Operators Manual
212 Pages
Preview
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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.
Contents Contents... i Safety Information... 1 Safety Warnings ... 1 Safety Cautions ... 3
Introduction... 5 Intended Use ... 5 How to Use this Manual ... 6
Symbols, Controls, Displays and Indicators... 7 About the Front Panel ... 7 About the Rear Panel ... 8 About the Symbols ... 9 About the Controls ... 10 About the Displays ... 11 Pleth Display ... 11 Blip Display ... 12 Real-Time Trend Display ... 14 SpO2 and Pulse Rates ... 14 About the Visual Indicators ... 16 About the Audible Indicators ... 19
Setting Up the Monitor... 21 List of Components ... 23 Connecting to an AC Power Source ... 24 Connecting an OXIMAX Sensor ... 26
Operating the Battery... 27 Operating on Battery Power ... 27 Low Battery Indicator ... 29 Description of Low and Critical Battery Conditions ... 30 Battery Fuel Gauge Indicator ... 34
Using the Monitor... 35 Overview ... 35 Menu Description ... 35 Menu Structure ... 36 Parameter Ranges ... 40 Turning On the Monitor ... 43
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Contents OXIMAX Sensor Attached ... 45 No OXIMAX Sensor Attached ... 49 Turning the Backlight On or Off ... 50 Adjusting the Screen Contrast ... 50 Adjusting the Backlight Brightness ... 50 Selecting the Pleth View ... 51 Selecting the Blip View ... 51 Selecting the Real-Time Trend View ... 52 Selecting the Trend Data Display ... 53 Setting the Trend Time Scale Display ... 53 Setting the Trend Amplitude Scale Display ... 54 Setting the Pulse Beep Volume ... 54 Setting the Alarm Volume ... 55 Setting the Date and Time ... 56 Setting the Alarm Silence Duration ... 58 Disabling Audible Alarms ... 59 Selecting the Standby Mode ... 60 Adult-Pediatric or Neonatal Settings ... 61 Setting Patient Adult-Pediatric or Neonatal Modes ... 62 Alarm Limit Changed Indicator ... 63 Setting Alarm Limits ... 63 Setting SatSeconds Alarm Limit ... 65 Setting Monitor Response Mode ... 66 Selecting the Display Language ... 68 OXIMAX Sensor Messages ... 69 OXIMAX Sensor Adjust Condition Messages ... 70 OXIMAX Sensor Adjust Messages ... 71
Using Monitor Trend Data... 73 Overview ... 73 Storing Trend Data ... 75 OXIMAX Sensor Type ... 76 Selecting the Trend Data Display Scale ... 76 Reading the Trend Data Display ... 78 Dual Trend Data Display ... 79 SpO2 Trend Display ... 80 Pulse Rate Trend Display ... 80 Histogram Trend Data Display ... 81 Pulse Amplitude Trend Data Display ... 82 Clearing Trend Information ... 83
Using OXIMAX Sensor Event Records... 85 Overview ... 85 Setting up OXIMAX Sensor Messages ... 87
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Setting In-Sensor Data Type ... 88 OXIMAX Sensor Data Type ... 89 OXIMAX Sensor Event Record Data Available ... 90 OXIMAX Sensor Event Record Not Available ... 91 OXIMAX Sensor Event Record Graphical Data ... 92 Viewing and Printing OXIMAX Sensor Event History Data ... 94 OXIMAX Sensor Tabular Event Data ... 96 Viewing and Printing In-Sensor Tabular Event History Data ... 97
Printing Monitor Trend Data... 99 Overview ... 99 Printing ... 99 Monitor Trend Data in ASCII Mode ... 102 Trend Data in Graph Mode ... 103 Real-Time Display/Printout Format ... 103 Column Headings ... 105 Data Source ... 105 Software Version ... 106 Alarm Limits ... 106 Monitor Mode ... 106 Response Mode ... 107 Data Column Headings ... 107 Time ... 108 Patient Data ... 108 Operating Status ... 108
Using the Data Port... 111 Overview ... 111 Connecting to the Data Port ... 112 Data Port Pinouts ... 112 Data Port Setup ... 114 Using the Nurse Call Interface ... 116 Setting Nurse Call RS-232 Polarity ... 117 Setting Nurse Call Relays Normally Open/Closed ... 118 Calculating the Analog Voltage Output ... 118
OXIMAX Sensors and Accessories... 121 Overview ... 121 Selecting an OXIMAX Sensor ... 122 OXIMAX Sensor Features ... 126 Biocompatibility Testing ... 126 Optional Accessories ... 127 GCX Mounting Plate ... 128 GCX Vertical Wall Mount Arm ... 129
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Contents GCX Roll Stand ... 130 Soft-Sided Carrying Case ... 131
Performance Considerations... 133 Overview ... 133 Performance Considerations ... 134 Dysfunctional Hemoglobins ... 134 Anemia ... 135 Saturation ... 135 Pulse Rates ... 135 OXIMAX Sensor Performance Considerations ... 135
Troubleshooting... 139 Overview ... 139 On-Screen Help ... 140 Accessing Multiple Topics ... 140 Accessing Single Topics ... 143 Error Codes ... 145 Prompts and Error Messages ... 148 Primary Speaker Failure ... 151 Help and Support ... 153 EMI (Electromagnetic Interference) ... 158 Obtaining Technical Assistance ... 159 Returning your Monitor ... 159
Maintenance... 161 Overview ... 161 Service ... 161 Periodic Safety Checks ... 161 Cleaning ... 162
Using SatSeconds... 163 Overview ... 163 SatSeconds “Safety Net” ... 165 SatSeconds Display ... 165
Factory Default Settings... 167 Overview ... 167 Neonate Default Settings ... 167 Adult Default Settings ... 168
Principles of Operation... 171 Overview ... 171 Automatic Calibration ... 172
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Functional versus Fractional Saturation ... 173 Measured versus Calculated Saturation ... 174 OXIMAX Technology ... 175 Functional Testers and Patient Simulators ... 176
Specifications... 177 Performance ... 177 Electrical ... 178 Environmental Conditions ... 180 Physical Characteristics ... 182 Compliance ... 182 Manufacturer’s Declaration ... 183
Index... 197
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Contents
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Safety Information
Safety Information
Safety Warnings
Warnings are identified by the WARNING symbol shown above. Warnings alert you 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-600x when recording the sensor event record to the sensor. The accuracy of the date/time is the responsibility of the N-600x. It is recommended that the N-600x 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.
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Safety Information
WARNING: Explosion hazard. Do not use the N-600x 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.
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-600x pulse oximeter.
WARNING: Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.
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N-600x Operator’s Manual
Safety Information
Safety Cautions
Cautions are identified by the CAUTION symbol shown above. Cautions alert you to exercise care necessary for the safe and effective use of the N-600x pulse oximeter. Caution: When connecting the N-600x to any instrument, verify proper operation before clinical use. Both the N-600x 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 60950 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-600x 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-600x 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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Safety Information
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N-600x Operator’s Manual
Introduction
Introduction
WARNING: The N-600x is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
Intended Use The N-600x pulse oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600x is intended for use with neonatal, pediatric, and adult 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. Note: Home Care use is defined as managed or used by a lay person (parent or other similar noncritical caregiver) in the home environment. Use with any particular patient requires the selection of an appropriate oxygen OXIMAX sensor as described in this manual.
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Introduction
How to Use this Manual All users should read this manual thoroughly. More experienced users of the N-600x can directly go to the topics for the information they require. This manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html
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N-600x Operator’s Manual
Symbols, Controls, Displays and Indicators
Symbols, Controls, Displays and Indicators
About the Front Panel
1. SpO2 OXIMAX Sensor Port, page 26. 2. Low Battery Indicator, page 17. 3. AC Power Indicator, page 16. 4. ON/STANDBY Button, page 10. 5. Battery Fuel Gauge Indicator, page 34. 6. Waveform Display, page 12. 7. SatSecondsTM Indicator, page 18. 8. %SpO2 Display, page 16. 9. Pulse Rate Display, page 16. 10. Alarm Silence Indicator, page 17. 11. ALARM SILENCE Button, page 10.
12. ADJUST UP Button, page 10. 13. ADJUST DOWN Button, page 10. 14. Neonate Mode Indicator, page 18. 15. HELP/CONTRAST Button, page 11. 16. Fast Response Mode Indicator, page 18. 17. Softkeys, page 11. 18. Menu Bar, page 11. 19. Data In-Sensor Indicator, page 18. 20. Interference Indicator, page 17. 21. Pulse Search Indicator, page 17. 22. Monitor Speaker.
Figure 1: Front Panel Buttons and Symbols
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Symbols, Controls, Displays and Indicators
About the Rear Panel
1. Equipotential Terminal (Ground). 2. AC Power Connector, page 24. 3. Data Port Connector, page 112. 4. Fuse Holder. 5. Supply Voltage Selector Switch, page 24.
Figure 2: Rear Panel Components
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N-600x Operator’s Manual
Symbols, Controls, Displays and Indicators
About the Symbols The symbols, located on the rear panel of the N-600x, are as follows.
Table 1: Symbols and Descriptions
Symbol
Description
See Instructions for Use Fuse Replacement Equipotential Terminal (ground) Date of Manufacture Data Interface Type BF Applied Part - Not defibrillator proof
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Symbols, Controls, Displays and Indicators
About the Controls
ON/STANDBY Button Turns the monitor on and off. Note: Pressing a button, except the ON/STANDBY button, should result in either a valid or an invalid key tone (refer to Table 3). If the key pressed fails to emit a tone, contact qualified service personnel. ALARM SILENCE Button Silences 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. The ALARM SILENCE button clears “SENSOR OFF,” “LOW BATTERY,” and “SENSOR DISCONNECT” messages from the display. ADJUST UP Button Increases variable parameters of the monitor. ADJUST DOWN Button Decreases variable parameters in the monitor.
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Symbols, Controls, Displays and Indicators
HELP/CONTRAST Button Enables you to access the on-screen help and adjust the monitor screen contrast. •
Pressing and releasing the HELP/CONTRAST button launches the on-screen help.
•
Pressing and holding the HELP/CONTRAST button while simultaneously pressing the ADJUST UP and ADJUST DOWN buttons lightens or darkens the display screen.
Softkey Menu Bar Displays the current functions for each of the four softkey buttons.
About the Displays Pleth Display The pleth display is user selectable. Refer to Selecting the Pleth View on page 51.
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Symbols, Controls, Displays and Indicators
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 pulse rate indicates the respective limits have been changed from the power on defaults (Overview on page 73). Plethysmographic waveforms with peak to peak amplitudes less than ten PAUs are associated. Caution: Verify the movement of the blip bar or plethysmographic waveform or beating heart before accepting any displayed data as a current measurement. When the monitor is powered by the internal battery, the pleth display includes a horizontal battery fuel gauge positioned in the upper left corner which shows the remaining charge (operating hours) on the battery. If a monitor reporting low battery is connected to an AC power source, the battery fuel gauge displays the charging progress. The battery fuel gauge is cleared from the display once the monitor can provide at least 15 minutes of operating time.
Blip Display 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.
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N-600x Operator’s Manual
Symbols, Controls, Displays and Indicators
When the monitor is powered by internal battery, the blip display includes a horizontal battery fuel gauge positioned in the upper left corner that shows the remaining charge (operating hours) on battery. If a monitor reporting a low battery is connected to AC power, the battery fuel gauge shows the charging progress. The battery fuel gauge is cleared from the display once the monitor can provide at least 15 minutes of operating time on battery.
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