TruSat Users Guide March 2005

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 +358 10 394 11 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

i

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

ii

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

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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 O2Hb x 100 = O Hb + HHb HbTOTAL – COHb – MetHb 2

(

)

(

) x 100

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.

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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 (SpO2) measurement value

2

SpO2 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

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TruSat User’s Guide

Connectors WARNING: When you connect equipment to the monitor, you are configuring a medical system and are responsible for ensuring that the system complies with IEC 60601–1–1 and with local requirements. Connect 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.

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. 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-232 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.

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Features and Use

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 SpO2 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.

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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 onscreen 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.

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Features and Use

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. 2.

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 SpO2 and pulse rate. The backlight remains ON if it is set to ON.

• (Trend Download option only) A patient number (P01, P02, 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 SpO2 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 SpO2 and pulse rate values.

7.

Place the sensor on your finger again. After the SpO2 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.

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TruSat User’s Guide

Choosing 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.

Connecting 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.

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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.

2.

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 SpO2 connector on the monitor.

Features and Use

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: Conditions 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.

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Changing monitor settings Using the ComWheel 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 SpO2 setting below 85% will be reset to 85%. The current high and low alarm limit settings for SpO2 and pulse rate are displayed beside the SpO2 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 SpO2, low SpO2, high pulse rate, or low pulse rate).

2.

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.

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Features and Use

Adjusting pulse beep and alarm volume 1.

Use the ComWheel to move the pointer to the pulse beep volume symbol or the alarm volume symbol. The number of shaded bars indicates the current volume level. Pulse beep volume 0, 1, 2, 3, or 4 shaded bars (0 = OFF) Alarm volume 1, 2, 3, or 4 shaded bars (1 = low)

2.

Press the ComWheel and, when the pointer flashes, turn the ComWheel to change the volume. NOTE: Press the ComWheel to select the new setting if you plan to change more monitor settings.

Switching the backlight ON/OFF When the monitor is powered ON, the backlight setting is the same as when the monitor was last powered OFF. To change the backlight setting, use the ComWheel to move the pointer to the backlight symbol, then press the ComWheel. When you switch the backlight ON, the backlight symbol remains visible for several seconds.

Locking/unlocking monitor settings You can lock the monitor to protect against unwanted changes to settings. You can set, then lock alarm limit settings, volume settings, and the backlight. You can also silence alarms indefinitely with the Alarm Silence button, then lock the monitor with the alarms silenced indefinitely. Important: When you silence alarms indefinitely and lock the monitor, only visual alarm signals are activated when alarms occur. Audible alarm signals are silenced. To lock or unlock monitor settings, press the ComWheel five times, holding it in for five seconds on the fifth press. A tone sounds each time you lock or unlock the monitor. The lock indicator is displayed at the lower right of the screen while monitor settings are locked. If alarms are silenced indefinitely before the monitor is locked, only the power button is functional. The ComWheel can be used only to unlock the monitor as described above.

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Displaying the perfusion index (PIr) To display the PIr value, use the ComWheel to select the PIr symbol. The pointer continues to flash as long as the PIr value is displayed. To cancel the display, press the ComWheel.

Figure 2-3. Perfusion index (PIr) display NOTE: If a pulse rate alarm occurs while the PIr value is displayed, the alarm LED flashes yellow. An alarm tone sounds unless alarms are silenced. Press the ComWheel to view the pulse rate display.

Changing the line power filter For the best low perfusion performance, set the line power filter to match the line power frequency of your local AC power source. The software line power filter will then eliminate potential interference when you use AC power or when you use battery power near an AC power source. When you power OFF the monitor, the line power filter setting (50 or 60) is displayed in the high pulse rate alarm area. 1.

To change the line power filter setting, power ON the monitor. Press the ComWheel seven times, holding it in on the seventh press until the new setting is displayed: 50 H(z) or 60 H(z).

Figure 2-4. Changing the line power filter 2.

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To check the setting, power OFF and verify that the new setting is displayed in the high pulse rate alarm area.