Model 9847 Operators Manual 4963-000-05

Caution:

Federal law (USA) restricts this device to sale by or on the order of a physician.

Caution:

Read this manual carefully before using the 9847.

The information in this manual has been carefully checked and is believed to be accurate. In the interest of continued product development, 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. 2605 Fernbrook Lane North Plymouth, MN 55447-4755 USA (763) 553-9968 (800) 356-8874 (USA and Canada) Fax (763) 553-7807 [email protected] www.nonin.com

0123

References to “NONIN” in this manual shall imply Nonin Medical, Inc. Nonin is a registered trademark of Nonin Medical, Inc. ©2004 Nonin Medical, Inc.

Authorized EC Representative: MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany

Guide to Symbols ATTENTION: See Instructions for Use

Type BF Equipment (Patient isolation from electrical shock.) CE Marking indicating conformance to EC directive No. 93/42/EEC concerning medical devices.

C

SSIFIE LA

D

C

Do Not Reuse

UL US

UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 2601-1 and CAN/CSA C22.2 No. 601.1.

IPX1

Protected Against Dripping Water

IPX4

Protected Against Splashing Water

Guide to Symbols

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Introduction Indications for Use The NONIN Model 9847 Pulse Oximeter and Carbon Dioxide Detector is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and approximate carbon dioxide (CO2) changes in the airway of intubated patients. These functions may be used separately or simultaneously.

Figure 1. The Model 9847 Pulse Oximeter and Carbon Dioxide Detector

Pulse Oximeter Intended Use The pulse oximeter is intended to be used for noninvasively monitoring oxygen saturation and pulse rate for adult, pediatric, and neonatal patients in hospital, ambulatory, and Emergency Medical Services (EMS) environments. The pulse oximeter may be used for spot checking and/or continuous monitoring when attended by a healthcare professional.

Carbon Dioxide Detector Intended Use The CO2 detector is a mainstream device intended to be used for semi-quantitative detection of CO2 levels in intubated patients during patient transport, and for short-term hospital use (e.g., emergency rooms or crash carts), and where gaseous anesthetic is not present. The CO2 detector may be used to initially confirm proper placement of the endotracheal tube and to provide continued confirmation of correct endotracheal tube placement and patient respiration status. The CO2 detector is not intended for prolonged CO2 monitoring. The CO2 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.

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Introduction

Precautions for Use Contraindications • • • •

Do not operate the Model 9847 in an MRI environment. Do not use the Model 9847 CO2 detector for patients less than 3 years old and under 10 kg due to the dead space introduced by the airway adapter tube. Do not use the Model 9847 CO2 detector during mouth-to-tube ventilation. The presence of CO2 in the exhaled breath from the person performing resuscitation will cause inaccurate readings. The Model 9847 CO2 detector cannot distinguish between oropharyngeal tube placement and endotracheal tube placement if the airway is patent. Standard clinical assessment must be used.

Warnings • • • • • • • •

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Explosion hazard. Do not use the Model 9847 in the presence of flammable anesthetics. The Model 9847 is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. General operation of the Model 9847 may be affected by the use of an electrosurgical unit (ESU). Do not use a damaged sensor. This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed carefully to verify normal operation. The use of accessories, sensors, and cables other than those specified in this manual may result in increased emission and/or decreased immunity of this device. Use only NONIN manufactured pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for NONIN Pulse Oximeters. Using other manufacturer's sensors may cause improper pulse oximeter performance. Check the pulse oximeter sensor application site frequently to determine the circulation, positioning, and skin sensitivity of the patient. Each patient's sensitivity to NONIN sensors may vary depending on their medical status or the condition of their skin.

Precautions for Use

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Discontinue use of the NONIN double-backed adhesive tape strips or the Hydrogel tape strips if the patient exhibits allergic reactions to the adhesive material. Do not stretch the adhesive tape while applying the pulse oximeter sensor. This may cause inaccurate readings or skin blisters. Do not reuse the Model 9840AAT Airway Adapter Tube. If the airway adapter tube becomes contaminated or damaged, discard it and replace it with a new one. Cleaning the interior will damage the anti-fog coating and cause inaccurate readings. The Model 9840AAT Airway Adapter Tube will increase dead space by approximately 6 cubic centimeters; this may adversely affect ventilation for patients with small tidal volumes. Do not use the airway adapter tube if the airway adapter tube is below 5 °C. An airway adapter tube that is below 5 °C may frost, causing a false reading. Warm the airway adapter tube to above 5 °C by putting it in a warm place (for example in your hands or in a vehicle) prior to use. If the Model 9847 CO2 detector results are inconclusive, the correct anatomic location of the endotracheal tube must be confirmed by other methods. Do not use the Model 9847 CO2 detector with a humidifier or nebulizer in the breathing circuit, as the fine mist may cause erroneous readings.

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Cautions •

Federal law (USA) restricts this device to sale by or on the order of a physician. Read this manual carefully before using the Model 9847. Before use, carefully read the package insert provided with the sensors. Model 9847 Pulse Oximeter and Carbon Dioxide Detectors are sensitive electronic instruments and must be repaired by knowledgeable and specially trained personnel only. Ensure that the Model 9847, the airway adapter tube, and the sensors have stabilized at the specified environmental operating conditions before use. Verify that all audible and visible indications are operating properly during the power on self-test. If any self-test event does not occur or functions incorrectly, do not use the Model 9847. Consult the troubleshooting guide or contact NONIN Customer Support. Do not immerse the Model 9847 or NONIN sensors in liquid. Do not use caustic or abrasive cleaning agents on the Model 9847 or the sensors.

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Precautions for Use

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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 not remove any covers other than the battery cover when replacing batteries. There are no user serviceable parts inside other than the replaceable batteries. Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components, including batteries. Alkaline batteries may leak or explode if used or disposed of improperly. Do not block the audible indicator speaker holes. Blocking the speakers will significantly reduce the sound volume. Verify that the audible alarms can be heard over the ambient noise of the operating environment. This equipment complies with International Standard EN 60601-12:2001 for electromagnetic compatibility for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in this manual. Portable and mobile RF communications equipment can affect medical electrical equipment. The Model 9847 pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement. The Model 9847 pulse oximeter may not work on all patients. If you are unable to achieve stable readings, discontinue use. The Model 9847 pulse oximeter may not work on all patients. If you are unable to achieve stable readings, discontinue use. The Model 9847 pulse oximeter may interpret motion artifact as good pulse quality. The Model 9847 pulse oximeter is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin may affect the accuracy of the measurement. Cardiogreen and other intravascular dyes, depending on the concentration, may affect the accuracy of the SpO2 measurement. Precautions for Use

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Some fingernail polish colors (particularly blues and blacks) may reduce light transmission and thereby affect SpO2 accuracy. Ear Clip and Reflectance pulse oximeter sensors are not recommended for pediatric or neonatal use. The accuracy of these sensors has not been established for pediatric or neonatal use. Remove earrings from the patient’s ear before applying the Ear Clip Sensor. Water or other liquid between the airway adapter tube and the CO2 sensor may cause erroneous readings. Ensure that all connections to the airway adapter tube are tight and leak-free, and that the airway adapter tube is properly attached to the CO2 sensor. An airway adapter tube that is between 5 °C and 10 °C may cause inaccurate readings due to fogging of optical surfaces. It is recommended that the airway adapter tube be warmed to above 10 °C before use. Gastric distention with air prior to intubation may introduce CO2 into the stomach and esophagus and yield false results. Observe six breaths before interpreting results. This device has not been tested for immunity to electromagnetic disturbances. The Model 9847 CO2 detector must not be used with gaseous anesthetics.

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Precautions for Use

Manufacturer’s Declaration Refer to the following table for specific information regarding this device’s compliance to IEC Standard 60601-1-2. Table 1: Electromagnetic Emissions Emissions Test

Compliance

Electromagnetic Environment- Guidance

This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. RF Emissions CISPR 11

Group 1

This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

Harmonic Emissions IEC 61000-3-2

N/A

This device is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

N/A

Precautions for Use

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General Description The Model 9847 Pulse Oximeter and Carbon Dioxide Detector is a hand-held, battery-operated, noninvasive monitoring device that has visible and audible indicators for tracking patient and equipment status. 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 CO2 detection and pulse oximetry. The 9847 requires no routine calibration or maintenance. Serial Data Infrared Link

SpO2 Display (Percent Oxygen Saturation)

Pulse Rate Display

Pulse Oximeter Sensor Connector

%SpO

Tri-Color Pulse Quality Indicator

CO

CO2 Display Absence of Breath (Apnea) Indicator APN

Low Battery Indicator

On / Off Switch

CO2 Sensor Connector

Advance Switch

Alarm Limit Review Switch

Audible Indicators (Speakers)

“Audible Alarm Disabled” Indicator (Yellow) Audible Alarm Disable Switch

Figure 2. Model 9847 Controls and Indicators

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Precautions for Use

Audible Alarms and Informational Tones The Model 9847 uses audible alarms and informational tones (along with visible indicators) to alert healthcare providers to several patient and equipment conditions. A Model 9847 high priority (patient) alarm alerts the healthcare provider to absence of breath (apnea), high or low oxygen saturation, high or low pulse rate, or inadequate pulse quality conditions. A medium priority (equipment) alarm either indicates that the batteries have reached a critically low power state, or that a CO2 sensor alarm or a pulse oximeter sensor alarm condition is occurring. An informational tone (a beep) indicates a non-alarm event (a breath). The audible alarms can be “permanently” or “temporarily” disabled using the audible alarm disable switch. The informational tones (breath beeps) will only sound during the quiet part of an alarm burst sequence. The volume of the breath beeps can be turned “off ” using the advance switch. The breath beeps default to a “variable pitch” mode unless “fixed pitch” is selected during setup. (Refer to “Audible Breath Beep” on page 36.)

Precautions for Use

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Pulse Oximeter The Model 9847 determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passed through perfused tissue. Changes in absorption caused by pulsation of blood in the vascular bed are used to determine arterial saturation and pulse rate. Oxygen saturation and pulse rate values are indicated on light-emitting diode (LED) digital displays. On each detected pulse, the pulse quality indicator flashes. Patient pulse quality signals are graded as good, marginal, or inadequate and are indicated as such by the pulse quality indicator flashing green, yellow, or red respectively. This simple method gives the user a pulse-by-pulse visual indication of waveform signal quality without requiring the user to perform complex waveform analysis during critical patient care situations. If a pulse oximeter sensor signal is detected but the amplitude is too low to measure the SpO2, then the pulse quality indicator will flash red and a high priority patient audible alarm will sound. If the SpO2 or the pulse rate matches or exceeds the operator-set high or low alarm limits, then the corresponding numerical value will flicker on the SpO2 or the pulse rate displays (unless “latched” or continuing for a critical battery state, when 3 flickering dashes will be displayed). In addition, a high priority patient audible alarm will sound. If the pulse oximeter sensor is initially connected to the Model 9847 and is functional, and then is either disconnected or malfunctions, or an adequate pulse oximeter sensor signal is not detected, then:

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a dash will appear to the left of the SpO2 value on the SpO2 display and the displayed SpO2 and pulse rate numerical values will freeze for 10 seconds and a medium priority equipment audible alarm will sound (unless the audible alarms are disabled or unless an audible high priority patient alarm is in progress).

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If, 10 seconds after the first dash appeared, adequate pulse signals still are not detected, the SpO2 and pulse rate numerical values will be replaced by dashes in the middle digits of each display. These dashes will flicker if there was a pulse oximeter patient alarm before that time.

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Precautions for Use

Carbon Dioxide Detector The Model 9847 determines approximate CO2 changes in the airway of intubated patients by measuring the absorption of mid-infrared light passed through the airway adapter tube. The approximate CO2 concentration change is indicated by an 8-segment LED bar graph display (the CO2 display). The CO2 detector relies on the assumption that the inhaled air contains negligible amounts of CO2. Breaths are indicated when the CO2 level increases by approximately 5 mmHg during exhalation. A detected breath is indicated on the CO2 display and by an audible breath beep. When the CO2 detector measures an absence of breath (apnea) condition (no breath detected during a set delay time interval, measured in seconds), then:

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a high priority patient audible alarm sounds and the absence of breath (apnea) indicator flashes and the CO2 display bottom bar will be illuminated, and this display will be able to display CO2 readings (it remains enabled) if a breath is again detected.

If the CO2 sensor is initially connected and operating and then:

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the CO2 sensor is unplugged, or the airway adapter tube is removed from the CO2 sensor, or the light path is blocked, or a CO2 sensor failure occurs,

then a medium priority equipment audible alarm is started (unless the audible alarms are disabled or unless an audible high priority patient alarm is in progress). The third and sixth bars on the CO2 display will be steadily illuminated. The visible indication is defined as a CO2 sensor fault.

Precautions for Use

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Unpacking Your Model 9847 Contact the carrier immediately if the shipping carton for the 9847 is damaged. Carefully unpack the instrument and its accessories. Confirm that the items listed below are packed with the Model 9847 Pulse Oximeter and Carbon Dioxide Detector. The Model 9847 complete system includes:

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1 Model 9847 Pulse Oximeter and Carbon Dioxide Detector 1 Operator’s Manual for the Model 9847 1 Model 8000AA-1 Adult Articulated Finger Clip Sensor 1 Model 9840SA Carbon Dioxide Sensor 3 Model 9840AAT Airway Adapter Tubes 6 AA Size Alkaline Batteries

If any item on this list is missing or damaged, contact your local distributor.

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Precautions for Use

Basic Operation Batteries The Model 9847 Pulse Oximeter and Carbon Dioxide Detector is powered by six AA size alkaline batteries that will typically provide 20 to 90 hours of continuous operation, depending on how the Model 9847 is used. The Model 9847 will typically operate for 90 hours continuously between alkaline battery replacements for pulse oximetry alone, or typically 20 hours continuously with both CO2 detection and pulse oximetry operating concurrently. The low battery indicator steadily illuminates when the battery power is marginal. The batteries should be replaced as soon as possible. When the low battery indicator flashes and a medium priority equipment audible alarm is started (unless an audible high priority patient alarm is in progress), the battery power has reached a critical level and the batteries must be replaced before using the Model 9847. The Model 9847 will not monitor patients after the batteries reach a critical power level. If the batteries are critically low at power on, setup mode will be disabled and the displays will be blank. If the battery level then returns to a marginal level (after removing a sensor or after the power on self-test, for example), the Model 9847 will be functional but setup mode will remain disabled. Notes:

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To conserve battery life, NONIN recommends disconnecting the CO2 sensor from the Model 9847 when CO2 detection is not in use. The flashing lamp in the CO2 sensor consumes a significant amount of energy. Setting the month to “00” disables the calendar and clock functions and helps conserve battery life. Refer to “Choosing Calendar Settings” on page 26 for additional information. The memory of the Model 9847 may be erased when the batteries are removed. Replacing batteries may erase the clock settings of the Model 9847.

Basic Operation

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Replacing Batteries in the Model 9847 1. Remove the battery door on the bottom of the Model 9847. 2.

Remove all six used batteries. If necessary, gently tap the device against the palm of your hand to dislodge all of the batteries.

3.

Replace all six used batteries with fresh AA size batteries. Be sure to use the correct battery orientation when installing the new batteries. IMPORTANT: Insert these two batteries first.

Battery Orientation

Battery Door

Figure 3. Replacing Batteries in the Model 9847

IPX1

0123 UL2601-1 30EM

SN

Serial Number

NONIN MEDICAL, INC. PLYMOUTH, MN USA MADE IN U.S.A.

MODEL 9847 PULSE OXIMETER/CO2 DETECTOR

Battery Door

Battery Orientation 6x1.5V AA IEC LR6 US PATENT # Re. 33,643

2577-003 06

Figure 4. Rear View of the Model 9847 14

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Basic Operation

Connecting the Sensors Pulse Oximeter Sensor Connect the sensor (with the NONIN logo facing up) to the top of the Model 9847 as shown in Figure 5. Ensure that an appropriate sensor is firmly plugged in, and position the sensor on the patient.

Pulse Oximeter Sensor

CO2 Sensor and Airway Adapter Tube

Figure 5. Connecting Sensors to the Model 9847

Carbon Dioxide Sensor and Airway Adapter Tube Connect the CO2 sensor (with the NONIN logo facing up) to the side of the Model 9847 as shown in Figure 5. Ensure that the sensor is firmly plugged in. Refer to “Carbon Dioxide Sensor” on page 44 for more information.

Turning On the Model 9847 Turn on the Model 9847 by pressing the on/off switch on the front of the unit. Refer to Figure 2 on page 8 for a detailed illustration of the Model 9847 controls and indicators. Refer to “Detailed Operation” on page 20 for detailed information on entering setup mode, disabling the alarms, and on general operation of the Model 9847.

Basic Operation

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Power On Self-Test When the Model 9847 is turned on for normal operation, it cycles through a self-test before displaying valid data. When entering setup mode at power on, the 9847 cycles through the same self-test routine. Verify that all audible and visible indications are operating properly during the power on self-test. If any self-test event does not occur or functions incorrectly, do not use the Model 9847. Consult the troubleshooting guide or contact NONIN Customer Support.

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The audible breath beep will sound three times.

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The absence of breath (apnea) indicator will display for approximately 2 seconds.

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The low battery indicator will display for approximately 2 seconds, then will remain off unless the batteries are low.

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The pulse quality indicator will first flash red, then green, then will either continue to flash if a pulse oximeter sensor is connected to the unit, or will turn off if no pulse oximeter sensor is connected.

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The SpO2 and pulse rate ♥ displays will cycle through the following sequence:

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APN

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“888 888”;

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the current time (if set) or “00 00” if the time is not set;

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the software revision number;

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then will either remain blank if no pulse oximeter sensor is connected to the Model 9847, or

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will display a single dash (-) in the middle digit of both displays if a pulse oximeter sensor is connected to the Model 9847 but is not detecting an adequate signal. (The Model 9847 will then begin to display values when the pulse oximeter detects an adequate signal.) or

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will display “Alr” and “dFt” if entering setup mode.

Basic Operation

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The CO2 display will cycle through the following sequence: ramp up and then down; turn all bars off; and finally either remain blank (until a CO2 sensor is connected to the unit, and after exiting the setup mode, if applicable) or illuminate the bottom bar when ready for use. The yellow “audible alarm disabled” indicator will illuminate steadily for several seconds. The indicator will then flicker after the power on self-test (and after exiting the setup mode, if applicable).

75 m 50 m H 30 g 20

10

10

1.3

6

0.8

2

0.3

7 k P 4 a 2.6

“Audible Alarm Disabled” Indicator (Yellow)

NOTE: After the Model 9847 is turned on and until a pulse oximeter or CO2 sensor is plugged in for the first time, the “audible alarm disabled” indicator will flicker. This “audible alarm disabled” indication cannot be turned off until a sensor is plugged in. (This is the only illuminated indicator until a sensor is detected, and provides an “on” indication to the user.) NOTE: If the Model 9847 is powered on with the alarms permanently disabled, the yellow “audible alarm disabled” indicator will be steadily illuminated.

Basic Operation

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Overview of Monitoring Pulse Oximeter Verify that the pulse oximeter sensor is properly positioned. Ensure that the pulse oximeter is sensing adequate pulse quality by:

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verifying that the pulse quality indicator ( ) is flashing green and verifying that the pulse rate (♥) and SpO2 (%SpO2) displays are showing readings and verifying that the pulse quality indicator flashing is correlated to the pulse rate for at least 10 seconds

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If the pulse quality indicator light is flashing red or yellow or is flashing erratically, reposition the sensor or try a different sensor. If no pulse oximeter sensor is attached to the pulse oximeter after system initialization (a few seconds after powering on), both the SpO2 and pulse rate displays will remain blank, and the “audible alarm disabled” indicator will flicker, indicating that the 9847 is on.

Carbon Dioxide Detector Verify that the airway adapter tube is properly attached to the CO2 sensor and that the CO2 sensor is properly connected to the Model 9847. Next, verify that the lower bar of the CO2 display is illuminated and the lamp inside the CO2 sensor is flashing on and off. (When CO2 is detected, the illuminated bars on the CO2 display will indicate the approximate change in CO2 level.) Attach the CO2 sensor/airway adapter tube assembly to the patient’s endotracheal tube. The CO2 detector will reflect appropriate values and breath beeps for each breath (if the breath beep sound volume is not set to “off ”). If the CO2 sensor is initially connected and operating and then:

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the CO2 sensor is unplugged, or the airway adapter tube is removed from the CO2 sensor, or the light path is blocked, or a CO2 sensor failure occurs,

then a medium priority equipment audible alarm is started (unless the audible alarms are disabled or unless an audible high priority patient alarm is in progress). The third and sixth bars of the CO2 display will be steadily illuminated (indicating a CO2 sensor fault).

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Basic Operation