Nonin Medical BT4000 Puls oximeter display containing Bluetooth User Manual Bluetooth English
Nonin Medical, Inc. Puls oximeter display containing Bluetooth Bluetooth English
Users Manual
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| Document ID | 360136 |
| Application ID | cpuanPV5TaYVEtqPRaU73Q== |
| Document Description | Users Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 68.79kB (859838 bits) |
| Date Submitted | 2003-09-26 00:00:00 |
| Date Available | 2003-09-25 00:00:00 |
| Creation Date | 2003-09-25 16:01:57 |
| Producing Software | Acrobat Distiller 5.0.5 (Windows) |
| Document Lastmod | 2003-09-25 16:01:57 |
| Document Title | Bluetooth English.book |
| Document Creator | FrameMaker 5.5.6p145 |
| Document Author: | racheld |
Operator’s Manual ::: XXX Pulse Oximetry System with Bluetooth® Wireless Technology 0123 English 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 XXX Pulse 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 North Plymouth, Minnesota 55447-4755 USA +1 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax +1 (763) 553-7807 mail@nonin.com www.nonin.com Authorized EC Representative: MPS Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany References 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 ......................................................... 1 Precautions for Use ...................................................... 2 Using the XXX Pulse Oximetry System ...................... 5 Indications for Use ..........................................................5 General Information about Bluetooth Technology ...6 Installing the Battery Pack in the Display Unit ...........7 Installing Batteries in the POD .....................................8 Displays, Indicators, and Controls ................................9 Setting Up the XXX System ........................................13 Verifying System Operation .........................................15 Device Pairing ................................................................16 Default Settings ..............................................................17 Accessing User Functions ............................................18 Dislay Unit DIP switches .............................................21 Care and Maintenance ..................................................22 Alarms and Limits ...................................................... 23 Alarms and Informational Tones ................................23 Alarm Summary .............................................................24 Silencing Alarms ............................................................24 Setting and Changing Volume and Alarm Limits .....25 Error Codes ....................................................................26 Communication ......................................................... 27 Memory Features ...........................................................27 Playing Back Memory Data ..........................................28 Real-Time Patient Data Output ..................................29 Printing Options ............................................................30 Parts and Accessories ................................................ 33 Service, Support, and Warranty ................................. 34 Troubleshooting ......................................................... 35 Guide to Symbols Detailed information for functional symbols can be found in “Using the XXX Pulse Oximetry System.” Regulatory Symbols Attention: See Instructions for Use or related materials. SSIFIE LA UL Type BF Applied Part (Patient isolation from electrical shock). US 0123 SN 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). Precautions for Use Precautions for Use Contraindications Do 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. Warnings 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 performance. 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 represents 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 oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin, 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. Cautions This equipment complies with International Standard EN 60601-1-2:2001 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 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 situation 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 application 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 recycling of the device and device components, including batteries. Use only NONINapproved 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 minimized. 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. Precautions for Use Declaration of Conformity with FCC Rules for Electromagnetic Compatibility Nonin 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) Notice This 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. Modifications The 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 radio license. NOTE: This device and its antenna must not be co-located or operating in conjunction with any other antenna or transmitter. Using the XXX Pulse Oximetry System This 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 bands Indications for Use The 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. Using the XXX Pulse Oximetry System General Information about Bluetooth Technology Bluetooth 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 Bluetoothenabled 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). 30' ™ 30' Point-to-Point Communications The 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. Installing the Battery Pack in the Display Unit NOTE: 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. Using the XXX Pulse Oximetry System Installing Batteries in the Pulse Oximeter Device (POD) Displays, Indicators, and Controls This section describes the XXX System’s displays, indicators, and controls. Parameter Displays %SpO2 Display Numeric light-emitting diodes (LEDs) on the upper left-hand corner of the XXX System display blood oxygen saturation in percent. Pulse Rate Display The 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 LEDs Numeric 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 Buttons ON/STANDBY Button Pressing 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 Button This button displays the time and date. Year, month, day, hour, and minute can be set using the Plus (+) and Minus (-) buttons. Volume Button This 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. Using the XXX Pulse Oximetry System Alarm Silence Button This button toggles the alarm between silenced and audible. Pressing the Alarm Silence button will silence the alarm for two minutes. Alarm Limits Button and Indicator This 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 Button These 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 Button This button is used to enter Memory Playback mode. Bluetooth Control Button ™ Press 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. 10 Indicators and Icons Main Alarm LED This 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 LED This 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 LED This LED indicates when a sensor has become disconnected, has failed, or has not been applied correctly. Pulse Strength Bargraph LED This 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 strength Amber = a marginal pulse strength Red = a low pulse strength, high priority alarm When displaying battery charge, this LED indicates charge in 10% increments in green, displaying the depleted portion in amber. Alarm Silence LED This 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 LEDs These amber LEDs indicate that the XXX System’s Time, Month, Day, or Year displays can be reviewed or adjusted using the Plus (+) and Minus (-) buttons. Pulse Volume LED This amber LED indicates that the Pulse Volume can be reviewed or adjusted using the Plus (+) and Minus (-) buttons. 11 Using the XXX Pulse Oximetry System Alarm Volume LED This amber LED indicates that the Alarm Volume can be reviewed or adjusted using the Plus (+) and Minus (-) buttons. Connection Status LED This 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 LED This 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 LED This 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. 12 Setting Up the XXX System Use 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.) 13 Using the XXX Pulse Oximetry System 6. 14 Secure the wristband to the patient’s wrist. Verifying System Operation When 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. 2. 3. 4. 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.) Apply the wrist-worn POD around the wrist. 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. Verify that a good SpO2 reading is displayed, that a pulse rate value appears, and that the Pulse Strength Bargraph LED is active. 15 Using the XXX Pulse Oximetry System Device Pairing Use 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. 16 Default Settings The XXX System features Factory Default and User-Defined Default settings. Factory Default Setting In 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 Setting In 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. 17 Using the XXX Pulse Oximetry System Accessing User Functions The XXX System includes Basic, Set, and Advanced Functions. Basic Functions Basic functions are generally easy to use and involve only a single button. The XXX System has several basic functions. Function Button Instruction 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. Turn the display unit on and off. 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. or ™ Press the Bluetooth Control button during normal operation. Invoke the print-ondemand 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. 18 Set Functions Set functions are those that require multiple buttons to alter a measurement or device parameter for normal operation. Function Button Instruction Set alarm limits. then or Set pulse and alarm volumes. then or Set time and date. then or Press the Alarm Limits button to step through the Limits menu. Use the Plus or Minus buttons to adjust alarm limits. Press the Volume button to select pulse or alarm volume. Use the Plus or Minus buttons to adjust the selected volume. 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. 19 Using the XXX Pulse Oximetry System Advanced Functions Advanced functions are restricted to trained users; they require multiple button presses in order to prevent accidental activation. Function Button Instruction Pair 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 UserDefined Alarm Limit Settings Enter Patient Playback and Memory Clear Menu 20 Press and hold both the Alarm Limits and ON/STANDBY buttons when turning on the display unit. Press and hold the Memory button while turning on the display unit. This menu functions with NONIN’s nVISION® software. Dislay Unit DIP switches The 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 Function Switch 1 Reserved for Future Use Switch 2 Alarm Disable Lock Up—Alarm volume may be disabled Down—Alarm volume cannot be disabled Switch 3 Date Format Up—International Date format (Day-Month-Year) Down—U.S.A. Date format (Month-Day-Year) Switch 4 Data Output Up—Real-time (once per second) data output Down—Print on demand Switch 5 Normal / Fast Responding SpO2 Output Up—Fast responding SpO2 serial output Down—Normal SpO2 serial output Switch 6 Normal / Slow SpO2 and Pulse Rate Averaging Up—Slow Averaging (8 beat exponential average) Down—Normal Averaging (4 beat exponential average) Switch 7 Reserved for Future Use Switch 8 Factory / User-Defined Defaults Up—User-Defined Defaults for Alarm Limits and Volume Settings Down—Factory Defaults for Alarm Limits and Volume Settings 21 Using the XXX Pulse Oximetry System Care and Maintenance The 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 System Clean 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 use caustic 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. 22 Alarms and Limits This chapter describes alarms and limits for the XXX Pulse Oximetry System. Alarms and Informational Tones The XXX System provides high and medium priority audible and visual alarms, as well as informational tones. High Priority Alarms High 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 Alarms Medium 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 Tones Informational 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). 23 Alarms and Limits Alarm 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. High Priority Alarm Description Default Adjustment Range Step Value SpO2 Upper Alarm Limit Off Off, 80 to 100 1% SpO2 SpO2 Lower Alarm Limit 80% Off, 50 to 95 1% SpO2 Pulse Upper Alarm Limit 200 BPM Off, 75 to 275 5 BPM Pulse Lower Alarm Limit 50 BPM Off, 30 to 110 5 BPM Silencing Alarms Momentary (2-Minute) Alarm Silence To silence alarms for two minutes, press the Alarm Silence button. Continuous Alarm Silence In 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. 24 Setting 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 Limits 1. 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 Volumes 1. 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. 25 Alarms and Limits Error Codes The 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. 26 Communication This chapter describes the memory, printing, and real-time capabilities of the XXX Pulse Oximetry System. Memory Features The 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. 27 Communication Playing Back Memory Data The XXX Pulse Oximetry System has a Memory Playback feature, allowing stored data to be output through the RS232 serial connection. 1. 2. 3. 4. 5. 6. 28 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. 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. 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. A CLr no message will be displayed, and three informational tones will sound. (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. Press the ON/STANDBY button to return to normal operation. Real-Time Patient Data Output The 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=YYY where 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 F where 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* 29 Communication Printing Options The 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. 30 Specifications WRIST-WORN PULSE OXIMETER (POD) Oxygen Saturation Range (%SpO2) 0% to 100% Pulse Rate Range 18 to 300 pulses per minute Accuracy Blood Oxygen Saturation (%SpO2) (± 1 S.D.)a 70-100% ±2 digits for adults using Finger Clip Sensor Pulse Rate ± 3% Measurement Wavelengths and Output Power Red 660 nanometers @ 3 mw nominal Infrared 910 nanometers @ 3 mw nominal Internal Power Battery Two 1.5 volt AA batteries Operating Life minimum 140 hours of continuous operation with new batteries Storage Life 10 months Weight 4.4 ounces with batteries (125 grams) DISPLAY UNIT Displays Numeric Displays 3-digit LEDs, Tricolor (red, green, amber) Pulse Strength Bargraph LED Tricolor LED segments Power Requirements Mains 100-240 VAC 50-60 Hz DC Input 12 VDC AC adapter Internal Power Battery 7.2 volt battery pack (6 cells) Operating Life minimum 25 hours of continuous operation with a fully charged battery pack Storage Life 17 days Recharge 4 hours Dimensions 5.5” H x 7.25” W x 4.5” D Weight 2.2 lbs with battery Memory 33.5 hours minimum 31 Specifications SYSTEM Temperature Operating 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 Humidity Operating 10% to 90% relative humidity, noncondensing Storage/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 antenna Antenna Gain +2 dB (typ.), +3 dB (max.) Classifications per IEC 60601- 1 / CSA601.1 / UL2601-1 Type of Protection Class I (when on AC power with 300PS-UNIV battery charger) Internally powered (on battery power) a. 32 Degree of Protection Type BF-Applied Part Mode of Operation Continuous S.D. (Standard Deviation) is a statistical measure; up to 32% of the readings may fall outside these limits. Parts and Accessories Model Number AVANTB XXX Manual 300PS-UNIV Contact your distributor or NONIN for options. Description Battery Pack Operator’s Manual for XXX Pulse Oximetry System Battery Charger, Universal Desktop w/IEC320 Connector Cord Set, Charger External Cables UNI-RS232 3100I RS-232 Cable Adapter cable for use with Nonin-compatible sensors Pulse Oximeter Sensors 8000AA-WO 8000J-WO 8000JFW Adult Articulated Finger Clip Sensor (1 meter) Adult Flex Pulse Oximeter Sensor Adult FlexiWrap Sensor Wrap Mounting Accessories Pole Mount Avant PC Avant RS Pole Mount Pole Mount Clamp Avant Rolling Stand; available in standard or deluxe Other Accessories nVISION® 4100WB Avant CC Avant Printer nVISION® software for Microsoft Windows 95/98/2000/ NT 4.0 operating systems Replacement Wrist Bands for Pulse Oximeter Device (POD) Carrying case for Avant products Portable thermal printer For 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. 33 Service, Support, and Warranty Service, Support, and Warranty A 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 North Plymouth, Minnesota 55447-4755 USA (800) 356-8874 (USA and Canada) Fax +1 (763) 553-7807 www.nonin.com +1 (763) 553-9968 (outside USA and Canada) E-mail: customersupport@nonin.com Warranty NONIN 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. 34 Troubleshooting Problem Possible Cause Possible Solution The 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. 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. You are unable to obtain a green pulse display on the bargraph. 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. 35 Tr oubleshooting Problem Possible Cause Possible Solution Unable 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 line Reduce 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. 36 Reduce patient motion. Problem Possible Cause Possible Solution A 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. 37 Tr oubleshooting Problem Possible Cause Possible Solution 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 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. The devices will not pair. PATIENT OUT OF RANGE? INTERFERENCE? THE UNIT IS NOT PAIRED TO THE CORRECT POD DETACH/REATTACH SENSOR If 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. 38
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