Datex-Ohmeda 3800 User Manual

3800 Pulse Oximeter

TruTrak

User’s Manual

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130

3800

TruTrak®

6050-0006-380

Printed in USA

Important

This device performs as described in this manual, and in accompanying labels and inserts, when assembled, operated, maintained, and repaired in accordance with the instructions provided.

Attention! Consult the accompanying instructions before using this device.

The safety, reliability, and performance of this device can be assured only under the following conditions:

• If it is used according to the accompanying operating instructions.

• If fittings, extensions, readjustments, changes, or repairs are carried out by

agents authorized by Datex-Ohmeda.

• If it is used in buildings having ground equalization wiring that complies with relevant local standards and regulations.

CAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the USA, check local laws for any restriction that may apply.

This device must be cleaned and checked periodically. Do not use a defective device. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. If repair or replacement becomes necessary, request service advice from Datex-Ohmeda (information is listed on the back cover). Do not repair this device or any of its parts other than in accordance with written instructions provided by Datex-Ohmeda.

The user of this device shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, unauthorized service, damage, or alteration by anyone other than Datex-Ohmeda.

Trademarks

Datex®, Ohmeda®, OxyTip®, PerfTrak®, TruTrak®, and PIr™ are the property of Instrumentarium Corp. or its subsidiaries.

Cidex is a registered trademark of Johnson & Johnson.

Microsoft Windows Terminal is a trademark of Microsoft Corporation.

ProComm is a trademark of DataStorm Technologies.

All other product and company names are the property of their respective owners.

Text revised: October 2002

Table of Contents

1/Overview

Product description.....................................................................................................................................1-1

Intended use........................................................................................................................................1-1

TruTrak

PIr pulsatile value............................................................................................................................1-2

Other features.....................................................................................................................................1-2

Functional components................................................................................................................1-3

Principles of operation..................................................................................................................1-4

Front panel.......................................................................................................................................................1- 6

Alarm silence button......................................................................................................................1-7

Numeric display...............................................................................................................................1-7

Graphic display .................................................................................................................................1-8

SpO2 alarm limits, high and low............................................................................................1-8

Pulse rate alarm limits, high and low..................................................................................1-9

Display contrast adjuster..............................................................................................................1-9

Power/Standby button/AC power light..............................................................................1-9

Carrying handle ................................................................................................................................1-9

Sensor connector...........................................................................................................................1-10

Pulse beep volume button .......................................................................................................1-10

Alarm volume button..................................................................................................................1-10

Rear panel......................................................................................................................................................1-11

Power entry module .................................................................................................................... 1-11

Equipotential ground connector........................................................................................... 1-11

Product information label ........................................................................................................ 1-11

Mode Switch ....................................................................................................................................1-11

RS-232 serial connector..............................................................................................................1-12

Precautions....................................................................................................................................................1-12

Warnings............................................................................................................................................1-12

Cautions..............................................................................................................................................1-14

+ technology......................................................................................................................1-1

Calibration..............................................................................................................................1-5

Alarm silence ........................................................................................................................1-7

All mute....................................................................................................................................1-7

Battery operation.................................................................................................................1-9

Failure of operation........................................................................................................1-12

Explosion hazard..............................................................................................................1-12

Electrical shock and flammability hazard........................................................1-12

Electrical shock hazard ................................................................................................ 1-12

Data validity........................................................................................................................1-13

Patient safety.......................................................................................................................1-13

Patient safety (sensors)..................................................................................................1-13

RS-232 system interconnection................................................................................1-13

Handle the monitor with care.................................................................................. 1-14

Cleaning................................................................................................................................1-14

Battery.....................................................................................................................................1-14

Sensors...................................................................................................................................1-14

Disposal.................................................................................................................................. 1-14

Miscellaneous.....................................................................................................................1-14

Table of Contents

2/Setup and Operations

Powering the oximeter...............................................................................................................................2-1

Setup....................................................................................................................................................................2- 2

Factory settings and default settings .....................................................................................2-2

Mode switch settings......................................................................................................................2-3

Checkout procedure...................................................................................................................................2- 5

Signal and data validity............................................................................................................................2- 8

Plethysmographic waveform.....................................................................................................2-8

Numeric display...............................................................................................................................2-9

Trend data......................................................................................................................................................2-10

Before powering on the oximeter ..............................................................................2-2

After powering on the oximeter .................................................................................2-2

Language..................................................................................................................................2-3

Averaging mode...................................................................................................................2-4

Patient mode..........................................................................................................................2-4

PIr pulsatile value display.............................................................................................2-4

EMI line frequency ............................................................................................................2-4

Low perfusion.......................................................................................................................2-8

Signal noise............................................................................................................................2-9

SpO2...........................................................................................................................................2-9

Pulse rate ..............................................................................................................................2-10

PIr pulsatile value............................................................................................................2-10

3/Messages and Troubleshooting

Messages.............................................................................................................................................................3-1

Alarm categories............................................................................................................................................3-4

High priority........................................................................................................................................3-4

Medium priority................................................................................................................................3-4

Low priority.........................................................................................................................................3-5

System failure.....................................................................................................................................3-5

Troubleshooting.............................................................................................................................................3-6

4/Maintenance and Service

Cleaning.............................................................................................................................................................4-1

Oximeter................................................................................................................................................4-1

Recharging the battery..............................................................................................................................4-2

Replacing the battery.................................................................................................................................4-2

Replacing the fuses.....................................................................................................................................4-3

Repair policy and procedure.................................................................................................................4-4

Packaging and return procedure............................................................................................4-4

Parts list ..............................................................................................................................................................4-5

Table of Contents

A/Compliance and Specifications

Compliance with standards...................................................................................................................A-1

General safety requirements.....................................................................................................A-1

Electromagnetic compatibility (EMC) .................................................................................A-2

Electromagnetic effects...................................................................................................A-2

Safety checks for software..........................................................................................................A-2

Specifications.................................................................................................................................................A-3

Circuitry................................................................................................................................................A-3

Audio indicators...............................................................................................................................A-3

Audible alarms.................................................................................................................................A-3

Alarm limits ..........................................................................................................................A-3

Displays.................................................................................................................................................A-4

Numeric display (Light-Emitting Diodes–LEDs) ..............................................A-4

Graphic display (Liquid Crystal Display–LCD)................................................A-4

Mode switch.......................................................................................................................................A-4

SpO2.......................................................................................................................................................A-4

Interfering substances.....................................................................................................A-4

Pulse rate..............................................................................................................................................A-5

PIr pulsatile value...........................................................................................................................A-5

Sensor emitter wavelength ranges........................................................................................A-5

Environmental...................................................................................................................................A-5

Electrical...............................................................................................................................................A-5

Battery.......................................................................................................................................A-5

Power........................................................................................................................................A-6

Current leakage...................................................................................................................A-6

Fuses..........................................................................................................................................A-6

Serial output, RS-232.....................................................................................................................A-6

Dimensions and weight ...............................................................................................................A-6

B/Communications

Serial device communications..............................................................................................................B-1

Requirements....................................................................................................................................B-1

RS-232 interface cable—serial pinout...................................................................................B-2

Connection..........................................................................................................................................B-2

Serial communication output................................................................................................................B-3

Auto-output mode............................................................................................................................B-3

Trend-output mode......................................................................................................................... B-4

Warranty

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List of Figures

Name Page

Figure 1-1. Signal processing block diagram ...........................................................................1-3

Figure 1-2. Comparative light absorption...................................................................................1-4

Figure 1-3. Extinction versus wavelength graph....................................................................1-4

Figure 1-4. 3800 Pulse Oximeter front panel............................................................................1-6

Figure 1-5. 3800 Pulse Oximeter rear panel..........................................................................1-11

Figure 2-1. Typical adult plethysmographic waveform .....................................................2-8

Figure 2-2. Typical neonate plethysmographic waveform...............................................2-8

Figure 2-3. Low perfusion waveform............................................................................................2-8

Figure 2-4. Noisy plethysmographic waveform ......................................................................2-9

1/Overview

This chapter

• Introduces the product, including the principles of its operation.

• Describes the oximeter’s controls and features.

• Lists the precautions you must take when using the oximeter.

Product description

The Datex-Ohmeda Model 3800 pulse oximeter with TruTrak features two easy-to-read displays that present patient data and status information.

• The numeric display shows the SpO2 and pulse rate values.

• The graphic display shows the plethysmographic waveform, messages, the

Relative Perfusion Index (PIr™) pulsatile value, and the high and low alarm limit settings for SpO2 and pulse rate.

Intended use

The 3800 pulse oximeter with TruTrak+ technology is indicated for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion.1 This device is intended for use with adult, pediatric, and neonatal patients in both hospital and non-hospital environments.

Important: Only Datex-Ohmeda OxyTip

TruTrak+ technology

TruTrak+ technology improves pulse oximetry performance during conditions of clinical patient motion. In the clinical environment, oximetry readings are affected by several types of patient motion. The types of motion include clenching, pressing, and rubbing as well as extending, flexing, and kicking. Unlike motion technologies that use only a single method to correct for motion, TruTrak+ selects one of many proprietary motion-correction algorithms, depending on the type and intensity of the motion.

+ technology

+ sensors can be used with this monitor.

TruTrak+ technology employs a patented five-step process that consists of

1) high-speed data sampling; 2) motion identification, quantification, and

Anesthesia & Analgesia. 2002;94,1S, S54-S60

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PIr pulsatile value

correction; 3) calculation of the SpO2 value; 4) weighting and averaging of the SpO2 value; and 5) the display of an improved SpO2 value. The result of this process is a more accurate and stable displayed SpO2 value, with fewer false alarms or dashed displays.

Important: For TruTrak+ performance, the averaging mode must be set to Long. See Setup in chapter 2.

The PIr pulsatile value indicates the strength of the pulse signal at the sensor site: the higher the PIr value, the stronger the pulse signal. A strong pulse signal increases the validity of SpO2 and pulse rate data.

PIr is a relative value that varies from patient to patient. Clinicians can use the PI value to compare the strength of the pulse signal at different sites on a patient in order to locate the best site for the sensor (the site with the strongest pulse signal).

You can choose to display or not display the PIr value (see Setup in chapter 2).

Other features

• PerfTrak® waveform display, an automatic scale of the plethysmographic

• Large SpO2 digital display for clear differentiation from the pulse rate value.

• Backlit display and contrast control for excellent visibility in subdued lighting

• Direct access to user-selectable high and low alarm limits for SpO2 and pulse

• An audible pulse indicator with an adjustable volume; the automatic pitch

• Visual and audible (adjustable volume) alarms.

• An alarm-silence feature that silences audible alarms for 120 seconds.

• An all-mute feature that silences audible alarms until deactivated.

• Automatic tiered alarm messages.

• Short, medium, or long SpO2 response averaging modes.

• Adult or neonatal patient modes for default pulse rate alarm settings.

• Automatic storage of up to 12 hours of SpO2, pulse rate, and alarm limit

• An automatic self-test and calibration check at start-up. After start up, the

• Rechargeable, sealed, lead-acid battery operation, including battery status

waveform to provide a relative indication of the sensor site perfusion level.

conditions; adjustable viewing angle, using the pull-down feet under the monitor.

rate.

modulation reflects changing SpO2 level.

violations data in trend memory, which can be output through the RS-232 serial connector.

oximeter continuously performs background self-tests.

reporting.

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Functional components

The 3800 oximeter uses the following key electrical component elements to determine SpO2, pulse rate, and PIr pulsatile values:

• The sensor

• Sensor-signal processing

• Microprocessor calculations

The sensor consists of

• The light source—red and infrared light-emitting diodes (LEDs)

• The photodetector—an electronic device that produces an electrical current

proportional to incident light intensity

Timing

Control

1/Overview

Sensor

Figure 1-1. Signal processing block diagram

The two light wavelengths generated by the LEDs pass through the tissue at the sensor site. The photodetector collects this light (partially absorbed and modulated) and converts it into an electronic signal that is sent to the oximeter for further processing.

The electronic circuitry receives the photodetector’s electronic signal, processes it, and passes it on to the microprocessor for calculation of the SpO2, pulse rate, and PIr pulsatile value.

Analog

Processing

A/D

Converter

Digital

Processing

Input/

Output

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Principles of operation

The 3800 pulse oximeter uses a two-wavelength pulsatile system—red and infrared light—to distinguish between oxygenated (O2Hb) and reduced (HHb) hemoglobin, each of which absorbs different amounts of light emitted from the oximeter sensor. The system then calculates the relative percentage of these two constituents and displays SpO

Variable absorption (due to arterial pulse)

Arterial blood absorption

Venous blood absorption

Absorption

Other tissue absorption

ime

Figure 1-2. Comparative light absorption

Arterial blood pulsation at the test site modulates transmission of the oximeter sensor’s light. Since other fluids and tissues present generally don’t pulsate, they don’t modulate the light passing through that location. The attenuation of light energy due to arterial blood flow is detected and isolated by using the pulsatile portion of the incoming signal. PIr pulsatile value is a measure of the relative size of this portion of the signal.

(Red)

660 nm

(Infrared)

940 nm

Extinction (10x)

O2Hb

-1

HHb

-2 600 700 800 900 1000

Wavelength (nm)

Figure 1-3. Extinction versus wavelength graph

The sensor’s photodetector converts the light, which is partially absorbed and modulated as it passes through the tissue sample, into an electronic signal. Since O2Hb and HHb allow different amounts of light to reach the photodetector at the selected wavelengths, the electronic signal varies according to the light source that

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1/Overview

is “on” and the oxygenation of the arterial hemoglobin. Analog and digital signal processing then converts the light-intensity information into SpO2, pulse rate, and PIr pulsatile values for display on the monitor.

Calibration

A CO-oximeter typically uses four or more wavelengths of light and calculates reduced hemoglobin (HHb), oxyhemoglobin (O2Hb), carboxyhemoglobin (COHb), and methemoglobin (MetHb). Datex-Ohmeda pulse oximeters use two wavelengths ranges, 650 nm - 665 nm and 930 nm - 950 nm, both with an average power of less than 1 mW. These wavelengths are used to calculate the presence of O2Hb and reduced HHb. Because of this, pulse oximetry readings will be different than CO-oximetry readings in situations where a patient’s COHb or MetHb are increased.

Two different methods of calibration are currently used by manufacturers of pulse oximeters: fractional and functional.

Important: This pulse oximeter uses the functional calibration method. The user cannot change the calibration method to fractional.

• Fractional saturation is represented mathematically as the percentage of the total amount of hemoglobin carrying oxygen. It is determined by dividing the oxyhemoglobin by the total hemoglobin.

Fractional SpO2 = x 100 = x 100

• Functional saturation is represented mathematically as the percentage of hemoglobin capable of carrying oxygen that is carrying oxygen.

Functional SpO2 = x 100 = x 100

The calculation of SpO2 assumes 1.6% carboxyhemoglobin (COHb), 0.4% methemoglobin (MetHb), and no other pigments. Appreciable variation from these values will influence SpO2 accuracy. These values are based on the DatexOhmeda Pulse Oximeter Empirical Calibration Study.

O2Hb

TOTAL

O2Hb

- COHb - MetHb O2Hb + HHb

TOTAL

O2Hb + HHb + COHb + MetHb

O2Hb

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Front panel

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Figure 1-4. 3800 Pulse Oximeter front panel

1 Alarm silence button

2 Numeric display (LED)

3 Graphic display (LCD)

4 SpO2 alarm limits, high/low setting buttons

5 Pulse rate alarm limits, high/low setting buttons

6 Display contrast adjust slide

7 Power/Standby button

8 Carrying handle

9 Sensor connector

10 Pulse beep volume button

11 Alarm volume button

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1/Overview

1 Alarm silence button

This button has two functions:

• 120-second alarm silence—activated by a single press.

• Continuous all mute—activated by three quick presses (if the all-mute

feature is enabled). Press once to deactivate.

Alarm silence

When an active alarm condition exists, press this button to silence the audible portion of the alarm for 120 seconds. The flashing red or yellow alarm light becomes a steady light. If an alarm condition still exists after 120 seconds, the audible tone and flashing light resume.

Exceptions: Both NO SENSOR and SENSOR OFF audible alarms will not be activated until after the unit obtains a valid signal. The same conditions apply to an active audible alarm for NO SENSOR, SENSOR OFF, or SENSOR FAILURE that has been silenced; i.e., once the sensor alarm condition is acknowledged by silencing the audible alarm, a new audible alarm will not sound until the condition has been cleared and the unit obtains a valid signal.

NOTE: Pressing the alarm silence button produces 120 seconds of silence, regardless of other alarm conditions that may occur during this 120-second interval, except for the SYSTEM FAILURE, CONNECT UNIT TO LINE POWER, and BUTTON STUCK alarms.

All mute

To continuously silence any alarm that can be silenced, press the alarm silence button three times within three seconds. After you have activated all mute, the all mute icon flashes between the SpO2 and pulse rate alarm limit settings on the right side of the screen display. When an alarm condition occurs, the alarm button light flashes and the alarm message appears on the waveform display but no audible alarm sounds.

When all mute is active, press the alarm silence button once to deactivate this feature and enable all audible alarms.

2 Numeric display

SpO2 numeric area—calculated SpO

Pulse rate numeric area—calculated pulse rate

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3 Graphic display

1 Plethysmographic waveform

2 Message area

3 SpO2 and pulse rate alarm limits

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The PerfTrak waveform display appears after the monitor has detected data from the sensor. It represents the blood volume change of the hemodynamic system, assuming no other factors (e.g., motion artifact) are present. This waveform scales automatically to the perfusion level or strength of the signal being received at the patient monitoring site.

Status and alarm messages appear above the waveform area on the waveform display (the height of the waveform is reduced while messages are displayed). Status messages give you information about the oximeter's operating condition. Alarm messages alert you to conditions that need your attention. See chapter 3 for complete alarm and status message information.

The high and low alarm limit settings appear here. If a limit is set to OFF, three dashes appear in the location for that limit.

When an SpO2 or pulse rate limit is violated, the LED on the numeric display and the LCD’s limit value flashes for that alarm.

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Dashes (- - -) appear if the following conditions exist: no sensor is connected to the unit, the sensor is not attached to the patient, the sensor has failed, there is insufficient light penetrating the tissue site, or there is too much ambient light.

4 SpO2 alarm limits, high and low

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The top button sets the high alarm limit and the bottom button sets the low alarm limit. For either limit, press the + side of the button to raise the value or the – side to lower it. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 100, the value does not cycle (or wrap) to 50 or OFF.

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5 Pulse rate alarm limits, high and low

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The top button sets the high alarm limit, the bottom button sets the low alarm limit. For either limit, press the + side to raise the value or the – side to lower it. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 235, the value does not cycle (or wrap) to 30 or OFF.

6 Display contrast adjuster

Use this sliding lever to adjust the vertical viewing angle of the graphic display Slide the lever to the left to reduce the contrast and to the right to increase it.

7 Power/Standby button/AC power light

This button toggles between On (operational mode) and Off (standby mode). The battery recharges as long as the unit is plugged into the AC power supply. No displays are visible in the Off/Standby mode.

The green light to the right of the button is lit when the unit is connected to an AC power supply.

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Battery operation

The oximeter runs for at least five and one-half hours on a new, fully charged battery at normal operating temperatures. LOW BATTERY appears when between 5 and 15 minutes of battery operation time remain. Plug the monitor into AC power to continue monitoring and recharge the battery. The unit will operate with a dead or defective battery when it is connected to the AC power supply.

When the CONNECT UNIT TO LINE POWER message appears, you must immediately plug the oximeter into the AC power supply or the unit turns itself off after 10 seconds.

When operating on battery power, an icon appears between the two pairs of alarm limit values on the right side of the LCD. This icon indicates the batter condition as follows:

Charged/not low

Low

If the all mute condition exists, the display of this icon alternates with the display of the all mute icon.

This icon appears on the status screen:

Depleted, not installed, or defective

8 Carrying handle

The lower front portion of the oximeter’s case is designed to be a carrying handle for ease of moving the unit from one place to another.

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9 Sensor connector

The sensors for this oximeter plug into this nine-contact connector. Use only Datex-Ohmeda sensors compatible with this oximeter (see Parts list in chapter 4).

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10 Pulse beep volume button

This button adjusts the volume level for the pulse indicator in incremental steps from OFF to level 5 (default is 2). Press the + side of the button to increase the volume or the – side to decrease it; you will hear the volume level as you press the button. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 5, the value does not cycle (or wrap) to OFF.

As you adjust the volume, the volume setting is shown in the message area above the waveform.

NOTE: The pitch of the pulse tone changes as the SpO2 value increases or decreases—the higher the SpO2 value, the higher the pitch of the pulse tone.

11 Alarm volume button

This button adjusts the audible alarm volume level in incremental steps from 1 to 5 (default is 3). You cannot set the alarm volume to OFF. Press the + side of the button to increase the alarm volume or the – side to decrease it; you will hear the volume level as you press the button. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 5, the value does not cycle (or wrap) to 1.

As you adjust the volume, the volume setting is shown in the message area above the waveform.

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