Avant Model 9600 Operators Manual May 2002

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Declaration of Conformity Manufacturer: Address:

Model Number:

Nonin Medical, Inc. 2605 Fernbrook Lane North Plymouth, Minnesota 55447-4755 USA 9600

We herewith declare that the above-mentioned pulse oximeter monitor is classified as Class IIb (using Rule 10) and comply with EC Directive No. 93/42/ EEC concerning medical devices for all devices manufactured after May 1, 2002. This declaration is based on: Certification of a Quality System to ISO 9001 : 1994 / EN 46001 : 1996 / ISO 13405 : 1996 Certificate Number: Q1Z 01 09 24497 006 Issued by: TUV Product Service GmbH Date: October 2001 Certification according to Annex II, Clause 3 of EC Directive No. 93/42/ EEC concerning medical devices. Certificate Number: G1 01 11 24497 007 Issued by: TUV Product Service GmbH Date: November 2001 Place: Date:

Nonin Medical, Inc. Plymouth Minnesota 01 May 2002

Name: Title:

Gary Tschautscher CEO

Authorized EC Representative: MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany

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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 Avant™ 9600 Digital Pulse Oximeter.

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 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax (763) 553-7807 [email protected] www.nonin.com

References to “NONIN” in this manual shall imply Nonin Medical, Inc. Nonin is a registered trademark of Nonin Medical, Inc. © 2002 Nonin Medical, Inc.

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Table of Contents Guide to Symbols ...1-1 Precautions for Use ...2-1 Using the Avant 9600 ...3-1 Intended Use ...3-2 Installing the Batteries ...3-3 Verifying Avant 9600 Operation ...3-4 Displays, Indicators, and Controls ...3-4 User Functions ...3-8 Avant 9600 DIP switches ...3-11 Nurse Call Feature ...3-12 Care and Maintenance ...3-13 Alarms and Limits ...4-1 High and Medium Priority Alarms ...4-1 Informational Tones ...4-1 Error Codes ...4-2 Alarm Summary ...4-2 Setting and Changing Volume and Alarm Limits ...4-3 Silencing Alarms ...4-4 Latched and Unlatched Alarms ...4-4 Patient Security Mode ...4-5 Communication ...5-1 Memory Features ...5-1 Playing Back Memory Data ...5-2 Real-Time Patient Data Output ...5-3 Theory of Operation ...6-1 Specifications ...7-1 Parts and Accessories ...8-1 Service, Support, & Warranty ...9-1 Troubleshooting ...10-1

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Chapter 1 Guide to Symbols

This table describes the symbols that are found on the Avant 9600.

Regulatory Symbols Attention: See Instructions for Use or related materials.

!

C

SSIFIE LA

D

C

Type BF Applied Part (Patient isolation from electrical shock).

UL 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).

Signal Output (located on back of unit).

Alarm Call (located on back of unit).

Parameter Symbols %SpO2

Percent Oxygen Saturation

Pulse Rate

1-1

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Guide to Symbols

Button Symbols ON/STANDBY

Time/Date

Volume

Alarm Silence

Limits

Plus

Minus

LED Symbols Numeric LEDs

Main Alarm Pulse Quality

Pulse Oximeter Sensor

1-2

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Pulse Strength Bargraph

Upper Alarm Limit Lower Alarm Limit Alarm Silence

Time

Month

Day

Year

Pulse Volume

Alarm Volume

AC Power Adapter Battery

1-3

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Precautions for Use

Chapter 2 Precautions for Use Contraindications Do not use the Avant 9600 in an MRI environment. Explosion Hazard: Do not use the Avant 9600 in an explosive atmosphere or in the presence of flammable anesthetics or gases.

Warnings The Avant 9600 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 of the Avant 9600 may be affected by the use of an electrosurgical unit (ESU). Use only NONIN-manufactured 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 the Avant 9600 in or around water or any other liquid when the AC power adapter is used. As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement or strangulation. Use the Avant 9600 with 300PS-XX AC power adapters, where XX represents the power supply designation. The 9600’s Nurse Call feature should not be used as the primary source of alarm notification. The audible and visual alarms of the monitor, used in conjunction with clinical signs and symptoms, are the primary sources for notifying medical personnel that an alarm condition exists. All parts and accessories connected to the serial port of the Avant 9600 must be certified according to IEC Standard EN 60950 or UL 1950 for data-processing equipment.

2-1

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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 such interference due to close proximity or strength of a source might disrupt the performance of this device. If the Avant 9600 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. The Avant 9600 might misinterpret motion as good pulse quality. Minimize finger motion or change the type of sensor being used (e.g., ear clip). 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 times for each sensor.. Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and the circulation and skin sensitivity of the patient. Patient sensitivity to sensors may vary due to medical status or skin condition. Ear Clip or Reflectance sensors are not recommended for pediatric use. The accuracy of the sensors has not been established for pediatric use. Do not place liquids on top of the Avant 9600. Do not immerse the Avant 9600 or sensors in any liquids. Do not use caustic or abrasive cleaning agents on the unit or sensors. Do not gas sterilize or autoclave the Avant 9600. 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 NONIN-approved battery packs, and remove batteries if the Avant 9600 is not used within 30 days. When using the 300PS-UNIV battery charger, ensure that the AC cord is plugged into a grounded outlet.

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Using the Avant 9600

Chapter 3 Using the Avant 9600

This chapter describes how to use the NONIN Avant 9600 Digital Pulse Oximeter. Chapter Contents

Page

3-1

3.1

Intended Use ... 3-2

3.2

Installing the Batteries ... 3-3

3.3

Verifying Avant 9600 Operation ... 3-4

3.4

Displays, Indicators, and Controls ... 3-4

3.5

User Functions ... 3-8

3.6

Avant 9600 DIP switches ... 3-11

3.7

Nurse Call Feature ... 3-12

3.8

Care and Maintenance ... 3-13

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3.1

Intended 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 is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 is intended for continuous monitoring and/or spotchecking of patients.

9600

3-2

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Using the Avant 9600

3.2

Installing the Batteries

NOTE: Contact NONIN to purchase or replace battery packs. NOTE: Reposition the back cover carefully, and tighten the screws firmly-being careful not to over-tighten.

3-3

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3.3

Verifying Avant 9600 Operation

Press the ON/STANDBY button. When the unit is first turned on, the Avant 9600 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 Avant 9600. Contact NONIN Customer Support for assistance. In order to verify that the Avant 9600 is functioning properly, it is important to monitor SpO2 and pulse rate readings. Use the following procedure to verify that the pulse oximeter sensor is functioning properly. 1. 2. 3.

3.4

Ensure that the Avant 9600 is on, with the sensor connected. Apply the pulse oximeter sensor. Verify that a good SpO2 reading is displayed, that a pulse rate value appears, and that the pulse strength bargraph LED is active.

Displays, Indicators, and Controls

This section describes the Avant 9600’s displays, indicators, and controls.

Avant 9600 Parameter Displays %SpO2 Display Numeric light-emitting diodes (LEDs) on the upper left-hand corner of the Avant 9600 display blood oxygen saturation in percent.

Pulse Rate Display The pulse rate display is located on the upper right-hand corner of the Avant 9600 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. 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 when reviewing or changing limits, volumes, date, or time.

3-4

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Using the Avant 9600

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 solid.

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 8-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 12% 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 solid, 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 Avant 9600’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.

3-5

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Alarm Volume LED This amber LED indicates that the Alarm Volume can be reviewed or adjusted using the Plus (+) and Minus (-) buttons.

AC Power Adapter LED This green LED is displayed when an external power supply is providing power to the Avant 9600.

Battery LED This amber LED indicates a marginal battery charge when blinking. In addition, this LED-when lit solidly-indicates that the battery charge is being displayed. This LED does not indicate that the Avant 9600 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.

Avant 9600 Keyboard Buttons ON/STANDBY Button Pressing this button once turns on the Avant 9600. Holding this button for at least 1 second shuts down the 9600. The ON/ STANDBY button must be held for five seconds in Patient Security mode. Momentarily pressing this button while the unit is on displays the battery charge in 12% increments for 4 seconds in green.

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 pulse volume, alarm volume, and off.

Alarm Silence Button This button toggles the alarm between silenced and audible. Pressing the Alarm Silence button will silence the alarm for two minutes. In addition, pressing the Alarm Silence button cancels both audible and visual alarms when in Latched Alarms mode.

3-6

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Using the Avant 9600

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 Avant 9600’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 Avant 9600 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 Avant 9600 is not in any setting mode, adjusts the intensity of the LED displays.

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3.5

User Functions

The functions for operating the Avant 9600 can be broken down into three groups: Basic Functions, Set Functions, and Advanced Functions.

Basic Functions Basic functions are generally easy to use and involve only a single button. The Avant 9600 has several basic functions. Function

Button

Instruction Momentarily press the ON/ STANDBY button to turn on the Avant 9600. Press and hold the button for at least one second to turn off the Avant 9600. Hold the ON/STANDBY button for five seconds when the unit is in Patient Security mode.

Turn the Avant 9600 on and off.

Check the battery charge.

Momentarily 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).

Momentarily press the Alarm Silence button.

Cancel latched alarms (when in Latched Alarms mode).

Momentarily press the Alarm Silence button.

Adjust the display intensity (brightness).

Momentarily press the Plus or Minus button. or

NOTE: When DIP switch 6 is in the DOWN position, the display intensity will be automatically reduced when the switch from AC to battery power occurs.

3-8

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Using the Avant 9600

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

3-9

or

Momentarily press the Alarm Limits button to step through the Limits menu. Use the Plus or Minus buttons to adjust alarm limits.

Momentarily press the Volume button to select pulse or alarm volume. Use the Plus or Minus buttons to adjust the selected volume.

Momentarily 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.