Nellcor N-200 Operators Manual Feb 2003

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 OAS, U.K.

To obtain information about a warranty, if any, for this product, contact Nellcor Technical Services or your local Nellcor representative. NELLCOR, DURASENSOR, DURA-Y, OXIBAND, OXICLIQ, OXISENSOR, OXISENSOR II, OXINET, C-LOCK, and the Nellcor knob configuration are trademarks of Nellcor Incorporated. ThinkJet is a trademark of Hewlett-Packard Company. 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; 4,911,167; 4,928,692; 4,934,372; 5,078,136.

CONTENTS Figures Tables

Safety Information ... Warnings... General ... Alarms... Electrical ... Sensors ... Measurements ... Symbols ... Quick Guide to Operation ... Basic Operation ... Alarm Functions ... Check Alarm Limits... Adjust Alarm Limits ... Adjust Alarm Volume ... Silence Alarm Temporarily... Adjust Alarm Silence Period ... Pulse Tone Volume... Features ... Overview ... Automatic Self-Test and Startup ... Oximeter Configurable Settings ... Principles of Operation ... Operating Principles... C-LOCK ECG Synchronization... Automatic Calibration... Functional versus Fractional Saturation... Measured versus Calculated Saturation... Setup ... Unpacking and Inspection... Testing ... Components ... Display ... Controls ... Front Panel ... Interface/Powerbase Rear Panel ...

1 1 2 2 2 2 3 5 7 7 7 7 7 8 8 8 8 9 9 9 10 11 11 11 12 12 13 15 15 15 16 16 16 16 18

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Contents

Rear-Panel Switches ... C-13-200 and C-20-200 Patient Modules ... C-13-200M Patient Module ... NELLCOR Sensors ... Selecting a NELLCOR Sensor ... Cleaning and Reuse ... Performance Considerations ... Guide to Operation ... Basic Operation ... Pulse Oximetry Subsystem Features... Pulse Tone ... Alarm Functions ... Oximetry Operating Modes ... C-LOCK ECG Synchronization... Trend and Event Memories ... User-Defined Events... Limit Events ... Communications Formats ... Interface/Powerbase ... Battery Operation... Connecting to Other Instruments ... Overview ... RS-232 Communication Protocol ... Serial Data Connector Pin Assignments ... Communications Formats ... Setting Baud Rate... Connecting the N-7000 Interface ... Connecting to the N-7500 Network... Connecting the N-9000 Recorder/Interface ... Connecting Other Strip-Chart Recorders... Connecting the Thinkjet Printer... Connecting the P-200 Printer ... Maintenance ... Service ... Cleaning ... Battery Testing... Determining Software Version ... Technical Assistance ... Returning the N-200...

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20 20 21 23 23 24 25 27 27 28 28 29 33 34 38 43 44 49 58 59 61 61 61 61 63 65 65 66 66 67 68 69 71 71 71 71 72 72 73

Contents

Troubleshooting ... Status Messages ... Troubleshooting Guide... General System Problems ... General Oximetry Subsystem Problems ... Trend Memory Problems ... Specifications ... Performance ... ECG ... Environmental Conditions ... Electrical Characteristics... Physical Characteristics...

75 75 77 78 79 84 85 85 86 87 88 89

FIGURES 1 2 3 4 5 6 7 8

Oxyhemoglobin Dissociation Curve ... N-200 Front Panel ... Interface/Powerbase Rear Panel ... C-13-200 and C-20-200 Patient Modules ... C-13-200M Patient Module ... Standard Limb Lead Selection ... Sample ThinkJet Trend Graph ... Sample ThinkJet Event Graph ...

13 16 18 20 21 36 41 46

Rear-Panel Dip Switch ... Selected NELLCOR Sensors... Default Alarm Settings ... SERIAL COMM Connector Pin Assignments ... Output Format Switch Settings ... Baud Rate Switch Settings ...

20 24 31 62 63 65

TABLES 1 2 3 4 5 6

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SAFETY INFORMATION Warnings

WARNINGS General DANGER! Explosion hazard. Do not use in the presence of flammable anesthetics. The N-200 is to be operated by qualified personnel only. Before use, carefully read this manual, accessory directions for use, all precautionary information, and specifications. The user must check that the equipment functions safely and see that it is in proper working condition before being used. The N-200 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. Do not use NELLCOR pulse oximeters during magnetic resonance image (MRI) scanning. Adverse reactions include: potential burns to patients as a result of contact with attachments heated by the MRI RF pulse; potential degradation of the MR image; and, potential reduced accuracy of oximeter measurements. Always remove oximetry devices and attachments from the MR imaging environment before scanning a patient. For preamplification requirements, only an N-200 patient module should be used with the N-200 pulse oximeter. Do not use any other patient module (for example, the N-100 patient module).

1

Safety Information

Alarms Do not silence the audible alarm or decrease its volume if patient safety could be compromised. Check the audible alarm silence duration before temporarily silencing the audible alarm. Each time the monitor is used, check alarm limits to ensure they are appropriate for the patient being monitored. Electrical Electric shock hazard. Cover to be removed only by qualified service personnel. There are no userserviceable parts inside. Note: Do not connect to an electrical outlet controlled by a wall switch because power to the monitor could be inadvertently turned off. Sensors Before use, carefully read the sensor Directions for Use. Use only NELLCORoxygen transducers (sensors). Use of other oxygen transducers may cause improper oximeter performance. Tissue damage can be caused by incorrect application or use of a sensor (for example, wrapping the sensor too tightly or applying supplemental tape). Inspect the sensor site routinely to ensure skin integrity and correct positioning and adhesion of the sensor. If skin integrity changes, move the sensor to another site. Inspect the sensor and cable for fraying, cracking, breakage, or other damage. If defects are noted, do not use the sensor. Do not immerse sensor completely in water, solvents, or cleaning solutions (because the connector is not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide.

2

Safety Information

Measurements Loss of pulse signal can occur for the following reasons: ¥

The sensor is too tight. ¥

There is excessive illumination, such as from sunlight or a surgical or bilirubin lamp. ¥

The sensor is placed on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. ¥

The patient is in shock, has hypotension, severe vasoconstriction or anemia, hypothermia, arterial occlusion proximal to the sensor, or cardiac arrest. Inaccurate measurements may be caused by: ¥

Incorrect application or use of a sensor. ¥

Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin. ¥

Significant levels of indocyanine green, methylene blue, or other intravascular dyes. ¥

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. Exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material. ¥

Excessive patient movement. ¥

Venous pulsations. ¥

High-frequency electrosurgical interference and defibrillators. ¥

Placement of the sensor on an extremity that has a blood pressure cuff, arterial catheter, or intravascular line. 3

SYMBOLS

Attention: Refer to Manual

Fuse Replacement Symbol

Caution: Shock Hazard

5

QUICK GUIDE TO OPERATION Basic Operation Alarm Functions Pulse Tone Volume

BASIC OPERATION 1.

Select the appropriate NELLCOR sensor and apply it to the patient, following sensor directions for use. Connect the sensor to the patient module.

2.

Plug the N-200 into a properly grounded AC outlet using a hospital-grade power cord. Alternatively, operate the N-200 on its internal battery. Turn on the system: switch the ON/STDBY switch to the ON position.

3.

For C-LOCK ® ECG synchronization, connect an appropriate ECG signal source to the N-200.

4.

Check alarm limits. If necessary, adjust them to suit the patient’s needs.

ALARM FUNCTIONS Check Alarm Limits Press the appropriate alarm button (HIGH SAT, LOW SAT, HIGH RATE, or LOW RATE). When the button is pressed, the selected limit will show in the display. Adjust Alarm Limits Press the appropriate alarm button (HIGH SAT, LOW SAT, HIGH RATE, or LOW RATE), and turn the control knob until the desired setting appears.

7

Quick Guide to Operation

Adjust Alarm Volume Simultaneously, press the LOW SAT and HIGH SAT buttons. Turn the control knob until the desired setting appears in OXYGEN SATURATION display. Pushing the LOW SAT and HIGH SAT buttons activates the audible alarm to indicate volume. Silence Alarm Temporarily Press the AUDIO ALARM OFF button. The ALARM OFF indicator lights steadily during the alarm-off period. Do not silence the alarm if patient safety could be compromised. Adjust Alarm Silence Period Press and hold AUDIO ALARM OFF button and turn the control knob until the desired setting (30–120 seconds) appears in the OXYGEN SATURATION display. PULSE TONE VOLUME Turn the control knob to adjust the pulse tone volume.

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FEATURES Overview

OVERVIEW The NELLCOR N-200 pulse oximeter measures functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The system consists of three components: the N-200 pulse oximeter, an interface/powerbase, and a patient module. The N-200 monitors SpO 2 and pulse rate continuously and noninvasively, with measurements updated at each pulse beat. The interface/powerbase is a detachable AC power supply and external interface for the N-200. It provides isolated power for operating the monitor and charging its internal batteries. In addition, the interface/powerbase provides analog and digital outputs for external data recording devices and an input for C-LOCK ECG synchronization. A fiber optic output can be used to connect the N-200 to a NELLCOR N-7500 pulse oximetry network. The patient module (models C-13-200, C-20-200, or C-13-200M) provides a connector for the oximetry sensor and provides initial oximetry signal processing; models C-13-200 and C-20-200 also provide an ECG input connector. Automatic Self-Test and Startup The N-200 provides immediate use after startup, without need for operator calibration or configuration. It offers: •

Automatic self-test and error messages

•

Automatic oximetry calibration

•

Visible oximetry display

•

An early warning system that provides an audible indicator for both SpO2 and pulse rate: a tone sounds on each pulse, and its pitch varies with changes in SpO2

•

Operator-configured visible and audible oximetry alarms, with default alarm limits preset for adults or neonates 9

Features

Oximeter Configurable Settings The N-200 provides the operator with the capability to tailor the system for specific clinical applications. Capabilities include: •

Audible alarms that can be silenced; the alarm has adjustable volume.

•

C-LOCK ECG synchronization that enhances oximetry signal processing during patient movement or for patients with low perfusion.

•

Three oximetry operating modes that change measurement averaging time to suit varied clinical applications.

•

Oximetry trend memory, with up to 12-hour SpO2 and pulse rate trend data storage.

•

Oximetry and pulse rate event memory, with 1-hour event data storage. Data storage of event memory markers includes: alarm-limit-defined events and user-defined events.

•

Analog and digital output of saturation, pulse rate, and pulse waveform data. When an ECG signal is provided to the patient module three-lead ECG connector, the N-200 provides an analog output of the ECG waveform.

WARNING: Do not use the ECG analog output as a trigger for synchronous defibrillation.

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PRINCIPLES OF OPERATION Operating Principles OPERATING PRINCIPLES Pulse oximetry is based on two principles: that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (that is, spectrophotometry), and that the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (that is, plethysmography). A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared lowpower light-emitting diodes (LEDs) in the oximetry sensor serve as light sources; a photodiode serves as the photodetector. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation. To identify the oxygen saturation of arterial hemoglobin, the monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vascular bed, and blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The monitor bases its SpO2 measurements on the difference between maximum and minimum absorption (that is, measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous blood. C-LOCK ECG Synchronization C-LOCK ECG synchronization: read through motion to provide valid readings for many types of motion. During C-LOCK signal processing, the monitor requires two signals that reflect cardiac activity: the electrical pulse from the ECG and the optical pulse from the oximetry sensor.

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Principles of Operation

The delay between the electrical ECG pulse and the optical pulse at the sensor site is relatively stable for a given patient and sensor site. C-LOCKprocessing takes advantage of this temporal relationship, using the QRS complex as a reference point for identifying the oximetry pulse and for timing SpO2 measurements. This enhances “good” pulses and minimizes the effect of random artifacts associated with motion and low perfusion. Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies, an oximeter must know the mean wavelength of the sensor’s red LED to accurately measure SpO2. During manufacturing, the mean wavelength of the red LED is encoded in a resistor in the sensor. During monitoring, the instrument’s software reads this resistor and selects coefficients that are appropriate for the wavelength of that sensor’s red LED; these coefficients are then used to determine SpO2. This resistor is read when the monitor is turned on, periodically thereafter, and each time a new sensor is connected. Additionally, to compensate for differences in tissue thickness, the intensity of the sensor’s LEDs are adjusted automatically. Functional versus Fractional Saturation This monitor measures functional saturation-oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, laboratory hemoximeters report fractional saturation-oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins. To compare functional saturation measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted as follows: functional saturation =

12

fractional saturation 100 - (% carboxyhemoglobin + % methemoglobin)

x100

Principles of Operation

Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the calculated value may differ from the SpO2 measurement of a pulse oximeter. This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO 2 and saturation (Figure 1): pH, temperature, the partial pressure of carbon dioxide (PCO 2), 2,3-DPG, and fetal hemoglobin.

Saturation (%)

100

pH Temperature PCO2 2,3-DPG Fetal Hb

pH Temperature PCO2 2,3-DPG

50

0

50

100

PO2 (mmHg)

Figure 1: Oxyhemoglobin Dissociation Curve

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SETUP Unpacking and Inspection Testing Components

UNPACKING AND INSPECTION Notify the carrier immediately if the N-200 shipping carton is damaged. Carefully unpack the instrument and its accessories. Confirm that the following items are included: 1

N-200 pulse oximeter

1

interface/powerbase

1

hospital-grade power cord

1

patient module

1

operator’s manual

1

guide to operations

Inspect each component. If any component is missing or damaged, contact Nellcor’s Customer Service Department or your local Nellcor representative. TESTING Verify all functions as described in the Guide to Operation section. If a difficulty occurs, refer to the Troubleshooting section. If that does not resolve the difficulty, contact qualified service personnel or your local Nellcor representative.

15

Setup

COMPONENTS Display Two three-digit red alphanumeric displays for oxygen saturation and pulse rate. Sixteen-segment bar graph for pulse amplitude indicator. Indicators for LOW BATT, PULSE SEARCH, HIGH SAT, LOW SAT, HIGH RATE, and LOW RATE alarms, ECG LOST, and AUDIO ALARM OFF. Annunciators for BATT IN USE and ECG IN USE. Controls Control knob to adjust volume and set alarm limits, and five buttons to select alarm limits and disable audio alarm. Rear-panel switches for adult/neonatal alarm settings, analog voltage output range (0–1 V or 0–10 V), analog saturation output scale (0–100% or 50–100%), RS-232 format, baud rate; rear-panel buttons for printing trend and event data, analog full scale output, and analog zero output. Front Panel 1

2

3 4

5

6

7

HIGH SAT STD BY

BATT IN USE

LOW SAT

PULSE SEARCH

EC NN TI

D

E

TE

EL

C

LOW BATT

ON

CO

ON

REFER TO MANUAL

ECG LOST

SpO2 PERCENT

LOW RATE

ECG IN USE

IS O L A

15

BEATS PER MINUTE

14 13

12

11

Figure 2: N-200 Front Panel

16

HIGH RATE

AUDIO ALARM OFF

10

9

8

Setup

1.

ON/STDBY switch.

2.

BATT IN USE indicator.

3.

LOW BATT indicator: Flashes when five or fewer minutes of battery power remain.

4.

PULSE SEARCH indicator: Flashes when the N-200 is attempting to locate the patient’s pulse.

5.

OXYGEN SATURATION display.

6.

Control knob: Changes instrument settings or limits.

7.

HIGH SAT, LOW SAT, HIGH RATE, LOW RATE indicators: Flash during an alarm state.

8.

HIGH SAT, LOW SAT, HIGH RATE, LOW RATE buttons: Display alarm limits.

9.

AUDIO ALARM OFF button: Temporarily silences audible alarms.

10. AUDIO ALARM OFF indicator: Lights steadily when the audio alarm has been temporarily silenced; flashes when the audio alarm has been disabled. 11. PULSE RATE display. 12. Pulse amplitude indicator: Vertical column of light bars that qualitatively indicates pulse amplitude. 13. ECG IN USE indicator: Flashes when the N-200 locates an ECG signal; lights steadily when the N-200 locks onto the signal. 14. ECG LOST indicator. 15. Patient module connection socket.

17

Setup

Interface/Powerbase Rear Panel 16 17 18 19 20 21

NELLCOR INCORPORATED INTERFACE/POWERBASE

ZERO

FULL

PULSE

SAT

SERIAL NO. ELETRICAL RATING 100-120 Vac .3A

50/60 Hz

WARNING REPLACE FUSE AS MARKED

TREND

S a O2 % SCALE

USE .5A SLOW BLOW FUSE ONLY

DATA

VOLT

0100 50100

0-1

1

EVENT

2

ECG

RATE

IN/OUT

0-10

SERIAL COMM

22 1 2 3 4 5

1 MADE IN USA NELLCOR INC, PLEASANTON, CA 94588

33

2 3 4 5

6 7 8

REFER TO MANUAL

32 31

ADULT/ NEONATAL ALARM RS232 FORMAT

6 7 8

BAUD RATE

30 29 28 27 26

1

2 3 4 5

6 7 8

25

24

23

Figure 3: Interface/Powerbase Rear Panel 16. ZERO button: Provides a zero-volt signal on PULSE, SAT, and RATE analog outputs. 17. FULL button: Provides a full-scale signal on PULSE, SAT, and RATE analog outputs. (The voltage depends on VOLT switch setting). 18. SpO 2% SCALE switch: Sets the analog output scale for oxygen saturation at 0–100% or 50%–100%. 19. VOLT switch: Sets the voltage output range for the analog outputs. 20. TREND button: Initiates a trend memory output sequence. 21. EVENT button: Initiates an event memory output sequence. 22. ECG IN/OUT connector: Provides an analog ECG output signal or can be used for an input from an external ECG monitor. 18