Operators Manual
210 Pages
Preview
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Nellcor, Durasensor, Dura-Y, Max-Fast, OxiCliq, Oxiband, OxiMax, Oxinet, Pedi-Check, SatSeconds, OxiMax SPD Alert, and SoftCare are trademarks of Nellcor Puritan Bennett LLC. The OxiMax N-600x™ pulse oximeter is covered by one or more of the following U.S. patents and foreign equivalents: Patent No. 5,485,847; 5,676,141; 5,743,263; 6,035,223; 6,226,539; 6,411,833; 6,463,310; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774; 7,212,847, 7,400,919. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department at 1.800.635.5267 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 LLC.
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
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Contents Turning On the Monitor ... 43 OXIMAX Sensor Attached ... 45 No OXIMAX Sensor Attached ... 48 Turning the Backlight On or Off ... 49 Adjusting the Screen Contrast ... 49 Adjusting the Backlight Brightness ... 49 Selecting the Pleth View ... 50 Selecting the Blip View ... 50 Selecting the Real-Time Trend View ... 51 Selecting the Trend Data Display ... 52 Setting the Trend Time Scale Display ... 52 Setting the Trend Amplitude Scale Display ... 53 Setting the Pulse Beep Volume ... 53 Setting the Alarm Volume ... 54 Setting the Date and Time ... 55 Setting the Alarm Silence Duration ... 57 Disabling Audible Alarms ... 58 Selecting the Standby Mode ... 59 Adult-Pediatric or Neonatal Settings ... 60 Setting Patient Adult-Pediatric or Neonatal Modes ... 61 Alarm Limit Changed Indicator ... 62 Setting Alarm Limits ... 62 Setting SatSeconds Alarm Limit ... 64 Setting Monitor Response Mode ... 65 Selecting the Display Language ... 67 OXIMAX Sensor Messages ... 68 OXIMAX Sensor Adjust Condition Messages ... 69 OXIMAX Sensor Adjust Messages ... 70
Using Monitor Trend Data...71 Overview ... 71 Storing Trend Data ... 73 OXIMAX Sensor Type ... 74 Selecting the Trend Data Display Scale ... 74 Reading the Trend Data Display ... 76 Dual Trend Data Display ... 77 SpO2 Trend Display ... 78 Pulse Rate Trend Display ... 78 Histogram Trend Data Display ... 79 Pulse Amplitude Trend Data Display ... 80 Clearing Trend Information ... 81
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Using OXIMAX Sensor Event Records... 83 Overview ... 83 Setting up OXIMAX Sensor Messages ... 85 Setting In-Sensor Data Type ... 86 OXIMAX Sensor Data Type ... 87 OXIMAX Sensor Event Record Data Available ... 88 OXIMAX Sensor Event Record Not Available ... 89 OXIMAX Sensor Event Record Graphical Data ... 90 Viewing and Printing OXIMAX Sensor Event History Data ...92 OXIMAX Sensor Tabular Event Data ... 94 Viewing and Printing In-Sensor Tabular Event History Data ...95
Printing Monitor Trend Data... 97 Overview ... 97 Printing ... 97 Monitor Trend Data in ASCII Mode ... 100 Trend Data in Graph Mode ... 101 Real-Time Display/Printout Format ... 101 Column Headings ... 103 Data Source ... 103 Software Version ... 104 Alarm Limits ... 104 Monitor Mode ... 104 Response Mode ... 105 Data Column Headings ... 105 Time ... 106 Patient Data ... 106 Operating Status ... 106
Using the Data Port... 109 Overview ... 109 Connecting to the Data Port ... 110 Data Port Pinouts ... 110 Data Port Setup ... 112 Using the Nurse Call Interface ... 114 Setting Nurse Call RS-232 Polarity ... 115 Setting Nurse Call Relays Normally Open/Closed ...116 Calculating the Analog Voltage Output ... 116
OXIMAX Sensors and Accessories... 119 Overview ... 119 Selecting an OXIMAX Sensor ... 120 OXIMAX Sensor Features ... 124 Biocompatibility Testing ... 124 N-600x Operator’s Manual
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Contents Optional Accessories ... 125 GCX Mounting Plate ... 126 GCX Vertical Wall Mount Arm ... 127 GCX Roll Stand ... 128 Soft-Sided Carrying Case ... 129
Performance Considerations...131 Overview ... 131 Performance Considerations ... 132 Dysfunctional Hemoglobins ... 132 Anemia ... 133 Saturation ... 133 Pulse Rates ... 133 OXIMAX Sensor Performance Considerations ... 133
Troubleshooting...137 Overview ... 137 On-Screen Help ... 138 Accessing Multiple Topics ... 138 Accessing Single Topics ... 141 Error Codes ... 143 Prompts and Error Messages ... 146 Primary Speaker Failure ... 149 Help and Support ... 151 EMI (Electromagnetic Interference) ... 156 Obtaining Technical Assistance ... 157 Returning your Monitor ... 157
Maintenance...159 Overview ... 159 Service ... 159 Periodic Safety Checks ... 159 Cleaning ... 160
Using SatSeconds...161 Overview ... 161 SatSeconds “Safety Net” ... 163 SatSeconds Display ... 163
Factory Default Settings...165 Overview ... 165 Neonate Default Settings ... 165 Adult Default Settings ... 166
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Principles of Operation... 169 Overview ... 169 Automatic Calibration ... 170 Functional versus Fractional Saturation ... 171 Measured versus Calculated Saturation ... 172 OXIMAX Technology ... 173 Functional Testers and Patient Simulators ... 174
Specifications... 175 Performance ... 175 Electrical ... 176 Environmental Conditions ... 178 Physical Characteristics ... 180 Compliance ... 180 Manufacturer’s Declaration ... 181
Index... 195
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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 determined by the date/time setting 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 110. 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. WARNING: Pressing ALARM SILENCE will keep ALL alarms from sounding for the alarm silence duration period. 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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N-600x Operator’s Manual
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 50.
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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 71). 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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