Avant Model 4100 Operators Manual

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 4000 Digital 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. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA +1 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax +1 (763) 553-7807 [email protected] www.nonin.com

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

References to “NONIN” in this manual shall imply Nonin Medical, Inc. Nonin is a registered trademark of Nonin Medical, Inc. The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Nonin Medical, Inc. is under license. Other trademarks and trade names are those of their respective owners. © 2005 Nonin Medical, Inc.

Guide to Symbols ... 1 Precautions for Use ... 2 Using the Avant® 4000 Pulse Oximetry System ... 6 Indications for Use ...6 General Information about Bluetooth Technology ...7 Installing the Battery Pack in the Display Unit ...8 Installing Batteries in the Patient Module ...9 Displays, Indicators, and Controls ...11 Setting Up the Avant 4000 System ...15 Verifying System Operation ...17 Device Pairing ...18 Default Settings ...19 Accessing User Functions ...20 Display Unit DIP switches ...23 Nurse Call Feature ...24 Care and Maintenance ...25 Alarms and Limits ... 26 Alarms and Informational Tones ...26 Alarm Summary ...27 Silencing Alarms ...27 Adjusting Volume and Alarm Limits ...28 Error Codes ...29 Communication ... 30 Memory Features ...30 Playing Back Memory Data ...31 Real-Time Patient Data Output ...32 Printing Options ...33 Specifications ... 34 Parts and Accessories ... 36 Service, Support, and Warranty ... 37 Troubleshooting ... 38

Guide to Symbols Detailed information for functional symbols can be found in “Using the Avant 4000 Digital Pulse Oximetry System.”

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 60601-1 30EM and CAN/CSA C22.2 No. 601.1. CE Marking indicating conformance to EC directive No. 93/42/EEC concerning medical devices. Serial Number (located under the back cover).

Indicates separate collection for electrical and electronic equipment (WEEE).

Non-ionizing electromagnetic radiation. Equipment includes RF transmitters; interference may occur in the vicinity of equipment marked with this symbol.

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). Use only NONIN-manufactured PureLight™ 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 in or around water or any other liquid when the AC power adapter is used. Use this pulse oximetry system with 300PS-XX AC power adapters, where XX represents the power supply designation. As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation. All parts and accessories connected to the serial port of this system must be certified according to IEC Standard EN 60950 or UL 1950 for data-processing equipment. To avoid the risk of confusing or misinterpreting patient data, verify that the Model 4100 wristworn patient module is paired with the correct display unit. This pulse oximetry system is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin, such as methemoglobin, might affect the accuracy of the measurement. The battery pack must be installed at all times while the device is operating-even when operating on AC power. If it is necessary to operate the device without batteries, audible alarms and memory functions may not be available. DO NOT use the device without batteries when patient safety relies upon audible alarms. Use the Avant 4000 system only within its designated range (approximately 30 feet-spherical radius-from patient module to display). Moving outside this range may cause missing, lost, and/or inaccurate data. Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that no blood flow restrictors (e.g., blood pressure cuff) hinder pulse measurements. This system may be interfered with by other equipment, even if that equipment complies with CISPR emission requirements. This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed carefully to verify normal operation. In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor’s contact information. The use of accessories, sensors, and cables other than those listed in this manual may result in increased emission and/or decreased immunity of this device.

2

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. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in this manual. Portable and mobile RF communications equipment can affect medical electrical equipment. If this pulse oximetry system 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. This system might misinterpret motion as good pulse quality. Minimize finger motion. 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 information for each sensor. Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary due to medical status or skin condition. Do not place liquids on top of this pulse oximetry system. Do not immerse the pulse oximetry system or sensors in any liquids. Do not use caustic or abrasive cleaning agents on the unit or sensors. Do not gas sterilize or autoclave this pulse oximetry system. 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 system is not used within 30 days. When using the 300PS-UNIV battery charger, ensure that the AC cord is plugged into a grounded outlet. Do not fasten the patient module too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could result. Caution: Exposure to Radio Frequency Radiation. The radiated output power of the display unit is far below FCC radio frequency exposure limits. Nevertheless, the device must be used in such a way that the potential for human contact during normal operation is minimized. To avoid the possibility of exceeding FCC radio frequency exposure limits, remain at least 20cm (8 inches) away from the display unit’s internal antenna during normal operation. The wrist-worn patient module has been tested and meets allowed limits for exposure. This device has not been tested for immunity to electromagnetic disturbances. Verify all alarm settings during system startup to ensure that they are set as intended.

3

Precautions for Use

Declaration of Conformity with FCC and Canadian Ministry of Health Rules for Electromagnetic Compatibility •

Nonin Medical, Inc., of 2605 Fernbrook Lane North, Plymouth, Minnesota, 55447, declares under its sole responsibility that the Models 4000 and 4100, to which this declaration relates, comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Ministry of Health (Canada), Safety Code 6: standards include a substantial safety margin designed to ensure the safety of all persons, regardless of age and health. The exposure standard for wireless mobile phones employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6W/kg.

•

Federal Communications Commission (FCC) Notice This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on. The user is encouraged to try to correct the interference by one or more of the following measures: (1) Reorient or relocate the receiving antenna, (2) Increase the distance between the equipment and the receiver, (3) Connect the equipment to an outlet on a circuit different from the outlet where the receiver is connected, or (4) Consult the dealer or an experienced radio/TV technician for assistance. The Model 4100 wrist-worn patient module is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the U.S. Government. These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population. The guidelines are based on the safety standards previously set by both U.S. and international standards bodies. This EUT has been shown to be capable of compliance for localized specific absorption rate (SAR) for uncontrolled environment/ general population exposure limits specified in ANSI/IEEE Std. C95.1-1992 and has been tested in accordance with the measurement procedures specified in FCC/OET Bulletin 65 Supplement C (2001) and IEEE Std. 1528-200X (Draft 6.5, January 2002). RF Exposure: For body worn operation, to maintain compliance with FCC RF exposure guidelines, use only accessories that contain no metallic components and provide a separation distance of 15mm (0.6 inches) to the body. Use of other accessories may violate FCC RF exposure guidelines and should be avoided. The FCC requires the user to be notified that any changes or modifications to this device that are not expressly approved by Nonin Medical, Inc. may void the user’s authority to operate the equipment. NOTE:No modifications to this device are allowed that in any way affect or alter its antenna or antenna configuration.

4

Manufacturer’s Declaration Refer to the following table for specific information regarding this device’s compliance to IEC Standard 60601-1-2. Table 1: Electromagnetic Emissions 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. RF Emissions CISPR 11

Group 2

This device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF Emissions CISPR 11

Class B

Harmonic Emissions IEC 61000-3-2

A

This device is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

N/A

5

Using the Avant™ 4000 Digital Pulse Oximetry System

Using the Avant® 4000 Digital Pulse Oximetry System This chapter describes how to use the Avant® 4000 Digital Pulse Oximetry System. The system includes the following components: • Avant 4000 display unit with rechargeable battery pack • Avant 4100 Wrist-Worn Patient Module with AA batteries • 8000AA-WO finger-clip sensor • Operator’s manual • Universal Desktop Battery Charger with IEC320 Connector • 3 wrist bands

Indications for Use

The NONIN® Avant® 4000 Digital Pulse Oximetry System is indicated for measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients. It is indicated for spot checking and/or continuous monitoring.

™

The Avant 4000 Digital Pulse Oximetry System: Display Unit and Patient Module.

6

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. Bluetooth uses a license-free, globally available frequency range in the ISM band- intended to ensure communication compatibility worldwide. Nonin’s use of Bluetooth Wireless Technology allows SpO2, pulse rate, and plethysmographic data to be transmitted through a Bluetooth radio to a compatible Bluetooth-enabled device. Nonin’s system removes the connection from the sensor cable to the display unit, giving patients increased ability to move freely-without being hindered by cables. Nonin’s patient module uses a class II Bluetooth radio with a battery life of about 120 hours and a range of about 30 feet (spherical radius). The display unit has a minimum operating battery life of 18 hours.

30' ™

30'

Point-to-Point Communications The Avant 4000 System features point-to-point communications, allowing one master device (the display unit) to be paired to one slave device (the patient module). Once connected, neither device is detectable by any other Bluetooth-enabled device, which reduces the risk of interference and preserves data integrity.

7

Using the Avant™ 4000 Digital Pulse Oximetry System

Installing the Battery Pack in the Display Unit WARNING: The battery pack must be installed at all times while the device is operating-even when operating on AC power. If it is necessary to operate the device without batteries, audible alarms and memory functions may not be available. DO NOT use the device without batteries when patient safety relies upon audible alarms.

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.

8

Installing Batteries in the Patient Module

9

Using the Avant™ 4000 Digital Pulse Oximetry System

1 2 4 3

8

7 5

12

14

13

9

15

10

6 19

11 25 16

17

18

21

22

23

™

24

26

20

1 2 3 4 5 6 7 8 9 10 11 12 13

10

Main Alarm LED Alarm Silence LED Numeric LEDs for %SpO2 data Pulse Oximeter Sensor LED Pulse Strength Bargraph LED Pulse Quality LED Numeric LEDs for Pulse Rate data Alarm Silence Button Alarm Limits Button and Indicator Plus Button Minus Button Time LED Month LED

14 15 16 17 18 19 20 21 22 23 24 25 26

Day LED Year LED Pulse Volume LED Alarm Volume LED Connection Status LED Remote Battery Status LED Bluetooth Control Button Memory Button Time/Date Button Volume Button AC Power Adapter LED Battery LED ON/STANDBY Button

Displays, Indicators, and Controls

This section describes the Avant 4000 System’s displays, indicators, and controls.

Parameter Displays %SpO2 Display Numeric light-emitting diodes (LEDs) on the upper left-hand corner of the Avant 4000 display unit display blood oxygen saturation in percent.

Pulse Rate Display The pulse rate display is located on the upper right-hand corner of the Avant 4000 display unit 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. They also display device identification numbers and error codes. 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 for medium priority alarms and when reviewing or changing limits, volumes, date, or time.

Front Panel Buttons ON/STANDBY Button Pressing this button once turns on the Avant 4000 display unit. Holding this button for at least 1 second shuts down the display unit. Briefly pressing this button while the unit is on displays the battery charge in 10% increments for 4 seconds in green. This button also controls the device’s event marker and print-on-demand features. See this manual’s “Communication” section for more information.

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 alarm volume and pulse volume.

11

Using the Avant™ 4000 Digital 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. The Alarm Limits button cycles users through the display unit’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 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 display unit is not in any setting mode, adjusts the intensity of the LED displays. These buttons are also used to select from multiple wristworn patient modules during pairing.

Memory Button This button is used to enter Memory Playback mode.

Bluetooth Control Button ™

Press and hold this button while turning on the display unit to begin the device pairing process. A maximum of five “pairable” patient modules may be displayed separately, with the device identification number appearing in the pulse rate and SpO2 display area. While five devices may be shown, only one may be selected (paired). Select the patient module you want to pair with by using the Plus or Minus buttons to scroll through the available modules. When the identification number of the patient module you wish to pair with is shown-and is not flashing-press the Bluetooth Control button again. When the pairing process is complete, normal operation resumes automatically. After the device is paired to a patient module, it will remain paired until the above process is repeated. During normal operation, pressing the Bluetooth Control button displays the selected patient module’s device identification number for three seconds in the pulse rate and SpO2 display area. See “Device Pairing” for more information.

12

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.

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 10-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 10% 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 steadily, 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 display unit’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.

13

Using the Avant™ 4000 Digital 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 patient module is connected with the display unit. It is lit amber when no devices are connected, and it blinks during device pairing. The Connection Status LED works in sync with the patient module’s connection status indicator.

Remote Battery Status LED This amber LED alerts users to marginal or critical battery conditions for the wrist-worn patient module. When the patient module’s batteries are marginal, this LED blinks. When battery capacity is critical, it remains lit steadily.

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

Battery LED This amber LED indicates a marginal battery charge when blinking. In addition, this LED-when lit steadily-indicates that the battery charge is being displayed. This LED does not indicate that the display unit 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. WARNING: The battery pack must be installed at all times while the device is operating-even when operating on AC power. If it is necessary to operate the device without batteries, audible alarms and memory functions may not be available. DO NOT use the device without batteries when patient safety relies upon audible alarms.

14

Setting Up the Avant 4000 Digital Pulse Oximetry System

Use the following procedure to set up the Avant 4000 Digital Pulse Oximetry System. (Refer to the Avant 4100 Patient Module instruction insert for additional information about using that product.) 1.

Ensure that batteries are installed in the display unit and wrist-worn patient module.

WARNING: The battery pack must be installed at all times while the device is operating-even when operating on AC power. If it is necessary to operate the device without batteries, audible alarms and memory functions may not be available. DO NOT use the device without batteries when patient safety relies upon audible alarms. 2.

Plug in and connect the AC adapter for the display unit.

3.

Attach a sensor to the patient module. (The patient module is automatically activated when a sensor is connected.)

15

Using the Avant™ 4000 Digital Pulse Oximetry System

4.

Press the ON/STANDBY button to turn on the display unit.

5.

Verify operation of the display unit, and pair the display unit with the desired wrist-worn patient module. (See “Verifying System Operation” and “Device Pairing” for more information.

6.

Secure the wristband to the patient’s wrist.

NOTE:

16

If desired, any excess strap material may be trimmed and discarded.

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. After this initialization sequence, the amber Connection Status LED and amber dashes are displayed, turning green when communication is established and a Bluetooth connection is made (devices must be paired before a Bluetooth connection can be established; see “Device Pairing” on the next page). The Main Alarm LED and Pulse Oximeter LED blink amber until the oximeter produces valid readings. CAUTION: Verify all alarm settings during system startup to ensure that they are set as intended. Use the procedure below to monitor SpO2 and pulse rate readings in order to verify that the device is functioning properly. 1. 2. 3. 4. 5.

Ensure that the display unit is turned on, and that the unit has been paired with the desired wrist-worn patient module. (See “Device Pairing” for more information.) Connect a sensor to the patient module, pressing firmly to make sure it is securely connected. Apply the patient module around the wrist, and attach the sensor to the patient’s finger. Connecting the sensor automatically activates the patient module; there are no buttons to press. Verify that the Connection Status LEDs on both the display unit and the patient module are green. Verify that a good SpO2 reading is displayed, that a pulse rate value appears, and that the Pulse Strength Bargraph LED is active.

17