Nonin 2500A PalmSAT Operator's Manual

Pulse oximeter with alarms
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Operator's Manual
Model 2500A PalmSAT
®
Pulse Oximeter with Alarms
English
0123
0123

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Summary of Contents for Nonin 2500A PalmSAT

  • Page 1 Operator’s Manual Model 2500A PalmSAT ® Pulse Oximeter with Alarms English 0123 0123...
  • Page 2 Authorized EC Representative: MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany References to “Nonin” in this manual shall imply Nonin Medical, Inc. Nonin, PalmSAT, PureLight and nVISION are registered trademarks or trademarks of Nonin Medical, Inc. ® ® Microsoft and Windows are registered trademarks of Microsoft Corporation.
  • Page 3: Table Of Contents

    Contents Indications for Use ..................1 Contraindications....................1 Warnings ........................ 1 Cautions ......................... 2 Guide to Symbols ..................4 Displays and Indicators ................5 Display ......................5 Pulse Rate Display ....................5 Pulse Quality Display....................5 Low Battery Indicator....................5 Sensor Fault Display ....................
  • Page 4 Contents (Continued) Playing Back the Data Stored in Memory ............19 Clearing the Memory.....................20 Choosing Memory Clear Settings ..............20 Choosing Calendar and Clock Settings ..............20 Communications ..................21 Serial Output ......................21 Service, Support and Warranty..............22 Warranty........................23 Parts and Accessories.................24 Troubleshooting ...................25 Technical Information ..................28 Manufacturer’s Declaration ...................28 Equipment Response Time...................31 Testing Summary ....................32...
  • Page 5 Figures Figure 1. Displays, Indicators and Buttons..............7 Figure 2. Rear View....................8 Figure 3. Installing Batteries..................9 Figure 4. Connecting a Sensor................. 11...
  • Page 6 Tables Table 1. Labeling Symbols..................4 Table 2. Adjustable Parameters and Settings............13 Table 3. High and Medium Priority Alarms .............. 16 Table 4. Alarm Limits ....................17 Table 5. Pulse Oximeter Sensor Connector Pin Assignments......... 21 Table 6. Electromagnetic Emissions................ 28 Table 7.
  • Page 7: Indications For Use

    Use only with Nonin-branded PureLight pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for Nonin Pulse Oximeters. Using other manufacturers’ sensors may cause improper pulse oximeter performance. Using other manufacturers’ sensors can result in improper pulse oximeter performance.
  • Page 8: Cautions

    Verify that all visible indicators illuminate and that an audible indicator sounds during the startup (initialization) sequence. If any indicator is not lit or the audible indicator does not sound, do not use the device. Contact Nonin Technical Service for assistance.
  • Page 9 Do not attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty. Any sign or evidence of opening the system, field service by non-Nonin personnel, tampering, or any kind of misuse or abuse of the system, shall void the warranty in its entirety.
  • Page 10: Guide To Symbols

    Guide to Symbols Guide to Symbols This table describes the symbols that are found on the Model 2500A and in this manual. Table 1: Labeling Symbols Symbol Description CAUTION! Consult Instructions for Use. Follow Instructions for Use. Type BF Applied Part (Patient isolation from electrical shock). UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA-C22.2 No.
  • Page 11: Displays And Indicators

    Displays and Indicators Displays and Indicators Display The SpO display is the upper numeric display (identified by the %SpO symbol). This 3-digit light-emitting diode (LED) display shows the current oxygen saturation percentage. This display flashes for SpO alarms. Pulse Rate Display The Pulse Rate display is the lower numeric display (identified by the symbol).
  • Page 12: Alarm Bar

    Displays and Indicators Alarm Bar The Alarm Bar flashes amber or red, indicating medium or high priority alarms, respectively. This indicator is located near the top of the device. Alarm Silence Indicator The Alarm Silence indicator (identified by the symbol) is located to the left of the On/Off button. Whenever the Alarm Silence indicator is flashing, all audible alarms are temporarily silenced.
  • Page 13: Using The Palmsat Pulse Oximeter

    Using the PalmSAT Pulse Oximeter Using the PalmSAT Pulse Oximeter The Model 2500A PalmSAT is a digital handheld pulse oximeter that displays numerical values for blood oxygen saturation (%SpO ) and pulse rate. It provides audible and visual alarms for both medium and high priority conditions.
  • Page 14: Unpacking The Model 2500A

    Using the PalmSAT Pulse Oximeter The Model 2500A Pulse Oximeter may be used with a variety of Nonin-branded PureLight pulse oximeter sensors. A sensor disconnect or malfunction is indicated by an inadequate Pulse Quality display blinking and/or a dash to the left of the SpO value on the LED display.
  • Page 15: Figure 3. Installing Batteries

    Using the PalmSAT Pulse Oximeter Low and critically low battery capacity is indicated with a flashing Low Battery indicator and a medium priority alarm. When batteries are critically low, the digital displays will go blank, and the Pulse Quality indicator will blink amber or red, but not green. Any SpO or pulse rate alarms in effect when critically low battery capacity is reached will be latched, and flashing dashes will appear on the corresponding display.
  • Page 16: Important Notes About Battery Use

    • AA alkaline batteries cannot be recharged in the charging stand. Connecting the Sensor Connect the pulse oximeter sensor (with the Nonin logo facing up) to the top of the device as shown. Ensure that the sensor is firmly plugged in. Refer to “Specifications” or to the specific...
  • Page 17: Power On/Off

    LED display segments and ensure that the audible indicator sounds. If any indicator is not functioning, do not use the device. Contact Nonin Technical Service for repair or replacement. During its normal startup sequence, the device will cycle as follows: •...
  • Page 18: Monitoring

    Using the PalmSAT Pulse Oximeter Monitoring Verify that the pulse oximeter sensor is properly positioned on the patient. Ensure that the pulse oximeter is sensing adequate pulse quality by: • verifying that the Pulse Quality display is blinking green and •...
  • Page 19: Detailed Operation

    Detailed Operation Detailed Operation All functions of the Model 2500A are controlled by the On/Off and Advance buttons located on the front of the unit. Setup Mode Setup mode is used to adjust alarm, memory clear, and memory playback functions, as well as to set the calendar and clock.
  • Page 20 Detailed Operation Table 2: Adjustable Parameters and Settings (Continued) Appears in SpO Range of Values Appears Default Setting in Pulse Rate Display Value Display High Alarm 80 - 100, 0FF Audible Alarms Hi, Lo, 0FF Memory Clear yes or no Delete (confirm clear) yes or no Year...
  • Page 21: Care And Maintenance

    Care and Maintenance Care and Maintenance Clean the device separately from the sensors. For instructions on cleaning pulse oximeter sensors, refer to the respective sensor instructions for use. CAUTION: Do not autoclave or immerse the device or sensors in liquid. Do not expose the device or components to excessive moisture or liquids.
  • Page 22: Alarm Functions

    Pulse Quality LED is blank. Display “dash” sign in LED, freeze both numeric displays for disconnect, bad cable, leftmost SpO Medium Nonin incompatible 10 seconds, display “dash” sign in middle LED of sensor) and pulse rate numeric displays. or pulse rate data Display “dash”...
  • Page 23: Adjusting Alarm Settings

    Alarm Functions Table 3: High and Medium Priority Alarms (Continued) Alarm Condition Visible Indication Priority Pulse rate date not updated for more than Pulse rate numeric display goes to dashes. Medium 30 seconds Battery low indicator flashing (2500A). No other Battery marginal Medium displays are affected.
  • Page 24: Reviewing Alarm Settings

    Attempt to clear the error by turning the device off and on. If the problem persists, contact Nonin Technical Service. WARNING: When a system fault occurs, the patient will no longer be monitored.
  • Page 25: Memory Functions

    30 seconds after removing the batteries. Replace batteries immediately to avoid losing stored data. Nonin’s nVISION data management software is available for use with Microsoft Windows 2000/ XP/Vista/7 operating systems. The memory in the device functions as an “endless loop.” When the memory fills up, the unit begins overwriting the oldest data with the newest.
  • Page 26: Clearing The Memory

    Memory Functions Clearing the Memory The Memory Clear function allows you to delete all data currently stored in memory. Choosing Memory Clear Settings 1. Enter Setup mode, and scroll through the settings until CLr is displayed. 2. CLr may be set to no or yES. •...
  • Page 27: Communications

    Communications Communications Serial Output The Model 2500A provides real-time data output capability via the pulse oximeter sensor connector (a 9-pin Sub-D connector). The pulse oximeter sensor connector pin assignments are listed below. Table 5: Pulse Oximeter Sensor Connector Pin Assignments Pin Number Assignment ®...
  • Page 28: Service, Support And Warranty

    Fax: +31 (0)13 - 79 99 042 E-mail: technicalserviceintl@nonin.com nonin.com All non-warranty work shall be done according to Nonin standard rates and charges in effect at the time of delivery to Nonin. All repairs include a complete retest of the Model 2500A using factory test fixtures.
  • Page 29: Warranty

    This warranty excludes cost of delivery to and from Nonin. All repaired units shall be received by the purchaser at Nonin's place of business. Nonin reserves the right to charge a fee for a warranty repair request on any device that is found to be within specifications.
  • Page 30: Parts And Accessories

    For more information about Nonin parts and accessories: • See the Parts and Accessories List on the Operator’s Manual CD. • Contact your distributor or Nonin at (800) 356-8874 (USA and Canada), +1 (763) 553 9968, or +31 (0)13 - 79 99 040 (Europe).
  • Page 31: Troubleshooting

    The batteries are installed orientations. Refer to Figure 3: incorrectly. The device won’t turn on. Installing Batteries. A metal contact in the battery Contact Nonin Technical compartment is missing or Service. damaged. Verify that the sensor is A sensor fault exists. The sensor...
  • Page 32 Troubleshooting Problem Possible Cause Possible Solution The Pulse Quality display Examine the patient: reposition The quality of the pulse signal at is blinking amber with sensor or select an alternate the sensor site is marginal. each pulse. sensor site. Low patient pulse strength; the sensor site is poorly perfused;...
  • Page 33 Nonin Technical Service. NOTE: If these solutions do not correct the problem with your device, please contact Nonin Technical Service at (800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe).
  • Page 34: Technical Information

    Technical Information Technical Information NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. CAUTION: A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. CAUTION: All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard EN 60950 or UL 1950 for data- processing equipment.
  • Page 35: Table 7. Electromagnetic Immunity

    Technical Information Table 7: Electromagnetic Immunity IEC 60601 Electromagnetic Immunity Test Compliance Level Test Level Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is used in such an environment. Electrostatic ±6 kV contact ±6 kV contact...
  • Page 36: Table 8. Guidance And Manufacturer's Declaration-Electromagnetic Immunity

    Technical Information Table 8: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity IEC 60601 Compliance Electromagnetic Environment— ImmunityTest Test Level Level Guidance This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 37: Equipment Response Time

    Technical Information Table 9: Recommended Separation Distances This table details the recommended separation distances between portable and mobile RF communications equipment and this device. This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 38: Testing Summary

    Tim e in seconds • The response of the 4-beat average is 1.5 seconds. Testing Summary accuracy, and low perfusion testing were conducted by Nonin Medical, Inc., as described below: Accuracy Testing During motion and no-motion conditions at an independent research laboratory, SpO...
  • Page 39: Principles Of Operation

    18 to 321 beats per minute (BPM) Accuracy – Sensors Declared accuracy data for compatible sensors can be found in Nonin’s Sensor Accuracy document. Measurement Wavelengths and Output Power* Red: 660 nanometers @ 0.8 mW maximum avg. Infrared: 910 nanometers @ 1.2 mW maximum avg.
  • Page 40 Technical Information Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL 60601-1 Type of Protection: Internally powered (on battery power) Degree of Protection: Type BF-Applied Part Mode of Operation: Continuous Enclosure Degree of Ingress Protection IP32 This device is not made with natural rubber latex.

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