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Nonin Avant 2120 Operator's Manual

Pulse oximeter and nibp monitor
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Operator's Manual
vant 2120
™
Avant 2120
™
Pulse Oximeter
and NIBP Monitor
English
0123

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  • Page 1 Operator’s Manual vant 2120 ™ Avant 2120 ™ Pulse Oximeter and NIBP Monitor English 0123...
  • Page 2 D-35619 Braunfels, Germany References to “NONIN” in this manual imply Nonin Medical, Inc. NONIN, Flexi-Form, FlexiWrap, PureLight and nVISION are registered trademarks or trademarks of Nonin Medical, Inc. Microsoft® and Windows® are registered trademarks of Microsoft Corporation. © 2007 NONIN Medical, Inc.

  • Page 3: Table Of Contents

    Contents Guide to Symbols ...............1 Indications for Use .............2 Contraindications ..............2 Warnings ................... 2 Cautions ..................5 Displays, Indicators, and Controls ........8 Parameter Displays ..............8 Indicators and Icons ..............9 Display Panel Buttons .............12 Operating the Device ............15 Installing the Batteries .............15 Verifying Operation ..............16 Alarm Limit Defaults ..............16...
  • Page 4 Technical Information ............46 Manufacturer’s Declaration .............46 Equipment Response Time .............50 Testing Summary ..............51 NIBP Testing Summary ............52 Specifications ................53...

  • Page 5: Guide To Symbols

    Guide to Symbols This Table describes the symbols that are found on the Avant Model 2120. See Section titled Displays, Indicator, and Controls for detailed information about functional symbols. Symbol Description/Function Consult Instructions for Use Defibrillation-Proof Type BF Applied Part (Patient isolation from electrical shock).

  • Page 6: Indications For Use

    Indications for Use The NONIN Avant 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO ), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments.
  • Page 7 AC power. The audible alarms and memory will not function if batteries are removed from the device. Do not use the device without batteries. Use this device only with Power Adapters supplied by NONIN Medical.
  • Page 8 To obtain accurate results, and for important safety reasons, the blood pressure cuff must only be placed on the patient’s arm. Use only NONIN-specified blood pressure cuffs and hoses with the device. Using other cuffs might result in inaccurate readings or inability to operate the device.

  • Page 9: Cautions

    Cautions This equipment complies with IEC 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 such interference due to close proximity or strength of a source might disrupt the...
  • Page 10 If you are unsure how to reach your distributor, please call NONIN for your distributor’s contact information. Data is overwritten ONE RECORD AT A TIME so if the entire memory is filled with a single record, portions of that record will be deleted when a new record begins.
  • Page 11 Cautions (Continued) This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following: - excessive ambient light - excessive motion - electrosurgical interference - blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines)

  • Page 12: Displays, Indicators, And Controls

    Displays, Indicators, and Controls This section describes the displays, indicators, and controls used on the Avant 2120. mmHg Parameter Displays %SpO Display Numeric light-emitting diodes (LEDs) on the upper left-hand corner of the device display blood oxygen saturation in percent.

  • Page 13: Indicators And Icons

    MAP (Mean Arterial Pressure) Display The MAP display is a 3-digit LED display near the middle right-hand side of the device. The MAP number displayed is a calculated value in mmHg, based on measurements of systolic and diastolic pressure: MAP = 2/3 diastolic + 1/3 systolic LED means “light-emitting diode.”...
  • Page 14 Program mode. The cycle time can be adjusted using the Plus (+) and Minus (-) buttons. Display Panel LED Indicators Display panel LED indicators display whether or not the Avant 2120 is functioning in certain modes (NIBP History mmHg Display mode or Initial Cuff Pressure Display mode).
  • Page 15 Battery LED This amber LED indicates a marginal battery capacity by blinking in sync with the Main Alarm LED indicator. This LED, when lit solid, indicates that the battery capacity is being displayed. This LED does not indicate that the Avant 2120 is running on battery power.

  • Page 16: Display Panel Buttons

    Display Panel Buttons NIBP Button This button is used to begin or cancel a single blood pressure measurement. While the device is taking a blood pressure reading, pressing any button on the front panel will cancel the action and deflate the cuff. Auto NIBP Cycle Time Button This button is used to display the automatic blood pressure measurement cycle time.
  • Page 17 ON/STANDBY Button This button toggles the device between ON and STANDBY modes. Pressing this button once turns on the device. Pressing and holding this button for at least 1 second turns off the device. Briefly pressing this button while the device is on displays the battery capacity, in 10% increments.

  • Page 18: Volume Button

    Time/Date Button This button displays the time and date. Pressing the button allows the user to set the year, month, day, hour, and minute, with the Plus (+) and Minus (-) buttons. In US mode, pressing the button allows the user to set the year, month, day, hour, and minute with the Plus (+) and Minus (-) buttons.

  • Page 19: Operating The Device

    Operating the Device Installing the Batteries The battery pack must be installed at all times while the WARNING: device is operating, even when operating on AC power. The audible alarms and memory will not function if batteries are removed from the device. Do NOT use the device without batteries.

  • Page 20: Verifying Operation

    Verify that all LEDs, except the AC Power Adapter LED, are illuminated and the unit beeps three times during the start-up sequence. If any LED is not lit, do not use the device and contact NONIN Technical Service for assistance.

  • Page 21: Nibp And %Spo2 Functions

    Avant 2120 can be used separately or simultaneously. To take %SpO measurements, ensure that the device is on with a Nonin- branded PureLight sensor connected to the monitor. Apply the sensor, following the Instructions for Use provided with the sensor. SpO...

  • Page 22: Operator Functions

    Contraindication: The blood pressure monitor is not intended for use with neonates. Use only NONIN-specified blood pressure cuffs and WARNING: hoses with the device. Using other cuffs might result in inaccurate readings or inability to operate the device.
  • Page 23 NIBP Cuff Placement Apply the cuff around the bicep of the left or right arm slightly above the elbow, so the inflation bladder is centered over the brachial artery (the inflation bladder is approximately half of the entire length of the cuff). Do not apply the blood pressure cuff to an arm with an IV.
  • Page 24 • Attach the straight or coiled tubing to the monitor; attach the cuff to the tubing as illustrated below. • Connect the pulse oximeter sensor as illustrated below, with the NONIN logo facing up. Connecting the Blood Pressure Cuff and Finger Clip Sensor...
  • Page 25 Place the blood pressure cuff around the patient’s arm. Apply the finger clip sensor on the patient (see Sensor Instructions for Use for proper placement). Press the NIBP button to begin a single blood pressure measurement. The cuff will begin inflating, and the cuff pressure value will appear in the Time LED display.

  • Page 26: Automatic And Demand Nibp Measurements

    Automatic and Demand NIBP Measurements The Auto NIBP Cycle Time button is used to begin or end timed blood pressure measurements and display the Auto NIBP Cycle time, which can be adjusted using the Plus (+) and Minus (-) buttons. Blood pressure readings can be started every 1, 2, 3, 5, 10, 15, 30, 45, 60, or 90 minutes after the previous reading is complete.

  • Page 27: Calibrating Blood Pressure

    Calibrating Blood Pressure Calibration should be performed after every 10,000 inflations or once per year, using the following procedure. Calibration should only be performed by qualified personnel. Suggested Equipment: • Mercury Manometer • Pneumatic T-Adapter • Pressure Bulb With the device turned off, connect a mercury manometer and pressure bulb to the device using a T-adapter.

  • Page 28: Advanced Features

    Advanced Features This section describes the advanced features available on the Avant 2120. Button Combinations This device offers two advanced features that are available by using multiple button combinations. The device must be in Standby mode before using either of the advanced features.

  • Page 29: Dip Switches

    DIP Switches The DIP switches are located under the blue battery cover on the rear of the device. A small Phillips screwdriver must be used to remove the battery cover. The default for all switches is the DOWN position. Switch Function UP: Calibration Mode DOWN: Normal Operation (Default)

  • Page 30: Quick Reference For Printing

    Quick Reference for Printing The Avant 2120 features printing capabilities that allow you to print on demand or in real-time. These are controlled by DIP switch 4, which is located under the battery cover at the back of the device.

  • Page 31: Communication

    Communication Memory Features The Avant 2120 can collect and store up to 33.5 hours of SpO and pulse rate information. Data may be downloaded with NONIN’s nVISION data management software. Only SpO and pulse rate data are available for download.

  • Page 32: Using Nvision Data Management Software

    Using nVISION Data Management Software This device has a Memory Download feature, allowing stored data to be transferred to NONIN’s nVISION data management software for analysis. When downloading data, use the following procedure. With the device off, attach the null modem cable to the RS-2323 connector port of the device and to the back of your computer.

  • Page 33: Real-Time Patient Data Output

    Real-Time Patient Data Output The Avant 2120 provides real-time data output capability via the RS232 connector port. A null modem cable must be connected from the device to the receiving computer. RS232 Connector Port The information from the device in the real-time mode is sent in an ASCII serial format at 9600 baud with 9 data bits, 1 start bit, and 1 stop bit.

  • Page 34: Care And Maintenance

    If the device is not functioning properly, see “Troubleshooting” or contact NONIN Technical Service. Cleaning Clean the Avant 2120 separately from the sensors. For instructions regarding cleaning pulse oximeter sensors, refer to the appropriate pulse oximeter sensor Instructions for Use.

  • Page 35: Alarms And Limits

    Error Codes This device includes various error codes to indicate potential problems with the device. The following table describes the error codes present on the Avant 2120. Error Codes NIBP Module, User Cancelled: NIBP module was cancelled from taking blood pressure reading.
  • Page 36 System Error: Retry reading. If reading is not possible, turn the device off and on again and retry. Calibration may be required. Call NONIN Technical Service if error persists. NIBP Module, Bad Signals: NIBP module cannot complete reading. Failure could be due to patient’s blood pressure falling outside module’s range.
  • Page 37 When a watchdog alarm is activated, it can be cleared by shutting down the device (press and hold the ON/STANDBY button for one second). If the watchdog alarm does not clear, contact NONIN Technical Service.

  • Page 38: Alarm Summary

    Informational Tones Informational tones include the startup/initialization tone and the pulse rate tone (which changes in pitch with SpO values). They are typically single “beeps” or a series of three “beeps.” Alarm Summary If patient readings meet or exceed the upper alarm limit, or if they meet or are below the lower alarm limit, the device will signal a high priority alarm.

  • Page 39: Setting And Changing Volume And Alarm Limits

    Setting and Changing Volume and Alarm Limits The alarm limits automatically reset themselves to default values NOTE: each time the device is turned on. To retain previously adjusted alarm limits, hold the Limits button while turning on the device. Setting or Changing SpO and/or Pulse Rate Alarm Limits Press the Limits button;...
  • Page 40 Setting or Changing Alarm and Pulse Volumes Press the Volume button; the Alarm Volume LED illuminates and 08, default value, appears on the display screen. Use the Plus (+) and Minus (-) buttons to adjust the alarm volume to the appropriate level; Alarm Volume range is 08-15. When the appropriate alarm volume is displayed, press one of the following: •...

  • Page 41: Setting And Changing Nibp Settings

    Setting and Changing NIBP Settings Setting or Changing Automatic NIBP Cycle Time Press the Auto NIBP Cycle Time button. The Auto NIBP LED illuminates and OFF, default value, appears on the display screen. Use the Plus (+) and Minus (-) buttons to adjust the automatic NIBP cycle time, in minutes, to the appropriate intervals.

  • Page 42: Parts And Accessories

    UNI-EXT-9 Extension Cable - 30 feet (9 m) Battery Charger, Universal Desktop with 300PS-UNIV IEC320 Connector Contact your distributor or Cord Set, Charger, Printer NONIN for options. 2120 Pole Mount Pole Mount UNI-RS232 RS-232 Cable Pulse Oximeter Reusable Sensors 8000AA-1...
  • Page 43 2120 and a PC running Microsoft Windows 95/ 98 operating systems) For more information about NONIN parts and accessories, contact your distributor, or contact NONIN at (800) 356-8874 (USA and Canada) or (763) 553-9968.instructions. The use of accessories other than those specified in...

  • Page 44: Service, Support And Warranty

    Thus, there are no critical parts to drift, and no calibration of the pulse oximeter module is required. The Avant 2120 NIBP module should be calibrated after every 10,000 checks or once per year, whichever comes first.

  • Page 45: Warranty

    NONIN warrants the pulse oximetry module of the Avant 2120 for a period of three years from the date of purchase, and the blood pressure cuff for a period of 90 days from the date of purchase.

  • Page 46: Troubleshooting

    Troubleshooting Problem Possible Cause Possible Solution The battery pack is Check the batteries. inserted incorrectly. The device will not Plug in the device to activate. The batteries are recharge its batteries, or depleted. replace the batteries. Reposition the sensor or apply the sensor to a different finger, and keep The patient pulse...
  • Page 47 Dry the finger and the The finger is wet. sensor’s inner surfaces. The red LED is not Contact NONIN’s illuminated in the Technical Service finger insertion area. Department. Excessive patient Reduce patient motion.
  • Page 48 Contact NONIN’s functioning. Technical Service. An error code See “Error Codes Table” The device appears in the or contact NONIN encountered an error. display area. Technical Service. Ensure that the cuff is applied and positioned The cuff is on correctly. See “NIBP Cuff...
  • Page 49 Return the device to The battery does not NONIN Technical Service charge. for repair or replacement. If these solutions do not correct the problem, please contact NONIN Technical Service at (800) 356-8874 (USA and Canada) or (763) 553-9968.

  • Page 50: Technical Information

    Technical Information Manufacturer’s Declaration Refer to the following table for specific information regarding compliance to IEC 60601-1-2 for this device. Table 1: Electromagnetic Emission Emissions Test Compliance Electromagnetic Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment.
  • Page 51 Table 2: Electromagnetic Immunity IEC 60601 Compliance Electromagnetic Environment— Immunity Test Test Level Level Guidance This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Floors should be wood, concrete, Electrostatic or ceramic tile.
  • Page 52 Table 3: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity IEC 60601 Test Compliance Electromagnetic Environment— Immunity Test Level Level Guidance This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 53 Table 4: Recommended Separation Distances This table details the recommended separation distances between portable and mobile RF communications equipment and this device. This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to maximum output power of the communications equipment.

  • Page 54: Equipment Response Time

    Equipment Response Time Values Average Latency Standard/Fast Averaged SpO 4 beat exponential 2 beats Extended Averaged SpO 8 beat exponential 2 beats Pulse Rate Values Response Latency Standard/Fast Averaged Pulse Rate 4 beat exponential 2 beats Extended Averaged Pulse Rate 8 beat exponential 2 beats Example - SpO...

  • Page 55: Testing Summary

    Testing Summary ® accuracy, and low perfusion testing were conducted by NONIN Medical, Inc., as described below: Accuracy Testing accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to dark-skinned subjects during motion and no-motion conditions in an independent research laboratory. The...

  • Page 56: Nibp Testing Summary

    NIBP Testing Summary Clinical evaluation for accuracy of the NIBP module was performed on 93 subjects ranging in age from 3 to 70 years, arm circumference of 16-41 cm, with 3 readings per subject for a total of 279 readings. The evaluation was conducted over a range of pressures 91 - 221 mmHg for systolic and 46-119 mmHg for diastolic.

  • Page 57: Specifications

    Specifications 0% to 100% SpO Oxygen Saturation Display Range Pulse Rate Display Range 18 to 300 beats per minute (BPM) Displays Numeric Displays: 3-digit LEDs, Tricolor (red, green, amber) Pulse Indicator: Amber LED Saturation Declared Accuracy Range 70 to 100% SpO 8000AA, 8000AP / 8000J Series Finger Clip Sensor No Motion Adults, Pediatrics:...
  • Page 58 Measurement Wavelengths and Output Power** Red: 660 nanometers @ 1.2 mw max avgerage Infrared: 910 nanometers @ .8 mw max average Oscillometric Method of Measurement Systolic: 40 mmHg to 260 mmHg Blood Pressure Range Diastolic: 25 mmHg to 200 mmHg MAP = 1/3 Systolic + 2/3 Diastolic ±3 mmHg between 0 mmHg and 300 Pressure Transducer Accuracy...
  • Page 59 52-72 dBA Alarm Volume Range Informational Tone Volume Range 50-70 dBA Altitude (Operating) Up to 40,000 feet Altitude (Hyperbaric Pressure): Up to 4 atmospheres Dimensions 4.5 x 7.5 x 5.4 in. (11.4 x 19.0 x 13.8 cm) Weight 45.3 oz. (1.28 kG) with batteries Classifications per IEC 60601-1;...

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