 connector. 10. Complete the procedure in paragraph Monitor Assembly on page 66. User Interface PCB Removal/Replacement Removal 1. Complete the procedures in paragraphs Prior to Disassembly on page 64, and Monitor Disassembly on page 65.
Disassembly Guide 7. Remove the User Interface PCB from the top case. Figure 12: User Interface PCB Replacement Caution: When installing the User Interface 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.
Disassembly Guide 11. Connect the speaker cable to J12 of the User Interface PCB. 12. Connect the CCFL wire harness with two white wires to J5 of the User Interface PCB. 13. Connect the Display PCB ribbon cable to J13 of the User Interface PCB. Install the clip over the J13 connector.
Disassembly Guide 3. Pull the holding clip back from the speaker and lift the speaker out of the top case. Figure 13: Alarm Speaker Replacement 4. Pull the holding clip back, and insert the speaker into the top case. 5. Connect speaker wire harness to J12 on the User Interface PCB. 6.
Disassembly Guide Top Case Assembly Removal/Replacement Removal 1. Complete the procedures in paragraphs Prior to Disassembly on page 64, and Monitor Disassembly on page 65. 2. Complete the procedural steps 1 through 6 in paragraph User Interface PCB Removal/Replacement on page 76. Replacement Caution: When installing the User Interface PCB, hand-tighten the five screws to a maximum of 4 inch-pounds.
Nellcor's Technical Services provides technical assistance information and replacement parts. To obtain replacement parts, contact Nellcor or your local Nellcor representative. Refer to parts by the part names and part numbers. Spare parts and accessories for the N-595 are listed on the Internet at: http://mallinckrodt.com/respiratory/resp/Serv_Supp/Apartweb/main/PartAcceMenu.html...
Spare Parts Parts List Table 12: Parts List Item Description Part Number Top Case Assembly International (with 036652 Membrane Panel) Top Case Assembly U.S.A. (with Membrane 036657 Panel) Fuse Drawer 691500 Fuses 691032 Power Entry Module 691499 Cooling Fan 035469 Power Supply SP036603/UT036603 Display PCB...
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 Nellcor warranty. If the original shipping carton is not available, use another suitable carton; North American customers may call Nellcor’s Technical Services Department to obtain...
Packing for Shipment 1. Place the monitor and, if necessary, accessory items in original packaging. Figure 15: Packing 2. Place in shipping carton and seal carton with packing tape. 3. Label carton with shipping address, return address, and RGA number, if applicable.
Packing for Shipment Repacking in a Different Carton If the original carton is not available, use the following procedure to pack the N-595: 1. Place the monitor in a plastic bag. 2. Locate a corrugated cardboard shipping carton with a bursting strength of at least 200 pounds per square inch (psi).
S p e c i f i c a t i o n s Performance Measurement Range 1% to 100% Pulse Rate 20 beats per minute (bpm) to 250 bpm Perfusion Range 0.03% to 20% Accuracy and Motion Tolerance Saturation 70 to 100% ±2 digits Without Motion - Adult 70 to 100% ±3 digits...
Specifications Electrical Instrument Power Requirements rated at 108 to 132 volts AC (nominal 120 VAC) or 200 to 240 volts AC (nominal 230 VAC), 20 volt/amps to be compliant with IEC 60601-1 sub-clause 10.2.2 Fuses qty 2, 0.5 A, 250 volts, slow-blow, IEC (5 x 20 mm) Battery The battery provides at least 2 hours of battery life when new and fully charged with no alarms, no serial data, no analog output, no nurse call output, with backlight on while...
Page 99
Specifications Operating Relative Humidity 15% to 95% non-condensing to be compliant with IEC 60601-1, sub-clause 44.5 Transport and Storage (not in shipping container) Temperature -20 ºC to 60 ºC (-4 ºF to 140 ºF) Altitude -390 m to 5,574 m (-1,254 ft.
Specifications Sensor Power Dissipation Sensor Dissipation OxiCliq I 52.5 mW OxiCliq A 52.5 mW 52.5 mW ® Dura-Y D-YS MAX-FAST 52.5 mW Physical Characteristics Weight 5.8 lbs. (2.6 kg) Dimensions 3.3 in. x 10.4 in. x 6.8 in. (8.4 cm x 26.4 cm x 17.3 cm)
Specifications Compliance Item Compliant With Equipment classification Safety Standards: IEC 60601-1 (same as EN60601-1), CSA 601.1, UL 2601-1, EN865, EN/IEC 60601-1-2 (second edition) Type of protection Class 1 (on AC power) Internally powered (on battery power) Degree of protection Type BF - Applied part Mode of operation Continuous N-595 resistant to liquid ingress...
Page 102
Specifications Item Compliant With N-595 power entry module fuse holder IEC 60601-1, sub-clause 59.3 N-595 exterior markings IEC 60601-1, sub-clause 6.1, 6.3, and 6.4; EN 865, clause 6 Front panel and case labeling IEC 60878, EN 980, ISO 7000, EN 60417-1, EN 60417-2 N-595 button spacing ISO 7250...
Specifications Declaration Manufacturer’s WARNING: The use of accessories, O sensors, and cables other than those specified may result in increased emission and/or decreased immunity of the N-595 pulse oximeter. Table 13: Electromagnetic Emissions The N-595 is suitable for use in the specified electromagnetic environment. The customer and/or user of the N-595 should assure that it is used in an electromagnetic environment as described below: Electromagnetic Environment...
Specifications Table 14: Electromagnetic Immunity The N-595 is suitable for use in the specified electromagnetic environment. The customer and/or user of the N-595 should assure that it is used in an electromagnetic environment as described below. Electromagnetic Immunity IEC 60601-1-2 Compliance Environment Test...
Page 105
Specifications Table 14: Electromagnetic Immunity The N-595 is suitable for use in the specified electromagnetic environment. The customer and/or user of the N-595 should assure that it is used in an electromagnetic environment as described below. Electromagnetic Immunity IEC 60601-1-2 Compliance Environment Test...
Specifications Table 15: Electromagnetic Immunity, Portable RF Equipment The N-595 is suitable for use in the specified electromagnetic environment. The customer and/or user of the N-595 should assure that it is used in an electromagnetic environment as described below: Electromagnetic Immunity IEC 60601-1-2 Compliance...
Specifications Table 16: Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the N-595 (IEC 60601-1-2) Frequency of 26 MHz to 80 MHz to 800 MHz to Transmitter 80 MHz 800 MHz 2.5 GHz Equation d = 1.2√P d = 1.2√P d = 2.3√P...
Specifications Earth Leakage Current IEC 60601-1 Neutral AC Polarity Line Cord AAMI/ UL 2601-1 Cord ANSI-ES1 Normal Closed Closed 500 µA 300 µA Reversed Closed Closed 500 µA 300 µA Normal Open Closed 1000 µA 500 µA 1000 µA 500 µA Normal Closed Open...
Page 111
Specifications Power Line AC Line Neutral Ground 60601-1 AAMI/ANSI-ES1 Polarity Line Cable UL 2601-1 Reversed Closed Open 500 µA 50 µA ** ** These requirements are generally for IEC 60601-1 Class 1, TYPE-CF classified products. N-595...
Specifications Patient Isolation Risk Current Power Line AC Line Neutral IEC 60601-1 AAMI/ Ground Polarity Line UL 2601-1 ANSI-ES1 Cable Normal Closed Closed 5 mA 50 µA *** Reversed Closed Closed 5 mA 50 µA *** *** These requirements are generally for IEC 60601-1 Class 1, TYPE-CF classified products.
Introduction When connected to the data port on the back of the N-595, printouts can be obtained or patient data can be communicated to a Nellcor Oxinet II monitoring system, Nellcor Intouch Remote Oximetry Notification System or personal computer (PC). Analog signals representing %SpO , pulse rate, and pulse amplitude are also provided by the data port.
Data Port Interface Protocol AGILENT (HP Agilent monitors) SPACELBS (Spacelabs monitors) MARQ (GE Marquette monitors) DATEX (Datex-Ohmeda AS/3 monitor) BACK (back to Setup menu) EXIT (back to Main menu) NCALL (Nurse Call) NORM + NORM - BACK (back to Setup menu) EXIT (back to Main menu) NEXT ANALOG...
The selections are: • ASCII used for printouts • OXINET to enable communication with Oxinet II • CLINICAL intended for Nellcor use only • GRAPH for graphic printouts • AGILENT interfaces the N-595 with an Agilent (HP) monitor •...
Data Port Interface Protocol 1. Turn on the N-595 by pressing the ON/STANDBY button. 2. Press the SETUP softkey. SETUP 3. Press the NEXT softkey. NEXT 4. Press the NEXT softkey. NEXT 5. Press the COMM softkey. COMM 6. Press the SELECT softkey. SELECT 7.
Data Port Interface Protocol 2. Press the SETUP softkey. SETUP 3. Press the NEXT softkey. NEXT 4. Press the LANG softkey. LANG 5. Use the ADJUST UP and ADJUST DOWN buttons to select the desired language. 6. Press the BACK softkey to save the language setting. BACK Nurse Call Setup The voltage polarity for the Nurse Call, available at pins 11 and 5, can be selected...
Data Port Interface Protocol 5. Press the NCALL softkey. NCALL NORM + 6. Press the NORM+ (+5 to +12 VDC) or NORM- (-5 to -12 VDC) softkey as required for your nurse call system. NORM - Analog Calibration Setup Analog calibration signals are provided to adjust a recorder to the output of the instrument.
(A05 option) to interface with the N-595 pulse oximeter. The RS-232 hardwire interface cable has a DB-15 connector for the N-595 and the applicable connector for the Agilent monitor. Nellcor cable part number 902256 is recommended for this interface. A blank screen on the Agilent monitor will indicate corrupt data. The Agilent monitor will detect corrupt data in less than 100 milliseconds.
N-595 pulse oximeter. The interface module comes with an interface cable, GE Marquette part number 417961-033, that connects to the Nellcor interface cable. The RS-232 hardwire interface cable has a DB-15 connector for the N-595 and the applicable connector for the Marquette Octanet interface module cable.
Data Port Interface Protocol Datex-Ohmeda Communications The Datex-Ohmeda monitor AS/3 must be configured for communications with the Nellcor N-200 monitor in order to communicate with the N-595 monitor. Refer to the AS/3 operator's manual for instructions on configuring the AS/3 monitor.
Data Port Interface Protocol Table 18: Data Port Pin Outs Signal Signal Ground (isolated from earth ground) AN_SpO (analog saturation output) Normally Open (N.O.), Dry Contacts, for Nurse Call (N.O. with no audible alarm) Normally Closed (N.C.), Dry Contacts, for Nurse Call (N.C. with no audible alarm) RXD- (R-422 negative output) Signal Ground (isolated from earth ground)
Dump Instrument Info (Option 1) This allows Instrument Info to be printed or displayed on the PC screen. This option is intended for Nellcor’s field service personnel. Instrument Info is a single line of data, which includes software version, CRC number, and total operating time.
The information that can be viewed includes instrument type, software revision level, printout type, time of printout, operating time of the recorded error, error number, task number, address, and count. This option is intended for Nellcor’s field service personnel. Exit Interactive Mode (Option 5) Selecting option 5 exits the interactive mode and returns the data port to normal operation.
Data Port Interface Protocol Real-Time Printout When a real-time display or printout is being transmitted to a printer or PC, a new line of data is printed every 2 seconds. Every 25th line is a Column Heading line. A column heading line is also printed any time a value in the column heading line is changed.
Data Port Interface Protocol Column Heading To explain the printout, it is necessary to break it down to its key components. The first two lines of the chart are the Column Headings shown below. Every 25th line a Column Heading is printed. A column heading is also printed whenever a value of the Column Heading is changed.
Data Port Interface Protocol for SpO is 70% and the upper alarm limit is 100%. Pulse Rate alarm limits are 60 BPM (lower), and 160 BPM (upper). Monitor Status The monitor status, ADULT or NEO (Neonate), is displayed on the second line of the heading.
Data Port Interface Protocol Patient Data Patient data and the operating status of the unit are highlighted in the display above. Parameter values, at the time of the printout, are displayed directly beneath the heading for each parameter. In this example the %SpO is 100, and the pulse rate (BPM) is 190 beats per minute.
Data Port Interface Protocol Table 19: Operating Status Codes Code Meaning Pulse Search Sensor Disconnect Saturation Upper Limit Alarm Saturation Lower Limit Alarm - - - No Data Available Alarm Parameter Being Violated Note: A Sensor Disconnect will also cause three dashes (- - -) to be displayed in the patient data section of the printout.
Data Port Interface Protocol supports Epson ESC protocol. To print in the Graph mode the monitor protocol must be changed to GRAPH. See Communication Protocol on page 107. Figure 19: Monitor Trend Data Printout (Graph Mode) Figure 20: Sensor Event Record Printout (Graph Mode) Nurse Call An RS-232 Nurse Call signal (pins 5 and 11) can be obtained by connecting to the data port.
Data Port Interface Protocol alarm and no alarm conditions, and for instrument off. Table 21 defines the ratings of the Nurse Call relay. Table 20: Nurse Call Relay Pin States No Alarm or Audible Instrument Alarm Alarm Silenced 7 N.O. Open Closed Closed...
T e c h n i c a l D i s c u s s i o n Oximetry Overview The N-595 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying an O sensor to a pulsating arteriolar vascular bed, such as a finger or toe.
Figure 21: Oxyhemoglobin Dissociation Curve SatSeconds Alarm Management The N-595 utilizes Nellcor SatSeconds alarm management technique. SatSeconds is a function of the software within the N-595. With the SatSeconds technique, upper and lower alarm limits are set in the same way as traditional alarm management.
N-595 to read through challenging motion conditions to deliver accurate saturation and pulse rate values. For a definition of motion, as applicable to the N-595, contact Nellcor's Technical Services Department. Technology The N-595 pulse oximeter is designed to use Nellcor brand O sensors containing O technology. These O sensors can be identified by the deep blue color of their plug.
Technical Discussion Block Diagram Theory The monitor block diagram is shown in Figure 22. Figure 22: Block Diagram The N-595 main printed circuit board (PCB) consists of three main parts: • The Secondary Input Port/Secondary Output Port (SIP/SOP) • The FE-102 front end •...
Page 137
Technical Discussion The microprocessor is responsible for interacting with the analog front end, and communicates with the front end through control signals. The microcontroller receives the analog voltages from the front end analog-to-digital (A/D) converters. The resultant data is used to calculate SpO and pulse rate values.
Page 138
Technical Discussion functionality. The FE-102 front end power supply for the N-595 is an isolated switcher which generates +5 volts and ±12 volts. The patient is connected to the N-595 via an O sensor and pulse oximetry cable. The SpO analog front end drives the O sensor’s LEDs, conditions the incoming signal, and provides adjustable gain status.
FERRITE DC FERRITE Figure 44 Linear Power Supply Assembly Drawing...
Page 156
I n d e x Date and Time Datex-Ohmeda Communications Digital Multimeter Accessories on Internet Disassembly Guide Adult Default Settings Disinfecting Agilent (HP) Communications Display PCB Replacement Alarm Management, SatSeconds Downld Softkey Alarm Off Dump Error Log Alarm Range Limits Dump Instrument Info Alarm Silence Dump Trend...
Index Instrument Info Dump Param Softkey Invalid Silence Duration Parts List Invalid SpO2 Limit Patient Applied Risk Current Patient Applied Risk Current Specifications 34, 104 Patient Isolation Risk Current Performance Tests Language Selection Performance Verification Periodic Safety Checks LED Excitation Test Physical Characteristics Low Battery Power Entry Module Replacement...
Page 158
Index Relative Humidity 91 Service Functions, Accessing Setting Temperature 91 Date and Time 115 Trend Data Printout (ASCII Mode) Setting Institutional Defaults Trend Dump Trend Printout (Graph Mode) Trend Softkey Softkey Menu Troubleshooting Guide Software Version SpaceLabs Communications Spare Parts on Internet User Interface PCB Replacement Specifications Using Data on the PC...
Need help?
Do you have a question about the OxiMax N-595 and is the answer not in the manual?
Questions and answers