OxiMax N-600 Operators Manual Oct 2005

Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, Dura-Y, Max-Fast, SoftCare, and OxiMax are trademarks of Nellcor Puritan Bennett Inc. Cet appareil ISM est conforme à la norme NMB-001 Canada. To obtain information about a warranty, if any, contact Nellcor’s Customer 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 Contents... i Tables... vi Figures... vii Safety Information... 1 Warnings ... 1 Cautions ... 2 Notes ... 3

Introduction... 5 Intended Use for the N-600 ... 5 How to Use this Manual ... 6

Description of Controls, Indicators, and Symbols... 7 Identification of Front Panel Buttons and Symbols ... 7 Identification of Rear Panel Components ... 8 N-600 Symbols ... 8 Description of Controls ... 9 Description of Displays and Indicators ... 10 Description of Audible Indicators ... 14

Setting up the N-600... 17 List of Components ... 19 Connecting the N-600 to AC Power ... 19 Connecting an OxiMax Sensor to the N-600 ... 21

Battery Operation... 23 Operating the N-600 on Battery Power ... 23 Low Battery Indicator ... 24

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Contents

Using the N-600... 31 Introduction ... 31 Turning On the N-600 ... 34 OxiMax Sensor Attached ... 36 No OxiMax Sensor Attached ... 38 Turning the Backlight On or Off ... 39 Adjusting Screen Contrast ... 39 Selecting the Pleth View ... 40 Selecting the Blip View ... 41 Setting the Pulse Beep Volume ... 41 Setting the Alarm Volume ... 42 Setting the Date and Time ... 43 Setting Alarm Silence Duration ... 45 Disabling Audible Alarms ... 46 Selecting Standby Mode ... 47 Adult-Pediatric or Neonatal Settings ... 48 Setting Patient Adult-Pediatric/Neonatal Mode ... 49 Alarm Limit Changed Indicator ... 50 Setting Alarm Limits ... 50 Setting SatSeconds Alarm Limit ... 52 Setting the N-600 Response Mode ... 53 Selecting the Display Language ... 55 OxiMax Sensor Messages ... 56 OxiMax Sensor Adjust Condition Messages ... 57 OxiMax Sensor Adjust Messages ... 58

N-600 Trend... 59 N-600 Trend Data ... 59 Trend Data Operation ... 61 Selecting the Trend Data Display Scale ... 62 Reading the Trend Data Display ... 64 Dual Trend Data Display ... 65 SpO2 Trend Display ... 65 Pulse Rate Trend Display ... 66 Histogram Trend Data Display ... 67 Pulse Amplitude Trend Data Display ... 68 Clearing Trend Information ... 69

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Contents

OxiMax Sensor Event Record... 71 Setting In-Sensor Data Type ... 72 OxiMax Sensor Type ... 74 OxiMax Sensor Data Type ... 75 OxiMax Sensor Event Record Data Available ... 75 OxiMax Sensor Event Record Not Available ... 77 OxiMax Sensor Event Record Graphical Data ... 77 Viewing and Printing OxiMax Sensor Event History Data ... 79 OxiMax Sensor Tabular Event Data ... 81 Viewing and Printing In-Sensor Tabular Event History Data ... 82

Printing... 85 Printing N-600 Trend Information ... 85 N-600 Trend Data in ASCII Mode ... 88 Trend Data in Graph Mode ... 89 Real-Time Display/Printout Format ... 89 Column Headings ... 91 Data Source ... 91 Software Version ... 91 Alarm Limits ... 92 Monitor Mode ... 92 Response Mode ... 92 Data Column Headings ... 93 Time ... 93 Patient Data ... 93 Operating Status ... 95

Using the Data Port... 97 Overview ... 97 Connecting to the Data Port ... 97 Data Port Pinouts ... 98 Data Port Setup ... 99 Using the Nurse Call Interface ... 101 Setting Nurse Call RS-232 Polarity ... 102 Setting Nurse Call Relays Normally Open/Closed ... 103 Calculating the Analog Voltage Output ... 103

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Contents

OxiMax Sensors and Accessories... 105 OxiMax Sensor Event Record Data ... 105 Selecting an OxiMax Sensor ... 105 OxiMax Sensor Features ... 109 Biocompatibility Testing ... 110 Optional Accessories ... 110 GCX Mounting Plate ... 111 GCX Vertical Wall Mount Arm ... 112 GCX Roll Stand ... 113 Soft-Sided Carrying Case ... 114

Performance Considerations... 117 Performance Verification ... 117 N-600 Performance Considerations ... 117 Dysfunctional Hemoglobins ... 118 Anemia ... 118 Saturation ... 118 Pulse Rates ... 118 OxiMax Sensor Performance Considerations ... 119

Troubleshooting... 123 Error Codes ... 123 Prompts and Error Messages ... 125 Corrective Action ... 128 EMI (Electromagnetic Interference) ... 131 Obtaining Technical Assistance ... 133 OxiMax Sensor Message Setup ... 133

Maintenance... 135 Returning the N-600 ... 135 Service ... 135 Periodic Safety Checks ... 136 Cleaning ... 136

Menu Structure... 137 N-600 Menu Description ... 137

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Contents

SatSeconds... 141 Describing SatSeconds ... 141 SatSeconds “Safety Net” ... 143 SatSeconds Display ... 144

Factory Defaults... 145 Neonate Default Settings ... 145 Adult Default Settings ... 146

Principles of Operation... 149 Oximetry Overview ... 149 Automatic Calibration ... 150 Functional versus Fractional Saturation ... 150 Measured versus Calculated Saturation ... 151 OxiMax Technology ... 152

Specifications... 153 Performance ... 153 Electrical ... 154 Environmental Conditions ... 156 Physical Characteristics ... 158 Compliance ... 158 Manufacturer’s Declaration ... 160

Index... 167

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Tables

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:

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Audible Indicators ... 14 Low Battery and Critical Battery ... 26 Parameter Ranges ... 31 Reading Trend Display ... 62 Data Port Pinouts ... 96 Analog Pinouts ... 101 Nellcor Oximetry Sensor Models and Patient Weights ... 105 OxiMax Sensor Features ... 107 Error Codes ... 122 Prompt/Error Messages ... 124 Neonate Factory Defaults ... 143 Adult Factory Defaults ... 144 Electromagnetic Emissions ... 157 Electromagnetic Immunity, RF Portable Equipment ... 158 Recommended Separation Distances ... 161 Cable Compliance ... 162

Contents

Figures Figure 1: Front Panel Buttons and Symbols ... 7 Figure 2: Rear Panel Components ... 8 Figure 3: Trend Overwriting ... 59 Figure 4: ASCII Mode Printout ... 86 Figure 5: Graph Mode Printout ... 87 Figure 6: Real-Time Printout ... 88 Figure 7: Data Port Pin Layout ... 97 Figure 8: GCX Mounting Plate ... 109 Figure 9: GCX Poly-Mount Vertical Wall Mount ... 110 Figure 10: GCX Poly-Mount Horizontal Wall Mount ... 111 Figure 11: GCX Poly-mount Roll Stand ... 112 Figure 12: GCX Utility Basket ... 113 Figure 13: Soft-Sided Carrying Case ... 114 Figure 14: Alarm Response with SatSeconds ... 140 Figure 15: Oxyhemoglobin Dissociation Curve ... 149

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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-600 when recording the sensor event record to the sensor. The accuracy of the date/time is the responsibility of the N-600. It is recommended that the N-600 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-600 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-600 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-600 pulse oximeter.

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Safety Information

Caution: When connecting the N-600 to any instrument, verify proper operation before clinical use. Both the N-600 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-600 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-600 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.

Notes

Notes are identified by the Note symbol shown above. Notes provide additional useful information.

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Introduction

WARNING: The N-600 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-600 The OxiMax® N-600 pulse oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600 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. 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 manual.

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Introduction

How to Use this Manual All users should read this manual thoroughly. More experienced users of the N-600 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 21 2. AC Power Indicator, page 12 3. On/Standby Button, page 9 4. Low Battery Indicator, page 12 5. Waveform Display, page 11 6. SatSecondsTM Indicator, page 13 7. %SpO2 Display, page 12 8. Pulse Rate Display, page 12 9. Alarm Silence Indicator, page 13 10. Alarm Silence Button, page 10 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. Interference Indicator, page 13 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 19 5. Supply Voltage Selector Switch, page 17 3. Data Port Connector, page 97

Figure 2: Rear Panel Components

N-600 Symbols The symbols that are located on the rear panel of the N-600 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-600.

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-600 on or off.

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Description of Controls, Indicators, and Symbols

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. 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 N-600. The Adjust Down button. Used to decrease variable parameters in the N-600. 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 40.

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Description of Controls, Indicators, and Symbols

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 indicate that the respective limits have been changed from the power on defaults (N-600 Trend Data on page 59).

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 matrices within the N-600 algorithm. Some of these, are used to assess the severity of conditions presented to the N-600 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-600 front panel. The advanced signal processing in the N-600 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 six seconds to seven seconds (approximately three seconds in Fast Mode). During conditions such as those caused by low perfusion, interference (e.g., external interference like ambient light), or a combination of the two, the N-600 algorithm automatically extends the amount of data required beyond the minimum as set by the response mode. See Setting the N-600 Response Mode on page 53. 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

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