Nonin Avant 4000 User manual

Operator’s Manual
Avant
®
4000 Digital
Pulse Oximetry System
with Bluetooth
®
Wireless Technology
 

Avant 4000
®
0123
English

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.
2605 Fernbrook Lane North
Plymouth, Minnesota 55447-4755
USA
[phone]
[phone] (USA and Canada)
Fax [phone]
[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.
© 2004 Nonin Medical, Inc.

Guide to Symbols ......................................................... 1
Precautions for Use ......................................................2
Using the Avant 4000 System .......................................5
Indications for Use ..........................................................5
General Information about Bluetooth Technology ...6
Installing the Battery Pack in the Display Unit ...........7
Installing Batteries in the Patient Module ....................8
Displays, Indicators, and Controls ..............................10
Setting Up the Avant 4000 System .............................14
Verifying System Operation .........................................16
Device Pairing ................................................................17
Default Settings ..............................................................18
Accessing User Functions ............................................19
Display Unit DIP switches ...........................................22
Care and Maintenance ..................................................23
Alarms and Limits ...................................................... 24
Alarms and Informational Tones ................................24
Alarm Summary .............................................................25
Silencing Alarms ............................................................25
Adjusting Volume and Alarm Limits .........................26
Error Codes ....................................................................27
Communication ......................................................... 28
Memory Features ...........................................................28
Playing Back Memory Data ..........................................29
Real-Time Patient Data Output ..................................30
Printing Options ............................................................31
Specifications ............................................................. 32
Parts and Accessories ................................................ 34
Service, Support, and Warranty ................................. 35
Troubleshooting ......................................................... 36

1
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.
Type BF Applied Part
(Patient isolation from electrical shock).
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 C22.2 No. 601.1.
CE Marking indicating conformance to EC
directive No. 93/42/EEC concerning medical
devices.
Serial Number (located under the back cover).
!
C
L
A
S
S
I
F
I
E
D
US
CUL
0123
SN

2
Precautions for Use
Precautions for Use
Contraindications
Warnings
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.
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 manufac-
tured 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 repre-
sents 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 wrist-worn patient module is paired with the correct display unit.
This pulse oximetry system is designed to determine the percentage of arterial oxy-
gen saturation of functional hemoglobin. Significant levels of dysfunctional hemo-
globin, 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.

3
Cautions
This equipment complies with International Standard EN 60601-1-2:2001 for
electromagnetic compatibility for medical electrical equipment and/or systems. This stan-
dard 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 interference due to close proximity or strength of a source
might disrupt the device’s performance.
If this pulse oximetry system fails to respond as described, discontinue use until the situa-
tion 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 appli-
cation 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 recy-
cling 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.

4
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.

5
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
Using the Avant™ 4000 Digital Pulse Oximetry System
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.
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.
™
30'
30'

7
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
Using the Avant™ 4000 Digital Pulse Oximetry System
Installing Batteries in the Patient Module

9
™
1
2
3
4
5
6
78
9
10
11
12 13 14 15
16 17 18
19
20
21 22 23 24
25
26
1 Main Alarm LED
2 Alarm Silence LED
3 Numeric LEDs for %SpO2 data
4 Pulse Oximeter Sensor LED
5 Pulse Strength Bargraph LED
6 Pulse Quality LED
7 Numeric LEDs for Pulse Rate data
8 Alarm Silence Button
9 Alarm Limits Button and Indicator
10 Plus Button
11 Minus Button
12 Time LED
13 Month LED
14 Day LED
15 Year LED
16 Pulse Volume LED
17 Alarm Volume LED
18 Connection Status LED
19 Remote Battery Status LED
20 Bluetooth Control Button
21 Memory Button
22 Time/Date Button
23 Volume Button
24 AC Power Adapter LED
25 Battery LED
26 ON/STANDBY Button

10
Using the Avant™ 4000 Digital Pulse Oximetry System
Displays, Indicators, and Controls
This section describes the Avant 4000 System’s displays, indicators, and controls.
Parameter Displays
%SpO2Display
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 %SpO2and 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
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 SpO2and 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 wrist-
worn 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 SpO2display 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 SpO2display area. See “Device
Pairing” for more information.
™

12
Using the Avant™ 4000 Digital Pulse Oximetry System
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 Yea r 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
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
Using the Avant™ 4000 Digital Pulse Oximetry System
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
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: If desired, any excess strap material may be trimmed and
discarded.

16
Using the Avant™ 4000 Digital Pulse Oximetry System
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.
Use the procedure below to monitor SpO2and pulse rate readings in order to verify
that the device is functioning properly.
1. 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.)
2. Connect a sensor to the patient module, pressing firmly to make sure it is
securely connected.
3. 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.
4. Verify that the Connection Status LEDs on both the display unit and the
patient module are green.
5. Verify that a good SpO2reading is displayed, that a pulse rate value appears,
and that the Pulse Strength Bargraph LED is active.

17
Device Pairing
Use the following procedure to pair the display unit with a desired wrist-worn
patient module.
NOTE: To ensure proper pairing, disconnect and then reconnect the
sensor from the patient module before beginning.
NOTE: The Avant 4000 display unit must be OFF before pairing devices.
1. Press and hold the Bluetooth Control button while turning on the display unit
to begin the device pairing process. Notice that amber dashes flash in the
SpO2and Pulse Rate display areas as the system searches for patient modules
available for pairing. (If a patient module is available, its identification number
will appear on the display unit screen within 10 seconds.)
2. When available patient module(s) are detected, a maximum of five “pairable”
patient modules will be displayed separately, with the device identification
number appearing in the SpO2and Pulse Rate display areas. (A unique device
identification number is included on the sides of each patient module.)
3. If multiple patient modules are available for pairing, use the Plus or Minus
buttons to scroll through the available modules. (While five devices may be
available, only one may be selected for pairing.)
4. 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 to
complete the pairing process. Normal operation resumes automatically when
the pairing process is complete.
5. To confirm that the pairing process was successful, ensure that the
Connection Status LED is lit green.
NOTE: After the display unit is paired to a patient module, it will remain
paired until the above process is repeated.