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.
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 .....................................
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. ! C SSIFIE LA UL D C 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.
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).
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.
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.
Using the XXX Pulse Oximetry System This chapter describes how to use the XXX Pulse Oximetry System.
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.
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) 8
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 .
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.
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.
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.
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.
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.
