N-395 Operators Manual Dec 2002

Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton, CA 94588 USA Toll Free: 1.800.NELLCOR Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS, U.K.

Nellcor Puritan Bennett Inc. is a division of Tyco Healthcare. Nellcor and Nellcor Puritan Bennett are trademarks of Tyco Healthcare. To obtain information about a warranty, if any, for this product, contact Nellcor Puritan Bennett Technical Services Department, or your local Nellcor Puritan Bennett 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. The following are trademarks of Nellcor Puritan Bennett Inc.: Durasensor, Oxisensor II, Oxinet, Dura-Y, Oxiband, and Oxicliq. 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; 4,928,692; 4,934,372; 5,351,685; 5,368,026; 5,485,847; 5,533,507, and 5,662,106.

CONTENTS Figures Tables Contents ...iii Figures... vii Tables... viii Safety Information ...1 General Safety Information ...1 Introduction ...3 Intended Use ...3 General Operating Principles and Conditions...3 Controls, Indicators, and Symbols ...5 Displays, Controls, Indicators, and Connectors ...5 N-395 Symbols ...6 Description of Controls ...7 Function Buttons ...7 Description of Displays and Visual Indicators ...8 Description of Audible Indicators...9 Setup ...11 Unpacking and Inspection ...11 Performance Verification ...11 List of Components ...11 Optional Accessories ...12 Monitor Setup ...18 General Warnings ...18 Connecting the N-395 to AC Power...19 Operating on a Discharged Battery ...19 Language Selection...21 Sensors ...23 Selecting a Sensor ...23 Biocompatibility Testing...24 Performance Considerations...25 Start-up and Use ...27 Basic Operation ...27 Power-On Self-Test (POST) ...28 Adult-Pediatric and Neonatal Settings ...30 Contrast...31 Monitoring Mode ...31 Pulse Search...32

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Contents At Initial Power-Up (Sensor Attached to Monitor)... 32 At Initial Power-Up (No Sensor Attached to Monitor) ... 32 After Taking Measurements ... 33 Sensor Disconnected ... 33 Sensor Off ... 33 Automatic Shutdown ... 33 Alarms ... 34 Description of Alarms ... 34 SatSeconds Alarm Management... 35 SatSeconds "Safety Net"... 37 Determining the SatSeconds... 37 SatSeconds Display ... 38 Adjustable Settings ... 38 Pulse Beep Volume ... 38 Alarm Volume ... 39 Alarm Silence Duration... 39 Disabling Audible Alarms ... 40 Alarm Silence Reminder... 40 Menu ... 41 Menu Structure ... 41 Limits... 42 Overview... 42 Viewing Current Alarm Limits ... 42 Changing Alarm Limits ... 43 Alarm Limits Changed Indicator ... 46 Trend... 46 View ... 48 Zoom ... 50 Time ... 51 Scale ... 51 Auto ... 52 40-Second Trends Table... 52 Next ... 53 Delete ... 53 Print ... 53 Setup... 54 View ... 54 Clock ... 54 Comm ... 55 Lang ... 59

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Contents Ncall ...60 Analog ...60 Light ...60 Default Settings...60 Nurse Call Feature...62 Battery Operation ...63 Low Battery Indicator ...63 Disposal of Device Components ...64 Performance Considerations...64 Impact of Patient Conditions on Monitor Readings ...64 Troubleshooting and maintenance...67 Troubleshooting...67 Error Codes...67 Other Messages...68 Suggested Corrective Actions ...69 EMI (Electromagnetic Interference) ...72 Obtaining Technical Assistance ...73 Returning The N-395...73 Maintenance ...74 Service ...74 Periodic Safety Checks...74 Performance Verification ...74 Cleaning ...74 Specifications...77 Performance ...77 Measurement Range ...77 Accuracy ...77 Electrical ...78 Instrument ...78 Battery ...78 Environmental conditions ...79 Transport and Storage (in shipping container)...79 Transport and Storage (not in shipping container)...79 Operation ...79 Physical Characteristics ...80 Compliance...80 Quick Guide to Operation ...81 Introduction...81 Settings Adjustments...81

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Contents Principles of Operation... 87 Oximetry Overview... 87 Automatic Calibration ... 87 Functional versus Fractional Saturation... 88 Measured versus Calculated Saturation ... 88 DATA Port protocol... 91 Overview ... 91 Connecting to the DATA port... 91 Baud Rate ... 93 Setting data port protocol... 93 Real-time display format ... 94 Column Headings ... 95 Patient Data and Operating Status... 97 Trend Data Printout (ASCII Mode)... 98 Trend data printout (Graph Mode) ... 100 Nurse Call ... 100 Analog Outputs ... 102 INDEX ... 103

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Contents

FIGURES Figure 1: N-395 Front Panel Display (Pleth View) ...5 Figure 2: N-395 Rear Panel ...6 Figure 3: GCX Mounting Plate ...13 Figure 4: GCX Poly-mount (vertical wall mount with 19-inch channel) ...14 Figure 5: GCX Poly-mount (horizontal wall mount with rail adapter) ...15 Figure 6: GCX Roll Stand Poly-mount ...16 Figure 7: GCX Utility Basket ...17 Figure 8: Soft Sided Carrying Case ...18 Figure 9: Monitoring Mode Display - Pleth View ...30 Figure 10: Monitoring Mode Display – Blip (Magnified) View ...30 Figure 11: Alarm Response with SatSeconds ...36 Figure 12: Alarm Limits Selection ...46 Figure 13: SpO2 Trend ...47 Figure 14: Dual Trend Display ...48 Figure 15: SpO2 Trend Display ...49 Figure 16: Pulse Rate Trend Display ...49 Figure 17: Histogram...50 Figure 18: AMP Trend Display ...50 Figure 19: ZOOM Sub-menu...51 Figure 20: 40-Second Trends ...52 Figure 21: SpaceLabs Connection...57 Figure 22: Oxyhemoglobin Dissociation Curve...89 Figure 23: Data Port Pin Layout...93 Figure 24: Real-Time Printout ...95 Figure 25: Trend Data Printout (ASCII Mode)...99 Figure 26: Trend Data Printout (Graph Mode) ...100

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Contents

TABLES Table 1: Nellcor Sensors ... 24 Table 2: Limits Menu ... 43 Table 3: Trend Menu ... 44 Table 4: Setup Menu ... 45 Table 5: Trend Scale ... 47 Table 6: Factory Default Settings (Adult)... 61 Table 7: Factory Default Settings (Neonate) ... 62 Table 8: Error Codes and Messages... 68 Table 9: Settings Adjustments ... 81 Table 10: Data Port Pinouts... 92 Table 11: Status Codes ... 98 Table 12: Voltage Between Pins 10 and 11 ... 99 Table 13: Analog Pinouts... 101

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SAFETY INFORMATION General Safety Information

GENERAL SAFETY INFORMATION This section contains important safety information related to general use of the N-395 pulse oximeter. Other important safety information appears throughout the manual in sections that relate specifically to the precautionary information. Read all text surrounding all precautionary information. Important! Before use, carefully read this manual, accessory directions for use, all precautionary information in boldface type, and specifications. WARNING: Explosion hazard. Do not use the N-395 pulse oximeter in the presence of flammable anesthetics or gases. WARNING: The N-395 is a prescription device and is to be operated by qualified personnel only. WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information. WARNING: Chemicals from a broken LCD display panel are toxic when ingested. Use caution when handling a monitor with a broken display panel.

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Safety Information

Caution: When connecting the N-395 to any instrument, verify proper operation before clinical use. Both the N-395 and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the monitor’s data interface must be certified according to IEC Standard 950 for data-processing equipment or IEC Standard 601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port (N-395 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 601-1-1 and the electromagnetic compatibility system standard IEC Standard 601-1-2. The N-395 accuracy may degrade if it is connected to secondary I/O devices when the instrument is not connected to earth reference. To ensure accurate readings, consider the environmental conditions that are present and the condition of the patient. See the appropriate sections of the manual for specific safety information related to these conditions.

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INTRODUCTION Intended Use General Operating Principles and Conditions

The latest version of this manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ ProductManuals.html INTENDED USE The N-395 is a portable pulse oximeter intended for use as a continuous non-invasive monitor of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The intended patient population comprises adult, pediatric, and neonatal patients. The intended environments of use are hospitals, hospitaltype facilities, intra-hospital transport environments, and home care. The N-395 is for prescription use only. 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 such as surgicenters, sub-acute centers, special nursing facilities, and sleep labs, outside of the hospital. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. WARNING: The N-395 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. GENERAL OPERATING PRINCIPLES AND CONDITIONS The N-395 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light source and a photodetector.

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Introduction

Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated into a measurement of functional oxygen saturation (SpO2). Note:

For an explanation of functional versus fractional saturation, refer to Principles of Operation.

Because a measurement of SpO2 is dependent upon light from the sensor, excessive ambient light can interfere with this measurement. Specific information about ambient environmental conditions, sensor application, and patient conditions is contained throughout this manual.

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CONTROLS, INDICATORS, AND SYMBOLS Displays, Controls, Indicators, and Connectors N-395 Symbols Description of Controls Description of Displays and Visual Indicators Description of Audible Indicators

DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS Figure 1 and Figure 2 show the front and rear views of the N-395 and identify displays, controls, and connectors.

1 2 3 4 5 6 7 8 9

SpO2 Sensor Port AC Power Indicator Power On/Off Button Low Battery Indicator Waveform Display SatSeconds Timer %SpO2 Display Pulse Rate Display Alarm Silence Indicator

10 11 12 13 14 15 16 17 18

ALARM SILENCE Button ADJUST UP Button ADJUST DOWN Button CONTRAST Button Softkeys Menu Bar Motion Indicator Pulse Search Indicator Speaker

Figure 1: N-395 Front Panel Display (Pleth View)

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Controls, Indicators, and Symbols

1. Equipotential (ground) Terminal 2. Data Port Connector

3. Fuse Receptacle 4. Supply Voltage Selector Switch

Figure 2: N-395 Rear Panel N-395 SYMBOLS See Instructions for Use Fuse Replacement Equipotential Terminal Type BF Applied Part - Not defibrillator proof Date of Manufacture Data Interface

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Controls, Indicators, and Symbols

DESCRIPTION OF CONTROLS Function Buttons

The Power On/Off Button. Used to turn the N-395 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. The ALARM SILENCE button clears “Sensor Off” and “Sensor Disconnect” messages from the display. The ADJUST UP Button. Used to increase alarm limit values, alarm silence duration, pulse beep volume, alarm volume, contrast, date and time values, data port baud rate, and to move the cursor to the right (in the trend view). The ADJUST DOWN Button. Used to decrease alarm limit values, alarm silence duration, pulse beep volume, alarm volume, contrast, date and time values, data port baud rate, and to move the cursor to the left (in the trend view). The CONTRAST Button. Used in conjunction with the ADJUST UP/DOWN Buttons to lighten or darken the display screen. The softkey buttons have multiple uses depending on the legend displayed above the button.

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Controls, Indicators, and Symbols

DESCRIPTION OF DISPLAYS AND VISUAL INDICATORS The %SpO2 Display. Shows the saturation of hemoglobin oxygen. The displayed value flashes zeros during loss-of-pulse alarms and flashes the SpO2 value when SpO2 is outside of 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 (100.). 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 (magnified) view. The displayed value flashes zeros during loss-of-pulse alarms and flashes the pulse rate value when pulse rate is outside of 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 pulse rate value (95.). 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. The AC Power Indicator. Lights continuously when the N-395 is connected to AC power. It also indicates that the battery is charging. It is off when the monitor is being powered by its internal battery. The Low Battery Indicator. Lights continuously to indicate that 15 or fewer minutes of battery capacity remains. 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.

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Controls, Indicators, and Symbols

The Motion Indicator. Lights when the monitor detects motion artifact. The Pulse Search Indicator. Lights continuously prior to initial acquisition of a pulse signal, and during prolonged and challenging monitoring conditions. It flashes during a loss-of-pulse signal. The SatSeconds Indicator. Fills in clockwise as the SatSeconds alarm management system approaches the SatSeconds alarm limit threshold. DESCRIPTION OF AUDIBLE INDICATORS Following are descriptions of N-395 audible indicators. Power-On Self-Test Pass

A 1-second tone indicating that the N-395 has been turned on and successfully completed the poweron self-test

Valid Button Press

A short, medium-pitched tone indicating that an appropriate button has been pressed

Invalid Button Press

A short, low-pitched tone indicating that a button has been pressed that is not appropriate for the current state of the monitor

High Priority Alarm

A high-pitched, fast-pulsing tone indicating loss of pulse

Medium Priority Alarm

A medium-pitched, pulsing tone indicating an SpO2 or pulse rate limit violation

Low Priority Alarm

A low-pitched, slow-pulsing tone indicating a sensor disconnect, sensor off, low battery, or monitor failure.

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Controls, Indicators, and Symbols

10

Alarm Silence Reminder

Three beeps that sound approximately every 3 minutes when alarms are silenced with the alarm silence duration set to OFF.

Pulse Beep

A single beep sounds for each detected pulse. The pitch changes as monitored SpO2 values increase or decrease.

Volume Setting Tone

A continuous tone that is used to adjust the alarm volume.

Confirmation Tone

Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been deleted.

SETUP Unpacking and Inspection Performance Verification List of Components Monitor Setup Language Selection

UNPACKING AND INSPECTION Notify the carrier if the shipping carton is damaged. Unpack the N-395 and components. If anything is missing or damaged, contact Nellcor Puritan Bennett Technical Services Department or your local Nellcor Puritan Bennett representative. PERFORMANCE VERIFICATION The N-395 performance can be verified by following the procedures outlined in the Performance Verification section of the N-395 service manual. Qualified service personnel should perform this procedure before using the monitor for the first time in a clinical setting. LIST OF COMPONENTS 1

N-395 Pulse Oximeter

1

Nellcor sensor or assortment pack

1

SCP-10 or MC-10 Pulse Oximeter Sensor Cable

1

N-395 Operator’s Manual

1

Hospital Grade Power Cord

2

Fuses

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Setup Optional Accessories

Several mounting configurations, a utility basket, and a carrying case are offered with the N-395. Contact Nellcor Puritan Bennett’s Technical Services Department or your local Nellcor Puritan Bennett representative for information about these accessories.

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GCX Mounting Plate. See Figure 3, page 13.

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GCX Poly-mount (vertical wall mount with 19-inch channel). See Figure 4, page 14.

•

GCX Poly-mount (horizontal wall mount with rail adapter). See Figure 5, page 15.

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GCX Roll Stand Poly-mount. See Figure 6, page 16.

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GCX Utility Basket. See Figure 7, page 17.

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Soft Sided Carrying Case. See Figure 8, page 18.