GE TruSat User manual

GE Healthcare
TruSat™ Pulse Oximeter
User’s Guide

GE Healthcare
TruSat™ Pulse Oximeter
User’s Guide
6050-0006-815
March 005

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
© 005 General Electric Company. All rights reserved.

ontents
i
1. Overview
Monitor description...................................................................................................1–1
Trend Download option.......................................................................................................................1–1
Intended use .............................................................................................................................................1–1
TruSat pulse oximetry .............................................................................................1–2
TruSignal Enhanced SpO ..................................................................................................................1–
PIr pulsatile value ...................................................................................................................................1–
Measurement characteristics ..........................................................................................................1–
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................................................................................................................................................. –
Information label and symbols ....................................................................................................... –
Buttons and indicators ........................................................................................................................ –3
Power button and power LED................................................................................................. –3
Alarm Silence button and indicator ..................................................................................... –3
Alarm LED.......................................................................................................................................... –3
Battery indicator............................................................................................................................ –4
On-screen controls................................................................................................................................ –4
Using the monitor ......................................................................................................2–5
Monitor checkout.................................................................................................................................... –5
Choosing the sensor ............................................................................................................................. –6
Connecting the sensor......................................................................................................................... –6
Monitoring the patient ......................................................................................................................... –7
Plethysmographic pulse bar (pleth bar)............................................................................. –7
hanging monitor settings...................................................................................2–8
Using the ComWheel............................................................................................................................ –8
Setting alarm limits................................................................................................................................ –8
Adjusting pulse beep and alarm volume.................................................................................... –9
Switching the backlight ON/OFF..................................................................................................... –9
Locking/unlocking monitor settings.............................................................................................. –9
Displaying the perfusion index (PIr)............................................................................................ –10
Changing the line power filter....................................................................................................... –10

ontents
ii
3. Alarms, Troubleshooting, & Maintenance
Alarms..............................................................................................................................3–1
Alarm priorities.........................................................................................................................................3–1
Alarm activation ......................................................................................................................................3–1
Alarm signals.............................................................................................................................................3–
Signals for multiple alarms .......................................................................................................3–
Signals for silenced alarms.......................................................................................................3–
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. ompliance and Specifications
ompliance....................................................................................................................4–1
Specifications ...............................................................................................................4–2
Measurement............................................................................................................................................4–
General................................................................................................................................................4–
SpO .....................................................................................................................................................4–
Pulse rate...........................................................................................................................................4–
PIr pulsatile value...........................................................................................................................4–
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

ontents
iii
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 P 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

1–1
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 SpO 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:
• SpO , 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. 00 ;94,1S, S54-S60

TruSat User’s Guide
1–
TruSat pulse oximetry
TruSignal Enhanced SpO2
TruSignal Enhanced SpO 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 SpO 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 (O Hb) 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.
Absorption
Time
Figure 1-1. omparative light absorption
Variable absorption
(due to arterial pulse)
Arterial blood absorption
Venous blood absorption
Other tissue absorption

Overview
1–3
The photodetector in the sensor converts the light intensity information into an
electronic signal. Since O Hb 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 O Hb and HHb. The monitor processes the
electronic signal it receives from the photodetector. The SpO and pulse rate
measurements are continuously calculated as a 1 -second “moving” average.
Interfering substances
Increased patient carbo yhemoglobin may falsely increase SpO2 readings in all brands
of pulse o imeters. 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.
alibration
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 SpO = ( ) x 100 = ()
x 100
The calculation of SpO assumes 1.6% carboxyhemoglobin (COHb), 0.4%
methemoglobin (MetHb), and no interfering dyes. These values are based on the Datex-
Ohmeda Pulse Oximeter Empirical Calibration Study. Appreciable variation from these
values will influence SpO 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 O Hb and HHb. CO-oximeter readings and pulse
oximeter readings will differ when COHb or MetHb is present.
OHb
OHb + HHb
OHb
HbTOTAL – COHb – MetHb

TruSat User’s Guide
1–4
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.
autions
AUTIONS 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 (EM )
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
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
1 Oxygen saturation (SpO ) measurement value
SpO high and low alarm limit settings, adjustable
3 Pulse rate measurement value
4 Pulse rate high and low alarm limit settings, adjustable
5 Plethysmographic pulse bar (pleth bar)
6 Alarm LED
7 Alarm Silence button
8 ComWheel navigation and selection knob for changing monitor settings
9 Display area for on-screen control symbols
10 Battery indicator
11 Power button and external power LED

TruSat User’s Guide
–
onnectors
WARNING: When you connect equipment to the monitor, you are configuring
a medical system and are responsible for ensuring that the system complies
with IE 60601–1–1 and with local requirements. onnect only external
devices specified for use with this monitor.
WARNING: 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.
Figure 2-2. Monitor connectors
Information label and symbols
A label on the underside of the monitor contains the model number, serial number, date
of manufacture, and other information about the monitor. The following symbols also
appear on this label and/or on the packaging for the monitor:
Sensor connector; defibrillation-proof
type BF applied part
DC current
RS- 3 connector (Trend Download
option)
Manufacturer
Power supply connector; external
power in
Other symbols on the monitor or the screen are described in the appropriate sections of
this manual.
Sensor connector
Connect an OxyTip+
sensor or cable only.
Trend Download connector (RS-232)
Connect the TruSat printer or PC cable. See
Trend Download option later in this manual.
Power connector
Plug the power supply cable into this connector. Then, plug the
power cord into the power supply and into the AC power outlet.

Features and Use
–3
Buttons and indicators
Power button and power LED
Press the power button to power ON the monitor.
Press the button again to power OFF.
A green LED beside the power button is ON only while the monitor is connected to
external power. It does not indicate whether the monitor is powered ON or OFF.
NOTE: When you power OFF, all alarm limits and other monitor settings are saved.
When you power ON, all settings are restored with one exception: an SpO low alarm
limit setting below 85% is reset to 85%.
Alarm Silence button and indicator
WARNING: When alarms are silenced, observe the patient frequently.
A tone sounds each time you press the Alarm Silence button. The alarm LED is lit yellow
while alarms are silenced.
Press the Alarm Silence button once to silence all alarms for two
minutes.
Press it three times (rapidly) to silence all alarms indefinitely.
The alarm silence indicator is displayed at the upper right of the
screen while alarms are silenced. When alarms are silenced
indefinitely, it flashes ON/OFF.
To cancel the alarm silence, press the Alarm Silence button once again.
Alarm LED
The alarm LED beside the Alarm Silence button indicates the presence of an alarm and
the alarm priority:
LED Status Priority Meaning
Red ON or
Red flashing ON/OFF
High Serious situation requiring an immediate
response.
Yellow flashing ON/OFF Medium Situation requiring a prompt response.
NOTE: The alarm LED is lit yellow while alarms are silenced.
For details about the TruSat alarm system, including all visual and audible alarm
indicators, see Alarms in chapter 3.

TruSat User’s Guide
–4
Battery indicator
The battery indicator is displayed at all times, including when the monitor is powered
OFF and/or disconnected from AC power.
If external power is disconnected or lost during monitoring, the monitor switches to
battery power automatically.
Indicates the battery is fully charged. The number of shaded
segments decreases as the charge decreases.
NOTE: The number of shaded segments may temporarily decrease
when the monitor is connected to AC power and starts to recharge
the battery.
Indicates a low battery alarm condition; flashes ON/OFF. Monitor
can be powered by the battery only 10 to 60 minutes longer.
Connect the monitor to AC power to continue monitoring.
Important: When the battery is completely depleted, monitoring stops. A continuous
alarm tone sounds and the monitor powers OFF automatically. Connect the monitor to
external power immediately.
On-screen controls
You use the ComWheel to change alarm limit settings. You also use it to access the on-
screen controls represented by the symbols described below.
Pulse beep volume
Alarm volume
Backlight, ON/OFF
PIr pulsatile value display, ON/OFF
Start/stop printing to a connected printer. For details, see Trend
Download option later in this manual.
Instructions for using the ComWheel to change and lock monitor settings are located
later in this chapter.

Features and Use
–5
Using the monitor
Monitor checkout
Always check the operation of the monitor before using it to monitor a patient.
WARNING: Do not use the monitor if the startup tones do not sound, the
validity of data is questionable, or if the monitor fails to function as
described. Refer to the appropriate sections of this manual to identify and
correct the malfunction.
1. Plug the power supply cable into the power connector on the monitor. Then, connect
the power supply to the power outlet.
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.
. Press the power button to power ON. Verify the following during startup:
• The power-on tones sound.
• All display elements, including on-screen symbols, illuminate briefly.
• The alarm LED is lit red, then yellow.
• The backlight is ON until dashes are displayed for the SpO and pulse rate. The
backlight remains ON if it is set to ON.
• (Trend Download option only) A patient number (P01, P0 , etc.) is displayed.
3. Power OFF and check the line power filter setting shown in the high pulse rate alarm
area: 50 (Hz) or 60 (Hz). If the setting matches your local line power frequency, go to
the next step. If it is different, go to Changing the line power filter later in this chapter.
4. Choose a sensor designed for use on a finger, place it on your finger, and connect it
to the monitor. Power ON the monitor.
NOTE: All pleth bar segments pulsate until the measured values are displayed.
5. When the SpO and pulse rate values are displayed, verify that the lowest pleth bar
segment remains visible while one or more of the other segments pulsate.
6. Remove the sensor from your finger. Verify that the alarm LED flashes red, an alarm
tone sounds, and dashes replace the SpO and pulse rate values.
7. Place the sensor on your finger again. After the SpO and pulse rate values are
displayed, unplug the sensor from the monitor. Verify that the alarm LED flashes red,
an alarm tone sounds, and dashes replace the values.
8. Check the battery indicator. If the battery is low, recharge the battery before using
the monitor.
Important: If the startup tones do not sound or if the monitor fails to function as
described, DO NOT use the monitor until the malfunction has been corrected. Refer to
Troubleshooting later in this manual.

TruSat User’s Guide
–6
hoosing the sensor
WARNING: Discard a damaged sensor or cable immediately. Never repair a
damaged sensor or cable; never use a sensor or cable repaired by others.
Choose a sensor that is appropriate for the patient and the situation. Use clean, dry, and
undamaged sensors and cables.
Important: Only OxyTip®+ sensors can be used with this monitor.
Reusable Sensors
Finger sensor. Widely-used. Quick application is
possible; may be used on toe.
Ear sensor. Similar in appearance to finger sensor,
but smaller.
Wrap sensor. Flexible sensor that is positioned
inside a soft wrap or tape and wraps around the
site (usually fingers, toes, or the fleshy part of a
hand or foot). Useful for small children.
Adhesive Sensors
Adhesive sensor that wraps around a finger or toe.
Used to minimize the effects of motion at the
sensor site.
Adhesive sensor with integrated cable. The sensor
is positioned inside tape that is wrapped around the
site to secure the sensor. Used on fingers, toes, and
the fleshy part of a hand or foot.
onnecting the sensor
To ensure the correct application and use of a sensor, refer to the instructions that were
provided with the sensor.
WARNING: To prevent erroneous readings, do not use a blood pressure cuff
or arterial blood pressure measurement device on the same limb as the
sensor.
1. Apply the sensor to a clean, well-perfused site that is appropriate for the type of
sensor and for the patient. Use an adhesive sensor if the patient is exhibiting
significant motion that may interfere with the measurement.
. To minimize movement of the sensor, tape the sensor cable to the limb. Use a clip to
attach an ear sensor cable to bed clothes.
3. Plug the sensor cable into the SpO connector on the monitor.

Features and Use
–7
Monitoring the patient
If your monitor is configured with the Trend Download option, be sure to set the clock
before you begin monitoring. For instructions, see Trend Download option later in this
manual.
WARNING: onditions that may cause inaccurate readings and impact
alarms include interfering substances, excessive ambient light, electrical
interference, excessive motion, low perfusion, low signal strength, incorrect
sensor placement, poor sensor fit, and movement of the sensor on the
patient.
WARNING: Patient conditions (such as reddening, blistering, skin
discoloration, ischemic skin necrosis, and skin erosion) may warrant
changing the sensor site frequently or using a different style of sensor.
WARNING: The power supply may reach a temperature that can cause
patient discomfort. Position the power supply so that it will not come into
contact with the patient.
Each time you monitor a patient:
• Verify that the signal strength is adequate and that the displayed values agree with
your clinical evaluation of the patient.
• Routinely check skin integrity and circulatory status at the sensor site.
• Adjust alarm limits according to the clinical condition of the patient.
Plethysmographic pulse bar (pleth bar)
The pleth bar—a column of up to ten pulsating segments—represents the
plethysmographic waveform. The pleth bar is displayed when a sensor is
correctly applied to the patient and connected to the monitor.
During monitoring, the lowest segment is always displayed; the other segments pulsate
(flash ON/OFF) in proportion to the pulse volume.
• The rate at which the segments pulsate represents the pulse rate.
• The highest pulsating segment indicates the strength of the pulse—the number of
pulsating segments increases as pulse strength increases.
The number of pulsating segments also indicates perfusion at the sensor site. For
example, a peak of ten segments indicates relatively high perfusion.

TruSat User’s Guide
–8
hanging monitor settings
Using the omWheel
You use the ComWheel to change monitor settings.
Press the ComWheel to display the pointer ( or ).
The backlight temporarily switches ON (if OFF). The on-screen control
symbols are displayed for several seconds.
Turn the ComWheel to move the pointer.
As you turn the ComWheel, the pointer appears beside each alarm limit
value or above each on-screen control symbol.
Press the ComWheel. New settings are effective immediately.
NOTE: When you press the ComWheel to change an alarm limit or
volume setting, the pointer flashes. Turn the ComWheel to display the
desired alarm limit or volume. The new setting is effective immediately,
however, if you want to continue changing settings, press the
ComWheel. Then turn the ComWheel to move the pointer to the next
setting.
Setting alarm limits
WARNING: To avoid rendering the alarm system useless, always set
reasonable alarm limits based on the clinical condition of the patient.
Alarm limit settings are saved and remain in effect each time you power ON the monitor
with one exception: a low SpO setting below 85% will be reset to 85%. The current high
and low alarm limit settings for SpO and pulse rate are displayed beside the SpO and
pulse rate values.
NOTE: Audible and visual alarm signals are not generated for any alarm limit that is set
to OFF.
1. Press the ComWheel to display the pointer. Turn the ComWheel to move the pointer
to the limit you want to change (high SpO , low SpO , high pulse rate, or low pulse
rate).
. Press the ComWheel and, when the pointer flashes, turn the ComWheel until the
desired alarm limit or OFF (– – –) is displayed.
NOTE: Press the ComWheel to select the new setting if you plan to change more
monitor settings.