Related Manuals for Nonin 9847
Summary of Contents for Nonin 9847
- Page 1 Operator’s Manual Model 9847 Handheld Pulse Oximeter and Carbon Dioxide (CO ) Detector English 0123 0123...
- Page 2 0123 0123 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 ® Windows are registered trademarks of Microsoft Corporation.
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Page 3: Table Of Contents
Pulse Quality Indicator..................13 Low Battery Indicator.................... 13 Sensor Fault or Inadequate Signal Display ............13 Using the 9847 Pulse Oximeter ..............14 Connecting the Sensors ..................14 Pulse Oximeter Sensor ..................14 Carbon Dioxide Sensor and Airway Adapter Tube ........... 14 Turn On/Standby .................... - Page 4 Contents (Continued) Alarm Limit Review ....................22 Pulse Quality Indicator ..................22 No Breath Indicator....................23 Bar Graph ....................23 Low Battery Indicator ..................24 Audible Alarm Disabled Indicator...............24 Audible Indicators....................25 Audible and Visible Indicator Functions During Alarm Conditions.....25 Audible Breath Beep..................26 Audible Critically Low Battery Alarm..............27 Audible SpO High or Low Alarm ..............27 Audible Pulse Rate High or Low Alarm..............27...
- Page 5 Contents (Continued) Parts and Accessories ................40 Troubleshooting ..................41 Technical Information ................. 43 Manufacturer’s Declaration................... 43 Equipment Response Time .................. 46 Testing Summary ....................47 Accuracy Testing..................47 Pulse Rate Motion Testing................47 Low Perfusion Testing ..................47 Principles of Operation ..................48 Specifications .......................
- Page 6 Figures Figure 1. Model 9847 Pulse Oximeter and Carbon Dioxide Detector with Alarms ..7 Figure 2. Model 9847 Controls and Indicators ............7 Figure 3. Replacing Batteries - Model 9847, example only ........11 Figure 4. Rear View - Model 9847, example only ............. 11 Figure 5.
- Page 7 Tables Table 1. Symbols....................... 5 Table 2. Patient Alarm Limit, Breath Beep Pitch, Calendar, and Clock Mode Parameters ..................... 18 Table 3. Alarm Limits Displayed During an Alarm Limit Review ......22 Table 4. Audible and Visible Functions During Alarm Conditions ......25 Table 5.
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Page 8: Indications For Use
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor. Verify all alarm settings and limits during system startup to ensure that they are set as intended. A hazard can exist if different presets are used on multiple 9847 monitors in one care area. -
Page 9: 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 10 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 11 Indications for Use Cautions (Continued) Do not use the airway adapter tube if the airway adapter tube is below 5 °C (41 °F). An airway adapter tube that is below 5 °C (41 °F) may frost, causing a false reading. Warm the airway adapter tube to above 5 °C (41 °F) by putting it in a warm place (for example, in your hands or in a vehicle) prior to use.
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Page 12: Guide To Symbols
Guide to Symbols Guide to Symbols This table describes the symbols that are found on the Model 9847 and in this manual. Table 1: Symbols Symbols Description CAUTION! Consult Instructions for Use. Follow Instructions for Use. Type BF Applied Part (Patient isolation from electrical shock). - Page 13 Guide to Symbols Table 1: Symbols (Continued) Symbols Description Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Front Panel Buttons ON/Standby Advance/Breath Beep Volume Control Alarm Limit Review Audible Alarm Disable Display Indicators %SpO Display...
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Page 14: General Description
The 9847 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 15: Audible Alarms And Informational Tones
General Description Audible Alarms and Informational Tones 9847 uses audible alarms and informational tones (along with visible indicators) to alert healthcare providers to several patient and equipment conditions. A high priority (patient) alarm alerts the healthcare provider of a patient’s absence of breath, high or low oxygen saturation, pulse rate, or inadequate pulse quality signal. -
Page 16: Carbon Dioxide Detector
Unpacking the Model 9847 Contact the carrier immediately if the shipping carton is damaged. Carefully unpack the device and its accessories. Nonin’s standard package configuration consists of the following items: • 1 Model 9847 Pulse Oximeter and CO Indicator •... -
Page 17: Installing And Using The Batteries
General Description Installing and Using the Batteries 9847 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. Low battery indicator illuminates when the battery capacity is low. The batteries should be replaced as soon as possible. -
Page 18: Figure 3. Replacing Batteries - Model 9847, Example Only
General Description IMPORTANT: Insert these two batteries first. Battery Orientation Battery Door Figure 3: Replacing Batteries - Model 9847, example only 0123 IP32 Serial UL 60601-1 Number 30EM NONIN MEDICAL, INC. PLYMOUTH, MN USA MODEL 9847 Battery PULSE OXIMETER/CO2 DETECTOR... -
Page 19: Important Notes About Battery Use
• Setting the month to “00” disables the calendar and clock functions and helps conserve battery life. Refer to “Calendar Settings” on page 20 for additional information. • The memory of the 9847 may be erased when the batteries are removed. • Replacing batteries may erase the clock settings of the 9847. -
Page 20: 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 21: Using The 9847 Pulse Oximeter
Using the 9847 Pulse Oximeter Using the 9847 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. Verify the sensor is securely connected. Pulse Oximeter Sensor... -
Page 22: Pulse Oximeter Startup
(Yellow) NOTE: The audible alarm disabled indication cannot be turned off until a sensor is plugged in. NOTE: When 9847 is turned on and the alarms are disabled, the yellow audible alarm disabled indicator will remain illuminated. Pulse Oximeter Startup Apply the pulse oximeter sensor to the patient as directed in the sensor Instructions for Use. -
Page 23: Carbon Dioxide Detector
CO sensor fault. Setup On / Standby Advance / All functions of the 9847 are controlled by buttons found on the keypad on Breath Beep the front of the device. Volume Control Press the On/Standby button to turn the device on or to enter Standby Alarm Limit mode. -
Page 24: Disabling The Audible Alarms
NOTE: You may exit setup mode at any point and save your current patient alarm limit changes (without stepping through the remainder of the setup mode menu options). Complete the desired selections, then turn off the 9847. Next, enter setup mode again and choose “rCL” (recall stored limits) from the alarm mode settings. -
Page 25: Table 2: Patient Alarm Limit, Breath Beep Pitch, Calendar, And Clock Mode Parameters
Using the 9847 Pulse Oximeter 2. Release the audible alarm disable button when “888 888” is displayed on the %SpO pulse rate displays. After the power on self-test, the “audible alarm disabled” indicator will illuminate steadily. The patient alarms will be set at the default limits. The audible alarms can be re-enabled by pressing the audible alarm disable button again. -
Page 26: Alarm Mode Setting
Choosing “dFt” (default alarm limits) will set up the system-defined (default) patient alarm limit settings. Choosing “rCL” (recall stored limits) will set up the last stored patient alarm limit settings of the 9847. Choosing “C02” (no breath alarm limits and sensor alarms) will disable the oxygen saturation high and low and the pulse rate high and low settings temporarily by setting them to “0FF”. -
Page 27: Pulse Rate Alarm Limit Settings
Using the 9847 Pulse Oximeter Pulse Rate Alarm Limit Settings 1. Upon entering the pulse rate low alarm limit, “H L” will appear in the SpO display. The pulse rate low alarm limit may be set from 30 to 110 (beats per minute) in increments of 5, or to “0FF”. -
Page 28: Visible Indicators
Using the 9847 Pulse Oximeter Visible Indicators Refer to Figure 2 on page 7 for a detailed illustration of the 9847 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 29: Alarm Limit Review
Using the 9847 Pulse Oximeter Alarm Limit Review When the alarm limit review button is pressed and held, the patient alarm limits in effect for %SpO no breath delay time (in seconds), SpO , and pulse rate, as well as the breath beep pitch setting will display in sequence for approximately 2 seconds in the order and format shown in Table 3. -
Page 30: No Breath Indicator
When a breath is again detected, the visible and audible no breath indicators will stop. The no breath delay timer is first started when the CO sensor is plugged into the 9847 and the system is not in setup mode (when the lower bar is illuminated on the CO display). -
Page 31: Low Battery Indicator
“audible alarm disabled” indicator will blink. Disabled Indicator After the 9847 is turned on (and after exiting the setup mode, if applicable) and (Yellow) until a pulse oximeter or CO sensor is plugged in for the first time, the “audible alarm disabled”... -
Page 32: Audible Indicators
• Latched prior high priority patient alarm Battery level critically low priority patient alarm is • All other visible indicators off (the 9847 latched is unavailable for use) numeric display blinking; if latched for High priority patient... -
Page 33: Audible Breath Beep
Each time the 9847 is turned on, the audible breath beep will default to the medium sound volume setting. During normal operation, pressing the advance switch cycles the audible breath beep sound volume between low, medium, high, and off. -
Page 34: Audible Critically Low Battery Alarm
The audible critically low battery alarm is a medium priority equipment alarm indicating that the batteries have reached a critically low level and must be replaced immediately. The 9847 will not monitor patients after the batteries reach a critical power level. Also during this medium priority alarm, the visible low battery indicator blinks. -
Page 35: Audible Pulse Oximeter Sensor Alarm
(For example, a critical battery condition could begin while a no breath condition is occurring). Therefore, the 9847 software uses a set of “rules” to determine the priority of these sounds. These sound control rules are described in Table 5. -
Page 36: Table 5. Audible Indicator Sound Control Priorities
Using the 9847 Pulse Oximeter Table 5: Audible Indicator Sound Control Priorities Condition Sound Control Priorities Normal sound operation; steadily illuminated low battery Low Battery Level indicator only. • Critically Low Battery Medium priority audible alarm unless a prior high priority patient Level or alarm is “latched”. -
Page 37: 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 9847. 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 38: Airway Adapter Tube
) Sensor and Airway Adapter Tube Airway Adapter Tube WARNING: Do not use the Model 9847 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 39: 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 40: 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 9847 Model 9840SA Model 9840AAT sensor Airway Adapter Tube Endotracheal Tube Figure 9: The Airway Adapter Tube and the Breathing Circuit... -
Page 41: 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 9847 in liquid or clean it with agents containing ammonium chloride, isopropyl alcohol, or products that are not listed in this User’s Guide. -
Page 42: Memory Functions
Memory Functions Memory Functions Memory The 9847 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 43 Memory Functions memory as long as the batteries are good, so if the memory must be cleared, remove the batteries for a period of 60 seconds or longer. Playing back the data in memory does not clear any data from the memory.
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Page 44: Communications
Communications Communications Real-Time Serial Output The 9847 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 45: 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 46: 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 47: 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 48: Troubleshooting
A non-compatible sensor is being used. Replace the sensor with a Nonin- branded PureLight sensor. The ECG monitor may not be Assess the patient. - Page 49 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 50: 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. -
Page 51: Table 7. Electromagnetic Immunity
Technical Information Table 7: Electromagnetic Immunity Compliance Electromagnetic Environment— Immunity Test IEC 60601 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. Electrostatic ±6 kV contact ±6 kV contact... -
Page 52: 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— Immunity Test 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 53: 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 54: 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 55: 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 56 Technical Information Humidity Operating: 10% to 95% noncondensing Humidity (Storage/Transportation): 10% to 95% noncondensing 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.