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Related Manuals for Nonin Avant 9700
Summary of Contents for Nonin Avant 9700
- Page 1 Operator’s Manual ® Avant 9700 Digital Pulse Oximeter English...
- Page 2 +31 (0)13 - 79 99 040 (Europe) Fax: +31 (0)13 - 79 99 042 E-mail: infointl@nonin.com nonin.com References to “Nonin” in this manual imply Nonin Medical, Inc. Nonin, PureLight, and nVISION are registered trademarks or trademarks of Nonin Medical, Inc. ® ® MicroSoft and Windows are registered trademarks of Microsoft Corporation.
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Page 3: Table Of Contents
Indicators and Icons ....................6 LCD Indicators and Icons ..................8 Front Panel Buttons....................9 Installing the Batteries and Serial Port Cover........... 11 Operating the Avant 9700 ................12 Factory Default ..................... 12 User-Defined Defaults ..................12 Operator Functions....................13 Basic Functions.................... - Page 4 Contents (Continued) Using nVISION Data Management Software ............25 Serial Patient Data Outputs...................26 Print-On-Demand Output...................26 Real-Time Patient Data Output................26 Connecting the Device into a Medical System ............27 Care and Maintenance .................28 Cleaning the Model 9700 ..................28 Parts and Accessories.................29 Troubleshooting ...................30 Service, Support, and Warranty..............32 Warranty........................32 Technical Information ..................34...
- Page 5 Figures Figure 1. Displays, Indicators, and Controls............... 5 Figure 2. Installing the Batteries and Serial Port Cover ........... 11 Figure 3. Plethysmographic Waveform ..............16 Figure 4. Trend Waveform ..................17 Figure 5. Trend Histogram ..................18 Figure 6. Monitor Rear View..................19...
- Page 6 Tables Table 1. Symbols ....................... 4 Table 2. Factory Default Settings................12 Table 3. Basic Functions..................13 Table 4. User-Defined Defaults................14 Table 5. Option Switches ..................15 Table 6. High Priority Alarms ................... 20 Table 7. Medium Priority Alarms................21 Table 8.
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Page 7: Indications For Use
(SpO ) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, sleep laboratories, and subacute environments. The Avant 9700 is intended for continuous monitoring and/or spot-checking of patients during both motion and no- motion conditions, and for patients who are well or poorly perfused. -
Page 8: Cautions
Indications for Use Warnings (Continued) Use the device only with Nonin-specified power supplies. The device’s Nurse Call feature should not be used as the primary source of alarm notification. All parts and accessories connected to the serial port of the device must be certified according to at least IEC 60950 or UL 1950 for data-processing equipment. - Page 9 If you are unsure how to reach your distributor, please call Nonin for your distributor’s contact information. If the device fails to respond as described, discontinue use until the situation is corrected by qualified personnel.
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Page 10: Guide To Symbols
Guide to Symbols Guide to Symbols This table describes the Nonin symbols located on the Avant 9700. 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 Type BF Applied Part (Patient isolation from electrical shock). -
Page 11: Displays, Indicators, And Controls
Displays, Indicators, and Controls Displays, Indicators, and Controls This section describes the displays, indicators, and controls for the Avant 9700. Alarm Silence Se ttings Plus / Increase Value or LED Intensity Minus / Decrease Value or LED Intensity On / Standby... -
Page 12: Spo 2 Display
NOTE: LED means “light-emitting diode.” Pulse Rate Display The Pulse Rate Display, located on the front panel of the Avant 9700, is identified by the symbol. This display shows the pulse rate in beats per minute, from 18 to 300. The numeric display blinks during pulse rate alarm conditions. - Page 13 AC Power Supply LED This green LED is displayed when an external power supply is providing power to the Avant 9700. Any time this LED is displayed, the battery is charging. NOTE: When the external power supply is disconnected, the device automatically switches to battery power without loss of functionality.
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Page 14: Lcd Indicators And Icons
Patient Security Mode This icon can be advanced between NO (default) and YES to lock and unlock the Avant 9700’s alarms. Selecting YES activates Patient Security mode, locking all alarms to prevent accidental activation or adjustment. The Plus (+) and Minus (-) buttons must be pressed and held for 3 seconds to advance between NO and YES. -
Page 15: Front Panel Buttons
Displays, Indicators, and Controls Front Panel Buttons ON/STANDBY • 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 • Press momentarily while the unit is on: •... - Page 16 The Plus (+) and Minus (-) buttons are used to adjust time, date, volume, and upper and lower alarm limits. When the Avant 9700 is in Plethysmographic Waveform View, and the device is not in program mode, pressing either button adjusts the intensity of the front panel LED Display.
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Page 17: Installing The Batteries And Serial Port Cover
Figure 2: Installing the Batteries and Serial Port Cover NOTES: • Contact Nonin to purchase or replace battery packs. • Reposition the back cover carefully, and tighten the screws firmly. Do not over-tighten. • The serial port cover must be installed at all times unless serial cable is attached. -
Page 18: Operating The Avant 9700
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 9700 is on, and the sensor is connected to the monitor. 2. Apply the pulse oximeter sensor to the patient. -
Page 19: Operator Functions
Operating the Avant 9700 Operator Functions Basic Functions The Avant 9700 basic functions are described in the table below. Table 3: Basic Functions Function Button Instruction Turns device on and Using the ON/STANDBY button: • Press once (turns the device on) •... -
Page 20: User-Defined Defaults
Function Button Instruction Recall Previous Press and hold the Settings button while User-Defined turning on the Avant 9700. Settings NOTE: Previous user-defined settings can also be recalled within the Parameter Adjustment menu, which is accessed by pressing the Settings button. -
Page 21: Option Switches
3 seconds. Option Switches The Avant 9700 contains eight option switches located under the back cover (See “Installing the Batteries” for instructions on removing the back cover). The device is supplied with all option switches in the DOWN position. -
Page 22: Lcd Display Views
Operating the Avant 9700 Table 5: Option Switches (Continued) Switch Function Switch 5 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... -
Page 23: Trend Waveform View
Operating the Avant 9700 Trend Waveform View Trend Waveform allows viewing of the last 24 hours of patient SpO and Pulse Rate data stored in nonvolatile patient memory. The SpO displayed in green and Pulse Rate waveform displayed in red, appear on the same LCD screen. -
Page 24: Trend Histogram View
Condition *1 and *2 have both occurred for this record. Nurse Call Feature The Avant 9700 features a nurse call circuit that can be connected to a facility nurse call system, allowing alarm conditions to be recognized at a central monitoring location and on the device. -
Page 25: Figure 6. Monitor Rear View
Figure 6: Monitor Rear View NOTE: It is the user’s responsibility to implement the interface between the Nurse Call system and the Avant 9700, and to adequately test the interface between the Avant 9700 and the Nurse Call system to ensure operation. -
Page 26: Alarms And Limits
Alarms and Limits Alarms and Limits CAUTION: Review all limits to ensure they are appropriate for the patient. CAUTION: Setting alarm limits to extremes can render the alarm system useless. The intended operator’s position for correctly perceiving a visual alarm signal and its priority is 1 meter (3.3 feet), per IEC 60601-1-8. -
Page 27: Medium Priority Alarms
2. The limits can be adjusted by using the Plus (+) or Minus (-) buttons until the appropriate limits are displayed. NOTE: The upper and lower SpO and pulse rate alarm limits are always displayed at the bottom of the LCD display when the Avant 9700 is in Plethysmographic Waveform view. -
Page 28: Silencing Alarms
Do not cover or otherwise hinder any speaker openings. Recalling Previous Settings The Avant 9700 allows the operator to recall settings in use when the device was turned off: • SpO high and low alarm limits •... -
Page 29: Patient Security Mode
3. “NO” appears next to the padlock, confirming you have exited Patient Security mode. Error Codes This device includes error codes that indicate error conditions. The following table describes the error codes for the Avant 9700. Table 8: Error Codes Error Code... -
Page 30: Clearing Error Codes 06, 08, Or 10
3. If the error is not cleared, note the error code and contact Nonin Technical Service at (800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe). -
Page 31: Memory And Data Output Features
The audible alarms and memory will not function if batteries are removed from the device. Using nVISION Data Management Software The Avant 9700 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: 1. -
Page 32: Serial Patient Data Outputs
Demand option, allowing users to output data each time the ON/STANDBY button is pressed. When the Avant 9700 is in Trend Histogram view, all data from the recording selected on the trend display are output, including the start time of the record, the record’s SpO histogram data, the record’s pulse rate histogram data, and the record’s ending time. -
Page 33: Connecting The Device Into A Medical System
Memory and Data Output Features Connecting the Device into a Medical System Incorporating the device into a medical system requires the integrator to identify, analyze, and evaluate the risks to patient, operators, and third parties. Subsequent changes to the medical system after device integration could introduce new risks and will require additional analysis. -
Page 34: Care And Maintenance
Datrend Systems, Inc. can be used to verify operation of the pulse oximeter. Cleaning the Model 9700 Clean the Avant 9700 with a soft cloth dampened with a mild detergent or a 10% bleach/90% water solution (household bleach [containing less than 10% sodium hypochlorite]). Do not pour or spray any liquids onto the device, and do not allow any liquid to enter any openings in the device. -
Page 35: 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) 533-9968, or +31 (0)13 - 79 99 040 (Europe). -
Page 36: Troubleshooting
New battery packs must complete one charge/ discharge/recharge cycle before the Battery LED displays the actual capacity. The battery pack will not Contact Nonin Technical Service for charge. repair or replacement. Unable to obtain a green The patient pulse strength is... - Page 37 The battery is missing. Contact your distributor or Nonin Technical Service. If these solutions do not correct the problem, please contact Nonin Customer Support at (800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe).
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Page 38: Service, Support, And Warranty
Avant 9700 battery pack. Nonin warrants the pulse oximetry module of the Avant 9700 for a period of three years from the date of purchase. Extended warranties are available on most Nonin pulse oximeter models. Please consult your local Nonin distributor for additional information. - Page 39 Service, Support, and Warranty 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.
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Page 40: Technical Information
Technical Information Technical Information NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. CAUTION: A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. CAUTION: All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard EN 60950 or UL 1950 for data- processing equipment. -
Page 41: Table 10. Electromagnetic Immunity
Technical Information Table 10: Electromagnetic Immunity IEC 60601 Electromagnetic Immunity Test Compliance Level Test Level 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. Electrostatic Discharge ±6 kV contact ±6 kV contact... -
Page 42: Table 11. Guidance And Manufacturer's Declaration-Electromagnetic Immunity
Technical Information Table 11: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity IEC 60601 Compliance Immunity Test Electromagnetic Environment—Guidance Test Level Level 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 43: Table 12. Recommended Separation Distances
Technical Information Table 12: 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. -
Page 44: Equipment Response Time
Technical Information Equipment Response Time If the signal from the sensor is inadequate, the last measured SpO and pulse rate values freeze for 10 seconds and are then replaced with dashes. Values Average Latency Standard/Fast Averaged SpO 4 beat exponential 2 beats Extended Averaged SpO 8 beat exponential... -
Page 45: Testing Summary
Technical Information Testing Summary accuracy, and low perfusion testing were conducted by Nonin Medical, Inc., as described below: Accuracy Testing During motion and no-motion conditions in an independent research laboratory, SpO accuracy testing is conducted during induced hypoxia studies on healthy, male and female, non-smoking, light- to dark-skinned subjects that are 18 years of age and older. -
Page 46: Specifications
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. System Measurement Wavelengths and Output Power*: Red: 660 nanometers @ 0.8 mW max. avg. -
Page 47: Nurse Call
Technical Information Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL60601-1 Type of Protection: Class II (on AC power with MPP30 power supply). Internally powered (on battery power) Degree of Protection: Type BF-Applied Part Enclosure Degree of Ingress Protection: IP22 Mode of Operation: Continuous Nurse Call Voltage...