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GE Healthcare
TruSat
Pulse Oximeter
User's Guide

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Table of Contents
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Summary of Contents for GE TruSat

  • Page 1 GE Healthcare TruSat Pulse Oximeter ™ User’s Guide...
  • Page 3 GE Healthcare TruSat Pulse Oximeter ™ User’s Guide 6050-0006-815 March 2005...
  • Page 4 Trademarks Datex®, Ohmeda®, TruSat™ and other trademarks (ComWheel™, OxyTip®, PI r ®, TruSignal™, TruTrak®) are the property of GE Healthcare Finland Oy. All other product and company names are the property of their respective owners. 0537...
  • Page 5: Table Of Contents

    Contents 1. Overview Monitor description....................1–1 Trend Download option........................1–1 Intended use .............................1–1 TruSat pulse oximetry .....................1–2 TruSignal Enhanced SpO 2 ........................1–2 PI r 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...
  • Page 6 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 SpO 2 ..............................4–2 Pulse rate............................4–2...
  • Page 7: Trend Download Option

    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...
  • Page 9: Intended Use

    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 PI r ®, a relative perfusion index. The monitor is powered by an internal battery, which is charged through an external power supply.
  • Page 10: Trusat Pulse Oximetry

    TruSat User’s Guide TruSat pulse oximetry TruSignal Enhanced SpO 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.
  • Page 11: Interfering Substances

    ( 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.
  • Page 12: Safety Precautions

    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.
  • Page 13: Features And Use

    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 Oxygen saturation (SpO ) measurement value high and low alarm limit settings, adjustable...
  • Page 14: Connectors

    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.
  • Page 15: Buttons And Indicators

    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. 2–3...
  • Page 16: Battery Indicator

    TruSat User’s Guide 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.
  • Page 17: Using The Monitor

    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.
  • Page 18: Choosing The Sensor

    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.
  • Page 19: Monitoring The Patient

    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...
  • Page 20: Changing Monitor Settings

    TruSat User’s Guide Changing monitor settings Using the ComWheel You use the ComWheel to change monitor settings. Press the ComWheel to display the pointer ( The backlight temporarily switches ON (if OFF). The on-screen control symbols are displayed for several seconds.
  • Page 21: Adjusting Pulse Beep And Alarm Volume

    Features and Use Adjusting pulse beep and alarm volume 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)
  • Page 22: Displaying The Perfusion Index (Pi R )

    TruSat User’s Guide Displaying the perfusion index (PI r ) To display the PI r value, use the ComWheel to select the PI r symbol. The pointer continues to flash as long as the PI r value is displayed. To cancel the display, press the ComWheel.
  • Page 23: Alarms, Troubleshooting, & Maintenance

    3. ALARMS, TROUBLESHOOTING, & MAINTENANCE This chapter contains: • Information about the alarm system. • A chart for troubleshooting situations that may occur while using the monitor. • Maintenance information, including a list of supplies and accessories that are approved for use with the monitor. Alarms Alarms are visual or audible signals that alert you to a physiological or technical alarm condition.
  • Page 24: Alarm Signals

    TruSat User’s Guide Alarm signals An alarm condition generates audible and visual signals according to the alarm priority. When an alarm condition occurs, the backlight switches ON (if OFF) until the alarm condition ends. All audible and visual alarm signals are cleared when the alarm condition ends.
  • Page 25: Troubleshooting

    Alarms, Troubleshooting, & Maintenance Troubleshooting Always check the condition of the patient first. If a problem persists, contact authorized service personnel. Situation Cause Recommendation Low battery. Monitor can be Connect the monitor to external power to powered by battery only 10 to 60 recharge the battery.
  • Page 26 TruSat User’s Guide Situation Cause Recommendation Pulse rate and/or pleth bar Incorrect sensor placement, motion • Apply the sensor as directed in the vary significantly from the at the sensor site, low signal instructions for the sensor. palpated pulse rate.
  • Page 27: Maintenance

    Alarms, Troubleshooting, & Maintenance Maintenance Battery To extend the life of the battery: • Fully charge the battery once a month. NOTE: After all four battery segments are shaded, wait at least 20 minutes before you disconnect the monitor from the external power source so the monitor can refresh the battery.
  • Page 28: Supplies And Accessories

    All monitor configurations include a power supply and a power cord. Monitors configured with the Trend Download option also include the Trend Download software CD and the TruSat/PC RS-232 cable. Service kits and replacement parts are also available. They are listed in the TruSat Technical Reference Manual. Sensors Refer to the sensor chart that accompanies this manual for a list of the sensors and sensor-related accessories approved for use with this monitor.
  • Page 29: Trend Download Option

    Trend Download option Trend Download option, upgrade kit............6050-0007-164 For installation by authorized service personnel only. Includes Trend Download software CD, TruSat/PC RS-232 cable, circuit board with RS-232 connector, and installation hardware Trend Download software CD............... 6050-0006-586 Cable, TruSat/PC RS-232 ................. 6050-0006-924 Cable, TruSat/serial printer................
  • Page 31: Compliance And Specifications

    4. COMPLIANCE AND SPECIFICATIONS This chapter contains: • Medical electrical equipment standards and compliance information for the monitor. • Specifications. Compliance European Union Medical Device Directive 93/42/EEC: Class IIb EN 60601-1 Medical electrical equipment – Part 1: General requirements for safety (including Amendments 1 and 2) •...
  • Page 32: Specifications

    TruSat User’s Guide Specifications Specifications are nominal and are subject to change without notice. Measurement General Pulse oximetry sensors: OxyTip+ sensors only Method: red and infrared light absorption Red LED wavelength range: 650 to 670 nm Infrared (IR) LED wavelength range: 930 to 950 nm Average power: ≤...
  • Page 33: Monitor

    Compliance and Specifications Monitor General Lock function: locks/unlocks alarm limits and other settings Factory calibrated; power-on self-test with calibration check Recovery time after exposure to defibrillation voltage: ≤ 30 seconds Display Liquid crystal display (LCD) Backlight LED: ON or OFF Plethysmographic pulse bar (pleth bar): ten-segment column;...
  • Page 34: External Power

    TruSat User’s Guide External power Power supply (AC to DC converter) AC power input: 100–240 V, 0.5 A, 50–60 Hz Power supply (DC to DC) DC power input from vehicle cigaretter lighter: 12 V Power supply output to monitor: 12 VDC, 1.25 A, 15 watt...
  • Page 35: Trend Data Collection

    A. TREND DOWNLOAD OPTION Monitors configured with the Trend Download option are equipped with an RS-232 port for connecting a portable printer or a computer. The Trend Download option expands the capabilities of the monitor to include the following: • Collecting and storing patient monitoring data, or trends.
  • Page 36: Alarm Annunciation Capability

    TruSat User’s Guide Alarm annunciation capability The Trend Download option lets you connect the TruSat to your local “nurse call” system for automatic transmission of signals when alarms occur. To enable this feature, authorized service personnel must do the following: •...
  • Page 37: Printing To The Portable Printer

    Connecting the printer The TruSat/serial printer cable, a roll of paper, a battery pack, and a power supply for the printer are included with the printer. 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.
  • Page 38: Printing Summary Statistics For One Or More Patients

    TruSat User’s Guide Printing summary statistics for one or more patients You can print a statistical summary of each record stored in the monitor. Trends for the most recent patient are printed first. After monitoring one or more patients, unplug the sensor from the monitor.
  • Page 39: Printing Real-Time Data

    Trend Download Option Printing real-time data Real-time printouts are intended for archival or record-keeping purposes only. The patient record is also stored in trend memory. Connect the printer and begin to monitor the patient. To start printing, use the ComWheel to move the pointer to the print symbol, then press the ComWheel.
  • Page 40: Trend Download Pc Software

    You can create detailed, easy-to-read reports containing trends for individual patients. The Trend Download option includes the following equipment for connecting a PC to the TruSat and downloading trends: • Compact disc (CD) containing the Trend Download PC software and instructions (pdf).
  • Page 41: Setup

    IEC 60601–1–1 and with local requirements. Connect only external devices specified for use with this monitor. Connect the TruSat/PC RS-232 cable to the RS-232 port on the PC and to the Trend Download RS-232 port on the side panel of the monitor.
  • Page 43: Warranty

    B. WARRANTY The TruSat pulse oximeter (the Product) is sold by GE Healthcare (the Company) only under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of the Product directly from the Company’s Authorized Dealers as new merchandise and are extended to the first buyer thereof, other than for resale.

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