Nonin 9847 Operator'S Manual Download Page 2

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Nonin

reserves the right to make changes and improvements to this manual and the products it

describes at any time, without notice or obligation.

Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, Minnesota 55441, USA

+1 (763) 553-9968

(800) 356-8874 (USA and Canada)

Fax: +1 (763) 553-7807

E-mail: [email protected]

Nonin Medical B.V.

Prins Hendriklaan 26

1075 BD Amsterdam, Netherlands

+31 (0)13 - 79 99 040 (Europe)

Fax: +31 (0)13 - 79 99 042
E-mail: [email protected]

nonin.com

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.

7409-101-06

Follow Instructions for Use.

0123

EC REP

Summary of Contents for 9847

Page 1: ...Operator s Manual Model 9847 Handheld Pulse Oximeter and Carbon Dioxide CO2 Detector 0123 0123 English...

Page 2: ...V Prins Hendriklaan 26 1075 BD Amsterdam Netherlands 31 0 13 79 99 040 Europe Fax 31 0 13 79 99 042 E mail infointl nonin com nonin com MPS Medical Product Service GmbH Borngasse 20 D 35619 Braunfels...

Page 3: ...13 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...

Page 4: ...eath Alarm 27 Audible Pulse Oximeter Sensor Alarm 28 Audible CO2 Sensor Alarm 28 Description of Alarm Sounds 28 Audible Indicator Sound Control Priorities 28 Carbon Dioxide CO2 Sensor and Airway Adapt...

Page 5: ...0 Troubleshooting 41 Technical Information 43 Manufacturer s Declaration 43 Equipment Response Time 46 Testing Summary 47 SpO2 Accuracy Testing 47 Pulse Rate Motion Testing 47 Low Perfusion Testing 47...

Page 6: ...Batteries Model 9847 example only 11 Figure 4 Rear View Model 9847 example only 11 Figure 5 Connecting Sensors to the Model 9847 14 Figure 6 Model 9840SA Carbon Dioxide Sensor 30 Figure 7 Model 9840A...

Page 7: ...uring an Alarm Limit Review 22 Table 4 Audible and Visible Functions During Alarm Conditions 25 Table 5 Audible Indicator Sound Control Priorities 29 Table 6 Electromagnetic Emissions 43 Table 7 Elect...

Page 8: ...O2 detector is not intended for long term monitoring of end tidal CO2 The CO2 detector is not intended for use in patients younger than 3 years old and weighing less than 10 kg 22 lb Contraindication...

Page 9: ...urate readings If the airway adapter tube packaging appears to be damaged or open discard it and replace it with a new one The Model 9840AAT Airway Adapter Tube will increase dead space by approximate...

Page 10: ...pes with this device Do not use different types of batteries at the same time Do not mix fully charged and partially charged batteries at the same time These actions may cause the batteries to leak Do...

Page 11: ...ections to the airway adapter tube are tight and leak free and that the airway adapter tube is properly attached to the CO2 sensor Ensure that this device the airway adapter tube and the sensors have...

Page 12: ...601 1 SN Serial Number located on the back cover IP32 Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and ingress of solid foreign objects greater than or e...

Page 13: ...nt Panel Buttons ON Standby Advance Breath Beep Volume Control Alarm Limit Review Audible Alarm Disable Display Indicators SpO2 SpO2 Display Battery Indicator Pulse Rate Display Pulse Quality Indicato...

Page 14: ...when used for both CO2 detection and pulse oximetry Figure 1 Model 9847 Pulse Oximeter and Carbon Dioxide Detector with Alarms Figure 2 Model 9847 Controls and Indicators CO2 SpO2 888 Model 9847 888 N...

Page 15: ...d pulse the pulse quality indicator blinks Patient pulse quality signals are graded as good marginal or inadequate and are indicated as such by the pulse quality indicator blinking green yellow or red...

Page 16: ...uminated and CO2 readings will be displayed with the next breath detected Medium priority equipment alarms occur when the CO2 sensor is unplugged the airway adapter tube is removed from the CO2 sensor...

Page 17: ...e NOTE Setting the month to 00 disables the calender and clock functions and helps conserve battery life Refer to Calender Settings on page 20 for additional information Replacing Batteries 1 Slide op...

Page 18: ...mple only IMPORTANT Insert these two batteries first Battery Door Battery Orientation 5808 005 04 US PATENT Re 33 643 6x1 5V AA IEC LR6 PULSE OXIMETER CO2 DETECTOR MODEL 9847 PLYMOUTH MN USA NONIN MED...

Page 19: ...with approximately 90 hours of continuous operation Calendar clock settings can affect battery storage life Batteries drain during storage but they drain more quickly when the unit s calendar clock f...

Page 20: ...are not updated After about 10 seconds the values are replaced with dashes indicating that readings are not possible Low Battery Indicator When battery level is low the low battery indicator is lit W...

Page 21: ...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 L...

Page 22: ...uminates when ready for use if CO2 sensor is connected to the device The yellow audible alarm disabled indicator is lit until initialization is complete and a CO2 or pulse oximeter sensor is connected...

Page 23: ...e on or to enter Standby mode Setup Mode Setup mode is used to control the audible and visible patient alarm limits the breath beep pitch the calendar and the internal time of day clock In setup mode...

Page 24: ...o the next sequential parameter no breath delay time alarm limit etc as listed in Table 2 3 Continue this process until all parameters are set When the setting sequence has been completed the 9847 1 e...

Page 25: ...alues Default Value Alarm Mode dFt default limits rCL recall stored limits C02 only no breath and the sensor alarms ALr dFt rCL C02 dFt No Breath Delay seconds nbd 15 to 60 by 5 OFF 20 Oxygen Saturati...

Page 26: ...e no breath delay time setting No Breath Delay Time Setting 1 Upon entering the no breath delay time setup nbd will appear in the SpO2 display The no breath delay time may be set from 15 to 60 seconds...

Page 27: ...th beep pitch selection may be toggled between ON or OFF Calendar Settings NOTE Setting the month to 00 disables the calendar and clock functions The calendar and clock functions are used to time stam...

Page 28: ...or inadequate signal continues Also during this medium priority alarm an audible indicator will occur If the sensor fault or inadequate signal is not corrected dashes will be displayed in the middle...

Page 29: ...ges color to indicate changes in the pulse waveform signal that may affect the SpO2 data The pulse quality indicator may blink one of three colors Green indicates that the pulse waveform signal is of...

Page 30: ...stop The no breath delay timer is first started when the CO2 sensor is plugged into the 9847 and the system is not in setup mode when the lower bar is illuminated on the CO2 display CO2 Bar Graph The...

Page 31: ...monitor a patient once the batteries reach a critically low level The batteries must then be replaced before further use of the 9847 NOTE Removing batteries may delete memory and all user defined sett...

Page 32: ...on Audible Indication Visible Indication Low battery level None Low battery indicator steadily illuminated Battery level critically low Medium priority alarma unless audible high priority patient alar...

Page 33: ...nd volume between low medium high and off A volume beep will sound each time the advance switch is pressed to indicate the current setting unless an audible alarm is in progress NOTE The advance switc...

Page 34: ...g this high priority alarm a visible alarm indication will occur See SpO2 and Pulse Rate Displays on page 21 for more information The audible and visible indicators will stop when the condition is cle...

Page 35: ...dible and visible CO2 sensor alarm indicators will stop when the condition is corrected Description of Alarm Sounds The pitch of the alarm sounds is the same as a volume beep the tone heard when chang...

Page 36: ...he onset of a high priority patient alarm condition will cause the initiation of the high priority patient alarm If a medium priority equipment alarm condition occurs after the onset of a patient alar...

Page 37: ...40SA Carbon Dioxide Sensor WARNING Do not use the Model 9847 CO2 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 adapte...

Page 38: ...tube WARNING Do not reuse the Model 9840AAT Airway Adapter Tube WARNING If the airway adapter tube becomes contaminated or damaged discard it and replace it with a new one Cleaning the interior will d...

Page 39: ...e other pair of tabs You should hear a clicking sound as the pieces are connected together Figure 8 C Figure 8 Connecting the Airway Adapter Tube to the CO2 Sensor 3 Ensure that the airway adapter tub...

Page 40: ...irway Adapter Tube Figure 9 The Airway Adapter Tube and the Breathing Circuit Model 9840AAT Airway Adapter Tube Model 9847 Endotracheal Tube Model 9840SA CO2 sensor The Breathing Circuit a breathing d...

Page 41: ...2 Sensor with a soft cloth dampened with isopropyl alcohol Do not pour or spray any liquids onto the Model 9840SA CO2 Sensor Allow the Model 9840SA CO2 Sensor to dry thoroughly before reusing Returnin...

Page 42: ...300 pulses per minute NOTE CO2 detector data is not stored in memory During data retrieval the last data recorded is the first displayed For example the last four minutes of data recorded are the fir...

Page 43: ...this file will depend on the amount of data saved in the memory The most recent data are played back first The memory data format is in binary Bad data is represented by FF hexadecimal or 255 decimal...

Page 44: ...he mark condition Therefore the real time data may be read as 8 data bits no parity Real time data may be printed or displayed by compatible devices On power up a header is sent identifying the format...

Page 45: ...at must be evaluated include Changing the system configuration Adding devices to or disconnecting devices from the system Updating or upgrading equipment connected to the system Issues resulting from...

Page 46: ...he 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 The Model 9847 is a precision electronic...

Page 47: ...body tissue and application can be found in the respective sensor Instructions for Use WARNING The use of accessories sensors and cables other than those specified in the Parts and Accessories List m...

Page 48: ...fy the sensor connection A sensor failure Replace the sensor with a Nonin branded PureLight sensor The displayed pulse rate does not correlate to the pulse rate displayed on the ECG monitor when used...

Page 49: ...er blood pressure cuff infusion line Reduce or eliminate the source The Pulse Quality display is blinking red and the SpO2 and or Pulse Rate displays are dashes Inadequate pulse signal at sensor site...

Page 50: ...s equipment can affect medical electrical equipment Table 6 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance This device is intended for use in the electromagne...

Page 51: ...t Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode N A N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage va...

Page 52: ...eters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveyc should be less than the compliance level in each frequency range d Interference may occur in the vic...

Page 53: ...tput Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum...

Page 54: ...range of 70 to 100 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 80601 2 61 Medical Electrical Equipment Particular requirements for the basic safety and...

Page 55: ...Breath Detection Threshold 5 mmHg Accuracy Sensors Declared accuracy data for compatible sensors can be found in Nonin s Sensor Accuracy document CO2 Accuracy of Bar Graph Thresholds Arms 25 of readi...

Page 56: ...equirements Six 1 5V AA size alkaline batteries 90 hours Pulse Oximeter only 20 hours CO2 and Pulse Oximeter 24 hours CO2 only Dimensions 8 cm W x 15 cm H x 2 5 cm D 3 in W x 6 in H x 1 in D Weight 31...

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