GE TruSat User manual

GE Healthcare

TruSat™ Pulse Oximeter

User’s Guide

GE Healthcare

TruSat™ Pulse Oximeter

User’s Guide

6050-0006-815 March 2005

Important

Rx Only (USA)

Attention! Consult the accompanying instructions, including all safety precautions, before using this device.

Responsibility of the manufacturer

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

•Assembly, extensions, readjustments, modifications, and repairs are carried out by authorized personnel.

•The electrical installation complies with relevant standards and regulations.

•The device is used in accordance with this manual and is serviced and maintained in accordance with the TruSat Technical Reference Manual.

Service and repair

Service and repair procedures must be performed by authorized service personnel. Repair this device or its parts only in accordance with instructions provided by the manufacturer. To order replacement parts or for assistance, contact an authorized service office. When shipping the monitor for repair, clean the monitor, allow it to dry completely, and pack it for shipment in the original shipping container, if possible.

Trademarks

Datex®, Ohmeda®, TruSat™ and other trademarks (ComWheel™, OxyTip®, PIr®, TruSignal™, TruTrak®) are the property of GE Healthcare Finland Oy. All other product and company names are the property of their respective owners.

0537

GE Healthcare Finland Oy Helsinki, Finland

[phone] www.gehealthcare.com

© 2005 General Electric Company. All rights reserved.

	Contents
1. Overview
Monitor description...................................................................................................	1–1
Trend Download option.......................................................................................................................	1–1
Intended use .............................................................................................................................................	1–1
TruSat pulse oximetry .............................................................................................	1–2
TruSignal Enhanced SpO2..................................................................................................................	1–2
PIr pulsatile value ...................................................................................................................................	1–2
Measurement characteristics ..........................................................................................................	1–2
Interfering substances................................................................................................................	1–3
Calibration ........................................................................................................................................	1–3
Safety precautions ....................................................................................................	1–4
Warnings.....................................................................................................................................................	1–4
Cautions ......................................................................................................................................................	1–4
Electromagnetic compatibility (EMC)............................................................................................	1–4
Disposal.......................................................................................................................................................	1–4
2. Features and Use
Monitor features.........................................................................................................	2–1
Connectors.................................................................................................................................................	2–2
Information label and symbols .......................................................................................................	2–2
Buttons and indicators ........................................................................................................................	2–3
Power button and power LED.................................................................................................	2–3
Alarm Silence button and indicator .....................................................................................	2–3
Alarm LED..........................................................................................................................................	2–3
Battery indicator............................................................................................................................	2–4
On-screen controls ................................................................................................................................	2–4
Using the monitor ......................................................................................................	2–5
Monitor checkout....................................................................................................................................	2–5
Choosing the sensor .............................................................................................................................	2–6
Connecting the sensor.........................................................................................................................	2–6
Monitoring the patient .........................................................................................................................	2–7
Plethysmographic pulse bar (pleth bar).............................................................................	2–7
Changing monitor settings ...................................................................................	2–8
Using the ComWheel............................................................................................................................	2–8
Setting alarm limits................................................................................................................................	2–8
Adjusting pulse beep and alarm volume....................................................................................	2–9
Switching the backlight ON/OFF.....................................................................................................	2–9
Locking/unlocking monitor settings..............................................................................................	2–9
Displaying the perfusion index (PIr)............................................................................................	2–10
Changing the line power filter.......................................................................................................	2–10

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Contents

3. Alarms, Troubleshooting, & Maintenance

Alarms ..............................................................................................................................	3–1
Alarm priorities.........................................................................................................................................	3–1
Alarm activation ......................................................................................................................................	3–1
Alarm signals.............................................................................................................................................	3–2
Signals for multiple alarms .......................................................................................................	3–2
Signals for silenced alarms.......................................................................................................	3–2
Troubleshooting..........................................................................................................	3–3
Maintenance.................................................................................................................	3–5
Battery..........................................................................................................................................................	3–5
Cleaning.......................................................................................................................................................	3–5
Monitor................................................................................................................................................	3–5
Sensors ...............................................................................................................................................	3–5
Supplies and accessories....................................................................................................................	3–6
Sensors ...............................................................................................................................................	3–6
TruSat pulse oximeters ...............................................................................................................	3–6
Miscellaneous..................................................................................................................................	3–6
Trend Download option..............................................................................................................	3–7
TruSat manuals ..............................................................................................................................	3–7

4. Compliance and Specifications

Compliance....................................................................................................................	4–1
Specifications ...............................................................................................................	4–2
Measurement............................................................................................................................................	4–2
General................................................................................................................................................	4–2
SpO2.....................................................................................................................................................	4–2
Pulse rate...........................................................................................................................................	4–2
PIr pulsatile value...........................................................................................................................	4–2
Monitor .........................................................................................................................................................	4–3
General................................................................................................................................................	4–3
Display ................................................................................................................................................	4–3
Alarms .................................................................................................................................................	4–3
Audio....................................................................................................................................................	4–3
External power................................................................................................................................	4–4
Internal battery power................................................................................................................	4–4
Trend Download option..............................................................................................................	4–4
Environmental conditions..........................................................................................................	4–4
Dimensions and weight..............................................................................................................	4–4

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	Contents
A. Trend Download Option
Trend data collection ..............................................................................................	A–1
Patient identification number...........................................................................................................	A–1
Alarm annunciation capability..........................................................................	A–2
Setting the clock ........................................................................................................	A–2
Printing to the portable printer.........................................................................	A–3
Connecting the printer.........................................................................................................................	A–3
Printing summary statistics for one or more patients.........................................................	A–4
Sample printout: Summary statistics ................................................................................	A–4
Printing real-time data.........................................................................................................................	A–5
Sample printout: Real-time data..........................................................................................	A–5
Trend Download PC software .............................................................................	A–6
PC requirements......................................................................................................................................	A–6
Software installation.............................................................................................................................	A–6
Setup.............................................................................................................................................................	A–7
Starting the Trend Download program .......................................................................................	A–7
Trend Download program options.......................................................................................	A–7
B. Warranty
Warranty ........................................................................................................................	B-1

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1. OVERVIEW

This chapter contains:

•A preview of the pulse oximetry features and measurement.

•General safety precautions to consider when using the monitor.

•A brief description of the monitor.

Monitor description

The TruSat™ pulse oximeter is a durable, reliable, and portable monitor. It features TruSignal™ Enhanced SpO2 and PIr®, a relative perfusion index. The monitor is powered by an internal battery, which is charged through an external power supply.

Important: When using the monitor for the first time or after removing it from extended storage, charge the battery for three hours BEFORE you power ON.

The monitor contains an easy-to-read display with a backlight for low-light conditions. Information that appears on the display includes the following:

•SpO2, pulse rate, and PIr measurements.

•All alarm limit settings.

•Indicators for plethysmographic pulse, battery capacity, and silenced alarms.

The monitor also contains on-screen controls for changing monitor settings, such as alarm limits, volume, and the backlight. A lock function, when activated, protects against unintended changes to settings.

The alarm system generates audible and visual signals that vary according to the priority of the alarm.

Trend Download option

The Trend Download option allows you to set the monitor clock, print, and download trends to a computer. Monitors can be factory-configured with this option. An upgrade kit is also available.

NOTE: If your monitor is configured with the Trend Download option, be sure to set the monitor clock before monitoring patients.

Intended use

The TruSat pulse oximeter is indicated for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion1 or low perfusion. This device is intended for use with adult, pediatric, and neonatal patients in both hospital and non-hospital environments.

Important: Only OxyTip®+ sensors can be used with this monitor.

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

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TruSat User’s Guide

TruSat pulse oximetry

TruSignal Enhanced SpO2

TruSignal Enhanced SpO2 offers improved performance, especially during challenging conditions of clinical motion and low perfusion. With ultra-low-noise technology, TruSignal selects the appropriate clinically-developed algorithm to compensate for weak or motion-induced signals and generate reliable saturation readings.

PIr pulsatile value

The perfusion index measurement—the PIr pulsatile value—is a quick and easy-to-use clinical tool that provides a dynamic numeric reflection of perfusion at the sensor site. PIr is a relative value that varies from patient to patient.

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. Clinicians can use the PIr 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.

Measurement characteristics

The pulse oximetry measurement uses a two-wavelength pulsatile system—red and infrared light—to distinguish between oxyhemoglobin (O2Hb) and reduced hemoglobin (HHb). The light is emitted from the oximeter sensor, which contains the light source and a photodetector.

•The light source consists of red and infrared light-emitting diodes (LEDs).

•The photodetector is an electronic device that produces an electrical current proportional to incident light intensity.

The two light wavelengths generated by the LEDs are transmitted through the tissue at the sensor site and are modulated by arterial blood pulsation. Since other fluids and tissues present generally don’t pulsate, they don’t modulate the light. The pulsatile portion of the incoming signal is used to detect and isolate the attenuation of light energy due to arterial blood flow.

Variable absorption (due to arterial pulse)

Arterial blood absorption

Venous blood absorption

Absorption

Other tissue absorption

Time

Figure 1-1. Comparative light absorption

1–2

Overview

The photodetector in the sensor converts the light intensity information into an electronic signal. Since O2Hb and HHb absorb different amounts of the light that is emitted from the oximeter sensor, different amounts of light reach the photodetector at the selected wavelengths. The electronic signal varies according to which light source is “on” (red or infrared) and the oxygenation of the arterial hemoglobin. This information is used to calculate the relative percentage of O2Hb and HHb. The monitor processes the electronic signal it receives from the photodetector. The SpO2 and pulse rate measurements are continuously calculated as a 12-second “moving” average.

Interfering substances

Increased patient carboxyhemoglobin may falsely increase SpO2 readings in all brands of pulse oximeters. Therefore, saturation readings may be higher for smokers, victims of smoke inhalation, and patients with carbon monoxide (CO) intoxication. The level of increase is approximately equal to the amount of carboxyhemoglobin present.

Methemoglobin from certain therapies, dyes that change arterial pigmentation, and substances at the sensor site that contain dyes ( fingernail polish, for example) may also cause erroneous readings.

Calibration

The TruSat pulse oximeter uses the functional calibration method. Functional saturation is represented mathematically as the percentage of hemoglobin capable of carrying oxygen that is carrying oxygen.

	Functional SpO2	=		O2Hb		x 100 =		O2Hb		x 100
			(HbTOTAL – COHb – MetHb )				(O2Hb + HHb )

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

NOTE: A hospital-grade CO-oximeter, which requires a sample of arterial blood and typically uses four or more wavelengths of light, calculates carboxyhemoglobin (COHb) and methemoglobin (MetHb) as well as O2Hb and HHb. CO-oximeter readings and pulse oximeter readings will differ when COHb or MetHb is present.

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TruSat User’s Guide

Safety precautions

Precautions associated with following safe practices while using the monitor appear throughout this manual. General precautions are listed below. Carefully read all precautions in this manual before using the monitor.

NOTE: For complete information about the safe and appropriate use of a sensor, consult the instructions for that sensor.

Warnings

WARNINGS indicate potentially harmful situations that may cause injury to a patient or operator.

•It is possible for any device to malfunction. Always verify unusual data by performing a formal patient assessment.

•Do not use the monitor in the presence of any flammable anesthetic mixture.

•Use only hospital-grade, grounded power outlets.

•Use only sensors and cables specified for use with this monitor. Failure to do so may cause interference with the measurement or result in increased emissions, decreased immunity, or damage to the equipment or system.

•This monitor does not measure respiration and should never be used as a substitute for an apnea monitor.

•This monitor is not intended for use in a magnetic resonance imaging (MRI) environment.

Cautions

CAUTIONS indicate conditions that may lead to equipment damage or malfunction.

•Do not store or use the monitor outside the temperature and humidity ranges stated in the Specifications section of this manual.

Electromagnetic compatibility (EMC)

Electromagnetic interference, including interference from portable and mobile radio frequency (RF) communications equipment, can affect this monitor.

When using this monitor, take precautions to ensure electromagnetic compatibility. For more information, refer to the Technical Reference Manual.

Disposal

Recycle or dispose of this medical device, its components, and its packing materials in accordance with local environmental and waste disposal regulations.

1–4

2. FEATURES AND USE

This chapter contains:

•Descriptions of the monitor’s features and controls.

•Instructions for using the monitor.

•Instructions for changing monitor settings.

Monitor features

NOTE: The monitor is shown without the handle.

Figure 2-1. Monitor features

1Oxygen saturation (SpO2) measurement value

2 SpO2 high and low alarm limit settings, adjustable

3Pulse rate measurement value

4 Pulse rate high and low alarm limit settings, adjustable 5 Plethysmographic pulse bar (pleth bar)

6Alarm LED

7Alarm Silence button

8 ComWheel navigation and selection knob for changing monitor settings 9 Display area for on-screen control symbols

10Battery indicator

11Power button and external power LED

2–1