N-3000 Patient Monitor Operators Manual Dec 1996

Corporate Headquarters Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, California 94588 USA Tel. 510 463-4000 1-800-NELLCOR European Office Nellcor Puritan Bennett Europe BV Hambakenwetering 1 5231 DD ’s-Hertogenbosch The Netherlands Tel. +31.73.6485200 Asia/Pacific Office Nellcor Puritan Bennett HK Ltd. Room 1602 Evergo House 38 Gloucester Road Wanchai Hong Kong Tel. +852.2529.0363 Regional/Local Offices Nellcor Puritan Bennett UK Ltd. 10 Talisman Business Centre London Road Bicester, Oxfordshire OX6-0JX United Kingdom Tel. +44.1869.322700

Nellcor Puritan Bennett Germany GmbH Black-&-Decker-Strasse 28 65510 Idstein Germany Tel. +49.6126.5930 Nellcor Puritan Bennett Belgium NV/SA Interleuvenlaan 62/8, Zone 2 B-3001 Heverlee Belgium Tel. +32.16.400467 Nellcor Puritan Bennett France 3 avenue du Canada, Batiment Sigma LP851 Les Ulis 91975 Courtaboeuf Cedex France Tel. +33.01.69.82.14.00 Nellcor Puritan Bennett Germany GmbH Black-&-Decker-Strasse 28 65510 Idstein Germany Tel. +49.6126.5930 Nellcor Puritan Bennett Italia Srl Via dei Tulipani, 3 20090 Pieve Emanuele (MI) Italy Tel. +39.2.90786404 Nellcor Puritan Bennett Finland Oy Kappelitie 6 B 02200 Espoo Finland Tel. +358.0.452.65.343

To obtain information about a warranty, if any, for this product, contact Nellcor Puritan Bennett Technical Services 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, Nellcor Symphony, Oxisensor II, Dura-Y, Oxismart, OxiCliq, and the Nellcor Puritan Bennett knob configuration. 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; 4,869,254; 5,078,136; 5,351,685; and 5,368,026.

CONTENTS Figures Tables

Safety Information ... Warnings... General Warnings ... Measurements ... N-3000 and Other Equipment... Introduction ... Intended Use ... About This Manual... Controls, Indicators, and Symbols ... Displays, Controls, Indicators, and Connectors ... N-3000 Symbols ... Rear Panel ... Right Side Panel ... SPS External Power Supply Symbols ... Description of Controls ... Description of Visible Indicators and Displays ... Description of Audible Indicators ... Setup ... Connecting to an External Power Supply ... Battery Operation ... Stacking with the N-3100 or N-3200 ... Connecting the N-3000 to the N-3100 or N-3200 ... Removing the N-3000 from the N-3100 or N-3200... Serial Interface ... Sensors and ECG Leads ... Selecting a Nellcor Puritan Bennett Sensor... Connecting SpO2 Sensors ... Sensor Performance Considerations... Selecting a Nellcor Puritan Bennett ECG Lead ... Color Coding ... Applying ECG Leads ... Start-up and Use ... Power-on and Self-Test ... Automatic Self-Tests ... Turning On the N-3000... Clearing Data ...

1 1 1 2 3 5 5 5 7 7 9 9 9 9 10 10 13 15 15 16 16 17 18 18 21 21 22 22 23 23 24 27 27 27 27 29 iii

Contents

Neonatal Mode ... Patient Trend Data ... Format 1 ... Format 2 ... Format 3 ... Pacer Filter... ECG Low Frequency Filter ... Respiration Sensitivity ... Description of Alarms ... Management of Loss-of-Pulse Alarm... Alarm Descriptions ... All Alarm Silence... Latching Alarm Option... Alarm Summary ... Adjusting Alarm Limits... Overview... Selecting Alarm Limit to be Adjusted ... Heart/Pulse Rate Alarm Limits ... Setting Respiration Rate Monitoring to Off ... Respiration Noise Timeout ... Alarm Limits Changed Indicator ... Selecting “Smart”Heart/Pulse Rate Alarm Limits... Adjusting Audible Alarm Silence Duration... Shortcut to Select OFF for Audible Alarm Silence Duration ... Adjusting Audible Alarm Volume ... Audible Alarm Off Reminder ... Adjusting Pulse “Beep” Volume ... ECG Noise ... Technical Staff Adjustable Features ... Nellcor Symphony Instruments in Stack... Troubleshooting and Maintenance... Troubleshooting... Error Codes... EEE 055... EEE 058... EEE 060/EEE 062... EEE 081... Error Conditions ... EMI Interference... Service... Cleaning...

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29 30 30 30 30 31 31 31 32 32 35 37 38 39 40 40 40 41 42 43 43 43 44 45 46 46 46 47 48 49 51 51 51 51 51 52 52 52 55 56 56

Contents

Battery Maintenance ... 57 Obtaining Technical Assistance ... 57 Returning System Components ... 57 Specifications ... 59 Electrical ... 59 Protection Class ... 59 Degree of Protection ... 59 Mode of Operation ... 59 Patient Applied Waveforms... 59 Factory Settings ... 59 Factory Alarm Default Settings... 59 Factory General Default Settings... 60 Performance... 60 Measurement Range ... 60 Pulse Rate Display Update Frequency ... 61 Heart Rate Averaging Type ... 61 Alarm Limit Range - Adult/Pediatric and Neonate... 61 Alarm Characteristics ... 61 ECG-Specific Performance Characteristics ... 62 Accuracy ... 64 Environmental Conditions... 65 Temperature ... 65 Altitude/Barometric Pressure ... 65 Relative Humidity... 65 Appendix: Principles of Oximetry Operation ... A-1 Pulse Oximetry Overview ... A-1 Automatic Calibration ... A-2 Functional versus Fractional Saturation ... A-2 Measured versus Calculated Saturation... A-2

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Contents

FIGURES 1 N-3000 Front Panel ... 7 2 N-3000 Rear Panel ... 8 3 N-3000 Right Side Panel ... 8 4 N-3000 Top Panel ... 8 5 N-3000 Left Side Panel ... 9 6 Removing the N-3100 Top Cover ... 17 7 Connecting SpO2 Sensor to SCP-10 Cable ... 22 8 Standard ECG Leads Placement ... 25 9 Modified Chest Lead (MCL1) Placement ... 25 10 Standard Neonate ECG Leads Placement ... 26 11 Monitoring Conditions and Alarm Responses... 33 12 Setting Audible Alarm Silence Duration to Off ... 45 A-1 Oxyhemoglobin Dissociation Curve ... A-3 TABLES 1 2 3

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Compatible Nellcor Puritan Bennett Sensors... 22 Nellcor Puritan Bennett ECG Leads ... 23 Audible Alarm Off Duration... 37

SAFETY INFORMATION Warnings

WARNINGS General Warnings Explosion hazard. Do not use the N-3000 patient monitor in the presence of flammable anesthetics. The N-3000 is to be operated by qualified personnel only. Before use, carefully read this manual, accessory directions for use, all precautionary information, and specifications. The N-3000 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. Electric shock hazard. Covers to be removed only by qualified service personnel. There are no user-serviceable parts inside. Do not connect to an electrical outlet controlled by a wall switch. Do not expose the N-3000 to extreme moisture levels such as direct exposure to rain. Exposure to extreme moisture levels may cause incorrect or inaccurate performance, or device failure during or after exposure. Do not use the N-3000 or Nellcor Puritan Bennett oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The N-3000 may affect the MRI image, and the MRI unit may affect the accuracy of oximetry measurements. Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Such transients may be minimized by proper electrode and cables placement, as specified in this manual and electrode directions for use.

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Safety Information

The safety and effectiveness of the N-3000 patient monitor in the detection of apnea, particularly in apnea of premature or infant patients, has not been established. Nellcor Puritan Bennett’s oxygen transducers (sensors) can be categorized as surface devices contacting skin for a limited duration of time. Biocompatibility testing has been conducted on Nellcor Puritan Bennett’s sensors in compliance with ISO 10993-1, which suggests cytotoxicity, sensitization and irritation or intracutaneous reactivity testing be performed on devices falling into this category. The sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993-1. Measurements If the accuracy of any measurement does not seem reasonable, check the patient’s vital signs by alternate means, then check the N-3000 for proper functioning. Inaccurate measurements may be caused by: •

incorrect sensor application or use

•

significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or methemoglobin)

•

intravascular dyes such as indocyanine green or methylene blue

•

exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight

•

excessive patient movement

•

venous pulsations

•

placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line

You can continue to use the N-3000 on a patient during defibrillation, but the readings may be inaccurate for a short 2

Safety Information

time. Loss of pulse signal can occur in any of the following situations: •

the sensor is too tight

•

there is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight

•

a blood pressure cuff is inflated on the same extremity as the one to which an SpO2 sensor is attached

•

the patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia

•

there is arterial occlusion proximal to the sensor

•

the patient is in cardiac arrest or is in shock

N-3000 and Other Equipment When connecting the N-3000 to any instrument, verify proper operation before clinical use. Refer to the other device’s manual for full instructions. 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 configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 601-1-1. If in doubt, consult Nellcor Puritan Bennett’s Technical Services Department or your local Nellcor Puritan Bennett representative. Noninvasive blood pressure monitors may interrupt N-3000 pulse rate measurements, creating false alarms. A stacked N-3100 Nellcor Symphony blood pressure monitor informs the N-3000 of an inflation in progress, reducing the likelihood of false alarms. It is recommended that only a stacked N-3100 blood pressure monitor be used with the 3

Safety Information

N-3000.

4

INTRODUCTION Intended Use About this Manual

INTENDED USE The purpose and function of the Nellcor Symphony N-3000 patient monitor is to noninvasively and continuously monitor functional arterial oxygen saturation, pulse rate, heart rate, and respiration rate for adult, pediatric, and neonatal patients in all hospital areas and hospital-type facilities. It may be used during hospital transport when powered by its internal battery. The N-3000 can operate as a standalone monitor or it can be connected to (stacked with) other Nellcor Symphony instruments, such as the N-3100 blood pressure monitor and N-3200 display/printer. When used with the N-3200 display/printer, the instruments can display and print out ECG, respiration, and plethysmographic waveforms and SpO2, pulse rate, heart rate, and respiration rate tabular data. ABOUT THIS MANUAL This manual explains how to set up and use the N-3000 patient monitor. Important safety information relating to general use of the N-3000 appears before this introduction. Other important safety information is located throughout the text where appropriate. Read the entire Safety Information section before you operate the monitor. In addition to the safety section, this manual includes the following sections: •

Controls, Indicators, and Symbols shows the monitor, locates all controls, indicators, and symbols, and explains their functionality.

•

Setup explains how to set up the monitor and connect it to other Nellcor Symphony instruments and accessories.

•

Sensors and ECG Leads describes Nellcor Puritan Bennett sensors, ECG leads, and accessories used with the monitor.

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Introduction

6

•

Startup and Use explains how to operate the monitor.

•

Troubleshooting and Maintenance provides information about servicing the monitor and obtaining technical assistance.

•

Specifications lists technical specifications for the monitor, default alarm limit settings, and performance ranges.

•

Appendix: Principles of Oximetry Operation presents a clinical explanation of the how pulse oximetry and the N-3000 works.

CONTROLS, INDICATORS, AND SYMBOLS Displays, Controls, Indicators, and Connectors N-3000 Symbols SPS External Power Supply Symbols Description of Controls Description of Visible Indicators and Displays Description of Audible Indicators

DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS Figures 1 through 5 show the front, rear, side, and top views of the N-3000 and identify displays, controls, and connectors.

Figure 1: N-3000 Front Panel 1 2 3 4 5 6 7 8 9 10

SpO2% Display Pulse Amplitude Indicator ECG Heart Rate Indicator Heart/Pulse Rate Display Respiration Rate Display Neonatal Mode Indicator Audible Alarm Off Indicator On/Standby Button Power On Indicator Stacked Indicator

11 12 13 14 15

Print Button Battery in Use/Battery Low Indicator Battery Charging Indicator Linked Indicator * RF Locked Indicator *

16 17 18 19 20

Lower Alarm Limit Button Upper Alarm Limit Button Leads Off Indicator Pulse Search Indicator Patient Motion Indicator

* Not used on this model

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Controls, Indicators, and Symbols

Figure 2: N-3000 Rear Panel

Figure 3: N-3000 Right Side Panel

Figure 4: N-3000 Top Panel

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Controls, Indicators, and Symbols

Figure 5: N-3000 Left Side Panel N-3000 SYMBOLS Rear Panel New Patient/Neonatal Button Data Interface Attention: Refer to Manual Right Side Panel SpO2

SpO2 Cable Input Type CF Equipment Type CF Equipment with Defibrillator Protection

SPS EXTERNAL POWER SUPPLY SYMBOLS Input Voltage Output Voltage Equipotential (Ground) Terminal

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Controls, Indicators, and Symbols

Caution: Shock Hazard Power Available Indicator DESCRIPTION OF CONTROLS The ON/STANDBY button is used to turn the N-3000 on or off. Three consecutively higherpitched beeps sound when turning the N-3000 on, and three consecutively lower-pitched beeps sound when turning the N-3000 off. The NEW PATIENT/NEONATAL button on the rear panel is used to clear stored patient data or to switch between adult-pediatric and neonatal modes. The AUDIBLE ALARM OFF button is used to silence current audible alarms for the selected alarm silence duration period. The PRINT button is used when the N-3000 and the N-3200 display/printer are stacked to cause the N-3200 to begin printing current N-3000 data. The UPPER ALARM LIMIT button is used to view and set upper alarm limits. The LOWER ALARM LIMIT button is used to view and set lower alarm limits. When used by itself, the knob adjusts pulse beep volume on the N-3000. It is also used with other controls to adjust alarm limits, audible alarm silence duration, and alarm volume. DESCRIPTION OF VISIBLE INDICATORS AND DISPLAYS The SpO2% display shows patient arterial hemoglobin oxygen saturation level. It is updated with each pulse. The SpO2% display flashes and an alarm sounds when SpO2% is outside the alarm limits. During Pulse Search, the display will alternate between dashed lines and the last qualified oxygen saturation measurement. 10

Controls, Indicators, and Symbols

The PULSE AMPLITUDE indicator is a 10-segment display that shows the relative pulse amplitude. The bottom segment remains lit as long as an SpO2 cable and SpO2 sensor are connected to the N-3000. As the detected pulse becomes stronger, more contiguous segments light with each pulse. The ECG HEART RATE indicator lights continuously while ECG is being used as the heart/pulse rate source. The HEART/PULSE RATE display shows the pulse or heart rate (whichever one is configured as the primary source) in beats per minute. It is updated with each pulse or heartbeat. It flashes and an alarm sounds when the pulse or heart rate are outside the alarm limits. During pulse search, the display alternates between dashed lines and the last detected pulse rate. If the detected pulse is lost or no heartbeat is detected, a flashing zero is displayed and an alarm sounds. The RESPIRATION RATE display shows the respiration rate in breaths per minute. It is updated with each breath. It flashes and an alarm sounds when the respiration rate is outside the alarm limits. If no respiration is detected, a flashing zero is displayed and an alarm sounds. PULSE SEARCH

The PULSE SEARCH indicator lights during power-up, prior to initial acquisition of a pulse signal and during pulse search mode (applicable only when SpO2 derived pulse rate is the primary source of heart/pulse rate measurement).

MOTION

The MOTION indicator lights when patient motion is detected by the N-3000.

LEADS OFF

The LEADS OFF indicator lights when the ECG electrodes have become disconnected from the patient or when the leads have been disconnected from the electrodes or the cable. Also, if the cable is connected to the N-3000 ECG cable connector when the monitor is turned on, and is later disconnected, the LEADS OFF indicator lights. 11

Controls, Indicators, and Symbols

NEONATAL

The NEONATAL indicator lights when the N-3000 is in neonatal mode. The POWER ON indicator to the right of the ON/STANDBY button lights continuously while the N-3000 is on. The AUDIBLE ALARM OFF indicator lights steadily to signify that the current audible alarm has been temporarily silenced. If the alarm condition ceases prior to the end of the alarm silence duration, the light goes out. While the condition exists, the indicator remains lit for the selected duration or until a higher priority alarm condition arises, in which case the AUDIBLE ALARM OFF indicator is no longer illuminated and an alarm sounds. The indicator flashes when the audible alarm silence duration is set to “OFF”. When the N-3000 (or an attached N-3100) has the audible alarm silence duration set to “OFF” during an alarm condition, the AUDIBLE ALARM OFF indicator flashes and the audible alarm off reminder will sound at 3-minute intervals. This occurs only if the N-3000 (or any attached N-3100) has had the audible alarm off reminder enabled (using the service mode as described in the N-3000 service manual). The BATTERY IN USE/BATTERY LOW indicator lights continuously when the battery is in use. When 15 minutes or less battery capacity remains, the indicator flashes and a medium priority alarm sounds.

WARNING: If the unit is turned off while the BATTERY IN USE/BATTERY LOW indicator is flashing and then turned on again without recharging, the indicator may take up to 30 seconds to begin flashing, even though the battery has less than 15 minutes of use left. Always recharge the battery after turning off an N-3000 with a flashing BATTERY IN USE/BATTERY LOW indicator.

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Controls, Indicators, and Symbols

The BATTERY CHARGING indicator is always lit when the N-3000 is connected to AC power and turned on. When the N-3000 is connected to AC power and the monitor is turned off, the BATTERY CHARGING indicator will remain lit for approximately 14 hours and then turns off. If there are any power interruptions, the 14 hour charging period begins again when power is restored. An illuminated BATTERY CHARGING indicator is not necessarily an indication that the battery contains less than a full charge. It is merely used as a timer to indicate that the battery has been continuously charging for less than 14 hours. The N-3000 may be used with a less than fully charged battery but with a corresponding decrease in operating time from that charge. The STACKED indicator lights when the N-3000 is stacked with the N-3100, the N-3200, or both and communication between the instruments is established. DESCRIPTION OF AUDIBLE INDICATORS Audible indicators listed previously in this section have symbols associated with them. The list below represents tones for which there is no accompanying symbol or button. Valid keypress

1 high-pitched beep

Invalid keypress

1 low-pitched beep

Power-on self-tests passed

1 one-second medium-pitched beep

“Smart” Pulse Rate Alarm Limits Set

3 medium-pitched beeps

Pulse/heart “beep”

Beeps that are synchronous with each measured pulse or heartbeat

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SETUP Connecting to an External Power Supply Battery Operation Stacking with the N-3100 or N-3200 Serial Interface

CONNECTING TO AN EXTERNAL POWER SUPPLY The N-3000 may be used alone or stacked with the N-3100 blood pressure monitor, the N-3200 display/printer, or both. If transporting the monitor, or if AC power is not available, you may operate the N-3000 on battery power for a limited amount of time. In that case, skip Steps 2 through 6 below. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Do not place the monitor or external power supply in any position that might cause it to fall on the patient. Do not lift the monitor by the power supply cord. Disconnection could cause the monitor to drop on the patient. 1.

Place the N-3000 on a flat surface near the patient. With an optional mounting adapter such as the Nellcor Symphony DB-1 mounting kit, the N-3000 may be attached to an IV pole, bed rail, wall mount, or headboard.

2.

When connecting the N-3000 to the SPS-N1, place the external power supply on a flat surface near the N-3000 so the power supply cable will reach the N-3000. (If you are connecting the N-3000 to the PSS-1 power supply, follow the PSS directions for use and skip to step 5.)

Caution: For AC operation, use only the Nellcor Symphony SPS-N1 or PSS-1 power supply. Use of other power supplies may result in damage to or improper operation of the N-3000.

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