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Summary of Contents for Nonin 9843
- Page 1 Operator’s Manual Model 9843 Handheld Pulse Oximeter and Carbon Dioxide (CO ) Detector English...
- Page 2 +31 (0)13 - 79 99 040 (Europe) Fax: +31 (0)13 - 79 99 042 E-mail: infointl@nonin.com nonin.com 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 ®...
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Page 3: Table Of Contents
Pulse Quality Indicator..................12 Low Battery Indicator.................... 12 Sensor Fault or Inadequate Signal Display ............12 Using the 9843 Pulse Oximeter ..............13 Connecting the Sensors ..................13 Pulse Oximeter Sensor ..................13 Carbon Dioxide Sensor and Airway Adapter Tube ........... 13 Turn On/Standby .................... - Page 4 Contents (Continued) Carbon Dioxide (CO ) Sensor and Airway Adapter Tube......20 Carbon Dioxide Sensor ..................20 Airway Adapter Tube.....................21 Attaching the Airway Adapter Tube to the Carbon Dioxide Sensor ....22 Care and Maintenance .................24 Maintenance......................24 Cleaning the CO Sensor..................24 Returning the CO Sensor for Service ..............24 Memory Functions ..................25 Memory .........................25...
- Page 5 Figures Figure 1. Model 9843 Pulse Oximeter and Carbon Dioxide Detector ......7 Figure 2. Model 9843 Controls and Indicators ............7 Figure 3. Replacing Batteries - Model 9843, example only........10 Figure 4. Rear View - Model 9843, example only ............ 10 Figure 5.
- Page 6 Tables Table 1. Symbols ....................... 5 Table 2. Calendar and Clock Mode Parameters............16 Table 3. Electromagnetic Emissions................ 33 Table 4. Electromagnetic Immunity................34 Table 5. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity..35 Table 6. Recommended Separation Distances ............36...
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Page 7: Indications For Use
Indications for Use Indications for Use ® The Nonin Model 9843 Pulse Oximeter and Carbon Dioxide Detector is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO ), pulse rate, and approximate carbon dioxide (CO ) changes in the airway of intubated patients. -
Page 8: Cautions
Before use, carefully read the Instructions for Use provided with sensors and airway adapters. This device is a precision electronic instrument and must be repaired by trained Nonin personnel only. Field repair of the device is not possible. Do not attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty. - Page 9 This device contains WEEE materials; please contact your distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor’s contact information.
- Page 10 Indications for Use Cautions (Continued) This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following: - excessive ambient light - improperly applied sensor - cardiogreen and other intravascular - excessive motion...
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Page 11: Guide To Symbols
Guide to Symbols Guide to Symbols This table describes the symbols that are found on the Model 9843 and in this manual. Table 1 : Symbols Symbol Description CAUTION! Consult Instructions for Use. Follow Instructions for Use. Type BF Applied Part (Patient isolation from electrical shock). - Page 12 Guide to Symbols Table 1 : Symbols (Continued) Symbol Description Front Panel Buttons ON/Standby Advance/Beep Volume Control Set-up/Event Marker Display Indicators %SpO Display Battery Indicator Pulse Rate Display Pulse Quality Indicator Change in CO Concentration No Alarms...
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Page 13: A General Description
The 9843 will typically operate for 90 hours continuously between battery replacements when used for pulse oximetry alone, or for 20 hours continuously when used for both CO detection and pulse oximetry. -
Page 14: About Pulse Oximetry
Unpacking the Model 9843 Contact the carrier immediately if the shipping carton is damaged. Carefully unpack the device and its accessories. Nonin’s standard packaging configuration consists of the items listed below: • 1 Model 9843 Pulse Oximeter and CO Indicator •... -
Page 15: Installing And Using The Batteries
A General Description Installing and Using the Batteries 9843 is powered by six AA size alkaline batteries. Approximate battery capacity: • Pulse Oximeter (SpO ) only: 90 hours • CO and Pulse Oximeter: 20 hours • CO only: 24 hours. -
Page 16: Figure 3. Replacing Batteries - Model 9843, Example Only
A General Description IMPORTANT: Insert these two batteries first. Battery Orientation Battery Door Figure 3: Replacing Batteries - Model 9843, example only Serial Number 0123 IP32 UL 60601-1 30EM NONIN MEDICAL, INC. PLYMOUTH, MN USA MODEL 9843 Battery PULSE OXIMETER/CO2 DETECTOR... -
Page 17: Important Notes About Battery Use
• Setting the month to “00” disables the calendar and clock functions and helps conserve battery life. Refer to “Calendar Setting” on page 16 for additional information. • The memory of the 9843 may be erased when the batteries are removed. • Replacing batteries may erase the clock settings of the 9843. -
Page 18: Displays And Indicators
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. This 3-digit LED display shows the pulse rate in pulses per minute. -
Page 19: Using The 9843 Pulse Oximeter
Using the 9843 Pulse Oximeter Using the 9843 Pulse Oximeter Connecting the Sensors Pulse Oximeter Sensor Attach the sensor (with the Nonin logo facing up) to the device as shown in Figure 5 below. Verify the sensor is securely connected. Pulse Oximeter Sensor... -
Page 20: Startup Self-Test
When the device is turned on, the device will cycle through a startup/initialization sequence before displaying valid data. During startup, always check for any missing indicators or LED display segments. If any indicator is not functioning, do not use the device. Contact Nonin Technical Service for repair or replacement. -
Page 21: Carbon Dioxide Detector
(if the breath beep sound volume is not turned off). Setup All functions of the 9843 are controlled by buttons found on the keypad on the front of the device. Press the On/Standby button to turn the device on or to enter Standby mode. -
Page 22: Choosing Settings
SpO display to the next sequential parameter as listed in Table 2. 3. Continue this process until all parameters are set. When the setting sequence has been completed, the 9843: a. exits the setup mode, and b. begins normal operation. -
Page 23: Visible Indicators
Visible Indicators Refer to Figure 2 on page 7 for a detailed illustration of the 9843 controls and indicators. The intended operator’s position for correctly perceiving a visual alarm signal and its priority is 1 meter (3.3 feet), per IEC 60601-1-8. -
Page 24: Pulse Quality Indicator
Using the 9843 Pulse Oximeter Pulse Quality Indicator CAUTION: The device may misinterpret motion artifact as good pulse quality. The pulse quality indicator blinks once for each pulse while measuring oxygen saturation. The pulse quality indicator changes color to indicate changes in the pulse waveform signal that may affect the SpO data. -
Page 25: Low Battery Indicator
Each time the 9843 is turned on, the audible breath beep will default to the medium sound volume setting. During normal operation, pressing the set-up/event marker button cycles the audible breath beep sound volume between low, medium, high, and off. -
Page 26: Carbon Dioxide (Co 2 ) Sensor And Airway Adapter Tube
The Model 9840SA CO Sensor is a crescent-shaped device containing light emitting and detecting elements (Figure 6) on the end of a cable that connects to the 9843. The CO sensor is connected on to the Model 9840AAT Airway Adapter Tube, which in turn is connected between the endotracheal tube and the breathing circuit of intubated patients. -
Page 27: Airway Adapter Tube
) Sensor and Airway Adapter Tube Airway Adapter Tube WARNING: Do not use the Model 9843 CO detector for patients younger than 3 years old and weighing less than 10 kg (22 lb) due to the dead space introduced by the airway adapter tube. -
Page 28: Attaching The Airway Adapter Tube To The Carbon Dioxide Sensor
Carbon Dioxide (CO ) Sensor and Airway Adapter Tube Attaching the Airway Adapter Tube to the Carbon Dioxide Sensor 1. While grasping the large end of the airway adapter tube, place the clear windows of the tube toward the CO sensor (Figure 8-A). -
Page 29: Figure 9. The Airway Adapter Tube And The Breathing Circuit
Carbon Dioxide (CO ) Sensor and Airway Adapter Tube The Breathing Circuit (a breathing device, breathing bag, ventilator, etc.) Model 9843 Model 9840SA Model 9840AAT sensor Airway Adapter Tube Endotracheal Tube Figure 9: The Airway Adapter Tube and the Breathing Circuit... -
Page 30: 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 place the Model 9843 in liquid or clean it with agents containing ammonium chloride, isopropyl alcohol, or products that are not listed in this user’s guide. -
Page 31: Memory Functions
Memory Functions Memory Functions Memory The 9843 can collect and store up to 24 hours of SpO and pulse rate information. ® Nonin offers nVISION Data Management Software for Oximetry Screening, for use with a personal ® computer. nVISION is an easy to use Windows -based program for pulse oximetry data retrieval, analysis, report generation, and data storage. -
Page 32: Memory Playback Mode
Memory Functions Memory Playback Mode 1. With the unit off, press and hold the set-up/event marker button while pressing and then releasing the on/standby button. 2. Release the set-up/event marker button when “888 888” is displayed on the SpO and pulse rate displays. -
Page 33: Communications
Communications Communications Real-Time Serial Output The 9843 provides real-time data output capability via the pulse oximeter sensor connector (a 9-pin Sub-D connector). The sensor connector pin assignments are listed below. Pin Number Assignment Sensor Detect IR Drive Red Drive Serial Data Output... -
Page 34: Connecting The Device Into A Medical System
Communications Connecting the Device into a Medical System Incorporating the device into a medical system requires the integrator to identify, analyze, and evaluate the risks to patient, operators, and third parties. Subsequent changes to the medical system after device integration could introduce new risks and will require additional analysis. Changes to the medical system that must be evaluated include: •... -
Page 35: Service, Support And 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 unit found to be within specifications. -
Page 36: 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 37: Troubleshooting
The Battery Low indicator The battery level is low or critically Replace all six batteries of the 9843. is steadily lit or flashing. low. An incorrect battery installation. Verify correct battery orientation. - Page 38 Electromagnetic interference (EMI). Remove the device from the EMI performance. environment. 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).
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Page 39: 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, IEC 62368-1, or UL 1950 for data-processing equipment. -
Page 40: Table 4. Electromagnetic Immunity
Technical Information Table 4 : Electromagnetic Immunity IEC 60601 Test Electromagnetic Immunity Test Compliance Level 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 41: Table 5. Guidance And Manufacturer's Declaration-Electromagnetic Immunity
Technical Information Table 5 : Guidance and Manufacturer’s Declaration—Electromagnetic Immunity IEC 60601 Test Compliance Immunity Test Electromagnetic Environment—Guidance 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. -
Page 42: Equipment Response Time
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. -
Page 43: Testing Summary
• 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 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to dark-skinned subjects during motion and no-motion conditions in an independent research laboratory. -
Page 44: Principles Of Operation
1 to 60 breaths per minute Breath Detection Threshold 5 mmHg Accuracy – Sensors Declared accuracy data for compatible sensors can be found in Nonin’s Sensor Accuracy document. Accuracy of Bar Graph Thresholds (A )* ±25% of reading (typical) Measurement Wavelengths and Output Power** Red: 660 nanometers @ 0.8 mW max. - Page 45 Technical Information Altitude Operating: Up to 3,000 meters (10,000 feet) Hyperbaric Pressure: Up to 4 atmospheres Power Requirements Six 1.5V AA-size alkaline batteries. 90 hours - Pulse Oximeter only. 20 hours - CO and Pulse Oximeter. 24 hours - CO only.
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