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Operator’s Manual Models 8500 and 8500M Handheld Pulse Oximeters English 0123 0123...
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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, PureLight and nVISION are registered trademarks or trademarks of Nonin Medical, Inc. ® ® Microsoft and Windows are registered trademarks of Microsoft Corporation.
Pulse Quality Indicator.................... 5 Low Battery Indicator....................5 Sensor Fault or Inadequate Signal Display ............5 Using the 8500 and 8500M Pulse Oximeters..........7 Unpacking the Model 8500 and 8500M..............7 Installing and Using the Batteries ................7 Important Notes about Battery Use ................ 8 With AA Batteries ....................
Indications for Use ® Nonin Models 8500 and 8500M Handheld Pulse Oximeters are indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate for adult, pediatric, and neonatal patients in hospitals, ambulatory, home and EMS environments.
Verify that all visible indicators illuminate during the startup (initialization) sequence. If any indicator is not lit, do not use the device. Contact Nonin Technical Service for assistance. The presence of a defibrillator may interfere with the performance of this device.
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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.
Guide to Symbols Guide to Symbols This table describes the symbols that are found on the Models 8500 and 8500M 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).
Displays and Indicators Displays and Indicators Display The SpO display is identified by the SpO symbol. This 3-digit light-emitting diode (LED) display shows the current oxygen saturation percentage. Pulse Rate Display ♥ The Pulse Rate display is identified by the symbol.
Contact the carrier immediately if the shipping carton is damaged. Installing and Using the Batteries Models 8500 and 8500M are powered by 6 AA-size alkaline batteries. WARNING: Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.
Using the 8500 and 8500M Pulse Oximeters Figure 2: Installing Batteries in the 8500 When batteries are critically low, the digital displays will go blank, and the Pulse Quality display will blink amber or red, but not green. After 10 minutes at critically low battery capacity, the pulse oximeter will shut off automatically.
6 weeks. 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 sensor Instructions for Use.
“n” “n” and “no” for Model 8500. • ( - ) a dash appears for Model 8500 in the displays until a valid pulse signal is detected. Apply the pulse oximeter sensor to the patient’s finger; ensure the system is obtaining an adequate pulse signal by verifying: •...
Detailed Operation Detailed Operation Setup Mode Setup mode is used to: 1. Set the calendar and clock. 2. Memory download function (8500M only). In Setup mode, the Advance/Dimmer button and the ON ( ) button are used to make all selections.
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.
Visual Indicators Visual Indicators The following table describes conditions and visual indicators. Condition Visual Indication Pulse Waveform Signal is • Pulse Quality LED blinks red inadequate Sensor fault (i.e., sensor • Pulse Quality LED blank disconnect, failure, or • Dash (-) appears in the leftmost position of the SpO incompatibility with the monitor) display •...
3 minutes after removing the batteries. Replacing the batteries before 3 minutes have elapsed most likely will result in corrupt data. Nonin’s nVISION data management software is available for use with Microsoft Windows 2000/XP/Vista/7 operating systems. Refer to “Parts and Accessories.”...
Communications Communications Serial Output Models 8500 and 8500M provide 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 2: Pulse Oximeter Sensor Connector Pin Assignments...
Nonin does not recommend field repair of Models 8500 and 8500M. The circuit board in Models 8500 and 8500M is a multi-layer board using very narrow traces. Due to the very small trace size, extreme care must be used when replacing components to prevent permanent, non-repairable damage to the circuit board.
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Model 8500 or 8500M, field service by non-Nonin personnel, tampering, or any kind of misuse or abuse of the Model 8500 or 8500M, shall void the warranty in its entirety. All non-warranty work shall be done according to Nonin standard rates and charges in effect at the time of delivery to Nonin.
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).
The batteries are installed Verify battery orientation, incorrectly. illustrated inside the battery compartment or in Figure 2: Installing Batteries in the 8500 section of this operator’s manual. A metal contact in the battery Contact Nonin Technical compartment is missing or Service.
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A non-compatible sensor is being Replace the sensor with a used. Nonin-branded Purelight sensor. The ECG monitor may not be Assess the patient. functioning properly. An inconsistent Pulse The ESU may be interfering with Assess the patient.
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Sensor failure. Replace the sensor. 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).
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.
Technical Information Table 4: 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...
Technical Information Table 5: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity IEC 60601 Compliance Immunity Test Electromagnetic Environment—Guidance Test Level Level 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.
Technical Information Table 6: 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.
Specific to this example: • The response of the 4-beat average is 1.5 seconds. Testing Summary accuracy, and low perfusion testing was conducted by Nonin Medical, Inc., as described below: Accuracy Testing During motion and no-motion conditions at an independent research laboratory, SpO...
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 max. avg. Infrared: 910 nanometers @ 1.2 mW max. avg.
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