Nonin Medical BT4000 Puls oximeter display containing Bluetooth User Manual Bluetooth English

Nonin Medical, Inc. Puls oximeter display containing Bluetooth Bluetooth English

Users Manual

Operator’s ManualPulse Oximetry Systemwith Bluetooth® Wireless TechnologyXXX0123English
CAUTION! Federal law (USA) restricts this device to sale by or on the order of a physician.CAUTION! Read this entire manual carefully before using the XXXPulse Oximetry System.The information in this manual has been checked carefully 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 NorthPlymouth, Minnesota 55447-4755USA+1 (763) 553-9968(800) 356-8874 (USA and Canada)Fax +1 (763) 553-7807mail@nonin.comwww.nonin.comAuthorized EC Representative:MPS Medical Product Service GmbHBorngasse 20D-35619 Braunfels, GermanyReferences to “NONIN” in this manual shall imply Nonin Medical, Inc.Nonin is a registered trademark of Nonin Medical, Inc.The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Nonin Medical, Inc. is under license. Other trademarks and trade names are those of their respective owners.© 2003 Nonin Medical, Inc.
Guide to Symbols ......................................................... 1Precautions for Use ......................................................2Using the XXX Pulse Oximetry System ......................5Indications for Use ..........................................................5General Information about Bluetooth Technology ...6Installing the Battery Pack in the Display Unit ...........7Installing Batteries in the POD .....................................8Displays, Indicators, and Controls ................................9Setting Up the XXX System ........................................13Verifying System Operation .........................................15Device Pairing ................................................................16Default Settings ..............................................................17Accessing User Functions ............................................18Dislay Unit DIP switches .............................................21Care and Maintenance ..................................................22Alarms and Limits ...................................................... 23Alarms and Informational Tones ................................23Alarm Summary .............................................................24Silencing Alarms ............................................................24Setting and Changing Volume and Alarm Limits .....25Error Codes ....................................................................26Communication ......................................................... 27Memory Features ...........................................................27Playing Back Memory Data ..........................................28Real-Time Patient Data Output ..................................29Printing Options ............................................................30Parts and Accessories ................................................ 33Service, Support, and Warranty ................................. 34Troubleshooting ......................................................... 35
1Guide to SymbolsDetailed information for functional symbols can be found in “Using the XXX Pulse Oximetry System.” Regulatory SymbolsAttention: See Instructions for Use or related materials.Type BF Applied Part(Patient isolation from electrical shock).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 C22.1 No. 601.1.CE Marking indicating conformance to EC directive No. 93/42/EEC concerning medical devices.Serial Number (located under the back cover).!CLASSIFIEDUSCUL0123SN
2Precautions for UsePrecautions for UseContraindicationsWarningsDo not use any part of this system in an MRI environment.Explosion Hazard: Do not use this system in an explosive atmosphere or in the presence of flammable anesthetics or gases.This system is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.Oximeter readings may be affected by the use of an electrosurgical unit (ESU).Use only NONIN-manufactured 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 perfor-mance.Do not use a damaged sensor.Do not use in or around water or any other liquid when the AC power adapter is used.Use this pulse oximetry system with 300PS-XX AC power adapters, where XX repre-sents the power supply designation.As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation.All parts and accessories connected to the serial port of this system must be certified according to IEC Standard EN 60950 or UL 1950 for data-processing equipment.To avoid the risk of confusing or misinterpreting patient data, verify that the patient is paired with the correct display unit.This pulse oximetry system is designed to determine the percentage of arterial oxy-gen saturation of functional hemoglobin. Significant levels of dysfunctional hemo-globin, such as methemoglobin, might affect the accuracy of the measurement.Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that no blood flow restrictors (e.g., blood pressure cuff) hinder pulse measurements.
3CautionsThis equipment complies with International Standard EN 60601-1-2:2001 for electromagnetic compatibility for medical electrical equipment and/or systems. This stan-dard 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 interference due to close proximity or strength of a source might disrupt the device’s performance.If this pulse oximetry system fails to respond as described, discontinue use until the situa-tion is corrected by qualified personnel.Cardiogreen and other intravascular dyes may affect the accuracy of SpO2 measurements.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.This system might misinterpret motion as good pulse quality. Minimize finger motion.Some nail polish colors or artificial nails can reduce light transmission and affect SpO2 accuracy.Before using any sensor, carefully read the Directions for Use, which contain specific appli-cation information for each sensor.Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary due to medical status or skin condition.Do not place liquids on top of this pulse oximetry system.Do not immerse the pulse oximetry system or sensors in any liquids.Do not use caustic or abrasive cleaning agents on the unit or sensors.Do not gas sterilize or autoclave this pulse oximetry system.Batteries might leak or explode if used or disposed of improperly.Follow local governing ordinances and recycling instructions regarding disposal or recy-cling of the device and device components, including batteries. Use only NONIN-approved battery packs, and remove batteries if the system is not used within 30 days.When using the 300PS-UNIV battery charger, ensure that the AC cord is plugged into a grounded outlet.Do not fasten the pulse oximeter device (POD) too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could result.Caution: Exposure to Radio Frequency Radiation. The radiated output power of the display unit is far below the FCC radio frequency exposure limits. Nevertheless, the device must be used in such a way that the potential for human contact during normal operation is mini-mized. In order to avoid the possibility of exceeding the FCC radio frequency exposure limits, remain at least 20cm (8 inches) away from the display unit’s internal antenna during normal operation.
4Precautions for UseDeclaration of Conformity with FCC Rules for Electromagnetic CompatibilityNonin Medical, Inc., of 2605 Fernbrook Lane North, Plymouth, Minnesota, 55447, declares under its sole responsibility that the products 4000 and 4100, to which this declaration relates, comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.Federal Communications Commission (FCC) NoticeThis equipment has been tested and found to comply with the limits for a class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on. The user is encouraged to try to correct the interference by one or more of the following measures:• Reorient or relocate the receiving antenna.• Increase the distance between the equipment and the receiver.• Connect the equipment to an outlet on a circuit different from the outlet where the receiver is connected.• Consult the dealer or an experienced radio/TV technician for assistance.ModificationsThe FCC requires the user to be notified that any changes or modifications to this device that are not expressly approved by Nonin Medical, Inc. may void the user’s authority to operate the equipment.NOTE: This device may employ a transmitter antenna of gain up to 3 dB.Systems employing antenna gains above this value require a radiolicense.NOTE: This device and its antenna must not be co-located or operating inconjunction with any other antenna or transmitter.
5Using the XXX Pulse Oximetry SystemThis chapter describes how to use the XXX Pulse Oximetry System. The system includes the following components:• Model 4000 display unit with rechargeable battery pack• Model 4100 wrist-worn pulse oximeter device (POD) with AA batteries• 8000AA-WO finger-clip sensor• Operator’s manual• Universal Desktop Battery Charger with IEC320 Connector• 3 wrist bandsIndications for UseThe NONIN® XXX Pulse Oximetry System with Bluetooth® Wireless Technology is indicated for measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for use in hospitals, medical facilities, ambulatory, subacute, and sleep study environments.The XXX Pulse Oximetry System: Display Unit and Wrist-Worn POD.™
6Using the XXX Pulse Oximetry SystemGeneral Information about Bluetooth TechnologyBluetooth is a technology that enables automatic wireless connections between a variety of electronic communications and computing devices, making it possible to connect any compatible devices without cables or wires. The technology is based on a radio link that offers fast and reliable transmissions of voice, video, and data. Bluetooth uses a license-free, globally available frequency range in the ISM band—intended to ensure communication compatibility worldwide.Nonin’s use of Bluetooth Wireless Technology allows SpO2, pulse rate, and plethysmographic data to be transmitted through a Bluetooth radio to a Bluetooth-enabled device. Nonin’s system removes the connection from the sensor cable to the display unit, giving patients increased ability to move freely—without being hindered by cables. Nonin’s system uses a class II Bluetooth radio with a battery life of approximately 4.5 days and a range of about 30 feet (spherical radius). Point-to-Point CommunicationsThe XXX Pulse Oximetry System features point-to-point communications, allowing one master device (the display unit) to be connected to one slave device (the POD). Once connected, neither device is detectable by any other Bluetooth-enabled device, which reduces the risk of interference and preserves data integrity.Nonin’s Wrist-Worn POD can be connected to any compatible Bluetooth device with supporting software. To create a connection to a compatible device, refer to that device’s user instructions.™30'30'
7Installing the Battery Pack in the Display UnitNOTE: Contact your distributor or NONIN to purchase or replace battery packs.NOTE: Reposition the back cover carefully, and tighten the screws firmly—being careful not to over-tighten.
8Using the XXX Pulse Oximetry SystemInstalling Batteries in the Pulse Oximeter Device (POD)
9Displays, Indicators, and ControlsThis section describes the XXX System’s displays, indicators, and controls.Parameter Displays%SpO2 DisplayNumeric light-emitting diodes (LEDs) on the upper left-hand corner of the XXX System display blood oxygen saturation in percent. Pulse Rate DisplayThe pulse rate display is located on the upper right-hand corner of the XXX System and is identified by the symbol. This display shows the pulse rate in beats per minute.Numeric LEDsNumeric LEDs display %SpO2 and pulse rate values. When setting the device, these LEDs also display values for alarm limits, volume, year, month, day, hour, and minute displays. They also display device identification numbers and error codes.Under normal conditions, these LEDs display in green. For high priority (patient) alarms, the corresponding values are displayed in red, blinking fast. The values are displayed in amber for medium priority alarms and when reviewing or changing limits, volumes, date, or time.Front Panel ButtonsON/STANDBY ButtonPressing this button once turns on the XXX System. Holding this button for at least 1 second shuts down the XXX System. Briefly pressing this button while the unit is on displays the battery charge in 10% increments for 4 seconds in green. This button also controls the device’s event marker and print-on-demand features. See this manual’s “Communication” section for more information.Time/Date ButtonThis button displays the time and date. Year, month, day, hour, and minute can be set using the Plus (+) and Minus (-) buttons. Volume ButtonThis button allows users to set and review the pulse or alarm volume, depending upon which corresponding LED is illuminated. This button cycles users between alarm volume and pulse volume.
10Using the XXX Pulse Oximetry SystemAlarm Silence ButtonThis button toggles the alarm between silenced and audible. Pressing the Alarm Silence button will silence the alarm for two minutes. Alarm Limits Button and IndicatorThis button displays the upper and lower limits for alarm indications for SpO2 and heart rate measurements. These limits can be adjusted using the Plus (+) and Minus (-) buttons. The Alarm Limits button cycles users through the XXX System’s alarm settings, allowing users to both set and review alarm limits.The upper LED on the Alarm Limits button indicates the upper alarm limit, and the lower LED indicates the lower alarm limit.Plus Button and Minus ButtonThese buttons adjust values for many XXX System functions. The Plus and Minus buttons are used to adjust time, date, volume, and upper and lower alarm limits. Pressing either of these buttons alone, when the XXX System is not in any setting mode, adjusts the intensity of the LED displays. These buttons are also used to select from multiple pulse oximeter devices (PODs) during pairing.Memory ButtonThis button is used to enter Memory Playback mode.Bluetooth Control ButtonPress and hold this button while turning on the display unit to begin the device pairing process. A maximum of five “pairable” devices will be displayed separately, with the device identification number appearing in the pulse rate and SpO2 display area.Select the device you want to pair with by using the Plus or Minus buttons to scroll through the available Bluetooth devices. When the identification number of the device you wish to pair with is shown—and is not flashing—press the Bluetooth Control button again. When the pairing process is complete, normal operation resumes automatically. After the device is paired to a POD, it will remain paired until the above process is repeated. During normal operation, pressing the Bluetooth Control button displays the selected POD’s device identification number for three seconds in the pulse rate and SpO2 display area. See “Device Pairing” for more information.™
11Indicators and IconsMain Alarm LEDThis LED indicates all alarm conditions. For high priority (patient) alarms, the indicator is displayed in red, blinking fast. For medium priority alarms, the indicator is displayed in amber, blinking slowly.Pulse Quality LEDThis LED blinks to indicate a poor pulse signal. If there is a sustained period of poor quality signals, this LED will illuminate steadily.Pulse Oximeter Sensor LEDThis LED indicates when a sensor has become disconnected, has failed, or has not been applied correctly. Pulse Strength Bargraph LEDThis 10-segment tricolor bargraph indicates pulse strength as determined by the oximeter. The height of the Pulse Strength Bargraph LED is proportional to the pulse signal, and the color is determined by pulse strength:Green = a good pulse strengthAmber = a marginal pulse strengthRed = a low pulse strength, high priority alarmWhen displaying battery charge, this LED indicates charge in 10% increments in green, displaying the depleted portion in amber. Alarm Silence LEDThis amber LED indicates that the audible alarm is silenced for two minutes when it blinks. When lit steadily, the Alarm Silence LED indicates that the audible alarm volume is set to zero.Time, Month, Day, and Year LEDsThese amber LEDs indicate that the XXX System’s Time, Month, Day, or Yea r displays can be reviewed or adjusted using the Plus (+) and Minus (-) buttons.Pulse Volume LEDThis amber LED indicates that the Pulse Volume can be reviewed or adjusted using the Plus (+) and Minus (-) buttons.
12Using the XXX Pulse Oximetry SystemAlarm Volume LEDThis amber LED indicates that the Alarm Volume can be reviewed or adjusted using the Plus (+) and Minus (-) buttons.Connection Status LEDThis LED is lit green when a Bluetooth device is connected. It is lit amber when no devices are connected, and it blinks during device pairing. The Connection Status LED works in sync with the POD’s connection status indicator. Remote Battery Status LEDThis amber LED alerts users to marginal or critical battery conditions for the wrist-worn POD. When the POD’s batteries are marginal, this LED blinks. When battery capacity is critical, it remains lit steadily. AC Power Adapter LED This green LED is displayed when an external power supply is providing power to the XXX System.Battery LEDThis amber LED indicates a marginal battery charge when blinking. In addition, this LED—when lit steadily—indicates that the battery charge is being displayed. This LED does not indicate that the XXX System is running on battery power. The battery charge indication will not be accurate before one full charge/discharge/recharge cycle with a new battery pack.
13Setting Up the XXX SystemUse the following procedure to set up the XXX Pulse Oximetry System. (Refer to the Wrist-Worn Pulse Oximeter Device instruction insert for additional information about using that product.)1. Ensure that batteries are installed in the display unit and POD.2. Plug in and connect the AC adapter for the display unit.3. Press the ON/STANDBY button to turn on the display unit. 4. Verify operation of the display unit, and pair the display unit with the desired wrist-worn POD. (See “Verifying System Operation” and “Device Pairing” for more information.5. Attach a sensor to the wrist-worn POD. (The POD is automatically activated when a sensor is connected.)
14Using the XXX Pulse Oximetry System6. Secure the wristband to the patient’s wrist.
15Verifying System OperationWhen the display unit is first turned on, it performs a brief startup (initialization) sequence. Verify that all LEDs illuminate and the unit beeps three times during the first phase of the startup sequence. If any LED is not lit (except the AC Power Adapter LED), do not use the device. Contact your distributor or NONIN Customer Support for assistance. After this initialization sequence, the amber Connection Status LED and amber dashes are displayed, turning green when communication is established and a Bluetooth connection is made (devices must be paired before a Bluetooth connection can be established; see “Device Pairing”). The Main Alarm LED and Pulse Oximeter LED blink amber until the oximeter produces valid readings. Use the procedure below to monitor SpO2 and pulse rate readings in order to verify that the device is functioning properly. 1. Ensure that the display unit is turned on, and that the unit has been paired with the desired POD. (See “Device Pairing” for more information.)2. Apply the wrist-worn POD around the wrist.3. Connect a sensor to the POD, and attach it to the patient’s finger. Connecting the sensor automatically activates the POD; there are no buttons to press.4. Verify that a good SpO2 reading is displayed, that a pulse rate value appears, and that the Pulse Strength Bargraph LED is active.
16Using the XXX Pulse Oximetry SystemDevice PairingUse the following procedure to pair the display unit with a desired wrist-worn POD.NOTE: To ensure proper pairing, disconnect and then reconnect the sensor before beginning.1. Hold the Bluetooth Control button while turning on the display unit to begin the device pairing process. Notice that amber dashes flash in the SpO2 and Pulse Rate display areas as the system searches for devices available for pairing.2. When available device(s) are detected, a maximum of five “pairable” devices will be displayed separately, with the device identification number appearing in the SpO2 and Pulse Rate display areas. (A unique device identification number is found on the sides of each POD.)3. If multiple PODs are available for pairing, use the Plus or Minus buttons to scroll through the available PODs.4. When the identification number of the device you wish to pair with is shown—and is not flashing—press the Bluetooth Control button again to complete the pairing process. Normal operation resumes automatically when the pairing process is complete.NOTE: After the display unit is paired to a POD, it will remain paired until the above process is repeated.
17Default SettingsThe XXX System features Factory Default and User-Defined Default settings. Factory Default SettingIn Factory Default setting, all adjustable alarm and volume parameters are set at their default values. Factory Default setting is the system’s default operating setting. It is indicated by DIP switch 8 in the DOWN position. For more information about default alarm values, refer to this manual’s “Alarms and Limits” section.User-Defined Default SettingIn User-Defined Default Setting (DIP switch 8 in the UP position), alarm limit settings must be adjusted. When this setting is first activated, valid limit settings must be entered for SpO2 and pulse rate alarm limits; the system will not return to normal operating mode until all limits have been set. Once set, the adjusted values are used as defaults until the system is turned on with DIP switch 8 in the DOWN position, at which time the device restarts in Factory Default setting.IMPORTANT! In order to initiate User-Defined Defaults, the unit must be turned on with DIP switch 8 in the UP position.
18Using the XXX Pulse Oximetry SystemAccessing User FunctionsThe XXX System includes Basic, Set, and Advanced Functions. Basic FunctionsBasic functions are generally easy to use and involve only a single button. The XXX System has several basic functions.Function Button InstructionTurn the display unit on and off.Press the ON/STANDBY button to turn on the display unit. Press and hold the button for at least one second to turn off the display unit. Check the battery charge.Press the ON/STANDBY button while the unit is on. Battery charge is displayed (in 12% increments, for 4 seconds in green) on the Pulse Strength Bargraph. Mute the audible alarms (2 minutes—toggle).Press the Alarm Silence button. Adjust the display intensity (brightness).Press the Plus or Minus button.View the last paired device.Press the Bluetooth Control button during normal operation.Invoke the print-on-demand feature.With DIP switch 4 in the DOWN position, press the ON/STANDBY button.Invoke the event marker.Press the ON/STANDBY button during real-time printing.or™
19Set FunctionsSet functions are those that require multiple buttons to alter a measurement or device parameter for normal operation. Function Button InstructionSet alarm limits. Press the Alarm Limits button to step through the Limits menu. Use the Plus or Minus buttons to adjust alarm limits.Set pulse and alarm volumes.Press the Volume button to select pulse or alarm volume. Use the Plus or Minus buttons to adjust the selected volume.Set time and date. Press the Time/Date button to step through the Time/Date menu. Use the Plus or Minus buttons to adjust the time and date values.orthenorthenorthen
20Using the XXX Pulse Oximetry SystemAdvanced FunctionsAdvanced functions are restricted to trained users; they require multiple button presses in order to prevent accidental activation. Function Button InstructionPair Devices Press the Bluetooth Control button while turning on the unit. A maximum of five “pairable” devices will be displayed, with the device identification number appearing in the pulse rate and SpO2 display areas. When the desired device’s identification number is displayed, pressing the Bluetooth Control button completes the pairing process. Retain Previous User-Defined Alarm Limit SettingsPress and hold both the Alarm Limits and ON/STANDBY buttons when turning on the display unit.Enter Patient Playback and Memory Clear MenuPress and hold the Memory button while turning on the display unit. This menu functions with NONIN’s nVISION® software.+™++
21Dislay Unit DIP switchesThe XXX System contains eight DIP switches that are located behind the back cover of the unit. The UP position is toward the top of the unit, and the DOWN position is toward the bottom of the unit. The factory setting for all DIP switches is the DOWN position. Switch FunctionSwitch 1 Reserved for Future UseSwitch 2 Alarm Disable LockUp—Alarm volume may be disabledDown—Alarm volume cannot be disabledSwitch 3 Date FormatUp—International Date format (Day-Month-Year)Down—U.S.A. Date format (Month-Day-Year)Switch 4 Data OutputUp—Real-time (once per second) data outputDown—Print on demandSwitch 5 Normal / Fast Responding SpO2 OutputUp—Fast responding SpO2 serial outputDown—Normal SpO2 serial outputSwitch 6 Normal / Slow SpO2 and Pulse Rate AveragingUp—Slow Averaging (8 beat exponential average)Down—Normal Averaging (4 beat exponential average)Switch 7 Reserved for Future UseSwitch 8 Factory / User-Defined DefaultsUp—User-Defined Defaults for Alarm Limits and Volume SettingsDown—Factory Defaults for Alarm Limits and Volume Settings12345678
22Using the XXX Pulse Oximetry SystemCare and MaintenanceThe advanced digital circuitry within the pulse oximeter of this system requires no calibration or periodic maintenance other than battery replacement. Field repair of system circuitry is not possible. Do not attempt to open the case or repair the electronics. Opening the case will damage the unit and void the warranty. If the system is not functioning properly, see “Troubleshooting.”Cleaning the XXX SystemClean all system components with a soft cloth dampened with isopropyl alcohol. Do not pour or spray any liquids onto components, and do not allow any liquids to enter any openings in the device. Allow the unit to dry thoroughly before reuse.IMPORTANT! Do not immerse the device in liquid, and do not usecaustic or abrasive cleaning agents on the device.Clean the device separately from its associated sensors. For instructions regarding cleaning pulse oximeter sensors, refer to the appropriate pulse oximeter sensor package inserts.
23Alarms and LimitsThis chapter describes alarms and limits for the XXX Pulse Oximetry System.Alarms and Informational TonesThe XXX System provides high and medium priority audible and visual alarms, as well as informational tones.High Priority AlarmsHigh priority alarms are those that require immediate attention to the patient. They include SpO2, pulse rate, and low perfusion alarms. On the display unit, high priority alarms are indicated with rapidly blinking red LED displays when alarm limits are met or exceeded. In addition, the pulse strength bargraph LED may illuminate a red segment to indicate low perfusion.High priority alarms are sounded as follows: “beep, beep, beep,” (short pause), “beep, beep” (10-second pause).Medium Priority AlarmsMedium priority alarms are those that signal potential problems with the equipment or other non-life-threatening situations. On the display unit, medium priority alarms are indicated with slowly blinking amber displays.Medium priority alarms are illuminated amber on the Main Alarm LED and on the appropriate indicator(s) or numeric displays, sometimes displaying an error code to help the user identify the source of the error. Medium priority alarms are sounded as follows: “beep, beep, beep,” (25-second pause), “beep, beep, beep.”Informational TonesInformational tones communicate important information. They are typically single “beeps” or a series of three “beeps.” Informational tones include the startup/initialization tone and the pulse rate tone (which changes in pitch with SpO2 values).
24Alarms and LimitsAlarm Summary If patient SpO2 or pulse readings are equal to or above the upper alarm limit, or if they are equal to or below the lower alarm limit, the system will signal an alarm. Silencing AlarmsMomentary (2-Minute) Alarm SilenceTo silence alarms for two minutes, press the Alarm Silence button.Continuous Alarm SilenceIn order to permanently silence all alarms, DIP switch 2 must be placed in the UP position. This allows the alarm volume to be set to zero. The Alarm Silence LED will remain illuminated when the alarm volume is set to zero. Refer to “DIP Switches” for more information.High Priority Alarm Description Default Adjustment Range Step ValueSpO2 Upper Alarm Limit Off Off, 80 to 100 1% SpO2SpO2 Lower Alarm Limit 80% Off, 50 to 95 1% SpO2Pulse Upper Alarm Limit 200 BPM Off, 75 to 275 5 BPMPulse Lower Alarm Limit 50 BPM Off, 30 to 110 5 BPM
25Setting and Changing Volume and Alarm Limits IMPORTANT! Alarm limits reset themselves to default values each time the unit is powered up.Reviewing, Setting, or Changing SpO2 and/or Pulse Alarm Limits1. Ensure that the display unit is on.2. Press the Alarm Limits button.• Notice that the upper round LED is illuminated to the left of the Alarm Limits button. This indicates the upper alarm limit, while the lower LED indicates the lower alarm limit.• Notice that the current setting appears in the %SpO2 display. • Continue to presss the Alarm Limits button until the alarm limit you want to adjust is displayed. • The Alarm Limits button can also be cycled to exit Set/Change mode, or Set/Change mode will exit automatically after ten seconds with no activity.3. Ensure that the appropriate upper or lower Alarm Limit LED is illuminated, and that the alarm limit you want to change is displayed.4. Press the Plus (+) or Minus (-) buttons to adjust the values as desired. Reviewing, Setting, or Changing Pulse and/or Alarm Volumes1. Ensure that the display unit is on.2. Press the Volume button once to change the alarm volume, or twice to change the pulse volume.• After pressing the Volume button once, notice that the Alarm Volume LED appears, and the current setting appears in the Pulse Rate display area. • After pressing the Volume button twice, notice that the Pulse Volume LED appears, and the current setting appears in the Pulse Rate display area.• The Volume button can also be cycled to exit Set/Change mode, or Set/Change mode will exit automatically after ten seconds with no activity.3. Use the Plus (+) or Minus (-) buttons to adjust the alarm or pulse volumes as desired.
26Alarms and LimitsError CodesThe XXX Pulse Oximetry System includes error codes that indicate problems with the unit. To correct error conditions, perform the following steps: 1. Turn the unit off and then back on again to remove the error code.2. If the error persists, disconnect all power (AC and battery), and then reconnect the power and turn the unit back on.3. If the error still persists, note the error code and contact your distributor, or contact Nonin Customer Support at (800) 356-8874 (USA and Canada) or +1 (763) 553-9968.
27CommunicationThis chapter describes the memory, printing, and real-time capabilities of the XXX Pulse Oximetry System. Memory FeaturesThe display unit can collect and store up to 33.5 hours of SpO2 and pulse rate information.Data may be played back with data retrieval software (NONIN’s nVISION® software is recommended). If you wish to create your own software, contact NONIN for the data format. NOTE: Only SpO2 and pulse rate data are available for data retrieval.The memory in the system functions much like an “endless loop” tape. When the memory fills up, the unit begins overwriting the oldest data with the new data.Each time the system is turned on, the current time/date information (if the clock is set properly) is stored in memory, starting a new recording session. Only recording sessions greater than one minute in length are stored in memory.Patient SpO2 and pulse rate are sampled every 2 seconds. The extreme value is stored every 4 seconds. Oxygen saturation values are stored in 1% increments in the range of 0 to 100%.The stored pulse rate ranges from 18 to 300 pulses per minute. The stored values are in increments of one pulse per minute in the interval from 18 to 200, and in increments of 2 pulses per minute in the interval from 201 to 300.
28CommunicationPlaying Back Memory DataThe XXX Pulse Oximetry System has a Memory Playback feature, allowing stored data to be output through the RS232 serial connection. 1. With the display unit off, connect the RS-232 connector port of the display unit to the back of your computer using a null modem cable.2. With the display unit still off, press and hold the Memory button while pressing the ON/STANDBY button. • All LEDs will illuminate briefly. PLy bac will appear in the SpO2 and Pulse Rate LED display areas. This message signals that the device is in Playback mode. 3. The PLy bAC message will disappear when memory playback is complete. (Memory playback may take up to 8 minutes, depending upon the amount of data.) Pressing the ON/STANDBY button will exit Playback mode.4. A CLr no message will be displayed, and three informational tones will sound. 5. (OPTIONAL): To clear the memory:• Use the Plus or Minus buttons to select Clr YES.• Press the ON/STANDBY button.• To confirm the clearing of memory, use the Plus or Minus buttons to select DEL YES.• Press the ON/STANDBY button again.•dnE CLr confirms that the memory is clear.6. Press the ON/STANDBY button to return to normal operation.
29Real-Time Patient Data OutputThe system provides real-time data output capability via the RS232 connector port. A null modem cable must be connected from the display unit to the receiving computer. The information from the system in the real-time mode is sent in an ASCII serial format at 9600 baud with 8 data bits, no parity, and 1 stop bit. The data are output at a rate of once per second (on separate lines).Real-time data may be printed or displayed by devices other than the pulse oximeter. Upon power up, a header is sent identifying the format and the time and date. Thereafter, the data are sent once per second by the system in one of the following formats:• If DIP switch 8 is in the DOWN position, the data will be displayed as follows:SPO2=XXX HR=YYYwhere XXX is the SpO2 value and YYY is the heart rate value.• If DIP switch 8 is in the UP position, the data will be displayed as follows:SPO2=XXX HR=YYY Fwhere XXX and YYY are the fast-responding SpO2 and pulse rate values.• If there are no data from the oximeter, the formats will appear as follows:SPO2=--- HR=---Nonin’s XXX System includes an event marker feature. Events are indicated by a single “*” whenever ON/STANDBY is pressed to enter Battery Capacity Display mode. (ON/STANDBY may be pressed again to exit, or Battery Capacity Display mode will time out after approximately 10 seconds.) This feature can be used to mark exceeded alarm limits, or in other situations as desired.SPO2=XXX HR=YYY*
30CommunicationPrinting OptionsThe XXX Pulse Oximetry System features printing capabilities that allow printing on demand or in real-time. These printing options are controlled by DIP switch 4, which is found under the battery cover at the back of the unit.• When DIP switch 4 is in the UP position, real-time (once per second) data output is available via the RS232 connector port, using a null modem cable. • When DIP switch 4 is in the DOWN position (default), the Print-on-Demand mode is activated, allowing you to print only when desired.To print displayed data on demand, press the ON/STANDBY button.Important Notes• Event markers are not available in Print-On-Demand mode.• Print functions are available only with a 9600 baud serial ASCII printer.• Printing features are not available during memory playback.
31SpecificationsWRIST-WORN PULSE OXIMETER (POD)Oxygen Saturation Range (%SpO2)0% to 100%Pulse Rate Range 18 to 300 pulses per minuteAccuracyBlood Oxygen Saturation (%SpO2) (± 1 S.D.)a70-100% ±2 digits for adults using Finger Clip SensorPulse Rate ± 3%Measurement Wavelengths and Output PowerRed 660 nanometers @ 3 mw nominalInfrared 910 nanometers @ 3 mw nominalInternal PowerBattery Two 1.5 volt AA batteriesOperating Life minimum 140 hours of continuous operation with new batteriesStorage Life 10 monthsWeight 4.4 ounces with batteries (125 grams)DISPLAY UNITDisplaysNumeric Displays 3-digit LEDs, Tricolor (red, green, amber)Pulse Strength Bargraph LEDTricolor LED segmentsPower RequirementsMains 100-240 VAC 50-60 HzDC Input 12 VDC AC adapterInternal PowerBattery 7.2 volt battery pack (6 cells)Operating Life minimum 25 hours of continuous operation with a fully charged battery packStorage Life 17 daysRecharge 4 hoursDimensions 5.5” H x 7.25” W x 4.5” DWeight 2.2 lbs with batteryMemory 33.5 hours minimum
32SpecificationsSYSTEMTemperatureOperating 50° to +104°F (10° to +40°C)Storage/Transportation -4° to +122°F (-20° to +50°C)Operating Altitude Up to 40,000 feet HumidityOperating 10% to 90% relative humidity, noncondensingStorage/Transportation 10% to 95% relative humidity, noncondensing*If transferred from a non-operating temperature and/or humidity condition, allow at least one hour of stabilization time before use.Antenna Type Inverted F type antennaAntenna Gain +2 dB (typ.), +3 dB (max.)Classifications per IEC 60601- 1 / CSA601.1 / UL2601-1Type of Protection Class I (when on AC power with 300PS-UNIV battery charger)Internally powered (on battery power)Degree of Protection Type BF-Applied PartMode of Operation Continuousa. S.D. (Standard Deviation) is a statistical measure; up to 32% of the readings may fall outside these limits.
33Parts and AccessoriesFor more information about NONIN parts and accessories, contact your distributor, or contact NONIN at (800) 356-8874 (USA and Canada) or +1 (763) 553-9968. This information is also available on NONIN’s website: www.nonin.com.Model Number Description AVANTB Battery Pack XXX Manual Operator’s Manual for XXX Pulse Oximetry System 300PS-UNIV Battery Charger, Universal Desktop w/IEC320 Connector Contact your distributor or NONIN for options. Cord Set, ChargerExternal Cables. UNI-RS232 RS-232 Cable 3100I Adapter cable for use with Nonin-compatible sensorsPulse Oximeter Sensors 8000AA-WO Adult Articulated Finger Clip Sensor (1 meter) 8000J-WO Adult Flex Pulse Oximeter Sensor 8000JFW Adult FlexiWrap Sensor WrapMounting Accessories Pole Mount Pole Mount Avant PC Pole Mount Clamp Avant RS Avant Rolling Stand; available in standard or deluxeOther Accessories nVISION®nVISION® software for Microsoft Windows 95/98/2000/NT 4.0 operating systems 4100WB Replacement Wrist Bands for Pulse Oximeter Device (POD) Avant CC Carrying case for Avant products Avant Printer Portable thermal printer
34Service, Support, and WarrantyService, Support, and WarrantyA return authorization number is required before returning any product to NONIN. To obtain this return authorization number, contact NONIN Customer Support: Nonin Medical, Inc.2605 Fernbrook Lane NorthPlymouth, Minnesota 55447-4755 USA(800) 356-8874 (USA and Canada) +1 (763) 553-9968 (outside USA and Canada)Fax +1 (763) 553-7807 E-mail: customersupport@nonin.comwww.nonin.comWarrantyNONIN MEDICAL, INCORPORATED, (NONIN) warrants to the purchaser, for a period of three years from the date of purchase, each display unit and wrist-worn pulse oximeter (POD). NONIN warrants the battery pack for the display unit for a period of one year from the date of purchase. NONIN shall repair or replace any XXX Pulse Oximetry System found to be defective in accordance with this warranty, free of charge, for which NONIN has been notified by the purchaser by serial number that there is a defect, provided said notification occurs within the applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any XXX Pulse Oximetry System delivered to the purchaser which is found to be defective in any manner, whether such remedies be in contract, tort, or by law.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 XXX Pulse Oximetry System that is found to be within specifications.This system is a precision electronic instrument and must be repaired by knowledgeable and specially trained NONIN personnel only. Accordingly, any sign or evidence of opening the devices, field service by non-NONIN personnel, tampering, or any kind of misuse or abuse of the system, shall void the warranty in its entirety. All non-warranty work shall be done according to NONIN standard rates and charges in effect at the time of delivery to NONIN.DISCLAIMER/EXCLUSIVITY OF WARRANTY:THE EXPRESS WARRANTIES SET FORTH IN THIS MANUAL ARE EXCLUSIVE AND NO OTHER WARRANTIES OF ANY KIND, WHETHER STATUTORY, WRITTEN, ORAL, OR IMPLIED, INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY, SHALL APPLY.
35TroubleshootingProblem Possible Cause Possible SolutionThe display unit will not activate. The unit has no power. Plug in the AC adapter.The display unit will not operate on batteries.The battery pack is not connected.Check the battery pack connection.The battery pack is not charged. Plug in the AC Adapter to charge the battery pack.The battery pack is inoperable.Contact your distributor or NONIN Customer Support for repair or replacement.You are unable to obtain a green pulse display on the bargraph.The patient pulse strength is low or perfused poorly.Reposition the digit or insert a different digit, and keep the sensor motionless for at least 10 seconds. Warm the digit by rubbing or covering with a blanket.Position the sensor at a different site.NOTE: In some instances, patient perfusion may be inadequate for pulse detection.Circulation is reduced because of excess pressure on the sensor (between the sensor and a hard surface) after inserting digit.Allow the hand to rest comfortably without squeezing or pressing the sensor on a hard surface.The digit is cold. Warm the digit by rubbing or covering with a blanket.Position the sensor at a different site.The POD is not connected to the display.Verify that the POD is paired with the display.
36TroubleshootingUnable to obtain a green pulse display on the bargraph, cont’d.The sensor is applied incorrectly.Apply the sensor correctly.There is possible interference from one of the following sources:• arterial catheter• blood pressure cuff• electrosurgical procedure• infusion lineReduce or eliminate any interference. Make sure that the sensor is not placed on the same arm being used for other patient therapies or diagnostics (e.g., blood pressure cuff).The red LED is not illuminated in the finger insertion area.Ensure that the sensor is securely attached to the Bluetooth POD.Check the POD’s batteries.Check the sensor for any visible signs of deterioration.Contact your distributor or NONIN Customer Support.Frequent or steady pulse quality indication.There is excessive ambient light.Shield the sensor from the light source.The sensor is applied to a polished or artificial fingernail.Apply the sensor to a finger without artificial or polished nails.Position the sensor at a different site.The red LED is not illuminated in the finger insertion area.Ensure that the sensor is securely attached to the POD.Check the sensor for any visible signs of deterioration.Contact your distributor or NONIN Customer Support.Patient motion is excessive.Reduce patient motion.Problem Possible Cause Possible Solution
37A dash (-) appears in the %SpO2 display.A poor signal from the digit is being detected.Reposition the digit or insert a different digit and keep the sensor motionless for at least 10 seconds.Position the sensor at a different site.The digit was removed from the sensor.Reinsert the digit and keep the sensor motionless for at least 10 seconds.The XXX System is not functioning.Turn off the unit, check all connections, and retry.Verify that the POD is paired with the display.Contact your distributor or NONIN Customer Support.An error code appears in the display area.The XXX System encountered an error. 1. Turn the unit off and then back on again to remove the error code.2. If the error persists, disconnect all power (AC and battery), and then reconnect the power and turn the unit back on.3. If the error still persists, note the error code and contact your distributor or NONIN Customer Support.The patient is out of range.Ensure that the patient stays within the range of the XXX System.Problem Possible Cause Possible Solution
38TroubleshootingPATIENT OUT OF RANGE?INTERFERENCE?THE UNIT IS NOT PAIRED TO THE CORRECT PODDETACH/REATTACH SENSORIf these solutions do not correct the problem, please contact your distributor, or contact NONIN Customer Support at (800) 356-8874 (USA and Canada) or +1 (763) 553-9968.The unit is in Alarm mode, but no audible alarms can be heard.The 2-minute Alarm Silence button is activated.Press the Alarm Silence button to re-engage alarm volume, or wait for two minutes—and alarm tones will automatically re-engage.DIP switch 2 is in the UP position, and the unit’s volume is set to zero.Adjust the alarm volume, or return DIP switch 2 to the DOWN position if you desire audible alarms.The system is not functioning correctly.Contact your distributor or NONIN Customer Support.The patient is out of range.Ensure that the patient stays within the range of the XXX System.The devices will not pair.The sensor has not been disconnected and reconnected.Disconnnect and reconnect the sensor to the POD.The patient is out of range.Ensure that the patient stays within the range of the XXX System.Problem Possible Cause Possible Solution

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