Operators Manual
184 Pages
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N-595 Pulse Oximeter Operator’s Manual
Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, Dura-Y, MAX-FAST, and OXIMAX are trademarks of Nellcor Puritan Bennett Inc. 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; 4,802,486; 4,869,254; 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.
Contents Contents... i Figures... vi Tables... vi
Safety Information and Introduction Safety Information... 1 Warnings ... 1 Cautions ... 2
Introduction... 5 Intended Use for the N-595 ... 5 How to Use this Manual ... 6
Using the N-595 Description of Controls, Indicators, and Symbols... 7 Identification of Front Panel Buttons and Symbols ... 7 Identification of Rear Panel Components ... 8 N-595 Symbols ... 8 Description of Controls ... 9 Description of Displays and Indicators ... 10 Description of Audible Indicators ... 14
Setting up the Monitor... 15 List of Components ... 17 Connecting the N-595 to AC Power ... 17 Connecting an OXIMAX Sensor to the N-595 ... 19
Battery Operation... 21 Operating the N-595 on Battery Power ... 21 Low Battery Indicator ... 22
Using the Monitor... 27 Introduction ... 27
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Contents Turning On the Monitor ... 29 OXIMAX Sensor Attached ... 31 No OXIMAX Sensor Attached ... 33 Turning the Backlight On or Off ... 34 Adjusting Screen Contrast ... 34 Selecting the Pleth View ... 34 Selecting the Blip View ... 35 Setting the Pulse Beep Volume ... 36 Setting the Alarm Volume ... 36 Setting the Date and Time ... 37 Setting Alarm Silence Duration ... 38 Disabling Audible Alarms ... 39 Selecting Standby Mode ... 41 Adult-Pediatric or Neonatal Settings ... 42 Setting Patient Adult-Pediatric/Neonatal Mode ... 42 Alarm Limit Changed Indicator ... 44 Setting Alarm Limits ... 44 Setting SatSeconds Alarm Limit ... 46 Setting Monitor Response Mode ... 47 Selecting the Display Language ... 48 OXIMAX Sensor Messages ... 49 OXIMAX Sensor Adjust Condition Messages ... 50 OXIMAX Sensor Adjust Messages ... 51
Monitor Trend... 53 Monitor Trend Data ... 53 Trend Data Operation ... 55 Selecting the Trend Data Display Scale ... 55 Reading the Trend Data Display ... 57 Dual Trend Data Display ... 58 SpO2 Trend Display ... 59 Pulse Rate Trend Display ... 59 Histogram Trend Data Display ... 60 Pulse Amplitude Trend Data Display ... 61 Clearing Trend Information ... 62
Sensors and Accessories OXIMAX Sensor Event Record... 65 Setting In-Sensor Data Type ... 66 OXIMAX Sensor Type ... 68 OXIMAX Sensor Data Type ... 68 OXIMAX Sensor Event Record Data Available ... 69 ii
Contents OXIMAX Sensor Event Record Not Available ... 70 OXIMAX Sensor Event Record Graphical Data ... 71 Viewing and Printing OXIMAX Sensor Event History Data ... 73 OXIMAX Sensor Tabular Event Data ... 75 Viewing and Printing In-Sensor Tabular Event History Data ... 76
Printing... 79 Printing Monitor Trend Information ... 79 Monitor Trend Data in ASCII Mode ... 81 Trend Data in Graph Mode ... 82 Real-Time Display/Printout Format ... 83 Column Headings ... 85 Data Source ... 85 Software Version ... 85 Alarm Limits ... 86 Monitor Mode ... 86 Response Mode ... 86 Data Column Headings ... 87 Time ... 87 Patient Data ... 87 Operating Status ... 88
Using the Data Port... 91 Overview ... 91 Connecting to the Data Port ... 91 Data Port Pinouts ... 92 Data Port Setup ... 93 Using the Nurse Call Interface ... 95 Setting Nurse Call RS-232 Polarity ... 96 Setting Nurse Call Relays Normally Open/Closed ... 97 Calculating the Analog Voltage Output ... 97
OXIMAX Sensors and Accessories... 99 OXIMAX Sensor Event Record Data ... 99 Selecting an OXIMAX Sensor ... 99 OXIMAX Sensor Features ... 103 Biocompatibility Testing ... 103 Optional Accessories ... 103 GCX Mounting Plate ... 105 GCX Poly-Mount (vertical wall mount with 19-inch channel) ... 106 GCX Poly-Mount (horizontal wall mount with rail adapter) . 107 GCX Poly-Mount Roll Stand ... 108 GCX Utility Basket ... 109
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Contents Soft-Sided Carrying Case ... 110
Performance Considerations... 111 Performance Verification ... 111 N-595 Monitor Performance Considerations ... 111 Dysfunctional Hemoglobins ... 112 Anemia ... 112 Saturation ... 112 Pulse Rates ... 112 OXIMAX Sensor Performance Considerations ... 113
Troubleshooting Troubleshooting... 117 Error Codes ... 117 Prompts and Error Messages ... 119 Corrective Action ... 122 EMI (Electro-magnetic Interference) ... 125 Obtaining Technical Assistance ... 126 OXIMAX Sensor Message Setup ... 127
Maintenance... 129 Returning the N-595 ... 129 Service ... 129 Periodic Safety Checks ... 130 Cleaning ... 130
Menu Structure... 131 N-595 Menu Description ... 131
Technical Information SatSeconds... 135 Describing SatSeconds ... 135 SatSeconds “Safety Net” ... 137 SatSeconds Display ... 137
Factory Defaults... 139 Neonate Default Settings ... 139 Adult Default Settings ... 140
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Contents
Principles of Operation... 143 Oximetry Overview ... 143 Automatic Calibration ... 144 Functional versus Fractional Saturation ... 144 Measured versus Calculated Saturation ... 145 OXIMAX Technology ... 145
Specifications... 147 Performance ... 147 Electrical ... 148 Environmental Conditions ... 149 Physical Characteristics ... 151 Compliance ... 152 Manufacturer’s Declaration ... 155
Index... 167
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Contents
Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: Figure 11: Figure 12: Figure 13: Figure 14:
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Front Panel Buttons and Symbols ... 7 Rear Panel Components ... 8 ASCII Mode Printout ... 82 Graph Mode Printout ... 83 Real-Time Printout ... 84 Data Port Pin Layout ... 93 GCX Mounting Plate ... 105 GCX Poly-Mount (vertical wall mount with 19-inch channel) ... 106 GCX Poly-mount (horizontal wall mount with rail adapter) ... 107 GCX Poly-mount Roll Stand ... 108 GCX Utility Basket ... 109 Soft-Sided Carrying Case ... 110 Alarm Response with SatSeconds ... 136 Oxyhemoglobin Dissociation Curve ... 145
Contents
Ta b l e s Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Table 13: Table 14: Table 15: Table 16: Table 17:
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Audible Indicators ... 14 Low Battery and Critical Battery ... 23 Parameter Ranges ... 27 Reading Trend Display ... 57 Data Port Pinouts ... 92 Analog Pinouts ... 97 Nellcor OXIMAX Sensor Models and Patient Sizes ... 101 OXIMAX Sensor Features ... 103 Error Codes ... 118 Prompt/Error Messages ... 120 Neonate Factory Defaults ... 139 Adult Factory Defaults ... 140 Electromagnetic Emissions ... 155 Electromagnetic Immunity ... 156 Electromagnetic Immunity, RF Portable Equipment ... 159 Recommended Separation Distances ... 161 Cables ... 162
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Safety Information
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. The accuracy of the date/time is the responsibility of the N-595. It is recommended that the N-595 user set the time/ date to the correct value before a sensor event record-enabled sensor is connected, and that this date/time not be changed while the sensor remains connected. Since a sensor with sensor event record data can be transported from one monitor to another, having discrepancies in the date/time between monitors and the sensor event record data will affect the order the sensor event record data appears. To eliminate this possible problem, all monitors within an institution should be set to the same time.
WARNING: Explosion hazard. Do not use the N-595 pulse oximeter in the presence of flammable anesthetics or gases.
WARNING: Chemicals from a broken LCD display panel are toxic when ingested. Use caution when handling a pulse oximeter with a broken display panel.
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Safety Information
WARNING: Pulse oximetry readings and pulse signals can be affected by certain environmental conditions, OXIMAX sensor application errors, and certain patient conditions. See the appropriate sections of this manual for specific safety information.
WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or decreased immunity and inaccurate readings of the N-595 pulse oximeter.
WARNING: Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.
Cautions
Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the N-595 pulse oximeter.
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Safety Information
Caution: When connecting the N-595 to any instrument, verify proper operation before clinical use. Both the N-595 and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the pulse oximeter’s data interface must be certified according to IEC Standard 950 for data-processing equipment or IEC Standard 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port (N-595 data port connector) configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. The N-595 accuracy may degrade if it is connected to secondary I/O devices when the instrument is not connected to earth reference. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution: Dispose of battery in accordance with local requirements and regulations.
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Introduction
WARNING: The N-595 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
Intended Use for the N-595 The N-595 pulse oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-595 is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only. Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. Home Care use is defined as managed/used by a lay person (parent or other similar non-critical caregiver) in the home environment. Use with any particular patient requires the selection of an appropriate oxygen OXIMAX sensors as described in this Operator's Manual.
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Introduction
Motion performance claims are applicable to models MAX-A, MAX-AL, MAX-P, MAX-N, and MAX-I Nellcor OXIMAX TM oximetry sensors.
How to Use this Manual All users should read this manual thoroughly. More experienced users of the N-595 will be able to go to the topics for the information they require. The current copy of this manual is available on the internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html
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Description of Controls, Indicators, and Symbols
Identification of Front Panel Buttons and Symbols
1. SpO2 OXIMAX Sensor Port, page 19 2. AC Power Indicator, page 12 3. ON/STANDBY Button, page 9 4. Low Battery Indicator, page 12 5. Waveform Display, page 10 6. SatSecondsTM Indicator, page 13 7. %SpO2 Display, page 12 8. Pulse Rate Display, page 12 9. Alarm Silence Indicator, page 12 10. ALARM SILENCE Button, page 9 11. ADJUST UP Button,page 10
12. ADJUST DOWN Button, page 10 13. Neonate Mode Indicator, page 13 14. CONTRAST Button, page 10 15. Fast Response Mode Indicator, page 13 16. Softkeys, page 10 17. Menu Bar, page 10 18. Data In Sensor Indicator, page 13 19. Motion Indicator, page 12 20. Pulse Search Indicator, page 13 21. Speaker
Figure 1: Front Panel Buttons and Symbols
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Description of Controls, Indicators, and Symbols
Identification of Rear Panel Components
1. Equipotential Terminal (Ground) 4. Fuse Holder 2. AC Power Connector, page 17 5. Supply Voltage Selector Switch, page 17 3. Data Port Connector, page 91
Figure 2: Rear Panel Components
N-595 Symbols The symbols that are located on the rear panel of the N-595 are as follows:
See Instructions for Use Fuse Replacement
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Description of Controls, Indicators, and Symbols
Equipotential Terminal (ground) Date of Manufacture Data Interface There is one symbol located on the front panel of the N-595.
Type BF Applied Part - Not defibrillator proof.
Description of Controls
Note: A button press, except the ON/STANDBY button, should result in either a valid or an invalid key tone (refer to Table 1 on page 14). If the key pressed fails to emit a tone, contact qualified service personnel. The ON/STANDBY button. Used to turn the N-595 monitor on or off. The ALARM SILENCE button. Used to silence current alarms for the alarm silence duration period. When an alarm has been silenced, pressing the button again reactivates, or “unsilences” the alarm. It is also used to view and adjust alarm silence duration and alarm volume. N-595
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Description of Controls, Indicators, and Symbols
The ALARM SILENCE button clears “SENSOR OFF,” “LOW BATTERY,” and “SENSOR DISCONNECT” messages from the display. The ADJUST UP button. Used to increase variable parameters of the monitor. The ADJUST DOWN button. Used to decrease variable parameters in the monitor. The CONTRAST button. Used in conjunction with the ADJUST UP and ADJUST DOWN buttons to lighten or darken the display screen. The softkey buttons have multiple uses depending on the legend displayed above the button.
Description of Displays and Indicators The type of display is user selectable. Refer to Selecting the Pleth View on page 34.
The pleth display includes a “wiper bar” plethysmographic waveform, menu bar, and current measured %SpO2 and pulse rate. If SatSeconds are enabled, the pleth display includes the SatSeconds indicator and SatSeconds setting. A decimal point after the %SpO2 or
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Description of Controls, Indicators, and Symbols
pulse rate indicate that the respective limits have been changed from the power on defaults (Monitor Trend Data on page 53).
The blip display includes a pulse amplitude blip bar, current measured %SpO2 and pulse rate, and current upper and lower %SpO2 and pulse rate limits. If SatSeconds are enabled, the blip display includes the SatSeconds indicator and SatSeconds setting. Decimal points after the %SpO2 or pulse rate indicate that the respective limits have been changed from the power-on defaults. There are various matrixes within the OXIMAX algorithm. Some of these, are used to assess the severity of conditions presented to the N-595 in measuring SpO2 and pulse rate on a patient. These individual matrices or combinations of these matrices are used to drive the LED indicators on the N-595 front panel. The OxiMax algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measurement conditions. During normal measurement conditions the averaging time is 6-7 seconds. During challenging measurement conditions which could be caused by low perfusion, motion, external interference like ambient light, or a combination of these, the OXIMAX algorithm automatically extends the amount of data required beyond 7 seconds. If the resulting dynamic averaging time exceeds 20 seconds, the pulse search indicator is lit solid and SpO2 and Pulse Rate will continue to be updated every second. As these conditions become even more challenging, the amount of data required continues to extend. If the dynamic averaging time reaches 40 seconds, the pulse search indicator begins flashing, the SpO2 and pulse rate displays flash zeros indicating a loss-of-pulse condition.
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Description of Controls, Indicators, and Symbols
WARNING: Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements. The %SpO2 Display. Shows the hemoglobin oxygen saturation level. The display value flashes zeros during loss-of-pulse alarms and flashes the SpO2 value when the SpO2 is outside the alarm limits. During Pulse Search, the monitor continues to update the display. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the SpO2 value (81.). The Pulse Amplitude Indicator (blip bar). Indicates pulse beat and shows the relative pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse. This indicator is available only in the blip view. The Pulse Rate Display. Shows the pulse rate in beats per minute. It flashes during loss-of-pulse alarms and when the pulse rate is outside of the alarm limits. During Pulse Search, the monitor continues to update the display. Pulse rates outside of the pulse rate range (20 to 250 bpm) are displayed as the closest value within the range. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the BPM value (112.). The AC Power Indicator. Lights continuously when the N-595 is connected to AC power. It also indicates that the battery is charging. It is off when the monitor is being powered by internal battery. The Low Battery Indicator. Lights continuously when 15 or fewer minutes of battery capacity remain. Flashes when the battery capacity reaches critical condition. The Alarm Silence Indicator. Lights continuously when an audible alarm has been silenced. It flashes when the alarm silence duration has been set to Off. The Motion Indicator. The motion indicator is lit whenever the OXIMAX algorithm detects the presence of artifacts1 independent of its severity or the impact on the SpO2 or pulse rate values. When the
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