Model 9847 Operators Manual

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.

Consult Instructions for Use.

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 55441-5443 USA +1 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax +1 (763) 553-7807 [email protected] www.nonin.com

References to “NONIN” in this manual shall imply Nonin Medical, Inc. NONIN, Flexi-Form, FlexiWrap, PureLight and nVISION are registered trademarks or trademarks of NONIN Medical, Inc. Microsoft® and Windows® are registered trademarks of Microsoft Corporation.

© 2009 Nonin Medical, Inc. 7409-101-01

Contents Indications for Use ...1 Contraindications ...1 Warnings ... 2 Cautions ...4

Guide to Symbols ...9 General Description ...10 Unpacking the Model 9847 ...13 Installing and Using the Batteries ...14 Important Notes about Battery Use ...17

Displays and Indicators ...18 SpO2 Display ...18 Pulse Rate Display ...18 Pulse Quality Indicator ...18 Low Battery Indicator ...18 Sensor Fault or Inadequate Signal Display ...18

Using the 9847 Pulse Oximeter ...20 Connecting the Sensors ...20 Turn On/Standby ...20 Startup Self-Test ...21 Setup ...23 Indicators ...29

Carbon Dioxide (CO2) Sensor and Airway Adapter Tube 42 Carbon Dioxide Sensor ...42 Airway Adapter Tube ...43

Care and Maintenance ...46 Cleaning the CO2 Sensor ...46 Returning the CO2 Sensor for Service ...46

Memory Functions ...47 Memory ...47

Communications ...49 Real-Time Serial Output ...49

Service, Support and Warranty ...51 Warranty ...52

Accessories ...53 Troubleshooting ...55

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Technical Information ...59 Manufacturer’s Declaration ...60 Equipment Response Time ...64 Testing Summary ...65 Specifications ...66

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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.

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 (22 lb).

Contraindications Do not use this device in an MR environment. 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 adapter tube. This device is not defibrillation proof per IEC 60601-1:1988 + A2:1995 clause 17h.

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Warnings Explosion Hazard: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses. This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. 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. Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU). Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the 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 may result in increased emission and/or decreased immunity of this device. Use only with NONIN-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for NONIN Pulse Oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance. Check the pulse oximeter sensor application site every 6 to 8 hours 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.

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Warnings (Continued) As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction 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. Cleaning the interior will damage the anti-fog coating and cause inaccurate 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 approximately 6 cubic centimeters (0.4 cubic inches); this may adversely affect ventilation for patients with small tidal volumes. 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. This device is a precision electronic instrument and must be repaired by qualified technical professionals. 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. This device 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. Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.

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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. 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. Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors and/or double-backed adhesive strips may vary due to medical status or skin condition. This device is not an apnea monitor. 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. This device may not work on all patients. If you are unable to achieve stable readings, discontinue use. This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality. Minimize patient motion as much as possible. Ear Clip and Reflectance sensors are not recommended for pediatric or neonatal use. The accuracy of these sensors has not been established for pediatric or neonatal use. Do not autoclave or immerse the device or sensors in liquid. Do not expose the device or components to excessive moisture or liquids. Do not use caustic or abrasive cleaning agents on the device or the sensors. 4

Cautions (Continued) The oximeter sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation, or reposition the sensor. The device is not designed to retain data in memory once the batteries are removed. Memory will clear 60 seconds after removing the batteries. Replacing the batteries before 60 seconds have elapsed most likely will result in corrupt data. Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the same time as this may cause the batteries to leak. Use only NONIN-specified battery types 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 not remove any covers other than the battery cover when replacing batteries. There are no user-serviceable parts inside other than the replaceable batteries. Batteries may leak or explode if used or disposed of improperly. Remove the batteries if the device will be stored for more than 1 month. Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. 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. All parts and accessories connected to the serial port of this device must be certified according to at least IEC 60950 or UL1950 for dataprocessing equipment.

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Cautions (Continued) This equipment complies with IEC 60601-1-2:2007 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. 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. An airway adapter that is between 5° C (41° F) and 10° C (50° F) may cause inaccurate reading due to fogging of optical surfaces. It is recommended that the airway adapter tube be warmed to above 10° C (50° F) before use.

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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 - excessive motion - electrosurgical interference - blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.) - moisture in the sensor - improperly applied sensor - incorrect sensor type - inadequate signal - venous pulsations - anemia or low hemoglobin concentrations - cardiogreen and other intravascular dyes - carboxyhemoglobin - methemoglobin - dysfunctional hemoglobin - artificial nails or fingernail polish.

Portable and mobile RF communications equipment can affect medical electrical equipment. A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. 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. Ensure that this device, the airway adapter tube, and the sensors have stabilized at the specified environmental operating conditions before use.

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Cautions (Continued) Gastric distention with air prior to intubation may introduce CO2 into stomach and esophagus and yield false results. Observe six breaths before interpreting results. This device’s CO2 detector must not be used with gaseous anesthetics. 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.

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Guide to Symbols This table describes the symbols that are found on the Model 9847. Table 1: Symbols

Consult Instructions for Use.

SSI FI E LA

D

C

Type BF Applied Part (Patient isolation from electrical shock).

C UL US

UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 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 equal to 2.5 mm (0.1 in) in diameter per IEC 60529. Indicates separate collection for electrical and electronic equipment (WEEE). Front 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 Indicator

 CO2 Change in CO2 Concentration No Breath Absence of CO2 Detection

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General Description NONIN Model 9847 Pulse Oximeter and Carbon Dioxide Detector is a hand-held, battery-operated, noninvasive monitoring device that has visible and/or 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.

Figure 1: Model 9847 Pulse Oximeter and Carbon Dioxide Detector with alarms.

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Alarm Indicator

Pulse Oximeter Sensor Connector

Tri-Color Pulse Quality (LED) Indicator

SpO2 Display

888 888

Pulse Rate (LED) Display

CO2  Bar Graph Display

CO 2

%SpO 2

m m H g

k P a

No Breath Indicator

No Breath

On / Standby CO2 Sensor Connector

Advance/ Breath Beep Volume Control

Keypad

Alarm Limit Review

Audible Indicator (Speaker)

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

Model 9847

Low Battery (LED) Indicator

Figure 2: Model 9847 Controls and Indicators

Audible Alarms and Informational Tones Model 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,

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pulse rate, or inadequate pulse quality signal. A medium priority (equipment) alarm indicates the batteries have reached critically low capacity, or that a sensor alarm condition is occurring. An informational tone (a beep) indicates a non-alarm event (a breath). The audible alarms can be silenced or temporarily disabled using the audible alarm disable button.

About Pulse Oximetry 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 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 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 an inadequate pulse is detected, the pulse quality indicator will blink red and a high priority patient audible alarm will sound. If the SpO2 or the pulse rate meets or exceeds user-defined alarm limits, the corresponding numerical value will blink on the SpO2 or pulse rate displays and a high priority patient audible alarm will sound. If the pulse oximeter sensor is disconnected, malfunctions, or an adequate signal is not detected: • a dash appears in the leftmost position of the SpO2 display, • the displayed SpO2 and pulse rate values will freeze for 10 seconds, and • a medium priority equipment alarm will sound (unless the audible alarms are disabled or unless overridden by a high priority patient alarm). • 10 seconds after the first dash appears, the SpO2 and pulse rate values will be replaced by dashes, if the condition is not corrected, and • dashes will blink if there was a patient alarm in process.

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Carbon Dioxide Detector 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 detector relies on the assumption that the inhaled air contains minimal 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 bar graph and by an audible breath beep. When no breath is detected: • a high priority patient audible alarm sounds, • the no breath indicator blinks, • the lowest CO2 bar graph segment will be illuminated, 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, the light path is blocked, or a CO2 sensor failure occurs.

A high priority (patient) alarm overrides a medium priority alarm. If the audible alarms are disabled, the third and sixth bars will be solidly illuminated.

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 CO2 Indicator 1 Operator’s Manual (on CD) 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 distributor.

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Installing and Using the Batteries Model 9847 is powered by six AA size alkaline batteries. Approximate battery capacity: • Pulse Oximeter (SpO2) only: 90 hours • CO2 and Pulse Oximeter: 20 hours. • CO2 only: 24 hours. Low battery indicator illuminates when the battery capacity is low. The batteries should be replaced as soon as possible. Critical battery capacity is indicated by: • low battery indicator blinks • medium priority (equipment) alarm To avoid loss of monitoring, batteries must be replaced immediately. NOTE: Audible high priority patient alarms override medium priority

alarms. If the batteries are critically low when the device is turned on, setup mode will be disabled and the displays will be blank. Replace the batteries before continuing.

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CAUTION: Use only NONIN-specified battery types with this

device.

NOTE: To conserve battery life disconnect the CO2 sensor not in use. NOTE: Setting the month to “00” disables the calender and clock

functions and helps conserve battery life. Refer to “Calender Settings” on page 28 for additional information.

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Replacing Batteries 1. 2. 3.

Slide open and remove the battery door on the bottom of the device. Remove all six batteries. Replace all six batteries with new AA size batteries as illustrated below with the proper battery orientation noted on the back of the device. !

CAUTION: The device is not designed to retain data in memory

once the batteries are removed. Memory will clear 60 seconds after removing the batteries. Replacing the batteries before 60 seconds have elapsed most likely will result in corrupt data. Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the same time as this may cause batteries to leak.

IMPORTANT: Insert these two batteries first.

Battery Orientation

Battery Door Figure 3: Replacing Batteries - Model 9847, example only.

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IP32 UL 60601-1

30EM

SN

Serial Number

NONIN MEDICAL, INC. PLYMOUTH, MN USA MODEL 9847

PULSE OXIMETER/CO2 DETECTOR SEE ACCOMPANYING DOCUMENTS

Battery Orientation

6x1.5V AA IEC LR6 US PATENT # Re. 33,643 5808-002-04

Battery Door

Figure 4: Rear View - Model 9847, example only. When batteries are critically low, the digital displays will go blank, and the Pulse Quality display will blink yellow or red, but not green. .

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CAUTION: Replace the batteries as soon as possible after a low

battery indication. Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the same time. This may cause the batteries to leak. CAUTION: Remove the batteries if the device will be stored for

more than 1 month.