Operator’s Manual ® Avant 9600 Digital Pulse Oximeter 0123 English
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Consult Instructions for Use. Nonin® reserves the right to make changes and improvements to this manual and the products it describes at any time, without notice or obligation. Nonin Medical, Inc. 13700 1st Avenue North Plymouth, Minnesota 55441-5443, USA +1 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax: +1 (763) 553-7807 E-mail: info@nonin.
Contents Indications for Use ........................................................................................ 1 Contraindications.................................................................................................... 1 Warnings ................................................................................................................ 1 Cautions ................................................................................................................. 2 Guide to Symbols .....
Contents (Continued) Serial Patient Data Outputs...................................................................................22 Print-on-Demand Output....................................................................................22 Real-Time Patient Data Output..........................................................................22 Using with Philips VueLink ....................................................................................23 Connecting to the VueLink Module.................
Figures Figure 1. Avant 9600 Front and Back View................................................................ 5 Figure 2. Installing the Batteries................................................................................. 9 Figure 3. Monitor Rear View..................................................................................... 15 Figure 4. Avant 9600 Connection to Philips Monitor ................................................
Tables Table 1. Symbols ....................................................................................................... 4 Table 2. Factory Default Settings............................................................................. 10 Table 3. Basic Functions.......................................................................................... 11 Table 4. User-Defined Defaults................................................................................ 12 Table 5. Advanced Functions ........
Indications for Use Indications for Use The Nonin® Avant® 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and subacute environments. It may also be used in patient transport, sleep laboratories, and EMS environments.
Indications for Use Warnings (Continued) The battery pack must be installed at all times while the device is operating, even when operating on AC power. The audible alarms and memory will not function if batteries are removed from the device. To comply with relevant product safety standards, ensure that all alarm volumes are set appropriately and are audible in all situations. ! Cautions Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity.
Indications for Use ! Cautions (Continued) When using the 300PS-UNIV power supply, ensure that the AC cord is plugged into a grounded outlet. To prevent potential loss of monitoring, do not use ear clip or reflective sensors on pediatric or neonatal patients. This product complies with ISO 10993.
Guide to Symbols Guide to Symbols This table describes the Nonin symbols located on the Avant 9600. See Section titled Displays, Indicators and Controls for detailed information about functional symbols. Table 1: Symbols Symbol Description Consult Instructions for Use Follow Instructions for Use C SSIFIE LA UL D C Type BF Applied Part (Patient isolation from electrical shock).
Displays, Indicators, and Controls Displays, Indicators, and Controls This section describes the displays, indicators, and controls for the Avant 9600. 9600 Figure 1 : Avant 9600 Front and Back View %SpO2 Display The %SpO2 Display is located on the front panel of the Avant 9600 and is identified by the %SpO2 symbol. This display shows blood oxygen saturation, from 0 to 100 percent. The numeric LEDs blink during SpO2 alarm conditions. NOTE: LED means “light-emitting diode”.
Displays, Indicators, and Controls Indicators and Icons Main Alarm LED Red, rapidly blinking LEDs indicate a High Priority patient alarm. Amber slowly blinking LEDs indicate a medium priority (equipment) alarm. Pulse Quality LED This LED blinks to indicate an inadequate pulse signal. If there is a sustained period of inadequate pulse signals, this LED will illuminate solid.
Displays, Indicators, and Controls AC Power Supply LED This green LED is displayed when an external power supply is providing power to the Avant 9600. Any time this LED is displayed, the battery pack is charging. Battery LED This amber LED indicates marginal battery capacity when blinking. When solidly lit, the LED indicates that the battery pack is not installed. This LED does not indicate that the device is running on battery power.
Displays, Indicators, and Controls Alarm Limits Button and Indicator The upper LED on the Alarm Limits button indicates the upper alarm limit, and the lower LED indicates the lower alarm limit for SpO2 and heart rate measurements. The limits can be adjusted using the Plus (+) and Minus () buttons. Pressing the Alarm Limits buttons allows the user to manually advance through the alarm settings to review and set alarm limits. The limit values are displayed in amber.
Installing the Batteries Installing the Batteries WARNING: The battery pack must be installed at all times while the 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 this device without batteries. NOTE: New battery packs must be fully charged before use; minimum recharge time is 4 hours. Figure 2 : Installing the Batteries NOTES: • Contact Nonin to purchase or replace battery packs.
Operating the Avant 9600 Operating the Avant 9600 Press the ON/STANDBY button to perform the start-up (initialization) sequence. Verify that all LEDs, except the AC Power Supply LED, are illuminated and the unit beeps three times during the start-up sequence. Contact Nonin Technical Service for assistance. Use the following procedure to verify that the pulse oximeter sensor is functioning properly. 1. Ensure that the Avant 9600 is on, and the sensor is connected to the monitor. 2.
Operating the Avant 9600 Operator Functions Basic Functions The Avant 9600 basic functions are described in the table below. Table 3: Basic Functions Function Button Turns device on and off Instruction Using the ON/STANDBY button: • Press once (turns the device on) • Hold 1 second (turns the device off) • Hold 5 seconds (turns the device off when in Patient Security mode) Battery capacity Briefly press the ON/STANDBY button while the device is on to display battery capacity.
Operating the Avant 9600 User-Defined Defaults Table 4: User-Defined Defaults 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 scroll through the Limits menu. Adjust alarm limits with the Plus or Minus button. Press the Volume button to select pulse or alarm volume. Adjust the selected volume with the Plus or Minus button. Press the Time/Date button to scroll through the Time/Date menu.
Operating the Avant 9600 Table 5: Advanced Functions (Continued) Function Button Patient Security + Action • To access patient Security Mode, press and hold both the Alarm Limits and Time/ Date buttons for five seconds; either “111 111” (enabled mode, Green LEDs), or “000 000”, (disabled mode, Amber LEDs) will be displayed. • To change Patient Security Mode, press the Volume button while the mode is displayed.
Operating the Avant 9600 Table 6: Option Switches (Continued) Switch Switch 5 Function US / International Date Format Up—International Date Format Down—US Date Format Switch 6 Power Saving During Battery Use (Dims Display) Up—Power Saving Disabled Down—Power Saving Enabled Switch 7 Nurse Call Output Up—Continuous Down—One second audible alarm at 60 second intervals Switch 8 Serial Data Output Up—Fast SpO2 and pulse rate output Down—SpO2 and pulse rate output, as determined by the position of option
Operating the Avant 9600 Nurse Call Connection RS232 Serial Connection Power Connection Nurse Call Switch 1 2 3 4 5 6 7 8 Figure 3 : Monitor Rear View NOTE: It is the user’s responsibility to implement the interface between the Nurse Call system and the Avant 9600, and to adequately test the interface between the Avant 9600 and the Nurse Call system to ensure operation.
Alarms and Limits Alarms and Limits High Priority Alarms High priority alarms require immediate attention to the patient. High priority alarms are indicated with rapidly blinking red LEDs in sync with the Main Alarm LED, when alarm limits are met or exceeded. Low perfusion is indicated by a red segment on the Pulse Strength Bar Graph LED. High priority alarms are: 3 beeps, pause, 2 beeps and a 10-second pause. This sequence repeats until the alarm is cleared or silenced.
Alarms and Limits Watchdog Alarms Watchdog alarms are loud, two-tone, steadily beeping signals that indicate a hardware or software malfunction. When a watchdog alarm is activated, it can be cleared by shutting down the device. If the watchdog alarm does not clear, remove the battery and contact your distributor or Nonin Technical Service. Informational Tones Informational tones are at startup/initialization (speaker verification) and the pulse rate tone (which changes in pitch with SpO2 values).
Alarms and Limits Serial Output Rates 1. Simultaneously press and hold the Time/Date and Volume buttons for 3 seconds. • Use the Plus or Minus buttons to adjust the serial output to the appropriate rate.
Alarms and Limits Locked and Unlocked Alarms The Avant 9600 allows users to switch between Locked or Unlocked Alarms with Option Switch 3, located under the back cover. Unlocked alarms (Option Switch 3 in the DOWN position) is the default. When the device is in Unlocked Alarms, the Main Alarm LED and the exceeded alarm value will flash, and the audible alarm will sound until the alarm condition is no longer present.
Alarms and Limits Error Codes This device includes error codes that indicate error conditions. The following table describes the error codes for the Avant 9600.
Memory and Data Output Features Memory and Data Output Features Memory Features Model 9600 collects and stores a minimum of 115 hours of SpO2 and pulse rate data. Data may be downloaded with Nonin’s nVISION data management software. The memory in the device functions as an “endless loop” tape. When the memory fills up, the device overwrites the oldest data with the new data.
Memory and Data Output Features 5. Memory CLear (OPTIONAL): • Simultaneously press and hold the ON/STANDBY button and the Plus (+) button to select CLr yES. • Press the ON/STANDBY button for the next prompt. • Use the Plus (+) and/or Minus (-) buttons to select dEL yES if desired. • Press the ON/STANDBY button for the next prompt. • dnE CLr confirms that the memory is clear. 6. Press the ON/STANDBY button to return to normal operation. 7.
Memory and Data Output Features Using with Philips VueLink The Avant 9600 supports the Phillips VueLink Open Interface (V.O.I.), and will communicate with a Philips VueLink Auxiliary Plus Type B module (product number M1032A#A05). Refer to the operator’s manual for additional instructions and information. Connecting to the VueLink Module The 9600 is connected with the VueLink Module via a Philips cable (product number M1032A#K6C), which connects to the RS-232 Serial Connection on the 9600.
Memory and Data Output Features Patient Alarms Only one alarm condition can be reported to the VueLink at a time. Because of this, patient alarm conditions are assigned priorities—with only the highest priority alarm displayed at any one time. Alarms are sent to the VueLink even when the oximeter’s alarms are silenced. Alarm priorities are assigned as follows: a. SpO2 Low Limit b. Pulse Rate High Limit c. Pulse Rate Low Limit d. SpO2 High Limit e.
Memory and Data Output Features Parameter Displayed Text Sensor Fault SpO2 SENSOR No SpO2 Data Available NO SpO2 Data No Pulse Data Available NO Pulse Data Low Battery Battery: Pulse Ox 25
Care and Maintenance Care and Maintenance The Avant 9600 requires no calibration or periodic maintenance other than battery replacement. Do not attempt to open the case or repair the electronics. Opening the case will damage the device and void the warranty. If the device is not functioning properly, see “Troubleshooting.” Cleaning the Model 9600 Clean the Avant 9600 with a soft cloth dampened with isopropyl alcohol.
Parts and Accessories Parts and Accessories For more information about Nonin parts and accessories: • See the Parts and Accessories List on the Operator’s Manual CD. • Contact your distributor or Nonin at (800) 356-8874 (USA and Canada), +1 (763) 553 9968, or +46 650 401500 (Europe). • Visit www.nonin.com.
Troubleshooting Troubleshooting Problem Device will not activate. Unable to obtain a green pulse display on the bar graph. Possible Cause The device has no power. Plug in the AC power supply. The battery pack is connected incorrectly. Check the battery pack connector orientation. The battery pack is not charged. Plug in the device AC power supply to charge the battery pack. New battery packs must complete one charge/discharge/ recharge cycle before the Battery LED displays the actual capacity.
Troubleshooting Problem Unable to obtain a green pulse display on the bar graph. (continued) Possible Cause The sensor is applied to a Apply the sensor to a finger without polished or artificial fingernail. fingernail polish or an artificial nail. Excessive patient motion. A dash (-) appears in the %SpO2 display. Possible Solution Reduce patient motion. An inadequate signal from the Reposition the sensor or apply the sensor finger is being detected.
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 Technical Service: Nonin Medical, Inc. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA (800) 356-8874 (USA and Canada) +1 (763) 553-9968 (outside USA & Canada) Fax: +1 (763) 553-7807 E-mail: technicalservice@nonin.
Service, Support, and Warranty Accordingly, any sign or evidence of opening the Avant 9600, field service by non-Nonin personnel, tampering, or any kind of misuse or abuse of the Avant 9600, 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.
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 10: 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.
Technical Information Table 11: Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level 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.
Technical Information Table 12: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level 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.
Technical Information Table 13: 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.
Technical Information Equipment Response Time SpO2 Values Average Latency Standard/Fast Averaged SpO2 4 beat exponential 2 beats Extended Averaged SpO2 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 - SpO2 Exponential Averaging SpO2 decreases 0.75% per second (7.
Technical Information Testing Summary SpO2 accuracy, and low perfusion testing were conducted by Nonin Medical, Inc., as described below: SpO2 Accuracy Testing SpO2 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.
Technical Information Specifications Oximeter Oxygen Saturation Display Range: 0 to 100% SpO2 Pulse Rate Display Range: 18 to 300 pulses per minute (BPM) Displays: Numeric Displays: 3-digit LEDs, Tricolor (red, green, amber) Pulse Strength Bar Graph LED: Tri-color LED segments Accuracy - Sensors: Declared accuracy data for compatible sensors can be found in Nonin’s Sensor Accuracy document. Measurement Wavelengths and Output Power* Red 660 nanometers @ 0.8 mW max. avg. Infrared 910 nanometers @ 1.
Technical Information System Temperature: Operating: 32 °F to 122 °F (0 °C to 50 °C) Storage/Transportation: -22 °F to 122 °F (-30 °C to 50 °C) Humidity: Operating: 10 % to 90 % noncondensing Storage/Transportation: 10 % to 95 % noncondensing Power Requirements: 7.2 volt battery pack (6 cells) or 12 VDC 1.5A AC power supply Battery Life: Operating: Minimum 12 hours of continuous operation with a fully charged battery pack Storage: 27 days Battery Recharge Time: 4 hours Dimensions: 5.5” H x 7.25” W x 4.
Technical Information Nurse Call Voltage 30 VAC or DC (non-polarized), maximum Current 100mA continuous (maximum) Output Impedance 30 ohms (maximum) Ground Reference Isolated ground Electrical Isolation 1500 VDC Output Normally Open or Normally Closed; switch selectable Output Connector Type 0.
